The FDA Food Safety Modernization Act (FSMA) was signed into law in January 2011. FSMA reflects the need for a modern, global food safety system that prevents problems rather than primarily reacting to them after they have occurred.

The law, which received bipartisan support, followed a series of severe outbreaks of foodborne illness. It responds to 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.

Since FSMA was enacted, FDA has carried out extensive work to implement the law by publishing key FSMA proposed rules that would provide needed food safety protections for the American public, while at the same time making the proposed rules as flexible as possible and workable.

These proposed rules were informed by current industry practices and by conducting extensive outreach and dialogue across the country and overseas with farmers, manufacturers, commercial food handlers, consumers, and government partners.

Currently, FDA is under court-ordered deadlines to issue all seven of these key final rules:

• The final rules for preventive controls for human and animal foods are due on August 30, 2015;
• The final rules on produce safety, Foreign Supplier Verification Programs, and accreditation of third party auditors are due on October 31, 2015; and
• The final rules for sanitary transportation and intentional adulteration are due on March 31, 2016, and May 31, 2016, respectively.

Implementation

Developing reasonable, effective, and flexible rules is just the first step in FSMA implementation. Much more needs to be done to ensure smooth and effective implementation in late 2016 and 2017. And additional funding is needed to support the following areas:

• Inspection modernization and training;
• Furthering the National Integrated Food Safety System;
• Education and technical assistance for industry;
• Technical staffing and guidance development at FDA;
• Building the new import safety system; and
• Risk analytics and evaluation.

FDA is also committed to change within the agency itself to enhance industry compliance with the FSMA rules. First, FDA is overhauling its inspection model to fulfill FSMA’s prevention mandate. To carry out the new model, FDA will increase specialization of the inspection and compliance workforce, build a new compliance culture within FDA that uses a variety of tools and incentives to achieve compliance, and invest in training to ensure expert and consistent inspections and sound decision making.

Second, the agency will assume that most in industry want to comply with food safety standards and thus will educate before and while it regulates through guidance, education, and technical assistance.

Third, the frequency and manner of FDA’s inspections will be guided by a company’s food safety culture and performance.

The allocation of funds needed in FY 2016 to make these changes is outlined below.

FY 2016 plans for requested budget authority

With a total of $1.3 billion in budget authority, an increase of $109.5 million, requested in the President’s Budget, FDA will make improvements in the following areas, continuing improvements that began with FY 2015 funds.

1. Inspection Modernization and Training – $25 million

FSMA fundamentally changes FDA’s approach to food safety oversight, from primarily reacting to problems to preventing them in the first place. New inspection and compliance strategies will be a key component of this shift. FDA is not requesting more inspectors for domestic inspections, but rather will increase efficiency and effectiveness of current inspectors through the use of new inspectional models and approaches. Inspectors are currently trained to inspect food manufacturers using a compliance model focused on finding evidence of violations and bringing enforcement cases. The new food safety paradigm will be focused on whether firms are implementing systems that effectively prevent food contamination, requiring fundamentally different approaches to food safety inspection and compliance. For example, FDA will deploy more specialized inspectors, supported by technical experts, to assess the soundness and performance of a facility’s overall food safety system and will use data to guide risk-based inspection priority, frequency, depth, and approach. FDA will also focus on ensuring consistency among inspections conducted by FDA or the states on behalf of FDA.

This 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. FDA has also committed to improving risk-based targeting, which will require better data about facilities, new IT systems to identify and track risk, and methods for assessing and tracking inspection efficiency and inspector competency.

2. National Integrated Food Safety System – $32 million

Congress recognized that the success of FSMA implementation depends on fundamentally new approaches to collaboration among the more than 3,000 state, local, and tribal government agencies involved in food safety. Building a National Integrated Food Safety System is a complex and long-term process. To be successful in aligning state programs with FDA’s new facility inspection and compliance approach, approximately 1,000 state inspectors will need training, and the states will need real-time information sharing capacity with FDA and other states, state laboratory accreditation, and inspector certification programs. Those processes, which will be carried out mostly via FDA grants and cooperative agreements to states, have been ongoing but must be ramped up significantly in 2016 to help ensure that states conduct sound, consistent inspections when industry must comply with the new preventive controls rules starting in late 2016. In addition, to successfully implement the produce safety rule, FDA must build state partnerships and capacity in 2016 to provide education and technical assistance to growers in anticipation of the rule starting to be implemented in 2017.

3. Education and Technical Assistance for Industry – $11.5 million

With FDA’s new approach to ensuring food safety, education and technical assistance are needed to help farmers, processors, and importers—especially small businesses—implement the new prevention-oriented standards. Approximately 300,000 entities could be subject to the final FSMA rules. FDA believes that it should expend substantial financial resources to provide such assistance and will make training materials widely available to protect public health. FDA would use a large portion of these resources to provide financial support to state agencies and public-private-academic collaborative entities, such as the Produce Safety Alliance and the Preventive Controls Alliance.

4. Technical Staffing and Guidance Development at FDA – $4 million

Maintaining an adequate number of highly qualified technical staff at FDA is always a priority and challenge, but FSMA makes it essential to achieve this goal. In addition to regulatory standards for FSMA, FDA is issuing guidance documents that express the agency’s current thinking and are essential to helping industry to comply with the FSMA requirements. Funds are needed now to recruit additional experts at FDA who can ensure that guidance development, which is now underway, is based on the best science and knowledge of industry practices. More experts are also needed to conduct outreach to industry, academia, and state extension services to ensure that their concerns are heard, that their advice is solicited and utilized, and that the guidance documents reflect the most cost-effective solutions achievable. They 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

Improving oversight of imported food is crucial to protect public health and ensure consumer confidence in food safety, regardless of whether food is produced domestically or imported. The food consumed by Americans today comes from over 200,000 different food facilities, more than half of which are located outside the United States. For example, about 50% of fresh fruits, 20% of fresh vegetables, and 80% of seafood consumed by Americans is imported. The volume of imported food has increased enormously over the past 20 years, going from fewer than 200,000 line-entries in the early 1990s to an estimated 12 million in 2013. The Foreign Supplier Verification Program (FSVP) mandated by FSMA, will require importers to implement supplier verification plans to help ensure food produced overseas meets U.S. food safety standards. This shift presents an enormous challenge for both FDA and food importers, given that there were approximately 88,000 consignees receiving food shipments last year. To be successful, FSVP implementation will require a substantial regulatory development process, training of more than 400 current FDA investigative and compliance personnel, and the addition of new staff (including 50 in 2016) with the audit skills needed to assess importer safety plans. It will also require extensive training and technical assistance for importers.

6. Risk Analytics and Evaluation – $4.5 million

Focusing decisions and resources on areas of greatest risk to health is a key element of FSMA, so FDA is developing new tools that will provide the information needed to do so. This includes new tools for ranking risks, prioritizing program activities based on opportunities to reduce risk, and linking risk-based priorities more clearly with budget formulation and execution. For example, these tools will better inform FDA about which foods, including animal foods, are most vulnerable to which bacterial contaminants, and where it should invest its research efforts to most effectively identify how to reduce contamination of food. This will improve FDA’s productivity in all areas, including research and standard setting, inspections, and guidance to industry.

Note: The $109.5 million increase in the food safety budget for FDA includes $7 million for necessary infrastructure costs.

Conclusion

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 late 2016 and 2017. 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. 

Source: This article has been adapted from a paper authored by FDA, which can be accessed here.