FDA Extends Enforcement Discretion on Certain FSMA Provisions


On January 5, 2018, FDA published a Guidance for Industry, "Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs" and associated Fact Sheet. See 83 Fed. Reg. 598. The guidance immediately extends enforcement discretion to four types of entities and activities as follows:

Farm-Related Activities

FDA is extending enforcement discretion and possibly changing the definition of "Farm" to clarify whether the food is subject to the Produce Safety, PC Human Food or PC Animal Food rules.  As currently defined, Farm activities are limited to:

Further, to be a Farm these activities must be performed where the crop is grown (the "primary production farm") or at a second site that is majority owned (singly or jointly) by the primary production farm(s) that grows, harvests, and/or raises the majority of the RACs harvested, packed, held, or undergoing farm-related activities at the facility. 

FDA is re-evaluating whether facilities should be treated as Farms for the purposes of the CGMP and PC rules if the operation would be a Farm except that any or a combination of the following are true: 
 

Until it has a chance to undertake rulemaking, FDA is exercising enforcement discretion with regard to:

Written Assurances under the "Customer Provisions" 

Under the current PC Human Food rule, where a hazard will be controlled by a downstream processor, the manufacturer must identify which hazards have not been controlled and get written assurances that its customer will control for those hazards. 21 CFR §§ 117.136(a)(2) - (a)(4). There are equivalent provisions within the PC Animal Food rule (21 CFR §§ 507.36(a)(2) - (a)(4)), Produce Safety rule (21 CFR §§ 112.2(b)(2) - (b)(4) and (b)(6)), and FSVP rule (21 CFR § 1.507). FDA has received many comments that the requirement for written assurances will result in vastly more customer assurances being issued than FDA had considered when making the rule. Thus, FDA is extending enforcement discretion to the written customer assurance provisions. Manufacturers, processors, importers and farmers must still disclose to their customers which relevant hazards have not been controlled. Customers are still required to not introduce or deliver for introduction adulterated food into interstate commerce, which means that they will still have to handle these hazards in their own food safety plan. In the meantime, FDA will consider rulemaking regarding the written assurance provisions.   

Importation of Food-Contact Substances (FCSs) under FSVP

The FSVP requires that food importers analyze the hazards of the foods imported and evaluate their foreign suppliers. Under the FSVP rule, the definition of "food" includes food contact substances (FCSs; any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in the food). FDA is extending enforcement discretion with regard to the application of FSVP to imported FCSs. FDA will continue to enforce the prohibition against the introduction or delivery for introduction of adulterated food into interstate commerce. FDA decided to exempt FCSs from FSVP for the following reasons: (1) FCSs generally are demonstrated to be safe through food contact notifications (FCNs) or food additive petitions (FAPs); (2) the PC Human Food rule does not include FCSs in the supply chain requirements (21 CFR Part 117 Subpart G); and (3) FCSs present a low risk to health. Keller and Heckman has published a more detailed client alert regarding FSVP and FCSs.

Certain Manufacturing/Processing Activities for Human Food By-Products for Use as Animal Food

Facilities that manufacture human food, but which also separate and hold by-products for use in animal food are subject to PC Human Food rule, Human Food CGMPs, and Animal Food CGMPs related to holding and distribution (21 CFR § 507.28) or the equivalent for human food (21 CFR § 117.95). If there is any additional processing, all animal food CGMPs must be followed. FDA has made it clear that the only permissible further manufacturing permitted to remain within the former scenario is passive dewatering and holding by-products at temperature to facilitate transportation. FDA received comments describing other activities that may also be done to facilitate holding (see below) and has determined that generally these processes will not affect safety if done in compliance with CGMP requirements (either human or animal food). More complex manufacturing steps that might impact safety, however, may require the additional protections. As a result, FDA intends to consider changes to the requirements and is exercising enforcement discretion in the following circumstances: 

The enforcement discretion does not apply when these activities are performed to prevent or significantly minimize animal food hazards or when these activities introduce animal food hazards.


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National Law Review, Volume VIII, Number 9