This update provides an overview of the recent U.S. Food and Drug Administration (FDA) summary of key funding required from Congress for the FDA’s efforts to implement the Food Safety Modernization Act (FSMA) based on its current and proposed budget authority. FDA has publicized that it’s at a “critical juncture” and that a lot of work must be done right now to smoothly and effectively implement FSMA rules in late 2016 and 2017.

Over the next 14 months, FDA is under a mandate to issue the following final rules: (1) Preventive Controls for Human and Animal Foods, due on August 30, 2015; (2) Produce Safety, Foreign Supplier Verification Programs, and Accreditation of Third-Party Auditors, due on October 31, 2015; (3) Sanitary Transportation, due on March 31, 2016; and (4) Intentional Adulteration, due on May 31, 2016.

Although creating final rules is difficult, obtaining increased funding to meaningfully enforce those rules in today’s political climate is something else altogether. FDA is requesting a budget of $4.9 billion as part of the president’s fiscal year (FY) 2016 budget—a 9 percent increase over the enacted budget for FY 2015. The overall request includes $109.5 million in budget authority for initiatives tied to implementation of the FSMA.

FDA has already stepped up its inspections of high-risk food firms and increased inspections of foreign facilities to about 1,200 each year. The additional funding is needed, the FDA argues, to comply with the FSMA requirements in the following areas:

• Inspection modernization and training;

• Furthering the National Integrated Food Safety System (IFSS);

• Education and technical assistance for industry;

• Technical staffing and guidance development at the FDA;

• Building the new import safety system; and

• Risk analytics and evaluation.

Allocation of Funding
FDA summary provides a detailed breakdown on how it plans to allocate the requested funding of $109.5 million within these areas (with $7 million allocated for “necessary infrastructure costs”).

1. Inspection Modernization and Training – $25 million
FSMA changes FDA’s approach to food safety from primarily reacting to problems to preventing them in the first place. Accordingly, the agency seeks funding for “revised inspection and compliance strategies.” For domestic inspections, FDA is not requesting more inspectors and will instead try to increase the efficiency of its current inspectors by using “new inspectional models and approaches.” Specifically, rather than inspect food manufacturers for evidence of violations, the revised approach focuses more broadly on whether firms are implementing systems and controls that effectively prevent food contamination. The new approach, however, requires more specialized inspectors and support by technical experts to properly evaluate a facility’s food safety system. FDA states that “[t]his new paradigm involves a major reorientation and retraining of more than 2,000 FDA inspectors, compliance officers, and other staff involved in food safety activities.”

2. National Integrated Food Safety System – $32 million
FSMA implementation relies on building the IFSS to provide enhanced collaboration among the state, local and tribal government agencies involved in food safety. The requested funding is to help provide approximately 1,000 state inspectors with relevant training, and provide the states with “real-time information sharing capacity with FDA and other states, state laboratory accreditation, and inspector certification programs.” In addition, FDA seeks to build state partnerships and its capacity to provide education and assistance to growers in anticipation of the produce safety rule that will be implemented in 2017.

3. Education and Technical Assistance for Industry – $11.5 million
Approximately 300,000 entities could be subject to the final FSMA rules. Therefore, funding is requested to provide education and technical assistance to help farmers, processors, and importers implement the new prevention-oriented standards.  

4. Technical Staffing and Guidance Development at the FDA – $4 million
FDA seeks funds to recruit additional experts to help it develop and provide guidance based on “the best science and knowledge of industry practices” and to “conduct outreach to industry, academia and state extension services.” According to the FDA summary, these experts will also play an essential role in supporting FDA’s inspection and compliance force in properly overseeing implementation of the new standards and achieving high rates of compliance.

5. New Import Safety Systems – $25.5 million
Presently, food consumed in the United States comes from over 200,000 different food facilities and more than half those are located outside the United States. And the volume of imported food has increased from “fewer than 200,000 line-entries in the early 1990s to an estimated 12 million in 2013.” Accordingly, FSMA mandates a Foreign Supplier Verification Program that requires importers to implement supplier verification plans to ensure food produced overseas meets U.S. food safety standards. Accordingly, FDA seeks funds for training of more than 400 current FDA investigative and compliance personnel, and the addition of new staff to assess importer safety plans.

6. Risk Analytics and Evaluation – $4.5 million
Finally, FDA seeks to develop new tools for ranking risks to health, prioritizing program activities based on opportunities to reduce risk and “linking risk-based priorities more clearly with budget formulation and execution.” The agency believes that such tools will provide better information on which foods, including animal foods, are most vulnerable to which bacterial contaminants, and where FDA should invest its research efforts to most effectively identify how to reduce contamination of food.

Conclusion
FDA concludes its summary by stating, “Without an immediate investment now, and sustained funding in future years, there is a risk of delayed, uneven, and potentially disruptive implementation of FSMA, to the detriment of public health and the food industry.” In today’s political climate, however, some delay seems inevitable.

In addition, FDA’s request must also contend with the president’s recent proposal to consolidate food safety functions at FDA and the U.S. Department of Agriculture and proposed legislation in this regard introduced in early February titled the Safe Food Act of 2015. Although the goal of the proposed legislation, introduced and sponsored by Democrats in both houses of Congress, is to build on the improvements to food safety in the FSMA, the consolidation process would undoubtedly require additional time and resources to implement. Ultimately, the most likely scenario is that FDA will only receive a portion of its requested funding which it will then allocate among the highest priority areas for implementing FSMA.

David L. Ter Molen is partner and member of the Food Industry Team at Freeborn & Peters LLP (Chicago).