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Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA or we) is amending our regulation for Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food in two fundamental ways. First, we are modernizing the long-standing current good manufacturing practice requirements. Second, we are adding requirements for domestic and foreign facilities that are subject to our regulation for Registration of Food Facilities to establish and implement hazard analysis and risk-based preventive controls for human food. We also are revising certain definitions in our regulation for Registration of Food Facilities to clarify the scope of the exemption from registration requirements provided for “farms” and, in so doing, to clarify which domestic and foreign facilities are subject to the requirements for hazard analysis and risk-based preventive controls for human food. We are taking this action as part of our announced initiative to revisit the current good manufacturing practice requirements since they were last revised in 1986 and to implement new statutory provisions in the FDA Food Safety Modernization Act. The rule is intended to build a food safety system for the future that makes modern, science- and risk-based preventive controls the norm across all sectors of the food system.

DATES:

This rule is effective November 16, 2015, except for the amendment to part 110 in instruction 13, which is effective September 17, 2018 and paragraph (2) of the definition of “qualified auditor” in § 117.3, and §§ 117.5(k)(2), 117.8, 117.405(a)(2), 117.405(c), 117.410(d)(2)(ii), 117.430(d), 117.435(d), 117.475(c)(2) and 117.475(c)(13). FDA will publish a document in the Federal Register announcing the effective dates of paragraph (2) of the definition of “qualified auditor” in § 117.3, and §§ 117.5(k)(2), 117.8, 117.405(a)(2), 117.405(c), 117.410(d)(2)(ii), 117.430(d), 117.435(d), 117.475(c)(2), and 117.475(c)(13). See section LVI for the compliance dates.

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FOR FURTHER INFORMATION CONTACT:

Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2166.

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SUPPLEMENTARY INFORMATION:

Table of Contents

Executive Summary

Purpose and Coverage of the Rule

Summary of the Major Provisions of the Rule

Costs and Benefits

I. Background

A. FDA Food Safety Modernization Act

B. Stages in the Rulemaking for the Human Preventive Controls Rule

C. Summary of the Major Provisions of Proposed Human Preventive Controls Rule

D. Draft Risk Assessment

E. Definition of “Retail Food Establishment”

F. Public Comments

II. Legal Authority

A. Changes to Current 21 CFR Part 1, Subparts H, I, and J

B. Changes to Current 21 CFR Part 110

C. Hazard Analysis and Risk-Based Preventive Controls

D. Comments on Legal Authority

III. General Comments on the Proposed Rule

IV. Comments on Proposed Revisions to the Definitions in the Section 415 Registration Regulations (21 CFR Part 1, Subpart H) and the Section 414 Recordkeeping Regulations (21 CFR Part 1, Subpart J)

A. Definitions That Impact a Determination of Whether an Establishment Is a “Farm”

B. Proposed Revisions to the Definition of Farm

C. Proposed New Definition of Harvesting

D. Proposed Revision to the Definition of Holding

E. Proposed Revision to the Definition of Manufacturing/Processing

F. Proposed New Definition of Mixed-Type Facility

G. Proposed Revision to the Definition of Packing

V. Comments on the Organizing Principles for How the Status of a Food as a Raw Agricultural Commodity or as a Processed Food Affects the Requirements Applicable to a Farm Under Sections 415 and 418 of the FD&C Act

VI. Rulemaking Required by Section 103(c) of FSMA: On-Farm Activities

A. Section 103(c)(1)(C) of FSMA

B. Comments on Qualitative Risk Assessment of On-Farm Activities Outside of the Farm Definition

C. Comments Regarding an Exemption for Small and Very Small Farm Mixed-Type Facilities Under Section 421 of the FD&C Act

VII. Comments on Proposed General Revisions to Current Part 110 (Final Part 117)

A. Title of Part 117

B. Proposed Revisions for Consistency of Terms

C. Proposed Additions Regarding Allergen Cross-Contact

D. Proposed Revisions for Consistency With the Definition of “Food”

E. Proposed Revisions To Address Guidance in Current Part 110

F. Proposed Editorial Changes

G. General Comments on Current Part 110 (Final Part 117)

VIII. Subpart A: Comments on Proposed § 117.1—Applicability and Status

A. Comments on Proposed § 117.1(a)—Applicability

B. Comments on Proposed § 117.1(b)—Prohibited Act

C. Comments on Proposed § 117.1(c)—Specific CGMP Requirements

IX. Subpart A: Comments on Proposed § 117.3—Definitions

A. Redesignation

B. Definitions in Current Part 110 That We Proposed To Delete

C. Definitions That We Proposed To Establish in Part 117

D. Comments Asking FDA To Establish Additional Definitions or Otherwise Clarify Terms Not Defined in the Rule

E. Additional Definitions To Clarify Terms Not Defined in the Proposed Rule

X. Subpart A: Comments on Qualifications of Individuals Who Manufacture, Process, Pack, or Hold Food

A. Applicability and Qualifications of All Individuals Engaged in Manufacturing, Processing, Packing, or Holding Food (Final § 117.4(a), (b), and (d))

B. Additional Requirements Applicable to Supervisory Personnel (Final § 117.4(c))

XI. Subpart A: Comments on Proposed § 117.5—Exemptions

A. General Comments on the Proposed Exemptions

B. Proposed § 117.5(a)—Exemption Applicable to a Qualified Facility

C. Proposed § 117.5(b) and (c)—Exemptions Applicable to Food Subject to HACCP Requirements for Fish and Fishery Products (21 CFR Part 123) or for Juice (21 CFR Part 120)

D. Proposed § 117.5(d)—Exemption Applicable to Food Subject to Part 113—Thermally Processed Low-Acid Foods Packaged In Hermetically Sealed Containers

E. Proposed § 117.5(e)—Exemption Applicable to a Facility That Manufactures, Processes, Packages, or Holds a Dietary Supplement

F. Proposed § 117.5(f)—Exemption Applicable to Activities Subject to Standards for Produce Safety in Section 419 of the FD&C Act

G. Proposed §§ 117.5(g) and (h)—Exemptions Applicable to On-Farm Low-Risk Activity/Food Combinations Conducted by a Small or Very Small Business

H. Proposed § 117.5(i)—Exemption Related to Alcoholic Beverages

I. Proposed § 117.5(j)—Exemption Applicable to Facilities Solely Engaged in Storage of Raw Agricultural Commodities Other Than Fruits and Start Printed Page 55909Vegetables Intended for Further Distribution or Processing

J. Proposed § 117.5(k)—Exemption Applicable to Farms, Fishing Vessels, Activities of “Farm Mixed-Type Facilities” Within the Definition of “Farm,” the Holding or Transportation of One or More Raw Agricultural Commodities, and Specified Activities Conducted on Specified Raw Agricultural Commodities

K. Comments Requesting Additional Exemptions

XII. Subpart A: Comments on Proposed § 117.7—Applicability of Part 117 to a Facility Solely Engaged in the Storage of Unexposed Packaged Food

XIII. Subpart B: Comments on Proposed § 117.10—Personnel

A. Management Responsibility for Requirements Applicable to Personnel

B. Proposed § 117.10(a)—Disease Control

C. Proposed § 117.10(b)—Cleanliness

XIV. Subpart B: Comments on Proposed § 117.20—Plant and Grounds

A. Proposed § 117.20(a)—Grounds

B. Proposed § 117.20(b)—Plant Construction and Design

XV. Subpart B: Comments on Proposed § 117.35—Sanitary Operations

A. Proposed § 117.35(a)—General Maintenance

B. Proposed § 117.35(b)—Substances Used in Cleaning and Sanitizing; Storage of Toxic Materials

C. Proposed § 117.35(c)—Pest Control

D. Proposed § 117.35(d)—Sanitation of Food-Contact Surfaces

E. Proposed § 117.35(d)(1)—Food-Contact Surfaces Used for Manufacturing/Processing or Holding

F. Proposed § 117.35(d)(2)—Wet Cleaning

G. Proposed § 117.35(d)(3)—Single-Service Articles

H. Proposed § 117.35(e)—Sanitation of Non-Food-Contact Surfaces

I. Proposed § 117.35(f)—Storage and Handling of Cleaned Portable Equipment and Utensils

XVI. Subpart B: Comments on Proposed § 117.37—Sanitary Facilities and Controls

A. Proposed § 117.37(a)—Water Supply

B. Proposed § 117.37(b)—Plumbing

C. Proposed § 117.37(c)—Sewage Disposal

D. Proposed § 117.37(d)—Toilet Facilities

E. Proposed § 117.37(e)—Hand-Washing Facilities

XVII. Subpart B: Comments on Proposed § 117.40—Equipment and Utensils

A. Proposed § 117.40(a)—Design, Construction, Use, Installation, and Maintenance of Equipment and Utensils

B. Proposed § 117.40(b)—Seams on Food-Contact Surfaces

C. Proposed § 117.40(c)—Construction of Equipment

D. Proposed § 117.40(d)—Holding, Conveying, and Manufacturing Systems

E. Proposed § 117.40(e)—Freezer and Cold Storage Compartments

F. Proposed § 117.40(f)—Accurate and Precise Instruments and Controls

G. Proposed § 117.40(g)—Compressed Air or Other Gases

XVIII. Subpart B: Comments on Proposed § 117.80(a)—General Processes and Controls

A. Proposed § 117.80(a)(1)—Adequate Sanitation Principles

B. Proposed § 117.80(a)(2)—Quality Control Operations

C. Proposed § 117.80(a)(3)—Supervision of Overall Sanitation

D. Proposed § 117.80(a)(4)—Production Procedures

E. Proposed § 117.80(a)(5)—Chemical, Microbial, or Extraneous-Material Testing Procedures

F. Proposed § 117.80(a)(6)—Contaminated Food

XIX. Subpart B: Comments on Proposed § 117.80(b)—Processes and Controls for Raw Materials and Other Ingredients

A. Proposed § 117.80(b)(1)—Inspection, Segregation and Handling of Raw Materials and Other Ingredients

B. Proposed § 117.80(b)(2)—Levels of Microorganisms in Raw Materials and Other Ingredients

C. Proposed § 117.80(b)(3)—Natural Toxins in Raw Materials and Other Ingredients

D. Proposed § 117.80(b)(4)—Pests, Undesirable Microorganisms and Extraneous Materials in Raw Materials and Other Ingredients

E. Proposed § 117.80(b)(5)—Holding Raw Materials, Other Ingredients, and Rework in Bulk

F. Proposed § 117.80(b)(7)—Liquid or Dry Raw Materials and Other Ingredients

G. Proposed § 117.80(b)(8)—Raw Materials and Other Ingredients That Are Food Allergens

XX. Subpart B: Comments on Proposed § 117.80(c)—Manufacturing Operations

A. Proposed § 117.80(c)(1)—Condition of Equipment, Utensils, and Finished Food Containers

B. Proposed § 117.80(c)(2)—Conditions and Controls for Food Manufacturing, Processing, Packing, and Holding

C. Proposed § 117.80(c)(3)—Food That Can Support the Rapid Growth of Undesirable Microorganisms

D. Proposed § 117.80(c)(4)—Measures To Destroy or Prevent the Growth of Undesirable Microorganisms

E. Proposed § 117.80(c)(5)—Work-in-Process and Rework

F. Proposed § 117.80(c)(6)—Finished Food

G. Proposed § 117.80(c)(7)—Equipment, Containers, and Utensils

H. Proposed § 117.80(c)(8)—Metal or Other Extraneous Material

I. Proposed § 117.80(c)(9)—Disposal of Adulterated Food, Raw Materials, and Other Ingredients

J. Proposed § 117.80(c)(10)—Performing Manufacturing Steps

K. Proposed § 117.80(c)(11)—Heat Blanching and Growth and Contamination by Thermophilic Microorganisms During Manufacturing Operations

L. Proposed § 117.80(c)(12)—Batters, Breading, Sauces, Gravies, Dressings, and Other Similar Preparations

M. Proposed § 117.80(c)(13)—Filling, Assembling, Packaging and Other Operations

N. Proposed § 117.80(c)(14)—Food That Relies on the Control of Water Activity for Preventing the Growth of Undesirable Microorganisms

O. Proposed § 117.80(c)(15)—Food That Relies on the Control of pH for Preventing the Growth of Undesirable Microorganisms

P. Proposed § 117.80(c)(16)—Requirements for Ice Used in Contact With Food

Q. Proposed Deletion of Current § 110.80(b)(17)—Food-Manufacturing Areas and Equipment

XXI. Subpart B: Comments on Proposed § 117.93—Warehousing and Distribution

XXII. Subpart B: Comments on Proposed § 117.110—Natural or Unavoidable Defects in Food for Human Use That Present No Health Hazard

XXIII. Subpart C: Comments on Overall Framework for Hazard Analysis and Risk-Based Preventive Controls

XXIV. Subpart C: Comments on Proposed § 117.126—Food Safety Plan

A. Proposed § 117.126(a)(1)—Requirement for a Food Safety Plan

B. Proposed § 117.126(a)(2)—Preparation of the Food Safety Plan by a Preventive Controls Qualified Individual

C. Proposed § 117.126(b)—Contents of a Food Safety Plan

D. Proposed § 117.126(c)—Records

E. Comments on Potential Requirements for Submission of a Facility Profile to FDA

XXV. Subpart C: Comments on Proposed § 117.130—Hazard Analysis

A. Proposed § 117.130(a)—Requirement for a Written Hazard Analysis

B. Proposed § 117.130(b)—Hazard Identification

C. Proposed § 117.130(c)—Evaluation of Whether a Hazard Requires a Preventive Control

XXVI. Subpart C: Comments on Proposed § 117.135—Preventive Controls

A. Proposed § 117.135(a)—Requirement To Identify and Implement Preventive Controls

B. Proposed § 117.135(b)—Requirement for Written Preventive Controls

C. Proposed § 117.135(c)(1)—Process Controls

D. Proposed § 117.135(c)(2)—Food Allergen Controls

E. Proposed § 117.135(c)(3)—Sanitation Controls

F. Proposed § 117.135(c)(4)—Supply-Chain Controls

G. Proposed § 117.135(c)(5)—Recall Plan

H. Proposed § 117.135(c)(6)—Other Controls

XXVII. Subpart C: Circumstances in Which the Owner, Operator, or Agent in Charge of a Manufacturing/Processing Facility Is Not Required To Implement a Preventive Control (Final §§ 117.136 and 117.137)

XXVIII. Subpart C: Comments on Proposed Requirements for a Recall Plan (Final § 117.139)

A. Proposed § 117.137(a)—Requirement for a Written Recall Plan (Final § 117.139(a))

B. Proposed § 117.137(b)—Procedures That Describe the Steps To Be Taken, and Assign Responsibility for Taking Those Steps (Final § 117.139(b))Start Printed Page 55910

XXIX. Comments on Proposed § 117.140—Preventive Control Management Components

A. Proposed § 117.140(a)—Flexible Requirements for Monitoring, Corrective Actions and Corrections, and Verification

B. Proposed § 117.140(b)—Applicability of Preventive Control Management Components to the Supply-Chain Program

C. Proposed § 117.140(c)—Recall Plan is Not Subject to Preventive Control Management Components

XXX. Subpart C: Comments on Proposed § 117.145—Monitoring

A. Our Tentative Conclusion To Require Monitoring of the Performance of Preventive Controls

B. Proposed § 117.145(a)—Flexibility in Requirements for Monitoring

C. Proposed § 117.145(b)—Records

XXXI. Subpart C: Comments on Proposed § 117.150—Corrective Actions and Corrections

A. Proposed § 117.150(a)(1)—Requirement To Establish and Implement Corrective Action Procedures

B. Proposed § 117.150(a)(2)—Content of Corrective Action Procedures

C. Proposed § 117.150(b)—Corrective Action in the Event of an Unanticipated Problem

D. Proposed § 117.150(c)—Corrections

E. Proposed § 117.150(d)—Records

XXXII. Subpart C: Comments on Proposed § 117.155—Verification

A. Flexibility in Requirements for Verification

B. Proposed § 117.155(a)—Verification Activities

C. Proposed § 117.155(b)—Documentation of Verification Activities

D. Comments on Potential Requirements Regarding Complaints

XXXIII. Subpart C: Comments on Proposed § 117.160—Validation

A. Flexibility in the Requirements To Validate Preventive Controls

B. Proposed § 117.160(b)(1)—When Validation Must Be Performed and Role of the Preventive Controls Qualified Individual in Validation

C. Proposed § 117.160(b)(2)—What Validation Must Include

D. Proposed § 117.160(b)(3)—Preventive Controls for Which Validation Is Not Required

XXXIV. Subpart C: Comments on Proposed § 117.165—Verification of Implementation and Effectiveness

A. Flexibility in the Requirements To Conduct Activities To Verify Implementation and Effectiveness

B. Proposed § 117.165(a)(1)—Calibration

C. Comments Directed to Proposed Requirements for Both Product Testing (Proposed § 117.165(a)(2) and (b)(2)) and Environmental Monitoring (Proposed § 117.165(a)(3) and (b)(3))

D. Proposed § 117.165(a)(2)—Product Testing

E. Proposed § 117.165(a)(3)—Environmental Monitoring

F. Proposed § 117.165(a)(4)—Review of Records

G. Proposed § 117.165(b)—Written Procedures

XXXV. Subpart C: Comments on Proposed § 117.170—Reanalysis

A. Proposed § 117.170(a)—Circumstances Requiring Reanalysis

B. Proposed § 117.170(b)—Timeframe To Complete Reanalysis

C. Proposed § 117.170(c)—Requirement To Revise the Written Food Safety Plan or Document Why Revisions Are Not Needed

D. Proposed § 117.170(d)—Requirement for Oversight of Reanalysis by a Preventive Controls Qualified Individual

E. Proposed § 117.170(e)—Reanalysis on the Initiative of FDA

XXXVI. Subpart C: Comments on Proposed § 117.180—Requirements Applicable to a Preventive Controls Qualified Individual and a Qualified Auditor

A. Proposed § 117.180(a) and (b)—What a Preventive Controls Qualified Individual or Qualified Auditor Must Do or Oversee

B. Proposed § 117.180(c)—Qualification Requirements

C. Proposed § 117.180(d)—Records

XXXVII. Subpart C: Comments on Proposed § 117.190—Implementation Records

A. Proposed § 117.190(a)—List of Required Records

B. Proposed § 117.190(b)—Applicability of Subpart F

XXXVIII. Subpart D: Comments on Proposed § 117.201—Modified Requirements That Apply to a Qualified Facility

A. Comments on Submission of a Certification Statement

B. General Comments on Modified Requirements That Apply to a Qualified Facility

C. Proposed § 117.201(a)—Documentation To Be Submitted

D. Proposed § 117.201(b)—Procedure for Submission

E. Proposed § 117.201(c)—Frequency of Determination and Submission

F. Proposed § 117.201(d)—Notification to Consumers (Final § 117.201(e))

G. Proposed § 117.201(e)—Records (Final § 117.201(f))

XXXIX. Subpart D: Comments on Proposed § 117.206—Modified Requirements That Apply to a Facility Solely Engaged in the Storage of Unexposed Packaged Food

A. Proposed § 117.206(a)—Modified Requirements for Unexposed Refrigerated Packaged Food That Requires Time/Temperature Controls

B. Proposed § 117.206(b)—Records

XL. Subpart E: Comments on Proposed New Provisions for Withdrawal of a Qualified Facility Exemption

A. Proposed § 117.251—Circumstances That May Lead FDA To Withdraw a Qualified Facility Exemption

B. Proposed § 117.254—Issuance of an Order To Withdraw a Qualified Facility Exemption

C. Proposed § 117.257—Contents of an Order To Withdraw a Qualified Facility Exemption

D. Proposed § 117.260—Compliance With, or Appeal of, an Order To Withdraw a Qualified Facility Exemption

E. Proposed § 117.264—Procedure for Submitting an Appeal

F. Proposed § 117.267—Procedure for Requesting an Informal Hearing

G. Proposed § 117.270—Requirements Applicable to an Informal Hearing

H. Proposed § 117.287—Reinstatement of a Qualified Facility Exemption That Was Withdrawn

I. Conforming Amendment to 21 CFR part 16

J. Other Comments on the Withdrawal Provisions

XLI. Subpart F: Comments on Proposed New Recordkeeping Requirements

A. Proposed § 117.301—Records Subject to the Requirements of Subpart F

B. Proposed § 117.305—General Requirements Applying to Records

C. Proposed § 117.310—Additional Requirements Applying to the Food Safety Plan

D. Proposed § 117.315—Requirements for Record Retention

E. Proposed § 117.320—Requirements for Official Review

F. Proposed § 117.325—Public Disclosure

G. Proposed § 117.330—Use of Existing Records

H. Final § 117.335—Special Requirements Applicable to a Written Assurance

I. Other Comments on the Recordkeeping Requirements of Subpart F

XLII. Subpart G: General Comments on Proposed Requirements for a Supply-Chain Program

XLIII. Subpart G: Comments on Requirement To Establish and Implement a Supply-Chain Program

A. Requirement for a Written Supply-Chain Program (Final § 117.405(a)(1) and (b))

B. Circumstances That Do Not Require a Written Supply-Chain Program (Final § 117.405(a)(2))

C. Exemption for Food Supplied for Research or Evaluation (Final § 117.405(a)(3))

D. Additional Requirements for Non-Suppliers (Final § 117.405(c))

E. Proposed General Requirements for the Supply-Chain Program That We Are Not Including in the Final Rule (Proposed § 117.136(a)(4) and (5))

XLIV. Subpart G: Comments on General Requirements Applicable to a Supply-Chain Program

A. Description of What the Supply-Chain Program Must Include (Final § 117.410(a))

B. Appropriate Supplier Verification Activities ((Final § 117.410(b))

C. Purpose of Supplier Verification Activities for Raw Materials and Other Ingredients (Final § 117.410(c))

D. Factors That Must Be Considered When Approving Suppliers and Determining Appropriate Supplier Verification Activities for Raw Materials and Other Ingredients (Final § 117.410(d))

E. Supplier Non-Conformance (Final § 117.410(e))

XLV. Subpart G: New Requirement Specifying Responsibilities of the Receiving Facility (Final § 117.415)

XLVI. Subpart G: Comments on Using Approved Suppliers and Determining Appropriate Supplier Verification ActivitiesStart Printed Page 55911

A. Using Approved Suppliers (Final § 117.420)

B. Determining Appropriate Verification Activities (Final § 117.425)

XLVII. Subpart G: Comments on Conducting Supplier Verification Activities for Raw Materials and Other Ingredients

A. Requirement to Conduct One or More Supplier Verification Activities (Final § 117.430(a))

B. Requirement for an Onsite Audit as a Verification Activity When a Hazard Has a Reasonable Probability of Resulting in Serious Adverse Health Consequences or Death to Humans (Final § 117.430(b))

C. Alternative Verification Activity When the Supplier Is a Qualified Facility (Final § 117.430(c))

D. Alternative Verification Activity When the Supplier Is a Produce Farm That Is Not a “Covered Farm” for the Purposes of the Future Produce Safety Rule (Final § 117.430(d))

E. Alternative Verification Activity When the Supplier Is a Shell Egg Producer That Has Less Than 3,000 Laying Hens (Final § 117.430(e))

F. Independence of Persons Who Conduct Supplier Verification Activities (Final § 117.430(f))

XLVIII. Subpart G: Comments on Onsite Audit

A. Requirements Applicable to an Onsite Audit (Final § 117.435(a) and (b))

B. Substitution of Inspection by FDA or an Officially Recognized or Equivalent Food Safety Authority

C. Onsite Audit by a Third-Party Auditor Accredited for the Purposes of Section 808 of the FD&C Act

XLIX. Subpart G: Comments on Records Documenting the Supply-Chain Program

A. Applicability of the Recordkeeping Requirements of Subpart F (Final § 117.475(a))

B. Requirement To Review Records of the Supply-Chain Program (Final § 117.475(b))

C. Documentation Demonstrating Use of the Written Procedures for Receiving Raw Materials and Other Ingredients (Final § 117.475(c)(5))

D. Documentation of the Conduct of an Onsite Audit (Final § 117.475(c)(7))

E. Documentation of Sampling and Testing (Final § 117.475(c)(8))

F. Documentation of Other Appropriate Supplier Verification Activity (Final § 117.475(c)(10))

G. Documentation of an Alternative Verification Activity for a Supplier That Is a Farm That Is Not a “Covered Farm” for the Purposes of the Future Produce Safety Rule (Final § 117.475(c)(13))

L. Holding Human Food By-Products Intended for Use in Animal Food

LI. Comments by Foreign Governments and Foreign Businesses

LII. Editorial and Conforming Changes

LIII. Comments on FSMA's Rulemaking Provisions

A. Comments on Requirements in Section 418(n)(3) of the FD&C Act Regarding Content

B. Comments on Requirements in Section 418(n)(5) of the FD&C Act Regarding Review of Hazard Analysis and Preventive Controls Programs in Existence on the Date of Enactment of FSMA

LIV. Comments on Proposed Removal of 21 CFR part 110—Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food

LV. Comments on Proposed Conforming Amendments

LVI. Effective and Compliance Dates

A. Effective and Compliance Dates for Part 117

B. Effective and Compliance Dates for Revisions to Part 1

C. Effective Dates for Conforming Amendments

D. Delayed Effective Dates for Provisions That Refer to the Forthcoming Rules for Produce Safety and Third-Party Certification

LVII. Compliance and Enforcement

LVIII. Executive Order 13175

LIX. Economic Analysis of Impacts

LX. Analysis of Environmental Impact

LXI. Paperwork Reduction Act of 1995

LXII. Federalism

LXIII. References

Executive Summary

Purpose and Coverage of the Rule

This rule is part of FDA's implementation of the FDA Food Safety Modernization Act (FSMA), which intends to better protect public health by, among other things, adopting a modern, preventive, and risk-based approach to food safety regulation. This rule creates certain new requirements for the production of human food by registered food facilities, and revises previous requirements, in three key ways.

First, this rule creates new requirements for certain domestic and foreign facilities to establish and implement hazard analysis and risk-based preventive controls for human food. In general, these requirements apply to establishments that are required to register with FDA as a food “facility.” This portion of the rule requires registered food facilities to maintain a food safety plan, perform a hazard analysis, and institute preventive controls for the mitigation of those hazards, unless an exemption applies. Facilities must also monitor their controls, conduct verification activities to ensure the controls are effective, take appropriate corrective actions, and maintain records documenting these actions.

Second, this rule modernizes FDA's long-standing current good manufacturing practice (CGMP) regulations regarding the manufacturing, processing, packing, or holding of human food. We have updated, revised, and otherwise clarified certain requirements within the CGMP regulations, which were last updated in 1986.

Third, this rule clarifies the scope of the exemption for “farms” in FDA's current food facility registration regulations and makes corresponding revisions to FDA's current regulations for the establishment, maintenance, and availability of records. These revisions affect who is subject to the existing regulations for registration and recordkeeping, as well as the new requirements for hazard analysis and risk-based preventive controls requirements established here.

This final rule is the result of significant stakeholder engagement, beginning before the proposed rule. In response to extensive stakeholder input on the proposed rule, we revised key provisions in a supplemental notice of proposed rulemaking. After the supplemental notice of proposed rulemaking, we conducted even more outreach to the stakeholder community to ensure that the risk-based, preventive requirements in this final rule are practical and protective of public health.

Summary of the Major Provisions of the Rule

The final rule implements the requirements of FSMA for covered facilities to establish and implement a food safety system that includes a hazard analysis and risk-based preventive controls. Specifically, the rule establishes requirements for:

  • A written food safety plan;
  • Hazard analysis;
  • Preventive controls;
  • Monitoring;
  • Corrective actions and corrections;
  • Verification;
  • Supply-chain program;
  • Recall plan; and
  • Associated records.

We have added flexibility and clarity to these provisions in response to comments. Although there are similarities between these requirements of FSMA and the requirements of food safety systems known as Hazard Analysis and Critical Control Point (HACCP) systems, not every provision in FSMA is identical to the provisions of HACCP systems, and we have revised much of our terminology to distinguish FSMA's requirements for hazard analysis and risk-based preventive controls from HACCP requirements. A facility subject to the rule must conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at the facility to determine whether Start Printed Page 55912there are any hazards requiring preventive controls. The first step of a hazard analysis is hazard identification, which must consider known or reasonably foreseeable hazards, including biological, chemical, and physical hazards. The hazard analysis must consider hazards that may be present in the food because they occur naturally, are unintentionally introduced, or are intentionally introduced for purposes of economic gain. We continue to believe that hazards that may be intentionally introduced for economic gain will need preventive controls in rare circumstances, usually in cases where there has been a pattern of economically motivated adulteration in the past. Economically motivated adulteration that affects product integrity or quality, for example, but not food safety, is out of the scope of this rule.

A facility subject to the rule must identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by the facility will not be adulterated. The rule establishes preventive control management components (monitoring, corrective actions and corrections, and verification) as appropriate to ensure the effectiveness of the preventive controls. One way we have clarified the risk-based flexibility of these requirements is by clearly stating in the final rule that a facility must take into account the nature of the preventive control and the facility's food safety system when considering which activities are appropriate for that facility.

We have also added flexibility and made risk-based modifications for specific preventive control management components. For example, the final rule allows flexibility for the specific records required to document monitoring of refrigeration controls during storage of a food that requires time/temperature control for safety. These records can be either affirmative records demonstrating temperature is controlled or “exception records” demonstrating loss of temperature control. As another example, the rule includes tailored, less burdensome requirements for corrections. A correction is defined in this rule as an action to identify and correct a problem that occurred during the production of food, without other actions associated with a corrective action procedure (such as actions to reduce the likelihood that the problem will recur, evaluate all affected food for safety, and prevent affected food from entering commerce). The final rule clarifies that corrections must be taken in a timely manner and must be recorded when appropriate, but they do not, for example, need to be included in a written plan or accompanied by a reanalysis of the written food safety plan.

As a third example, the final rule provides flexibility for which verification activities must occur. In general, a facility is required to conduct verification activities, as appropriate to the nature of the preventive control and its role in the facility's food safety system, including validation, verification of monitoring, verification of corrective actions, verification of implementation and effectiveness, and reanalysis. Validation is not required for all controls. For example, the rule specifies that validation is not required for certain types of preventive controls (i.e., food allergen controls, sanitation controls, supply-chain controls, and the recall plan) and provides flexibility for the facility to not validate other preventive controls with a written justification based on factors such as the nature of the hazard, and the nature of the preventive control and its role in the facility's food safety system. Product testing and environmental monitoring are listed as possible verification activities, but, like other preventive control management components in general, they are only required as appropriate to the food, facility, the nature of the preventive control, and the preventive control's role in the facility's food safety system. In many cases, neither product testing nor environmental monitoring will be appropriate. For example, there would be little or no benefit to product testing or environmental monitoring in facilities that pack or hold produce raw agricultural commodities that are rarely consumed raw, such as potatoes.

A facility must reanalyze the food safety plan as a whole at least once every three years. The final rule provides the flexibility for a facility to only reanalyze the applicable portion of the food safety plan under certain other circumstances, such as when a facility becomes aware of new information about potential hazards associated with a food.

The final rule also adds flexibility to the preventive controls requirements and recognizes the reality of modern distribution chains by not requiring a manufacturing/processing facility to implement a preventive control in certain circumstances when the hazard requiring a preventive control will be controlled by another entity in the distribution chain. For example, if a facility's customer (or another entity in the distribution chain) will control the hazard, then that facility can rely on its customer to provide written assurance that the identified hazard will be controlled by an entity in the distribution chain, with flexibility for how the customer provides that written assurance depending on whether the customer, or an entity subsequent to the customer, will control the hazard. We have identified four specific circumstances in which a manufacturing/processing facility can rely on another entity in the distribution chain to control a hazard, with practical solutions explained further in section XXVII. We also have provided flexibility for a facility to establish, document, and implement an alternative system that ensures adequate control, at a later distribution step, of the hazards in the food product distributed by a manufacturing/processing facility such that the facility would not need to implement a preventive control.

We revised the proposed provisions for a supplier program to add flexibility, recognizing that the receiving facility and the supplier may be separated by several entities in a supply chain. We are allowing entities such as distributors, brokers, and aggregators to determine, conduct, and document appropriate supplier verification activities as a service to the receiving facility, provided that the receiving facility reviews and assesses applicable documentation provided by the other entity and documents that review and assessment. However, because the approval of suppliers is ultimately the responsibility of the receiving facility, the rule specifies that only a receiving facility can approve suppliers. To improve clarity and readability we redesignated the proposed provisions into eight distinct sections of regulatory text in a newly established subpart G (Supply-Chain Program).

Each facility subject to the rule must have a recall plan for a food with a hazard requiring a preventive control.

Many activities required by the final rule must be conducted (or overseen) by a preventive controls qualified individual, a new term we are coining here. A preventive controls qualified individual is a qualified individual who has successfully completed certain training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system.

The rule establishes several exemptions (including modified requirements in some cases) from the requirements for hazard analysis and risk-based preventive controls. All of Start Printed Page 55913these exemptions are expressly authorized by FSMA. A facility that manufactures, processes, packs, or holds food and that is required to register with FDA would be required to comply with the requirements for hazard analysis and risk-based preventive controls unless it is covered by an exemption, as shown in the following table.

Proposed Exemptions From the New Requirements for Hazard Analysis and Risk-Based Preventive Controls

Who or what is exempt from the requirements for hazard analysis and risk-based preventive controlsNotes
“Qualified Facility” as defined by FSMA: • Business with average annual sales of <$500,000 and at least half the sales to consumers or local retailers or restaurants (within the same state or within 275 miles); or • Very small business, which the rule defines as a business (including any subsidiaries and affiliates) averaging less than $1,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee)Modified requirements apply—i.e., a qualified facility is required to: • Notify FDA about its status; and • Either: ○ Notify FDA that it is addressing hazards through preventive controls and monitoring; or ○ Notify FDA that it complies with applicable non-Federal food safety regulations, and notify consumers of the name and complete business address of the facility where the food was manufactured or processed. • The notification is in the form of an attestation, and must be submitted every two years, during the same timeframe as the facility is required to update its facility registration.
• Low-risk, on-farm activities performed by small business (<500 full-time equivalent employees) -or- • Low-risk, on-farm activities performed by a very small business (dollar threshold of $1,000,000, as described previously)Small and very small on-farm businesses conducting only the specified low-risk activities are exempt from the requirements for hazard analysis and risk-based preventive controls. We define the low-risk, on-farm activities that qualify for the exemption, including the specific foods to which they relate (such as making jams, jellies, and preserves from acid fruits, and making milled grain products such as cornmeal).
Activities that are subject to the seafood HACCP requirements of part 123 (21 CFR part 123)The facility must be in compliance with part 123.
Activities that are subject to the juice HACCP requirements of part 120 (21 CFR part 120)The facility must be in compliance with part 120.
Activities that are subject to the “low-acid canned food” requirements of part 113 (21 CFR part 113)• The exemption applies only with respect to microbiological hazards regulated under part 113. • The facility must be in compliance with part 113.
The manufacturing, processing, packaging, or holding of a dietary supplement that is subject to the CGMP requirements of part 111 (21 CFR part 111)• The facility must be in compliance with part 111. • The facility must be in compliance with requirements for serious adverse event reporting for dietary supplements.
Activities of a facility that are subject to section 419 of the Federal Food, Drug, and Cosmetic Act (Standards for Produce Safety)These activities will be established in FDA's forthcoming rule for produce safety.
Alcoholic beverages at a facility that is required to obtain a permit from, register with, or obtain approval of a notice or application from the Secretary of the Treasury as a condition of doing business in the United StatesThe exemption also applies to food other than alcoholic beverages at such a facility, provided that the food is in prepackaged form and constitutes not more than 5 percent of the overall sales of the facility.
Facilities that are solely engaged in the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processingA facility that stores raw agricultural commodities that are fruits and vegetables is not exempt.
A facility solely engaged in the storage of packaged food that is not exposed to the environmentModified requirements apply for the storage of unexposed packaged food that must be refrigerated for safety.

The rule includes procedures for withdrawing a qualified facility exemption, in the event of an active investigation of a foodborne illness outbreak that is directly linked to the facility, or if FDA determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on relevant conditions or conduct associated with the qualified facility. The final rule provides procedures for a facility to appeal an order to withdraw a qualified facility exemption, for a facility to request an informal hearing, for the conduct of an informal hearing, for an appeal, for revoking an order to withdraw a qualified facility exemption, and for reinstating an exemption that was withdrawn.

The rule finalizes recordkeeping provisions associated with the new provisions for hazard analysis and risk-based preventive controls. These records allow facilities to show, and FDA to determine, compliance with the new requirements. To meet these requirements, a facility may use existing records as appropriate.

In addition to finalizing new requirements for hazard analysis and risk-based preventive controls as required by FSMA, the rule does two more key things. First, it modernizes the existing CGMPs. Second, it revises the “farm” definition.

The rule makes several revisions to the CGMPs to update and clarify them. For example, the final CGMPs do not include nonbinding provisions, because it is no longer FDA's practice to include guidance in the regulatory text. The rule finalizes some of the previously nonbinding provisions in the CGMPs as binding requirements, including a requirement for education and training, but deletes other nonbinding provisions. We have revised some key terms for consistency and clarity. And we have clarified FDA's long-standing position that the CGMPs address allergen cross-contact by making that explicit in the regulatory text. Finally, the rule revises a long-standing exemption from the CGMP requirements regarding specific activities conducted on raw agricultural commodities to reflect the contemporary regulatory framework associated with the “farm” definition. In addition, elsewhere in this issue of the Federal Start Printed Page 55914Register, in a final rule that establishes requirements for hazard analysis and risk-based preventive controls for food for animals, FDA is establishing an additional revision to the human food CGMPs to address comments about the practice of human food manufacturers sending by-products to local farmers or animal food manufacturers for use as animal food. Because we proposed these requirements as part of the rulemaking for the animal preventive controls rule, we are finalizing these provisions in the final animal preventive controls rule rather than in this rule.

Finally, the rule clarifies the “farm” definition that is central to the determination of whether certain entities must register as a food facility and, thus, become subject to the new requirements for hazard analysis and risk-based preventive controls. The final “farm” definition reflects current farming practices, differentiates between two types of farm operations (i.e., a “primary production farm” and a “secondary activities farm”), and allows for a consistent—although not identical—regulatory approach across similar operations, to the extent possible. In general, a “primary production farm” is an operation under one management in one general (but not necessarily contiguous) physical location devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities. A farm packs and holds raw agricultural commodities and may conduct certain manufacturing/processing activities (i.e., drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), treatment to manipulate the ripening of raw agricultural commodities (such as by treating produce with ethylene gas), and packaging and labeling). The term farm also now includes a “secondary activities farm,” which is an operation, not located on a primary production farm, devoted to the key farming operations of harvesting, packing, and/or holding of raw agricultural commodities, provided that the primary production farm(s) that grow, harvest, and/or raise the majority of the raw agricultural commodities harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm. A secondary activities farm may also conduct those additional activities allowed on a primary production farm.

Costs and Benefits

This final regulation requires domestic and foreign facilities to adopt a food safety plan, perform a hazard analysis, and to institute preventive controls for the mitigation of those hazards. It also includes requirements for facilities to institute risk-based environmental monitoring, product testing, and a supply-chain program as appropriate to the food, the facility, and the nature of the preventive controls, as well as a requirement to institute controls to help prevent hazards associated with economically motivated adulteration. The total annualized domestic costs are estimated to be approximately $381 million per year, estimated with a 3 percent discount rate, and $382 million per year, estimated at 7 percent when discounted over 10 years. We estimate that processed foods covered by this rulemaking are responsible for approximately 903,000 foodborne illnesses each year, at a total cost to the American public of approximately $2.2 billion. Our break-even analysis shows that for the rule to be cost effective, it would have to prevent $382 million worth of foodborne illness; approximately 17 percent of the total annual illnesses, or approximately 157,000 illnesses when using a discount rate of 7 percent. For the rule to be cost effective using a discount rate of 3 percent, it would have to prevent $381 million worth of foodborne illness (about 17 percent or 156,000 illnesses).

Costs and Health Benefits

[$ millions]

PCHF ProvisionOne-time cost first yr compliance periodOne-time cost second yr compliance period (small businesses <500 FTE's)One-time cost third yr compliance period (very small businesses <$1 million)Annual cost (annually recurring costs)Total annualized cost at 7%Total Annualized cost at 3%
Learn about Rule$6$96$21$0$16$14
Total Costs Subparts A & D1714888154341
Total Costs Subparts C & G91830340323326
Total Domestic Costs32427109355382381
Total Foreign Costs68915234760820817
Total Costs1001,3423441,1151,2021,198
Total Health BenefitsNot Quantified. Break-even occurs when 157,000 illnesses are prevented per year (based on domestic costs discounted at 7 percent).

Table of Abbreviations and Acronyms

Abbreviation/acronymWhat it means
Bioterrorism ActPublic Health Security and Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107-188).
CFSANCenter for Food Safety and Applied Nutrition.
CGMPCurrent Good Manufacturing Practice.
CodexCodex Alimentarius Commission.
Start Printed Page 55915
Codex Validation Guidelines.Codex Guidelines for the Validation of Food Safety Control Measures.
CSACommunity Supported Agriculture.
CPGCompliance Policy Guide.
EOExecutive Order.
EPAU.S. Environmental Protection Agency.
EUEuropean Union.
FDA.U.S Food and Drug Administration.
FD&C ActFederal Food, Drug, and Cosmetic Act.
FSISFood Safety and Inspection Service of the U.S. Department of Agriculture.
FSIS Validation GuidelinesFSIS' Compliance Guidelines on HACCP Systems Validation.
FSMAFDA Food Safety Modernization Act.
FSPCAFood Safety Preventive Controls Alliance.
GFSIGlobal Food Safety Initiative.
HACCPHazard Analysis and Critical Control Point.
HIPAAHealth Insurance Portability and Accountability Act of 1996.
Infant formula ruleCurrent Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula, June 10, 2014 (79 FR 33057).
ISOInternational Organization for Standardization.
LACFThermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers (commonly called “Low-Acid Canned Foods”).
N/ANot Applicable.
NCIMSNational Conference on Interstate Milk Shipments.
NIFANational Institute of Food and Agriculture.
NOPNational Organic Program.
OMBOffice of Management and Budget.
PHS ActPublic Health Service Act.
PMOPasteurized Milk Ordinance.
PMO facilitiesFacilities that comply with the PMO and are regulated under the NCIMS system.
PFPPartnership for Food Protection.
PRAPaperwork Reduction Act.
PSAProduce Safety Alliance.
RACRaw agricultural commodity.
RFRReportable Food Registry.
Section 103(c)(1)(C) draft RADraft Qualitative Risk Assessment: Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm.
Section 103(c)(1)(C) RAQualitative Risk Assessment: Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm (Final).
SBASmall Business Administration.
SECGSmall Entity Compliance Guide.
TCS foodTime/Temperature Control for Safety Food.
USDAU.S. Department of Agriculture.

I. Background

A. FDA Food Safety Modernization Act

The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), signed into law by President Obama on January 4, 2011, is intended to allow FDA to better protect public health by helping to ensure the safety and security of the food supply. FSMA enables us to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides new enforcement authorities to help achieve higher rates of compliance with risk-based, prevention-oriented safety standards and to better respond to and contain problems when they do occur. In addition, the law contains important new tools to better ensure the safety of imported foods and encourages partnerships with State, local, tribal, and territorial authorities. A top priority for FDA are those FSMA-required regulations that provide the framework for industry's implementation of preventive controls and enhance our ability to oversee their implementation for both domestic and imported food. To that end, we proposed the seven foundational rules listed in table 1 and requested comments on all aspects of these proposed rules.

Table 1—Published Foundational Rules for Implementation of FSMA

TitleAbbreviationPublication
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food2013 proposed human preventive controls rule78 FR 3646, January 16, 2013
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption2013 proposed produce safety rule78 FR 3504, January 16, 2013
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals2013 proposed animal preventive controls rule78 FR 64736, October 29, 2013
Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals2013 proposed FSVP rule78 FR 45730, July 29, 2013
Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications2013 proposed third-party certification rule78 FR 45782, July 29, 2013
Start Printed Page 55916
Focused Mitigation Strategies To Protect Food Against Intentional Adulteration2013 proposed intentional adulteration rule78 FR 78014, December 24, 2013
Sanitary Transportation of Human and Animal Food2014 proposed sanitary transportation rule79 FR 7006, February 5, 2014

We also issued a supplemental notice of proposed rulemaking for the rules listed in table 2 and requested comments on specific issues identified in each supplemental notice of proposed rulemaking.

Table 2—Published Supplemental Notices of Proposed Rulemaking for the Foundational Rules for Implementation of FSMA

TitleAbbreviationPublication
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food2014 supplemental human preventive controls notice79 FR 58524, September 29, 2014
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption2014 supplemental produce safety notice79 FR 58434, September 29, 2014
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals2014 supplemental animal preventive controls notice79 FR 58476, September 29, 2014
Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals2014 supplemental FSVP notice79 FR 58574, September 29, 2014

As FDA finalizes these seven foundational rulemakings, we are putting in place a framework for food safety that is modern and brings to bear the most recent science on provisions to enhance food safety, that is risk-based and focuses effort where the hazards are reasonably likely to occur, and that is flexible and practical given our current knowledge of food safety practices. To achieve this, FDA has engaged in a great deal of outreach to the stakeholder community to find the right balance in these regulations of flexibility and accountability.

Since FSMA was enacted in 2011, we have been involved in approximately 600 engagements on FSMA and the proposed rules, including public meetings, webinars, listening sessions, farm tours, and extensive presentations and meetings with various stakeholder groups (Ref. 1) (Ref. 2). As a result of this stakeholder dialogue, FDA decided to issue the four supplemental notices of proposed rulemaking to share our current thinking on key issues and get additional stakeholder input on those issues. As we move forward into the next phase of FSMA implementation, we intend to continue this dialogue and collaboration with our stakeholders, through guidance, education, training, and assistance, to ensure that everyone understands and engages in their role in food safety. FDA believes these seven foundational final rules, when implemented, will fulfill the paradigm shift toward prevention that was envisioned in FSMA and be a major step forward for food safety that will protect consumers into the future.

B. Stages in the Rulemaking for the Human Preventive Controls Rule

With regard to this rulemaking, we published proposed provisions in the 2013 proposed human preventive controls rule and we published new and re-proposed provisions in the 2014 supplemental human preventive controls notice. In the 2014 supplemental human preventive controls notice, we reopened the comment period only with respect to specific proposed provisions. In addition, we emphasized that the re-proposed provisions we included in the regulatory text were based on a preliminary review of the comments.

In this document, we use the broad term “proposed human preventive controls rule” to refer to the complete proposed regulatory text, including both the proposed provisions we published in the 2013 proposed human preventive controls rule and the new and re-proposed provisions we published in the 2014 supplemental human preventive controls notice. We use the narrow terms “2013 proposed human preventive controls rule” and “2014 supplemental human preventive controls notice” to refer to specific text published in the Federal Register of January 16, 2013 (78 FR 3646) and September 29, 2014 (79 FR 58524), respectively. We use the terms “final human preventive controls rule” and “this rule” to refer to the regulations we are establishing as a result of this rulemaking.

We issued a notice correcting several typographical and stylistic errors in the 2013 proposed human preventive controls rule and a mistake in the date of a reference (78 FR 17142, March 20, 2013). In that correction notice, we republished the Appendix in its entirety (78 FR 17142 at 17143 through 17155; the corrected Appendix) because all the references to the Appendix as published in the 2013 proposed human preventive controls rule (78 FR 3646 at 3812 through 3824) had been numbered incorrectly. We also extended the comment periods for the 2013 proposed human preventive controls rule, its information collection provisions, and a related risk assessment (see section I.D) in response to several requests that we do so.

C. Summary of the Major Provisions of Proposed Human Preventive Controls Rule

As part of our announced initiative (Ref. 3) to revisit the CGMP requirements since they were last revised in 1986, we proposed to amend our regulation for Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food (currently established in part 110 (21 CFR part 110)) to: (1) Modernize it; (2) adjust and clarify what activities fall within the long-standing exemption from the CGMP requirements for establishments engaged solely in the harvesting, storage, or distribution of one or more raw agricultural commodities (RACs) based on experience and changes in related areas Start Printed Page 55917of the law since issuance of the CGMP regulation; (3) delete some non-binding provisions of current part 110; and (4) re-establish the provisions of current part 110 in new part 117 (21 CFR part 117). We also requested comment on: (1) Additional proposed revisions or clarifications to our CGMP regulations, including whether to further implement opportunities for CGMP modernization, such as on how best to revise the current provisions for training; and (2) whether to revise some non-binding provisions to establish new requirements in proposed part 117, or to simply retain them as useful provisions of a comprehensive CGMP.

As part of our implementation of new statutory provisions in FSMA, we also proposed to add, in newly established part 117, requirements for certain domestic and foreign facilities to establish and implement hazard analysis and risk-based preventive controls for human food. As directed by FSMA (see section 418 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)), these new provisions would apply to domestic and foreign facilities that are required to register under section 415 of the FD&C Act and our regulation for Registration of Food Facilities (21 CFR part 1, subpart H; the section 415 registration regulations). As directed by FSMA (see sections 418(l) and (m) of the FD&C Act), we proposed to establish modified requirements for certain facilities. We requested comment on all aspects of the proposed requirements, including an opportunity for public comment on potential requirements for product testing, environmental monitoring, a supply-chain program, and hazards that may be intentionally introduced for purposes of economic gain.

As directed by section 103 of FSMA, we proposed to clarify the scope of the exemption from the section 415 registration regulations for “farms” by revising the “farm” definition and by adding or modifying the definitions for certain activities (i.e., for “harvesting,” “holding,” “manufacturing/processing,” and “packing” activities) that govern, in part, whether a business that is devoted to the growing of crops, the raising of animals, or both is within the “farm” definition. We also proposed to add or revise these definitions in our current regulation (implementing section 414 of the FD&C Act) for Establishment and Maintenance of Records for Foods (21 CFR part 1, subpart J; the section 414 recordkeeping regulations), which also have an exemption for “farms.”

We proposed to establish the requirements for CGMPs, for hazard analysis and risk-based preventive controls, and related requirements in new part 117 as shown in table 3:

Table 3—Proposed Subparts in New Part 117

SubpartTitle
AGeneral Provisions.
BCurrent Good Manufacturing Practice.
CHazard Analysis and Risk-Based Preventive Controls.
DModified Requirements.
EWithdrawal of an Exemption Applicable to a Qualified Facility.
FRequirements Applying to Records That Must Be Established and Maintained.

D. Draft Risk Assessment

We issued for public comment a “Draft Qualitative Risk Assessment: Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm” (the section 103(c)(1)(C) draft RA) (78 FR 3824, January 16, 2013). The purpose of the section 103(c)(1)(C) draft RA was to provide a science-based risk analysis of those activity/food combinations that would be considered low risk when conducted in a facility co-located on a farm. We used the tentative conclusions of the section 103(c)(1)(C) draft RA to propose to exempt food facilities that are small or very small businesses that are engaged only in specific types of on-farm manufacturing, processing, packing, or holding activities from the requirements for hazard analysis and risk-based preventive controls. We are including the final risk assessment (the section 103(c)(1)(C) RA) in the docket established for this document (Ref. 4).

E. Definition of “Retail Food Establishment”

An establishment that meets the definition of “retail food establishment” is exempt from the requirements of the section 415 registration regulations and, thus, from FSMA's requirements for hazard analysis and risk-based preventive controls. Section 102(c) of FSMA requires that we revise the definition of “retail food establishment” in § 1.227 to clarify its intent. We are addressing the requirements of section 102(c) of FSMA in a separate rulemaking and issued a separate proposed rule to amend the definition of “retail food establishment” in the section 415 registration regulations and the section 414 recordkeeping regulations (80 FR 19160, April 9, 2015). We intend to issue a final rule to amend the definition of “retail food establishment” in the section 415 registration regulations in the near future.

F. Public Comments

We received more than 8,000 public submissions on the 2013 proposed human preventive controls rule, and more than 1,300 public submissions on the 2014 preventive controls supplemental notice, each containing one or more comments. We received submissions from diverse members of the public, including food facilities (including facilities co-located on a farm); farms; cooperatives; coalitions; trade organizations; consulting firms; law firms; academia; public health organizations; public advocacy groups; consumers; consumer groups; Congress; Federal, State, local, and tribal Government Agencies; and other organizations. Some submissions included signatures and statements from multiple individuals. Comments address virtually every provision of the proposed human preventive controls rule. In the remainder of this document, we describe these comments, respond to them, and explain any revisions we made to the proposed human preventive controls rule.

Some comments address issues that are outside the scope of this rule. For example, some comments express concern over pesticides being used on local crops being harmful to the honeybee population. Other comments address the requirements of the proposed produce safety rule, such as standards for water quality. Other comments express concern about the use of bioengineered food ingredients, and ask that foods containing such ingredients be labeled so that consumers can identify such foods and choose whether to consume them. Other comments assert that the rules should address social issues. We do not discuss such comments in this document.

II. Legal Authority

The proposed rule contained an explanation of its legal basis under authorities in the FDA Food Safety Modernization Act, the FD&C Act, and the Public Health Service Act. After considering comments received in response to the 2013 proposed human preventive controls rule and 2014 supplemental human preventive controls notice, FDA made changes in the final rule. The legal authorities relied on for the final rule are the same as in the proposed rule unless otherwise described in the sections that follow.Start Printed Page 55918

A. Changes to Current 21 CFR Part 1, Subparts H, I, and J

Sections 103(c)(2)(A) and (B) of FSMA require that the Secretary adopt final rules for purposes of section 415 of the FD&C Act (Registration of Food Facilities) with respect to “activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership” and “activities that constitute on-farm manufacturing or processing of food that is not consumed on that farm or on another farm under common ownership.” In section IV, we discuss our revision of the section 415 registration regulations (21 CFR part 1, subpart H) to clarify the types of activities that are included as part of the definition of the term “facility” under section 415 of the FD&C Act and the scope of the exemption for “farms” provided by section 415 of the FD&C Act. The final rule also makes corresponding changes in part 1, subpart I (Prior Notice of Imported Food) and in part 1, subpart J (Establishment, Maintenance, and Availability of Records). FDA's legal authority to modify these regulations is derived from section 103(c) of FSMA and sections 414, 415, 381(m) and 371(a) of the FD&C Act (21 U.S.C. 350c, 350d, 801(m), and 701(a)).

B. Changes to Current 21 CFR Part 110

The changes to the current CGMP regulation finalized in this document clarify the existing requirements of the regulation and update existing requirements to reflect changes in the food industry and in scientific understanding of food safety since issuance of the current regulation. FDA's legal authority to require Current Good Manufacturing Practices derives from sections 402(a)(3), (a)(4) and 701(a) of the FD&C Act (21 U.S.C. 342(a)(3), 342(a)(4), and 371(a)). Section 402(a)(3) of the FD&C Act provides that a food is adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food. Section 402(a)(4) of the FD&C Act provides that a food is adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Under section 701(a) of the FD&C Act, FDA is authorized to issue regulations for the efficient enforcement of the FD&C Act. The revisions we are making to the current CGMP regulation are necessary to prevent food from containing filthy, putrid, or decomposed substances, being otherwise unfit for food, or being prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

In addition to the FD&C Act, FDA's legal authority for the changes to current CGMP requirements derives from the PHS Act to the extent such measures are related to communicable disease. Authority under the PHS Act is derived from the provisions of sections 311, 361, and 368 (42 U.S.C. 243, 264, and 271) that relate to communicable disease. The PHS Act authorizes the Secretary to make and enforce such regulations as “are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States * * * or from one State * * * into any other State” (section 361(a) of the PHS Act). (See sec. 1, Reorg. Plan No. 3 of 1966 at 42 U.S.C. 202 for transfer of authority from the Surgeon General to the Secretary.) The revisions we are making to the current CGMP regulation are necessary to prevent the spread of communicable disease.

C. Hazard Analysis and Risk-Based Preventive Controls

Section 103 of FSMA, Hazard Analysis and Risk-Based Preventive Controls, amends the FD&C Act to create a new section 418, which mandates rulemaking. Section 418(n)(1)(A) of the FD&C Act requires that the Secretary issue regulations “to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls. . . .” Section 418(n)(1)(B) of the FD&C Act requires that the regulations define the terms “small business” and “very small business,” taking into consideration the study of the food processing sector required by section 418(l)(5) of the FD&C Act. Further, section 103(e) of FSMA creates a new section 301(uu) in the FD&C Act (21 U.S.C. 331(uu)) to prohibit “[t]he operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with section 418 [of the FD&C Act].”

In addition to rulemaking requirements, section 418 contains requirements applicable to the owner, operator, or agent in charge of a facility required to register under section 415. Section 418(a) is a general provision that requires the owner, operator, or agent in charge of a facility to evaluate the hazards that could affect food manufactured, processed, packed, or held by the facility, identify and implement preventive controls, monitor the performance of those controls, and maintain records of the monitoring. Section 418(a) specifies that the purpose of the preventive controls is to “prevent the occurrence of such hazards and provide assurances that such food is not adulterated under section 402 [of the FD&C Act] or misbranded under section 403(w) [of the FD&C Act]. . . .” In addition to the general requirements in section 418(a) of the FD&C Act, sections 418(b)-(i) contain more specific requirements applicable to facilities. These include hazard analysis (section 418(b)), preventive controls (section 418(c)), monitoring (section 418(d)), corrective actions (section 418(e)), verification (section 418(f)), recordkeeping (section 418(g)), a written plan and documentation (section 418(h)), and reanalysis of hazards (section 418(i)).

