2011-27529. Guidance for Industry on What You Need to Know About Administrative Detention of Foods; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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.” This guidance provides information pertaining to FDA's authority to order the administrative detention of food for human or animal consumption under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety and Modernization Act (FSMA).

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 requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

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.

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

FDA is announcing the availability of a guidance for industry entitled “What You Need to Know About Administrative Detention of Foods,” which replaces the guidance of the same title issued in November 2004. The guidance is 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 (21 U.S.C. 334(h)), as amended by section 207 of FSMA. It provides 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 identifies references that contain more information regarding FDA's authority to order administrative detention.

This guidance is being issued consistent with FDA's good guidance practices (GGPs) regulation § 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 § 10.115(g)(2) because the Agency has determined that prior public participation is not feasible or appropriate. The Agency made this determination because much of this guidance remains the same as the guidance issued in November 2004. In addition, this guidance simply reflects the statutory changes made by section 207 of FSMA to section 304(h)(1)(A) of the FD&C Act (21 U.S.C. 334(h)(1)(A)) 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. Although this guidance document is immediately in effect, it remains subject to comment in accordance with the Agency's GGPs regulation.

FSMA 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 FD&C Act 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 published an interim final rule in the Federal Register amending its regulations in part 1, subpart K (21 CFR part 1, subpart K), (76 FR 25538), that pertain to the criteria for ordering administrative detention. This interim final rule became effective on July 3, 2011.

The guidance represents the Agency's current thinking on its authority to order the administrative detention of human or animal 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 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 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 §§ 1.381(d) and 1.402 are 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(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 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. It is no longer necessary to send two copies of mailed 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 document at either http://www.fda.gov/​RegulatoryInformation/​Guidances/​default.htm or http://www.regulations.gov. Always access an FDA guidance document by using the FDA's Web site listed previously to find the most current version of the guidance.

Dated: October 20, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.