FSMA and Intentional Adulteration: FDA Issues Proposed Rule and Signals Approach to Economically Motivated Adulteration

By Ricardo Carvajal –

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.

Turning to the proposed rule on intentional adulteration, that rule would require registered food facilities to implement a HACCP-type system of controls to prevent high risk acts of intentional adulteration.  Failure to comply with the requirements of the rule would constitute a prohibited act.  The rule would require facilities to prepare and implement a written food defense plan that incorporates the following, as appropriate:

• Identification of actionable process steps, meaning “a point, step, or procedure in a food process at which food defense measures can be applied and are essential to prevent or eliminate a significant vulnerability or reduce such vulnerability to an acceptable level” (an actionable process step is analogous to a critical control point under HACCP);
• Identification and implementation of “focused mitigation strategies at each actionable process step to provide assurances that the significant vulnerability at each step will be significantly minimized or prevented and the food manufactured, processed, packed, or held by the facility will not be adulterated” (a focused mitigation strategy is analogous to a preventive control under HACCP);
• Establishment and implementation of procedures for monitoring focused mitigation strategies;
• Establishment and implementation of corrective action procedures when there is a failure to properly implement focused mitigation strategies;
• Verification activities; 
• Training of personnel;
• 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.

FDA acknowledges that the imposition of regulatory requirements to reduce the risk of intentional adulteration is unprecedented, and that the agency’s “endeavor is further complicated by the low probability and potentially high impact nature of such an attack which makes estimating potential public health benefits and establishing an appropriate threshold for requiring action difficult.”  FDA further acknowledges that the agency is “challenged by the paucity of data on the extent to which facilities have already implemented programs to mitigate this risk, and the effectiveness of various strategies to prevent intentional adulteration of food caused by acts of terrorism.”  For these reasons, FDA specifically requests comment on the following issues:

• 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.