Section 103(c)(2)(C) of FSMA requires that the Secretary adopt a final rule with respect to the requirements under sections 418 and 421 of the FD&C Act from which the Secretary may issue exemptions or modifications of the requirements for certain types of facilities. Sections 418(j)-(m) of the FD&C Act and sections 103(c)(1)(D) and (g) of FSMA provide authority for certain exemptions and modifications to the requirements of section 418 of the FD&C Act. These include provisions related to seafood and juice HACCP, and low-acid canned food (section 418(j)); activities of facilities subject to section 419 of the FD&C Act (Standards for Produce Safety) (section 418(k)); qualified facilities (section 418(l)); facilities that are solely engaged in the production of food for animals other than man, the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing, or the storage of packaged foods that are not exposed to the environment (section 418(m)); facilities engaged only in certain low-risk on-farm activities on certain foods conducted by small or very small businesses (section 103(c)(1)(D) of FSMA), and dietary supplements (section 103(g) of FSMA). In sections XI, XII, XXXVIII, and XXXIX, we discuss provisions that implement these exemptions and modified requirements.

In the 2014 supplemental human preventive controls notice, we included potential requirements for a supplier program, environmental monitoring, and product testing. We are including provisions for such activities in the final Start Printed Page 55919rule. Section 418(o)(3) of the FD&C Act provides supplier verification activities and an environmental monitoring program as examples of preventive controls. Section 418(f)(4) of the FD&C Act provides for the use of environmental and product testing programs as part of required verification that the preventive controls are effectively and significantly minimizing or preventing the occurrence of identified hazards.

In certain circumstances, the final rule does not require a manufacturing/processing facility to implement a preventive control for a hazard requiring a preventive control. Instead, the facility is permitted to rely on a subsequent entity in the distribution chain to significantly minimize or prevent the hazard. In such a circumstance, a facility must disclose in documents accompanying the food, that the food is “not processed to control [identified hazard].” This requirement is supported by sections 418 and 701(a) of the FD&C Act (21 U.S.C. 350g and 371(a)). The requirement that facilities apply preventive controls to significantly minimize or prevent hazards is fundamental to the public health benefits of the rule. To accommodate the realities of modern food production, the rule allows a facility to rely on a subsequent entity in the distribution chain rather than requiring that facility to apply the control. A food may pass through multiple entities in the distribution chain before it reaches consumers. Further, ordinarily it is not apparent from visual examination of the food whether a hazard requiring a preventive control has been addressed. Consequently, without labeling, a facility might not know that a facility upstream in the supply chain has not applied a preventive control and is relying on a downstream entity to do so. Therefore, the agency concludes that information that food has not been processed to control an identified hazard is necessary for a facility to fulfil its obligation under section 418 when a facility is relying on a subsequent entity to control the hazard. The agency also concludes that such labeling is necessary for the efficient enforcement of the Act because the labelling is critical for FDA to hold facilities responsible for their obligations under this regulatory scheme. Further, when the hazard can cause a communicable disease, FDA concludes that the requirement is necessary to prevent the spread of communicable disease from one state into another state and relies on sections 311, 361, and 368 of the PHS Act.

FDA concludes that the provisions in subpart C and related requirements in subparts A, D, F, and G should be applicable to activities that are intrastate in character. Facilities are required to register under section 415 of the FD&C Act regardless of whether the food from the facility enters interstate commerce (§ 1.225(b)). The plain language of section 418 of the FD&C Act applies to facilities that are required to register under section 415 (section 418(o)(2) of the FD&C Act) and does not exclude a facility from the requirements because food from such a facility is not in interstate commerce. Further, the prohibited act provision associated with section 418 (section 301(uu) of the FD&C Act) does not require interstate commerce for a violation.

FDA also is issuing the provisions in subpart C and related requirements in Subparts A, D, F, and G, under sections 402(a)(3), 402(a)(4), 403(w), and 701(a) of the FD&C Act to the extent such requirements are necessary to prevent food from being held under insanitary conditions whereby it may become contaminated with filth or rendered injurious to health, or being unfit for food; and to the extent necessary to prevent food from being misbranded under section 403(w). FDA also is finalizing those provisions under sections 311, 361, and 368 of the PHS Act relating to communicable disease to the extent those provisions are necessary to prevent the interstate spread of communicable disease.

D. Comments on Legal Authority

(Comment 1) One comment asserts that FDA does not have authority to regulate intrastate commercial activities. Another comment asserts that FDA does not have authority to regulate farms that are selling wholly intrastate.

(Response 1) With regard to farms, this rule does not apply. With respect to farms that engage in activities outside the farm definition (i.e., farm mixed-type facilities), this rule applies to the non-farm portion of the operation.

FDA disagrees with the comments regarding application of this rule to activities that are intrastate in character. Facilities are required to register under section 415 of the FD&C Act regardless of whether the food from the facility enters interstate commerce (§ 1.225(b)). The plain language of section 418 of the FD&C Act applies to facilities that are required to register under section 415 (section 418(o)(2) of the FD&C Act) and does not exclude a facility because food from such a facility is not in interstate commerce. Section 301(uu) of the FD&C Act (21 U.S.C. 331(uu)) provides that “the operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with section 418” is a prohibited act. Notably, other subsections in section 301 of the FD&C Act, and section 304 of the FD&C Act (21 U.S.C. 334) demonstrate that Congress has included a specific interstate commerce nexus in the provisions of the FD&C Act when that is its intent. Accordingly, it is reasonable to interpret sections 418 and 301(uu) of the FD&C Act as not limiting the application of the rule only to those facilities with a direct connection to interstate commerce.

FDA is mindful that its interpretation of FSMA and the FD&C Act should not cast doubt on their constitutionality. (See Solid Waste Agency of Northern Cook County v. U.S., 531 U.S. 159 (2001)). FDA has considered the relevant provisions of FSMA and the FD&C Act, FDA's responsibilities in implementing those laws, and the law interpreting the commerce clause of the Constitution (Article I, section 8). Congress' power to legislate under the commerce clause is very broad. However, such power is not without limits, see United States v. Lopez, 514 U.S. 549, 567 (1995); U.S. v. Morrison, 529 U.S. 598, 618 (2000), and these limits have been construed in light of relevant and enduring precedents. In particular, in Lopez, supra, the Supreme Court acknowledged the continuing vitality of Wickard v. Filburn, 317 U.S. 111 (1942), noting that “although Filburn's own contribution to the demand for wheat may have been trivial by itself, that was not `enough to remove him from the scope of Federal regulation where, as here, his contribution, taken together with that of many others similarly situated, is far from trivial.' ” (514 U.S. at 556.) See also Gonzales v. Raich, 545 U.S. 1, 17-25 (2005). This principle applies to the application of sections 418 and 301(uu) of the FD&C Act, as added by section 104 of FSMA. Accordingly, given the collective impact on commerce of facilities that manufacture, process, pack, or hold food that is sold in intrastate commerce, FDA concludes that such facilities should be subject to the rule. FDA notes that to the extent these facilities are very small, they are subject to modified requirements under § 117.201. This outcome regarding intrastate commerce is consistent with section 709 of the FD&C Act (21 U.S.C. 379a), which states that in any action to enforce the act's requirements respecting foods, drugs, devices, and cosmetics, any necessary connection Start Printed Page 55920with interstate commerce is presumed. Likewise, this outcome is consistent with FSMA's risk-based, preventive approach to food safety because the risk presented by unsafe food can be significant, whether or not the food moves from one state to another.

III. General Comments on the Proposed Rule

(Comment 2) Several comments ask us to develop guidance to accompany the rule, particularly with respect to the new requirements for hazard analysis and risk-based preventive controls. For example, comments ask us to provide guidance on topics such as hazard analysis, environmental monitoring, and validation. Some of these comments ask that drafts of the guidance first be made available for public comment.

Other comments emphasize the importance of education and outreach and ask us to provide support for ongoing education and outreach, including an active role in providing needed instructional examples and lessons learned from current investigations and foodborne outbreaks. Some comments ask us to convene a scientific workgroup that includes experts in food and laboratory science, public health, proficiency testing, quality control, and other areas on at least an annual basis to assess what pathogens should be addressed in a food safety plan.

Some comments ask that funding and information on funding for training be provided. Other comments assert that we must make available adequate resources to support outreach and technical assistance delivered by State regulatory agencies, as well as Cooperative Extension programs and non-governmental organizations that work directly with farmers and facilities.

(Response 2) We are developing several guidance documents, including general guidance on hazard analysis and preventive controls, as well as guidance on specific aspects such as environmental monitoring and food allergen control (Ref. 5). We also intend to develop guidance specific to a variety of food types based in part on technical information we obtained through a grant for this purpose, as well as on other topics, such as validation. We will develop and issue this guidance in accordance with our good guidance practices regulation, which establishes criteria for when we issue a guidance document as an initial draft, invite public comment, and prepare a final version of the guidance document that incorporates suggested changes, when appropriate (§ 10.115(g)) (21 CFR 10.115(g)). The public may submit comments on any guidance document at any time (§ 10.115(g)(5)).

We agree with comments that stress the importance of education and outreach. A central element of our strategy to gain industry compliance is to help make available to facilities subject to this rule the education and technical assistance they need to understand and implement the requirements (Ref. 6). Within the Agency we are establishing a Food Safety Technical Assistance Network and seeking funding to increase FDA staffing to provide a central source of information to support industry understanding and implementation of FSMA standards (Ref. 6). This will allow us to respond in a timely and consistent way to industry questions on preventive controls technical and compliance issues (Ref. 6).

We also are working in collaboration with the Food Safety Preventive Controls Alliance (FSPCA) to develop training materials and establish training and technical assistance programs (Ref. 5) and (Ref. 7). The Alliance includes members from FDA, State food protection agencies, the food industry, and academia. It is funded by a grant to the Illinois Institute of Technology's Institute for Food Safety and Health, a nationally-recognized leader in food safety. In addition to developing a standardized preventive controls training curriculum, the FSPCA is developing selected sections of model food safety plans for several food types that will provide needed instructional examples. Although we have provided funding to the FSPCA to develop a standardized preventive controls training curriculum, we are unable to fund training for individual groups who might need particular training materials.

We also are partnering with the National Institute of Food and Agriculture (NIFA) of the U.S. Department of Agriculture (USDA) to administer the FSMA-mandated National Food Safety Training, Education, Extension, Outreach, and Technical Assistance Program, a grant program to provide technical assistance for FSMA compliance to owners and operators of small and medium-size farms and small food processors (Ref. 8). Such efforts will help ensure widespread voluntary compliance by encouraging greater understanding and adoption of established food safety standards, guidance, and protocols.

At this time, we intend to rely on scientific publications and epidemiological findings to assess the potential that new pathogens, or more virulent pathogenic strains, have emerged, and do not intend to convene annual workgroups to assess that data and information.

(Comment 3) Several comments ask us to classify specific on-farm activities as harvesting, packing, holding, or manufacturing/processing so that an operation that conducts these activities on a farm can determine whether conducting that specific activity is within, or outside, the “farm” definition. These comments emphasize that a farm operation needs to know when a specific activity that it conducts would be outside the “farm” definition for the purposes of the requirements to register as a food facility and, thus, require that the farm operation both register as a food facility and comply with the new requirements for hazard analysis and risk-based preventive controls. Some of these comments focus on activities that we have previously classified in more than one way (e.g., “washing,” which we have previously classified as both “harvesting” and “manufacturing/processing,” depending on when the activity occurs) (See table 1 in the Appendix to the 2014 supplemental human preventive controls rule, 79 FR 58524 at 58571-58572.) Other comments ask us to periodically review our lists of harvesting, packing, holding, and manufacturing/processing activities to ensure that they reflect current practices. Some comments ask us to make a table of activities prominently available on our Internet site for easy access whenever the public seeks out information regarding the forthcoming produce safety rule and the human preventive controls rule.

(Response 3) We have added several examples of “harvesting,” “packing,” “holding,” and “manufacturing/processing” to the regulatory text (see §§ 1.227, 1.328, and 117.3 and Response 27, Response 28, Response 29, Response 31, Response 37, Response 38 and Response 39). However, it is not practical to include every possible activity conducted by farm operations in the regulatory text. Attempting to include a more extensive set of examples in the regulatory text has the potential to signal—incorrectly—that any activity not specified in the regulatory text cannot be considered to be within the definition of that activity. In addition, we have not previously discussed our approach to classifying some of the activities mentioned in the comments, and we believe that we should provide an opportunity for public comment on a more extensive list of activities classified as “harvesting,” packing,” “holding,” or “manufacturing/processing.”Start Printed Page 55921

To address these comments, in the near future we intend to issue a draft guidance with our current thinking on the classification of activities as “harvesting,” packing,” “holding,” or “manufacturing/processing.” In accordance with our regulation on good guidance practices (§ 10.115(g)(1)), we will review any comments received and prepare the final version of the guidance document that incorporates suggested changes, when appropriate; publish a notice in the Federal Register announcing that the guidance document is available; and post the guidance document on the Internet and make it available in hard copy. Under our good guidance practices regulation (§ 10.115(g) and (h)), the public can comment on any guidance document at any time, and we will revise guidance documents in response to public comments when appropriate.

In addition, our previously issued “Guidance for Industry: Questions and Answers Regarding Food Facility Registration” (Ref. 9) is in its sixth edition, and we intend to update it in the near future to reflect the changes to the definitions of “farm,” “harvesting,” packing,” “holding,” and “manufacturing/processing” that we are establishing in this rulemaking.

(Comment 4) Some comments ask us to prepare a table or flow chart of activities that make an operation a farm, a retail food establishment, or a facility because food businesses will need to be able to easily determine their regulatory classification to comply with the applicable regulations. Other comments ask us to amend the definition of “manufacturing/processing” to ensure that community supported agriculture (CSA) programs will not become subject to the requirements for hazard analysis and risk-based preventive controls. Other comments ask us to clarify how the revised definitions we are establishing in the section 415 registration regulations will affect entities classified as research and development entities, pilot plants, test kitchens, shared use storage facilities, co-packers, sales offices, corporate offices, private residences, and registered foreign facilities that only send samples to the United States. Some comments ask us to clarify how the revised definitions we are establishing in the section 415 registration regulations will affect a determination of whether an entity or program (such as a farmers' market, roadside stand, CSA program, commissary kitchen, community and incubator kitchens) is a retail food establishment that is not required to register as a food facility in the human preventive controls rule rather than through a separate rulemaking. One comment notes that its farm has a store and a café that use products from the farm, and it is not clear if the store and café will be under regulations while nearby restaurants and grocery stores are not. Some comments ask us to define farmers' markets, CSA programs, roadside stands, and other direct-to-consumer programs as retail food establishments not subject to registration as part of the human preventive controls rulemaking rather than through a separate rulemaking.

(Response 4) Section 102(c) of FSMA requires that we revise the definition of “retail food establishment” in § 1.227 to clarify that, in determining the primary function of an establishment or a retail food establishment under the section 415 registration regulations, the sale of food products directly to consumers by such establishments includes the sale of such food products or food directly to consumers by such establishment at a roadside stand or farmers' market where such stand or market is located other than where the food was manufactured or processed; the sale and distribution of such food through a CSA program; and the sale and distribution of such food at any other such direct sales platform as determined by the Secretary of HHS. As discussed in section I.E, we have begun the process of amending the definition of “retail food establishment” in a separate rulemaking conducted under section 102(c) of FSMA, and are continuing that separate rulemaking by issuing a separate final rule. We intend to issue a final rule to amend the definition of “retail food establishment” in the section 415 registration regulations in the near future. We also intend to update our previously issued “Guidance for Industry: Questions and Answers Regarding Food Facility Registration” (Ref. 9) to reflect any changes to a determination of whether an entity is a retail food establishment as a result of that rulemaking. In the meantime, commenters may find our existing guidance helpful in addressing their questions.

(Comment 5) Some comments ask us to explain how we will enforce the rule, particularly with respect to coordination with State and local authorities and with other Federal agencies. For example, some comments ask whether FDA or the States will pay for inspections, whereas other comments ask us to coordinate inspection of imports with USDA's Food Safety and Inspection Service (FSIS) or ask us to combine our inspections with those of USDA where possible (such as when USDA conducts inspections for adherence to organic standards). Some comments express concern about the time gap between the effective date of this rule and the time it will take to incorporate applicable provisions into State law.

(Response 5) We are working through the Partnership for Food Protection (PFP) (a group of dedicated professionals from Federal, State, local, tribal, and territorial governments with roles in protecting the food supply and public health) to develop and implement a national Integrated Food Safety System consistent with FSMA's emphasis on establishing partnerships for achieving compliance (see section 209(b) of FSMA). For an example of our current thinking on establishing partnerships for achieving compliance, see the “best practices” document made available by PFP (Ref. 10). This “best practices” document provides information to FDA field and State programs on a variety of issues, including how to coordinate compliance activities. Our document entitled “Operational Strategy for Implementing FSMA” also recognizes the importance of developing operational partnerships with States and other government counterparts to optimize the effectiveness, efficiency, and consistency of FSMA implementation domestically (Ref. 11).

We are implementing a new inspection paradigm focused on whether firms are implementing systems that effectively prevent food contamination, requiring fundamentally different approaches to food safety inspection and compliance (Ref. 12). This new paradigm involves a major reorientation and retraining, for which we are seeking funding, of more than 2,000 FDA inspectors, compliance officers, and other staff involved in food safety activities, as well as thousands of State, local, and tribal inspectors (Ref. 12).

(Comment 6) Some comments ask us to specify that the human preventive controls rule does not apply to activities subject to the animal preventive controls rule.

(Response 6) The human preventive controls rule does not apply to activities subject to the animal preventive controls rule. The title of the rule (i.e., Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food) narrows its applicability to human food. Moreover, regulations directed to food for animals are established in subchapter E of 21 CFR (i.e., Animal Drugs, Feeds, And Related Products, parts 500-599), whereas regulations directed to human food are established Start Printed Page 55922in subchapter B of 21 CFR (i.e., Food For Human Consumption, parts 100-199).

(Comment 7) Some comments ask us to look to existing industry information technology solutions where possible to lower the burden on industry for implementation. These comments also ask us to adopt a centralized information technology solution with robust functionality to facilitate tracking stakeholders' compliance with the rule.

(Response 7) The rule allows for use of any available information technology (e.g., in the creation and retention of records) that will allow industry to comply with the rule, and we encourage the use of information technology to streamline compliance. The long-standing CGMP requirements allow for the use of automated systems (see § 117.40(d)). We are developing new electronic systems to track compliance. However, our internal procedures for tracking compliance are outside the scope of this rule.

(Comment 8) Some comments ask us to re-evaluate the proposed human preventive controls rule, compare it with existing programs, and identify a mechanism for integrating compliance verification with existing industry and governmental programs. These comments note that many handlers/processors use and understand voluntary food safety management systems such as HACCP and HACCP-based certification programs (e.g., certification to Global Food Safety Initiative (GFSI) benchmark schemes) and ask us why we proposed to create a separate inspection framework for FSMA, without integrating that inspection framework with existing programs.

(Response 8) We decline this request. As previously discussed, we are establishing this rule as required by section 103 of FSMA (78 FR 3646 at 3657-3659 and 3668-3669). However, where compliance with this rule mirrors compliance with existing regulatory requirements, there is no need to duplicate existing records, which may be supplemented as necessary to include all of the required information. (See also Response 5 regarding implementation of a national Integrated Food Safety System.)

(Comment 9) Some comments ask us to make the various rules we are establishing to implement FSMA consistent with each other.

(Response 9) We have aligned the provisions of the various rules to the extent practicable. For example, we use the same definitions of “farm” and the same terms used in the definition of “farm” (i.e., harvesting, packing, holding, and manufacturing/processing) in this rule, the animal preventive controls rule, and the proposed produce safety rule. However, the statutory direction is not the same for all the rules, and this difference in statutory direction does lead to some differences between the rules. For example, section 418(l) of the FD&C Act (which relates to this rule) provides for modified requirements for facilities that are very small businesses in addition to facilities that satisfy criteria for sales to qualified end-users, but section 419(f) of the FD&C Act (which relates to the proposed produce safety rule) only provides for modified requirements for direct farm marketing.

Likewise, we have worked to align the provisions of this rule with the provisions of the FSVP rule. Again, however, there are statutory differences that lead to some differences between the rules. For example, section 805 of the FD&C Act (21 U.S.C. 348a) applies to an importer whereas section 418 of the FD&C Act applies to a facility that is required to register under section 415 of the FD&C Act.

(Comment 10) Some comments ask us to clarify how the requirements for hazard analysis and risk-based preventive controls will apply to an establishment that supplies raw materials and other ingredients to a registered facility.

(Response 10) The requirements for hazard analysis and risk-based preventive controls apply to facilities that are required to register under section 415 of the FD&C Act. If an establishment that supplies raw materials and other ingredients to a registered facility is itself a facility that is required to register under section 415 of the FD&C Act, that establishment is subject to the requirements for hazard analysis and risk-based preventive controls. If that establishment is not itself a facility that is required to register under section 415 of the FD&C Act, that establishment is not subject to the requirements for hazard analysis and risk-based preventive controls. However, such facilities may be subject to verification activities of manufacturers/processors that are required to verify controls implemented by their suppliers.

(Comment 11) Some comments express concern about the potential for unfair enforcement of the rule relating to business size. Some comments assert that we should strictly enforce the rule for big industry, but be lenient towards small farms.

(Response 11) We intend to enforce the rule in a fair and reasonable manner. We note that farms are not covered by this rule, and the rule contains special provisions applicable to a farm mixed-type facility that is a small or very small business. Specifically, a small or very small business that is a farm mixed-type facility is exempt from the requirements for hazard analysis and risk-based preventive controls if the only activities that it conducts are the low-risk activity/food combinations listed in § 117.5(g) and (h). A very small business that is a farm mixed-type facility, but does not satisfy the criteria for the exemptions for only conducting low-risk activity/food combinations, is eligible for modified requirements as a qualified facility, and we will enforce the modified requirements, rather than the full requirements for hazard analysis and risk-based preventive controls, for such very small businesses.

(Comment 12) Some comments express concern that we will enforce the rule more strictly for domestic facilities than for foreign facilities—e.g., because we lack the funds and manpower to enforce the rule for foreign facilities. Other comments assert that it is unprecedented for importing countries to regulate the production processes in exporting countries and that no scientific evidence supports such regulation. These comments express concern that this regulatory requirement will greatly increase trading costs and might constitute a barrier to trade for exporting countries.

(Response 12) We intend to enforce this rule in a consistent manner to ensure that imported and domestically produced foods are in full compliance with the requirements of this rule. We note that the forthcoming FSVP rule will require importers to help ensure that food imported into the United States is produced in compliance with processes and procedures, including reasonably appropriate risk-based preventive controls, that provide the same level of public health protection as those required under this rule. The implementation of these supplier verification programs by U.S. importers will thus provide assurances that imported food is in compliance with this regulation.

We disagree that we are seeking to “regulate the production processes in exporting countries” inappropriately. This rule provides for a flexible set of principles and a framework for hazard analysis and risk-based preventive controls to be applied to a given production process in order to ensure the production of safe food destined for the United States. Mandating that a finished food is manufactured under general methods applicable to all foods (e.g., good manufacturing practices) is a widely accepted regulatory practice and Start Printed Page 55923fundamentally different than mandating that food be produced in a certain way. We note that many countries have adopted food safety regulations that mandate certain principles and conditions be applied to food manufacturing. These include mandatory HACCP programs for seafood and other foods. For example, in a guidance document on food safety import requirements, the European Commission stated: “The EU rules on food hygiene confirm that all food businesses in third countries after primary production must put in place, implement and maintain a procedure based on the HACCP principles.” The mandate that preventive controls be applied to control hazards in the production of foods in this rule is similar to the European Union (EU) rules. Because the requirements being implemented by FDA under this regulation are flexible and not prescriptive, we do not agree that this regulation will significantly increase costs or impede trade.

We also disagree that there is no scientific evidence supporting this rule. In the 2013 proposed preventive controls rule, we provided an extensive background discussing the scientific evidence and international food safety standards upon which this rule is based (78 FR 3646 at 3659 through 3667, January 16, 2013). That discussion reviews a number of well documented food safety risks and how they can be controlled by modern food safety systems including the Codex HACCP principles contained in the HACCP Annex of the Codex General Principles of Food Hygiene (78 FR 3646 at 3667, January 16, 2013). In that discussion we stated: “The proposed rule would require that a food safety system similar to HACCP be implemented in food facilities and would harmonize our requirements with the recommendations and requirements of internationally recognized food safety experts/authorities, such as experts/authorities in [Codex Alimentarius], [Food Safety Authority Australia New Zealand], [Canadian Food Inspection Agency], and the European Union.” (78 FR 3646 at 3663, January 16, 2013) In addition, the Appendix to the 2013 proposed preventive controls rule provided additional scientific information on activities such as product testing and environmental monitoring to support their role in ensuring safe food and how these align with international standards such as those of Codex Alimentarius (78 FR 3646 at 3818-3820); republished in its entirety with corrected reference numbers on March 20, 2013, 78 FR 17142 at 17149-17151).

(Comment 13) Some comments assert that the rule should be more concise, and that the average person without a team of experts should be able to understand the rule and manage the application of the rule.

(Response 13) We agree the rule needs to be understandable. We have incorporated plain language techniques—e.g., by using active voice in the new requirements for hazard analysis and risk-based preventive controls. We also have established additional definitions that enable us to improve readability (e.g., “qualified facility exemption,” “raw agricultural commodity,” “unexposed packaged food,” and “you.”) The comprehensive nature of the new requirements for hazard analysis and risk-based preventive controls reflects the extensive statutory provisions they implement and the broad range of activities and foods covered. We have used examples in the regulatory text, where relevant, and provided examples throughout the preamble to assist with understanding the requirements. Likewise, the long-standing CGMP requirements need to be comprehensive, because they are broadly directed to all stages of the production of food. We will be producing guidance documents that will be helpful in understanding the rule (see Response 2).

We will issue a Small Entity Compliance Guide (SECG) in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121). A Small Entity Compliance Guide is a guidance that explains the actions a small or very small business must take to comply with a rule.

(Comment 14) Some comments ask whether we will translate the rule into foreign languages, such as Japanese.

(Response 14) We do not intend to translate the rule. As discussed in Response 13, to help small and very small businesses comply with a rule we issue a SECG. We are considering whether to translate the SECG and outreach and technical assistance materials into additional languages.

(Comment 15) Some comments assert that the rule incorrectly assumes that all bacteria are harmful.

(Response 15) We have long recognized that some bacteria have a role in food production, such as the lactic-acid producing bacteria that our regulations explicitly acknowledge as being added to yogurt (see, e.g., the standards of identity for yogurt, low fat yogurt, and nonfat yogurt, in 21 CFR 131.200, 131.203, and 131.206, respectively). The rule defines the terms “microorganism” and “pathogen,” and the definition of “microorganism” explains that the term “undesirable microorganism” includes those microorganisms that are pathogens, that subject food to decomposition, that indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated. The CGMP provisions directed to either preventing the growth of undesirable microorganisms or preventing contamination with undesirable microorganisms are long-standing, and these comments do not provide any examples of how we have interpreted the CGMP requirements in the past in a way that does not recognize that some bacteria have a role in food production or that creates practical problems for the future. With regard to biological hazards, the new requirements for hazard analysis and risk-based preventive controls focus on pathogens.

(Comment 16) Some comments assert that the rule will disproportionately affect New England farmers because they are small and production costs are higher compared to elsewhere in the country and that the cost of the rule will have negative consequences on New England's food supply. Other comments assert that the rule will force small farmers out of business, forcing us to rely on foreign suppliers who are under very little FDA oversight, and that FDA oversight should be reduced so that the public can continue supporting small, local farmers. Other comments express concern that excessive rules will discourage farmers from supplying the Farm to School market.

(Response 16) We believe that the “farm” definition that we are establishing in this rule greatly reduces the impact on farms of all size, because several operations that would have been required to register as a food facility under the section 415 registration regulations as established in 2003 (68 FR 58894, October 10, 2003) will no longer be required to do so. (See the discussion of the changes to the “farm” definition in section IV.B) In addition, a farm mixed-type facility that is a small or very small business, and that only conducts low-risk activity/food combinations for manufacturing, processing, packing, and holding foods that are not RACs, is exempt from the new requirements for hazard analysis and risk-based preventive controls. A farm mixed-type facility that does not satisfy these criteria for exemption, but is a very small business, is a qualified facility that is subject to modified requirements. All of these factors will reduce the burden on small farms.Start Printed Page 55924

(Comment 17) Some comments express concern about contamination of produce and other food in open containers by sulfuric hydrogen being discharged from lead acid batteries that are used to operate forklifts.

(Response 17) The long-standing CGMP provisions require that the food establishment must appropriately use equipment to avoid the adulteration of food with such contaminants (see § 117.40(a)(2)).

(Comment 18) Some comments assert that we do not address comments submitted by individuals.

(Response 18) We address comments on the provisions of the rule regardless of who submits the comments. However, we group similar comments together, and do not discuss the specific text of each submitted comment letter when the point being made by one comment letter can be included in a general discussion of several comment letters that express similar points of view.

(Comment 19) Some comments assert that we need specific standards and quantifiable guidelines for compressed air.

(Response 19) We agree that specific standards and quantifiable guidelines for material such as compressed air could be useful to food establishments that use such material in the production of food. However, we disagree that such standards and guidelines need to be included in the rule. The rule is intended to establish procedures for the safe manufacturing, processing, packing, and holding of food, and for hazard analysis and risk-based preventive controls in the production of food, rather than to set standards for specific levels of contaminants in specific raw materials and other ingredients. If a facility believes that its use of compressed air should be addressed in its food safety plan, then it should do so.

(Comment 20) Some comments ask us to address model laboratory standards and accreditation to ensure that laboratories are using sound and reliable test methods for detecting and identifying pathogens.

(Response 20) We decline this request. A separate section of FSMA addresses “Laboratory Accreditation For Analyses Of Foods” (see section 202 of FSMA). This rule focuses on section 103 of FSMA (section 418 of the FD&C Act).

IV. Comments on Proposed Revisions to the Definitions in the Section 415 Registration Regulations (21 CFR Part 1, Subpart H) and the Section 414 Recordkeeping Regulations (21 CFR Part 1, Subpart J)

A. Definitions That Impact a Determination of Whether an Establishment Is a “Farm”

We previously described section 103(c) of FSMA (78 FR 3646 at 3674). In brief, section 103(c) of FSMA directs us to conduct rulemaking to clarify the on-farm manufacturing, processing, packing, and holding activities that would trigger a requirement for a farm to register as a food facility and, thus, be subject to section 418 of the FD&C Act. We discussed the current legal and regulatory framework for farms under sections 415 and 418 of the FD&C Act, and explained how the status of a food as a RAC or a processed food affects the requirements applicable to a farm under sections 415 and 418 of the FD&C Act. We then articulated a comprehensive set of organizing principles that formed the basis for proposed revisions to the section 415 registration regulations. Because these definitions also are established in the section 414 recordkeeping regulations, these organizing principles also formed the basis for proposed revisions to definitions in the section 414 recordkeeping regulations.

Our previous description (78 FR 3646 at 3675-3676) of the current legal and regulatory framework that governs the determination of when an establishment is required to register as a food facility in accordance with the section 415 registration regulations focused on the framework that governs whether an establishment that grows and harvests crops or raises animals satisfies the definition of “farm,” because the facility registration requirements of section 415 of the FD&C Act do not apply to “farms.” Under that framework, a key factor in whether an establishment falls within the definition of “farm,” even with respect to crops it grows and harvests itself, is whether the activities conducted by the establishment fall within definitions of “harvesting,” “packing” or “holding” (which are within the “farm” definition). Another key factor is whether activities conducted by the establishment fall within the definition of manufacturing/processing (which have been outside the “farm” definition).

We previously described comments regarding proposed revisions to the definitions of “farm,” “harvesting,” “packing” and “holding,” as well as comments regarding the triggers for an activity to be considered manufacturing/processing (79 FR 58524 at 58530-58538). In the 2014 supplemental human preventive controls notice, we proposed additional revisions to the definitions of “farm,” “harvesting,” “packing,” and “holding” to address these comments.

Even after the revisions we proposed in the 2014 supplemental human preventive controls notice, some comments assert that the overall “farm” definition still presents an unrealistic and incomplete understanding of how most farms in the United States are structured with regard to their physical location(s) and business models. Most of the comments suggest alternative or additional regulatory text (see, e.g., Comment 22, Comment 23, Comment 24, Comment 25, Comment 27, Comment 37, Comment 39, and Comment 50) or ask us to clarify how we will interpret the provisions (see, e.g., Comment 26, Comment 28, Comment 29, Comment 40, Comment 41, Comment 42, Comment 43, Comment 44, Comment 47, and Comment 48).

As discussed in section I.A, there are several FSMA-required regulations that provide the framework for industry's implementation of preventive controls and enhance our ability to oversee their implementation for both domestic and imported food (see the seven foundational rules listed in table 1). Two of the proposed rules listed in table 1 (i.e., the 2013 proposed animal preventive controls rule and the 2013 proposed intentional adulteration rule) proposed to include a cross-reference to the “farm” definition in § 1.227, and a third proposed rule (i.e., the 2013 proposed produce safety rule) proposed to establish the same “farm” definition as would be in § 1.227. A fourth proposed rule (i.e., the 2013 proposed FSVP rule) did not propose to establish the “farm” definition (or a cross-reference to the “farm” definition in § 1.227), but under its proposed definition of “foreign supplier” some foreign suppliers would be farms—i.e., establishments that harvest food that is exported to the United States. As a result, we received comments relevant to the “farm” definition for all of these rules. The majority of the comments submitted to these other rulemakings addressed issues that were the same as, or similar to, the issues raised in the comments submitted to this rulemaking. One comment submitted to the proposed rulemaking for the forthcoming FSVP rule requested clarification regarding harvesting companies, and we are also providing Start Printed Page 55925that clarification in this rulemaking. See Response 32.

We proposed to redesignate all definitions in § 1.227 in the section 415 registration regulations (i.e., current § 1.227) to eliminate paragraph designations (such as (a) and (b)). We received no comments that disagreed with our proposed redesignations and are finalizing them as proposed.

We proposed several technical amendments and conforming changes to the section 415 registration regulations and to the section 414 recordkeeping regulations. No comments opposed the proposed technical amendments and conforming changes, except for comments noting that our proposed technical amendment to § 1.361 was unnecessary because we had already made this change in a different rulemaking (see 77 FR 10662, February 23, 2012). We are finalizing these technical amendments and conforming changes without change.

In the following sections, we discuss comments that ask us to clarify the proposed requirements or that disagree with, or suggest one or more changes to, the proposed requirements. After considering these comments, we have revised the proposed definitions as shown in table 4, with editorial and conforming changes as shown in table 52. We also are establishing a new provision to allow off-farm establishments that package, pack, and hold RACs that are produce as will be defined in the produce safety rule to comply with the CGMPs in part 117, subpart B by complying with the applicable requirements for packing and holding that will be established in the final produce safety rule (see § 117.8 and Response 25). Because the new provision refers to provisions in a future produce safety rule, we will publish a document in the Federal Register announcing the effective date of § 117.8 once we finalize the produce safety rule.

Table 4—Revisions to the Proposed Definitions in the Section 415 Registration Regulations and the Section 414 Recordkeeping Regulations

DefinitionRevision
Farm• A farm is an “operation” rather than an “establishment.” • There are two types of farms: (1) Primary production farm; and (2) secondary activities Farm.
Primary production farm• A primary production farm is “under one management” rather than “under one ownership.” • Although a primary production farm continues to be “in one general physical location,” we have clarified that “one general physical location” is “not necessarily contiguous.”
• A primary production farm is an operation devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities. Although some primary production farms both grow and harvest crops, other primary production farms grow crops but do not harvest them, and other primary production farms harvest crops but do not grow them.
• Treatment to manipulate the ripening of RACs, and packaging and labeling the treated RACs, without additional manufacturing/processing, is within the “farm” definition.
• We added an example of drying/dehydrating RACs to create a distinct commodity that would fall within the “farm” definition (i.e., drying/dehydrating grapes to produce raisins), as well as an example of additional manufacturing/processing that would cause an operation that dries/dehydrates RACs to create a distinct commodity to fall outside the “farm” definition (i.e., slicing).
• We added an example of additional manufacturing/processing that can cause an operation that packages and labels RACs to fall outside the “farm” definition (i.e., irradiation).
Secondary activities farm• A “secondary activities farm” is an operation, not located on a primary production farm, devoted to harvesting (such as hulling or shelling), packing, and/or holding of RACs, provided that the primary production farm(s) that grows, harvests, and/or raises the majority of the RACs harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm. • A secondary activities farm may also conduct those additional activities allowed on a primary production farm.
Harvesting• We added additional examples of harvesting activities.
Holding• We added additional examples of holding activities.
Manufacturing/Processing• We added additional examples of manufacturing/processing activities.

B. Proposed Revisions to the Definition of Farm

We proposed to revise the “farm” definition to: (1) Provide for on-farm packing and holding of RACs to remain within the farm definition regardless of ownership of the RACs; (2) include, within the “farm” definition, a description of packing activities that include packaging RACs grown or raised on a farm without additional manufacturing/processing; and (3) provide for drying/dehydrating RACs to create a distinct commodity (such as the on-farm drying of grapes to produce raisins), and packaging and labeling such commodities, without additional manufacturing/processing, to remain within the farm definition. We also requested comment on whether we should retain, remove, or modify the phrase “in one general physical location” in the “farm” definition.

(Comment 21) Most of the comments support our proposed revision to provide for on-farm packing and holding of RACs to remain within the farm definition regardless of ownership of the RACs. However, some comments oppose this proposed revision. Some comments ask us to require that a farm that packs, packs and sells, commingles lots, and holds produce grown on a farm under different ownership comply with the requirements of this rule for hazard analysis and risk-based preventive controls for six reasons: (1) Commingling. Contamination from one farm could find its way to another farm, leading to potential contamination of products from both farms, making it difficult to pinpoint the source of contamination in the event of a recall. (2) Recall Plan. It is critical for everyone in the produce supply chain to be “recall ready,” especially those packing, commingling lots, and selling produce grown on another farm under different ownership. (3) Traceability. It is important that produce be traceable from the specific farm where it was grown to the end-user, and from the end-user back to the farm where it was grown. (4) Exemptions. A covered farmer packing, packing and selling, commingling lots, or holding others' produce might be doing so from a farm that is exempt from the produce safety rule. (5) Supplier program. Under the Start Printed Page 55926human preventive controls rule a farmer would be required to have a valid supplier program. (We note that a farmer might be a supplier to a facility that is subject to the human preventive controls rule, and could be subject to the facility's supplier program, but would not itself be required to “have a valid supplier program.”) With this requirement, receiving facilities could purchase in confidence knowing that if the farm did pack others' produce it was produced in accordance with the rules required by FSMA. (6) Conflict with the National Organic Program (NOP). Under the NOP, a grower that purchases produce from another farm under different ownership, packs produce from another farm, or mixes produce is no longer considered a crop producer and must seek certification as a handler—an operation that has additional requirements to approve suppliers, segregate product, and maintain records necessary to demonstrate compliance. Comments assert that this NOP requirement is logical and is a practice that FDA should take into consideration.

Other comments assert that allowing a farm to pack produce from another farm must account for the problem created by our proposal to exempt farm vehicles transporting RACs from the sanitary transportation rule. These comments argue that unless we revise that rule to prevent possible contamination during transport, we should develop guidance for farms packing produce that is transported from another farm, particularly where the commodity is high risk.

(Response 21) The final “farm” definition continues to provide for on-farm packing and holding of RACs to remain within the farm definition regardless of ownership of the RACs. We have acknowledged that doing so would have consequences such as those described in these comments, as well as other consequences (see 79 FR 58524 at 58532). Although comments pointed out consequences that we had already considered, they did not point to any other consequences. Therefore, we affirm our tentative conclusion that impacts such as these, while not always optimal, are necessary to establish a sensible framework of risk-based regulations that both implement FSMA and reflect common farm activities. We intend to issue the final produce safety rule in the near future and respond to comments related to traceability of produce, including whether to include a requirement that a farm supplying produce to another farm that will pack or hold that produce should provide to the farm that receives the produce its name, complete business address, and description of the produce in any individual shipment, as well as respond to comments on whether it would be appropriate to also require the farm that receives the shipment maintain such record of information and, if so, for what specified period of time.

In the 2014 proposed sanitary transportation rule, we explained our reasons for tentatively concluding that the sanitary transportation practices that would be required by that proposed rule are not necessary to prevent RACs from becoming adulterated during transportation by farms (79 FR 7006 at 7016, February 5, 2014). For example, we explained that we are not aware of instances in which insanitary conditions (e.g., improper temperature control, improper equipment construction, inadequate equipment cleaning) with regard to transportation operations conducted by farms involving the transportation of RACs have contributed to foodborne illness, regardless of whether the farms are conducting transportation operations for their own RACs or for others' RACs. We will consider comments we receive on our proposal to exempt farm vehicles transporting RACs from the sanitary transportation rule when we issue a final sanitary transportation rule. We will consider necessary guidance in light of the final sanitary transportation rule, but we note that good transportation practices are already included in our 1998 guidance for industry entitled “Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables” (Ref. 13).

(Comment 22) Some comments assert that farms are neither facilities nor establishments. These comments ask us to revise the “farm” definition to use a term more suited to the nature of farming.

(Response 22) We consider a farm to be a type of “establishment” but have nonetheless revised the “farm” definition to refer to an “operation” rather than an “establishment” as requested by these comments.

(Comment 23) Many comments address the role of “ownership” in the “farm” definition. Some of these comments emphasize that farming operations are complex, with complex business structures, and are often not held under sole ownership. Some comments describe the role of multiple business models (such as cooperatives, on-farm packinghouses under ownership by multiple growers, food aggregators, and food hubs) in modern farming and ask us to revise the “farm” definition to provide for such business models. Other comments emphasize ownership of the land on which crops are grown or animals are raised, noting that some farms are operated by “tenant” farmers who do not own the land used in the farm's operations. Some comments ask us to replace the concept of ownership with the concept of a responsible party, such as a “farm operator” and to define a farm operator as “the person or entity that has operational control over the farm and benefits in whole or in part from the farm's normal operation. A farm operator may be an owner, a tenant, a partner, or an employee.”

Some comments ask us to remove the phrase “under one ownership” to allow sugar makers who share equipment and sugarhouses to qualify as a farm. Other comments ask us to clarify how renting or leasing storage rooms or facilities would affect the definition of a farm.

(Response 23) We have revised the “farm” definition by replacing the phrase “under one ownership” with the phrase “under one management.” Although the original phrase “under one ownership” was not referring to a single owner, we agree that the “farm” definition should reflect modern business models (such as cooperatives, on-farm packinghouses under ownership by multiple growers, food aggregators, and food hubs) and use language that the modern farming community understands. We decline the request to define and introduce a new term, such as “farm operator.” The term “management” has a common meaning that captures the request of these comments and is suitable for the purposes of the farm definition. (Management. The person or persons controlling and directing the affairs of a business, institution, etc.) (Ref. 14).

Under either the previous or the revised “farm” definition, leasing land to grow or store crops or raise animals does not impact whether an operation is within the “farm” definition. Under the previous definition, “ownership” focused on ownership of the business entity conducting farm operations, not ownership of the land. Leasing land is a business practice common to a variety of business types, not just farms. Likewise, leasing buildings to store RACs does not impact whether an operation is within the “farm” definition. See also Response 24 regarding comments on “one general physical location.”

To the extent that sugar makers who share equipment and sugarhouses only conduct activities that are within the “farm” definition, the revision from “under one ownership” to “under one management” should clarify that those operations would be within the “farm” Start Printed Page 55927definition. However, when sugar makers conduct operations outside the “farm” definition, they are facilities that are required to register under the section 415 registration regulations, not “farms” that are exempt from that registration requirement. A sugar maker that is a small or very small farm mixed-type facility that only conducts the low-risk activity/food combinations listed in the exemptions in § 117.5(g) and (h) (such as making syrup and sugar (e.g., making maple syrup from maple sap)) is exempt from the requirements of this rule. However, a farm mixed-type facility that is not a small or very small business as those terms are defined in this rule, or that conducts activities in addition to the low-risk activity/food combinations listed in the exemptions in § 117.5(g) and (h), is subject to the requirements for hazard analysis and risk-based preventive controls. Consistent with the discussion in Response 228, a farm mixed-type facility that must comply with the requirements for hazard analysis and risk-based preventive controls and makes sugar from sugarcane or sugar beets can consider the findings of the section 103(c)(1)(C) RA (i.e., that this is a low-risk activity/food combination) in determining whether there are any hazards requiring a preventive control. A facility that appropriately determines through its hazard analysis that there are no hazards requiring preventive controls would document that determination in its written hazard analysis but would not need to establish preventive controls and associated management components. For additional information about the section 103(c)(1)(C) RA and the exemptions for on-farm low-risk activity/food combinations for farm mixed-type facilities that are small or very small businesses, see sections VI and XI.G.

(Comment 24) Many comments address the role of “one general physical location” in the “farm” definition and ask us to revise the “farm” definition to acknowledge that farms may be composed of multiple parcels, buildings, or structures that may or may not be contiguous. Some comments point out that there are many farming operations that may fall under the same management and ownership, but are separated by either a strip of land, body of water, or another structure, particularly with respect to sites designated for packing and holding operations. Some comments assert that as long as an economic unit is operating a farm it should be irrelevant where the land is located, and state that this interpretation is consistent with a USDA definition of a “farm operator.” Some comments note that sugar makers rely on sap from existing stands of trees that are often not concentrated in a single area or even nearby the sugarhouse where the maple products are made. Some comments suggest that the term “reasonable distance” could be used to better define “general physical location.” Some comments ask us to issue guidance that will clarify and further designate the boundaries of “one general physical location.”

Some comments note that the “farm” definition we proposed in the 2014 supplemental human preventive controls notice correctly considers a farm operation to remain within the “farm” definition even if it packs and holds produce from another farm. However, these comments state that it is confusing that if the same two farms pack and hold produce together at an off-farm location, using the exact same practices, that packing location is considered a “facility” even though there is no difference in risk. Other comments state that both in-line and off-line egg production facilities should be considered farms. According to these comments, off-line egg production facilities receive eggs laid by hens at nearby farms, whereas in-line egg production facilities receive eggs laid by hens in henhouses adjacent to the plant and located on the same property.

Some comments ask us to retain “one general physical location” in the “farm” definition because the word “farm,” and USDA's definition of “farm,' are “place-based.” Other comments assert that if we delete the phrase “in one general physical location” then a fully integrated operation could be a single farm even though it was made up of numerous distinct farms possibly in several different states. Other comments ask us to retain “one general physical location” in the “farm” definition because different locations may have different food safety risks, different water sources, different personnel, and even different types of crops. Some comments assert that considering each unique and individually State-permitted dairy farm to be an individual “farm” regardless of common ownership or geographic proximity will prevent conflict and interference with the permitting and inspection activities of the Grade “A” program while maintaining food safety. Other comments state that regardless of whether we retain “one general physical location” in the “farm” definition, we must interpret the term “farm” to cover a very limited geographic area and that separate locations that are not in close proximity to each other should not be considered the same “farm.”

(Response 24) We have revised the “farm” definition to specify that a farm is “in one general (but not necessarily contiguous) physical location.” We have concluded that adding “not necessarily contiguous” makes it clear that farming operations that are under one management but have some physical separation (e.g., with respect to the location of packing operations) can remain within the “farm” definition and that both in-line and off-line egg production facilities would be considered “farms.”

We agree that separate locations that are not in close proximity to each other should not be considered the same “farm.” As the comments point out, there already is a framework of State inspections for farms such as dairy farms, and we will need to work with our State regulatory partners to identify farms covered by the produce safety rule. However, even without the new phrase “not necessarily contiguous,” some situations would be complex. We intend to address these types of situations with our State food safety partners. (See Response 5.)

We do not see that adding “not necessarily contiguous” creates a “farm” definition that is not “place-based,” as was asserted by some comments, because the definition continues to specify “in one general physical location.” We also do not see that adding “not necessarily contiguous” presents any food safety concerns, as asserted by comments noting that different locations may have different food safety risks, different water sources, different personnel, and different types of crops. For example, a farm that will be covered by the forthcoming produce safety rule will be subject to standards for all of its water sources, all of its personnel, and all food subject to that rule. Likewise, we also do not believe that adding “not necessarily contiguous” affects a determination of whether a fully integrated operation could be a single farm.

(Comment 25) Some comments ask us to consider revising the regulatory text to ensure that similar activities would be treated the same way under either the produce safety rule or the human preventive controls rule and be held to the same risk-based requirements. These comments point out some of the differences between the requirements that would be established under the proposed human preventive controls rule and the requirements that would be established under the proposed produce safety rule. For example, comments state that the proposed human Start Printed Page 55928preventive controls rule, but not the proposed produce safety rule, would require off-farm packinghouses and off-farm cooling and storage facilities to have a written hazard analysis; written preventive controls; written procedures for monitoring and corrective actions; validation of process controls; a written recall plan; environmental monitoring and product testing requirements; and a written supplier program. As another example, comments state that off-farm packing and holding operations would be required to comply with the human preventive controls rule one year earlier than we proposed that similar sized on-farm packing and holding operations would be required to comply with the forthcoming produce safety rule.

Some comments recommend options to achieve the goal of regulating on-farm and off-farm packinghouses the same way. These options include adding an exclusion to the “farm” definition in the produce safety rule; adding provisions to the human preventive controls rule to enable off-farm packinghouses to meet their obligation by complying with specified, applicable subparts of the produce safety rule; shortening the “farm” definition to simply state “Farm means an establishment under one ownership devoted to the growing and/or harvesting of crops, the raising of animals (including seafood), or any or all of these activities;” addressing off-farm establishments engaged solely in “low-risk” farming and harvesting activities by adding low-risk activities such as hulling, shelling, and drying of tree nuts; expanding the scope of the produce safety rule to include registered facilities; and allowing modified requirements in the human preventive controls rule to allow off-farm packinghouses to be subject to requirements (and exemptions) of the produce safety rule within the framework of the human preventive controls rule.

Some comments emphasize that farm activities are farm activities, regardless of where they happen. Some comments assert that establishments that are engaged solely in traditional harvesting, holding, or packing activities associated with a RAC that will be covered by the produce safety rule should be subject to the produce safety rule, rather than the human preventive controls rule, regardless of physical location, ownership, or legal ties to an operation devoted to the growing and harvesting of produce. Some comments assert that an off-farm operation that packs and holds RACs could be regulated in an identical fashion to an on-farm operation that packs and holds RACs without changing the section 415 requirement for registration by making them subject to the requirements of the produce safety rule for compliance purposes. Some comments ask us to provide an exemption from, or waiver for, the requirements of the human preventive controls rule if a business entity provides documentation that the entity is following the standards of the produce safety rule even though it is not on a farm. Other comments ask us to clarify that a farm can pack or hold RACs that have already undergone packing or holding activities by another farm.

Some comments ask to revise the “farm” definition to include establishments solely engaged in “packing” and “holding” activities performed on RACs, regardless of whether the establishment grows crops. Other comments emphasize that any revisions to the “farm” definition must allow genuine farm operators to carry out harvesting, packing, and holding without opening loopholes for packing and processing businesses. Some comments ask us to revise the “farm” definition to provide for a multi-ownership operation provided that all of the partial owners are themselves farmers.

Some comments ask us to provide that off-farm packing and holding operations that do not change the status of a RAC into a processed food should be able to comply with either the produce safety rule or with the CGMPs in subpart B of the human preventive controls rule. According to these comments, we could simply apply the same logic that we applied when providing that the packing and holding of RACs that have been dried/dehydrated to create a distinct commodity that is a processed food (i.e., no longer a RAC) may achieve compliance with the CGMP requirements by complying either with subpart B of the human preventive controls rule or by complying with the applicable requirements for packing and holding produce RACs in the produce safety rule (see § 117.5(k)(2)).

(Response 25) We have revised the “farm” definition to provide for two types of farms: (1) A primary production farm and (2) a secondary activities farm (see § 117.3). We use the term “primary production farm” to refer to the “farm” definition as proposed, with the revisions described in this final rule. We use the term “secondary activities farm” to mean an operation, not located on a primary production farm, devoted to harvesting (such as hulling or shelling), packing, and/or holding of RACs, provided that the primary production farm(s) that grows, harvests, and/or raises the majority of the RACs harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm. A secondary activities farm may also conduct those additional activities allowed on a primary production farm. With the added definition of “secondary activities farm,” off-farm packinghouses that are managed by a business entity (such as a cooperative) that is different from the business entity growing crops (such as individual farms) can be within the “farm” definition. We are making these changes to reflect the current reality of what it means to be a farm. The changes will allow farms that use certain business models to harvest, pack, and/or hold produce to be able to comply with the produce safety rule for all of their operations. We believe that this flexibility allows for the requirements of the produce safety rule to apply to a wider array of activities than our original proposal without opening the “farm” definition to operations that have no connection to the growing of crops or the raising of animals—the core activities of a farm. By specifying that the farms that grow or raise the majority of the RACs harvested, packed, and/or held by the operation must own, or jointly own, a majority interest in the secondary activities farm, the revised “farm” definition does, as requested by comments, allow “farms” to carry out harvesting, packing, and holding activities in the same way as the produce safety rule.

We are, as requested by some comments, establishing a new provision to allow off-farm establishments that package, pack, and hold RACs that are produce as will be defined in the produce safety rule to comply with the CGMPs in part 117, subpart B by complying with the applicable requirements for packing and holding that will be established in the final produce safety rule (see § 117.8). Because the new provision refers to provisions in a future produce safety rule, we will publish a document in the Federal Register announcing the effective date of that provision once we finalize the produce safety rule.

However, the revised “farm” definition does not, as requested by some comments, establish the exact same regulatory framework for operations, such as certain packinghouses and hulling/shelling operations, that are within the “farm” definition as for operations that conduct similar activities but are outside the “farm” definition by allowing off-farm operations to be subject to the produce Start Printed Page 55929safety rule rather than the requirements for hazard analysis and risk-based preventive controls. We disagree that the statutory framework provides flexibility for entities such as packinghouses and hulling/shelling operations that do not have a connection to a farm to be subject to the requirements of the produce safety rule for compliance purposes. (See the discussion at 79 FR 58524 at 58536.) We continue to believe that an off-farm packinghouse that is subject to this rule will be able to draw from the provisions of the produce safety rule in developing its food safety plan and establishing preventive control management components that are appropriate in light of the nature of the preventive controls and their role in the facility's food safety system. For example, as previously discussed (79 FR 58524 at 58536) we expect that the food safety plan for an off-farm packinghouse would focus on a few key preventive controls, including some that would have counterparts in the proposed produce safety rule, such as maintaining and monitoring the temperature of water used during packing (which would have counterparts under proposed § 112.46(c) in the proposed produce safety rule). We also expect that an off-farm packinghouse would establish sanitation controls to address the cleanliness of food-contact surfaces (including food-contact surfaces of utensils and equipment) and the prevention of cross-contamination from insanitary objects and from personnel to food, food-packaging material, and other food-contact surfaces. On-farm packinghouses would be subject to similar, but not identical, requirements (see e.g., proposed § 112.111(b) for cleanliness of food-contact surfaces and proposed § 112.113 for protection against contamination).

We acknowledge that some of the provisions of the human preventive controls rule have no explicit counterparts in the proposed produce safety rule (e.g., the requirements for product testing and environmental monitoring as verification activities). As discussed in Response 525, we do not expect either product testing or environmental monitoring to be common in facilities that process, pack, or hold produce RACs.

Finally, in response to comments that ask for a clarification that a farm can pack or hold RACs that have already undergone packing or holding activities by another farm, we presume that the commenter was asking about a case where the farm that did the previous packing and holding activities was not the farm on which the RACs were grown and harvested. The definition of “farm” allows packing and holding of one's own RACs and other's RACs, even if they have been previously packed or held by another farm that was not the farm on which the RACs were grown and harvested.

(Comment 26) Some comments ask us to clarify whether the “and” between provisions that allow a farm to dry/dehydrate RACs to create a distinct commodity, and provisions that allow a farm to package and label RACs, means that an operation must do both of these activities to remain within the farm definition. These comments state that they do not think this is the intended (or logical) outcome, which is to provide that farms can do either or both activities and still be within the farm definition and ask us to consider editorial changes (such as replacing “and” with “or,” or adding a new paragraph that would encompass both activities).

(Response 26) The rule does not require a farm to do both activities (i.e., drying/dehydrating RACs to create a distinct commodity, and packaging and labeling RACs) to remain within the farm definition.

(Comment 27) Some comments ask us to add artificial ripening of RACs as an activity that is within the farm definition. Some comments assert that artificial ripening of RACs is not manufacturing/processing because artificial ripening does not transform a RAC into a processed food.

(Response 27) We have revised the “farm” definition to specify that treatment to manipulate the ripening of RACs (such as by treating produce with ethylene gas), and packaging and labeling the treated RACs, without additional manufacturing/processing, are within the “farm” definition. We agree that a treatment such as artificial ripening does not transform a RAC into a processed food but disagree that such a treatment is not manufacturing/processing. To make that clearer, we have added “treating to manipulate ripening” to the list of examples of manufacturing/processing in the definition of that term. As discussed during the rulemaking to establish the section 415 registration regulations, artificial ripening constitutes manufacturing/processing because it involves treating, modifying, or manipulating food (68 FR 58894 at 58912, October 10, 2003). See also our previous statements about artificial ripening in this rulemaking (78 FR 3646 at 3683 and 79 FR 58524 at 58572).

As previously discussed, the activities that transform a RAC into a processed food (and are sometimes therefore referred to as “processing” in the context of a food's status as a RAC or processed food) are not coextensive with the activities described in our definition of “manufacturing/processing” (78 FR 3646 at 3679). When we first established the section 415 registration regulations, a key criterion in determining whether a business entity was a “farm” or a “facility” was whether the operation conducted activities classified as “manufacturing/processing.” Indeed, in the 2013 proposed preventive controls rule we continued to rely on that key criterion in proposing revisions to the “farm” definition. However, as already discussed, some changes to the “farm” definition are necessary to establish a sensible framework of risk-based regulations that both implement FSMA and reflect common farm activities (see Response 21). One of these changes is to specify those manufacturing/processing activities that are within the “farm” definition, rather than attempt to re-classify an activity that arguably is manufacturing/processing as harvesting, packing, or holding in order to provide for the activity to remain within the “farm” definition.

