The Food and Drug Administration (FDA) on January 4, 2013, two years after the Food Safety Modernization Act (FSMA) was enacted, proposed two sweeping rules aimed at preventing the contamination of produce and processed foods. These proposed rules represent a monumental change in the way the FDA regulates food, which historically involved taking regulatory action after contamination had been identified and foodborne illness had been documented. These proposed rules now shift the regulatory focus of the FDA to prevention from after-the-fact containment based on voluntary recalls, such as recent crises involving contaminated products ranging from cantaloupes to peanut butter.
Some of the significant changes outlined in these two proposed rules include requirements for companies to draft and comply with highly specific food safety plans; to adhere to much more extensive record keeping; and to implement new safety measures, including, for example, requiring that farm workers wash their hands and installing portable toilets in fields, as well as developing corrective action plans for handling outbreaks. FSMA gives the FDA broad new powers, including the authority to mandate that companies recall products as well as the ability to review internal records at farms and food-production plants. For the first time, food-processing companies would be required to design and document an exhaustive program of sanitary measures varying from pest control to what factory workers are allowed to wear while on duty.
The Preventative Controls proposed rule will implement Section 103 of FSMA, which requires food facilities to evaluate hazards, identify and implement preventative controls, verify that the preventative controls are adequate to control the hazards identified, take corrective action when needed and maintain a written food safety plan. The requirements outlined are similar to the Hazard Analysis and Critical Control Point (HACCP) systems that are currently in place for juice and seafood, in which operators of a facility are required to understand the hazards that are reasonably likely to occur in their operation and to put into place controls to minimize and prevent the hazards.
This proposed rule applies to facilities that manufacture, process, pack or hold human food, which means that this generally applies to facilities that are required to register with FDA under Section 415 of the Food, Drug and Cosmetic Act (FDCA). The proposed rule exempts certain facilities, but the rule explicitly states that the FDA may withdraw certain exemptions if it determines it is necessary to protect the public health. Such exemptions may be readily revoked, allowing FDA to reassess its enforcement parameters. Facilities such as warehouses that only store packaged foods and that are not exposed to the environment would not be subject to the proposed rule, nor would other activities that are already governed by established HACCP regulations, such as those involving seafood, low-acid canned food and juice. Dietary supplements would also be exempt as they must comply with the dietary supplement CGMPs (Current Good Manufacturing Practices).
Furthermore, each covered facility would be required to prepare and implement a written food safety plan by a qualified individual (someone who successfully completes training in accordance with a standard curriculum or is qualified by training and experience). Written plans must include a written hazard analysis that identifies and evaluates known or reasonably foreseeable hazards for each type of food manufactured, processed, packed or held at the facility. Each plan must also include preventative controls, including controls for process, food allergen and sanitation, and a recall plan should a hazard be discovered. In addition, facilities will be required to develop monitoring procedures to document and verify that the preventative controls are consistently performed and implemented. In order for the FDA to verify during inspection that these activities have occurred, facilities also will be required to provide FDA with copies of their food safety plans, including the hazard analysis, as well as records of the preventative controls, monitoring, corrective actions and verification procedures.
While food producers would have some autonomy in how they comply, they are still required to adhere to all the provisions laid out in the proposed rule and, should they fail, enforcement action may include mandatory recall of the contaminated product or regulatory correspondence requesting swift corrective action.
The Produce Safety proposed rule is based on Section 105 of FSMA, which directs the FDA to set science-based standards that, if effectively implemented, should minimize the risk of serious adverse health consequences or death from contaminated produce. FDA defined “produce” in a somewhat peculiar way that farmers and producers need to be aware of. In particular, FDA deems “produce” to include fruits and vegetables grown for human consumption, such as spinach, cantaloupe, tomatoes, sprouts, mushrooms, strawberries and tree nuts, such as walnuts and almonds, just to name a few in a very long list. In addition, the rule also applies to mixes of intact fruits and vegetables, such as fruit baskets. Somewhat counterintuitively, however, “produce” does not apply to a long list of raw agricultural commodities that are rarely consumed raw, most notably, potatoes, corn, squash, Brussels sprouts, asparagus, artichokes, beets and eggplant. Nor does "produce" include products produced for personal or on-farm consumption or products destined for commercial processing such as canning, as this process reduces microorganisms of public health concern.
