â€œWhat™’s Next?â€ has the pleasure of interviewing San Francisco-based Chris Van Gundy, a partner in Keller Heckman™’s Litigation and Food and Drug Practices. Chris and his colleagues focus on food law litigation, regulation, and policy, including class actions, product liability defense, supply chain liability and authenticity (â€œfood fraudâ€) issues, false advertising and food marketing claims, brand protection, trademark disputes, distribution disputes, and development and enforcement of food standards.
Chris, we very much appreciate your time.Â What are the big trends in food safety policy and litigation that smart companies and institutions should be preparing for?Â
Perhaps the chief trend for smart food companies is to embrace not only the letter, but the spirit of, FDA™’s new food safety system embodied in the FDA Food Safety Modernization Act (â€œFSMAâ€) and its implementing regulations. As many companies know already, the regulations completely revamp food safety procedures with a focus on prevention, verification and documentation. The regulations for preventive controls for human food have a compliance deadline in September of this year. The regulations have been in the works for some time, and so this is not news for the larger companies. However, by â€œspirit,â€ I mean that many smart companies are obtaining food safety certifications from independent auditors such as SQF and BCR. These certifications may in some cases go beyond what is required in FSMA, and they serve as a disciplined way to deploy a compliance program.Â
What should institutions know about the latest food-borne recall developments?
Another major trend in food regulation is food-borne pathogen outbreaks and recalls. Almost every week one reads of events, which often involve strains of Listeria or Salmonella. Grand jury subpoenas and criminal prosecutions are also on the rise in the wake of these events. Smart companies will have in place a recall program as part of their food safety plan, should have adequate insurance in place, and skilled counsel lined up in advance. Insurance is available, and sometimes will provide for a significant premium discount for recall training. Given the concern for human safety, the window for determining whether a recall is necessary can be narrow, so having in place a plan, properly trained employees, skilled counsel and adequate insurance can make a huge difference in the success of the company.
What else can companies do to prepare for a recall?Â
Another aspect of recall preparedness is of course prevention. FDA and the Centers for Disease Control are employing increasingly more sophisticated tools to â€œtrace backâ€ and â€œtrace forwardâ€ the origin of a pathogen. It is essential that food companies have in place not only a rigorous food safety plan mandated by FSMA, but aggressive product and environmental testing protocols, as well as a supplier verification program. While compliance is laudable (and required), prevention is the key. FSMA requires a searching validation of suppliers from outside the US, but companies should develop their own programs to ensure with certainty that their foreign and domestic suppliers are doing everything they can to avoid a food-borne illness outbreak or recall. Obtaining meaningful indemnity agreements from suppliers, and getting added as an â€œadditional insuredâ€ under a supplier™’s insurance, when done correctly, are also ways smart companies can protect themselves.Â