(Comment 28) Some comments disagree that we should provide for drying/dehydrating RACs to create a distinct commodity to be within the “farm” definition because this activity is a manufacturing/processing activity and should be subject to the requirements for hazard analysis and risk-based preventive controls. Other comments agree that we should provide for this activity but assert that “drying/dehydrating RACs to create a distinct commodity” is confusing to the average reader and ask us to add examples of what this means. Some comments ask us to clarify whether this activity applies to specific situations, such as drying/baling of hops (because hops are a low-risk product and beer brewing should eliminate any pathogens on the hops), drying plums to create prunes, and concentrating maple sap into maple syrup, cream, and candy. Some comments assert that maple syrup should be considered a RAC because the process of producing maple syrup mirrors the regulatory text “drying/dehydrating RACs to create a distinct commodity,” because maple syrup can only be produced through the concentration of maple sap and the process of that concentration is akin to the harvesting of other raw products. Other comments assert that the processing of sap is more appropriately viewed as a harvesting activity (rather than food manufacturing).Start Printed Page 55930

Other comments ask us to clarify the specific methods of drying/dehydrating that we would consider to be within the “farm” definition—e.g., whether drying/dehydrating is constrained to in situ, with no heat or mechanical air circulation, because the example we discussed in the 2014 supplemental preventive controls notice was “natural condition raisins.” These comments ask us to specify the allowable methods of drying to avoid confusion, and assert that there is no food safety reason to exclude use of heat or air, especially if sun and light are to be permitted. Other comments ask us to clarify what we mean by “without additional manufacturing/processing.”

(Response 28) We are retaining drying/dehydrating RACs to create a distinct commodity as an activity that is within the “farm” definition even though it is manufacturing/processing. As previously discussed, the processes (described in comments to the 2013 proposed human preventive controls rule) for drying grapes to “natural condition raisins” are akin to other harvesting activities traditionally conducted by farms on RACs grown and harvested on farms, because they are traditionally performed by farms for the purpose of removing RACs from the place they were grown or raised and preparing them for use as food (79 FR 58524 at 58533). As also previously discussed, the information provided by the comments to the 2013 proposed human preventive controls rule included information that “natural condition raisins” are produced with either sun-drying or artificial dehydration (79 FR 58524 at 58533). We did not intend to limit the processes for drying/dehydrating RACs to sun-drying, and the regulatory text includes no such limitation. We decline the request to specify specific methods of drying/dehydrating that would remain within the “farm” definition because doing so could imply that the list of methods was exhaustive and preclude use of new technology in the future.

However, we are adding “boiling” and “evaporating” to the list of activities that we classify as manufacturing/processing to preclude interpretations, such as those expressed in some of these comments, that the processes to produce products such as maple syrup, maple cream, and maple candy are “drying/dehydrating.” In the 2013 proposed human preventive controls rule we included “Boiling/evaporation of maple sap to make maple syrup” as a low-risk manufacturing/processing activity/food combination in the exemption for small and very small businesses that only conduct specified on-farm low-risk activity/food combinations (proposed § 117.5(h)), and we have retained—and broadened—that activity/food combination as an on-farm, low-risk manufacturing/processing activity/food combination in the final human preventive controls rule (see § 117.5(h), which includes making sugar and syrup from fruits and vegetables (e.g., dates), grains (e.g., rice, sorghum), other grain products (e.g., malted grains such as barley), saps (e.g., agave, birch, maple, palm), sugar beets, and sugarcane). Processes such as “boiling,” “concentrating,” and “evaporating” are not “drying/dehydrating” as the term “drying/dehydrating” is used in this rule, and maple syrup is a processed food, not a RAC. See also the discussion in Response 23 regarding how a farm mixed-type facility that makes sugar from sugarcane or sugar beets can consider the findings of the section 103(c)(1)(C) RA (i.e., that this is a low-risk activity/food combination) in determining whether there are any hazards requiring a preventive control. A farm mixed-type facility that makes maple products from maple sap could follow the same approach.

We have added “slicing” to the regulatory text as an example of additional manufacturing/processing that would be outside the “farm” definition. We also have added “drying/dehydrating grapes to produce raisins” to the regulatory text as an example of what we mean by “drying/dehydrating RACs to create a distinct commodity.” Drying plums to produce prunes is another example of drying/dehydrating RACs to create a distinct commodity. Drying/baling hops is within the “farm” definition, but as a “holding” activity because drying/baling hops does not create a distinct commodity. As discussed in Response 39, we have revised the definition of “holding” to add drying/dehydrating RACs when the drying/dehydrating does not create a distinct commodity (such as drying/dehydrating hay or alfalfa) as an example of a holding activity.

(Comment 29) Some comments agree that the activities of packaging and labeling RACs should remain within the “farm” definition but ask us to reclassify these activities so that they are not considered manufacturing/processing because they do not transform a RAC into a processed food or change the nature of the RAC. These comments ask us to add examples to regulatory text to explain what we mean by “packaging and labeling without additional manufacturing/processing.” As an example, these comments ask whether a farm that packs produce grown by another farm, and washes the produce before packing it, would be conducting “additional manufacturing/processing.”

Other comments ask us to clarify whether packaged RACs are processed food because “packaging” is defined as a manufacturing/processing operation. These comments also ask us to clarify whether a farm would be precluded from holding RACs packaged in retail form because the packaged RACs are processed food.

(Response 29) See Response 27. We decline the request to reclassify packaging and labeling so that they would not be considered manufacturing/processing. Although we classify packaging and labeling as manufacturing/processing, packaging and labeling RACs do not transform the RACs into processed food, and we classify “packaged RACs” as RACs.

We classify washing RACs as a harvesting or packing activity when done on RACs before or during packing or packaging, regardless of whether a farm is packing or packaging its own RACs or others' RACs. As requested by the comments, we have added an example of additional manufacturing/processing that would not be within the “farm” definition—i.e., irradiating—to both the “farm definition” and to the definition of “manufacturing/processing.” This example is different from the example we used in the preamble of the 2014 supplemental human preventive controls notice to describe a limitation on activities within the “farm definition”—i.e., “modified atmosphere packaging” (see 79 FR 58524 at 58532). We have decided to not restrict the specific types of packaging procedures that are within the “farm” definition because doing so could be confusing. Moreover, the specific safety concern that can be associated with modified atmosphere packaging (i.e., the production of Clostridium botulinum toxin), would be addressed by a proposed provision in the forthcoming produce safety rule, if that provision is finalized (see proposed § 112.115; 78 FR 3504 at 3589 and 3638). To clarify that “modified atmosphere packaging” is a type of “packaging,” we have revised the definition of “manufacturing/processing” to specify “packaging (including modified atmosphere packaging)” as an example of a manufacturing/processing activity.

(Comment 30) Some comments assert that non-produce botanicals require treatments that do not create a new commodity and ask us to recognize these treatments as farm activities rather than manufacturing/processing activities. As examples, these comments Start Printed Page 55931assert that activities such as cutting, slicing, drying, freezing, wet or dry heat treating to kill plant tissues, and aging or fermenting are all activities that are traditionally performed by farms on non-produce botanicals for the purpose of removing non-produce botanical RACs from the place where they were grown and preparing them for use as food. These comments also assert that we have been inconsistent in our activity classifications because we both state that “heat treatment” is a food processing activity and state that activities traditionally performed by farmers to prepare crops for use are farm activities. These comments express concern that farmers won't use heat treatments to control pests, based on a misunderstanding of what constitutes “food processing.”

(Response 30) We note that these comments used the term “non-produce botanicals,” which is not a term we have used or defined, and it is not clear to us what the commenters intended this term to represent. In this document, we are not addressing the question of whether certain “botanicals” are or are not “produce.” The term “produce” was proposed to be defined in the forthcoming produce safety rule, and we intend to define it in that rule.

However, we can address in this rule these commenters' questions about activity classification. Some of these activities are within the “farm” definition. For example, drying/dehydrating a RAC without creating a distinct commodity is part of “holding” and drying/dehydrating a RAC that creates a distinct commodity, without additional manufacturing/processing, is manufacturing/processing that is included within the “farm” definition. (See Response 28.) Cutting (or otherwise separating) the edible portion of the RAC from the crop plant and removing or trimming part of the RAC (e.g., foliage, husks, roots or stems) are harvesting activities. (See Response 37.) We have revised the definition of “holding” to include the example of “fumigating food during storage.” (See Response 39.) We decided to include this example of a holding activity based on previous discussions of how we classify fumigating as a type of pest control (see, e.g., 78 FR 3646 at 3682 and 79 FR 28524 at 28571). Although we have not previously classified heat treatment for purposes of pest control, we agree that we should classify heat treatment for purposes of pest control the same way that we have classified fumigating for purposes of pest control—i.e., as a holding activity. Regarding classification of the other activities listed in these comments, see Response 3.

(Comment 31) Some comments assert that the “farm” definition is too limited and ask us to include standard farm activities such as culling, conveying, sorting, waxing, labeling, storing, packaging and shipping of raw, whole produce. These comments assert that these normal activities do not change the shape or structure of RACs, or alter the hazards, and should be covered under the produce safety rule rather than the human preventive controls rule.

(Response 31) All of the activities described by these comments could be within the “farm” definition (see 79 FR 58524 at 58571-58572), either because they are specified in the “farm” definition itself or because they are examples of activities within the definition of “packing” or holding.” Packaging and labeling RACs, without additional manufacturing/processing, are specified in the regulatory text of the “farm” definition. Sorting and culling are included in the regulatory text of the definition of “packing.” Storing is simply another term for “holding.” We had already included “weighing and conveying” as an example of a low-risk packing or holding activity in the exemption applicable to on-farm low-risk activity/food combinations (§ 117.5(g)). To give more prominence to this packing activity, we have added it to the definition of “packing” as well.

(Comment 32) One comment, submitted to Docket No. FDA-2011-N-0143 for the FSVP rulemaking, notes that RACs often are harvested by a contract harvest company (Ref. 16). This comment asks us to clarify what is meant by “establishment that harvests a food” in the definition of “foreign supplier” and whether, in such circumstances, the supplier of the RAC would be the contract harvest company or the establishment that owns the crop and sells it to an importer.

(Response 32) The 2014 supplemental human preventive controls notice had similar phrasing (“establishment that harvests the food”) in the definition of “supplier.” In the final rule the definition of “supplier” has changed in relevant part to include the “establishment that grows the food,” consistent with changes to the farm definition and as described in the following paragraphs.

There are several different business models in which RACs are harvested by a contract harvester (Ref. 17). In one business model, a grower contracts with a harvester to perform harvesting on behalf of the grower. In another business model, a third-party handler enters into separate contracts with the grower and the harvester. In another business model, a grower sells its crop to an entity that contracts with a separate harvester to harvest the RACs and then packs the RACs. There are variations on these business models, such as when a grower sells its crop to an entity that both harvests and packs the RACs, without a contract with a separate harvester.

Growing and harvesting operations are not under the same management in some of these business models. As discussed in Comment 23, comments emphasize that farming operations can have complex business structures, and ask us to revise the “farm” definition to provide for these business models. To explicitly include these business models in the “farm” definition, we have revised the “farm” definition to mean an operation under one management in one general (but not necessarily contiguous) physical location devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities. With this revision, an operation can be within the “farm” definition if it grows crops but does not harvest them or if it harvests crops but does not grow them.

The “farm” definition established in the section 415 registration regulations in 2003 (68 FR 58894), and the proposed revisions to the “farm” definition in the 2013 proposed human preventive controls rule and the 2014 supplemental human preventive controls notice, all describe a “farm” as an entity “devoted to the growing and harvesting of crops” (emphasis added). In light of the revision to the “farm” definition and as discussed more fully in section IX.C.35, we have revised the “supplier” definition to include the establishment that “grows the food” rather than the establishment that “harvests the food.” With this change in the “supplier” definition, the supplier is the farm that grows the food regardless of the business model for harvesting the food.

(Comment 33) Some comments ask us to modify the “farm” definition to exclude feed mills that provide feed to more than 5 other farms. These comments assert that egg farms are most likely to be company owned and the median number of farms owned by a company is under 8 and cite USDA as the source of this information. These comments assert that setting the limit at 5 would not automatically exempt feed mills operated by these large egg laying businesses from the animal preventive controls rule.

(Response 33) We decline this request. The statutory exemption from Start Printed Page 55932the section 415 registration regulations (and, thus, from the requirements for hazard analysis and risk-based preventive controls) for “farms” is based on the activities that an operation conducts rather than on the size of the operation.

(Comment 34) Some comments assert that the hulling or dehydration of walnuts should not be considered processing and, thus, that an establishment that conducts hulling or dehydration activities on tree nuts such as walnuts should not be considered a facility subject to the requirements for hazard analysis and risk-based preventive controls. These comments also assert that all growers who hull and dry should operate under the same rules, regardless of whether or not they own their own crop. Some comments assert that the hulling and shelling operations in the nut industry are part of the harvesting operation in which the outer shells are removed. These comments state that regardless of whether activities are conducted on the farm in which they are grown or at an off-farm facility that provides hulling and shelling services, the food is a RAC, the activity is low-risk and does not transform the RAC into a processed food, and the product is delivered to a processing facility and is not distributed in commerce. The comments argue that for all these reasons and because hulling and shelling activities are not subject to subpart B, it is not appropriate to subject facilities that conduct such activities to subpart C. Comments request that hulling, shelling, and drying of tree nuts be considered “on farm” for the purposes of this rule. Other comments ask us to specify that the production of “natural dried raisins,” dried plums, and dried hops are within the “farm” definition.

(Response 34) Hulling of tree nuts (such as walnuts, almonds, and pistachios) is a harvesting activity that is within the “farm” definition when conducted on a farm or the farm part of a farm mixed-type facility. Drying/dehydrating RACs without creating a distinct commodity (such as drying walnuts and hops) is a holding activity that also is within the “farm” definition when conducted on a farm or farm mixed-type facility. As discussed in Response 25, we have revised the “farm” definition to provide that an operation, not located on a primary production farm, devoted to harvesting (such as hulling or shelling), packing, and/or holding of RACs is within the “farm” definition (as a “secondary activities farm”), provided that the primary production farm(s) that grows, harvests, and/or raises the majority of the RACs harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm.

Drying/dehydrating RACs (such as grapes and plums) to create a distinct commodity, and packaging and labeling such commodities, without additional manufacturing/processing is within the “farm” definition when conducted on a farm or farm mixed-type facility. (See Response 28.) However, additional manufacturing/processing activities (such as removing pits from dried plums) are outside the “farm” definition, and a farm or farm mixed-type facility that conducts such activities becomes a facility that is required to register and is subject to the requirements for hazard analysis and risk-based preventive controls for those activities outside the farm definition. The exception is when a farm is a small or very small business eligible for the exemptions in § 117.5(g) and (h) for a farm mixed-type facility that only conducts low-risk activity/food combinations. Such a small or very small business must still register as a food facility, but will be exempt from the requirements for hazard analysis and risk-based preventive controls. (See also the discussion in in the 2014 supplemental human preventive controls notice (79 FR 58524 at 58533-58534 and table 1 in the Appendix to the 2014 supplemental human preventive controls notice (79 FR 58524 at 58571-58572)).

(Comment 35) Some comments assert that we have referred to raw milk as being “inherently dangerous” and should not consider any activities that result in the preparation of an inherently unsafe product for sale to consumers to be within the “farm” definition (i.e., production of raw milk for direct human consumption should not be considered “harvesting” or “packing”). These comments ask us to re‐consider the definition of “farm” as it applies to the production of raw milk for human consumption. Specifically, these comments ask us to consider such activities to be outside the traditional business of a dairy farm and to subject businesses that conduct such activities to FSMA's requirements for hazard analysis and risk-based preventive controls requirements as a means of advancing public health.

(Response 35) We decline this request. Producing milk is a traditional activity of a dairy farm, regardless of whether the milk produced by that dairy farm is pasteurized and introduced into interstate commerce in accordance with § 1240.61 (Mandatory pasteurization for all milk and milk products in final package form intended for direct human consumption) or sold unpasteurized to consumers within a State consistent with applicable State laws and regulations. Distributing raw milk in interstate commerce would be unlawful, but would not form the basis for a decision that the business is “not a farm.”

(Comment 36) Some comments express concern that farmers who grow seed that is sold as animal feed must register as a food facility. These comments ask why sales of grain for animal feed are included in a rule that is focused on the safety of human food and ask us to exempt this category of farms and their sales of grain for animal feed from the registration rule.

(Response 36) Establishments that satisfy the “farm” definition, including farms that grow seed that is sold as animal food, are not required to register as a food facility. These comments may mistakenly believe that we intended any food establishment that is required to register as a food facility to comply with the regulations we are establishing in part 117 regarding human food, regardless of whether the facility produces food for consumption by humans or food for consumption by animals. This is not the case. We simply proposed to revise definitions in the section 415 registration regulations relevant to the definition of “facility” in the same notice in which we proposed to modernize the current CGMPs for food and establish requirements for hazard analysis and risk-based preventive controls for human food, because section 103 of FSMA addresses the definitions in the section 415 registration regulations, as well as the requirements for hazard analysis and risk-based preventive controls. If a facility sells grain for use as animal food, and is not exempt from the section 415 registration regulations, that facility would be subject to the animal preventive controls rule, not the human preventive controls rule that is the subject of this document.

C. Proposed New Definition of Harvesting

We proposed to define “Harvesting,” as a new definition in §§ 1.227 and 1.328, to apply to farms and farm mixed-type facilities and to mean activities that are traditionally performed by farms for the purpose of removing RACs from the place they were grown or raised and preparing them for use as food. We proposed that harvesting be limited to activities performed on RACs on a farm, and that harvesting does not include activities that transform a RAC into a processed Start Printed Page 55933food. The proposed definition included examples of activities that would be harvesting. As noted in table 52 of this document, we have reorganized the listed examples of harvesting to present them in alphabetical order. We also have modified the proposal that harvesting be limited to activities performed on RACs on a farm to provide that harvesting can also be performed on processed foods created by drying/dehydrating a RAC without additional manufacturing/processing, because processed foods created by drying/dehydrating RACs are within the “farm” definition. See Response 28 and 79 FR 58524 at 58533 regarding drying/dehydrating RACs to create a distinct commodity.

(Comment 37) Some comments ask us to provide more examples of harvesting activities, in the regulatory text and in guidance. Examples of the requested activities include braiding; bunching; cutting the edible portion of the crop from the plant; hydro-cooling; maintaining hydration of product; refrigerating; removing foliage; removing free water from (e.g., spinning); removing or trimming roots; trimming the tops of bunches of allium crops such as leeks, chives, or garlic and root crops such as carrots, beets, turnips, parsnips, etc. to prepare them for sale; and trimming the lower stems of harvested herb crops such as parsley, basil, or cilantro, or the lower stems of leafy greens. Other comments ask us to specify that harvesting also encompasses seed conditioning (i.e., cleaning the seed, including removal of leaves, stems, and husks to prepare for marketing), ripening (artificial or natural) of fruit, and waxing or coating of RACs.

(Response 37) We have added or modified several examples of harvesting in the regulatory text (i.e., cutting (or otherwise separating) the edible portion of the RAC from the crop plant, removing or trimming part of the RAC (e.g., foliage, husks, roots or stems), field coring, and hulling). In table 1 in the Appendix to the 2014 supplemental human preventive controls notice (79 FR 58524 at 58571-58572), we provided a more extensive list of examples of harvesting activities, including examples that are not in the regulatory text. Although we have classified some of these activities in more than one way (see 79 FR 58524 at 58571-58572), in general these activities would fall within the “farm” definition when conducted on RACs that are not otherwise processed. For example, coating RACs with wax/oil/resin for the purpose of storage or transport can be a packing (not harvesting) activity, but waxing also has long been considered a manufacturing/processing activity during the production of processed food (because it involves making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food) (see 78 FR 3646 at 3679). Artificial ripening of fruit is manufacturing/processing (not harvesting), but is now within the “farm” definition (see § 117.3 and Response 27). Regarding classification of the other activities listed in these comments, see Response 3.

(Comment 38) Some comments assert that fermenting cocoa beans and coffee beans should be classified as “harvesting” rather than “holding.”

(Response 38) We agree that the process of fermenting cocoa beans and coffee beans begins as a “harvesting” activity, when the pods are harvested and the beans are removed; it continues as “holding,” while the harvested beans ferment. Thus, fermenting cocoa beans and coffee beans has elements of both “harvesting” and “holding,” which are both within the “farm” definition. It is not necessary to place the process of fermenting cocoa beans and coffee beans squarely in one activity or the other for the regulatory purpose of determining whether an operation is within the “farm” definition. See also Response 41.

D. Proposed Revision to the Definition of Holding

We proposed to revise the definition of “Holding” in §§ 1.227 and 1.328 to add that holding also includes activities performed incidental to storage of a food, but does not include activities that transform a RAC into a processed food. Holding facilities could include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks.

(Comment 39) Some comments ask us to provide more examples of holding activities, in the regulatory text and in guidance. Examples of the requested activities include fumigating RACs; application of chemicals (including fungicides, sanitizers, and anti-oxidants); application of ripening agents; using wax as a carrier of fungicides or anti-oxidants applied before storage; and waxing or coating of RACs, including “coating” grain RACs with diatomaceous earth to control insects. According to these comments, these activities are incidental to storage and do not transform RACs into processed food.

(Response 39) We have added or modified several examples of holding in the regulatory text (i.e., fumigating food during storage, and drying/dehydrating RACs when the drying/dehydrating does not create a distinct commodity (such as drying/dehydrating hay or alfalfa)). In table 1 in the Appendix to the 2014 supplemental human preventive controls notice (79 FR 58524 at 58571-58572), we provided a more extensive list of examples of holding activities, including examples that are not in the regulatory text. We have previously classified some of these activities in more than one way (see 79 FR 58524 at 58571-58572) depending on when the activity occurs. For example, sorting, culling, and grading RACs can be either a holding activity or a packing activity. Drying/dehydrating RACs is holding when the drying/dehydrating does not create a distinct commodity, but is manufacturing/processing when the drying/dehydrating creates a distinct commodity (see Response 28). Regarding classification of the other activities listed in these comments, see Response 3.

(Comment 40) Some comments ask us to clarify that mixing or blending intact RACs is considered “holding” regardless of whether the RACs are the same or different.

(Response 40) We use the term “blending” when referring to RACs such as grain and when the RACs are the same. For example, we consider the activity of “blending” different lots of the same grain to meet a customer's quality specifications to be a practical necessity for product distribution and, thus, to be within the definition of “holding” (see 79 FR 58524 at 58537). However, we use the term “mixing” when the RACs are different. For example, we consider the activity of “mixing” corn and oats in the production of animal food to be manufacturing/processing, because mixing two different foods is “making food from one or more ingredients” (which is our definition of “manufacturing/processing”), and the animal food produced by mixing corn and oats is a processed food.

We classify “mixing” intact RACs that does not create a processed food as incidental to, and therefore part of, “packing” or “holding” as applicable.

(Comment 41) Some comments ask us to clarify whether the expanded definition of holding that we proposed in the 2014 supplemental human preventive controls notice would mean that a warehouse that both stores cocoa beans and fumigates the cocoa beans to prevent pest infestation would be exempt from the requirements for hazard analysis and risk-based preventive controls for a facility solely engaged in the storage of RACs (other than fruits and vegetables) for further distribution or processing (§ 117.5(j)).Start Printed Page 55934

(Response 41) Fumigating RACs such as cocoa beans to prevent pest infestation would be within the definition of “holding.” Therefore, such fumigation would not prevent a facility that stores RACs (other than fruits and vegetables) from being eligible for the exemption in § 117.5(j), provided that the facility does not conduct other activities not classified as “holding.” However, a threshold question for any facility solely engaged in the storage of RACs is whether the stored RACs are fruits or vegetables. We classify cocoa beans within the category of “fruits and vegetables” (78 FR 3646 at 3690) and, thus, a facility that stores cocoa beans is not eligible for the exemption in § 117.5(j).

(Comment 42) Some comments ask us to clarify whether there is a timeframe associated with holding and to better distinguish between “holding” and “storage.”

(Response 42) There is no timeframe (maximum or minimum) associated with holding. The definition of holding states “Holding means storage of food” and, thus, there is no distinction between “holding” and “storing.”

(Comment 43) Some comments ask us to clarify how the definition of holding relates to practices, such as fumigation, on almond hull stockpiles held on a farm, a farm mixed-type facility, or off-farm.

(Response 43) Practices that are incidental to storage of food, such as fumigation of almond hull stockpiles, are holding, regardless of whether they are conducted on-farm, on a farm mixed-type facility, or off-farm.

(Comment 44) Some comments ask us to clarify that value added activities (such as repacking and blast freezing) conducted in facilities such as warehouses would be considered holding when product is not exposed to the environment.

(Response 44) We consider the activities described in these comments to be activities performed as a practical necessity for the distribution of the food and, thus, to be within the definition of holding.

(Comment 45) Some express concern that the definition of holding would prevent a facility that samples food (such as sugar) for grading or quality control purposes from qualifying for the exemption for facilities engaged solely in holding unexposed packaged food because they would temporarily expose otherwise unexposed packaged food to the environment. These comments ask us to make clear that the requirements for hazard analysis and risk-based preventive controls only apply to the sampling activities and that engaging in sampling activities does not remove a warehouse's exemption altogether.

(Response 45) We consider that sampling food in the manner described by this comment is a practical necessity for the distribution of the food within the definition of “holding,” and that the exemption still applies to a facility that conducts such sampling. Importantly, the sampling must be in done in accordance with CGMPs such that the exposure does not result in contamination of the food.

E. Proposed Revision to the Definition of Manufacturing/Processing

We proposed to revise the definition of “Manufacturing/Processing” in §§ 1.227 and 1.328 by adding to the existing definition a criterion applicable to farms and farm mixed-type facilities. As noted in table 52, we have reorganized the listed examples of manufacturing/processing to present them in alphabetical order.

(Comment 46) Some comments express concern that some activities included in the definition of “manufacturing/processing” overlap with activities (such as trimming, washing, and cooling) included in the definition of “harvesting.”

(Response 46) We acknowledge that there is some overlap in the activities that the regulatory text lists as examples of both “manufacturing/processing” and “harvesting,” because some activities can occur during more than one operation (see also the discussion at 79 FR 58524 at 58538 and table 1 in the Appendix to the 2014 supplemental human preventive controls notice (79 FR 58524 at 58571-58572)). For example, “cutting” the core of the lettuce from the crop plant can occur on-farm in the field where the lettuce is harvested, and “cutting” the core of the lettuce from the rest of the harvested lettuce also can occur in a fresh-cut processing facility. An important consequence of the multiple revisions we have made to the “farm” definition in this rulemaking is that there are fewer situations in which classification of a particular activity is the only trigger for an operation to be subject to the section 415 registration regulations. For example, the revised “farm” definition no longer classifies the packing and holding of others' RACs to be a manufacturing/processing activity that triggers the registration requirement. As another example, the revised “farm” definition specifies three manufacturing/processing activities that are within the “farm” definition. We conclude that the overlap in the examples of activities listed in the definitions of “harvesting” and “manufacturing/processing” does not create problems with determining the status of an operation as a “farm” or a “facility” and we are retaining examples in both definitions because doing so reflects current practices on farms and in manufacturing/processing facilities.

(Comment 47) Some comments ask us to clarify that the traditional activities of a packing shed—cleaning and packing intact fruits and vegetables—do not constitute “manufacturing/processing” that would trigger the requirement to register as a facility.

(Response 47) Packing activities are within the definition of “packing,” and holding activities are within the definition of “holding,” regardless of whether the packing or holding activities take place on-farm or off-farm. In other words, neither packing produce nor holding produce would be classified as manufacturing/processing merely because the business entity conducting the activity is a facility that is subject to the section 415 registration regulations. As discussed in Response 25, we have revised the “farm” definition to provide that an operation devoted to harvesting (such as hulling or shelling), packing, and/or holding of RACs is within the “farm” definition (as a “secondary activities farm”), provided that the primary production farm(s) that grows, harvests, and/or raises the majority of the RACs harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm. With this revision, some off-farm packinghouses that are managed by a business entity (such as a cooperative) that is different from the business entity growing crops (such as individual farms) can be within the “farm” definition, provided that the primary production farm(s) that grows, harvests, or raises the majority of the RACs harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the packing operation.

(Comment 48) Some comments ask us to make clear, in our response to comments in the final rule, that any adjustments we make to the definition of manufacturing/processing in no way change the definitions of “raw agricultural commodity,” “processing,” and “processed food,” which were mutually agreed to by EPA and FDA (Ref. 15) to address regulatory responsibilities for antimicrobials applied to food, process water contacting food, or hard food-contact surfaces.

(Response 48) The revisions we made to the “farm” definition, and to the classification of activities relevant to the Start Printed Page 55935“farm” definition, do not change the statutory definitions of “raw agricultural commodity,” and “processed food,” or impact our interpretation of the definition of “processing,” with respect to regulatory jurisdiction for antimicrobials applied to food, process water contacting food, or hard food-contact surfaces.

F. Proposed New Definition of Mixed-Type Facility

We proposed to define “Mixed-type facility,” as a new definition in §§ 1.227 and 1.328, to mean an establishment that engages in both activities that are exempt from registration under section 415 of the FD&C Act and activities that require the establishment to be registered. We specified in the regulatory text that an example of such a facility is a “farm mixed-type facility,” which is an establishment that grows and harvests crops or raises animals and may conduct other activities within the farm definition, but also conducts activities that require the establishment to be registered. As a conforming change associated with the revisions to the “farm” definition, we have revised the example of a “farm mixed-type facility” to specify that it is an establishment that is a farm, but also conducts activities outside the farm definition that require the establishment to be registered.

(Comment 49) Some comments assert that there is no scientific basis for the definition of mixed-type facility.

(Response 49) The proposed definition is not a science-based definition. It is a descriptive term that we are using to refer to certain food establishments. We used this same term during the rulemaking to establish the section 415 registration regulations (see response to comment 46, 68 FR 58894 at 58906, October 10, 2003).

(Comment 50) Some comments ask us to revise the definition to add more details about activities that are inside the farm definition and activities that are outside the farm definition.

(Response 50) We decline the request of these comments. Adding such details would detract from the focus of the definition—i.e., that it refers to a facility that conducts both activities that are inside the farm definition and activities that are outside the farm definition. We have included additional examples of “harvesting,” “packing,” and “holding” activities in the regulatory text of the definitions for those terms (see §§ 1.227, 1.328 and 117.3 and Response 31, Response 37 and Response 39). (See also Response 3.)

(Comment 51) Some comments ask us to revise the definition to exclude those establishments that only conduct low-risk activities specified in the exemptions for on-farm, low-risk activity/food combinations (§ 117.5(g) and (h)).

(Response 51) We decline this request. Whether a particular establishment that falls within the definition of “mixed-type facility” is subject to the requirements for hazard analysis and risk-based preventive controls is governed by the exemptions established in this rule.

G. Proposed Revision to the Definition of Packing

We proposed to revise the definition of “Packing” in §§ 1.227 and 1.328 by adding that packing includes activities performed incidental to packing a food, but does not include activities that transform a RAC into a processed food. We have revised the definition to clarify that packing includes “re-packing.”

(Comment 52) Some comments ask us to include minimal “manufacturing/processing” of RACs in the definition of packing when the minimal “manufacturing/processing” does not transform the RAC into a processed food. The comments describe waxing of fresh fruit (such as apples) and vegetables as examples of activities that do not transform a RAC into a processed food.

(Response 52) As already discussed, the activities that transform a RAC into a processed food (and are sometimes therefore referred to as “processing” in the context of a food's status as a RAC or processed food) are not coextensive with the activities described in our definition of “manufacturing/processing.” (See Response 27.) Although waxing has long been considered a manufacturing/processing activity during the production of processed food (because it involves making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food), we classify coating RACs with wax/oil/resin for the purpose of storage or transport as a packing activity. (See Response 37).

(Comment 53) Some comments ask us to clarify the distinction between “packing” and “packaging” because the terms are different but seem to be used interchangeably. These comments express concern that “placing food into containers” on farms that have traditionally done so will be classified as “manufacturing/processing” and trigger the requirement to register as a food facility and ask us to reclassify “packaging” within the definition of “packing.” Other comments ask us to remove the words “other than packaging of food” from the definition of “packing.” Some comments state that when a RAC is packed in the field and/or is placed into a clamshell container, as a practical matter it is considered to have been “packed,” not “packaged.”

(Response 53) We acknowledge that farms traditionally refer to field packing, including placing RACs into clamshell containers that will serve as a consumer package, as “packing,” not “packaging.” Indeed, in the 2013 human preventive controls rule we proposed to revise the definition of “packing” to specify that, for farms and farm mixed-type facilities, “packing” includes “packaging.” However, in the 2014 supplemental human preventive controls notice we proposed a simpler approach to accommodate requests such as those in these comments, by simply specifying in the “farm” definition that packaging and labeling RACs, without additional manufacturing/processing, is within the “farm” definition. We conclude that the distinctions between the terms “packing” and “packaging” do not create problems with determining the status of an operation as a “farm” or a “facility.” Further, we note that we have given these terms identical meanings across multiple FDA regulations that are applicable to facilities.

(Comment 54) Some comments refer to discussions at a “listening session” regarding harvesting several varieties of lettuce, washing them, and combining heads or bunches of the different varieties in one bag that is sealed with a knot or twist tie. During these discussions, this type of activity was classified as being within the “farm” definition. These comments ask how this activity can be classified as being within the “farm” definition when mixing and washing are listed as manufacturing/processing activities that trigger registration as a food facility and whether there is a discrepancy between what the rule requires and what they heard at the listening session. Other comments express the view that mixing RACs that have not been transformed into processed food (such as bagging mixed greens or different types of whole produce, such as potatoes, beets, and carrots) should not put a farm in the category of a mixed-type facility.

(Response 54) Removing several varieties of lettuce from the place in which they were grown, washing them on the farm, and combining heads or bunches of the different varieties in one bag that is sealed with a knot or twist tie on the farm are all activities within the “farm” definition. We classify “washing” and “mixing” in more than one way depending on when the activity occurs, and the “farm” definition now specifies that Start Printed Page 55936“packaging” RACs (without additional manufacturing/processing, such as slicing) is a farm activity, even though it is a type of “manufacturing/processing.” We have recognized “washing” as a harvesting activity since we first issued the section 415 registration regulations (68 FR 58894 at 58961, October 10, 2003), even though we also classify “washing” RACs as “manufacturing/processing” when done in a food processing facility (such as a fresh-cut processing facility). We classify “mixing” intact RACs that does not create a processed food as incidental to, and therefore part of, “packing” or “holding” as applicable. Mixing heads or bunches of lettuce as described in the example does not create a processed food, because he mixing has not created a distinct commodity, but only a set of mixed RACs. On the other hand, mixing that creates a processed food is not “packing” or “holding.” The definitions of both “packing” and “holding” are limited so that they do not include activities that transform a RAC into processed food. Some kinds of mixing of RACs do create a distinct commodity (for example, mixing corn and oats to make animal food). In such cases, the mixing is manufacturing/processing and is not within the farm definition. Likewise, although we classify placing RACs in a plastic bag with a twist tie as “packaging” rather than “packing” when the plastic bag is the container that the consumer receives, we have provided for ”packaging” RACs as an activity within the “farm” definition.

V. Comments on the Organizing Principles for How the Status of a Food as a Raw Agricultural Commodity or as a Processed Food Affects the Requirements Applicable to a Farm Under Sections 415 and 418 of the FD&C Act

In the 2014 supplemental human preventive controls notice, we discussed comments on the organizing principles that formed the basis for proposed revisions to the section 415 registration regulations and the section 414 recordkeeping regulations (79 FR 58524 at 58538). We also explained how our proposed revisions to the “farm” definition would require us to reconsider those organizing principles (79 FR 58524 at 58538).

(Comment 55) Some comments assert that we should revise the organizing principles to reflect the realities and range of activities that farms conduct to prepare their crops for market and to make the organizing principles consistent with FSMA's risk-based mandate. These comments ask us to revise the organizing principles as follows: (1) The basic purpose of farms is to produce RACs and deliver them for sale to end-users or other buyers; (2) activities that involve RACs and that farms perform for the purposes of selling their own RACs, including growing them, harvesting them, preparing them for consumption in their raw and unprocessed state, and packing, sorting, grading, packaging, labeling, holding, transporting, marketing, and delivering them, should all be within the definition of “farm;” (3) even though farms traditionally also do a wide variety of activities that may be considered processing, for the purpose of these organizing principles, activities should be classified based on whether the activity transforms a RAC into a processed food (as defined by these rules); (4) manufacturing/processing, packing, or holding food—whether RACs or processed foods, from any source—for consumption on the farm should remain within the farm definition.

(Response 55) We have revised the “farm” definition to refer to farms as “operations” rather than “facilities” or “establishments”; reflect modern business models (such as cooperatives, on-farm packinghouses under ownership by multiple growers, food aggregators, and some types of food hubs (e.g., those that consolidate and distribute RACs but do not conduct activities that transform the RACs into a processed food)); specify that a farm is in one general (but not necessarily contiguous) physical location; and provide that an operation devoted to harvesting (such as hulling or shelling), packing, and/or holding of RACs is within the “farm” definition as a secondary activities farm, provided that the primary production farm(s) that grows, harvests, and/or raises the majority of the RACs harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm (e.g., an off-farm produce packinghouse owned by farmers or a farmer-owned tree nut hulling and drying operation). (See Response 22, Response 23, Response 24, and Response 25.) All of these changes to the “farm” definition do, as requested by these and other comments, reflect the realities and range of activities that farms conduct. See table 5 for organizing principles regarding classification of activities on-farm and off-farm in light of the changes to the “farm” definition.

Table 5—Organizing Principles Regarding Classification of Activities On-Farm and Off-Farm

No.Organizing principle
1The basic purpose of farms is to produce RACs, and RACs are the essential products of farms.
2A farm is in one general (but not necessarily contiguous) location.
3Farm operations include business models such as cooperatives, on-farm packinghouses under ownership by multiple growers, food aggregators, and some types of food hubs.
4Activities that involve RACs and that farms traditionally do for the purposes of growing RACs, removing them from the growing areas, and preparing them for use as a food RAC, and for packing, holding, and transporting them, are all within the “farm” definition.
5Activities are classified based in part whether the activity transforms a RAC into a processed food.
6A limited number of traditional operations that farms do for the purpose of preparing RACs for use as a food RAC, but that are classified as “manufacturing/processing,” are within the “farm” definition. These are: (1) Drying/dehydrating RACs to create a distinct commodity, and packaging and labeling such commodities, without additional manufacturing/processing; (2) treatment to manipulate the ripening of RACs, and packaging and labeling the treated RACs, without additional manufacturing/processing; and (3) packaging and labeling RACs, when these activities do not involve additional manufacturing/processing.
7Manufacturing/processing, packing, or holding food—whether RACs or processed foods, from any source—for consumption on the farm is within the farm definition.
Start Printed Page 55937

VI. Rulemaking Required by Section 103(c) of FSMA: On-Farm Activities

A. Section 103(c)(1)(C) of FSMA

We previously described provisions of FSMA that direct us to conduct a science-based risk analysis to cover specific types of on-farm packing, holding, and manufacturing/processing activities that would be outside the “farm” definition and, thus, subject to the requirements for hazard analysis and risk-based preventive controls (see section 103(c)(1)(C) of FSMA and 78 FR 3646 at 3674 and 3689-3691). Consistent with this statutory direction, we developed the section 103(c)(1)(C) draft RA and made it available for public comment (Ref. 18 and 78 FR 3824). We are including the final risk assessment (the section 103(c)(1)(C) RA) in the docket established for this document (Ref. 4).

We previously described provisions of FSMA that direct us to consider the results of the science-based risk analysis and exempt facilities that are small or very small businesses from the requirements for hazard analysis and risk-based preventive controls (or modify these requirements, as we determine appropriate), if such facilities are engaged only in specific types of on-farm activities that we determine to be low risk involving specific foods that we determine to be low risk (see section 103(c)(1)(D) of FSMA and 78 FR 3646 at 3675, 3691, and 3705-3707). Later in this document (see section XI.G), we discuss the provisions we are establishing in § 117.5(g) and (h), based on the results of the section 103(c)(1)(C) RA, to exempt farm mixed-type facilities that are small or very small businesses from requirements for hazard analysis and risk-based preventive controls if the only activities that the business conducts that are subject to those requirements are low-risk activity/food combinations.

We also previously described provisions of FSMA that direct us to: (1) Identify high risk-facilities and allocate resources to inspect facilities according to the known safety risks of the facilities (as determined by several factors) and immediately increase the frequency of inspection of all facilities (see the discussion of section 421 of the FD&C Act at 78 FR 3646 at 3654-3655); and (2) consider a possible exemption from or modification of requirements of section 421 of the FD&C Act as we deem appropriate (see the discussion of section 103(c)(1)(D) of FSMA at 78 FR 3646 at 3658). We tentatively concluded that we should not exempt or modify the frequency requirements under section 421 based solely upon whether a facility only engages in low-risk activity/food combinations and is a small or very small business and requested comment on this tentative conclusion.

B. Comments on Qualitative Risk Assessment of On-Farm Activities Outside of the Farm Definition

(Comment 56) Some comments address the qualitative nature of the section 103(c)(1)(C) draft RA and assert that it is based on professional judgment rather than data. These comments ask us to update the section 103(c)(1)(C) draft RA when more data become available. Some comments assert that we should not rely on data from the Food Processing Sector Study (Ref. 19), but instead collect data from large-scale surveys of actual farm mixed-type facilities and their activities. Other comments ask us to dedicate resources and enter into agreements with agencies/organizations to collect, analyze, and interpret data. Some comments ask us to consult with subject matter experts to ensure that the final risk assessment reflects sufficient geographic diversity.

(Response 56) We have acknowledged the limitations of the section 103(c)(1)(C) draft RA (Ref. 18; see section I.F in that document). Rather than limit public input to subject matter experts, we requested comment from all interested persons, and received a number of comments alerting us to activity/food combinations conducted on farms and farm mixed-type facilities, including comments from diverse geographic areas. We also received comments about activity/food combinations focused on botanicals that might be used in the production of dietary ingredients. We disagree that we need to conduct large scale surveys, or enter into agreements with agencies/organizations, to collect additional information in light of the previous opportunity for broad public input regarding the activity/food combinations conducted on farms and farm mixed-type facilities. (See also Response 139 regarding the Food Processing Sector Study.)

(Comment 57) Some comments state that it is not clear how certain high- or moderate-risk practices (e.g., washing), which are necessary to move product from the field, will affect exemptions. These comments recommend that future risk assessments examine the impact of these practices by commodity and volume of intact fruits and vegetables marketed through small and very small farm mixed-type facilities. Other comments ask us to re-examine our data sources in assessing commodity-specific risks, and assert that it is likely that many will be found to be low risk. Other comments suggest that the Centers for Disease Control and Prevention (CDC) expand its data analysis effort (Ref. 20) to separate out commodities to assess attribution of foodborne illnesses for additional commodities.

(Response 57) Because of changes we made to the farm definition, practices such as washing that are necessary to move product from the field are within the farm definition and are not addressed in the section 103(c)(1)(C) RA. We disagree that we should re-examine our data sources in assessing commodity-specific risks. As we discussed in the section 103(c)(1)(C) draft RA, we focused on considering the risk of activity/food combinations rather than separately considering the risk of specific food categories because doing so would better enable us to focus on whether a specific manufacturing, processing, packing, or holding activity conducted on food by a farm mixed-type facility warranted an exemption from, or modified requirements for, the provisions of section 418 of the FD&C Act. The comments did not identify additional data sources to use in assessing commodity-specific risks. However, we did revise the section 103(c)(1)(C) draft RA by taking into consideration: (1) Comments submitted to Docket FDA-2012-N-1258 on the section 103(c)(1)(C) Draft RA; (2) comments submitted to Docket FDA-2011-N-0920 on the proposed rule relevant to activities conducted on foods on farms; and (3) a revised Food Processing Sector Study on domestic establishments co-located on farms (Ref. 21). This led us to include additional activity/food combinations in our evaluation, and many were found to be low risk. With respect to CDC expanding its data analysis effort, the CDC publication cited by the comments (Ref. 20) is the most up-to-date publication available, and more finely grained data for additional commodities are not currently available.

(Comment 58) Some comments assert that we should revise the section 103(c)(1)(C) draft RA and then make it available for additional public comment before finalizing the rule.

(Response 58) As we previously noted (78 FR 3824 at 3826, January 16, 2013), we subjected the section 103(c)(1)(C) draft RA to peer review in accordance with the requirements of the Final Information Quality Bulletin for Peer Review (issued by the Office of Management and Budget to implement the Information Quality Act (Pub. L. 106-554)) before we made it available for broader public comment during a Start Printed Page 55938time period that exceeded 10 months. The additional iterative process recommended by these comments is not necessary and would go beyond the processes we routinely apply for public input on a risk assessment.

C. Comments Regarding an Exemption for Small and Very Small Farm Mixed-Type Facilities Under Section 421 of the FD&C Act

1. Request for Comment on Data Submission Requirements

We requested comment on whether we should establish data submission requirements that would allow us to identify types of facilities in order to exempt them from the inspection frequencies, or modify the inspection frequencies that apply to them, under section 421 of the FD&C Act. We provided examples of such data elements, including identification of a facility as a farm mixed-type facility, annual monetary value of sales, number of employees, and food category/activity type. We also requested comment on any other criteria that may be appropriate for the purposes of allocating inspection resources to these facilities.

Comments did not support these data submission requirements. We are not establishing any data submission requirements that would allow us to identify types of facilities in order to exempt them from the inspection frequencies, or modify the inspection frequencies that apply to them, under section 421 of the FD&C Act.

2. Request for Comment on an Exemption From the Requirements of Section 421 of the FD&C Act

We received no comments that disagreed with our tentative conclusion that we should not exempt or modify the inspection frequency requirements under section 421 based solely upon whether a facility only engages in low-risk activity/food combinations and is a small or very small business. We are not establishing any exemption from, or modification to, the inspection frequency requirements under section 421 for facilities that only engage in low-risk activity/food combinations and are a small or very small business.

VII. Comments on Proposed General Revisions to Current Part 110 (Final Part 117)

We proposed some general revisions to the CGMP requirements in part 110, including revising the title; redesignating the provisions in part 117; revising some terms for consistency within the rule; referring to the “owner, operator, or agent in charge” rather than to “plant management” or “operator”; revising provisions directed to preventing contamination of food and food-contact substances so that they also are consistently directed to preventing contamination of food-packaging materials; revising several provisions to explicitly address allergen cross-contact, as well as contamination; referring to “raw materials and ingredients” rather than “raw materials and other ingredients”; deleting some non-binding provisions; and making some editorial revisions (78 FR 3646 at 3692 to 3693).

Some comments support one or more of these proposed general revisions without change. For example, some comments agree that there is no meaningful distinction between “manufacturing/processing,” “packing,” and “holding” as defined in the proposed revisions to §§ 1.227 and 1.328 and those terms as they have been used in the long-standing CGMP requirements. These comments also agree that consistent use of these terms throughout proposed part 117, in reference to activities taking place in food facilities, establishments, or plants, would make the regulations more clear and have no substantive effect on the current requirements. Other comments support the proposed replacement of the term “facility” or “facilities” in the CGMP requirements with the term “establishment” or “plant” whenever the term “facility” or “facilities” could be confused with the firms that are subject to the proposed requirements for hazard analysis and risk-based preventive controls. Other comments agree that it is appropriate to replace the word “shall” with the term “must.” Some comments that support the proposed provisions suggest alternative or additional regulatory text (see, e.g., Comment 59, Comment 63, and Comment 65).

We received no comments that disagreed with our proposed redesignations and are finalizing them as proposed. In the following sections, we discuss comments that ask us to clarify the proposed requirements or that disagree with, or suggest one or more changes to, the proposed requirements. After considering these comments, we have revised the proposed provisions as shown in table 6.

Table 6—Outcome of the Proposed General Revisions to Part 110

Proposed revisionOutcome
Establish the title of part 117We have revised the title to read “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.”
Consistency of terms: Activities subject to part 117We are establishing in part 117 the same definitions for the terms “manufacturing/processing,” “packing,” and ” holding” as we are establishing in the section 415 registration regulations and the section 414 recordkeeping regulations.
Consistency of terms: FacilityWe have made the following changes to the proposed rule: 1. We have revised the definition of “plant” to focus it on the building, structure, or parts thereof, used for or in connection with the manufacturing, processing, packing, or holding of human food.
2. We have revised applicable provisions to use “establishment” rather than “plant” when focusing on a business entity rather than on buildings or other structures.
3. We have made conforming changes throughout the rule.
Consistency of terms: Owner, operator, or agent in chargeWe are: (1) Defining the term “you” to mean, for purposes of part 117, the owner, operator, or agent in charge of a facility and (2) limiting use of the term “you” to provisions directed to “facilities” (i.e., provisions in subparts C, D, E, and G).
Consistency of terms: Food-packaging materialsWe received no comments that disagreed with our proposal that provisions of current part 110 directed to preventing contamination of food and food-contact substances consistently be directed to preventing contamination of food-packaging materials as well and are finalizing the applicable provisions as proposed.
Additions regarding allergen cross-contactThe CGMPs that we are establishing in subpart B explicitly address allergen cross-contact.
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Revisions for consistency with the definition of “food”We have retained the current phrase “raw materials and other ingredients” (rather than the proposed phrase “raw materials and ingredients”) throughout the rule to make it clear that raw materials are ingredients.
Revisions to delete some non-binding provisionsWe are deleting those nonbinding provisions of current part 110 that we proposed to delete. (For a list of these deleted provisions, see table 8 in the 2013 proposed human preventive controls rule, 78 FR 3646 at 3714).
Revisions to re-establish some non-binding provisions of part 110 as binding provisions in part 117With one exception, we are, as proposed, re-establishing certain non-binding provisions of part 110 in part 117 as binding provisions. See table 11 in the 2013 proposed human preventive controls rule (78 FR 3646 at 3728). The exception is one provision of § 110.80(b)(1) regarding inspecting containers of raw materials on receipt, which we are deleting rather than re-establishing it as a requirement.
Editorial changesWe are finalizing the proposed editorial changes regarding “Federal Food, Drug, and Cosmetic Act,” “includes, but is not limited to,” “must,” “adulteration,” and “when” as proposed, except that we are retaining the term “such as” in place of the proposed term “including” in two provisions.

A. Title of Part 117

We proposed to re-establish the provisions of current part 110 in new part 117 and to establish the title of part 117 as “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” (78 FR 3646 at 3691). (Note that in the 2013 proposed human preventive controls rule, we described this as revising the title of “current subpart B.” We should have described this as revising the title of current part 110.)

(Comment 59) Some comments ask us to revise the title to read “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.”

(Response 59) We have revised the title of the rule as requested.

B. Proposed Revisions for Consistency of Terms

1. Activities Subject to Proposed Part 117

We noted that we had previously described activities that may be considered “manufacturing, processing, packing, or holding” by establishing definitions for these terms in the section 415 registration regulations and the section 414 recordkeeping regulations (78 FR 3646 at 3692). We proposed to revise these existing definitions (see sections IV.D, IV.E, and IV.G) and to incorporate the revised definitions in part 117. We tentatively concluded that there is no meaningful distinction between these terms as we would define them in the revised definitions and these terms as they had been used in the CGMPs. We also tentatively concluded that consistent use of these terms throughout part 117, in reference to activities taking place in food facilities, establishments, or plants, would make the regulations more clear and have no substantive effect on the current requirements (78 FR 3646 at 3692). In the 2014 preventive controls supplemental notice, we proposed revisions to the definitions of “holding” and “packing” after considering comments submitted to the 2013 proposed human preventive controls rule.

(Comment 60) Some comments ask us to clarify how we were “revising” the definitions of the terms manufacturing, processing, packing, and holding because these terms had not been defined in the CGMPs in part 110.

(Response 60) The comments are correct that these terms had not been defined in the CGMPs in part 110. We proposed to “revise” these definitions in the section 415 registration regulations and the section 414 recordkeeping regulations and then establish in part 117 those revised definitions.

(Comment 61) Some comments from the produce industry state that it is difficult to assess whether there is a meaningful distinction between “packing” and “holding” as would be defined in the proposed human preventive controls rule and as had been used in the CGMPs in part 110 because most harvesting and post-harvest handling activities of RACs had been excluded from the CGMP requirements under § 110.19.

(Response 61) We assume that these comments are concerned about distinguishing “packing” from “holding” because some exemptions (e.g., the exemption in § 117.5(k) from the CGMP requirements for holding RACs and the exemption in § 117.5(j) from the requirements for hazard analysis and risk-based preventive controls) apply to “holding” RACs. As previously discussed, we have previously classified several on-farm activities in more than one way (79 FR 58524 at 58538 and 58571) depending on when the activity occurs. For example, sorting, culling, and grading RACs can occur during both packing and holding activities. However, we disagree that the full regulatory text of the definitions for “packing” and “holding” are not adequate to provide a meaningful distinction between the two terms. “Packing” means, in part, “placing food into a container” whereas holding means, in part “storage of food.” “Placing food into a container” is in no way similar to “storage of food.”

(Comment 62) Some comments disagree with our tentative conclusion that there is no meaningful distinction between “manufacturing/processing,” “packing,” and “holding” as we would define them in the revised definitions and these terms as they had been used in the CGMPs. These comments ask us to define these terms differently in the human preventive controls rule. These comments state that although they do not object to the consistent use of these terms throughout part 117 in reference to activities taking place in food facilities, establishments, or plants, they believe there are significant distinctions in these terms that need to be considered when finalizing the requirements of part 117.

(Response 62) These comments provide neither specific suggestions for how we should define these terms for the purpose of the human preventive controls rule nor specific reasons for their assertion that there are significant distinctions in these terms that need to be considered when finalizing the requirements of part 117. Without more specific information, we assume that the changes we have made to the definitions of “farm,” “holding,” and “packing” adequately address these comments.

2. The Term “Facility”

We proposed to replace the term “facility” or “facilities” in current part 110 with the term “establishment” or “plant” in proposed part 117 whenever the term “facility” or “facilities” could be confused with the firms that are subject to the proposed requirements for hazard analysis and risk-based Start Printed Page 55940preventive controls required by section 418 of the FD&C Act (78 FR 3646 at 3692). However, we tentatively concluded that it would not be necessary to replace the use of the term “facilities” in current requirements directed to specific functional parts of a plant or establishment, such as “toilet facilities” and “hand-washing facilities,” because the use of the term “facilities” in these contexts would not create confusion.

(Comment 63) Some comments state that it would not be helpful to use “plant” interchangeably with “establishment” when referring to a business that is not required to register. These comments ask us to consistently use one of these terms and to define a term that would mean “a business that is not required to register” to help distinguish such businesses from “facilities.”

(Response 63) We agree that it is appropriate to consistently use one term when referring to a business entity. However, we disagree that it is necessary to establish a definition for a business entity that is not required to register. A business that meets the definition of “facility” is required to register; a business that is not required to register is simply a business that does not meet the definition of “facility.”

To address these comments, we have revised provisions of the rule in three ways. First, we have revised the definition of “plant” to focus it on the building, structure, or parts thereof, used for or in connection with the manufacturing, processing, packing, or holding of human food, rather than on the “building or establishment.” Second, we have revised applicable provisions of part 117 to use “establishment” rather than “plant” when focusing on a business entity rather than on buildings or other structures. Third, we have revised provisions that use the terms “plant,” “establishment,” or both to conform to the definition of “plant” and the described usage of “establishment.” For example, § 117.10 establishes requirements for “the management of the establishment” rather than “plant management,” because “establishment” is the term focusing on the business entity. As another example, § 117.20(a)(1) establishes requirements for properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the “plant” rather than within the immediate vicinity of the “plant buildings or structures,” because the defined term “plant” focuses on the buildings and structures, and it is not necessary to repeat “buildings and structures” when the term “plant” is used.

3. Owner, Operator, or Agent in Charge

In the 2013 proposed human preventive controls rule, we requested comment on whether there is any meaningful difference between the persons identified in current part 110 and the “owner, operator, or agent in charge” identified in section 418 of the FD&C Act. We also requested comment on whether it would be appropriate to refer to the “owner, operator, or agent in charge” of a plant, establishment, or facility throughout proposed part 117 and, if so, whether the requirements would be clear if we revised the proposed rule to use pronouns (such as “you” and “your”) within proposed part 117 (78 FR 3646 at 3693). In the 2014 supplemental human preventive controls notice, we described comments on these issues and we tentatively concluded that we could simplify the regulations directed to the “owner, operator, or agent in charge of a facility” in provisions in subparts C, D, and E by using pronouns, without creating confusion, if we (1) define the term “you” to mean, for purposes of part 117, the owner, operator, or agent in charge of a facility and (2) limit use of the term “you” to provisions in proposed subparts C, D, and E (79 FR 58524 at 58556).

We received no comments that disagreed with the proposed definition of “you” and are finalizing that proposed definition without change.

4. Food-Packaging Materials

We proposed that provisions of current part 110 directed to preventing contamination of food and food-contact surfaces consistently be directed to preventing contamination of food-packaging materials as well (78 FR 3646 at 3693). We received no comments that disagreed with this proposal and are finalizing provisions directed to preventing contamination of food-packaging materials as proposed. For additional discussion regarding the term “food-packaging materials,” see Comment 107.

C. Proposed Additions Regarding Allergen Cross-Contact

We proposed to revise several CGMP provisions to explicitly address cross-contact (see 78 FR 3646 at 3693 and table 10 of the 2013 proposed human preventive controls rule, 78 FR 3646 at 3718-3719). In the 2014 supplemental human preventive controls notice, we proposed to define and use the term “allergen cross-contact” rather than “cross-contact,” and we are finalizing the definition of the term “allergen cross-contact” in this rule (see § 117.3). As discussed in sections XIII-XXII, the CGMPs that we are establishing in subpart B explicitly address allergen cross-contact, with some revisions requested by comments.

