TK: Published today, here is an FDA Q and A providing guidance to industry on the "reportable food registry." Go here for the full report.
Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007; Draft Guidance
Contains Nonbinding Recommendations
This guidance document is being distributed for comment purposes only.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance within 45 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this draft document contact the Center for Food Safety and Applied Nutrition (CFSAN) at 301-436-1500.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Contains Nonbinding Recommendations
Draft — Not for Implementation
Table of Contents
Contains Nonbinding Recommendations
Draft — Not for Implementation
Guidance for Industry1
Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007
This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.
This draft guidance is intended to assist those parties responsible for complying with the Reportable Food Registry requirements prescribed by the Food and Drug Administration Amendments Act of 2007 (Pub. L.110-085). As required by section 1005(f) of this law, we are issuing guidance to industry about submitting reports of instances of reportable food through the electronic portal and providing notifications to other persons in the supply chain of such articles of food.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
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 (FD&C Act) by creating a new section referred to as 417, Reportable Food Registry. Section 417 of the FD&C Act requires the Secretary of Health and Human Services (the Secretary) to establish within the Food and Drug Administration (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" (Pub. L. 110-085, section 1005(a)(4)). The Secretary has delegated to the Commissioner of the Food and Drug Administration the responsibility for administering the FD&C Act, including section 417. To further the development of the Reportable Food Registry, section 417 of the FD&C 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.
This guidance document contains questions and answers relating to the requirements under section 417 of the FD&C Act, including (1) how, when and where to submit reports to FDA; (2) who is required to submit reports to FDA; (3) what is required to be submitted to FDA; and (4) what may be required when providing notifications to other persons in the supply chain of an article of food.
III. Questions and Answers
1. How will FDA implement the FDAAA requirement to establish an electronic portal?
The Reportable Food electronic portal will be implemented as a part of FDA's new electronic system for collecting, submitting and processing adverse event reports and other safety information for all FDA-regulated products: the MedWatchPlus Portal.
2. When will the Reportable Food electronic portal be available?
The Reportable Food electronic portal will be listed and available on the FDA.GOV website on September 8, 2009.
3. Will the Reportable Food electronic portal as described in this guidance be the final version?f
FDA will launch release 1.0 of the Reportable Food electronic portal on September 8, 2009. However, new versions (enhancements and upgrades) may be released subsequent to this launch as FDA continues to consolidate and improve its agency-wide data collection systems. FDA intends that the Reportable Food electronic portal will stay consistent with current FDA Web policy, which currently includes supporting the most widely used versions of Internet Explorer and Firefox browsers.
4. How will I access the Reportable Food electronic portal?
When the Reportable Food electronic portal becomes available, it will be accessible through a link on the FDA.GOV web site home page (http://www.fda.gov) under the heading "Report a Problem." Alternatively, you will be able to access the Reportable Food electronic portal directly by entering the following URL into your browser: http://www.accessdata.fda.gov/scripts/ReportableFoodRegistry/. Upon entering the site, you will be asked some general questions pertaining to the criteria for a Reportable Food Registry report and, based on your answers, you will be directed to the appropriate screens for submitting such reports.
5 Will there be additional instructions available on how to use the Reportable Food electronic portal?
Yes. Additional instructions and detailed directions will be available on the Reportable Food Registry web page on September 8, 2009.
6. When must I comply with the requirements of the Reportable Food Registry (Section 417 of the FD&C Act)?
You must comply with the requirements of the Reportable Food Registry (Section 417 of the FD&C Act) on September 8, 2009. The prohibited act provisions of the FD&C Act related to the Registry will also apply on September 8, 2009.
7. Who is the "responsible party" that must submit a report regarding instances of reportable food to FDA through the Reportable Food electronic portal?
The responsible party is the person who submits the registration under section 415(a) of the FD&C Act (21 U.S.C. 350d) for a food facility that is required to register under section 415(a), at which such article of food is manufactured, processed, packed, or held. Persons who are required to submit a facility registration under section 415 of the act are the owner, operator, or agent in charge of a domestic or foreign facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States.
(Section 417(a)(1) of the FD&C Act).
12. I received a positive microbiological test result indicating the presence of a pathogen in food. Based on this test result, the food would be "reportable." However, I retested the food for the pathogen and the second test result did not indicate the presence of the pathogen. Should I still consider the food to be reportable?
Yes. There are a number of explanations why a food may test positive for a pathogen in one test and negative in one or more additional tests although the food continues to be contaminated. For example, the distribution of a pathogen in the food may not be homogeneous. Therefore, absent other circumstances clearly demonstrating the inaccuracy of the first test result, the first test result upon which the reportable food determination was made should be considered valid.
13. When is a responsible party required to report an instance of reportable food to FDA?
A responsible party is required to submit a report to FDA through the Reportable Food electronic portal as soon as practicable, but in no case later than 24 hours after determining that an article of food is a reportable food. (Section 417(d)(1) of the FD&C Act).
14. Is a responsible party required to investigate and report the cause of the adulteration?
Yes, if the adulteration of the article of food may have originated with the responsible party, the responsible party shall investigate the cause of the adulteration and report their findings when known. (Sections 417(d)(1)(B) and 417(e)(5) of the FD&C Act).
15. When is a responsible party not required to submit a reportable food report to FDA?
A responsible party is not required to submit a reportable food report when all of the following criteria are met:
* The adulteration originated with the responsible party; AND
* The responsible party detected the adulteration prior to any transfer to another person of such article of food; AND
* The responsible party
o corrected such adulteration; or
o destroyed or caused the destruction of such article of food. (Section 417(d)(2)(A)-(C) of the FD&C Act).
16. Will a reportable food report be issued a number by FDA?
Yes. FDA will issue a unique number for that instance of reportable food to the person who submits the report. (Section 417(d)(4) of the FD&C Act).
17. What are the data elements that a responsible party must include in an initial report to FDA (i.e., when the responsible party determines that a food is a reportable food other than by receiving a notification under section 417 of the FD&C Act from another responsible party)?
The following data elements must be included in an initial report:
1. (1) The registration numbers of the responsible party under section 415(a)(3) of the FD&C Act;
2. (2) The date on which the article of food was determined to be a reportable food;
3. (3) A description of the article of food including the quantity or amount;
4. (4) The extent and nature of the adulteration;
5. (5) The results of any investigation of the cause of the adulteration if it may have originated with the responsible party, when known;
6. (6) The disposition of the article of food, when known; and
7. (7) The product information typically found on packaging including product codes, use-by dates, and the names of manufacturers, packers, or distributors sufficient to identify the article of food.
In addition, upon submission of a report, a unique number as discussed in response to Question 16 above will be issued through the Reportable Food electronic portal to the person submitting the report. This unique number will be used by responsible parties for submitting amended reports and providing notifications. (Sections 417(d)(1)(A), 417(d)(4), and 417(e) of the FD&C Act).