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Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions

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AGENCY:

Regulatory Information Service Center.

ACTION:

Introduction to the Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions.

SUMMARY:

The Regulatory Flexibility Act requires that agencies publish semiannual regulatory agendas in the Federal Register describing regulatory actions they are developing that may have a significant economic impact on a substantial number of small entities (5 U.S.C. 602). Executive Order 12866 “Regulatory Planning and Review,” signed September 30, 1993 (58 FR 51735), and incorporated in Executive Order 13563, “Improving Regulation and Regulatory Review” issued on January 18, 2011 (76 FR 3821) establish guidelines and procedures for agencies' agendas, including specific types of information for each entry.

The Unified Agenda of Federal Regulator and Deregulatory Actions (Unified Agenda) helps agencies fulfill these requirements. All Federal regulatory agencies have chosen to publish their regulatory agendas as part of the Unified Agenda. The complete 2014 Unified Agenda and Regulatory Plan, which contains the regulatory agendas for Federal agencies, is available to the public at http://reginfo.gov.

The fall 2014 Unified Agenda publication appearing in the Federal Register consists of The Regulatory Plan and agency regulatory flexibility agendas, in accordance with the publication requirements of the Regulatory Flexibility Act. Agency regulatory flexibility agendas contain only those Agenda entries for rules that are likely to have a significant economic impact on a substantial number of small entities and entries that have been selected for periodic review under section 610 of the Regulatory Flexibility Act.

The complete fall 2014 Unified Agenda contains the Regulatory Plans of 30 Federal agencies and the regulatory agendas of 31 other Federal agencies.

ADDRESSES:

Regulatory Information Service Center (MVE), General Services Administration, 1800 F Street NW., 2219F, Washington, DC 20405.

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FOR FURTHER INFORMATION CONTACT:

For further information about specific regulatory actions, please refer to the agency contact listed for each entry.

To provide comment on or to obtain further information about this publication, contact: John C. Thomas, Executive Director, Regulatory Information Service Center (MVE), General Services Administration, 1800 F Street NW., 2219F, Washington, DC 20405, (202) 482-7340. You may also send comments to us by email at: risc@gsa.gov.

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SUPPLEMENTARY INFORMATION:

TABLE OF CONTENTS

Introduction to the Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions

I. What are The Regulatory Plan and the Unified Agenda?

II. Why are The Regulatory Plan and the Unified Agenda published?

III. How are The Regulatory Plan and the Unified Agenda organized?

IV. What Information appears for each entry?

V. Abbreviations

VI. How can users get copies of the Plan and the Agenda?

Introduction to the Fall 2014 Regulatory Plan

AGENCY REGULATORY PLANS

Cabinet Departments

Department of Agriculture

Department of Commerce

Department of Defense

Department of Education

Department of Energy

Department of Health and Human Services

Department of Homeland Security

Department of Housing and Urban Development

Department of the Interior

Department of Justice

Department of Labor

Department of Transportation

Department of the Treasury

Department of Veterans Affairs

Other Executive Agencies

Architectural and Transportation Barriers Compliance Board

Environmental Protection Agency

Equal Employment Opportunity Commission

General Services Administration

National Aeronautics and Space Administration

National Archives and Records Administration

Office of Personnel Management

Pension Benefit Guaranty Corporation

Small Business Administration

Social Security Administration

Independent Regulatory Agencies

Consumer Financial Protection Bureau

Consumer Product Safety Commission

Federal Trade Commission

National Indian Gaming Commission

Nuclear Regulatory Commission

AGENCY AGENDAS

Cabinet Departments

Department of Agriculture

Department of Commerce

Department of Defense

Department of Education

Department of Energy

Department of Health and Human Services

Department of Homeland Security

Department of the Interior

Department of Justice

Department of Labor

Department of Transportation

Other Executive Agencies

Architectural and Transportation Barriers Compliance Board

Environmental Protection Agency

General Services Administration

National Aeronautics and Space Administration

Small Business Administration

Joint Authority

Department of Defense/General Services Administration/National Aeronautics and Space Administration (Federal Acquisition Regulation)

Independent Regulatory Agencies

Commodity Futures Trading Commission

Consumer Financial Protection Bureau

Federal Communications Commission

Federal Reserve System

Nuclear Regulatory Commission

Securities and Exchange Commission

Surface Transportation Board

INTRODUCTION TO THE REGULATORY PLAN AND THE UNIFIED AGENDA OF FEDERAL REGULATORY AND DEREGULATORY ACTIONS

I. What are the Regulatory Plan and the Unified Agenda?

The Regulatory Plan serves as a defining statement of the Administration's regulatory and deregulatory policies and priorities. The Plan is part of the fall edition of the Unified Agenda. Each participating agency's regulatory plan contains: (1) A narrative statement of the agency's regulatory and deregulatory priorities, and, for the most part, (2) a description of the most important significant regulatory and deregulatory actions that the agency reasonably expects to issue in proposed or final form during the upcoming fiscal year. This edition includes the regulatory plans of 30 agencies.

The Unified Agenda provides information about regulations that the Government is considering or reviewing. The Unified Agenda has appeared in the Federal Register twice each year since 1983 and has been available online since 1995. The complete Unified Agenda is available to the public at http://reginfo.gov. The online Unified Agenda offers flexible search tools and access to the historic Unified Agenda database to 1995.

The fall 2014 Unified Agenda publication appearing in the Federal Register consists of The Regulatory Plan and agency regulatory flexibility Start Printed Page 76457agendas, in accordance with the publication requirements of the Regulatory Flexibility Act. Agency regulatory flexibility agendas contain only those Agenda entries for rules that are likely to have a significant economic impact on a substantial number of small entities and entries that have been selected for periodic review under section 610 of the Regulatory Flexibility Act. Printed entries display only the fields required by the Regulatory Flexibility Act. Complete agenda information for those entries appears, in a uniform format, in the online Unified Agenda at http://reginfo.gov.

These publication formats meet the publication mandates of the Regulatory Flexibility Act and Executive Order 12866 (incorporated in Executive Order 13563), as well as moved the Agenda process to the goal of online availability, resulting in a reduced cost in printing. The current online format does not reduce the amount of information available to the public. The complete online edition of the Unified Agenda includes regulatory agendas from 61 Federal agencies. Agencies of the United States Congress are not included.

The following agencies have no entries identified for inclusion in the printed regulatory flexibility agenda. An asterisk (*) indicates agencies that appear in The Regulatory Plan. The regulatory agendas of these agencies are available to the public at http://reginfo.gov.

Department of Housing and Urban Development*

Department of State

Department of Treasury*

Department of Veterans Affairs*

Advisory Council on Historic Preservation

Agency for International Development

Commission on Civil Rights

Committee for Purchase From People Who Are Blind or Severely Disabled

Corporation for National and Community Service

Court Services and Offender Supervision Agency for the District of Columbia

Equal Employment Opportunity Commission*

Institute of Museum and Library Services

National Archives and Records Administration*

National Endowment for the Arts

National Endowment for the Humanities

National Science Foundation

Office of Government Ethics

Office of Management and Budget

Office of Personnel Management*

Peace Corps

Pension Benefit Guaranty Corporation*

Railroad Retirement Board

Social Security Administration*

Consumer Financial Protection Bureau*

Consumer Product Safety Commission*

Farm Credit Administration

Federal Deposit Insurance Corporation

Federal Energy Regulatory Commission

Federal Housing Finance Agency

Federal Maritime Commission

Federal Trade Commission*

Gulf Coast Ecosystem Restoration CouncilNational Credit Union Administration

National Credit Union Administration

National Indian Gaming Commission*

National Labor Relations Board

National Transportation Safety Board

Postal Regulatory Commission

Recovery Accountability and Transparency Board

The Regulatory Information Service Center compiles the Unified Agenda for the Office of Information and Regulatory Affairs (OIRA), part of the Office of Management and Budget. OIRA is responsible for overseeing the Federal Government's regulatory, paperwork, and information resource management activities, including implementation of Executive Order 12866 (incorporated in Executive Order 13563). The Center also provides information about Federal regulatory activity to the President and his Executive Office, the Congress, agency officials, and the public.

The activities included in the Agenda are, in general, those that will have a regulatory action within the next 12 months. Agencies may choose to include activities that will have a longer timeframe than 12 months. Agency agendas also show actions or reviews completed or withdrawn since the last Unified Agenda. Executive Order 12866 does not require agencies to include regulations concerning military or foreign affairs functions or regulations related to agency organization, management, or personnel matters.

Agencies prepared entries for this publication to give the public notice of their plans to review, propose, and issue regulations. They have tried to predict their activities over the next 12 months as accurately as possible, but dates and schedules are subject to change. Agencies may withdraw some of the regulations now under development, and they may issue or propose other regulations not included in their agendas. Agency actions in the rulemaking process may occur before or after the dates they have listed. The Regulatory Plan and Unified Agenda do not create a legal obligation on agencies to adhere to schedules in this publication or to confine their regulatory activities to those regulations that appear within it.

II. Why Are The Regulatory Plan and the Unified Agenda published?

The Regulatory Plan and the Unified Agenda helps agencies comply with their obligations under the Regulatory Flexibility Act and various Executive orders and other statutes.

Regulatory Flexibility Act

The Regulatory Flexibility Act requires agencies to identify those rules that may have a significant economic impact on a substantial number of small entities (5 U.S.C. 602). Agencies meet that requirement by including the information in their submissions for the Unified Agenda. Agencies may also indicate those regulations that they are reviewing as part of their periodic review of existing rules under the Regulatory Flexibility Act (5 U.S.C. 610). Executive Order 13272 entitled “Proper Consideration of Small Entities in Agency Rulemaking,” signed August 13, 2002 (67 FR 53461), provides additional guidance on compliance with the Act.

Executive Order 12866

Executive Order 12866 entitled “Regulatory Planning and Review,” signed September 30, 1993 (58 FR 51735), requires covered agencies to prepare an agenda of all regulations under development or review. The Order also requires that certain agencies prepare annually a regulatory plan of their “most important significant regulatory actions,” which appears as part of the fall Unified Agenda. Executive Order 13497, signed January 30, 2009 (74 FR 6113), revoked the amendments to Executive Order 12866 that were contained in Executive Order 13258 and Executive Order 13422.

Executive Order 13563

Executive Order 13563 entitled “Improving Regulation and Regulatory Review,” issued on January 18, 2011, supplements and reaffirms the principles, structures, and definitions governing contemporary regulatory review that were established in Executive Order 12866, which includes the general principles of regulation and public participation, and orders integration and innovation in coordination across agencies; flexible approaches where relevant, feasible, and consistent with regulatory approaches; scientific integrity in any scientific or technological information and processes used to support the agencies' regulatory actions; and retrospective analysis of existing regulations.Start Printed Page 76458

Executive Order 13132

Executive Order 13132 entitled “Federalism,” signed August 4, 1999 (64 FR 43255), directs agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have “federalism implications” as defined in the Order. Under the Order, an agency that is proposing a regulation with federalism implications, which either preempt State law or impose non-statutory unfunded substantial direct compliance costs on State and local governments, must consult with State and local officials early in the process of developing the regulation. In addition, the agency must provide to the Director of the Office of Management and Budget a federalism summary impact statement for such a regulation, which consists of a description of the extent of the agency's prior consultation with State and local officials, a summary of their concerns and the agency's position supporting the need to issue the regulation, and a statement of the extent to which those concerns have been met. As part of this effort, agencies include in their submissions for the Unified Agenda information on whether their regulatory actions may have an effect on the various levels of government and whether those actions have federalism implications.

Unfunded Mandates Reform Act of 1995

The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, title II) requires agencies to prepare written assessments of the costs and benefits of significant regulatory actions “that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more . . . in any 1 year . . . . ” The requirement does not apply to independent regulatory agencies, nor does it apply to certain subject areas excluded by section 4 of the Act. Affected agencies identify in the Unified Agenda those regulatory actions they believe are subject to title II of the Act.

Executive Order 13211

Executive Order 13211 entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” signed May 18, 2001 (66 FR 28355), directs agencies to provide, to the extent possible, information regarding the adverse effects that agency actions may have on the supply, distribution, and use of energy. Under the Order, the agency must prepare and submit a Statement of Energy Effects to the Administrator of the Office of Information and Regulatory Affairs, Office of Management and Budget, for “those matters identified as significant energy actions.” As part of this effort, agencies may optionally include in their submissions for the Unified Agenda information on whether they have prepared or plan to prepare a Statement of Energy Effects for their regulatory actions.

Small Business Regulatory Enforcement Fairness Act

The Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121, title II) established a procedure for congressional review of rules (5 U.S.C. 801 et seq.), which defers, unless exempted, the effective date of a “major” rule for at least 60 days from the publication of the final rule in the Federal Register. The Act specifies that a rule is “major” if it has resulted, or is likely to result, in an annual effect on the economy of $100 million or more or meets other criteria specified in that Act. The Act provides that the Administrator of OIRA will make the final determination as to whether a rule is major.

III. How Are The Regulatory Plan and the Unified Agenda organized?

The Regulatory Plan appears in part II in a daily edition of the Federal Register. The Plan is a single document beginning with an introduction, followed by a table of contents, followed by each agency's section of the Plan. Following the Plan in the Federal Register, as separate parts, are the regulatory flexibility agendas for each agency whose agenda includes entries for rules which are likely to have a significant economic impact on a substantial number of small entities or rules that have been selected for periodic review under section 610 of the Regulatory Flexibility Act. Each printed agenda appears as a separate part. The sections of the Plan and the parts of the Unified Agenda are organized alphabetically in four groups: Cabinet departments; other executive agencies; the Federal Acquisition Regulation, a joint authority (Agenda only); and independent regulatory agencies. Agencies may in turn be divided into subagencies. Each printed agency agenda has a table of contents listing the agency's printed entries that follow. Each agency's part of the Agenda contains a preamble providing information specific to that agency. Each printed agency agenda has a table of contents listing the agency's printed entries that follow.

Each agency's section of the Plan contains a narrative statement of regulatory priorities and, for most agencies, a description of the agency's most important significant regulatory and deregulatory actions. Each agency's part of the Agenda contains a preamble providing information specific to that agency plus descriptions of the agency's regulatory and deregulatory actions.

The online, complete Unified Agenda contains the preambles of all participating agencies. Unlike the printed edition, the online Agenda has no fixed ordering. In the online Agenda, users can select the particular agencies whose agendas they want to see. Users have broad flexibility to specify the characteristics of the entries of interest to them by choosing the desired responses to individual data fields. To see a listing of all of an agency's entries, a user can select the agency without specifying any particular characteristics of entries.

Each entry in the Agenda is associated with one of five rulemaking stages. The rulemaking stages are:

1. Prerule Stage—actions agencies will undertake to determine whether or how to initiate rulemaking. Such actions occur prior to a Notice of Proposed Rulemaking (NPRM) and may include Advance Notices of Proposed Rulemaking (ANPRMs) and reviews of existing regulations.

2. Proposed Rule Stage—actions for which agencies plan to publish a Notice of Proposed Rulemaking as the next step in their rulemaking process or for which the closing date of the NPRM Comment Period is the next step.

3. Final Rule Stage—actions for which agencies plan to publish a final rule or an interim final rule or to take other final action as the next step.

4. Long-Term Actions—items under development but for which the agency does not expect to have a regulatory action within the 12 months after publication of this edition of the Unified Agenda. Some of the entries in this section may contain abbreviated information.

5. Completed Actions—actions or reviews the agency has completed or withdrawn since publishing its last agenda. This section also includes items the agency began and completed between issues of the Agenda.

Long-Term Actions are rulemakings reported during the publication cycle that are outside of the required 12-month reporting period for which the Agenda was intended. Completed Actions in the publication cycle are rulemakings that are ending their lifecycle either by Withdrawal or completion of the rulemaking process. Therefore, the Long-Term and Completed RINs do not represent the Start Printed Page 76459ongoing, forward-looking nature intended for reporting developing rulemakings in the Agenda pursuant to Executive Order 12866, section 4(b) and 4(c). To further differentiate these two stages of rulemaking in the Unified Agenda from active rulemakings, Long-Term and Completed Actions are reported separately from active rulemakings, which can be any of the first three stages of rulemaking listed above. A separate search function is provided on http://reginfo.gov to search for Completed and Long-Term Actions apart from each other and active RINs.

A bullet (•) preceding the title of an entry indicates that the entry is appearing in the Unified Agenda for the first time.

In the printed edition, all entries are numbered sequentially from the beginning to the end of the publication. The sequence number preceding the title of each entry identifies the location of the entry in this edition. The sequence number is used as the reference in the printed table of contents. Sequence numbers are not used in the online Unified Agenda because the unique Regulation Identifier Number (RIN) is able to provide this cross-reference capability.

Editions of the Unified Agenda prior to fall 2007 contained several indexes, which identified entries with various characteristics. These included regulatory actions for which agencies believe that the Regulatory Flexibility Act may require a Regulatory Flexibility Analysis, actions selected for periodic review under section 610(c) of the Regulatory Flexibility Act, and actions that may have federalism implications as defined in Executive Order 13132 or other effects on levels of government. These indexes are no longer compiled, because users of the online Unified Agenda have the flexibility to search for entries with any combination of desired characteristics. The online edition retains the Unified Agenda's subject index based on the Federal Register Thesaurus of Indexing Terms. In addition, online users have the option of searching Agenda text fields for words or phrases.

IV. What information appears for each entry?

All entries in the online Unified Agenda contain uniform data elements including, at a minimum, the following information:

Title of the Regulation—a brief description of the subject of the regulation. In the printed edition, the notation “Section 610 Review” following the title indicates that the agency has selected the rule for its periodic review of existing rules under the Regulatory Flexibility Act (5 U.S.C. 610(c)). Some agencies have indicated completions of section 610 reviews or rulemaking actions resulting from completed section 610 reviews. In the online edition, these notations appear in a separate field.

Priority—an indication of the significance of the regulation. Agencies assign each entry to one of the following five categories of significance.

(1) Economically Significant

As defined in Executive Order 12866, a rulemaking action that will have an annual effect on the economy of $100 million or more or will adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities. The definition of an “economically significant” rule is similar but not identical to the definition of a “major” rule under 5 U.S.C. 801 (Pub. L. 104-121). (See below.)

(2) Other Significant

A rulemaking that is not Economically Significant but is considered Significant by the agency. This category includes rules that the agency anticipates will be reviewed under Executive Order 12866 or rules that are a priority of the agency head. These rules may or may not be included in the agency's regulatory plan.

(3) Substantive, Nonsignificant

A rulemaking that has substantive impacts but is neither Significant, nor Routine and Frequent, nor Informational/Administrative/Other.

(4) Routine and Frequent

A rulemaking that is a specific case of a multiple recurring application of a regulatory program in the Code of Federal Regulations and that does not alter the body of the regulation.

(5) Informational/Administrative/Other

A rulemaking that is primarily informational or pertains to agency matters not central to accomplishing the agency's regulatory mandate but that the agency places in the Unified Agenda to inform the public of the activity.

Major—whether the rule is “major” under 5 U.S.C. 801 (Pub. L. 104-121) because it has resulted or is likely to result in an annual effect on the economy of $100 million or more or meets other criteria specified in that Act. The Act provides that the Administrator of the Office of Information and Regulatory Affairs will make the final determination as to whether a rule is major.

Unfunded Mandates—whether the rule is covered by section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). The Act requires that, before issuing an NPRM likely to result in a mandate that may result in expenditures by State, local, and tribal governments, in the aggregate, or by the private sector of more than $100 million in 1 year, agencies, other than independent regulatory agencies, shall prepare a written statement containing an assessment of the anticipated costs and benefits of the Federal mandate.

Legal Authority—the section(s) of the United States Code (U.S.C.) or Public Law (Pub. L.) or the Executive order (E.O.) that authorize(s) the regulatory action. Agencies may provide popular name references to laws in addition to these citations.

CFR Citation—the section(s) of the Code of Federal Regulations that will be affected by the action.

Legal Deadline—whether the action is subject to a statutory or judicial deadline, the date of that deadline, and whether the deadline pertains to an NPRM, a Final Action, or some other action.

Abstract—a brief description of the problem the regulation will address; the need for a Federal solution; to the extent available, alternatives that the agency is considering to address the problem; and potential costs and benefits of the action.

Timetable—the dates and citations (if available) for all past steps and a projected date for at least the next step for the regulatory action. A date displayed in the form 12/00/14 means the agency is predicting the month and year the action will take place but not the day it will occur. In some instances, agencies may indicate what the next action will be, but the date of that action is “To Be Determined.” “Next Action Undetermined” indicates the agency does not know what action it will take next.

Regulatory Flexibility Analysis Required—whether an analysis is required by the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) because the rulemaking action is likely to have a significant economic impact on a substantial number of small entities as defined by the Act.

Small Entities Affected—the types of small entities (businesses, governmental jurisdictions, or organizations) on which the rulemaking action is likely to have an impact as defined by the Regulatory Flexibility Act. Some agencies have chosen to indicate likely effects on small entities even though they believe Start Printed Page 76460that a Regulatory Flexibility Analysis will not be required.

Government Levels Affected—whether the action is expected to affect levels of government and, if so, whether the governments are State, local, tribal, or Federal.

International Impacts—whether the regulation is expected to have international trade and investment effects, or otherwise may be of interest to the Nation's international trading partners.

Federalism—whether the action has “federalism implications” as defined in Executive Order 13132. This term refers to actions “that have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Independent regulatory agencies are not required to supply this information.

Included in the Regulatory Plan—whether the rulemaking was included in the agency's current regulatory plan published in fall 2014.

Agency Contact—the name and phone number of at least one person in the agency who is knowledgeable about the rulemaking action. The agency may also provide the title, address, fax number, email address, and TDD for each agency contact.

Some agencies have provided the following optional information:

RIN Information URL—the Internet address of a site that provides more information about the entry.

Public Comment URL—the Internet address of a site that will accept public comments on the entry. Alternatively, timely public comments may be submitted at the Governmentwide e-rulemaking site, http://www.regulations.gov.

Additional Information—any information an agency wishes to include that does not have a specific corresponding data element.

Compliance Cost to the Public—the estimated gross compliance cost of the action.

Affected Sectors—the industrial sectors that the action may most affect, either directly or indirectly. Affected sectors are identified by North American Industry Classification System (NAICS) codes.

Energy Effects—an indication of whether the agency has prepared or plans to prepare a Statement of Energy Effects for the action, as required by Executive Order 13211 “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” signed May 18, 2001 (66 FR 28355).

Related RINs—one or more past or current RIN(s) associated with activity related to this action, such as merged RINs, split RINs, new activity for previously completed RINs, or duplicate RINs.

Statement of Need—a description of the need for the regulatory action.

Summary of the Legal Basis—a description of the legal basis for the action, including whether any aspect of the action is required by statute or court order.

Alternatives—a description of the alternatives the agency has considered or will consider as required by section 4(c)(1)(B) of Executive Order 12866.

Anticipated Costs and Benefits—a description of preliminary estimates of the anticipated costs and benefits of the action.

Risks—a description of the magnitude of the risk the action addresses, the amount by which the agency expects the action to reduce this risk, and the relation of the risk and this risk reduction effort to other risks and risk reduction efforts within the agency's jurisdiction.

V. Abbreviations

The following abbreviations appear throughout this publication:

ANPRM—An Advance Notice of Proposed Rulemaking is a preliminary notice, published in the Federal Register, announcing that an agency is considering a regulatory action. An agency may issue an ANPRM before it develops a detailed proposed rule. An ANPRM describes the general area that may be subject to regulation and usually asks for public comment on the issues and options being discussed. An ANPRM is issued only when an agency believes it needs to gather more information before proceeding to a notice of proposed rulemaking.

CFR—The Code of Federal Regulations is an annual codification of the general and permanent regulations published in the Federal Register by the agencies of the Federal Government. The Code is divided into 50 titles, each title covering a broad area subject to Federal regulation. The CFR is keyed to and kept up to date by the daily issues of the Federal Register.

EO—An Executive order is a directive from the President to Executive agencies, issued under constitutional or statutory authority. Executive orders are published in the Federal Register and in title 3 of the Code of Federal Regulations.

FR—The Federal Register is a daily Federal Government publication that provides a uniform system for publishing Presidential documents, all proposed and final regulations, notices of meetings, and other official documents issued by Federal agencies.

FY—The Federal fiscal year runs from October 1 to September 30.

NPRM—A Notice of Proposed Rulemaking is the document an agency issues and publishes in the Federal Register that describes and solicits public comments on a proposed regulatory action. Under the Administrative Procedure Act (5 U.S.C. 553), an NPRM must include, at a minimum:

  • A statement of the time, place, and nature of the public rulemaking proceeding;
  • a reference to the legal authority under which the rule is proposed; and
  • either the terms or substance of the proposed rule or a description of the subjects and issues involved.

Public Law (or Pub. L.)—A public law is a law passed by Congress and signed by the President or enacted over his veto. It has general applicability, unlike a private law that applies only to those persons or entities specifically designated. Public laws are numbered in sequence throughout the 2-year life of each Congress; for example, Pub. L. 112-4 is the fourth public law of the 112th Congress.

RFA—A Regulatory Flexibility Analysis is a description and analysis of the impact of a rule on small entities, including small businesses, small governmental jurisdictions, and certain small not-for-profit organizations. The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires each agency to prepare an initial RFA for public comment when it is required to publish an NPRM and to make available a final RFA when the final rule is published, unless the agency head certifies that the rule would not have a significant economic impact on a substantial number of small entities.

RIN—The Regulation Identifier Number is assigned by the Regulatory Information Service Center to identify each regulatory action listed in the Regulatory Plan and the Unified Agenda, as directed by Executive Order 12866 (section 4(b)). Additionally, OMB has asked agencies to include RINs in the headings of their Rule and Proposed Rule documents when publishing them in the Federal Register, to make it easier for the public and agency officials to track the publication history of regulatory actions throughout their development.

Seq. No.—The sequence number identifies the location of an entry in the printed edition of the Regulatory Plan and the Unified Agenda. Note that a specific regulatory action will have the Start Printed Page 76461same RIN throughout its development but will generally have different sequence numbers if it appears in different printed editions of the Unified Agenda. Sequence numbers are not used in the online Unified Agenda.

U.S.C.—The United States Code is a consolidation and codification of all general and permanent laws of the United States. The U.S.C. is divided into 50 titles, each title covering a broad area of Federal law.

VI. How can users get copies of the plan and the agenda?

Copies of the Federal Register issue containing the printed edition of The Regulatory Plan and the Unified Agenda (agency regulatory flexibility agendas) are available from the Superintendent of Documents, U.S. Government Printing Office, P.O. Box 371954, Pittsburgh, PA 15250-7954. Telephone: (202) 512-1800 or 1-866-512-1800 (toll-free).

Copies of individual agency materials may be available directly from the agency or may be found on the agency's Web site. Please contact the particular agency for further information.

All editions of The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions since fall 1995 are available in electronic form at http://reginfo.gov, along with flexible search tools.

The Government Printing Office's GPO FDsys Web site contains copies of the Agendas and Regulatory Plans that have been printed in the Federal Register. These documents are available at http://www.fdsys.gov.

Start Signature

Dated: September 19, 2014.

John C. Thomas,

Executive Director.

End Signature

INTRODUCTION TO THE 2014 REGULATORY PLAN

Executive Order 12866, issued in 1993, requires the production of a Unified Regulatory Agenda and Regulatory Plan. Executive Order 13563, issued in 2011, reaffirmed the requirements of Executive Order 12866.

Consistent with these Executive Orders, the Office of Information and Regulatory Affairs is providing the 2014 Unified Regulatory Agenda (Agenda) and the Regulatory Plan (Plan) for public review. The Agenda and Plan are preliminary statements of regulatory and deregulatory policies and priorities under consideration. The Agenda and Plan include “active rulemakings” that agencies could possibly conclude over the next year. As in previous years, however, this list may also include some rules that agencies will not end up issuing in the coming year.

The Plan provides a list of important regulatory actions that agencies are considering for issuance in proposed or final form during the 2015 fiscal year. In contrast, the Agenda is a more inclusive list, including numerous ministerial actions and routine rulemakings, as well as long-term initiatives that agencies do not plan to complete in the coming year but on which they are actively working.

A central purpose of the Agenda is to involve the public, including State, local, and tribal officials, in federal regulatory planning. The public examination of the Agenda and Plan will facilitate public participation in a regulatory system that, in the words of Executive Order 13563, protects “public health, welfare, safety, and our environment while promoting economic growth, innovation, competitiveness, and job creation.” We emphasize that rules listed on the Agenda must still undergo significant development and review before they are issued. No regulatory action can become effective until it has gone through the legally required processes, which generally include public notice and comment. Any proposed or final action must also satisfy the requirements of relevant statutes, Executive Orders, and Presidential Memoranda. Those requirements, public comments, and new information may or may not lead an agency to go forward with an action that is currently under contemplation.

Among other information, the Agenda also provides an initial classification of whether a rulemaking is “significant” or “economically significant” under the terms of Executive Orders 12866 and 13563. Whether a regulation is listed on the Agenda as “economically significant” within the meaning of Executive Order 12866 (generally, having an annual effect on the economy of $100 million or more) does not necessarily indicate whether it imposes high costs on the private sector. Economically significant actions may impose small costs or even no costs.

Regulations may count as economically significant because they confer large benefits or remove significant burdens. For example, the Department of Health and Human Services issues regulations on an annual basis, pursuant to statute, to govern annual changes in Medicare payments. These payment regulations effectively authorize transfers of billions of dollars to hospitals and other health care providers each year. Regulations might therefore count as economically significant not because they impose significant regulatory costs on the private sector, but because they involve transfer payments as required or authorized by law.

EOs 13563 and 13610: The Retrospective Review of Regulation

Executive Order 13563 reaffirms the principles, structures, and definitions in Executive Order 12866, which has long governed regulatory review. Executive Order 13563 explicitly points to the need for predictability and certainty, as well as for use of the least burdensome means to achieving regulatory ends. These Executive Orders include the requirement that, to the extent permitted by law, agencies should not proceed with rulemaking in the absence of a reasoned determination that the benefits justify the costs; they establish public participation, integration and innovation, flexible approaches, scientific integrity, and retrospective review as areas of emphasis in regulation. In particular, Executive Order 13563 explicitly draws attention to the need to measure and to improve “the actual results of regulatory requirements”—a clear reference to the importance of retrospective evaluation.

Executive Order 13563 addresses new regulations that are under development as well as retrospective review of existing regulations that are already in place. With respect to agencies' review of existing regulations, the Executive Order calls for careful reassessment based on empirical analysis. The prospective analysis required by Executive Order 13563 may depend on a degree of prediction and speculation about a rule's likely impacts, and the actual costs and benefits of a regulation may be lower or higher than what was anticipated when the rule was originally developed.

Executive Order 13610, Identifying and Reducing Regulatory Burdens, issued in 2012, institutionalizes the retrospective or lookback mechanism set out in Executive Order 13563 by requiring agencies to report to OMB and the public twice each year (January and July) on the status of their retrospective review efforts, to “describe progress, anticipated accomplishments, and proposed timelines for relevant actions.”

Executive Orders 13563 and 13610 recognize that circumstances may change in a way that requires reconsideration of regulatory requirements. Lookback analysis allows agencies to reevaluate existing rules and to streamline, modify, or eliminate those regulations that do not make sense in their current form. The agencies' lookback efforts so far during this Administration have yielded nearly $20 billion in near term savings for the Start Printed Page 76462American public, with significantly more to come.

The Administration is continuing to work with agencies to institutionalize retrospective review so that agencies regularly review existing rules on the books to ensure they remain effective, cost-justified, and based on the best available science. By institutionalizing retrospective review of regulations, the Administration will continue to examine what is working and what is not, and eliminate unjustified and outdated regulations.

Regulatory lookback is an ongoing exercise, and continues to be a high priority for the Administration. As part of that prioritization, the Administration requires that agencies regularly report about recent progress and coming initiatives. In accordance with Executive Order 13610 and Executive Order 13563, in July 2014, agencies submitted to OIRA the latest updates of their retrospective review plans. Federal agencies will again update their retrospective review plans this winter. We have also asked agencies to continue to emphasize regulatory lookbacks in their latest Regulatory Plans.

Reflecting that focus, the current agenda lists 83 rules that are characterized as retroactively reviewing existing programs. Below are some examples of agency plans to reevaluate current practices, in accordance with Executive Orders 13563 and 13610:

—The Department of Health and Human Services (HHS) is working on a rule to revise the requirements that Long-Term Care facilities must meet to participate in the Medicare and Medicaid programs. These proposed changes are necessary to reflect the substantial advances that have been made over the past several years in the theory and practice of service delivery and safety. These proposals are also an integral part of HHS's efforts to achieve broad-based improvements both in the quality of health care furnished through Federal programs, and in patient safety, while at the same time reducing procedural burdens on providers.

—The Department of Housing and Urban Development (HUD) is working on a final rule to streamline the inspection and home warranty requirements for Federal Housing Administration (FHA) single family mortgage insurance and, in doing so, would increase choice and lower the costs for FHA borrowers. First, HUD would remove regulations that require the use of an inspector from the FHA Inspector Roster as a condition for FHA mortgage insurance. This change is based on the recognition of the sufficiency and quality of inspections carried out by local jurisdictions, and HUD expects the rule will increase competition and choice of inspectors among lenders. Second, this rule would also remove the regulations requiring homeowners to purchase 10-year protection plans from FHA-approved warranty issuers in order to qualify for high loan-to-value FHA-insured mortgages. This change is based on the increased quality of construction materials and the standardization of building codes and building code enforcement, and HUD expects the rule will reduce burden on homeowners that do not want to purchase warranties and increase choice for the homeowners that still want to purchase warranties. In total, HUD estimates up to $29 million in warranty expenditures avoided, $100,000 in paperwork burden savings for the public, and $50,000 in administrative cost savings for HUD.

—The Department of Labor is working to revise existing Sex Discrimination Guidelines, which have not been substantively updated since 1973, and to replace them with regulations that align with current law and legal principles in order to address their application to current workplace practices and issues.

E.O. 13609: International Regulatory Cooperation

In addition to using regulatory lookback as a tool to make our regulatory system more efficient, the Administration has been focused on promoting international regulatory cooperation. International regulatory cooperation supports economic growth, job creation, innovation, trade and investment, while also protecting public health, safety, and welfare. In May 2012 President Obama issued Executive Order 13609, Promoting International Regulatory Cooperation, which emphasizes the importance of these efforts as a key tool for eliminating unnecessary differences in regulation between the United States and its major trading partners. Additionally, as part of the regulatory lookback initiative, Executive Order 13609 requires agencies to “consider reforms to existing significant regulations that address unnecessary differences in regulatory requirements between the United States and its major trading partners . . . when stakeholders provide adequate information to the agency establishing that the differences are unnecessary.”

Executive Order 13609 also directed agencies to submit a Regulatory Plan that includes “a summary of its international regulatory cooperation activities that are reasonably anticipated to lead to significant regulations, with an explanation of how these activities advance the purposes of Executive Order 13563,” and Executive Order 13609. Further, Executive Order 13609 requires agencies to “ensure that significant regulations that the agency identifies as having significant international impacts are designated as such” in the Regulatory Agenda. In furtherance of this focus on international regulatory cooperation, this summer, the Administration and Canada released the U.S.-Canada Regulatory Cooperation Council (RCC) Joint Forward Plan.[1] The Forward Plan represents a significant pivot point for the Administration's regulatory cooperation relationships with Canada, and outlines new Federal agency-level partnership arrangements to help institutionalize the way our regulators work together. The Forward Plan will help remove duplicative requirements, develop common standards, and identify potential areas where future regulation may unnecessarily differ. This kind of international cooperation on regulations between the United States and Canada will help eliminate barriers to doing business in the United States or with U.S. companies, grow the economy, and create jobs. The Forward Plan identifies 24 areas of cooperation where the United States and Canada will work together to implement over the next three to five years in order to modernize our thinking around international regulatory cooperation and develop a toolbox of strategies to address international regulatory issues as they arise. We expect that future Agendas will reflect strong evidence of this partnership.

The Administration continues to foster a regulatory system that emphasizes that careful consideration of costs and benefits, public participation, integration and innovation, flexible approaches, and science. These requirements are meant to produce a regulatory system that draws on recent learning, that is driven by evidence, and that is suited to the distinctive circumstances of the twenty-first century.Start Printed Page 76463

Department of Agriculture

Sequence No.TitleRegulation identifier No.Rulemaking stage
1National Organic Program, Origin of Livestock, NOP-11-00090581-AD08Proposed Rule Stage.
2National Organic Program, Organic Pet Food Standards0581-AD20Proposed Rule Stage.
3National Organic Program, Organic Apiculture Practice Standard, NOP-12-00630581-AD31Proposed Rule Stage.
4National Organic Program—Organic Aquaculture Standards0581-AD34Proposed Rule Stage.
5Exemption of Producers and Handlers of Organic Products From Assessment Under a Commodity Promotion Law0581-AD37Proposed Rule Stage.
6Noninsured Crop Disaster Assistance Program0560-AI20Final Rule Stage.
7Conservation Compliance0560-AI26Final Rule Stage.
8Conservation Reserve Program (CRP)0560-AI30Final Rule Stage.
9Brucellosis and Bovine Tuberculosis; Update of General Provisions0579-AD65Proposed Rule Stage.
10Establishing a Performance Standard for Authorizing the Importation and Interstate Movement of Fruits and Vegetables0579-AD71Proposed Rule Stage.
11Viruses, Serums, Toxins, and Analogous Products; Single Label Claim for Veterinary Biological Products0579-AD64Final Rule Stage.
12User Fees for Agricultural Quarantine and Inspection Services0579-AD77Final Rule Stage.
13Emergency Supplemental Nutrition Assistance for Victims of Disasters Procedures0584-AE00Proposed Rule Stage.
14Child Nutrition Program Integrity0584-AE08Proposed Rule Stage.
15Child and Adult Care Food Program: Meal Pattern Revisions Related to the Healthy, Hunger-Free Kids Act of 20100584-AE18Proposed Rule Stage.
16Enhancing Retailer Eligibility Standards in SNAP0584-AE27Proposed Rule Stage.
17Supplemental Nutrition Assistance Program: Farm Bill of 2008 Retailer Sanctions0584-AD88Final Rule Stage.
18Child Nutrition Programs: Local School Wellness Policy Implementation Under the Healthy, Hunger-Free Kids Act of 20100584-AE25Final Rule Stage.
19SNAP: Employment and Training (E&T) Performance Measurement, Monitoring and Reporting Requirements0584-AE33Final Rule Stage.
20Requirements for the Disposition of Non-Ambulatory Disabled Veal Calves0583-AD54Proposed Rule Stage.
21Mandatory Inspection of Fish of the order Siluriformes and Products Derived From Such Fish0583-AD36Final Rule Stage.
22Electronic Export Application and Certification as a Reimbursable Service and Flexibility in the Requirements for Official Export Inspection Marks, Devices, and Certificates0583-AD41Final Rule Stage.
23Descriptive Designation for Needle- or Blade-Tenderized (Mechanically Tenderized) Beef Products0583-AD45Final Rule Stage.
24Records to be Kept by Official Establishments and Retail Stores That Grind Raw Beef Products0583-AD46Final Rule Stage.
25Forest Service Manual 2020—Ecological Restoration and Resilience Policy0596-AC82Final Rule Stage.
26Land Management Planning Rule Policy0596-AD06Final Rule Stage.
27Rural Energy for America Program0570-AA76Final Rule Stage.
28Business and Industry (B&I) Guaranteed Loan Program0570-AA85Final Rule Stage.
29Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program0570-AA93Final Rule Stage.
30Agricultural Conservation Easement Program0578-AA61Final Rule Stage.
31Environmental Quality Incentives Program (EQIP) Interim Rule0578-AA62Final Rule Stage.
32Conservation Stewardship Program Interim Rule0578-AA63Final Rule Stage.

Department of Commerce

Sequence No.TitleRegulation identifier No.Rulemaking stage
33Requirements for Importation of Fish and Fish Product under the U.S. Marine Mammal Protection Act0648-AY15Proposed Rule Stage.
34Designation of Critical Habitat for the North Atlantic Right Whale0648-AY54Proposed Rule Stage.
35Revision of Hawaiian Monk Seal Critical Habitat0648-BA81Proposed Rule Stage.
36Revision of the National Standard 1 Guidelines0648-BB92Proposed Rule Stage.
37Fishery Management Plan for Regulating Offshore Marine Aquaculture in the Gulf of Mexico0648-AS65Final Rule Stage.

Department of Defense

Sequence No.TitleRegulation identifier No.Rulemaking stage
38Limitations on Terms of Consumer Credit Extended to Service Members and Dependents0790-AJ10Proposed Rule Stage.
39Defense Industrial Base (DIB) Cyber Security/Information Assurance (CS/IA) Activities: Amendment0790-AJ14Proposed Rule Stage.
40Service Academies0790-AI19Final Rule Stage.
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41Foreign Commercial Satellite Services (DFARS Case 2014-D010)0750-AI32Final Rule Stage.
42CHAMPUS/TRICARE: Pilot Program for Refills of Maintenance Medications for TRICARE For Life Beneficiaries Through the TRICARE Mail Order Program0720-AB60Final Rule Stage.

Department of Education

Sequence No.TitleRegulation identifier No.Rulemaking stage
43Pay As You Earn1840-AD18Proposed Rule Stage.
44Workforce Innovation and Opportunity Act1830-AA21Proposed Rule Stage.

Department of Energy

Sequence No.TitleRegulation identifier No.Rulemaking stage
45Energy Conservation Standards for General Service Lamps1904-AD09Prerule Stage.
46Energy Efficiency Standards for Manufactured Housing1904-AC11Proposed Rule Stage.
47Energy Conservation Standards for Residential Non-weatherized Gas Furnaces1904-AD20Proposed Rule Stage.

Department of Health and Human Services

Sequence No.TitleRegulation identifier No.Rulemaking stage
48Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals0910-AG10Proposed Rule Stage.
49Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption0910-AG35Proposed Rule Stage.
50Current Good Manufacturing and Hazard Analysis, and Risk-Based Preventive Controls for Human Food0910-AG36Proposed Rule Stage.
51Reports of Distribution and Sales Information for Antimicrobial Active Ingredients Used in Food-Producing Animals0910-AG45Proposed Rule Stage.
52Foreign Supplier Verification Program0910-AG64Proposed Rule Stage.
53“Tobacco Products” Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act0910-AG38Final Rule Stage.
54Food Labeling: Calorie Labeling of Articles of Food Sold in Vending Machines0910-AG56Final Rule Stage.
55Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments0910-AG57Final Rule Stage.
56Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications0910-AG66Final Rule Stage.
57Revision of Postmarketing Reporting Requirements Discontinuance or Interruption in Supply of Certain Products (Drug Shortages)0910-AG88Final Rule Stage.
58Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products0910-AG94Final Rule Stage.
59Veterinary Feed Directive0910-AG95Final Rule Stage.
60Reform of Requirements for Long-Term Care Facilities (CMS-3260-P)0938-AR61Proposed Rule Stage.
61Mental Health Parity and Addiction Equity Act of 2008; the Application to Medicaid Managed Care, CHIP, and Alternative Benefit Plans (CMS-2333-P)0938-AS24Proposed Rule Stage.
62Electronic Health Record (EHR) Incentive Programs—Stage 3 (CMS-3310-P)0938-AS26Proposed Rule Stage.
63CY 2016 Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1631-P)0938-AS40Proposed Rule Stage.
64Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2016 Rates (CMS-1632-P)0938-AS41Proposed Rule Stage.
65CY 2016 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1633-P)0938-AS42Proposed Rule Stage.
66Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Exchange Eligibility Appeals, and Other Eligibility and Enrollment Provisions (CMS-2334-F2)0938-AS27Final Rule Stage.
67Child Care and Development Fund Reforms to Support Child Development and Working Families0970-AC53Final Rule Stage.
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Department of Homeland Security

Sequence No.TitleRegulation identifier No.Rulemaking stage
68Ammonium Nitrate Security Program1601-AA52Final Rule Stage.
69Asylum and Withholding Definitions1615-AA41Proposed Rule Stage.
70New Classification for Victims of Criminal Activity; Eligibility for the U Nonimmigrant Status1615-AA67Proposed Rule Stage.
71Exception to the Persecution Bar for Asylum, Refugee, and Temporary Protected Status, and Withholding of Removal1615-AB89Proposed Rule Stage.
72Administrative Appeals Office: Procedural Reforms to Improve Efficiency1615-AB98Proposed Rule Stage.
73Classification for Victims of Severe Forms of Trafficking in Persons; Eligibility for T Nonimmigrant Status1615-AA59Final Rule Stage.
74Application of Immigration Regulations to the Commonwealth of the Northern Mariana Islands1615-AB77Final Rule Stage.
75Special Immigrant Juvenile Petitions1615-AB81Final Rule Stage.
76Employment Authorization for Certain H-4 Dependent Spouses1615-AB92Final Rule Stage.
77Enhancing Opportunities for H-1B1, CW-1, and E-3 Nonimmigrants and EB-1 Immigrants1615-AC00Final Rule Stage.
78Vessel Requirements for Notices of Arrival and Departure, and Automatic Identification System1625-AA99Final Rule Stage.
79Inspection of Towing Vessels1625-AB06Final Rule Stage.
80Transportation Worker Identification Credential (TWIC); Card Reader Requirements1625-AB21Final Rule Stage.
81Amendments to Importer Security Filing and Additional Carrier Requirements1651-AA98Proposed Rule Stage.
82Air Cargo Advance Screening (ACAS)1651-AB04Proposed Rule Stage.
83Changes to the Visa Waiver Program To Implement the Electronic System for Travel Authorization (ESTA) Program1651-AA72Final Rule Stage.
84Implementation of the Guam-CNMI Visa Waiver Program1651-AA77Final Rule Stage.
85Definition of Form I-94 to Include Electronic Format1651-AA96Final Rule Stage.
86Security Training for Surface Mode Employees1652-AA55Proposed Rule Stage.
87Standardized Vetting, Adjudication, and Redress Services1652-AA61Proposed Rule Stage.
88Passenger Screening Using Advanced Imaging Technology1652-AA67Final Rule Stage.
89Adjustments to Limitations on Designated School Official Assignment and Study By F-2 and M-2 Nonimmigrants1653-AA63Final Rule Stage.

Department of Housing and Urban Development

Sequence No.TitleRegulation identifier No.Rulemaking stage
90Economic Opportunities for Low- and Very Low-Income Persons (FR-4893)2529-AA91Proposed Rule Stage.

Department of Justice

Sequence No.TitleRegulation identifier No.Rulemaking stage
91Implementation of the ADA Amendments Act of 2008 (Section 504 of the Rehabilitation Act of 1973)1190-AA60Proposed Rule Stage.
92Nondiscrimination on the Basis of Disability; Accessibility of Web Information and Services of Public Accommodations1190-AA61Proposed Rule Stage.
93Nondiscrimination on the Basis of Disability; Movie Captioning and Audio Description1190-AA63Proposed Rule Stage.
94Nondiscrimination on the Basis of Disability: Accessibility of Web Information and Services of State and Local Governments1190-AA65Proposed Rule Stage.
95Implementation of the ADA Amendments Act of 2008 (Title II and Title III of the ADA)1190-AA59Final Rule Stage.

