Reportable Food Registry Third Annual Report Questions and Answers
View the Reportable Food Registry Annual Report.
1. What has FDA released?
The Third Annual Reportable Food Registry Report. It covers the period from September 8, 2011 to September 7, 2012.
2. What is the Reportable Food Registry (RFR)?
An electronic portal, part of the the Department of Health and Human Services’ Safety Reporting Portal (www.safetyreporting.hhs.gov) to which industry must, and public health officials may, report when they have information about a Reportable Food. Congress mandated that FDA establish the Reportable Food Registry (RFR or the Registry) in Section 1005 of the FDA Amendments Act of 2007. 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.
3. What is a Reportable Food?
An article of food/feed 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.
4. What is the significance of this third Annual RFR Report?
The report indicates that, as in its first year, the RFR continues to help FDA identify food and feed adulteration and target inspection resources to quickly remove adulterated food/feed from commerce and prevent foodborne illnesses.
5. What foods are covered by the Reportable Food Registry?
All foods regulated by FDA, including animal food/feed (including pet food). Infant formula and dietary supplements are covered by other mandatory reporting systems and are not subject to the RFR. By law, the RFR cannot 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, for whom FDA has other reporting systems.
6. Who is required to report to the RFR?
A Responsible Party, i.e., the person who submits the registration information to FDA under section 415(a) of the Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 350d(a)) for a food/feed facility that manufactures, processes, packs, or holds food for human or animal consumption in the U.S. The term person, as defined in section 201(e) of the FD&C Act (21 U.S.C. 321(e)) includes individuals, partnerships, corporations and associations. Federal, state, and local public health officials who may have information about reportable foods may submit reports but are not required to do so.
7. Is help available for food/feed facilities that have questions about the RFR?
FDA has created an RFR home page at www.fda.gov/ReportableFoodRegistry, which provides detailed information about the RFR and includes a link to the RFR Draft Guidance for Industry (also available in Spanish, French and Chinese). FDA also provides two RFR email help desks:
The RFR Help Center at RFRSupport@fda.hhs.gov answers questions about policies, procedures and interpretations, and
The SRP Service Desk at firstname.lastname@example.org answers technical and computer-related questions about the Safety Reporting Portal which includes the RFR.
8. What does FDA do with the information in these reports?
FDA determines whether the food/feed reported meets the definition of a reportable food standard, i.e., presents 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. FDA then works with the food /feed facilities that submit the reports and the state and local public health officials with jurisdiction over the reporting facilities to locate the potentially hazardous foods in the supply chain in order to prevent them from reaching consumers.
9. Is the RFR FDA’s only source of information about potentially hazardous food/feed?
No. Reportable Food reports are one of many signals FDA receives. Other signals include but are not limited to inspection findings, recall data, PetNet, adverse event reports, consumer complaints and pet food reports. FDA has begun major initiatives to address all the signals it receives.
10. Does the Food Safety Modernization Act affect the RFR?
The Food Safety Modernization Act included Section 211, which amends the RFR section of the FD&C Act (§417) to provide that:
FDA may require a responsible party to submit to FDA consumer-oriented information regarding a reportable food. The critical information must include a description of the article of food; affected product identification codes, such as UPC, SKU, or lot or batch numbers sufficient for the consumer to identify the article of food; contact information for the responsible party; and any other information FDA determines is necessary to enable a consumer to accurately identify whether such consumer is in possession of the reportable food. Fruits and vegetables that are raw agricultural commodities are exempted from this requirement.
FDA is required to prepare the critical information as a standardized one-page summary and publish the one-page summary on FDA.gov in a format that grocery stores can easily print.
Grocery stores that have 15 or more physical locations and have sold a reportable food that is the subject of a one-page critical information summary published on FDA.gov are required to notify consumers by prominently displaying the one-page summary or information from such summary within 24 hours of its FDA web posting and maintain the display for 14 days.
FDA is required to develop and publish a list of acceptable conspicuous locations and manners from which grocery stores must select at least one method for displaying a consumer notification about the reportable food. The list must include:
posting the notification at or near the register
providing the location of the reportable food;
providing targeted recall information given to customers upon purchase of a food; and
posting other such prominent and conspicuous locations and manners utilized by grocery stores as of the date of enactment of FSMA to provide notice of such recalls to consumers as considered appropriate by the FDA.
Substantive information gathering and analysis is underway as FDA works to analyze available data and engage stakeholders to better understand the benefits and costs of implementing the provisions in Section 211 of FSMA with minimum disruption of the industry and maximum public health protection. FDA is considering the possibility of issuing an Advance Notice of Proposed Rulemaking to solicit additional input.