The Food and Drug Administration on Jan. 4 announced that it intends to exercise enforcement discretion for certain provisions in four of the rules that implement the F.D.A. Food Safety Modernization Act (FSMA). This means that during the enforcement discretion period, the agency does not intend to enforce the provisions as they currently apply to certain entities or activities.
The F.D.A. said it was exercising enforcement discretion to allow time to consider changes or other approaches to address concerns regarding the application of the provisions to certain activities or entities. Agency officials had previously extended the compliance dates for many of the provisions covered by the enforcement discretion guidance but is now exercising enforcement discretion.
The provisions that will not be enforced apply to four areas. The first relates to certain facilities conducting farm-related activities that are subject to the preventive controls requirements. The F.D.A. explained some establishments that fall outside of the current “farm” definition conduct activities that also are typically conducted on farms, but because the establishments are not considered farms, they are subject to the preventive controls and Current Good Manufacturing Practices requirements.
The F.D.A. said it intends to initiate a rulemaking that may change the way the requirements in the preventive control rules apply to such facilities and will exercise enforcement discretion for the requirements in the preventive control rules for the specific entities and activities until the completion of the future rulemaking.
The second area of enforcement discretion relates to the written assurances in the “customer provisions” in four FSMA rules — Preventive Controls Human Food, Preventive Controls Animal Food, Foreign Supplier Verification Program (F.S.V.P.), and Produce Safety. Each of the rules includes customer provisions intended to provide written assurance to the manufacturer, processor, importer or farmer that the food will be processed to control for hazards before the food reaches consumers.
The F.D.A. commented it has received “feedback” that certain product distribution chains “would require vastly more written assurances and resources to comply than was anticipated by the F.D.A. during the rulemaking process.” The F.D.A. said it would exercise enforcement discretion for the written assurance requirements while it considers rulemaking that takes into consideration the complexity of supply chain relationships and the resources that will be required for compliance.
The third area relates to the importation of food contact substances under the F.S.V.P. The F.D.A. said it has determined that because of certain characteristics related to the nature of food contact substances, the F.D.A.’s premarket review and oversight of the substances, and the regulatory framework for the substances, it was appropriate to exercise enforcement discretion.
The fourth area of enforcement discretion relates to certain manufacturing/processing activities for human food byproducts for use as animal food. The F.D.A. said it has become aware of concerns about how the preventive controls requirements apply to certain activities performed on human food byproducts for use as animal food before they are stored or transported and that do not affect their safety profile.
Scott Gottlieb, Ph.D., F.D.A. administrator, said in explaining the agency’s action, “While we’ve been setting in place the public health gains envisioned as part of FSMA by issuing new standards for food safety, we recognize that such a fundamental change in our food safety approach may require adjustments along the way to address issues that had not been previously anticipated.”
Peter G. Lurie, Ph.D., president, Center for Science in the Public Interest, responded to the F.D.A.’s announcement stating, “Make no mistake: The Trump administration is today undermining that landmark legislation by indefinitely delaying enforcement of the rules that would put it into effect.”
Dr. Lurie said when the same food safety rules were created, and then delayed for a finite period under the Obama administration, the rules were subject to public notice and comment before being published.
“During that period, industry had adequate opportunity to raise the very concerns used by F.D.A. today to justify today’s announcement,” he said. “But under the Trump administration, these indefinite delays are being unveiled in a surprise final guidance without public input.”