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FDA Should Make ‘Significant Revisions’ To Food Defense Proposal: IDFA, NMPF


In light of the “significant revisions” that they are recommending to the Food and DrugAdministration’s (FDA) proposed food defense rule, the National Milk Producers Federation (NMPF) and International Dairy Foods Association (IDFA) want the agency to publish a re-proposal of the proposed rule that allows an opportunity for stakeholders to comment on any modifications FDA plans to make in response to comments.

FDA had published its proposed rule on “Focused Mitigation Strategies to Protect Food Against Intentional Adulteration” in December of 2013, with a 90-day comment period that was later extended by another 90 days, to June 30, 2014.

Under the proposed rule, a food facility would be required to have a written food defense plan that addresses significant vulnerabilities in its food production process. Facilities would then need to identify and implement strategies to address these vulnerabilities, establish monitoring procedures and corrective actions, verify that the system is working, ensure that personnel assigned to the vulnerable areas receive appropriate training, and maintain certain records.

As FDA itself has recognized, food defense is different from food safety, both from scientific and risk-analysis perspectives, and therefore the two issues should be approached differently in FDA’s regulations, NMPF and IDFA noted. Food safety is grounded in scientific knowledge in the natural science areas, such as microbiology, toxicology and chemistry, while food defense is based more on social sciences, such as criminology, and is not readily quantifiable because of the inexact nature of the subject matter.

Another area of divergence is the approach to analyzing risk, NMPF and IDFA continued. Food safety is focused on analyzing whether a risk is “known or reasonably foreseeable” or “reasonably likely to occur,” while food defense deals with threats that are not known, reasonably unforseeable, or not reasonably likely to occur.

The second major concern that IDFA and NMPF have with the proposed rule is that it does not encourage facilities to engage in a thoughful, tailored analysis of the specific threats that could affect the food they process.

The final “macro” concern that NMPF and IDFA have about the proposed rule is the proposed approach of distinguishing between broad and focused mitigation strategies. Under the proposed rule, only focused mitigation strategies are required. However, in the proposed rule’s preamble, FDA recognizes the importance of broad mitigation strategies and suggests it is “prudent” for facilities to implement such strategies.

Recommended Revisions
NMPF and IDFA support a regulation that sets a broad requirement for every facility to analyze threats, identify vulnerabilities, and implement mitigation strategies in a tailored manner that best fits its own circumstances. The regulation should encourage facilities to be proactive, such that they take action when needed, but also to consider food defense in the Send more more information