On January 5, 2018, the US Food and Drug Administration (FDA) released guidance entitled Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs: Guidance for Industry. The guidance states that the FDA will exercise enforcement discretion for certain parts of the Food Safety Modernization Act (FSMA) rules. Essentially, the agency does not intend to enforce certain provisions in four regulations implementing FSMA. This agency action is not shocking given how the Trump Administration has been rolling back Obama-era rules and regulations and since FDA Commissioner Scott Gottlieb has not been focusing his efforts on FSMA implementation; his priority list has instead focused on things like the opioid crisis, drug pricing, mobile medical application development, and streamlining clinical trials.
Specifically, the enforcement discretion covers certain entities or activities covered by the Hazard Analysis, and Risk-Based Preventive Controls (HARPC) for Human and Animal food rules (Preventive Controls (PC) for Human Food and Animal Food), Current Good Manufacturing Practice (CGMP), the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule (Produce Safety rule) and the Foreign Supplier Verification Program (FSVP) rule.
Importers of food contact substances who had to comply with the FSVP regulations will be subject to the agency’s new discretionary enforcement. The agency stated in the guidance that due to the nature of food contact substances, the existing regulatory framework for these substances, and the FDA’s strong premarket review and oversight of food contact substances already, “it is appropriate to consider the exercise of [FDA] enforcement discretion to not require importers of food contact substances to meet FSVP requirements.” Specifically, the agency reasoned that by its very definition, food contact substances were not intended to have a technical effect in food.
The FDA has clarified in its guidance that regardless of its enforcement discretion, the prohibitions against the introduction or delivery for introduction into interstate commerce of adulterated food (under section 301(a) of the Federal Food Drug & Cosmetic Act (21 USC 331(a)) still applies to food contact substances. Further, the agency has left open the possibility that it may consider reversing course on its discretionary enforcement, if, for example, it receives new information regarding food safety concerns.
Further, the guidance aims to change how the FSMA rules would apply to entities that conduct farm-related activities but are not farms. Farms are exempt from the PC and CGMP requirements, while produce farms are typically covered by the Produce Safety rule, unless an exemption applies. The guidance applies to certain facilities conducting farmrelated activities and establishments that fall outside of the current “farm” definition, since these entities typically are subject to the PC and CGMP requirements. The agency intends to initiate a rulemaking that could change the way the requirements in the PC rules apply to these facilities that conduct farmrelated activities, and in the interim, the agency intends to exercise enforcement discretion for the requirements in the PC rules for these specific entities and activities. Notably, the statutory prohibition against the introduction or delivery for introduction of adulterated food into interstate commerce would still apply to these entities and activities.
Additionally, the FDA intends to use its enforcement discretion with written assurance, or “customer assurance,” requirements for manufacturers, processors, importers, and farmers under the PC, FSVP, and Produce Safety rules. However, during this enforcement policy period, these groups must still disclose to their customers that the relevant hazards have not been controlled. Additionally, those customers (or other customers thereafter) will still have to comply with all other applicable requirements in federal, state, or local laws.
Moreover, the guidance explains that the agency has become aware of industry concerns about how the PC requirements apply to “certain activities performed on human food by-products for use as animal food before they are stored or transported and which do not affect their safety profile.” To address these concerns, the agency has stated that it intends to exercise enforcement discretion for the following activities:
Drying/dehydrating, evaporating, pressing, chopping and similar activities to reduce weight, bulk, or volume and/or mixing, centrifuging, and similar activities to combine ingredients or separate components (e.g., water and solids).
Notably, this enforcement discretion does not apply when these activities are performed with the aim of significantly minimizing or preventing altogether animal food hazards, or when these activities introduce animal food hazards. Additionally, the statutory prohibition against the introduction or delivery for introduction of adulterated food into interstate commerce will still apply.
FDA Commissioner Scott Gottlieb also released a statement on January 4, 2018 explaining that the agency values the feedback it has received on the new FSMA rules from farmers, manufacturers, and other stakeholders regarding the challenges that they have faced while trying to implement the new rules. The agency is trying to fix these remaining issues through rulemaking and other means; however, the agency acknowledged that such changes would take a long time. Thus, the agency released this guidance outlining the key FSMA areas where it seeks to exercise enforcement discretion in an effort to assist these stakeholders, while the agency tries to make long term, permanent fixes to the rules.
Facilities should determine if they are impacted by the FDA’s new discretionary enforcement and modify their FSMA preparations and processes accordingly. The Health Law Pulse will continue to monitor FSMA updates.