Department of Labor

Sequence No.TitleRegulation identifier No.Rulemaking stage
96Workforce Innovation and Opportunity Act1205-AB73Proposed Rule Stage.
97Respirable Crystalline Silica1219-AB36Proposed Rule Stage.
98Criteria and Procedures for Proposed Assessment of Civil Penalties1219-AB72Proposed Rule Stage.
99Proximity Detection Systems for Mobile Machines in Underground Mines1219-AB78Proposed Rule Stage.
100Proximity Detection Systems for Continuous Mining Machines in Underground Coal Mines1219-AB65Final Rule Stage.
101Infectious Diseases1218-AC46Prerule Stage.
102Occupational Exposure to Crystalline Silica1218-AB70Proposed Rule Stage.
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103Improve Tracking of Workplace Injuries and Illnesses1218-AC49Final Rule Stage.

Department of Transportation

Sequence No.TitleRegulation identifier No.Rulemaking stage
104Operation and Certification of Small Unmanned Aircraft Systems (sUAS)2120-AJ60Proposed Rule Stage.
105Slot Management and Transparency for LaGuardia Airport, John F. Kennedy International Airport, and Newark Liberty International Airport2120-AJ89Proposed Rule Stage.
106Drug and Alcohol Testing of Certain Maintenance Provider Employees Located Outside of the United States2120-AK09Proposed Rule Stage.
107Pilot Records Database (HR 5900)2120-AK31Proposed Rule Stage.
108Safety Management Systems for Certificate Holders2120-AJ86Final Rule Stage.
109National Goals and Performance Management Measures (MAP-21)2125-AF53Proposed Rule Stage.
110National Goals and Performance Management Measures (MAP-21)2125-AF54Proposed Rule Stage.
111Carrier Safety Fitness Determination2126-AB11Proposed Rule Stage.
112Electronic Logging Devices and Hours of Service Supporting Documents (MAP-21)2126-AB20Proposed Rule Stage.
113Commercial Driver's License Drug and Alcohol Clearinghouse (MAP-21)2126-AB18Final Rule Stage.
114Fuel Efficiency Standards for Medium- and Heavy-Duty Vehicles and Work Trucks: Phase 22127-AL52Proposed Rule Stage.
115Sound for Hybrid and Electric Vehicles2127-AK93Final Rule Stage.
116Electronic Stability Control Systems for Heavy Vehicles (MAP-21)2127-AK97Final Rule Stage.
117State Safety Oversight (MAP-21)2132-AB19Proposed Rule Stage.
118Pipeline Safety: Safety of On-Shore Liquid Hazardous Pipelines2137-AE66Proposed Rule Stage.
119Pipeline Safety: Gas Transmission (RRR)2137-AE72Proposed Rule Stage.
120Hazardous Materials: Enhanced Tank Car Standards and Operational Controls for High-Hazard Flammable Trains2137-AE91Final Rule Stage.

Department of Veterans Affairs

Sequence No.TitleRegulation identifier No.Rulemaking stage
121Expedited Senior Executive Removal Authority2900-AP30Final Rule Stage.

Environmental Protection Agency

Sequence No.TitleRegulation identifier No.Rulemaking stage
122Review of the National Ambient Air Quality Standards for Ozone2060-AP38Proposed Rule Stage.
123Review of the National Ambient Air Quality Standards for Lead2060-AQ44Proposed Rule Stage.
124Carbon Pollution Emission Guidelines for Existing Stationary Sources: EGUs in Indian Country and U.S. Territories2060-AR33Proposed Rule Stage.
125Greenhouse Gas Emissions and Fuel Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles—Phase 22060-AS16Proposed Rule Stage.
126Renewable Fuel 2015 Volume Standards2060-AS22Proposed Rule Stage.
127Pesticides; Certification of Pesticide Applicators2070-AJ20Proposed Rule Stage.
128Polychlorinated Biphenyls (PCBs); Reassessment of Use Authorizations2070-AJ38Proposed Rule Stage.
129Lead; Renovation, Repair, and Painting Program for Public and Commercial Buildings2070-AJ56Proposed Rule Stage.
130Revisions to the National Oil and Hazardous Substances Pollution Contingency Plan; Subpart J Product Schedule Listing Requirements2050-AE87Proposed Rule Stage.
131User Fee Schedule for Electronic Hazardous Waste Manifest2050-AG80Proposed Rule Stage.
132Modernization of the Accidental Release Prevention Regulations Under Clean Air Act2050-AG82Proposed Rule Stage.
133Petroleum Refinery Sector Risk and Technology Review and New Source Performance Standards2060-AQ75Final Rule Stage.
134Standards of Performance for Greenhouse Gas Emissions From New Stationary Sources: Electric Utility Generating Units2060-AQ91Final Rule Stage.
135Implementation of the 2008 National Ambient Air Quality Standards for Ozone: State Implementation Plan Requirements2060-AR34Final Rule Stage.
136Carbon Pollution Standards for Modified and Reconstructed Stationary Sources: Electric Utility Generating Units2060-AR88Final Rule Stage.
137Pesticides; Agricultural Worker Protection Standard Revisions2070-AJ22Final Rule Stage.
138Formaldehyde; Third-Party Certification Framework for the Formaldehyde Standards for Composite Wood Products2070-AJ44Final Rule Stage.
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139Formaldehyde Emissions Standards for Composite Wood Products2070-AJ92Final Rule Stage.
140Standards for the Management of Coal Combustion Residuals Generated by Commercial Electric Power Producers2050-AE81Final Rule Stage.
141Revising Underground Storage Tank Regulations—Revisions to Existing Requirements and New Requirements for Secondary Containment and Operator Training2050-AG46Final Rule Stage.
142Effluent Limitations Guidelines and Standards for the Steam Electric Power Generating Point Source Category2040-AF14Final Rule Stage.
143Water Quality Standards Regulatory Revisions2040-AF16Final Rule Stage.
144Definition of “Waters of the United States” Under the Clean Water Act2040-AF30Final Rule Stage.

Equal Employment Opportunity Commission

Sequence No.TitleRegulation identifier No.Rulemaking stage
145Federal Sector Equal Employment Opportunity Process3046-AB00Prerule Stage.
146The Federal Sector's Obligation To Be a Model Employer of Individuals With Disabilities3046-AA94Proposed Rule Stage.
147Amendments to Regulations Under the Americans With Disabilities Act3046-AB01Proposed Rule Stage.
148Amendments to Regulations Under the Genetic Information Nondiscrimination Act of 20083046-AB02Proposed Rule Stage.

Social Security Administration

Sequence No.TitleRegulation identifier No.Rulemaking stage
149Revised Medical Criteria for Evaluating Digestive Disorders (3441P)0960-AG65Proposed Rule Stage.
150Revisions to Representative Code of Conduct (3835P)0960-AH63Proposed Rule Stage.
151Revised Medical Criteria for Evaluating Neurological Impairments (806F)0960-AF35Final Rule Stage.
152Revised Medical Criteria for Evaluating Hematological Disorders (974F)0960-AF88Final Rule Stage.
153Revised Medical Criteria for Evaluating Growth Disorders and Weight Loss in Children (3163F)0960-AG28Final Rule Stage.
154Use of Date of Written Statement as Filing Date (3431F)0960-AG58Final Rule Stage.
155Revised Medical Criteria for Evaluating Immune (HIV) System Disorders (3466F)0960-AG71Final Rule Stage.
156Revised Medical Criteria for Evaluating Cancer (Malignant Neoplastic Diseases) (3757F)0960-AH43Final Rule Stage.
157Submission of Evidence in Disability Claims (3802F)0960-AH53Final Rule Stage.
158Social Security Number Card Applications (3855I)0960-AH68Final Rule Stage.

Nuclear Regulatory Commission

Sequence No.TitleRegulation identifier No.Rulemaking stage
159Revision of Fee Schedules: Fee Recovery for FY 2015 [NRC-2014-0200]3150-AJ44Proposed Rule Stage.

DEPARTMENT OF AGRICULTURE (USDA)

Statement of Regulatory Priorities

In FY 2015, USDA will focus on a number of high-priority regulations necessary to implement the Agricultural Act of 2014 (Farm Bill). This legislation, which was signed into law on February 7, 2014, provides authorization for services and programs that impact every American and millions of people around the world. The new Farm Bill builds on historic economic gains in rural America over the past five years, while achieving meaningful reform and billions of dollars in savings for the taxpayer. The new Farm Bill will allow USDA to continue record accomplishments on behalf of the American people, while providing new opportunity and creating jobs across rural America. It will enable USDA to further expand markets for agricultural products at home and abroad, strengthen conservation efforts, create new opportunities for local and regional food systems and grow the biobased economy. It will provide a dependable safety net for America's farmers, ranchers and growers. It will maintain important agricultural research and ensure access to safe and nutritious food for all Americans. USDA's regulatory efforts in the coming year will modify existing regulations and introduce new regulatory actions necessary to implement the 2014 Farm Bill and to achieve the following goals identified in the Department's Strategic Plan for 2010-2015:

  • Assist rural communities to create prosperity so they are self-sustaining, re-populating, and economically thriving. USDA is the leading advocate for rural America. The Department supports rural communities and enhances quality of life for rural residents by improving Start Printed Page 76468their economic opportunities, community infrastructure, environmental health, and the sustainability of agricultural production. The common goal is to help create thriving rural communities with good jobs where people want to live and raise families where children have economic opportunities and a bright future.
  • Ensure our national forests and private working lands are conserved, restored, and made more resilient to climate change, while enhancing our water resources. America's prosperity is inextricably linked to the health of our lands and natural resources. Forests, farms, ranches, and grasslands offer enormous environmental benefits as a source of clean air, clean and abundant water, and wildlife habitat. These lands generate economic value by supporting the vital agriculture and forestry sectors, attracting tourism and recreational visitors, sustaining green jobs, and producing ecosystem services, food, fiber, timber and non-timber products. They are also of immense social importance, enhancing rural quality of life, sustaining scenic and culturally important landscapes, and providing opportunities to engage in outdoor activity and reconnect with the land.
  • Help America promote agricultural production and biotechnology exports as America works to increase food security. A productive agricultural sector is critical to increasing global food security. For many crops, a substantial portion of domestic production is bound for overseas markets. USDA helps American farmers and ranchers use efficient and sustainable production, biotechnology, and other emergent technologies to enhance food security around the world and find export markets for their products.
  • Ensure that all of America's children have access to safe, nutritious, and balanced meals. A plentiful supply of safe and nutritious food is essential to the well-being of every family and the healthy development of every child in America. USDA provides nutrition assistance to children and low-income people who need it and works to improve the healthy eating habits of all Americans, especially children. In addition, the Department safeguards the quality and wholesomeness of meat, poultry, and processed egg products, and it addresses and prevents loss or damage from pests and disease outbreaks.

Important regulatory activities supporting the accomplishment of these goals in 2015 will include the following:

  • Strengthening Food Safety Inspection. USDA will continue to develop science-based regulations that improve the safety of meat, poultry, and processed egg products in the least burdensome and most cost-effective manner. Existing regulations will be revised to address emerging food safety challenges, streamlined to remove excessively prescriptive requirements, and updated to be made consistent with Hazard Analysis and Critical Control Point principles. Among other actions, USDA will amend regulations so that information presented on food packaging is useful in assisting consumers with purchasing and preparation decisions. The agency will also use technology to streamline and improve the integrity of export certificates. To help small businesses comply with food safety regulatory requirements, FSIS will continue its collaboration with other USDA and State partners in its small business outreach program.

Improving Access to Nutrition Assistance and Dietary Behaviors. As changes are made to the nutrition assistance programs, USDA will work to ensure access to program benefits, strengthen program integrity, improve diets and healthy eating, and promote physical activity consistent with the national effort to reduce obesity. In support of these activities in 2014, the Food and Nutrition Service (FNS) plans to publish a proposed rule updating meal pattern revisions for the Child and Adult Care Food Program, as well as a proposal to enhance the eligibility standards for SNAP retailers to increase access to more healthful foods. FNS will continue to work to implement rules that minimize participant and vendor fraud in its nutrition assistance programs.

  • Collaborating with Producers to Conserve Natural Resources. The Natural Resources Conservation Service (NRCS) is amending the Conservation Stewardship Program (CSP) and Environmental Quality Incentives Program (EQIP) regulations to incorporate programmatic changes as authorized by the Farm Bill. CSP promotes consultation at the local level to identify priority resource concerns in geographic areas within a State. CSP encourages producers to address environmental concerns while improving and conserving the quality and condition of natural resources in a comprehensive manner. EQIP provides assistance to landowners to address natural resource issues that impact soil, water and related natural resources, including grazing lands, wetlands, and wildlife habitat. The Farm Bill folded the former Wildlife Habitat Incentives Program (WHIP) into EQIP.
  • Promoting Innovation through Partnerships. NRCS has a long history of providing science-based, technically sound, and proven conservation practices, advice, and alternatives to America's farmers and ranchers. Traditionally, NRCS has worked with USDA agencies, universities, and other nongovernmental organizations to identify and refine new cutting-edge technology through on-farm trials and research. Using this approach, NRCS continually reviews and revises conservation practices based on new research or changes in technology.

Through the Conservation Innovation Grants (CIG) component of EQIP, NRCS involves additional partners in identifying and demonstrating new approaches for possible NRCS adoption. CIG's purpose is to stimulate the adoption of innovative conservation approaches and technologies in agricultural production and leverage additional investments in conservation. Partners assist NRCS with meeting the CIG goals of identifying new conservation technologies and practices, conducting demonstrations and field tests, and integrating widely applicable technologies and practices into NRCS' toolkit of practices and activities to help agricultural producers better address natural resource concerns. NRCS is updating the CIG section of the EQIP regulation to be consistent with Farm Bill amendments.

  • Protecting Productive Agricultural Lands and Wetlands. The Farm Bill combined several NRCS easement programs, including the Wetlands Reserve Program (WRP), the Farm and Ranch Lands Protection Program (FRPP), and the Grassland Reserve Program (GRP) into the new Agricultural Conservation Easement Program (ACEP). ACEP will require its own regulation to replace those of the repealed WRP, FRPP, and GRP programs. ACEP will have two components: an agricultural land easement component under which NRCS assists eligible entities to protect agricultural land by limiting non-agricultural land uses and a wetland reserve easement component under which NRCS provides technical and financial assistance directly to landowners to restore, protect and enhance wetlands through the purchase of wetlands reserve easements. NRCS will maintain the existing easements and contracts formed under the previous programs; however, they will all be considered part of ACEP enrollment.
  • Addressing Conservation Concerns on a Regional Level. The Farm Bill established the Regional Conservation Start Printed Page 76469Partnership Program (RCPP) to promote the implementation of conservation activities through providing support for agreements between producers and partner groups. Producers receive technical and financial assistance through RCPP while NRCS and its partners help producers install and maintain conservation activities. These projects may focus on water quality and quantity, soil erosion, wildlife habitat, drought mitigation, flood control, and other regional priorities. Partners include producer associations, State or local governments, Indian tribes, non-governmental organizations, and institutions of higher education. RCPP projects affect multiple agricultural or nonindustrial private forest operations on a local, regional, State, or multistate level. The Farm Bill combined several regional conservation initiatives into this program. RCPP is implemented through an announcement of program funding through Grants.gov; however, NRCS is publishing updates in the CSP, EQIP and ACEP regulations to indicate that these are covered programs through which RCPP can operate.
  • Establish Framework for Managing our Nation's Forests and Grasslands. The Forest Service will publish proposed guidance for implementation of the 2012 Land Management Planning Rule. This guidance will provide the detailed monitoring, assessment, and documentation requirements that the managers of our national forests and grasslands require to begin revising their land management plans under the 2012 Planning Rule. Currently 70 of the 120 Forest Service's Land Management Plans are expired and in need of revision.
  • Making Marketing and Regulatory Programs More Focused. The Animal and Plant Health Inspection Service (APHIS) plans to amend its veterinary biologics regulations to provide for the use of a simpler, uniform label format to better meet the needs of veterinary biologics consumers. APHIS also plans to revise tuberculosis and brucellosis regulations to better reflect the distribution of these diseases and thereby minimize the impacts on livestock producers while continuing to address these livestock diseases. In the area of plant health, APHIS proposes to expand the streamlined method of considering the importation and interstate movement of fruits and vegetables. The Agricultural Marketing Service (AMS) will support the organic sector by updating the National List of Allowed and Prohibited Substances as advised by the National Organic Standards Board, streamlining organic regulatory enforcement actions, developing organic pet food standards, and proposing that all existing and replacement dairy animals from which milk or milk products are intended to be sold as organic must be managed organically from the last third of gestation.
  • Promoting Biobased Products. USDA will continue to promote sustainable economic opportunities to create jobs in rural communities through the purchase and use of biobased products through the BioPreferred® program. USDA will finalize regulations to revise the BioPreferred® program guidelines to continue adding designated product categories to the preferred procurement program, including intermediates and feedstocks and finished products made of intermediates and feedstocks. The Federal preferred procurement and the certified label parts of the program are voluntary; both are designed to assist biobased businesses in securing additional sales.

Retrospective Review of Existing Regulations

Pursuant to section 6 of Executive Order 13563 “Improving Regulation and Regulatory Review (Jan. 18, 2011), the following initiatives are identified in the Department's Final Plan for Retrospective Analysis. The final agency plans, as well as periodic status updates for each initiative, are available online at http://www.whitehouse.gov/​21stcenturygov/​actions/​21st-century-regulatory-system.

RINTitleSignificantly reduce burdens on small businesses
0583-AC59Prior Labeling Approval System: Generic Label ApprovalYes.
0583-AD41Electronic Export Application and Certification FeeYes.
0583-AD32Modernization of Poultry Slaughter InspectionYes.
0570-AA76Rural Energy America ProgramYes.
0570-AA85Business and Industry Loan Guaranteed ProgramYes.
0575-AC91Community Facilities Loan and GrantsYes.
0596-AD01National Environmental Policy Act (NEPA) EfficienciesYes.

Subsequent to EO 13563 and consistent with its goals as well as the importance of public participation, President Obama issued Executive Order 13610 on Identifying and Reducing Regulatory Burdens in May 2012. Executive Order 13610 directs agencies, in part, to give priority consideration to those initiatives that will produce cost savings or significant reductions in paperwork burdens. Accordingly, reducing the regulatory burden on the American people and our trading partners is a priority for USDA, and we will continually work to improve the effectiveness of our existing regulations. As a result of our ongoing regulatory review and burden reduction efforts, USDA has identified the following burden-reducing initiatives:

  • Increase Use of Generic Approval and Regulations Consolidation. FSIS is finalizing a rule that will expand the circumstances in which the labels of meat and poultry products will be deemed to be generically approved by FSIS. The rule will reduce regulatory burdens and generate a discounted Agency cost savings of $3.3 million over 10 years (discounted at 7 percent).
  • Implement Electronic Export Application for Meat and Poultry Products. FSIS is finalizing a rule to provide exporters a fee-based option for transmitting U.S. certifications to foreign importers and governments electronically. Automating the export application and certification process will facilitate the export of U.S. meat, poultry, and egg products by streamlining the processes that are used while ensuring that foreign regulatory requirements are met.
  • Streamline Forest Service National Environmental Policy Act (NEPA) Compliance. The Forest Service, in cooperation with the Council on Environmental Quality, is promulgating rulemaking to establish three new Categorical Exclusions for simple restoration activities. These Categorical Exclusions will improve and streamline the NEPA process and reduce the paperwork burden, as it applies to Forest Service projects without reducing environmental protection.Start Printed Page 76470
  • Increase Accessibility to the Rural Energy for America Program (REAP). Under REAP, Rural Development provides guaranteed loans and grants to support the purchase, construction, or retrofitting of a renewable energy system. This rulemaking will streamline the application process for grants, lessening the burden on the applicant. The rulemaking is expected to reduce the information collection.
  • Reduced Duplication in Farm Programs. The Farm and Foreign Agricultural Services (FFAS) mission area is reducing the paperwork burden on program participants by consolidating the information collections required to participate in farm programs administered by the Farm Service Agency (FSA) and the Federal crop insurance program administered by the Risk Management Agency (RMA). As a result, producers will be able to spend less time reporting information to USDA. Additionally, FSA and RMA will be better able to share information, thus improving operational efficiency. FFAS is simplifying and standardizing, to the extent practical, acreage reporting processes, program dates, and data definitions across the various USDA programs and agencies. FFAS is making improvements to allow producers to use information from their farm-management and precision agriculture systems for reporting production, planted and harvested acreage, and other key information needed to participate in USDA programs. FFAS is also streamlining the collection of producer information by FSA and RMA with the agricultural production information collected by the National Agricultural Statistics Service. These process changes allow for program data that is common across agencies to be collected once and utilized or redistributed to agency programs in which the producer chooses to participate. FFAS will conduct a pilot project in spring 2015 to test the ability of FSA county offices to receive electronic acreage reports through a third-party service provider; the pilot will add additional States following the 2014 small “proof-of-concept” in Illinois.

Periodic status updates for these burden-reducing initiatives can be found online at: http://www.whitehouse.gov/​21stcenturygov/​actions/​21st-century-regulatory-system.

In addition to regulatory review initiatives identified under Executive Order 13563 and the paper work burden reduction initiatives identified under the Executive Order 13610, USDA has plans to initiate the following additional streamlining initiatives in 2015.

  • Simplify FSA NEPA Compliance. FSA proposed revisions to its regulations that implement NEPA to update, improve, and clarify requirements. It also proposed new categorical exclusions and removing obsolete provisions. FSA will revise the regulations with any additional improvements being made based on public comments to the proposed rule. Annual cost savings to FSA as a result of this rule could be $345,000 from conducting 314 fewer environmental assessments per year, while retaining strong environmental protection.
  • Simplify Equipment Contracts for Rural Utilities Service (RUS) Loans. RUS is proposing a rule that would result in a new standard Equipment Contract Form for use by Telecommunications Program borrowers. This new standardized contract would ensure that certain standards and specifications are met, and this new form would replace the current process that requires all construction providers to use their own resources to develop a contract for each project.
  • Consolidate Community Facilities Programs Loan and Grant Requirements. The Rural Housing Service (RHS) is proposing to consolidate seven of the regulations used to service Community Facilities direct loans and grants into one streamlined regulation. This rule will reduce the time burden on RHS staff and provide the public with a single document that clearly outlines the requirements for servicing Community Facilities direct loans and grants.
  • Update Tuberculosis and Brucellosis Programs. Given the success USDA has had in nearly eradicating tuberculosis and brucellosis in ruminants, APHIS will propose rulemaking to update and consolidate its regulations regarding these diseases to better reflect the current distribution of these diseases and the changes in which cattle, bison, and captive cervid are produced in the United States.

Promoting International Regulatory Cooperation Under Executive Order 13609:

President Obama issued Executive Order 13609 on promoting international regulatory cooperation in May 2012. The Executive order charges the Regulatory Working Group, an interagency working group chaired by the Administrator of Office of Information and Regulatory Affairs (OIRA), with examining appropriate strategies and best practices for international regulatory cooperation. The Executive order also directs agencies to identify factors that should be taken into account in evaluating the effectiveness of regulatory approaches used by trading partners with whom the U.S. is engaged in regulatory cooperation. At this time, USDA is identifying international regulatory cooperation activities that are reasonably anticipated to lead to significant regulations, while working closely with the Administration to refine the guidelines implementing the Executive order. Apart from international regulatory cooperation, the Department has continued to identify regulations with international impacts, as it has done in the past. Such regulations are those that are expected to have international trade and investment effects or otherwise may be of interest to our international trading partners.

USDA is diligently working to carry out the President's Executive order mandate with regard to regulatory cooperation as new regulations are developed. Several agencies within the Department are also actively engaged in interagency and Departmental regulatory cooperation initiatives being pursued as part of the U.S.-Mexico High Level Regulatory Cooperation Council (HLRCC) and the U.S.-Canada Regulatory Cooperation Council (RCC), as well as other fora. Specific projects are being pursued by USDA agencies such as AMS, APHIS, and FSIS and address a variety of regulatory oversight processes and requirements related to meat, poultry, and animal and plant health. Projects related to electronic certification, equivalence, meat nomenclature, and the efficient and safe flow of plants, animals and food across our shared borders are all regulatory cooperation pursuits these agencies are undertaking in order to secure better alignment among our countries without compromising the high standards of safety we have in place in the U.S. relative to food safety and public health, as well as plant and animal health, that are so critical to American agriculture.

Major Regulatory Priorities

This following represents summary information on prospective priority regulations as called for in Executive Orders 12866 and 13563:

Food and Nutrition Service

Mission: FNS works to end hunger and obesity through the administration of federal nutrition assistance programs including WIC, Supplemental Nutrition Assistance Program (SNAP), and school meals.Start Printed Page 76471

Priorities: In addition to responding to provisions of legislation authorizing and modifying Federal nutrition assistance programs, FNS's 2015 regulatory plan supports USDA's Strategic Goal to “ensure that all of America's children have access to safe, nutritious and balanced meals” and its related objectives:

  • Increase Access to Nutritious Food. This objective represents FNS's efforts to improve nutrition by providing access to program benefits (food consumed at home, school meals, commodities) and distributing State administrative funds to support program operations. To advance this objective, FNS plans to publish a final rule implementing the Healthy, Hunger-Free Kids Act of 2010's Community Eligibility Provision, which eliminates the burden of household applications and increases access to free school lunches and breakfasts for children in eligible high-poverty schools. FNS will also publish a proposed rule to codify procedures for providing temporary SNAP benefits during emergencies for victims of disasters.
  • Improve Program Integrity. FNS also plans to publish a number of rules to increase efficiency, reduce the burden of program operations, and further reduce improper payments. Program integrity provisions will continue to be strengthened in the SNAP and Child Nutrition programs to ensure Federal taxpayer dollars are spent effectively. To support this objective, FNS plans to publish a final rule from the 2008 Farm Bill that increases the penalty for SNAP authorized stores that are involved in the trafficking of Program benefits. Additionally, FNS plans to publish a proposed rule to establish consistent, outcome-focused performance measures for the SNAP Employment and Training Program. For Child Nutrition, FNS plans to publish a proposed rule to strengthen oversight requirements and institution disqualification procedures, allow the imposition of fines by USDA or State agencies for egregious and/or repeated program violations, and address several deficiencies identified through program audits and reviews.
  • Promote Healthy Diet and Physical Activity Behaviors. This objective represents FNS's efforts to ensure that program benefits meet appropriate standards to effectively improve nutrition for program participants, to improve the diets of its clients through nutrition education, and to support the national effort to reduce obesity by promoting healthy eating and physical activity. To implement provisions included in the Healthy Hunger Free Kids Act of 2010. FNS plans to publish a proposed rule that updates the meal patterns for the Child and Adult Care Food Program to align them with the latest Dietary Guidelines for Americans and final rules that establish professional standards for school food service and State child nutrition program directors, require schools to develop local wellness policies that promote the health of students and address the growing problem of childhood obesity. Additionally, FNS plans to publish a proposed rule to implement the 2014 Farm Bill governing the eligibility of retail food stores participating in SNAP that will improve SNAP participants' access to healthy food options.

Food Safety and Inspection Service

Mission: FSIS is responsible for ensuring that meat, poultry, and processed egg products in interstate and foreign commerce are wholesome, not adulterated, and are properly marked, labeled, and packaged.

Priorities: FSIS is committed to developing and issuing science-based regulations intended to ensure that meat, poultry, and processed egg products are wholesome and not adulterated or misbranded. FSIS regulatory actions support the objective to protect public health by ensuring that food is safe under USDA's goal to ensure access to safe food. To reduce the number of foodborne illnesses and increase program efficiencies, FSIS will continue to review its existing authorities and regulations to ensure that it can address emerging food safety challenges, to streamline excessively prescriptive regulations, and to revise or remove regulations that are inconsistent with the FSIS's Hazard Analysis and Critical Control Point (HACCP) regulations. FSIS is also working with the Food and Drug Administration (FDA) to improve coordination and increase the effectiveness of inspection activities. FSIS's priority initiatives are as follows:

  • Implement Inspection of Certain Fish, Including Catfish and Catfish Products. FSIS plans to issue a final rule to implement a new inspection system for all fish of the order Siluriformes, as required by the 2014 Farm Bill. The rule will define inspection requirements for this type of fish and will take into account the conditions under which the fish is raised and transported to a processing establishment.
  • Streamline Export Application Processes through the Public Health Information System (PHIS). To support its food safety inspection activities, FSIS is continuing to implement PHIS, a user-friendly and Web-based system that automates many of the Agency's business processes. PHIS also enables greater exchange of information between FSIS and other Federal agencies, such as U.S. Customs and Border Protection, which is involved alongside FSIS in tracking cross-border movement of import and export shipments of meat, poultry, and processed egg products. To facilitate the implementation of some PHIS components, FSIS is finalizing regulations to provide for electronic export application and certification processes.
  • Update Nutrition Facts Panels for Meat and Poultry Products. FSIS will propose to amend its regulations so that the nutrition labeling requirements for meat and poultry products reflect recent scientific research and dietary recommendations and to improve the presentation of nutrition information to assist consumers in maintaining healthy dietary practices. These revisions will be consistent with the recent changes that the Food and Drug Administration proposed for conventional foods and will ensure that there is consistency in how nutrition information is presented across the food supply.
  • Ensure Accurate Labeling of Mechanically Tenderized Beef. FSIS has concluded that without proper labeling, raw or partially cooked mechanically tenderized beef products could be mistakenly perceived by consumers to be whole, intact muscle cuts. The fact that a cut of beef has been needle or blade-tenderized is a characterizing feature of the product and, as such, is a material fact likely to affect consumers' purchase decisions and should affect their preparation of the product. FSIS has also concluded that the addition of validated cooking instruction is required to ensure that potential pathogens throughout the product are destroyed. Without thorough cooking, pathogens that may have been introduced to the interior of the product during the tenderization process may remain in the product. The Agency will finalize regulations requiring that raw, mechanically tenderized (needle or blade) beef products be labeled to indicate that they are “mechanically tenderized.”
  • Improve the Efficiency of Product Recalls. FSIS is developing a final rule that will amend recordkeeping regulations to specify that all official establishments and retail stores that grind or chop raw beef products for sale in commerce must keep records that disclose the identity of the supplier of all source materials that they use in the preparation of each lot of raw ground or chopped product and identify the names of those source materials. FSIS Start Printed Page 76472investigators and public health officials frequently use records kept by all levels of the food distribution chain, including the retail level, to identify and trace back product that is the source of the illness to the suppliers that produced the source material for the product. Access to this information will improve FSIS's ability to conduct timely and effective consumer foodborne illness investigations and other public health activities throughout the stream of commerce.
  • Improve Compliance with the Humane Methods of Slaughter Act. FSIS has concluded that prohibiting the slaughter of all non-ambulatory disabled veal calves will improve compliance with the Humane Methods of Slaughter Act of 1978 (7 U.S.C. 1901 et seq.) and will also improve the Agency's inspection efficiency by eliminating the time that FSIS inspection program personnel spend re-inspecting non-ambulatory disabled veal calves. FSIS plans to propose to amend its regulations on ante-mortem inspection to remove a provision that permits establishments to set apart and hold for treatment veal calves that are unable to rise from a recumbent position and walk because they are tired or cold (9 CFR 309.13(b)). Under the proposed rule, non-ambulatory disabled veal calves that are offered for slaughter will be condemned and promptly euthanized.
  • FSIS Small Business Implications. The great majority of businesses regulated by FSIS are small businesses. FSIS conducts a small business outreach program that provides critical training, access to food safety experts, and information resources, such as compliance guidance and questions and answers on various topics, in forms that are uniform, easily comprehended, and consistent. FSIS collaborates in this effort with other USDA agencies and cooperating State partners. For example, FSIS makes plant owners and operators aware of loan programs available through USDA's Rural Business and Cooperative programs to help them in upgrading their facilities. FSIS employees will meet with small and very small plant operators to learn more about their specific needs and explore how FSIS can tailor regulations to better meet the needs of small and very small establishments, while maintaining the highest level of food safety.

Animal and Plant Health Inspection Service

Mission: A major part of the mission of APHIS is to protect the health and value of American agricultural and natural resources. APHIS conducts programs to prevent the introduction of exotic pests and diseases into the United States and conducts surveillance, monitoring, control, and eradication programs for pests and diseases in this country. These activities enhance agricultural productivity and competitiveness and contribute to the national economy and the public health. APHIS also conducts programs to ensure the humane handling, care, treatment, and transportation of animals under the Animal Welfare Act.

Priorities: APHIS continues to pursue initiatives to update its regulations to make them more flexible and performance-based. For example, in the area of animal health, APHIS is preparing a final rule to amend its veterinary biologics regulations to provide for the use of a simpler, uniform label format that would allow biologics licensees and permittees to more clearly communicate product performance information to the end user. In addition, the rule would simplify the evaluation of efficacy studies and reduce the amount of time required by APHIS to evaluate study data, thus allowing manufacturers to market their products sooner. APHIS has also prepared a proposed rule that would revise and consolidate its regulations regarding bovine tuberculosis and brucellosis to better reflect the distribution of these diseases and the current nature of cattle, bison, and captive cervid production in the United States. In the area of plant health, APHIS has prepared a proposed rule that would establish performance standards and a notice-based process for approving the interstate movement of fruits and vegetables from Hawaii and the U.S. Territories and the importation of those articles from other countries. In addition, APHIS will revise agricultural quarantine and inspection user fees so that fees collected are commensurate with the cost of providing the activity.

Agricultural Marketing Service

Mission: AMS's mission is to facilitate the competitive and efficient marketing of agricultural products. AMS provides marketing services to producers, manufacturers, distributors, importers, exporters, and consumers of food products. AMS also manages the government's food purchases, supervises food quality grading, maintains food quality standards, supervises the Federal research and promotion programs, and oversees the country of origin labeling program as well as the National Organic Program (NOP).

Priorities: AMS intends to support the government's initiative to streamline regulatory actions by establishing a process to communicate fees for our voluntary user fee programs annually through publication of a Federal Register notice. AMS is also committed to ensuring the integrity of USDA organic products in the U.S. and throughout the world. In addition to its ongoing work to develop organic pet food, apiculture, and aquaculture standards, the Agency is moving forward with the following priority rulemakings that affect the organic industry:

  • Research and Promotion Programs Organic Exemption. USDA intends to implement the 2014 Farm Bill provision to expand the organic exemption for research and promotion program assessments. This action would exempt organic operations with “100 percent organic” and “organic” products, including certain split operations, from paying research and promotion program assessments.
  • Transitioning Dairy Animals into Organic Production. Members of the organic community, including dairy producers, organic interest groups, and the National Organic Standards Board have advocated for rulemaking on the allowance for transitioning dairy animals into organic production. Stakeholders have interpreted the current standard differently, creating inconsistencies across dairy producers. AMS has submitted a proposed rule for clearance on this issue. This proposed change to the organic standards is intended to level the playing field for organic dairy producers.

Farm Service Agency

Mission: FSA's mission is to deliver timely, effective programs and services to America's farmers and ranchers to support them in sustaining our Nation's vibrant agricultural economy, as well as to provide first-rate support for domestic and international food aid efforts. FSA has successfully expedited the implementation of several major regulatory priorities resulting from the 2014 Farm Bill, including new programs such as the Agriculture Risk Coverage Program, Price Loss Coverage Program, Margin Protection Program for Dairy, Dairy Product Donation Program, Cotton Transition Assistance Program, and improvements to existing programs such as disaster assistance programs, entity eligibility for Farm Loan Programs, and Microloans. FSA supports USDA's strategic goals by stabilizing farm income, providing credit to new or existing farmers and ranchers who are temporarily unable to obtain credit from commercial sources, and helping farm operations recover from the effects of disaster. FSA administers several conservation programs directed toward Start Printed Page 76473agricultural producers. The largest program is the Conservation Reserve Program, which protects up to 32 million acres of environmentally sensitive land.

Priorities: FSA is focused on continuing to implement the 2014 Farm Bill while providing the best possible service to producers while protecting the environment by updating and streamlining environmental compliance. FSA's priority initiatives are as follows:

  • Noninsured Crop Disaster Assistance Program (NAP). FSA will revise its NAP regulations to implement the 2014 Farm Bill changes. The 2014 Farm Bill changes include enhanced protection under NAP, which is also known as NAP buy-up to allow producers to buy additional NAP coverage for an additional premium; revised NAP eligibility requirements for coverage on tilled native sod; added coverage for sweet sorghum and biomass sorghum; service fee waivers for beginning and socially disadvantaged farmers.
  • Conservation Compliance. FSA, working in coordination with NRCS and RMA, will revise the USDA conservation compliance regulations to implement the 2014 Farm Bill changes. The 2014 Farm Bill changes linking eligibility for any premium subsidy paid by FCIC on a policy or plan of federally reinsured crop insurance to be in compliance with Highly Erodible Land Conservation and Wetlands Conservation provisions. Since enactment of the 1985 Farm Bill, eligibility for most commodity, disaster, and conservation programs has been linked to compliance with the Highly Erodible Land Conservation and Wetland Conservation provisions. The 2014 Farm Bill continues the requirement that producers adhere to conservation compliance guidelines to be eligible for most programs administered by FSA and NRCS.
  • Marketing Assistance Loans (MAL) and Loan Deficiency Payments (LDP). FSA will revise its MAL and LDP regulations to implement the 2014 Farm Bill changes. The 2014 Farm Bill changes reauthorize MAL and LDP for all eligible commodities including cotton, honey, and sugar loans, for the 2014 through 2018 crop years. The MAL and LDP Programs allow producers to receive short-term loans against their crops so that producers can market their crops at a time that is convenient for them, rather than being forced to sell immediately after harvest to pay the bills. The MAL and LDP programs are continued with no changes to the loan rates except for cotton, and there are no other changes to the basic structure of the programs. The changes extend the program years and add clarity to the regulations. MALs, LDPs and sugar loans are Commodity Credit Corporation (CCC) programs administered by the Farm Service Agency (FSA).
  • Farm Loan Programs (FLP) changes. FSA will revise its FLP regulations to implement the 2014 Farm Bill changes. The 2014 Farm Bill changes include expanding lending opportunities for thousands of farmers and ranchers to begin and continue operations, including greater flexibility in determining eligibility, raising loan limits, and emphasizing beginning and socially disadvantaged producers. Specific changes include: Eliminating loan term limits for guaranteed operating loans, modifying the definition of beginning farmers, allowing debt forgiveness on youth loans, increasing the guaranteed amount on conservation loans from 75 to 80 percent and 90 percent for beginning farmers and socially disadvantaged producers, changing the interest rate on Direct Farm Ownership loans that are made in conjunction with other lenders, and increasing the maximum loan amount for the down payment loan program from $225,000 to $300,000.
  • Biomass Crop Assistance Program (BCAP). FSA will revise its BCAP regulations to implement the 2014 Farm Bill changes. The 2014 Farm Bill changes include extending BCAP through 2018 and revising BCAP to add some new payment amounts and eligibility restrictions. Specific changes include: revising eligible materials to remove bagasse, add materials used for research material, and require that all woody biomass be harvested directly from the land and reducing the payment for collection, harvest, storage, and transportation matching payments to $20 per dry ton. BCAP provides financial assistance to producers who establish and harvest biomass crops and requires at least 10 percent of payments to be matching payments.
  • Conservation Reserve Program (CRP). FSA will revise its CRP regulations to implement the 2014 Farm Bill changes. The 2014 Farm Bill changes include extending the authority to enroll acreage in CRP through September 30, 2018, and requiring enrollment to be no more than 24 million acres beginning October 1, 2016. There are 25.6 million acres enrolled in CRP, of which 2 million expired on September 30, 2014.
  • Streamline Environmental Compliance (NEPA). FSA will revise its regulations that implement NEPA. The changes improve the efficiency, transparency, and consistency of NEPA implementation. Changes include aligning the regulations to NEPA regulations and guidance from the President's Council on Environmental Quality, providing a single set of regulations that reflect the Agency's current structure, clarifying the types of actions that require an Environmental Assessment (EA), and adding to the list of actions that are categorically excluded from further environmental review because they have no significant effect on the human environment. FSA will develop any additional changes resulting from public comments to the proposed rule.

Forest Service

Mission: FS's mission is to sustain the health, productivity, and diversity of the Nation's forests and rangelands to meet the needs of present and future generations. This includes protecting and managing National Forest System lands; providing technical and financial assistance to States, communities, and private forest landowners, plus developing and providing scientific and technical assistance; and the exchange of scientific information to support international forest and range conservation. FS regulatory priorities support the Department's goal to ensure our National forests are conserved, restored, and made more resilient to climate change, while enhancing our water resources.

Priorities: FS is committed to developing and issuing science-based regulations intended to ensure public participation in the management of our Nation's national forests and grasslands, while also moving forward the Agency's ability to plan and conduct restoration projects on National Forest System lands. FS will continue to review its existing authorities and regulations to ensure that it can address emerging challenges, to streamline excessively burdensome business practices, and to revise or remove regulations that are inconsistent with the USDA's vision for restoring the health and function of the lands it is charged with managing. FS's priority initiatives are as follows:

  • Implement Land Management Planning Framework. The Forest Service promulgated a new Land Management Planning Rule at 36 CFR part 219 in April 2012 that sets out the requirements for developing, amending, and revising land management plans for units of the National Forest System. The planning directives, once finalized, will be used to implement the planning framework which fosters collaboration with the public during land management planning, is science-based and responsive to change and promotes Start Printed Page 76474social, economic, and ecological sustainability.
  • Strengthen Ecological Restoration Policies. This policy would recognize the adaptive capacity of ecosystems and includes the role of natural disturbances and uncertainty related to climate and other environmental change. The need for ecological restoration of National Forest System lands is widely recognized, and the Forest Service has conducted restoration-related activities across many programs for decades. “Restoration” is a common way of describing much of the Agency's work, and the concept is threaded throughout existing authorities, program directives, and collaborative efforts such as the National Fire Plan, a 10-Year comprehensive strategy and implementation plan, and the Healthy Forests Restoration Act. However, the Agency did not have a definition of “restoration” established in policy. The lack of a definition was identified as a barrier to collaborating with the public and partners to plan and accomplish restoration work.

Rural Development

Mission: Rural Development (RD) promotes a dynamic business environment in rural America that creates jobs, community infrastructure, and housing opportunities in partnership with the private sector and community-based organizations by providing financial assistance and business planning services and supporting projects that create or preserve quality jobs, advance energy efficiency and the bioeconomy, and strengthen local and regional food systems while focusing on the development of single- and multi-family housing and community infrastructure. RD financial resources are often leveraged with those of other public and private credit source lenders to meet business and credit needs in under-served areas. Recipients of these programs may include individuals, corporations, partnerships, cooperatives, public bodies, nonprofit corporations, Indian tribes, and private companies.

Priorities: RD regulatory priorities will facilitate sustainable renewable energy development and enhance the opportunities necessary for rural families to thrive economically. RD's rules will minimize program complexity and the related burden on the public while enhancing program delivery and Rural Business-Cooperative Service oversight.

  • Increase Accessibility to the Rural Energy for America Program (REAP). Under REAP, Rural Development provides guaranteed loans and grants to support the purchase, construction, or retrofitting of a renewable energy system. This rulemaking will streamline the application process for grants, lessening the burden to the customer. The rulemaking is expected to reduce the information collection. REAP will also be revised to ensure a larger number of applicants will be made available through the issuing of smaller grants. As a result, funding will be distributed evenly across the applicant pool and encourage greater development of renewable energy.
  • Broadband Access Loans. Increasing access to broadband service is a critical factor in improving the quality of life in rural America and in providing the foundation needed for creating jobs. The A 2014 Farm Bill revises program provisions particularly with regard to broadband speed and application priority. Revised regulations for the Broadband Access Loan Program are anticipated to be published in the Federal Register in the spring of 2015.
  • Modify review of Single Family Housing Direct Loans. RD will publish the certified loan packager regulation to streamline oversight of the agency's vast network of committed Agency-certified packagers. This action will help low- and very low-income people become homeowners. It will also reduce the burden on program staff, enabling them to focus on implementation and delivery, and will ensure specialized support is available to them to complete the application for assistance, improving the quality of loan application packages.

Departmental Management

Mission: Departmental Management's mission is to provide management leadership to ensure that USDA administrative programs, policies, advice and counsel meet the needs of USDA programs, consistent with laws and mandates, and provide safe and efficient facilities and services to customers.

Priorities:

  • Promote Biobased Products: In support of the Department's goal to increase prosperity in rural areas, USDA's Departmental Management plans to publish regulations to implement the requirement in the Agricultural Act of 2014 (Farm Bill) to establish eligibility criteria for forest and other traditional biobased products in the BioPreferred® program.

Aggregate Costs and Benefits

USDA will ensure that its regulations provide benefits that exceed costs, but are unable to provide an estimate of the aggregated impacts of its regulations. Problems with aggregation arise due to differing baselines, data gaps, and inconsistencies in methodology and the type of regulatory costs and benefits considered. Some benefits and costs associated with rules listed in the regulatory plan cannot currently be quantified as the rules are still being formulated. For 2015, USDA's focus will be to implement the changes to programs in such a way as to provide benefits while minimizing program complexity and regulatory burden for program participants.

USDA—Agricultural Marketing Service (AMS)

Proposed Rule Stage

1. National Organic Program, Origin of Livestock, NOP-11-0009

Priority: Other Significant.

Legal Authority: 7 U.S.C. 6501

CFR Citation: 7 CFR 205.

Legal Deadline: NPRM, Statutory, December 31, 2014.

The proposed action would eliminate the two-track system and require that upon transition, all existing and replacement dairy animals from which milk or milk products are intended to be sold, labeled, or represented as organic, must be managed organically from the last third of gestation.

Abstract: The current regulations provide two tracks for replacing dairy animals which are tied to how dairy farmers transition to organic production. Farmers who transition an entire distinct herd must thereafter replace dairy animals with livestock that has been under organic management from the last third of gestation. Farmers who do not transition an entire distinct herd may perpetually obtain replacement animals that have been managed organically for 12 months prior to marketing milk or milk products as organic. The proposed action would eliminate the two-track system and require that upon transition, all existing and replacement dairy animals from which milk or milk products are intended to be sold, labeled, or represented as organic must be managed organically from the last third of gestation.

Statement of Need: This action is being taken because of concerns raised by various parties, including the National Organic Standards Board (NOSB), about the dual tracks for dairy replacement animals. The proposed action would institute the same requirements across all producers.Start Printed Page 76475

Summary of Legal Basis: The National Organic Program regulations stipulate the requirements for dairy replacement animals in section 205.236(a)(2) Origin of Livestock. In addition, in response to the final ruling in the 2005 case, Harvey v. Johanns, the USDA committed to rulemaking to address the concerns about dairy replacement animals.

Alternatives: The program considered initiating the rulemaking with an ANPRM. It was determined that there is sufficient awareness of the expectations of the organic community to proceed with a proposed rule. As alternatives, we considered the status quo, however, this would continue the disparity between producers who can continually transition conventional dairy animals into organic production and producers who source dairy animals that are organic from the last third of gestation. We also considered an action that would restrict the source of breeder stock and movement of breeder stock after they are brought onto an organic operation; however, this would minimize the flexibility of producers to purchase breeder stock from any source as specified under the Organic Foods Production Act.

Anticipated Cost and Benefits:

Risks: Continuation of the two-track system jeopardizes the viability of the market for organic heifers. A potential risk associated with the rulemaking would be a temporary supply shortage of dairy replacement animals due to the increased demand.

Timetable:

ActionDateFR Cite
NPRM12/00/14
Final Action05/00/16

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses, Organizations.

Government Levels Affected: None.

