By: T.H. Lyda, Esq. and Edwin B. Palmer, Esq.
The Food Safety Modernization Act (FSMA) was signed into law by President Obama on January 4, 2011. The FSMA is the most significant expansion of food safety requirements and the Food and Drug Administration’s (FDA) food safety authority in over 70 years. The Act charges the FDA with improving food safety and sets broad parameters for future regulation of the food industry. The focus of the FSMA is on preventing food safety problems, rather than taking more of a reactive approach to problems after they occur.
The FSMA imposes a number of requirements on individuals and entities that manufacture, process, pack, transport, distribute, receive or hold food and food products. The Act also grants the FDA increased authority to regulate food facilities and imposes new requirements for those facilities.
The overall purpose of the Act is to build a preventive food borne illness regime similar to that used by the United States Department of Agriculture (USDA). Under the FSMA, FDA food safety inspections will increase and the FDA is provided mandatory recall authority. Additionally, the FSMA imposes increased recordkeeping requirements on industry, as well as requires industry to identify possible causes of contamination and develop food contamination prevention plans for the future. The FSMA does not affect meat, poultry and egg products regulated by the Food and Drug Administration (FDA).
Despite its admirable intentions, major portions of the FSMA have not been enacted some 20 months after the statute was signed into law. Admittedly, the FSMA is a complex piece of legislation and the FDA has been tasked with authoring approximately 50 new rules, documents, reports and studies. Nonetheless, several regulations implementing the Act have been drafted and have been awaiting approval by the Office of Management and Budget since late 2011.
Until final regulations are published, food manufacturers are unsure of what the ramifications of the Food Safety Modernization Act will ultimately be. This blog post will provide a brief overview of the FSMA – where things currently stand, general requirements that food manufacturers and distributors can expect, and a brief discussion of what food manufacturers and distributors can do to prepare for the eventual enactment of the these regulations.
While many of the FSMA regulations have yet to be enacted, the FDA has certain new powers that have gone into effect. With the enactment of the FSMA, the FDA received authority to order mandatory recalls. Prior to the FSMA, the FDA only had mandatory recall authority on four types of products: infant formula, medical devices, human tissue products and tobacco products. In addition, it could only request that companies institute a voluntary recall of FDA-regulated products.
Under the FSMA, the voluntary recall procedure is still preferred and encouraged. However, if the responsible party declines to issue a voluntary recall within the time period requested by the FDA, the agency may order the responsible party to cease distribution of the food product and to notify all persons manufacturing, distributing or selling the article to cease all sales and distributions. The FDA is also granted the authority to impose civil and criminal penalties on a party that refuses to comply with a mandatory recall. The FDA’s enforcement authority provides a strong incentive for responsible parties to cooperate with the FDA and institute a voluntary recall when requested.
In addition to mandatory recall authority, the FDA issued a rule allowing the agency to administratively detain foods which the agency has reason to believe may be adulterated or misbranded. The FDA also has given itself the authority to suspend the registration of any regulated food facility if the food facility is producing food which, in the judgment of the FDA, presents a reasonable probability of causing serious adverse health effects or death.
Despite these developments, there is nonetheless considerable uncertainty and anxiety among regulated food companies as to what specifically will be asked of them under the FSMA regulations and when those regulations will go into effect. Regulations implementing the FSMA have been awaiting approval by the Office of Management and Budget (OMB) for more than nine months. The OMB is responsible for evaluating the proposed regulations’ effectiveness and consistency with administration policies. Among the rules currently awaiting OMB approval are:
- Safety standards for irrigation water, manure, worker hygiene and wildlife that can contaminate fresh fruits and vegetables
- The requirements for foreign supplier verification programs that make importing companies responsible for the safety of foods they bring into the United States
- The specific requirements of the food safety plans that will be required of all food companies identifying potential sources of contamination and the specific steps the companies will take to address those hazards.
Although there is considerable uncertainty as to what will specifically be required of food manufacturers and distributors, we can anticipate the general requirements that will be required by FSMA regulations. Under the FSMA, food companies will be required to adopt “Food Safety Plans.” More specifically, regulated food companies will be required to develop and closely follow the Hazard Analysis and Critical Control Point (HACCP) methodology.
Under a HACCP plan, a food processor would identify those hazards likely to affect the safety of its food (including the introduction of chemical, physical and microbiological contaminants) and then establish various critical control points where interventions could be made to prevent, reduce or control those hazards. There is no one-size-fits-all HACCP plan. Each food processor will have to identify and address a set of hazards that are unique to its facility and particular food products.
HACCP was first developed by Pillsbury in the 1960s as a quality control program governing the production of food for the United States space program. By the 1990s, the USDA required HACCP plans for all meat and poultry production in the United States. The FDA has required HACCP for all seafood production and the domestic juice industry for a number of years. Thus, we can expect that the FDA will ultimately require all food companies regulated by the agency to develop and closely follow their own HACCP plans. Specifically, companies will need to formally consider and identify all reasonably foreseeable food safety hazards; develop written plans addressing each of those hazards and closely follow those plans. As part of the HACCP process, companies will be expected to develop procedures to follow in the event a hazard is identified, including an assessment of the cause of the contamination, procedures for the disposal of the affected product, and written documentation of any corrective actions. Additionally, regulated food companies will be required to audit their HACCP plan to verify that the plan is working correctly.
When developing a formal HACCP strategy, companies should recognize that the plan will become a de facto FDA regulation of their particular food processing operation that must be strictly followed. Accordingly, all companies should strongly consider obtaining advice from industry consultants and lawyers when drafting their HACCP plans.
While no one knows precisely when FSMA regulations will be enacted, food producers can assess their facility risk based on the criteria identified in the FSMA, as well as the facilities of other companies, domestic and foreign, in their supply chain, and begin to develop plans to address those hazards.
Additionally food production companies should review their insurance policies. Questions to ask include:
- Does my policy include coverage for recalls? Does my policy only cover government-ordered recalls?
- Does my policy cover third-party issues such as the recall of ingredients manufactured by a third party that are used in my product?
- Does my policy cover damage claims by downstream customers and distributors of my product?
Obviously, it is difficult to itemize in great detail every step that you should take to ensure compliance with the FSMA requirements as well as the continued safety and security of your food manufacturing process. This is particularly so when the food manufacturing process faces its own unique set of hazards. For a detailed review of your company’s policies and procedures, contact an attorney familiar with the federal, state and local regulations that apply to your particular situation.
T.H. Lyda is a Member of the firm and concentrates his practice in railroad, products liability, toxic tort, civil rights, professional negligence, medical malpractice defense and insurance defense litigation, with a particular interest in occupational disease litigation.
Edwin B. Palmer is also a Member of the firm and focuses his practice on the defense of products liability, toxic tort and occupational illness claims involving complex medical and scientific issues relating to exposures to solvents, diesel fumes, and other substances and the defense of repetitive stress injury matters.