FDA WON’T ENFORCE CERTAIN FSMA RULES WHILE IT SEEKS RULEMAKING
Updated: Jul 22
January 23, 2018 / Nicole Cook
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On January 4, 2018, the Food and Drug Administration (FDA) issued Industry Guidance announcing that, effective immediately, it intends not to enforce certain provisions in four of the agency’s rules implementing the Food Safety Modernization Act (FSMA), and will seek rulemaking to address issues that have been raised since the FSMA rules became final.
Specifically, the agency will extend enforcement discretion as follows:
To facilities that conduct farm-related activities that are subject to the preventive control (PC) requirements;
Regarding written assurances in the “customer provisions” in the PC Human Food, PC Animal Food, Foreign Supplier Verification Program (FSVP) and Produce Safety rules;
Regarding the importation of food contact substances (FCSs) under FSVP; and
Regarding certain manufacturing/processing activities for human food by-products for use as animal food.
What Does This Mean For Facilities Conducting Farm-Related Activities?
A facility is generally defined under FDA’s regulations as “[a]ny establishment, structure, or structures under one ownership at one general physical location, or, in the case of a mobile facility, traveling to multiple locations, that manufactures/processes, packs, or holds food for consumption in the [U.S.]” The FDA’s new enforcement policy applies to facilities that fall outside of the current “Farm” definition, and also conduct farm-related activities.
Farm-Related activities are activities within the definition of “Farm” if performed on farms. They typically include growing and harvesting crops, raising animals (including seafood), and some manufacturing/processing activities like drying or dehydrating raw agricultural commodities (RACs) to create a distinct commodity, treating RACs to manipulate ripening, and packaging and labeling RACs. RACs are a food in its raw or natural state, including fruits that are washed, colored, or otherwise treated in their unpeeled form. Grains and eggs are examples of non-produce RACs.
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.
Most Farms are currently exempt from the PC and Current Good Manufacturing Production (CGMP) requirements, while most facilities that conduct farm-related activities are subject to the PC and CGMP requirements unless an exemption applies.
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 (e.g., an operation that grows and harvests oranges, but also colors them, is a farm mixed-type facility that would be entirely a Farm if it did not color RACs). FDA defines RAC as including coloring, but failed to include this operation within the definition of Farms and now wants to consider whether this discrepancy should be remedied.
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 wants 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 making silage is an extension of harvesting. Accordingly, FDA wants 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.
FDA has provided two tables in its Fact Sheet summarizing its enforcement policy with regard to Human Food and Animal Food.
Note that the statutory prohibition against the introduction or delivery for introduction into interstate commerce of adulterated food (21 U.S.C. 331(a)) is still applicable and will be enforced. A food is deemed to be adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health (21 U.S.C. 342(a)(4)).
How Does This Impact The Need To Get 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 commercial customer will control for those hazards. There are equivalent requirements within the PC Animal Food rule, Produce Safety rule, and FSVP rule.
FDA received many comments that these requirement for written assurances will result in “vastly more written assurances (and consequently resources to comply with the requirement)” than anticipated when the rule was written. “For example, a manufacturing facility may sell food products subject to the customer provisions to a distributor, who may sell numerous items requiring assurances to multiple restaurants, cafeterias, delicatessens, and other distributors. It is estimated that this could result in hundreds or even thousands of written assurances needed by a single distributor.” Based on the comments, FDA is extending enforcement discretion to the written customer assurance requirements.
Manufacturers, processors, importers and farmers still must 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 and comply with any additional applicable Federal and/or state and local laws and regulations. In the meantime, FDA will consider rulemaking regarding the written assurances requirements.
How Does This Impact The Importation of Food Contact Substances under FSVP?
The FSVP requires that food importers analyze the hazards for the foods imported and evaluate their foreign suppliers to ensure that the foreign suppliers use processes and procedures that provide the same level of public health protection as those required under the PC or Produce Safety rules, as well as assurances that the imported food is not adulterated and that human food is not misbranded with respect to allergen labeling. Under the FSVP rule, the definition of “food” includes food contact substances (FCSs). An FCS is 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 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; and (3) FCSs present a low risk to health.
FDA will continue to enforce the prohibition against the introduction or delivery for introduction of adulterated food into interstate commerce.
How Does This Affect Certain Manufacturing/Processing Activities For Human Food By-Products For Use As Animal Food?
Facilities that manufacture human food, but which also manufacture, process, pack, and hold human food by-products for use in animal food are subject to the PC Human Food rule, the Human Food CGMPs, and the Animal Food CGMPs with regard to the holding and distribution of the human food by-products. 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 of only being subject to the PC Human Food rule, the Human Food CGMPs, and the Animal Food CGMPs with regard to the holding and distribution of the human food by-products and not subject to all Animal Food CGMPs is passive dewatering and holding by-products at temperature to facilitate transportation (e.g., keeping a syrup or oil warm to maintain liquidity or holding frozen blocks of by-product).
Based on comments the FDA received describing other activities that may also be done to facilitate the storage and transportation of human food by-products for use as animal food, the agency determined that these processes generally will not affect safety if done in compliance with CGMP requirements (either human or animal food):
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).
As a result, FDA intends to consider changes to the requirements and is exercising enforcement discretion when these activities are done to facilitate the storage and transportation of human food by-products for use as animal food. 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. In addition, more complex manufacturing steps that might impact safety, may require the additional protections.
You can read the FDA’s announcement in the Federal Register. You will also find information there about how to submit comments concerning the agency’s new enforcement intent.
The FDA’s guidance is not binding. It merely describes the agency’s current thinking on a topic. Seek legal advice if you have any questions about whether or how the FDA’s new enforcement policy may affect your business.
For more information about food safety requirements and compliance, check out these upcoming food safety training workshops offered throughout Maryland this winter by the Maryland Department of Agriculture, University of Maryland Extension, and ALEI:
Jan. 25 – Mechanicsville, MD – Food Safety and Recall Readiness Workshop for Agritourism Operators (Provided by the Department of Agricultural & Resource Economics (AREC) and supported by a grant from the Northeast Sustainable Agriculture Research and Education (SARE) program)
Feb. 5 – Queenstown, MD – 2018 Basic GAP – Basic Good Agricultural Practices Training
Feb. 5-7 – UMES – Seafood HACCP Basic Course
Feb. 7 – Webinar – Food Safety and Recall Readiness Webinar Series (Provided by the Department of Agricultural & Resource Economics (AREC) and supported by a grant from the Northeast Sustainable Agriculture Research and Education (SARE) program)
Feb. 8 – UMES – Seafood Sanitation Control Procedures (SCP) Course
Feb. 12-15 – Salisbury, MD – FSMA Combined Produce Safety and Preventive Controls Rules Trainings
March 12 – Annapolis, MD – 2018 Advanced GAP Training
Mar. 19-22 – Keedysville, MD – FSMA Combined Produce Safety and Preventive Control Rules Training