Agency Contact: Melissa R. Bailey, Director, Standards Division, Department of Agriculture, Agricultural Marketing Service, 14th & Independence Avenue SW., Room 2646-South Building, Washington, DC 20250, Phone: 202 720-3252, Fax: 202 205-7808, Email: melissa.bailey@usda.gov.

RIN: 0581-AD08

USDA—AMS

2. National Organic Program, Organic Pet Food Standards

Priority: Other Significant.

Legal Authority: 7 U.S.C. 6501.

CFR Citation: 7 CFR 205.

Legal Deadline: NPRM, Statutory, April 30, 2015.

The National Organic Program (NOP) is establishing national standards governing the marketing of organically produced agricultural products.

Abstract: The National Organic Program (NOP) is establishing national standards governing the marketing of organically produced agricultural products. In 2004, the National Organic Standards Board (NOSB) initiated the development of organic pet food standards, which had not been incorporated into the NOP regulations, by forming a task force which included pet food manufacturers, organic consultants, etc. Collectively, these experts drafted organic pet food standards consistent with the Organic Foods Production Act of 1990, Food and Drug Administration requirements, and the Association of American Feed Control Officials (AAFCO) Model Regulations for Pet and Specialty Pet Food. The AAFCO regulations are scientifically based regulations for voluntary adoption by State jurisdictions to ensure the safety, quality, and effectiveness of feed. In November 2008, the NOSB approved a final recommendation for organic pet food standards incorporating the provisions drafted by the pet food task force.

Statement of Need: This action is necessary to ensure consistency in the composition and labeling of pet food products bearing organic claims. While the NOP has maintained that pet food may be certified in accordance with the existing USDA organic regulations, the requirements for processed products are intended for human foods and are not entirely applicable to pet food. The uncertainty about pet food composition and labeling requirements causes confusion in the marketplace with potentially negative impacts for the credibility of the organic label in general. This action responds to a 2008 recommendation of the National Organic Standards Board (NOSB) and industry requests for organic pet food standards.

Summary of Legal Basis: The Organic Foods Production Act of 1990 (OFPA) authorizes the Secretary of Agriculture to establish an organic certification program for producers and handlers of agricultural products that have been produced using organic methods (7 U.S.C. 6503(a)). The OFPA also authorizes the NOSB to provide recommendations to the Secretary regarding the implementation of the National Organic Program (7 U.S.C. 6518(k)(1)).

Alternatives: AMS has considered the implications of developing specific composition and labeling standards for organic pet food versus maintaining the status quo and not pursuing regulatory action. In addition, AMS is examining options regarding potential implementation periods. Finally, AMS considered the viability of composition requirements that vary from those recommended by the NOSB.

Anticipated Cost and Benefits: This proposed rule would facilitate the marketing of organic pet food by establishing clear, enforceable requirements for the composition and labeling of these products. This action will clarify how pet food may be produced, certified, and marketed as organic and the significance of organic claims on pet food. That standardization would provide certainty to pet food handlers and certifying agents for manufacturing and certifying pet foods, respectively, and bolster consumer confidence. AMS does not expect this action to result in significant costs for the $109 million organic pet food sector (2012 sales). This action may be an incentive for some handlers that are using organic claims on noncertified pet food products to pursue certification. AMS intends to solicit specific public comments to validate this expectation.

Risks: AMS does not anticipate risks to be associated with this action. The NOSB and industry participated in the development of organic pet food standards and have strongly encouraged their adoption since 2008. This action may provoke questions about the Agency's intent with regard to a separate 2013 NOSB recommendation that would, in effect, prohibit the use of certain amino acids in organic pet food. AMS is evaluating the impact of that action; however, that recent recommendation is not expected to affect this rulemaking.

Timetable:

ActionDateFR Cite
NPRM04/00/15
Final Action08/00/16

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses, Organizations.

Government Levels Affected: Federal, Local, Tribal.

Agency Contact: Melissa R. Bailey, Director, Standards Division, Department of Agriculture, Agricultural Marketing Service, 14th & Independence Avenue SW., Room 2646-South Building, Washington, DC 20250, Start Printed Page 76476 Phone: 202 720-3252, Fax: 202 205-7808, Email: melissa.bailey@usda.gov.

RIN: 0581-AD20

USDA—AMS

3. National Organic Program, Organic Apiculture Practices Standard, NOP-12-0063

Priority: Other Significant.

Legal Authority: 7 U.S.C. 6501.

CFR Citation: 7 CFR 205.

Legal Deadline: NPRM, Statutory, July 31, 2015.

This action proposes to amend the USDA organic regulations to reflect an October 2010 recommendation submitted to the Secretary by the National Organic Standards Board (NOSB) concerning the production of organic apicultural (i.e. beekeeping) products.

Abstract: This action proposes to amend the USDA organic regulations to reflect an October 2010 recommendation submitted to the Secretary by the National Organic Standards Board (NOSB) concerning the production of organic apicultural (i.e. beekeeping) products. Instead of continuing to allow certifying agents to certify apiculture to the organic livestock standards, this action would establish certification standards specifically for organic bees and bee products.

Statement of Need: This action is necessary to establish uniform standards for certification of organic apiculture operations. Currently, certifying agents adapt the organic livestock standards to certify organic apiaries. This action is necessary to distinguish apiculture as a unique production system that merits separate organic standards and would address practices that are not covered in the general organic livestock requirements. This action is needed to ensure consistency across certifying agents in the inspection and certification of apiculture operations.

Summary of Legal Basis: Bees are regarded as “nonplant life” under definitions in the current Organic Foods Production Act (OFPA) and implementing regulations. Based on these definitions, apicultural products (bees and bee products) may currently be certified under the livestock provisions of the USDA organic regulations (7 CFR part 205).

Alternatives: AMS is considering variations in the implementation period needed for any existing organic honey producers to comply with a new proposed forage zone requirement. The agency is also considering an alternative to align with Canadian and EU apiculture which require land within the forage zone to be “organically managed,” rather than certified as crop or wild crop.

Anticipated Cost and Benefits: Issuing standards for management of bees and bee products will benefit the industry by bringing greater consistency across certifiers. The introduction of formal standards will encourage new producers to enter the market and increase consumer confidence in apiculture products marketed under the USDA organic seal. In terms of costs, accredited certifying agents that currently certify apiculture operations as livestock would be required to request to extend the scope (current possible scopes of accreditation are crops, livestock, handling, and wild crop) of their accreditation to include apiculture. AMS is currently evaluating how the new rule would impact the costs to existing organic producers.

Risks: AMS does not expect controversy as a result of this action. One provision that AMS anticipates public comment on during rulemaking pertains to a 1.8 mile forage zone radius around bee hives. Under the proposed standard, this forage zone would need to be comprised of certified organic cropland and/or certified wild crop harvest area. This provision may limit new producers in some parts of the world from entering the market. However, there is widespread recognition of the proposed requirements among certified operations, as many certifiers have started using the 2010 NOSB recommendation as guidance for certification of apiculture operations.

Timetable:

ActionDateFR Cite
NPRM07/00/15
Final Action12/00/16

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations.

Government Levels Affected: Federal, Local, State, Tribal.

Agency Contact: Melissa R. Bailey, Director, Standards Division, Department of Agriculture, Agricultural Marketing Service, 14th & Independence Avenue SW., Room 2646-South Building, Washington, DC 20250, Phone: 202 720-3252, Fax: 202 205-7808, Email: melissa.bailey@usda.gov

RIN: 0581-AD31

USDA—AMS

4. • National Organic Program—Organic Aquaculture Standards

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: Undetermined.

Legal Authority: 7 U.S.C. 6501 to 6522

CFR Citation: 7 CFR 205.

Legal Deadline: NPRM, Statutory, February 28, 2015.

This action will establish standards for organic farmed aquatic animals and their products to allow U.S. producers to compete in the organic seafood market. The Organic Foods Production Act authorizes the NOP to regulate organic claims on fish used for food. The USDA organic regulations do not include organic aquaculture standards. This action will open the market for U.S. organic aquaculture production and ensure that organic aquatic animal products sold in the U.S. meet a consistent standard.

Abstract: This action proposes to establish standards for organic production and certification of farmed aquatic animals and their products in the USDA organic regulations. This action would also add aquatic animals as a scope of certification and accreditation under the National Organic Program. This action is necessary to establish standards for organic farmed aquatic animals and their products which would allow U.S. producers to compete in the organic seafood market. This action is also necessary to address multiple recommendations provided by USDA by the National Organic Standards Board (NOSB). In 2007 through 2009, the NOSB made five recommendations to establish standards for the certification of organic farmed aquatic animals and their products. Finally, the U.S. currently has organic standards equivalence arrangements with Canada and the European Union (EU). Both Canada and the EU have recently established standards for organic aquaculture products. Because the U.S. does not have organic aquaculture standards, the U.S. is unable to include aquaculture in the scope of these arrangements. Establishing U.S. organic aquaculture may provide a basis for expanding those trade partnerships.

Statement of Need: In 2005, The Secretary of Agriculture appointed an Aquaculture Working Group to advise the National Organic Standards Board (NOSB) on drafting a recommendation on the production of organic farmed aquatic animals. The NOSB considered the Aquaculture Working Group's draft recommendations and provided USDA with a series of five recommendations Start Printed Page 76477from 2007-2009 for technical standards for the production and certification of organic farmed aquatic animals. Based on the NOSB recommendations, this action proposed to establish standards for organic production and certification of farmed aquatic animals and their products in the USDA organic regulations. This action would also add aquatic animals as an area of certification and accreditation under NOP.

Summary of Legal Basis: The Agricultural Marketing Service (AMS) National Organic Program (NOP) is authorized by the Organic Foods Production Act of 1990 (OFPA) to establish national standards governing the marketing of organically produced agricultural products (7 U.S.C. 6501-6522). The USDA organic regulations set the requirements for the organic certification of agricultural products (7 CFR Part 205). Participation under the NOP is voluntary. However, if organic producers or handlers choose to sell, represent, or label more than $5,000 in organic products, certification under the USDA organic regulations is required.

Alternatives: An alternative to providing organic aquatic animal standards would be to not publish such standards and allow aquatic animal products to continue to be sold as organic based on private standards or other countries standards. Organic seafood producers have expressed a strong interest in having USDA organic standards for fish and other aquatic animal products. U.S. aquaculture operations are generally hesitant to invest in organic aquaculture without published standards for organic aquatic animals and their products. Selecting such an alternative could result in failure for this sector of organic agriculture to develop in the United States.

Anticipated Cost and Benefits: The cost for existing conventional aquaculture operations to convert and participate in this voluntary marketing program will generally be incurred in the cost of changing management practices, increased feed costs, and obtaining organic certification. There will also be some costs to certifying agents who would need to add aquaculture to their areas of accreditation under the USDA organic regulations. These costs include application fees and expanded audits to ensure certifying agents meet the accreditation requirements needed for providing certification services to aquaculture operations. Certification of organic operations under the NOP is provided as a user-fee service by AMS-accredited private sector certifying agents and State agencies. AMS provides accreditation services to private and State agency certifiers on a cost-recovery, user-fee basis. AMS will not require additional appropriated funds to implement this program. By providing organic standards for organic aquatic animal products, producers will be able to sell certified organic aquatic animal products for up to 75-100 percent above the price of conventionally produced seafood. In addition, organic aquatic animal products imported into the U.S. from other countries will be required to meet a consistent, enforced standard. Organic consumers will be assured that organic aquatic animal products comply with the USDA organic regulations. The new standards will also provide the basis for expanding our organic standards equivalency agreements to include this additional area of organic products.

Risks: There are no known risks to providing these additional standards for certification of organic products.

Timetable:

ActionDateFR Cite
NPRM02/00/15
Final Action07/00/16

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses, Organizations.

Government Levels Affected: Federal.

Federalism: This action may have federalism implications as defined in EO 13132.

Agency Contact: Melissa R. Bailey, Director, Standards Division, Department of Agriculture, Agricultural Marketing Service, 14th & Independence Avenue SW., Room 2646-South Building, Washington, DC 20250, Phone: 202 720-3252, Fax: 202 205-7808, Email: melissa.bailey@usda.gov.

RIN: 0581-AD34

USDA—AMS

5. • Exemption of Producers and Handlers of Organic Products From Assessment Under a Commodity Promotion Law

Priority: Other Significant.

Unfunded Mandates: Undetermined.

Legal Authority: 7 U.S.C. 7401; Pub. L. 113-79.

CFR Citation: 7 CFR 900.

Legal Deadline: NPRM, Statutory, November 30, 2014.

This action would amend the general regulations that apply to the 29 marketing orders for fruits, vegetables, and specialty crops and the orders and/or rules and regulations of the 22 research and promotion programs under AMS oversight.

Abstract: As a result of this action, certified “organic” commodities (those comprising at least 95 percent organic components) would no longer be subject to assessment for promotion activities conducted under marketing order or research and promotion programs. In addition, certified organic commodities that are produced, handled, marketed, or imported by operations that also deal in conventional products would be eligible for exemptions. Currently, only products that are certified “100 percent organic” and that are produced and handled by entities that deal exclusively with organic products are exempt from assessments. This action is expected to reduce the assessment obligation for organic industry operators by as much as $13.7 million. Conversely, the impact on the marketing programs will be a loss of approximately $13.7 million in funds for generic commodity promotions.

Statement of Need: Section 501 of the Federal Agriculture Improvement and Reform Act of 1996 (7 U.S.C. 7401) (FAIR Act), as amended, currently exempts entities that produce and market solely 100 percent organic products from payment of assessments under commodity promotion laws. Section 10004 of the Agricultural Act of 2014 (Pub. L. 113-79) (Farm Bill) further amended the FAIR Act to provide exemptions for all certified organic products, including those produced and handled by operators that also deal in conventional products. This action is needed to bring existing Federal regulations governing commodity promotion activities into compliance with the FAIR Act, as amended by the Farm Bill.

Summary of Legal Basis: Section 10004 of the Agricultural Act of 2014 (Pub. L. 113-79) (Farm Bill) further amended the FAIR Act to provide exemptions for all certified organic products, including those produced and handled by operators that also deal in conventional products. This action is needed to bring existing Federal regulations governing commodity promotion activities into compliance with the FAIR Act, as amended by the Farm Bill.

Alternatives: Currently, only products that are certified “100 percent organic” and that are produced and handled by entities that deal exclusively with organic products are exempt from assessments. So the alternative, would be to continue in this manner.

Anticipated Cost and Benefits: This action is expected to reduce the assessment obligation for organic Start Printed Page 76478industry operators by as much as $13.7 million.

Risks: Conversely, the impact on the marketing programs will be a loss of approximately $13.7 million in funds for generic commodity promotions.

Timetable:

ActionDateFR Cite
NPRM11/00/14
Final Action07/00/15

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Governmental Jurisdictions.

Government Levels Affected: Undetermined.

Agency Contact: Michael V. Durando, Chief, Marketing Order Administration Branch, Department of Agriculture, Agricultural Marketing Service, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237, Phone: 202 720-2491, Fax: 202 720-8938.

RIN: 0581-AD37

USDA—Farm Service Agency (FSA)

Final Rule Stage

6. Noninsured Crop Disaster Assistance Program

Priority: Other Significant.

Legal Authority: 7 U.S.C. 7333.

CFR Citation: 7 CFR 1437.

Legal Deadline: None.

Abstract: The Commodity Credit Corporation (CCC) is amending regulations for the Noninsured Crop Disaster Assistance Program (NAP). NAP is administered for CCC by the Farm Service Agency (FSA). NAP provides producers of crops that are not eligible for crop insurance with a basic level of risk management coverage. NAP provides financial assistance to producers of non-insurable crops when low yield, loss of inventory, or prevented plantings occur due to a natural disaster. The rule includes changes to NAP required by the 2014 Farm Bill. The changes include revised NAP eligibility requirements for coverage on tilled native sod, and added coverage for sweet sorghum and biomass sorghum. Beginning and socially disadvantaged farmers will be eligible for service fee waivers. New “buy up” provisions will allow producers to buy additional NAP coverage for an additional premium. While the rule does not have a statutory deadline, the 2014 Farm Bill requires changes to the NAP program beginning with the 2015 coverage year, which begins as early as May 2014. In addition to the 2014 Farm Bill changes, the rule also makes the following changes:

  • Adds NAP coverage for organic crops.
  • Expands NAP coverage for mollusks, a common aquaculture crop. Specifically, it removes the current requirement that eligible mollusk inventory be seeded and raised in containers or similar devices designed to protect the aquaculture species.

Statement of Need: This rule is needed to update the FSA regulations to implement the 2014 Farm Bill changes.

Summary of Legal Basis: The Agricultural Act of 2014 (Pub. L. 113-79).

Alternatives: There are no alternatives to this rule, the changes are legislatively mandated.

Anticipated Cost and Benefits: A cost benefit analysis was prepared for this rule and will be made available when the rule is published.

Risks: None.

Timetable:

ActionDateFR Cite
Interim Final Rule12/00/14

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

URL For Public Comments: regulations.gov.

Agency Contact: Deirdre Holder, Director, Regulatory Review Group, Department of Agriculture, Farm Service Agency, 1400 Independence Avenue SW., Washington, DC 20250-0572, Phone: 202 205-5851, Fax: 202 720-5233, Email: deirdre.holder@wdc.usda.gov.

RIN: 0560-AI20

USDA—FSA

7. • Conservation Compliance

Priority: Other Significant.

Legal Authority: 7 U.S.C. 1501 et seq.; 16 U.S.C. 3811 and 3812; 16 U.S.C. 3821 and 3822.

CFR Citation: 7 CFR 12.

Legal Deadline: None.

Abstract: The interim rule implements mandatory changes to the conservation compliance regulations in 7 CFR part 12 as required by the Agricultural Act of 2014 (the 2014 Farm Bill). The current regulations require participants in most USDA programs to comply with conservation compliance measures on any land that is highly erodible or that is considered a wetland. The 2014 Farm Bill expands current conservation compliance requirements to apply to producers who obtain subsidized Federal crop insurance under the Federal Crop Insurance Act. It also slightly modifies the existing wetlands “Mitigation Banking” program to remove the requirement that USDA hold easements in the mitigation program.

Statement of Need: This rule is needed to update the FSA regulations to implement the 2014 Farm Bill changes.

Summary of Legal Basis: The Agricultural Act of 2014 (Pub. L. 113-79).

Alternatives: There are no alternatives to this rule; the changes are legislatively mandated.

Anticipated Cost and Benefits: A cost benefit analysis was prepared for this rule and will be made available when the rule is published.

Risks: None.

Timetable:

ActionDateFR Cite
Interim Final Rule02/00/15

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: None.

URL For Public Comments: regulations.gov.

Agency Contact: Deirdre Holder, Director, Regulatory Review Group, Department of Agriculture, Farm Service Agency, 1400 Independence Avenue SW., Washington, DC 20250-0572, Phone: 202 205-5851, Fax: 202 720-5233, Email: deirdre.holder@wdc.usda.gov.

RIN: 0560-AI26

USDA—FSA

8. • Conservation Reserve Program (CRP)

Priority: Other Significant.

Legal Authority: 16 U.S.C. 3831 to 3835.

CFR Citation: 7 CFR 1410.

Legal Deadline: None.

Abstract: The rule implements changes to CRP required by the 2014 Farm Bill. CRP assists producers in conserving and improving soil, water, and wildlife resources by converting highly erodible and other environmentally sensitive acreage to a long-term vegetative cover. The core scope of CRP will not change. The changes required by the 2014 Farm Bill include providing an “early out” for contract cancellations in 2015, removing the requirement for a payment reduction for emergency haying and grazing, and allowing non-cropland (grasslands) in CRP. CRP is a Commodity Credit Start Printed Page 76479Corporation (CCC) program administered by the Farm Service Agency (FSA).

Statement of Need: This rule is needed to update the FSA regulations to implement the 2014 Farm Bill changes.

Summary of Legal Basis: The Agricultural Act of 2014 (Pub. L. 113-79).

Alternatives: There are no alternatives to the rule; the changes are legislatively mandated.

Anticipated Cost and Benefits: A cost-benefit analysis will be prepared for the rule and will be made available when the rule is published.

Risks: None.

Timetable:

ActionDateFR Cite
Interim Final Rule04/00/15

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: None.

URL For Public Comments: regulations.gov.

Agency Contact: Deirdre Holder, Director, Regulatory Review Group, Department of Agriculture, Farm Service Agency, 1400 Independence Avenue SW., Washington, DC 20250-0572, Phone: 202 205-5851, Fax: 202 720-5233, Email: deirdre.holder@wdc.usda.gov.

RIN: 0560-AI30

USDA—Animal and Plant Health Inspection Service (APHIS)

Proposed Rule Stage

9. Brucellosis and Bovine Tuberculosis; Update of General Provisions

Priority: Other Significant.

Legal Authority: 7 U.S.C. 1622; 7 U.S.C. 8301 to 8317; 15 U.S.C. 1828; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701.

CFR Citation: 9 CFR 50 and 51; 9 CFR 71; 9 CFR 76 to 78; 9 CFR 86; 9 CFR 93; 9 CFR 161.

Legal Deadline: None.

Abstract: This rulemaking would consolidate the regulations governing bovine tuberculosis (TB), currently found in 9 CFR part 77, and those governing brucellosis, currently found in 9 CFR part 78. As part of this consolidation, we are proposing to transition the TB and brucellosis programs away from a State status system based on disease prevalence. Instead, States and tribes would implement an animal health plan that identifies sources of the diseases within the State or tribe and specifies mitigations to address the risk posed by these sources. The consolidated regulations would also set forth standards for surveillance, epidemiological investigations, and affected herd management that must be incorporated into each animal health plan, with certain limited exceptions; conditions for the interstate movement of cattle, bison, and captive cervids; and conditions for APHIS approval of tests for bovine TB or brucellosis. Finally, the rulemaking would revise the import requirements for cattle and bison to make these requirements clearer and ensure that they more effectively mitigate the risk of introduction of the diseases into the United States.

Statement of Need: The current regulations were issued during a time when the prevalence rates for the disease in domestic, cattle, bison, and captive cervids were much higher than they are today. As a result, the regulations specify measures that are necessary to prevent these diseases from spreading through the interstate movement of infected animals. The regulations are effective in this regard, but do not address reservoirs of tuberculosis and brucellosis that exist in certain States. Moreover, the regulations presuppose one method of dealing with infected herds—whole-herd depopulation—and do not take into consideration the development of other methods, such as test-and-remove protocols, that are equally effective but less costly for APHIS and producers. Finally, our current regulations governing the importation of cattle and bison do not always address the risk that such animals may pose of spreading brucellosis or bovine tuberculosis, and need to be updated to allow APHIS to take appropriate measures when prevalence rates for bovine tuberculosis or brucellosis increase or decrease in foreign regions.

Summary of Legal Basis: Under the Animal Health Protection Act (7 U.S.C. 8301 et seq.), the Secretary of Agriculture has the authority to issue orders and promulgate regulations to prevent the introduction into the United States and the dissemination within the United States of any pest or disease of livestock.

Alternatives: One alternative would be to leave the current regulations unchanged. As noted above, the current regulations are effective in preventing the interstate movement of infected animals, but do not address reservoirs of brucellosis and tuberculosis that exist in certain States and thus do not address the root cause of such infection. They also are written in a prescriptive manner which does not allow States to take into consideration scientific developments and other emerging information in determining how best to deal with infected animals and herds. Finally, APHIS' current regulations governing the importation of cattle and bison do not always address the risk that such animals may pose of spreading bovine tuberculosis or brucellosis.

A second alternative considered was to limit the scope of the regulatory changes to the Agency's domestic tuberculosis and brucellosis program. However, in recent years, when tuberculosis-affected animals have been discovered at slaughtering facilities within the United States, these animals have usually been of foreign origin. This has led us to reexamine the current import regulations. As a result of this reevaluation, we have determined that the import regulations need to be revised to assure that they more effectively mitigate the risk of introduction of these diseases into the United States.

Anticipated Cost and Benefits: Certain additional costs may be incurred by producers as a result of this rule. For example, the proposed rule would impose new interstate movement restrictions on rodeo, event, and exhibited cattle and bison and impose additional costs for producers of such cattle and bison. These new testing requirements could cost, in aggregate, between $651,000 and $1 million. Also, the proposed additional restrictions for the movement of captive cervids could result in additional costs for producers. Adhering to these new requirements may have a total cost to the captive cervid industry of between about $157,000 and $485,000 annually. States and tribes would incur costs associated with this proposed rule, in particular in developing animal health plans for bovine tuberculosis and brucellosis. The proposed animal health plans for brucellosis and bovine tuberculosis would build significantly on existing operations with respect to these diseases. We anticipate that all 50 States and as many as 3 tribes would develop animal health plans. Based on our estimates of plan development costs, the total cost of the development of these 53 animal health plans could be between about $750,000 and $2.9 million. We expect that under current circumstances, four or five States are likely to develop recognized management area plans as proposed in this rule as part of their animal health plans. Based on our estimates of recognized management area plan development costs, the cost of developing recognized management area plans by these States could total Start Printed Page 76480between $56,000 and $274,000. While direct effects of this proposed rule for producers should be small, whether the entity affected is small or large, consolidation of the brucellosis and bovine tuberculosis regulations is expected to benefit the affected livestock industries. Disease management would be more focused, flexible and responsive, reducing the number of producers incurring costs when disease concerns arise in an area. Also, the competitiveness of the United States in international markets depends on its reputation for producing healthy animals. The proposed rule would enhance this reputation through its comprehensive approach to the control of identified reservoirs of bovine tuberculosis or brucellosis in wildlife populations in certain parts of the United States and more stringent import regulations consistent with domestic restrictions. We expect that the benefits would justify the costs.

Risks: If we do not issue this proposed rule, reservoirs of brucellosis and tuberculosis that exist in certain States will not be adequately evaluated and addressed. Additionally, our current regulations regarding the importation of cattle and bison do not always address the risk that such animals may pose of spreading brucellosis or bovine tuberculosis.

Timetable:

ActionDateFR Cite
NPRM01/00/15
NPRM Comment Period End03/00/15

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses, Governmental Jurisdictions.

Government Levels Affected: Local, State, Tribal.

Additional Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.

Agency Contact: Langston Hull, National Center for Import and Export, VS, Department of Agriculture, Animal and Plant Health Inspection Service, 4700 River Road, Unit 39, Riverdale, MD 20737, Phone: 301 851-3300.

C. William Hench, Senior Staff Veterinarian, Ruminant Health Programs, National Center for Animal Health Programs, VS, Department of Agriculture, Animal and Plant Health Inspection Service, 2150 Centre Avenue, Building B-3E20, Ft. Collins, CO 80526, Phone: 970 494-7378.

RIN: 0579-AD65

USDA—APHIS

10. Establishing a Performance Standard for Authorizing the Importation and Interstate Movement of Fruits and Vegetables

Priority: Other Significant.

Legal Authority: 7 U.S.C. 450; 7 U.S.C. 7701 to 7772; 7 U.S.C. 7781 to 7786; 21 U.S.C. 136 and 136a.

CFR Citation: 7 CFR 318 and 319.

Legal Deadline: None.

Abstract: This rulemaking would amend our regulations governing the importations of fruits and vegetables by broadening our existing performance standard to provide for consideration of all new fruits and vegetables for importation into the United States using a notice-based process. Rather than authorizing new imports through proposed and final rules and specifying import conditions in the regulations, the notice-based process uses Federal Register notices to make risk analyses available to the public for review and comment, with authorized commodities and their conditions of entry subsequently being listed on the Internet. It would also remove the region- or commodity-specific phytosanitary requirements currently found in these regulations. Likewise, we are proposing an equivalent revision of the performance standard in our regulations governing the interstate movements of fruits and vegetables from Hawaii and the U.S. territories (Guam, Northern Mariana Islands, Puerto Rico, and the U.S. Virgin Islands) and the removal of commodity-specific phytosanitary requirements from those regulations. This proposal would allow for the consideration of requests to authorize the importation or interstate movement of new fruits and vegetables in a manner that enables a more flexible and responsive regulatory approach to evolving pest situations in both the United States and exporting countries. It would not, however, alter the science-based process in which the risk associated with importation or interstate movement of a given fruit or vegetable is evaluated or the manner in which risks associated with the importation or interstate movement of a fruit or vegetable are mitigated.

Statement of Need: The revised regulations are needed to streamline the administrative process involved in consideration of fruits and vegetables currently not authorized for interstate movement or importation, while continuing to provide opportunity for public comment and engagement on the science and risk-based analysis associated with such imports and interstate movements. The proposal would also enable us to adapt our import requirements more quickly in the event of any changes to a country's pest or disease status or as a result of new scientific information or treatment options.

Summary of Legal Basis: Under section 7701 of the Plant Protection Act (PPA), given that the smooth movement of enterable plants and plant products into, out of, or within the United States is vital to the U.S. economy, it is the responsibility of the Secretary of Agriculture to facilitate exports, imports, and interstate commerce in agricultural products and other commodities that pose a risk of harboring plant pests or noxious weeds in ways that will reduce, to the extent practicable, as determined by the Secretary, the risk of dissemination of plant pests or noxious weeds. Decisions regarding exports, imports, and interstate commerce are required to be based on sound science.

Alternatives: We considered taking no action at this time and leaving the regulations as they are currently written. We decided against this alternative because leaving the regulations unchanged would not address the needs identified immediately above.

Anticipated Cost and Benefits: Consumers and businesses would benefit from the more timely access to fruits and vegetables for which entry or movement would currently require rulemaking. This benefit would be reduced to the extent that certain businesses would face increased competition for the subject fruits and vegetables sooner due to their more timely approval. APHIS has not identified other costs that may be incurred because of the proposed rule.

Risks: The performance-based process more closely links APHIS' decision to authorize importation of a fruit or vegetable with the pest risk assessment and brings us in line with other countries that authorize importation of a fruit or vegetable with the pest risk assessment. Some countries have viewed the rulemakings for fruits and vegetables that follow completion of the pest risk assessment as a non-technical trade barrier and may have slowed the approval of U.S. exports (including, but not limited to, fruits and vegetables) into their markets, or placed additional restrictions on existing exports from the United States.

Timetable:

ActionDateFR Cite
NPRM09/09/1479 FR 53346
NPRM Comment Period End11/10/14
Start Printed Page 76481
Final Rule04/00/15

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Federal.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Additional Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.

Agency Contact: Matthew Rhoads, Associate Executive Director, Plant Health Programs, PPQ, Department of Agriculture, Animal and Plant Health Inspection Service, 4700 River Road, Unit 131, Riverdale, MD 20737-1231, Phone: 301 851-2133.

RIN: 0579-AD71

USDA—APHIS

Final Rule Stage

11. Viruses, Serums, Toxins, and Analogous Products; Single Label Claim for Veterinary Biological Products

Priority: Other Significant.

Legal Authority: 21 U.S.C. 151 to 159

CFR Citation: 9 CFR 112.

Legal Deadline: None.

Abstract: This rulemaking will amend the Virus-Serum-Toxin Act regulations to replace the current label format, which reflects any of four different levels of effectiveness, with a single, uniform label format. It will also require biologics licensees to provide a standardized summary, with confidential business information removed, of the efficacy and safety data submitted to the Animal and Plant Health Inspection Service in support of the issuance of a full product license or conditional license. A single label format along with publicly available safety and efficacy data will help biologics producers to more clearly communicate product performance to their customers.

Statement of Need: The intent of this proposal is to address a request made by our stakeholders and to more clearly communicate product performance information to the user by requiring a uniform label format and a summary of efficacy and safety data (with confidential business information removed).

Summary of Legal Basis: APHIS administers and enforces the Virus-Serum-Toxin Act, as amended (21 U.S.C. 151 to 159). The regulations issued pursuant to the Act are intended to ensure that veterinary biological products are pure, safe, potent, and efficacious when used according to label instructions.

Alternatives: We could retain the current APHIS labeling guidance, but maintaining the status quo would not address the concern reported by stakeholders concerning the interpretation of product performance.

Anticipated Cost and Benefits: APHIS anticipates that the only costs associated with the proposed labeling format would be one-time costs incurred by licensees and permittees in having labels for existing licensed products updated in accordance with the proposed new format. A simpler, uniform label format would allow biologics licensees and permittees to more clearly communicate product performance information to the end user. In addition, the rule would simplify the evaluation of efficacy studies and reduce the amount of time required by APHIS to evaluate study data, thus allowing manufacturers to market their products sooner.

Risks: APHIS has not identified any risks associated with this proposed action.

Timetable:

ActionDateFR Cite
Notice05/24/1176 FR 30093
Comment Period End07/25/11
NPRM04/21/1479 FR 22048
NPRM Comment Period End06/20/14
Final Action05/00/15

Regulatory Flexibility Analysis Required: Undetermined.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Additional Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.

Agency Contact: Donna L Malloy, Operational Support Section, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, VS, Department of Agriculture, Animal and Plant Health Inspection Service, 4700 River Road, Unit 148, Riverdale, MD 20737-1231, Phone: 301 851-3426.

RIN: 0579-AD64

USDA—APHIS

12. User Fees for Agricultural Quarantine and Inspection Services

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority: 7 U.S.C. 7701 to 7772; 7 U.S.C. 7781 to 7786; 7 U.S.C. 8301 to 8317; 21 U.S.C. 136 and 136a; 49 U.S.C. 80503

CFR Citation: 7 CFR 354.

Legal Deadline: None.

Abstract: This rulemaking will amend the user fee regulations by adding new fee categories and adjusting current fees charged for certain agricultural quarantine and inspection services that are provided in connection with certain commercial vessels, commercial trucks, commercial railroad cars, commercial aircraft, and international passengers arriving at ports in the customs territory of the United States. It will also adjust the fee caps associated with commercial vessels, commercial trucks, and commercial railcars. Based on the conclusions of a third party assessment of the user fee program and on other considerations, we have determined that revised user fee categories and revised user fees are necessary to recover the costs of the current level of activity, to account for actual and projected increases in the cost of doing business, and to more accurately align fees with the costs associated with each fee service.

Statement of Need: Regarding certain agricultural quarantine and inspection services that are provided in connection with certain commercial vessels, commercial trucks, commercial railroad cars, commercial aircraft, and international passengers arriving at ports in the customs territory of the United States, we have determined that revised user fee categories and revised user fees are necessary to recover the costs of the current level of activity, to account for actual and projected increases in the cost of doing business, and to more accurately align fees with the costs associated with each fee service.

Summary of Legal Basis: Section 2509(a) of the Food, Agriculture, Conservation, and Trade (FACT) Act of 1990 (21 U.S.C. 136a) authorizes APHIS to collect user fees for certain agricultural quarantine and inspection (AQI) services. The FACT Act was amended on April 4, 1996, and May 13, 2002. The FACT Act, as amended, authorizes APHIS to collect user fees for AQI services provided in connection with the arrival, at a port in the customs territory of the United States, of commercial vessels, commercial trucks, commercial railroad cars, commercial aircraft, and international passengers. According to the FACT Act, as amended, these user fees should recover the costs of:Start Printed Page 76482

  • Providing the AQI services for the conveyances and the passengers listed above;
  • Providing preclearance or preinspection at a site outside the customs territory of the United States to international passengers, commercial vessels, commercial trucks, commercial railroad cars, and commercial aircraft;
  • Administering the user fee program; and
  • Maintaining a reasonable reserve.

In addition, the FACT Act, as amended, contains the following requirement:

  • The fees should be commensurate with the costs with respect to the class of persons or entities paying the fees. This is intended to avoid cross-subsidization of AQI services.

Alternatives: APHIS focused on three alternatives composed of different combinations of paying classes. The first or preferred alternative is the proposed rule; the second alternative differed from the first by not including user fees for recipients of AQI treatment services; and under the third alternative, recipients of commodity import permits and pest import permits would pay user fees, in addition to the classes that would pay fees under the proposed rule. The latter two alternatives were rejected.

Anticipated Cost and Benefits: The proposed changes in user fees would ensure that the program can continue to protect America's agricultural industries and natural resource base against invasive species and diseases while more closely aligning, by class, the cost of AQI services provided and user fee revenue received.

Risks: AQI services benefit U.S. agricultural and natural resources by protecting them from the inadvertent introduction of foreign pests and diseases that may enter the country and the threat of intentional introduction of pests or pathogens as a means of agroterrorism. In the extreme, failure to maintain the nation's biosecurity could disrupt American agricultural production, erode confidence in the U.S. food supply, and destabilize the U.S. economy.

Timetable:

ActionDateFR Cite
NPRM04/25/1479 FR 22895
NPRM Comment Period End06/24/14
NPRM Comment Period Reopened07/01/1479 FR 37231
NPRM Comment Period Reopened End07/24/14
Final Rule12/00/14

Regulatory Flexibility Analysis Required: Undetermined.

Small Entities Affected: Businesses.

Government Levels Affected: Federal.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Additional Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.

Agency Contact: William E Thomas, Senior Agriculturist, Office of the Deputy Administrator, PPQ, Department of Agriculture, Animal and Plant Health Inspection Service, 4700 River Road, Unit 130, Riverdale, MD 20737, Phone: 301 851-2306.

Kris Caraher, Branch Chief, Review and Analysis, Financial Management Division, MRPBS, Department of Agriculture, Animal and Plant Health Inspection Service, 4700 River Road, Unit 55, Riverdale, MD 20737, Phone: 301 851-2834.

RIN: 0579-AD77

USDA—FOOD AND NUTRITION SERVICE (FNS)

Proposed Rule Stage

13. Emergency Supplemental Nutrition Assistance for Victims of Disasters Procedures

Priority: Other Significant.

Legal Authority: Food and Nutrition Act of 2008

CFR Citation: 7 CFR 280.

Legal Deadline: None.

Abstract: The Food and Nutrition Act of 2008 (FNA) provides authority for the Secretary of Agriculture to establish temporary emergency standards of eligibility for the duration of an emergency for households who are victims of a disaster that disrupts commercial channels of food distribution. FNS plans to publish a Proposed Rule for D-SNAP that will codify longstanding policies disseminated through previous guidance.

Statement of Need: A 2007 Office of Inspector General (OIG) report (Audit 27099-49-Te: Disaster Food Stamp Program for Hurricanes Katrina and Rita—Louisiana, Mississippi, and Texas—Final Report) found some deficits in the design and review of State D-SNAP plans of operation and inadequate controls to prevent recipient fraud and duplicate participation. OIG attributed the deficits, in part, to a lack of detailed procedures in regulations and, in response, recommended that FNS amend D-SNAP policy on those specific topics and promulgate D-SNAP regulations.

Summary of Legal Basis: The Food and Nutrition Act of 2008 (FNA) provides authority for the Secretary of Agriculture to establish temporary emergency standards of eligibility for the duration of an emergency for households who are victims of a disaster which disrupts commercial channels of food distribution.

Alternatives: None identified; this Proposed Rule primarily will codify long-standing D-SNAP procedures.

Anticipated Cost and Benefits: As the Proposed Rule primarily will codify longstanding D-SNAP procedures, FNS anticipates that this rule will not result in any significant costs.

Risks: No risks are anticipated as the proposed rule will codify longstanding procedures.

Timetable:

ActionDateFR Cite
NPRM03/00/15
NPRM Comment Period End05/00/15

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: Local, State.

Agency Contact: Charles H. Watford, Regulatory Review Specialist, Department of Agriculture, Food and Nutrition Service, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 605-0800, Email: charles.watford@fns.usda.gov.

Lynnette M. Thomas, Chief, Planning and Regulatory Affairs Branch, Department of Agriculture, Food and Nutrition Service, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 605-4782, Email: lynnette.thomas@fns.usda.gov.

RIN: 0584-AE00

USDA—FNS

14. Child Nutrition Program Integrity

Priority: Other Significant.

Legal Authority: Pub. L. 111-296.

CFR Citation: 7 CFR 210; 7 CFR 215; 7 CFR 220; 7 CFR 225; 7 CFR 226; 7 CFR 235.

Legal Deadline: None.

Abstract: This rule proposes to codify three provisions of the Healthy, Hunger-Free Kids Act of 2010 (the Act). Section 303 of the Act requires the Secretary to establish criteria for imposing fines against schools, school food authorities, or State agencies that fail to correct severe mismanagement of the program, Start Printed Page 76483fail to correct repeat violations of program requirements, or disregard a program requirement of which they had been informed. Section 322 of the Act requires the Secretary to establish procedures for the termination and disqualification of organizations participating in the Summer Food Service Program (SFSP). Section 362 of the Act requires that any school, institution, service institution, facility, or individual that has been terminated from any program authorized under the Richard B. Russell National School Lunch Act or the Child Nutrition Act of 1966, and appears on either the SFSP or the Child and Adult Care Food Program's (CACFP's) disqualified list, may not be approved to participate in or administer any other programs authorized under those two Acts.

Statement of Need: There are currently no regulations imposing fines on schools, school food authorities, or State agencies for program violations and mismanagement. This rule will: (1) Establish criteria for imposing fines against schools, school food authorities, or State agencies that fail to correct severe mismanagement of the program or repeated violations of program requirements; (2) establish procedures for the termination and disqualification of organizations participating in the Summer Food Service Program (SFSP); and (3) require that any school, institutions, or individual that has been terminated from any Federal Child Nutrition Program and appears on either the SFSP or the Child and Adult Care Food Program's (CACFP's) disqualified list may not be approved to participate in or administer any other Child Nutrition Program.

Summary of Legal Basis: This rule codifies Sections 303, 322, and 362 of the Healthy, Hunger-Free Kids Act of 2010 (Pub. L. 111-296).

Alternatives: None identified; this rule implements statutory requirements.

Anticipated Cost and Benefits: This rule is expected to help promote program integrity in all of the child nutrition programs. FNS anticipates that these provisions will have no significant costs and no major increase in regulatory burden to States.

Risks: None identified.

Timetable:

ActionDateFR Cite
NPRM01/00/15
NPRM Comment Period End03/00/15

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: Local, State.

Federalism: This action may have federalism implications as defined in EO 13132.

Agency Contact: James F Herbert, Regulatory Review Specialist, Department of Agriculture, Food and Nutrition Service, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 305-2572, Email: james.herbert@fns.usda.gov.

Lynnette M Thomas, Chief, Planning and Regulatory Affairs Branch, Department of Agriculture, Food and Nutrition Service, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 605-4782, Email: lynnette.thomas@fns.usda.gov.

RIN: 0584-AE08

USDA—FNS

15. Child and Adult Care Food Program: Meal Pattern Revisions Related to the Healthy, Hunger-Free Kids Act of 2010

Priority: Other Significant.

Legal Authority: Pub. L. 111-296

CFR Citation: 7 CFR 210; 7 CFR 215; 7 CFR 220; 7 CFR 226.

Legal Deadline: None.

Abstract: This proposal would implement section 221 of the Healthy, Hunger-Free Kids Act of 2010 (Pub. L. 111-296; the Act) which requires USDA to review and update, no less frequently than once every 10 years, requirements for meals served under the Child and Adult Care Food Program (CACFP) to ensure that meals are consistent with the most recent Dietary Guidelines for Americans and relevant nutrition science.

Statement of Need: Section 221 of the Healthy, Hunger-Free Kids Act of 2010 (Pub. L. 111-296, the Act) requires USDA to review and update, no less frequently than once every 10 years, requirements for meals served under the Child and Adult Care Food Program (CACFP) to ensure that meals are consistent with the most recent Dietary Guidelines for Americans and relevant nutrition science. The Act also clarifies the purpose of the program, restricts the use of food as a punishment or reward, outlines requirements for milk and milk substitution, and introduces requirements for the availability of water. This rule will establish the criteria and procedures for implementing these provisions of the Act.

Summary of Legal Basis: Section 221 of the Healthy, Hunger-Free Kids Act of 2010 (Pub. L. 111-296).

Alternatives: There are several instances throughout this rule and its associated Regulatory Impact Analysis that offer alternatives for review and comment to the various criteria and procedures discussed in this proposed rule.

Anticipated Cost and Benefits: This rule is expected to improve the nutritional quality of meals served and the overall health of children participating in the CACFP. Most CACFP meals are served to children from low-income households. At this time, we cannot estimate the financial impact the proposed rule will have on State agencies, sponsoring organizations, and child care institutions, but we expect that there will be a small cost increase associated with the implementation of improved meal pattern requirements. A regulatory impact analysis will be conducted to determine these cost implications.

Risks: None identified.

Timetable:

ActionDateFR Cite
NPRM11/00/14
NPRM Comment Period End01/00/15

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Governmental Jurisdictions.

Government Levels Affected: Local, State.

Agency Contact: James F. Herbert, Regulatory Review Specialist, Department of Agriculture, Food and Nutrition Service, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 305-2572, Email: james.herbert@fns.usda.gov.

Lynnette M. Thomas, Chief, Planning and Regulatory Affairs Branch, Department of Agriculture, Food and Nutrition Service, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 605-4782, Email: lynnette.thomas@fns.usda.gov.

RIN: 0584-AE18

USDA—FNS

16. Enhancing Retailer Eligibility Standards In SNAP

Priority: Other Significant.

Legal Authority: Sec 3, U.S.C. 2012; sec 9, U.S.C. 2018

CFR Citation: 7 CFR 271.2; 7 CFR 278.1.

Legal Deadline: None.

Abstract: This rulemaking will address the criteria used to authorize redemption of SNAP benefits (especially by restaurant-type operations).

Statement of Need: The 2014 Farm Bill amended the Food and Nutrition Start Printed Page 76484Act of 2008 to increase the requirement that certain SNAP authorized retail food stores have available on a continual basis at least three varieties of items in each of four staple food categories to a mandatory minimum of seven. The 2014 Farm Bill also amended the Act to increase for certain SNAP authorized retail food stores the minimum number of categories in which perishable foods are required from two to three. This rule would codify these mandatory requirements. Further, using existing authority in the Act and feedback from an expansive Request for Information, the rulemaking also proposes changes to address depth of stock, redefine staple and accessory foods, and amend the definition of retail food store to clarify when a retailer is a restaurant rather than a retail food store.

Summary of Legal Basis: Section 3(k) of the Food and Nutrition Act of 2008 (the Act) generally (with limited exception) (1) requires that food purchased with SNAP benefits be meant for home consumption and (2) forbids the purchase of hot foods with SNAP benefits. The intent of those statutory requirements can be circumvented by selling cold foods, which may be purchased with SNAP benefits, and offering onsite heating or cooking of those same foods, either for free or at an additional cost. In addition, Section 9 of the Act provides for approval of retail food stores and wholesale food concerns based on their ability to effectuate the purposes of the Program.

Alternatives: Because this proposed rule is under development, alternatives are not yet articulated.

Anticipated Cost and Benefits: The proposed changes will allow FNS to improve access to healthy food choices for SNAP participants and to ensure that participating retailers effectuate the purposes of the Program. FNS anticipates that these provisions will have no significant costs to States.

Risks: None identified.

Timetable:

ActionDateFR Cite
NPRM08/00/15

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: State.

Agency Contact: Charles H. Watford, Regulatory Review Specialist, Department of Agriculture, Food and Nutrition Service, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 605-0800, Email: charles.watford@fns.usda.gov.

Lynnette M. Thomas, Chief, Planning and Regulatory Affairs Branch, Department of Agriculture, Food and Nutrition Service, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 605-4782, Email: lynnette.thomas@fns.usda.gov.

RIN: 0584-AE27

USDA—FNS

Final Rule Stage

17. Supplemental Nutrition Assistance Program: Farm Bill of 2008 Retailer Sanctions

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority: Pub. L. 110-246

CFR Citation: 7 CFR 276.

Legal Deadline: None.

