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For Your Information: F32-09-Reportable Food Registry

New Zealand Food Safety Authority
Date: 8 July 2009 (1)
From: John Lee, Market Access Counsellor (North America)

1 FDA Reportable Food Registry

1.1 Introduction

The Food, Drug and Cosmetics Act Amendment in 2007 made provision for the Secretary of Health and Human Services (the Secretary) to establish within the Food and Drug Administration (FDA) a Reportable Food Registry by introducing a new section to the Food, Drugs and Cosmetics Act, Section 417. This makes provision for FDA to set up an electronic reporting portal for those manufacturing, processing, packing or storing food (as defined in the Act – includes animal food and pet food), whether domestic or foreign exporting to the USA.

A FR Notice was issued 11 June, 2009 titled:

Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Amendment Act of 2007; Availability; Announcement of Further Delay in Implementation of the Food and Drug Amendment Act of 2007. http://edocket.access.gpo.gov/2009/pdf/E9-13614.pdf

The full guidance document can be found at:

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodSafety/ucm165626.htm

This will, when implemented on 8 September 2009, be a reporting system for collecting, submitting and processing adverse event reports and other safety information for all FDA-regulated products to FDA. The portal will be accessible via the FDA Home Page.

For the purposes of this requirement food is as defined in the Act, but excludes infant formula:

All food and food products, including animal feed and pet food under FDA's jurisdiction, are required to be reported if they meet the definition of a "reportable food."

A “reportable food” is defined in the Act:

A "reportable food" is an article of food (other than infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.

1.2 Facility registration

The Food, Drug and Cosmetics Act (FD&C Act) already has a section on registration (S415) which put into place the facilities registration requirements introduced by the Bioterrorism Act 2002. The reportable Food Registry will utilise the registration number of a registered facility when making a report.

1.3 Reporting

All food and food products, including animal feed and pet food under FDA's jurisdiction, are required to be reported if they meet the definition of a "reportable food”.

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.

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

• corrected such adulteration; or

• destroyed or caused the destruction of such article of food.

1.4 Required data elements when reporting

The following data elements must be included in an initial report:

• The registration numbers of the responsible party (under section 415(a)(3) of the FD&C Act);

• The date on which the article of food was determined to be a reportable food;

• A description of the article of food including the quantity or amount;

• The extent and nature of the adulteration;

• The results of any investigation of the cause of the adulteration if it may have originated with the responsible party, when known;

• The disposition of the article of food, when known; and

• 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 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.

1.5 Possible FDA actions following submission of a report

FDA may initiate consultation with the responsible party, FDA may require the responsible party to perform, as soon as practicable, but in no case later than the time specified by FDA, one or more of the following actions:

• Amend the report they submitted to FDA to include the contact information for the immediate previous source and/or immediate subsequent recipient of the article of food directly linked in the supply chain and notified by the responsible party;

• Provide notification to the immediate previous source and/or immediate subsequent recipient of the article of food that includes the following data elements:

1. the date on which the article of food was determined to be a reportable food;

2. a description of the article of food including the quantity or amount;

3. the extent and nature of the adulteration;

4. the results of any investigation of the cause of the adulteration if it may have originated with the responsible party, if known;

5. the disposition of the article of food, when known;

6. 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;

7. contact information for the responsible party;

8. the contact information for parties directly linked in the supply chain and notified by the responsible party;

9. the unique report number issued through the Reportable Food electronic portal to the person submitting the report;

10. the actions that the recipient of the notification shall perform (i.e., submit a report to FDA, investigate the cause of the adulteration, and/or provide a notification to the recipient's immediate previous source and/or immediate subsequent recipient), as may be specified by FDA; and

11. any other information FDA may require.

If a responsible party (Party A) notifies the immediate previous source or immediate subsequent recipient of the article of food (Party B), FDA recommends that Party B submit a report to FDA as soon as practicable, and within 24 hours after receiving the notification regarding the reportable food (section 417(d)(1) of the FD&C Act). FDA may also require Party B to submit a report to FDA as soon as practicable, but in no case later than a time specified by FDA, and/or to provide a notification to Party B's own immediate previous source and/or immediate subsequent recipient of the reportable food (section 417(d)(7) of the FD&C Act). Where there are multiple previous sources or multiple immediate subsequent recipients then all parties should file a report.

Disclaimer: This ‘For Your Information’ is intended for use as a guideline only and should not be taken as definitive or exhaustive. NZFSA endeavours to keep this information current and accurate. However, it may be subject to change without notice. NZFSA will not accept liability for any loss resulting from reliance on this information.