On January 4, 2018, the Food and Drug Administration (FDA) released guidance to industry announcing that it does not intend to enforce certain regulatory requirements contained in rules promulgated under the Food Safety Modernization Act (FSMA). FDA’s guidance responds to industry feedback requesting additional clarity on which facilities are exempt from key requirements as “farms” and addressing feasibility of compliance with other requirements at this time.
Under the enforcement policy announced in the guidance document, FDA plans to exercise “enforcement discretion” with respect to requirements under four significant FSMA rules: the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls rules for both human and animal food (CGMP & PC Rules); the Foreign Supplier Verification Programs rule (FSVP); and Standards for Growing, Harvesting, Packing and Holding of Produce for Human Consumption rule (Produce Safety Rule).
Preventive Controls and CGMPs at Facilities Conducting “Farm-Related” Activities
The guidance announced that FDA will exercise discretion in enforcing preventive controls requirements at certain facilities conducting “farm-related” activities. Facilities that are “farms” are exempt from registration requirements, and in turn are also exempt from human and animal food preventive controls requirements and Current Good Manufacturing Practices (CGMPs). As part of FSMA rulemaking, FDA amended the definition of “farm” to clarify the scope of these exemptions.
FDA’s guidance announced that it would exercise enforcement discretion at certain facilities conducting “farm-related” activities — including certain facilities that would qualify as farms but for ownership limitations or because they undertake limited activities such as coloring raw agricultural commodities (RACs) or packaging, labeling, or holding dried or dehydrated RACs.
According to the guidance document, FDA does not does not intend to enforce all human and animal preventive control requirements, all animal food CGMPs, and all human food CGMPs for non-produce RACs. Produce farms, however, remain covered by the Produce Safety Rule, and an FDA factsheet notes that human food CGMPs can be satisfied through compliance with the Produce Safety Rule for certain activities involving produce RACs.
Customer Provisions Requiring Written Assurances
The four rules referenced above each include “customer provisions” requiring written assurance to be provided to manufacturers, processors, importers, or farmers that the food will be further processed to control for hazards before the food product is consumed. These provisions generally allow facilities to avoid implementing preventive controls where those hazards will be controlled by another entity in the distribution chain, provided that the direct customer of the facility provides written assurances and agrees to act consistently with the assurance document. In response to industry comments that the written assurance requirements may be overly burdensome in some complex supply chains, FDA has announced that it will exercise enforcement discretion with respect to written assurance requirements contained in these rules. However, FDA’s policy does not excuse compliance with disclosure requirements under 21 CFR parts 117, 507, or 112 or the FSVP regulation.
Importation of Food Contact Substances under FSVP Regulation
The FSVP regulation requires food importers to develop, maintain, and follow an FSVP. The regulations that apply to “food” and “food contact substances” are included in this definition for purposes of the FSVP regulation. Due to concerns about feasibility, FDA had previously extended the compliance date for provisions related to importation of food contact substances. FDA’s guidance announces that it will exercise enforcement discretion to effectively push this compliance deadline out to at least May 28, 2019.
Use of Human Food By-product as Animal Food
The FSMA animal food rule included provisions streamlining the requirements for human food facilities to manufacture, process, pack, and hold human food by-products for use as animal food. After release of draft guidance on these new requirements, FDA’s newest guidance notes that the agency heard concerns from industry about how the animal food rule applies to certain processing activities performed on human food by-product to facilitate its storage or transport for use as animal food. Until FDA can more fully consider this question, EPA is proposing to exercise discretion in enforcing animal food preventive control requirements on human food facilities, provided the manufacturing or processing activities performed on human food by-product are limited to (i) drying, dehydrating, evaporating, pressing, chopping, and similar activities to reduce weight, bulk, or volume; or (ii) mixing, centrifuging, and similar activities to combine ingredients or components. Activities covered by this enforcement policy also cannot be performed for the purpose of preventing or reducing the risk of animal food hazards and may not themselves introduce new hazards to the human food by-product.
For more information about FSMA implementation and compliance, contact your Michael Best attorney.