FDA will revise produce safety rules, hold additional comment period

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SALEM, Ohio — Produce growers should find out over the next few months what the new, federal produce safety rules will look like. And, once again, they will have an opportunity to comment.

The rules are part of the Food Safety Modernization Act — a comprehensive food safety reform package signed into law Jan. 4, 2011, by President Barack Obama. The last public comment period for produce rules ended in November, after three extensions.

But after thousands of comments and ongoing concern about some of the rules, the FDA announced in December it will revise some of the rules and hold an additional comment period after the new rules are announced in early summer.

“We believe that significant changes will be needed in key provisions of the two proposed rules affecting small and large farmers,” said Michael Taylor, the FDA’s deputy commissioner for foods, in a released statement.

What’s extended

These provisions include water quality standards and testing; standards for using raw manure and compost; certain provisions affecting mixed-use facilities; and procedures for withdrawing the qualified exemption for certain farms.

“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,” Taylor said.

“Everyone shares the goal of ensuring produce safety,” he continued. “But, as we said at the beginning of the process, the new safety standards must be flexible enough to accommodate reasonably the great diversity of the produce sector, and they must be practical to implement.”

Making the rules flexible and accommodating were some of the first concerns among producers in Ohio, where the state ranges from large-scale mechanized farms, to farms that are run with horses. Farmers were concerned, at first, that FDA was going to form a one-size-fits-all law.

Legitimately concerned

Their concern apparently had some merit. Speaking at the Ohio Ecological Food and Farm Association conference Feb. 16 in Granville, former U.S. Agriculture Deputy Secretary Kathleen Merrigan said the rules were worse when first introduced.

“You didn’t even see some of the earlier versions,” she said, noting that at one point, there was a rule farmers couldn’t even spit or chew gum.

“Government is there to help, but it also can do harm if these regulations are not well-calibrated to your needs,” she said.


Still, Merrigan said the FSMA has the potential to be a “real game-changer” for agriculture. For one thing, it’s the largest food safety overhaul in 70 years, and the new law will provide producers a new line of defense against food safety issues.Sustainable agriculture. One OEFFA workshop, led by the National Sustainable Agriculture Coalition, was specifically about the FSMA and where it stands.

Related: FDA hears produce safety concerns in Wooster.

Shavaun Evans, grassroots coordinator with NSAC, said more than 25,000 comments were submitted to FDA. The biggest concerns were the program cost, and rules pertaining to raw manure and compost, as well as water quality.

Although the process has been lengthy, Evans said the law includes “several wins” for sustainable agriculture, including that it now treats farmers according to the size and scale of their operation. In general, producers are OK with the delays, she said, if it means the rules get done right.


The FSMA came about in response to many factors, including the cost of foodborne illnesses, and post-9/11 concerns about food safety. It shifts the nation’s focus from responding to contamination, to preventing it.

In addition to new produce safety standards, the FSMA mandates certain preventive controls for food facilities, mandates inspections, and expands FDA’s authority to access industry records, issue recalls and suspend a food facility’s registration.

Michael Geary, executive director of the Ohio Produce Growers and Marketers Association, said getting the rule right is most important.

“The delays really do not bother us,” he said. “We’d rather the rules be as perfect as possible and as understandable as possible.”

In addition to the actual rules, Geary said it’s important that the federal government fund whatever mandates it imposes.

This has been a concern among state agriculture directors, as well, who say they are unsure what the program may cost their state agencies.

Ohio plan

While all eyes have been on the federal law, Ohio growers have developed a new marketing plan they believe can meet the requirements of FSMA and also give Ohio growers a new form of food certification.

Known as the Ohio Produce Marketing Agreement, or OPMA, this voluntary plan has been in effect for the past couple years and was designed to meet the food safety certification requirements of producers of all sizes and farming practices.

The OPMA plan offers a nationally recognized certification plan open to any U.S. producer. The plan is being reviewed by the Ohio Department of Agriculture, with approval expected any day.

Although the Ohio plan is already in use, having the support of ODA will enhance its credibility and user participation, Geary said.

The ultimate goal, Geary said, is to “bring more value to Ohio’s crops” and a “greater trust in the quality of the fresh products coming out of Ohio.”


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