(Comment 64) Some comments ask us to clarify that allergen cross-contact has a meaning that is distinct from “contamination.”

(Response 64) We previously noted that, in the past, inadvertent incorporation of an allergen into a food was referred to as “contamination” or “cross-contamination,” but that more recently the term “cross-contact” (rather than “contamination” or “cross-contamination”) has been applied with respect to unintentional transfer of allergenic proteins from a food containing the proteins to one that does not, because an allergen is a normal component of food, and not itself a contaminant (78 FR 3646 at 3693). Given this shift in the scientific literature distinguishing “cross-contact” from “contamination” and “cross-contamination,” we tentatively concluded that we should begin using the term “cross-contact” (now “allergen cross-contact”) to describe inadvertent incorporation of an allergen into food, rather than the general term “contamination,” for purposes of clarity. In this final rule, we affirm that tentative conclusion.

To further improve clarity, we reviewed the provisions of the rule directed to preventing both allergen cross-contact and preventing contamination and made editorial changes throughout. For example, § 117.10(b)(1) requires that hygienic practices must include wearing outer garments suitable to the operation in a manner that protects against allergen cross-contact and against the contamination of food, food-contact surfaces, or food-packaging materials. For additional provisions that include these editorial changes, see table 52.

D. Proposed Revisions for Consistency With the Definition of “Food”

We proposed to retain the definition for “food” as already defined in § 110.3 (78 FR 3646 at 3693). Food means food as defined in section 201(f) of the FD&C Act and includes raw materials and ingredients. For consistency with the definition of food (which refers to “raw materials and ingredients” rather than “raw materials and other ingredients”), we proposed to change the title of current § 110.80(a) (which would be proposed § 117.80(b)) to “Raw materials and ingredients” rather than “Raw materials and other ingredients.” As a Start Printed Page 55941companion change to this change in title, we proposed to substitute “ingredients” for “other ingredients” throughout provisions in current § 110.80 that refer to both raw materials and ingredients (78 FR 3646 at 3693-3694).

(Comment 65) Some comments ask us to add a definition for “raw materials.”

(Response 65) We decline this request. During a previous rulemaking to revise the umbrella CGMPs, we explained that it is not possible to categorically distinguish raw materials and other ingredients because raw materials are ingredients, and both raw materials and ingredients are food within the meaning of the FD&C Act (51 FR 22458 at 22461, June 19, 1986). We have broadly defined “food” in this rule to include both raw materials and ingredients.

However, we have decided to retain the current phrase “raw materials and other ingredients” (rather than the proposed phrase “raw materials and ingredients”) throughout the rule to make it clear that raw materials are ingredients. See the regulatory text of §§ 117.80(b), 117.80(c)(6), (7), and (9); and 117.130(c)(2)(iii).

(Comment 66) Some comments ask us to revise the current definition of food (see Comment 87, Comment 88, and Comment 89).

(Response 66) See Response 87, Response 88, and Response 89 for our reasons for declining to revise the definition of “food” in this rule.

E. Proposed Revisions To Address Guidance in Current part 110

We proposed to delete some non-binding provisions of current part 110 (e.g., provisions using “should” or “compliance may be achieved by”) (78 FR 3646 at 3694 and 3714-3717). We also requested comment on whether to revise other non-binding provisions to establish new requirements in proposed part 117 or to simply retain them as useful provisions of a comprehensive CGMP (78 FR 3646 at 3694 and 3728-3729).

(Comment 67) Some comments ask us to retain the provisions we proposed to delete—e.g., because the information helps to clarify the intended effect of the regulations, suggests means of compliance with the requirements, and can educate small, new, or foreign companies. These comments assert that the benefits to both the regulated industry and to the general public of retaining the information we proposed to delete far outweigh any stylistic or other concerns. Likewise, some comments ask us to retain any non-binding provisions that we proposed to re-establish as requirements if, after considering comments, we do not finalize these provisions as requirements.

(Response 67) We agree that the non-binding provisions we proposed to delete, or considered re-establishing as requirements, provide useful information for reasons such as those mentioned in the comments. However, these provisions are more appropriately included in guidance, and we are deleting those non-binding provisions of part 110 that we are not establishing as requirements. We intend to transfer some of the CGMP recommendations that are currently in part 110, but that will be deleted from part 117, to guidance with editorial changes and changes that reflect current technology and industry practices. For a list of non-binding provisions that we are deleting, see table 7 in this document and table 8 in the 2013 proposed human preventive controls rule (78 FR 3646 at 3714-3717). See Response 321 for a discussion of our reasons for deleting the recommendation listed in table 7 in this document.

Table 7—Nonbinding Provisions That We Are Deleting in Addition to the Non-Binding Provisions Listed in Table 8 in the 2013 Proposed Human Preventive Controls Rule

Designation in part 110Description
§ 110.80(a)(1) (Processes and controls—raw materials and ingredients—final sentence)Containers and carriers of raw materials should be inspected on receipt to ensure that their condition has not contributed to the contamination or deterioration of food.

F. Proposed Editorial Changes

We proposed to revise current part 110 to make five editorial changes: (1) Refer to the “Federal Food, Drug, and Cosmetic Act” rather than to “the act”; (2) replace the term “shall” with the term “must”; (3) replace the phrase “includes, but is not limited to” with “includes”; (4) replace the phrase “adulteration within the meaning of the act” with the single term “adulteration”; and (5) replace the term “whenever” with “when.”

We received no comments that disagreed with our proposed editorial changes regarding “Federal Food, Drug, and Cosmetic Act,” “must,” “adulteration,” and “when” and are finalizing these editorial changes as proposed.

(Comment 68) Some comments ask us to either retain “includes, but is not limited to” wherever the list which follows is not intended to be exhaustive, or replace “includes, but is not limited to” with “such as,” to make clear that a following list is not complete.

(Response 68) The word “include” means to have (someone or something) as part of a group or total; to contain (someone or something) in a group or as a part of something (Ref. 22). The word “includes” does not need to be followed by “but is not limited to” to clearly communicate that a following list is not complete.

We proposed that two provisions (proposed § 117.80(c)(14) and (15)) replace the term “such as” with the term “including” (or variations of “including”). In light of the comment's view that “such as” would be clearer, we have retained the term “such as” in those provisions. We decline the request to more broadly revise the rule to replace “includes” with “such as.” In many cases the term “such as” cannot replace “includes” when used as a verb. We note that several provisions of the rule do use “such as” when that term is grammatically appropriate, such as in parenthetical phrases (see, e.g., the definitions of “holding” and “packing” in § 117.3).

G. General Comments on Current Part 110 (Final Part 117)

We proposed specific revisions and deletions to our long-standing umbrella CGMP requirements to modernize them. We also proposed to redesignate some of these CGMP requirements. For example, we proposed to redesignate the provisions found in six sentences that precede current § 110.80(a) by creating paragraph designations (a)(1) through (6) in new § 117.80. As corresponding changes, we proposed to redesignate current § 110.80(a) as § 117.80(b) and to redesignate current § 110.80(b) as § 117.80(c).

Several comments suggest specific modifications to the umbrella CGMPs beyond what we proposed to revise. In Start Printed Page 55942this section and in sections XIII through XXII, we address these specific suggestions and have amended the regulatory text where warranted.

(Comment 69) Some comments ask us to reorganize some of the current provisions to reduce redundancy, such as by combining provisions that address similar topics or deleting some provisions that the comments view as unnecessary in light of other provisions. For example, one comment suggests we move § 117.80(b)(5) (storage of raw materials, other ingredients, and rework) to § 117.80(a)(1) (general requirements) and another comment suggests we delete requirements in § 117.80(b)(1) for storing raw materials and ingredients because they are redundant with the storage requirements in § 117.80(b)(7).

(Response 69) We decline these requests. We acknowledge that there is some redundancy in subpart B and that we could improve the logical structure of subpart B by moving some of the requirements as recommended by some comments. However, these provisions have been in effect for decades, either since 1969 (when the umbrella CGMPs were first established (34 FR 6977, April 26, 1969) or since 1986 (when we last revised the umbrella CGMPs (51 FR 22458, June 19, 1986), and the comments do not provide examples of how we have been interpreting these provisions in a way that does not accomplish the goal of the umbrella CGMPs. Furthermore, we disagree with some of the comments on whether some provisions are redundant. For example, we disagree that § 117.80(b)(1) is redundant with § 117.80(b)(7) because § 117.80(b)(7) is narrowly directed to raw materials and other ingredients received in bulk and § 117.80(b)(1) is more generally directed to all raw materials and other ingredients.

Rather than reorganize and combine requirements, or delete requirements that some comments view as redundant with other requirements, we have focused on comments requesting specific changes to the current requirements to reflect current practices in the manufacturing, processing, packing, and holding of human food and to make these current requirements clearer (see sections XIII through XXII). Doing so is consistent with the goals of modernizing the umbrella CGMP requirements. However, we have declined many of these requests to make specific changes to particular CGMP provisions. In general, in evaluating the requested specific changes, we considered whether the comments described a problem with the current regulatory text, or instead focused on hypothetical problems that could occur in the future. Because most of these comments do not explain how the long-standing regulatory text has created a problem, we have declined many of these requests.

Likewise, in this document, we describe several editorial revisions that we made to improve the clarity of the CGMP requirements. However, we do not discuss comments that suggest editorial changes that simply suggest using different words in the regulatory text, but without explaining why the editorial revisions would improve the clarity of the provisions. These long-standing CGMPs have been in place and interpreted for decades, and we see no reason to revise them without a reason to do so.

(Comment 70) Some comments ask us to specify that several of the CGMP requirements in subpart B only apply “where the potential for contamination exists.” (See table 8.) Other comments ask us to change some requirements to recommendations or to specify that they only apply “as appropriate.” (See table 8.)

Table 8—CGMP Requirements That Comments Ask Us To Apply “Where the Potential for Contamination Exists” or Ask Us To Change to Recommendations

Examples of CGMP requirements that comments ask us to apply “where the potential for contamination exists”Examples of CGMP requirements that comments ask us to change to recommendations
§ 117.20(a)—Management responsibility for maintaining grounds§ 117.35(a)—General maintenance.
§ 117.20(b)—Suitability of plant construction and design§ 117.35(b)(1)—Cleaning Compounds and Sanitizing Agents.
§ 117.35(a)—General maintenance§ 117.35(b)(2)—Identification and Storage of Toxic Materials.
§ 117.35(c)—Pest control§ 117.35(c)—Pest control.
§ 117.37—Sanitary facilities and controls§ 117.35(d)—Sanitation of food-contact surfaces.
§ 117.40(a)(1)—Design of plant equipment and utensils§ 117.40(a)(6)—Maintenance of food-contact surfaces.
§ 117.40(a)(3)—Installation and maintenance of equipment§ 117.40(b)—Seams on food-contact surfaces.
§ 117.40(b)—Seams on food-contact surfaces§ 117.40(c)—Construction of equipment.
§ 117.40(c)—Construction of equipment§ 117.40(e)—Freezer and cold storage compartments.
§ 117.40(d)—Holding, conveying, and manufacturing systems.
§ 117.80(a)(1)—Adequate sanitation principles.
§ 117.80(a)(3)—Supervision of overall sanitation.

(Response 70) We decline these requests. These long-standing provisions apply generally to the plant, equipment and utensils in the plant, sanitary operations and sanitary facilities in a plant, and operations conducted in a plant. To suggest otherwise is inconsistent with the precepts of good manufacturing practices.

For example, as required by § 117.20(a), an establishment must have control of its grounds regardless of the specific food being produced, because litter, waste, weeds, and grass can all attract and harbor pests, and the first step for pest control in the plant is to avoid attracting pests. As required by § 117.20(b), a plant requires suitable construction and design regardless of the specific potential for contamination at any particular location in the plant. Each of the seven more specific provisions governed by § 117.20(b) adds the context that the requirements are directed to what is “adequate” (e.g., adequate space, adequate precautions, and adequate cleaning), and the defined term “adequate” provides context that the purpose of the requirements for plant construction and design are related to public health. As required by § 117.40, a plant requires clean and sanitary equipment regardless of the specific potential for contamination associated with a particular piece of equipment or the type of food being produced, because dirty equipment at one location in a plant can attract pests or become a harborage for environmental pathogens that can eventually lead to contamination in multiple locations in the plant. As required by § 117.80(a)(10), a food plant requires adequate sanitation regardless of the specific potential for contamination, and the term “adequate” provides flexibility for how an Start Printed Page 55943establishment designs and implements its sanitation program when the potential for contamination is low. As required by § 117.80(a)(3), a plant requires adequate sanitation regardless of the specific potential for contamination, and someone must be in charge of sanitation to determine what needs to be done, where it needs to be done, and how often it needs to be done. The individual(s) who supervises the sanitation of the plant has flexibility in the design and implementation of a sanitation program when the potential for contamination is low.

In addition, the CGMP requirements are flexible requirements that each establishment can adapt to its own operations, equipment, and food products. For example, § 117.35(a) requires that buildings, fixtures, and other physical facilities of the plant must be maintained in a clean and sanitary condition and must be kept in repair adequate to prevent food from becoming adulterated. Cleaning and sanitizing of utensils and equipment must be conducted in a manner that protects against allergen cross-contact and against contamination of food, food-contact surfaces, or food-packaging materials. The standards established by the requirement are to protect against contamination and allergen cross-contact, and the defined term “adequate” provides the context that the specific measures adopted by an establishment are related to public health.

(Comment 71) Some comments ask us to change the phrase “work-in-process” to “in-process materials” in several provisions throughout proposed subpart B because they believe “in-process materials” to be more familiar, straightforward, and commonly understood than “work-in-process.”

(Response 71) “Work-in-process” is the common industry term used in widely disseminated industry publications (Ref. 23) (Ref. 24) and has been in use for more than 30 years in the umbrella CGMPs. In addition, we did not receive any comments objecting to the use of this term when we proposed to include it in previous revisions to the umbrella CGMPs (proposed rule 44 FR 33238 at 33247, June 8, 1979; final rule, 51 FR 22458, June 19, 1986). Therefore, we have retained the phrase “work-in-process” in the final rule.

VIII. Subpart A: Comments on Proposed § 117.1—Applicability and Status

We proposed to redesignate § 110.5 as proposed § 117.1, and to add a provision relevant to FSMA's statutory provisions for a prohibited act under section 301(uu) of the FD&C Act (21 U.S.C. 331(uu)). Some comments support the proposed provisions without change. For example, one comment expresses the view that one strength of the long-standing CGMPs is their applicability to the broad spectrum of food manufacturing, from the manufacture of processed products and packaging of fresh produce to production of food additives and GRAS substances. (We note that some packaging of fresh produce (e.g., packaging of RACs on a farm) is not subject to the CGMPs.)

Some comments that support the proposed provisions ask us to clarify how we will interpret the provisions (see, e.g., Comment 72).

In the following paragraphs, we discuss comments that ask us to clarify the proposed requirements or that disagree with, or suggest one or more changes to, the proposed requirements. After considering these comments, we are finalizing the provisions as proposed, with editorial and conforming changes as shown in table 52.

A. Comments on Proposed § 117.1(a)—Applicability

We proposed that the criteria and definitions in part 117 apply in determining whether a food is adulterated: (1) Within the meaning of section 402(a)(3) of the FD&C Act in that the food has been manufactured under such conditions that it is unfit for food; or (2) within the meaning of section 402(a)(4) of the FD&C Act in that the food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. We also proposed that the criteria and definitions in part 117 also apply in determining whether a food is in violation of section 361 of the Public Health Service Act (42 U.S.C. 264).

(Comment 72) Some comments ask us to clarify that part 117 does not apply to activities that are subject to the requirements for CGMPs, hazard analysis and risk-based preventive controls for animal food and feed by inserting “intended for consumption by humans” after “food” in § 117.1(a).

(Response 72) We decline this request. As discussed in Response 6, the applicability of these regulations to human food is specified in the regulatory text by the title of the rule and by its placement in Subchapter B, rather than Subchapter E, of 21 CFR.

(Comment 73) Some comments assert that there is a clear difference between the criteria in proposed § 117.1(a)(1) used to describe adulterated food and the referenced criteria in section 402(a)(3) of the FD&C Act, in that proposed § 117.1(a)(1) describes manufacturing conditions whereas section 402(a)(3) of the FD&C Act describes actual adulterated product.

(Response 73) We disagree with these comments. We interpret “otherwise unfit for food” in this long-standing statement of applicability to be broader than physical properties of the food and to apply to the manufacturing conditions of the food.

(Comment 74) Some comments note that FSMA granted FDA mandatory recall authority for adulterated food. These comments express concern that theoretically we could use a violation of the requirements for hazard analysis and risk-based preventive controls to determine that food is adulterated, thereby providing the basis for a mandatory recall of that food. These comments raise three issues regarding how we will apply § 117.1(a), with consequences for a potential mandatory recall of food.

First, these comments note that the regulatory text stating that the “criteria and definitions” apply in making a determination of adulteration appears to encompass the entirety of the rule. As a result, farms or facilities that violate any of the requirements in the proposed rule, including components not directly related to the safety of the food (such as recordkeeping requirements), could face a risk that we would deem their food adulterated.

Second, these comments assert that the regulatory text suggests that we would not automatically consider a food adulterated as a result of a violation of the proposed rule, because it states that the criteria and definitions “apply in determining” whether a food will be considered adulterated, rather than that the food “is” adulterated.

Third, these comments state that it is not clear how the exemption applicable to qualified facilities is included in the “criteria and definitions” used in making a determination of adulteration. These comments ask us to clarify that we will not just automatically assume that qualified facilities are selling adulterated food because they are by definition exempt from the requirements for hazard analysis and risk-based preventive controls.

(Response 74) The comments are correct that the criteria and definitions “apply in determining” whether a food will be considered adulterated, rather than that the food “is” adulterated. In determining whether a food that is manufactured, processed, packed, or held in violation of part 117 (including a violation of the recordkeeping Start Printed Page 55944requirement) is adulterated, we would consider the totality of the available data and information about the violation and the food before reaching a conclusion that the food is adulterated.

Although this rule does not address the mandatory recall provisions of FSMA, the statutory provisions establish two basic criteria. (See section 423(a) of the FD&C Act (21 U.S.C. 350l).) First, we must determine that there is a “reasonable probability” that the food is adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act. A violation of part 117 would be relevant to determining whether a food is adulterated under section 402. Second, we must determine that there is a reasonable possibility that the use of, or exposure to, that food will cause serious adverse health consequences or death to humans or animals. Not all food that is adulterated has a reasonable probability of causing serious adverse health consequences or death to humans or animals. For examples of food contamination with a reasonable probability of causing serious adverse health consequences or death to humans or animals, see the annual reports of the Reportable Food Registry (RFR) (Ref. 25) (Ref. 26) (Ref. 27) (Ref. 28).

A facility that is exempt from any requirement of part 117, including the requirements for hazard analysis and risk-based preventive controls, would not be in violation of part 117 if it did not comply with provisions that it is not subject to.

B. Comments on Proposed § 117.1(b)—Prohibited Act

We proposed that the operation of a facility that manufactures, processes, packs, or holds food for sale in the United States is a prohibited act under section 301(uu) of the FD&C Act (21 U.S.C. 331(uu)) if the owner, operator, or agent in charge of such facility is required to comply with, and is not in compliance with, section 418 of the FD&C Act or subparts C, D, E, or F of part 117 (proposed § 117.1(b)).

(Comment 75) Some comments from State regulatory agencies note that this new provision is not covered under the applicable State statute and that making any changes to the State statute can be a lengthy process that takes up to 3 years to complete.

(Response 75) See Response 5 for a discussion of our approach to working with our food safety partners in the States.

C. Comments on Proposed § 117.1(c)—Specific CGMP Requirements

We proposed to redesignate § 110.5(b) as proposed § 117.1(c) with no changes. We received no comments that disagreed with our proposal, and are finalizing the proposed provision without change.

IX. Subpart A: Comments on Proposed § 117.3—Definitions

We proposed to revise some definitions that had been established in part 110, redesignate and re-establish the remaining definitions in part 117 (except for the definition of “shall,” which we proposed to delete), and establish several new definitions in part 117. Some comments support one or more of these proposed definitions without change. For example, some comments state that they support the proposed definitions for the following terms with no suggested revisions: critical control point, facility, food allergen, food-contact surfaces, microorganism, mixed-type facility, monitor, plant, safe-moisture level, subsidiary, and validation. Some comments support our proposal, in the 2014 supplemental preventive controls notice, to use the phrase “chemical (including radiological)” in the definition of “hazard,” noting that doing so is consistent with FSMA, current industry practice, and Codex and global HACCP standards. Some comments that support a proposed definition suggest alternative or additional regulatory text, such as adding examples to make the definition clearer (see, e.g., Comment 81 and Comment 87). Some comments that support a proposed definition ask us to clarify how we will interpret the definition (see, e.g., Comment 77 and Comment 87).

In the following sections, we discuss comments that ask us to clarify the proposed definitions or that disagree with, or suggest one or more changes to, the proposed definitions. After considering these comments, we have revised the proposed requirements as shown in table 9, with editorial and conforming changes as shown in table 52. We also have deleted the definition of “should,” because the final rule does not use that term.

We also discuss definitions for additional terms (i.e., “audit,” “correction,” “defect action level,” “full-time equivalent employee,” “qualified facility exemption,” “raw agricultural commodity,” “supply-chain-applied control,” “written procedures for receiving raw materials and other ingredients,” and “unexposed packaged food”) that we are establishing in the final rule to simplify the regulatory text throughout the regulations and improve clarity. We also discuss a new name (i.e., “preventive controls qualified individual”) for the definition of a term that we had proposed to name “qualified individual” and are establishing a new definition for the term “qualified individual.” Finally, we discuss definitions that comments ask us to add, but that we did not add, to the final rule.

Table 9—Definitions That We Proposed To Establish in § 117.3

DefinitionCurrent definition (§ 110.3) or new definition?If current, did we propose any revisions?Did we receive any comments that disagreed with the definition we proposed to include in part 117?Did we make any changes to the proposed definition other than the editorial and conforming changes listed in Table 52?
Acid foods or acidified foodsCurrentNoNoNo.
AdequateCurrentNoYesNo.
AffiliateNewN/AYesNo.
Allergen cross-contactNewN/AYesNo.
AuditNew in the final ruleN/AN/AN/A.
BatterCurrentNoNoNo.
BlanchingCurrentNoNoNo.
Calendar dayNewN/ANoNo.
CorrectionNew in the final ruleN/AN/AN/A.
Critical control pointCurrentYesYesNo.
Defect action levelNew in the final ruleN/AN/AN/A.
Environmental pathogenNewN/AYesYes.
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FacilityNewN/AYesNo.
FarmNewN/ASee discussion of § 1.227 in section IV.BNo.1
FDANewN/ANoNo.
FoodCurrentNoYesNo.
Food allergenNewN/AYesNo.
Food-contact surfacesCurrentYesNoNo.
Full-time equivalent employeeNew in the final ruleN/AN/AN/A.
HarvestingNewN/ASee discussion of § 1.227 in section IV.CYes.
HazardNewN/AYesYes.
HoldingNewN/ASee discussion of § 1.227 in section IV.DYes.
Known or reasonably foreseeable hazardNewN/AYesYes.
LotCurrentNoYesYes.
Manufacturing/processingNewN/ASee discussion of § 1.227 in section IV.EYes.
MicroorganismsCurrentYesYesNo.
Mixed-type facilityNewN/ASee discussion of § 1.227 in section IV.FNo.
MonitorNewN/AYesYes.
Packaging (when used as a verb)NewN/AYesThe final rule does not include a definition of packaging (when used as a verb).
PackingNewN/ASee discussion of § 1.227 in section IV.GNo.
PathogenNewN/AYesNo.
PestCurrentNoYesNo.
PlantCurrentYesYesReplace the term “establishment” with “structure”.
Preventive controlsNewN/AYesNo.
Preventive controls qualified individualNewN/AYesNo, except to change the name of the term from “qualified individual” to “preventive controls qualified individual”.
Qualified auditorNewN/AYesYes.
Qualified end-userNewN/AYesYes.
Qualified facilityNewN/AYesNo.
Qualified facility exemptionNew in the final ruleN/AN/AN/A.
Qualified individualNew in the final ruleN/AN/AN/A.
Quality control operationCurrentNoNoNo.
Raw agricultural commodityNew in the final ruleN/AN/AN/A.
Ready-to-eat (RTE) foodNewN/AYesNo.
Receiving facilityNewN/AYesNo.
ReworkCurrentNoNoNo.
Safe-moisture levelCurrentYesNoNo.
SanitizeCurrentYesYesYes.
ShouldCurrentNoNoDeleted the definition.
Significant hazardNewN/AYesYes, including changing the term to “hazard requiring a preventive control”.
Significantly minimizeNewN/AYesNo.
Small businessNewN/AYesYes.
SubsidiaryNewN/AYesNo.
SupplierNewN/AYesYes.
Supply-chain -applied controlNew in the final ruleN/AN/AN/A.
Unexposed packaged foodNew in the final ruleN/AN/AN/A.
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ValidationNewN/AYesYes.
VerificationNewN/AYesYes.
Very small businessNewN/AYesYes.
Water activityCurrentNoNoNo.
Written procedures for receiving raw materials and other ingredientsNew in the final ruleN/AN/AN/A.
YouNewN/ANoNo.
1 The “farm” definition in § 117.3 is a cross-reference to the “farm” definition in the section 415 registration regulations. Although we did revise the “farm” definition in the section 415 registration regulations (see section IV.B), the cross-reference we are establishing in § 117.3 is unchanged.

A. Redesignation

We proposed to redesignate all definitions in § 110.3(a) through (r) as proposed § 117.3, eliminate paragraph designations (such as (a), (b), and (c)), and add new definitions in alphabetical order. We received no comments that disagreed with our proposal, and are finalizing the proposed redesignations.

B. Definitions in Current Part 110 That We Proposed To Delete

We proposed to delete the definition of “shall” and use “must” instead. We received no comments that disagreed with our proposal, and are deleting the definition of “shall” as proposed.

C. Definitions That We Proposed To Establish in Part 117

1. Adequate

We proposed to define the term “adequate” to mean that which is needed to accomplish the intended purpose in keeping with good public health practice.

(Comment 76) Some comments assert that the definition is vague and ask us to clarify what constitutes “adequate” for systems such as operating systems for waste treatment and disposal. Other comments ask us to develop guidance on thresholds and processes that qualify as “adequate.” Other comments assert that the word “adequate” must be used in combination with the word “reasonable” to properly describe the intended measures and precautions. As an example, these comments assert that the definition of “adequate” could lead to excessive requirements when applied to the provisions for disease control and hygiene (§ 117.10).

(Response 76) We disagree that this long-standing definition of the term “adequate” is vague. The comments do not provide any examples of how we have interpreted this definition in the past in a way that creates practical problems when applying CGMP requirements, including requirements directed to the management of waste or the provisions for disease control and hygiene. Our intent in using the term “adequate” is to provide flexibility for a food establishment to comply with the requirement in a way that is most suitable for its establishment. We decline the request to develop guidance to explicitly address “thresholds” or to describe processes that qualify as adequate. The CGMPs established in this are broadly applicable procedures and practices rather than very specific procedures and practices where additional interpretation from FDA might be appropriate.

2. Affiliate and Subsidiary

We proposed to define the term “affiliate” to mean any facility that controls, is controlled by, or is under common control with another facility. We proposed to define the term “subsidiary” to mean any company which is owned or controlled directly or indirectly by another company. These proposed definitions would incorporate the definition in sections 418(l)(4)(A) and (D) of the FD&C Act and would make the meanings of these terms clear when used in the proposed definition of “qualified facility.”

(Comment 77) Some comments ask us to clarify that a facility that has no material connection with another food processing operation would not be considered as an “affiliate” of that operation.

(Response 77) It is not clear what the comments mean by “no material connection with another food processing operation.” To the extent that a facility does not control, is not controlled by, or is not under common control with another facility, we agree that the facility would not be considered an affiliate of that food processing operation.

(Comment 78) Some comments assert that the definitions of “affiliate” and “subsidiary” fail to account for the legal differences between a piece of property (i.e., a facility) and a business entity or person. These comments ask us to consider amending the proposed definition of “qualified facility” to clarify what sales to include in determining whether a facility so qualifies.

(Response 78) See Response 118.

3. Allergen Cross-Contact

We proposed to define the term “allergen cross-contact” to mean the unintentional incorporation of a food allergen into a food.

(Comment 79) Some comments assert that the term “incorporation” used in the definition is a vague term that has entirely different meanings when used by different segments of the food industry (e.g., the term would mean something different to a produce wholesaler than to a cereal manufacturer). These comments ask us to provide either a clarification or a definition for the term “incorporation.”

(Response 79) By “unintentional incorporation of a food allergen into food” we mean that the food allergen would be in a food when the producer of the food did not intend it to be in the food—e.g., if a milk-based beverage contains soybeans in addition to milk. Several provisions of the rule require that a facility take steps to prevent such unintentional incorporation of a food allergen into food. See our previous discussion of the importance of preventing allergen cross-contact (78 FR 3646 at 3693).

4. Critical Control Point

We proposed to revise the definition for “critical control point” to mean a point, step, or procedure in a food process at which control can be applied and is essential to prevent or eliminate Start Printed Page 55947a food safety hazard or reduce such hazard to an acceptable level.

(Comment 80) Some comments ask us to specify that a critical control point is essential to reduce the presence of hazards such as microorganisms to “minimize the risk of foodborne illness” rather than to “reduce such hazard to an acceptable level.” These comments assert that this revision would be consistent with the approach in the proposed produce safety rule. Other comments disagree with the proposed definition because it does not define a term (i.e., acceptable level) used in the definition.

(Response 80) We decline to modify the definition as requested by these comments. The proposed definition matches the statutory definition in section 418(o)(1) of the FD&C Act and is consistent with definitions in the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry (78 FR 3646 at 3695). The proposed produce safety rule, which did not propose to define “critical control point,” focused on biological hazards. However, critical control points may be established to control chemical or physical hazards in addition to biological hazards. The standard suggested by the comments is not inconsistent with the definition we proposed for “critical control point” in the human preventive controls rule, because preventing or eliminating a food safety hazard or reducing such hazard to an acceptable level would minimize the risk of foodborne illness. However, the standard suggested by the comments was narrowly directed to biological hazards, because chemical and physical hazards generally cause injury rather than illness.

We do not need to define every term used in the definition. By specifying that a point, step, or procedure in a food safety process would reduce a hazard to an “acceptable level,” the definition provides flexibility for a facility to determine an appropriate level in a particular circumstance. Consistent with the approach recommended in the proposed produce safety rule (78 FR 3504 at 3545), a facility could use current FDA guidance on microbiological hazards (e.g., Ref. 29 and Ref. 30) to inform its decision on what constitutes an acceptable level. In those documents, we use the phrase “adequately reduce” to mean capable of reducing the presence of Salmonella to an extent sufficient to prevent illness. The extent of reduction sufficient to prevent illness usually is determined by the estimated extent to which Salmonella spp. may be present in the food combined with a safety factor to account for uncertainty in that estimate. For example, if it is estimated that there would be no more than 1000 (i.e., 3 logs) Salmonella organisms in the food, and a safety factor of 100 (i.e., 2 logs) is employed, a process adequate to reduce Salmonella spp. would be a process capable of reducing Salmonella spp. by 5 logs.

5. Environmental Pathogen

We proposed to define the term “environmental pathogen” to mean a pathogen capable of surviving and persisting within the manufacturing, processing, packing, or holding environment such that food may be contaminated and may result in foodborne illness if that food is consumed without treatment to significantly minimize or prevent the environmental pathogen. We also proposed to specify that environmental pathogen does not include the spores of pathogenic sporeformers.

(Comment 81) Some comments ask us to include Salmonella spp. and L. monocytogenes in the regulatory text as examples of environmental pathogens because of the likelihood that these environmental pathogens could contaminate ready-to-eat (RTE) food. Other comments ask us to provide a broader list (including Escherichia coli, Campylobacter, pathogenic Vibrio, Staphylococcus aureus, Clostridium botulinum, Shigella, Yersinia enterocolitica, and viruses such as rotoviruses and noroviruses) in the preamble to the final rule or in guidance, and to make clear that the list is not all-inclusive. Some comments emphasize the need for flexible language because any list of microorganisms might change over time, particularly as new environmental pathogens emerge.

Some comments ask us to include the indicator organism Listeria spp. in the regulatory text, because analysis of Listeria spp. is faster than analysis of L. monocytogenes. Other comments ask us to include pathogens that have been associated with RACs, as reported by CDC.

(Response 81) We agree that Salmonella spp. and L. monocytogenes are useful examples of environmental pathogens and have added these two examples to the proposed definition, which had not included examples. As the comments point out, adding these two examples to the definition does not mean that these two pathogens are the only environmental pathogens that a facility must consider in its hazard analysis. New environmental pathogens can emerge at any time, and other pathogens (e.g., Cronobacter spp.) can also be environmental pathogens (78 FR 3646 at 3816).

We have not included the indicator organism Listeria spp. as an example of an environmental pathogen, whether in the regulatory text, in the preamble of this document, or in guidance. Although we agree that Listeria spp. is an appropriate indicator organism when conducting verification testing for sanitation controls, the definition in question is for a pathogen, not for indicators of a pathogen. Other provisions of the rule are more appropriate to provide the context that a facility has flexibility for how to conduct verification testing for an environmental pathogen, including an option to test for an indicator organism. (See, e.g., § 117.165(a)(2) and (3).)

L. monocytogenes, Salmonella spp., and some of the other pathogens mentioned in the comments have been associated with RACs. To the extent that the comments are asking us to identify some environmental pathogens that have been associated with RACs, by identifying these pathogens in the regulatory text or in this preamble we have done so. However, it is important to note that the term “environmental pathogen” as defined in this rule is directed to pathogens in the food processing environment (such as the insanitary conditions in a facility that packed cantaloupes linked to an outbreak of listeriosis (78 FR 3646 at 3814)), not to pathogens present in the growing environment for a RAC.

(Comment 82) Some comments ask us to define “environmental pathogen” as a microorganism that is of public health significance and is capable of surviving and persisting within the manufacturing, processing, packing, and holding environment of the food being prepared.

(Response 82) We decline this request. The definition of “environmental pathogen” should not change depending on the food being prepared in a particular facility. As a practical matter, the facility will consider the manufacturing, processing, packing, and holding environment of the food being prepared when it conducts its hazard analysis (§ 117.130).

(Comment 83) Some comments ask us to focus attention on the areas where environmental monitoring is particularly important by modifying the definition to address the risk of contamination to RTE food and to foods exposed to the environment after a lethality step. Other comments ask us to consider the number and types of different products produced, the complexity of processing procedures, Start Printed Page 55948the amount of product produced, and whether an environmental sampling program is in place.

(Response 83) We decline these requests, which are asking us to specify in a definition factors associated with developing an environmental monitoring program. The purpose of a definition is to simply explain what a term means, not to establish requirements, or provide guidance about requirements, that use the term.

(Comment 84) Some comments ask us to clarify the meaning of the term “persisting” as used in the definition, such as whether it means that a sanitation process will not remove the microorganism.

(Response 84) We use the term “persisting” to mean that a pathogen can become established if cleaning is not adequate. Once a pathogen becomes established, appropriate sanitation measures can remove the pathogen. However, sanitation procedures necessary to eliminate an environmental pathogen that has become established generally are more aggressive than routine sanitation procedures.

(Comment 85) Some comments ask us to revise the definition to specify that the microorganisms are “potentially” of public health significance.

(Response 85) We decline this request. The definition is only directed at those microorganisms that are of public health significance.

(Comment 86) One comment asserts that the proposed definition of “environmental pathogen” excludes the waterborne pathogens Cyclospora and Cryptosporidium and asks us to revise the definition so that these pathogens will be considered “environmental pathogens” for the purposes of the human preventive controls rule. The comment asserts that excluding these waterborne pathogens does not take into account the considerable food safety hazard of “spores” of “pathogenic sporeformers” that can be present in and delivered to a food processing facility by processing and ingredient water, both well water and surface water from either private or municipal supply, in both domestic and foreign facilities. The comment asks us to delete the statement that an environmental pathogen does not include the spores of pathogenic sporeformers so that, according to the comment, Cyclospora and Cryptosporidium would fall within the definition of “environmental pathogen.”

(Response 86) We disagree that the pathogens Cyclospora and Cryptosporidium should be considered “environmental pathogens” as we use that term in this rule. Our definition of “environmental pathogen” is directed to those pathogens that are capable of surviving and persisting within the manufacturing, processing, packing, or holding environment of a food establishment, not the water that is used in a food processing establishment. See the discussion of environmental pathogens in the food processing environment in section I.D of the Appendix to the 2013 proposed human preventive controls rule (78 FR 3646 at 3813-3815, with corrected reference numbers at 78 FR 17142 at 17144-17146). As discussed in that Appendix, the available data and information associate insanitary conditions in food facilities with contamination of a number of foods with Salmonella spp. and L. monocytogenes. Such contamination has led to recalls and to outbreaks of foodborne illness. As a result, the rule includes several provisions directed to those pathogens, such as Salmonella spp. and L. monocytogenes, that are capable of surviving and persisting within a food establishment (thereby serving as a source of contamination of the food establishment environment) and uses the defined term “environmental pathogens” to describe those pathogens. These specific provisions do not apply to waterborne pathogens that do not survive and persist within a food establishment.

By “pathogenic sporeformers,” we mean “pathogenic sporeforming bacteria,” and we are substituting the term “pathogenic sporeforming bacteria” for “pathogenic sporeformers” in the definition of “environmental pathogen” to make that clearer. Both of the waterborne pathogens discussed by this comment are protozoan parasites, not bacteria (Ref. 31).

The fact that waterborne organisms such as Cyclospora and Cryptosporidium are not “environmental pathogens” as that term is used in this rule does not mean that a facility has no responsibility to evaluate whether Cyclospora or Cryptosporidium are known or reasonably foreseeable hazards that require a preventive control. For example, when a fresh-cut produce processing facility receives produce from a geographic region where Cyclospora or Cryptosporidium have been associated with food safety problems, the facility likely would address the potential for contamination of incoming produce with Cyclospora or Cryptosporidium in its supply-chain program (see subpart G for the requirements of the supply-chain program).

6. Facility

We proposed to define the term “facility” to mean a domestic facility or a foreign facility that is required to register under section 415 of the FD&C Act in accordance with the requirements of 21 CFR part 1, subpart H. Comments directed to the meaning of the term “facility” address its meaning as established in the section 415 registration regulations, rather than this definition established in part 117. See Comment 4 and Response 4.

7. Farm

We proposed to define the term “farm” by reference to the definition of that term in proposed § 1.227 rather than by repeating the full text of the “farm” definition in part 117. See section IV.B for a discussion of the “farm” definition that we are establishing in § 1.227.

8. Food

We proposed to define the term “food” to mean food as defined in section 201(f) of the FD&C Act and to include raw materials and ingredients. Under section 201(f), the term “food” means: (1) Articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.

(Comment 87) Some comments ask us to include examples in the definition, particularly dietary supplements and dietary ingredients. These comments also ask us to clarify whether the definition applies to food for human consumption, animal consumption, or both.

(Response 87) We decline the request to include examples in the definition. Dietary supplements and dietary ingredients are articles used for food or drink for man, as are many other articles. There are many examples of food and adding a limited list of examples could be confusing rather than helpful. Although the definition of food includes food for both human consumption and animal consumption, the provisions of the rule are clearly directed to food for human consumption (see Response 6 and Response 72).

(Comment 88) Some comments ask us to consider fundamental and important differences between food additives and GRAS substances and finished food. These comments explain that food additives and GRAS substances may be synthesized using various chemical and biochemical processes, or may be extracted, hydrolyzed or otherwise modified from their natural sources, and result in food safety hazards that are quite different from finished food Start Printed Page 55949preparations. These comments also explain that food additives and GRAS substances are often produced using processes that minimize microbial contamination hazards and are almost always used in food products that undergo further downstream processing. These comments assert that food additives and GRAS substances generally present a significantly lower public health hazard compared to finished food and should be regulated accordingly.

(Response 88) Substances such as food additives and GRAS substances are food and are subject to the requirements of this rule. Both the CGMP requirements in subpart B and the requirements for hazard analysis and risk-based preventive controls in subparts C and G provide flexibility to address all types of food. (As discussed in section XLII, the final rule establishes the requirements for a supply-chain program in subpart G, rather than within subpart C as proposed. As a result, this document refers to subparts C and G when broadly referring to the requirements for preventive controls.) Some comments point out that one strength of the long-standing CGMPs is their applicability to the broad spectrum of food manufacturing, from the manufacture of processed products to production of food additives and GRAS substances (see section VIII). A manufacturer of a food additive or GRAS substance has flexibility to comply with the requirements of the rule based on the nature of the production processes and the outcome of the hazard analysis for that food substance. (See also Response 221.)

(Comment 89) Some comments ask us to limit the definition of “food” as it would apply to the new requirements for hazard analysis and risk-based preventive controls to only cover produce and processed foods covered by the rules, rather than all food (human and animal, produce and non-produce, low-risk and high-risk).

(Response 89) We decline this request. It is not necessary to modify the definition of “food” to limit applicability of the rule to human food. (See Response 6.) The umbrella CGMPs that we are establishing in subpart B are long-standing provisions that establish basic requirements for the manufacturing, processing, packing, and holding of food to prevent adulteration and are not “one-size-fits-all.” (See Response 221.) The new requirements for hazard analysis and risk-based preventive controls likewise are not “one-size-fits-all,” and facilities that are subject to the rule would consider the risk presented by the products as part of their hazard evaluation; a facility that appropriately determines through its hazard analysis that there are no hazards requiring preventive controls would document that determination in its written hazard analysis but would not need to establish preventive controls and associated management components. (See Response 222.)

9. Food Allergen

We proposed to define the term “food allergen” to mean a major food allergen as defined in section 201(qq) of the FD&C Act.

(Comment 90) Some comments ask us to narrow the definition of food allergen by specifying that a substance is only a food allergen when it is not disclosed on the product label.

(Response 90) We decline this request, which appears to confuse the distinction between what a food allergen is and when a product would be misbranded under section 403(w) of the FD&C Act. The substances listed in section 201(qq) of the FD&C Act are food allergens; if any of those substances are not disclosed on the product label, then the product would be misbranded under section 403(w) of the FD&C Act.

(Comment 91) Some comments ask us to expand the existing exemption for RACs from the definition of major food allergen in section 403(w)(1) of the FD&C Act to include raw fish.

(Response 91) This comment is unclear and appears to be confusing the definition of “major food allergen” in section 201(qq) of the FD&C Act with criteria for when a food shall be deemed to be misbranded under section 403(w) of the FD&C Act. Under section 403(w), a food shall be deemed misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless certain labeling requirements are met. Under section 201(r) of the FD&C Act, the term “raw agricultural commodity” means any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing. Fish are food and, thus, raw, unprocessed fish are RACs within the meaning of section 403(w). Thus, the misbranding provisions of section 403(w) would not apply to raw, unprocessed fish, because those misbranding provisions do not apply to RACs. However, the exemption in section 403(w) from the conditions under which a food shall be deemed to be misbranded do not establish an exemption for RACs in the definition of “major food allergen” in section 201(qq).

To the extent that the comment is asking us to revise either the statutory definition of “major food allergen” in section 201(qq) of the FD&C Act, or to revise the criteria for when a food shall be deemed misbranded under section 403(w) of the FD&C Act, we do not have authority to do so.

(Comment 92) Some comments ask us to include an example of an ingredient derived from an allergen in the definition.

(Response 92) We decline this request. The definition of “major food allergen” in section 201(qq) of the FD&C Act is sufficient to define the term. Casein and whey protein, each of which are derived from milk, are examples of ingredients that would satisfy the definition of “major food allergen” in section 201(qq).

10. Harvesting

We proposed to establish in § 117.3 the same definition of “harvesting” as we proposed to establish in §§ 1.227 and 1.328. See section IV.C for a discussion of comments we received to the proposed definition of “harvesting” in §§ 1.227 and 1.328, and our responses to those comments.

11. Hazard

We proposed to define the term “hazard” to mean any biological, chemical (including radiological), or physical agent that is reasonably likely to cause illness or injury in the absence of its control.

(Comment 93) Some comments express concern that the rule would refer to four levels of “hazard”—i.e., “hazard,” “known or reasonably foreseeable hazard,” “significant hazard,” and “serious adverse health consequences or death to humans or animals” hazard. These comments ask us to provide sufficient clarity to be able to distinguish between these types of hazards and to provide examples in guidance as to how these terms will be applied in determining compliance with the rule. Other comments express concern that the definitions do not establish a meaningful distinction between “hazard” and “significant hazards” and do not sufficiently distinguish between the hazards identified in the first and second steps of the hazard analysis (first narrowing hazards to “known or reasonably foreseeable hazards” and then narrowing the “known or reasonably foreseeable hazards” to “significant hazards”).

(Response 93) The rule uses three of these terms (i.e., “hazard,” “known or reasonably foreseeable hazard,” and the proposed term “significant hazard”) to Start Printed Page 55950establish a tiered approach to the requirements for hazard analysis and risk-based preventive controls. The term “hazard' is the broadest of these three terms—any biological, chemical (including radiological), or physical agent that is reasonably likely to cause illness or injury. To conduct its hazard analysis, a facility starts by first narrowing down the universe of all potential hazards to those that are “known or reasonably foreseeable” for each type of food manufactured, processed, packed, or held at its facility. The outcome of the facility's hazard analysis is a determination of “significant hazards”—i.e., the subset of those known or reasonably foreseeable hazards that require a preventive control.

To make this clearer, we have: (1) Revised the proposed definition of “hazard”; (2) changed the term “significant hazard” to “hazard requiring a preventive control”; and revised the definition of “hazard requiring a preventive control” (formerly “significant hazard”). See Response 94, Response 126, Response 127, Response 128, and Response 129.

The rule does not define the term “serious adverse health consequences or death to humans or animals” hazard. However, the requirements for a supply-chain program refer to a hazard for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans (see § 117.430(b)). For additional information on how we interpret “serious adverse health consequences or death to humans or animals,” see our guidance regarding the Reportable Food Registry (Ref. 32) (Ref. 33), which addresses statutory requirements regarding “reportable foods.” As explained in that guidance, a “reportable food” is an article of food (other than dietary supplements or infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals. The guidance includes examples of circumstances under which food might be reportable.

(Comment 94) Some comments assert that the distinction between the definitions of “hazard” and “significant hazard” is not discernable because the proposed definition of “hazard” currently takes into account whether or not a “hazard” is or is not controlled. These comments ask us to delete the phrase “in the absence of its control” from the definition of “hazard” to clarify that hazards are simply the agents that are reasonably likely to cause illness or injury. Likewise, other comments assert that any hazard that is “reasonably likely to cause illness or injury in the absence of its control” will, if known or reasonably foreseeable, likely be controlled by any knowledgeable person.

(Response 94) We have deleted the phrase “in the absence of its control” from the definition of “hazard.” As previously discussed, the phrase “in the absence of its control” is not included in the definition of “hazard” in the Codex HACCP Annex, our HACCP regulation for seafood, or the HACCP regulation for meat and poultry, although it is included in the NACMCF HACCP Guidelines and our HACCP regulation for juice (78 FR 3646 at 3697). We agree that deleting this phrase from the definition of “hazard” will more clearly distinguish between the terms “hazard” and “hazard requiring a preventive control” that we are establishing in this rule. We see no reason to propose an analogous change to the definition of “hazard” in our HACCP regulation for juice because that regulation only defines the single term “hazard” and, thus, the issue discussed in these comments does not apply.

We also replaced the phrase “that is reasonably likely to cause illness or injury” with “that has the potential to cause illness or injury” to more clearly distinguish “hazard” from “known or reasonably foreseeable hazard.” This increases the alignment of the definition of “hazard” in this rule with the Codex definition of “hazard.”

(Comment 95) Some comments ask us to add that the term hazard also means any agent that would cause a food to become adulterated under section 402 of the FD&C Act.

(Response 95) The suggested addition is inconsistent with current national and international understanding of what constitutes a hazard (Ref. 34) (Ref. 35) because it would include agents such as filth, which would adulterate food within the meaning of section 402(a)(4) of the FD&C Act but would be unlikely to cause illness or injury (Ref. 36).

12. Holding

We proposed to establish in § 117.3 the same definition of “holding” as we proposed to establish in §§ 1.227 and 1.328. See section IV.D for a discussion of comments we received to the proposed definition of “holding” in §§ 1.227 and 1.328, and our responses to those comments.

13. Known or Reasonably Foreseeable Hazard

We proposed to define the term “known or reasonably foreseeable hazard” to mean a biological, chemical (including radiological), or physical hazard that has the potential to be associated with the facility or the food.

(Comment 96) Some comments support the definition as proposed, noting that it implies that the implementation of a preventive control is based both on the severity and likelihood of the hazard, can help to distinguish between the requirements of this rule and HACCP requirements, and provides for the proper consideration of both the food and the facility when determining whether a hazard is “known or reasonably foreseeable.” Other comments ask us to modify the definition to specify that the term means a hazard “that is known to be, or has the potential to be,” associated with the facility or the food” to better align with the term as FDA proposed to define it in the proposed FSVP rule. (See 79 FR 58574 at 58595.)

(Response 96) We have revised the definition as requested by the comments to better align with the proposed FSVP rule.

(Comment 97) Some comments ask us to revise the definition so that it addresses a hazard that is known to be, or has the potential to be, associated with a food, the facility in which it is manufactured/processed, or the location or type of farm on which it is grown or raised. These comments assert that the type of farm may affect those hazards that are known or reasonably foreseeable.

(Response 97) We decline this request, which appears related to another difference between the definition proposed in this rule and the definition of this term in the proposed FSVP rule. The proposed FSVP rule would define “known or reasonably foreseeable hazard” as a hazard that is known to be, or has the potential to be, associated with a food or the facility “in which it is manufactured/processed.” (See 79 FR 58574 at 58595.) In this rule, we do not need to specify that the applicable facility is the one “in which the food is manufactured/processed” because this rule applies to the owner, operator, or agent in charge of the facility in which the food is manufactured, processed, packed, or held, and that applicability does not need to be repeated in each provision. To the extent that this comment is expressing concern about raw materials or other ingredients that a facility would receive from a farm, those concerns would be considered in the facility's hazard analysis, which would include a hazard evaluation that considers factors such as those related to the source of Start Printed Page 55951raw materials and other ingredients (see § 117.130(c)(2)(iii)).

(Comment 98) Some comments ask us to include “food allergens” in the parenthetical where we list radiological hazards as a type of chemical hazard.

(Response 98) We decline this request. As previously discussed, the definitions of “hazard” or “food hazard” in the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry all define hazard with respect to biological, chemical, and physical agents, and we proposed to include radiological agents to implement section 418(b)(1)(A) of the FD&C Act (78 FR 3646 at 3697). We subsequently proposed to include radiological hazards as a subset of chemical hazards because comments recommended that we do so, and we believe that facilities in the past have considered radiological hazards as chemical hazards when conducting a hazard analysis for the development of HACCP plans (79 FR 58524 at 58557).

In this document, we affirm our proposal to implement section 418(b)(1)(A) of the FD&C Act by specifically including radiological hazards in the definition of hazard. We acknowledge that food allergen hazards (together with pesticide and drug residues, natural toxins, decomposition, and unapproved food or color additives) also are a subset of chemical hazards but do not find it necessary to list all examples of chemical hazards in the definition of hazard, just as we do not find it necessary to list multiple examples of biological and physical hazards in the definition of hazard. The requirement to consider food allergen hazards in the hazard analysis is already explicit in the requirements for hazard identification (see § 117.130(b)(1)(ii)).

(Comment 99) Some comments suggest using the phrase “reasonably anticipated contaminants” as a useful phrase that clearly defines all hazards, whether deliberate or accidental, that can cause adulteration in the food supply.

(Response 99) We decline this request. We see no meaningful difference between “reasonably expected” and “reasonably anticipated.” We also see no benefit in specifying that a hazard is a “contaminant” rather than an “agent” (which is the term used in the definition of “hazard”).

14. Lot

We proposed to define “lot” to mean the food produced during a period of time indicated by a specific code.

(Comment 100) Some comments ask us to modify the proposed definition to make it more flexible and robust. These comments assert that the proposed definition appears to ignore other potential definitions, such as products with common characteristics (such as origin, variety, type of packing, packer, consignor, markings) and that multiple “lots” can be produced during the same time but with different lot designations. Other comments ask us to modify the proposed definition so that it is not limited by a period of time and suggest using an approach that would allow for a lot to be defined by either time or by a specific identifier. Other comments express the view that the individual operators should be able to define their lot designations and make these definitions available to FDA upon request. Other comments assert that the proposed definition is too prescriptive and inflexible in that timeframe is not necessarily the most logical way to identify a lot (e.g., for batch production). Some comments suggest specific changes to the text of the proposed definition, such as “Lot means a body of food designated by the facility with common characteristics, e.g., origin, variety, type of packing, packer, consignor, markings or time of harvest, packing or processing, which is separable by such characteristics from other bodies of food.”

(Response 100) As judged by these comments, the long-standing definition of “lot” has the potential to be misinterpreted to mean that the “specific code” must be based on time, such as a date. This is not the case. Although the term “lot” is associated with a period of time, an establishment has flexibility to determine the code, with or without any indication of time in the code. For example, a code could be based on a date, time of day, production characteristic (such as those mentioned in the comments), combination of date/time/production characteristic, or any other method that works best for the establishment. To clarify that the rule does not require that time be “indicated” by the code, and emphasize the establishment's flexibility to determine the code, we have revised “period of time indicated by a specific code” to “period of time and identified by an establishment's specific code.”

(Comment 101) Some comments ask us to clarify the purpose of the “specific code” associated with the lot (i.e., that it should give insight into production history of the associated food) and to define a term such as “lot code” or “production code.”

(Response 101) The purpose of the specific code associated with a lot is to identify the food and associated production records—e.g., when investigating a food safety problem or conducting a recall. We decline the request to define a term such as “lot code” or “production code.” The definition of “lot” is intended to provide flexibility for an establishment to determine the mechanism of assigning a code that is best suited to the food it produces.

(Comment 102) Some comments ask us to clarify the factors that can affect the size of a “lot.” These comments assert that minimizing the size of a lot could be beneficial to an establishment if a recall is needed and express concern that our proposed definition may differ from that used by a specific establishment.

(Response 102) The definition provides a company with flexibility to determine an appropriate size of a lot.

15. Manufacturing/Processing

We proposed to establish in § 117.3 the same definition of “manufacturing/processing” as we proposed to establish in §§ 1.227 and 1.328. See section IV.E for a discussion of comments we received to the proposed definition of “manufacturing/processing” in §§ 1.227 and 1.328, and our responses to those comments.

16. Microorganisms

We proposed to define the term “microorganisms” to mean yeasts, molds, bacteria, viruses, protozoa, and microscopic parasites and include species having public health significance. We also proposed that the term “undesirable microorganisms” includes those microorganisms that are of public health significance, that subject food to decomposition, that indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated.

(Comment 103) Some comments express concern that the term “undesirable microorganisms” includes microorganisms that subject food to decomposition. These comments assert that the definition would expand regulation beyond food safety and ask us to clarify that decomposition means a degradation of product that is only relevant when it affects the safety of the product, rather than simple spoilage, because the presence of microorganisms that can cause spoilage is an unavoidable condition of fresh produce.

(Response 103) We have not modified the regulatory text of this long-standing definition of the term “undesirable microorganisms” regarding Start Printed Page 55952microorganisms that subject food to decomposition. As we noted during the rulemaking to first establish this definition, the regulations are designed to prevent the growth of undesirable microorganisms, and the scope of the definition is not limited to pathogens because these regulations are also concerned with sanitation, decomposition, and filth (51 FR 22458 at 22460). The comments do not provide any examples of how we have interpreted this provision in the past in a way that creates practical problems to the fresh produce industry when applying CGMP requirements directed to preventing the growth of undesirable microorganisms.

(Comment 104) Some comments ask us to specify that the term “undesirable microorganisms” includes microorganisms that are resistant to drugs or antibiotics.

(Response 104) We decline this request. The requirements of this rule directed to preventing contamination with microorganisms are intended to keep microorganisms out of food regardless of whether a particular strain of a specific microorganism (including a pathogen, a microorganism that subjects food to decomposition, and a microorganism that indicates that food is contaminated with filth) has the particular characteristic of being resistant to drugs or antibiotics.

(Comment 105) Some comments ask us to provide lists of microorganisms that we consider indicative of “contamination with filth” and our rationale for such consideration.

(Response 105) We decline this request, which is better suited for guidance. In other circumstances, we have discussed coliforms and fecal coliforms as indicators that food has been contaminated by manufacturing practices conducted under insanitary conditions (see, e.g., the discussion in the proposed rule to establish Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for the Production of Infant Formula, 61 FR 36154 at 36171, July 9, 1996). As another example, “Compliance Policy Guide Sec. 527.300 Dairy Products—Microbial Contaminants and Alkaline Phosphatase Activity” provides that dairy products may be considered adulterated within the meaning of section 402(a)(4) of the FD&C Act (21 U.S.C. 342(a)(4)), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, when (nontoxigenic) E. coli is found at certain levels (Ref. 37).

17. Mixed-Type Facility

We proposed to establish in § 117.3 the same definition of “mixed-type facility” as we proposed to establish in §§ 1.227 and 1.328. See section IV.F for a discussion of comments we received to the proposed definition of “mixed-typed facility” in §§ 1.227 and 1.328, and our responses to those comments.

18. Monitor

We proposed to define the term “monitor” to mean to conduct a planned sequence of observations or measurements to assess whether a process, point, or procedure is under control and to produce an accurate record for use in verification.

