The FDA just put an elastic waistband in the industry’s dress pants. The agency gave growers a little more breathing room in the latest revisions to food safety rules.
On Sept. 19 — ten days before the rules will appear in the Federal Register — the Food and Drug Administration has released the text of four food safety rules related to the Food Safety Modernization Act.
The produce safety rule is found in its entirety at this link, with the prepublication preventive controls for human food rule at this link and preventive contols for animal food at this link and the foreign supplier verification program rule at this link.
Here is a summary that FDA published on Friday about the FSMA proposals:
FDA Seeks to Make FSMA Proposals More Flexible, Targeted
The U.S. Food and Drug Administration is 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.
FDA 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 is planning to hold a public meeting on the revised proposals on Thursday, November 13, 2014 in College Park, Md. Details will be forthcoming.
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TK: In general, the FDA has responded to grower concerns. In that sense, the agency is moving in the “right direction,” apparently adding flexibility to rules about water standards and use of manure.
On the other hand, the proposed regulations on preventive controls for facilities that handle human food include new language about product testing, environmental monitoring and supplier controls.
In regard to foreign supplier verification, the FDA said the revised approach represents a hybrid of two options listed in the proposed rule, providing importers “more flexibility” to determine appropriate verification methods based on food and supplier risks.