[Federal Register Volume 71, Number 186 (Tuesday, September 26, 2006)]
[Rules and Regulations]
[Pages 56006-56007]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-8241]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1 and 11

[Docket No. 2005D-0356]


Guidance for Industry: Questions and Answers Regarding the Final 
Rule on Establishment and Maintenance of Records (Edition 4); 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability of guidance.

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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 (Edition 4).'' The guidance 
responds to various questions raised about the Public Health Security 
and Bioterrorism Preparedness and Response Act of 2002 (the 
Bioterrorism Act) and the agency's implementing regulation, which 
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. Persons covered by the regulation who 
employ 500 or more full-time equivalent employees (FTEs) had to be in 
compliance by December 9, 2005, and those who employ 11 to 499 FTEs had 
to be in compliance by June 9, 2006. Persons who employ 10 or fewer 
FTEs have until December 11, 2006, to be in compliance. ``Person'' 
includes an individual, partnership, corporation, and association.

DATES: Submit written or electronic comments on the agency guidance at 
any time.

ADDRESSES: You may submit comments, identified by 2005D-0356, by any of 
the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.To 
ensure more timely processing of comments, FDA is no longer accepting 
comments submitted to the agency by e-mail. FDA encourages you to 
continue to submit electronic comments by using the Federal eRulemaking 
Portal or the agency Web site, as described in the Electronic 
Submissions portion of this paragraph.
    Instructions: All submissions received must include the agency name 
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN 
number has been assigned) for this rulemaking. All comments received 
may be posted without change to http://www.fda.gov/ohrms/dockets/default.htm, including any personal information provided. For 
additional information on submitting comments, see the ``Comments'' 
heading of the SUPPLEMENTARY INFORMATION section of this document.

[[Page 56007]]

    Docket: For access to the docket to read background documents or 
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm 
and insert the docket number(s), found in brackets in the heading of 
this document, into the ``Search'' box and follow the prompts and/or go 
to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Center for Food Safety and Applied 
Nutrition at 1-888-SAFEFOOD, Fax: 1-877-366-3322, or by e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 9, 2004 (69 FR 71562), FDA 
issued a final rule to implement section 306 of the Bioterrorism Act. 
The regulation 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. Persons subject to the 
regulation who employ 500 or more FTEs had to be in compliance by 
December 9, 2005, and those who employ 11-499 FTEs had to be in 
compliance by June 9, 2006. Persons who employ 10 or fewer FTEs have 
until December 11, 2006 to be in compliance. ``Person'' includes an 
individual, partnership, corporation, and association.
    On September 12, 2005, FDA issued the first edition of a guidance 
entitled ``Questions and Answers Regarding Establishment and 
Maintenance of Records.'' On November 22, 2005, FDA issued a second 
edition of that guidance and on June 6, 2006, FDA issued a third 
edition of that guidance. This document is the fourth edition of that 
guidance entitled ``Questions and Answers Regarding Establishment and 
Maintenance of Records (Edition 4)'' and responds to questions 
regarding persons covered by the regulation, and persons excluded by 
the regulation, including additional guidance on the farm exclusion. In 
addition, we are amending the response to question 4.2 to clarify that 
while post-harvesting activities related to hay are subject to the 
rule, certain activities that are part of harvesting remain within the 
farm exemption. This guidance is intended to help the industry better 
understand and comply with the regulation in 21 CFR part 1, subpart J. 
FDA is issuing this guidance as a Level 1 guidance. The guidance 
represents the agency's current thinking on the topic. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public.
    Consistent with FDA's good guidance practices regulation Sec.  
10.115(g)(2) (21 CFR 10.115), the agency will accept comments, but it 
is implementing the guidance document immediately, in accordance with 
Sec.  10.115(g)(2), because the agency has determined that prior public 
participation is not feasible or appropriate. As noted, persons who 
employ 500 or more FTEs had to begin to establish and maintain records 
identifying the immediate previous sources and immediate subsequent 
recipients of food by December 9, 2005, and those who employ 11-499 
FTEs had to be in compliance by June 9, 2006. Persons who employ 10 or 
fewer FTEs have until December 11, 2006, to be in compliance. 
Clarifying the provisions of the final rule will facilitate prompt 
compliance with these requirements and complete the rule's 
implementation.
    FDA continues to receive large numbers of questions regarding the 
records final rule, and is responding to these questions under Sec.  
10.115 as promptly as possible, using a question-and-answer format. The 
agency believes that it is reasonable to maintain all responses to 
questions concerning establishment and maintenance of records in a 
single document that is periodically updated as the agency receives and 
responds to additional questions. The following four indicators will be 
employed to help users of this guidance identify revisions: (1) The 
guidance will be identified as a revision of a previously issued 
document, (2) the revision date of the guidance will appear on its 
cover, (3) the edition number of the guidance will be included in its 
title, and (4) questions and answers that have been added to the 
original guidance will be identified as such in the body of the 
guidance.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding the guidance 
at any time. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. Received comments and the 
guidance may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
http:// www.cfsan.fda.gov/~dms/recguid3.html.

    Dated: September 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-8241 Filed 9-21-06; 1:22 pm]
BILLING CODE 4160-01-S