(Comment 106) Some comments assert that our proposed definition of monitoring is directed to the narrow circumstance of monitoring that would be applied to a CCP under the NACMCF HACCP guidelines and the Codex HACCP Annex. These comments also assert that, using such definitions, monitoring would not apply to control measures for which parameters cannot be established and that are not amenable to documentation. These comments suggest that we use a definition of monitoring consistent with that provided in ISO 22000:2005 (conducting a planned sequence of observations or measurements to assess whether control measures are operating as intended) to clarify that monitoring may be conducted where appropriate for preventive controls that are not CCPs. (ISO is an abbreviation for “International Organization for Standardization.” ISO develops and publishes international standards.) According to these comments, an advantage of this definition is that it also would clarify the difference between monitoring activities (observations conducted during the operation of a control measure to ensure that it is under control) and verification activities (to evaluate performance of a control measure).

(Response 106) We have revised the definition of monitor to mean to conduct a planned sequence of observations or measurements to assess whether control measures are operating as intended. We agree that the revised definition, which reflects an international standard, more effectively communicates that monitoring also applies to controls that are not at CCPs and may apply to control measures for which parameters cannot be established. However, we disagree that this definition signals that it is not possible to obtain documentation when monitoring preventive controls that are not at CCPs, such as for controls that are not process controls and do not involve parameters and maximum or minimum values, or combinations of values, to which a parameter must be controlled to significantly minimize or prevent a hazard requiring a preventive control. For example, it is possible to monitor that a specific sanitation control activity has taken place, such as the cleaning of a piece of equipment to prevent allergen cross-contact.

The requirement for documenting monitoring in records is established by the requirements for monitoring, not by the definition of monitor. As discussed in Response 468, we have made several revisions to the regulatory text, with associated editorial changes, to clarify that monitoring records may not always be necessary.

19. Packaging (When Used as a Verb)

We proposed to establish in § 117.3 the same definition of “packaging (when used as a verb)” as we proposed to establish in §§ 1.227 and 1.328.

(Comment 107) Some comments express concern about establishing the definition of “packaging (when used as a verb)” in part 117. These comments ask us to clarify how this proposed definition relates to other uses of the word “packaging” in part 117, including use as an adjective in the common phrase “food-packaging materials,” and including some provisions directed to controlling allergen cross-contact and contamination in “food-packaging materials.” Some comments ask us to establish definitions for terms such as “food-packaging materials” or “primary packaging” to clarify the meaning of the term “packaging” as it has previously been used in part 110. Other comments ask us to clarify that provisions directed to preventing allergen cross-contact and contamination in “food-packaging materials” apply only to “food-contact packaging,” not “secondary packaging.” Some comments focus on the differences between the definition of the term “packing” and “packaging” with respect to activities conducted on RACs. Some comments ask us to clarify how the term “packaging (when used as a noun)” would apply when used in part 117, even though we did not propose to establish a definition for “packaging (when used as a noun)” in part 117.

(Response 107) We have decided not to establish the definition “packaging (when used as a verb)” in part 117. That definition was established in the section 415 registration regulations, in part, to identify those food establishments that would be subject to those regulations based, in part, on the activity of placing food into a container that directly Start Printed Page 55953contacts the food and that the consumer receives. In addition, because the term “packaging” (when used as a noun) can be used in a very general way to refer to both the container that directly contacts the food and to the outer packaging of food that does not contact the food, the section 414 recordkeeping regulations established a definition of “packaging” (when used as a noun) to narrowly refer to “the outer packaging of food that bears the label and does not contact the food,” because this narrow definition was also necessary for the purposes of those recordkeeping regulations.

However, the term “packaging” has long been used as a noun in the CGMPs to generally refer to the container that directly contacts the food, rather than to the outer packaging of food that does not contact the food (as it means in the section 414 recordkeeping regulations). Thus, the very specific connotation for the term “packaging” (when used as a noun) that was established in the section 414 recordkeeping regulations does not apply, and is causing confusion. As the comments point out, our proposed definition of “packaging (when used as a verb)” is already causing confusion in the context of part 117. Therefore, for clarity and simplicity in part 117 we are not including in the final rule a definition of “packaging (when used as a verb).” A definition for “packaging (when used as a verb)” remains in the section 415 registration regulations, where a business can continue to use the definition for purposes of determining whether either or both of those regulations applies to its business.

Part 117 establishes requirements for manufacturing, processing, packing, and holding human food. The definition of “manufacturing/processing” we are establishing in this rule makes clear that “packaging” (when used as a verb) is a manufacturing/processing activity and, thus, that requirements that apply to manufacturing or processing activities apply to packaging activities. Because part 117 is not the regulation that describes whether a food establishment is subject to the section 415 registration regulations or the section 414 recordkeeping regulations, it is not necessary for part 117 to do more.

The comments that express concern about the distinction between “packing” and “packaging (when used as a verb)” with respect to activities conducted on RACs no longer apply in light of the revised “farm” definition that we are establishing in the section 415 registration regulations. The revised “farm” definition provides for packaging RACs when packaging does not involve additional manufacturing/processing (such as cutting).

20. Packing

We proposed to establish in § 117.3 the same definition of “packing” as we proposed to establish in §§ 1.227 and 1.328. See section IV.G for a discussion of comments we received to the proposed definition of “packing” in §§ 1.227 and 1.328, and our responses to those comments.

21. Pathogen

We proposed to define the term “pathogen” to mean a microorganism of public health significance.

(Comment 108) Some comments ask us to revise the definition to mean a “microorganism of such severity and exposure that it would be deemed of public health significance” because the significance of pathogens to public health depends on the organism's severity and the nature of exposure.

(Response 108) We decline this request. Our purpose in defining the term pathogen was to simplify the regulations, including our long-standing CGMP regulations, by substituting a single term (i.e., “pathogen”) for a more complex term (i.e., “microorganism of public health significance”) throughout the regulations. These comments appear to be objecting to the use of the long-standing phrase “microorganism of public health significance,” which has been in our CGMP regulations for decades, rather than to our proposal to define and use a simpler term in its place. These comments fail to explain how we have interpreted the current term “microorganism of public health significance” in a way that does not take into account factors such as the severity of illness and the route of exposure.

22. Pest

We proposed to define the term “pest” to refer to any objectionable animals or insects including birds, rodents, flies, and larvae.

(Comment 109) Some comments ask us to include reptiles in the definition due to a past instance of Salmonella linked to lizard feces in an RTE nut-manufacturing facility.

(Response 109) We decline this request. This long-standing definition does not limit pests to those already included as examples. Reptiles are objectionable animals that are known to carry human pathogens and are considered pests.

(Comment 110) Some comments ask us to clarify the meaning of the term “objectionable.” These comments state that, under the Canadian Pest Control Products Act, objectionable means that an animal does not belong in a food processing environment and suggest that we follow this meaning of “objectionable.” These comments also note that there may be circumstances where the presence of an animal is acceptable, such as the use of guide dogs.

(Response 110) We decline this request. The meaning of the term “objectionable” as described in these comments is consistent with our interpretation of this long-standing definition of “pest,” but we do not believe it is necessary to provide a definition. See the provisions for pest control (§ 117.35(c)), which allow the use of guard, guide, and pest-detecting dogs.

23. Plant

We proposed to define the term “plant” to mean the building or establishment or parts thereof, used for or in connection with the manufacturing, processing, packing, or holding of human food. See Comment 63 for the comments on the definition of “plant” and Response 63 for our response to those comments.

24. Preventive Controls

We proposed to define the term “preventive controls” to mean those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis.

(Comment 111) Some comments ask us to clarify the meaning of “current scientific understanding” because scientific understanding can vary depending on the risk profile of a commodity.

(Response 111) By “current scientific understanding,” we mean to emphasize that scientific information changes over time and a facility needs to keep current regarding safe handling and production practices such that the facility has the information necessary to apply appropriate handling and production practices.

25. Preventive Controls Qualified Individual

We proposed to define the term “qualified individual” to mean a person who has successfully completed training in the development and application of risk-based preventive Start Printed Page 55954controls at least equivalent to that received under a standardized curriculum recognized as adequate by the FDA or is otherwise qualified through job experience to develop and apply a food safety system. We have changed the proposed term “qualified individual” to “preventive controls qualified individual” because we are establishing a new definition for “qualified individual,” with a meaning distinct from “preventive controls qualified individual.” To minimize the potential for confusion for when the term “qualified individual” refers to the proposed meaning of the term and when the term “qualified individual” refers to the meaning of that term as finalized in this rule, in the remainder of this document we use the new term “preventive controls qualified individual” whenever we mean “a person who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by the FDA or is otherwise qualified through job experience to develop and apply a food safety system,” even though the proposed rule used the term “qualified individual.” Likewise, we use the new term “preventive controls qualified individual” for the proposed term “qualified individual” when describing the comments to the proposed rule, even though those comments use the term “qualified individual.”

In the following paragraphs, we discuss comments on this proposed definition. (See also our discussion (in section XXXVI) of the requirements applicable to the preventive controls qualified individual (§ 117.180(c)).)

(Comment 112) Some comments assert that the proposed definition of preventive controls qualified individual is ambiguous.

(Response 112) The comments provide no basis for asserting that this definition is ambiguous, such as difficulties in how we have interpreted similar regulatory text in enforcing our HACCP regulations for seafood and juice (§§ 123.10 and 120.13(b), respectively). The proposed definition includes a performance standard (qualified to develop and apply a food safety system), two criteria for how a person can become qualified (specialized training or job experience), and a description of the type of applicable training (development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum). The proposed definition provides flexibility for how an individual can become qualified, but this flexibility does not make the definition ambiguous.

(Comment 113) Some comments ask us to expand the definition so that it includes a team of preventive controls qualified individuals, not just a single person.

(Response 113) We decline this request. The definition applies to each preventive controls qualified individual that a facility relies on to satisfy the requirements of the rule without limiting the number of such preventive controls qualified individuals. The requirements of the rule make clear that a facility may rely on more than preventive controls qualified individual (see, e.g., § 117.180(a)).

(Comment 114) One comment asks us to include “trusted trader” (i.e., a company or entity in the supply chain proven to be low risk) in the definition of preventive controls qualified individual.

(Response 114) We decline this request. The concept of “trusted trader” applies to a facility's suppliers, not to individuals qualified to develop and apply a food safety system.

26. Qualified Auditor

We proposed to define the term “qualified auditor” to mean a person who is a preventive controls qualified individual as defined in this part and has technical expertise obtained by a combination of training and experience appropriate to perform the auditing function as required by § 117.180(c)(2). As discussed in Response 569, we have revised the definition to specify that “qualified auditor” means a person who is a “qualified individual” as that term is defined in this final rule, rather than a “preventive controls qualified individual,” because some auditors may be auditing businesses (such as produce farms) that are not subject to the requirements for hazard analysis and risk-based preventive controls, and it would not be necessary for such an auditor to be a “preventive controls qualified individual.” We also have clarified that the technical expertise is obtained through education, training, or experience (or a combination thereof) necessary to perform the auditing function to align the description of applicable education, training, and experience with the description of applicable education, training, and experience in the definition of “qualified individual” (see § 117.3).

(Comment 115) Some comments ask us to revise the definition of qualified auditor to include persons who have technical expertise obtained by a combination of training, experience, or education appropriate to perform audits. Some comments ask us to recognize that training and/or experience can make a person a qualified auditor; the comments state that people with experience performing audits likely have applicable training but might not have completed a specific regimen of courses. Some comments maintain that we should recognize the role of the education of a potential qualified auditor, as well as training and experience to meet the criteria.

(Response 115) We agree that a qualified auditor might obtain the necessary auditing expertise in part through education, as well as through training and experience, and we have revised the definition of qualified auditor accordingly. However, we conclude that a person must have at least some actual experience in auditing to meet the definition of a qualified auditor, i.e., the necessary technical expertise cannot be obtained solely through education and/or training. Therefore, the revised definition retains the proposed criterion that a qualified auditor has technical expertise obtained by experience, as well as by education and training.

(Comment 116) Some comments that support the proposed definition ask us to revise the definition to specify certain individuals who would be considered qualified auditors, such as FDA inspectors, properly trained Federal auditors, and State and private auditors operating under a contract with the Federal Government.

(Response 116) We have revised the regulatory text to specify that examples of a qualified auditor include: (1) A government employee, including a foreign government employee and (2) an audit agent of a certification body that is accredited in accordance with regulations in part 1, subpart M (i.e., regulations in our forthcoming third-party certification rule implementing section 808 of the FD&C Act (21 U.S.C. 348d)). Although we agree that it is useful to include examples of individuals who would have the appropriate qualifications, the example of an audit agent of a certification body that has been accredited in accordance with regulations in our forthcoming third-party certification rule adds context about the standard for such individuals. Because paragraph (2) of the new provision refers to provisions in a future third-party certification rule, we will publish a document in the Federal Register announcing the effective date of paragraph (2) once we finalize the third-party certification rule.Start Printed Page 55955

27. Qualified End-user

We proposed to define the term “qualified end-user” to mean, with respect to a food, the consumer of the food (where the term consumer does not include a business); or a restaurant or retail food establishment (as those terms are defined in § 1.227) that: (1) Is located (a) in the same State as the qualified facility that sold the food to such restaurant or establishment; or (b) not more than 275 miles from such facility; and (2) is purchasing the food for sale directly to consumers at such restaurant or retail food establishment. We have revised the definition of “qualified end-user” to add “or the same Indian reservation” to clarify for purposes of this rule so that “in the same State” under section 418(l)(4)(B)(ii)(I) of the FD&C Act includes both within a State and within the reservation of a Federally-Recognized Tribe.

(Comment 117) Some comments object to the description of a qualified end-user as being not more than 275 miles from a facility that sold the food and assert that there is no scientific or risk-based reason to support the distance of 275 miles. Other comments ask us to clarify whether the criterion of not more than 275 miles from a facility that sold the food would provide for qualified end-users to be located across State lines and/or international borders relative to the facility that sold the food. Other comments ask us to revise the definition of “restaurant or retail food establishment” to include businesses such as supermarkets, supermarket distribution centers, food hubs, farm stands, farmers markets, and CSA.

(Response 117) We have not revised the definition of “qualified end-user,” which reflects section 418(l)(4) of the FD&C Act, in response to these comments. As discussed in Response 581, we intend to focus on records demonstrating that a facility is a very small business (i.e., financial records demonstrating that a business averages less than a specified dollar threshold) rather than records demonstrating sales directly to qualified end-users. Likewise, we have not revised the definition of “restaurant or retail food establishment” to clarify whether particular businesses such as those mentioned in the comments would be considered as “qualified end-users.” Focusing on whether a facility is a very small business makes it unnecessary to determine whether an enterprise that receives the food is a retail food establishment. However, as discussed in section I.E, we have issued a separate proposed rule to amend the definition of “retail food establishment” in the section 415 registration regulations. We intend to issue a final rule to amend the definition of “retail food establishment” in the section 415 registration regulations in the near future. (See also Response 4.)

28. Qualified Facility

We proposed to define “qualified facility” by incorporating the description of “qualified facility” in section 418(l)(1) of the FD&C Act with editorial changes to improve clarity. That definition includes two types of facilities: (1) A facility that is a very small business as defined in this rule; and (2) A facility to which certain statutory criteria apply regarding the average monetary value of food sold by the facility and the entities to whom the food was sold.

Some comments discuss issues related to the definition of very small business. See Comment 154, Comment 156, Comment 157, and Comment 158 and our associated responses.

(Comment 118) Some comments assert that the definitions of “affiliate” and “subsidiary” in the definition of “qualified facility” fail to account for the legal differences between a piece of property (i.e., a facility) and a business entity or person. These comments ask us to consider revising the proposed definition of “qualified facility” to clarify what sales to include in determining whether a facility so qualifies.

(Response 118) We have not revised the proposed definition of “qualified facility” as requested by these comments. The sales to be included when a facility determines whether it meets the definition of a qualified facility are the sales of human food by a business entity, which includes the parent company and all its subsidiaries and affiliates. The total sales are applicable to each entity, whether it is the parent, the subsidiary, or the affiliate. We intend to address issues such as these in guidance as directed by section 418(l)(2)(B)(ii) of the FD&C Act. (See also Comment 77 regarding the definitions of “affiliate” and “subsidiary” and our associated responses. See also Response 154 regarding the applicability of the monetary threshold of sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee).)

(Comment 119) Some comments ask us to clarify who will determine whether a particular facility is a qualified facility.

(Response 119) Any facility that determines that it satisfies the criteria for a “qualified facility” must notify FDA of that determination (see § 117.201) and, thus, the first determination will be made by the facility itself. During inspection, the investigator could ask to see the records that support the facility's determination to verify the facility's determination.

(Comment 120) Some comments address that part of the definition that discusses “average annual monetary value of the food manufactured, processed, packed, or held at such facility, that is sold.” These comments ask us to clarify whether the operative word in the clause is “held” or “sold.”

(Response 120) The operative word, for the purpose of calculating the average monetary value of that food, is “sold.” (See also Response 154 regarding the applicability of the monetary threshold of sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee).)

29. Ready-to-Eat Food (RTE Food)

We proposed to define the term “ready-to-eat food” to mean any food that is normally eaten in its raw state or any other food, including processed food, for which it is reasonably foreseeable that the food would be eaten without further processing that will significantly minimize biological hazards.

(Comment 121) Some comments ask us to substitute “reasonably expected” for “reasonably foreseeable.”

(Response 121) We decline this request. We see no substantive difference between “reasonably expected” and “reasonably foreseeable.” The term “reasonably foreseeable” is used in other provisions of the rule, including the defined term “known or reasonably foreseeable hazard.”

(Comment 122) Some comments ask us to clarify the distinction between a food that satisfies the definition of “ready-to-eat” and a food that satisfies the definition of a RAC. Some of these comments express concern that if tree fruits are classified as “RTE food” rather than as a RAC, we could force packers to do mandatory product testing.

(Response 122) The terms RTE food and RAC are not mutually exclusive. Some RACs (such as lettuce, tomatoes, berries, and apples) are ready-to-eat, whereas other RACs (such as artichokes and potatoes) are not. The requirements for product testing as a verification activity are flexible requirements that depend on the facility, the food, and the Start Printed Page 55956nature of the preventive control (see § 117.165). See also Response 525.

30. Receiving Facility

We proposed to define the term “receiving facility” to mean a facility that is subject to subpart C of this part and that manufactures/processes a raw material or ingredient that it receives from a supplier.

(Comment 123) Some comments ask us to modify the definition to specify that the receiving facility could receive the raw material or ingredient directly from a supplier or by means of an intermediary entity. These comments assert that without this added regulatory text the proposed definition implies that the material or ingredient must be received directly from the supplier.

(Response 123) We decline this request. As discussed in Response 658, the two parties that are critical to the supplier verification program are the receiving facility and the supplier, even if there are entities in the supply chain between the two. The definition of receiving facility does not preclude the participation of intermediary entities in the supply chain, and the rule does provide for such participation (see Response 657). However, the definition of receiving facility does highlight the fact that a receiving facility must have a link to a supplier.

(Comment 124) Some comments that support the definition of receiving facility ask us to clarify that a cold storage facility is not by definition a receiving facility because it is not engaged in manufacturing/processing, but could be a supplier if temperature controls are needed to control a significant hazard.

(Response 124) We agree that a cold storage facility is not likely to be a receiving facility if it is not engaged in manufacturing/processing. However, it is the nature of the activity as manufacturing/processing, rather than the use of a preventive control for purposes other than manufacturing/processing, that is relevant here. By definition, the supplier must also be engaged in manufacturing/processing, raising animals, or growing food (see the definition of “supplier” in § 117.3). A cold storage facility has a responsibility to maintain foods that require temperature control for safety at an appropriate temperature, but generally does not engage in manufacturing/processing. However, a cold storage facility in the supply chain between the supplier and the receiving facility could participate in supplier verification activities (see Response 657).

31. Sanitize

We proposed to define “sanitize” to mean to adequately treat cleaned food-contact surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer. We proposed to revise this otherwise long-standing definition by inserting the term “cleaned” before “food-contact surfaces” because chemical sanitizers can be inactivated by organic material and, thus, are not effective unless used on clean surfaces (78 FR 3646 at 3697).

(Comment 125) Some comments ask us to adopt a definition of “sanitize” similar to that found in the Pasteurized Milk Ordinance (PMO), which recognizes that cleaning and sanitizing do not always have to be separate, sequential steps. These comments report that the definition in the PMO is “the application of any effective method or substance to properly cleaned surfaces for the destruction of pathogens, and other microorganisms, as far as is practicable.” Other comments agree with the proposed definition as it applies to chemical sanitizers, but disagree that clean surfaces are required for effective sanitizing for those systems that use steam and dry heat, such as those authorized by Appendix F of the PMO. These comments ask us to clarify that the “cleaning” should be appropriate to the specific food system and method used for sanitizing, and that cleaning should only be required when the sanitizing process alone would not be effective without a prior cleaning step.

Some comments express concern about whether the proposed definition of “sanitize” would preclude the continued, routine use of dry cleaning methods with no sanitizing step. These comments note that adding routine aqueous-based cleaning and sanitizing procedures could create a public health risk in certain operations such as low-moisture food production. These comments also note that dry cleaning procedures can result in equipment that, while sanitary, is neither visibly clean nor suitable for aqueous chemical sanitizers.

(Response 125) We consider that systems such as steam systems clean the surfaces, as well as sanitize them and, thus, satisfy the definition of “sanitize.” The definition of “sanitize” does not preclude the continued use of dry cleaning methods with no sanitizing step because the definition describes the meaning of the term “sanitize” without establishing any requirement for when equipment must be sanitized.

We have revised the definition so that it means adequately treating “surfaces” rather than “food-contact surfaces.” Doing so is consistent with the definition of “sanitize” in the PMO. As a technical matter, adequately treating any surface—regardless of whether it is a food-contact surface—by a process that is effective in destroying vegetative cells of pathogens, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer, is “sanitizing” the surface. Clarifying this technical meaning of the term “sanitize” imposes no requirements to sanitize surfaces other than food-contact surfaces; the requirements for sanitizing surfaces are established by provisions such as § 117.37(d), not by the definition of the term “sanitize.”

32. Significant Hazard (Hazard Requiring a Preventive Control)

We proposed to define the term “significant hazard” to mean a known or reasonably foreseeable hazard for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would, based on the outcome of a hazard analysis, establish controls to significantly minimize or prevent the hazard in a food. The rule would use the term “significant hazard” rather than “hazard reasonably likely to occur” to reduce the potential for a misinterpretation that all necessary preventive controls must be established at CCPs (79 FR 58524 at 58526).

(Comment 126) Comments support using a term other than “hazard reasonably likely to occur” and agree that using a term other than “hazard reasonably likely to occur” throughout the rule will reduce the potential for a misinterpretation that all necessary preventive controls must be established at CCPs.

Some comments support the regulatory text of the proposed definition of the term “significant hazard.” These comments state that the proposed regulatory text more closely aligns with the principles in FSMA (“reasonably foreseeable” and “significantly minimize or prevent”) and provides operators the flexibility to implement a range of preventive controls that are commensurate with the risk and probability posed by a specific hazard. Some comments agree that the proposed regulatory text can clarify the difference between HACCP rules and the human preventive controls rule. Start Printed Page 55957Some comments state that the proposed regulatory text plainly reflects the concept that significant hazards are those hazards to be addressed through the very broad category of preventive controls, and the rule is explicit that preventive controls may be controls other than at CCPs. Some comments state that the definition reflects the risk-based nature (i.e., both the severity of a potential hazard and the probability that the hazard will occur) of the requirements and provides additional flexibility so that facilities can take into account the nature of the preventive control in determining when and how to establish and implement appropriate preventive control management components. Some comments support including the phrase “based on the outcome of a hazard analysis” in the definition because it ensures that identification of significant hazards will be risk based. Some comments ask us to preserve in the final definition two key aspects that grant the food industry the flexibility that it needs: (1) The logical conclusion that not all hazards will have the same impact or will even constitute “significant hazards” at all, depending on the facility's products and position in the supply chain; and (2) the fact that a “person knowledgeable about the safe manufacturing, processing, packing, or holding of food” must be knowledgeable about the specific food produced at that facility and in that specific sector of the food industry.

Some of the comments that support the regulatory text of the proposed definition nonetheless express concern about the term “significant hazard.” Some of these comments express concern that a facility may not recognize hazards that need to be controlled because they do not rise to the commonly understood meaning of “significant.” Other comments express concern that the adjective “significant” is subject to many interpretations and suggest that the term “hazard requiring control” would be more straightforward, accurate, and suitable.

Other comments express concern that the term “significant hazard” could cause confusion because it has implications in HACCP systems. For example, “significant hazard” is often used in the context of CCPs, and preventive controls are not necessarily established at CCPs. Some of these comments suggest that we eliminate the term and instead use the full regulatory text of the proposed definition in place of “significant hazard” throughout the regulations. Other comments suggest using a term such as “food safety hazard” or “actionable hazard” instead of “significant hazard” to avoid a term that has HACCP implications. Other comments state that the term “significant hazard” has implications for facilities that follow the Codex HACCP Annex and express concern that foreign facilities would be especially likely to be confused by the term “significant hazard.”

Some comments ask us to ensure that the term “significant hazard” is used consistently and express the view that some regulatory text refers to a “hazard” or “known or reasonably foreseeable hazard” where “significant hazard” should instead be used. As discussed in Comment 93, some comments express concern that the rule would refer to multiple levels of hazard and ask us to provide sufficient clarity to be able to distinguish between these types of hazards.

(Response 126) We have changed the term “significant hazard” to “hazard requiring a preventive control.” The new term uses the explicit language of FSMA (i.e., “preventive control”), is consistent with the specific suggestion of one comment (i.e., hazard requiring a control”), and is not commonly associated with HACCP systems. We decline the request to use the term “food safety hazard” because that term already is established in Federal HACCP regulations for seafood and meat/poultry, and the comments are particularly concerned about using a term that has implications for HACCP systems. We also decline the request to use the term “actionable hazard,” because the term “actionable” is associated with violations at a food processing plant.

We reviewed the full regulatory text of proposed subpart C and replaced “significant hazard” with “hazard requiring a preventive control” in most cases. See table 10 for the provisions where we made that change and for an explanation of those provisions where we replaced “significant hazard” with “hazard” or “hazard requiring a process control.”

Table 10—Substitutions for the Term “Significant Hazard”

SectionDescriptionTerm substituted for “significant hazard”Reason for substituting a term other than “hazard requiring a preventive control”
117.130(a)(1)Requirement to conduct a hazard analysisHazard requiring a preventive controlN/A.1
117.135(a)(1)Requirement to identify and implement preventive controlsHazard requiring a preventive controlN/A.1
117.135(c)(2)(ii)Maximum and minimum values associated with process controlsHazard requiring a process controlThe provision is narrowly directed to a specific category of preventive controls—i.e., process controls.
117.139Recall planHazard requiring a preventive controlN/A.1
117.160ValidationHazardSpecifying that a facility must validate that the preventive controls are adequate to control “the hazard” adequately communicates the requirement. In contrast, specifying that a facility must validate that the preventive controls are adequate to control the “hazard requiring a preventive control” would be unnecessarily bulky and awkward.
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117.165(a)Activities for verification of implementation and effectiveness of preventive controlsHazardSpecifying that a facility must verify that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing “the hazards” adequately communicates the requirement. In contrast, specifying that a facility must verify that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing “the hazards requiring a preventive control” would be unnecessarily bulky and awkward.
117.165(a)(3)Requirement for environmental monitoring to verify implementation and effectiveness of preventive controlsHazard requiring a preventive controlN/A.1
1 N/A = Not applicable.

We also reviewed the full regulatory text of proposed subpart C to evaluate whether there were any circumstances where the regulatory text should more appropriately refer to “hazard requiring a preventive control” rather than “hazard” or “known or reasonably foreseeable hazard.” The term “known or reasonably foreseeable hazard” appears only once, in the requirement for a facility to conduct a hazard analysis (§ 117.130(a)). We are retaining “known or reasonably foreseeable hazard” in that requirement because it is necessary to implement the tiered approach to the requirements for hazard analysis and risk-based preventive controls (see Response 93). To reinforce this tiered approach, and emphasize that the facility only conducts a hazard analysis for known or reasonably foreseeable hazards, we revised “hazard” to “known or reasonably foreseeable hazard” in two additional provisions in the requirements for hazard identification (see the introductory regulatory text for § 117.130(b)(1) and (2)).

In our review of the full regulatory text of proposed subpart C, we did not identify any circumstances where we believe it is appropriate and necessary to specify “hazard requiring a preventive control” in place of “hazard.” It is not necessary for the regulatory text of requirements for preventive controls, the supply-chain program, the recall plan, corrective actions, and verification to specify “hazard requiring a preventive control” every time that the requirements use the term “hazard” because the context of the requirement establishes the applicability to “hazards requiring a preventive control.” Although we acknowledge that using “hazard requiring a preventive control” in place of “hazard” throughout applicable provisions of proposed subpart C would emphasize the tiered approach to the requirements for hazard analysis and risk-based preventive controls, doing so would make the regulatory text unnecessarily bulky and awkward and would be inconsistent with comments that ask us to make the regulatory text understandable (see Comment 13).

(Comment 127) Some comments express concern that the proposed definition of “significant hazard,” which contains the phrase “for which a person . . . would establish controls” is problematic in that facilities are likely to have already established preventive controls for a variety of hazards that may not rise to the level of control management required for a “significant hazard” and would instead routinely be addressed in “prerequisite programs.” These comments express particular concern that identification of these hazards in and of themselves should not elevate control of these hazards to the category of being a “significant hazard.” Some comments ask us to allow facilities to continue to implement existing controls outside the framework of this rule (i.e., outside the framework that requires preventive control management components as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the food safety system) when a hazard addressed by the existing controls does not rise to the level of “significant hazard.”

Other comments express concern that the term “significant hazard” may create a disincentive for facilities to voluntarily implement preventive controls for hazards that only pose a remote risk or are very rarely encountered, because implementing preventive controls for hazards of very low probability and severity may be misinterpreted as requiring preventive controls applicable to a “significant hazard” even if the hazard does not meet the definition of “significant hazard” established in the rule. Some comments ask us to revise the definition to provide facilities with the flexibility and discretion to establish appropriate preventive controls for hazards that do not rise to the criteria of a “significant hazard,” as well as ensuring that preventive controls that address remote or very unlikely hazards not be subject to the preventive control management requirements for a “significant hazard.”

(Response 127) We have revised the definition to specify that the term “hazard requiring a preventive control” applies when a knowledgeable person would, based on the outcome of a hazard analysis, “establish one or more preventive controls” rather than “establish controls.” By narrowing “controls” to “one or more preventive controls,” we mean to signify that the proposed term “significant hazard” (which we now refer to as “hazard requiring a preventive control”) only applies to those controls that the facility establishes to comply with the Start Printed Page 55959requirements of subparts C and G for hazard analysis and risk-based preventive controls. A facility that establishes other controls (such as those that the comments describe as “prerequisite programs,” or controls directed to hazards of very low probability and severity) for hazards that are not, based on the outcome of the facility's hazard analysis, “hazards requiring a preventive control” would not need to establish preventive control management components for such controls. However, some controls previously established in “prerequisite programs” would be considered “preventive controls.” We provide some flexibility for facilities with respect to how they manage preventive controls, and the preventive control management components may be different for hazards that have been managed as “prerequisite programs” compared to those managed with CCPs. A facility that is concerned about the potential for an investigator to disagree during inspection that certain controls are not directed to “hazards requiring a preventive control” could, for example, include information relevant to its classification of those other controls in its hazard analysis, whether by merely listing the “other controls” or by providing a brief explanation why such controls are not “preventive controls” as that term is defined in this rule.

(Comment 128) Some comments assert that the proposed definition of “significant hazard” is tautological because it essentially establishes a “significant hazard” to be a known or reasonably foreseeable hazard (i.e., the type of hazards identified in the first step of the analysis) for which preventive controls should be implemented. These comments assert that the proposed definition of “significant hazard” would collapse the second step of hazard analysis into the first, which in turn would lead to the unintended consequence of facilities identifying the same hazards in the second step as in the first. Other comments ask us to revise the definition to clarify and distinguish the two steps of the hazard analysis by specifying within the definition that a significant hazard is a known or reasonably foreseeable hazard for which there is a reasonable probability, based on experience, illness data, scientific reports, or other information relevant to the food or the facility, that adverse health consequence or death will occur in the absence of its control. Some comments ask us to revise the definition to include evaluation of severity and probability, because these concepts are integral for making a proper determination of whether a hazard is significant. Other comments ask us to revise the definition to better reflect the risk-based approach that preventive controls be implemented to control hazards that have a higher probability of resulting in public health consequence in the absence of control.

(Response 128) We have revised the definition of “significant hazard” (which we now refer to as “hazard requiring a preventive control”) to specify that the hazard analysis includes an assessment of the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls. By specifying that the determination of a “significant hazard” is based on the outcome of a hazard analysis, the proposed definition did, as requested by the comments, include the risk-based nature of the determination. However, explicitly adding that the hazard analysis is based on probability and severity (i.e., risk) makes the risk-based nature of the determination clearer.

We disagree that the proposed definition was tautological and would collapse the second step of hazard analysis into the first. As discussed in Response 93, a facility begins its hazard analysis by narrowing down the universe of all hazards to those that are “known or reasonably foreseeable” for each type of food manufactured, processed, packed, or held at its facility. The outcome of the facility's hazard analysis is a determination of a subset of those known or reasonably foreseeable hazards—i.e., those hazards requiring a preventive control. To the extent that these comments are asserting that the tautology was created by the phrase “in the absence of its control” in the proposed definition of “hazard,” we have deleted that phrase from the final definition of “hazard” (see Response 94).

We decline the request to modify the definition to specify that a hazard requiring a preventive control is one for which there is a reasonable probability, based on experience, illness data, scientific reports, or other information relevant to the food or the facility, that adverse health consequence or death will occur in the absence of its control. The standard for harm in the definition of “hazard” is illness or injury. We disagree that the standard for harm in the definition of “hazard requiring a preventive control” should be different from (i.e., adverse health consequences), or greater than (i.e., death), the standard for harm in the definition of “hazard.” We also disagree that the definition of “hazard requiring a preventive control” needs to be modified to state that preventive controls are implemented to control hazards that have a higher probability of resulting in public health consequence in the absence of control. The definition already communicates the role of risk (i.e., severity and probability) in conducting the hazard analysis that identifies those hazards requiring a preventive control.

We also decline the request to repeat in the definition of “hazard requiring a preventive control” the requirement for the types of information that a facility would consider in conducting its hazard analysis. The requirements for hazard analysis clearly specify that a facility must conduct its hazard analysis based on experience, illness data, scientific reports, and other information (see § 117.130(a)).

(Comment 129) Some comments that broadly address the overall framework for the new requirements for hazard analysis and risk-based preventive controls ask us to consistently refer to “the nature of the preventive control” (rather than simply to “the preventive control”) when communicating the flexibility that a facility has in identifying preventive controls and associated preventive control management components. (See Comment 455). Other comments that broadly address the overall framework for the new requirements for hazard analysis and risk-based preventive controls ask us to emphasize that the requirements for preventive control management components convey not only that the application of a particular element is appropriate (i.e., capable of being applied), but also necessary for food safety. Some comments recommend that we do so by specifying that preventive control management components take into account the role of the preventive control in the food safety system. (See Comment 455.)

(Response 129) We agree with these comments and have revised the definition of “hazard requiring a preventive control” to specify that preventive control management components are established as appropriate to “the nature of the preventive control and its role in the facility's food safety system.” (See also Response 455, where we describe additional provisions that we have revised to clarify that preventive control management components are established as appropriate to the nature of the preventive control and its role in the facility's food safety system.)

(Comment 130) Some comments ask us to modify the definition of “significant hazard” to specify that the Start Printed Page 55960preventive control management components be established as appropriate to both the food and the intended use of the food.

(Response 130) We decline this request. It is not necessary to repeat in the definition of “hazard requiring a preventive control” the requirement for the hazard evaluation to consider the intended use of the food. The requirements for hazard evaluation clearly specify that a facility must consider the intended or reasonably foreseeable use of the food (see § 117.130(c)(2)(viii)).

(Comment 131) Some comments assert that the problem is how to separate the hazards addressed by “HACCP” from those addressed by CGMPs. These comments suggest that control measures that are implemented for hazards from ingredients and food-contact packaging material, and from production and process, be called CCPs and that control measures that are implemented for hazards from personnel, equipment, and the plant be called preventive controls.

(Response 131) The facility must control hazards through the application of CGMPs and preventive controls as appropriate to the hazard. Although some preventive controls will be established at CCPs, and “CCP” is a term commonly used in HACCP systems, this rule establishes requirements for hazard analysis and risk-based preventive controls, not “HACCP,” and this rule provides that preventive controls include controls at CCPs, if there are any CCPs, as well as controls, other than those at CCPs, that are also appropriate for food safety (see § 117.135(a)(2)).

Under the rule, some hazards may be addressed by CGMPs and others by preventive controls. For example, if a facility manufactures egg biscuit sandwiches, it could establish a preventive control, as a CCP, for cooking the eggs and establish CGMP controls to address the potential for personnel to contaminate the cooked egg and the egg biscuit sandwiches. As another example, a facility could control a physical hazard such as metal using screens and magnets under CGMPs and then use a metal detector as a preventive control. See also Response 437, in which we give examples regarding when a facility might control food allergen hazards through a combination of CGMP controls and “food allergen controls,” which are a particular type of preventive control (see § 117.135(c)(2)).

(Comment 132) Some comments ask us to add examples throughout the regulatory text (e.g., in the requirements for hazard analysis, preventive controls, and recall plan) to reflect food allergens as a significant hazard.

(Response 132) We decline this request. Food allergens are included as an example of a chemical hazard that a facility must consider when determining whether there are any known or reasonably foreseeable hazards requiring a preventive control (§ 117.130(b)(1)(ii)), and the rule specifically provides for food allergen controls where relevant. It is not necessary to include examples of food allergens as hazards requiring a preventive control throughout the regulatory text.

(Comment 133) Some comments express concern that too much flexibility may make it harder for us to inspect conditions in a facility over time. These comments emphasize that we must not permit facilities to interpret the term “significant hazard” as allowing them to substitute inadequate sanitation programs—which may not require documentation of monitoring or verification measures—for necessary critical control points.

(Response 133) We acknowledge that there can be a tension between the need for flexible requirements that must apply to diverse food processing facilities and the regulatory need to evaluate compliance with requirements. See Response 5 regarding our approach to enforcing the rule. Although preventive controls, such as sanitation controls, are not always directed to critical control points (see § 117.135(a)(2)(ii)), we agree that there could be circumstances where we would disagree with a facility about the measures it has in place regarding sanitation. We will address such circumstances on a case-by-case basis.

(Comment 134) Some comments express concern that the term “significant hazard” may lead to misunderstanding by medium and smaller processors and ask how businesses with limited food safety experience will understand the difference between a food safety hazard that is “reasonably likely to occur” (and, thus, must be controlled by a full HACCP Plan) and a “Significant Hazard” that can be controlled by a preventive control plan.

(Response 134) In most cases, it will not be necessary for a food processor to understand the difference between a hazard that is “reasonably likely to occur” in the concept of HACCP requirements and a “hazard requiring a preventive control” in the context of this rule. Instead, a food processor must identify those regulations that apply to it. For example, a processor of juice products is subject to our HACCP regulations for juice, but is not subject to the requirements of this rule.

(Comment 135) Some comments express concern about the potential for divergent interpretations of the definition by industry and regulators. Some comments state that a baseline understanding between industry and regulatory officials will need to be established as to what constitutes a “significant hazard” and what preventive controls will be deemed to be adequate to control such a hazard. Some comments ask us to provide guidance or allow “inter-state compacts” to provide guidelines on what constitutes significant hazards in major food industries. Other comments assert that the FSPCA provides the best forum to identify what constitutes “significant hazards” in food, and to develop timely and appropriate guidance and training for addressing such hazards. Other comments ask to engage with us early and often on the development of applicable guidance documents regarding what constitutes a “significant hazard” for produce industry operations and provide an opportunity to explain and discuss current industry best practices and preventive controls to address identified significant hazards. Some comments ask us to develop an administrative procedure to adjudicate differences in professional opinion between a regulated firm and a Federal or State regulatory agency regarding hazard “significance.”

(Response 135) We agree that guidance will help create an understanding between industry and regulatory officials as to FDA recommendations for hazards that require preventive controls and appropriate preventive controls for those hazards. See Response 2 and Response 5. We decline the request to develop an administrative procedure to adjudicate differences in professional opinion between a regulated firm and a Federal or State regulatory agency regarding hazard “significance.” We note that existing procedures provide for an outside party to obtain internal agency review of a decision by an employee other than the Commissioner (see § 10.75). The comments do not explain what they mean by “inter-state compacts” or provide any examples of “inter-state compacts” and, thus, it is not clear what, if any, role an “inter-state compact” could play in determining what constitutes a significant hazard in major food industries.

(Comment 136) Some comments ask us to concur that “temporal hazards” in milk and dairy products (specifically, Start Printed Page 55961aflatoxin, pesticides, and radiological contamination) do not represent “significant hazards” that require monitoring and verification activities on an ongoing basis. These comments also ask us to acknowledge that in many cases the testing done by FDA and others is sufficient for protecting public health and that it is not necessary to require ongoing monitoring by individual dairy facilities to comply with the rule.

(Response 136) We decline these requests because such a determination should be facility specific. However, we have revised the considerations for the hazard evaluation to clarify that in making the determination as to what hazards require preventive controls, the facility can consider factors such as the temporal nature of the hazard (see § 117.130(c)(2)(x) and Response 407). In determining the appropriate preventive control management components, the facility can take into account the nature of the preventive control and its role in the facility's food safety system (see § 117.140(a)).

(Comment 137) One commenter asserts that municipal drinking water supplies can be variable such that they could be a hazard that is reasonably likely to occur and that relying on municipal water will compromise food safety. The commenter asks us to “close the gap” in Federal risk assessment policies by adding regulatory text to the proposed definition of “significant hazard” to specify that the hazards are based on the outcome of a hazard analysis that includes any water used by the facility, whatever its source. The commenter further asserts that FDA must require full scientific water risk analysis and written water safety plans and water treatment where necessary and that the written water safety plans must comply with FSMA standards for accurate and precise measurement instruments, monitoring, verification, and documentation. The commenter asserts that in lieu of a full assessment and testing, the plant could disinfect all incoming water to a preventive control standard, and track and document compliance. The commenter further asserts that its commercially available technology provides the most cost effective disinfection for a wide range of sporeformers, bacteria, viruses, algae and molds.

In addition, the commenter asserts that food manufacturers who are not required to make a special effort to understand the status of their water supply through a required risk assessment process will not be aware of the need to institute preventive controls for their water supply. To support its position, the commenter makes assertions about the purpose of water standards established by the U.S. Environmental Protection Agency (EPA), the risk presented by water quality to the production of safe food, and the impact to food safety of EPA's 2013 changes to the National Primary Drinking Water regulations (EPA's NPDW regulations; 41 CFR parts 141 and 142) regarding total coliforms (EPA's total coliform rule) (78 FR 10270, February 13, 2013).

The commenter asserts that EPA's NPDW regulations hold public water suppliers to a standard that is protective of drinking water, not food manufacturing water. For example, the commenter describes EPA's NPDW regulations as requiring water suppliers to treat at least 95 percent of the water they distribute to the public to the treatment technique standard of the treatment they use and then argues that a user of the water would not necessarily know if it was getting some of the “allowable 5 percent off-spec water.” The commenter also asserts that current standards in EPA's NPDW regulations are not universally achieved by all public water systems. The commenter also asserts that EPA's total coliforms rule further reduces the applicability of municipal water standards to food manufacturing (e.g., because it reduced the frequencies of water monitoring and public notices about water quality and instead shifted the regulatory scheme towards corrective action).

According to the commenter 95,000 public water systems do not disinfect the water they provide to the public, and some studies have found infective viruses in drinking water samples in communities that did not disinfect their water. According to the commenter, water supplies close to aquifers that were not disinfected before distribution have recently had boil water advisories, demonstrating that problems with the water supply are reasonably likely to occur. The commenter questions whether the food manufacturing plants using that water had water safety back-up plans, stopped production, had monitoring measures in place to determine the impact of the unsafe water, or recalled product manufactured during the period when the municipal water systems had coliform positive tests but had not yet confirmed these tests and therefore had not yet issued the advisory. The commenter also asks whether the facilities relied on the traditional assumption that if they use municipal water their food safety risk analysis does not have to cover water, they do not need a written water safety plan, and they do not need to monitor the safety of their water.

(Response 137) We decline the request to change the regulatory text to explicitly require that the hazard analysis address any water used by the facility, whatever its source. Many of the commenter's assertions address issues under the jurisdiction of EPA, such as “allowing” “5 percent off-spec water”; whether current standards are universally achieved by all public water systems; and whether it is appropriate to allow some water systems to not disinfect the water they supply. Such issues that are under the jurisdiction of EPA are outside the scope of this rulemaking. We consider that water standards directed to drinking water for household use would also be adequate for the production of food products and, thus, have no reason to question whether a facility can rely on the standards in EPA's NPDW regulations to satisfy the long-standing CGMP requirement that any water that contacts food, food-contact surfaces, or food-packaging materials must be safe and of adequate sanitary quality (§ 117.37(a)). For example, we consider that water standards that EPA concludes are appropriate for drinking water are also appropriate for the production of water-based beverages, which are mostly water. We also see no reason to specifically require that a facility that satisfies the CGMP requirement for water also address water quality in its hazard analysis. Further, if a facility chooses to address the safety of water in its hazard analysis (e.g., water used in washing fresh-cut produce), we consider it more likely that the facility would treat the water onsite, obtain the water supplier's records documenting the results of its water testing, or simply test the water on a periodic basis, rather than conduct a risk assessment for the water source.

Under § 117.37(a), we expect any food establishment—regardless of whether it is a facility subject to FSMA's requirements for hazard analysis and risk-based preventive controls—to be vigilant regarding public health advisories such as a “boil water advisory” and to take appropriate action in light of such advisories. It is not necessary for the regulatory text to specify each potential problem or to specify the actions a food establishment must take to address each potential problem.

33. Significantly Minimize

We proposed to define the term “significantly minimize” to mean to reduce to an acceptable level, including to eliminate.Start Printed Page 55962

(Comment 138) Some comments assert that the definition of “acceptable level” for fresh produce is unclear because of the presence of spoilage microorganisms, which subject food to decomposition and reduce quality, but are not a public health concern. These comments ask us to revisit and change regulatory text that either does not clarify, or over-steps the intention of, the rule.

(Response 138) We proposed to define “significantly minimize” to give context to the term used in FSMA to define “preventive control.” Thus, in this rule the term “significantly minimize” relates to hazards that will be addressed by preventive controls. The term “significantly minimize” would not be relevant to spoilage microorganisms unless the facility determines, through its hazard analysis, that the spoilage microorganisms are a hazard requiring a preventive control. The standard of “acceptable level” is a flexible standard. By “acceptable level,” we mean a level that will not cause illness or injury or result in adulterated food.

34. Small Business

We proposed to define the term “small business” to mean, for the purposes of part 117, a business employing fewer than 500 persons. As previously discussed, we conducted a Food Processing Sector Study as required by section 418(l)(5) of the FD&C Act (Ref. 19) and used the results of the study in defining the term “small business” (78 FR 3646 at 3700 to 3701). We made the results of the Food Processing Sector Study available in Docket No. FDA-2011-N-0920 and requested public comment on that study.

(Comment 139) Some comments express concern that the Food Processing Sector Study is not comprehensive. Some comments assert that FDA did not sufficiently collaborate with USDA, and that FDA significantly underestimated the number of mixed-use facilities, particularly by neglecting to count farms that perform the processing steps on RACs to become a processed food. Other comments assert that the Food Processing Sector Study is woefully inadequate and must be undertaken again to comply with the law.

(Response 139) We previously acknowledged the limitations of the Food Processing Sector Study (78 FR 3646 at 3700-3701). We have revised and extended the results of our earlier study by expanding our data sources and by including representatives from USDA's Economic Research Service, USDA's Agricultural Marketing Service, and the American Farm Bureau to help oversee the revised study. The revised Food Processing Sector Study is available in the docket of this rule (Ref. 21).

Our original analysis was based on the merger of Dun & Bradstreet data and FDA's Food Facility Registration data to help us estimate the number of manufacturing facilities that are also classified as farms. We have updated that data source and added data sources. To better account for farms that perform processing activities, we included Census of Agriculture (Ag Census) data both to provide a count of total U.S. farms and to estimate the number of farms conducting food processing activities, to the extent that the data identifies processing activities. We also included the Agricultural Resource Management Survey (ARMS) data because it included questions about some processing activities for select commodities.

Both the Ag Census and ARMS are silent about many processing activities. Therefore, we also obtained estimates from commodity specialists at trade associations, USDA, and universities with in-depth knowledge of the processing activities for specific agricultural commodities. We also reached out to directors of promotion and marketing boards, and considered marketing agreements and marketing orders for various vegetables, fruits, and tree nuts to obtain information about the portion of farms that conduct food processing activities for use in this study.

(Comment 140) Some comments ask us to explain how to calculate the number of full-time equivalent employees—e.g., with respect to temporary workers, seasonal workers, and part-time workers.

(Response 140) As previously discussed, we proposed to establish the same definition for small business as that which has been established by the U.S. Small Business Administration (SBA) under 13 CFR part 121 for most food manufacturers, and the limit of 500 employees would include all employees of the business rather than be limited to the employees at a particular facility (78 FR 3646 at 3701). We will base the calculation on “full-time equivalent employees” and use the same approach to calculating full-time equivalent employees for the purpose of this rule as we used to calculate full-time equivalent employees in the section 414 recordkeeping regulations (see § 1.328). This approach is similar to the approach we used to calculate the small business exemption for nutrition labeling of food (21 CFR 101.9(j)(18)(iv)(D)). Under this approach, the number of full-time equivalent employees is determined by dividing the total number of hours of salary or wages paid directly to employees of the business entity claiming the exemption and of all of its affiliates and subsidiaries by the number of hours of work in 1 year, 2,080 hours (i.e., 40 hours × 52 weeks).

We received similar comments during the rulemaking to establish the section 414 recordkeeping regulations, and in response to those comments we established the definition of “full-time equivalent employee” in the definitions for that rule. As with the section 414 recordkeeping regulations and the nutrition labeling regulations, the calculation for the number of employees affects exemptions (i.e., the exemptions for on-farm, low-risk activity/food combinations in § 117.5(g) and (h), which apply only to small and very small businesses), not just compliance dates. Therefore, we are establishing the definition of “full-time equivalent employee” in the definitions for this rule (§ 117.3) and modifying the definition of “small business” to use the term “500 full-time equivalent employees” rather than “500 persons.”

(Comment 141) Some comments ask us to base the definition of “small business” on the amount of sales, rather than on the number of employees, for consistency with the definition of “very small business.”

(Response 141) We decline this request. As previously discussed, we based the definition of “very small business” on sales because the criterion of being a “very small business” plays a significant role in determining whether a facility is a “qualified facility,” and because the other principal criterion for being a “qualified facility” is based on sales (section 418(l)(1)(C) of the FD&C Act; see 79 FR 58524 at 58556). In contrast, section 418(l) of the FD&C Act does not specify any particular criterion (whether sales or number of employees) for the definition of “small business,” other than direct us to consider the results of the Food Processing Sector Study. Basing the definition of “small business” on the number of employees is consistent with our approach to defining “small business” for our HACCP regulation for juice (§ 120.1(b)(1)), the section 414 recordkeeping regulations (69 FR 71562, December 9, 2004), and our CGMP regulation for manufacturing, packaging, labeling, or holding operations for dietary supplements (72 FR 34752, June 25, 2007).

(Comment 142) Some comments assert that the specified number of Start Printed Page 55963employees (i.e., 500) has no relevance to food safety.

(Response 142) The definition of “small business” is relevant to two aspects of this rule. First, it is relevant to the compliance date for the establishment, and provides an additional year for establishments satisfying the definition to comply with the rule. As discussed in the Final Regulatory Impact Analysis (FRIA) (Ref. 38), we estimate that the number of small businesses that will be eligible is 45,936, accounting for 5.4 percent of the food supply. Although the purpose of the rule is to improve food safety, delaying the effective date for approximately 6 percent of the food supply will not significantly affect food safety in the long term.

Second, the definition of “small business” is relevant to the statutory exemptions for on-farm, low-risk activity/food combinations for manufacturing/processing, packing, and holding food by farm mixed-type facilities. These statutory exemptions, although expressly authorized only for small and very small businesses, encompass risk and are limited, because a small or very small farm mixed-type facility is only eligible for the exemption if the only activities that the facility conducts are the specified on-farm low-risk activity/food combinations.

(Comment 143) Some comments assert that the specified number of employees (i.e., 500) may or may not be indicative of business size. As an example, the comment notes that harvest employees may operate under contract rather than be the grower's employees.

(Response 143) If a farm mixed-type facility that is subject to this rule employs harvest employees under contract, the facility would include these employees in its calculation of full-time equivalent employees and would adjust for the temporary, seasonal nature of the increased number of employees when it calculates the 12 month average number of full-time equivalent employees. (See Response 140 for the calculation of full-time equivalents.)

(Comment 144) Some comments assert that the human preventive controls rule and the produce safety rule should use the same definition of “small business.”

(Response 144) We tailored the definitions of “small business” to the characteristics of the sectors of industry subject to the two rules.

(Comment 145) Some comments assert that the definition of a small business as less than 500 employees makes the very small business exemption irrelevant. These comments ask us to create a simple and broad small business exemption for any small business conducting “low-risk activities.”

(Response 145) We disagree that the definition of a small business makes the very small business exemption irrelevant and decline the request to create a “simple and broad small business exemption” for any small business conducting “low-risk activities.” Although both small and very small businesses are eligible for the exemption for such businesses that only conduct specified low-risk activity/food combinations, other provisions apply solely to very small businesses. For example, the compliance date for a very small business is different from the compliance date for a small business, and a very small business (but not a small business) is eligible for modified requirements.

35. Supplier

We proposed to define the term “supplier” to mean the establishment that manufactures/processes the food, raises the animal, or harvests the food that is provided to a receiving facility without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or similar activity of a de minimis nature.

As discussed in Response 32, we have revised the “farm” definition to explicitly include business models in which one operation grows crops but does not harvest them, and another operation, not under the same management, harvests crops but does not grow them. As also discussed in Response 32, this revision represents a change from the existing and proposed “farm” definitions, which describe a “farm” as an entity “devoted to the growing and harvesting of crops” (emphasis added). We proposed the “supplier” definition in the context of a single business entity “devoted to the growing and harvesting of crops” (emphasis added). We used the term “harvesting,” rather than “growing,” to reflect the last stage of production on a farm, except for packing.

Because the proposed “supplier” definition contemplated that the same business entity that grows crops also harvests them, we have revised the “supplier” definition so that the grower remains the supplier when the harvester is under separate management. Specifically, “supplier” is now defined to include an establishment that “grows” food rather than an establishment that “harvests” food. Doing so focuses the requirements for the supply-chain program (see subpart G) on the entity that produces the food, rather than on the entity that removes the food from the growing area, when the grower and the harvester are not under the same management. Doing so also simplifies the determination of who the supplier is in complex business models, such as when a “handler” arranges for harvest by another business entity.

As discussed in Response 22, we consider a farm to be a type of “establishment” even though we revised the “farm” definition to refer to an “operation” rather than an “establishment” within that definition.

(Comment 146) Some comments assert that the definition of supplier is not workable because the status of warehouses and brokers is unclear in the definition. Other comments ask us to modify the definition to specify, in addition to the proposed definition, that the supplier could be an intermediary entity that takes responsibility on behalf of the receiving facility to ensure that the food meets the requirements of this part.

(Response 146) As discussed in Response 657, we agree that the role of intermediaries in the supply chain is critical, and we have added options for entities other than the receiving facility to perform certain supplier verification activities, provided that the receiving facility reviews and assesses the documentation produced by the other entity and documents that review and assessment. However, this does not mean that these entities take on the role of the supplier. As discussed in Response 658 and Response 123, we believe it is important to supplier verification to retain the identities of two parties involved—the receiving facility and the supplier. Therefore, we are retaining our definition of supplier.

(Comment 147) Some comments regarding RACs ask us to modify the definition of supplier in the case of commingled RACs, such that the supplier would be the person immediately back from the receiving facility in the supply chain provided that this entity (presumably a warehouse or aggregator) voluntarily complies with the requirements of subpart C of this part.

(Response 147) We decline this request. As discussed in Response 657, we recognize that doing supplier verification with commingled products will be a challenge. However, we believe it is important that there be a link between the receiving facility (which is manufacturing/processing the Start Printed Page 55964food) and the supplier (who controlled the hazard(s) in the food). We are allowing an entity such as an aggregator or distributor to perform some verification activities, so the outcome requested by these comments will be achieved while maintaining the identities of the two primary parties in the supplier verification relationship (see Response 657).

(Comment 148) One comment asks us to clarify who would be the supplier in a situation in which dairy farms are providing milk to a cooperative collecting milk.

(Response 148) In this example, the dairy farms would be the suppliers because they are raising the animals.

(Comment 149) One comment asks us to clarify that the proposed definition of supplier does not include sources of processing aids or chemicals required for post-harvest treatments and packing processes (including waxes, fungicides, detergents and sanitizers).

(Response 149) As defined, the supplier is the establishment growing the food, not those establishments providing inputs (such as waxes, fungicides, detergents and sanitizers) to that entity.

36. Validation and Verification

We proposed to define the term “validation” to mean that element of verification focused on collecting and evaluating scientific and technical information to determine whether the food safety plan, when properly implemented, will effectively control the identified hazards. We proposed to define the term “verification” to mean those activities, other than monitoring, that establish the validity of the food safety plan and that the system is operating according to the plan.

