2010-18763. Report: A New Approach to Targeting Inspection Resources and Identifying Patterns of Adulteration: The Reportable Food Registry; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a report entitled “A New Approach to Targeting Inspection Resources and Identifying Patterns of Adulteration: The Reportable Food Registry.” The report presents FDA's experience with the Reportable Food Registry (RFR or the Registry) from the opening of the Reportable Food electronic portal on September 8, 2009, until March 31, 2010.

ADDRESSES:

Submit written requests for single copies of the report 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 report.

FOR FURTHER INFORMATION CONTACT:

Kathy Gombas, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1807.

SUPPLEMENTARY INFORMATION:

I. Introduction

The Reportable Food Registry was created by Public Law 110-85 which mandated that the FDA establish an electronic portal to which industry must and public health officials may report when there is a reasonable probability that an article of human food or animal food/feed (including pet food) will cause serious adverse health consequences or death to humans or animals. The Congressional intent of the Registry is to help FDA better protect public health by tracking patterns of food and feed adulteration and targeting inspection resources. This report presents FDA's experience with the RFR from the opening of the Reportable Food electronic portal on September 8, 2009, until March 31, 2010. Because the Registry has been operational for only a short period, FDA cautions that it is too early to draw inferences concerning patterns of food and feed adulteration.

II. Background

The RFR was established by section 1005 of the Food and Drug Administration Amendments Act of 2007 (Public Law 110-85) which amended the Federal Food, Drug, and Cosmetic Act by creating a new section 417, Reportable Food Registry (21 U.S.C. 350f), and required FDA to establish an electronic portal by which reports about instances of reportable food must be submitted to FDA within 24 hours by responsible parties and may be submitted by public health officials. These reports may be primary, the initial submission about a reportable food, or subsequent, a report by either a supplier (upstream) or a recipient (downstream) of a food or food ingredient for which a primary report has been submitted.

The RFR covers all human and animal food/feed (including pet food) regulated by FDA except infant formula and dietary supplements. Other mandatory reporting systems exist for problems with infant formula and dietary supplements. Submissions to the Reportable Food electronic portal provide early warning to FDA about potential public health risks from reportable foods and increase the speed with which the agency and its partners at the State and local levels can investigate the reports and take appropriate followup action, including ensuring that the reportable foods are removed from commerce when necessary.

The RFR does not receive reports about drugs or other medical products, reports about products under the exclusive jurisdiction of the U.S. Department of Agriculture, or reports from consumers.

The RFR is helping FDA better protect public health by tracking patterns of adulteration in human and animal food/feed (including pet food). The report presents FDA's experience with the RFR from the opening of the Reportable Food electronic portal on September 8, 2009, until March 31, 2010.

III. Electronic Access

Persons with access to the Internet may obtain the report at http://www.fda.gov/​Food/​FoodSafety/​FoodSafetyPrograms/​RFR/​ucm200958.htm.

Dated: July 12, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.