In the past year, great strides have been made to implement the FDA Food Safety Modernization Act (FSMA), with five of seven rules becoming final in September and November 2015 to provide science-based protections for domestic and imported foods—for both people and animals.
FDA’s broad objective has been to provide needed food safety protections for the American public while also making the rules as flexible as possible and workable across the great diversity of the nation’s food system. The substance of these rules has been informed by current industry practices and by extensive outreach across the country and overseas to farmers, manufacturers, commercial food handlers, consumers, and government partners.
FDA requested, and received, a significant increase in FY 2016—$104.5 million in new budget authority—in anticipation of implementing the final rules. A further increase is essential in FY 2017, primarily in the key areas of state funding for produce safety and ensuring the safety of imported food, to fully realize the public health and public confidence benefits promised by FSMA. In his FY 2017 Budget Request, the President has proposed additional resources that include an increase of $25.3 million of new budget authority to implement FSMA.
Full implementation of FSMA helps address the significant burden of foodborne illness in the United States each year, which the Centers for Disease Control and Prevention estimate at 48 million illnesses, 128,000 hospitalizations, and 3,000 deaths. The economic losses to industry, including farmers, are enormous, estimated at over $75 billion per year. FSMA reflects the need for a modern, global food safety system that prevents problems rather than primarily reacting to them after they have occurred.
Status of Rulemaking
FDA issued four key proposed rules in 2013—produce safety, preventive controls for human food, preventive controls for animal food, and Foreign Supplier Verification Programs (FSVP) —and conducted extensive outreach to have in-person dialogue with farmers and other stakeholders and to see farms and other food operations first-hand.
Based on what was learned through these visits and from many of the comments received in response to the proposed rules, FDA took the unusual step of issuing supplemental proposals in 2014 that proposed significant revisions to the original 2013 proposals.
In addition, FDA issued three more key proposed FSMA rules in 2013-2014, covering accreditation of third party auditors, focused mitigation strategies to protect food from intentional adulteration, and sanitary transportation of human and animal food.
Five of the seven rules are now final. The final rules for preventive controls for human and animal foods were published in the Federal Register on Sept. 17, 2015; the final rules on produce safety, FSVP, and accreditation of third party auditors were published on Nov. 27, 2015.
The final rules for sanitary transportation and intentional adulteration are due to be sent to the Federal Registeron March 31, 2016, and May 31, 2016, respectively.
To ensure successful implementation of FSMA, FDA has begun crucial planning and taken initial steps in the following areas:
inspection modernization and associated FDA and state staff training;
guidance development, education and technical assistance for industry;
building state capacity to partner with FDA on FSMA implementation; and
establishing an import safety system that addresses problems before food from other countries reaches the U.S. border.
FSMA funding received through FY 2016 is enabling FDA to lay a strong foundation for the success of FSMA, but additional funding is needed to meet congressional and public expectations, primarily in the areas of produce safety and oversight of imported food.
FY 2017 Plans for Requested Budget Authority
With the increase of $25.3 million requested in the President’s Budget for FY 2017, FDA will build on work that began with FY 2016 funds in two key areas.
National Integrated Food Safety System - $11.3 million Collaborating with state, local and tribal governments through the National Integrated Food Safety System is a central element of FDA’s strategy to achieve full, effective, and efficient implementation of FSMA. The requested funding will be used primarily to support state capacity to implement the produce safety rule by delivering education and technical assistance to farmers and providing on-going compliance support and oversight. The states have been clear that they cannot perform these essential functions in furtherance of national food safety objectives without federal resources.
New Import Safety Systems - $14.0 million The priority will be implementing the FSVP rule, which makes importers responsible for ensuring that the foods they bring in from other countries are produced in a manner that is consistent with U.S. food safety standards. FDA will use its FY 2017 funding to hire staff to perform FSVP inspections and provide training, technical assistance and outreach. The agency will also expand its overseas presence, increasing and better targeting FDA inspections of foreign food facilities, as well as working with and assisting foreign governments to ensure the safety of food before it is exported to the United States.
Developing reasonable, effective, and flexible rules to create a modern, prevention-based food safety system is a formidable job, but it is just the first step in FSMA implementation. Much more needs to be done to lay the groundwork for smooth and effective implementation of FSMA in FY 2017.