The Food and Drug Administration announced on Monday that it would extend the comment period for the proposed Food Safety Modernization Act rule on food defense. The “Focused Mitigation Strategies to Protect Food Against Intentional Adulteration” addresses potential acts of terrorism that could cause massive public harm and economic disruption, and focuses on processes that are likely to occur at most food manufacturing facilities.
In the Federal Register notice, FDA said it received numerous requests for an extension to allow stakeholders more time to analyze the proposed approaches and consider their full operational and economic impact. FDA also wants to ensure that the proposal is flexible enough to address the many types of food operations that will be affected.
As currently written, the proposed rule would require each facility to prepare a Food Defense Plan that would include a review of whether the facility has one or more key activity types and, if so, identify focused mitigation strategies and procedures for monitoring, taking corrective actions and verifying activities. Companies would be required to document all food defense activities, and these documents would be subject to FDA inspection.
The new deadline for comments is June 30, 2014. IDFA is concerned with some of the aspects of the proposed rule and welcomes the additional time to explore better alternatives.
FDA also is extending the comment period on the designation of high-risk foods for tracing until May 22, which provides an additional 45 days for comment. This document requests comment on the proposed methodology for determining which foods are high risk.
According to “FDA’s Draft Approach for Designating High-Risk Foods,” FDA is considering classifying foods for the risk ranking based on the 28 categories of food included in the Reportable Food Registry. That means all dairy products would fall into under one category for dairy, and “representative foods” would be selected and used in the model.
The high-risk designation would be based on a comprehensive evaluation of a set of criteria, including outbreak frequency, illness occurrence, severity of illness, the likelihood of microbial or chemical contamination, potential for the food to support pathogen growth, food consumption patterns, the probability of contamination and steps taken during manufacturing to reduce contamination.
“IDFA is opposed to FDA using the broad categories mentioned in the model,” said Clay Detlefsen, IDFA vice president of regulatory affairs and FSMA expert. “We want to see further refinements to FDA’s approach to avoid any negative impact on foods without associated high risks. Our preferred approach is for FDA to utilize the category designations in the Food Facility Registration database. Hopefully FDA will see the wisdom in making the two consistent.”
IDFA will work with members to draft and submit comments on the proposed food defense rule and the document on high-risk foods.
For more information, contact Detlefsen at email@example.com.