This PDF is the current document as it appeared on Public Inspection on 06/19/2017 at 08:45 am.
Food and Drug Administration, HHS.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of reporting and recordkeeping requirements for firms that process acidified foods and thermally processed low-acid foods in hermetically sealed containers.
Submit either electronic or written comments on the collection of information by August 21, 2017.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 21, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of August 21, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
Submit electronic comments in the following way:
- Federal eRulemaking Portal: https://www.regulations.gov/. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov/ will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov/.
- If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
- Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
- For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
Instructions: All submissions received must include the Docket No. FDA-2013-N-1119 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov/ or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
- Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov/. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov/ and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.Start Further Info
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, PRAStaff @fda.hhs.gov.End Further Info End Preamble Start Supplemental Information
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, Start Printed Page 28070including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers—21 CFR 108.25 and 108.35, and Parts 113 and 114—OMB Control Number 0910-0037—Extension
Section 402 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 342) deems a food to be adulterated, in part, if the food bears or contains any poisonous or deleterious substance which may render it injurious to health. Section 301(a) of the FD&C Act (21 U.S.C. 331(a)) prohibits the introduction or delivery for introduction into interstate commerce of adulterated food. Under section 404 of the FD&C Act (21 U.S.C. 344), our regulations require registration of food processing establishments, filing of process or other data, and maintenance of processing and production records for acidified foods and thermally processed low-acid foods in hermetically sealed containers. These requirements are intended to ensure safe manufacturing, processing, and packing procedures and to permit us to verify that these procedures are being followed. Improperly processed low-acid foods present life-threatening hazards if contaminated with foodborne microorganisms, especially Clostridium botulinum. The spores of C. botulinum need to be destroyed or inhibited to avoid production of the deadly toxin that causes botulism. This is accomplished with good manufacturing procedures, which must include the use of adequate heat processes or other means of preservation.
To protect the public health, our regulations require that each firm that manufactures, processes, or packs acidified foods or thermally processed low-acid foods in hermetically sealed containers for introduction into interstate commerce register the establishment with us using Form FDA 2541 (§§ 108.25(c)(1) and 108.35(c)(2) (21 CFR 108.25(c)(1) and 108.35(c)(2)). In addition to registering the plant, each firm is required to provide data on the processes used to produce these foods, using Form FDA 2541a for all methods except aseptic processing, or Form FDA 2541c for aseptic processing of low-acid foods in hermetically sealed containers (§§ 108.25(c)(2) and 108.35(c)(2)). Plant registration and process filing may be accomplished simultaneously. Process data must be filed prior to packing any new product, and operating processes and procedures must be posted near the processing equipment or made available to the operator (21 CFR 113.87(a)).
Regulations in parts 108, 113, and 114 (21 CFR parts 108, 113, and 114) require firms to maintain records showing adherence to the substantive requirements of the regulations. These records must be made available to FDA on request. Firms also must document corrective actions when process controls and procedures do not fall within specified limits (§§ 113.89, 114.89, and 114.100(c)); to report any instance of potential health-endangering spoilage, process deviation, or contamination with microorganisms where any lot of the food has entered distribution in commerce (§§ 108.25(d) and 108.35(d) and (e)); and to develop and keep on file plans for recalling products that may endanger the public health (§§ 108.25(e) and 108.35(f)). To permit lots to be traced after distribution, acidified foods and thermally processed low-acid foods in hermetically sealed containers must be marked with an identifying code (§§ 113.60(c)) (thermally processed foods) and 114.80(b) (acidified foods)).
The records of processing information are periodically reviewed during factory inspections by FDA to verify fulfillment of the requirements in parts 113 or 114. Scheduled thermal processes are examined and reviewed to determine their adequacy to protect public health. In the event of a public health emergency, records are used to pinpoint potentially hazardous foods rapidly and thus limit recall activity to affected lots.
As described in our regulations, processors may obtain the paper versions of Forms FDA 2541, FDA 2541a, and FDA 2541c by contacting us at a particular address. Processors mail completed paper forms to us. However, processors who are subject to § 108.25, § 108.35, or both, have an option to submit Forms FDA 2541, FDA 2541a, and FDA 2541c electronically (Ref. 1) (see also 76 FR 11783 at 11785; March 3, 2011).
Although we encourage commercial processors to use the electronic submission system for plant registration and process filing, we will continue to make paper-based forms available. To standardize the burden associated with process filing, regardless of whether the process filing is submitted electronically or using a paper form, we are offering the public the opportunity to use four forms, each of which pertain to a specific type of commercial processing and are available both on the electronic submission system and as a paper-based form. The electronic submission system and the paper-based form “mirror” each other to the extent practicable. The four process filing forms are as follows:
- Form FDA 2541d (Food Process Filing for Low-Acid Retorted Method) (Ref. 3);
- Form FDA 2541e (Food Process Filing for Acidified Method) (Ref. 4);
- Form FDA 2541f (Food Process Filing for Water Activity/Formulation Control Method) (Ref. 5); and
- Form FDA 2541g (Food Process Filing for Low-Acid Aseptic Systems) (Ref. 6).
