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United Fresh Outlines Problems in FSMA Rules

SAN DIEGO — United Fresh industry leaders feel that certain aspects of the Food Safety Modernization Act will negatively impact many produce operations without clear benefit, they said at the United Fresh conference here.

Their biggest issue is with the definition of a “mixed-type facility.”

“Right now a farmer that produces fresh produce and packs it in his own on-farm packinghouse is covered under the produce safety rule,” said Walter Ram, chairman of United Fresh’s Food Safety & Technology Council.

“If that same farmer brings in product from across the street from another farm, he’s then deemed to be a mixed-type facility,” and subject to the preventive controls rule, which has much more rigorous requirements.

“There are very, very many packing operations in the U.S. that just aren’t set up to meet these requirements, and the benefits would be marginal at best. And not to mention the costs involved. It could do severe economic damage without any clear, substantial benefit,” said Ram, who is also vice president of food safety at The Giumarra Companies.


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While the Food and Drug Administration cannot change what’s in the law, the industry’s comments could affect the final regulations, Ram said.

“Actually it’s our responsibility to speak up loudly and clearly on this issue because it could adversely affect our industry and once the final rule is issued, it will literally take an act of Congress — literally — to change it,” said Ram.

United Fresh also has concerns that parts of the preventive controls rule were not designed with the produce industry in mind. This rule “covers everything from yogurt to bakeries to packing fresh citrus to fresh cut lettuce, pretty much you name it,” said Bob Elliott, vice-chairman of the Food Safety and Technology Council.

In particular, Elliott said requirements for validation of food safety plans could be overly onerous for produce operations.

“This regulation was written by FDA people who really had very little if any produce experience,” said Elliott, who is director of food safety at Sunkist Growers.

In addition, Elliott said microbiological testing procedures don’t make sense for produce because, unlike manufactured food, one small sample does not represent the entire lot, and the perishable nature of the product makes holding it difficult.

Speakers also spoke out against exemptions for small farms and facilities.

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“United Fresh opposes these exemptions and will continue to oppose those. Unfortunately, it’s part of the law. We won’t be able to affect anything directly by our comments with FDA. However, we want to have it on record and with the idea that hopefully this can be challenged. We think that size and distribution should not be a factor in food safety regulation,” said Elliott.

While United Fresh did find fault with certain parts of the proposed rules, Ram said that “FDA got a lot right in there.” He said the industry was pleased FDA took a risk-based approach to commodities in the produce safety rule, and recordkeeping requirements are “not as bad as we feared.”

The strongest message from the FSMA presentation was that United Fresh members should all submit their own comments, whether positive or negative, to FDA by the Sept. 16 deadline.

“We will never again have the influence that we do now to effect change to how the Food Safety Modernization Act affects our industry. And it will rock our world,” said Ram.

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