FSMA Revisions Speak Volumes

“You spoke. We heard you.”

So declared FDA’s deputy commissioner for foods and veterinary medicine, Michael R. Taylor, when discussing what might be the best year-end news for the fresh produce industry: revised language on two of the most contentious proposed rules under the Food Safety Modernization Act (FSMA), and additional time for public comments through March 31, 2014.

The provisions undergoing major revisions involve water quality standards and testing, mixed-use facilities, and procedures for withdrawing qualified exemptions for certain farms. In a blog post penned shortly after announcing the newest proposals, Taylor said the FDA made its decision largely in response to the careful consideration of those in the produce industry leading the charge – foremost to which is the United Fresh Produce Association and its member companies – which Taylor said were critical “to fulfilling a commitment to getting it right.

“We began 2013 with the proposal in January of two rules required by the FDA Food Safety Modernization Act: the Produce Safety Rule and Preventive Controls for Human Food. The former would set science-based standards for the produce industry, while the latter would set safety requirements for food facilities,” according to Taylor’s post, additional excerpts of which continue in the next four paragraphs below.

“We were determined from the beginning to be transparent in our processes and to engage all stakeholders in the work of crafting final regulations that would work across the broad spectrum of food-producing operations. An unparalleled outreach effort followed the proposal of these rules. My team and I traveled across the country and around the world to discuss these food-safety requirements with the people who would be most affected, including farms of varying types and sizes.

“In our travels, we saw first-hand how everyone is committed to food safety. We especially spent a lot of time talking to farmers, both those who are smaller and work the land their family has owned for generations, and those who oversee large, diverse operations. We have heard concerns that certain 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.

“And because of the input we received from farmers and the concerns they expressed about the impact of these rules on their lives and livelihood, we realized that significant changes must be made, while ensuring that the proposed rules remain consistent with our food safety goals.

“For that reason, we are planning to revise language in the proposed rules affecting farmers and plan to publish it in the Federal Register for public comment by early summer.”

Positive Responses to FDA Decision

David Gombas, United Fresh’s SVP of food safety and technology, graciously responded: “We are encouraged that FDA took seriously the extensive input they received from produce farmers and others in the agricultural sector with respect to the proposed Produce Safety and Preventive Controls rules.”

The American Feed Industry Association was among the key groups joining United Fresh in cheering the news from the FDA, whose decision not only recognized the complexity of the rules, but also demonstrated the agency's willingness to take the extra step to ensure the final version will be as practical as possible for implementation by the industry.

“We appreciate FDA’s willingness to rethink these provisions and propose requirements that are more science- and risk-based,” added United’s Gombas, further affirming how critical it is “that FDA gets these FSMA rules right … We believe this is a step in the right direction.”

FSMA (or FISMA, as it’s more commonly known) was signed into law on Jan. 4, 2011. As the most sweeping food safety legislation to occur in the past 70 years, FSMA shifts the focus from responding to food safety issues to prevention.

In another FSMA-related move, the FDA also unveiled a proposed rule that would require large food businesses to take measured steps to prevent intentional contamination of their products.The measure marks the first time the agency has proposed a regulatory approach for preventing intentional adulteration of the food supply. FDA will continue to seek public input to refine and further focus the scope of its first regulatory effort to stop food sabotage, including economically motivated adulteration.

Since Sept. 11, 2001, and the subsequent passage of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the FDA has developed a variety of guidances and other tools to help industry protect the food supply against intentional adulteration; FSMA aims to build on those efforts, as well as the steps industry has taken

At present, FDA is proposing staggered implementation dates for the proposed FSMA rule based on business size, ranging from one year to three years after publication of the final version.

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