Abstract: This final rule would implement provisions under section 4132 of the Food, Conservation, and Energy Act of 2008, giving the Department of Agriculture's Food and Nutrition Service (FNS) the authority to assess a civil penalty and to disqualify a retail or wholesale food store authorized to participate in SNAP.

Statement of Need: This final rule implements the provisions of the 2008 Farm Bill that provide the U.S. Department of Agriculture greater flexibility in assessing sanctions against retail food stores and wholesale food concerns found in violation of the Supplemental Nutrition Assistance Program rules. This rule updates SNAP retailer sanction regulations to include authority granted in the 2008 Farm Bill to allow the Food and Nutrition Service (FNS) to impose a civil penalty in addition to disqualification, raise the allowable penalties per violation and provide greater flexibility to the Department for minor violations.

Summary of Legal Basis: Section 4132, Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246).

Alternatives: For the new trafficking civil penalty, FNS considered alternatives for assessing a civil penalty in addition to permanent disqualification for stores sanctioned for trafficking.

Anticipated Cost and Benefits: The changes to the retailer sanction regulations will improve program integrity by increasing the deterrent effect of sanctions on the small number of authorized firms that commit program violations.

Risks: The risk that retail or wholesale food stores will violate SNAP rules, or continue to violate SNAP rules, is expected to be reduced by refining program sanctions for participating retailers and wholesalers.

Timetable:

ActionDateFR Cite
NPRM08/14/1277 FR 48461
NPRM Comment Period End10/15/12
Final Action01/00/15

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: State.

Additional Information: Note: This RIN replaces the previously issued RIN 0584-AD78.

Agency Contact: Charles H. Watford, Regulatory Review Specialist, Department of Agriculture, Food and Nutrition Service, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 605-0800, Email: charles.watford@fns.usda.gov.

Lynnette M. Thomas, Chief, Planning and Regulatory Affairs Branch, Department of Agriculture, Food and Nutrition Service, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 605-4782, Email: lynnette.thomas@fns.usda.gov.

RIN: 0584-AD88

USDA—FNS

18. Child Nutrition Programs: Local School Wellness Policy Implementation Under the Healthy, Hunger-Free Kids Act of 2010

Priority: Other Significant.

Legal Authority: Pub. L. 111-296

CFR Citation: 7 CFR 210; 7 CFR 220.

Legal Deadline: None.

Abstract: This final rule codifies a provision of the Healthy, Hunger-Free Kids Act (Pub. L. 111-296; the Act) under 7 CFR parts 210 and 220. Section 204 of the Act requires each local educational agency (LEA) to establish, for all schools under its jurisdiction, a local school wellness policy. The Act requires that the wellness policy include goals for nutrition, nutrition education, physical activity, and other school-based activities that promote student wellness. In addition, the Act requires that local educational agencies ensure stakeholder participation in development of their local school wellness policies, and periodically assess compliance with the policies, and disclose information about the policies to the public.

Statement of Need: Schools play a critical role in promoting student health, preventing childhood obesity, and combating problems associated with poor nutrition and physical inactivity. To formalize and encourage this role, section 204 of the Child Nutrition and WIC Reauthorization Act of 2004 (Pub. L. 108-265), required each Start Printed Page 76485local educational agency (LEA) participating in the National School Lunch Program (NSLP) and/or the School Breakfast Program (SBP) to establish a local school wellness policy by School Year 2006. Subsequently, section 204 of the Healthy, Hunger-Free Kids Act of 2010 (HHFKA, Pub. L. 111-296, December 13, 2010) added a new section 9A to the Richard B. Russell National School Lunch Act (NSLA) (42 U.S.C. 1758b) which expands the scope of wellness policies; brings additional stakeholders into the development, implementation, and review of local school wellness policies; and requires public updates on the content and implementation of the wellness policies.

Summary of Legal Basis: Section 204 of the Child Nutrition and WIC Reauthorization Act of 2004 (Pub. L. 108-265); Section 204 of the Healthy, Hunger-Free Kids Act of 2010 (HHFKA, Pub. L. 111-296).

Alternatives: Alternatives to some of the policy provisions were outlined in the proposed rule and will be discussed in the final rule.

Anticipated Cost and Benefits: The rule strengthens local school wellness policy requirements. As described in the Regulatory Impact Analysis, we expect this to improve health outcomes for students, though we are not able to quantify these benefits. Minimal administrative expenses are estimated in relation to additional reporting and recordkeeping requirements.

Risks: None identified.

Timetable:

ActionDateFR Cite
NPRM02/26/1479 FR 10693
NPRM Comment Period End04/28/14
Final Action04/00/15

Regulatory Flexibility Analysis Required:: Yes.

Small Entities Affected: Governmental Jurisdictions.

Government Levels Affected: Local, State.

Agency Contact: James F. Herbert, Regulatory Review Specialist, Department of Agriculture, Food and Nutrition Service, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 305-2572, Email: james.herbert@fns.usda.gov.

Lynnette M. Thomas, Chief, Planning and Regulatory Affairs Branch, Department of Agriculture, Food and Nutrition Service, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 605-4782, Email: lynnette.thomas@fns.usda.gov.

RIN: 0584-AE25

USDA—FNS

19. • SNAP: Employment and Training (E&T) Performance Measurement, Monitoring and Reporting Requirements

Priority: Other Significant.

Legal Authority: Pub. L. 113-79

CFR Citation: 7 CFR 273.

Legal Deadline: None.

Abstract: This rule will implement the E&T provisions of section 4022 of The Agricultural Act of 2014. The provisions of the Agricultural Act of 2014 require reporting measures for States' E&T programs.

Statement of Need: Section 4022 of Agricultural Act of 2014 states that “Not later than 18 months after the date of enactment of this Act, the Secretary shall issue interim final regulations implementing the amendments made by subsection (a)(2).” This interim rule will address the amendments in subsection (a)(2). This rule will also address the USDA Office of Inspector General (OIG) audit entitled “Food Stamp Employment and Training Program” (OIG #27601-16-AT), released March 31, 2008, that recommended FNS establish performance measures for the SNAP E&T Program. This rule will bring closure to that audit recommendation.

Summary of Legal Basis: Section 4022 of Agricultural Act of 2014.

Alternatives: Alternatives will be identified in the interim final rule.

Anticipated Cost and Benefits: Costs and Benefits will be identified in the interim final rule.

Risks: Risks, if applicable, will be identified in the interim final rule.

Timetable:

ActionDateFR Cite
Interim Final Rule04/00/15

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: Local, State.

Agency Contact: Charles H. Watford, Regulatory Review Specialist, Department of Agriculture, Food and Nutrition Service, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 605-0800, Email: charles.watford@fns.usda.gov.

Lynnette M. Thomas, Chief, Planning and Regulatory Affairs Branch, Department of Agriculture, Food and Nutrition Service, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 605-4782, Email: lynnette.thomas@fns.usda.gov.

RIN: 0584-AE33

USDA—Food Safety and Inspection Service (FSIS)

Proposed Rule Stage

20. Requirements for the Disposition of Non-Ambulatory Disabled Veal Calves

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Legal Authority: Federal Meat Inspection Act (21 U.S.C. 601 et seq.)

CFR Citation: 9 CFR 309.

Legal Deadline: None.

Abstract: FSIS is proposing to amend the ante-mortem inspection regulations to remove a provision that permits establishments to set apart and hold for treatment veal calves that are unable to rise from a recumbent position and walk because they are tired or cold (9 CFR 309.13(b)). The regulations permit such calves to proceed to slaughter if they are able to rise and walk after being warmed or rested. FSIS is proposing to require that non-ambulatory disabled (NAD) veal calves that are offered for slaughter be condemned and promptly euthanized. The existing regulations require that NAD mature cattle be condemned on ante-mortem inspection and that they be promptly euthanized (9 CFR 309.3(e)). FSIS believes that prohibiting the slaughter of all NAD veal calves would improve compliance with the Humane Methods of Slaughter Act of 1978 (HMSA), and the humane slaughter implementing regulations. It would also improve the Agency's inspection efficiency by eliminating the time that FSIS inspection program personnel (IPP) spend assessing and supervising the treatment of NAD veal calves.

Statement of Need: Removing the provision from 9 CFR 309.13(b) would eliminate uncertainty as to what is to be done with veal calves that are non-ambulatory disabled because they are tired or cold, or because they are injured or sick, thereby ensuring the appropriate disposition of these animals. In addition, removing the provision in 9 CFR 309.13(b) would improve inspection efficiency by eliminating the time that FSIS IPP spend assessing the treatment of non-ambulatory disabled veal calves.

Summary of Legal Basis: 21 U.S.C. 603 (a) and (b).

Alternatives: The Agency considered two alternatives to the proposed amendment: The status quo and prohibiting the slaughter of non-ambulatory disabled “bob veal,” which are calves generally less than one week old.

Anticipated Cost and Benefits: If the proposed rule is adopted, non-Start Printed Page 76486ambulatory disabled veal calves will not be re-inspected during ante-mortem inspection. The veal calves that are condemned during ante-mortem inspection will be euthanized. The estimated annual cost to the veal industry would range between $2,368 and $161,405.

The expected benefits of this proposed rule are not quantifiable. However, the proposed rule will ensure the humane disposition of the non-ambulatory disabled veal calves. It will also increase the efficiency and effective implementation of inspection and humane handling requirements at official establishments.

Risks: None.

Timetable:

ActionDateFR Cite
NPRM04/00/15

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: Dr. Daniel L. Engeljohn, Assistant Administrator, Office of Policy and Program Development, Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, 349-E JWB, Washington, DC 20250, Phone: 202 205-0495, Fax: 202 720-2025, Email: daniel.engeljohn@fsis.usda.gov.

RIN: 0583-AD54

USDA—FSIS

Final Rule Stage

21. Mandatory Inspection of Fish of the Order Siluriformes and Products Derived From Such Fish

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority: Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 to 695); Pub. L. 110-246, sec 11016; Pub. L. 113-79, sec 12106

CFR Citation: 9 CFR ch III, subchapter F (new).

Legal Deadline: Final, Statutory, Final Regulations not later than 60 days after enactment of the Agricultural Act of 2014 (Pub. L. 113-79). The Agriculture Act of 2014 directs the Department to publish final regulations not later than 60 days after the date of enactment.

Abstract: The 2008 Farm Bill (Pub. L. 110-246, sec. 11016), amended the Federal Meat Inspection Act (FMIA) to make “catfish” a species amenable to the FMIA and, therefore, subject to FSIS inspection. In addition, the 2008 Farm Bill gave FSIS the authority to define the term “catfish.” On February 24, 2011, FSIS published a proposed rule that outlined a mandatory catfish inspection program and presented two options for defining “catfish.” The 2014 Farm Bill (Pub. L. 113-79, sec. 12106), amended the FMIA to remove the term “catfish” and to make “all fish of the order Siluriformes” subject to FSIS jurisdiction and inspection. As a result, FSIS inspection of Siluriformes is mandated by law and non-discretionary.

Statement of Need: The 2008 and 2014 Farm Bills amended the Federal Meat Inspection Act, making all fish of the order Siluriformes amenable species to the FMIA, requiring FSIS inspection.

Summary of Legal Basis: 21 U.S.C. 601 to 695, Public Law 110-246, section 11016, Public Law 113-79, section 12106.

Alternatives: The option of no rulemaking is unavailable.

Anticipated Cost and Benefits: FSIS anticipates benefits from uniform standards and the more extensive and intensive inspection service it will provide. The requirements for imported Siluriformes will be equivalent to those applied to domestically raised and processed fish of this type.

Risks: In the final rule, the Agency will consider any risks to public health or other pertinent risks associated with the production, processing, and distribution of catfish and catfish products.

Timetable:

ActionDateFR Cite
NPRM02/24/1176 FR 10434
NPRM Comment Period End06/24/11
Final Action12/00/14

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Dr. Daniel L. Engeljohn, Assistant Administrator, Office of Policy and Program Development, Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, 349-E JWB, Washington, DC 20250, Phone: 202 205-0495, Fax: 202 720-2025, Email: daniel.engeljohn@fsis.usda.gov.

RIN: 0583-AD36

USDA—FSIS

22. Electronic Export Application and Certification as a Reimbursable Service and Flexibility in the Requirements for Official Export Inspection Marks, Devices, and Certificates

Priority: Other Significant.

Legal Authority: Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 to 695); Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 to 470); Egg Products Inspection Act (EPIA) (21 U.S.C. 1031 to 1056); Agricultural Marketing Act (AMA) (7 U.S.C. 1622(h)

CFR Citation: 9 CFR 312.8; 9 CFR 322.1 and 322.2; 9 CFR 350.7; 9 CFR 362.5; 9 CFR 381.104 to 381.106; 9 CFR 590.407; 9 CFR 592.20 and 592.500.

Legal Deadline: None.

Abstract: FSIS is developing final regulations to amend the meat, poultry, and egg product inspection regulations to provide for an electronic export application and certification system. The electronic export application and certification system will be a component of the Agency's Public Health Information System (PHIS). The export component of PHIS will be available as an alternative to the paper-based application and certification process. FSIS intends to charge users for the use of the system. FSIS is establishing a formula for calculating the fee. FSIS is also providing establishments that export meat, poultry, and egg products with flexibility in the official export inspection marks, devices, and certificates. In addition, FSIS is amending the egg product export regulations to parallel the meat and poultry export regulations.

Statement of Need: These regulations will facilitate the electronic processing of export applications and certificates through the Public Health Information System (PHIS), a computerized, Web-based inspection information system. This rule will provide the electronic export system as a reimbursable certification service charged to the exporter.

Summary of Legal Basis: 21 U.S.C. 601 to 695; 21 U.S.C. 451 to 470; 21 U.S.C. 1031 to 1056; 7 U.S.C. 1622(h).

Alternatives: The electronic export applications and certification system is being proposed as a voluntary service; therefore, exporters have the option of continuing to use the current paper-based system. Therefore, no alternatives were considered.

Anticipated Cost and Benefits: FSIS is charging exporters an application fee for the electronic export system. Automating the export application and certification process will facilitate the exportation of U.S. meat, poultry, and Start Printed Page 76487egg products by streamlining and automating the processes that are in use, while ensuring that foreign regulatory requirements are met. The cost to an exporter would depend on the number of electronic applications submitted. An exporter that submits only a few applications per year would not be likely to experience a significant economic impact. Under this rate, inspection personnel workload will be reduced through the elimination of the physical handling and processing of applications and certificates. When an electronic government-to-government system interface or data exchange is used, fraudulent transactions, such as false alterations and reproductions, will be significantly reduced, if not eliminated. The electronic export system is designed to ensure authenticity, integrity, and confidentiality. Exporters will be provided with a more efficient and effective application and certification process. The egg product export regulations provide the same export requirements across all products regulated by FSIS and consistency in the export application and certification process. The total annual paperwork burden to the egg processing industry to fill out the paper-based export application is approximately $32,340 per year for a total of 924 hours a year. The average establishment burden would be 11 hours, and $385.00 per establishment.

Risks: None.

Timetable:

ActionDateFR Cite
NPRM01/23/1277 FR 3159
NPRM Comment Period End03/23/12
Final Action02/00/15

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: None.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Rita Kishore, Acting Director, Import/Export Coordinator and Policy Development Staff, Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Office of Policy and Program Development, Room 2147, South Building, Washington, DC 20250, Phone: 202 720-6508, Fax: 202 720-7990, Email: rita.kishore@fsis.usda.gov.

RIN: 0583-AD41

USDA—FSIS

23. Descriptive Designation for Needle- or Blade-Tenderized (Mechanically Tenderized) Beef Products

Priority: Other Significant.

Legal Authority: 21 U.S.C. 601 to 695

CFR Citation: 9 CFR 317.2(e)(3).

Legal Deadline: None.

Abstract: FSIS has proposed regulations to require the use of the descriptive designation “mechanically tenderized” on the labels of raw or partially cooked needle- or blade-tenderized beef products, including beef products injected with marinade or solution, unless such products are destined to be fully cooked at an official establishment. Beef products that have been needle- or blade-tenderized are referred to as “mechanically tenderized” products. This rule would require that the product name for such beef products include the descriptive designation “mechanically tenderized,” and an accurate description of the beef component. The rule would also require that the print for all words in the descriptive designation as the product name appear in the same style, color, and size, and on a single-color contrasting background. In addition, this rule would require that labels of raw and partially-cooked needle- or blade-tenderized beef products destined for household consumers, hotels, restaurants, or similar institutions include validated cooking instructions stating that these products need to be cooked to a specified minimum internal temperature, and whether they need to be held at that minimum internal temperature for a specified time before consumption, i.e., dwell time or rest time, to ensure that they are thoroughly cooked.

Statement of Need: FSIS has concluded that without proper labeling, raw or partially cooked mechanically tenderized beef products could be mistakenly perceived by consumers to be whole, intact muscle cuts. The fact that a cut of beef has been needle- or blade-tenderized is a characterizing feature of the product and, as such, a material fact that is likely to affect consumers' purchase decisions and that should affect their preparation of the product. FSIS has also concluded that the addition of validated cooking instruction is necessary to ensure that potential pathogens throughout the product are destroyed. Without thorough cooking, pathogens that may have been introduced to the interior of the product during the tenderization process may remain in the product.

Summary of Legal Basis: 21 U.S.C. 601 to 695.

Alternatives: The Agency considered two options: Option 1, extend labeling requirements to include vacuum-tumbled beef products and enzyme-formed beef products; and Option 2, extend the proposed labeling requirements to all needle- or blade-tenderized meat and poultry products.

Anticipated Cost and Benefits: The proposed rule estimated the one-time cost to produce labels for mechanically tenderized beef at $1.05 million. The annualized cost is $140,000 at 7 percent for 10 years ($120,000 and when annualized at 3 percent for 10 years). The proposed rule estimated an additional one-time total cost to produce labels for mechanically tenderized beef at $1.57 million or $209,000 when annualized at 7 percent for 10 years ($179,000 when annualized at 3 percent for 10 years), if this proposed rule becomes final before the added-solution rule is finalized. The proposed rule estimated the expected number of E. coli O157:H7 illnesses prevented would be 453 per year, with a range of 133 to 1,497, if the predicted percentages of beef steaks and roasts are cooked to an internal temperature of 160 °F (or 145 °F and 3 minutes of dwell time). These prevented illnesses amount to $1,486,000 per year in benefits with a range of $436,000 to $4,912,000. Therefore, the expected annualized net benefits are $296,000 to $4,772,000, with a primary estimate of $1,346,000. If, however, this rule is in effect before the added solutions rule, the expected annualized net benefits are then $1,137,000, with a range of $87,000 to $4,563,000, plus the unquantifiable benefits of increased consumer information and market efficiency, minus an unquantified consumer surplus loss and an unquantified cost associated with food service establishments changing their standard operating procedures.

Risks: FSIS estimates that approximately 1,965 illnesses annually are attributed to mechanically tenderized beef, either with or without added solutions. If all the servings are cooked to a minimum of 160 degrees F then the number of illnesses drops to 78. This number of illnesses is due to a data set for all STEC and not just O157 data. FSIS estimates that 1,887 out of 1,965 would be prevented annually if mechanically tenderized meat were cooked to 160 degrees F.

Timetable:

ActionDateFR Cite
NPRM06/10/1378 FR 34589
NPRM Comment Period End08/09/13
Start Printed Page 76488
NPRM Comment Period Extended08/09/1378 FR 48631
NPRM Comment Period Reopened12/03/1378 FR 72597
Final Action12/00/14

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: Rosalyn Murphy-Jenkins, Director, Labeling and Program Delivery Staff (LPDS), Department of Agriculture, Food Safety and Inspection Service, Office of Policy and Program Development, Patriots Plaza 3, 1400 Independence Avenue SW., Room 8-148, Mailstop 5273, Washington, DC 20250-5273, Phone: 301 504-0879, Fax: 202 245-4792, Email: rosalyn.murphy-jenkins@fsis.usda.gov.

RIN: 0583-AD45

USDA—FSIS

24. Record To Be Kept by Official Establishments and Retail Stores That Grind Raw Beef Products

Priority: Other Significant.

Legal Authority: 21 U.S.C. 601 et seq.

CFR Citation: 9 CFR 320.

Legal Deadline: None.

Abstract: FSIS proposed to amend its recordkeeping regulations to specify that all official establishments and retail stores that grind raw beef products for sale in commerce must keep records that disclose the identity of the supplier of all source materials that they use in the preparation of each lot of raw ground product, and identify the names of those source materials.

Statement of Need: Under the authority of the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and its implementing regulations, FSIS investigates complaints and reports of consumer foodborne illness possibly associated with FSIS-regulated meat products. Many such investigations into consumer foodborne illnesses involve those caused by the consumption of raw beef ground, by official establishments or retail stores. FSIS investigators and public health officials frequently use records kept by all levels of the food distribution chain, including the retail level, to identify and traceback product that is the source of the illness to the suppliers that produced the source material for the product. The Agency, however, has often been thwarted in its effort to traceback ground beef products, some associated with consumer illness, to the suppliers that provided source materials for the products. In some situations, official establishments and retail stores have not kept records necessary to allow traceback and traceforward activities to occur. Without such necessary records, FSIS's ability to conduct timely and effective consumer foodborne illness investigations and other public health activities throughout the stream of commerce is also affected, thereby placing the consuming public at risk. Therefore, for FSIS to be able to conduct traceback and traceforward investigations, foodborne illnesses investigations, or to monitor product recalls, the records kept by official establishments and retail stores that grind raw beef products must disclose the identity of the supplier and the names of the sources of all materials that they use in the preparation of each lot of raw ground beef product.

Summary of Legal Basis: Under 21 U.S.C. 642, official establishments and retail stores that grind raw beef products for sale in commerce are persons, firms, or corporations that must keep such records and correctly disclose all transactions involved in their businesses subject to the Act. This is because they engage in the business of preparing products of an amenable species for use as human food, and they engage in the business of buying or selling (as meat brokers, wholesalers or otherwise) in commerce products of carcasses of an amenable species. These businesses must also provide access to, and inspection of, these records by FSIS personnel. Further, under 9 CFR 320.1(a), every person, firm, or corporation required by section 642 of the FMIA to keep records must keep those records that will fully and correctly disclose all transactions involved in his or its business subject to the Act. Records specifically required to be kept under section 320.1(b) include, but are not limited to, bills of sale; invoices; bills of lading; and receiving and shipping papers. With respect to each transaction, the records must provide the name or description of the livestock or article; the net weight of the livestock or article; the number of outside containers; the name and address of the buyer or seller of the livestock or animal; and the date and method of shipment.

Alternatives: FSIS considered two alternatives to the proposed requirements: The status quo and a voluntary recordkeeping program.

Anticipated Cost and Benefits: Costs occur because about 76,093 retail stores and official establishments will need to develop and maintain records, and make those records available for the Agency's review. Using the best available data, FSIS believes that industry recordkeeping costs would be approximately $1.46 million. Agency costs of approximately $0.01 million would result from record reviews at official establishments and retail stores, as well as travel time to and from retail stores. Annual benefits from this rule come from estimated averted Shiga toxin-producing E.coli illnesses and averted cases of Salmonellosis. Non-monetized benefits will accrue to industry due to an expected smaller volume of recalls, given everything else being equal, and due to the reduced industry vulnerability to reputation-damaging food safety events. Avoiding loss of business reputation is an indirect benefit. The Government will benefit in that the rule will enable it to operate in a more efficient manner in identifying and tracking recalls of adulterated raw ground beef products. Consumers will benefit from a reduction in foodborne illnesses due to quicker recalls, correction of process failures at establishments producing ground beef, and improved guidance and industry practices.

Risks: None.

Timetable:

ActionDateFR Cite
NPRM07/22/1479 FR 42464
NPRM Comment Period End10/22/14
Final Action07/00/15

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: Victoria Levine, Program Analyst, Issuances Staff (IS), Department of Agriculture, Food Safety and Inspection Service, Office of Policy and Program Development, 1400 Independence Avenue SW., Room 6079, South Building, Washington, DC 20250-3700, Phone: 202 720-5627, Fax: 202 690-0486, Email: victoria.levine@fsis.usda.gov.

RIN: 0583-AD46

USDA—FOREST SERVICE (FS)

Final Rule Stage

25. Forest Service Manual 2020—Ecological Restoration and Resilience Policy

Priority: Other Significant.

Legal Authority: FSM 2020

CFR Citation: None.

Legal Deadline: None.

Abstract: This policy establishes a common definition for ecological restoration and resilience that is Start Printed Page 76489consistent with the 2012 Land Planning rule. The directive provides additional guidance in implementing the definition throughout Forest Service program areas by incorporating it into the Forest Service Manual. Restoration objectives span a number of initiatives in various program areas, including the invasive species strategy; recovery of areas affected by high-severity fires, hurricanes, and other catastrophic disturbances; fish habitat restoration and remediation; riparian area restoration; conservation of threatened and endangered species; and restoration of impaired watersheds and large-scale watershed restoration projects. The restoration policy allows agency employees to more effectively communicate Forest Service work in meeting restoration needs at the local, regional, and national levels. Currently an internal Forest Service interim policy for this final directive has been implemented in the field units, without any issues. This final directive brings the Forest Service policy into alignment with current ecological restoration science and with congressional and Forest Service authorizations and initiatives.

Statement of Need: There is a critical need for ecological restoration on National Forest System lands and the concept of restoration is threaded throughout existing agency authorities and collaborative efforts such as the National Fire Plan. However, without a definition in Forest Services' Directive System there has not been consistent interpretation and application. This established policy was necessary for consistency and for the landscape to better weather disturbances, especially under future environmental conditions.

Summary of Legal Basis: The Forest Service amended the Forest Service Manual (FSM) to add a new title: FSM 2020 Ecological Restoration and Resilience. This final directive reinforced adaptive management, use of science, and collaboration in planning and decision making. These foundational land management policies, including use of restoration to achieve desired conditions, underwent formal public review during revision of the Planning Rule (36 CFR 219) and amendment of associated directives (FSM 1900, 1920).

Alternatives: No alternatives were considered as an established policy is necessary for agency consistency.

Anticipated Cost and Benefits: This final directive had no monetary effect to the agency or the public. The final directive helped agency employees and partners to more effectively communicate restoration needs and accomplishments at the local, regional, and national levels.

Risks: There is no risk identified with this rulemaking.

Timetable:

ActionDateFR Cite
Proposed Directive09/12/1378 FR 56202
Proposed Directive Comment Period End11/12/13
Final Directive02/00/15

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: LaRenda C. King, Assistant Director, Directives and Regulations, Department of Agriculture, Forest Service, ATTN: ORMS, D&R Branch, 1400 Independence Avenue SW., Washington, DC 20250-0003, Phone: 202 205-6560, Email: larendacking@fs.fed.us.

RIN: 0596-AC82

USDA—FS

26. Land Management Planning Rule Policy

Priority: Other Significant.

Legal Authority: 5 U.S.C. 302; 16 U.S.C. 1604; 16 U.S.C. 1613

CFR Citation: 36 CFR 219.

Legal Deadline: None.

Abstract: The Forest Service issued proposed planning directives on February 27, 2013 (RIN # 0596-AD06), which would provide guidance to agency staff on implementation of the recently revised land management planning regulation at 36 CFR 219 (RIN 0596-AC94) (the “2012 Planning Rule”), which was effective May 9, 2012. A 60-day period, extended for an additional 15 days, for the public to comment on the proposed directives concluded on May 24, 2013. The proposed directives have been revised, based on public comment, and the agency seeks to publish a Notice of Availability of the final Directives.

The National Forest Management Act (NFMA) requires that the Forest Service develop land management plans for each unit of the National Forest System, and the agency maintain regulations (Planning Rule) that guide the development and content of such plans. In addition to formal regulations, the agency uses its system of directives to provide more detailed guidance on how to meet the requirements of the Planning Rule.

Statement of Need: The existing direction in the Forest Service Manual 1920 and the Forest Service Handbook 1909.12 regarding Land Management Planning needs to be updated to support implementation of the 2012 Planning Rule (36 CFR 219). This brings the planning directives in line with the new planning rule and clarifies substantive and procedural requirements to implement the rule. The updated directives implements a planning framework that fosters collaboration with the public during land management planning, and is science-based, responsive to change, and promotes social, economic, and ecological sustainability.

Summary of Legal Basis: The Forest Service promulgated a new land management planning regulation at 36 CFR 219 (the “2012 Planning Rule”). The final Planning rule and record of decision was published on April 9, 2012 (77 FR 21162).

Alternatives: The Forest Service finalized the directives to bring the Forest Services' internal directives in-line with the CFR.

Anticipated Cost and Benefits: No new costs to the agency or the public are associated with these directives. The amended directives results in more effective and efficient planning within the Agency's capability.

Risks: There are no risks to the public or to the Forest Service associated with this rulemaking.

Timetable:

ActionDateFR Cite
Proposed Directive02/27/1378 FR 13316
Comment Period End04/29/13
Final Directive02/00/15

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: LaRenda C. King, Assistant Director, Directives and Regulations, Department of Agriculture, Forest Service, ATTN: ORMS, D&R Branch, 1400 Independence Avenue SW., Washington, DC 20250-0003, Phone: 202 205-6560, Email: larendacking@fs.fed.us.

RIN: 0596-AD06

USDA—Rural Business-Cooperative Service (RBS)

Final Rule Stage

27. Rural Energy for America Program

Priority: Economically Significant. Major status under 5 U.S.C. 801 is undetermined. Start Printed Page 76490

Legal Authority: 7 U.S.C. 8107

CFR Citation: 7 CFR 4280-B.

Legal Deadline: None.

Abstract: The Agency published a proposed rule for the Rural Energy for America Program (REAP) on April 12, 2013 (78 FR 22044). The agency is authorized under section 9007 of the Food, Conservation, and Energy Act of 2008 (as amended by the Agricultural Act of 2014) to provide grants for energy audits and renewable energy development assistance; grants for renewable energy system feasibility studies; and financial assistance for energy efficiency improvements and renewable energy systems. The 2014 Farm Bill directs that at least 20 percent of funds be used for grants of $20,000 or less, and up to 4 percent of mandatory funds for energy audits and Renewable Energy Development Assistance Grants. Eligible entities for energy audits and renewable energy development assistance include units of State, tribal, or local government; an instrumentality of a State, tribal, or local government; land grant or other institutions of higher education; rural electric cooperatives; RCID Councils or public power entities. Eligible entities for financial assistance for energy efficiency improvements and renewable energy systems include agricultural producers and rural small businesses. The agency identified REAP as one of the Department's periodic retrospective review of regulations under Executive Order 13563, and has proposed a tiered application approach that reduces applicant burden for technical reports and streamlines the narrative portion of the application.

Statement of Need: The agency needs to incorporate amendments from the Agricultural Act of 2014. Prior to the Agricultural Act of 2014, the agency modified the program to reduce the applicant burden and improve program delivery. In order to make these changes to 7 CFR 4280, subpart B, a final rule needs to be published.

Summary of Legal Basis: REAP was authorized by the 2002 Farm Bill, and continued by the 2014 Farm Bill which made available $50,000,000 in mandatory funding for 2014, and each year thereafter through 2018, and authorized for appropriations $20,000,000 in discretionary funding for each fiscal year 2014 through 2018. The program provides for grants and guaranteed loans for renewable energy systems and energy efficiency improvements, and grants for energy audit and renewable energy development assistance. The purpose of the program is to reduce the energy consumption and increase renewable energy production.

Alternatives: The alternatives are to: (1) Continue operating the program under the 7 CFR 4280, subpart B as it currently is written; (2) revise 7 CFR 4280, subpart B based on public comments received on the interim rule and issue a final rule.

Anticipated Cost and Benefits: Benefits of the rule may include a reduction in energy consumption, an increase in renewable energy production and reduced burden for certain loan and grant applications.

Risks: There are no associated risks to the public health, safety or the environment.

Timetable:

ActionDateFR Cite
Interim Final Rule04/14/1176 FR 21109
Interim Final Rule Effective04/14/11
Interim Final Rule Comment Period End06/13/11
NPRM04/12/1378 FR 22044
Final Action11/00/14

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Kelley Oehler, Branch Chief, Department of Agriculture, Rural Business-Cooperative Service, STOP 3225, 1400 Independence Avenue SW., Washington, DC 20250-3225, Phone: 202 720-6819, Fax: 202 720-2213, Email: kelley.oehler@wdc.usda.gov.

RIN: 0570-AA76

USDA—RBS

28. Business and Industry (B&I) Guaranteed Loan Program

Priority: Other Significant.

Legal Authority: Consolidated Farm and Rural Development Act

CFR Citation: 7 CFR 4287; 7 CFR 4279.

Legal Deadline: None.

Abstract: The Agency published a proposed rule for the Business and Industry Guaranteed Loan Program on September 15, 2014 (78 FR 22044), which, when finalized, would revise the 1996 B&I regulations. While there have been some minor modifications to the B&I Guaranteed Loan Program regulations since 1996, this action is in response to the implement 2014 Farm Bill provisions and makes needed refinements to the regulation. These changes are design to enhance the program, improve efficiency, correct minor inconsistencies, clarify the regulations, and ultimately reduce delinquencies. The Agency held several lender meetings throughout the country to see how changes to the program could benefit lenders who utilize the program. The proposed changes being considered may result in a lower the subsidy rate. The rule, when finalized, is intended to increase lending activity, expand business opportunities, and create more jobs in rural areas, particularly in areas that have historically experienced economic distress.

Statement of Need: With the passage of the 2014 Farm Bill, there is the need to conform certain portions of the B&I Guaranteed Loan Program regulations with requirements found in the 2014 Farm Bill, such as the addition of cooperative equity security guarantees, the locally and regionally grown agricultural food products initiative, and exceptions to the rural area definition. In addition, with the passage of time, the Agency proposed revisions intended to improve program delivery and administration, leverage program resources, better align the regulation with the program's goals and purposes, clarify the regulations, and reduce delinquencies and defaults. These proposed revisions may also improve program subsidy costs. A reduction in program subsidy costs may increase funding availability for additional projects, further improving the economic conditions of rural America. This may result in increased lending activity, the expansion of business opportunities, and the creation of more jobs in rural areas.

Summary of Legal Basis: Consolidated Farm and Rural Development Act, as amended by the 2008 and 2014 Farm Bill.

Alternatives: The only alternative would be the status quo, which is not an acceptable alternative.

Anticipated Cost and Benefits: The benefits of the proposed rule include a possible reduction in loan losses, a lower subsidy rate, and streamline program delivery. The program changes have a cumulative effect of lowering the program cost; however, the amount of the change in cost cannot be estimated with any reasonable precision.

Risks: There are no associated risks to the public health, safety or the environment.

Timetable:

ActionDateFR Cite
Proposed Rule09/15/1479 FR 55316
Final Rule09/00/15
Start Printed Page 76491

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: Brenda Griffin, Loan Specialist, B&I Processing Division, Department of Agriculture, Rural Business-Cooperative Service, 1400 Independence Avenue SW., Washington, DC 20250, Phone: 202 720-6802, Fax: 202 720-6003, Email: brenda.griffin@wdc.usda.gov.

RIN: 0570-AA85

USDA—RBS

29. • Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Legal Authority: 7 U.S.C. 8103

CFR Citation: 7 CFR 4279 subpart C; 7 CFR 4287 subpart D.

Legal Deadline: None.

Abstract: The Biorefinery Assistance Program was authorized under the 2008 Farm Bill. The 2014 Farm Bill continues the authority established by the 2008 Farm Bill but made changes to the program that require revisions to existing regulations. The 2014 Farm Bill changed the program's name to the Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program and mandated that the program provide loan guarantees for the development, construction, and retrofitting of commercial-scale biorefineries as well as biobased product manufacturing facilities. Increasing production of homegrown renewable fuels, chemicals, and biobased products has grown; so has the need to develop and produce them. Rural Business—Cooperative Service (RBS) offers opportunities to producers to develop and manufacture such products through the Biorefinery, Renewable Chemical, and Biobased Product Manfacturing Assistance Program. RBS published the Biorefinery Assistance Program proposed rule in the Federal Register on April 18, 2010, (75 FR 20044) and an interim rule on February 14, 2011, both with 60-day comment periods. Comments were received from biofuel and bio-products producers, banking and investment institutions, attorneys, and research and development companies. In addition to the program changes required by the 2014 Farm Bill, RBS needs to address the comments received to the February 14, 2011, interim rule. The Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program focuses on accelerating the commercialization of production of advanced biofuels and renewable chemicals, as well as biobased product manufacturing.

Statement of Need: The 2014 Farm Bill made changes to the program that require revisions to the program rule, and RBS needs to address the comments received on the interim rule published on February 14, 2011.

Summary of Legal Basis: The Biorefinery Assistance Program was authorized under the 2008 Farm Bill. The 2014 Farm Bill continues the authority and provides $100 million for the program in fiscal year 2014 and $50 million in both fiscal years 2015 and 2016, of which not more than 15 percent can be used for Biobased Product Manufacturing.

Alternatives: The alternatives are: (1) Implement the Section 9003 provisions of the Farm Bill immediately through publishing a subsequent interim rule. This alternative will require the Department to exercise the Hardin memo exemption to implement the Farm Bill amendments; however, it will also enable Rural Development to respond to the comments received to the interim rule published in 2011 and incorporate updates into the subsequent interim rule. Option 1 is the agency's preferred alternative. (2) Implement the Section 9003 Farm Bill provisions immediately by publishing a final rule. This alternative will also require the Department to exercise the Hardin memo exemption the Farm Bill amendments; however, this alternative precludes stakeholder and public comment to the new rule. (3) Implement the Section 9003 Farm Bill provisions by publishing a proposed rule. This alternative is the Department's traditional rulemaking process and enables public comment, but would delay implementation of the program and utilization of funding into fiscal year 2015 (or beyond) and may increase the risk of a rescission of fiscal year 2014 funds.

Anticipated Cost and Benefits: Benefits include increase in renewable energy/advance biofuel, renewable chemical, and biobased manufacturing.

Risks: There are no associated risks to the public health, safety or the environment.

Timetable:

ActionDateFR Cite
Interim Final Rule03/00/15
Interim Final Rule Effective04/00/15
Interim Final Rule Comment Period End05/00/15

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations.

Government Levels Affected: None.

Agency Contact: Todd Hubbell, Loan Specialist, Specialty Lenders Division, Department of Agriculture, Rural Business—Cooperative Service, STOP 3225, 1400 Independence Avenue SW., Washington, DC 20250-3225, Phone: 202 690-2516, Email: todd.hubbell@wdc.usda.gov.

RIN: 0570-AA93

USDA—NATURAL RESOURCES CONSERVATION SERVICE (NRCS)

Final Rule Stage

30. • Agricultural Conservation Easement Program

Priority: Other Significant.

Legal Authority: Pub. L. 113-79

CFR Citation: Not Yet Determined.

Legal Deadline: Other, Statutory, November 4, 2014, 270 days from enactment of Public Law 113-79.

Abstract: The Agricultural Act of 2014 (the 2014 Act) consolidated the Wetlands Reserve Program (WRP), the Farm and Ranch Lands Protection Program (FRPP), and the Grassland Reserve Program (GRP) into a single Agricultural Conservation Easement Program (ACEP). The consolidated easement program has two components—an agricultural land easement component and a wetland reserve easement component. The agricultural land easement component is patterned after the former FRPP with GRP's land eligibility components merged into it. The wetland reserve easement component is patterned after WRP. Land previously enrolled in the three contributing programs is considered enrolled in the new ACEP.

Statement of Need: The Agricultural Act of 2014 (2014 Act) consolidated several of the Title XII (of the Food Security Act of 1985) conservation easement programs and provided for the continued operations of former programs. NRCS is promulgating a consolidated conservation easement regulation to reflect the 2014 Act's consolidation of the WRP, FRPP, and GRP programs.

Summary of Legal Basis: NRCS seeks to publish an interim rule to implement Start Printed Page 76492the consolidated conservation easement program. This regulation action is pursuant to section 1246 of the Food Security Act of 1985, as amended by the 2014 Act, which requires regulations necessary to implement Title II of the 2014 Act through an interim rule with request for comments.

Alternatives: NRCS determined that rulemaking was the appropriate mechanism through which to implement the 2014 Act consolidation of the three source conservation easement programs. Additionally, NRCS determined that the Agency needs standard criteria for implementing the program and program participants need predictability when initiating an application and conveying an easement. The regulation aims to establish a comprehensive framework for working with program participants to implement ACEP. Upon consideration of public comment, NRCS will promulgate final program regulations.

Anticipated Cost and Benefits: The 2014 Act has consolidated three conservation easement programs into a single conservation easement program with two components. The program will be implemented under the general supervision and direction of the Chief of NRCS, who is a Vice President of the Commodity Credit Corporation (CCC). Through ACEP, NRCS will continue to purchase wetland reserve easements directly and will contribute funds to eligible entities for their purchase of agricultural land easements that protect working farm and grazing lands. Participation in the program is voluntary.

The primary benefits associated with this rulemaking are:

  • Provides an opportunity for public comment in program regulations.
  • Provides a regulatory framework for NRCS to implement a consolidated conservation easement program.
  • Provides transparency to the public potential applicants on NRCS program requirements.

The primary costs imposed by this regulation are:

  • The costs incurred by private landowners are negative or zero since this is a voluntary program and they are compensated for the rights that they transfer.
  • Other costs incurred by society through market changes are localized or negligible.

Risks: N/A.

Timetable:

ActionDateFR Cite
Interim Final Rule12/00/14
Final Rule07/00/15

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Leslie Deavers, Acting Farm Bill Coordinator, Department of Agriculture, Natural Resources Conservation Service, 1400 Independence Avenue, Washington, DC 20250, Phone: 202 720-5484, Email: leslie.deavers@wdc.usda.gov.

RIN: 0578-AA61

USDA—NRCS

31. • Environmental Quality Incentives Program (EQIP) Interim Rule

Priority: Other Significant.

Legal Authority: 15 U.S.C. 714b and 714c; 16 U.S.C. 3839AA-3839-8

CFR Citation: 7 CFR 1466.

Legal Deadline: Other, Statutory, November 4, 2014, 270 days from enactment of Public Law 113-79.

Abstract: NRCS promulgated the current EQIP regulation on January 15, 2009 through an interim rule. The interim rule incorporated programmatic changes authorized by the Food, Conservation, and Energy Act of 2008 (the 2008 Act). NRCS published a correction to the interim rule on March 12, 2009, and an amendment to the interim rule on May 29, 2009. NRCS has implemented EQIP in FY 2009 through FY 2013 under the current regulation. The Agricultural Act of 2014 (2014 Act) amended Chapter 4 of Subtitle D of Title XII of the Food Security Act of 1985 by making the following changes to EQIP program requirements: (1) Eliminates requirement that contract must remain in place for a minimum of 1 year after last practice implemented, but keeps requirement that the contract term is not to exceed 10 years, (2) Consolidates elements of Wildlife Habitat Incentives Program (WHIP), and repeals WHIP authority, (3) Replaces rolling 6-year payment limitation with payment limitation for FY 2014-FY 2018, 4) Requires Conservation Innovation Grants (CIG) reporting no later than December 31, 2014 and every 2 years thereafter, (4) Establishes payment limitation established at $450,000 and eliminates waiver authority, (5) Modifies the special rule for foregone income payments for certain associated management practices and resource concern priorities, (6) Makes advance payments are available up to 50 percent for eligible historically underserved participants to purchase material or contract services instead of the previous 30 percent, (7) Provides flexibility for repayment of advance payment if not expended within 90 days, and (8) Requires that for each fiscal year from of the FY 2014 to FY 2018, at least five percent of available EQIP funds shall be targeted for wildlife related conservation practices. The 2014 Act further identifies EQIP as a contributing program authorized to accomplish the purposes of the Regional Conservation Partnership Program (RCPP) (Subtitle I of Title XII of the Food Security Act of 1985, as amended). RCPP replaces the Agricultural Water Enhancement Program (AWEP), Chesapeake Bay Watershed Program (CBWP), Cooperative Conservation Partnership Initiative (CCPI), and the Great Lakes Basin Program for soil erosion and sediment control. Like the programs it replaces, RCPP will operate through regulations in place for contributing programs. The other contributing programs include the Conservation Stewardship Program, the Healthy Forests Reserve Program, and the new Agricultural Conservation Easement Program (ACEP). NRCS seeks to publish an interim rule to incorporate the 2014 Act changes to EQIP program administration. This regulation action is pursuant to Section 1246 of the Food Security Act of 1985, as amended by section 2608 of the 2014 Act, which requires regulations necessary to implement Title II of the 2014 Act be promulgated through the interim rule process.

Statement of Need: The Agricultural Act of 2014 (the 2014 Act) consolidated several of the Title XII conservation programs and provided for the continued operations of former programs. NRCS is updating the EQIP regulation to incorporate the 2014 Act changes, including consolidation of the purposes formerly addressed through the Wildlife Habitat Incentives Program (WHIP).

Summary of Legal Basis: The 2014 Act has reauthorized and amended the Environmental Quality Incentives Program (EQIP). EQIP was first added to the Food Security Act of 1985 (1985 Act) (16 U.S.C. 3801 et seq.) by the Federal Agriculture Improvement and Reform Act of 1996 (1996 Act) (16 U.S.C. 3839aa). The program is implemented under the general supervision and direction of the Chief of NRCS, who is a Vice President of the Commodity Credit Corporation (CCC).

Alternatives: NRCS considered only making the changes mandated by the 2014 Farm Bill. This alternative would have missed opportunities to improve the implementation of the program.

Anticipated Cost and Benefits: Through EQIP, NRCS provides assistance to farmers and ranchers to Start Printed Page 76493conserve and enhance soil, water, air, and related natural resources on their land. Eligible lands include cropland, grassland, rangeland, pasture, wetlands, nonindustrial private forest land, and other agricultural land on which agricultural or forest-related products, or livestock are produced and natural resource concerns may be addressed. Participation in the program is voluntary.

The primary benefits associated with this rulemaking are:

  • Provides continued consistency for the NRCS to implement EQIP.
  • Provides transparency to potential applicants on NRCS program requirements.

The primary costs imposed by this regulation:

  • All program participants must follow the same requirements, even though they are very different types of agricultural operations in different resource contexts.
  • Most program participants are required to contribute at least 25 percent of the resources needed to implement program practices. However, such costs are standard for such financial assistance programs.

Risks: N/A.

Timetable:

ActionDateFR Cite
Interim Final Rule11/00/14
Final Rule07/00/15

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Leslie Deavers, Acting Farm Bill Coordinator, Department of Agriculture, Natural Resources Conservation Service, 1400 Independence Avenue, Washington, DC 20250, Phone: 202 720-5484, Email: leslie.deavers@wdc.usda.gov.

RIN: 0578-AA62

USDA—NRCS

32. Conservation Stewardship Program Interim Rule

Priority: Other Significant.

Legal Authority: 16 U.S.C. 3838d to 3838g.

CFR Citation: 7 CFR 1470.

Legal Deadline: None.

