Wednesday 24 January 2018

FDA Annouces Significant Overhaul of Proposed Produce Safety Rule

The US Food and Drug Administration (FDA) announced today it will seek significant changes to key provisions of the proposed produce safety rule issued under the Food Safety Modernization Act (FSMA). The announcement follows  Michael R. Taylor,  FDA’s Deputy Commissioner for Foods and Veterinary Medicine, tour of farms earlier this year. It also comes on the heels of of Congressional and industry push back on FSMA. Just three weeks ago 75 members of Congress signed a letter to the FDA complaining about the impact of the produce safety rule on constituents. It appears the uproar has not gone unnoticed. From today’s announcement:


To achieve this goal [of food safety], we believe that significant changes will be needed in key provisions of the two proposed rules affecting small and large farmers. These provisions include water quality standards and testing, standards for using raw manure and compost, certain provisions affecting mixed-use facilities, and procedures for withdrawing the qualified exemption for certain farms. We have heard the concern that these provisions, as proposed, would not fully achieve our goal of implementing the law in a way that improves public health protections while minimizing undue burden on farmers and other food producers.

The FDA went on to announce it expects a revised rule in the summer of 2014. The revisions will then be subject to a comment period, which like all other FSMA rules has been extend beyond the traditional 60-90 day time frame. This means it may not be until early 2015 before the produce safety rule goes into effect.

The produce safety rule is at the heart of the Food Safety Modernization Act, enacting reforms for the first time on farms. Once finalized it will be the first serious regulation of the growing and harvesting of produce since the enception of the Food and Drug Act. The FDA is under pressure to both quickly enact a rule, such as the lawsuit it faces for missing required rule deadlines, and pressure to enact the least burdensome rule possible. This is a precarious balance to strike and one that appears to require more time.

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