FSMA-mania and myths - The Packer

FSMA-mania and myths

10/25/2013 12:00:00 PM
Coral Beach

Coral BeachTwo empty chairs at this food safety panel discussion at PMA’s Fresh Summit were reserved for Food and Drug Administration officials, but the government shutdown kept them from attending, even though federal workers were back to work. Participating in the panel were PMA’s chief science and technology officer Bob Whitaker (left), PMA’s vice president of food safety and technology Jim Gorny (center), and Tom O’Brien, a Washington D.C. attorney who works with PMA and has extensive experience with the Food Safety Modernization Act.NEW ORLEANS — It’s just a money grab. It’s because of problems with foreign imports. It’s big government and big business in cahoots. Isn’t it time to make consumers take some responsibility? It’s impossible to have food safety without a written plan.

Such questions and comments spurred the Produce Marketing Association to include a workshop at Fresh Summit this year to dispel myths and calm the industry concern about the Food Safety Modernization Act.

“We’ve been collecting questions and want to answer some of the most common ones today,” said Bob Whitaker, workshop moderator and PMA’s chief science and technology officer.

“Today we want to stick to the science behind the proposed rule and dispel some misinformation.”

The two other panelists on stage were former employees of the FDA and the U.S. Department of Agriculture and offered insight into how the act came about and how the rulemaking process works.

Panelist Jim Gorny, PMA’s vice president of food safety and technology, was senior adviser for produce safety at the Center for Food Safety and Applied Nutrition before joining the PMA this summer.

Panelist Tom O’Brien, a Washington D.C. attorney and PMA’s Washington representative, was associate administrator and chief of staff at the USDA’s Agricultural Marketing Service.

The first misconception the panel cleared up for Fresh Summit attendees concerned whether the FDA’s produce safety rule is in effect.

Whitaker said he has heard many in the industry say the rule is written and people must comply now.

“False,” he said.

The produce rule is not yet final. The FDA will continue to accept comments on it through Nov. 15.

The panelists encouraged attendees to file comments if they have not yet done so. The agency is under court order to have the rule in place in mid-2015.

“The proposed rule and the public comment period are key to our democratic process,” Gorny said.

Gorny and Whitaker pointed to the irrigation water requirements in the proposed rule as an example of how the comment process is already having an impact on FDA officials.

Taylor and Assar spent weeks this summer visiting different growing regions and looking at operations for different commodities in response to industry objections.

Taylor has said the water regulations will definitely be revised, but he has not provided specifics.

Other myths and misconceptions discussed by the panel ranged from possible import fees to when the industry will have to comply with the proposed produce safety rule.

  • How about an interim final rule?

O’Brien said some people think it would be better for FDA to publish an interim final rule so changes could be made after implementation. However, the federal rulemaking process isn’t that simple.

“An interim final rule can be a red herring,” O’Brien said. “The concern is that the interim rule would just stay on the books because to change it you have to go through the entire proposal and comment period process again.” That process generally takes years to complete, he said.

  • Isn’t FSMA just a reaction to unsafe food from foreign countries?

Whitaker said he has heard many coffee shop conversations that blame imports for imposing regulations on the U.S. growers and shippers.

There is a nugget of truth to that rumor, O’Brien said.

“That drove some of it, but U.S. outbreaks were also a factor,” O’Brien said. “International trade law requires you to have the same rules for yourself as you do for other countries.”

Gorny said many off-shore operations have stellar food safety records and programs that are second to none.

O’Brien and Whitaker agreed, but O’Brien recalled how discussions on Capitol Hill after the 2006 E. coli outbreak linked to fresh spinach showed broad concern about imports.

“In the Senate hearing on the spinach outbreak, we were only three questions into the discussion when it turned to imports,” O’Brien said, adding that no imports were involved in that outbreak.

  • When are consumers going to take some responsibility and wash their fresh produce before they eat it?

Gorny, who has a doctorate in plant biology and a master’s degree in food safety, has worked extensively with researchers in the past 25 years. He said science repeatedly has proved that consumer washing of produce can somewhat reduce pathogen risk, but it does not kill everything.

“Also, consumers can’t control who retailers buy from or other factors in the supply chain, so they have very little control,” Gorny said.

  • Isn’t it just a money grab, especially if import fees are imposed to pay for it?

Gorny said the FDA knows there will be issues at the border once FSMA goes into


“User fees are still on the table because FDA doesn’t have the resources it needs,” Gorny said.

O’Brien said the FDA won’t be able to impose such fees without action from Congress, though, because the agency doesn’t have that authority on its own.

  • How can I tell if I’m in compliance already?

No one knows if they are in compliance with the proposed rule as it now stands because FDA has not yet written the compliance documents that supplement the rule, Gorny said.

“FDA couldn’t tell you today if you are in compliance,” Gorny said. “We’re at the 50,000-feet level now, and the compliance guide doesn’t come until we get to the boots-on-the-ground level.”

  • Why doesn’t the rule require a written food safety plan?

Gorny said FDA officials considered requiring produce businesses to have written food safety plans but rejected the idea.

“Pieces of paper on a shelf don’t protect people,” Gorny said of the rationale used by FDA officials.

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