FDA Releases First Rules as Part of Food Safety Modernization Act Implementation

On Wednesday, the Food and Drug Administration (FDA) released its first two rules implementing portions of the Food Safety Modernization Act (FSMA). It released both rules as interim final rules, each of which will go into effect on July 3, 2011.

Rule One: Modified Standards for Food or Animal Feed Detention

The first rule modifies the standard under which FDA agents may administratively detain food or animal feed.  Under the 2002 Bioterrorism Act, FDA agents had the power to administratively detain food under what amounted to a Class I recall-type situation – where 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.  FSMA Section 207 and this new implementing rule change that standard to allow FDA agents to administratively detain food where they have reason to believe an article of food is adulterated or misbranded. 

FDA explained that in the years since it received the administrative detention powers, it had never administratively detained an article a food.  It views this revised standard as similar to situations in which a Class II recall would be warranted – i.e., where the use of exposure to a product "may cause temporary or medically-reversible adverse health consequences or where the probability of serious adverse health consequences is remote."  Thus in addition to the mandatory recall powers it has been granted in Class I-type situations, FDA now also has the power to administratively detain food in Class II-type recalls, including situations where a food item is merely misbranded.  Finally, the Federal Register notice contemplates that FDA expects to actually use its newfound power in the future. 

Rule Two: Amendment to Prior Notice Regulations

The second rule implements Section 304 of FSMA by amending the existing prior notice regulations to include a requirement that the prior notice include information as to "any country to which the article has been refused entry."  Since implementation of the 2002 Bioterrorism Act, certain information about all food, including food for animals, imported into the U.S. must be provided prior to importation.  This "prior notice" information is meant to give FDA and the Department of Homeland Security (DHS) sufficient information to determine if it needs to further inspect or detain foods.  Under this new rule, importers will also need to provide information as to whether the food articles have been refused entry into any other countries, so presumably FDA and DHS can also refuse entry of the food articles into the U.S. 

FDA Still Seeking Comments

While both rules go into effect on July 3, 2011, FDA is still actively seeking comments on the rule.  Interested parties can submit comments at http://www.regulations.gov for the following dockets:

• Docket No. FDA-2011-N-0197: Criteria Used to Order Administrative Detention of Food
• Docket No. FDA-2011-N-0179: Information Requires in Prior Notice of Imported Foods

Further information about the Food Safety Modernization Act and its implementation can be found at:

• Summary of FDA Hearing on Imported Foods Provisions of FSMA
• Summary of FDA Hearing on Preventive Measures Provisions of FSMA

Faegre & Benson will continue to monitor implementation of FSMA and provide updates as appropriate.