WASHINGTON, Dec. 19, 2013 – FDA today said it is planning major changes to its proposed produce and preventative-control food safety rules and will seek additional public comment once they are completed.

The regulations are part of an overhaul mandated by the 2011 Food Safety Modernization Act (FSMA).

Provisions that will be altered include those dealing with water quality standards and testing, raw manure and compost, mixed-use facilities and exemptions for certain farms, the agency said.

The FDA said it expects the proposed changes to be finalized by early summer.

“We have heard the concern that these provisions, as proposed, would not fully achieve our goal of implementing the law in a way that improves public health protections while minimizing undue burden on farmers and other food producers,” Michael Taylor, the FDA’s deputy commissioner for foods and veterinary medicine, said in a statement.

A number of farming and agriculture groups had complained the original proposed rules, first released in January 2013, were too burdensome and inflexible, particularly for small farmers.

For example, many said a provision requiring all agricultural water to meet EPA’s recreational water quality standards would require overly rigorous rounds of expensive and regular testing. Producers also complained they had little control over the sources of their water and so could not be held responsible for deficiencies in quality.

The United Fresh Produce Association, in particular, singled out the proposed produce safety rule’s definition of “mixed-type facilities,” which it argued were “not based on risk nor an understanding of actual operations in the produce industry.”

“[A] one-size-fits-all approach that lumps produce packing sheds, warehouses and coolers together with food processing plants does not increase public health and is likely counterproductive,” the association wrote in its comments.

Agriculture industry stakeholders indicated they were generally pleased with today’s announcement, particularly FDA’s decision to allow another round of public comment before the final rules are due in June 2015.

“We think this is great news,” said Ray Gilmer, vice president of issues management and communications at United Fresh.

“Because this is such a complex regulatory structure, trying to regulate a very broad diverse produce industry with so many types of farms and operations, it is the wisest course to release a second round” of proposed rules, he said, adding that his association was looking forward to working with FDA on changes.

In September, the National State Departments of Agriculture (NASDA) released its own policy statement in support of a second draft of proposed rules.

But National Sustainable Agriculture Coalition (NSAC) Policy Director Ferd Hoefner said changes offered in today’s announcement might not be enough for many producers.

Hoefner said he would also like to see adjustments to exemptions for direct marketing operations, more coordination with state agriculture departments, and new economic cost-benefit and environment analyses, among other changes.

“Farmers need to know that food safety rules are not going to put them out of business,” he said in a statement.

According to the Centers for Disease Control and Prevention, about 48 million Americans are sickened each year by foodborne diseases, 128,000 are hospitalized, and 3,000 die.


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