Abstract: NRCS seeks to publish an interim rule to incorporate the 2014 Act changes to Conservation Stewardship Program (CSP) program administration. This regulation action is pursuant to Section 1246 of the Food Security Act of 1985, as amended by the 2014 Act, which requires regulations necessary to implement Title II of the 2014 Act through an interim rule with request for comments. Background: The Food, Conservation, and Energy Act of 2008 Act (2008 Act) amended the Food Security Act of 1985 (1985 Act) to establish CSP and authorize the program in fiscal years 2009 through 2013. The Agriculture Act of 2014 (the 2014 Act) re-authorizes and revises CSP. The purpose of CSP is to encourage producers to address priority resource concerns and improve and conserve the quality and condition of the natural resources in a comprehensive manner by: (1) Undertaking additional conservation activities; and (2) improving, maintaining, and managing existing conservation activities. The Secretary of Agriculture delegated authority to the Chief, Natural Resources Conservation Service (NRCS), to administer CSP. Through CSP, NRCS provides financial and technical assistance to eligible producers to conserve and enhance soil, water, air, and related natural resources on their land. Eligible lands include private or tribal cropland, grassland, pastureland, rangeland, non-industrial private forest lands and other land in agricultural areas (including cropped woodland, marshes, and agricultural land or capable of being used for the production of livestock) on which resource concerns related to agricultural production could be addressed. Participation in the program is voluntary. CSP encourages land stewards to improve their conservation performance by installing and adopting additional activities, and improving, maintaining, and managing existing activities on eligible land. NRCS makes funding for CSP available nationwide on a continuous application basis.

Statement of Need: The Agricultural Act of 2014 (the 2014 Act) amended several of the Title XII conservation programs and provided for the continued operations of former programs. NRCS is updating the CSP regulation to incorporate the 2014 Act changes.

Summary of Legal Basis: The 2014 Act has reauthorized and amended the Conservation Stewardship Program (CSP). CSP was first added to the Food Security Act of 1985 (1985 Act) (16 U.S.C. 3801 et seq.) by the Food, Conservation, and Energy Act of 2008. The program is implemented under the general supervision and direction of the Chief of NRCS, who is a Vice President of the Commodity Credit Corporation (CCC).

Alternatives: NRCS considered only making the changes mandated by the 2014 Farm Bill. This alternative would have missed opportunities to improve the implementation of the program. NRCS would consider alternatives suggested during the public comment period.

Anticipated Cost and Benefits: CSP is a voluntary program that encourages agricultural and forestry producers to address priority resource concerns by: (1) Undertaking additional conservation activities, and (2) improving and maintaining existing conservation systems. CSP provides financial and technical assistance to help land stewards conserve and enhance soil, water, air, and related natural resources on their land.

CSP is available to all producers, regardless of operation size or crops produced, in all 50 States, the District of Columbia, and the Caribbean and Pacific Island areas. Eligible lands include cropland, grassland, prairie land, improved pastureland, rangeland, nonindustrial private forest land, and agricultural land under the jurisdiction of an Indian tribe. Applicants may include individuals, legal entities, joint operations, or Indian tribes.

CSP pays participants for conservation performance the higher the performance, the higher the payment. It provides two possible types of payments. An annual payment is available for installing new conservation activities and maintaining existing practices. A supplemental payment is available to participants who also adopt a resource conserving crop rotation.

Through five-year contracts, NRCS makes payments as soon as practical after October 1 of each fiscal year for contract activities installed and maintained in the previous year. A person or legal entity may have more than one CSP contract but, for all CSP contracts combined, may not receive more than $40,000 in any year or more than $200,000 during any five-year period.

The primary benefits associated with this rulemaking are:

  • Provides continued consistency for the NRCS to implement CSP.
  • Provides transparency to potential applicants on NRCS program requirements.

The primary costs imposed by this regulation are that all program participants must follow the same basic programmatic requirements, even though they are very different types of agricultural operations in different resource contexts.

The 2014 Act further identifies CSP as a contributing program authorized to accomplish the purposes of the Regional Conservation Partnership Program Start Printed Page 76494(RCPP) (subtitle I of title XII of the Food Security Act of 1985, as amended). RCPP replaces the Agricultural Water Enhancement Program (AWEP), Chesapeake Bay Watershed Program (CBWP), Cooperative Conservation Partnership Initiative (CCPI), and the Great Lakes Basin Program for soil erosion and sediment control. Like the programs it replaces, RCPP will operate through regulations in place for contributing programs. The other contributing programs include the Environmental Quality Incentives Program, the Healthy Forests Reserve Program, and the new Agricultural Conservation Easement Program (ACEP).

Risks: N/A.

Timetable:

ActionDateFR Cite
Interim Final Rule11/05/1479 FR 65835
Interim Final Rule Effective11/05/14
Interim Final Rule Comment Period End01/05/15
Final Rule07/00/15

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Leslie Deavers, Acting Farm Bill Coordinator, Department of Agriculture, Natural Resources Conservation Service, 1400 Independence Avenue, Washington, DC 20250, Phone: 202 720-5484, Email: leslie.deavers@wdc.usda.gov.

RIN: 0578-AA63

DEPARTMENT OF COMMERCE (DOC)

Statement of Regulatory and Deregulatory Priorities

Established in 1903, the Department of Commerce (Commerce) is one of the oldest Cabinet-level agencies in the Federal Government. Commerce's mission is to create the conditions for economic growth and opportunity by promoting innovation, entrepreneurship, competitiveness, and environmental stewardship. Commerce has 12 operating units, which are responsible for managing a diverse portfolio of programs and services, ranging from trade promotion and economic development assistance to broadband and the National Weather Service.

Commerce touches Americans daily, in many ways—making possible the daily weather reports and survey research; facilitating technology that all of us use in the workplace and in the home each day; supporting the development, gathering, and transmission of information essential to competitive business; enabling the diversity of companies and goods found in America's and the world's marketplace; and supporting environmental and economic health for the communities in which Americans live.

Commerce has a clear and compelling vision for itself, for its role in the Federal Government, and for its roles supporting the American people, now and in the future. To achieve this vision, Commerce works in partnership with businesses, universities, communities, and workers to:

  • Innovate by creating new ideas through cutting-edge science and technology from advances in nanotechnology, to ocean exploration, to broadband deployment, and by protecting American innovations through the patent and trademark system;
  • Support entrepreneurship and commercialization by enabling community development and strengthening minority businesses and small manufacturers;
  • Maintain U.S. economic competitiveness in the global marketplace by promoting exports, ensuring a level playing field for U.S. businesses, and ensuring that technology transfer is consistent with our nation's economic and security interests;
  • Provide effective management and stewardship of our nation's resources and assets to ensure sustainable economic opportunities; and
  • Make informed policy decisions and enable better understanding of the economy by providing accurate economic and demographic data.

Commerce is a vital resource base, a tireless advocate, and Cabinet-level voice for job creation.

The Regulatory Plan tracks the most important regulations that implement these policy and program priorities, several of which involve regulation of the private sector by Commerce.

Responding to the Administration's Regulatory Philosophy and Principles

The vast majority of the Commerce's programs and activities do not involve regulation. Of Commerce's 12 primary operating units, only the National Oceanic and Atmospheric Administration (NOAA) will be planning actions that are considered the “most important” significant preregulatory or regulatory actions for FY 2015. During the next year, NOAA plans to publish five rulemaking actions that are designated as Regulatory Plan actions. The Bureau of Industry and Security (BIS) may also publish rulemaking actions designated as Regulatory Plan actions. Further information on these actions is provided below.

Commerce has a long-standing policy to prohibit the issuance of any regulation that discriminates on the basis of race, religion, gender, or any other suspect category and requires that all regulations be written so as to be understandable to those affected by them. The Secretary also requires that Commerce afford the public the maximum possible opportunity to participate in Departmental rulemakings, even where public participation is not required by law.

National Oceanic and Atmospheric Administration

NOAA establishes and administers Federal policy for the conservation and management of the Nation's oceanic, coastal, and atmospheric resources. It provides a variety of essential environmental and climate services vital to public safety and to the Nation's economy, such as weather forecasts, drought forecasts, and storm warnings. It is a source of objective information on the state of the environment. NOAA plays the lead role in achieving Commerce's goal of promoting stewardship by providing assessments of the global environment.

Recognizing that economic growth must go hand-in-hand with environmental stewardship, Commerce, through NOAA, conducts programs designed to provide a better understanding of the connections between environmental health, economics, and national security. Commerce's emphasis on “sustainable fisheries” is designed to boost long-term economic growth in a vital sector of the U.S. economy while conserving the resources in the public trust and minimizing any economic dislocation necessary to ensure long-term economic growth. Commerce is where business and environmental interests intersect, and the classic debate on the use of natural resources is transformed into a “win-win” situation for the environment and the economy.

Three of NOAA's major components, the National Marine Fisheries Services (NMFS), the National Ocean Service (NOS), and the National Environmental Satellite, Data, and Information Service (NESDIS), exercise regulatory authority.

NMFS oversees the management and conservation of the Nation's marine Start Printed Page 76495fisheries, protects threatened and endangered marine and anadromous species and marine mammals, and promotes economic development of the U.S. fishing industry. NOS assists the coastal States in their management of land and ocean resources in their coastal zones, including estuarine research reserves; manages the national marine sanctuaries; monitors marine pollution; and directs the national program for deep-seabed minerals and ocean thermal energy. NESDIS administers the civilian weather satellite program and licenses private organizations to operate commercial land-remote sensing satellite systems.

Commerce, through NOAA, has a unique role in promoting stewardship of the global environment through effective management of the Nation's marine and coastal resources and in monitoring and predicting changes in the Earth's environment, thus linking trade, development, and technology with environmental issues. NOAA has the primary Federal responsibility for providing sound scientific observations, assessments, and forecasts of environmental phenomena on which resource management, adaptation, and other societal decisions can be made.

In the environmental stewardship area, NOAA's goals include: Rebuilding and maintaining strong U.S. fisheries by using market-based tools and ecosystem approaches to management; increasing the populations of depleted, threatened, or endangered species and marine mammals by implementing recovery plans that provide for their recovery while still allowing for economic and recreational opportunities; promoting healthy coastal ecosystems by ensuring that economic development is managed in ways that maintain biodiversity and long-term productivity for sustained use; and modernizing navigation and positioning services. In the environmental assessment and prediction area, goals include: Understanding climate change science and impacts, and communicating that understanding to government and private sector stakeholders enabling them to adapt; continually improving the National Weather Service; implementing reliable seasonal and interannual climate forecasts to guide economic planning; providing science-based policy advice on options to deal with very long-term (decadal to centennial) changes in the environment; and advancing and improving short-term warning and forecast services for the entire environment.

Magnuson-Stevens Fishery Conservation and Management Act

Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) rulemakings concern the conservation and management of fishery resources in the U.S. Exclusive Economic Zone (generally 3-200 nautical miles). Among the several hundred rulemakings that NOAA plans to issue in FY 2015, a number of the preregulatory and regulatory actions will be significant. The exact number of such rulemakings is unknown, since they are usually initiated by the actions of eight regional Fishery Management Councils (FMCs) that are responsible for preparing fishery management plans (FMPs) and FMP amendments, and for drafting implementing regulations for each managed fishery. NOAA issues regulations to implement FMPs and FMP amendments. Once a rulemaking is triggered by an FMC, the Magnuson-Stevens Act places stringent deadlines upon NOAA by which it must exercise its rulemaking responsibilities. FMPs and FMP amendments for Atlantic highly migratory species, such as bluefin tuna, swordfish, and sharks, are developed directly by NOAA, not by FMCs.

FMPs address a variety of issues including maximizing fishing opportunities on healthy stocks, rebuilding overfished stocks, and addressing gear conflicts. One of the problems that FMPs may address is preventing overcapitalization (preventing excess fishing capacity) of fisheries. This may be resolved by market-based systems such as catch shares, which permit shareholders to harvest a quantity of fish and which can be traded on the open market. Harvest limits based on the best available scientific information, whether as a total fishing limit for a species in a fishery or as a share assigned to each vessel participant, enable stressed stocks to rebuild. Other measures include staggering fishing seasons or limiting gear types to avoid gear conflicts on the fishing grounds and establishing seasonal and area closures to protect fishery stocks.

The FMCs provide a forum for public debate and, using the best scientific information available, make the judgments needed to determine optimum yield on a fishery-by-fishery basis. Optional management measures are examined and selected in accordance with the national standards set forth in the Magnuson-Stevens Act. This process, including the selection of the preferred management measures, constitutes the development, in simplified form, of an FMP. The FMP, together with draft implementing regulations and supporting documentation, is submitted to NMFS for review against the national standards set forth in the Magnuson-Stevens Act, in other provisions of the Act, and other applicable laws. The same process applies to amending an existing approved FMP.

Marine Mammal Protection Act

The Marine Mammal Protection Act of 1972 (MMPA) provides the authority for the conservation and management of marine mammals under U.S. jurisdiction. It expressly prohibits, with certain exceptions, the take of marine mammals. The MMPA allows NMFS to permit the collection of wild animals for scientific research or public display or to enhance the survival of a species or stock. NMFS initiates rulemakings under the MMPA to establish a management regime to reduce marine mammal mortalities and injuries as a result of interactions with fisheries. The MMPA also established the Marine Mammal Commission, which makes recommendations to the Secretaries of the Departments of Commerce and the Interior and other Federal officials on protecting and conserving marine mammals. The Act underwent significant changes in 1994 to allow for takings incidental to commercial fishing operations, to provide certain exemptions for subsistence and scientific uses, and to require the preparation of stock assessments for all marine mammal stocks in waters under U.S. jurisdiction.

Endangered Species Act

The Endangered Species Act of 1973 (ESA) provides for the conservation of species that are determined to be “endangered” or “threatened,” and the conservation of the ecosystems on which these species depend. The ESA authorizes both NMFS and the Fish and Wildlife Service (FWS) to jointly administer the provisions of the MMPA. NMFS manages marine and “anadromous” species, and FWS manages land and freshwater species. Together, NMFS and FWS work to protect critically imperiled species from extinction. Of the approximately 1,300 listed species found in part or entirely in the United States and its waters, NMFS has jurisdiction over approximately 60 species. NMFS' rulemaking actions are focused on determining whether any species under its responsibility is an endangered or threatened species and whether those species must be added to the list of Start Printed Page 76496protected species. NMFS is also responsible for designating, reviewing, and revising critical habitat for any listed species. In addition, under the ESA's procedural framework, Federal agencies consult with NMFS on any proposed action authorized, funded, or carried out by that agency that may affect one of the listed species or designated critical habitat, or is likely to jeopardize proposed species or adversely modify proposed critical habitat that is under NMFS' jurisdiction.

NOAA's Regulatory Plan Actions

While most of the rulemakings undertaken by NOAA do not rise to the level necessary to be included in Commerce's regulatory plan, NMFS is undertaking five actions that rise to the level of “most important” of Commerce's significant regulatory actions and thus are included in this year's regulatory plan. A description of the five regulatory plan actions is provided below.

1. Revisions to the General section and Standards 1, 3, and 7 of the National Standard Guidelines (0648-BB92): This action would propose revisions to the National Standard 1 (NS1) guidelines. National Standard 1 of the Magnuson-Stevens Fishery Conservation and Management Act states that “conservation and management measures shall prevent overfishing while achieving, on a continuing basis, the optimum yield from each fishery for the United States fishing industry.” The National Marine Fisheries Service last revised the NS1 Guidelines in 2009 to reflect the requirements enacted by the Magnuson-Stevens Fishery Conservation and Management Reauthorization Act of 2006 for annual catch limits and accountability measures to end and prevent overfishing. Since 2007, the National Marine Fisheries Service (NMFS) and the Regional Fishery Management Councils have been implementing the new annual catch limit and accountability measures requirements. Based on experience gained from implementing annual catch limits and accountability measures, NMFS has developed new perspectives and identified issues regarding the application of the NS1 guidelines that may warrant them to be revised to more fully meet the intended goal of preventing overfishing while achieving, on a continuing basis, the optimum yield from each fishery. The focus of this action is to improve the NS1 guidelines.

2. Proposed Rule To Designate Critical Habitat for North Atlantic Right Whale (0648-AY54): The National Marine Fisheries Service (NMFS) proposes to revise critical habitat for the North Atlantic right whale. This proposal would modify the critical habitat previously designated in 1994.

3. Fishery Management Plan for Regulating Offshore Marine Aquaculture in the Gulf of Mexico (0648-AS65): The purpose of this fishery management plan is to develop a regional permitting process for regulating and promoting environmentally sound and economically sustainable aquaculture in the Gulf of Mexico exclusive economic zone. This fishery management plan consists of ten actions, each with an associated range of management alternatives, which would facilitate the permitting of an estimated 5 to 20 offshore aquaculture operations in the Gulf of Mexico over the next 10 years, with an estimated annual production of up to 64 million pounds. By establishing a regional permitting process for aquaculture, the Gulf of Mexico Fishery Management Council will be positioned to achieve their primary goal of increasing maximum sustainable yield and optimum yield of federal fisheries in the Gulf of Mexico by supplementing harvest of wild caught species with cultured product. This rulemaking would outline a regulatory permitting process for aquaculture in the Gulf of Mexico, including: (1) Required permits; (2) duration of permits; (3) species allowed; (4) designation of sites for aquaculture; (5) reporting requirements; and (6) regulations to aid in enforcement.

4. Requirements for Importation of Fish and Fish Products Under the U.S. Marine Mammal Protection Act (0648-AY15): With this action, the National Marine Fisheries Service is developing procedures to implement the provisions of section 101(a)(2) of the Marine Mammal Protection Act for imports of fish and fish products. Those provisions require the Secretary of Treasury to ban imports of fish and fish products from fisheries with bycatch of marine mammals in excess of U.S. standards. The provisions further require the Secretary of Commerce to insist on reasonable proof from exporting nations of the effects on marine mammals of bycatch incidental to fisheries that harvest the fish and fish products to be imported.

5. Revised Proposed Rule To Designate Critical Habitat for the Hawaiian Monk Seal (0648-BA81): The National Marine Fisheries Service (NMFS) is developing a rule to designate critical habitat for the Hawaiian monk seal in the main and Northwestern Hawaiian Islands. In response to a 2008 petition from the Center for Biological Diversity, Kahea, and the Ocean Conservancy to revise Hawaiian monk seal critical habitat, NMFS published a proposed rule in June 2011 to revise Hawaiian monk seal critical habitat by adding critical habitat in the main Hawaiian Islands and extending critical habitat in the Northwestern Hawaiian Islands. Proposed critical habitat includes both marine and terrestrial habitats (e.g., foraging areas to 500 meter depth, pupping beaches, etc.). To address public comments on the proposed rule, NOAA Fisheries is augmenting its prior economic analysis to better describe the anticipated costs of the designation. NOAA Fisheries is analyzing new tracking data to assess monk seal habitat use in the main Hawaiian Islands.

At this time, NOAA is unable to determine the aggregate cost of the identified Regulatory Plan actions as several of these actions are currently under development.

Bureau of Industry and Security

The Bureau of Industry and Security (BIS) advances U.S. national security, foreign policy, and economic objectives by maintaining and strengthening adaptable, efficient, and effective export control and treaty compliance systems as well as by administering programs to prioritize certain contracts to promote the national defense and to protect and enhance the defense industrial base.

In August 2009, the President directed a broad-based interagency review of the U.S. export control system with the goal of strengthening national security and the competitiveness of key U.S. manufacturing and technology sectors by focusing on the current threats and adapting to the changing economic and technological landscape. In August 2010, the President outlined an approach under which agencies that administer export controls will apply new criteria for determining what items need to be controlled and a common set of policies for determining when an export license is required. The control list criteria are to be based on transparent rules, which will reduce the uncertainty faced by our Allies, U.S. industry and its foreign customers, and will allow the Government to erect higher walls around the most sensitive export items in order to enhance national security.

Under the President's approach, agencies will apply the criteria and revise the lists of munitions and dual-use items that are controlled for export so that they:

Distinguish the types of items that should be subject to stricter or more Start Printed Page 76497permissive levels of control for different destinations, end-uses, and end-users;

Create a “bright line” between the two current control lists to clarify jurisdictional determinations and reduce Government and industry uncertainty about whether particular items are subject to the control of the State Department or the Commerce Department; and

Are structurally aligned so that they potentially can be combined into a single list of controlled items.

BIS' current regulatory plan action is designed to implement the initial phase of the President's directive, which will add to BIS' export control purview, military related items that the President determines no longer warrant control under rules administered by the State Department.

Major Programs and Activities

BIS administers four sets of regulations. The Export Administration Regulations (EAR) regulate exports and reexports to protect national security, foreign policy, and short supply interests. The EAR also regulates participation of U.S. persons in certain boycotts administered by foreign Governments. The National Defense Industrial Base Regulations provide for prioritization of certain contracts and allocations of resources to promote the national defense, require reporting of foreign Government-imposed offsets in defense sales, and address the effect of imports on the defense industrial base. The Chemical Weapons Convention Regulations implement declaration, reporting, and on-site inspection requirements in the private sector necessary to meet United States treaty obligations under the Chemical Weapons Convention treaty. The Additional Protocol Regulations implement similar requirements with respect to an agreement between the United States and the International Atomic Energy Agency.

BIS also has an enforcement component with nine offices with enforcement responsibilities covering the United States. BIS export control officers are also stationed at several U.S. embassies and consulates abroad. BIS works with other U.S. Government agencies to promote coordinated U.S. Government efforts in export controls and other programs. BIS participates in U.S. Government efforts to strengthen multilateral export control regimes and to promote effective export controls through cooperation with other Governments.

BIS' Regulatory Plan Actions

As the agency responsible for leading the administration and enforcement of U.S. export controls on dual-use and other items warranting controls but not under the provisions of export control regulations administered by other departments, BIS plays a central role in the Administration's efforts to fundamentally reform the export control system. Changing what we control, how we control it and how we enforce and manage our controls will help strengthen our national security by focusing our efforts on controlling the most critical products and technologies, and by enhancing the competitiveness of key U.S. manufacturing and technology sectors.

In FY 2011, BIS took several steps to implement the President's Export Control Reform Initiative (ECRI). BIS published a final rule (76 FR 35275, June 16, 2011) implementing a license exception that authorizes exports, reexports and transfers to destinations that do not pose a national security concern, provided certain safeguards against diversion to other destinations are taken. BIS also proposed several rules to control under the EAR items that the President has determined do not warrant control under the International Traffic in Arms Regulations (ITAR), administered by the Department of State rule (76 FR 41957), and its United States Munitions List (USML).

In FY 2012, BIS followed up on its FY 2011 successes with the ECRI and proposed rules that would move items currently controlled in nine categories of the USML to control under the Commerce Control List (CCL), administered by BIS. In addition, BIS proposed a rule to ease the implementation process for transitioning items and re-proposed a revised key definition from the July 15 Rule, “specially designed,” that had received extensive public comment. In FY 2013, after State Department notification to Congress of the transfer of items from the USML, BIS expects to be able to publish a final rule incorporating many of the proposed changes and revisions based on public responses to the proposals.

In FY 2013, BIS activities crossed an important milestone with publication of two final rules that began to put ECRI policies into place. An Initial Implementation rule (73 FR 22660, April 16, 2013) sets in place the structure under which items the President determines no longer warrant control on the United States Munitions List will be controlled on the Commerce Control List. It also revises license exceptions and regulatory definitions, including the definition of “specially designed” to more make those exceptions and definitions clearer and to more close align them with the International Traffic in Arms Regulations, and adds to the CCL certain military aircraft, gas turbine engines and related items. A second final rule (78 FR 40892, July 8 2012) followed on by adding to the CCL military vehicles, vessels of war submersible vessels, and auxiliary military equipment that President determined no longer warrant control on the USML.

In FY 2014, BIS continued its emphasis on the ECRI by publishing three final rules adding to the Commerce Control List, items the President determined no long warrant control on the United States Munitions List (including a rule returning jurisdiction over Commercial Satellites to the Department of Commerce), as follows:

January 2—Control of Military Training Equipment, Energetic Materials, Personal Protective Equipment, Shelters, Articles Related to Launch Vehicles, Missiles, Rockets, Military Explosives and Related Items;

May 13—Revisions to the Export Administration Regulations (EAR): Control of Spacecraft Systems and Related Items the President Determines No Longer Warrant Control Under the United States Munitions List (USML); and

July 1—Revisions to the Export Administration Regulations (EAR): Control of Military Electronic Equipment and Other Items the President Determines No Longer Warrant Control Under the United States Munitions List

BIS expects to publish additional ECRI final rules in FY 2015.

Promoting International Regulatory Cooperation

As the President noted in Executive Order 13609, “international regulatory cooperation, consistent with domestic law and prerogatives and U.S. trade policy, can be an important means of promoting” public health, welfare, safety, and our environment as well as economic growth, innovation, competitiveness, and job creation. Accordingly, in EO 13609, the President requires each executive agency to include in its Regulatory Plan a summary of its international regulatory cooperation activities that are reasonably anticipated to lead to significant regulations.

The Department of Commerce engages with numerous international bodies in Start Printed Page 76498various forums to promote the Department's priorities and foster regulations that do not “impair the ability of American business to export and compete internationally.” EO 13609(a). For example, the United States Patent and Trademark Office is working with the European Patent Office to develop a new classification system for both offices' use. The Bureau of Industry and Security, along with the Department of State and Department of Defense, engages with other countries in the Wassenaar Arrangement, through which the international community develops a common list of items that should be subject to export controls because they are conventional arms or items that have both military and civil uses. Other multilateral export control regimes include the Missile Technology Control Regime, the Nuclear Suppliers Group, and the Australia Group, which lists items controlled for chemical and biological weapon nonproliferation purposes. In addition, the National Oceanic and Atmospheric Administration works with other countries' regulatory bodies through regional fishery management organizations to develop fair and internationally-agreed-to fishery standards for the High Seas.

BIS is also engaged, in partnership with the Departments of State and Defense, in revising the regulatory framework for export control, through the President's Export Control Reform Initiative (ECRI). Through this effort, the United States Government is moving certain items currently controlled by the United States Military List (USML) to the Commerce Control List (CCL) in BIS' Export Administration Regulations. The objective of ECRI is to improve interoperability of U.S. military forces with those of allied countries, strengthen the U.S. industrial base by, among other things, reducing incentives for foreign manufacturers to design out and avoid U.S.-origin content and services, and allow export control officials to focus Government resources on transactions that pose greater concern. Once fully implemented, the new export control framework also will benefit companies in the United States seeking to export items through more flexible and less burdensome export controls.

Retrospective Review of Existing Regulations

Pursuant to section 6 of Executive Order 13563 “Improving Regulation and Regulatory Review” (Jan. 18, 2011), the Department has identified several rulemakings as being associated with retrospective review and analysis in the Department's final retrospective review of regulations plan. Accordingly, the Agency is reviewing these rules to determine whether action under E.O. 13563 is appropriate. Some of these entries on this list may be completed actions, which do not appear in The Regulatory Plan. However, more information can be found about these completed rulemakings in past publications of the Unified Agenda on Reginfo.gov in the Completed Actions section for the Agency. These rulemakings can also be found on Regulations.gov. The final Agency retrospective analysis plan can be found at: http://open.commerce.gov/​sites/​default/​files/​Commerce%20Plan%20for%20Retrospective%20Analysis%20of%20Existing%20Rules%20-%202011-08-22%20Final.pdf

DOC—National Oceanic and Atmospheric Administration (NOAA)

Proposed Rule Stage

33. Requirements for Importation of Fish and Fish Product Under the U.S. Marine Mammal Protection Act

Priority: Other Significant.

Legal Authority: 16 U.S.C. 1371 et seq.

CFR Citation: 50 CFR 216.

Legal Deadline: None.

Abstract: With this action, NMFS is developing procedures to implement the provisions of section 101(a)(2) of the Marine Mammal Protection Act for imports of fish and fish products. Those provisions require the Secretary of Treasury to ban imports of fish and fish products from fisheries with bycatch of marine mammals in excess of U.S. standards. The provisions further require the Secretary of Commerce to insist on reasonable proof from exporting nations of the effects on marine mammals of bycatch incidental to fisheries that harvest the fish and fish products to be imported. Implementation of this rule may have trade implications. However, the impacts will be limited primarily to foreign entities, with no anticipated impacts to U.S. fishermen.

Statement of Need: The Marine Mammal Protection Act requires that the United States prohibit imports of fish caught in a manner that results in bycatch of marine mammals in excess of U.S. standards.

Summary of Legal Basis: Marine Mammal Protection Act.

Alternatives: An alternative to this rulemaking that would facilitate marine mammal conservation overseas would be through cooperation and assistance programs. While the U.S. has developed effective bycatch mitigation techniques and applied these in many fisheries, there is no guarantee that these methods will be freely adopted in foreign fisheries. Technical and financial assistance for the development and implementation of marine mammal bycatch mitigation measures would not be precluded by this rulemaking, but market access incentives will increase the likelihood of action by harvesting nations exporting to the U.S.

Anticipated Cost and Benefits: Potential benefits of this rulemaking include: an incentive for exporting nations to adopt and implement marine mammal conservation standards comparable to the U.S. as a condition for access to the U.S. seafood market, establishing a review process for determining the effectiveness of mitigation measures adopted by foreign nations; decreasing the likelihood that marine mammal stocks will be further depleted; and increasing the availability of information on marine mammal distribution and abundance and the threats posed by fisheries interactions. Anticipated costs include: increased administrative costs of monitoring trade and making determinations about foreign fisheries bycatch of marine mammals; increased costs on seafood importers related to certifying import eligibility, and increased requests for international cooperation and assistance and attendant costs to implement mitigation measures.

Risks: Prohibiting imports from seafood exporting nations that cause bycatch of marine mammals in excess of U.S. standards will diminish the risk of further declines in marine mammal stocks that are affected by foreign fisheries.

Timetable:

ActionDateFR Cite
ANPRM04/30/1075 FR 22731
Reopening ANPR comment period07/01/1075 FR 38070
NPRM02/00/15
Final Action08/00/15

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Rodney Mcinnis, Director, Office of International Affairs, Department of Commerce, National Oceanic and Atmospheric Start Printed Page 76499Administration, 1315 East-West Hwy, Silver Spring, MD 20910, Phone: 562 980-4005, Email: rod.mcinnis@noaa.gov.

Related RIN: Related to 0648-AX36

RIN: 0648-AY15

DOC—NOAA

34. Designation of Critical Habitat for the North Atlantic Right Whale

Priority: Other Significant.

Legal Authority: 16 U.S.C. 1361 et seq.; 16 U.S.C. 1531 to 1543.

CFR Citation: 50 CFR 226; 50 CFR 229.

Legal Deadline: None.

Abstract: National Marine Fisheries Service proposes to revise critical habitat for the North Atlantic right whale. This proposal would result in modifying the critical habitat that was designated in 1994.

Statement of Need: Under section 4 of the Endangered Species Act, NOAA Fisheries is required to designate critical habitat for newly listed species and revise as new information becomes available.

Summary of Legal Basis: Endangered Species Act

Alternatives: Critical habitat is defined as (i) the specific areas within the geographical area occupied by the species, at the time it is listed, on which are found those physical or biological features (I) essential to the conservation of the species and (II) which may require special management considerations or protection; and (ii) specific areas outside the geographical area occupied by the species at the time it is listed, upon a determination by the Secretary that such areas are essential for the conservation of the species. In developing this rule, NOAA Fisheries is analyzing best available information regarding where these areas occur and performing economic impact analysis to inform designation.

Anticipated Cost and Benefits: Because this rule is presently in the beginning stages of development, no analysis has been completed at this time to assess costs and benefits.

Risks: Loss of critical habitat for a species listed as protected under the ESA and Marine Mammals Protection Act, as well as potential loss of right whales due to habitat loss.

Timetable:

ActionDateFR Cite
NPRM01/00/15
2

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Donna Wieting, Fishery Biologist, Office of Protected Resources, Department of Commerce, National Oceanic and Atmospheric Administration, National Marine Fisheries Service, 1315 East-West Highway, Silver Spring, MD 20910, Phone: 301 713-2322.

RIN: 0648-AY54

DOC—NOAA

35. Revision of Hawaiian Monk Seal Critical Habitat

Priority: Other Significant.

Legal Authority: 16 U.S.C. 1533

CFR Citation: 50 CFR 226.

Legal Deadline: None.

Abstract: National Oceanic and Atmospheric Administration (NOAA) Fisheries is developing a revised proposed rule to designate critical habitat for the Hawaiian monk seal in the main and Northwestern Hawaiian Islands. In response to a 2008 petition from the Center for Biological Diversity, Kahea, and the Ocean Conservancy to revise Hawaiian monk seal critical habitat, NOAA Fisheries published a proposed rule in June 2011 to revise Hawaiian monk seal critical habitat by adding critical habitat in the main Hawaiian Islands and extending critical habitat in the Northwestern Hawaiian Islands. Proposed critical habitat includes both marine and terrestrial habitats (e.g., foraging areas to 500 meter depth, pupping beaches, etc.). To address public comments on the proposed rule, NOAA Fisheries is augmenting its prior economic analysis to better describe the anticipated costs of the designation. NOAA Fisheries is analyzing new tracking data to assess monk seal habitat use in the main Hawaiian Islands.

Statement of Need: Hawaiian monk seal critical habitat was last designated in 1988. Since the 1988 designation, new information regarding Hawaiian monk seal habitat use has become available. A revision to this designation would allow NMFS to more accurately define those features and areas that are important to support Hawaiian monk seal conservation by modifying existing critical habitat in the Northwestern Hawaiian Islands and proposing critical habitat in the main Hawaiian Islands. NMFS published a proposed rule to designate critical habitat in 2011. The agency has made changes to the 2011 proposed rule in response to public comment, and now plans to release a second, revised proposed rule to provide an opportunity for the public to comment on these changes.

Summary of Legal Basis: Endangered Species Act.

Alternatives: In the 2011 proposed rule, NMFS considered the alternative of not revising critical habitat for the Hawaiian monk seal, the alternative of designating all potential critical habitat areas, and the alternative of designating a subset of all potential critical habitat areas, excluding those areas where the benefits of exclusion outweigh the benefits of designation in accordance with 4(b)(2) of the Endangered Species Act. Under the preferred alternative NMFS proposed for designation 10 specific areas in the Northwestern Hawaiian Islands and 6 specific areas in the main Hawaiian Islands which support terrestrial pupping and haul-out areas as well as marine foraging areas. Within four of the main Hawaiian Islands specific areas, NMFS proposed exclusions to reduce the impacts to national security.

Anticipated Cost and Benefits: The economic analysis is currently being revised to reflect changes in response to public comments received. The primary benefit of designation is the protection afforded under section 7 of the Endangered Species Act, requiring all Federal agencies to insure their actions are not likely to destroy or adversely modify designated critical habitat. In addition to these protections, the designation may also result in other forms of benefits including, but not limited to: Educational awareness and outreach benefits, benefits to tourism and recreation, and improved or sustained habitat quality. The designation of critical habitat typically does not impose additional costs in occupied habitat, where Federal agencies are already required to consult with NMFS as a consequence of the listed species being present. However, in unoccupied habitat the rule may impose administrative costs on Federal agencies as well as costs on Federal agencies and third parties stemming from project modifications to mitigate impacts to critical habitat.

Risks: The Endangered Species Act requires designation of critical habitat following the listing of a species. If critical habitat is not designated, the species will not be protected to the extent provided for in the Endangered Species Act, posing a risk to the species continued existence and recovery.

Timetable:

ActionDateFR Cite
NPRM06/02/1176 FR 32026
Start Printed Page 76500
Notice of Public Meetings07/14/1176 FR 41446
Other06/25/1277 FR 37867
Second NPRM02/00/15

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations.

Government Levels Affected: Federal, Local, State.

Agency Contact: Donna Wieting, Fishery Biologist, Office of Protected Resources, Department of Commerce, National Oceanic and Atmospheric Administration, National Marine Fisheries Service, 1315 East-West Highway, Silver Spring, MD 20910, Phone: 301 713-2322.

Related RIN: Related to 0648-AX23

RIN: 0648-BA81

DOC—NOAA

36. Revision of the National Standard 1 Guidelines

Priority: Other Significant.

Legal Authority: 16 U.S.C. 1801 et seq.; Pub. L. 94-265.

CFR Citation: 50 CFR 600.

Legal Deadline: None.

Abstract: This action would propose revisions to the National Standard 1 (NS1) guidelines. National Standard 1 of the Magnuson-Stevens Fishery Conservation and Management Act states that conservation and management measures shall prevent overfishing while achieving, on a continuing basis, the optimum yield from each fishery for the United States fishing industry. National Oceanic and Atmospheric Administration Fisheries last revised the NS1 Guidelines in 2009 to reflect the requirements enacted by the Magnuson-Stevens Fishery Conservation and Management Reauthorization Act of 2006 for annual catch limits and accountability measures to end and prevent overfishing. Since 2007, the National Marine Fisheries Service and the Regional Fishery Management Councils have been implementing the new annual catch limit and accountability measures requirements. Based on experience gained from implementing annual catch limits and accountability measures, NMFS has developed new perspectives and identified issues regarding the application of the NS1 guidelines that may warrant them to be revised to more fully meet the intended goal of preventing overfishing while achieving, on a continuing basis, the optimum yield from each fishery. The focus of this action is to improve the NS1 guidelines.

Statement of Need: Since 2007, fisheries management within the U.S. has experienced many changes, in particular the implementation of annual catch limits and accountability measures under all fishery management plans. Based on this experience, the NMFS believes the National Standard guidelines can be improved to enhance the utility of the guidelines for managers and the public. The objective of the proposed revisions is to improve and streamline the guidelines, address concerns raised during the implementation of annual catch limits and accountability measures, and provide flexibility within current statutory limits to address fishery management issues.

Summary of Legal Basis: Magnuson-Stevens Fishery Conservation and Management Act.

Alternatives: The rule attempts to improve fisheries management by proposing alternatives that clarify guidance in the following topic areas: (1) Identifying fishery management objectives; (2) identifying whether stocks require conservation and management; (3) managing data limited stocks; (4) stock complexes; (5) aggregate maximum sustainable yield estimates; (6) depleted stocks; (7) multi-year overfishing determinations; (8) optimum yield; (9) acceptable biological catch control rules; (10) accountability measures; (11) establishing annual catch limits and accountability measures mechanisms in Fishery Management Plans; and (12) flexibility in rebuilding stocks.

Anticipated Cost and Benefits: The changes to the guidelines would not establish any new requirements and thus are technical in nature. As such, the changes would allow, but do not require the Fishery Management Councils or the Secretary of Commerce, to make changes to their Fishery Management Plans. Because changes to the guidelines would not directly alter the behavior of any entities that operate in federally managed fisheries, no direct economic effects are expected to result from this action. The potential benefits of revising the National Standard guidelines include: improving and streamlining the guidance, providing additional clarity, and providing flexibility to address fishery management issues.

Risks: NMFS anticipates that a revision to the National Standard guidelines would enhance the utility of the guidelines. NMFS does not foresee any risks associated with revising the National Standard guidelines.

Timetable:

ActionDateFR Cite
ANPRM05/03/1277 FR 26238
ANPRM Comment Period Extended07/03/1277 FR 39459
NPRM12/00/14

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: Federal.

Agency Contact: Alan Risenhoover, Director, Office of Sustainable Fisheries, Department of Commerce, National Oceanic and Atmospheric Administration, Room 13362, 1315 East-West Highway, Silver Spring, MD 20910, Phone: 301 713-2334, Fax: 301 713-0596, Email: alan.risenhoover@noaa.gov.

Related RIN: Related to 0648-AV60

RIN: 0648-BB92

DOC—NOAA

Final Rule Stage

37. Fishery Management Plan for Regulating Offshore Marine Aquaculture in the Gulf of Mexico

Priority: Other Significant.

Legal Authority: 16 U.S.C. 1801 et seq.

CFR Citation: 50 CFR 622.

Legal Deadline: None.

Abstract: The purpose of this fishery management plan is to develop a regional permitting process for regulating and promoting environmentally sound and economically sustainable aquaculture in the Gulf of Mexico exclusive economic zone. This fishery management plan consists of ten actions, each with an associated range of management alternatives, which would facilitate the permitting of an estimated 5 to 20 offshore aquaculture operations in the Gulf of Mexico over the next 10 years, with an estimated annual production of up to 64 million pounds. By establishing a regional permitting process for aquaculture, the Gulf of Mexico Fishery Management Council will be positioned to achieve their primary goal of increasing maximum sustainable yield and optimum yield of federal fisheries in the Gulf of Mexico by supplementing harvest of wild caught species with cultured product. This rulemaking would outline a regulatory permitting process for aquaculture in the Gulf of Mexico, including: (1) Required permits; (2) duration of permits; (3) species allowed; Start Printed Page 76501(4) designation of sites for aquaculture; (5) reporting requirements; and (6) regulations to aid in enforcement.

Statement of Need: Demand for protein is increasing in the United States and commercial wild-capture fisheries will not likely be adequate to meet this growing demand. Aquaculture is one method to meet current and future demands for seafood. Supplementing the harvest of domestic fisheries with cultured product will help the U.S. meet consumers' growing demand for seafood and may reduce the Nation's dependence on seafood imports. Currently, the U.S. imports over 80 percent of the seafood consumed in the country, and the annual U.S seafood trade deficit is at an all time high of over $9 billion.

Summary of Legal Basis: Magnuson-Stevens Fishery Conservation and Management Act, 16 U.S.C. 1801 et seq.

Alternatives: The Council's Aquaculture FMP includes 10 actions, each with an associated range of alternatives. These actions and alternatives are collectively intended to establish a regional permitting process for offshore aquaculture. Management actions in the FMP include: (1) Aquaculture permit requirements, eligibility, and transferability; (2) duration aquaculture permits are effective; (3) aquaculture application requirements, operational requirements, and restrictions; (4) species allowed for aquaculture; (5) allowable aquaculture systems; (6) marine aquaculture siting requirements and conditions; (7) restricted access zones for aquaculture facilities; (8) recordkeeping and reporting requirements; (9) biological reference points and status determination criteria; and (10) framework procedures for modifying biological reference points and regulatory measures.

Anticipated Cost and Benefits: Environmental and social/economic costs and benefits are described in detail in the Council's Aquaculture FMP. Potential benefits include: establishing a rigorous review process for reviewing and approving/denying aquaculture permits; increasing optimum yield by supplementing the harvest of wild domestic fisheries with cultured products; and reducing the Nation's dependence on imported seafood. Anticipated costs include increased administration and oversight of an aquaculture permitting process, and potential negative environmental impacts to wild marine resources. Approval of an aquaculture permitting system may also benefit fishing communities by creating new jobs.

Risks: Currently, 90% of seafood consumed in the United States is imported. Offshore aquaculture operations will aid in meeting the increasing demand for seafood and improve U.S. food security.

Timetable:

ActionDateFR Cite
Notice of Availability06/04/0974 FR 26829
NPRM08/28/1479 FR 26829
Final Action05/00/15

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Roy E. Crabtree, Southeast Regional Administrator, Department of Commerce, National Oceanic and Atmospheric Administration, 263 13th Avenue South, St. Petersburg, FL 33701, Phone: 727 824-5305, Fax: 727 824-5308, Email: roy.crabtree@noaa.gov.

RIN: 0648-AS65

DEPARTMENT OF DEFENSE

Statement of Regulatory Priorities

Background

The Department of Defense (DoD) is the largest Federal department, consisting of three Military departments (Army, Navy, and Air Force), nine Unified Combatant Commands, 17 Defense Agencies, and ten DoD Field Activities. It has 1,357,218 military personnel and 853,102 civilians assigned as of June 30, 2014, and over 200 large and medium installations in the continental United States, U. S. territories, and foreign countries. The overall size, composition, and dispersion of DoD, coupled with an innovative regulatory program, presents a challenge to the management of the Defense regulatory efforts under Executive Order 12866 “Regulatory Planning and Review” of September 30, 1993.

Because of its diversified nature, DoD is affected by the regulations issued by regulatory agencies such as the Departments of Commerce, Energy, Health and Human Services, Housing and Urban Development, Labor, State, Transportation, and the Environmental Protection Agency. In order to develop the best possible regulations that embody the principles and objectives embedded in E.O. 12866, there must be coordination of proposed regulations among the regulatory agencies and the affected DoD components. Coordinating the proposed regulations in advance throughout an organization as large as DoD is a straightforward, yet formidable, undertaking.

DoD issues regulations that have an effect on the public and can be significant as defined in E.O. 12866. In addition, some of DoD's regulations may affect other agencies. DoD, as an integral part of its program, not only receives coordinating actions from other agencies, but coordinates with the agencies that are affected by its regulations as well.

Overall Priorities

The Department needs to function at a reasonable cost, while ensuring that it does not impose ineffective and unnecessarily burdensome regulations on the public. The rulemaking process should be responsive, efficient, cost-effective, and both fair and perceived as fair. This is being done in DoD while reacting to the contradictory pressures of providing more services with fewer resources. The Department of Defense, as a matter of overall priority for its regulatory program, fully incorporates the provisions of the President's priorities and objectives under Executive Order (E.O.) 12866.

International Regulatory Cooperation

As the President noted in Executive Order 13609, “international regulatory cooperation, consistent with domestic law and prerogatives and U.S. trade policy, can be an important means of promoting” public health, welfare, safety, and our environment as well as economic growth, innovation, competitiveness, and job creation. Accordingly, in Executive Order 13609, the President requires each executive agency to include in its Regulatory Plan a summary of its international regulatory cooperation activities that are reasonably anticipated to lead to significant regulations.

The Department of Defense, along with the Department of State and the Department of Commerce, engages with other countries in the Wassenaar Arrangement, through which the international community develops a common list of items that should be subject to export controls.

Retrospective Review of Existing Regulations

Pursuant to section 6 of Executive Order 13563 “Improving Regulation and Regulatory Review (January 18, 2011), the following Regulatory Identifier Numbers (RINs) have been identified as associated with retrospective review and analysis in the Department's final retrospective review of regulations plan. Start Printed Page 76502All are of particular interest to small businesses. Some of these entries on this list may be completed actions, which do not appear in The Regulatory Plan. However, more information can be found about these completed rulemakings in past publications of the Unified Agenda on Reginfo.gov in the Completed Actions section for that agency. These rulemakings can also be found on Regulations.gov. The final agency plan and all updates to the plan can be found at: http://www.regulations.gov/​#!docketDetail;​D=​DOD-2011-OS-0036.

