Importantly, the law gives FDA authority to demand access to a written plan that describes the procedures put in place as well as the required recordkeeping during an inspection or at any other time. For the past several years, FDA has issued a significant number of warning letters to seafood processors following inspections, citing their failure to have and implement a written HACCP plan. One predictable consequence of the new law is the extension of this type of warning letter to all other food processors. In egregious cases, or after repeated warnings, FDA may seek to suspend a facility's registration.
Not later than 18 months after the effective date of FSMA (i.e., not later than July 2012), FDA is required to adopt regulations to establish standards for hazard analysis and preventive controls. FSMA's provisions regarding hazard analysis and preventive controls go into effect at this same time.
The new legislation directs FDA, in coordination with USDA, to determine the most significant foodborne contaminants at least every two years. Based on this review, and when appropriate to reduce the risk of serious illness or death to humans or animals, FDA is to issue contaminant-specific, science-based guidance documents or regulations aimed at controlling these contaminants, which may include action levels. This may result in mandatory preventive controls and new limits for microorganisms, heavy metals, and other contaminants.
Tracking and tracing
The new law does not establish new traceability requirements for food ingredients, but it takes a big step in this direction. It directs FDA to establish pilot projects in coordination with the food industry to explore methods to rapidly identify recipients of food that may be contaminated. Watch for new traceability requirements to follow.
Fees and funding
The price tag for FDA's implementation of these provisions has been estimated by the Congressional Budget Office at $1.4 billion over the next five years. This includes FDA's hiring of 2,000 new inspectors.
Earlier versions of the law would have had a significant portion of this expense borne by the food industry in the form of new user fees. As enacted, however, the law allows FDA to collect only modest fees. Fees may be collected from facilities subject to reinspection and from responsible parties who fail to comply with recall orders, for example. FDA's ability to fully implement the law will obviously depend on adequate Congressional appropriations.
This overview is aimed at highlighting several features of the new law of interest to food processors. It is not a comprehensive overview. Food processing facilities should promptly review their operations with a complete checklist of compliance issues raised by the new law.
Food processors should also pay attention to developments in the area of FDA funding. Some features of the new law, notably the requirement of more frequent inspections, obviously cannot be carried out without new resources. Others, such as FDA's mandatory food recall authority, are not dependent on new appropriations.
Finally, the law is noteworthy for at least one item it does not include. Consumer advocates and some in Congress have long called for the creation of a single food agency, one that would combine the food regulatory functions of FDA, USDA and others under one large roof. This idea has been rejected and hopefully put to bed as a costly and unnecessary reshuffling, not likely to have a real impact on food safety.