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  1. CFSAN Constituent Updates

Stakeholders Will Be Able to Comment on First Two Volumes of the Intentional Adulteration Rule Draft Guidance Together

Constituent Update

December 4, 2018

If you plan to comment on the first installment of the three-part draft Intentional Adulteration (IA) Rule guidance, you will have an additional opportunity to do so. Although the closing date for public comment on the first installment is December 17, the U.S. Food and Drug Administration (FDA) intends to ask for comments on both the first and upcoming second volumes during the comment period after the second installment of the draft guidance is issued.

In June, the FDA released the first installment of the draft guidance designed to support compliance with the IA Rule under the FDA Food Safety Modernization Act (FSMA). This rule is aimed at preventing intentional adulteration of food designed to cause wide-scale harm to public health, including terrorism targeting the food supply.

The second installment of the draft guidance will be presented in early 2019 alongside the first installment, so that the public can view content from both together. The FDA wants to give stakeholders an opportunity to consider the available guidance materials when drafting their comments. When the second installment is published, there will be an additional 120 days to comment on the expanded guidance. It’s important to note that regardless of closing dates, the public may comment on an FDA guidance document at any time.

The first compliance date for larger businesses under the IA Rule is July 26, 2019.

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