[Federal Register Volume 78, Number 46 (Friday, March 8, 2013)]
[Notices]
[Pages 15017-15018]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-05470]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0643]


Guidance for Industry: What You Need To Know About Administrative 
Detention of Foods; Small Entity Compliance Guide; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``What You Need to 
Know About Administrative Detention of Foods; Small Entity Compliance 
Guide'' (SECG) which updates an earlier guidance of similar title. 
Previously, this guidance restated the legal requirements of FDA's 
administrative detention regulation. This document also at one time 
served as FDA's guidance for administrative detention. In October 2011, 
FDA revised an earlier version of this guidance document to be 
consistent with the changes made by an interim final rule (IFR) issued 
in the Federal Register of May 5, 2011, and to serve as guidance for 
industry on administrative detention. FDA has since issued a final rule 
adopting the IFR as final without changes which was published in the 
Federal Register of February 5, 2013. Accordingly, FDA is further 
revising the existing guidance document to provide guidance intended to 
help any entity comply with the requirements in FDA's administrative 
detention regulation, including the amendments to these requirements 
made by the final rule. This notice also clarifies that this document 
continues to serve as FDA's guidance for administrative detention.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: 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 one self-addressed adhesive label 
to assist that office in processing your request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments on the guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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

SUPPLEMENTARY INFORMATION:

I. Background

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) was 
signed into law on January 4, 2011. Section 207 of FSMA amended the 
criteria for ordering administrative detention in section 304(h)(1)(A) 
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
334(h)(1)(A)) to provide FDA the authority to order administrative 
detention if there is reason to believe that an article of food is 
adulterated or misbranded. On May 5, 2011, in accordance with FSMA, FDA

[[Page 15018]]

published an IFR in the Federal Register amending its regulations in 21 
CFR part 1, subpart K (76 FR 25538), that pertain to the criteria for 
ordering administrative detention. This IFR became effective on July 3, 
2011. On February 5, 2013, FDA issued a final rule which adopted the 
IFR as final without changes. FDA is announcing the availability of an 
update to an existing guidance document that will also serve as FDA's 
SECG.
    In October 2011, FDA updated an existing guidance which had 
restated the legal requirements of FDA's administrative detention 
regulation at 21 CFR part 1, subpart K, implementing section 304(h) of 
the FD&C Act, as added by the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002. This document had also served as 
FDA's guidance for 21 CFR part 1, subpart K in accordance with the 
Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA). 
The title of the October 2011 guidance was ``What You Need to Know 
About Administrative Detention of Foods,'' (76 FR 66073, October 25, 
2011). The guidance was intended to provide individuals in the human 
and animal food industries with an understanding of FDA's authority to 
order the administrative detention of human or animal food under 
section 304(h) of the FD&C Act, as amended by section 207 of FSMA. It 
provided practical information, including who can approve an 
administrative detention order, what food may be subject to 
administrative detention, who receives a copy of an administrative 
detention order, and the process for appealing an administrative 
detention order. Additionally, the guidance identified references that 
contain more information regarding FDA's authority to order 
administrative detention.
    FDA received one general comment about FDA decisionmaking to the 
docket associated with the October 2011 version (Docket Number FDA-
2011-D-0643). The comment stated that it would like to ensure that FDA 
makes sound decisions based on testing from qualified laboratories. As 
such, the comment continued, FDA and private laboratories must be 
accredited and must follow good laboratory practices in their testing 
programs. In addition, the comment stated that testing should be 
conducted using validated testing methods that have been accredited and 
approved. Sound science is the cornerstone of FDA regulatory programs 
and actions and, to that extent, FDA agrees with the comment; however, 
in the context of administrative detention, FDA is not limited, as 
implied by the comment, to relying on analytical test results to 
determine whether FDA has a reason to believe a food is adulterated or 
misbranded. All evidence available to the Agency may be considered when 
making such a determination.
    Since then, in the Federal Register of February 5, 2013 (78 FR 
7994), FDA issued a final rule adopting the IFR as final without 
changes. The final rule adopts without change the interim final rule's 
amendments to certain regulations in 21 CFR part 1, subpart K to be 
consistent with amendments to the criteria for ordering administrative 
detention of human or animal food made by FSMA. The final rule, which 
adopts the interim final rule as final, is effective upon publication 
in the Federal Register.
    The Regulatory Flexibility Act (5 U.S.C. 601-612) requires Agencies 
to determine whether a final rule will have a significant impact on 
small entities when an Agency issues a final rule ``after being 
required * * * to publish a general notice of proposed rulemaking.'' 
Although FDA is not required to perform a regulatory flexibility 
analysis because, in accordance with 5 U.S.C. 553(b)(3)(B) and 21 CFR 
10.40(e)(1), the Agency found for good cause that use of prior notice 
and comment procedures were contrary to the public interest; FDA has 
nonetheless examined the economic implications of the final rule in 
accordance with the Regulatory Flexibility Act and determined that the 
final rule will not have a significant economic impact on a substantial 
number of small entities (78 FR 7994). Similarly because FDA is not 
required to perform a final regulatory flexibility analysis under 5 
U.S.C. 605(b) for the final rule, FDA is not required to issue a 
guidance to comply with section 212 of SBREFA (Pub. L.104-121); 
nevertheless, FDA has updated this guidance to state in plain language 
the requirements of 21 CFR part 1, subpart K.
    FDA is issuing this guidance consistent with FDA's good guidance 
practices regulation (21 CFR 10.115(c)(2)). This guidance represents 
the Agency's current thinking on administrative detention of foods. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative 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 collections of information 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 collections of 
information in Sec. Sec.  1.381(d) and 1.402 are exempt from OMB review 
under 44 U.S.C. 3518(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(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 decision to detain an article of food.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/RegulatoryInformation/Guidances/default.htm 
or http://www.regulations.gov. Always access an FDA guidance document 
by using FDA's Web site listed previously to find the most current 
version of the guidance.

    Dated: March 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-05470 Filed 3-7-13; 8:45 am]
BILLING CODE 4160-01-P