FDA’s 2024 Food Facility Registration biennial renewal kick’s off today for 2024-2026 cycle. This is a good reason to revisit the law and its application.
Regulatory History
Registration mandate came from the Congress under Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act/BTA), which amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), codified under 21 U.S.C. 350d. With few exceptions, FDA has determined that all domestic and foreign food facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States must register with the FDA. FDA promulgated a series of regulations, which are codified under 21 CFR, Part 1, Subpart H (21 CFR 1.225 through 1.245).
Foreign (non-U.S.) Facilities
FDA food facility registration requirement affects multiple parties within supply chain, including overseas warehouses that consolidate food products for shipment to the United States. This is done under the “holding food for consumption in the United States” rubric. See Questions and Answers Regarding Food Facility Registration, 27 (7th Ed. 2018). Non-U.S. warehouses can also be regarded as manufacturers/processors under some circumstances. To figure out the role or – who is who? – read on to “manufacturing/processing defined” below, but fist, let’s address de minimis.
The foreign facility need not register if all of the food held by that facility undergoes further manufacturing/processing of more than a de minimis nature in another facility outside the United States. Id. at 29, citing 21 CFR 1.226(a).
De Minimis Rule
Generally, a foreign storage facility that holds food prior to export to the United States is required to register with FDA. However, if the food subsequently undergoes manufacturing/processing of more than a de minimis nature in another foreign facility, the foreign storage facility prior to that manufacturing/processing facility is not required to register. See Questions and Answers Regarding Food Facility Registration, 28-29 (7th Ed. 2018). So what is de minimis from FDA’s vantage point?
- FDA has concluded that de minimis manufacturing/processing does not involve direct manipulation of food. Therefore, most of the activities included in the comment (blending, sieving, particle size distribution, and drying crops) are not de minimis because they manipulate food. Regarding ‘‘re-packaging,’’ it is not clear whether this activity would contact the food itself or merely involve contact with outer materials that do not contact the food. If the re-packaging involves contact with the food itself, it would not be considered de minimis. See Interim Final Rule. 68 FR 58902 (10/10/2003).
- Mere labeling is “de minimis” activity: Under both the proposed rule and this interim final rule, suppliers of food need not register if another foreign facility subsequently manufactures/processes the food before it is exported to the United States, unless the subsequent facility is conducting de minimis activities, such as labeling. In the latter situation, both facilities would have to register. Id.
- A food is not considered to have been further processed solely because labeling was added or other de minimis activity was performed with respect to the food.
This gets us to the Multiple Foreign Facility Rule
Here, Small Entity Compliance Guide is useful, which at page 5 lists the following chart:
Reporting Facility Through FDA Portal
Once registration becomes apparent, then a person who does reporting should become familiar with reporting terminology, or “activity types” using FDA jargon.
Manufacturing/Processing Defined (Packer, Packager, Labeler, Relabeler – Who is Who?)
Definition is within 21 CFR 1.227 states: “Manufacturing/processing means making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients. Examples of manufacturing/processing activities include: Baking, boiling, bottling, canning, cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), evaporating, eviscerating, extracting juice, formulating, freezing, grinding, homogenizing, irradiating, labeling, milling, mixing, packaging (including modified atmosphere packaging), pasteurizing, peeling, rendering, treating to manipulate ripening, trimming, washing, or waxing. For farms and farm mixed-type facilities, manufacturing/processing does not include activities that are part of harvesting, packing, or holding.”
So labeling and packaging would be considered a manufacturing activity. But packaging is not the same as packing!
Packing v. Packaging under 21 CFR 1.227:
- Packaging (when used as a verb) means placing food into a container that directly contacts the food and that the consumer receives.
- Packing means placing food into a container other than packaging the food and also includes re-packing and activities performed incidental to packing or re-packing a food.
It the Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities, 9 (2016), FDA further clarifies the distinction:
Note that our definitions distinguish between “packing” and “packaging.” The first key distinction is that we use the term “packaging” to mean placing food into a container that directly contacts the food and that the consumer receives, but we use the term “packing” when food is placed into containers that are not consumer containers. For example, placing strawberries into consumer containers that directly contact the food (e.g., plastic “clamshells”) is “packaging,” but placing apples into boxes and sending them to distribution centers or retailers is “packing.” The second key distinction is that we classify “packaging” as a manufacturing/processing activity, but we do not classify “packing” as a “manufacturing/processing” activity.
With respect to labeling, FDA says in the same publication:
Similarly, we consider labeling, including stickering, to be a “manufacturing/processing” activity.
FDA Regulations further chime in on the definitions under 21 CFR 1.232(a)(8):
- Labeler/Relabeler: A facility that affixes the original labeling to a food product or changes in any way the labeling on a food product without affecting the product or its container.
- Manufacturer/Processor: A non-farm facility that makes food from one or more ingredients, or synthesizes, prepares, treats, modifies, or manipulates food, including food crops or ingredients. For purposes of this activity type option, examples of manufacturing/processing activities include: baking, boiling, bottling, canning, cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), evaporating, eviscerating, extracting juice, extruding (of animal food), formulating, freezing, grinding, homogenizing, irradiating, labeling, milling, mixing, packaging (including modified atmosphere packaging), pasteurizing, peeling, pelleting (of animal food), rendering, treating to manipulate ripening, trimming, washing, or waxing.
- Packer/Repacker: A facility that packs a food product or products into different containers without making any change in the form of the product.
The terminology affects many, but not all non-U.S. prospective registrants. Hope this article helps in filling out Section 9a within the food facility registration portal correctly.
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