Farmers are now faced with making costly changes to how they conduct business that may include building fences to keep out wildlife, waiting a certain period of time before harvesting crops where domestic animals have grazed to ensure that the crops aren’t contaminated by animal waste, and ensuring and documenting that equipment and buildings are sanitized appropriately. In addition, farmers would have to ensure via periodic testing that all agricultural water used on their crops is safe and of adequate sanitary quality.
This rule, like the Preventative Controls rule, allows for farmers to find alternative means of compliance; however, alternatives will only be considered acceptable if the alternative is scientifically established to provide the same amount of protection without increasing the risk of adulteration. The rule also allows a state or foreign country that imports products into the U.S. to request a modification from some or all of the provisions of the rule, but the request is not automatically granted. Rather, the FDA will take into consideration whether or not granting the modification is necessary in light of local growing conditions, and whether the practices under the proposed modification provide the same level of public health protection without increasing the risk of adulteration.
The expected costs of complying with these new rules is a major concern for industry. FDA has estimated that the overall first-year cost to industry for the Preventative Controls proposed rule will be $701 million, with an annualized cost of $472 million. FDA estimates the annualized cost of the Produce Safety rule at $460 million annually for domestic farms and $170 million for foreign farms, for a grand total of $630 million annually. Many observers believe that FDA has underestimated the costs by a significant degree and that many operations may be forced out of business by the costs and burdens imposed. Specific feedback from industry will be particularly important in helping to shape the final versions of these proposed rules.
The expected costs to FDA and the impact on the budget deficit are also major concerns. FSMA calls on the FDA to increase inspections, particularly at “high-risk” facilities prone to contamination, and to hire about 2,000 new inspectors, of which the estimated cost for the government is $1.4 billion over the first five years. FDA will most likely request congressional authorization for user fees from food companies and farms, which would help pay for the increased oversight costs as mandated by FSMA, increasing the costs further for an industry already faced with looming costs associated with implementation of the rules. It is not inconceivable that many of these costs will be passed onto consumers, driving the cost of food even higher and making it harder for American families to make ends meet.
FDA will consider comments received during the comment period of 120 days from the official publication date of January 16, 2013, at which point it may decide to revise the rules based on the comments prior to issuing the final rule. The effective date for implementation would be 60 days after a final rule is published, with an understanding that compliance dates would be dependent on whether a business would fall into categories of small and very small businesses, in which case it would have additional years to comply.
The issuance of these proposed rules marks the start of what will be a lengthy and challenging rulemaking proceeding. Wiley Rein’s Food & Drug Practice includes seasoned attorneys with FDA experience, including in the development, implementation, and enforcement of FDA’s food safety policies. There are many issues within the rules, and industry may want FDA to modify or relax its proposals around them. FDA may be flexible on some issues, but on others, the agency’s views will be difficult or impossible to change. Knowing where and how to press for reasonable modifications to the proposals is crucial, and our attorneys are uniquely attuned to the dynamics of FDA’s positioning with respect to these policies. We invite affected companies to confer with us regarding options for ensuring your views are fully considered by the FDA as it works to finalize the regulations.
Sonali Gunawardhana and James N. Czaban are Members of Wiley Rein’s Food & Drug Law practice group.
Ms. Gunawardhana draws on her nearly 10 years’ experience as an attorney at the U.S. Food and Drug Administration (FDA) to offer clients detailed and practical guidance on how to avoid and resolve FDA regulatory challenges. Ms. Gunawardhana also served in FDA's Center for Food Safety and Applied Nutrition (CFSAN), where she was immersed in numerous aspects of food safety policy and regulatory implementation related to the recently enacted Food Safety Modernization Act (FSMA), including serving as the lead regulatory counsel and regulation writer on both the Sanitary Food Transportation Act Proposed Rule and the Product Tracing Proposed Rule as required by the FSMA. She can be reached at (202) 719-7454.
Mr. Czaban has extensive experience in government regulation of pharmaceutical, biotechnology, food, medical device and healthcare-related companies. His practice focuses on counseling such clients on complex regulatory strategies and compliance matters, and representing clients in administrative and judicial enforcement actions and other proceedings involving the Food & Drug Administration (FDA) and other federal and state agencies. He can be reached at (202) 719-7411.