FDA releases revised produce rule

The Food and Drug Administration on Friday released revised safety rules for produce. The FDA revised its original draft after onion growers and other producers complained the rule's water quality regulations were economically unviable.

BOISE — The U.S. Food and Drug Administration today released revisions to its proposed produce safety rule that it says are less burdensome and more flexible for farmers than the original.

The revisions were announced on the Federal Register website: www.federalregister.gov.

During a conference call with reporters, FDA officials said the revisions include substantial changes to the agency’s proposed water quality standards for produce.

The produce rule is one of seven the FDA has proposed to meet the requirements of the Food Safety Modernization Act, passed by Congress in December 2010. The FDA agreed to revise a previous draft regulation after producers complained it was not economically viable.

The produce rule proposed Friday would apply to more than 200 commodities that could be consumed raw and the water quality standards would apply to any produce likely to come into contact with agricultural water.

Under the previous proposal, produce farmers would have been required to test their irrigation water regularly and stop using it if exceeded minimum microbial levels.

Many farmers, particularly onion growers in the Treasure Valley of Idaho and Oregon, said that virtually none of the surface irrigation water they use could meet the previous standard.

Michael Taylor, FDA’s deputy commissioner for foods, said the revised rule contains water quality standards that are more flexible and take into consideration the different sources and quality of irrigation water.

“It’s a lot more flexible,” he said.

The revised produce rule includes a provision that would allow farmers whose water initially doesn’t meet the microbial standards to meet them through different means.

That includes establishing an interval from the last day of irrigation until harvest that would allow for potentially dangerous microbes to die off. This provision could also apply to the time between harvest and when produce leaves storage.

The die-off rate is codified in the revised rule.

“We are allowing for a rate of die-off per day,” Taylor said.

In a fact sheet sent to reporters, FDA states that “any of these options would have to provide the same level of public health protection and not increase the likelihood that the covered produce will be adulterated.”

The agency will defer action on a provision of the produce rule that would have established a minimum nine-month time interval between the time an untreated biological soil amendment of animal origin, including raw manure, is applied and the crop is harvested.

Taylor said that provision is not feasible for organic and many other farmers around the nation who depend on raw manure and the FDA will delay taking action on that issue until it can conduct a research-based effort in conjunction with the U.S. Department of Agriculture.

The FDA is accepting comments on the revisions for 75 days.

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