FDA hits the start button on major new food safety rules

By Ed Maixner

© Copyright Agri-Pulse Communications, Inc.



WASHINGTON, Nov. 13, 2015 -- FDA on Friday rolled out the first federal food-safety standards for fresh produce and also finalized regulations for verifying that imported foods are free of pathogens -- in rules mandated by the landmark Food Modernization Act signed into law nearly five years ago.

Michael Taylor, FDA deputy commissioner for foods and veterinary medicine, called them “the most groundbreaking” of the FSMA rules. They address the growing and handling of most fresh produce, comprehensive food safety for imports, plus the accreditation of auditors to oversee compliance with FSMA standards in food facilities abroad.

Taylor said the rules mark a “paradigm shift” in food safety responsibility from FDA and state inspectors, who have long been charged with correcting problems once they are evident, to producers and handlers of food, who will now be accountable for the integrity of their products. “There really is no substitute for private entities taking responsibility for the safety of their product and building systems to do that, including auditing their own suppliers,” he says.

Lets Talk Food

Sandra Eskin, food safety expert for The Pew Charitable Trusts, agrees. She calls the new rules a “game changer” that “employ the prevention-based approach of the FSMA.” But now the most immediate challenge for the new regs is funding to implement them, she says. “FDA is committed to partnering with states,” she says, “toward compliance on the produce rule,” for example, “but that can only happen if Congress can give states the money to do the job.”

FDA estimates that collaboration with states on the produce rule by itself will cost $50 million, and $109 million is needed overall for implementing FSMA regulations in the year that started Oct. 1. But the Senate has so far allotted only $45 million, and the House, $41.5 million. Eskin says food safety advocates hope to get those sums raised substantially as Congress wraps up its FY 2016 spending package in the weeks ahead, and she says it appears the lawmakers' recent budget agreement may well let that occur.

Big food-sector groups such as the Grocery Manufacturers Association are pressing for the needed funding. The new law “represents a comprehensive system of preventative measures, so it is essential that FDA be appropriately resourced,” GMA president Pamela G. Bailey declared.

It should be noted that Friday marks just one benchmark in implementing the three new rules. First, they don't go into effect until late January, then implementation will be strung out for years. FDA took years to propose them, consult affected industries and then re-propose them. Now, compliance with the new produce standards, for example, won't begin until early 2018; compliance for clean water in irrigating and washing produce, four years from now.


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The extensive stakeholder input has ended with rules largely encouraged and supported by industry, especially big producers and food companies, most of whose food safety systems are at or near compliance with the new regulations. The United Fresh Produce Association calls them “the culmination of years of efforts by FDA and the fresh produce industry to develop reasonable, fair and practical standards for both domestic and foreign growers, based on the best available science.”

The new regs also get a thumbs up from Laura Batcha, executive director of the Organic Trade Association, which represents the largest organic farms and food companies. FDA, for example, made its new standard consistent with USDA organic standards on use of compost. It also puts off new prescriptions on how long before harvest that raw manure must be applied in the field, letting the OTA's affiliate Organic Center complete research on the risk of pathogen in manure as field fertilizer before mandating the pre-harvest intervals.

Eskin notes, meanwhile, that the produce rule will have its biggest impact on medium and smaller size producers who haven't had to comply with industry standards that wholesalers and retailers impose on the largest growers and packers.

Watching out for small farmers' interests in the produce rules for years has been Sophia Kruszewski with the National Sustainable Agriculture Coalition's Sophia Kruszewski, who commended the agency for a fistful of amendments made at growers' request, including language assuring farmers that the regs won't require them to avoid or undo on-farm conservation and wildlife practices.

But, in an overview of the new rules, NSAC still finds difficulties with the produce rule, including a failure to define the “reliable” audits and certification programs, and how FDA can require third-party audits “in light of FSMA's clear language prohibiting FDA from requiring audits.”  


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