US: Can food be too safe?
Posted: July 5th, 2012 - 6:04pm
Source: FDA Law Blog
We raised this question at the recent ABA Section of Litigation Food & Supplements Second Annual Workshop as a way of commenting on emerging threads of resistance to the imposition of greater food safety-related requirements at all levels of government, but especially at the federal level. It appears that questions are arising as to whether some requirements and restrictions proposed or imposed in the name of food safety go too far. Sometimes the questions are raised in defense of specific foods such as raw oysters and raw milk, but they have also arisen in support of more broad based movements mounted under the banner of food freedom. In some instances, concerns have been expressed about the attendant costs – including potential unintended consequences (e.g., destruction of wildlife habitat and a rise in allergic and autoimmune disorders as a result of efforts to eradicate pathogens from the food supply).
We happily leave it to others to resolve any underlying scientific issues, but it seems to us that the voices of resistance are only likely to increase as implementation of FSMA goes forward and the full impact of that law is felt throughout the chain of food production and distribution. At that point, the issue of how the government assesses progress on food safety could make a bid for center stage. The issue is far from trivial. Two years ago, FDA, FSIS, and CDC held public meetings to gather information on food safety metrics. Shortly thereafter (and presumably coincidentally), CDC published a revised estimate of the toll of foodborne illness which suggested that the previous estimate of deaths associated with foodborne illness was too high – the very same estimate that was bandied about in Congressional deliberations leading up to the passage of FSMA.
Questions as to how the government assesses potential food safety risks also could sharpen. You may recall that FSMA’s provision on preventive controls requires the owner, operator, or agent in charge of a facility to identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility. In some instances, there could be significant divergence between a manufacturer’s and the government’s assessment of whether a given hazard is reasonably foreseeable and thereby worthy of further analysis and possible mitigation. Given the consequences that could flow from that assessment, we expect debates over the standard of “reasonable foreseeability” to be spirited.