On January 4, 2011, President Obama signed into law the most comprehensive food safety reform in U.S. history: the Food Safety Modernization Act (FSMA, pronounced "fizz-ma" by those working to implement the law). While the Federal Food, Drug, and Cosmetic Act of 1938 (FFDCA) and the Food Additives Amendment of 1958 provided significant food oversight authority to the Food and Drug Administration (FDA), neither was as precise or far-reaching as FSMA, which FDA's Deputy Commissioner for Foods Michael Taylor has touted as allowing FDA "to build a whole new food safety system."
The new law hopes to take the way FDA handles food safety issues and transform it from a reactive system dependent on recalling tainted food after it makes people sick to a proactive system wherein new measures, including hazard analysis and preventive controls, preemptively protect the population by preventing tainted food from entering the marketplace in the first place. FSMA intends to do this by expanding FDA's role and responsibilities and by placing greater responsibility for preventive food safety efforts on the food industry.
New Authority, New Requirements
FSMA gives FDA new authority and new opportunities to aggressively pursue food safety measures. At the same time, it also places a substantial burden of new food safety responsibilities on FDA. One question left unanswered is the extent to which FDA will receive the funding necessary for full implementation of FSMA - estimated by the Congressional Budget Office at $1.4 billion over five years - particularly given the vagaries of the budget process during a period of extreme cost-consciousness in the run-up to a presidential election year. Consequently, the success of FSMA in the short to mid-term will depend not only on the implementation efforts of FDA and its affiliated agencies, but also on the efforts of those on Capitol Hill and elsewhere defending FSMA's mission against opponents who, for budgetary or political reasons, would seek to gut, shrink or sideline the legislation.
Under FSMA, FDA has new authority that is largely focused on preventive measures and the supply chain and gives special attention to imported food. Like many other commodities, the food supply has gone global and so have the challenges associated with keeping food safe. In 2009, the President's Food Safety Working Group found that the United States imports food from more than 150 countries through more than 300 ports of entry. In 2007, melamine-contaminated pet food from China killed thousands of cats and dogs in America, and China has had repeated problems keeping infant formula melamine-free, a problem that, in 2008, sickened hundreds of thousands of Chinese children and killed at least six. These tragedies have resulted in greater congressional scrutiny of, and public interest in, the wholesomeness of imported food. To address heightened concerns over the safety of imported food, FSMA's provisions are designed to prevent bad actors from port shopping and give FDA more power to inspect food imports and detain problematic shipments, as well as require importers to prove through certification programs that the food they are bringing into the United States is safe.
FSMA also endows FDA with significant new enforcement powers against companies who fail to keep food safe. Most controversial is that FDA can now suspend a food facility's registration when food that has passed through it (in any of a variety of ways) has a reasonable probability of presenting a serious health risk or a risk of death, and the facility caused - or knew about - the problem. FSMA also finally conferred upon FDA the mandatory recall authority for which the agency and food safety advocates had been begging for years, and especially since salmonella-contaminated peanut butter resulted in several deaths and widespread sickness in 2009. Although voluntary recalls will likely remain the industry standard, this new authority will allow FDA to order - or even carry out - recalls of dangerous foods when a firm refuses to do so voluntarily.
As noted, FSMA also places new obligations on FDA. As with the agency's expanded authority, FDA's new duties also break along domestic/international lines. However, the ambitious scope, short timeframe and unfunded nature of some of these requirements may demand more political acumen than scientific savvy on the part of the agency. For example, FDA must establish offices in foreign countries to assist these governments in ensuring the safety of food and other FDA-regulated products bound for the United States. In doing so, the agency needs to liaise with the Departments of State and Homeland Security and the Office of the U.S. Trade Representative and then to report to Congress by October 1, 2011, as to the basis for selection of countries, the progress made and its plans to establish additional foreign offices. That the agency is being asked to mount an overseas expansion and then report on accomplishments and further expansion within 10 months of the law's enactment may speak to Congress's sense of urgency as well as to what may be characterized as an optimistic view of FDA's - and the bureaucracy's - possibilities.
However, establishing overseas offices is only one of several ambitious, foreign-focused provisions in FSMA. Parallel to its overseas expansion, FDA has been handed a mandate to build the food safety capacity of foreign countries that export food to the United States by expanding the technical, scientific and regulatory capacity of foreign governments and their food industries through a process that involves stakeholders from, among others, executive agencies, the food industry, consumer NGOs and, of course, the foreign governments themselves. FDA must also establish a voluntary qualified importer program (known as VQIP) to facilitate expedited review and importation of certified participating importers' food shipments, as well as a foreign supplier verification program for importers to verify that imported food is neither adulterated nor misbranded. Additionally, FSMA requires the agency to develop a strategy to prevent smuggled food from entering the country. Fortunately for the agency, implementation timelines are more generous for these items (with the exception of the smuggled food provision), ranging from 12 months to two years from FSMA's enactment.
