In the latest major rulemaking initiative under the Food Safety Modernization Act ("FSMA"), FDA issued a proposed rule to implement provisions of FSMA that address intentional adulteration. Further below we summarize major provisions of the proposed rule. However, we note at the outset that the scope of the proposed rule is limited to acts of intentional adulteration that are high risk, meaning "acts intended to cause massive public health harm, including acts of terrorism." The proposed rule excludes from its scope economically motivated adulteration ("EMA") and acts motivated by an intent to harm a company's reputation. Those types of intentional adulteration would be addressed under the preventive controls rules for human and animal food. Because the proposed preventive controls rules currently do not address intentional adulteration, FDA "plans to provide new language and an analysis of costs" associated with any intentional adulteration provisions added to those rules, and to seek comment.
Folding intentional adulteration provisions into the preventive controls rules would place the burden on facilities covered under those rules to identify hazards related to EMA that are reasonably likely to occur, "for example, when obtaining certain ingredients from a country in which [EMA] has occurred in those ingredients in the past." In the case of a well-known economic adulterant such as melamine, EMA might be judged as reasonably likely to occur "even if there is no known history regarding the specific supplier or the specific food product." The potential for EMA of products exempt from the preventive controls rules (namely seafood, juice, and dietary supplements) would be addressed through amendment of the HACCP and GMP regulations specific to those products.
Establishment and maintenance of certain records.
Certain types of activities would be exempt, including holding food (except liquid storage tanks), activities subject to FDCA 419 (produce safety), further manufacturing activities where the food's immediate container remains intact, and manufacturing, processing, packing, or holding of animal food.
From which entities would implementation of measures to protect against intentional adulteration derive the greatest benefit to public health protection? How could this proposed regulation be modified to better target such entities?
Would it be feasible to require measures to protect against intentional adulteration only in the event of a credible threat? If so, would such an approach be consistent with the intentional adulteration provisions of FSMA? How would such requirements be communicated to industry in a timely and actionable manner?
What is an appropriate level of public health protection with respect to intentional adulteration, considering the intentional adulteration provisions of FSMA?
Are there other ways to further focus the scope of the rule?
FDA also requests comment on the scope of any exemption for certain activities conducted by small or very small businesses.
According to FDA's economic analysis, the proposed rule carries an estimated $370 million price tag. The benefits – namely "reduction in the possibility of illness, death, and economic disruption resulting from intentional adulteration of food" – are not quantifiable. However, the economic analysis examines various scenarios in which the prevention of attacks would yield benefits that exceed costs. Also, the preamble to the proposed rule notes that melamine contamination is estimated to have cost the Chinese dairy industry $3 billion in losses. Comments are due by March 31, 2014.