FDA Food Safety Modernization Act: Update
May 5, 2011
Dear International Colleagues:
As promised in earlier letters regarding our new food safety legislation in the U.S., I am writing today to provide you with a further update on the U.S. Food and Drug Administration’s (U.S. FDA) implementation progress regarding this new law (the FDA Food Safety Modernization Act (FSMA)). Also, I wanted to assure that you and your colleagues know how to get the latest information on the FSMA.
We recently unveiled a new, updated FSMA web site at www.fda.gov/fsma. I hope that some of you have already had the chance to visit it. It contains many useful items such as FSMA requirements we have met, frequently asked questions, recent speeches, and upcoming events. In addition, a subscription service allows you to get automatic emails when something new has been added. Here is the link: https://service.govdelivery.com/service/subscribe.html?code=USFDA_206. I hope you will sign-up and encourage others to do the same.
As to our progress in implementing this law, we have recently met several of the requirements that this law imposed on us.
- On April 4, we unveiled our new consumer-friendly recall search engine. We hope that stakeholders will see this as a good example of how we are trying to be as inclusive as possible in our implementation action. The U.S. FDA consulted with numerous stakeholder groups to gain their insights on how to most effectively and easily communicate recall information to consumers (http://www.fda.gov/Safety/Recalls/default.htm).
- We also have completed our first required report to Congress: “Annual Report to Congress on Food Facilities, Food Imports, and FDA Foreign Offices Provisions of the FDA Food Safety and Modernization Act” (http://www.fda.gov/Food/FoodSafety/FSMA/ucm250569.htm).
- On April 27, the U.S. FDA released the 4th edition of the “Fish and Fishery Products Hazards and Controls Guidance.” It contains our latest recommendations to the seafood industry for reducing and eliminating food safety hazards in the fish and fishery products they process ((http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments
- Today, we issued an interim final rule that requires anyone importing food (human or animal) into the United States to inform the U.S. FDA if any country has refused entry to the same product. This new requirement will provide our agency with more information about foods that are being imported and will improve our ability to target foods that may pose a significant risk to public health (http://www.gpo.gov/fdsys/pkg/FR-2011-05-05/pdf/2011-10955.pdf).
- Also today, we released an interim final rule on administrative detention of food. This interim final rule allows the U.S. FDA administratively to detain food we believe has been produced under unsanitary or unsafe conditions. Previously, our ability to detain food products applied only when our agency had credible evidence that a food product presented was contaminated or mislabeled in a way that presented a threat of serious adverse health consequences or death to humans or animals (http://www.gpo.gov/fdsys/pkg/FR-2011-05-05/html/2011-10953.htm).
As for outreach activities, we have held two public meetings on the new law that I hope many of you or your staff were able to attend. The first, held on March 29, focused on key import provisions of the new law; the second, held on April 20, focused on preventive controls in facilities.
If you have general comments or questions regarding how FDA will implement FSMA, we look forward to receiving them and to continuing to work with our foreign counterparts as we continue our efforts to implement our new law. If you or your colleagues have questions, please forward them electronically to FSMA@fda.hhs.gov . Also, if your government wishes to comment formally as part of the World Trade Organization (WTO) notification process for FSMA, document SPS/N/USA/2156, please send those comments electronically to FSMAWTO@fda.hhs.gov or by fax to +1 201-436-2618.
We will continue to keep you apprised of our progress through letters, such as this one, and also encourage you and your colleagues to check our web site.
Murray M. Lumpkin, M.D., M.Sc.