CMG Chipotle Mexican Grill Inc

The Food and Drug Administration completed long-awaited rules that give the agency sweeping oversight of the produce industry and imported foods to help avert foodborne-illness outbreaks.

The regulations issued Friday moved the government closer to implementing a law passed by Congress in 2010, which marked the biggest overhaul of federal food-safety oversight in 70 years. The regulations follow a wave of deadly outbreaks in the past decade that have been traced to produce—such as tainted spinach, cantaloupe and caramel apples—and are aimed at creating a food-safety system that will be less reactive and better at preventing contamination.

The produce rule for the first time sets federal standards for how fruits and vegetables are grown, harvested, packed and stored to reduce contamination risks. Farmers must test the water they use to raise crops for the presence of potentially harmful bacteria, as well as take measures such as training workers on health and hygiene practices and inspecting fields for wildlife encroachment.

The imported-foods rule enables the FDA for the first time to hold importers accountable for ensuring their foreign suppliers meet U.S. safety standards. Food importers must monitor suppliers through steps such as audits of processing facilities or the sampling and testing of foods.

"FDA is engaging in regulatory activity where we haven't done it before," said Michael Taylor, the agency's deputy commissioner for food and veterinary medicine, in an interview. The rules help complete the "farm-to-table comprehensive system of prevention."

Critics of the current system say the FDA often has failed to take meaningful action until after food contamination has occurred.

Friday's announcement means just two of the seven major rules under the 2010 Food Safety Modernization Act still need to be finalized by the deadline next year.

It is unclear, however, if the FDA will receive all of the funding the Obama administration says it needs to fully implement and enforce the law. The FDA has said it requires $260 million, including $109.5 million for the fiscal year that began Oct. 1. President Barack Obama requested that amount, but appropriations bills in both the House and Senate included just $41.5 million and $45 million, respectively, for fiscal 2016, when all the rules will be finalized.

The produce rules come as Chipotle Mexican Grill Inc. has struggled to determine the culprit in an E. coli outbreak that so far has sickened 50 people in Washington and Oregon, including 14 who have been hospitalized. Public health officials earlier this month said they hadn't yet been able pinpoint the exact source of the contamination, but that their investigation indicated produce.

The FDA's original rule for produce, released in 2013, was widely criticized by small produce growers, who argued it was burdensome and could force some to go out of business.

The agency on Friday said the final rule aims to minimize the risk of harmful contamination while allowing producers more flexibility.

James Gorny, vice president of food safety for the Produce Marketing Association, applauded the FDA for instituting what he called mostly common-sense regulations. Still, he said he remained worried that the requirement for produce farms to regularly test water for E. coli bacteria would be disproportionately costly for smaller growers.

The finalized produce rule goes into effect for larger farms in about two years, though smaller farms have longer to comply. Some importers will have to comply with their new regulation 18 months after the final rule is published in the Federal Register.

According to the produce rule, growers must test their water supplies—from rivers to groundwater wells—up to 20 times in the first four years after the rules take effect, depending on the type of source, and up to five times each year after that. With each test typically costing $75 to $100, "it's just difficult to justify" for smaller growers, Mr. Gorny said.

Organic-food growers and distributors welcomed the new rules, which also ensure that the current practice of spreading raw manure on organic-food fields up to 90 days before harvest can continue. The FDA stepped back from an earlier proposal to prohibit organic-food growers from applying raw manure to crop fields less than nine months before harvest. Organic growers had rejected the nine-month proposal, saying it was burdensome and wouldn't enhance food safety.

Food-safety advocates said the import rule could help guard against salmonella outbreaks, like one in September in which imported Mexican cucumbers eventually were linked to more than 700 illnesses and four deaths in the U.S.

Ilan Brat contributed to this article.

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(END) Dow Jones Newswires

November 13, 2015 17:45 ET (22:45 GMT)

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