RINRule title (* expected to significantly reduce burdens on small businesses)
0701-AA76Air Force Freedom of Information Act Program.
0701-AA77Air Force Privacy Act Program.
0703-AA87United States Navy Regulations and Official Records.
0703-AA90Guidelines for Archaeological Investigation Permits and Other Research on Sunken Military Craft and Terrestrial Military Craft Under the Jurisdiction of the Department of the Navy.
0703-AA91Unofficial Use of the Seal, Emblem, Names, or Initials of the Marine Corps.
0703-AA92Professional Conduct of Attorneys Practicing Under the Cognizance and Supervision of the Judge Advocate General.
0710-AA66Civil Monetary Penalty Inflation Adjustment Rule.
0710-AA60Nationwide Permit Program Regulations.*
0750-AG47Safeguarding Unclassified Controlled Technical Information (DFARS Case 2011-D039).
0750-AG62Patents, Data, and Copyrights (DFARS Case 2010-D001).
0750-AH11Only One Offer (DFARS Case 2011-D013).
0750-AH19Accelerated Payments to Small Business (DFARS Case 2011-D008).
0750-AH54Performance-Based Payments (DFARS Case 2011-D045).
0750-AH70Defense Trade Cooperation Treaty With Australia and the United Kingdom (DFARS Case 2012-D034).
0750-AH86Forward Pricing Rate Proposal Adequacy Checklist (DFARS Case 2012-D035).
0750-AH87System for Award Management Name Changes, Phase 1 Implementation (DFARS Case 2012-D053).
0750-AH90 0750-AH94 0750-AH95 0750-AI02 0750-AI10 0750-AI19 0750-AI27Clauses With Alternates.
0750-AI03Approval of Rental Waiver Requests (DFARS Case 2013-D006).
0750-AI07Storage, Treatment, and Disposal of Toxic or Hazardous Materials—Statutory Update (DFARS Case 2013-D013).
0750-AI18Photovoltaic Devices (DFARS Case 2014-D006).
0750-AI34State Sponsors of Terrorism (DFARS Case 2014-D014).
0790-AI24DoD Freedom of Information Act (FOIA) Program Regulation.
0790-AI30Defense Contract Management Agency (DCMA) Privacy Program.
0790-AI42Personnel Security Program.
0790-AI51DoD Freedom of Information Act (FOIA) Program; Amendment.
0790-AI54Defense Support of Civilian Law Enforcement Agencies.
0790-AI63Alternative Dispute Resolution.
0790-AI71National Industrial Security Program (NISP): Procedures for Government Activities Relating to Foreign Ownership, Control or Influence (FOCI).
0790-AI73Withholding of Unclassified Technical Data From Public Disclosure.
0790-AI75Presentation of DoD-Related Scientific and Technical Papers at Meetings.
0790-AI77Provision of Early Intervention and Special Education Services to Eligible DoD Dependents.
0790-AI84National Defense Science and Engineering Graduate (NDSEG) Fellowships.
0790-AI86Defense Logistics Agency Privacy Program.
0790-AI87Defense Logistics Agency Freedom of Information Act Program.
0790-AI88Shelter for the Homeless.
0790-AI90DoD Assistance to Non-Government, Entertainment-Oriented Media Productions.
0790-AI92Inspector General; Privacy Act; Implementation.
0790-AJ00Civilian Employment and Reemployment Rights of Applicants for, and Service Members and Former Service Members, of the Uniformed Services.
0790-AJ03DoD Privacy Program.
0790-AJ04Unlawful Discrimination (On the Basis of Race, Color, National Origin, or Age in Programs or Activities Receiving Federal Financial Assistance From the DoD).
0790-AJ05End Use Certificates (EUCs).
0790-AJ06Voluntary Education Programs.
0790-AJ07Historical Research in the Files of the Office of the Secretary of Defense (OSD).
0790-AJ10Enhancement of Protections on Consumer Credit for Members of the Armed Forces and Their Dependents.
0790-AJ20DoD Privacy Program Pursuant to Executive Order 13563, DoD also removed 32 CFR part 513, “Indebtedness of Military Personnel,” because the part is obsolete and the governing policy is now codified at 32 CFR part 112.

Administration Priorities

1. Rulemakings That Are Expected To Have High Net Benefits Well in Excess of Costs

The Department plans to—

  • Finalize the DFARS rule to implement section 806 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2011, as amended by section 806 of the NDAA for FY 2013. Section 806 requires the evaluation of offerors' supply chain risks for information technology purchases relating to national security systems. This rule enables agencies to exclude sources that are identified as having a supply chain risk in order to minimize Start Printed Page 76503the potential risk for purchased supplies and services to maliciously introduce unwanted functions and degrade the integrity and operation of sensitive information technology systems.
  • Finalize the DFARS rule to provide guidance to contractors for the submittal of forward pricing rate proposals to ensure the adequacy of forward pricing rate proposals submitted to the Government. The rule provides guidance to contractors to ensure that forward pricing rate proposals are thorough, accurate, and complete.
  • Finalize the DFARS rule to implement section 1602 of the NDAA for FY 2014. Section 1602 prohibits award of a contract for commercial satellite services from certain foreign entities if the Secretary of Defense reasonably believes that the foreign entity is one in which the government of a foreign country has an ownership interest that enables the government to affect satellite operations. There is a potential risk to national security if DoD uses commercial satellite services for DoD communications and the government of a covered foreign country has an ownership interest that enables the government to affect satellite operations. Likewise, if launch or other satellite services under the contract are occurring in a covered country, the government of that country could impact the ability of the foreign entity to adequately provide those services.

2. Rulemakings of Particular Interest to Small Businesses

The Department plans to—

  • Finalize the DFARS rule to delete text in DFARS part 219 that implemented 10 U.S.C. 2323 because 10 U.S.C. 2323 has expired. Removal of the obsolete implementing coverage for 10 U.S.C. 2323 will bring DFARS up to date and provide accurate and indisputable regulations affecting the small business and vendor communities. 10 U.S.C. 2323 had provided the underlying statutory authority for DoD's Small Disadvantaged Business (SDB) Program and served as the basis for DoD's use of certain solicitation techniques to further its SDB participation rate. Notwithstanding removal of this statutory authority from the DFARS, DoD's fundamental procurement policies continue to provide strong support for SDB participation as evidenced by DoD meeting or exceeding the annual Governmentwide statutory SDB prime contracting goals since 2001.
  • Through “Policy for Domestic, Municipal, and Industrial Water Supply Uses of Reservoir Projects Operated by the Department of the Army, U.S. Army Corps of Engineers,” (RIN 0710-AA72), update and clarify the policies governing the use of storage in U.S. Army Corps of Engineers reservoir projects for domestic, municipal, and industrial water supply.

3. Rulemakings That Streamline Regulations, Reduce Unjustified Burdens, and Minimize Burdens on Small Businesses

The Department plans to—

  • Finalize the DFARS rule to implement section 802 of the NDAA for FY 2012 to allow a covered litigation support contractor access to technical, proprietary, or confidential data for the sole purpose of providing litigation support. DFARS Case 2012-D029, Disclosure to Litigation Support to Contractors, pertains.
  • Finalize the DFARS rule to require scientific and technical reports be submitted in electronic format. This rule, DFARS Case 2014-D0001, will streamline the submission process by no longer requiring the electronically initiated report to be printed for submission.

4. Rules To Be Modified, Streamlined, Expanded, or Repealed To Make the Agency's Regulatory Program More Effective or Less Burdensome in Achieving the Regulatory Objectives

  • DFARS Cases 2013-D005, Clauses with Alternates—Foreign Acquisition, 2013-D025, Clauses with Alternates—Taxes, and 2014-D004, Clauses with Alternates—Special Contracting Methods, Major System Acquisition, and Service Contract—Propose a new convention for prescribing clauses with alternates to provide alternate clauses in full text. This will facilitate selection of alternate clauses using automated contract writing systems. The inclusion of the full text of the alternate clauses in the regulation for use in solicitations and contracts should make the terms of the alternate clauses clearer to offerors and contractors by clarifying paragraph substitutions. As a result, inapplicable paragraphs from the basic clause that are superseded by the alternate will not be included in solicitations or contracts, reducing the potential for confusion.
  • Finalize the rule for DFARS, DFARS Case 2014-D014, State Sponsors of Terrorism, to clarify and relocate coverage relating to state sponsors of terrorism, add an explicit representation, and conform the terminology to replace the term “terrorist country” with the more accurate term “country that is a state sponsor of terrorism.” DFARS subpart 209.1 text is being relocated to subpart 225.7. Subpart 225.7 is a better location because the prohibition is based on ownership or control of an offeror by the government of specified countries, rather than the responsibility of the individual offeror. Correspondingly, the provision at 252.209-7001 is being removed and replaced by a newly proposed provision 252.225-70XX.

5. Rulemakings That Have a Significant International Impact

  • Finalize the rule to revise the DFARS to improve awareness, compliance, and enforcement of DoD policies on combating trafficking in persons. The rule will further improve stability, productivity, and certainty in the contingency operations that DoD supports and ensure that DoD contractors do not benefit from the use of coerced labor.

Specific DoD Priorities

For this regulatory plan, there are six specific DoD priorities, all of which reflect the established regulatory principles. DoD has focused its regulatory resources on the most serious environmental, health, and safety risks. Perhaps most significant is that each of the priorities described below promulgates regulations to offset the resource impacts of Federal decisions on the public or to improve the quality of public life, such as those regulations concerning acquisition, health affairs, education, and cyber security.

1. Defense Procurement and Acquisition Policy

The Department of Defense continuously reviews the DFARS and continues to lead Government efforts to—

  • Revise the DFARS to improve presentation and clarity of the regulations by (1) initiating a new convention to construct clauses with alternates in a manner whereby the alternate clauses are included in full text making the terms of the alternates clearer by clarifying paragraph substitutions and (2) streamline the DFARS by screening the text to identify any DoD procedural guidance that does not have a significant effect beyond the internal operating procedures of DoD or have a significant cost or administrative impact on contractors or offerors, which should be more correctly relocated from the DFARS to the DFARS Procedures, Guidance, and Information (PGI).
  • Employ methods to facilitate and improve efficiency of the contracting process such as (1) employing a checklist to assist contractors in providing initial submission of FPRA proposals that are thorough, accurate, and complete and (2) requiring Start Printed Page 76504scientific and technical reports to be submitted electronically.

2. Health Affairs, Department of Defense

The Department of Defense is able to meet its dual mission of wartime readiness and peacetime health care by operating an extensive network of medical treatment facilities. This network includes DoD's own military treatment facilities supplemented by civilian health care providers, facilities, and services under contract to DoD through the TRICARE program. TRICARE is a major health care program designed to improve the management and integration of DoD's health care delivery system. The program's goal is to increase access to health care services, improve health care quality, and control health care costs.

The Defense Health Agency plans to publish the following rule:

  • Final Rule: CHAMPUS/TRICARE: Pilot Program for Refills of Maintenance Medications for TRICARE Life Beneficiaries through the TRICARE Mail Order Program. This final rule implements section 716 of the National Defense Authorization Act for Fiscal Year 2013 (Pub. L. 112-239), which establishes a 5-year pilot program that would generally require TRICARE for Life beneficiaries to obtain all refill prescriptions for covered maintenance medications from the TRICARE mail order program or military treatment facility pharmacies. Covered maintenance medications are those that involve recurring prescriptions for chronic conditions, but do not include medications to treat acute conditions. Beneficiaries may opt out of the pilot program after one year of participation. This rule includes procedures to assist beneficiaries in transferring covered prescriptions to the mail order pharmacy program. The interim final rule was published December 11, 2013 (78 FR 75245) with an effective date of February 14, 2014. DoD anticipates publishing a final rule in the first quarter of FY 2015.

3. Personnel and Readiness, Department of Defense

The Department of Defense plans to publish a rule regarding Service Academies:

  • Final Rule: Service Academies. This rule establishes policy, assigns responsibilities, and prescribes procedures for Department of Defense oversight of the Service Academies. Administrative costs are negligible, and benefits are clear, concise rules that enable the Secretary of Defense to ensure that the Service Academies are efficiently operated and meet the needs of the armed forces. The proposed rule was published October 18, 2007 (72 FR 59053), and included policy that has since changed. The final rule, particularly the explanation of separation policy, will reflect recent changes in the “Don't Ask, Don't Tell” policy. It will also incorporate changes resulting from interagency coordination. DoD anticipates publishing the final rule in the first or second quarter of FY 2015.

4. Military Community and Family Policy, Department of Defense

The Department of Defense has proposed a revision to the regulation implementing the Military Lending Act, which prescribes limitations on the terms of consumer credit extended to Service members and dependents:

  • Proposed Rule: Limitations on Terms of Consumer Credit Extended to Service Members and Dependents. In this proposed rule, the Department of Defense (Department) proposes to amend its regulation that implements the Military Lending Act, herein referred to as the “MLA”. Among other protections for Service members, the MLA limits the amount of interest that a creditor may charge on “consumer credit” to a maximum annual percentage rate of 36 percent. The Department proposed to amend its existing regulation primarily for the purpose of extending the protections of the MLA to a broader range of closed-end and open-end credit products, rather than the limited credit products currently defined as consumer credit. In addition, the Department proposed to amend its existing regulation to amend the provisions governing a tool a creditor may use in assessing whether a consumer is a “covered borrower,” modify the disclosures that a creditor must provide to a covered borrower implement the enforcement provisions of the MLA, as amended, among other purposes. The revisions to this rule are part of DoD's retrospective plan under Executive Order 13563 completed in August 2011.

5. Chief Information Officer, Department of Defense

The Department of Defense plans to amend the voluntary cyber security information sharing program between DoD and eligible cleared defense contractors:

  • Proposed Rule: Defense Industrial Base (DIB) Voluntary Cyber Security/Information Assurance (CS/IA) Activities. The Department proposes to amend the DoD-DIB CS/IA Voluntary Activities regulation (32 CFR part 236) in response to section 941 National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2013, which requires the Secretary of Defense to establish procedures that require each cleared defense contractor (CDC) to report to DoD when a network or information system has a cyber-intrusion. The revised rule also expands eligibility to participate in the DIB CS/IA voluntary cyber threat information sharing program to all CDCs. DoD anticipates publishing a proposed rule in the first or second quarter of FY 2015.

DOD—OFFICE OF THE SECRETARY (OS)

Proposed Rule Stage

38. Limitations on Terms of Consumer Credit Extended to Service Members and Dependents

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority: 10 U.S.C. 987

CFR Citation: 32 CFR 232.

Legal Deadline: None.

Abstract: The Department of Defense (“Department”) proposes to amend its regulation that implements the Military Lending Act, herein referred to as the “MLA.” Among other protections for servicemembers, the MLA limits the amount of interest that a creditor may charge on “consumer credit” to a maximum annual percentage rate of 36 percent. The Department is proposing to amend its existing regulation primarily for the purpose of extending the protections of the MLA to a broader range of closed-end and open-end credit products, rather than the limited credit products currently defined as consumer credit. In addition, the Department is proposing to amend its existing regulation to amend the provisions governing a tool a creditor may use in assessing whether a consumer is a “covered borrower,” modify the disclosures that a creditor must provide to a covered borrower, implement the enforcement provisions of the MLA, as amended, and for other purposes. The revisions to this rule are part of DoD's retrospective plan under Executive Order 13563 completed in August 2011. DoD's full plan can be accessed at: http://exchange.regulations.gov/​exchange/​topic/​eo-13563.

Statement of Need: This regulation identifies the negative impact of high-cost consumer credit lending on servicemembers and their dependents quality of life and on general troop readiness. Servicemembers are younger than the population as a whole with 43 percent 25 years old or less. Thirty-five percent of enlisted servicemembers in Start Printed Page 76505the grades E1-E4 are married and 20 percent of them have children. This is compared with approximately 12 percent of their contemporaries in the U.S. population 18 through 24 who are married (2012 U.S. Census Bureau). The majority of recruits come to the military from high school with little financial literacy education.

The initial indoctrination provided to servicemembers is critical providing basic requirements for their professional and personal responsibilities and their successful adjustment to military life. Part of this training is in personal finance which is an integral part of their personal and often professional success. The Department of Defense (the Department) continues to provide them messages to save, invest, and manage their money wisely throughout their career.

A major concern of the Department has been the debt accumulation of some servicemembers and the continued financial turmoil caused by their use of credit particularly high-cost credit. The regulation has provided limitation on the use of credit posing the most significant concerns (short-term high-cost credit secured by pay, vehicle title, or tax return). Other forms of high-cost credit outside of the definitions in the regulation have been developed since the regulation was initially released in 2007 and the proposed changes to the regulation have been developed in part to extend protections to servicemembers and their families to cover these new developments.

The Department views the support provided to military families as essential to sustaining force readiness and military capability. From this perspective it is not sufficient for the Department to train servicemembers on how best to use their financial resources. Financial protections are an important part of fulfilling the Departments compact with servicemembers and their families and most importantly of sustaining force readiness and military capability.

Summary of Legal Basis: Public Law 109-364 the John Warner National Defense Authorization Act for Fiscal Year 2007 670 Limitations on Terms of Consumer Credit Extended to Servicemembers and Dependents (October 17 2006). Section 670 of Public Law 109-364 which was codified as 10 U.S.C. 987 requires the Secretary of Defense to prescribe regulations to carry out the new section.

Alternatives: No other regulatory alternatives are available. Education represents a non-regulatory alternative that is an important aspect of the overall protection provided servicemembers and their families. However education has not been proven to change behavior and has not been sufficient to prepare many of servicemembers to avoid financial products and services that can cause them financial harm. This regulation works in tandem with on-going efforts to educate Service members and prepare them to manage their finances.

Anticipated Cost and Benefits: Increased costs to the creditors as a result of the Regulation have been articulated in the Paperwork Reduction Act Submission as part of the EO 12866 review. The Department anticipates that its regulation, if adopted as proposed, might impose costs of approximately $96 million during the first year, as creditors adapt their systems to comply with the requirements of the MLA and the Department's regulation. However, after the first year and on an ongoing basis, the annual effect on the economy is expected to be between approximately $7 million net (quantitative) costs and $117 million net (quantitative) benefits. The potentially anticipated net benefits of the proposed regulation are attributable to the cost savings to the Department that would result from the reduction in involuntary separations of Service members due to financial distress; at some points in the range of estimates the Department has used to assess the proposal, these savings are estimated to exceed the compliance costs that would be borne by creditors.

Risks: The Regulation currently covers payday loans, vehicle-title loans, and tax refund anticipation loans (RALs). Some other credit products with favorable terms as well as terms that can increase the interest rate well beyond the limits prescribed by 10 U.S.C. 987 were not initially covered by the regulation. However access to payday and vehicle title loans has changed to include variations that are no longer covered by the regulation and there are other high-cost credit products that have become more of an issue for servicemembers and their families who have over extended their credit.

The regulation continues to complement other actions taken by the Department to include initial and follow-on financial education financial awareness campaigns savings campaigns free financial counseling at military installations and available 24 hours 7 days per week through Military OneSource. To complement these efforts Military Aid Societies provide grants and no-interest loans and a growing number of financial institutions located on military installations are providing low-cost small-dollar loans.

Timetable:

ActionDateFR Cite
ANPRM06/17/1378 FR 36134
ANPRM Comment Period End08/01/13
NPRM09/29/1479 FR 58601
NPRM Comment Period End11/28/14
Final Action05/00/15

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Marcus Beauregard, Department of Defense, Office of the Secretary, 4000 Defense Pentagon, Washington, DC 20301-4000, Phone: 571 372-5357.

RIN: 0790-AJ10

DOD—OS

39. Defense Industrial Base (DIB) Cyber Security/Information Assurance (CS/IA) Activities: Amendment

Priority: Other Significant.

Legal Authority: EO 12829

CFR Citation: 32 CFR 236.

Legal Deadline: None.

Abstract: This rule amends the DoD-DIB CS/IA Voluntary Activities regulation in response to section 941 National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2013 which requires the Secretary of Defense to establish procedures that require each cleared defense contractor (CDC) to report when a network or information system that meets the criteria reports cyber intrusions.

Statement of Need: The Department of Defense (DoD) will amend the DoD-DIB CS/IA Voluntary Activities (32 CFR part 236) regulation to incorporate changes as required by section 941 NDAA for FY 2013 to include mandated cyber intrusion incident reporting by all cleared defense contractors (CDCs).

Summary of Legal Basis: This regulation is proposed under the authorities of section 941 NDAA for FY 2013.

Alternatives: DoD analyzed the requirements in section 941 NDAA for FY 2013 and determined that implementation must be accomplished through the rulemaking process. This will allow the public to comment on the implementation strategy.

Anticipated Cost and Benefits: Implementing the amended rule to meet the requirements of section 941 NDAA for FY 2013 affects approximately 8,700 CDCs. Each company will require DoD approved, medium assured certificates Start Printed Page 76506to submit the mandatory cyber incident reporting to the DoD-access controlled Web site. The cost per certificate is $175. In addition, it is estimated that the average burden per reported incident is 7 hours, which includes identifying the cyber incident details, gathering and maintaining the data needed, reviewing the collection of information to be reported, and completing the report. Note, these costs are the same as those associated with 32 CFR part 236 (DoD-DIB CS/IA Voluntary Activities), but are now applicable across a larger population of defense contractors. The benefit of this amended rule is satisfying the legal mandate from section 941 NDAA for FY 2013 as well as informing the Department of incidents that impact DoD programs and information. DoD needs to have the ability to assess the strategic and operational impacts of cyber incidents and determine appropriate mitigation activities.

Risks: There will likely be significant public interest in DoD's implementation of section 941 NDAA for FY 2013. DoD will need to assure the public that DoD will provide for the reasonable protection of trade secrets, commercial or financial information, and information that can be used to identify a specific person that may be evident through the cyber incident reporting and media analysis.

Timetable:

ActionDateFR Cite
NPRM03/00/15

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: Vicki Michetti, Department of Defense, Office of the Secretary, 6000 Defense Pentagon, Washington, DC 20301-6000, Phone: 703 604-3177, Email: vicki.d.michetti.civ@mail.mil.

RIN: 0790-AJ14

DOD—OS

Final Rule Stage

40. Service Academies

Priority: Other Significant.

Legal Authority: 10 U.S.C. 403; 10 U.S.C. 603; 10 U.S.C. 903

CFR Citation: 32 CFR 217

Legal Deadline: None.

Abstract: The Department is revising and updating policy guidance and oversight of the military service academies. This rule implements 10 U.S.C. 403, 603, and 903 for the establishment and operation of the United States Military Academy, the United States Naval Academy, and the United States Air Force Academy. The proposed rule was published October 18, 2007 (72 FR 59053), and included policy that has since changed. The final rule, particularly the explanation of separation policy, will reflect recent changes in the Don't Ask, Don't Tell policy.

Statement of Need: The Department of Defense revises and updates the current rule providing the policy guidance and oversight of the military service academies. This rule implements 10 U.S.C. 403, 603, and 903 for the establishment and operation of the United States Military Academy, the United States Naval Academy, and the United States Air Force Academy.

Summary of Legal Basis: 10 U.S.C. chapters 403, 603, 903.

Alternatives: None. The Federal statute directs the Department of Defense to develop policy, assign responsibilities, and prescribe procedures for operations and oversight of the service academies.

Anticipated Cost and Benefits: Administrative costs are negligible and benefits would be clear, concise rules that enable the Secretary of Defense to ensure that the service academies are efficiently operated and meet the needs of the Armed Forces.

Risks: None.

Timetable:

ActionDateFR Cite
NPRM10/18/0772 FR 59053
NPRM Comment Period End12/17/07
Final Action02/00/15

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Additional Information: DoD Instruction 1322.22.

Agency Contact: Paul Nosek, Department of Defense, Office of the Secretary, 4000 Defense Pentagon, Washington, DC 20301-4000, Phone: 703 695-5529.

RIN: 0790-AI19

DOD—Defense Acquisition Regulations Council (DARC)

Final Rule Stage

41. Foreign Commercial Satellite Services (DFARS Case 2014-D010)

Priority: Other Significant.

Legal Authority: 41 U.S.C. 1303; Pub. L. 113-66, sec 1602

CFR Citation: 48 CFR 204; 48 CFR 212; 48 CFR 225; 48 CFR 252.

Legal Deadline: Other, Statutory, December 26, 2013, 10 U.S.C. 2279, as added by sec 1602 of the NDAA for FY 2014 (Pub. L. 113-66), which was effective on enactment 12/26/13.

Abstract: DoD issued an interim rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement section 1602 of the National Defense Authorization Act for Fiscal Year 2014, which prohibits award of a contract for commercial satellite services to a foreign entity if the Secretary of Defense believes that the foreign entity (1) is an entity in which the government of a covered foreign country has an ownership interest that enables the government to affect satellite operations; or (2) plans to, or is expected to, provide or use launch or other satellite services under the contract from a covered foreign country. This rule is not expected to have a significant economic impact on a substantial number of small entities.

Statement of Need: This action is necessary because 10 U.S.C. 2279 as added by section 1602 of the National Defense Authorization Act for FY 2014 (Pub. L. 113-66) became effective upon enactment on December 26 2013. 10 U.S.C. 2279 restricts the acquisition of commercial satellite services from certain foreign entities. The statute prohibits the award of contracts for commercial satellite services to a foreign entity that (1) is an entity in which the government of a covered foreign country (i.e., the Peoples Republic of China, North Korea, Cuba, Iran, Sudan, or Syria) has an ownership interest that enables the government to affect satellite operations; or (2) plans to or is expected to provide or use launch or other satellite services under the contract from a covered foreign country.

Summary of Legal Basis: This rule is proposed under the authority of title 10 U.S.C. 2279 as added by section 1602 of the National Defense Authorization Act for FY 2014 (Pub. L. 113-66).

Alternatives: DoD was not able to identify any alternatives that meet the statutory requirements of 10 U.S.C. 2279 and the objectives of this rule.

Anticipated Cost and Benefits: Benefits associated with this rule outweigh the cost of compliance. The rule reduces the potential risk to national security by prohibiting the acquisition of commercial satellite services from certain foreign entities as in those case where the foreign entity is either (1) an entity in which the government of a covered foreign country has an ownership interest that enables the government to affect satellite Start Printed Page 76507operations; or (2) plans to or is expected to provide or use launch or other satellite services under the contract from a covered foreign country. The rule requires an annual representation as to whether the offeror is or is not a foreign entity subject to the prohibitions of the statute or is or is not offering commercial satellite services provided by such a foreign entity. DoD estimates that the total estimated annual public burden for the collection of this information is negligible (approximately $4275.00) based on Federal Procurement Data System data for FY 2013. There were 380 unique contractors that received contract or orders for PSC D304 (ADP Telecommunications and Transmission Services) of which commercial satellite services are a subset so 380 is an estimate at the highest end of the possible range of respondents. We estimate that these respondent will spend an average of 0.25 hours to complete and submit one response per year. Additionally DoD estimates that the rule will not have a significant impact on small entities unless they are offering commercial satellite services provided by a foreign entity that is subject to the restrictions of this rule. According to the FPDS data for fiscal year 2013, 111 small entities were awarded contracts or orders for services in PSC D304 (ADP Telecommunications and Transmission Services) of which commercial satellite services are a subset.

Risks: Until this statute is implemented in the DFARS there is risk that contracting officers may acquire commercial satellite services in violation of the law increasing the risk to the U.S. military operations and lost opportunities for the U.S. industrial base.

Timetable:

ActionDateFR Cite
Interim Final Rule08/05/1479 FR 45662
Interim Final Rule Effective08/05/14
Interim Final Rule Comment Period End10/06/14
Final Action03/00/15

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: Federal.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Manuel Quinones, Department of Defense, Defense Acquisition Regulations Council, 4800 Mark Center Drive, Suite 15D07-2, Alexandria, VA 22350, Phone: 571 372-6088, Email: manuel.quinones.civ@mail.mil.

RIN: 0750-AI32

DOD—Office of Assistant Secretary for Health Affairs (DODOASHA)

Final Rule Stage

42. Champus/TRICARE: Pilot Program for Refills of Maintenance

Medications for TRICARE for Life Beneficiaries Through the TRICARE Mail Order Program

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority: 5 U.S.C. 301; 10 U.S.C. ch 55

CFR Citation: 32 CFR 199.

Legal Deadline: None.

Abstract: This interim final rule implements section 716 of the National Defense Authorization Act for Fiscal Year 2013 (Pub. L. 112-239), which establishes a 5-year pilot program that would generally require TRICARE for Life beneficiaries to obtain all refill prescriptions for covered maintenance medications from the TRICARE mail order program or military treatment facility pharmacies. Covered maintenance medications are those that involve recurring prescriptions for chronic conditions, but do not include medications to treat acute conditions. Beneficiaries may opt out of the pilot program after 1 year of participation. This rule includes procedures to assist beneficiaries in transferring covered prescriptions to the mail-order pharmacy program. This regulation is being issued as an interim final rule in order to comply with the express statutory intent that the program begin in calendar year 2013.

Statement of Need: The Department of Defense (DoD) proposed rule establishes processes for the new program of refills of maintenance medications for TRICARE for Life beneficiaries through military treatment facility pharmacies and the mail order pharmacy program.

Summary of Legal Basis: This regulation is proposed under 5 U.S.C. 301; 10 U.S.C. chapter 55; 32 CFR 199.21.

Alternatives: The rule fulfills a statutory requirement, therefore there are no alternatives.

Anticipated Cost and Benefits: The effect of the statutory requirement, implemented by this rule, is to shift a volume of prescriptions from retail pharmacies to the most cost-effective point-of-service venues of military treatment facility pharmacies and the mail order pharmacy program. This will produce savings to the Department of approximately $104 million per year, and savings to beneficiaries of approximately $34 million per year in reduced copayments.

Risks: Loss of savings to both the Department and beneficiaries. No risk to the public.

Timetable:

ActionDateFR Cite
Interim Final Rule12/11/1378 FR 75245
Interim Final Rule Comment Period End02/10/14
Interim Final Rule Effective02/14/14
Final Action01/00/15

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: George Jones, Department of Defense, Office of Assistant Secretary for Health Affairs, Defense Pentagon, Washington, DC 20301, Phone: 703 681-2890.

RIN: 0720-AB60

DEPARTMENT OF EDUCATION

Statement of Regulatory Priorities

I. Introduction

The U.S. Department of Education (Department) supports States, local communities, institutions of higher education, and others in improving education nationwide and in helping to ensure that all Americans receive a high-quality education. We provide leadership and financial assistance pertaining to education at all levels to a wide range of stakeholders and individuals, including State educational and other agencies, local school districts, providers of early learning programs, elementary and secondary schools, institutions of higher education, career and technical schools, nonprofit organizations, postsecondary students, members of the public, families, and many others. These efforts are helping to ensure that all children and students from pre-kindergarten through grade 12 will be ready for, and succeed in, postsecondary education and that students attending postsecondary institutions are prepared for a profession or career.

We also vigorously monitor and enforce the implementation of Federal civil rights laws in educational Start Printed Page 76508programs and activities that receive Federal financial assistance, and support innovative programs, research and evaluation activities, technical assistance, and the dissemination of research and evaluation findings to improve the quality of education.

Overall, the laws, regulations, and programs that the Department administers will affect nearly every American during his or her life. Indeed, in the 2014-2015 school year, about 55 million students will attend an estimated 130,000 elementary and secondary schools in approximately 13,600 districts, and about 21 million students will enroll in degree-granting postsecondary schools. All of these students may benefit from some degree of financial assistance or support from the Department.

In developing and implementing regulations, guidance, technical assistance, and monitoring related to our programs, we are committed to working closely with affected persons and groups. Specifically, we work with a broad range of interested parties and the general public, including families, students, and educators; State, local, and tribal governments; and neighborhood groups, community-based early learning programs, elementary and secondary schools, colleges, rehabilitation service providers, adult education providers, professional associations, advocacy organizations, businesses, and labor organizations.

If we determine that it is necessary to develop regulations, we seek public participation at the key stages in the rulemaking process. We invite the public to submit comments on all proposed regulations through the Internet or by regular mail. We also continue to seek greater public participation in our rulemaking activities through the use of transparent and interactive rulemaking procedures and new technologies.

To facilitate the public's involvement, we participate in the Federal Docketing Management System (FDMS), an electronic single Government-wide access point (www.regulations.gov) that enables the public to submit comments on different types of Federal regulatory documents and read and respond to comments submitted by other members of the public during the public comment period. This system provides the public with the opportunity to submit comments electronically on any notice of proposed rulemaking or interim final regulations open for comment, as well as read and print any supporting regulatory documents.

We are continuing to streamline information collections, reduce the burden on information providers involved in our programs, and make information easily accessible to the public.

II. Regulatory Priorities

A. The Higher Education Act of 1965, as Amended

Gainful Employment. On March 25, 2014, the Secretary issued a notice of proposed rulemaking for the Federal Student Aid programs authorized under title IV of the Higher Education Act of 1965, as amended (HEA). Specifically, the proposed regulations would amend the regulations on institutional eligibility under the HEA and the Student Assistance General Provisions to establish measures for determining whether certain postsecondary educational programs prepare students for gainful employment in a recognized occupation, the conditions under which these educational programs remain eligible for the title IV Federal Student Aid programs, and requirements for reporting and disclosure of relevant information. The public comment period for the proposed regulations closed on May 27, 2014, and the Department published final regulations on October 31, 2014.

Pay As You Earn. On June 9, 2014, the President issued a memorandum directing the Secretary to propose regulations by June 9, 2015, that will allow additional students who borrowed Federal Direct Loans to cap their Federal student loan payments at 10 percent of their income. The memorandum further directed the Secretary to issue final regulations after considering all public comments with the goal of making the repayment option available to borrowers by December 31, 2015. On September 3, 2014, we published a notice announcing our intention to establish a negotiated rulemaking committee to prepare proposed regulations governing the Federal William D. Ford Direct Loan Program. We also invited public comments regarding additional issues that should be considered for action by the negotiating committee.

Teacher Preparation. On April 25, 2014, the President directed the Department to propose a plan to strengthen America's teacher preparation programs for public comment and to publish a final rule within the next year. The Administration seeks to encourage and support States in developing systems that recognize excellence and provide all programs with information to help them improve, while holding them accountable for how well they prepare teachers to succeed in today's classrooms and throughout their careers. Specifically, the Department is preparing to issue proposed regulations under title II of the HEA that require States to provide more meaningful data in their State report cards on the performance of each teacher preparation program located in the State and to amend the regulations governing the Teacher Education Assistance for College and Higher Education (TEACH) Grant Program to update, clarify, and improve the current regulations and align them with data reported by States under title II.

B. Elementary and Secondary Education Act of 1965, as Amended

In 2010, the Administration released the “Blueprint for Reform: The Reauthorization of the Elementary and Secondary Education Act”, the President's plan for revising the Elementary and Secondary Education Act of 1965 (ESEA) and replacing the No Child Left Behind Act of 2001 (NCLB). The blueprint can be found at the following Web site: http://www2.ed.gov/​policy/​elsec/​leg/​blueprint/​index.html .

Additionally, as we continue to work with Congress on reauthorizing the ESEA, we continue to provide flexibility on certain provisions of current law for States that are willing to embrace reform. The mechanisms we are using will ensure continued accountability and commitment to high-quality education for all students while providing States with increased flexibility to implement State and local reforms to improve student achievement.

C. Carl D. Perkins Career and Technical Education Act of 2006

In 2012, we released “Investing in America's Future: A Blueprint for Transforming Career and Technical Education”, our plan for reauthorizing the Carl D. Perkins Career and Technical Education Act of 2006 (2006 Perkins Act). The Blueprint can be found at the following Web site: http://www2.ed.gov/​about/​offices/​list/​ovae/​pi/​cte/​transforming-career-technical-education.pdf.

The 2006 Perkins Act made important changes in Federal support for career and technical education (CTE), such as the introduction of a requirement that all States offer “programs of study.” These changes helped to improve the learning experiences of CTE students but did not go far enough to systemically create better outcomes for students and employers who are competing in a 21st-century global Start Printed Page 76509economy. The Administration's Blueprint would usher in a new era of rigorous, relevant, and results-driven CTE shaped by four core principles: (1) Alignment; (2) Collaboration; (3) Accountability; and (4) Innovation. The Administration's Blueprint proposal reflects a commitment to promoting equity and quality across these alignment, collaboration, accountability, and innovation efforts in order to ensure that more students have access to high-quality CTE programs.

D. Individuals With Disabilities Education Act

On September 18, 2013, the Secretary issued a notice of proposed rulemaking to amend regulations under Part B of the Individuals with Disabilities Education Act (IDEA) regarding local maintenance of effort (MOE) to ensure that all parties involved in implementing, monitoring, and auditing local educational agency (LEA) compliance with MOE requirements understand the rules. The Secretary intends to issue final regulations to amend the existing regulations that will clarify existing policy and make other related changes regarding: (1) The compliance standard; (2) the eligibility standard; (3) the level of fiscal effort required of an LEA in the year after it fails to maintain that effort; and (4) the consequence for a failure to maintain local effort.

E. Workforce Innovation and Opportunity Act

President Obama signed the Workforce Innovation and Opportunity Act (WIOA) into law on July 22, 2014. WIOA replaced the Workforce Investment Act of 1998 (WIA), including the Adult Education and Family Literacy Act (AEFLA), and amended the Wagner-Peyser Act and the Rehabilitation Act of 1973 (Rehabilitation Act). WIOA promotes the integration of the workforce development system's four “core programs”, including AEFLA and the vocational rehabilitation program under Title I of the Rehabilitation Act), into the revamped workforce development system under Title I of WIOA. In collaboration with the Department of Labor (DOL), the Department must issue an NPRM by January 18, 2015, and final regulations by January 22, 2016. The Department is working with DOL to meet this statutory deadline. The Department will also regulate on the programs it administers under the Rehabilitation Act and AEFLA that were changed by WIOA.

III. Retrospective Review of Existing Regulations

Pursuant to section 6 of Executive Order 13563, “Improving Regulation and Regulatory Review” (signed by the President on Jan. 18, 2011), the following Regulatory Identifier Numbers (RINs) have been identified as associated with retrospective review and analysis in the Department's final retrospective review of regulations plan. Some of the entries on this list may be completed actions that do not appear in The Regulatory Plan. However, more information can be found about these completed rulemakings in past publications of the Unified Agenda on Reginfo.gov in the Completed Actions section. These rulemakings can also be found on Regulations.gov. The final agency plan can be found at: www.ed.gov.

RINTitle of RulemakingDo we expect this rulemaking to significantly reduce burden on small businesses?
1810-AB16Title I—Improving the Academic Achievement of the DisadvantagedNo.
1820-AB65Assistance to States for the Education of Children with Disabilities—Maintenance of EffortNo.
1820-AB66American Indian Vocational Rehabilitation Services ProgramNo.
1820-AB68Workforce Innovation and Opportunity Act (OSERS)Undetermined.
1830-AA21Workforce Innovation and Opportunity Act (OCTAE)Undetermined.
1840-AD08Titles III and V of the Higher Education Act, as AmendedNo.
1840-AD14Negotiated Rulemaking Under Title IV of the HEANo.
1840-AD15Gainful EmploymentNo.
1840-AD16Violence Against Women ActNo.
1840-AD17William D. Ford Federal Direct Loan ProgramNo.

IV. Principles for Regulating

Over the next year, we may need to issue other regulations because of new legislation or programmatic changes. In doing so, we will follow the Principles for Regulating, which determine when and how we will regulate. Through consistent application of those principles, we have eliminated unnecessary regulations and identified situations in which major programs could be implemented without regulations or with limited regulatory action.

In deciding when to regulate, we consider the following:

  • Whether regulations are essential to promote quality and equality of opportunity in education.
  • Whether a demonstrated problem cannot be resolved without regulation.
  • Whether regulations are necessary to provide a legally binding interpretation to resolve ambiguity.
  • Whether entities or situations subject to regulation are similar enough that a uniform approach through regulation would be meaningful and do more good than harm.
  • Whether regulations are needed to protect the Federal interest, that is, to ensure that Federal funds are used for their intended purpose and to eliminate fraud, waste, and abuse.

In deciding how to regulate, we are mindful of the following principles:

  • Regulate no more than necessary.
  • Minimize burden to the extent possible, and promote multiple approaches to meeting statutory requirements if possible.
  • Encourage coordination of federally funded activities with State and local reform activities.
  • Ensure that the benefits justify the costs of regulating.
  • To the extent possible, establish performance objectives rather than specify compliance behavior.
  • Encourage flexibility, to the extent possible and as needed to enable institutional forces to achieve desired results.

ED—OFFICE OF POSTSECONDARY EDUCATION (OPE)

Proposed Rule Stage

43. • Pay as you Earn

Priority: Other Significant. Major under 5 U.S.C. 801.Start Printed Page 76510

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined.

Legal Deadline: None.

Abstract: On June 9 2014, the President issued a memorandum (79 FR 33843) directing the Secretary to propose regulations by June 9, 2015, that will allow additional students who borrowed Federal Direct Loans to cap their Federal student loan payments at 10 percent of their income. The memorandum further directed the Secretary to issue final regulations after considering all public comments with the goal of making the repayment option available to borrowers by December 31, 2015.

Statement of Need: The President has issued a memorandum directing the Secretary to propose regulations by June 9, 2015, that will allow additional student borrowers Federal Direct Loans to cap their Federal student loan payments at 10 percent of their income. The memorandum further directed the Secretary to issue final regulations after considering all public comments with the goal of making the repayment option available to borrowers by December 31, 2015.

Summary of Legal Basis: The President directed the Secretary to propose regulations that will allow additional student borrowers Federal Direct Loans to cap their Federal student loan payments at 10 percent of their income.

Alternatives: These will be discussed in the notice of proposed rulemaking.

Anticipated Cost and Benefits: These will be discussed in the notice of proposed rulemaking.

Risks: These will be discussed in the notice of proposed rulemaking.

Timetable:

ActionDateFR Cite
Notice of Intent to Establish Negotiated Rulemaking Committee09/03/1479 FR 52273
NPRM06/00/15

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

URL For Public Comments: www.regulations.gov.

Agency Contact: Wendy Macias, Department of Education, Office of Postsecondary Education, Room 8017, 1990 K Street NW., Washington, DC 20006, Phone: 202 502-7526, Email: wendy.macias@ed.gov.

RIN: 1840-AD18

ED—OFFICE OF CAREER, TECHNICAL, AND ADULT EDUCATION (OCTAE)

Proposed Rule Stage

44. • Workforce Innovation and Opportunity Act

Priority: Economically Significant. Major status under 5 U.S.C. 801 is undetermined.

Legal Authority: Pub. L. 113-128

CFR Citation: Not Yet Determined.

Legal Deadline: NPRM, Statutory, January 18, 2015, No later than 180 days after enactment. Final, Statutory, January 22, 2016, 18 months after enactment.

Abstract: WIOA was signed into law on July 22, 2014. It replaced the Workforce Investment Act of 1998, including the Adult Education and Family Literacy Act (AEFLA), and amended the Wagner-Peyser Act and the Rehabilitation Act of 1973. WIOA promotes the integration of the workforce development system's four core programs. In collaboration with the Department of Labor (DOL), the Department must issue an NPRM by January 18, 2015 and final regulations by January 22, 2016. To meet this statutory timeline, the Department will work with DOL on various issues. The Department will also regulate on the programs it administers under the Rehabilitation Act and the AEFLA that were changed by WIOA.

Statement of Need: WIOA replaces the Workforce Investment Act of 1998, including the AEFLA, and amends the Wagner-Peyser Act and the Rehabilitation Act of 1973. In collaboration with the Department of Labor (DOL), the Department must issue proposed regulations on the integration of the workforce development system's four core programs, and will also regulate on the programs it administers under the Rehabilitation Act and the AEFLA that were changed by WIOA.

Summary of Legal Basis: The Department will issue proposed regulations on the integration of the workforce development system's four core programs, and on the programs it administers under that were changed by WIOA.

Alternatives: These will be discussed in the NPRM Regulations.

Anticipated Cost and Benefits: These will be discussed in the NPRM Regulations.

Risks: These will be discussed in the NPRM Regulations.

Timetable:

ActionDateFR Cite
NPRM01/00/15

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

URL For Public Comments: www.regulations.gov.

Agency Contact: Mary Louise Dirrigl, Department of Education, Office of Special Education and Rehabilitative Services, Room 5156, PCP, 550 12th Street SW., Washington, DC 20202, Phone: 202 245-7324.

Cheryl Keenan, Department of Education, Office of Career, Technical, and Adult Education, 550 12th Street SW., Washington, DC 20202, Phone: 202 245-7810.

RIN: 1830-AA21.

DEPARTMENT OF ENERGY

Statement of Regulatory and Deregulatory Priorities

The Department of Energy (Department or DOE) makes vital contributions to the Nation's welfare through its activities focused on improving national security, energy supply, energy efficiency, environmental remediation, and energy research. The Department's mission is to:

  • Promote dependable, affordable and environmentally sound production and distribution of energy;
  • Advance energy efficiency and conservation;
  • Provide responsible stewardship of the Nation's nuclear weapons;
  • Provide a responsible resolution to the environmental legacy of nuclear weapons production; and
  • Strengthen U.S. scientific discovery, economic competitiveness, and improve quality of life through innovations in science and technology.

The Department's regulatory activities are essential to achieving its critical mission and to implementing major initiatives of the President's National Energy Policy. Among other things, the Regulatory Plan and the Unified Agenda contain the rulemakings the Department will be engaged in during the coming year to fulfill the Department's commitment to meeting deadlines for issuance of energy conservation standards and related test procedures. The Regulatory Plan and Unified Agenda also reflect the Department's continuing commitment to cut costs, reduce regulatory burden, and increase responsiveness to the public.Start Printed Page 76511

Retrospective Review of Existing Regulations

Pursuant to section 6 of Executive Order 13563 “Improving Regulation and Regulatory Review” (Jan. 18, 2011), several regulations have been identified as associated with retrospective review and analysis in the Department's final retrospective review of regulations plan. Some of these entries on this list may be completed actions, which do not appear in the Regulatory Plan. However, more information can be found about these completed rulemakings in past publications of the Unified Agenda on Reginfo.gov in the Completed Actions section for that agency. These rulemakings can also be found on Regulations.gov. The final agency plan can be found at http://www.whitehouse.gov/​sites/​default/​files/​other/​2011-regulatory-action-plans/​departmentofenergyregulatoryreformplanaugust2011.pdf.

Energy Efficiency Program for Consumer Products and Commercial Equipment

The Energy Policy and Conservation Act (EPCA) requires DOE to set appliance efficiency standards at levels that achieve the maximum improvement in energy efficiency that is technologically feasible and economically justified. The Department continues to follow its schedule for setting new appliance efficiency standards. These rulemakings are expected to save American consumers billions of dollars in energy costs.

The overall plan for implementing the schedule is contained in the Report to Congress under section 141 of EPACT 2005, which was released on January 31, 2006. This plan was last updated in the August 2014 report to Congress and now includes the requirements of the Energy Independence and Security Act of 2007 (EISA 2007) and the American Energy Manufacturing Technical Corrections Act (AEMTCA). The reports to Congress are posted at: http://www.eere.energy.gov/​buildings/​appliance_​standards/​schedule_​setting.html.

Estimate of Combined Aggregate Costs and Benefits

In FY 2014, the Department published final rules that adopted new or amended energy conservation standards for seven different products, including metal halide lamp fixtures, external power supplies, commercial refrigeration equipment, walk-in coolers and freezers, through the wall air conditioners and heat pumps, electric motors, and furnace fans. These standards when combined with the other final rules adopting standards since January 2009, are expected to save consumers hundreds of billions of dollars on their utility bills through 2030.

DOE believes that the three rulemakings that make up the Regulatory Plan will also substantially benefit the Nation. However, because of their current stage in the rulemaking process, DOE has not yet proposed candidate standard levels for these products and cannot provide an estimate of combined aggregate costs and benefits for these actions. DOE will, however, in compliance with all applicable law, issue standards that provide the maximum energy savings that are technologically feasible and economically justified. Estimates of energy savings will be provided when DOE issues the notice of proposed rulemakings for manufactured housing, general service lamps, and non-weatherized gas furnaces.

DOE—ENERGY EFFICIENCY AND RENEWABLE ENERGY (EE)

Prerule Stage

45. Energy Conservation Standards for General Service Lamps

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Unfunded Mandates: Undetermined.

Legal Authority: 42 U.S.C. 6295(i)(6)(A) and (B)

CFR Citation: 10 CFR 430.

Legal Deadline: Final, Statutory, January 1, 2017.

Abstract: Amendments to Energy Policy and Conservation Act (EPCA) in the Energy Independence and Security Act of 2007 (EISA) direct DOE to conduct two rulemaking cycles to evaluate energy conservation standards for GSLs, the first of which must be initiated no later than January 1, 2014. EISA specifically states that the scope of the rulemaking is not limited to incandescent lamp technologies. EISA also states that DOE must consider in the first rulemaking cycle the minimum backstop requirement of 45 lumens per watt for GSLs effective January 1, 2020, established by EISA. This rulemaking constitutes DOE's first rulemaking cycle.

