
[Federal Register Volume 77, Number 36 (Thursday, February 23, 2012)]
[Rules and Regulations]
[Pages 10662-10663]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-4167]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2011-D-0598]


Guidance for Industry: Questions and Answers Regarding 
Establishment and Maintenance of Records by Persons Who Manufacture, 
Process, Pack, Transport, Distribute, Receive, Hold, or Import Food 
(Edition 5)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of guidance availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance entitled ``Questions and Answers Regarding 
Establishment and Maintenance of Records by Persons Who Manufacture, 
Process, Pack, Transport, Distribute, Receive, Hold, or Import Food 
(Edition 5).'' This guidance provides updated information pertaining to 
the establishment and maintenance of records by persons who 
manufacture, process, pack, transport, distribute, receive, hold, or 
import food in the United States under the Federal Food, Drug, and 
Cosmetic Act (FD&C Act), as amended by the FDA Food Safety and 
Modernization Act (FSMA) of January 4, 2011.

DATES: February 23, 2012. Submit either electronic or written comments 
on Agency guidances at any time.

ADDRESSES: Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit written requests for single 
copies of the guidance to the Outreach and Information Center (HFS-
009), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send 
two self-addressed adhesive labels to assist that office in processing 
your request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance.

FOR FURTHER INFORMATION CONTACT: William A. Correll, Jr., Center for 
Food Safety and Applied Nutrition (HFS-607), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1611.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled 
``Questions and Answers Establishment and Maintenance of Records by 
Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, 
Hold, or Import Food (Edition 5),'' which replaces the fourth edition 
of a guidance of the same title issued in September 2006. The guidance 
is intended for persons who manufacture, process, pack, hold, or import 
human or animal foods intended for distribution to consumers, 
institutions, or food processors.
    In the Federal Register of December 9, 2004 (69 FR 71562), FDA 
published a final rule implementing sections 414 and 704 of FD&C Act 
(21 U.S.C. 350c and 374) as amended by section 306 of the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002. The 
final rule requires the establishment and maintenance of records by 
persons who manufacture, process, pack, transport, distribute, receive, 
hold, or import food in the United States. Such records are to allow 
for the identification of the immediate previous sources and the 
immediate subsequent recipients of food. FSMA, signed into law on 
January 4, 2011 (Pub. L. 111-353), amended sections 414 and 704 of the 
FD&C Act by expanding FDA's access to records relating to foods that 
may cause serious adverse health consequences or death to humans or 
animals. In February 2012, FDA issued an interim final rule that 
revises Sec.  1.361 (21 CFR 1.361) to reflect the FSMA amendments to 
the FD&C

[[Page 10663]]

Act. This guidance document has been updated to reflect these changes.
    On September 12, 2005, FDA issued the first edition of a guidance 
entitled ``Questions and Answers Regarding the Establishment and 
Maintenance of Records.'' This document is the fifth edition of that 
guidance and is updated to reflect changes to the FD&C Act made by 
FSMA. This guidance is intended to provide individuals in the human and 
animal food industries with an updated overview of FDA's access to 
records. It provides practical information by answering common 
questions that cover a range of topics, including who is subject to 
records requirements, the scope of records retention and availability 
requirements, and the consequences of failing to establish and maintain 
required records or failing to make required records available to FDA. 
This guidance is being issued consistent with FDA's good guidance 
practices regulation Sec.  10.115 (21 CFR 10.115) as a level 1 
guidance. The Agency will accept comments, but it is implementing this 
document immediately, in accordance with Sec.  10.115(g)(2) because the 
Agency has determined that prior public participation is not feasible 
or appropriate. The Agency made this determination because this 
guidance simply reflects the statutory changes made by section 101 of 
FSMA to sections 414 and 704 of the FD&C Act and seeks to remove any 
confusion that might arise due to the existence of a guidance document 
that is inconsistent with the FD&C Act and its implementing 
regulations. In addition, much of this guidance remains the same as the 
guidance issued in September 2006.
    This guidance represents the Agency's current thinking on its 
authority to access and copy records. It does not create or confer any 
rights for or on any person and does not operate to bind FDA or the 
public. An alternate approach may be used if such approach satisfies 
the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to information collection provisions found in 
FDA regulations. These collections of information are subject to review 
by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520). We conclude that the 
collection of information in Sec.  1.361 is exempt from OMB review 
under 44 U.S.C. 18(c)(1)(B)(ii) and 5 CFR 1320.4(a)(2) as collections 
of information obtained during the conduct of a civil action to which 
the United States or any official or Agency thereof is a party, or 
during the conduct of an administrative action, investigation, or audit 
involving an Agency against specific individuals or entities. The 
regulations in 5 CFR 1320.3(c) provide that the exception in 5 CFR 
1320.4(a)(2) applies during the entire course of the investigation, 
audit or action, but only after a case file or equivalent is opened 
with respect to a particular party. Such a case file would be opened as 
part of the request to access records under Sec.  1.361.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. 
Always access an FDA guidance document by using the Web sites listed 
previously to find the most current version of the guidance.

    Dated: February 17, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4167 Filed 2-22-12; 8:45 am]
BILLING CODE 4160-01-P


