The American Herbal Products Association (AHPA) submitted comments last week that urge the Food and Drug Administration (FDA) to significantly modify its proposed rule implementing the "Focused Mitigation Strategies to Protect Food Against Intentional Adulteration" requirements established by the FDA Food Safety Modernization Act (FSMA).
AHPA's nearly 30 pages of comments and recommended revisions express concern that regulations that require exclusive use of focused mitigation strategies would not be more effective than requiring use of broad mitigation strategies and that the proposed approach would be far more burdensome for the industry, especially smaller companies. Due to the significant changes needed, AHPA strongly urges FDA not to make the next step a final rule, but rather to publish a second set of proposed rules and invite additional comments specifically on any new or significantly changed provisions.
AHPA's comments note that, despite asserting that focused mitigation strategies are necessary and effective, FDA offers no supporting data. In its comments, AHPA recommends replacing the proposed rule with regulations requiring use of broad mitigation strategies because it could be more (or at least as effective as) use of focused mitigation strategies and less burdensome to implement.
"Based on the input of members with experience working in warehouses and on the production floor of food manufacturing facilities, there are various ways that the focused mitigation strategies are impractical and expensive to implement," said AHPA President Michael McGuffin. "Because the proposed Rule is also relatively vague, it is susceptible to idiosyncratic interpretations by management, consultants, and FDA officials."
AHPA's comments warn that many small companies will not be able to afford implementing the kinds of focused mitigation strategies contemplated by FDA's proposal. FDA proposes exempting businesses with less than $10 million in total annual food sales (by defining such companies as "very small businesses"). AHPA notes that this would leave an inappropriately broad range of companies subject to the rule.
"AHPA strongly urges FDA to extend the range of companies exempted from the Rule, as there is little benefit to be gained by imposing this costly rule on hundreds or thousands of smaller companies," McGuffin said.