(Comment 150) Some comments ask us to revise the definitions of “validation” and “verification” to be consistent with the Codex definitions. (Codex defines “validation” to mean obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome. Codex defines “verification” to mean the application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure is or has been operating as intended (Ref. 39).)

Some comments ask us to more clearly distinguish between “validation” and “verification.” Some comments assert that validation is not an element of verification as stated in our proposed definition and suggest that we clearly separate requirements for validation from requirements for verification—e.g., by moving the proposed requirements for verification to a distinct section in the regulatory text.

(Response 150) We have explained how our proposed definitions for “validation” and “verification” align with a variety of widely recognized definitions, including definitions established by Codex, the NACMCF HACCP guidelines, and Federal HACCP regulations for seafood, juice, and meat and poultry (78 FR 3646 at 3700). We disagree that validation is not an element of verification, but acknowledge it is not necessary to say so within the definition of “validation.” Although we have moved the details of the requirements for validation from its proposed location within the requirements for verification (i.e., proposed § 117.155(a)) to a separate section (§ 117.160), we did so as an editorial change to improve clarity and readability rather than as a substantive change to signal that validation is not an element of verification (see table 8 in the 2014 supplemental human preventive controls notice, 79 FR 58524 at 58557).

We agree that validation can apply to a specific control measure as specified in the Codex definition. We also agree that validation can apply to a combination of control measures as specified in the Codex definition. The food safety plan is one example of a combination of control measures.

Although we likewise agree that verification can apply to a specific control measure as specified in the Codex definition, we disagree that to be consistent with the Codex definition we should adopt a definition that excludes the application of verification to the food safety plan. It is well established that some verification measures, such as testing for a pathogen, verify that multiple control measures operated as intended. (See, e.g., Codex's discussion of verification for uncooked fermented sausages (Ref. 39)).

To more clearly distinguish between “validation” and “verification,” the definition of “validation” we are establishing in this rule specifies that validation means obtaining and evaluating scientific evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified hazards (emphasis added). We also made conforming changes associated with the revised definition of “validation” in the requirements for validation (see § 117.160(b)(2)). The definition of “verification” we are establishing in this rule specifies that verification means the application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended and to establish the validity of the food safety plan as a whole (emphasis added). Consistent with the request of the comments, the definition of “verification” uses the Codex description of verification as the application of methods, procedures, tests and other evaluations, in addition to monitoring.

37. Very Small Business

We proposed to define the term “very small business” to mean, for the purposes of proposed part 117, a business that has less than $1,000,000 in total annual sales of human food, adjusted for inflation. As discussed in the proposed rule, we conducted a Food Processing Sector Study as required by section 418(l)(5) of the FD&C Act (Ref. 19) and used the results of the study in defining the term “very small business” (78 FR 3646 at 3700 to 3702). We made the results of the Food Processing Sector Study available in Docket No. FDA-2011-N-0920 and requested public comment on that study. As discussed in Response 139, we have updated that study (Ref. 21).

(Comment 151) Some comments support the proposed dollar threshold of $1,000,000, noting that it would provide sufficient flexibility to companies that receive the exemption to allow them to continue to operate. Some comments that support the proposed dollar threshold of $1,000,000 state that this threshold is consistent with Congress's mandate that the FSMA rules provide flexibility for all sizes and types of businesses and facilities, including small processing facilities co-located on farms, and provide special considerations for small and very small businesses. These comments also state that our proposal to adopt the $1,000,000 threshold is appropriate in light of the two options Congress provided for facilities to qualify for modified requirements, and that although Congress directed us to consider the Food Processing Sector Study in establishing the very small business definition, it did not otherwise establish parameters for us to use in setting this definition, leaving it largely to our discretion. These comments argue that although Congress set out two options whereby facilities could qualify for modified requirements, Congress did not bind us to using both options. These comments express the view that when Start Printed Page 55965Congress is silent on an issue, the agency may reasonably interpret its authority. These comments state that proposing the $1,000,000 threshold for a very small business is entirely reasonable given that businesses this size account for such a small percentage of the food supply, and given Congress's mandate that FDA establish flexible standards considering the effects of the rules on small and very small businesses.

Other comments disagree with the proposed dollar threshold of $1,000,000. Some of these comments assert that the proposed dollar threshold of $1,000,000 would create a new category of exemption not contemplated by FSMA and will create confusion for both those who may be subject to the rule and those trying to enforce it. These comments ask us to instead adopt the $500,000 threshold we considered as “Option 2” in the 2013 proposed preventive controls rule (78 FR 3646 at 3702). Some comments assert that the proposed $1,000,000 threshold would expose a larger number of consumers to a heightened risk of contracting a foodborne illness.

Other comments reiterate their previous assertions that any dollar threshold that exceeds $250,000 would be contrary to Congressional intent and conflict with section 418(l) of the FD&C Act. Some of these comments assert that adopting a $1,000,000 threshold would conflict with the statutory structure of the qualified facility program in a way that effectively nullifies a section of the law. Some of these comments assert that the discussion in the 2014 supplemental human preventive controls notice did not adequately address their comments submitted to the 2013 proposed human preventive controls rule because that discussion does not explain why we believe the proposed $1,000,000 threshold is consistent with the statute's definitions of a qualified facility in section 418(l)(1) of the FD&C Act. These comments assert that the discussion in the 2014 supplemental human preventive controls notice clearly indicates that the definition is intended to abrogate the definition of a qualified facility under section 418(l)(1)(C) of the FD&C Act because the “definition would . . . simplify a facility's determination of whether it is a qualified facility because the facility would only need to calculate its total sales of human food rather than determine how much food was sold to qualified end‐users.” The comments assert that this discussion shows that we have made a deliberate decision to write qualified facilities under section 418(l)(1)(C) and the limitations on sales under section 418(l)(4)(B) out of the law and state that an agency has no authority to repeal a well‐considered act of Congress by fiat in a rulemaking.

(Response 151) We are establishing a $1,000,000 threshold for the definition of “very small business.” We disagree that a $1,000,000 threshold would create a new category of exemption not contemplated by FSMA. Under section 418(l)(1)(A) and (B) of the FD&C Act, a very small business is a qualified facility; under the exemption authorized in section 418(l)(2) of the FD&C Act, a qualified facility is subject to modified requirements rather than the requirements for hazard analysis and risk-based preventive controls. We have acknowledged that a $1,000,000 threshold exempts a greater portion of the food supply than thresholds of either $250,000 or $500,000 (79 FR 58524 at 58555), but reaffirm that under the $1,000,000 threshold the businesses that would be exempt from the requirements for hazard analysis and risk-based preventive controls would represent a small portion of the potential risk of foodborne illness; businesses that fall within this definition of “very small business,” collectively, produce less than 0.6 percent of the food supply (Ref. 38). In addition, most of these facilities will be subject to the CGMP requirements in subpart B; the only exemption from those CGMP requirements is the exemption in § 117.5(k) (which applies to: (1) Farms; (2) certain fishing vessels; (3) establishments solely engaged in the holding and/or transportation of one or more RACs; (4) activities of “farm mixed-type facilities” that fall within the definition of “farm”; and (5) establishments solely engaged in hulling, shelling, drying, packing, and/or holding nuts (without additional manufacturing/processing)).

We disagree that a $1,000,000 threshold for the definition of “very small business” will create confusion for both those who may be subject to the rule and those trying to enforce it; in contrast, it is our view that a $1,000,000 threshold will be less burdensome for both the qualified facilities and FDA. (See Response 581, where we explain that for compliance purposes we intend to focus on financial records demonstrating that a business averages less than the specified dollar threshold rather than records demonstrating that the average annual monetary value of the food manufactured, processed, packed, or held at such facility that is sold directly to qualified end-users during a three-year period exceeded the average annual monetary value of the food sold by the facility to all other purchasers.)

We reaffirm our view, expressed in the 2014 supplemental human preventive controls notice, that section 418 of the FD&C Act does not limit how we may define “very small business” other than by requiring us to consider the Food Processing Sector Study, and we have done so. (See also Response 152.) Therefore, we disagree that adopting a $1,000,000 threshold would conflict with the statutory structure of the qualified facility program in a way that effectively nullifies an entire section of the law. We also disagree that our explanation in the 2014 supplemental human preventive controls notice demonstrates that we have made a deliberate decision to write qualified facilities under section 418(l)(1)(C) of the FD&C Act, and the limitations on sales under section 418(l)(4)(B) of the FD&C Act, out of the law. Likewise, we disagree that we are in any way “repealing” a well‐considered act of Congress by fiat in a rulemaking.

(Comment 152) Some comments that support a dollar threshold of $250,000 rather than $1,000,000 assert that the rationale we presented in the 2014 supplemental human preventive controls notice for a $1,000,000 threshold is inconsistent with the rationale we presented in our “original draft” of the 2013 proposed human preventive controls rule. These comments quote that “original draft” of the 2013 proposed human preventive controls rule as follows: “FDA is proposing to define the term “very small business” to mean, for the purposes of part 110, a business that has less than $250,000 in total annual sales of foods, adjusted for inflation. We are proposing to define very small business using a dollar amount that is, for practical purposes, the same as the dollar amount of sales by a qualified facility to end users other than those that would satisfy the definition of “qualified end users.” The proposed definition is consistent with the findings of a study that we conducted as required by section 418(l)(5) of the FD&C Act.” These comments note that we acknowledged, in the 2014 supplemental preventive controls notice, that section 418(n)(1)(B) of the FD&C Act requires us to consider the Food Processing Sector Study for the purpose of defining “very small business” (79 FR 58524 at 58555) and argue that it is difficult to see how the same study that supported defining a very small business as one that has less than $250,000 in total annual sales of food now supports a definition that puts that threshold at less than $1,000,000.Start Printed Page 55966

(Response 152) These comments are citing a rationale in a draft version of the 2013 proposed human preventive controls rule, which we submitted to the Office of Management and Budget in 2011 (Ref. 40, p. 259). In that draft, we proposed a single option for the definition of “very small business” (i.e., less than $250,000) and explained the reasons for proposing that single option, including an explanation that the option was consistent with the findings of the Food Processing Sector Study. In contrast, in the published 2013 proposed human preventive controls rule that we issued for public comment we identified three options as part of a co-proposal for the definition of very small business, and provided a basis to support each option. For each option of the co-proposal, we made the same statement regarding the Food Processing Sector Study when we discussed the impact of the option on mixed-type facilities—i.e., that it is apparent that the number of co-located facilities is concentrated at the smaller end of the size spectrum. We see no conflict between a statement (made in the context of a single proposed option for the definition of “very small business”) that a specific proposed definition was consistent with the findings of the Food Processing Sector Study and a statement (made in the context of three proposed options for the definition of “very small business”) that it is apparent that the number of co-located facilities is concentrated at the smaller end of the size spectrum. (See also Response 139 regarding the Food Processing Sector Study.)

(Comment 153) Some comments assert that the proposed $1,000,000 threshold would be inconsistent with our explanation, in the 2014 proposed sanitary transportation rule, of the definition of a “non-covered business” as one having less than $500,000 in total annual sales. These comments note that we considered whether a less than $1 million threshold should be applied but concluded: “[W]e believe such an expansion would result in a greater risk of food becoming adulterated during transport due to insanitary food transportation practices.” (Ref. 41) These comments assert that if we were to apply the same analysis we used in the 2014 proposed sanitary transportation rule to the human preventive controls rule, the threshold for a very small business would be below $500,000.

(Response 153) The $500,000 threshold we proposed in the 2014 proposed sanitary transportation rule would apply to “non-covered businesses”—i.e., businesses that would be completely exempt from the requirements of the sanitary transportation rule. In contrast, the $1,000,000 threshold we are establishing in this rule applies to very small businesses that will be subject to modified requirements rather than be completely exempt. A very small business will have two options to comply with the modified requirements in the human preventive controls rule (the food safety practices option and the option to demonstrate compliance with other applicable non-Federal food safety law; see § 117.201(a)(2) and the discussion in sections XXXVIII.C.2 and XXXVIII.C.3). Regardless of which option a very small business chooses to comply with the modified requirements, we will inspect the business for compliance with the CGMPs and the modified requirements. In contrast, if the final sanitary transportation rule excludes a “non-covered business” as would be defined in that rule, that business would be completely exempt rather than subject to modified requirements and, thus, would be not be inspected for compliance with any aspect of the sanitary transportation rule.

(Comment 154) Some comments ask us to clarify how to classify the size of a business that does not take ownership of or directly sell food (e.g., warehouses and re-packing facilities) to determine status as a qualified facility.

(Response 154) We have revised the definition to specify that the $1,000,000 threshold applies to sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee). When there are no sales of human food, market value of the human food manufactured, processed, packed, or held without sale is a reasonable approach to calculating the dollar threshold for very small business.

(Comment 155) Some comments ask us to specify that the monetary threshold for the definition be based on average sales during a three-year period on a rolling basis because otherwise firms may be subject to significant changes in status from year to year. These comments also ask us to clarify that the sales are to be evaluated retrospectively, not prospectively.

(Response 155) We have revised the definition of very small business to specify that it is based on an average during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee). The applicable calendar year is the year after the 3 calendar years used to determine whether a facility is a very small business. The most recent applicable calendar year is the current year. For example, on June 3, 2024, 2024 is the most recent applicable calendar year and is the applicable calendar year when the 3 calendar years used to determine whether a facility is a very small business are 2021-2023. The exception is when 3 calendar years of records are not available, such as when a facility begins business after the compliance date for very small businesses. In such situations the applicable calendar year refers to the year during which the calculation is made but is not preceded by 3 calendar years used to determine whether a facility is a very small business.

As a companion change, we are explicitly requiring that a facility determine and document its status as a qualified facility on an annual basis by no later than July 1 of each calendar year (see § 117.201(c)(1)). Although this requirement was implicit in the proposed requirement that a facility must resubmit a notification to FDA if its status changes as a qualified facility (proposed § 117.201(c)(2), which we are finalizing as § 117.201(c)(3)), we are making this requirement explicit to clarify the responsibility of the facility to affirmatively determine its status when the calendar years that apply to the 3-year average change. The July 1 deadline for a facility to determine its status provides facilities with 6 months to make the determination after the end of the previous 3 calendar years.

We also are establishing an earlier compliance date for the financial records that a facility maintains to support its status as a very small business that is eligible for the qualified facility exemption in § 117.5(a). Specifically, the compliance date for a facility to retain records to support its status as a qualified facility is January 1, 2016. Even with this earlier compliance date for these records, we realize that although the calculation for “very small business” in the regulatory text is based on 3 calendar years, a facility will only be required to have 2 calendar years of records as of the general compliance date for very small businesses. Specifically, by September 17, 2018 a facility that begins retaining applicable financial records on January 1, 2016, would only have such records for 2 previous calendar years. Therefore, it would be reasonable for a facility to make the calculation based on the 2 previous calendar years. If a facility has records for 3 previous calendar years, the facility could make the calculation based on the longer time period. During inspection in 2018, when a facility has Start Printed Page 55967records for the preceding 2 calendar years, but not for the preceding 3 previous calendar years, we will accept records for the preceding 2 calendar years as adequate to support status as a qualified facility. We note that in some situations, a shorter time period is sufficient to determine that a facility is not a very small business. For example, a facility with sales exceeding $3,000,000 for the preceding calendar year cannot qualify as a very small business because no amount of sales from other years will reduce average sales below the threshold of $1,000,000.

The available financial records for a facility that begins operations between January 1, 2017 and September 17, 2018 would not cover even 2 calendar years by September 17, 2018. During the first 3 years of such a facility's operation, it would be reasonable for a facility to make the calculation based on records it has (i.e., for one or two preceding calendar years), and we will accept records for the preceding one or two years as adequate to support status as a qualified facility in these circumstances.

When a facility does not begin operations until after January 1, 2018, it would be reasonable for the facility to rely on a projected estimate of revenue (or market value) when it begins operations. We would evaluate the credibility of the projection considering factors such as the facility's number of FTEs. After the facility has records for one or two preceding years, it would be reasonable for the facility to make the calculation based on records it has (i.e., for one or two preceding calendar years) and we will accept records for the preceding one or two calendar years as adequate to support status as a qualified facility in these circumstances.

(Comment 156) Some comments ask us to only include the total annual sales of food in the United States, adjusted for inflation, for foreign facilities that export food to the United States.

(Response 156) We decline this request. The purpose of the definition of “very small business” is principally to enable such businesses to comply with modified requirements, because they have fewer resources to direct to full compliance with the rule. A foreign business that sells more than the threshold dollar amount of food has more resources than the businesses being excluded, even if less than that threshold dollar amount reflects sales to the United States. Likewise, a domestic business that sells more than the threshold dollar amount of food has more resources than the businesses being excluded, even if that domestic business exports some of its food and, as a result, less than that threshold dollar amount reflects sales within the United States.

As discussed in Response 154, to address facilities such as those warehouses and re-packing facilities that do not take ownership or directly sell food we have revised the definition of “very small business” to specify that the $1,000,000 threshold applies to sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee). As with “sales,” facilities such as those warehouses and re-packing facilities that pack or hold more than the $1,000,000 threshold would have more resources than the facilities being excluded.

(Comment 157) Some comments ask us to apply the rule to dairy farms with sales greater than $1 million annually of processed or packaged dairy products, rather than bulk sales of fluid milk. Other comments ask us to only include the annual monetary value of food covered by the preventive controls rule, rather than all human food. In particular, these comments argue that food covered by the produce safety rule should not be counted in the calculation of the sales of food for the purpose of defining very small business for the preventive controls rule. Some of these comments assert that basing the threshold on the monetary value of food covered by the preventive controls rule, rather than all human food, would be necessary to be consistent with the approach used in the proposed animal preventive controls rule, in which the sales threshold was based on sales of animal food (i.e., the product regulated by the rule).

(Response 157) We decline these requests. As discussed in Response 156, the purpose of the definition of “very small business” is principally to enable such businesses to comply with modified requirements, because they have fewer resources to direct to full compliance with the rule. Because of the exemptions in the human preventive controls rule (e.g., for processors of seafood, juice, low-acid canned foods (LACF), and dietary supplements), basing the threshold on the monetary value of food covered by the preventive controls rule, rather than all human food, could lead to a situation where a very large food processor (such as a juice processor with more than $20,000,000 in annual sales) would not need to comply with the human preventive controls rule for milk- and soy-based beverages that it produces, if the annual sales of milk- and soy-based beverages is less than $1,000,000.

We disagree that a threshold based on sales of human food, rather than food covered by the preventive controls rule, would be inconsistent with the threshold we proposed for the animal preventive controls rule. The threshold we proposed for the animal preventive controls rule was based on “total annual sales of food for animals, adjusted for inflation,” which is exactly parallel to our proposal to base the threshold on “total annual sales of human food, adjusted for inflation.” We proposed several exemptions to the animal preventive controls rule (see proposed § 507.5 (proposed 21 CFR 507.5)) and, thus, not all food for animals will be subject to the animal preventive controls rule.

(Comment 158) Some comments ask us to base the threshold on the total “volume of product” or “amount of product” handled or sold. These comments assert that an approach using product volume or amount would be more risk-based because it would correlate more closely to consumer exposures than dollar amounts, which can be skewed by product values.

(Response 158) We use sales as a proxy for volume. We acknowledge that dollar amounts can be skewed by product values and, thus, sales are an imperfect proxy for volume. However, we are not aware of a more practical way to identify a threshold based on volume or amount of product that could be applied across all product sectors, and the comments provide no suggestions for how their recommendation could be carried out.

(Comment 159) Some comments assert that our conclusion that our proposed definition of very small business is controlled by the two references in sections 418(l)(5) and 418(n)(1)(B) of the FD&C Act does not provide a reasonable justification for our decision. These comments assert that it is equally true that those two provisions would not prevent us from adopting one threshold (less than $250,000) for purposes of defining a qualified facility (and for a very small business conducting on‐farm low‐risk activity/food combinations) and another (less than $1 million) for setting compliance dates. These comments also assert that this is exactly the determination we made for our proposed animal preventive controls rule, where we proposed to define very small business, under the constraints of these same two references, as one with less than $2,500,000 in sales. To give full effect to the design of the qualified facility program while providing an adequate compliance deadline, these comments ask us to revise the definition of very small business to mean “a business that has less than $250,000 in total annual Start Printed Page 55968sales of human food, adjusted for inflation, except that for purposes of the effective dates in section 103(i) of the FDA Food Safety Modernization Act (21 U.S.C. 350g note) the term means less than $1,000,000 in total annual sales of human food.”

(Response 159) These comments are unclear. We agree that we proposed to define very small business, for the purposes of the animal preventive controls rule, as one with less than $2,500,000 in sales (79 FR 58476 at 58510), but disagree that we proposed to adopt one threshold for purposes of defining a qualified facility and another threshold for setting compliance dates. Regardless, we decline the request to adopt a threshold lower than $1,000,000 for purposes of defining a qualified facility, which appears to be the principal request of these comments (see Response 151).

(Comment 160) Some comments support the proposed dollar threshold of $1,000,000, provided that we also make changes to the “farm” definition to encompass activities of food hubs performing low-risk packing and holding activities on RACs for distribution in local food markets. If we do not revise the “farm” definition to encompass such activities, these comments assert that a threshold dollar amount of $2,000,000 would be necessary to allay concerns that making food hubs subject to the requirements for hazard analysis and risk-based preventive controls would cause many food hubs to fail, and would prevent the start of new food hubs.

(Response 160) See Response 23 and Response 25. Food hubs that pack and hold RACs are covered by the “farm” definition if the farm(s) that grow or raise the majority of the RACs packed and held by the food hub own, or jointly own, a majority interest in the food hub. Thus some food hubs will not be required to register as a food facility and, thus, will not be subject to the requirements for hazard analysis and risk-based preventive controls. Those food hubs that exceed the specified dollar threshold for a very small business and are not within the “farm” definition would be subject to the requirements for hazard analysis and risk-based preventive controls. However, the preventive controls that the food hub would establish and implement would depend on the food hub, the food, and the outcome of the facility's hazard analysis, and the preventive control management components that the food hub would establish and implement for its preventive controls would be established as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system. A facility that appropriately determines through its hazard analysis that there are no hazards requiring preventive controls would document that determination in its written hazard analysis but would not need to establish preventive controls and associated management components. (See Response 222).

(Comment 161) Some comments express concern that establishing a threshold based on U.S. dollars would place domestic firms at a disadvantage relative to foreign firms whose sales are often denominated in currencies valued lower than the dollar and often reflect much lower costs for factors such as land, labor, and environmental compliance. These comments ask us to base the threshold on an alternate measure, such as number of employees, or to calculate the sales of foreign very small businesses using an appropriate measure of purchasing power parity, if there is a straightforward way to do so.

(Response 161) We decline these requests. As previously discussed, we use dollar estimates to evaluate the percentage of all food produced in the United States that would not be covered by the rule (79 FR 58524 at 58555). We acknowledge that the definition of “small business” is based on number of employees, and that two exemptions (i.e., the exemptions in § 117.5(g) and (h) for on-farm, low-risk activity/food combinations) apply to small businesses. However, the exemptions for on-farm, low-risk activity/food combinations are limited to a narrow sector of the food industry, whereas the exemption applicable to a very small business will apply to all sectors of the food industry.

We do not know of a straightforward way to calculate the sales of foreign very small businesses using an appropriate measure of purchasing power parity and are basing the threshold only on U.S. dollars.

(Comment 162) Some comments assert that the reach of potential harm from foods imported from very small businesses that would meet the proposed threshold of $1,000,000 may be greater because they are more likely to be ingredients, such as spices, and argue that small amounts of spice can contaminate a large volume of food and, thus, cause widespread illnesses. Other comments assert that it is very likely that more facilities in exporting countries will be exempt under the definition, thus putting those located in the United States at a disadvantage. These comments assert that the definition of “very small business” should reflect the probability and severity of potential hazards in order to align with the rest of the regulation and promote public health interests.

(Response 162) We acknowledge that ingredients such as spices, which have been associated with outbreaks of foodborne illness and large recalls, can contaminate a large volume of food (78 FR 3646 at 3665 and 3737). However, the suggestion that we define “very small business” in a way that reflects the probability and severity of potential hazards is neither practical nor aligned with a size-based nature of the term.

The comments asserting that it is very likely that more facilities in exporting countries will be exempt under the definition, thus putting those located in the United States at a disadvantage, provided no basis for the assertion. As discussed in Response 156, we have declined the request to only include the total annual sales of food in the United States, adjusted for inflation, for foreign facilities that export food to the United States.

(Comment 163) Some comments express concern that the Food Processing Sector Study is not comprehensive.

(Response 163) See Response 139 regarding the Food Processing Sector Study.

38. You

We proposed to define the term “you” for purposes of part 117, to mean the owner, operator, or agent in charge of a facility. We received no comments that disagreed with this proposed definition and are finalizing it as proposed.

D. Comments Asking FDA To Establish Additional Definitions or Otherwise Clarify Terms Not Defined in the Rule

1. Corrections

(Comment 164) Some comments assert that clearly distinguishing between the terms “corrective actions” and “corrections” will be imperative for industry to comply with the rule and for regulators to enforce the rule. Some comments ask us to use the ISO definitions of “corrective actions” and “corrections.” (According to ISO 22000:2005 definition 3.13, a “correction” is action to eliminate a detected nonconformity; according to ISO 22000:2005 definition 3.14, corrective action is action to eliminate the cause of a detected nonconformity or other undesirable situation.) Other comments ask us to eliminate the term “correction” and instead revise the rule to clarify the type of situation in which “corrective actions” are neither Start Printed Page 55969necessary nor appropriate. As an example, these comments suggest that the proposed provisions for corrections could refer to “prompt actions taken in response to minor and isolated deviations that do not directly impact product safety.”

Other comments agree with the concept of simple “corrections” but assert that the term “corrections” is unnecessary and could be confusing because different facilities may use the term differently. These comments explain that sometimes “correction” is used to refer to the action taken to fix a deviation, and may or may not be part of an overall corrective action taken to identify the root cause of the deviation and to prevent a similar occurrence. These comments suggest that the provisions explain that prompt actions taken to address minor and isolated deviations are not subject to the same requirements as corrective actions to address potentially systemic concerns, without defining the term “corrections.”

(Response 164) We are defining the term “correction” to mean an action to identify and correct a problem that occurred during the production of food, without other actions associated with a corrective action procedure (such as actions to reduce the likelihood that the problem will recur, evaluate all affected food for safety, and prevent affected food from entering commerce). We agree that clearly distinguishing between the terms “corrective actions” and “corrections” will be important for both industry and regulators. We acknowledge that one way to distinguish between “corrective actions” and actions that we would consider “corrections” could be to avoid the term “corrections” and instead say what we mean each time the rule uses the term “corrections.” However, after reviewing the full regulatory text of proposed subpart C we concluded that it was not practical to do so, because the term “corrections” was used more often in a title or a cross-reference than in a provision where the full text of what we mean by the term “corrections” is necessary to communicate a requirement. Our definition of “corrections” focuses on the first step in a “corrective action procedure” (i.e., identify and correct the problem) and also specifies those aspects of a corrective action procedure that do not apply to a correction (i.e., actions to reduce the likelihood that the problem will recur, evaluate all affected food for safety, and prevent affected food from entering commerce). (A note to the ISO 22000:2005 definition of corrective action indicates that it includes cause analysis and is taken to prevent recurrence.) We believe that this definition will be adequate to distinguish “corrective actions” from “corrections.”

As an example, if a facility applies sanitation controls for an environmental pathogen such as L. monocytogenes and food residue is observed on “clean” equipment prior to production, corrections would involve re-cleaning and sanitizing the equipment before it is used. Because the observation of food residue was made prior to production of food, no food is affected, and no actions are needed with respect to food. Although there are actions that can be taken to prevent reoccurrence, such as re-training sanitation personnel, these types of actions are not always needed.

2. Defect Action Level

(Comment 165) Some comments that address the proposed provisions regarding “defect action levels” (proposed § 117.110) ask us to define that term so that its meaning will be clear.

(Response 165) We have added a definition of the term “defect action level” to mean a level of a non-hazardous, naturally occurring, unavoidable defect at which FDA may regard a food product “adulterated” and subject to enforcement action under section 402(a)(3) of the FD&C Act. This definition derives from the definition in our long-standing “Defect Levels Handbook” (Ref. 36), which we continue to reference in the provisions established in this rule regarding defect action levels. This definition also derives from the long-standing provisions in § 110.110, which referred to natural or unavoidable defects in food for human use that present no health hazard and noted that some foods contain natural or unavoidable defects that at low levels are not hazardous to health. These long-standing provisions also noted that we establish maximum levels for these defects in foods produced under current good manufacturing practice and use these levels in deciding whether to recommend regulatory action.

3. Food-Packaging Material

(Comment 166) Some comments point out that the proposed human preventive controls rule would amend certain provisions requiring prevention of contamination and allergen cross-contact of food and food-contact surfaces to add “food-packaging materials,” a term which is not defined. These comments ask us to clarify that “food-packaging materials” is limited to packaging materials that are capable of contaminating food and does not include shipping containers such as cartons and crates that pose no risk of introducing contaminants or food allergens into food.

(Response 166) For the purposes of the provisions that require protection against allergen cross-contact and against contamination of food, food-contact surfaces, and food-packaging materials, the term “food-packaging materials” does not include shipping containers such as cartons and crates that pose no risk of introducing contaminants or food allergens into food. We are not adding a definition of “food-packaging materials” to the definitions in § 117.3 because the provisions requiring protection against contamination are long-standing provisions that have been applied in the manner requested by the comment and, thus, adding a definition is not necessary to address the comment's request.

4. Must

(Comment 167) Some comments ask us to define the term “must.”

(Response 167) We decline this request. The term “must” has a common meaning, and it is not necessary to establish a specific meaning for this term specifically for this rule.

5. Parameter and Value as Used in the Requirements for Process Controls

(Comment 168) Some comments ask us to define the terms “parameter” and “value” used in the requirements for preventive controls (§ 117.135). These comments ask us to define “parameter” as a measurable attribute and “value” as a specific measurement.

(Response 168) We decline this request. Both of these terms are used in the context of process controls and both have common meanings when associated with process controls. Therefore, it is not necessary for the rule to define them.

6. Raw Materials

Some comments ask us to define “raw materials” (see Comment 65). As discussed in Response 65, we have declined to do so.

7. Qualified Facility Exemption

(Comment 169) Some comments note that some of the terminology associated with the exemption for qualified facilities in the human preventive controls rule is different from terminology associated with an exemption in the proposed produce safety rule. These comments point out that the exemption in the proposed produce safety rule refers to “qualified exemptions” (§ 112.5), whereas the Start Printed Page 55970exemption in the proposed human preventive controls rule refers to “exemptions” and “qualified facilities” (§ 117.5(a)). These comments ask us to harmonize the terminology associated with the exemption for qualified facilities in the human preventive controls rule with the terminology associated with “qualified exemptions” in the proposed produce safety rule.

(Response 169) We have revised the human preventive controls rule in two ways to better harmonize the terminology associated with the exemption for qualified facilities in the human preventive controls rule with an analogous exemption in the proposed produce safety rule. First, we have added a definition for the term “qualified facility exemption,” to mean an exemption applicable to a qualified facility under § 117.5(a) (see the regulatory text in § 117.3). Second, we also have made conforming changes throughout the rule to use the term “qualified facility exemption” when it applies. (See table 52.) It is not practical to fully harmonize the relevant terminology in these two rules due to differences in the framework applicable to food businesses subject to section 418 of the FD&C Act compared to the framework applicable to farms subject to section 419 of the FD&C Act. For example, a farm is not a “facility” and, thus, it would be confusing to refer to the applicable exemption established in the final produce safety rule as a “qualified facility exemption” or to refer to the business entities that would be exempt from the final produce safety rule as “qualified facilities.”

8. Unexposed Packaged Food

As discussed in section XII, some comments ask us to clarify that modified requirements for packaged food that is not exposed to the environment only apply to such food that requires time/temperature control for safety (TCS food). To do so, we are defining the term “unexposed packaged food” to mean packaged food that is not exposed to the environment and using this term throughout the rule. Doing so simplifies the regulatory text and makes it clearer.

(Comment 170) Some comments note that certain fruits and vegetables must be stored and distributed in vented packaging to allow for proper air circulation and the escape of gases produced in the ripening process. These comments ask us to interpret “not exposed to the environment” in a way that would include produce packed in such vented crates. Some comments assert that “exposed to the environment” must be meaningful from a food-safety standpoint and that produce shipped in vented crates presents virtually no food-safety risk because its environmental exposure is minimal. Some comments state that they do not believe Congress intended the term “not exposed to the environment” to mean only airtight, sealed containers.

(Response 170) We acknowledge that certain fruits and vegetables may need to be distributed in vented crates but disagree that such produce is “packaged food not exposed to the environment.” We consider “packaged food not exposed to the environment” and “unexposed packaged food” to mean that the food is in a form that prevents any direct human contact with the food (78 FR 3646 at 3712). Although environmental exposure to produce packed in vented crates would be less than environmental exposure to produce packed in open crates, a vented crate can subject produce to contamination from condensate in aerosols carried by the air handling system, moisture dripping onto containers, particulates blown through the facility by the air handling system, fingers of handlers during handling of crates, objects that may be inadvertently inserted through the vents, pests that can access the produce through the vents, etc. We believe it is appropriate for facilities storing produce in vented crates to conduct a hazard analysis and evaluate whether there are hazards that would require a preventive control.

(Comment 171) Some comments ask us to interpret “not exposed to the environment” to mean packaged with food grade material that is impermeable to outside bacteria or other contamination. These comments state that materials that prevent human contact with the food can nonetheless permit passage of contaminants and express concern about migration of chemicals, not approved as food-contact substances, from outer wrappers.

(Response 171) We decline this request. A facility that packages “unexposed packaged food” is responsible for complying with all applicable requirements for the production of the food, including requirements established under section 409 of the FD&C Act (21 U.S.C. 348) regarding indirect food additives and food contact substances when packaging food. Likewise, a facility that packs “unexposed packaged food” in outer wrappers is responsible to ensure the safety of the food it packed, including ensuring that food is not contaminated from chemicals in the outer wrappers. The exemption applicable to “unexposed packaged food” applies to the storage of such foods, not the manufacturing, processing, or packing of such foods. For practical purposes, food that is not exposed to the environment will be protected from outside bacteria by the packaging. See also the discussions in Response 170 and Response 232 regarding produce packed in “vented crates,” which is not “unexposed packaged food.”

E. Additional Definitions To Clarify Terms Not Defined in the Proposed Rule

1. Audit

As already noted, some comments ask us to make the various rules we are establishing to implement FSMA consistent with each other, and we have worked to align the provisions of this rule with the provisions of the FSVP rule to the extent practicable. (See Comment 9 and Response 9.) To align these provisions, we are establishing in this final rule a definition of “audit” analogous to the definition of “audit” we proposed for the FSVP rule. For the purposes of this rule, “audit” means the systematic, independent, and documented examination (through observation, investigation, records review, discussions with employees of the audited entity, and, as appropriate, sampling and laboratory analysis) to assess a supplier's food safety processes and procedures.

2. Full-Time Equivalent Employee

As discussed in Response 140, we have established a definition for “full-time equivalent employee” as a term used to represent the number of employees of a business entity for the purpose of determining whether the business qualifies for the small business exemption. The number of full-time equivalent employees is determined by dividing the total number of hours of salary or wages paid directly to employees of the business entity and of all of its affiliates and subsidiaries by the number of hours of work in 1 year, 2,080 hours (i.e., 40 hours × 52 weeks). If the result is not a whole number, round down to the next lowest whole number.

3. Raw Agricultural Commodity

We have added a definition of the term “raw agricultural commodity” to have the meaning given in section 201(r) of the FD&C Act. We decided to define this term in the rule to simplify the provisions in part 117 that refer to raw agricultural commodities.

4. Supply-Chain-Applied Control

We have added a definition of the term “supply-chain-applied control” to mean a preventive control for a hazard Start Printed Page 55971in a raw material or other ingredient when the hazard in the raw material or other ingredient is controlled before its receipt. We decided to define this term in the rule to simplify the provisions in part 117, and in the discussions in this document, that refer to preventive controls applied by a supplier before receipt by a receiving facility.

5. Written Procedures for Receiving Raw Materials and Other Ingredients

We have added a definition of the term “written procedures for receiving raw materials and other ingredients” to mean written procedures to ensure that raw materials and other ingredients are received only from suppliers approved by the receiving facility (or, when necessary and appropriate, on a temporary basis from unapproved suppliers whose raw materials or other ingredients are subjected to adequate verification activities before acceptance for use). We decided to define this term in the rule to simplify the provisions in part 117, and in this document, that refer to these procedures.

6. Qualified Individual

As discussed in section X.A., we are clarifying in new § 117.4(b)(1) that each individual engaged in manufacturing, processing, packing, or holding food (including temporary and seasonal personnel) or in the supervision thereof must have the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual's assigned duties. To better align with the FSVP rule, we using the term “qualified individual” in new § 117.4(b)(1) and are defining the term “qualified individual” to mean a person who has the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual's assigned duties. A qualified individual may be, but is not required to be, an employee of the establishment.

X. Subpart A: Comments on Qualifications of Individuals Who Manufacture, Process, Pack, or Hold Food

In 2002, FDA convened a CGMP Modernization Working Group (CGMP Working Group) to determine whether part 110 is in need of further revision. In 2005, the CGMP Working Group issued a report (CGMP Working Group Report) summarizing the comments we received, as well as our key findings (78 FR 3646 at 3651). One of the specific areas identified in the CGMP Working Group Report that presented an opportunity to modernize the regulation was to “require appropriate training for supervisors and workers to ensure that they have the necessary knowledge and expertise in food hygiene, food protection, employee health and personal hygiene to produce safe food products.” (78 FR 3646 at 3729)

As previously discussed, FSMA recognizes the importance of both training and CGMPs in preventing hazards from occurring in foods in its definition of preventive controls, which identifies supervisor, manager, and employee hygiene training, and CGMPs under part 110, as some of the procedures, practices, and processes that may be included as preventive controls (see sections 418(o)(3)(B) and 418(o)(3)(F) of the FD&C Act, respectively) (78 FR 3646 at 3729).

We proposed to re-establish part 110's recommendations for training as proposed § 117.10(c) (FR 3646 at 3720). In addition, we requested comment on how best to revise part 110's current recommendations to implement section 418(o)(3) of the FD&C Act and the recommendations of the CGMP Working Group with respect to training (FR 3646 at 3729). Specifically, we requested comment on whether we should merely replace the current recommendations for personnel education and experience with requirements or whether more detail would be appropriate. As examples of additional specificity, we requested comment on whether the rule should specify that each person engaged in food manufacturing, processing, packing, or holding (including temporary and seasonal personnel and supervisors) must receive training as appropriate to the person's duties; specify the frequency of training (e.g., upon hiring and periodically thereafter); specify that training include the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as applied at the facility; and specify that records document required training of personnel and, if so, specify minimum requirements for the documentation (e.g., the date of the training, the type of training, and the person(s) trained). We also requested comment on whether to establish some or all of the potential requirements for education and training in subpart B, subpart C, or both.

In the following paragraphs, we discuss comments that respond to our requests for comment on potential requirements for education and training and for whether to establish any requirements in subpart B, subpart C, or both. After considering these comments, we are establishing requirements for the qualifications of individuals engaged in manufacturing, processing, packing, or holding food in new § 117.4 in subpart A, with associated recordkeeping requirements established in § 117.9 in subpart A. The regulatory text makes clear that these requirements, established in subpart A, apply to individuals engaged in manufacturing, processing, packing, or holding food regardless of whether the individuals conduct these activities under the framework of the CGMPs established in subpart B or the framework for hazard analysis and risk-based preventive controls established in subparts C, D, E, and G. The regulatory text also makes clear that the qualification requirements apply to the recordkeeping requirements of subpart F. See table 11 for a description of these provisions.

Table 11—Provisions for Qualifications of Individuals Who Manufacture, Process, Pack, or Hold Food

Final section designationProposed section designationDescription
117.4(a)(1)N/AApplicability to individuals who manufacture, process, pack, or hold food subject to subparts B and F.
117.4(a)(2)N/AApplicability to individuals who manufacture, process, pack, or hold food subject to subparts C, D, E, F, or G.
117.4(b)(1)N/AEach individual engaged in manufacturing, processing, packing, or holding food must have the education, training, or experience (or combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual's assigned duties.
117.4(b)(2)117.10(c)Required training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene.
117.4(c)117.10(d)Additional qualifications of supervisory personnel.
117.4(d)N/ARecords of required training.
Start Printed Page 55972
117.9N/AThe required records are subject to the recordkeeping requirements of subpart F.

A. Applicability and Qualifications of All Individuals Engaged in Manufacturing, Processing, Packing, or Holding Food (Final § 117.4(a), (b), and (d))

(Comment 172) Some comments support changing the current recommendations for training to requirements, e.g., by replacing “should” with “must.” However, some of these comments also ask that the requirement allow sufficient flexibility for establishments to determine the scope and frequency of the training based on the establishment, types of products, and job responsibilities of the employee. Some of these comments assert that this position is consistent with the concept in the food safety plan of tailoring controls to the specific facility and operations, and also aligns with the Global Food Safety Initiative guidance document, which was based on the recommendations of the Codex Alimentarius Commission (Codex). Some of these comments ask that we specify “as applicable to the plant operation” and “applicable to their assigned duties” to allow establishments flexibility in establishing risk-based training requirements specific to their operations.

Other comments prefer more detail and ask that we establish requirements addressing all of the recommendations of the CGMP Working Group. Some of these comments note that doing so would be consistent with the proposed training requirements for the produce safety rule.

Other comments prefer that we continue to only provide recommendations for education and training and allow the food industry to determine the appropriate level of specific employee training that may be needed. These comments assert that overly prescriptive and binding requirements may not consider variables such as training course content, training provider, effectiveness of the course, and instructor and frequency of training per topic. In addition, comments assert that factors such as an employee's type and length of experience, nature of formal education, and the food product type and point in the food supply chain at which the employee works with the food product (close to the farm or close to the fork) will need to be considered. Other comments ask us to establish the recommendations of the CGMP Working Group in guidance rather than in the rule.

Some comments recommend that employees be trained “initially” and “periodically thereafter” but ask that we recognize the seasonal nature of a facility's workforce. Some comments ask that the training include the principles of food hygiene and food safety, including the importance of employee health and personal hygiene as applied at the facility.

Some comments ask that training requirements be established in subpart B so that the requirements apply to all establishments that manufacture, process, pack, or hold food, including establishments that are not subject to FSMA's requirements for hazard analysis and risk-based preventive controls. These comments assert that this broad training requirement would improve food safety overall. Some comments that recommend establishing the training requirement in subpart B assert that training is more appropriately considered a prerequisite program than a preventive control that would belong in subpart C.

Other comments ask that the training and related recordkeeping requirements for the facility's preventive controls qualified individuals be established under subpart C because this is directly related to the facility's food safety plan. Other comments ask that training requirements be established in both subpart B and subpart C. Other comments assert that including requirements for education and training in both subparts B and C would be confusing.

(Response 172) We are establishing a series of requirements for the qualifications of individuals engaged in manufacturing, processing, packing, or holding food in new § 117.4. First, to clarify how these qualification requirements apply to establishments subject to subparts B and F, we are requiring that the management of an establishment ensure that all individuals who manufacture, process, pack, or hold food subject to subparts B and F are qualified to perform their assigned duties (§ 117.4(a)(1)). To clarify how these qualification requirements apply to facilities, we are requiring that the owner, operator, or agent in charge of a facility ensure that all individuals who manufacture, process, pack, or hold food subject to subparts C, D, E, F, or G are qualified to perform their assigned duties (§ 117.4(a)(2)).

We are not requiring training specific to the person's assigned duties. Each establishment engaged in the manufacturing, processing, packing, and holding of food for human consumption would already have procedures in place to ensure that all individuals who manufacture, process, pack, or hold food know how to do their jobs. However, to emphasize that we expect all individuals who conduct such activities to know how to do their jobs, we are specifying that each individual engaged in manufacturing, processing, packing, or holding food (including temporary and seasonal personnel) or in the supervision thereof must have the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual's assigned duties (§ 117.4(b)(1)). To better align with the forthcoming FSVP rule, we are using the term “qualified individual” in new § 117.4(b)(1) and are defining the term “qualified individual” to mean a person who has the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual's assigned duties. A qualified individual may be, but is not required to be, an employee of the establishment. See the discussion of the term “preventive controls qualified individual” in section IX.C.25, including a discussion of how we have changed the proposed term “qualified individual” to “preventive controls qualified individual” because we are establishing a new definition for “qualified individual,” with a meaning distinct from “preventive controls qualified individual.”

We also are requiring that each individual engaged in manufacturing, processing, packing, or holding food (including temporary and seasonal personnel) or in the supervision thereof, Start Printed Page 55973receive training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as appropriate to the food, the facility and the person's assigned duties (see § 117.4(b)(2)). Records that document this required training must be established and maintained and are subject to the recordkeeping requirements of subpart F (§§ 117.4(d) and 117.9). The rule does not specify the frequency of the required training. We expect that production employees will receive training before working in production operations. Based on a 2010 survey of the domestic food manufacturing industry, we expect that most facilities will also provide some form of refresher training (Ref. 54).

We disagree that we should continue to only provide recommendations for education and training. Although the comments express concern about overly prescriptive requirements that may not consider variables that would affect an establishment's training program (such as training course content, training provider, effectiveness of the course and instructor and frequency of training per topic, an employee's type and length of experience, nature of formal education, and the food product type and point in the food supply chain at which the employee works with the food product), the training requirement we are establishing in the rule provides flexibility for each establishment to provide training, and determine the scope and frequency of the training, in a way that works best for the establishment.

We agree that it is appropriate to establish training requirements so that the requirements apply to all establishments that manufacture, process, pack, or hold food, including establishments that are not subject to FSMA's requirements for hazard analysis and risk-based preventive controls, and we are establishing the qualification and training requirements in subpart A to clarify the applicability of these requirements to all establishments and facilities subject to part 117. Although we agree that employees in facilities that are subject to the requirements for hazard analysis and risk-based preventive controls need to understand their responsibilities under the facility's food safety plan, we are setting forth a training requirement focused on the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as recommended in the report of the CGMP Working Group (Ref. 3). We consider training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, to be fundamental to the concept of CGMPs. We agree that establishing a training requirement in both subpart B and subpart C could be confusing.

(Comment 173) Some comments ask that training not be limited to a narrow class of processors. Other comments assert that anyone who works in the food industry should have mandatory training and re-training.

(Response 173) The training applies to all individuals engaged in manufacturing, processing, packing, or holding food, consistent with the requests of these comments.

(Comment 174) Some comments agree that training should be documented and assert that those records should show the date of training, a description of the training, and the name of the person trained. However, comments ask that we allow flexibility in the way these records are kept. Other comments assert that requiring that records document required training of personnel is burdensome, arbitrary, and capricious.

(Response 174) The rule requires that records that document training required by § 117.4(b)(2) be established and maintained without prescribing any content of those records. Although one approach to documenting training would be to provide the date of training, a description of the training, and the name of the person trained, the rule provides flexibility for each establishment to document its training in a way that works best for that establishment. We disagree that requiring records to document required training is burdensome, arbitrary, and capricious in light of the strong support in the comments regarding CGMP modernization for records documenting training and the flexibility provided by the rule for the content of training records.

(Comment 175) Some comments that support mandatory training nonetheless caution us to be flexible towards the development and deployment of mandatory training, including issuance of certificates, so as not to create road blocks for third-party service providers. These comments state that education and training and/or capacity building is a growing, rapidly evolving, and well-developed third-party service industry today, and that food companies often deliver their training to other raw material suppliers and contract manufacturers. Some comments assert that the training and education programs should be developed and implemented in close cooperation with State agencies, public institutions, and stakeholder organizations.

(Response 175) The requirements do not address issuance of certificates or any other provisions that could create road blocks for third-party providers. An establishment has flexibility to develop or otherwise provide training in cooperation with public and private organizations in a manner that suits its needs.

(Comment 176) Some comments agree that any requirements should include training appropriate to the person's duties but emphasize that the decision as to what is appropriate to the person's assigned duties should be determined by the establishment.

(Response 176) The requirement for employees to receive training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as appropriate to the person's assigned duties, provides flexibility for the establishment to provide training that is appropriate for its employees in light of each person's assigned duties. However, the rule does not require training specific to the person's assigned duties.

(Comment 177) Some comments assert that the training requirement would be an unreasonable burden for small businesses and that companies may incur substantial cost for the time that workers would be in training rather than in production. Some comments ask us to provide non-specific training recommendations for smaller food processors that need flexibility to control the cost of training. Some comments assert that the training and education requirements must be accessible and flexible enough to allow employers to bring in temporary help when demand is high without causing a delay in hiring.

Some comments assert that we must provide ongoing education, training, and outreach for previously regulated firms, newly regulated firms, regulators that will be responsible for implementing the rules, and educators who will help farmers and facilities understand and manage the new requirements. Some comments assert that training is needed to educate farmers, the food industry, and State and local authorities as well.

(Response 177) All employees will need enough training to do their jobs and understand the importance of hygiene for food safety. The training offered does not need to be expensive (e.g., off-site training or off-the-shelf purchased training) and we expect that much of the training will be provided in-house by knowledgeable employees. As discussed in Response 2, the FSPCA is developing a preventive controls training curriculum. These training Start Printed Page 55974materials will be available online, and we expect these training materials to be useful to small businesses to use for in-house training.

(Comment 178) Some comments ask us to continue to work with foreign governments on access to training and education to ensure that the industry as a whole is moving towards better advancements in food safety practices, no matter the size, channels of distribution, or geographic location.

(Response 178) As discussed in Response 717, we intend to work with the food industry, education organizations, USDA, the U.S. Agency for International Development, and foreign governments to develop tools and training programs to facilitate implementation of this rule.

(Comment 179) Some comments assert that the preventive controls qualified individual should perform the trainings. Some comments assert that the preventive controls qualified individual should be responsible for determining the appropriate frequency and scope of training for each facility and employee, and the records necessary to document that appropriate training has been conducted.

(Response 179) We decline these requests. Although we agree that the person delivering such training should be knowledgeable, we are providing flexibility for facilities to provide training as appropriate to the facility, including through on-line CGMP or other food safety courses.

(Comment 180) Some comments ask that this rule provide FDA (and those States under contract) the ability to require certification of industry managers and training of employees if serious operational hazards are found and management and staff are unable to answer basic questions concerning hazards and controls in the facility.

(Response 180) We decline this request. We address each compliance situation on a case-by-case basis.

B. Additional Requirements Applicable to Supervisory Personnel (Final § 117.4(c))

We received no comments that disagreed with our proposal to retain the requirement in part 110 that responsibility for ensuring compliance by all personnel with all requirements of this subpart must be clearly assigned to competent supervisory personnel. We are correcting “all requirements of this subpart” to “all requirements of this part.” As a conforming change for consistency with the provisions of § 117.4(b), we are replacing the phrase “competent supervisory personnel” with the phrase “supervisory personnel who have the education, training, or experience (or a combination thereof) necessary to supervise the production of clean and safe food.”

XI. Subpart A: Comments on Proposed § 117.5—Exemptions

We proposed to establish a series of exemptions from the requirements for hazard analysis and risk-based preventive controls that would be established in subpart C, with modified requirements in some cases. We also proposed to redesignate § 110.19(a) (a pre-existing exemption from CGMP requirements applicable to establishments engaged solely in the harvesting, storage, or distribution of one or more RACs) as § 117.5(k) and to revise this exemption to adjust and clarify what activities fall within this exemption based on experience and changes in related areas of the law since issuance of the CGMP regulation.

Some comments support one or more of the proposed exemptions without change. For example, some comments note that the exemptions are specified in FSMA and, thus, reflect the intent of Congress. Some comments state that some exemptions (i.e., those for products already subject to our HACCP regulations for seafood and juice, or to regulations for the control of microbiological hazards for LACF) make sense because they are risk-based. Other comments that support one or more of the proposed exemptions ask us to clarify particulars associated with these exemptions (see, e.g., Comment 209, Comment 210, Comment 211, and Comment 212) or expand the scope of some of these exemptions (see, e.g., Comment 185, Comment 196, Comment 197, Comment 208, and Comment 221). Other comments ask us to include additional exemptions in the rule (see section XI.K).

In the remainder of this section, we discuss comments that ask us to clarify the proposed exemptions or that disagree with, or suggest one or more changes to, the proposed exemptions. We also discuss comments that ask us to include additional exemptions in the rule. After considering these comments, we have revised the proposed exemptions as shown in table 12 with editorial and conforming changes as shown in table 52. A key conforming change that affects all proposed exemptions from the requirements of subpart C is that the final exemptions are from the requirements of subpart G, as well as subpart C. As discussed in section XLII, the final rule establishes the requirements for a supply-chain program in subpart G, rather than within subpart C as proposed.

Table 12—Revisions to the Proposed Exemptions

SectionExemptionModification
117.5(g)From the requirements of subpart C for on-farm packing or holding of food by a small or very small business if the only packing and holding activities subject to section 418 of the FD&C Act that the business conducts are the specified low-risk packing or holding activity/food combinations• Made changes consequential to the revised “farm” definition—i.e., no longer identifying any packing or holding activities for any RACs. • Clarified that the modified requirements do not apply to on-farm packing or holding of food by a very small business if the only packing and holding activities subject to section 418 of the FD&C Act that the business conducts are the listed low-risk packing or holding activity/food combinations. • Updated food categories consistent with the food categories included in table 1 in the section 103(c)(1)(C) RA. • Added low-risk packing or holding activity/food combinations as a result of an updated risk assessment. • Added a description of the food categories included in § 117.5(g) and (h).
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117.5(h)From the requirements of subpart C for on-farm manufacturing/processing activities conducted by a small or very small business for distribution into commerce if the only manufacturing/processing activities subject to section 418 of the FD&C Act that the business conducts are the specified low-risk manufacturing/processing activity/food combinations• Made changes consequential to the revised “farm” definition—i.e.: —No longer distinguish between manufacturing/processing activities conducted on a farm mixed-type facility's own RACs and manufacturing/processing activities conducted on food other than the farm mixed-type facility's own RACs; and —Eliminated activities, conducted on others' RACs, that would no longer be classified as manufacturing/processing and instead would be classified as harvesting, packing, or holding. • Clarified that the modified requirements do not apply to on-farm manufacturing/processing activities conducted by a very small business for distribution into commerce, if the only manufacturing/processing activities subject to section 418 of the FD&C Act that the business conducts are the listed low-risk manufacturing/processing activity/food combinations. • Updated food categories consistent with the food categories included in table 1 in the section 103(c)(1)(C) RA. •Added low-risk manufacturing/processing activity/food combinations as a result of an updated risk assessment.
117.5(k)(1)(iii)From the requirements of subpart B for the holding and transportation of RACsChanged from an exemption for specific activities (i.e., holding and transportation of RACs) to establishments solely engaged in one or both of those activities.
117.5(k)(1)(v)From the requirements of subpart B for certain activities conducted on nuts (without additional manufacturing/processing)Changed from an exemption for specific activities to establishments solely engaged in those activities.

A. General Comments on the Proposed Exemptions

(Comment 181) Some comments ask us to provide the same flexibility for foreign small businesses as for domestic small businesses.

(Response 181) The exemptions apply to both foreign small businesses and domestic small businesses.

(Comment 182) Some comments note that proposed § 117.10(c) recommends, but would not require, that the responsible individual at a food establishment have a background of education, experience or a combination of both to provide a level of competence necessary to produce clean and safe food. These comments ask us to make this a requirement, rather than a recommendation, for the responsible individual at any facility that is exempt from the requirements for hazard analysis and risk-based preventive controls. These comments also ask us to require presentation of the training information to us before an exemption is granted.

(Response 182) We decline these requests. The statute does not require that we pre-qualify a facility for an exemption.

(Comment 183) Some comments ask us to clarify whether an establishment that is exempt from the requirements for hazard analysis and risk-based preventive controls in subpart C remains subject to the CGMP requirements in subpart B.

(Response 183) An establishment that is exempt from the requirements for hazard analysis and risk-based preventive controls in subparts C and G remains subject to the CGMP requirements in subpart B, unless that establishment is exempt from subpart B under § 117.5(k) (which applies to: (1) Farms; (2) certain fishing vessels; (3) establishments solely engaged in the holding and/or transportation of one or more RACs; (4) activities of “farm mixed-type facilities” that fall within the definition of “farm”; and (5) establishments solely engaged in hulling, shelling, drying, packing, and/or holding nuts (without additional manufacturing/processing)).

B. Proposed § 117.5(a)—Exemption Applicable to a Qualified Facility

We proposed that subpart C would not apply to a qualified facility, except as provided by subpart E (Withdrawal of an Exemption Applicable to a Qualified Facility), and that qualified facilities would be subject to the modified requirements in § 117.201.

(Comment 184) Some comments support the proposed exemption for a qualified facility and assert that all farms should be eligible for this exemption until it is shown that food obtained from these farms makes people sick. Other comments oppose this proposed exemption, asserting that it is not risk based and expressing concern that qualified facilities would cause significant food safety problems. Some comments ask us to strictly construct and narrowly apply the exemptions to as few businesses as possible.

Some comments do not agree that qualified facilities should be subject to modified requirements because even the modified requirements are burdensome. Some comments assert that qualified facilities having an average annual value of food sold during the previous three-year period of $25,000 or less should be exempt from all requirements related to hazard analysis and risk-based preventive controls, including modified requirements.

(Response 184) The exemption for qualified facilities, including the criteria for being a qualified facility and the applicability of modified requirements, is expressly directed by section 418(l) of the FD&C Act. In defining “very small business” to mean a business (including any subsidiaries and affiliates) averaging less than $1,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee), we constructed this exemption to apply Start Printed Page 55976to businesses that, collectively, produce less than 0.6 percent of the food supply (Ref. 38). In addition, as discussed in Response 151, most of these facilities will be subject to the CGMP requirements in subpart B.

