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FDA Revises FSMA Proposals to be More Flexible, Targeted

Posted September 25, 2014

The Food and Drug Administration last week announced an extensive overhaul of sweeping food safety modernization rules proposed last year after an assortment of agricultural lobby groups complained that the regulations could hurt business.
FDA Communications
The final rules are due sometime next year, and the FDA has been struggling with the task of creating them since Congress passed the Food Safety Modernization Act (FSMA) in 2010. Regulators say balancing the need for tighter food safety standards after major food-borne illness outbreaks in various commodities against the resistance of various farming interests opposed to such regulations has been a challenge.

Based on the input received during their stakeholder outreach period, the FDA is now outlining various ways to make the original proposals more flexible, practical and targeted.

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.

In addition to regulating farms and food manufacturing facilities, the food safety law authorizes more inspections by the FDA and gave the agency additional powers to shut down facilities. The FSMA also requires considerably stricter standards on imported foods.

The new proposal will have a 75-day comment period. The FDA is legally required to finalize the rules by next year after being sued by the Center for Environmental Health last year for missing deadlines.