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Thorny details down on the farm still stalling FDA enforcement

In the seven years since the Food Safety Modernization Act (FSMA) became law, the question has always been the same. How is the Food and Drug Administration going to do down on the farm?

FDA last week gave itself “enforcement discretion” for some of those complex FSMA rules involving farms. FDA Commissioner Scott Gottlieb said it was all part of working “constructively with farmers and other producers to achieve our shared goals around food safety.”

Peter G. Lurie, president of the Center for Science in the Public Interest (CSPI), doesn’t exactly see it that way. Lurie says the new guidance for FSMA enforcement amounts to the Trump Administration “undermining that landmark legislation.”

“FSMA was intended to cover the entire food chain, from farm to fork, and the Trump Administration’s new guidance would create a gap in that safety chain by exempting, at least for now, some of those who harvest, package and hold food produced on farms,” Lurie said in a statement from CSPI.

The statement also said the FDA guidance would eliminate company-to-company food safety assurances required under the final FSMA rules that identify dangerous pathogens that should be addressed by downstream processors. The consumer advocacy group contends undoing those aspects of the regulations threatens to expose consumers to hazards like Salmonella and E. coli bacteria.

But the National Sustainable Agriculture Coalition (NSAC) praised FDA for hitting the hold button.

The way NSAC sees it, the delay is “FDA’s acknowledgment of the ongoing confusion that businesses have experienced in determining where they fall within FSMA’s regulatory regime, as well as the impracticality of having businesses conducting the same activity (i.e., packing and holding produce) follow different rules just because their ownership structures are different.”

The coalition is an alliance of grassroots organizations that advocate for federal policy reform to advance the sustainability of agriculture, food systems, natural resources, and rural communities. Its activities reach into most every state.

Since the FSMA’s Produce Safety Rule first included a distinction between a “farm” and a “facility,” NSAC says “this seemingly innocuous difference in definition has sent farmers and packers spinning.”

“One of the key sticking points yet to be fully worked out by FDA is whether operations that are only packing and holding intact, raw (unprocessed) produce will be subject to the provisions of the Produce Safety Rule or the Preventive Controls Rule, ” according to NSAC.

“How farms and processing facilities are defined has a direct and significant impact on which rules they are subject to, and by extension, these definitions affect the potential costs or administrative burdens producers/processors may have to undergo as part of compliance.”

FDA attempted to ease confusion and tensions around the rulemaking by extending the compliance dates for two types of operations. Farms, providing a majority of produce to operations, and facilities that solely pack and hold raw or unprocessed produce were included in Produce Safety Rule exemptions.

But they were still left subject to the Preventative Controls Rule.

FDA’s new guidance — that came out this past week — extends the enforcement delay for farmers to include the Preventive Controls Rule. NSAC says the further “enforcement discretion” policy will “ease stress on producers.”

“This new policy will ensure that the types of operations described above will not have the Preventive Controls requirements enforced against them at this time,” NSAC says.

This distinction between a “farm” and a “facility” is particularly important for food hubs or nonprofit packing operations, that do not fit traditional “majority ownership” definitions and have been as of yet unable to receive clear answers from FDA as to which requirements apply to them.

Under the new enforcement discretion policy, a nonprofit food hub that is aggregating and distributing unprocessed produce may still need to register with FDA and follow current good manufacturing practices (CGMPs), but they do not have to adopt the new Preventive Controls requirements until FDA finalizes a rulemaking clarifying which rule governs their activities.

NSAC says it supports “this process of clarification in an attempt to ease regulatory burdens on family farmers and food hubs. It looks forward to working with FDA and with its members to achieve an outcome that honors FSMA’s public health mandate to establish minimum requirements based in science and risk analysis, which are also flexible enough to work for operations of all types and sizes.

The FSMA, with its preventive approach to food safety, for the first time gives FDA authority to establish food safety requirements for farms producing fruits and vegetables. There are some permanent exceptions written into the law.

A farm that produces less than $25,000 in produce sales is exempt under the FSMA’s Tester Amendment, named for Sen. Jon Tester, D-MT.  And the FSMA concerns “covered produce,” meaning that is in its unprocessed state and usually consumed raw.

Thus farms that grow only grains fall outside the FSMA’s jurisdiction because grain isn’t considered produce. Still, the FSMA rules are complex, both individually and in combinations with one another.  Any determination of how the FSMA applies to an individual produce grower is a task filled with complexities.

NSAC was similarly engaged in FDA’s efforts to simplify the agricultural water standard in the Produce Safety Rule. In September 2017, FDA issued a proposed rule to extend the compliance dates for that complicated and inflexible standard to provide time to reevaluate its practicality and effectiveness.

Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA Food Safety Modernization Act enforcement discretion guidance
Guidance for Industry: Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs

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