Statement of Need: EPCA requires minimum energy efficiency standards for certain appliances and commercial equipment.

Summary of Legal Basis: Title III of the Energy Policy and Conservation Act of 1975 (EPCA or the Act) Public Law 94163 (42 U.S.C. 62916309 as codified) established the Energy Conservation Program for Consumer Products Other Than Automobiles. Pursuant to EPCA any new or amended energy conservation standard that the U.S. Department of Energy (DOE) prescribes for certain products such as general service lamps shall be designed to achieve the maximum improvement in energy efficiency that is technologically feasible and economically justified (42 U.S.C. 6295(o)(2)(A)) and result in a significant conservation of energy (42 U.S.C. 6295(o)(3)(B)).

Alternatives: The statute requires DOE to conduct rulemakings to review standards and to revise standards to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. In making this determination DOE conducts a thorough analysis of the alternative standard levels including the existing standard based on the criteria specified by the statute.

Anticipated Cost and Benefits: Because DOE has not yet proposed energy efficiency standards, DOE cannot provide an estimate of combined aggregate costs and benefits for these actions. DOE will, however, in compliance with all applicable law, issue standards that provide for increased energy efficiency that are economically justified. Estimates of energy savings will be provided when DOE issues the notice of proposed rulemaking action.

Risks:

Timetable:

ActionDateFR Cite
Framework Document Availibility; Public Meeting12/09/1378 FR 73737
Framework Document Comment Period Extended01/23/1479 FR 3742
Framework Document Comment Period End02/07/14
Preliminary Analysis12/00/14
NPRM02/00/16

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

URL For More Information: www1.eere.energy.gov/​buildings/​appliance_​standards/​rulemaking.aspx?​ruleid=​83.

URL For Public Comments: www.regulations.gov/​#!docketDetail;​D=​EERE-2013-BT-STD-0051.

Agency Contact: Lucy DeButts, Office of Buildings Technologies Program, EE-Start Printed Page 765125B, Department of Energy, Energy Efficiency and Renewable Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202 287-1604, Email: lucy.debutts@ee.doe.gov.

RIN: 1904-AD09

DOE—EE

Proposed Rule Stage

46. Energy Efficiency Standards for Manufactured Housing

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: This action may affect the private sector under Pub. L. 104-4.

Legal Authority: 42 U.S.C. 17071

CFR Citation: 10 CFR 460.

Legal Deadline: Final, Statutory, December 19, 2011.

Abstract: Section 413 of EISA requires that DOE establish standards for energy efficiency in manufactured housing. See 42 U.S.C. 17071(a)(1). DOE is directed to base the energy efficiency standards on the most recent version of the International Energy Conservation Code (IECC), except where DOE finds that the IECC is not cost effective, or a more stringent standard would be more cost effective, based on the impact of the IECC on the purchase price of manufactured housing and on total life-cycle construction and operating costs. On June 13, 2014, DOE published a notice of intent to establish a negotiated rulemaking working group for the manufactured housing rulemaking under the Appliance Standards and Rulemaking Federal Advisory Committee (ASRAC) in accordance with the Federal Advisory Committee Act (FACA) and the Negotiated Rulemaking Act (NRA) to negotiate proposed Federal standards for the energy efficiency of manufactured homes (79 FR 33873). The purpose of the working group is to discuss and, if possible, reach consensus on a proposed rule for the energy efficiency of manufactured homes.

Statement of Need: EISA requires DOE to establish minimum energy efficiency standards for manufactured housing.

Summary of Legal Basis: Section 413 of EISA 2007, 42 U.S.C. 17071, directs DOE to develop and publish energy standards for manufactured housing.

Alternatives: The statute requires DOE to conduct a rulemaking to establish standards based on the most recent version of the International Energy Conservation Code (IECC), except in cases in which the Secretary finds that the IECC is not cost effective or a more stringent standard would be more cost effective based on the impact of the IECC on the purchase price of manufactured housing and on total lifecycle construction and operating costs.

Anticipated Cost and Benefits: Because DOE has not yet proposed energy efficiency standards, DOE cannot provide an estimate of combined aggregate costs and benefits for these actions. DOE will, however, in compliance with all applicable law, issue standards that provide for increased energy efficiency that are economically justified. Estimates of energy savings will be provided when DOE issues the notice of proposed rulemaking.

Timetable:

ActionDateFR Cite
ANPRM02/22/1075 FR 7556
ANPRM Comment Period End03/24/10
Request for Information06/25/1378 FR 37995
NPRM11/00/14
Extension of Term; Notice of Public Meeting10/01/1479 FR 59154
NPRM02/00/15

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: None.

URL For More Information: www1.eere.energy.gov/​buildings/​appliance_​standards/​rulemaking.aspx?​ruleid=​97.

URL For Public Comments: www.regulations.gov/​#!docketDetail;​D=​EERE-2009-BT-BC-0021.

Agency Contact: Joseph Hagerman, Office of Building Technologies, EE-2J, Department of Energy, Energy Efficiency and Renewable Energy, 1000 Independence Ave. SW., Washington, DC 20585, Phone: 202 586-4549, Email: joseph.hagerman@ee.doe.gov.

RIN: 1904-AC11

DOE—EE

47. Energy Conservation Standards for Residential Non-weatherized Gas Furnaces

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: Undetermined.

Legal Authority: 42 U.S.C. 6295(f)(4)(e); 42 U.S.C. 6295(m)(1); 42 U.S.C. 6295(gg)(3)

CFR Citation: 10 CFR 430.

Legal Deadline: NPRM, Judicial, April 24, 2015, One year after issuance of the proposed rule. Final, Judicial, April 24, 2016.

Abstract: The Energy Policy and Conservation Act of 1975 (EPCA), as amended, prescribes energy conservation standards for various consumer products and certain commercial and industrial equipment, including residential furnaces. EPCA also requires the DOE to periodically determine whether more-stringent amended standards would be technologically feasible and economically justified and would save a significant amount of energy. DOE is amending its energy conservation standards for residential non-weatherized gas furnaces and mobile home gas furnaces in partial fulfillment of a court-ordered remand of DOE's 2011 rulemaking for these products.

Statement of Need: EPCA requires minimum energy efficiency standards for certain appliances and commercial equipment, including residential furnaces.

Summary of Legal Basis: Title III of the Energy Policy and Conservation Act of 1975 (EPCA or the Act), Public Law 94-163 (42 U.S.C. 6291-6309, as codified), established the Energy Conservation Program for Consumer Products Other Than Automobiles. Pursuant to EPCA, any new or amended energy conservation standard that the U.S. Department of Energy (DOE) prescribes for certain products, such as residential furnaces, shall be designed to achieve the maximum improvement in energy efficiency that is technologically feasible and economically justified (42 U.S.C. 6295(o)(2)(A)) and result in a significant conservation of energy (42 U.S.C. 6295(o)(3)(B)).

Alternatives: The statute requires DOE to conduct rulemakings to review standards and to revise standards to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. In making this determination, DOE conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified by the statute.

Anticipated Cost and Benefits: Because DOE has not yet proposed energy efficiency standards, DOE cannot provide an estimate of combined aggregate costs and benefits for these actions. DOE will, however, in compliance with all applicable laws, issue standards that provide for increased energy efficiency that are economically justified. Estimates of energy savings will be provided when Start Printed Page 76513DOE issues the notice of proposed rulemaking.

Risks:

Timetable:

ActionDateFR Cite
Notice of Public Meeting10/30/1479 FR 64517
NPRM12/00/14
Final Action12/00/15

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Local, State.

Federalism: Undetermined.

URL For More Information: www1.eere.energy.gov/​buildings/​appliance_​standards/​product.aspx/​productid/​72.

URL For Public Comments: www.regulations.gov.

Agency Contact: John Cymbalsky, Office of Building Technologies Program, EE-5B, Department of Energy, Energy Efficiency and Renewable Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202 287-1692, Email: john.cymbalsky@ee.doe.gov.

RIN: 1904-AD20

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Statement of Regulatory Priorities for Fiscal Year 2015

As the Federal agency with lead responsibility for protecting the health of all Americans and for providing supportive services for vulnerable populations, the Department of Health and Human Services (HHS) implements programs that strengthen the health care system; advance scientific knowledge and innovation; improve the health, safety, and well-being of the American people; and strengthen the Nation's health and human services infrastructure.

The Department's regulatory priorities for Fiscal Year 2015 reflect this complex mission through planned rulemakings structured to: Further increase access to health care for all Americans, especially by strengthening the Medicare, Medicaid and Children's Health Insurance programs; build from previous experiences to safeguard the Nation's food supply; provide consumers with information to help them make healthy choices; and marshal the best research and technology available to streamline and modernize the health care delivery and medical-product availability systems. The following overview highlights forthcoming rulemakings exemplifying these priorities.

Encouraging Delivery System Reforms To Ensure Consumer Access to High Quality, Affordable Care

The Affordable Care Act expands access to health insurance through improvements in Medicaid, the establishment of Affordable Insurance Exchanges, and coordination between Medicaid, the Children's Health Insurance Program, and the Exchanges. A forthcoming final rule will bring to completion regulatory provisions that support our efforts to assist States in implementing Medicaid eligibility determinations, appeals, enrollment changes, and other State health subsidy programs stemming from the Affordable Care Act. The intent of the rule is to afford each State substantial discretion in the design and operation of that State's exchange, with standardization provided only where directed by the Act or where there are compelling practical, efficiency or consumer-protection reasons.

A forthcoming proposed rule would establish policies related to “Stage 3” of the Medicare/Medicaid Electronic Health Record (EHR) Incentive Programs. The rule is necessary to further implement provisions of the American Recovery and Reinvestment Act that provide incentive payments to eligible providers, hospitals, and critical access hospitals participating in Medicare and Medicaid programs that adopt certified EHR technology. The proposal will offer for comment specific criteria that these providers and facilities would need to meet in order to successfully demonstrate “meaningful use,” focusing on advanced use of EHR technology to promote improved outcomes for patients.

The Mental Health Parity and Addiction Equity Act (MHPAEA) requires parity between mental health or substance use disorder benefits and medical/surgical benefits, with respect to financial requirements and treatment limitations under group health plans. A new proposed rule would build on the 2013 final rule implementing MHPAEA by proposing standards for Medicaid alternative benefit plans, Medicaid managed care organizations, and the Children's Health Insurance Program.

Another proposed rule would revise the requirements that long-term care facilities must meet to participate in the Medicare and Medicaid programs. The proposed changes are necessary to reflect advances in the theory and practice of service delivery and safety for patients in long-term care settings. The proposals are also an integral part of our efforts to achieve broad-based improvements both in the quality of health care furnished through Federal programs, and in patient safety, while at the same time reducing procedural burdens on providers.

In addition, nine Medicare payment rules will be updated to better reflect the current state of medical practice and to respond to feedback from providers seeking financial predictability and flexibility to better serve patients.

Streamlining Regulations Through Retrospective Review

Consistent with the President's Executive Order 13563, “Improving Regulation and Regulatory Review,” the Department remains committed to reducing regulatory burden on States, health care providers and suppliers, and other regulated entities by updating current rules to align them with emerging health and safety standards, and by eliminating outdated procedural provisions.

For example, CMS will continue its retrospective review efforts by finalizing an April 2014, proposal to amend the fire safety standards for hospitals, long-term care facilities, ambulatory surgery centers, and a variety of other inpatient care settings. Further, this rule will adopt the most recent edition of the Life Safety Code (LSC) and eliminate references in our regulations to all earlier editions, which will give clear guidance to providers and institutions for these important safety standards.

Similarly, a forthcoming final rule from the Administration for Children and Families (ACF) will provide the first comprehensive update of Child Care and Development Fund (CCDF) regulations since 1998. The CCDF is a Federal program that provides formula grants to States, territories, and tribes. The program provides financial assistance to low-income families to access child care so that they can work or attend a job-training or educational program. It also provides funding to improve the quality of child care and increase the supply and availability of child care for all families, including those who receive no direct assistance through CCDF.

Another ACF effort would modify existing Head Start performance standards to take into account increased knowledge in the early childhood field since the standards were last updated more than 15 years ago. Changes would strengthen requirements on curriculum and assessment, supervision, health and safety, and governance. The notice of proposed rulemaking would also streamline existing regulations to Start Printed Page 76514eliminate unnecessary or duplicative requirements.

Additionally, the Department, in collaboration with the President's Office of Science and Technology Policy will propose revisions to existing rules governing research on human subjects, often referred to as the Common Rule. This rule would apply to institutions and researchers supported by HHS as well as researchers throughout much of the Federal Government who are conducting research involving human subjects. The proposed revisions will aim to better protect human subjects while facilitating research, and also reducing burden, delay, and ambiguity for investigators.

Helping Consumers Identify Healthy Choices in the Marketplace

Since 1980, the prevalence of obesity among children and adolescents has almost tripled. Obesity has both immediate and long-term effects on the health and quality of life of those affected, increasing their risk for chronic diseases, including heart disease, type 2 diabetes, certain cancers, stroke, and arthritis—as well as increasing medical costs for the individual and the health system. Building on the momentum of the First Lady's “Let's Move” initiative, HHS has mobilized skills and expertise from across the Department to address this epidemic with research, public education, and public health strategies.

Adding to this effort, the Food and Drug Administration (FDA) plans to issue four final rules designed to provide more useful, easy to understand dietary information tools that will help millions of American families identify healthy choices in the marketplace. These rules, each benefiting from input received in extended public comment periods, will:

  • Require restaurants and similar retail food establishments with 20 or more locations to list calorie content information for standard menu items on restaurant menus and drive-through menu boards. Other nutrient information—total calories, fat, saturated fat, cholesterol, sodium, total carbohydrates, sugars, fiber, and total protein—would have to be made available in writing upon request;
  • Require vending machine operators who own or operate 20 or more vending machines to disclose calorie content for some items. The Department anticipates that such information will ensure that patrons of chain restaurants and vending machines have access to essential nutrition information;
  • Revise the nutrition and supplement facts labels on packaged food, which has not been updated since 1993 when mandatory nutrition labeling of food was first required. The aim of the proposed revision is to provide updated and easier to read nutrition information on the label to help consumers maintain healthy dietary practices; and
  • Update the serving-size information provided within the food label, providing current nutrition information based on the amount of food that is typically eaten as a serving, to assist consumers in maintaining healthy dietary practices.

Implementing the Food Safety Modernization Act

FDA will maintain the agency's ongoing effort to promulgate rules required under the Food Safety Modernization Act (FSMA), working with public and private partners to build a new system of food safety oversight. Responding to extensive feedback from stakeholders, the agency recently issued for further public comment supplemental proposals structured to:

  • Establish preventive controls in the manufacture and distribution of human foods and of animal feeds. These regulations constitute the heart of the FSMA food safety program by instituting uniform practices for the manufacture and distribution of food products, to ensure that those products are safe for consumption and will not cause or spread disease.
  • Ensure that produce sold in the United States meets rigorous safety standards. The regulation would set enforceable, science-based standards for the safe production and harvesting of fresh produce at the farm and the packing house, to minimize the risk of adverse health consequences.
  • Require food importers to establish a verification program to improve the safety of food imported into the United States. Specifically, FDA will outline proposed standards that foreign food suppliers must meet to ensure that imported food is produced in a manner that is as safe as food produced in the United States.

Reducing Tobacco Use

In 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act, authorizing FDA to regulate the manufacture, marketing, and distribution of tobacco products, to protect the public health and to reduce tobacco use by minors. In the coming fiscal year, benefiting from public scrutiny of an April 2014, regulatory proposal, FDA plans to issue a final rule that will clarify which products containing tobacco, in addition to cigarettes, are subject to the Agency's oversight. This rule would also allow FDA to establish regulatory standards on the sale and distribution of tobacco products, such as age-related access restrictions on advertising and promotion, as appropriate, to protect public health.

Modernizing Medical-Product Safety and Availability

In 2012, Congress provided new authorities under the Food and Drug Administration Safety and Innovation Act to support its mission of safeguarding the quality of medical products available to the public while ensuring the availability of innovative products. FDA is implementing this new authority with a focus on protecting the quality of medical products in the global drug supply chain; improving the availability of needed drugs and devices; and promoting better-informed decisions by health professionals and patients.

For example, the Agency plans to issue a final rule this year to require manufacturers of certain drugs, such as drugs used for cancer treatments, anesthesia drugs, and other drugs that are critical to the treatment of serious diseases and life-threatening conditions, to report discontinuances or interruptions in the manufacturing of these products. This rule will help FDA address and potentially prevent drug shortages, and it will help inform providers and public health officials earlier about potential drug shortages.

Another forthcoming final rule will update FDA's regulations to reflect the increased use of generic drugs in the current marketplace, and will describe approaches for brand name and generic drug manufacturers to update product labeling. This rule will revise and clarify procedures for updates to product labeling to reflect certain types of newly acquired safety information through submission of a “changes being effected” supplement.

Reducing Gun Violence

As part of the President's continuing efforts to reduce gun violence, HHS will issue a final rule to remove unnecessary legal barriers under the HIPAA Privacy Rule that may prevent States from reporting certain information to the National Instant Criminal Background Check System (NICS). The NICS helps to ensure that guns are not sold to those prohibited by law from having them, including felons, those convicted of domestic violence, and individuals involuntarily committed to a mental institution. However, the background check system is only as effective as the Start Printed Page 76515information that is available to it. The rule will give States and certain covered entities added flexibility to ensure accurate but limited information is reported to the NICS, which would not include clinical, diagnostic, or other mental health information. Instead, certain covered entities would be permitted to disclose the minimum necessary identifying information about individuals who have been involuntarily committed to a mental institution or otherwise have been determined by a lawful authority to be a danger to themselves or others.

HHS—FOOD AND DRUG ADMINISTRATION (FDA)

Proposed Rule Stage

48. Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: This action may affect the private sector under Pub. L. 104-4.

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 342; 21 U.S.C. 350c; 21 U.S.C. 350d note; 21 U.S.C. 350g; 21 U.S.C. 350g note; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 264; 42 U.S.C. 243; 42 U.S.C. 271;

CFR Citation: 21 CFR 507.

Legal Deadline: Final, Statutory, July 2012. Final, Judicial, August 30, 2015.

The FDA Food Safety Modernization Act (FSMA) mandates that FDA promulgate final regulations to establish preventive controls not later than 18 months after the date of enactment of FSMA. Certain requirements regarding standards for pet food and other animal feeds mandated by the FDA Amendment Act of 2007 will be subsumed in the FSMA rulemaking. Per consent decree, FDA will submit the final rule to the Federal Register for publication by 08/30/2015.

Abstract: This rule establishes requirements for good manufacturing practice, and requires that certain facilities establish and implement hazard analysis and risk-based preventive controls for animal food, including ingredients and mixed animal feed. This action is intended to provide greater assurance that food for all animals, including pets, is safe.

Statement of Need: Regulatory oversight of the animal food industry has traditionally been limited and focused on a few known safety issues so there could be problems that remain unaddressed potentially affecting animal health. The massive pet food recall due to adulteration with melamine and cyanuric acid in 2007 is an example. Actions taken by two protein suppliers in China affected a large number of pet food manufacturers in the United States and created a nationwide problem. By the time the cause of the problem was identified melamine- and cyanuric-acid contaminated ingredients had resulted in the adulteration of millions of individual servings of pet food sickening and killing pets. Salmonella contaminated pet food has been the cause of illness in humans: In 2007 people became ill handling pet food contaminated with a rare Salmonella serotype; over 200 people in the United Kingdom and United States became ill from handling Salmonella contaminated frozen mice (used for pet food) that came from a U.S. facility; and people were infected with Salmonella in 2012 that originated from contaminated dog and cat food. Other animal food recalls have resulted from contamination with aflatoxins, dioxins excessive vitamin D, and insufficient thiamine. Congress passed FSMA which the President signed into law on January 4, 2011 (Pub. L. 111-353). Section 103 of FSMA amended the Federal Food Drug and Cosmetic Act (FD&C Act) by adding section 418 (21 U.S.C. 350g) Hazard Analysis and Risk-Based Preventive Controls. In enacting FSMA Congress sought to improve the safety of food in the United States by taking a risk-based approach to food safety emphasizing prevention. Section 418 of the FD&C Act requires owners, operators, or agents in charge of food facilities to develop and implement a written hazard analysis and preventive controls to significantly minimize or prevent the occurrence of hazards and help prevent adulteration of food.

Summary of Legal Basis: FDA's authority for issuing this rule is provided in FSMA (Pub. L. 111-353), which amended the FD&C Act by establishing section 418, which directed FDA to publish implementing regulations. FSMA also amended section 301 of the FD&C Act to add 301(uu) that states 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 of the FD&C Act, is a prohibited act. FDA is also issuing this rule under the certain provisions of section 402 of the FD&C Act (21 U.S.C. 342) regarding adulterated food. In addition, section 701(a) of the FD&C Act (21 U.S.C. 371(a)) authorizes the Agency to issue regulations for the efficient enforcement of the Act. To the extent the regulations are related to communicable disease, FDA's legal authority also derives from sections 311, 361, and 368 of the Public Health Services Act (42 U.S.C. 243, 264, and 271). Finally, FDA is acting under the direction of section 1002(a) of title X of FDAAA of 2007 (21 U.S.C. 2102) which requires the Secretary to establish processing standards for pet food.

Alternatives: The Food Safety Modernization Act requires FDA to promulgate regulations to establish hazard analyses and risk-based preventive controls.

Anticipated Cost and Benefits: The benefits of the proposed rule would be fewer cases of contaminated animal food. Discovering contaminated food ingredients before they are used in a finished product would reduce the number of recalls of contaminated animal food products. Benefits would include reduced medical treatment costs for animals, reduced loss of market value of livestock, reduced loss of animal companionship, and reduced loss in value of animal food. More stringent requirements for animal food manufacturing would maintain public confidence in the safety of animal food, and protect animal and human health. FDA lacks sufficient data to quantify the benefits of the proposed rule. The compliance costs of the proposed rule would result from the additional labor and capital required to perform the hazard analyses, write and implement the preventive controls, monitor and verify the preventive controls, take corrective actions if preventive controls fail to prevent food from becoming contaminated, and implement the current good manufacturing practice regulations.

Risks: FDA is proposing this rule to provide greater assurance that food intended for animals is safe, and will not cause illness or injury to animals. This rule would implement a risk-based, preventive controls food safety system intended to prevent animal food containing hazards, which may cause illness or injury to animals or humans, from entering the food supply. The rule would apply to domestic and imported animal food (including raw materials and ingredients). Fewer cases of animal food contamination would reduce the risk of serious illness and death to animals.

Timetable:

ActionDateFR Cite
NPRM10/29/1378 FR 64736
Start Printed Page 76516
NPRM Comment Period Extension02/03/1479 FR 6111
NPRM Comment Period End02/26/14
NPRM Comment Period Extension End03/31/14
Supplemental NPRM09/29/1479 FR 58475
Supplemental NPRM Comment Period End12/15/14
Final Rule08/00/15

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: State.

Federalism: This action may have federalism implications as defined in EO 13132.

Agency Contact: Kim Young, Deputy Director, Division of Compliance, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, Room 106 (MPN-4, HFV-230), 7519 Standish Place, Rockville, MD 20855, Phone: 240 276-9207, Email: kim.young@fda.hhs.gov.

RIN: 0910-AG10

HHS—FDA

49. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: This action may affect the private sector under Pub. L. 104-4.

Legal Authority: 21 U.S.C. 342; 21 U.S.C. 350h; 21 U.S.C. 371; 42 U.S.C. 264; Pub. L. 111-353 (signed on January 4, 2011)

CFR Citation: 21 CFR 112.

Legal Deadline: Final, Judicial, October 2015.

Abstract: This rule will establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death. The purpose of the rule is to reduce the risk of illness associated with fresh produce.

Statement of Need: FDA is taking this action to meet the requirements of the FSMA and to address the food safety challenges associated with fresh produce and, thereby, protect the public health. Data indicate that between 1973 and 1997, outbreaks of foodborne illness in the U.S. associated with fresh produce increased in absolute numbers and as a proportion of all reported foodborne illness outbreaks. The Agency issued general good agricultural practice guidelines for fresh fruits and vegetables over a decade ago. Incorporating prevention-oriented public health principles, and incorporating what we have learned in the past decade into a regulation is a critical step in establishing standards for the production and harvesting of produce, and reducing the foodborne illness attributed to fresh produce.

Summary of Legal Basis: FDA is relying on the amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), provided by section 105 of the Food Safety Modernization Act (codified primarily in section 419 of the FD&C Act (21 U.S.C. 350h)). FDA's legal basis also derives in part from sections 402(a)(3), 402(a)(4), and 701(a) of the FD&C Act (21 U.S.C. 342(a)(3), 342(a)(4), and 371(a)). FDA also intends to rely on section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264), which gives FDA authority to promulgate regulations to control the spread of communicable disease.

Alternatives: Section 105 of the Food Safety Modernization Act requires FDA to conduct this rulemaking.

Anticipated Cost and Benefits: FDA estimates that the costs to more than 300,000 domestic and foreign producers and packers of fresh produce from the proposal would include one-time costs (e.g., new tools and equipment) and recurring costs (e.g., monitoring, training, recordkeeping). FDA anticipates that the benefits would be a reduction in foodborne illness and deaths associated with fresh produce. The monetized annual benefits of this rule are estimated to be $1 billion, and the monetized annual costs are estimated to be $460 million, domestically.

Risks: This regulation would directly and materially advance the Federal Government's substantial interest in reducing the risks for illness and death associated with foodborne infections associated with the consumption of fresh produce. Less restrictive and less comprehensive approaches have not been sufficiently effective in reducing the problems addressed by this regulation. FDA anticipates that the regulation would lead to a significant decrease in foodborne illness associated with fresh produce consumed in the United States.

Timetable:

ActionDateFR Cite
NPRM01/16/1378 FR 3503
NPRM Comment Period End05/16/13
NPRM Comment Period Extended04/26/1378 FR 24692
NPRM Comment Period Extended End09/16/13
NPRM Comment Period Extended08/09/1378 FR 48637
NPRM Comment Period Extended End11/15/13
Notice of Intent To Prepare an Environmental Impact Statement for the Proposed Rule08/19/1378 FR 50358
Notice of Intent To Prepare Environmental Impact Statement for the Proposed Rule Comment Period End11/15/13
NPRM Comment Period Extended11/20/1378 FR 69605
NPRM Comment Period Extended End11/22/13
Environmental Impact Statement for the Proposed Rule; Comment Period Extended03/11/1479 FR 13593
Environmental Impact Statement for the Proposed Rule; Comment Period Extended End04/18/14
Supplemental NPRM09/29/1479 FR 58433
Supplemental NPRM Comment Period End12/15/14
Final Rule10/00/15

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None

Agency Contact: Samir Assar, Supervisory Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Food Safety, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1636, Email: samir.assar@fda.hhs.gov.

RIN: 0910-AG35

Start Printed Page 76517

HHS—FDA

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

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: This action may affect the private sector under Pub. L. 104-4.

Legal Authority: 21 U.S.C. 342; 21 U.S.C. 371; 42 U.S.C. 264; Pub. L. 111-353 (signed on Jan. 4, 2011)

CFR Citation: 21 CFR 117.

Legal Deadline: Final, Statutory, July 4, 2012, Final rule must be published no later than 18 months after the date of enactment of the FDA Food Safety Modernization Act.

Abstract: This rule would require a food facility to have and implement preventive controls to significantly minimize or prevent the occurrence of hazards that could affect food manufactured, processed, packed, or held by the facility. This action is intended to prevent or, at a minimum, quickly identify foodborne pathogens before they get into the food supply.

Statement of Need: FDA is taking this action to meet the requirements of FSMA and to better address changes that have occurred in the food industry and thereby protect public health. High-profile outbreaks of foodborne illness over the last decade and data showing that such illnesses strike one in six Americans each year have caused a widespread recognition that we need a new modern food safety system that prevents food safety problems in the first place not a system that just reacts once they happen. Section 103 of FSMA amended the Federal Food Drug and Cosmetic Act (FD&C Act) by adding section 418 (21 U.S.C. 350g) Hazard Analysis and Risk Based Preventive Controls. In enacting FSMA Congress sought to improve the safety of food in the United States by taking a risk-based approach to food safety emphasizing prevention. Section 418 of the FD&C Act requires owners operators or agents in charge of food facilities to develop and implement a written plan that describes and documents how their facility will implement the hazard analysis and preventive controls required by this section. In addition to containing new provisions requiring hazard analysis and risk-based preventive controls this rule would also revise the existing Current Good Manufacturing Practice (CGMP) requirements found in 21 CFR part 110 that were last updated in 1986.

Summary of Legal Basis: FDA is relying on section 103 of the FSMA. FDA is also relying on sections 402(a)(3), (a)(4) and 701(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 342(a)(3), (a)(4), and 371(a)). Under section 402(a)(3) of the FD&C Act, 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. Under section 402(a)(4), a food is adulterated if it has been prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth, or 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. FDA's legal basis also derives from section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264), which gives FDA authority to promulgate regulations to control the spread of communicable disease.

Alternatives: An alternative to this rulemaking is not to update the CGMP regulations, and instead issue separate regulations to implement the FDA Food Safety Modernization Act.

Anticipated Cost and Benefits: FDA estimates that the costs from the proposal to domestic and foreign producers and packers of processed foods would include new one-time costs (e.g., adoption of written food safety plans, setting up training programs, implementing allergen controls, and purchasing new tools and equipment) and recurring costs (e.g., auditing and monitoring suppliers of sensitive raw materials and ingredients, training employees, and completing and maintaining records used throughout the facility). FDA anticipates that the benefits would be a reduced risk of foodborne illness and death from processed foods, and a reduction in the number of safety-related recalls.

Risks: This regulation will directly and materially advance the Federal Government's substantial interest in reducing the risks for illness and death associated with foodborne infections. Less restrictive and less comprehensive approaches have not been effective in reducing the problems addressed by this regulation. The regulation will lead to a significant decrease in foodborne illness in the U.S.

Timetable:

ActionDateFR Cite
NPRM01/16/1378 FR 3646
NPRM Comment Period End05/16/13
NPRM Comment Period Extended04/26/1378 FR 24691
NPRM Comment Period Extended End09/16/13
NPRM Comment Period Extended08/09/1378 FR 48636
NPRM Comment Period Extended End11/15/13
NPRM Comment Period Extended11/20/1378 FR 69604
NPRM Comment Period Extended End11/22/13
Supplemental NPRM09/29/1479 FR 58523
Supplemental NPRM Comment Period End12/15/14
Final Rule08/00/15

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Additional Information: Includes Retrospective Review under E.O. 13563.

Agency Contact: Jenny Scott, Senior Advisor, Department of Health and Human Services, Food and Drug Administration, Office of Food Safety, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1488, Email: jenny.scott@fda.hhs.gov.

RIN: 0910-AG36

HHS—FDA

51. Reports of Distribution and Sales Information for Antimicrobial Active Ingredients Used in Food-Producing Animals

Priority: Other Significant.

Legal Authority: 21 U.S.C. 360b(l)(3)

CFR Citation: 21 CFR 514.80.

Legal Deadline: None.

Abstract: This proposed rule would require that the sponsor of each approved or conditionally approved antimicrobial new animal drug product submit an annual report to the Food and Drug Administration (FDA or Agency) on the amount of each antimicrobial active ingredient in the drug product that is sold or distributed for use in food-producing animals, including any distributor-labeled product. In addition to codifying these requirements, FDA is exploring other requirements for the collection of additional drug distribution data.

Statement of Need: Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA) amended section 512 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require that the sponsor of each approved or conditionally appoved new animal drug Start Printed Page 76518product that contains an antimicrobial active ingredient submit an annual report to FDA on the amount of each antimicrobial active ingredient in the drug product that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. This legislation was enacted to assist FDA in its continuing analysis of the interactions (including drug resistance), efficacy, and safety of antibiotics approved for use in both humans and food-producing animals (H. Rpt. 110-804). This proposed rulemaking is to codify these requirements. In addition, FDA is exploring the establishment of other reporting requirements to provide for the collection of additional drug distribution data, including reporting sales and distribution data by species.

Summary of Legal Basis: Section 105 of ADUFA (Pub. L. 110-316; 122 Stat. 3509) amended section 512 of the FD&C Act (21 U.S.C. 360b) to require that sponsors of approved or conditionally approved applications for new animal drugs containing an antimicrobial active ingredient submit an annual report to the Food and Drug Administration on the amount of each such ingredient in the drug that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. FDA is also issuing this rule under its authority under section 512(l) of the FD&C Act to collect information relating to approved new animal drugs.

Alternatives: This rulemaking codifies the congressional mandate of ADUFA section 105. The annual reporting required under ADUFA section 105 is necessary to address potential problems concerning the safety and effectiveness of antimicrobial new animal drugs. Less frequent data collection would hinder this purpose.

Anticipated Cost and Benefits: Sponsors of antimicrobial drugs sold for use in food-producing animals currently report sales and distribution data to the Agency under section 105 of ADUFA; this rulemaking will codify in FDA's regulations a current statutory requirement. There may be a minimal additional labor cost if any other reporting requirement is proposed. Additional data beyond the reporting requirements specified in ADUFA section 105 will help the Agency better understand how the use of medically important antimicrobial drugs in food-producing animals may relate to antimicrobial resistance.

Risks: Section 105 of ADUFA was enacted to address the problem of antimicrobial resistance, and to help ensure that FDA has the necessary information to examine safety concerns related to the use of antibiotics in food-producing animals. 154 Congressional Record H7534.

Timetable:

ActionDateFR Cite
ANPRM07/27/1277 FR 44177
ANPRM Comment Period End09/25/12
ANPRM Comment Period Extended09/26/1277 FR 59156
ANPRM Comment Period End11/26/12
NPRM05/00/15

Regulatory Flexibility Analysis Required: Undetermined.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Sujaya Dessai, Supervisory Veterinary Medical Officer, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, MPN-4, Room 2620, HFV-212, 7529 Standish Place, Rockville, MD 20855, Phone: 240 276-9075, Email: sujaya.dessai@fda.hhs.gov.

RIN: 0910-AG45

HHS—FDA

52. Foreign Supplier Verification Program

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: This action may affect the private sector under Pub. L. 104-4.

Legal Authority: 21 U.S.C. 384a; title III, sec 301 of FDA Food Safety Modernization Act, Pub. L. 111-353, establishing sec 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)

CFR Citation: Not Yet Determined.

Legal Deadline: Final, Statutory, January 4, 2012.

Abstract: This rule describes what a food importer must do to verify that its foreign suppliers produce food that is as safe as food produced in the United States. FDA is taking this action to improve the safety of food that is imported into the United States.

Statement of Need: The proposed rule is needed to help improve the safety of food that is imported into the United States. Imported food products have increased dramatically over the last several decades. Data indicate that about 15 percent of the U.S. food supply is imported. FSMA provides the Agency with additional tools and authorities to help ensure that imported foods are safe for U.S. consumers. Included among these tools and authorities is a requirement that importers perform risk-based foreign supplier verification activities to verify that the food they import is produced in compliance with U.S. requirements, as applicable, and is not adulterated or misbranded. This proposed rule on the content of foreign supplier verification programs (FSVPs) sets forth the proposed steps that food importers would be required to take to fulfill their responsibility to help ensure the safety of the food they bring into this country.

Summary of Legal Basis: Section 805(c) of the FD&C Act (21 U.S.C. 384a(c)) directs FDA, not later than 1 year after the date of enactment of FSMA, to issue regulations on the content of FSVPs. Section 805(c)(4) states that verification activities under such programs may include monitoring records for shipments, lot-by-lot certification of compliance, annual onsite inspections, checking the hazard analysis and risk-based preventive control plans of foreign suppliers, and periodically testing and sampling shipments of imported products. Section 301(b) of FSMA amends section 301 of the FD&C Act (21 U.S.C. 331) by adding section 301(zz), which designates as a prohibited act the importation or offering for importation of a food if the importer (as defined in section 805) does not have in place an FSVP in compliance with section 805. In addition, section 301(c) of FSMA amends section 801(a) of the FD&C Act (21 U.S.C. 381(a)) by stating that an article of food being imported or offered for import into the United States shall be refused admission if it appears, from an examination of a sample of such an article or otherwise, that the importer is in violation of section 805.

Alternatives: We are considering a range of alternative approaches to the requirements for foreign supplier verification activities. These might include: (1) establishing a general requirement that importers determine and conduct whatever verification activity would adequately address the risks associated with the foods they import; (2) allowing importers to choose from a list of possible verification mechanisms, such as the activities listed in section 805(c)(4) of the FD&C Act; (3) requiring importers to conduct particular verification activities for certain types of foods or risks (e.g., for high-risk foods), but allowing flexibility in verification activities for other types of foods or risks; and (4) specifying use of a particular verification activity for each particular kind of food or risk. To the extent possible while still ensuring that verification activities are adequate to ensure that foreign suppliers are Start Printed Page 76519producing food in accordance with U.S. requirements, we will seek to give importers the flexibility to choose verification procedures that are appropriate to adequately address the risks associated with the importation of a particular food, and accounted for in the proposed rules that contain these requirements.

Anticipated Cost and Benefits: We are still estimating the cost and benefits for this proposed rule. However, the available information suggests that, if finalized, the costs will be significant. Our preliminary analysis of FY10 OASIS data suggests that this rule will cover about 60,000 importers, 240,000 unique combinations of importers and foreign suppliers, and 540,000 unique combinations of importers, products, and foreign suppliers. These numbers imply that provisions that require activity for each importer, each unique combination of importer and foreign supplier, or each unique combination of importer, product, and foreign supplier will generate significant costs. An example of a provision linked to combinations of importers and foreign suppliers would be a requirement to conduct a verification activity, such as an onsite audit, under certain conditions. The cost of onsite audits will depend, in part, on whether foreign suppliers can provide the same onsite audit results to different importers, or whether every importer will need to take some action with respect to each of their foreign suppliers. The benefits of this proposed rule will consist of the reduction of adverse health events linked to imported food that could result from increased compliance with applicable requirements, and are accounted for in the proposed rules that contain those requirements and are accounted for in the proposed rules that contain those requirements.

Risks: As stated above, about 15 percent of the U.S. food supply is imported, and many of these imported foods are high-risk commodities. According to recent data from the Centers for Disease Control and Prevention, each year, about 48 million Americans get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases. We expect that the adoption of FSVPs by food importers will benefit the public health by helping to ensure that imported food is produced in compliance with other applicable food safety regulations.

Timetable:

ActionDateFR Cite
NPRM07/29/1378 FR 45729
NPRM Comment Period End11/26/13
NPRM Comment Period Extended11/20/1378 FR 69602
NPRM Comment Period Extended End01/27/14
Supplemental NPRM09/29/1479 FR 58573
Supplemental NPRM Comment Period End12/15/14
Final Rule10/00/15

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Brian L. Pendleton, Senior Policy Advisor, Department of Health and Human Services, Food and Drug Administration, Office of Policy, WO 32, Room 4245, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-4614, Fax: 301 847-8616, Email: brian.pendleton@fda.hhs.gov.

RIN: 0910-AG64

HHS—FDA

Final Rule Stage

53. “Tobacco Products” Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: This action may affect the private sector under Pub. L. 104-4.

Legal Authority: 21 U.S.C. 301 et seq.; The Federal Food, Drug, and Cosmetic Act; Pub. L. 111-31; The Family Smoking Prevention and Tobacco Control Act

CFR Citation: Not Yet Determined.

Legal Deadline: None.

Abstract: The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) provides the Food and Drug Administration (FDA) authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Tobacco Control Act, permits FDA to issue regulations deeming other tobacco products to be subject to the FD&C Act. This rule would deem additional products meeting the statutory definition of “tobacco product” to be subject to the FD&C Act, and would specify additional restrictions.

Statement of Need: Currently, the Tobacco Control Act provides FDA with immediate authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. The Tobacco Control Act also permits FDA to issue regulations deeming other tobacco products that meet the statutory definition of “tobacco product” to also be subject to the FD&C Act. This regulation is necessary to afford FDA the authority to regulate additional products which include hookah, electronic cigarettes, cigars, pipe tobacco, other novel tobacco products, and future tobacco products.

Summary of Legal Basis: Section 901 of the FD&C Act, as amended by the Tobacco Control Act, permits FDA to issue regulations deeming other tobacco products to be subject to the FD&C Act. Section 906(d) provides FDA with the authority to propose restrictions on the sale and distribution of tobacco products, including restrictions on the access to, and the advertising and promotion of, tobacco products if FDA determines that such regulation would be appropriate for the protection of the public health.

Alternatives: In addition to the benefits and costs of both options for the proposed rule, FDA assessed the benefits and costs of several alternatives to the proposed rule: e.g., deeming only, but exempt newly-deemed products from certain requirements; exempt certain classes of products from certain requirements; deeming only, with no additional provisions; and changes to the compliance periods.

Anticipated Cost and Benefits: The proposed rule consists of two coproposals, option 1 and option 2. The proposed option 1 deems all products meeting the statutory definition of “tobacco product” except accessories of a proposed deemed tobacco product to be subject to chapter IX of the FD&C Act. Option 1 also proposes additional provisions that would apply to proposed deemed products as well as to certain other tobacco products. Option 2 is the same as option 1 except that it exempts premium cigars. We expect that asserting our authority over these tobacco products will enable us to take further regulatory action in the future as appropriate; those actions will have their own costs and benefits. The proposed rule would generate some direct benefits by providing information to consumers about the risks and Start Printed Page 76520characteristics of tobacco products which may result in consumers reducing their use of cigars and other tobacco products. Other potential benefits follow from premarket requirements which could prevent more harmful products from appearing on the market and worsening the health effects of tobacco product use. The proposed rule would impose costs in the form of registration submission labeling and other requirements; other likely costs are not quantifiable based on current data.

Risks: Adolescence is the peak time for tobacco use initiation and experimentation. In recent years, new and emerging tobacco products, sometimes referred to as “novel tobacco products,” have been developed and are becoming an increasing concern to public health due, in part, to their appeal to youth and young adults. Non-regulated tobacco products come in many forms, including electronic cigarettes, nicotine gels, and certain dissolvable tobacco products (i.e., those dissolvable products that do not currently meet the definition of smokeless tobacco under 21 U.S.C. 387(18) because they do not contain cut, ground, powdered, or leaf tobacco, and instead contain nicotine extracted from tobacco), and these products are widely available. This deeming rule is necessary to provide FDA with authority to regulate these products (e.g., registration, product and ingredient listing, user fees for certain products, premarket requirements, and adulteration and misbranding provisions). In addition, the additonal restrictions that FDA seeks to promulgate for the proposed deemed products will protect youth by restricting minors' access to these products and will increase consumer understanding of the impact of these products on public health. This rule is consistent with other approaches that the Agency has taken to address the tobacco epidemic and is particularly necessary, given that consumer use may be gravitating to the proposed deemed products.

Timetable:

ActionDateFR Cite
NPRM04/25/1479 FR 23142
NPRM Comment Period End07/09/14
NPRM Comment Period Extended06/24/1479 FR 35711
NPRM Comment Period End08/08/14
Final Action06/00/15

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Gerie Voss, Senior Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, Document Control Center, Building 71, Room G335, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 877 287-1373, Fax: 301 595-1426, Email: ctpregulations@fda.hhs.gov.

RIN: 0910-AG38

HHS—FDA

54. Food Labeling: Calorie Labeling of Articles of Food Sold in Vending Machines

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371

CFR Citation: Not Yet Determined.

Legal Deadline: None.

Abstract: FDA published a proposed rule to establish requirements for nutrition labeling of certain food items sold in certain vending machines. FDA also proposed the terms and conditions for vending machine operators registering to voluntarily be subject to the requirements. FDA is issuing a final rule, and taking this action to carry out section 4205 of the Patient Protection and Affordable Care Act.

Statement of Need: This rulemaking was mandated by section 4205 of the Patient Protection and Affordable Care Act (Affordable Care Act).

Summary of Legal Basis: On March 23, 2010, the Affordable Care Act (Pub. L. 111-148) was signed into law. Section 4205 amended 403(q)(5) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by, among other things, creating new clause (H) to require that vending machine operators, who own or operate 20 or more machines, disclose calories for certain food items. FDA has the authority to issue this rule under sections 403(q)(5)(H) and 701(a) of the FD&C Act (21 U.S.C. 343(q)(5)(H), and 371(a)). Section 701(a) of the FD&C Act vests the Secretary of Health and Human Services, and, by delegation, the Food and Drug Administration (FDA) with the authority to issue regulations for the efficient enforcement of the FD&C Act.

Alternatives: Section 4205 of the Affordable Care Act requires the Secretary (and by delegation, the FDA) to establish by regulation requirements for calorie labeling of articles of food sold from covered vending machines. Therefore, there are no alternatives to rulemaking. FDA has analyzed alternatives that may reduce the burden of the rulemaking, including analyzing the benefits and costs of: restricting the flexibility of the format for calorie disclosure, lengthening the compliance time, and extending the coverage of the rule to bulk vending machines without selection buttons.

Anticipated Cost and Benefits: Any vending machine operator operating fewer than 20 machines may voluntarily choose to be covered by the national standard. It is anticipated that vending machine operators that own or operate 20 or more vending machines will bear costs associated with adding calorie information to vending machines. FDA initially estimated that the total cost of complying with section 4205 of the Affordable Care Act and this rulemaking would be approximately $25.8 million initially, with a recurring cost of approximately $24 million.

Because comprehensive national data for the effects of vending machine labeling do not exist, FDA did not quantify the benefits associated with section 4205 of the Affordable Care Act and this rulemaking in the proposed rule. Some studies have shown that some consumers consume fewer calories when calorie content information is displayed at the point of purchase. Consumers will benefit from having this important nutrition information to assist them in making healthier choices when consuming food away from home. Given the very high costs associated with obesity and its associated health risks, FDA estimated that if 0.02 percent of the adult obese population reduces energy intake by at least 100 calories per week, then the benefits of section 4205 of the Affordable Care Act and this rulemaking would be at least as large as the costs.

Risks: Americans now consume an estimated one-third of their total calories from foods prepared outside the home, and spend almost half of their food dollars on such foods. This rule will provide consumers with information about the nutritional content of food to enable them to make healthier food choices, and may help mitigate the trend of increasing obesity in America.

Timetable: Start Printed Page 76521

ActionDateFR Cite
NPRM04/06/1176 FR 19238
NPRM Comment Period End07/05/11
Final Action11/00/14

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses, Governmental Jurisdictions.

Government Levels Affected: Federal, Local, State.

Federalism: This action may have federalism implications as defined in EO 13132.

Agency Contact: Daniel Reese, Food Technologist, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-820), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-2126, Email: daniel.reese@fda.hhs.gov.

RIN: 0910-AG56

HHS—FDA

55. Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: This action may affect the private sector under Pub. L. 104-4.

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371

CFR Citation: Not Yet Determined.

Legal Deadline: None.

Abstract: FDA published a proposed rule in the Federal Register to establish requirements for nutrition labeling of standard menu items in chain restaurants and similar retail food establishments. FDA also proposed the terms and conditions for restaurants and similar retail food establishments registering to voluntarily be subject to the Federal requirements. FDA is issuing a final rule, and taking this action to carry out section 4205 of the Patient Protection and Affordable Care Act.

Statement of Need: This rulemaking was mandated by section 4205 of the Patient Protection and Affordable Care Act (Affordable Care Act).

