[Federal Register Volume 86, Number 69 (Tuesday, April 13, 2021)]
[Notices]
[Pages 19214-19215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07519]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2021-0008]


Notice of Request To Revise an Approved Information Collection 
(Requirements To Notify FSIS of Adulterated or Misbranded Product, 
Prepare and Maintain Written Recall Procedures, and Document Certain 
HACCP Plan Reassessments)

AGENCY: Food Safety and Inspection Service (FSIS), USDA.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995 and the 
Office of Management and Budget (OMB) regulations, the Food Safety and 
Inspection Service (FSIS) is announcing its intention to revise the 
approved information collection regarding requirements for official 
establishments to notify FSIS of adulterated or misbranded product, 
prepare and maintain written recall procedures, and document certain 
HACCP plan reassessments. The approval for this information collection 
will expire on September 30, 2021. FSIS has decreased the burden 
estimate for this collection by 37,515 hours due to more recent, 
updated information. The public may comment on either the entire 
information collection or on one of its three parts.

DATES: Submit comments on or before June 14, 2021.

ADDRESSES: FSIS invites interested persons to submit comments on this 
Federal Register notice. Comments may be submitted by one of the 
following methods:
     Federal eRulemaking Portal: This website provides 
commenters the ability to type short comments directly into the comment 
field on the web page or to attach a file for lengthier comments. Go to 
https://www.regulations.gov. Follow the on-line instructions at that 
site for submitting comments.
     Mail: Send to Docket Clerk, U.S. Department of 
Agriculture, Food Safety and Inspection Service, 1400 Independence 
Avenue SW, Mailstop 3758, Washington, DC 20250-3700.
     Hand- or Courier-Delivered Submittals: Deliver to 1400 
Independence Avenue SW, Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2021-0008. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to https://www.regulations.gov.
    Docket: For access to background documents or comments received, 
call (202)205-0495 to schedule a time to visit the FSIS Docket Room at 
1400 Independence Avenue SW, Washington, DC 20250-3700.

FOR FURTHER INFORMATION CONTACT: Gina Kouba, Office of Policy and 
Program Development, Food Safety and Inspection Service, USDA, 1400 
Independence Avenue SW, Mailstop 3758, South Building, Washington, DC 
20250-3700; (202) 720-5627.

SUPPLEMENTARY INFORMATION:
    Title: Requirements To Notify FSIS of Adulterated or Misbranded 
Product, Prepare and Maintain Written Recall Procedures, and Document 
Certain HACCP Plan Reassessments.
    OMB Number: 0583-0144.
    Expiration Date of Approval: 9/30/2021.
    Type of Request: Renewal of an approved information collection.
    Abstract: FSIS has been delegated the authority to exercise the 
functions of the Secretary (7 CFR 2.18, 2.53), as specified in the 
Federal Meat Inspection Act (FMIA) (21 U.S.C. 601, et seq.), the 
Poultry Products Inspection Act (PPIA) (21 U.S.C. 451, et seq.), and 
the Egg Products Inspection Act (EPIA) (21 U.S.C. 1031, et seq.). These 
statutes mandate that FSIS protect the public by verifying that meat, 
poultry, and egg products are safe, wholesome, unadulterated, and 
properly labeled and packaged.
    FSIS is requesting revision of the approved information collection 
regarding requirements for official establishments to notify FSIS of 
adulterated or misbranded product, prepare and maintain written recall 
procedures, and document certain HACCP plan reassessments. FSIS has 
decreased the burden estimate for this collection by 37,515 hours due 
to more recent, updated information.
    The regulations at 9 CFR 418.2, 418.3 and 417.4(a)(3) require 
establishments to notify FSIS that they have shipped or received 
adulterated or misbranded product in commerce, prepare and maintain 
written recall procedures, and document certain HACCP plan 
reassessments. Accordingly, FSIS requires three information collection 
activities under these regulations.
    First, FSIS requires that official establishments notify the 
appropriate District Office that an adulterated or misbranded product 
received by or originating from the establishment has entered commerce, 
if the establishment believes or has reason to believe that this has 
happened. Industry representatives of official establishments may now 
use FSIS Form 5720-16, Industry Report of Adulteration, to notify FSIS 
that an adulterated or misbranded meat, meat food, poultry, or poultry 
product was received from or shipped to commerce by the official 
establishment. The form is available as a paper form and digitally in 
PHIS.
    Second, FSIS requires that establishments prepare and maintain 
written procedures for the recall of meat and poultry products produced 
and shipped by the establishment for use should it become necessary for 
the establishment to remove product from commerce. These written recall 
procedures have to specify how the establishment will decide whether to 
conduct a product recall, and how the establishment will effect the 
recall should it decide that one is necessary.
    Finally, FSIS requires that establishments document each 
reassessment of the establishment's HACCP plans. FSIS requires 
establishments to reassess their HACCP plans annually and whenever any 
changes occur that could affect the hazard analysis or alter the HACCP 
plan. For annual reassessments, if the establishment determines that no 
changes are necessary, documentation of this determination is not 
necessary.
    FSIS has made the following estimates as part of an information 
collection assessment.
    Estimate of burden: The public reporting burden for this collection 
of information is estimated to average .232 hours per response.
    Respondents: Official meat and poultry products establishments.
    Estimated annual Number of Respondents: 6,300.
    Estimated average number of responses per respondent: 6.8.
    Estimated annual number of responses: 42,900.
    Estimated total annual burden on respondents: 9,960.
    All responses to this notice will be summarized and included in the 
request for OMB approval. All comments will also become a matter of 
public record. Copies of this information collection

