FDA: Help us on produce safety rule - The Packer

FDA: Help us on produce safety rule

01/18/2013 08:43:00 AM
Tom Karst

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 FSMA logoJim 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.

Jim GornyGornyGorny 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?

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