November 28, 2021

Volume XI, Number 332


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:

  • Facilities that conduct farm-related activities that are subject to the preventive control (PC) requirements; 

  • Written assurances in the "customer provisions" in the PC Human Food, PC Animal Food, foreign supplier verification program (FSVP) and Produce Safety rules;

  • Importation of food-contact substances (FCSs) under FSVP; and

  • Certain manufacturing/processing activities for human food by-products for use as animal food.

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:

  • Growing crops or raising animals,

  • Harvesting,

  • Holding,

  • Packing, or

  • Other "farm-related activities"

    • Drying/dehydrating Raw Agricultural Commodities (RACs) to create a distinct commodity (like raisins or dried beans),

    • Treating RACs to manipulate ripening, and

    • Packaging and labeling RACs and RACs that have been dried/dehydrated to create a distinct commodity or treated to manipulate ripening.

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: 

  • The operation would be a secondary activities farm except that it fails to meet the common ownership requirement;

    • FDA acknowledges that the purposes for requiring common ownership may be met despite a lack of common ownership and it wishes to consider whether the requirement should be changed

  • The operation colors RACs;

    • FDA defines RAC as including coloring, but failed to include this operation within the definition of Farms

    • FDA wishes to consider whether this discrepancy should be remediated

  • The facility would meet the definition of a secondary activities farm except that it packs, packages, labels, or holds processed food that consists only of RACs that have been dried or dehydrated to create a distinct commodity;

    • The act of drying is a farm-related activity if performed on a primary production farm, but a secondary activities farm must be harvesting, holding, packing, labeling, or taking farm-related activities to RACs and not the distinct commodities resulting from drying or dehydrating

    • FDA wishes to consider whether to include such operations within the definition of Farm

  • The operation makes silage food for animals

    • FDA has received comments from industry that this activity is considered part of harvesting within the industry and FDA wishes to consider whether to include this operation within the definition of Farm.

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

  • PC Human Food, PC Animal Food, Animal Food CGMPs, Human Food CGMPs for non-produce RACs for facilities that would be secondary activity farms, but for the common ownership;

  • PC Human Food and Human Food CGMPs for non-produce RACs for facilities that would be Farms, but that they color RACs;

  • PC Animal Food and Animal Food CGMPs for facilities that would be Farms, but that they color RACS, and that generate by-products for use as animal food as a result of their coloring operations;

  • PC Human Food and Human Food CGMPs for non-produce RACs for facilities that would be Farms, but that they pack, package, label, or hold processed food that consists only of RACs that have been dried or dehydrated to create a distinct commodity;

  • PC Animal Food and Animal Food CGMPS for facilities that would be Farms, but that they pack, package, label, or hold processed food that consists only of RACs that have been dried or dehydrated to create a distinct commodity and that generate byproducts for use as animal food as a result of their coloring operations; and

  • Animal Food CGMPS and PC Animal Food for facilities that make silage food for animals.

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: 

  • Drying/dehydrating, evaporating, pressing, chopping, and similar activities to reduce weight, bulk, or volume, and/or

  • Mixing (e.g., combining different vegetable culls and trimmings, combining juice and dairy by-products, stirring), centrifuging, and similar activities to combine ingredients or separate components (e.g., water and solids).

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.

© 2021 Keller and Heckman LLPNational Law Review, Volume VIII, Number 9

About this Author

Melvin S. Drozen, FDA, regulatory lawyer, Keller Heckman, law firm

Melvin S. Drozen joined Keller and Heckman in 1987.

Mr. Drozen advises clients on a broad spectrum of FDA, FTC, USDA and EPA (pesticides) regulatory matters, ranging from premarket approval requirements for food additives, dietary supplement ingredients, drugs, and medical devices to advertising and labeling provisions applicable to all of these products. Prior to joining Keller and Heckman, he was an Assistant District Attorney in Brooklyn, N.Y., and then an attorney in the General Counsel's Office of the Food and Drug Administration for seven...

Devon Wm. Hill, Keller Heckman, Global Marketing Lawyer, Regulation Compliance Attorney

Devon Hill joined Keller and Heckman in 1996. Mr. Hill's practice focuses on assisting clients with the regulatory issues involved in the global marketing of new products. Specifically, Mr. Hill focuses on compliance and testing issues surrounding the regulation of food, cosmetics, and food and drug packaging materials in the United States and Europe.

Mr. Hill has experience in dealing with the compliance of food and drug packaging in most of the other countries of the world that have established regulatory systems. In addition, Mr. Hill advises...

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Evangelia C. Pelonis, food and drug regulatory lawyer, Keller Heckman law firm

Evangelia C. Pelonis joined Keller and Heckman in 2003 as a Food and Drug Associate. Ms. Pelonis' practice focuses on all regulatory and compliance matters of the U.S. Food and Drug Administration and the U.S. Department of Agriculture relating to human food, animal feed, food additives and ingredients, and dietary supplements. Ms. Pelonis' works with clients to achieve their marketing goals within the applicable legal frameworks. She counsels clients in all aspects of food development and marketing, from product formulation and manufacturing considerations to food...