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Stakeholders Offer Broad Range of Feedback on FSMA in First Public Meeting

Sunday, March 3, 2013 23:20
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The U.S. Food and Drug Administration heard a broad range of feedback from stakeholders on its draft food safety rules – on preventive controls and produce safety – in a public meeting held late last week in Washington, DC.

While everyone from consumer advocates to produce growers offered a variety of input, asked lots of questions, and raised some concerns, nearly every stakeholder also thanked FDA for moving forward with the provisions, which were mandated by the landmark Food Safety Modernization Act signed into law in early 2011.

“I appreciate the work you’ve done here,” Tony Corbo, a lobbyist for Food & Water Watch, told a panel of FDA officials during the public comment period. “The rules have a lot of moving parts and it’s obvious that you gave them a lot of thought.”

Commenters seemed to, for the most part, agree the regulations would be a positive step, as long as they are further clarified, based on science, and not overly burdensome for businesses, particularly small and very small businesses. Several testimonies also called on the White House Office of Management and Budget to release the next three major FSMA rules – the foreign supplier verification program, preventive controls for animal feed, and third party certification, so they can be considered as a suite of interlocking regulations.

During the public comment period, many stakeholders raised questions about how the agency would deal with exempt produce commodities, rapidly evolving science, small farm exemptions, and whether environmental and product testing would be explicitly required.

Jean Halloran, the director of food policy initiatives at Consumers Union, took particular issue with FDA’s proposed list of 35 fruits and vegetables that are rarely consumed raw, and are therefore exempt from the produce rule.

Halloran said she googled all of the exempt produce looking for recipes where the items are prepared raw and found at least several thousand recipe entries for each.

“Raw figs, with 5 million hits, and raw kale with 9 million hits, topped the items I entered, but there were still several hundred thousand entries for raw brussels sprouts and raw eggplant” she said. “I would therefore suggest to the FDA that they exclude from the produce rule, only those items that are generally not eaten raw because they are or can be toxic if uncooked.”

Sandra Eskin, director of the food safety campaign at the Pew Charitable Trusts, suggested that FDA develop a “flexible mechanism for updating its list of “covered” and “exempt” produce items.”

“By codifying this list in regulations, it will be next-to-impossible for the agency to respond rapidly to evolving contamination problems,” said Eskin in her testimony. “FDA should consider identifying “covered” and “exempt” fruits and vegetables in a guidance document, rather than in a regulation; this approach would enable the agency to more easily and quickly revise this list.”

The small, very small, and qualified exemptions for some food producers also generated a lot of discussion. Many of the big players in the food industry and some consumer advocates continued to express opposition to any exemptions to the proposed rules.

“We remain concerned by other provisions, such as the exemption for qualified operations, which potentially allows certain small operations to side-step food safety practices and provide consumers who buy directly from them a lesser level of food safety assurance than those who buy from conventional markets,” said David Gombas, senior vice president of food safety and technology at the United Fresh Produce Association. “After all, pathogens don’t know what size operation they’re on.”

“We urge as narrow an exemption as possible,” Kathy Means, vice president of government relations and public affairs at the Produce Marketing Association. “Safety is everyone’s responsibility.”

Donna Johnson of Naturipe Farms LLC in Salinas, California told the panel of FDA officials that she had concerns about why a produce packhouse under a different owner (than the owner of the produce) falls under preventive controls, but a packhouse handling produce under the same owner falls under the produce rule.

“I think this is going to be a problem,” she said.

She also asked FDA to clarify the definition of “farm,” which will be critical for small businesses, produce co-ops, and aggregators trying to figure out if they’re covered or exempt.

“This is an inherently complex area,” said Don Kraemer, Senior Adviser at FDA’s Center for Food Safety and Applied Nutrition, during Q&A. “It very much depends on every circumstance…we’ll be looking for comments to help us define that, because it’s important to define.”

The National Sustainable Agriculture Coalition asked for clarification on other “gray areas,” including how FDA will treat farm mixed-type facilities – which grow food and also do some processing – in determining if they qualify for certain exemptions under either proposed rules. Could one part of the farm mixed-type facility be covered and the other exempt, based on sales?

Product and environmental testing requirements were also frequently mentioned. Consumer advocates asked that some testing be required for verification, while industry groups emphasized the need for flexibility.

“It is troubling that, while FSMA specifically mentions testing as a method for verifying the effectiveness of measures aimed at minimizing contamination, the draft regulations are silent on it – and fail to even include the word “testing,” said Eskin, in testimony on the preventive controls rule. “Pew is committed to providing FDA with as much information as we can assemble supporting appropriate testing requirements to verify that measures taken to minimize hazards in processed food production are working.”

Eskin also said that consumers groups believe it may be appropriate to have similar testing requirements for some produce commodities, beyond just for sprouts and agricultural water, which both have some testing requirements under the proposed produce rule.

“Testing has an important role to pay to ensure the systems put in place to ensure food safety are actually doing that,” said Randy Napier, in an emotional testimony last week. Napier lost his mother, Nellie, in the 2009 peanut butter Salmonella outbreak.

The Food Marketing Institute asked that, if the agency does include environmental or product testing requirements, there be a supplemental rulemaking process for just that portion of the rule to ensure there is ample time to comment.

FDA said video and transcripts on the public meeting would be available over the next few weeks at www.fda.gov/fsma. The next FSMA public meetings on the proposed rules will be later this month in Chicago and Portland, Oregon.



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