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FDA issues long-awaited FSMA preventive controls, produce-safety regulations

WASHINGTON — The Food & Drug Administration Friday released two proposed regulations Jan. 4 that, for the first time, will require federal produce safety standards and new preventive controls for all food processors under the FDA Food Safety Modernization Act.

The more than 1,200 pages of new regulations, which are posted on the Federal Register website, are likely to have a major impact on the produce supply chain. Because the rules are so far-reaching, the FDA is allowing 120 days for comments and anticipates it will take up to a year to evaluate comments and write the final rules.

Just after the FDA posted the two rules the morning of Jan. 4, FDA Commissioner Margaret Hamburg and FDA Deputy Commissioner for Foods & Veterinary Medicine Mike Taylor held a midday press conference to explain the rules to reporters.

The FSMA regulations are the first step in moving the FDA away from being reactive to outbreaks and toward a new system of working with industry in preventing food-safety problems, Commissioner Hamburg said.

The preventive controls rule will require makers of food to be sold in the United States, whether produced at a foreign- or domestic-based facility, to develop a formal plan for preventing their food products from causing foodborne illness. Many food manufacturers will have to comply with the rule one year after its published, but small and very small businesses will be given additional time.

Many produce companies that hold, pack or store foods and are registered as FDA food facilities will have to comply with the new preventive-control standards, said Ray Gilmer, a spokesman for United Fresh Produce Association. Vertically integrated companies will need to comply with the produce growing standards and the preventive controls.

The second regulation is the long-awaited enforceable safety standards for production and harvesting of produce on farms. Large firms will have 26 months to comply with most of the produce requirements after the final rule is published, but the FDA is delaying compliance for small and very small farms and all farms will have additional time to comply with new water quality standards, the agency said.

"We've said all along we don't want a regulation that's one-size-fits-all," Mr. Taylor said. "As you look into the rules, you'll see many ways we've carefully tailored the regulatory requirements to target those commodities and practices where standards can make a practical difference for food safety."

Mr. Taylor said that water-quality rules would differ depending on whether irrigation water is applied directly to the edible portion of the crop or not. Products sent to canning operations would not be subject to the rule, nor would commodities such as potatoes and artichokes that are commonly cooked by consumers, he said.

Food industry groups welcomed the release of the FSMA rules, which had been stuck at the White House for more than a year.

"We're pleased to see the proposed rules released and are eager to review and assess them," said Bryan Silbermann, president and chief executive officer of the Produce Marketing Association. "In the coming days, we'll provide an online summary of the proposed rules and will be scheduling a free webinar for members with FDA and PMA experts.

"It's important to remember that these are the first two of many proposed rules that will have implications for every aspect of the global produce supply chain," Mr. Silbermann added.

Other regulations that are still being reviewed by the White House and next in line for release include: preventive controls of animal feed/pet food; new Foreign Supplier Verification Program requirements, and new parameters for third-party audit accreditation.

Mr. Gilmer said that United Fresh will set up a review committee of stakeholders and scientists led by David Gombas, the group's senior vice president food safety and technology, to evaluate the regulations.

United Fresh will be looking to see if the proposed produce-safety standards are commodity-specific, risk-based, applicable to all across the industry, flexible enough to respond to research findings and industry practices and applicable to all farms regardless of size, Mr. Gilmer said.