CFSAN Constituent Update - FDA Seeks Input on RFR & Extends Comment Period on Draft Approach for High-Risk Foods

Published: March 18, 2014

Center for Food Safety and Applied Nutrition - Constituent Update

Constituent Updates are also available on the web at

March 25, 2014

The following two Constituent Updates are now available:

  • FDA Seeks Input on Information to be Submitted to FDA's Reportable Food Registry and Used to Notify Consumers in Grocery Stores
  • FDA Announces Extension of Comment Period on Draft Methodological Approach for Designating High-Risk Foods

FDA Seeks Input on Information to be Submitted to FDA's Reportable Food Registry and Used to Notify Consumers in Grocery Stores

FDA is publishing an advance notice of proposed rulemaking (ANPRM) which seeks input to assist the Agency in implementing section 211 of the FDA Food Safety Modernization Act (FSMA), which added new provisions to the Reportable Food Registry (RFR) requirements of the Federal Food, Drug, and Cosmetic Act. Such amendments are intended to help keep consumers notified and safe from foodborne illness.

In general, section 211 of FSMA provides that FDA may require a responsible party to submit to the Agency "consumer-oriented" information regarding a "reportable food" (with the exception of fruits and vegetables that are raw agricultural commodities), including information necessary to enable a consumer to accurately identify whether the consumer is in possession of a reportable food. A reportable food is defined as a food (other than dietary supplements or infant formula) for which there is a reasonable probability that use of, or exposure to, such food will cause serious adverse health consequences or death to humans or animals. In addition, section 211 of FSMA directs FDA to use such "consumer-oriented" information to create one-page summaries that would be posted on FDA's website for the purposes of consumer notification. Further, grocery stores with 15 or more physical locations, that sold the reportable food, would be required to prominently display the one-page FDA summary, or information from the summary, within 24 hours of FDA's web posting. Grocery stores would also be required to display the information for 14 days.

Through the ANPRM, FDA is seeking input to help determine, among other things:

  • what information should be required in consumer notifications so that consumers can determine whether a food in their possession is a reportable food;
  • the format in which the information should be presented;
  • what types of retail establishments FDA should consider to be "grocery stores" subject to the consumer notification requirements;
  • how grocery stores should be made aware that the information has been published on FDA's website;
  • what constitutes prominent display or sharing of the information by a grocery store with its customers;
  • the impact on grocery stores from posting the information;
  • if consumers should be notified that this type of information will not be generated for dietary supplements, infant formula, and fruits and vegetables that are raw agricultural commodities; and
  • if FDA should require industry to submit consumer-oriented information to FDA, even if the food will not be available for sale to consumers at the retail level.

FDA will consider input received in implementing section 211 of FSMA. FDA believes that the information it obtains through the ANPRM will assist the Agency in implementing and efficiently enforcing the amendments under section 211 of FSMA.

All interested parties are invited to comment on the ANPRM.

Additional Information:

FDA Announces Extension of Comment Period on Draft Methodological Approach for Designating High-Risk Foods

FDA is announcing the extension of the comment period on the draft methodological approach to identifying high-risk foods, which was published in the Federal Register on February 4, 2014. FDA has considered requests to extend the comment period and is granting a 45-day extension to May 22, 2014. FDA is seeking comments and scientific data that will help to refine its approach. FDA is required under section 204(d)(2) of FSMA to designate high-risk foods for which additional recordkeeping requirements are appropriate and necessary in order to rapidly and effectively track and trace such foods during a foodborne illness outbreak or other event. This is an important step towards meeting that requirement. FDA plans to publish a list of these high-risk foods either before or at the same time that it issues a proposed rule under section 204(d)(1) of FSMA to establish the recordkeeping requirements for the designated high-risk foods.

The draft approach is based on an evaluation of chemical and microbial hazards combined with foods (i.e. food-hazard pairs) using criteria that encompass the factors required under section 204(d)(2)(A) of FSMA. Available data for each criterion are used to determine a total risk score for each food-hazard pair. The draft approach allows each criterion to be weighted where appropriate. No specific foods or hazards are included in the draft methodological approach. Although the analysis would encompass food-hazard pairs, we anticipate that the list would contain foods only, not food-hazard pairs. Where multiple hazards occur for a given food, a total risk score would be determined for that food.

Some of the specific issues on which FDA is inviting comments include: alternative approaches for identifying high-risk foods, whether or not the criteria should be weighted equally, changes in the scoring system, and how foods should be categorized.

Additional Information:

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