(Comment 185) Some comments assert that a qualified facility should be exempt from the CGMP requirements of subpart B, as well as the requirements for hazard analysis and risk-based preventive controls in subpart C.

(Response 185) The exemption for qualified facilities is expressly directed by section 418(l) of the FD&C Act and is limited to an exemption from the requirements for hazard analysis and risk-based preventive controls in subparts C and G. The comments provide no basis for why new statutory requirements for hazard analysis and risk-based preventive controls should in any way impact the long-standing CGMPs requirements that apply to the manufacturing, packing, and holding of human food. CGMPs provide the basic requirements for ensuring production of safe and sanitary food. Following the CGMPs is essential to properly address public health risks from very small facilities that are provided an exemption from subparts C and G in order to minimize the burden on such facilities. (See also Response 221.)

(Comment 186) Some comments ask us to clarify how the exemption applies to diversified farms that produce both exempt and non-exempt products.

(Response 186) We assume that this comment is referring to a farm mixed-type facility that produces some products (such as juice or dietary supplements) that are exempt from the requirements for hazard analysis and risk-based preventive controls, as well as some products that are not exempt from these requirements. The exemption only applies to products that are not otherwise exempt from the requirements for hazard analysis and risk-based preventive controls. However, see the discussion in Response 157 with our response to comments requesting that we base the dollar threshold for the definition of very small business only on the annual monetary value of food covered by the preventive controls rule, rather than all human food; we declined that request.

(Comment 187) Some comments ask us to provide that a qualified facility may voluntarily choose to comply with the requirements for hazard analysis and risk-based preventive controls.

(Response 187) A qualified facility may voluntarily choose to comply with the requirements for hazard analysis and risk-based preventive controls without a specific provision authorizing it to do so.

(Comment 188) Some comments ask us to specify in guidance that a qualified facility is not required to prepare and implement a food safety plan.

(Response 188) We intend to recommend in guidance how a qualified facility could comply with the modified requirements in § 117.201 without satisfying all of the requirements in subparts C and G.

C. Proposed § 117.5(b) and (c)—Exemptions Applicable to Food Subject to HACCP Requirements for Fish and Fishery Products (21 CFR Part 123) or for Juice (21 CFR Part 120)

We proposed that subpart C would not apply with respect to activities that are subject to part 123 (21 CFR part 123) at a facility if the owner, operator, or agent in charge of the facility is required to comply with, and is in compliance with, part 123 with respect to such activities. We also proposed that subpart C would not apply with respect to activities that are subject to part 120 (21 CFR part 120) at a facility if the owner, operator, or agent in charge of the facility is required to comply with, and is in compliance with, part 120 with respect to such activities. We requested comment on the criteria that should be used to determine whether a facility is in compliance with part 123 or part 120 (78 FR 3646 at 3704).

(Comment 189) Some comments ask us to clarify whether a seafood allergen that is identified as a hazard should be included in a seafood HACCP plan or in a facility's food safety plan. These comments also ask whether a food allergen that is identified as a hazard in juice subject to part 120 should be included in a juice HACCP plan or in a facility's food safety plan

(Response 189) There is no specific requirement in the seafood HACCP regulation in part 123 that food allergen hazards be addressed in the seafood HACCP plan. However, Chapter 19 in our guidance entitled “Fish and Fishery Products Hazards and Controls Guidance (Fourth Edition)” includes recommendations for the control of undeclared food allergens (Ref. 42). The juice HACCP regulation in part 120 requires that a juice processor consider the presence of undeclared ingredients that may be food allergens as part of its hazard analysis, and several sections in our guidance entitled “Juice HACCP Hazards and Controls Guidance (First Edition)” include recommendations for the control of food allergens (Ref. 43). Both seafood processors and juice processors would also address allergen hazards through application of CGMPs.

Facilities that are exempt from the requirements of subparts C and G with respect to activities that are subject to part 120 or part 123 are not required to prepare and implement a food safety plan in addition to their HACCP plans.

(Comment 190) Some comments note that our HACCP regulations for juice and seafood do not require facilities subject to those regulations to address radiological hazards and ask how radiological hazards should be addressed for activities that are subject to part 120 or part 123.

(Response 190) A facility that conducts activities that are subject to part 120 or part 123 is not required to address radiological hazards in its HACCP plan if the facility is required to comply with, and is in compliance with, part 120 or part 123 with respect to such activities. However, under some circumstances radiological hazards might need to be considered. Moreover, the facility would be subject to the CGMP requirement that storage and transportation of food must be under conditions that will, among other things, protect against chemical (including radiological) contamination of food (§ 117.93).

(Comment 191) Some comments state that what is needed to assess compliance with the applicable HACCP regulation is evidence of compliance with each specific requirement of the regulation, such as compliance with requirements for a written hazard analysis and Sanitation Standard Operating Procedures (SSOPs). Other comments ask us to provide guidance to industry and the regulatory community regarding the criteria that will be used to determine when a facility is “in compliance with” part 120 or part 123. Some comments note that any determination of compliance with one of our HACCP regulations would be product specific, and that we would only be able to assess compliance on the inspected product, not all of the products being produced at the facility. Some comments ask us to establish a transparent process to follow when determining when to nullify an exemption applicable to food subject to HACCP in part 120 or part 123. These comments made specific suggestions for such a process, including through a HACCP inspection of a domestic facility or a review of a facility's HACCP plan and corresponding HACCP records for a foreign facility. These comments assert that FDA actions such as issuing inspectional observations, issuing a Warning Letter, or making an imported product subject to detention without physical examination, should not be the basis for determining non-compliance Start Printed Page 55977because in such situations a facility would have an opportunity to respond to FDA with its approach to correcting problems.

Some comments assert that the key question for us to answer is when a situation will be so severe that it warrants requiring compliance with the human preventive controls rule rather than the applicable HACCP regulation. These comments raise questions about the practicality of requiring compliance with the human preventive controls rule for some products manufactured at a facility while continuing to require compliance with the applicable HACCP regulation for other products manufactured at that facility. These comments ask us to specify the added food safety protections that the human preventive controls rule can provide that cannot be obtained by compliance with the applicable HACCP regulation. These comments also ask us to consider the likelihood that a facility that cannot comply with the applicable HACCP regulation would be able to comply with the human preventive controls rule. Other comments ask whether we will modify existing guidance on compliance with applicable HACCP regulations to help facilities and inspectors understand what is needed for a facility to maintain its exemption.

Some comments assert that the statutory intent for compliance would be satisfied by enforcement actions (such as administrative detention, registration suspension, or mandatory recall) that will either ensure compliance with the applicable HACCP regulation, or prohibit that facility from distributing food.

(Response 191) We acknowledge the issues raised by these comments and agree that in many situations the appropriate action for us to take when a facility is out of compliance with an applicable HACCP regulation will be to employ existing enforcement tools to bring the facility into compliance with the applicable regulation. However, we also believe that there may be circumstances where an added food safety benefit could be achieved by requiring compliance with the human preventive controls rule when a facility does not comply with an applicable HACCP regulation. For example, the seafood HACCP regulation recommends—but does not require—that a seafood processor have and implement a written SSOP. In contrast, the human preventive controls rule requires that all preventive controls be written, and that preventive controls include, as appropriate to the facility and the food, sanitation controls, which include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens, biological hazards due to employee handling, and food allergen hazards (§ 117.135(c)(3)). A seafood processing facility that has ongoing sanitation problems and contamination with, for example, an environmental pathogen, but does not have a written SSOP, may be better able to address its sanitation problems by a combination of written sanitation controls and verification of those sanitation controls through environmental monitoring (§ 117.165(a)(3)). Likewise, a juice processor that has ongoing problems with microbial contamination of fruit it receives for processing may be better able to address its supply of fruit by complying with the specific requirements of the human preventive controls rule for a supply-chain program (subpart G).

We expect that situations in which enforcement actions to ensure compliance with an applicable HACCP regulation are insufficient to correct problems, and lead to a facility losing its exemption from the requirements of subparts C and G, will be rare and will depend on very specific circumstances. Therefore, at this time we do not anticipate issuing guidance on when violations of one of our HACCP regulations would cause us to require compliance with subparts C and G.

(Comment 192) Some comments ask us to revise our HACCP regulations for seafood and juice to be consistent with subpart C to avoid the burden of having two systems within facilities that produce seafood or juice products, as well as other foods.

(Response 192) We decline this request. Our HACCP regulations are already consistent with—though not identical to—subpart C. Further, it is not clear that such facilities would need two separate systems, given the similarities in requirements and flexibility we have provided for implementing preventive controls. The food safety plan for the products not subject to the HACCP regulations is likely to be very similar to that for the foods subject to the HACCP regulations (which includes monitoring of SSOPs). To the extent that subparts C and G contain additional requirements, a facility is free to perform similar actions for its products produced under a HACCP regulation.

(Comment 193) Some comments ask us to exempt the production of fresh cider from the rule.

(Response 193) Fresh cider is juice. A facility that produces fresh cider is eligible for the exemption for products subject to our HACCP regulation for juice.

D. Proposed § 117.5(d)—Exemption Applicable to Food Subject to Part 113—Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers

We proposed that subpart C would not apply with respect to activities that are subject to part 113 at a facility if the owner, operator, or agent in charge of the facility is required to comply with, and is in compliance with, part 113 with respect to such activities. We also proposed that this exemption would apply only with respect to the microbiological hazards that are regulated under part 113. We requested comment on the criteria that should be used to determine whether a facility is in compliance with part 113 (78 FR 3646 at 3704).

(Comment 194) Some comments express concern that the partial exemption for products subject to part 113 could generate confusion for both regulators and regulated facilities. These comments also assert that the partial exemption for products subject to part 113 would generate duplicative recordkeeping requirements under the two rules.

(Response 194) We acknowledge the potential for confusion and expect any confusion to decrease over time as both regulators and facilities gain experience with the new requirements. We also expect that in most instances a facility that is subject to part 113, and that evaluates potential microbiological hazards as part of its hazard analysis, would conclude that the potential hazards are controlled by the targeted requirements of part 113 and conclude there are no microbiological hazards that require preventive controls to significantly minimize or prevent the hazards.

We disagree that the partial exemption for products subject to part 113 would generate duplicative recordkeeping requirements. The requirements of part 113 to control biological hazards are different from the requirements of subparts C and G to conduct a hazard evaluation for chemical and physical hazards, and implement preventive controls and associated preventive control management components to address significant chemical and physical hazards. Likewise, the records associated with the control of biological hazards under part 113 are not the same as the records associated with a hazard analysis, preventive controls, and associated preventive control management components for control of Start Printed Page 55978chemical and physical hazards. However, to the extent that a facility appropriately determines that existing records required by part 113 can be used to demonstrate compliance with the requirements of subparts C and G, a facility may rely on those records (see § 117.330).

(Comment 195) Some comments ask us to provide guidance to industry and the regulatory community regarding the criteria that will be used to determine when a facility is “in compliance with” part 113.

(Response 195) We discuss similar comments regarding the exemptions for products subject to one of our HACCP regulations in Response 191. As an example, an LACF manufacturing facility that has ongoing problems controlling biological hazards may be better able to address biological hazards by preparing and implementing a written food safety plan. As with facilities subject to our HACCP regulations, we expect that situations in which enforcement actions to ensure compliance with part 113 are insufficient to correct problems, and lead to a facility losing its exemption from the requirements of subparts C and G, will be rare and will depend on very specific circumstances. Therefore, at this time we do not anticipate issuing guidance on when violations of part 113 could lead to this outcome.

E. Proposed § 117.5(e)—Exemption Applicable to a Facility That Manufactures, Processes, Packages, or Holds a Dietary Supplement

We proposed that subpart C would not apply to any facility with regard to the manufacturing, processing, packing, or holding of a dietary supplement that is in compliance with the requirements of part 111 (Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements) and section 761 (Serious Adverse Event Reporting for Dietary Supplements) of the FD&C Act. We requested comment on the criteria that should be used to determine whether a facility is in compliance with part 111 and section 761 of the FD&C Act (78 FR 3646 at 3705). As noted in table 52, we corrected the exemption to match the title of part 111—i.e., “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.”

(Comment 196) Some comments assert that the entire facility should be exempt from the requirements of subpart C if the facility implements the dietary supplement CGMP regulation even if the facility also makes food products that are not dietary supplements. Some comments assert that the exemption applicable to the manufacturing, processing, packing, or holding of a dietary supplement should also apply to the manufacturing, processing, packing, or holding of a dietary ingredient if the facility chooses to follow the dietary supplement CGMP regulation.

(Response 196) The proposed exemption is directed by section 103(g) of FSMA. None of these comments explain how the desired expansion of the exemption is consistent with section 103(g), which limits the provision to “the manufacturing, processing, packing, or holding of a dietary supplement” (78 FR 3646 at 3705).

(Comment 197) Some comments ask us to revise the exemption applicable to dietary supplements to add that subparts B and F do not apply to any facility with regard to the manufacturing, processing, packing, or holding of a dietary supplement that is in compliance with the requirements of part 111. These comments assert that it would be illogical to subject the dietary supplement industry to industry-specific CGMPs (part 111), as well as a more general (and inherently less applicable) CGMP standard in part 117. These comments also assert that the intent of the CGMPs in part 117 is to regulate industries and industry segments that have not previously been regulated and that failing to acknowledge the regulations already applicable to dietary supplements would be duplicative, redundant, and provide no additional safety or public health protection.

(Response 197) As discussed in the final rule establishing the dietary supplement CGMP regulation, we included in part 111 the existing requirements in part 110 that we believe are common to dietary supplement manufacturing (72 FR 34752 at 34764, June 25, 2007). We recognized that there may be operations related to the manufacturing of dietary supplements for which certain provisions in part 110 (now largely subpart B of part 117) apply, but that we did not determine to be common to most dietary supplement manufacturing operations (e.g., for dietary supplements that are dehydrated and rely on the control of moisture consistent with current § 110.80(b)(14) (proposed § 117.80(c)(14)). As was the case when we issued the final rule to establish dietary supplement CGMPs and continues to be the case now, a manufacturer would be required to comply with the CGMP regulations in subpart B of part 117 in addition to the regulations in part 111, unless the regulations conflict. To the extent that the regulations conflict, the dietary supplement manufacturer would comply with the regulation in part 111.

(Comment 198) Some comments ask us to clarify how the exemption applies to foods, other than dietary supplements, that may be held in a facility that conducts activities in compliance with the dietary supplement CGMP regulation.

(Response 198) The exemption does not apply to foods, other than dietary supplements, that may be held in a facility that conducts activities in compliance with the dietary supplement CGMP regulation. The owner, operator, or agent in charge of a facility that produces both dietary supplements and foods that are not dietary supplements must comply with the requirements of this rule for hazard analysis and risk-based preventive controls, unless another exemption applies as specified in § 117.5.

(Comment 199) Some comments ask us to use information collected in the biennial food facility registration to help determine whether a facility is in compliance with part 111.

(Response 199) We decline this request. It would be the observations and findings from an inspection, rather than information in a facility's registration, that could help us determine whether a facility is in compliance with part 111. Information collected during registration provides information on how we should inspect a facility, but has no bearing on whether the facility is complying with applicable regulations.

F. Proposed § 117.5(f)—Exemption Applicable to Activities Subject to Standards for Produce Safety in Section 419 of the FD&C Act

We proposed that subpart C would not apply to activities of a facility that are subject to section 419 (Standards for Produce Safety) of the FD&C Act (21 U.S.C. 350h). We received no comments that disagreed with this proposal and are finalizing it as proposed.

G. Proposed §§ 117.5(g) and (h)—Exemptions Applicable to On-Farm Low-Risk Activity/Food Combinations Conducted by a Small or Very Small Business

As discussed in section VI.A, consistent with the statutory direction in section 103(c) of FSMA, including conducting a qualitative risk assessment, we proposed three exemptions for on-farm activity/food combinations conducted by farm-mixed-type facilities that are small or very Start Printed Page 55979small businesses (proposed §§ 117.5(g), (h)(1), and (h)(2)).

1. General Comments on the Proposed Exemptions Applicable to On-Farm Low-Risk Activity/Food Combinations Conducted by a Small or Very Small Business

(Comment 200) Some comments assert that conducting a low-risk activity/food combination should be sufficient to qualify any facility for exemption from subpart C, regardless of whether the activity is conducted on-farm or off-farm, or meets the economic threshold for a small or very small business.

(Response 200) The statute provides specific direction for those facilities that can qualify for this exemption. (See sections 418(l) and 418(o)(2) of the FD&C Act.) See also Response 184 and Response 222.

(Comment 201) Some comments ask why the activity/food combinations listed in proposed § 117.5(g) are not consistent with the activity/food combinations listed in proposed § 117.5(h). Some comments state that the exemptions for farming activities are confusing.

(Response 201) The items listed in § 117.5(g) only specify the food or food category (rather than an activity/food combination) because the activities addressed in § 117.5(g) are, in all cases, the same—i.e., packing and holding activities. In contrast, the items listed in § 117.5(h) specify a particular activity (e.g., coating, mixing) in addition to a food or food category (e.g., peanuts and tree nuts) because there are multiple manufacturing/processing activities, each associated with a particular food or food category, listed in the provisions.

Although these exemptions are more complex than other exemptions (e.g., because they are directed to specific activities conducted on specific foods or food categories), the final “farm” definition has simplified them to the extent practicable. For example, under the “farm” definition in the 2013 proposed preventive controls rule, whether an activity was packing or manufacturing/processing depended, in part, on whether the RACs being packed were the farm's own RACs or others' RACs. In contrast, under the “farm” definition established in this rule, packing RACs is a “packing” activity, regardless of ownership of the RACs being packed.

(Comment 202) Some comments note a distinction between the exemptions for on-farm low-risk activity/food combinations conducted by small and very small businesses and the exemption for qualified facilities. Specifically, a farm mixed-type facility that only conducts low-risk activity/food combinations (such as making certain jams or syrups) would be exempt from the requirements of subpart C, whereas an off-farm qualified facility making those same jams and syrups, while exempt from the requirements of subpart C, would nonetheless be subject to modified requirements in § 117.201. These comments ask whether it would be better for a farm or farm mixed-type facility that satisfies criteria for a small or very small business, and also satisfies criteria for a qualified facility, to classify itself as a small or very small business or to classify itself as a qualified facility.

(Response 202) In light of the final “farm” definition, these comments no longer apply with respect to activities within the farm definition.

For activities conducted by a farm mixed-type facility, we acknowledge that the exemptions provided by § 117.5(g) and (h) for on-farm low-risk activity/food combinations are different from the exemption provided by § 117.5(a) for a qualified facility. A farm mixed-type facility that only conducts low-risk activity/food combinations listed in § 117.5(g) and (h) is fully exempt from the requirements of subparts C and G, and is not subject to the modified requirements in § 117.201, even if that farm mixed-type facility is also a very small business (and, thus, also is a qualified facility). To make this clear, we have revised proposed § 117.5(g) to specify that § 117.201 does not apply to on-farm packing or holding of food by a very small business if the only packing and holding activities subject to section 418 of the FD&C Act that the business conducts are the listed low-risk packing or holding activity/food combinations. Likewise, we have revised proposed § 117.5(h) to specify that § 117.201 does not apply to on-farm manufacturing/processing activities conducted by a very small business for distribution into commerce, if the only manufacturing/processing activities subject to section 418 of the FD&C Act that the business conducts are the listed low-risk manufacturing/processing activity/food combinations.

With these changes, a farm mixed-type facility that is a very small business and that only conducts the low-risk activity/food combinations listed in § 117.5(g) and/or (h) may find it advantageous to classify itself as a very small business eligible for the exemption in § 117.5(g) and/or (h) rather than as a qualified facility, which would be subject to the modified requirements in § 117.201.

(Comment 203) Some comments ask us to list activity/food combinations that are not low-risk activity/food combinations, or that should have modified requirement rather than be exempt (e.g., if the foods have been the subject of Class I recalls or outbreaks of foodborne illness).

(Response 203) We decline this request. With few exceptions, the exemptions are established by specifying the activities that are not subject to the requirements for hazard analysis and risk-based preventive controls, rather than the activities that are subject to these requirements. When an exemption does specify activities that are subject to certain requirements of the rule, the specified activities are a narrow exception (see § 117.5(k)). In the case of the exemptions for the low-risk activity/food combinations listed in § 117.5(g) and (h), the activity/food combinations that are subject to the requirements of subparts C and G are extensive and it is not feasible to identify and list all of them.

In developing the low-risk activity/food combinations that are exempt from the requirements, we conducted a qualitative risk assessment (Ref. 4) that considered whether manufacturing, processing, packing, or holding activities conducted on a farm mixed-type facility had been implicated in food that has been the subject of a Class I recall or outbreak of foodborne illness. However, whether specific types of food had been the subject of a Class I recall or outbreak of foodborne illness was only one factor we considered. For example, we also considered factors that impact the frequency and levels of contamination of the food (Ref. 4). For additional discussion, see the section 103(c)(1)(C) RA (Ref. 4).

(Comment 204) Some comments ask for a process to keep the list of low-risk activity/food combinations up to date, such as through guidance.

(Response 204) We decline this request. The exemptions established in this rule are binding, whereas any list of additional activity/food combinations established in a guidance document would not be binding. We established the list of activity/food combinations included in these exemptions through an extensive public process, including a request for comments on the section 103(c)(1)(C) draft RA. From this time forward, the process available to a person who wishes us to consider an additional activity/food combination is to submit a citizen petition in accordance with 21 CFR 10.30.Start Printed Page 55980

2. Proposed § 117.5(g)—Exemption Applicable to On-Farm Low-Risk Packing or Holding Activity/Food Combinations Conducted by a Small or Very Small Business

We proposed that subpart C would not apply to on-farm packing or holding of food by a small or very small business if the only packing and holding activities subject to section 418 of the FD&C Act that the business conducts are low-risk packing or holding activity/food combinations on food not grown, raised, or consumed on that farm mixed-type facility or another farm or farm mixed-type facility under the same ownership. As a consequential change in light of the final “farm” definition, the final exemption no longer identifies any packing or holding activities for any RACs (whether the farm's own RACs or others' RACs), because an on-farm establishment would no longer be subject to the requirements for hazard analysis and risk-based preventive controls when it packs or holds RACs, regardless of whether it is packing and holding its own RACs or others' RACs.

(Comment 205) Some comments ask us to expand the list of on-farm low-risk packing and holding activities to include packing and holding of food products not expressly covered by the proposed exemption. See the food products listed in table 13 and table 14.

(Response 205) We considered these comments within the context of the section 103(c)(1)(C) RA. Table 1 in the section 103(c)(1)(C) draft RA listed activity/food combinations that we identified as likely to be conducted by farm mixed-type facilities using broad food categories such as “grain” and “grain products.” In light of comments such as those described in Comment 205, table 1 in the final section 103(c)(1)(C) RA lists more types of food categories. The purpose of listing more types of food categories was to make it clearer when a particular food is encompassed within a particular activity/food combination. As one example, table 1 in the final section 103(c)(1)(C) RA lists food categories such as baked goods, milled grain products, and other grain products (e.g. dried pasta), in place of the original category “grain products.” As another example, table 1 in the section 103(c)(1)(C) RA lists the broad term “sap” and provides examples of different types of sap to make clear that activity/food combinations regarding sap are broader than “maple sap.”

We have revised the final exemption to list food categories consistent with the food categories included in table 1 in the section 103(c)(1)(C) RA and include those packing and holding activity/food combinations that the section 103(c)(1)(C) RA determines to be low-risk. For additional details about the outcome of the section 103(c)(1)(C) RA on the specific activity/food combinations described in the comments, see the section 103(c)(1)(C) RA (Ref. 4).

We also revised the proposed exemption to add two sets of information that we believe will be useful to a farm mixed-type facility when evaluating whether the farm's packing activities satisfy the criteria for the exemption.

First, we have added a new provision (§ 117.5(g)((1)) explaining that the exemption in § 117.5(g) applies to packing or holding of processed foods on a farm mixed-type facility, except for processed foods produced by drying/dehydrating RACs to create a distinct commodity (such as drying/dehydrating grapes to produce raisins, and drying/dehydrating fresh herbs to produce dried herbs), and packaging and labeling such commodities, without additional manufacturing/processing (such as chopping and slicing), the packing and holding of which are within the “farm” definition in § 1.227. Activities that are within the “farm” definition, when conducted on a farm mixed-type facility, are not subject to the requirements of subparts C and G of this part and therefore do not need to be specified in the exemption.

Second, we have added a provision (§ 117.5(g)((2)) describing the food categories listed in the exemption. For example, this provision explains that “milled grain products” include processed food products such as flour, bran, and cornmeal.

The first column in table 13 lists the food or food category that comments ask us to include in the exemption for on-farm, low-risk packing and holding activities. The second column lists the regulatory citation for the relevant exemption for on-farm packing and holding. Importantly, the full regulatory text of the exemption includes some limitations that were not specified in the comments, and table 13 should not be viewed as equating the requests of the comments with the final regulatory text of the exemption. For example, § 117.5(g)(2)(ix) specifies that the food category “baked goods” includes processed food products such as breads, brownies, cakes, cookies, and crackers, but does not include products that require time/temperature control for safety (such as cream-filled pastries). See § 117.5(g)(2) for a description of those food categories listed in the exemption for on-farm, low-risk packing and holding activity/food combinations in table 13.

Table 13—Requested Food or Food Category and Relevant Exemption for On-Farm Low-Risk Packing and Holding Activities

Food or food category requested in the commentsRelevant regulatory section
• Barley malt syrup§ 117.5(g)(3)(xix)—Sugar.
• Barley malt extract§ 117.5(g)(3)(xx)—Syrups.
• Other concentrated grain malt products in liquid or powder form§ 117.5(g)(3)(xxii)—Vinegar. § 117.5(g)(3)(xxiii)—Any other processed food that does not require time/temperature control for safety.
• Birch sap and syrup§ 117.5(g)(3)(xix)—Sugar.
• Cane syrup§ 117.5(g)(3)(xx)—Syrups.
• Coconut sap and sugar
• Date sugar
• Palm sap and sugar
• Sorghum juice and syrup
• Other concentrated natural sweetener having a water activity lower than 0.85 and made with an adequate microbial reduction step
Chips§ 117.5(g)(3)(xiii)—Other fruit and vegetable products.
• Crackers§ 117.5(g)(3)(i)—Baked goods.
• Bread crumbs
• Dry bread
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Crude “dietary ingredient botanicals” in cut, chopped, or powdered form§ 117.5(g)(3)(xiii)—Other fruit and vegetable products. § 117.5(g)(3)(xv) Other herb and spice products.
• Dried cereal§ 117.5(g)(3)(xiv)—Other grain products.
• Dried pasta
Dried herbs and spices, chopped or ground§ 117.5(g)(3)(xv)—Other herb and spice products.
Dry legume products (e.g., chickpea flour)§ 117.5(g)(3)(xiii)—Other fruit and vegetable products.
Dry, unsulfited, fruits and vegetables in cut, chopped, sliced, shredded, or other form§ 117.5(g)(3)(xiii)—Other fruit and vegetable products.
Gums and resins§ 117.5(g)(3)(vii)—Gums, latexes, and resins that are processed foods.
Herbal extracts (e.g., in solvents such as glycerin, alcohol and oil)§ 117.5(g)(3)(xv)—Other herb and spice products.
• Honey infused with dried herbs or spices§ 117.5(g)(3)(xv)—Other herb and spice products.
• Oil and/or vinegar infused with dried herbs or spices
Jerky§ 117.5(g)(3)(vi)—Game meat jerky.
Molasses and treacle§ 117.5(g)(3)(xi)—Molasses and treacle.
Potato starch§ 117.5(g)(3)(xiii)—Other fruit and vegetable products.
Popcorn§ 117.5(g)(3)(xiv)—Other grain products.
Salt, baking powder§ 117.5(g)(3)(xxiii)—Any other processed food that does not require time/temperature control for safety.
Vitamins, minerals, and processed dietary ingredients (e.g., bone meal) in powdered, granular, or other solid form§ 117.5(g)(3)(xxiii)—Any other processed food that does not require time/temperature control for safety.

In table 14, we list those foods or food categories, requested by comments, that are not included in the exemption for on-farm, low-risk packing and holding activities, and explain why.

Table 14—Why Certain Requested Food Categories Are Not Included in the Exemption for On-Farm Low-Risk Packing and Holding Activities

Food or food group requested in the commentsWhy the food or food group is not listed in the exemption
Barley malt and other grain maltsMalting increases the potential for a hazard, e.g., growth of microbial pathogens such as Salmonella, during the germination process. (However, the risk is mitigated when malting is done in conjunction with making sugar, syrups or vinegar.)
Crude “dietary ingredient botanicals” in whole, formThese are RACs, so packing and holding them is within the farm definition.
Dates (RACs)These are RACs, so packing and holding them is within the farm definition
Dried intact herbs and spicesAlthough these are processed foods, packing and holding them is specifically included within the farm definition.
Dried legumesAlthough these are processed foods, packing and holding them is specifically included within the farm definition.
Gums, resins, and exudates in solid, powdered, granular, or paste formGums, resins and exudates (including latexes such as chicle) are RACs, so packing and holding them is within the “farm” definition. These products are made into processed foods in some cases, such as by boiling or cutting. The powdered, granular and paste forms from further processing are considered in the risk assessment as “any other processed food that does not require time/temperature control for safety.”

3. Proposed § 117.5(h)—Exemption Applicable to On-Farm Low-Risk Manufacturing/Processing Activity/Food Combinations Conducted by a Small or Very Small Business

We proposed that subpart C would not apply to on-farm low-risk manufacturing/processing activities conducted by a small or very small business if the only manufacturing/processing activities subject to section 418 of the FD&C Act that the business conducts are those listed in the proposed exemption. The proposed exemption specified those activity/food combinations that would be exempt when conducted on a farm mixed-type facility's own RACs and those activity/food combinations that would be exempt when conducted on food other than the farm mixed-type facility's own RACs for distribution into commerce.

As a consequential change in light of the final “farm” definition, the final exemption no longer distinguishes between manufacturing/processing activities conducted on a farm mixed-type facility's own RACs and manufacturing/processing activities conducted on food other than the farm mixed-type facility's own RACs. As another consequential change, the exemption has been revised to eliminate activities, conducted on others' RACs, which no longer are classified as manufacturing/processing and instead are classified as harvesting, packing, or holding. In addition, as discussed in Response 205 we have revised the final exemption to list food categories consistent with the food categories included in table 1 in the section 103(c)(1)(C) RA.

We also revised the proposed exemption to add two sets of information that we believe will be useful to a farm mixed-type facility when evaluating whether the farm's manufacturing/processing activities satisfy the criteria for the exemption.Start Printed Page 55982

First, we have added a new provision (§ 117.5(h)((1)) explaining that the exemption in § 117.5(h) applies to manufacturing/processing of foods on a farm mixed-type facility, except for manufacturing/processing that is within the “farm” definition in § 1.227. Drying/dehydrating RACs to create a distinct commodity (such as drying/dehydrating grapes to produce raisins, and drying/dehydrating fresh herbs to produce dried herbs), and packaging and labeling such commodities, without additional manufacturing/processing (such as chopping and slicing), are within the “farm” definition in § 1.227. In addition, treatment to manipulate the ripening of RACs (such as by treating produce with ethylene gas), and packaging and labeling the treated RACs, without additional manufacturing/processing, is within the “farm” definition. In addition, coating intact fruits and vegetables with wax, oil, or resin used for the purpose of storage or transportation is within the “farm” definition. Activities that are within the “farm” definition, when conducted on a farm mixed-type facility, are not subject to the requirements of subparts C and G of this part and therefore do not need to be specified in the exemption.

Second, we have added a provision (§ 117.5(h)((2)) specifying that § 117.5(g)(2) describes the food categories listed in the exemption.

(Comment 206) Some comments ask us to include in the exemption a single list of low-risk manufacturing/processing activity/food combinations applicable to farm mixed-type facilities conducting activities on their own RACs and farm mixed-type facilities conducting activities on other's RACs.

(Response 206) These comments no longer apply. As a consequence of the “farm” definition established by this rule, the exemption no longer distinguishes between manufacturing/processing activities conducted on a farm mixed-type facility's own RACs and manufacturing/processing activities conducted on food other than the farm mixed-type facility's own RACs.

(Comment 207) Some comments ask us to include additional activity/food combinations in the exemption. See table 15 and table 16 for a list of the requested additional activity/food combinations.

(Response 207) We evaluated each of the requested activity/food combinations within the qualitative risk assessment (Ref. 4), unless the activity/food combination was out of scope of this rule (for example, if the requested activity/food combination was directed to animal food rather than human food). See table 15 and table 16 for the outcome of our evaluation of these requests, based on the findings of the section 103(c)(1)(C) RA as to whether the requested activity/food combination satisfies the criteria in that risk assessment for a low-risk activity/food combination. When we determined through the section 103(c)(1)(C) RA that the requested activity/food combination did not satisfy the criteria for a low-risk activity/food combination, table 16 explains why. See § 117.5(g)(2) for a description of the food categories listed in the exemption for on-farm, low-risk manufacturing/processing activity/food combinations in table 15 and table 16.

The first column in table 15 lists the activity/food combination that comments ask us to include in the exemption for on-farm, low-risk manufacturing/processing activity/food combinations. The second column lists the regulatory citation for the relevant exemption for an on-farm manufacturing/processing activity/food combination. Importantly, the full regulatory text of the exemption includes some limitations that were not specified in the comments, and table 15 should not be viewed as equating the requests of the comments with the final regulatory text of the exemption. For example, § 117.5(g)(2)(ix) specifies that the food category “baked goods” includes processed food products such as breads, brownies, cakes, cookies, and crackers, but does not include products that require time/temperature control for safety (such as cream-filled pastries).

Table 15—Requested Activity/Food Combinations and Relevant Exemption for On-Farm Low-Risk Manufacturing/Processing Activities

Activity/food combination requested in the commentsRegulatory section listing the exemption
Baking activities involving grain products§ 117.5(h)(3)(ix)—Making baked goods from milled grain products (e.g., breads and cookies).
Chopping, coring, cutting, peeling, pitting, shredding, and slicing. • Crackers, dry bread, bread crumbs • Dry cereal, popcorn • Gums, resins and exudates • Jerky§ 117.5(h)(3)(ii)—Chopping, coring, cutting, peeling, pitting, shredding, and slicing: • Baked goods • Other grain products • Gums/latexes/resins • Game meat jerky.
Cooking low-moisture foods with dry heat§ 117.5(h)(3)(xxv)—Roasting and toasting baked goods.
Drying/dehydrating cut fruits and vegetables that are immediately moved into a drying process§ 117.5(h)(3)(iv)—Drying/dehydrating (that includes additional manufacturing or is performed on processed foods) other fruit and vegetable products with pH less than 4.2, and other herb and spice products (e.g., chopped fresh herbs, including tea).
• Distilling mint • Extracting virgin olive oil • Extracting oils from seeds (e.g., sunflower seeds, flax seeds) • Making liquid botanical extracts from dry botanical raw material with solvents such as glycerin, ethanol, vinegar, honey§ 117.5(h)(3)(v)—Extracting (including by pressing, by distilling, and by solvent extraction) from: • Dried/dehydrated herb and spice products • Fresh herbs • Fruits and vegetables • Grains • Other herb and spice products.
Grinding/milling/cracking/crushing: • Crackers, dry bread, bread crumbs • Dry cereal, dry pasta, popcorn • Dry legumes§ 117.5(h)(3)(vii)—Grinding/milling/cracking/crushing: • Baked goods • Other grain products • Dried/dehydrated fruit and vegetable products.
Mixing • Honey infused with dried herbs or spices • Oil and/or vinegar infused with dried herbs or spices§ 117.5(h)(3)(xxii)—Mixing other herb and spice products.
Making maple cream, maple sugar, and molded maple candy§ 117.5(h)(3)(x)—Making candy.
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Making molasses and treacle from sugarcane and sugar beets§ 117.5(h)(3)(xiv)—Making molasses and treacle.
• Making apple syrup • Making syrups from sorghum, rice • Making syrups from malted barley • Making syrups such as birch and walnut syrup§ 117.5(h)(3)(xix)—Making sugar and syrup from: • Fruits and vegetables • Grains • Other grain products • Saps.
Making vinegar, including infused and flavored vinegars§ 117.5(h)(3)(xxi)—Making vinegar from fruits and vegetables, other fruit and vegetable products, and other grain products. § 117.5(h)(3)(xxii)—Mixing other herb and spice products.
Processing tea§ 117.5(h)(3)(iv)—Drying/dehydrating (that includes additional manufacturing or is performed on processed foods) other fruit and vegetable products with pH less than 4.2, and other herb and spice products (e.g., chopped fresh herbs, including tea).

Table 16—Why Certain Requested Activity/Food Combinations Are Not Included in the Exemption for On-Farm Low-Risk Manufacturing/Processing Activities

Food or food group requested in the commentsWhy the food or food group is not listed in the exemption
Acidifying, pickling, and fermenting low-acid fruits and vegetables made in compliance with CGMPsAcidifying, pickling, and fermenting activities control microbial hazards and, thus, are not low-risk activities.
Cucumbers, garlic scapes, peppers, and other low-acid foods that are preservedThe production of low-acid processed foods must control the microbial hazard C. botulinum and, thus, is not a low-risk activity.
Drying/dehydrating tea leaves (e.g., by withering)Drying/dehydrating tea leaves is within the “farm” definition.
Fermentation of vegetablesFermenting activities control microbial hazards and, thus, are not low-risk activities.
Food processing conducted in compliance with relevant State regulationIt is the risk associated with the activity/food combination, not the regulatory oversight by a State, that is relevant of this exemption.
Freezing fruit juicesFruit juices are outside the scope of the RA based on the statutory framework of FSMA.
Low-acid fruits and vegetables manufactured in compliance with CGMPs under the FD&C ActThe production of low-acid processed foods must control the microbial hazard C. botulinum and, thus, is not a low-risk activity.
Making pickles and salsaThe processes for making pickles and salsa must control microbial hazards and, thus, are not low-risk activities.
Roasting grains for animal feedThis activity involves the production of animal food, which is subject to the animal preventive controls rule rather than the human preventive controls rule.

H. Proposed § 117.5(i)—Exemptions Related to Alcoholic Beverages

Section 116 of FSMA (21 U.S.C. 2206) (Alcohol-Related Facilities) provides a rule of construction for certain facilities engaged in the manufacturing, processing, packing, or holding of alcoholic beverages and other food. In the proposed human preventive controls rule, we discussed our interpretation of section 116 of FSMA and requested comment on our interpretation. Based on our interpretation, we proposed that subpart C would not apply with respect to alcoholic beverages at facilities meeting two specified conditions (78 FR 3646 at 3707 to 3709). We also proposed that subpart C would not apply with respect to food other than alcoholic beverages at facilities described in the exemption, provided such food is in prepackaged form that prevents direct human contact with the food and constitutes not more than 5 percent of the overall sales of the facility.

(Comment 208) Some comments ask us to include the production of spent grains, distillers' grains, grape pomace, and other by-products of the manufacturing process within the alcohol exemption. These comments argue that the mere act of separating and disposing of those by-products by sale or otherwise should not trigger an obligation to meet the requirements of subpart C.

(Response 208) The exemption established under the rule of construction in section 116 of FSMA applies to alcoholic beverages, not to any other food (see section 116(c) of FSMA (21 U.S.C. 2206(c)), and we have revised the exemption to make the statutory applicability clearer (see table 52 and the regulatory text of § 117.5(i)). As previously discussed (79 FR 58524 at 58558), the by-products described in these comments appear to be products that would be used in food for animals rather than in human food, and we addressed these by-products in the 2014 supplemental animal preventive controls notice (79 FR 58476 at 58487-58489). (See also the discussion in section L regarding the specific CGMP provisions that will apply to these foods.)

I. Proposed § 117.5(j)—Exemption Applicable to Facilities Solely Engaged in Storage of Raw Agricultural Commodities Other Than Fruits and Vegetables Intended for Further Distribution or Processing

We proposed that subpart C would not apply to facilities that are solely engaged in the storage of RACs (other than fruits and vegetables) intended for further distribution or processing. In the following paragraphs, we discuss comments that ask us to clarify how the proposed exemption would apply to specific circumstances.

(Comment 209) Some comments ask whether this proposed exemption (proposed § 117.5(j)) would apply to facilities such as peanut buying points or bean elevators and assert that such Start Printed Page 55984commodities are analogous to grains and the activities conducted at such facilities are analogous to those performed by grain elevators.

(Response 209) We classify peanuts and beans (such as kidney beans, lima beans, and pinto beans) within the category of “fruits and vegetables”; we classify soybeans as grain (see the discussion of fruits and vegetables, 78 FR 3646 at 3690 and proposed §§ 112.1 and 112.2 in the proposed produce safety rule). The exemption for facilities solely engaged in storage of RACs intended for further distribution or processing does not apply to facilities that store fruit and vegetable RACs and, thus, does not apply to facilities such as peanut buying points and bean elevators. As discussed in Response 25, we have revised the “farm” definition to provide that an operation devoted to harvesting (such as hulling or shelling), packing, and/or holding of RACs is within the “farm” definition as a secondary activities farm, provided that the primary production farm(s) that grows, harvests, and/or raises the majority of the RACs harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm. With this revision, some operations dedicated to holding RACs, including fruit and vegetable RACs, will be within the “farm” definition.

Peanut buying points and bean elevators that do not meet the revised farm definition are storing RACs that are “fruits and vegetables” and do not meet the criteria for exemption under § 117.5(j). However, we would not expect such facilities to need an extensive food safety plan. A facility that appropriately determines through its hazard analysis that there are no hazards requiring preventive controls would document that determination in its written hazard analysis but would not need to establish preventive controls and associated management components.

(Comment 210) Some comments refer to our statement that there would not be significant public health benefit to be gained by subjecting facilities that solely store non-fruit and vegetable RACs intended for further distribution or processing to the requirements of subpart C (78 FR 3646 at 3709) and assert that the same conclusion applies to those portions of oilseed processing facilities that are devoted solely to RAC storage. According to these comments, in the overwhelming majority of cases the inclusion of a separate RAC storage area in the same building as the oilseed processing area will not introduce additional risk either to the processing area or to the operations that take place there and that storage areas, whether standing alone as a separate facility or incorporated into a larger processing facility, store RACs safely. These comments ask us to recognize that storage activities may include grain drying to standardize moisture levels and preserve product quality. These comments also ask us to expand the exemption in § 117.5(j) to also apply to distinct and physically separate storage areas that are used solely for storage of RACs (other than fruits and vegetables) intended for further distribution or processing.

(Response 210) The activities included within the definition of holding include activities that are performed as a practical necessity for the distribution of RACs. In the 2014 supplemental human preventive controls notice, we explained that facilities that conduct operations similar to those conducted at grain elevators and silos, such as some facilities that hold oilseeds, may satisfy the criteria for exemption if activities other than storage are performed as a practical necessity for the distribution of RACs (see 79 FR 58524 at 58537 and the definition of “holding” in § 117.3). Examples of holding activities include drying/dehydrating RACs when the drying/dehydrating does not create a distinct commodity (see § 117.3). Thus, the specific example of drying grains to standardize moisture levels and preserve product quality would fall within the definition of holding as a practical necessity for the distribution of RACs. A facility that stores oilseeds, and dries them as a practical necessity for the distribution of RACs, would be covered by the exemption in § 117.5(j).

However, we decline the request to modify the exemption in § 117.5(j) to also apply to distinct and physically separate storage areas that are used solely for storage of RACs (other than fruits and vegetables) intended for further distribution or processing. To the extent that the comments are asking us to do so to provide for facilities that conduct activities as a practical necessity for the distribution of RACs to be eligible for the exemption, doing so is not necessary in light of the definition of holding. To the extent that the comments are asking us to do so to provide for facilities that conduct manufacturing/processing activities in addition to holding activities, we disagree that doing so would be consistent with the statutory direction in FSMA. As previously discussed, section 418(m) of the FD&C Act provides in relevant part that we may by regulation exempt or modify the requirements for compliance under section 418 of the FD&C Act with respect to facilities that are solely engaged in the storage of RACs (other than fruits and vegetables) intended for further distribution or processing (78 FR 3646 at 3709). The plain meaning of “solely” is only, completely, entirely; without another or others; singly; alone (Ref. 44). Facilities that conduct manufacturing/processing activities in addition to holding activities are not “solely” engaged in the storage of RACs (other than fruits and vegetables) intended for further distribution or processing. See also Response 233 regarding a similar request regarding the applicability of the requirements for hazard analysis and risk-based preventive controls to a facility solely engaged in the storage of unexposed packaged food.

J. Proposed § 117.5(k)—Exemption Applicable to Farms, Fishing Vessels, Activities of “Farm Mixed-Type Facilities” Within the Definition of “Farm,” the Holding or Transportation of One or More Raw Agricultural Commodities, and Specified Activities Conducted on Specified Raw Agricultural Commodities

We proposed to redesignate § 110.19(a) as proposed § 117.5(k) and revise the exemption that had been in § 110.19(a) to provide that subpart B would not apply to: (1) Farms; (2) fishing vessels that are not required to register as a food facility; (3) the holding or transportation of one or more RACs; (4) activities of “farm mixed-type facilities” that fall within the definition of “farm”; and (5) hulling, shelling, and drying nuts (without manufacturing/processing, such as roasting nuts).

(Comment 211) Some comments ask us to clarify whether the proposed exemption for the holding or transportation of one or more RACs (proposed § 117.5(k)) would apply to any food establishment, or only apply to farms and farm mixed-type facilities.

(Response 211) The exemption applies to any food establishment.

(Comment 212) Some comments ask us to clarify that CGMP requirements (such as requirements for the plant design to permit the taking of adequate precautions to protect food in outdoor bulk vessels (§ 117.20(b)(3)) and requirements for warehousing and distribution (§ 117.93) do not apply to the bulk outdoor storage of RACs for further processing.

(Response 212) We are returning to the long-standing approach that the exemption applies to establishments “solely engaged” in specific activities. Under the exemption we are Start Printed Page 55985establishing in § 117.5(k)(1)(iii), those activities are holding and/or transportation of RACs. Under the exemption we are establishing in § 117.5(k)(1)(v), those activities are hulling, shelling, drying, packing, and/or holding nuts. We explain why in the following paragraphs.

These comments appear to interpret the proposed exemption in a way that goes beyond the long-standing “RAC exemption” in § 110.19 and is inconsistent with our intent in updating § 110.19 to adjust and clarify what activities fall within this exemption based on experience and changes in related areas of the law since issuance of this exemption from the CGMPs (78 FR 3646 at 3710). The suggestion of these comments—i.e., that CGMPs should not apply to the holding of RACS in a facility that manufactures, processes, or packs RACs-would not make sense in some circumstances and would create difficulties for establishments (in determining how to comply with the CGMP requirements) and for regulators (in determining how to enforce the CGMP requirements). For example, it does not make sense for the part of a facility that holds RACs prior to processing to be exempt and the parts of the facility that are processing the RACs and storing them after processing to be covered. Likewise, it does not make sense for part of a transportation vehicle to be covered and part to be exempt.

By revising these two proposed exemptions that derive from the “RAC exemption” so that they apply only to establishments “solely engaged” in the storage and/or transportation of RACs, and to establishments “solely engaged” in the hulling, shelling, drying, packing, and/or holding of nuts, we are providing for a predictable framework for interpreting exemptions for facilities “solely engaged” in other activities. For example, as discussed in Comment 209, comments ask us to expand the exemption (in § 117.5(j)) from the requirements for hazard analysis and risk-based preventive controls for facilities that are “solely engaged” in the storage of RACs (other than fruits and vegetables) intended for further distribution or processing to also apply to distinct and physically separate storage areas that are used solely for storage of such RACs. In our response, we noted that facilities that conduct manufacturing/processing activities in addition to holding activities are not “solely engaged” in the storage of such RACs (see Response 209). In addition, as discussed in Comment 233, comments ask us to apply the exemption (in § 117.7) from the requirements for hazard analysis and risk-based preventive controls for facilities that are “solely engaged” in the storage of unexposed packaged food to storage areas of facilities that also engage in food processing activities—e.g., for distributors that are engaged in limited food processing, such as cutting vegetables or packing ready-to-eat foods. In our response, we noted that such distributors are not “solely” engaged in the storage of unexposed packaged food (see Response 233).

The questions raised by these comments led us to reexamine the reasons we gave, in the 2013 proposed human preventive controls rule and the 2014 supplemental human preventive controls notice, for describing these exemption in terms of the activities conducted without specifying that the establishment is “solely engaged” in conducting these activities. For example, in the 2013 proposed human preventive controls rule we explained our assumption that if activities subject to the CGMPs take place in the same establishment, compliance with the CGMPs with respect to those activities should provide necessary protection. The comments led us to question that assumption. For example, with respect to the question posed by the comments about the outdoor bulk storage of RACs for further processing, it is not clear how conducting subsequent activities on the RACs in accordance with the CGMP requirements would protect the RACs during outdoor bulk storage. As discussed more fully in Response 660, processing fresh produce into fresh-cut products increases the risk of bacterial growth and contamination. RACs stored in bulk outdoors before being processed into fresh-cut produce must be stored in clean containers or vessels such that these do not contribute to contamination of the produce before it is processed. In addition, as already noted in this response, in interpreting the exemptions from subparts C and G for facilities that are solely engaged in the storage of RACs (other than fruits and vegetables) intended for further distribution or processing (§ 117.5(j)) and for facilities solely engaged in the storage of unexposed packaged food (§ 117.7), we do not consider that the exemption for these “holding” activities applies when holding is part of other operations conducted by the facility. For example, the exemption in § 117.7 would not apply to a packaged food warehouse of a processing facility, even if the warehouse only stores unexposed packaged food.

In the 2013 proposed human preventive controls rule we tentatively concluded that it would be reasonable to revise the RAC exemption in § 110.19 so that it would exempt the specifically identified activities when performed on RACs, regardless of whether the establishment that conducts those activities also conducts other activities that do not qualify for the exemption, in part because the exemptions in section 418(j)(1) applied to “activities” (i.e., covered by parts 120, 123, and 113) (see 78 FR 3646 at 3710). However, section 418(j)(1) is premised on the existence of similar mandatory requirements for those specific foods. In contrast, there are no requirements similar to subpart B in some situations that would be exempt under an exemption broadly directed to the activities of holding and transportation. For example, there would be no other requirements similar to subpart B (e.g., for pest control) applicable to an off-farm establishment that stores apples in a controlled atmosphere storage facility or to an establishment that stores harvested dry beans. We now believe that a better comparison is to other exemptions in FSMA, such as the exemption in section 103(c)(1)(D)(i) of FSMA for facilities engaged only in specific types of on-farm manufacturing, processing, packing or holding activities, and the exemption in section 418(m) of the FD&C Act for facilities solely engaged in storage of RACs (other than fruits and vegetables) intended for further distribution or processing. It is reasonable to infer that one reason for the use of “solely” in the statutory provisions in section 103(c)(1)(D)(i) of FSMA and in section 418(m) of the FD&C Act is to avoid some of the problems we have discussed in this response.

In the 2013 proposed human preventive controls rule, we stated our belief that activities should be regulated the same way regardless of whether activities subject to the CGMP requirements take place in same establishment. However, as with the exemptions in section 103(c)(1)(D)(i) of FSMA and section 418(m) of the FD&C Act, this is a situation where context matters. RACs that are the sole food in a warehouse are different from RACs being held in a manufacturing operation. As already noted in this response and as discussed more fully in Response 660, processing fresh produce into fresh-cut products increases the risk of bacterial growth and contamination, and produce being stored before processing into fresh-cut produce must be protected against contamination while being stored.

The exemptions we are establishing in this rule for establishments solely engaged in the storage and/or Start Printed Page 55986transportation of RACs, and for establishments solely engaged in hulling, shelling, drying, packing, and/or holding nuts (without additional manufacturing/processing, such as roasting nuts), remain consistent with our announced intent to adjust and clarify what activities fall within this exemption based, in part, on changes in related areas of the law since this exemption from the CGMP requirements was first issued. As discussed in section IV, we have made a number of changes to the “farm” definition, including changes that provide for an operation devoted to harvesting, packing, and/or holding of RACs to be a “farm” (i.e., a “secondary activities farm”) (and, thus, be exempt from the CGMP requirements under § 117.5(k)(1)(i)) even though the operation does not grow RACs (see § 117.3). With this revised “farm” definition, some establishments that had relied on the “RAC exemption” in § 110.19 to be exempt from CGMP requirements as establishments solely engaged in the “storage” of RACs, or because they were solely engaged in the harvesting (such as hulling and shelling) and storage (which includes drying) of nuts, will be exempt from the CGMP requirements because they are a “farm.” As a result, there are fewer operations that need to rely on exemptions that are an outgrowth of the long-standing RAC exemption in § 110.19.

K. Comments Requesting Additional Exemptions

1. Introduction

(Comment 213) We received comments requesting several additional exemptions from the requirements for hazard analysis and risk-based preventive controls in subpart C, the CGMP requirements of subpart B, or both. See the remainder of section XI.K for a description of the specific requests.

(Response 213) Each year, about 48 million Americans (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases, according to recent estimates from the Centers for Disease Control and Prevention (CDC) (Ref. 45). This is a significant public health burden that is largely preventable. We believe that improvements to our CGMP regulations, coupled with implementation of FSMA's directives to focus more on preventing food safety problems than on reacting to problems after they occur, can play an important role in reducing foodborne illness (other than foodborne illnesses that are the result of improper food handling practices in the home and food service settings, which would not be addressed by this rule). We did not propose any exemptions or exceptions from the requirements of subpart C other than those contained in section 103 of FSMA (78 FR 3646 at 3657). Likewise, we did not propose any additional exemptions from the CGMP requirements other than to adjust and clarify what activities fall within a long-standing exemption related to RACs based on experience and changes in related areas of the law since issuance of the CGMP regulation (78 FR 3646 at 3709-3711).

In the remainder of section XI.K, we respond to the specific requests for additional exemptions from the requirements of subparts C and G for hazard analysis and risk-based preventive controls. None of these specific requests describe (or otherwise provide) evidence demonstrating that the regulatory framework associated with the request would address all of the requirements of subparts C and G. Therefore, we have declined all of these requests. In some cases, a facility that is subject to other Federal, State, or local regulations that have some of the same requirements as subparts C and G will not have to repeat the same activity and will be able to use any existing records to demonstrate compliance and supplement those actions and records as necessary to demonstrate compliance with the remaining requirements of subparts C and G (see, e.g., 79 FR 58524 at 58542, Response 215, Response 216, Response 219, and the discussion of § 117.330 in section XLI.G). In one case (for facilities subject to the PMO; see Response 214), we have extended the date for compliance with the requirements of subparts C and G in light of comments expressing an intent to revise the current requirements of a Federal/State cooperative program to incorporate the requirements of this rule. In other cases, a facility may determine and document through its hazard analysis that no preventive controls are necessary to prevent its food products from being adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act (see, e.g., Response 222, Response 226, Response 229, and the discussion of § 117.130 in section XXV). Such facilities, although not exempt, will have a reduced burden to comply with the rule, if the outcome of their hazard analysis is that there are no hazards requiring preventive controls.

Likewise, in the remainder of section XI.K we respond to the specific requests for additional exemptions from the CGMP requirements of subpart B. None of these requests provide a basis for why the long-standing CGMP provisions that establish basic requirements for the manufacturing, processing, packing, and holding of food to prevent adulteration should no longer apply to a particular type of food establishment and, thus, we have declined these requests.

2. Facilities That Comply With the Pasteurized Milk Ordinance

(Comment 214) Some comments discuss facilities that comply with the Grade “A” PMO and are regulated under the National Conference on Interstate Milk Shipments (NCIMS) system (PMO facilities). NCIMS has been part of a cooperative program among the U.S. Public Health Service/FDA, the States and the dairy industry since 1950. Procedures for Governing the Cooperative Program of the NCIMS include procedures establishing milk sanitation standards, rating procedures, sampling procedures, laboratory procedures, laboratory evaluation and sample collector procedures. As previously discussed (78 FR 3646 at 3662), the PMO is a model regulation published and recommended by the U.S. Public Health Service/FDA for voluntary adoption by State dairy regulatory agencies to regulate the production, processing, storage and distribution of Grade “A” milk and milk products to help prevent milkborne disease. Appendix K—HACCP Program of the PMO—describes a voluntary, NCIMS HACCP Program alternative to the traditional inspection system. A milk plant, receiving station or transfer station may not participate in the voluntary NCIMS HACCP Program unless the regulatory agency responsible for the oversight of the facility agrees to participate with the dairy plant(s), receiving station(s) and transfer station(s) in the NCIMS HACCP Program. Currently all 50 States, the District of Columbia, and Puerto Rico have adopted the PMO by reference or have codified the PMO or similar provisions in State regulations. At its biennial conferences, the NCIMS considers changes and modifications to the Grade “A” PMO to further enhance the safety of Grade “A” milk and milk products, including the administrative and technical details on how to obtain satisfactory compliance. Changes ultimately accepted by NCIMS voting delegates (representatives from States and territories) are forwarded to FDA for concurrence before they become effective.

Some comments recommend that we make full use of the existing milk safety system of State regulatory oversight for Grade “A” milk and milk products provided through the NCIMS and the food safety requirements of the PMO. Some comments assert that we are Start Printed Page 55987exceeding our authority by requiring PMO-regulated facilities to comply with both the PMO and the requirements of FSMA for hazard analysis and risk-based preventive controls.

Some comments ask us to exempt PMO-regulated facilities (or the PMO-regulated part of a PMO facility that also produces food products not covered by the PMO) from the requirements of the rule for hazard analysis and risk-based preventive controls, or to otherwise determine that facilities operating in compliance with the PMO are also in compliance with those requirements. These comments suggest we could, as an interim step if we find it necessary, stay the application of these requirements to PMO-regulated facilities and work with the NCIMS cooperative program to enact any modifications to the PMO as may be needed to warrant an exemption or comparability determination. The comments characterize these changes as “minor.”

