YOUR SOURCE ON FOOD LITIGATION AND REGULATION

What recourse do businesses have when their products are incorrectly identified as the source of a foodborne illness outbreak? For the time being, it appears that the answer to that question is “very little.” In a recently dismissed lawsuit concerning FDA’s 2008 warnings linking tomatoes to a Salmonella outbreak in New Mexico and Texas, which proved to be wrong, a federal court held that the government’s error did not constitute a regulatory “taking” under the Fifth Amendment, even though the warnings had significant financial impact on the marketplace. Despite the court’s decision, and its impact on prospective regulatory takings claims, a compensation provision under the Food Safety Modernization Act (FSMA) provides a potential avenue of recourse for farmers, and it is likely that litigants will test this compensation theory in the future.

New regulations for poultry inspection from the USDA’s Food Safety and Inspection Service (FSIS) may end its long, acrimonious struggle to modernize the existing status quo. Given the competing interests surrounding the initiative, compromise was inevitable—and compromise is precisely what everyone got. As previously proposed, the rule would have mandated universal changes in the inspection system. The proposed rule directed all poultry slaughterers to initially examine and screen birds for cosmetic and other nonsafety-related defects—traditionally the role of USDA inspectors—and maintained the core government responsibility to identify problems associated with animal disease and other forms of product contamination. This system has been in effect—and successful—on a voluntary basis for more than a decade within the context of so-called pilot programs.

The Food Safety and Inspection Service (FSIS) recently proposed a rule that, if adopted, will require both processing establishments and retail facilities that grind raw beef products to maintain records in a newly prescribed format. That format will delineate source materials and the identity of suppliers as well as any carryover from one production lot to the next. Our FDA Practice discussed the details and implications of the rule, which was proposed in July, in a Food Industry LawFlash.

The proposed rule represents a significant new recordkeeping requirement at the retail/grocery level and should be examined closely by such businesses. Submitted comments to FSIS detailing potential recordkeeping burdens and logistical concerns will be important to ensure that the proposal balances practical considerations with the intended food-safety goals.