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FDA Releases Four Revised FSMA Rules

The U.S. Food and Drug Administration published its revised provisions to four of the Food Safety Modernization Act (FSMA) on Friday morning.

Certain aspects of the rules for produce safety, preventive controls for human food, preventive controls for animal food, and Foreign Supplier Verification Programs (FSVP) have been modified to provide more flexibility to producers and suppliers.

Michael Taylor, FDA deputy commissioner for foods and veterinary medicine, called the decision to take comments on revised proposals before moving the final rules “a very unusual step.” He added that implementing FSMA while under strict court deadlines is an “already daunting task,” but that the reissues show the agency’s “determination to get the rules right.”

Some of the most technical challenges to implementing the Act involve the produce safety rule. In the new language, FDA changes the microbial standard for water that is directly applied during the growing of produce, proposes a tiered and more targeted approach to testing each source of untreated water, removes the nine-month interval for between application of raw manure and harvest of a crop (deferring a decision on an appropriate interval until it conducts more research), eliminates the 45-day minimum application interval for compost, and redefines a “farm” so that farms that pack or hold food from neighboring farms won’t be subject to both the produce rule and the preventive controls for human food rules.

In the preventive control rules, there is now specific language on requirements for product testing, environmental monitoring and supplier controls, and the possibility that facilities will need to address economically motivated adulteration as part of their hazard analysis.

FDA is also modifying the current good manufacturing practice regulations to make the rules more applicable to animal food. Human food processors already complying with FDA human food safety requirements won’t need to implement additional preventive controls except to prevent physical and chemical contamination when holding and distributing the by-product — a win for brewers worried that compliance would be too costly.

The original proposed rule for FSVP presented two options for required supplier verification activities. “Now we are proposing one route that is a hybrid of the two options,” Taylor said.

When there’s reason to believe that a hazard could cause serious injury or harm, annual on-site auditing will be required, but importers with well-documented supply chain management systems would be allowed to use a different approach, such as less-frequent auditing.

The agency is seeking comments for the next 75 days, but only on the revised language — not on the provisions of the previously published rules.

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