Some comments ask for clarification as to whether the human preventive controls rule would preempt the PMO if there are any conflicts or duplications between the human preventive controls rule and the PMO. Some comments ask us to explain our position concerning the interstate movement of milk and milk products and imported milk if the final rule does not recognize that PMO-regulated facilities are also in compliance with the requirements of the human preventive controls rule for hazard analysis and risk-based preventive controls. These comments ask: (1) Whether the final rule will become the de facto standard or the standard enforced by the FDA for the movement of milk in interstate commerce and for imported milk; (2) how the final rule will affect States that have adopted the PMO as their law/regulation for the production and processing of products such as fluid milk products and cottage cheese; and (3) how a final rule that does not recognize the PMO and the products made under the PMO will affect other Federal rules, policy, procedures, or practices that require compliance with the PMO.

(Response 214) We agree that we should make use of the existing system of State regulatory oversight for Grade “A” milk and milk products provided through the NCIMS and the food safety requirements of the PMO. The NCIMS program has been effective from a regulatory standpoint, and has likely had a significant public health impact in reducing the incidence of foodborne illness attributable to milk and milk products. FDA is committed to the mission of the NCIMS and ensuring the continuance of an effective milk safety system with State regulatory oversight. However, the PMO does not address all of the requirements of subparts C and G, such as requirements relevant to the potential presence of environmental pathogens in the food processing environment (see, e.g., §§ 117.130(c)(1)(ii) and 117.150(a)(1)(ii)(B)). Such provisions could help to prevent food safety problems from the consumption of food produced by PMO facilities and play an important role in reducing foodborne illness. For example, in 2007, contamination of a PMO-regulated facility with the environmental pathogen L. monocytogenes was the cause of three deaths via listeriosis (Ref. 46). As another example, there have been large-scale recalls as a result of contamination of dried milk with the environmental pathogen Salmonella (Ref. 47).

In addition, the NCIMS HACCP Program is a voluntary program and, as of March 17, 2015, had been utilized by only 11 of approximately 625 PMO facilities (Ref. 48). Further, the current NCIMS HACCP Program does not address all of the requirements of subparts C and G, such as environmental monitoring as a verification of sanitation controls for environmental pathogens and a supply-chain program for non-dairy ingredients (Ref. 49). The PMO also does not address food allergen controls, which are appropriate for those Grade “A” facilities that also handle food containing allergens other than milk. The comments do not provide a basis for why we should exempt PMO facilities from the rule in light of the differences between the requirements of this rule and the requirements of the PMO.

NCIMS has initiated work to modify the PMO and that work is expected to include all of the requirements in a final human preventive controls rule. FDA has committed resources to work with the appropriate NCIMS Committees to make the necessary changes. However, the NCIMS process will not be complete in time for PMO facilities to meet the first two compliance dates for this rule (i.e., September 19, 2016 for businesses other than small and very small businesses, and September 18, 2017 for small businesses), because the next scheduled Conference following the publication of this final rule would be April 2017. Therefore, to make use of the existing system of State regulatory oversight for Grade “A” milk and milk products provided through the NCIMS and the food safety requirements of the PMO, we are extending the compliance date for PMO-regulated facilities to comply with the requirements of subparts C and G to September 17, 2018. Doing so is consistent with the request of comments asking us to “stay” the application of the requirements for hazard analysis and risk-based preventive controls to PMO-regulated facilities and work with the NCIMS cooperative program to effect the necessary modifications to the PMO so that it will include all of the requirements in the human preventive controls rule. The extended compliance date is not equivalent to an exemption. Regardless of whether the PMO is modified to include the requirements of a final human preventive controls rule by the extended compliance date, PMO facilities must comply with the human preventive controls rule on September 17, 2018.

The extended compliance date also is responsive to comments that identified complex implementation issues concerning the interstate movement of milk and milk products and imported milk. If the requirements of this rule for hazard analysis and risk-based preventive controls are incorporated into the PMO by the compliance date, such implementation issues will be moot, because a facility that complies with the revised PMO would also comply with this rule. As the compliance date approaches, it will be clearer as to whether any or all of the necessary revisions to the PMO will be in place by the compliance date for PMO facilities. If it appears that these revisions will not be in place by the compliance date for PMO facilities, we will take steps to address implementation issues specific to this Federal/State cooperative program.

In establishing a compliance date of September 17, 2018 for PMO facilities, we considered: (1) The extent of revisions that must be made to incorporate the requirements of this rule for hazard analysis and risk-based preventive controls into the PMO; (2) the process to revise the PMO; and (3) the date at which the necessary revisions to the PMO could begin to be made. We discuss each of these considerations in the following paragraphs.

We disagree that the necessary revisions to incorporate the requirements of this rule for hazard analysis and risk-based preventive controls into the PMO are “minor.” There are gaps between the requirements of this rule and the current required and voluntary provisions of the PMO (Ref. 49), and gaps such as provisions directed to environmental Start Printed Page 55988monitoring, supply-chain controls, and food allergen controls are not “minor.”

With respect to process, NCIMS considers changes and modifications to the Grade “A” PMO at its biennial conferences, and proposals with the necessary changes must be voted on at such a biennial meeting. The next scheduled biennial conference is in the spring of 2017. Although it may be possible for NCIMS to convene a special conference in 2016 for the purpose of voting on proposals to revise the PMO to make it comply with the requirements of this rule, practicalities such as the availability of funds for a special conference could interfere with any plans for a special conference. In addition, given that we do not view the necessary changes as “minor,” it could take more than one round of proposals for revising the PMO before a proposal receives the votes necessary to be adopted. Because the provisions of this rule will not be established until the date of publication of this final rule, any preliminary drafts of proposals to modify the PMO (e.g., to incorporate the provisions that we proposed in the 2014 supplemental preventive controls notice) before today's date may need revision to reflect the final provisions of the rule.

In light of all these considerations, we are establishing September 17, 2018 as the date for PMO facilities to comply with the requirements for hazard analysis and risk-based preventive controls in part 117, subparts C and G. The compliance date for PMO facilities to comply with the CGMP requirements of subpart B is also September 17, 2018, and PMO facilities will continue to comply with part 110 until that date. Under NCIMS procedures, changes agreed to by the voting delegates at the 2017 NCIMS conference (and to which FDA concurs) would be effective within one year of the electronic publication of the NCIMS documents; or by official notification by FDA to the States and the dairy industry of “Actions from the 2017 NCIMS Conference;” or by a previously determined effective date (e.g., September 17, 2018). We believe that the date of September 17, 2018 appropriately balances the need to realize the benefits of FSMA's requirements for hazard analysis and risk-based preventive controls with the practicalities associated with revising the PMO to incorporate the requirements of this rule.

3. Facilities That Have an Established HACCP Program

(Comment 215) Some comments ask us to recognize operations that have an established HACCP Program implemented by a trained individual as meeting the requirements of the human preventive controls rule. Some of these comments note that the NCIMS HACCP Program describes a voluntary, NCIMS HACCP Program alternative to the traditional inspection system. Other comments discuss the EU Dairy HACCP Program and assert that the preventive controls system mandated by FSMA is a HACCP-like system but is not as robust as the EU Dairy HACCP Program. Other comments ask us to support and recognize industry-driven, mandatory programs that afford the same level of public health protection as the human preventive controls rule.

Other comments note that facilities such as pizza manufacturing facilities are “dual jurisdiction” facilities, regulated and inspected by both FDA and USDA's Food Safety and Inspection Service (FSIS). These comments assert that such facilities already are operating under FSIS-approved HACCP plans, and their HACCP plans cover FDA-regulated products, as well as FSIS-regulated products. These comments acknowledge that there are differences between FSIS' HACCP regulation and FDA's proposed requirements for hazard analysis and risk-based preventive controls but nonetheless assert that requiring dual jurisdiction facilities to operate under two different food safety plans would result in unnecessary duplication of effort and confusion.

(Response 215) Whether a particular HACCP program implemented by a trained individual would satisfy the requirements of the human preventive controls rule will depend on whether the particular HACCP program satisfies all of the requirements of the rule. (See Response 213.) For operations that have implemented HACCP programs that are generally similar to the provisions of part 117, the burden of complying should be minimal in light of the provisions of § 117.330, which provides for use of existing records. As an example, if a facility has an existing HACCP plan (or multiple HACCP plans for different types of foods), supported by certain prerequisite programs that include food safety controls, the facility would not need to duplicate or re-write its existing HACCP plans or prerequisite programs, as long as the existing HACCP plans and prerequisite programs contain all of the required information and satisfy the requirements of subpart F, or are supplemented as necessary to include all of the required information and satisfy the requirements of subpart F (see § 117.330(a)). Because the rule also provides that the required information does not need to be kept in one set of records, a facility may supplement existing records associated with its HACCP plans and prerequisite programs with other required components of a food safety plan (such as recall plan and, when applicable, a supply-chain program and written verification procedures for environmental monitoring) (see § 117.330(b)). Moreover, the rule provides additional flexibility for a facility that relies on both existing records and newly established records to keep the records either separately or combined (see § 117.330(b)).

The flexibility provided by the provisions for use of existing records also enables a facility to comply with the requirement (in § 117.310) for the owner, operator, or agent in charge of a facility to sign and date the facility's food safety plan, even when components of the food safety plan are kept separately. For example, when the food safety plan consists of one or more existing HACCP plans, one or more prerequisite programs that include food safety controls, a recall plan, a written supply-chain program, written verification procedures such as environmental monitoring, and any other components required by the rule, one approach for signing and dating the food safety plan could be to collect all these documents in a single location (e.g., a binder or folder) with a cover page containing the signature of the owner, operator, or agent in charge of the facility and the date on which the cover page was signed. However, because the food safety plan also could be a set of documents kept in different locations within the facility, a facility could sign and date a list of the relevant documents (e.g., as in a Table of Contents). (See also the discussion in Response 369 that a food safety plan may be prepared as a set of documents kept in different locations within the facility (e.g., based on where they will be used)).

4. Facilities That Are Subject to Requirements for Acidified Foods

(Comment 216) Some comments ask us to exempt (or partially exempt) facilities that produce acidified foods from the requirements of subpart C, because acidified foods are subject to the specific food safety regulation in part 114 (21 CFR part 114) in addition to the CGMP requirements in subpart B. If we do not do so, these comments ask us to clarify whether a scheduled process established for an acidified food would be accepted as a process that had been validated as a preventive control for a microbiological hazard. Some of these comments mention specific acidified food products, such as salsa. Start Printed Page 55989Other comments ask us to withdraw part 114 and regulate acidified foods under part 117 to avoid confusion, and then consider acidification as a preventive control.

(Response 216) We agree that the specific CGMP requirements already established in part 114 play a key role in the safe production of acidified foods, but disagree that it would be appropriate to exempt facilities that are subject to part 114 from the requirements of subparts C and G. As the comments suggest, the long-standing requirements of part 114 could function as a type of preventive control. However, part 114 does not address all of the requirements of subparts C and G, such as the requirement to address chemical and physical hazards.

We also disagree that we should withdraw part 114 and simply consider acidification as a preventive control under subparts C and G. The long-standing requirements of part 114 provide many details that do not fit within the framework of this rule, and we do not believe that it is in the best interest of public health to simply eliminate those details.

A processor of acidified foods can consider its current scheduled processes, established in accordance with part 114, when conducting the hazard analysis required by this rule (§ 117.130). A processor of acidified foods could, through its hazard analysis, determine and document that the microbiological hazards associated with its products are addressed by preventive controls in its scheduled processes established under part 114. To the extent that the processor considers an existing scheduled process to be a preventive control as that term is defined in this rule, the processor would establish and implement preventive control management components (i.e., monitoring, corrective actions and corrections, and verification (including validation)) as appropriate to ensure the effectiveness of that preventive control, taking into account the nature of the preventive control. Again, a processor of acidified foods can consider its current procedures, established in accordance with part 114, when determining what preventive control management components to establish and implement. For example, a facility that previously validated a scheduled process can rely on its existing validation records and would not need to repeat the validation or make a new record. Processes issued by a process authority for acidified foods are generally accepted as validated processes. As another example, a facility can consider its current procedures for complying with the requirements of part 114, including frequent pH testing and recording of results, to exercise sufficient control so that the finished equilibrium pH values for acidified foods are not higher than 4.6 (§ 114.80(a)(2)), and to address deviations from scheduled processes (§ 114.89). A facility that produces acidified foods could demonstrate compliance with the requirements of subparts C and G of this rule by relying on the records it is currently required to establish and maintain (§ 114.100), as applicable, supplemented as necessary (see § 117.330).

(Comment 217) Some comments ask whether a qualified facility with activities that are subject to part 114 (Acidified Foods) would be exempt from the requirements of Subpart C.

(Response 217) A qualified facility is exempt from the requirements of subparts C and G, and instead subject to the modified requirements in § 117.201, for all foods that it produces, including acidified foods.

5. Egg Facilities

(Comment 218) Some comments ask us to exempt shell egg facilities that are also regulated by USDA and by State shell egg grading programs from the requirements of both subpart B and subpart C or at least recognize these establishments as meeting the requirements for subpart B and Subpart C without further routine FDA inspection. Some comments ask us to exempt shell egg establishments subject to part 118 (21 CFR part 118) (Production, Storage, And Transportation Of Shell Eggs) from the requirements of subpart C because part 118 already requires shell egg establishments to take specific, concrete, steps to prevent the hazard Salmonella from contaminating eggs on the farm and from further growth during storage and transportation.

(Response 218) Shell eggs are RACs. The on-farm production of shell eggs is exempt from both the CGMP requirements in subpart B (see the exemption for farms in § 117.5(k)(1)(i)) and from the requirements for hazard analysis and risk-based preventive controls in subparts C and G (because a “farm” is exempt from the requirement to register as a food facility). Likewise, the packing of shell eggs by egg packinghouses that are within the “farm” definition established during this rulemaking are exempt from both the CGMP requirements in subpart B and the requirements for hazard analysis and risk-based preventive controls in subparts C and G, (see Response 25).

Establishments that are solely engaged in the holding or transportation of shell eggs are exempt from the CGMP requirements in subpart B (see the exemption for establishments solely engaged in the holding or transportation of one or more RACs in § 117.5(k)(1)(iii)). Facilities that are required to register, but are solely engaged in the storage of shell eggs intended for further distribution or processing, are exempt from the requirements for hazard analysis and risk-based preventive controls in subparts C and G (see the exemption in § 117.5(j)).

Shell egg processing facilities that are regulated exclusively, throughout the entire facility, by USDA under the Egg Products Inspection Act (21 U.S.C. 1031 et seq.) are exempt from the section 415 registration regulations and, thus, are not subject to the requirements of this rule for hazard analysis and risk-based preventive controls (subparts C and G).

6. Facilities That Produce Infant Formula

(Comment 219) Some comments ask us to exempt the production of infant formula from the requirements of subpart C after we issue a final rule establishing requirements for CGMPs and quality control procedures for infant formula.

(Response 219) We issued an interim final rule entitled “Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula” on February 10, 2014 (79 FR 7934) and a final rule (the infant formula rule) adopting, with some modifications, that interim final rule on June 10, 2014 (79 FR 33057).

We agree that the requirements of the infant formula rule play a key role in the safe production of infant formula, but disagree that it would be appropriate to exempt facilities that are subject to the infant formula rule from the requirements of subparts C and G. The infant formula rule does not address all of the requirements of subparts C and G, such as requirements relevant to the potential presence of environmental pathogens in the food processing environment (see, e.g., §§ 117.130(c)(1)(ii) and 117.150(a)(1)(ii)(B)). As with products such as acidified foods (see Response 216), a manufacturer of infant formula could demonstrate compliance with the requirements of subparts C and G of this rule by relying on the records it is currently required to establish and maintain (§ 106.100), as applicable, Start Printed Page 55990supplemented as necessary (see § 117.330).

7. Small Businesses

(Comment 220) Some comments ask us to provide more exemptions for small farms and small facilities.

(Response 220) We decline this request. As discussed in Response 213, the exemptions we are establishing are those provided by section 103 of FSMA. Small farm that only conduct activities within the “farm” definition are not subject to the human preventive controls rule. Small farms that also conduct activities outside the “farm” definition (such as manufacturing jams or jellies) (and, thus, are farm mixed-type facilities) are eligible for an exemption if the only such activities they conduct are the low-risk activity/food combinations specified in the exemptions in § 117.5(g) and (h). Small farms that are subject to this rule as farm mixed-type facilities, and other small businesses, will have an extra year to comply with the rule. As discussed in Response 222, the new requirements for hazard analysis and risk-based preventive controls are flexible, and the preventive controls (if any) that a facility would establish and implement would depend on the outcome of the facility's hazard analysis and therefore would be tailored to the operation. These aspects of this rulemaking provide ample flexibility to small businesses.

8. Exemptions Based on Risk

(Comment 221) Some comments ask us to exempt facilities identified as conducting low-risk activities from the CGMP requirements.

(Response 221) We decline this request. The umbrella CGMPs that we are establishing in subpart B are long-standing provisions that establish basic requirements for the manufacturing, processing, packing, and holding of food to prevent adulteration. For example, food that is exposed must be protected against contamination from the plant's grounds, the design and construction of the plant, and sanitary operations regardless of whether the uncontaminated food could be “high-risk” or “low-risk”; contamination introduced during the production of food can adulterate any food. In addition, these umbrella CGMPs are not “one-size-fits-all” in that many provisions provide flexibility to tailor specific practices to the nature of the food and the activities being conducted. For example, many provisions establish a performance standard in which the measures taken must be “adequate” to comply with the rule, where adequate is defined as that which is needed to accomplish the intended purpose in keeping with good public health practice. As another example, provisions directed to raw materials require that they be washed or cleaned “as necessary” to remove soil or other contamination (see § 117.80(b)(1)). Moreover, some comments point out that one strength of the long-standing CGMPs is their applicability to the broad spectrum of food manufacturing, from the manufacture of processed products and packaging of fresh produce to production of food additives and GRAS substances (see section VIII). (As already noted, some packaging of fresh produce (e.g., packaging of RACs on a farm) is not subject to the CGMPs.)

(Comment 222) Some comments assert that we should not base the requirements for hazard analysis and risk-based preventive controls on the status of a business as a facility that is required to register under the section 415 registration regulations if there is no risk from consumption of food produced by that business. Some comments assert that a food safety plan should only be required for high-risk processing facilities because adhering to CGMPs is sufficient for low-risk facilities. Some comments assert a food safety plan should be required for large businesses, but not for small and medium-size businesses, including small businesses that manufacture low-risk foods that are sterilized before being eaten and already undergo a 48-point inspection twice a year.

Some comments ask us to adopt a commodity-specific approach to the exemptions and to only apply the requirements for hazard analysis and risk-based preventive controls to RACs that fall within the five highest-risk commodity groups and to any other specific commodities that we determine pose a comparable risk based on outbreak history and the commodity's characteristics.

Other comments note that some States provide “exemptions” for “non-potentially-hazardous foods.” These comments assert that there should be national agreement on what such foods are and, if such foods are truly low risk, there should not be onerous requirements regardless of the size of the business.

(Response 222) We decline these requests to establish additional exemptions based on risk, other than the exemptions for on-farm low-risk activity/food combinations provided by section 103(c)(1)(D) of FSMA (§ 117.5(g) and (h)). The applicability of the requirements of the human preventive controls rule to facilities that are required to register is required by the statute (see the definition of facility in section 418(o)(2) of the FD&C Act). Section 418(h) of the FD&C Act requires that a facility prepare and implement a food safety plan, unless an exemption applies. Neither FSMA nor this rule establishes a broad exemption for “low-risk” facilities, including “low-risk” facilities that are regularly inspected by State, local, or tribal government agencies. As discussed in Response 213, the exemptions we are establishing are those specifically authorized by the statute.

The new requirements for hazard analysis and risk-based preventive controls are not “one-size-fits-all,” and facilities that are subject to the rule would consider the risk presented by the products as part of their hazard evaluation. (See § 117.130(c)(1)(i), which requires that the hazard analysis include an evaluation of identified known or reasonably foreseeable hazards to assess the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls.) Although each facility subject to the rule must prepare and implement a food safety plan, the preventive controls that the facility would establish and implement would depend on the facility, the food, and the outcome of the facility's hazard analysis (§§ 117.130 and 117.135(c)). In addition, the preventive control management components (i.e., monitoring, corrective actions and corrections, and verification) that a facility would establish and implement for its preventive controls would be established as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (§ 117.140(a)). A facility that appropriately determines through its hazard analysis that no preventive controls are necessary to prevent its food products from being adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act would document that determination in its written hazard analysis but would not need to establish preventive controls and associated preventive control management components for its products. A facility that is a very small business as that term is defined in this rule is exempt from the requirements of subparts C and G, including the requirement to prepare and implement a food safety plan, and is instead subject to the modified requirements in § 117.201.Start Printed Page 55991

We expect that there will be many circumstances in which a facility appropriately determines that certain biological, chemical, or physical hazards are not hazards requiring a preventive control that must be addressed in the food safety plan. There are several types of food products for which a facility may determine that there are no hazards requiring a preventive control. Such products could include, but are not limited to: many crackers, most bread, dried pasta, many cookies, many types of candy (hard candy, fudge, maple candy, taffy and toffee), honey, molasses, sugar, syrup, soft drinks, and jams, jellies, and preserves from acid fruits.

9. Hullers/Shellers

(Comment 223) Some comments ask us to clarify whether an operation solely engaged in hulling/shelling would qualify for the exemption from the requirements for hazard analysis and risk-based preventive controls for facilities that solely are engaged in the storage of RACs (other than fruits and vegetables) intended for further distribution or processing (§ 117.5(j)). Other comments ask us to clarify whether an operation that is solely engaged in hulling/shelling and, thus, is exempt from the CGMP requirements of subpart B would also be exempt from the requirements for hazard analysis and risk-based preventive controls in subpart C. Some of these comments assert that it seems contrary to the principles of HACCP that a facility that is not required to implement CGMPs (which is a foundation of HACCP) would still need to develop a food safety plan. Some comments assert that requiring these operations to apply HACCP standards to what is an extension of harvesting is overkill, because the consumer is ultimately protected by processes at the handler (processor) level. Other comments assert that our clarification that operations that hull/shell/dry nuts are exempt from the CGMP requirements recognizes that hulling/shelling activities are low risk and do not alter the status of a RAC. Because the requirements for hazard analysis and risk-based preventive controls will be applied by those receiving product from the huller/sheller, it does not seem appropriate for an operation that is explicitly exempt from CGMP requirements to be required to conduct a hazard analysis, implement controls, conduct monitoring, etc.

(Response 223) Under the revised “farm” definition, some hulling/shelling operations will be within the “farm” definition (i.e., if the primary production farm(s) that grows, harvests, and/or raises the majority of the nuts owns, or jointly owns, a majority interest in the hulling/shelling operation). Because hulling/shelling is a harvesting activity, not a holding activity, those hulling/shelling operations that are not within the “farm” definition are not eligible for the exemption for facilities solely engaged in the storage of RACs (other than fruits and vegetables) intended for further distribution or processing (§ 117.5(j)). As discussed in Response 222, there is no exemption for “low-risk operations.” However, a facility that appropriately determines through its hazard analysis that there are no hazards requiring preventive controls would document that determination in its written hazard analysis but would not need to establish preventive controls and associated management components.

10. Fruit and Vegetable RACs

(Comment 224) Some comments ask us to clarify the two exemptions applicable to RACs—i.e., the exemption from CGMP requirements for the holding or transportation of one or more RACs (§ 117.5(k)) and the exemption from the requirements for hazard analysis and risk-based preventive controls for facilities solely engaged in the storage of RACs (other than fruits and vegetables) intended for further distribution or processing (§ 117.5(j)). These comments ask whether an off-farm holding facility that strictly deals with fruit and vegetable RACs would be exempt from subpart B, but not subpart C.

Some comments assert that operations that pack RACs other than fruits and vegetables intended for further distribution or processing should be exempt from both CGMP requirements and requirements for hazard analysis and risk-based preventive controls. These comments ask us to expand the exemption from CGMP requirements for the holding or transportation of one or more RACs to include the packing of RACs (other than fruits and vegetables). These comments also ask us to include packing RACs in the exemption from subpart C for facilities solely engaged in the storage of RACs (other than fruits and vegetables) intended for further distribution or processing.

(Response 224) Under the revised “farm” definition, some operations that pack RACs will be within the “farm” definition (i.e., if the farms that grow or raise the majority of the RACs own, or jointly own, a majority interest in the packing operation). Packing operations that are within the “farm” definition are exempt from the CGMP requirements (§ 117.5(k)(1)). However, the packing of RACs is not otherwise exempt from either the CGMP requirements or the requirements for hazard analysis and risk-based preventive controls. As discussed in Response 221, the umbrella CGMPs that we are establishing in subpart B are long-standing provisions that establish basic requirements for the manufacturing, processing, packing, and holding of food to prevent adulteration.

Packing operations that are within the “farm” definition are exempt from the requirements for hazard analysis and risk-based preventive controls (because “farms” are exempt from the section 415 registration requirements for “facilities”). As discussed more fully in Response 222, the new requirements for hazard analysis and risk-based preventive controls are not “one-size-fits-all.” Although each facility subject to the rule must prepare and implement a food safety plan, the preventive controls that the facility would establish and implement would depend on the facility, the food, and the outcome of the facility's hazard analysis. In addition, the preventive control management components that a facility would establish and implement for its preventive controls would be established as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system.

11. Enclosed Outdoor Vessels

(Comment 225) Some comments ask us to exempt enclosed outdoor vessels from the specific CGMP provisions (such as requirements for the plant design to permit the taking of adequate precautions to protect food in outdoor bulk vessels (§ 117.20(b)(3)) and requirements for warehousing and distribution (§ 117.93)) if they are properly “risk assessed” and covered by appropriate procedures for preventing contamination, and system verification is implemented.

(Response 225) We decline this request. The long-standing CGMP requirements are comprehensive, interrelated provisions intended to prevent the adulteration of food. Specifying particular provisions that would not apply if a food establishment appropriately implements other provisions would be contrary to this comprehensive approach to food safety, in addition to being both impractical and difficult to administer. If a food establishment has appropriately determined that its procedures for preventing contamination adequately address the requirements for the safe storage of food in enclosed outdoor Start Printed Page 55992vessels, it should have no difficulty demonstrating that during inspection.

12. Supermarket Distribution Centers

(Comment 226) Some comments ask us to exempt supermarket distribution centers from the requirements of subpart C and instead require them to have written CGMPs. If this request is not accepted, then these comments ask us to either exempt supermarket distribution centers from the requirements of subpart C for those packaged foods not exposed to the environment (with modified requirements for unexposed, refrigerated, packaged TCS foods), or specify that there are no significant hazards for such a facility to address in a food safety plan.

(Response 226) A supermarket distribution center must register as a food facility because it holds food for human consumption and does not satisfy any of the criteria for entities that are not required to register (see § 1.226). As discussed in Response 222, the preventive controls that a facility would establish and implement would depend on the facility, the food, and the outcome of the facility's hazard analysis, and any preventive control management components associated with a facility's preventive controls would be established as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system. In the case of a facility that is a supermarket distribution center, the facility would, as part of its evaluation, determine whether any preventive controls are necessary for unexposed, non-refrigerated packaged foods. The facility might determine that the modified requirements in § 117.206 for unexposed, refrigerated, packaged TCS foods are appropriate to apply to such foods that it holds. If so, the facility could establish its food safety plan by building on the provisions established in § 117.206.

13. Local and Regional Facilities Such as Kitchen Incubators, Food Hubs, and Grower Marketing Cooperatives

(Comment 227) Some comments ask us to provide flexibility to local and regional facilities that do not qualify for an exemption from subpart C (e.g., “kitchen incubators” and farm mixed-type facilities that are subject to State or local laws). Some comments ask us to exempt (or partially exempt) food hubs, grower marketing cooperatives, “produce auctions,” and similar entities. Some comments ask us not to cover facilities with less than $25,000 in annual sales (similar to a provision being considered under the 2013 proposed produce safety rule) or to establish a higher sales limit (i.e., $100,000) applicable to both the human preventive controls rule and the produce safety rule.

(Response 227) We decline the requests to exempt (or partially exempt) the business models described in these comments. (See Response 213.) None of these requests describe or provide evidence that the regulatory framework associated with the business model would address all of the requirements of subparts C and G. Many of the types of facilities listed have multiple business models that conduct different types of activities. For example, USDA defines a regional food hub as “a business or organization that actively manages the aggregation, distribution, and marketing of source-identified food products primarily from local and regional producers to strengthen their ability to satisfy wholesale, retail, and institutional demand.” (Ref. 50). Some food hubs have facilities at which they conduct activities, including dry and cold storage, grading, packing, labeling, and light processing (trimming, cutting, and freezing), whereas other food hubs never physically handle the product sold but instead rely on farmers and contract trucking firms to provide aggregation and transportation services (Ref. 50). Some food hubs have a farm-to-business model (e.g., selling to food cooperatives, grocery stores, institutional foodservice companies, and restaurants), while others have a farm-to-consumer model (i.e., selling directly to the consumer, e.g., through a CSA), and some are hybrids that do both (Ref. 50). Some food hubs combine produce distribution with food processing operations (shared commercial processing space, or “incubator kitchens”). Thus, some of these operations could be exempt. For example, some of these operations may fall within the revised “farm” definition (e.g., if the farms that grow or raise the majority of the RACs own, or jointly own, a majority interest in a food hub or a grower marketing cooperative and the food hub or grower marketing cooperative does not conduct any activities outside of the “farm” definition). Other operations could be exempt if they fall within the definition of “retail food establishment” (see Response 4). With respect to produce auction houses, to the extent that these operations are simply a location for buyers and sellers to meet and to sell and transfer produce and the food is not stored, we do not consider such facilities to be holding food and would not expect them to register; therefore these operations would not be subject to the requirements of subparts C and G for hazard analysis and risk-based preventive controls.

We also decline the request not to cover facilities with less than $25,000 or $100,000 in annual sales. (See the discussion in Response 220, in which we declined the request to provide more exemptions for small farm mixed-type facilities and other small facilities). However, if a local or regional facility such as those described in the comments is a very small business, the facility would be subject to modified requirements (§ 117.201) rather than to the full requirements for hazard analysis and risk-based preventive controls. When such an operation is not a farm, a retail food establishment, or a very small business, the preventive controls that a facility would establish and implement would depend on the facility, the food, and the outcome of the facility's hazard analysis, and any preventive control management components associated with a facility's preventive controls would be established as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system. (See Response 222.)

14. Production of Raw Sugar

(Comment 228) Some comments ask us to exempt the production of raw sugar that is destined for refining from the requirements in subpart C for hazard analysis and risk-based preventive controls.

(Response 228) Making sugar from sugarcane or sugar beets is a low-risk activity/food combination (see § 117.5(h)), and the statutory exemption in § 117.5(h) would apply to a small or very small business that makes sugar on-farm if the only other activities it conducts outside the farm definition are the low-risk activity/food combinations in § 117.5(g) and (h).

We decline the request to extend this exemption to a small or very small business that makes sugar off-farm or to a business that is not a small or very small business (see Response 213). As discussed in Response 222, the preventive controls that such businesses would establish and implement would depend on the facility, the food, and the outcome of the facility's hazard analysis, and any preventive control management components associated with a facility's preventive controls would be established as appropriate to ensure the effectiveness of the preventive controls, taking into account Start Printed Page 55993the nature of the preventive control and its role in the facility's food safety system. An off-farm facility that makes sugar from sugarcane or sugar beets can consider the findings of the section 103(c)(1)(C) RA (i.e., that this is a low-risk activity/food combination) in determining whether there are any hazards requiring a preventive control. A facility that appropriately determines through its hazard analysis that there are no hazards requiring preventive controls would document that determination in its written hazard analysis but would not need to establish preventive controls and associated management components.

15. Biological Hazards in Olive Oil

(Comment 229) Some comments ask us to establish an exemption for the consideration of biological hazards such as Salmonella and pathogenic E. coli in olive oil.

(Response 229) We decline this request. The rule requires the facility to conduct a hazard analysis to determine hazards requiring a preventive control. If the facility appropriately determines through its hazard analysis that biological hazards such as Salmonella and pathogenic E. coli are not hazards requiring a preventive control in its product, then these hazards would not be addressed in the facility's food safety plan.

We expect that there will be many circumstances in which a facility appropriately determines that certain biological, chemical, or physical hazards are not hazards requiring a preventive control that must be addressed in the food safety plan. The provisions of the rule that allow a facility to appropriately determine that a particular hazard is not a hazard requiring a preventive control in certain food products are not equivalent to an exemption from the rule. For example, a facility that appropriately determines that there are no hazards requiring a preventive control associated with its food products must document that determination in its written hazard analysis (§ 117.130(a)(2)); however, no preventive controls, including supplier verification activities, and associated management components would be required in such a situation. As discussed in Response 222, there are several types of food products for which a facility may determine that there are no hazards requiring a preventive control.

XII. Subpart A: Comments on Proposed § 117.7—Applicability of Part 117 to a Facility Solely Engaged in the Storage of Unexposed Packaged Food

We proposed that subpart C would not apply to a facility solely engaged in the storage of packaged food that is not exposed to the environment (proposed § 117.7(a)). We also proposed that a facility solely engaged in the storage of packaged food that is not exposed to the environment would be subject to the modified requirements that would be established in § 117.206 of subpart D (proposed § 117.7(b)).

Some comments support these proposed provisions without change. For example, one comment expresses the view that the safety of these products would be ensured during the manufacturing process by companies that comply with the stringent requirements of the proposed rule, and no new hazards will be introduced to the food at these facilities. Other comments that support the proposed provisions ask us to clarify some aspects of the provisions (see, e.g., Comment 230) or to clarify how the provisions will apply in particular circumstances (see, e.g., Comment 231 and Comment 232). Other comments that support the proposed provisions ask us to broaden them (see, e.g., Comment 233, Comment 234, and Comment 235).

In the following paragraphs, we discuss comments that ask us to clarify the proposed requirements or that disagree with, or suggest one or more changes to, the proposed requirements. After considering these comments, we have revised the proposed requirements as shown in table 17, with editorial and conforming changes as shown in table 52. A key conforming change that affects § 117.7 is that the final exemption is from the requirements of subpart G, as well as subpart C. As discussed in section XLII, the final rule establishes the requirements for a supply-chain program in subpart G, rather than within subpart C as proposed.

Table 17— Revisions to the Proposed Applicability of Subparts C and D to a Facility Solely Engaged in the Storage of Unexposed Packaged Food

SectionDescriptionRevision
117.7(b)Applicability of subpart DClarification that subpart D only applies to those unexposed packaged foods that require time/temperature control to significantly minimize or prevent the growth of, or toxin production by, pathogens.

(Comment 230) Some comments ask us to clarify the interplay between the proposed exemption (proposed § 117.7) and the proposed modified requirements (proposed § 117.206) to better reflect that the modified requirements would apply only to TCS foods. Some comments ask us to clarify that if a facility stores both TCS food and non-TCS food (i.e., unexposed packaged food that does not require time/temperature control for safety), then the modified requirements only apply for the portion of the facility that holds the TCS foods.

(Response 230) We have revised § 117.7(b) to clarify that a facility solely engaged in the storage of unexposed packaged food, including unexposed packaged food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, pathogens is subject to the modified requirements in § 117.206 of subpart D for any unexposed packaged food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, pathogens.

(Comment 231) Some comments ask us to revise the regulatory text to be explicit that frozen unexposed packaged food is not a TCS food subject to modified requirements.

(Response 231) We decline this request. In the 2013 proposed human preventive controls rule, we tentatively concluded that it would be rare for a frozen food to be a TCS food (78 FR 3646 at 3774), and we affirm that conclusion in this document. However, specifying in the regulatory text that a frozen food is not a TCS food would require us to conclude that a frozen food would “never” (rather than “rarely”) be a TCS food, and we lack information to support “never.”

(Comment 232) Some comments assert that a hazard analysis of the risks associated with storage of produce in vented crates would reveal no significant hazards and, thus, that even Start Printed Page 55994if we do not agree that produce packaged in vented crates satisfies the criterion “not exposed to the environment,” we should exercise enforcement discretion for produce packaged in vented crates.

(Response 232) As discussed in Response 170, produce stored in vented crates is not “unexposed packaged food.” Although environmental exposure to produce packed in vented crates would be less than environmental exposure to produce packed in open crates, a vented crate can subject produce to contamination. Thus, we disagree that we should not enforce the provisions of the rule for such produce. A facility that stores produce packed in vented crates must conduct a hazard analysis and evaluate whether there are any hazards requiring a preventive control. However, as discussed in Response 222, the preventive controls that the facility would establish and implement would depend on the facility, the food, and the outcome of the facility's hazard analysis, and any preventive control management components associated with a facility's preventive controls would be established as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system. A facility that appropriately determines through its hazard analysis that there are no hazards requiring a preventive control associated with its food products would document that determination in its written hazard analysis (§ 117.130(a)(2)) but would not need to establish preventive controls and associated preventive control management components for its products.

(Comment 233) Some comments ask us to apply the exemption to storage areas of facilities that also engage in food processing activities—e.g., for distributors that are engaged in limited food processing, such as cutting vegetables or packing RTE foods. These comments assert that the intent of the term “solely” is to make clear that a facility that conducts an activity subject to the exemption does not escape responsibility for complying with the requirements for hazard analysis and risk-based preventive controls when conducting activities that are not exempt. In the comment's example, a facility that cuts vegetables or packs RTE foods would prepare and implement a food safety plan for cutting vegetables and packing RTE foods, but would not conduct a hazard analysis to determine whether there are significant hazards for storing unexposed packaged food.

(Response 233) We disagree with the comment's interpretation of the term “solely.” The plain meaning of “solely” is only, completely, entirely; without another or others; singly; alone (Ref. 44). The facility described in the comment is not “solely” engaged in the storage of unexposed packaged food.

Such a facility must conduct a hazard analysis that addresses all activities conducted by the facility. As discussed in Response 222, the preventive controls that the facility would establish and implement would depend on the facility, the food, and the outcome of the facility's hazard analysis, and any preventive control management components associated with a facility's preventive controls would be established as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system. A facility that stores unexposed packaged food that is not a TCS food could, for example, determine that no preventive controls and associated management components would be necessary for those foods. A facility that stores unexposed refrigerated packaged TCS food could, for example, determine that preventive controls and management components patterned after the modified requirements in § 117.206 are adequate to address hazards requiring a preventive control associated with that food.

(Comment 234) Some comments ask us to allow a facility to designate a storage area as a separate facility for purposes of compliance with the requirements for hazard analysis and risk-based preventive controls. In the comments' view, an area solely engaged in the storage of unexposed packaged food could fall within the exemption in § 117.7 even though other areas would be subject to the requirements for hazard analysis and risk-based preventive controls.

Some comments contrast our proposed approach to applying the statutory provision for facilities “solely engaged in . . . storage” with our proposed approach to applying section 418 of the FD&C Act to farm mixed-type facilities and facilities that conduct activities subject to one of our HACCP regulations. These comments point out that, for farm mixed-type facilities, we determined that section 418 applies only with respect to the activities that trigger registration (78 FR 3646 at 3705). Likewise, these comments point out that for facilities that conduct activities subject to our HACCP regulations for seafood or juice, we determined that the facilities can be exempt from the requirements of section 418 with respect to the activities subject to those regulations but not with respect to other activities (78 FR 3646 at 3704).

(Response 234) We disagree that a designated storage area in an establishment that conducts manufacturing, processing, or packing in addition to storage can fall within the exemption for facilities “solely engaged in . . . storage.” The statute provides authority for us to exempt or modify the requirements for compliance with respect to “facilities” that are solely engaged in the storage of packaged foods that are not exposed to the environment (section 418(m) of the FD&C Act). The statute defines “facility” as a domestic facility or a foreign facility that is required to register under section 415 of the FD&C Act (section 418(o)(2) of the FD&C Act). The section 415 registration regulations define facility as “any establishment, structure, or structures under one ownership at one general physical location . . .” The comment's interpretation that we could view “areas” of registered facilities to be “facilities that are solely engaged in . . . the storage of packaged foods that are not exposed to the environment” is inconsistent with the statutory and regulatory framework under sections 415 and 418 of the FD&C Act.

See also the discussion in Response 233 regarding how a facility that both stores unexposed packaged food and conducts activities such as food processing or packing could address the requirements for hazard analysis and risk-based preventive controls for the storage activities conducted by the facility.

(Comment 235) Some comments ask us to consider an alternative to the exemption for unexposed packaged foods when a facility conducts manufacturing, processing, packing, or holding activities in addition to storing unexposed packaged food. Specifically, these comments ask us to recognize that the minimal risks of storing unexposed packaged foods can be addressed through a combination of compliance with the modified requirements for TCS foods (if applicable) and the CGMPs in subpart B and state that doing so would be consistent with our discussion in the 2013 proposed human preventive controls rule.

(Response 235) These comments appear to suggest the outcome of a facility's hazard analysis for storing unexposed packaged food—i.e., that the only hazards requiring a preventive control are the potential for growth of pathogens in refrigerated unexposed packaged foods and that the preventive controls and preventive control Start Printed Page 55995management components specified in the modified requirements for TCS food are adequate to address such hazards. It is the responsibility of the facility's preventive controls qualified individual to identify the hazards requiring a preventive control associated with the facility and the food it stores, as well as the appropriate preventive controls and preventive control management components. However, we agree that in some cases the approach suggested in these comments would be appropriate.

(Comment 236) Some comments assert that it is difficult to identify TCS foods and that the benefits of undertaking that work are unclear when existing CGMP requirements protect public health. These comments ask us to work with industry and professional organizations to develop guidance on when the modified requirements apply. Other comments ask us to specify that specific foods such as yogurt are not TCS foods and provide scientific information to support their request.

(Response 236) This document does not include guidance on whether specific foods, such as yogurt, are TCS foods. Information on whether specific foods are TCS foods is already widely available—e.g., in Annex 3, Chapter 1 (Purpose and Definitions) of the Food Code (Ref. 51) and in a report prepared for us under contract by the Institute of Food Technologists (Ref. 52). A facility solely engaged in storage of unexposed packaged food can consult the Food Code or work with the manufacturer of the food to identify TCS food. Alternatively, such a facility could simply treat any refrigerated food as a TCS food.

Although we agree with comments that in general yogurt would not be a TCS food, whether a particular yogurt is a TCS food would depend on what is added to the yogurt. For example, in 1989 an outbreak of foodborne botulism in the United Kingdom from the consumption of yogurt containing added hazelnut conserve (puree) caused 27 illnesses and one death (Ref. 53). The hazelnut puree had not been adequately processed to prevent toxin production by C. botulinum. Even though this particular outbreak was not related to the question of whether yogurt is a TCS food, it demonstrates the importance of having a preventive controls qualified individual consider all hazards associated with a product to determine whether there are hazards requiring a preventive control, including temperature control.

XIII. Subpart B: Comments on Proposed § 117.10—Personnel

We proposed to re-establish the provisions of § 110.10 in new § 117.10 with some revisions to modernize them. Some comments agree with one or more of these proposed provisions without change. For example, some comments state that the proposed provisions for disease control are already widely practiced across the produce industry and are part of most food safety guidance and standards. Some comments that support the proposed revisions suggest alternative or additional regulatory text (see, e.g., Comment 243 and Comment 244) or ask us to clarify how we will interpret the revised provision (see, e.g., Comment 239). Other comments that support provisions that we proposed to re-establish in part 117 without change ask us to revise or clarify those provisions (see, e.g., Comment 237, Comment 238, Comment 240, and Comment 241).

In the following sections, we discuss comments that ask us to clarify the proposed provisions or that disagree with, or suggest one or more changes to, the proposed provisions, including comments on provisions that we proposed to re-establish in § 117.10 with no changes. After considering these comments, we have revised the proposed provisions as shown in table 18, with editorial and conforming changes as shown in table 52.

Table 18—Personnel Provisions

ProvisionDid we propose revisions or request comment on potential revisions?Did we get comments that disagreed with the proposed provision?Did we modify the proposed regulatory text?
§ 117.10—Management ResponsibilityNoYesYes.
§ 117.10(a)—Disease ControlNoYesYes.
§ 117.10(b)—CleanlinessYesNoNo.
§ 117.10(b)(1)—Outer GarmentsYesYesNo.
§ 117.10(b)(2)—Personal CleanlinessNoNoNo.
§ 117.10(b)(3)—Washing HandsNoNoNo.
§ 117.10(b)(4)—Unsecured Jewelry and Other ObjectsYesYesNo.
§ 117.10(b)(5)—GlovesYesYesNo.
§ 117.10(b)(6)—Hair RestraintsNoNoNo.
§ 117.10(b)(7)—Clothing and Other Personal BelongingsYesYesNo.
§ 117.10(b)(8)—Eating Food, Drinking Beverages, and Using TobaccoYesYesYes.
§ 117.10(b)(9)—Any Other Necessary PrecautionsYesYesNo.
§ 117.10(c)—Education and TrainingYesYesShifted to § 117.4 as a requirement rather than a recommendation.
§ 117.10(d)—SupervisionYesNoShifted to § 117.4.

A. Management Responsibility for Requirements Applicable to Personnel

We proposed no revisions to the requirement that plant management must take all reasonable measures and precautions to ensure compliance with the provisions for disease control, cleanliness, and training.

(Comment 237) Some comments ask us to remove “all” because it is too extreme and prescriptive. These comments ask us to instead specify that the intended measures and precautions must be “adequate.”

(Response 237) We have revised the regulatory text to delete “all.” We disagree that the term “all” in this long-standing provision is too extreme and prescriptive, but find that the term “all” is not necessary to communicate the intent of the requirement. We decline the request to add “adequate.” The intent of the requirement is to communicate our expectation that these Start Printed Page 55996measures and precautions are reasonable. Other, more specific provisions that management must address specify that particular measures and precautions must be “adequate” (see § 117.10(b)(2), (3), and (4)).

B. Proposed § 117.10(a)—Disease Control

We proposed no revisions to the requirement that any person who, by medical examination or supervisory observation, is shown to have, or appears to have, an illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination by which there is a reasonable possibility of food, food-contact surfaces, or food-packaging materials becoming contaminated, must be excluded from any operations which may be expected to result in such contamination until the condition is corrected. Personnel must be instructed to report such health conditions to their supervisors.

(Comment 238) Some comments ask us to provide flexibility to not exclude from operations personnel who have an open lesion (such as boils, sores or any other infected wounds) that is covered completely using appropriate first aid materials.

(Response 238) We have revised the regulatory text to reflect flexibility such as that provided in FDA's Food Code (Ref. 51). Under the Food Code, workers need not be excluded if an open lesion on hands and wrists, or on exposed portions of arms, is protected by an impermeable cover, and workers need not be excluded if an open lesion on other parts of the body is covered by a dry, durable, tight-fitting bandage.

C. Proposed § 117.10(b)—Cleanliness

1. Proposed § 117.10(b)(1)—Outer Garments

We proposed that the methods for maintaining cleanliness include wearing outer garments suitable to the operation in a manner that protects against the contamination of food, food-contact surfaces, or food-packaging materials and to protect against the cross-contact of food.

(Comment 239) Some comments ask us to clarify whether the newly proposed requirement to prevent allergen cross-contact would require a line worker to change outer garments when switching between individual food-production lines if separate major allergens are present on the food production lines.

(Response 239) The provision does not prescribe the specific methods by which wearing outer garments must protect against allergen cross-contact and, thus, the establishment has flexibility to take appropriate steps to satisfy the requirements in the context of the establishment and the food it produces. Requiring a line worker to change outer garments when switching between individual food-production lines could be an appropriate precaution for some establishments. When a facility that is subject to the requirements for hazard analysis and risk-based preventive controls determines that it is necessary to require a line worker to change outer garments to prevent allergen cross-contact between food-production lines, the facility could decide to establish such a procedure as a food allergen control under § 117.135(c)(2).

2. Proposed § 117.10(b)(4)—Unsecured Jewelry and Other Objects

We proposed to require that the methods for maintaining cleanliness include removing all unsecured jewelry and other objects that might fall into food, equipment, or containers, and removing hand jewelry that cannot be adequately sanitized during periods in which food is manipulated by hand. If such hand jewelry cannot be removed, it may be covered by material which can be maintained in an intact, clean, and sanitary condition and which effectively protects against the contamination by these objects of the food, food-contact surfaces, or food-packaging materials.

(Comment 240) Some comments ask us to modify the requirements to provide that they only apply as appropriate to each operation and recommend that jewelry be removed when the company's hazard analysis determines that it is a hazard. These comments acknowledge that jewelry is a physical hazard in some instances, but assert that objects such as jewelry are not a physical hazard for operations conducted on many medium- to large-sized RACs (e.g., melons, apples, oranges, potatoes).

(Response 240) We decline this request. We included this long-standing provision of the umbrella CGMPs during our last revision of the food CGMPs based on public comments during that rulemaking (51 FR 22458 at 22463). The provision provides flexibility for an establishment to do what is appropriate in the context of its own operations—e.g., by limiting some requirements to “unsecured” jewelry and by providing options to cover hand jewelry during periods in which food is manipulated by hand. Although a facility could decide to also establish preventive controls for jewelry as a physical hazard following a hazard analysis, such preventive controls would be distinct from the more general CGMP requirements in this provision.

3. Proposed § 117.10(b)(5)—Gloves

We proposed that the methods for maintaining cleanliness include maintaining gloves, if they are used in food handling, in an intact, clean, and sanitary condition. We also proposed to delete a recommendation that gloves should be of an impermeable material. Although some comments ask us to retain this nonbinding recommendation, as discussed in Response 67 we are deleting those non-binding recommendations of part 110 that we are not establishing as requirements.

4. Proposed § 117.10(b)(7)—Clothing and Other Personal Belongings

We proposed to require that the methods for maintaining cleanliness include storing clothing or other personal belongings in areas other than where food is exposed or where equipment or utensils are washed.

(Comment 241) Some comments ask us to specify that the requirements only apply to “extra” clothing. These comments express concern that the requirement otherwise might be interpreted to mean that no personal clothing is allowed in these areas (e.g., that employees are permitted to wear only company‐issued uniforms).

(Response 241) We decline this request. This long-standing provision of the umbrella GMPs has been in place for decades. The comments do not provide any examples of how we have interpreted this provision in the past to mean that employees must wear company-issued uniforms.

5. Proposed § 117.10(b)(8)—Eating Food, Drinking Beverages, and Using Tobacco

We proposed to require that the methods for maintaining cleanliness include confining the following to areas other than where food may be exposed or where equipment or utensils are washed: eating food, drinking beverages, or using tobacco.

(Comment 242) Some comments note that the provision would no longer require that chewing gum be confined to areas other than where food may be exposed or where equipment or utensils are washed. These comments ask us whether this omission was intentional, or whether we are simply considering that requirements applicable to “chewing gum” are covered by those for “eating food.” Some comments state that it would not be immediately obvious to many laypersons as to whether the chewing of gum is included in “eating food.”Start Printed Page 55997

(Response 242) We agree that removing the phrase “chewing gum” from this provision could make it unclear that this long-standing requirement regarding chewing gum still applies and we have revised the proposed regulatory text to retain the express requirement regarding chewing gum. As the comments point out, the statute includes chewing gum in its definition of “food” (see section 201(f) of the FD&C Act). However, in this long-standing provision, the term “chewing gum” is used to mean “the act of chewing” rather than to refer to the gum itself.

(Comment 243) Some comments regarding processes conducted on RACs ask us to modify the regulatory text to distinguish “drinking beverages” from “drinking water.” These comments note that this provision is of concern to their industry because drinking water needs to be readily available to workers.

(Response 243) We decline this request. We acknowledge that workers may need ready access to drinking water when conducting activities on RACs, particularly in an environment that is largely outdoors (such as in an off-farm packinghouse that has a roof but is otherwise largely unenclosed). However, this provision does not apply to on-farm activities such as harvesting of RACs. During packing activities covered by this rule, workers must move away from the packing operations to get a drink. The establishment can make drinking water available in a designated area that is nearby, and provide multiple designated areas when appropriate to make drinking water readily available to all workers.

6. Proposed § 117.10(b)(9)—Any Other Necessary Precautions

We proposed that the methods for maintaining cleanliness include taking any other necessary precautions to protect against contamination of food, food-contact surfaces, or food-packaging materials with microorganisms or foreign substances (including perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin) and to protect against cross-contact of food.

(Comment 244) Some comments ask us to specify that the provision applies to “medicines or other products” applied to the skin.

(Response 244) We decline this request. The comment does not explain what “other products” applied to the skin are not already covered by “cosmetics” and “medicines.” For example, powders and lotions applied as “make-up” generally would be cosmetics and products such as sunscreen generally are classified as over-the-counter medicines.

XIV. Subpart B: Comments on Proposed § 117.20—Plant and Grounds

We proposed to re-establish the provisions of § 110.20 in new § 117.20 with some revisions to modernize them. Some comments agree with one or more of these proposed revisions without change. Some comments that support the proposed revisions suggest alternative or additional regulatory text (see, e.g., Comment 251 and Comment 256) or ask us to clarify how we will interpret the revised provision (see, e.g., Comment 253). Other comments that support provisions that we proposed to re-establish in part 117 without change ask us to revise or clarify those provisions (see, e.g., Comment 246, Comment 247, Comment 248, Comment 250, and Comment 254).

In the following sections, we discuss comments that ask us to clarify the proposed provisions or that disagree with, or suggest one or more changes to, the proposed provisions, including comments on provisions that we proposed to re-establish in § 117.20 with no changes. After considering these comments, we have revised the proposed provisions as shown in table 19, with editorial and conforming changes as shown in table 52.

Table 19—Provisions for Plant and Grounds

ProvisionDid we propose revisions or request comment on potential revisions?Did we get comments that disagreed with the proposed provision?Did we modify the proposed regulatory text?
§ 117.20(a)—GroundsNoYesNo.
§ 117.20(a)(1)—Equipment, Litter, Waste, Weeds, and GrassNoYesNo.
§ 117.20(a)(2)—Roads, Yards, and Parking LotsNoNoNo.
§ 117.20(a)(3)—Draining AreasNoNoNo.
§ 117.20(a)(4)—Operating Systems for Waste Treatment and DisposalNoYesYes.
§ 117.20(a)(5)—Grounds Not Under the Operator's ControlYesYesYes.
§ 117.20(b)—Plant Construction and DesignYesYesNo.
§ 117.20(b)(1)—Space for Equipment and MaterialsNoYesYes.
§ 117.20(b)(2)—Food Safety Controls, Operating Practices, or DesignYesYesYes.
§ 117.20(b)(3)—Outdoor Bulk VesselsYesYesYes.
§ 117.20(b)(4)—Plant ConstructionYesNoNo.
§ 117.20(b)(5)—LightingNoYesYes.
§ 117.20(b)(6)—VentilationYesYesYes.
§ 117.20(b)(7)—Screening or Other ProtectionNoYesNo.

A. Proposed § 117.20(a)—Grounds

1. Proposed § 117.20(a)—Management Responsibility for Maintaining Grounds

We proposed no revisions to the requirement that the grounds about a food plant under the control of the operator must be kept in a condition that will protect against the contamination of food.

(Comment 245) Some comments ask us to specify that the requirements do not apply to test/pilot kitchens.

(Response 245) We decline this request. An establishment must have control of the grounds under its control regardless of the specific food or amount of food being produced, because litter, waste, weeds, and grass can all attract and harbor pests, and the first step for pest control in the plant is to avoid attracting pests.Start Printed Page 55998

2. Proposed § 117.20(a)(1)—Equipment, Litter, Waste, Weeds, and Grass

We proposed no revisions to the requirement that the methods for adequate maintenance of grounds include properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding place, or harborage for pests.

(Comment 246) Some comments ask us to specify “immediately adjacent to” rather than “the immediate vicinity.” These comments also ask us to provide guidance on the importance of pollinator habitat so that inspectors will view such areas within the greater context of the farm and not immediately see that the farm is out of compliance.

(Response 246) We decline the request to modify the regulatory text of this long-standing provision. We note that a “farm” is not subject to the CGMP requirements of subpart B (see § 117.5(k)). We do not see that the suggested modification would provide any specific information to investigators who are inspecting a food establishment (such as a farm mixed-type facility or packing shed) that has pollinator habitat near plant buildings or structures. We expect that investigators will adapt their inspection programs to account for such circumstances and food establishments will take steps to prevent weeds or grass in a pollinator habitat from leading to problems with pests in the plant.

3. Proposed § 117.20(a)(4)—Operating Systems for Waste Treatment and Disposal

We proposed no revisions to the requirement that the methods for adequate maintenance of grounds must include operating systems for waste treatment and disposal in an adequate manner so that they do not constitute a source of contamination in areas where food is exposed. If the plant grounds are bordered by grounds not under the operator's control and not maintained in the manner described in § 117.20(a)(1) through (a)(3), care must be exercised in the plant by inspection, extermination, or other means to exclude pests, dirt, and filth that may be a source of food contamination.

(Comment 247) Some comments assert that the term “adequate” has been added to this provision and is ambiguous when used to describe the way in which “operating systems for waste treatment and disposal” must be managed, even though that term is defined in the rule. These comments ask us to clarify what constitutes “adequate” for the purpose of this provision, such as whether it requires compliance with local plumbing codes.

(Response 247) The term “adequate” has been in § 110.20(a) and (a)(4) since 1986 (51 FR 22477). This long-standing provision addresses matters under FDA's jurisdiction rather than local plumbing codes. An example of waste disposal under FDA's jurisdiction is an operating system for water disposal. Such an operating system would be inadequate if it allowed water to accumulate on the facility grounds and become an attractant for pests.

(Comment 248) Some comments ask us to clarify how the requirements in § 117.20(a) would apply to potential problems associated with neighboring grounds. Other comments note that we proposed to address potential problems with neighboring grounds within the final sentence of this provision (proposed § 117.20(a)(4)) and suggest editorial changes to more clearly identify the requirements regarding grounds under the control of a neighboring entity.

(Respons