FDA releases rules for produce safety

- FDA focusing on science-based risk analysis. - Requirements differ for each commodity. - More inspector visits expected.

THE Food & Drug Administration released much-anticipated proposed rules detailing standards for produce safety and preventive controls for human food production.

Releasing these rules is a major step in implementing the Food Safety Modernization Act (FSMA), which President Barack Obama signed into law two years ago. The law is the first significant overhaul to the nation's food safety laws since the 1930s.

Key players said they intend to move forward very aggressively in implementing the new rules, although many have already done so after FDA issued guidance in recent years or industry guidelines like it did for leafy greens after a major foodborne illness outbreak was linked to spinach, according to Kim Walker, leader of the Faegre Baker Daniels national food and agriculture industry team.

The rules follow extensive FDA outreach to the produce industry, consumers, other government agencies and the international community. Since January 2011, FDA staff have toured farms and facilities nationwide and participated in hundreds of meetings and presentations with global regulatory partners, industry stakeholders, consumer groups, farmers, state and local officials and the research community.

The Grocery Manufacturers Assn. welcomed the proposed rules and said "FSMA and its implementation effort can serve as a role model for what can be achieved when the private and public sectors work together to achieve a common goal."

The first rule proposed would require makers of food that's to be sold in the U.S., whether produced at a foreign- or domestic-based facility, to develop a formal plan for preventing their food products from causing foodborne illness and to have plans for correcting any problems that arise.

FDA is seeking public comments on this proposal. The agency is proposing that many food manufacturers be in compliance with the new preventive control rules one year after the final rules are published in the Federal Register, but small and very small businesses would be given additional time.

FDA also is seeking public comments on the second rule, which proposes enforceable safety standards for the production and harvesting of produce on farms. This rule proposes science- and risk-based standards for the safe production and harvesting of fruits and vegetables.

Sarah Brew, attorney at Faegre Baker Daniels specializing in food litigation and regulatory practice, commended FDA for not requiring a one-size-fits-all approach within the food industry but instead focusing on science-based risk analysis and placing different requirements on different commodities.

Brew noted that each commodity will have certain requirements based on historic risks such as previous outbreaks, how it is produced and what's done after it is harvested, e.g., whether it's cooked or canned. For example, potatoes are exempt, and green beans are exempt if they are going to be sent to a canning facility.

Walker added that the rule also identifies different pathways where contamination might occur and seeks to minimize the risk, whether from equipment and tools, agricultural water on site or animals in the growing area.

FDA is proposing that larger farms be in compliance with most of the produce safety requirements 26 months after the final rule is published in the Federal Register. Small and very small farms would have two to three years to comply, and all farms would have additional time to comply with certain requirements related to water quality.

Recordkeeping will be crucial in the new system and sometimes may simply require formulizing what companies are already doing, Brew said.

FSMA does provide FDA with heightened enforcement powers, which means more inspector visits at facilities.

"This will be a real change for many food companies, creating a much closer relationship with FDA in the nuts and bolts of what's going on in the plants," Brew said.

"With the aim of improving food safety through FSMA, Congress rejected a one-size-fits-all approach to food safety regulations," said Ariane Lotti, assistant policy director with the National Sustainable Agriculture Coalition (NSAC). "A one-size-fits-all approach would put small and midsized farm operations out of business, consolidate agricultural markets and eliminate opportunities for food and farm entrepreneurs in emerging sectors of agriculture, including organic and local and regional food systems. NSAC will be closely reading the rules to determine whether FDA followed congressional intent."

Walker said midsize to smaller companies may require additional resources internally for additional training or may reach out to third parties for help meeting the new guidelines. FDA also recognized these potential industry needs and formed an alliance to help develop some training programs, Walker added. He expects FDA to continue actively helping the industry, especially small companies.

FDA said the proposed rules build on significant strides made during the Obama Administration, including the first egg safety rule protecting consumers from salmonella, stepped-up testing for Escherichia coli in beef and enhanced existing voluntary industry guidelines for food safety, which many producers, growers and others currently follow.

To fully implement FSMA, FDA will issue more than 50 regulations aimed at improving food safety. Walker explained that the agriculture industry will be closely watching rules for feed and pet food facilities and importation of feed and food ingredients.

Editor's Note: Listen to the full interview with Walker and Brew in the Jan. 14 "Feedstuffs in Focus" podcast at www.Feedstuffs.com.

Volume:85 Issue:02

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