Government Connection

FDA Proposes Changes to FSMA Rules

On September 19th, the Food and Drug Administration announced that it would be proposing 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. According to FDA, the agency is proposing new 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.

The FDA will accept comments on the revised provisions for 75 days after publication in the Federal Register, which is anticipated to occur on or around September 29th. Fact sheets and pre-publication copies of the proposals can be found at the following links:

Produce Safety: Fact Sheet Proposal

Preventive Controls for Human Food: Fact Sheet Proposal

Preventive Controls for Animal Food: Fact Sheet Proposal

Foreign Supplier Verification Program: Fact Sheet Proposal

September 26, 2014


Drug Administration
Federal Register
Preventive Controls