As for regulation of U.S. industry, FDA has been tasked with a slate of goals centered on ensuring industry compliance with food safety norms, with an eye to accountability. Thus, the agency is required to establish produce safety standards and a food-tracing system; conduct an assessment on, and issue regulations to protect against, the intentional adulteration of food; and increase domestic and foreign food facility inspections while, additionally, targeting high-risk food facilities for increased inspection. Aside from these operational requirements aimed at reducing food safety risks on the "shop floor," FSMA also requires FDA to think strategically in the domestic context. The agency is to establish a working group on foodborne illness surveillance and integrated Food Safety Centers of Excellence, as well as to prepare the National Agriculture and Food Defense Strategy (in collaboration with the U.S. Department of Agriculture and coordination with the Department of Homeland Security). FDA has also been charged with establishing accreditation programs, both for laboratories that test foods and for third-party auditors who will issue certifications for foreign food and qualified importers. Further, the FSMA authorizes the FDA to collect fees from industry for reinspections, recalls and participation in VQIP, which are estimated to total just over $99 million for FY 2012.
According to GAO, 15 federal agencies collectively administer at least 30 food-related laws. Although the fragmentation of food oversight has often been criticized, FSMA recognizes that effective collaboration is critical to keeping food safe and is calling for enhanced cooperation and partnerships among the many governmental entities that oversee various aspects of food safety. Toward this goal, FSMA provides for food safety grants, training programs and technical assistance for state, local and tribal governments (and, in some cases, nonprofit organizations as well), as well as whistleblower protections to employees who report food safety violations.
The Industry Role
Even though FSMA places significant responsibilities on food companies, the food industry was largely supportive of its passage.Under FSMA, food companies are required to renew food facility registrations every two years, provide additional information when reporting a food in the reportable food registry, post information about reportable foods (only applies to grocery stores) and conduct risk-based foreign supplier verification activities (only applies to importers). The most substantial new requirement is that all food facilities have a food safety plan. This plan requires a food facility to (i) evaluate the hazards that could affect food manufactured, processed, packed or held by the facility; (ii) identify and implement preventive controls to significantly minimize or prevent the occurrence of these hazards and provide assurances that such food does not contain undeclared allergens; (iii) monitor the performance of those controls; and (iv) maintain records of this monitoring.
The first point, hazard analysis, is the most critical among these, as it sets the stage for each of the succeeding steps. Built on the Hazard Analysis and Critical Control Points (HACCP) framework pioneered in the early days of the U.S. space program, hazard analysis entails identification and evaluation of all known or reasonably foreseeable hazards - including biological, chemical, radiological, pesticidal, parasitic and allergenic hazards, among many others. Certain exemptions are built into the law (e.g. small businesses, food categories already subject to HACCP regulations), and FDA has discretionary authority to grant additional, limited exemptions, but compliance with FSMA's food safety plan provisions is otherwise required. While publicly welcomed by the affected industries' trade associations, the record-keeping and other requirements - as well as the additional costs to meet these requirements - may be cause for concern for mid-size firms.
Prospects And Resources
FSMA's provisions require more than 50 significant actions on the part of FDA, including a dozen regulations and rulemakings; another dozen-plus guidance or guidance-like documents; and a significant number of pilot projects, studies and reports to the Government Accountability Office and Congress. FDA proclaims it has hit the ground running and, although stretched for resources, plans to meet the tight timelines for issuing regulations that will implement the hazard analysis and risk-based preventive controls, produce safety standards and protection against the intentional adulteration of food provisions. The agency has already held four public meetings that have addressed imports, preventive controls, and inspections and compliance provisions. FDA is attempting to maximize its resources to implement the law effectively by establishing six implementation teams that oversee more than 20 workgroups largely staffed by FDA employees who continue their everyday pre-FSMA duties. The goal of this management structure is to streamline the work to meet expectations and keep individuals accountable for deliverables. As noted, funding will probably be the greatest challenge in implementing the provisions of FSMA; however, FDA says it will stretch its resources as far as possible.
Mark Mansour is a Partner and Emily K. Strunk is an Associate in the Food and Drug Law practice at Akin Gump Strauss Hauer & Feld LLP. Mr. Mansour and Ms. Strunk work with clients in the food, pharmaceutical, medical device, dietary supplement and cosmetic industries to secure regulatory approvals, maintain compliance and address public policy issues in the United States and in key global markets.