Food Safety Modernization Act Update

April 27, 2015

The Food & Drug Administration (FDA) is preparing for the roll out of the final rules relating to the Food Safety Modernization Act (FSMA), which became law in 2011. To this end the FDA convened a two-day meeting in Washington, DC on April 23-24, 2015, to bring the public up to date on progress that has been made in implementing this very significant law that will fundamentally change the role of the FDA and, it is hoped, improve the safety of foods that are produced domestically as well as which are imported. 

Unlike the current law and regulations under which FDA operates, FSMA is designed to transform the FDA’s approach to food safety from a system that responds to outbreaks to a system that prevents them.  To prepare for the sweeping changes that are coming, the FDA has reorganized itself as a public health agency whose main mission is to enhance food safety and not simply a regulatory agency who main mission has been to deal with  a crisis after the fact.  The FDA is currently operating under a settlement agreement reached with the Center for Food Safety that will require the publication of final rules relating to preventative controls for human food and preventative controls for animal food by August 30, 2015; produce safety, foreign supplier verification program and third party accreditation by October 31, 2015; for sanitary transport by March 31, 2016 and for intentional adulteration by May 31, 2016. 

While FSMA covers domestically produced food, as well as imports, highlighted below are some of the changes that food imports will be subject to:

FSMA will give FDA new authority to hold companies accountable for preventing contamination.  For the first time importers will be responsible for insuring the safety of its food supply chain under a Foreign Supplier Verification Program (FSVP).  Importers will now be responsible for performing supplier verification activities to ensure that imported food is safe.  With respect to certain high risk foods, the FDA will be able to impose a certification requirement in order to import foods identified as high risk.  Importers who bring in products requiring this certification will be eligible to join a voluntary qualified importer program to expedite release of such products.  The FDA will have authority to refuse admission to imported food if the foreign supplier refuses to allow an FDA inspection.  The FDA will also have recall authority for all food products, including imports.

The FDA has been working closely with the diverse members of the food industry, including state and foreign governmental bodies and trade and food inspection groups, but a number of questions remain unanswered at this time.  For example, it is unclear who the ‘importer’ responsible for verifying the safety procedures of the foreign supplier is under FSMA, since it may not always be the ‘importer of record’ who files the customs entry with the U.S. Customs.    Another unresolved issue is, what additional information will be required by the FDA at the time of entry.  For example, will the FDA require a declaration from the importer that it has complied with FSMA requirements?   It is anticipated that these and other important questions will be answered soon.