FDA unveils four revised FSMA rules

Changes have been made to the Produce Safety, Preventive Controls for Human Food, Preventive Controls for Animal Food, and Foreign Supplier Verification Programs.

The FDA is making changes to provisions of the four proposed rules based on feedback from the public during meetings and thousands of comments submitted on the proposed rules.

Since FSMA was signed into law in January 2011, FDA has proposed seven rules to implement FSMA.

Updated proposed rules​

Margaret Hamburg, FDA commissioner, said it has worked hard to gather and respond to comments from farmers and other stakeholders regarding the proposed FSMA regulations.

“The FDA believes these updated proposed rules will lead to a modern, science-based food safety system that will better protect American consumers from potentially hazardous food. We look forward to public comment on these proposals.”​

Changes include more flexible criteria for determining the safety of agricultural water for certain uses and a tiered approach to water testing for the Produce Safety rule.

The FDA is proposing a new definition of which farms would be subject to rule – meaning it would not apply to farms with $25,000 or less in produce sales, rather than setting the threshold based on sales of all foods produced on the farm.

It also involves a commitment to conduct research on the safe use of raw manure in growing areas and a risk assessment.

Pending these actions, FDA is deferring its decision on an appropriate time interval between the application of raw manure and the harvesting of a crop and removing the nine-month interval originally proposed.

FDA also plans to eliminate the 45-day minimum application interval for composted manure that meets proposed microbial standards and application requirements.

Rule changes based on feedback​

For the Preventive Controls for Human and Animal Foods rule, requirements that facilities, when appropriate, test products and the facility’s environment and implement certain supplier controls.

The Foreign Supplier Verification Program rule changes include more analysis of potential risks associated with foods and foreign suppliers, and more flexibility for importers in determining appropriate supplier verification measures based on their evaluation of those risks.

Michael Taylor, the FDA’s deputy commissioner for foods and veterinary medicine, said the changes will ensure a more flexible and targeted means to ensure food safety.

The FDA will accept comments on the proposed revisions for 75 days while continuing to review comments already received on the sections of the proposed rules that are staying the same.

It will consider both sets of comments before issuing final rules in 2015.

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