FDA aims to make FSMA practical

Deputy commissioner Mike Taylor shares that voluntary compliance, not enforcement, key to food safety rule implementation.

Working under tight court-mandated deadlines to finalize a series of Food Safety Modernization Act rules, Food and Drug Administration Deputy Commissioner Mike Taylor said his agency is focusing on three broad themes in implementing the 2011 law: the farm-to-table approach, practical common standards, and holding imports to the same standards as domestically produced foods. Taylor was speaking to a group of farmers and ranchers from across the country during a workshop at the American Farm Bureau Federation’s 96th Annual Convention Jan. 11.

FSMA, Taylor said, codified the agency’s farm-to-table approach for food safety, which means everyone from farmers and ranchers, to transporters, food processors, retail outlets and consumers, we all have a role in food safety.

In drafting rules that work for across a broad spectrum of farm type and regions, the agency is aiming to craft consistent standards applicable across the food system while ensuring those standards are workable for everyone.

“It’s our job to be clear about expectations—practical expectations—and to work with the [regulated] community to achieve them,” Taylor said. 

Central to FDA’s efforts with FSMA is ensuring imported food is as safe as U.S.-grown food. Currently, FDA inspectors only get a good look at 2% of imports. The proposed FSMA rules would shift that onus from FDA to importers who provide verification that the food meets U.S. standards.

In putting all of these rules in place, FDA is focusing on voluntary compliance, rather than enforcement, Taylor emphasized.

“Our operating assumption is that most people want to do the right thing. We’ll get a bigger public health bang for our buck if we’re working together with stakeholders on implementation,” he said. “We really see the agriculture community as a primary constituency, a collaborative partner.”

Produce rule

The U.S. Food and Drug Administration (FDA) has published a notice in the Federal Register that the Draft Environmental Impact Statement (EIS) (PDF:23MB) for the proposed produce safety rule—entitled Standards for Growing, Harvesting, Packing, and Holding Produce for Human Consumptionis available for public comment. FDA is also announcing a public meeting on the Draft EIS.

The Draft EIS considers the impact of the rule as originally proposed in January 2013 and as amended in a September 2014 supplemental proposal, in addition to alternative provisions. It focuses on four areas in the proposed rule that could significantly affect the environment: the definition of covered farms, water quality standards, the use of raw manure and compost, and provisions affecting domesticated and wild animals. Of these, only the water standards were found to potentially have a significant adverse environmental impact.

However, most covered farms would not need to switch from surface water to groundwater or chemically treat their water. There are critical groundwater shortages in certain parts of the country that would exist even if this proposed rule were not enacted. Actions that may lead to increases in groundwater drawdown in parts of the country experiencing severe shortages would be considered a significant environmental impact.

The Draft EIS identified the proposed supplemental changes, which would allow time for potentially dangerous microbes in agricultural water to die off, as the environmentally preferred option. The flexibility provided by this option is the reason why most covered farms would not need to change their water source or treat their water with chemicals.

The FDA estimates that the rule, if implemented as proposed, would prevent an estimated 1.57 million foodborne illnesses each year.

There will be a public meeting on the EIS on Tuesday, February 10, 2015 in College Park, MD. The comment period is 60 days, from Monday, January 12, 2015 to Friday, March 13, 2015. FDA does not plan to extend the comment period.

The produce rule is one of seven rules proposed to implement the FDA Food Safety Modernization Act (FSMA), which mandates the creation of a prevention-based, modern food safety system to protect consumers from foodborne illness. The supplemental rule was later proposed to make certain provisions, including water quality standards and testing, more flexible, reducing potential environmental impacts.

The FDA will consider comments from the public and other government agencies received during the comment period before drafting the final EIS. FDA will evaluate the potential alternatives that the final EIS presents and the environmental impacts of each, including related socioeconomic and human health effects, before finalizing the produce safety rule.

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