
[Federal Register: July 30, 2010 (Volume 75, Number 146)]
[Notices]               
[Page 44973-44974]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30jy10-60]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0260]

 
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.

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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,

[[Page 44974]]

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.
[FR Doc. 2010-18763 Filed 7-29-10; 8:45 am]
BILLING CODE 4160-01-S