[[Page 19215]]

assessment can be obtained from Gina Kouba, Office of Policy and 
Program Development, Food Safety and Inspection Service, USDA, 1400 
Independence Avenue SW, Mailstop 3758, South Building, Washington, DC 
20250-3700; (202) 720-5627.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of FSIS's 
functions, including whether the information will have practical 
utility; (b) the accuracy of FSIS's estimate of the burden of the 
proposed collection of information, including the validity of the 
method and assumptions used; (c) ways to enhance the quality, utility, 
and clarity of the information to be collected; and (d) ways to 
minimize the burden of the collection of information, including through 
the use of appropriate automated, electronic, mechanical, or other 
technological collection techniques, or other forms of information 
technology. Comments may be sent to both FSIS, at the addresses 
provided above, and the Desk Officer for Agriculture, Office of 
Information and Regulatory Affairs, Office of Management and Budget 
(OMB), Washington, DC 20253.
    Responses to this notice will be summarized and included in the 
request for OMB approval. All comments will also become a matter of 
public record.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication on-line through the FSIS web page located at: 
https://www.fsis.usda.gov/federal-register.
    FSIS will also announce and provide a link to this Federal Register 
publication through the FSIS Constituent Update, which is used to 
provide information regarding FSIS policies, procedures, regulations, 
Federal Register notices, FSIS public meetings, and other types of 
information that could affect or would be of interest to our 
constituents and stakeholders. The Constituent Update is available on 
the FSIS web page. Through the web page, FSIS can provide information 
to a much broader, more diverse audience. In addition, FSIS offers an 
email subscription service which provides automatic and customized 
access to selected food safety news and information. This service is 
available at: https://www.fsis.usda.gov/subscribe. Options range from 
recalls to export information, regulations, directives, and notices. 
Customers can add or delete subscriptions themselves and have the 
option to password protect their accounts.

USDA Non-Discrimination Statement

    In accordance with Federal civil rights law and U.S. Department of 
Agriculture (USDA) civil rights regulations and policies, the USDA, its 
Agencies, offices, and employees, and institutions participating in or 
administering USDA programs are prohibited from discriminating based on 
race, color, national origin, religion, sex, gender identity (including 
gender expression), sexual orientation, disability, age, marital 
status, family/parental status, income derived from a public assistance 
program, political beliefs, or reprisal or retaliation for prior civil 
rights activity, in any program or activity conducted or funded by USDA 
(not all bases apply to all programs). Remedies and complaint filing 
deadlines vary by program or incident.
    Persons with disabilities who require alternative means of 
communication for program information (e.g., Braille, large print, 
audiotape, American Sign Language, etc.) should contact the responsible 
Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or 
contact USDA through the Federal Relay Service at (800) 877-8339. 
Additionally, program information may be made available in languages 
other than English.
    To file a program discrimination complaint, complete the USDA 
Program Discrimination Complaint Form, AD-3027, found online (https://www.usda.gov/sites/default/files/documents/usda-program-discrimination-complaint-form.pdf) and at any USDA office or write a letter addressed 
to USDA and provide in the letter all of the information requested in 
the form. To request a copy of the complaint form, call (866) 632-9992. 
Submit your completed form or letter to USDA by: (1) Mail: U.S. 
Department of Agriculture, Office of the Assistant Secretary for Civil 
Rights, 1400 Independence Avenue SW, Washington, DC 20250-9410; (2) 
fax: (202) 690-7442; or (3) email: [email protected]. USDA is an 
equal opportunity provider, employer, and lender.

Paul Kiecker,
Administrator.
[FR Doc. 2021-07519 Filed 4-12-21; 8:45 am]
BILLING CODE 3410-DM-P