Industry scrutinizes FSMA rule coherence

02/24/2014 11:40:00 AM
Mike Hornick

How the Food and Drug Administration will ultimately define a raw agricultural commodity or the role audits play in the Foreign Supplier Verification Program are among the issues prompting an industry request for additional review of food safety rules.

The Nogales, Ariz.-based Fresh Produce Association of the Americas asked the FDA in a Jan. 27 letter for an opportunity to assess as a package the proposed Food Safety Modernization Act rules affecting fresh produce. That move came soon after the introduction of foreign supplier verification and third-party audit rules.

“Together with the produce safety rule, the preventive controls and even others that are still coming out, they’re all so intertwined that until the FDA gives the industry a chance to look at them all at once, you can’t really know how they’re going to interact or make effective recommendations about a particular one,” Lance Jungmeyer, FPAA president, said Feb. 6.

The definition of a raw commodity offers one example of the link among FDA rule proposals.

Should waxing fruits or vegetables or running them on a conveyor belt be considered processing activities? Under the draft version of the produce safety rule, they are. The trade group would like to see those and a few other activities exempted.

“Until you know what the FDA is allowing as raw, it’s hard to recommend how foreign supplier verification and third-party audit rules should come into effect,” Jungmeyer said.

It also becomes more difficult to say whether a grower will be covered by the produce safety or the preventive controls rule. The latter applies to processors.

“Fresh Express or Taylor Farms falls under processing facilities,” he said.

“But as the produce rule is originally written, if you’re waxing a cucumber then all of a sudden you’re a processing facility. We don’t feel that’s a correct approach. It should be considered a farm activity.”

The foreign supplier verification rule draft released in January considers two options for verifying food safety at the source — onsite audits or a mix of methods.

“We prefer the second option,” Jungmeyer said.

“There are instances where you could never do an audit before you’ve actually harvested. On an item like berries, your field might have a three-week harvest window. You might not get the results for a week, and if something needs work the whole window may come and go before you have an accredited audit.”

That’s especially true for ground new to production, he added.

“As the importer of record, you should be able to dictate that your supplier is doing the right thing according to your playbook,” Jungmeyer said.

“That’s not to say we don’t believe in audits playing an important role. But the first option under (the rule) is far too restrictive.”



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