MANAGING FDA AND USDA COMPLIANCE
RC: To what extent will the issuance of regulations to implement the Food Safety Modernization Act (FSMA) alter the way in which food and beverage companies do business? How will the FSMA transform the FDA’s enforcement of safety standards?
Krasny: The impact of the final FSMA regulations on food and beverage companies will vary, depending on the scope of food safety plans that were in place before FSMA, and any plans that were developed based on the proposed regulations. Regarding enforcement, the nature of inspections will change significantly when FSMA is implemented, shifting from mainly a summary of FDA’s observations to a focus on the audit of documents. In keeping with the statute’s purpose, FDA’s inspections also are likely to evaluate the effectiveness of the preventive controls that were adopted, in addition to reviewing a company’s ability to detect and respond to food safety problems. It is critical that FDA issues clear enforcement standards and adequately trains inspectors, federal and state, to ensure consistent determinations that alleged deficiencies in a company’s food safety plan constitute a violation of FSMA.
Condra: FSMA impacts food and beverage companies in two major ways. First, these companies are subject to additional regulatory burdens – for example, new food safety plans and increased recordkeeping requirements. Second, these companies are experiencing a culture shift around food safety. There is an increasing recognition at the top levels of business of the responsibility of company management at all levels to be aware of the business’ food safety activities. In recent cases involving major food-borne illness outbreaks, FDA brought criminal actions against top executives related to failures in the companies’ food safety practices. Companies may also find themselves working with new entities related to food safety compliance, as FDA is increasing its partnerships and collaborations with other public and private actors in order to effectively accomplish its goals with limited resources. Finally, as the scope of FDA’s role has grown, it is now increasingly interacting with farm gate processors. In this new role, FDA is still learning how to deal more successfully with these operators that are more commonly associated with production agriculture and with baseline conditions that may typically be remedied downstream in the supply chain.
Oct-Dec 2015 Issue
Davis Wright Tremaine LLP
Keller and Heckman LLP
Polsinelli