FDA Takes on Intentional Adulteration

As required by the Food Safety Modernization Act, FDA has published a proposed rule that would require registered food facilities to implement food defense plans to reduce the risk of intentional adulteration.

The proposed rule represents FDA’s first attempt to establish regulatory requirements to address intentional adulteration of food.  As the preamble states: “We acknowledge that regulation of entities in the food production system (in this case, facilities) to reduce the risk of intentional adulteration of food caused by acts of terrorism is, essentially, without precedent.”

As FDA also acknowledges, the problem the proposed rule is intended to address, intentional adulteration, is “exceedingly rare.”  FDA says there have been only several documented cases in the United States and mentions only three of them, though there have undoubtedly been more incidents overseas.  FDA characterizes intentional contamination of food as a low-probability, but high-consequence risk.

Nevertheless, FDA is proposing to create a fairly elaborate regulatory regime to address that “exceedingly rare” risk.  Its key features include the following:

• The proposed rule would only address the risk of terrorism, not other forms of intentional adulteration.  It would not address economically motivated adulteration (EMA), which FDA has tentatively decided to address in the preventive controls rules for human food and animal feed.  It also would not address tampering by disgruntled employees, consumers, or competitors, which FDA says generally poses a much smaller safety risk and does not require any separate regulatory requirements.

• FDA is proposing to apply a HACCP-type approach to intentional adulteration.  Domestic and foreign facilities that are required to register with FDA, unless exempt, would be required to have a written food defense plan.  Specifically, covered facilities would be required to:
  • Conduct a vulnerability assessment, or identify whether any steps in its process involve any of four “key activity types” (i.e., bulk liquid receiving and loading, liquid storage and handling, secondary ingredient handling, mixing and similar activities);
  • Identify “actionable process steps” where measures can be applied to control a “significant vulnerability” to intentional adulteration;
  • Implement “focused mitigation strategies” at each actionable process step;
  • Monitor the focused mitigation strategies;
  • Take corrective actions when a focused mitigation strategy is not properly implemented;
  • Verify implementation of focused mitigation strategies, monitoring, and corrective actions; and
  • Maintain records documenting all of the above.

• The proposal would not require any broad mitigation strategies (i.e., facility-wide measures, such as installing a perimeter fence around the plant).  Many such broad mitigation strategies are outlined in FDA guidance documents, and the agency encourages their adoption.  But, the proposed rule would only require focused mitigation strategies at actionable process steps.

• Businesses with less than $10 million in annual sales of food would be exempt.  They would be defined as “very small businesses” and would only be required to maintain documentation showing that they meet the definition of a “very small business.”  This is a much higher threshold than FDA has proposed for “very small businesses” in other FSMA rulemakings, but FDA believes that terrorist attacks are likely to focus on large, name-brand businesses, not small or medium-sized businesses.

• Other exemptions include facilities not required to register with FDA (e.g., restaurants, transportation carriers), animal feed operations, and warehouses (unless they include liquid storage tanks).  While farms that are not required to register with FDA are generally exempt, FDA is considering adding special requirements applicable to dairy farms.

The proposed rule raises a few questions:

1. Is it really necessary to require a HACCP approach to intentional adulteration with all that it entails?  In particular, is it really necessary to require another layer of paperwork (including a food defense plan, monitoring records, corrective action records, verification records, and training records) for food defense?  Is it possible that requiring so many records that will describe, in considerable detail, a facility’s food defense plan and its implementation could actually be counter-productive?  Could such records increase the risk of a successful terrorist attack if they were to fall into the wrong hands?
2. Will all of the focused mitigation strategies FDA has in mind be feasible?  While bulk liquids have long been recognized to pose a risk of intentional adulteration, the vulnerabilities posed by rework and in-process materials, staging of ingredients, and mixing operations are likely to be more difficult to control.
3. FDA acknowledges that focused mitigation strategies may not be amenable to scientific validation in the same way that preventive controls are.  According to FDA, “focused mitigation strategies for food defense… often are not of a nature that they can be scientifically validated.”  However, FDA is proposing that facilities verify that their focused mitigation strategies are effectively controlling significant vulnerabilities.  How can a facility be expected to verify what it cannot validate (i.e., that its mitigation strategies are effective)?
4. Is this really what Congress had in mind?  If Congress intended FDA to issue regulations requiring the food industry to implement food defense plans for nearly all foods, why does Federal Food, Drug, and Cosmetic Act Section 420 explicitly limit the coverage of FDA’s food defense regulations to foods specifically designated as being at high risk of intentional adulteration?  Or is the exemption of businesses with annual food sales of less than $10 million meant to be FDA’s way of designating foods at high risk of intentional adulteration, as required by Congress?

The preamble to the proposed rule requests comments on many issues, suggesting that this proposed rule, even more than usual, is not written in stone.