Summary of Legal Basis: On March 23, 2010, the Affordable Care Act (Pub. L. 111-148) was signed into law. Section 4205 of the Affordable Care Act amended 403(q)(5) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by, among other things, creating new clause (H) to require that certain chain restaurants and similar retail food establishments with 20 or more locations disclose certain nutrient information for standard menu items. FDA has the authority to issue this rule under sections 403(a)(1), 403(q)(5)(H), and 701(a) of the FD&C Act (21 U.S.C. 343(a)(1), 343(q)(5)(H), and 371(a)). Section 701(a) of the FD&C Act vests the Secretary of Health and Human Services, and, by delegation, the Food and Drug Administration (FDA) with the authority to issue regulations for the efficient enforcement of the FD&C Act.

Alternatives: Section 4205 of the Affordable Care Act requires the Secretary, and by delegation the FDA, to establish by regulation requirements for nutrition labeling of standard menu items for covered restaurants and similar retail food establishments. Therefore, there are no alternatives to rulemaking. FDA has analyzed alternatives that may reduce the burden of this rulemaking, including analyzing the benefits and costs of expanding and contracting the set of establishments covered by this rule, and shortening or lengthening the compliance time relative to the rulemaking.

Anticipated Cost and Benefits: Chain restaurants and similar retail food establishments covered by the Federal law operating in local jurisdictions that impose different nutrition labeling requirements will benefit from having a uniform national standard. Any restaurant or similar retail food establishment with fewer than 20 locations may voluntarily choose to be covered by the national standard. It is anticipated that chain restaurants with 20 or more locations will bear costs for adding nutrition information to menus and menu boards. FDA initially estimated that the total cost of section 4205 and this rulemaking would be approximately $80 million, annualized over 10 years, with a low annualized estimate of approximately $33 million and a high annualized estimate of approximately $125 million over 10 years. These costs (which are subject to change in the final rule) included an initial cost of approximately $320 million with an annually recurring cost of $45 million.

Because comprehensive national data for the effects of menu labeling do not exist, FDA did not quantify the benefits associated with section 4205 of the Affordable Care Act and this rulemaking. Some studies have shown that some consumers consume fewer calories when menus have information about calorie content displayed. Consumers will benefit from having important nutrition information for the approximately 30 percent of calories consumed away from home. Given the very high costs associated with obesity and its associated health risks, FDA estimated that if 0.6 percent of the adult obese population reduces energy intake by at least 100 calories per week, then the benefits of section 4205 of the Affordable Care Act and this rule would be at least as large as the costs.

Risks: Americans now consume an estimated one-third of their total calories on foods prepared outside the home, and spend almost half of their food dollars on such foods. Unlike packaged foods that are labeled with nutrition information, foods in restaurants, for the most part, do not have nutrition information that is readily available when ordered. Dietary intake data have shown that obese Americans consume over 100 calories per meal more when eating food away from home, rather than food at home. This rule will provide consumers information about the nutritional content of food to enable them to make healthier food choices, and may help mitigate the trend of increasing obesity in America.

Timetable:

ActionDateFR Cite
NPRM04/06/1176 FR 19192
NPRM Comment Period End07/05/11
Final Action11/00/14

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses, Governmental Jurisdictions.

Government Levels Affected: Federal, Local, State.

Federalism: This action may have federalism implications as defined in EO 13132.

Agency Contact: Daniel Reese, Food Technologist, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-820), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-2126, Email: daniel.reese@fda.hhs.gov.

RIN: 0910-AG57

HHS—FDA

56. Accreditation of Third-Party Auditors/Certification Bodies To Conduct Food Safety Audits and To Issue Certifications

Priority: Other Significant.

Legal Authority: 21 U.S.C. 384d; Pub. L. 111-353; sec 307 FDA Food Safety Modernization Act; other sections of FDA Food Safety Modernization Act, as appropriate; 21 U.S.C. 371; 21 U.S.C. 381; 21 U.S.C. 384b; . . .Start Printed Page 76522

CFR Citation: 21 CFR 1.

Legal Deadline: Final, Statutory, July 2012, Promulgate implementing regulations.

Final, Judicial, October 31, 2015.

Per Public Law 111-353, section 307, promulgate, within 18 months of enactment, certain implementing regulations for accreditation of third-party auditors to conduct food safety audits. Per consent decree, FDA will submit the final rule to the Federal Register for publication by 10/31/15.

Abstract: This rule establishes regulations for accreditation of third-party auditors to conduct food safety audits. FDA is taking this action to improve the safety of food that is imported into the United States.

Statement of Need: The use of accredited third-party auditors to certify food imports will assist in ensuring the safety of food from foreign origin entering U.S. commerce. Accredited third-party auditors auditing foreign facilities can increase FDA's information about foreign facilities that FDA may not have adequate resources to inspect in a particular year. FDA will establish identified standards creating overall uniformity to complete the task. Audits that result in issuance of facility certificates will provide FDA information about the compliance status of the facility. Additionally, auditors will be required to submit audit reports that may be reviewed by FDA for purposes of compliance assessment and work planning.

Summary of Legal Basis: Section 808 of the FD&C Act directs FDA to establish, not later than 2 years after the date of enactment, a system for the recognition of accreditation bodies that accredit third-party auditors, who, in turn, certify that their eligible entities meet the requirements. If within 2 years after the date of the establishment of the system, FDA has not identified and recognized an accreditation body, FDA may directly accredit third party auditors.

Alternatives: FSMA described in detail the framework for, and requirements of, the accredited third-party auditor program. Alternatives include certain oversight activities required of recognized accreditation bodies that accredit third-party auditors, as distinguished from third-party auditors directly accredited by FDA. Another alternative relates to the nature of the required standards and the degree to which those standards are prescriptive or flexible.

Anticipated Cost and Benefits: The benefits of the proposed rule would be less unsafe or misbranded food entering U.S. commerce. Additional benefits include the increased flow of credible information to FDA regarding the compliance status of foreign firms and their foods that are ultimately offered for import into the United States, which information, in turn, would inform FDA's work planning for inspection of foreign food facilities and might result in a signal of possible problems with a particular firm or its products, and with sufficient signals, might raise questions about the rigor of the food safety regulatory system of the country of origin. The compliance costs of the proposed rule would result from the additional labor and capital required of accreditation bodies seeking FDA recognition and of third-party auditors seeking accreditation to the extent that will involve the assembling of information for an application unique to the FDA third-party program. The compliance costs associated with certification will be accounted for separately under the costs associated with participation in the voluntary qualified importer program, and the costs associated with mandatory certification for high-risk food imports. The third-party program is funded through revenue neutral-user fees, which will be developed by FDA through rulemaking. User fee costs will be accounted for in that rulemaking.

Risks: FDA is proposing this rule to provide greater assurance the food offered for import into the United States is safe and will not cause injury or illness to animals or humans. The rule would implement a program for accrediting third-party auditors to conduct food safety audits of foreign food entities, including registered foreign food facilities, and based on the findings of the regulatory audit, to issue certifications to foreign food entities found to be in compliance with FDA requirements. The certifications could be used by importers seeking to participate in the Voluntary Qualified Importer Program for expedited review and entry of product, and would be a means to provide assurance of compliance as required by FDA based on risk-related considerations. The rule would apply to any foreign or domestic accreditation body seeking FDA recognition, any foreign or domestic third-party auditor seeking accreditation, any registered foreign food facility or other foreign food entity subject to a food safety audit (including a regulatory audit conducted for purposes of certification), and any importer seeking to participate in the Voluntary Qualified Importer Program. Fewer instances of unsafe or misbranded food entering U.S. commerce would reduce the risk of serious illness and death to humans and animals.

Timetable:

ActionDateFR Cite
NPRM07/29/1378 FR 45781
NPRM Comment Period End11/26/13
NPRM Comment Period Extended11/20/1378 FR 69603
NPRM Comment Period Extended End01/27/14
Final Action10/00/15

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: Undetermined.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Charlotte A. Christin, Acting Director, Division of Dietary Supplement Programs, Department of Health and Human Services, Food and Drug Administration, Division of Dietary Supplement Programs, Center for Food Safety and Applied Nutrition, 4D042, College Park, MD 20740, Phone: 240 402-3708, Email: charlotte.christin@fda.hhs.gov.

RIN: 0910-AG66

HHS—FDA

57. Revision of Postmarketing Reporting Requirements Discontinuance or Interruption in Supply of Certain Products (Drug Shortages)

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority: secs 506c, 506c-1, 506d, and 506f of the FDA&C Act, as amended by title X (Drug Shortages) of FDASIA, Pub. L. 112-144, July 9, 2012

CFR Citation: 21 CFR 314.81; 21 CFR 314.91.

Legal Deadline: NPRM, Statutory, January 9, 2014, Not later than 18 months after the date of enactment of FDASIA, FDA must adopt the final regulation implementing section 506C as amended.

Section 1001 of FDASIA states that not later than 18 months after the date of enactment of FDASIA, the Secretary shall adopt a final regulation implementing section 506(c) as amended.

Abstract: This rule would require manufacturers of certain drug products to report discontinuances or Start Printed Page 76523interruptions in the manufacturing of these products 6 months prior to the discontinuance or interruption, or if that is not possible, as soon as practicable. Manufacturers must notify FDA of a discontinuance or interruption in the manufacture of drugs that are life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition.

Statement of Need: The Food and Drug Administration Safety and Innovation Act (FDASIA), Public Law 112-144 (July 9, 2012), amends the FD&C Act to require manufacturers of certain drug products to report to FDA discontinuances or interruptions in the production of these products that are likely to meaningfully disrupt supply 6 months prior to the discontinuance or interruption, or if that is not possible, as soon as practicable. FDASIA also amends the FD&C Act to include other provisions related to drug shortages. Drug shortages have a significant impact on patient access to critical medications, and the number of drug shortages has risen steadily since 2005 to a high of 251 shortages in 2011. Notification to FDA of a shortage or an issue that may lead to a shortage is critical—FDA was able to prevent more than 100 shortages in the first 3 quarters of 2012 due to early notification. This rule will implement the FDASIA drug shortages provisions, allowing FDA to more quickly and efficiently respond to shortages, thereby improving patient access to critical medications, and promoting public health.

Summary of Legal Basis: Sections 506(c), 506(c)-1, 506(d), 506(e), and 506(f) of the FD&C Act, as amended by title X (Drug Shortages) of FDASIA.

Alternatives: The principal alternatives assessed were to provide guidance on voluntary notification to FDA, or to continue to rely on the requirements under the current interim final rule on notification. These alternatives would not meet the statutory requirement to issue the final regulation required by title X, section 1001 of FDASIA.

Anticipated Cost and Benefits: The rule would increase the modest reporting costs associated with notifying FDA of discontinuances or interruptions in the production of certain drug products. The rule would generate benefits in the form of the value of public health gains through more rapid and effective FDA responses to potential, or actual drug shortages that otherwise would limit patient access to critical medications.

Risks: Drug shortages can significantly impede patient access to critical, sometimes life-saving, medications. Drug shortages, therefore, can pose a serious risk to public health and patient safety. This rule will require early notification of potential shortages, enabling FDA to more quickly and effectively respond to potential or actual drug shortages that otherwise would limit patient access to critical medications.

Timetable:

ActionDateFR Cite
NPRM11/04/1378 FR 65904
NPRM Comment Period End01/03/14
Final Action01/00/15

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: None.

Agency Contact: Valerie Jensen, Associate Director, CDER Drug Shortage Staff, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO Building 22, Room 6202, 10903 New Hampshire Avenue, Silver Spring, MD 20903, Phone: 301 796-0737.

RIN: 0910-AG88

HHS—FDA

58. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products

Priority: Other Significant.

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 352; 21 U.S.C. 353; 21 U.S.C. 355; 21 U.S.C. 371; 42 U.S.C. 262; . . .

CFR Citation: 21 CFR 314.70; 21 CFR 314.97; 21 CFR 314.150; 21 CFR 601.12.

Legal Deadline: None.

Abstract: This rule would amend the regulations regarding new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) to revise and clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA's review of such change.

Statement of Need: In the current marketplace, approximately 80 percent of drugs dispensed are generic drugs approved in ANDAs. ANDA holders, like NDA holders and BLA holders, are required to promptly review all adverse drug experience information obtained or otherwise received, and comply with applicable reporting and recordkeeping requirements. However, under current FDA regulations, ANDA holders are not permitted to use the CBE supplement process in the same manner as NDA holders and BLA holders to independently update product labeling with certain newly acquired safety information. This regulatory difference recently has been determined to mean that an individual can bring a product liability action for “failure to warn” against an NDA holder, but generally not an ANDA holder. This may alter the incentives for generic drug manufacturers to comply with current requirements to conduct robust postmarketing surveillance, evaluation, and reporting, and to ensure that their product labeling is accurate and up-to-date. Accordingly, there is a need for ANDA holders to be able to independently update product labeling to reflect certain newly acquired safety information as part of the ANDA holder's independent responsibility to ensure that its product labeling is accurate and up-to-date.

Summary of Legal Basis: The FD&C Act (21 U.S.C. 301 et seq.) and the PHS Act (42 U.S.C. 201 et seq.) provide FDA with authority over the labeling for drugs and biological products, and authorize the Agency to enact regulations to facilitate FDA's review and approval of applications regarding the labeling for those products. FDA's authority to extend the CBE supplement process for certain safety-related labeling changes to ANDA holders arises from the same authority under which FDA's regulations relating to NDA holders and BLA holders were issued.

Alternatives: FDA is considering several alternatives described in comments submitted to the public docket established for the proposed rule.

Anticipated Cost and Benefits: FDA is reviewing comments submitted to the public docket and evaluating the anticipated costs and benefits that would be associated with a final rule.

Risks: This rule is intended to remove obstacles to the prompt communication of safety-related labeling changes that meet the regulatory criteria for a CBE supplement. The rule may encourage generic drug companies to participate more actively with FDA in ensuring the timeliness, accuracy, and completeness of drug safety labeling in accordance with current regulatory requirements. FDA's posting of information on its Web site regarding the safety-related labeling changes proposed in pending CBE supplements would enhance transparency, and facilitate access by health care providers and the public so that such information may be used to inform treatment decisions.

Timetable:Start Printed Page 76524

ActionDateFR Cite
NPRM11/13/1378 FR 67985
NPRM Comment Period End01/13/14
NPRM Comment Period Extended12/27/1378 FR 78796
NPRM Comment Period End03/13/14
Final Rule09/00/15

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Undetermined.

Agency Contact: Janice L. Weiner, Senior Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6268, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3601, Fax: 301 847-8440, Email: janice.weiner@fda.hhs.gov.

RIN: 0910-AG94

HHS—FDA

59. Veterinary Feed Directive

Priority: Other Significant.

Legal Authority: 21 U.S.C. 354; 21 U.S.C. 360b; 21 U.S.C. 360ccc; 21 U.S.C. 360ccc-1; 21 U.S.C. 371

CFR Citation: 21 CFR 514; 21 CFR 558.

Legal Deadline: None.

Abstract: The Animal Drug Availability Act created a new category of products called veterinary feed directive (VFD) drugs. This rulemaking is intended to provide for the increased efficiency of the VFD program.

Statement of Need: Before 1996, two options existed for regulating the distribution of animal drugs, including drugs in animal feed: (1) Over-the-counter (OTC); and (2) prescription (Rx). In 1996, the Animal Drug Availability Act (ADAA) created a new category of products called veterinary feed directive (VFD) drugs. VFD drugs are new animal drugs intended for use in or on animal feed, which are limited to use under the professional supervision of a licensed veterinarian in the course of the veterinarian's professional practice. In order for animal feed containing a VFD drug to be used in animals, a licensed veterinarian must first issue an order, called a veterinary feed directive (or VFD), providing for such use. The Food and Drug Administration (FDA, the Agency) finalized its regulation to implement the VFD-related provisions of the ADAA in December 2000. Since that time, FDA has received informal comments that the VFD process is overly burdensome. As a result, FDA began exploring ways to improve the VFD program's efficiency. To that end, FDA published an advanced notice of proposed rulemaking on March 29, 2010 (75 FR 15387), and draft text of a proposed regulation, which it published April 13, 2012 (77 FR 22247). The proposed revisions to the VFD process are also intended to support the Agency's initiative to transition certain new animal drug products containing medically important antimicrobial drugs from an OTC status to a status that requires veterinary oversight. The proposed rule, if finalized, will make the following changes to the VFD regulations at section 558.6 (21 CFR 558.6): (1) Reorganize the VFD regulations to make them more user-friendly. This proposal will replace the six subsections of the existing regulations with three subsections that better identify what is expected from each party involved in the VFD process; (2) provide increased flexibility for licensed veterinarians and animal producers to align with the most recent practice standards, technological and medical advances, and practical considerations, to assure the safe and effective use of VFD drugs; (3) provide for the continued availability through the current feed mill distribution system of those Category I drugs that move to VFD dispensing status. This will prevent potential shortages of antimicrobial drugs needed by food animal producers for judicious therapeutic uses on their farms and ranches; and (4) lower the recordkeeping burden for all involved parties to align with other feed manufacturing recordkeeping requirements, thus eliminating the need for two separate filing systems.

Summary of Legal Basis: FDA's authority for issuing this rule is provided in the ADAA (Pub. L. 104-250), which amended the Federal Food, Drug, & Cosmetic Act (FD&C Act) by establishing section 504.

Alternatives: An alternative to the proposed rule that would ease the burden on VFD drug manufacturers would be to allow additional time to comply with the proposed labeling requirements for currently approved VFD drugs, for example, 1 or more years after the final rule becomes effective. This would not affect any new VFD drug approvals after the effective date of the final rule, and it could provide a transition period for current VFD manufacturers to coordinate the labeling changes to the specimen labeling, representative labeling, the VFD form itself, and advertising within the usual frequency of label changes.

Anticipated Cost and Benefits: The estimated one-time costs to industry from this proposed rule, if finalized, are the costs to review the rule and prepare a compliance plan. In addition, FDA estimates that the government will incur costs associated with reviewing the VFD drug labeling supplements that are expected to be submitted by the existing VFD drug manufacturers. The expected benefit of this proposal is a general improvement in the efficiency of the VFD process. Additionally, the reduction in veterinarian labor costs due to this rule is expected to result in an annual cost savings.

Risks: As FDA continues to implement the judicious use principles for medically important antimicrobial drugs based on the framework set forth in Guidance for Industry #209, which published April 13, 2012, it is critical that the Agency makes the VFD program as efficient as possible for stakeholders while maintaining adequate protection for human and animal health. The provisions included in this proposed rule are based on stakeholder input received in response to multiple opportunities for public comment, and represent FDA's best effort to strike the appropriate balance between protection of human and animal health and programmatic efficiency.

Timetable:

ActionDateFR Cite
ANPRM03/29/1075 FR 15387
ANPRM Comment Period End06/28/10
NPRM12/12/1378 FR 75515
NPRM Comment Period End03/12/14
Final Rule04/00/15

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Sujaya Dessai, Supervisory Veterinary Medical Officer, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, MPN-4, Room 2620, HFV-212, 7529 Standish Place, Rockville, MD 20855, Phone: 240 276-9075, Email: sujaya.dessai@fda.hhs.gov.

RIN: 0910-AG95

Start Printed Page 76525

HHS—CENTERS FOR MEDICARE & MEDICAID SERVICES (CMS)

Proposed Rule Stage

60. Reform of Requirements for Long-Term Care Facilities (CMS-3260-P) (Rulemaking Resulting From a Section 610 Review)

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: This action may affect the private sector under Pub. L. 104-4.

Legal Authority: Pub. L. 111-148, sec 6102; 42 U.S.C. 263a; 42 U.S.C. 1302, 1395hh, 1395rr

CFR Citation: 42 CFR 405; 42 CFR 431; 42 CFR 447; 42 CFR 482; 42 CFR 483; 42 CFR 485; 42 CFR 488.

Legal Deadline: None.

Abstract: This proposed rule would revise the requirements that Long-Term Care facilities must meet to participate in the Medicare and Medicaid programs. These proposed changes are necessary to reflect the substantial advances that have been made over the past several years in the theory and practice of service delivery and safety. These proposals are also an integral part of our efforts to achieve broad-based improvements both in the quality of health care furnished through Federal programs, and in patient safety, while at the same time reducing procedural burdens on providers.

Statement of Need: CMS has not comprehensively reviewed the entire set of requirements for participation it imposes on facilities in many years. Over the years, the Agency and its stakeholders have identified problematic requirements. Accordingly, we conducted a review of the requirements in an effort to improve the quality of life, care, and services in facilities; optimize resident safety; reflect current professional standards; and improve the logical flow of the regulations. Based on our analysis, we decided to pursue those regulatory revisions that would reflect the advances that have been made in health care delivery and that would improve resident safety.

Summary of Legal Basis: The Medicare requirements for participation for long-term care facilities were published in the Federal Register on February 2, 1989. These regulations have been revised and added to since that time, principally as a result of legislation or a need to address a specific issue; however, they have not been comprehensively reviewed and updated since September 26, 1991, despite substantial changes in service delivery in this setting. Additionally, we are proposing to add the statutory authority citations for sections 1128I(b) and (c) of the Act to include the compliance and ethics program and Quality Assurance and Performance Improvement (QAPI) requirements under section 6102 of the Affordable Care Act.

Alternatives: The requirements for long-term care facilities have not been comprehensively updated in many years, but the effective and efficient delivery of health care services has changed substantially in that time. We could choose not to make any regulatory changes; however, we believe the changes we are proposing are necessary to ensure the requirements are consistent with current standards of practice and continue to meet statutory obligations. They will ensure that residents receive care that maintains or enhances quality of life and attains or maintains the resident's highest practicable physical, mental, and psychosocial well-being.

Anticipated Cost and Benefits: This proposed rule would implement comprehensive changes intended to update the current requirements for long-term care facilities and create new efficiencies and flexibilities for facilities. In addition, these changes will support improved resident quality of life and quality of care. Many of the quality of life improvements we are proposing are grounded in the concepts of person-centered care and culture change. These changes not only result in improved quality of life for the resident, but can result in improvements in the caregiver's quality of work life and in savings to the facility. Savings can be accrued through reduced turnover, decreased use of agency labor and decreased worker compensation costs. Facilities may also benefit from improved bed occupancy rates. As we move toward publication, estimates of the cost and benefits of these important initiatives will be included in the rule.

Risks: None. The proposed requirements in this rule would update the existing requirements for long-term care facilities to reflect current standards of practice. In addition, proposed changes would provide added flexibility to providers, improve efficiency and effectiveness, enhance resident quality of care and quality of life, and potentially improve clinical outcomes.

Timetable:

ActionDateFR Cite
NPRM03/00/15

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses, Governmental Jurisdictions.

Government Levels Affected: State.

Additional Information: Includes Retrospective Review under E.O. 13563.

Agency Contact: Ronisha Davis, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, Mail Stop S3-02-01, 7500 Security Blvd., Baltimore, MD 21244, Phone: 410 786-6882, Email: ronisha.davis@cms.hhs.gov.

RIN: 0938-AR61.

HHS—CMS

61. Mental Health Parity and Addiction Equity Act of 2008; The Application to Medicaid Managed Care, Chip, And Alternative Benefit Plans (CMS-2333-P)

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: Undetermined.

Legal Authority: 42 U.S.C. 1302; Pub. L. 110-343; Pub. L. 111-148, Sec 2001

CFR Citation: 42 CFR 438; 42 CFR 440; 42 CFR 456; 42 CFR 457.

Legal Deadline: None.

Abstract: This proposed rule would address the requirements under the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) to Medicaid Alternative Benefit Plans (ABPs), Children's Health Insurance Program (CHIP), and Medicaid managed care organizations (MCOs).

Statement of Need: A final rule implementing MHPAEA was published in the Federal Register on November 13, 2013. These final MHPAEA provisions do not apply to Medicaid MCOs, ABPs, or CHIP State plans. This rule proposes to address how MHPAEA requirements, including those implemented in the November 13, 2013, final rule, apply to MCOs, ABPs, and CHIP.

Summary of Legal Basis: There are several statutes that are directly related to MHPAEA application to Medicaid. These include the MHPAEA, sections 511 and 512 of the Tax Extenders and Alternative Minimum Tax Relief Act of 2008, the Employee Retirement Income Security Act of 1974 (ERISA), the Public Health Service Act (PHS Act), and the Internal Revenue Code of 1986 (Code). Section 2103(c) of the Social Security Act (the Act) added paragraph (6), which incorporates, by reference, provisions added to section 2705 of the Public Health Service Act (PHSA) to apply MHPAEA to CHIP. Finally, the Start Printed Page 76526Affordable Care Act expanded the application of MHPAEA to benefits in Medicaid ABPs.

Alternatives: None. A rule is needed to address the provisions of MHPAEA as they apply to Medicaid benchmark and benchmark-equivalent, CHIP, and MCOs.

Anticipated Cost and Benefits: As we move toward publication, estimates of the cost and benefits of these provisions will be included in the rule.

Risks: None. This rule approaches the application of MHPAEA to Medicaid MCOs, ABPs, and CHIP by building upon the policies set forth in the final MHPAEA regulation. Our goal is to align as much as possible with the approach taken in the final MHPAEA regulation in order to avoid confusion or conflict, while remaining true to the intent of the MHPAEA statute and the Medicaid program and CHIP.

Timetable:

ActionDateFR Cite
NPRM03/00/15

Regulatory Flexibility Analysis Required: Undetermined.

Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations.

Government Levels Affected: Federal, Local, State, Tribal.

Federalism: Undetermined.

Agency Contact: John O'Brien, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid and CHIP Services, MS: S2-14-26, 7500 Security Blvd., Baltimore, MD 21244, Phone: 410 786-5529, Email: john.o'brien3@cms.hhs.gov.

RIN: 0938-AS24

HHS—CMS

62. Electronic Health Record (EHR) Incentive Programs—Stage 3 (CMS-3310-P)

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: Undetermined.

Legal Authority: Pub. L. 111-5, title IV of Division B

CFR Citation: 45 CFR 170; 42 CFR 412; 42 CFR 413; 42 CFR 495.

Legal Deadline: None.

Abstract: This proposed rule would establish policies related to Stage 3 of meaningful use for the Medicare and Medicaid EHR Incentive Programs. Stage 3 will focus on improving health care outcomes and further advance interoperability.

Statement of Need: This rule is necessary to implement the provisions of the American Recovery and Reinvestment Act (ARRA) that provide incentive payments to eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) participating in Medicare and Medicaid programs that adopt and meaningfully use certified EHR technology. The rule specifies applicable criteria for demonstrating Stage 3 of meaningful use.

Summary of Legal Basis: ARRA amended titles XVIII and XIX of the Social Security Act (the Act) to authorize incentive payments to EPs, eligible hospitals, CAHs, and Medicare Advantage (MA) Organizations to promote the adoption and meaningful use of certified EHR technology.

Alternatives: None. In this proposed rule, CMS will implement Stage 3, another stage of the Medicare and Medicaid EHR Incentive Program as required by ARRA. We are proposing the Stage 3 criteria that EP's, eligible hospitals, and CAHs must meet in order to successfully demonstrate meaningful use under the Medicare and Medicaid EHR Incentive Programs, focusing on advanced use of EHR technology to promote improved outcomes for patients. Stage 3 will also propose changes to the reporting period, timelines, and structure of the program, including providing a single definition of meaningful use. These changes will provide a flexible, yet, clearer framework to ensure future sustainability of the EHR program and reduce confusion stemming from multiple stage requirements.

Anticipated Cost and Benefits:

We expect that benefits to the program will accrue in the form of savings to Medicare through the Medicare payment adjustments. Expected qualitative benefits, such as improved quality of care and better health outcomes are unable to be quantified at this time, but we believe that savings will likely result from reductions in the cost of providing care.

Risks: CMS anticipates many positive effects of adopting EHR on health care providers, apart from the incentive payments to be provided under this proposed rule. We believe there are benefits that can be obtained by eligible hospitals and EPs, including: Reductions in medical recordkeeping costs, reductions in repeat tests, decreases in length of stay, and reduced errors. When used effectively, EHRs can enable providers to deliver health care more efficiently. For example, EHRs can reduce the duplication of diagnostic tests, prompt providers to prescribe cost effective generic medications, remind patients about preventive care, reduce unnecessary office visits, and assist in managing complex care.

We are working with the Office of the National Coordinator for Health Information Technology to ensure that the Stage 3 meaningful use definition coordinates with the standards and certification requirements being proposed and that there is sufficient time to upgrade and implement these changes. Stage 2 has been extended so that Stage 3 will not begin until 2017.

Timetable:

ActionDateFR Cite
NPRM02/00/15

Regulatory Flexibility Analysis Required: Undetermined.

Small Entities Affected: Businesses, Governmental Jurisdictions.

Government Levels Affected: State.

Federalism: Undetermined.

Agency Contact: Elizabeth S. Holland, Director, HIT Initiatives Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410-786-1309, Email: elizabeth.holland@cms.hhs.gov.

RIN: 0938-AS26

HHS—CMS

63. • CY 2016 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1631-P)

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: Undetermined.

Legal Authority: Social Security Act, secs 1102, 1871, 1848

CFR Citation: Not Yet Determined.

Legal Deadline: Final, Statutory, November 1, 2015.

Abstract: This annual proposed rule would revise payment polices under the Medicare physician fee schedule, and make other policy changes to payment under Medicare Part B. These changes would apply to services furnished beginning January 1, 2016.

Statement of Need: The statute requires that we establish each year, by regulation, payment amounts for all physicians' services furnished in all fee schedule areas. This rule would implement changes affecting Medicare Part B payment to physicians and other Part B suppliers. The final rule has a statutory publication date of November 1, 2015, and an implementation date of January 1, 2016.Start Printed Page 76527

Summary of Legal Basis: Section 1848 of the Social Security Act (the Act) establishes the payment for physician services provided under Medicare. Section 1848 of the Act imposes an annual deadline of no later than November 1 for publication of the final rule or final physician fee schedule.

Alternatives: None. This implements a statutory requirement.

Anticipated Cost and Benefits: Total expenditures will be adjusted for CY 2016.

Risks: If this regulation is not published timely, physician services will not be paid appropriately, beginning January 1, 2016.

Timetable:

ActionDateFR Cite
NPRM06/00/15

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

Agency Contact: Kathy Bryant, Director, Division of Practitioner Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C4-01-27, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-3448, Email: kathy.bryant@cms.hhs.gov.

RIN: 0938-AS40

HHS—CMS

64. • Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2016 Rates (CMS-1632-P)

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: Undetermined.

Legal Authority: sec 1886(d) of the Social Security Act

CFR Citation: Not Yet Determined.

Legal Deadline: NPRM, Statutory, April 1, 2015.

Final, Statutory, August 1, 2015.

Abstract: This annual proposed rule would revise the Medicare hospital inpatient and long-term care hospital prospective payment systems for operating and capital-related costs. This proposed rule would implement changes arising from our continuing experience with these systems.

Statement of Need: CMS annually revises the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs to implement changes arising from our continuing experience with these systems. In addition, we describe the proposed changes to the amounts and factors used to determine the rates for Medicare hospital inpatient services for operating costs and capital-related costs. Also, CMS annually updates the payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs). The rule solicits comments on the proposed IPPS and LTCH payment rates and new policies. CMS will issue a final rule containing the payment rates for the FY 2016 IPPS and LTCHs at least 60 days before October 1, 2015.

Summary of Legal Basis: The Social Security Act (the Act) sets forth a system of payment for the operating costs of acute care hospital inpatient stays under Medicare Part A (Hospital Insurance) based on prospectively set rates. The Act requires the Secretary to pay for the capital-related costs of hospital inpatient and long-term care stays under a PPS. Under these systems, Medicare payment for hospital inpatient and long-term care operating and capital-related costs is made at predetermined, specific rates for each hospital discharge. These changes would be applicable to services furnished on or after October 1, 2015.

Alternatives: None. This implements a statutory requirement.

Anticipated Cost and Benefits: Total expenditures will be adjusted for FY 2016.

Risks: If this regulation is not published timely, inpatient hospital and LTCH services will not be paid appropriately beginning October 1, 2015.

Timetable:

ActionDateFR Cite
NPRM04/00/15

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Federal.

Agency Contact: Donald Thompson, Deputy Director, Division of Acute Care, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C4-01-26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-6504, Email: donald.thompson@cms.hhs.gov.

RIN: 0938-AS41

HHS—CMS

65. • CY 2016 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1633-P)

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: Undetermined.

Legal Authority: sec 1833 of the Social Security Act

CFR Citation: Not Yet Determined.

Legal Deadline: Final, Statutory, November 1, 2015.

Abstract: This annual proposed rule would revise the Medicare hospital outpatient prospective payment system to implement statutory requirements and changes arising from our continuing experience with this system. The proposed rule describes changes to the amounts and factors used to determine payment rates for services. In addition, the rule proposes changes to the ambulatory surgical center payment system list of services and rates.

Statement of Need: Medicare pays over 4,000 hospitals for outpatient department services under the hospital outpatient prospective payment system (OPPS). The OPPS is based on groups of clinically similar services called ambulatory payment classification groups (APCs). CMS annually revises the APC payment amounts based on the most recent claims data, proposes new payment policies, and updates the payments for inflation using the hospital operating market basket. Medicare pays roughly 5,000 Ambulatory Surgical Centers (ASCs) under the ASC payment system. CMS annually revises the payment under the ASC payment system, proposes new policies, and updates payments for inflation. CMS will issue a final rule containing the payment rates for the 2016 OPPS and ASC payment system at least 60 days before January 1, 2016.

Summary of Legal Basis: Section 1833 of the Social Security Act establishes Medicare payment for hospital outpatient services and ASC services. The rule revises the Medicare hospital OPPS and ASC payment system to implement applicable statutory requirements. In addition, the rule describes changes to the outpatient APC system, relative payment weights, outlier adjustments, and other amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system as well as changes to the rates and services paid under the ASC payment system. These changes would be applicable to services furnished on or after January 1, 2016.Start Printed Page 76528

Alternatives: None. This is a statutory requirement.

Anticipated Cost and Benefits: Total expenditures will be adjusted for CY 2016.

Risks: If this regulation is not published timely, outpatient hospital and ASC services will not be paid appropriately beginning January 1, 2016.

Timetable:

ActionDateFR Cite
NPRM07/00/15

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Federal.

Federalism: Undetermined.

Agency Contact: Marjorie Baldo, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C4-03-06, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4617, Email: marjorie.baldo@cms.hhs.gov.

RIN: 0938-AS42

HHS—CMS

Final Rule Stage

66. Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Exchange Eligibility Appeals, and Other Eligibility and Enrollment Provisions (CMS-2334-F2)

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority: Pub. L. 111-148, secs 1411, 1413, 1557, 1943, 2102, 2201, 2004, 2303, et al

CFR Citation: 42 CFR 430; 42 CFR 431; 42 CFR 433; 42 CFR 435; 42 CFR 457.

Legal Deadline: None.

Abstract: The Affordable Care Act expands access to health insurance through improvements in Medicaid; the establishment of Affordable Insurance Exchanges; and coordination between Medicaid, the Children's Health Insurance Program (CHIP), and Exchanges. This rule finalizes the remaining provisions proposed in the January 19, 2013, proposed rule, but not finalized in the July 15, 2013, final rule to continue our efforts to assist states in implementing Medicaid eligibility, appeals, and enrollment changes, and other State health subsidy programs.

Statement of Need: This final rule will implement provisions of the Affordable Care Act and the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA). This rule reflects new statutory eligibility provisions; changes to provide States more flexibility to coordinate Medicaid and CHIP eligibility notices, appeals, and other related administrative procedures with similar procedures used by other health coverage programs authorized under the Affordable Care Act; modernizes and streamlines existing rules, eliminates obsolete rules, and updates provisions to reflect Medicaid eligibility pathways; implements other CHIPRA eligibility-related provisions, including eligibility for newborns whose mothers were eligible for and receiving Medicaid or CHIP coverage at the time of birth. With publication of this final rule, we desire to make our implementing regulations available to States and the public as soon as possible to facilitate continued efficient operation of the State flexibility authorized under section 1937 of the Act.

Summary of Legal Basis: The Affordable Care Act extends and simplifies Medicaid eligibility. In the July 15, 2013, Federal Register, we issued the “Medicaid and Children's Health Insurance Programs: Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes, and Premiums and Cost Sharing; Exchanges: Eligibility and Enrollment” final rule that finalized certain key Medicaid and CHIP eligibility provisions included in the January 22, 2013, proposed rule. In this final rule, we are addressing the remaining provisions of the January 22, 2013, proposed rule.

Alternatives: The majority of Medicaid and CHIP eligibility provisions proposed in this rule serve to implement the Affordable Care Act. All of the provisions in this final rule are a result of the passage of the Affordable Care Act and are largely self-implementing. Therefore, alternatives considered for this final rule were constrained due to the statutory provisions.

Anticipated Cost and Benefits: The March 23, 2012 Medicaid eligibility final rule detailed the impact of the Medicaid eligibility changes related to implementation of the Affordable Care Act. The majority of provisions included in this final rule were described in detail in that rule, but in summary, we estimate a total savings of $465 million over 5 years, including $280 million in cost savings to the Federal Government and $185 million in savings to States.

Risks: None. Delaying publication of this final rule delays states from moving forward with implementing changes to Medicaid and CHIP, and aligning operations between Medicaid, CHIP and the Exchanges.

Timetable:

ActionDateFR Cite
Final Action11/00/14

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: Federal, Local, State, Tribal.

Agency Contact: Sarah DeLone, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop S2-01-16, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-0615, Email: sarah.delone@cms.hhs.gov.

Related RIN: Related to 0938-AR04.

RIN: 0938-AS27

HHS—ADMINISTRATION FOR CHILDREN AND FAMILIES (ACF)

Final Rule Stage

67. Child Care and Development Fund Reforms To Support Child Development and Working Families

Priority: Other Significant.

Legal Authority: Sec 658E and other provisions of the Child Care and Development Block Grant Act of 1990, as amended

CFR Citation: 45 CFR 98.

Legal Deadline: None.

Abstract: This rule would provide the first comprehensive update of Child Care and Development Fund (CCDF) regulations since 1998. It would make changes in four key areas: (1) Improving health and safety; (2) improving the quality of child care; (3) establishing family-friendly policies; and (4) strengthening program integrity. The rule seeks to retain much of the flexibility afforded to States, territories, and tribes consistent with the nature of a block grant.

Statement of Need: The CCDF program has far-reaching implications for America's poorest children. It provides child care assistance to 1.6 million children from nearly 1 million low-income working families and families who are attending school or job training. Half of the children served are living at or below poverty level. In addition, children who receive CCDF are cared for alongside children who do not receive CCDF, by approximately Start Printed Page 76529570,000 participating child care providers, some of whom lack basic assurances needed to ensure children are safe, healthy, and learning. Since 1996, a body of research has demonstrated the importance of the early years on brain development and has shown that high-quality, consistent child care can positively impact later success in school and life. This is especially true for low-income children who face a school readiness and achievement gap and can benefit the most from high-quality early learning environments. In light of this research, many States, territories, and tribes, working collaboratively with the Federal Government, have taken important steps over the last 15 years to make the CCDF program more child-focused and family-friendly; however, implementation of these evidence-informed practices is uneven across the country and critical gaps remain. This regulatory action is needed in order to increase accountability in the CCDF program by ensuring that all children receiving federally funded child care assistance are in safe, quality programs that both support their parent's labor market participation, and help children develop the tools and skills they need to reach their full potential. A major focus of this final rule is to raise the bar on quality by establishing a floor of health and safety standards for child care paid for with Federal funds. National surveys have demonstrated that most parents logically assume that their child care providers have had a background check, have had training in child health and safety, and are regularly monitored. However, State policies surrounding the training and oversight of child care providers vary widely. In some States, many children receiving CCDF subsidies are cared for by providers that have little to no oversight with respect to compliance with basic standards designed to safeguard children's well-being, such as first-aid and safe sleep practices. This can leave children in unsafe conditions, even as their care is being funded with public dollars. In addition, the final rule empowers all parents who choose child care, regardless of whether they receive a Federal subsidy, with better information to make the best choices for their children. This includes providing parents with information about the quality of child care providers and making information about providers' compliance with health and safety regulations more transparent so that parents can be aware of the safety track record of providers when it's time to choose child care.

Summary of Legal Basis: This final regulation is being issued under the authority granted to the Secretary of Health and Human Services by the CCDBG Act (42 U.S.C. 9858 et seq.) and section 418 of the Social Security Act (42 U.S.C. 618).

Alternatives: The Administration for Children and Families considered a range of approaches to improve early childhood care and education, including administrative and regulatory action. ACF has taken administrative actions to recommend that States adopt stronger health and safety requirements and provided technical assistance to States. Despite these efforts to assist States in making voluntary reforms, unacceptable health and safety lapses remain. An alternative to this rule would be to take no regulatory action or to limit the nature of the required standards and the degree to which those standards are prescriptive. ACF believes this rulemaking is the preferable alternative to ensure children's health and safety and promote their learning and development.

Anticipated Cost and Benefits: Changes in this final rule directly benefit children and parents who use CCDF assistance to pay for child care. The 1.6 million children who are in child care funded by CCDF would have stronger protections for their health and safety, which addresses every parent's paramount concern. All children in the care of a participating CCDF provider will be safer because that provider is more knowledgeable about health and safety issues. In addition, the families of the 12 million children who are served in child care will benefit from having clear, accessible information about the safety compliance records and quality indicators of providers available to them as they make critical choices about where their children will be cared for while they work. Provisions also will benefit child care providers by encouraging States to invest in high quality child care providers and professional development and to take into account quality when they determine child care payment rates. A primary reason for revising the CCDF regulations is to better reflect current State and local practices to improve the quality of child care. Therefore, there are a significant number of States, territories, and tribes that have already implemented many of these policies. The cost of implementing the changes in this final rule will vary depending on a State's specific situation. ACF does not believe the costs of this final regulatory action would be economically significant and that the tremendous benefits to low-income children justify costs associated with this final rule.

Risks: Not applicable.

Timetable:

ActionDateFR Cite
NPRM05/20/1378 FR 29422
NPRM Comment Period End08/05/13
Final Action12/00/14

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: State, Tribal.

Agency Contact: Andrew Williams, Policy Division Director, Department of Health and Human Services, Administration for Children and Families, Office of Child Care, 370 L'Enfant Promenade SW., Washington, DC 20447, Phone: 202 401-4795, Fax: 202 690-5600, Email: andrew.williams@acf.hhs.gov.

RIN: 0970-AC53

DEPARTMENT OF HOMELAND SECURITY (DHS)

Fall 2014 Statement of Regulatory Priorities

The Department of Homeland Security (DHS or Department) was created in 2003 pursuant to the Homeland Security Act of 2002, Public Law 107-296. DHS has a vital mission: To secure the Nation from the many threats we face. This requires the dedication of more than 225,000 employees in jobs that range from aviation and border security to emergency response, from cybersecurity analyst to chemical facility inspector. Our duties are wide-ranging, but our goal is clear—keeping America safe.

Our mission gives us six main areas of responsibility:

1. Prevent Terrorism and Enhance Security,

2. Secure and Manage Our Borders,

3. Enforce and Administer our Immigration Laws,

4. Safeguard and Secure Cyberspace,

5. Ensure Resilience to Disasters, and

6. Mature and Strengthen DHS

In achieving these goals, we are continually strengthening our partnerships with communities, first responders, law enforcement, and government agencies—at the State, local, tribal, Federal, and international levels. We are accelerating the deployment of science, technology, and innovation in order to make America more secure, and we are becoming Start Printed Page 76530leaner, smarter, and more efficient, ensuring that every security resource is used as effectively as possible. For a further discussion of our main areas of responsibility, see the DHS Web site at http://www.dhs.gov/​our-mission.

The regulations we have summarized below in the Department's fall 2014 regulatory plan and in the agenda support the Department's responsibility areas listed above. These regulations will improve the Department's ability to accomplish its mission.

The regulations we have identified in this year's fall regulatory plan continue to address legislative initiatives including, but not limited to, the following acts: The Implementing Recommendations of the 9/11 Commission Act of 2007 (9/11 Act), Public Law 110-53 (Aug. 3, 2007); the Consolidated Natural Resources Act of 2008 (CNRA), Public Law 110-229 (May 8, 2008); the Security and Accountability for Every Port Act of 2006 (SAFE Port Act), Public Law 109-347 (Oct. 13, 2006); and the Consolidated Security, Disaster Assistance, and Continuing Appropriations Act, 2009, Public Law 110-329 (Sep. 30, 2008).

DHS strives for organizational excellence and uses a centralized and unified approach in managing its regulatory resources. The Office of the General Counsel manages the Department's regulatory program, including the agenda and regulatory plan. In addition, DHS senior leadership reviews each significant regulatory project to ensure that the project fosters and supports the Department's mission.

The Department is committed to ensuring that all of its regulatory initiatives are aligned with its guiding principles to protect civil rights and civil liberties, integrate our actions, build coalitions and partnerships, develop human resources, innovate, and be accountable to the American public.

DHS is also committed to the principles described in Executive Orders 13563 and 12866 (as amended). Both Executive Orders direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.

Finally, the Department values public involvement in the development of its regulatory plan, agenda, and regulations, and takes particular concern with the impact its rules have on small businesses. DHS and each of its components continue to emphasize the use of plain language in our notices and rulemaking documents to promote a better understanding of regulations and increased public participation in the Department's rulemakings.

Retrospective Review of Existing Regulations

Pursuant to Executive Order 13563 “Improving Regulation and Regulatory Review” (Jan. 18, 2011), DHS identified the following regulatory actions as associated with retrospective review and analysis. Some of the regulatory actions on the below list may be completed actions, which do not appear in The Regulatory Plan. You can find more information about these completed rulemakings in past publications of the Unified Agenda (search the Completed Actions sections) on www.reginfo.gov. Some of the entries on this list, however, are active rulemakings. You can find entries for these rulemakings on www.regulations.gov.

RINRule
1601-AA58Professional Conduct for Practitioners Rules and Procedures, and Representation and Appearances.
1615-AB92Employment Authorization for Certain H-4 Spouses.
1615-AB95Immigration Benefits Business Transformation: Nonimmigrants; Student and Exchange Visitor Program.
1615-AC00Enhancing Opportunities for H-1B1, CW-1, and E-3 Nonimmigrants and EB-1 Immigrants.
1625-AB38Update to Maritime Security.
1625-AB80Revision to Transportation Worker Identification Credential (TWIC) Requirements for Mariners.
1651-AA96Definition of Form I-94 to Include Electronic Format.
1651-AB05Freedom of Information Act (FOIA) Procedures.
1652-AA61Standardized Vetting, Adjudication, and Redress Services.
1653-AA44Amendment to Accommodate Process Changes with SEVIS II Implementation.
1653-AA63Adjustments to Limitations on Designated School Official Assignment and Study By F-2 and M-2 Nonimmigrants.
1660-AA77Change in Submission Requirements for State Mitigation Plans.

Promoting International Regulatory Cooperation

Pursuant to Sections 3 and 4(b) of Executive Order 13609 “Promoting International Regulatory Cooperation” (May 1, 2012), DHS has identified the following regulatory actions that have significant international impacts. Some of the regulatory actions on the below list may be completed actions. You can find more information about these completed rulemakings in past publications of the Unified Agenda (search the Completed Actions sections) on www.reginfo.gov. Some of the entries on this list, however, are active rulemakings. You can find entries for these rulemakings on www.regulations.gov.

RINRule
1625-AB38Updates to Maritime Security.
1651-AA70Importer Security Filing and Additional Carrier Requirements.
1651-AA72Changes to the Visa Waiver Program To Implement the Electr