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Update on Proposed Rules under the FDA Food Safety Modernization Act (March 19, 2014 )

FDA appreciates the extensive input it has received and continues to receive on the various proposed rules under the FDA Food Safety Modernization Act (FSMA). The Agency is committed to providing adequate time to comment on proposed rules while recognizing the need to meet court-ordered deadlines for final rules.

Based on stakeholder requests for additional time to comment on the proposed rule on mitigation strategies to protect food against intentional adulteration, and the accompanying draft qualitative risk assessment, FDA will soon announce a 90-day extension of the comment period for both documents to June 30, 2014. 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. FDA will announce the extensions in the Federal Register and will issue CFSAN Constituent Updates to inform stakeholders.

On December 19, 2013, FDA announced that it would propose revised rule language for key provisions of the two proposed rules affecting farmers and would publish revised language in early summer 2014. This decision was based on public input that led FDA to believe that significant changes would be needed in key provisions of the proposed rule on produce safety and the proposed rule on preventive controls for human food. Because the proposed rule on current good manufacturing practice and preventive controls for food for animals is a companion rule to the proposed rule on human food, FDA is announcing that it will publish revised language for this proposed rule as well. For that reason, the comment period for the proposed rule on animal food, which ends March 31, 2014, is not being extended.

See FSMA Rules & Guidance for Industry, for addtional information on the proposed rules.

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