The ever-changing face of food safety and regulation has prompted Leavitt Partners, Faegre Baker Daniels (formerly Faegre & Benson) and FaegreBD Consulting (formerly B&D Consulting) to join forces in providing companies involved in the global food supply chain with a collaborative solution to food safety management. This joint effort offers guidance to companies seeking to navigate the shifting food safety challenges of today’s systems, and the new regulations resulting from the passage of the 2011 Food and Drug Administration Food Safety Modernization Act (FSMA).
The three collaborating partners have created a hypothetical situation for Feed & Grain magazine to describe how they would help companies effectively manage risk and meet the challenges in the food safety arena. When working with a joint client, the three organizations will operate together and through this synergism are able to provide a unique and powerful set of solutions to cover all aspects of a potential food safety issue.
Imagine this situation: A feed additive in the swine chain has some contaminant/adulterant that could impact the ultimate meat product, and may have entered into the consumer supply chain.
A legal perspective
Potentially contaminated or adulterated animal feed fed to swine can have varying legal implications ranging from customer management and regulatory compliance to complex litigation. Experienced legal counseling and representation is critical given the broad and varied implications of food safety issues, including regulatory enforcement and private litigation.
As soon as the client is aware of the feed additive that may have been contaminated or adulterated, Faegre Baker Daniels works with that client to create a response plan and engage in risk management. Faegre Baker Daniels is prepared to advise the client on supply chain management issues, counseling and reporting requirements, recall plans, avoiding or preparing for potential FDA enforcement actions, handling commercial claims and litigation arising from food contamination, addressing recall labeling issues, and advising on food labeling and recordkeeping requirements. Particularly important in this scenario, Faegre Baker Daniels will assist in navigating the complex jurisdictional and regulatory issues that arise when both U.S. Food and Drug Administration (FDA) (which regulates feed) and the United States Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) (which regulates meat) are involved in a food safety issue.
The first step would be to work with the client to fully understand the background and facts surrounding the potential contamination to estimate the breadth of the legal implications involved. From there, Faegre Baker Daniels’ experience with the relevant statutory scheme and agency guidance statements, and its deep experience with handling these crises for clients, will help the client understand what issues it may face in dealing with regulators. This evaluation is critical in assisting the client to determine what steps come next.
The next step would be to review the immediate required actions; for example, whether there are reporting requirements to FDA, such as to the Reportable Food Registry. Faegre Baker Daniels will also help the client assess the likelihood of a recall — to know if recall is necessary and, if so, to guide the client through each step of that recall procedure. This includes counseling on necessary steps during the process to minimize exposure to commercial and consumer claims, working with agencies to negotiate the least costly actions moving forward, and helping to obtain insurance coverage, if available.
Faegre Baker Daniels also assists in appropriate communication of the legal issues with customers of the potentially adulterated product. This is critical in managing downstream risk. If other litigation arises, such as food-borne illness litigation, consumer lawsuits, or other commercial claims, Faegre Baker Daniels is able to handle each step through the litigation process.