"US: "FDA enforcement discretion enhances flexibility"

As we enter the first year of compliance under Food and Drug Administration’s (FDA) new Produce Safety Rule, introduced as part of the Food Safety Modernization Act (FSMA), producers continue to experience frustration and confusion regarding FDA’s distinction between a “farm” and a “facility.” Since the Produce Safety Rule was first introduced, 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. 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.

Radish washing station. Photo credit: Lindsey Scalera.

In August 2016, FDA first attempted to ease confusion and tensions around the rulemaking by extending the compliance dates for two types of operations: (1) those that would satisfy FDA’s definition of a “farm” except that they don’t meet the requirement that the business be majority owned by the farm(s) that provide a majority of the produce to the operations, and (2) facilities that solely pack and hold raw or unprocessed produce. Extending the compliance dates linked those operations’ compliance dates with the Produce Safety Rule, but still left them subject to the Preventive Controls Rule.

Last week, FDA took another step to ease the stress on producers by establishing a new “enforcement discretion” policy through guidance. 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.

The National Sustainable Agriculture Coalition (NSAC) has applauded this move and praised 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.

In order to fully resolve this issue, FDA will be undertaking a future rulemaking. It is our hope that in so doing they reach a solution wherein any operation solely conducting farm-related activities on raw, unprocessed produce will be subject to the Produce Safety Rule requirements, not the Preventive Controls requirements.

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 (or 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 supports this process of clarification in an attempt to ease regulatory burdens on family farmers and food hubs. We look forward to working with FDA and with our 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. We are 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 in order to provide time to reevaluate its practicality and effectiveness.

Source: National Sustainable Agriculture Coalition