FDA seeks to revise four FSMA rules

FDA proposes changes to four original FSMA rules to make them more flexible, practical and targeted.

The Food & Drug Administration announced Sept. 19 that it is recommending changes to four rules proposed in 2013 to implement the FDA Food Safety Modernization Act (FSMA): Produce Safety, Preventive Controls for Human Food, Preventive Controls for Animal Food and Foreign Supplier Verification Program.

FDA said it is proposing new ways to make the original proposals more flexible, practical and targeted. The changes are based on the input received during an unprecedented level of outreach to stakeholders and valuable input received from farmers and others directly affected by the rules, with thousands of comments submitted electronically during the comment period.

For produce safety, the changes include more flexible criteria for determining the safety of agricultural water for certain uses, a tiered approach to water testing and a commitment to conduct extensive research on the safe use of raw manure in growing areas and to complete a risk assessment.

Pending those 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 proposes eliminating the 45-day minimum application interval for composted manure that meets proposed microbial standards and application requirements.

For preventive controls for human and animal foods, FDA is proposing requirements that human and animal food facilities, when appropriate, test products and the food facility’s environment, as well as implement certain supplier controls.

For the Foreign Supplier Verification Program, FDA is proposing a more comprehensive 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.

FDA will accept comments on the revised provisions for 75 days after publication in the Federal Register, while continuing to review comments already received on the original proposed rules. No additional comments will be accepted on the original proposals. FDA said it will consider both sets of comments (on the original rules and the revisions) before issuing final rules in 2015.

The agency plans to hold a public meeting on the revised proposals on Nov. 13 in College Park, Md. Details will be forthcoming.

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