Congress recently enacted and the President signed into law the most sweeping reform of food safety regulation in many decades. Known as the FDA Food Safety Modernization Act (FSMA), the new law includes several new items for FDA's enforcement toolbox that have long been sought by consumer advocates.
Following are seven things you should know about the new provisions and their impact on food processors.
FDA now has legal authority to order the recall of dangerous foods. Up until now, FDA has had authority to order the recall of infant formula, but could only ask, not demand, that other foods be recalled.
Under its new authority, the agency can order a responsible party to recall a food product if there is a reasonable probability the food is adulterated or misbranded and its use "will cause serious adverse health consequences or death to humans or animals." This quoted language matches the criteria for a Class I recall, the most serious type, as long defined in FDA's regulations.
Under the new provisions, FDA must first provide the responsible person with an opportunity to cease distribution and recall the product voluntarily. If the responsible person fails to do so on FDA's timeline, FDA may issue an order requiring an immediate recall. The responsible person may dispute FDA's recall order at an informal hearing. Civil penalties and fees may be assessed against any person who does not comply with a recall order.
It is difficult to imagine a food manufacturer — under normal circumstances — declining the opportunity to conduct a "voluntary" recall and instead waiting for issuance of a mandatory recall order. It is further difficult to imagine a food manufacturer prevailing at a hearing to dispute a recall order, unless FDA is operating under a very significant factual error. In practice, food manufacturers facing this situation will want to be seen as cooperating with FDA and will be concerned primarily with retaining consumer confidence in their products.
For these reasons, it is likely FDA will not actually issue many recall orders. The existence of this authority, however, changes the landscape. It is now more important than ever for food manufacturers to have standard procedures in place so recalls can be initiated promptly and effectively. FDA's new mandatory recall authority became effective immediately when President Obama signed the FSMA into law on Jan. 4.
The new law states that FDA shall increase the frequency of inspections at all food processing facilities. More specifically, domestic facilities identified as high-risk are to be inspected at least once in the five-year period following the date of enactment and at least once every three years thereafter. All other domestic food processing facilities are to be inspected at least once in the seven-year period following enactment and at least once every five years thereafter.
FDA is further instructed to increase inspection of food at ports of entry, which can be expected to lead to more shipments of food and food ingredients detained upon import. To meet these goals, FDA may rely on inspections carried out by other federal, state or local officials.
Facility registration and suspension of registration
Since the Bioterrorism Act of 2002, food processors have been required to register their facilities with FDA. Under the new provisions, these registrations will need to be renewed every two years. Registrations also will need to include an assurance that FDA will be permitted to inspect the facilities.
Most significantly, FDA now will be able to suspend the registration of a facility if it determines that food manufactured at the facility has a "reasonable probability of causing serious adverse health consequences or death to humans or animals." If a facility's registration is suspended, food from the facility cannot be introduced into interstate commerce in the U.S. This is similar to USDA's longstanding authority to withdraw inspection from a meat processing facility, effectively shutting it down.
The agency is required to adopt regulations to implement these provisions. Facilities will be subject to these requirements either on the date when FDA issues its implementing regulations or 180 days after enactment of the new legislation (i.e., this July) whichever comes sooner. It is likely July will come sooner than FDA's issuance of the regulations.
The impact of this authority on food processors is potentially significant, as it places a very powerful enforcement tool in the agency's hands. Even the implied threat of a registration suspension will likely draw concessions from an affected food processor.
HACCP and risk-based preventive controls
The new law requires every food processor to evaluate known or reasonably foreseeable hazards that may be associated with a facility, develop a written analysis of the hazards and identify and implement preventive controls. This is similar to the hazard analysis and critical control points (HACCP) programs that are currently mandatory for juice and seafood, but allows for the possibility that some operations will not include critical control points.
Food processing facilities will be required to monitor the effectiveness of their preventive controls, verify their adequacy, and undertake a periodic re-analysis of their plans. Facilities also will be required to maintain records for not less than two years documenting their monitoring of preventive controls and instances when corrective actions were implemented.