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IDFA and NMPF File Comments on FDA’s Intentional Adulteration Rule

Jul 02, 2014

IDFA and the NMPF together have submitted extensive comments on the Food and Drug Administration’s (FDA) proposed rule “Focused Mitigation Strategies To Protect Food Against Intentional Adulteration.” The rule would require registered domestic and foreign food facilities to address hazards that may be intentionally introduced.

“While IDFA and the National Milk Producers Federation (NMPF) support FDA’s efforts, we also want FDA to be mindful that the proposed rule is the first of its kind,” said Clay Detlefsen, IDFA vice president of regulatory affairs and counsel. “We want to make sure that FDA is aware of the success that voluntary efforts in this area have achieved without any regulation as there has been neither a credible threat against, nor any incident of massive public health harm involving the U.S. food supply since 9/11.”

Together NMPF and IDFA have asked FDA to publish a re-proposal that gives stakeholders an opportunity to comment on any modifications the agency plans to make in response to submitted comments on the proposed rule.

The groups’ comments on the proposed rule center on issues including:

  • The context of the current circumstances surrounding intentional adulteration, the state of the intelligence and how FDA can communicate it to the dairy industry, and the dairy industry’s use of mitigation strategies.
  • A recommended approach that requires every registered facility (unless exempt) to conduct a vulnerability assessment and then implement mitigation strategies for any significant vulnerabilities that were identified, applying practical and tailored management oversight as needed. It should be acceptable for the vulnerability assessment to be conducted prior to publication of the final rule, and FDA should deem a facility to be in compliance if that facility participated in a government-led vulnerability assessment process.

”The dairy industry already has robust mitigation strategies in place,” said Detlefsen. “We do not believe there is a high risk, and are asking FDA to address the lower risk in guidance.”

“In light of the significant revisions that we are recommending for the regulation, FDA should publish a re-proposal that allows an opportunity for stakeholders to comment on any modifications the agency plans to make in response to comments,” the submitted comments concluded. “This approach not only would be equitable, but also would be consistent with the agency’s plans for other significant Food Safety Modernization Act (FSMA) regulations.”

For more information, contact Detlefsen at cdetlefsen@idfa.org.
 
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