At this time, the paper-based versions of the four proposed replacement forms and their instructions are all available for review as references to this document (Refs. 4 through 6) or at https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/ucm2007436.htm.
Description of Respondents: The respondents to this information collection are commercial processors and packers of acidified foods and thermally processed low-acid foods in hermetically sealed containers.
FDA estimates the burden of this collection of information as follows:Start Printed Page 28071
|21 CFR section||FDA Form No.||Number of respondents||Number of responses per respondent||Total annual responses||Average burden per response||Total hours|
|§§ 108.25(c)(1) and 108.35(c)(2); Food canning establishment registration||2541||645||1||645||0.17 (10 minutes)||110|
|§ 108.25(c)(2); Food process filing for acidified method||2541e||726||11||7,986||0.333 (20 minutes)||2,659|
|§ 108.35(c)(2); Food process filing for low-acid retorted method||2541d||336||12||4,032||0.333 (20 minutes)||1,343|
|§ 108.35(c)(2); Food process filing for water activity/formulation control method||2541f||37||6||222||0.333 (20 minutes)||74|
|§ 108.35(c)(2); Food process filing for low-acid aseptic systems||2541g||42||22||924||0.75 (45 minutes)||693|
|§§ 108.25(d) and 108.35(d) and (e); Report of any instance of potential health endangering spoilage, process deviation, or contamination with microorganisms where any lot of the food has entered distribution in commerce||N/A||1||1||1||4||4|
|1 There are no capital costs or operating and maintenance costs associated with this collection of information.|
FDA bases its estimate of the number of respondents in table 1 on registrations, process filings, and reports received over the past 3 years. The hours per response reporting estimates are based on our experience with similar programs and information received from industry. The reporting burden for §§ 108.25(d) and 108.35(d) and (e), is minimal because notification of spoilage, process deviation, or contamination of product in distribution occurs less than once a year. Most firms discover these problems before the product is distributed and, therefore, are not required to report the occurrence. We estimate that we will receive one report annually under §§ 108.25(d) and 108.35(d) and (e). The report is expected to take 4 hours per response, for a total of 4 hours.
|21 CFR part||Number of recordkeepers||Number of records per recordkeeper||Total annual records||Average burden per recordkeeping||Total hours|
|108, 113, and 114||10,392||1||10,392||250||2,598,000|
|1 There are no capital costs or operating and maintenance costs associated with this collection of information.|
FDA bases its estimate of 10,392 recordkeepers in table 2 on its records of the number of registered firms, excluding firms that were inactive or out of business, yet still registered. To avoid double-counting, we have not included estimates for §§ 108.25(g), 108.35(c)(2)(ii), and 108.35(h) because they merely cross-reference recordkeeping requirements contained in parts 113 and 114 and have been accounted for in the recordkeeping burden estimate. We estimate that 10,392 firms will expend approximately 250 hours per year to fully satisfy the recordkeeping requirements in parts 108, 113 and 114, for a total of 2,598,000 hours.
Finally, our regulations require that processors mark thermally processed low-acid foods in hermetically sealed containers (§ 113.60(c)) and acidified foods (§ 114.80(b)) with an identifying code to permit lots to be traced after distribution. We seek OMB approval of the third party disclosure requirements in §§ 113.60(c) and 114.80(b). However, we have not included a separate table to report the estimated burden of these regulations. No burden has been estimated for the third-party disclosure requirements in §§ 113.60(c) and 114.80(b) because the coding process is done as a usual and customary part of normal business activities. Coding is a business practice in foods for liability purposes, inventory control, and process control in the event of a problem. Under 5 CFR 1320.3(b)(2), the time, effort, and financial resources necessary to comply with a collection of information are excluded from the burden estimate if the reporting, recordkeeping, or disclosure activities needed to comply are usual and customary because they would occur in the normal course of activities.
The following references are on display in the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov/. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.
1. FDA 2016. “Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541a and FDA 2541c (Food Process Filing Forms) to FDA in Electronic or Paper Format.” Available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceStart Printed Page 28072DocumentsRegulatoryInformation/AcidifiedLACF/ucm309376.htm.
2. Form FDA 2541. Food Process Filing for All Methods Except Low-Acid Aseptic. Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM076778.pdf.
3. Form 2541d. Food Process Filing for Low-Acid Retorted Method. Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465591.pdf.
4. Form 2541e. Food Process Filing for Acidified Method. Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465593.pdf.
5. Form 2541f. Food Process Filing for Water Activity/Formulation Control Method. Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465595.pdf.
6. Form 2541g. Food Process Filing for Low-Acid Aseptic Systems. Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465598.pdf.Start Signature
Dated: June 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12783 Filed 6-19-17; 8:45 am]
BILLING CODE 4164-01-P