News

FDA Announces Changes to Four FSMA Proposed Rules

The U.S. Food and Drug Administration (FDA) today proposed changes to four rules proposed in 2013 to implement the FDA Food Safety and Modernization Act (FSMA): Produce Safety, Preventive Controls for Human Food, Preventive Controls for Animal Food, and Foreign Supplier Verification Programs.

In a Constituent Update, the 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. Thousands of comments were submitted electronically during the comment period.

The changes include:

Produce Safety: More flexible criteria for determining the safety of agricultural water for certain uses and a tiered approach to water testing.
Produce Safety: A commitment to conduct extensive research on the safe use of raw manure in growing areas and 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.
Preventive Controls for Human and Animal Foods: Requirements that human and animal food facilities, when appropriate, test products and the food facility’s environment, as well as implement certain supplier controls.
Foreign Supplier Verification Program: 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.

The 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 will consider both sets of comments — on the original proposed rules and on the revisions — before issuing final rules in 2015.

The agency plans to hold a public meeting on the revised proposals on Thursday, Nov. 13, 2014 in College Park, MD. Details will be forthcoming.

For additional information, please see the following Fact Sheets and Federal Register Notices: