On May 5, 2011, the US Food and Drug Administration (FDA) published in the Federal Register two interim final rules implementing portions of the FDA Food Safety Modernization Act (FSMA).  The interim final rules, both of which go into effect on July 3, 2011, are the first to be issued by FDA under the new authorities granted by the FMSA.  FDA has allowed interested parties 30 days to submit comments.

Strengthening FDA’s Detention Authority

The first interim rule, "Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption," implements section 207 of the FSMA and addresses the standard under which FDA agents may administratively detain food or animal feed.  Under the 2002 Bioterrorism Act, FDA had the power to administratively detain food in cases in which there was credible evidence or information indicating the article of food presented a threat of serious adverse health consequences or death to humans or animals. 

However, under FSMA Section 207 and the new interim rule, FDA will have authority to order an administrative detention for 20 calendar days with a possible 10-calendar-day extension "if there is reason to believe that an article of food is adulterated or misbranded." FDA did not define "reason to believe," but stated the decision would be made on a case-by-case basis.

FDA indicated it is more likely to use administrative detention under the new rule because, while the old rule required FDA to find "credible evidence or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals,” the new standard is easier to meet, requiring only “reason to believe” that a food article is adulterated or misbranded.  FDA further explained that it views potential detention scenarios under FMSA Section 207 as analogous to situations in which the FDA would order a Class II recall.

This interim final rule, 76 Federal Register 25538, can be found here.

Prior Notice on Imported Food

FDA also issued an interim final rule and request for comments related to its regulations on prior notice of imported food. This interim final rule will implement section 304 of the FSMA and requires a person submitting prior notice of imported food for animals to report "any country to which the article of food has been refused entry."

This new requirement will provide the agency with more information about foods that are being imported, which improves the FDA’s ability to target foods that may pose a significant risk to public health.  The new reporting requirement will be administered through the FDA’s prior notice system for incoming shipments of imported food, which was established under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

FDA explained that prior notice will allow it to mobilize and assist in the detention and removal of products that may pose a serious health threat to humans or animals in cases in which there is a credible threat for a specific product or a specific manufacturer or processor.

This interim final rule, 76 Federal Register 25542, can be found here.

FDA Efforts to Implement FMSA

FDA’s publication of the interim final rules is the most recent step in FDA’s implementation of the FMSA.  In April, the FDA launched a web site feature to allow searches for recall information and issued the first annual report to Congress describing FDA’s activities in protecting the US food supply. FDA also released a guidance document to the seafood industry on ways to reduce or eliminate food safety hazards.  FDA has also held two public meetings with stakeholders on the FMSA since its passage in January. 

If you have any questions regarding the two interim final rules, please contact:

Brian P. Waldman
waldman.brian@arentfox.com
202.857.8971

Laura Farhang
farhang.laura@arentfox.com
202.857.6044