CFSAN Constituent Update
New information is available related to this Constituent Update:
June 17, 2014
FDA is reopening the comment period for an additional 60 days on its advance notice of proposed rulemaking entitled “Implementation of the Food and Drug Administration Food Safety Modernization Act (FSMA) Amendments to the Reportable Food Registry (RFR) Provisions of the Federal Food, Drug, and Cosmetic Act.” In the advance notice of proposed rulemaking, FDA requested comments, data and information that will help to implement the new provisions to the RFR requirements added by FSMA.
March 25, 2014
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.
You may comment electronically on http://www.regulations.gov using docket number FDA-2013-N-0590. Additional information on commenting and the proposed rulemaking is available in the Federal Register Notice, Advance Notice of Proposed Rulemaking: Implementation of the Food and Drug Administration Food Safety Modernization Act Amendments to the Reportable Food Registry Provisions of the Federal Food, Drug, and Cosmetic Act.