Calling the agricultural water provision the most complex and challenging in the Food and Drug Administration’s proposed produce safety rule, the agency is seeking research help from the industry and academic circles.

FDA: Help us on produce safety ruleJim Gorny, senior adviser for produce safety for the FDA, said the agency faced data gaps on microbial quality and safety of agriculture water. What’s more, he said there’s a lack of information regarding the die-off of human pathogens on some produce, regarding specific growing practices and conditions.

“The other major data gap for us is there is really lack of a perfect or ideal indicator organism — just look for this, and if it is not there (water quality) will be OK,” he said on Jan. 11, a week after the FDA released its proposal.

Gorny said the FDA is giving land grant universities and the industry more time to explore alternative approaches to the FDA’s requirements. Comments on the produce safety rule  are due in April, but growers won’t have to comply with water-related rules until up to six years after the final details in the Food Safety Modernization Act are published.

The produce safety rule sets standards for worker health and hygiene; the quality of irrigation water; use of animal manure as fertilizer; presence of animals near fields or packing areas; growing and harvesting operations; and equipment and building sanitation.

Commodity-specific risks

Members of the tree fruit industry have expressed concerns about the FDA’s approach for assessing risks. Apples, oranges and other items don’t have a history of foodborne disease outbreaks, but growers must follow the same rules for commodities more frequently associated with outbreaks.

FDA: Help us on produce safety ruleGorny said the FDA considered a commodity-specific risk approach, but concluded that poor practices could lead to contamination, even when the potential is low. The agency, however, is open to arguments about a commodity-specific approach, he said.

Gorny said relying only on historical outbreak data is problematic — just because an item hasn’t been linked to an outbreak before doesn’t mean it couldn’t happen.

“If someone can come up with a strictly commodity-based approach, we are all ears,” he said.

However, determining the timeframe of outbreaks — where they occurred, and the frequency of outbreaks — makes it a thorny problem.

Who’s exempt?

While some media coverage has reported 80% of farms are not covered by the produce safety rule, Gorny said statistics are different when viewed as total acreage of fruits and vegetables.

The rule exempts all farms producing less than $25,000 per year in sales, which represents about 1.5% of covered produce acres, he said.

FDA numbers indicate about half of fruit and vegetable acreage is covered by the produce rule. About 8% of the acres have a qualified exemption under the so-called Tester Amendment. Another 31% of the fruit and vegetable acres are exempt because of a kill step (processing) and 12% of the acres are 37 commodities that are rarely consumed raw, including asparagus and potatoes. 

Gorny said groups like the California and Arizona leafy greens marketing agreements, which have instituted food safety rules, are already in compliance with the many provisions of the proposed rule.

“Certainly rigorous audits conducted under a national or regional marketing agreement are an important tool for fostering compliance with the produce safety rule,” he said. “We anticipate there are going to be lots of significant incentives for accountability through nonregulatory audits.”

That could include buyer-mandated audits, he said.

While the Foreign Supplier Verification Program rule has not yet been published and is still under review by the Office of Management and Budget, Gorny said regulation should be published soon. Gorny said the FDA has taken its time to deliver flexible rules and is open to more industry input.

“If you wanted a one size fits all, we could have done that really quick,” he said. “I think this is a very thoughtful approach and it is integrated across all the rules.”