Another phase complete in process to finalize food safety regulations

Another phase complete in process to finalize food safety regulations

FDA takes in comments on re-proposed Food Safety and Modernization Act rules

The U.S. Food and Drug Administration last month took in comments on revised portions of its Food Safety and Modernization Act proposals, completing another leg of a marathon-like process that has extended from the President's signature on FSMA in 2011.

The comments, which closed Dec. 15, centered on three re-proposed rules that would establish safety requirements for human food, animal feed and pet food.

Related: FDA Will Delay Food Safety Reforms on Farmer Concerns

FDA takes in comments on re-proposed Food Safety and Modernization Act rules

FDA made changes to the three initial proposals after stakeholders and ag groups identified several key issues. Among the groups' concerns were small farm restrictions that some said conflicted with existing conservation and environmental standards and new controls on traditional animal feed practices like feeding spent brewers' grains to animals.

Commenting on the revised rules, the National Grain and Feed Association on Monday in a released statement said FDA should:

• make practical safety revisions to avoid "unnecessary requirements" that would increase industry's costs of complying with regulatory obligations that "aren't needed to ensure safety of animal and pet food."

• recognize the complex and comingled nature in which raw agricultural commodities and other bulk ingredients move through the supply chain; and

• provide a sufficient time period following publication of its final regulations to allow affected facilities to come into compliance with the rule's requirement.

The group also supported FDA's exemption for low-risk storage and packing activities of raw ag commodities other than fruits and vegetables, like grain elevators, and generally supported revisions that would create framework for facilities to control hazards commensurate to their risk.

Another group, the National Sustainable Agriculture Coalition, said last month that the FDA's revisions were "a significant improvement from the original proposals" but also highlighted several areas which they said required further improvement before implementation.

Related: FDA's FSMA and Animal Feed

While FDA cleared up a concern that farms would be regulated as industrial-scale food facilities just by packing and holding produce from other farms, a change in FDA's definition of "farm" still carries some ambiguity, NSAC said.


FDA’s definition of "farm" still risks inappropriately classifying farms as facilities because it defines a farm as "under one ownership" and "in one general location," NSAC said.

"This definition presents an unrealistic and incomplete understanding of how most American farms are structured," said NSAC policy specialist Sophia Kruszewski. This places significant burdens on some of the most innovative farms that are working together to get fresh produce into local markets, she said.

"The definition of "farm" that FDA ultimately codifies will be with us for a long time; to ensure an appropriate regulatory framework, it is critical that the definition provide an accurate characterization of farms and farm activities," she added.

Related: Legislators Push Back On Proposed FDA Rules

NSAC also said more clarity on farmers' allowed use of sustainable farming practices is required, as is revision of the supplier verification program in the Preventive Controls Rule.

The program, NSAC said, requires onsite audits in some circumstances, which go against Congress' directive and "could pose significant costs on small businesses and duplicative, burdensome requirements on covered farms."

FDA is required to issue both its final Current Good Manufacturing Practice and preventive controls rules for human food and animal feed/pet food by Aug. 30, and its final rule for foreign supplier verification programs by Oct. 31.

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