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U.S. FDA Proposes Changes to Food Safety Modernization Act (FSMA)

October 21, 2014

The U.S. Food and Drug Administration (FDA) has proposed changes to four rules proposed in 2013 to implement the FDA Food Safety and Modernization Act (FSMA) 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 as well as on 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 to complete a risk assessment. 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.