Recently, the FDA announced that it does not intend to enforce certain provisions in four of the rules that implement the FDA Food Safety Modernization Act (FSMA). The four rules affected by the enforcement discretion include the Preventive Controls for Human Food Rule, Preventive Controls for Animal Food Rule, the Foreign Supplier Verification Program (FSVP) Rule, and the Produce Safety Rule. FDA explained that the enforcement discretion would allow the agency time to address issues that had not been previously anticipated and to pursue permanent fixes.
Preventive Control Requirements for Certain Facilities Conducting Farm-Related Activities
While farms are exempt from the Preventive Controls and Current Good Manufacturing Practice (CGMP) requirements under the rules, there are certain facilities that do not fall under the current definition of “farm,” but conduct farm-related activities. Because these facilities are not considered farms, they are subject to the Preventive Controls and CGMP requirements. The FDA explained that it intends to initiate a rulemaking that could change the way the requirements in the Preventive Controls rules apply to facilities that conduct farm-related activities. In the meantime, the agency intends to exercise enforcement discretion for the requirements in the Preventive Controls rules for these facilities and their activities until the new rulemaking is completed. The FDA emphasized, however, that it will continue to enforce the statutory prohibition against the introduction or delivery for introduction of adulterated food into interstate commerce.
Written Assurances in the ‘Customer Provisions’
Each of the four FSMA rules includes “customer provisions” that require a customer to provide written assurance to its supplying manufacturer, processor, importer, or farmer that the food will be processed to control for hazards before reaching consumers. For the Preventive Controls rules, these provisions apply when a manufacturer or processor relies on other entities in the distribution chain, such as commercial customers, to control certain hazards. The FSVP rule includes customer provisions that apply when an entity imports food for which the hazards are controlled after importation. According to the feedback received by FDA, certain product distribution chains would require vastly more written assurances and resources in order to comply with the current requirements than was anticipated by the agency during the rulemaking process. FDA indicated that, during the enforcement discretion period (during which it would not require written assurances), it will consider rulemaking that is mindful of the complexity of supply chain relationships and the resources necessary to meet the current requirements of these provisions.
Importation of Food Contact Substances Under FSVP
In a fact sheet outlining the enforcement discretion, FDA asserted that it “does not intend to require importers of food contact substances to comply with the requirements of FSVP.” The FDA determined that enforcement discretion could be exercised for this provision because of certain characteristics related to the nature of food contact substances, the agency’s existing premarket review and oversight of food contact substances, and the existing regulatory framework for these substances.
Certain Manufacturing/Processing Activities for Human Food By-Products for Use as Animal Food
Under FSMA, facilities that produce human food, and that do not further manufacturer/process human food by-products for use as animal food, are only subject to a limited holding and distribution CGMP for their by-products. However, if these facilities do manufacture/produce their human food by-products for use as animal food, they are subject to all of the requirements under the Preventive Controls for Animal Food rule; these facilities do have the choice of complying with the Preventive Controls and CGMP requirements in the human food or animal food rules. The FDA noted that it became aware of concerns over how the Preventive Control requirements apply to certain activities performed on human food by-products for use as animal food before they are stored or transported and that do not affect their safety profile. As such, the agency intends to exercise enforcement discretion for such activities as those associated with reducing weight, bulk, or volume, including drying, evaporating, pressing, and chopping. Activities associated with combining or separating ingredients also will be subject to enforcement discretion.
As expected, the move received extensive industry support, while the consumer group Center for Science in the Public Interest (CSPI) characterized FDA’s announcement as undermining FSMA by indefinitely delaying enforcement of the rules. While the reaction of other consumer groups appeared muted, it is expected that these groups will continue to closely scrutinize FDA activity over concerns that it might expand enforcement discretion on FSMA.