2010-12456. Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2); Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability and request for comments.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled “Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2).” The draft guidance provides information to the industry in complying with the Reportable Food Registry requirements prescribed by the Food and Drug Administration Amendments Act of 2007 (FDAAA). Further, the draft guidance addresses inquiries that the agency has received through its Reportable Food Registry help desk and/or by other means since the implementation of the Reportable Food Registry on September 8, 2009, and provides information on the new Safety Reporting Portal. The agency is also seeking comments from industry on the Reportable Food Registry requirements, and specifically on the issue of “transfer” as discussed in the current Edition 1, and draft Edition 2 guidance.

DATES:

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comments on the draft guidance before it begins work on the final version of the guidance, submit electronic or written comments on the draft guidance by July 26, 2010.

ADDRESSES:

Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the draft guidance to the Office of Food Defense, Communication and Emergency Response (HFS-005), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT:

Faye Feldstein, Center for Food Safety and Applied Nutrition (HFS-005), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2428.

SUPPLEMENTARY INFORMATION:

I. Background

On September 27, 2007, the President signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA). This law amends the Federal Food, Drug, and Cosmetic Act (the act) by creating a new section 417 (21 U.S.C. 350f), Reportable Food Registry. Section 417 of the act requires the Secretary of Health and Human Services (the Secretary) to establish within FDA a Reportable Food Registry. The congressionally-identified purpose of the Reportable Food Registry is to provide a “reliable mechanism to track patterns of adulteration in food [which] would support efforts by the Food and Drug Administration to target limited inspection resources to protect the public health” (Pubic Law 110-085, section 1005(a)(4)). The Secretary has delegated to the Commissioner of Food and Drugs the responsibility for administering the act, including section 417. To further the development of the Reportable Food Registry, section 417 of the act requires FDA to establish an electronic portal by which instances of reportable food must be submitted to FDA by responsible parties and may be submitted by public health officials. After receipt of reports through the electronic portal, FDA is required to review and assess the information submitted for purposes of identifying reportable food, submitting entries to the Reportable Food Registry, issuing an alert or notification as FDA deems necessary, and exercising other existing food safety authorities under the act to protect the public health. The requirements under the Reportable Food Registry became effective on September 8, 2009.

In the Federal Register of June 11, 2009, FDA announced the availability of a draft guidance entitled “Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007” and gave interested parties an opportunity to submit comments by July 27, 2009 (74 FR 27803). The agency reviewed and evaluated these comments and issued a final guidance on September 9, 2009 (74 FR 46434). This draft guidance is the second edition of that guidance entitled “Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2)” and responds to inquiries that the agency has received through its Reportable Food Registry help desk and/or by other means since the implementation of the Reportable Food Registry on September 8, 2009, and informs industry about the new Safety Reporting Portal. The Safety Reporting Portal is a joint FDA-National Institutes of Health (NIH) system that facilitates the process of reporting several categories of safety information to the FDA and the NIH. As of May 24, 2010, the Reportable Food electronic portal will be a part of the Safety Reporting Portal.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on the topics discussed. 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 contains information collection provisions that 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). The collections of information in this guidance were approved under OMB control numbers 0910-0643 and 0910-0645. This guidance also refers to previously approved collections of information found in FDA regulations. The collection of information in 21 CFR 7.46 has been approved under OMB control number 0910-0249.

III. Request for Comments

In addition, although the industry is encouraged to submit comments regarding any of the requirements under the Reportable Food Registry, the agency is seeking comments specifically with regard to the meaning of the word “transfer” as it appears in section 417(d)(2)(B) of the act. The meaning of the word “transfer” in this context was discussed in Edition 1 of the guidance at Question and Answer numbers 27 and 28, and in the draft Edition 2 guidance at Question and Answer numbers E.4 and E.5.

Section 417(d)(2) of the act provides an exemption from the requirement that a responsible party submit a reportable food report. In order for the exemption to apply, the adulteration must have originated with the responsible party, the responsible party must have detected the adulteration “prior to any transfer to another person” of the article of food, and the responsible party must have corrected the adulteration or destroyed the food. However, Congress did not provide a definition for the term “transfer” as it is used in section 417(d)(2)(B) of the act. In Edition 1 of the guidance at Question and Answer numbers 27 and 28, and in the draft Edition 2 guidance at Question and Answer numbers E.4 and E.5, FDA said that a transfer to another person occurs when the responsible person releases the food to another person. In this document, FDA is asking for comment on whether this interpretation of the term “transfer” is appropriate, and if not, what other interpretations of the term “transfer” as it is used in section 417(d)(B)(2) of the act would be more appropriate. Specifically, we are requesting comment on whether the interpretation of the term “transfer” should be dependent upon possession of the food, whether the interpretation should be dependent on ownership of the food, or whether there are other interpretations we should consider, such as a combination of possession and/or ownership.

IV. 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.

V. Electronic Access

Persons with access to the Internet may obtain the draft guidance at http://www.fda.gov/​FoodGuidances or http://www.regulations.gov.

Dated: May 19, 2010.

David Dorsey,

Acting Deputy Commissioner for Policy, Planning and Budget.