FDA Food Processing Facility Registration

Initial Facility Registration

The Food and Drug Administration (FDA) requires registration from all facilities and operations that manufacture, pack, or hold food for human or animal consumption. Registration is required prior to the commercial facility starting their operations, regardless if the product will enter into interstate commerce. The facility's owner, operator, or agent in charge may authorize an individual to register on their behalf. It should be noted that the list of registered facilities, registration documents and information included in registration documents are not available to the public, i.e., the information is not subject to public disclosure under the Freedom of Information Act.

**Information required to complete an FDA food facility registration**
Facility name, address, phone number, and emergency contact phone number	Parent company name, address, and phone number (if the facility is a subsidiary of the parent company)	The facility’s acceptable UFI	All trade names the facility uses	Name, address, and phone number of the owner, operator, or agent in charge
Email address of the owner, operator, or agent in charge	Applicable food product categories of any food manufactured/processed, packed, or held at the facility.	The type(s) of activity at the facility for each food product category, as noted below	A statement in which the owner, operator, or agent in charge provides an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.	A statement in which the owner, operator, or agent in charge certifies that the information submitted is true and accurate.

Food processing operations will need to consider every product manufactured in order to appropriately classify themselves within the FDA's activity types. The food facility registration must include applicable food product categories of any food manufactured/processed, packed, or held at the facility per 21 CFR 1.232(a)(8). If an operation's processing activities cover multiple category types, all activity types should be selected on the registration. Considerations for each category are further defined in the Guidance for Industry: Questions and Answers Regarding Food Facility Registration.

**Food Facility Activity Types**
Ambient human food storage warehouse/holding facility	Refrigerated human food warehouse/holding facility	Frozen human food warehouse/holding facility	Interstate conveyance caterer/catering point	Contract sterilizer	Labeler/relabeler	Packer/repacker
Manufacturer/processor	Acidified food processor	Low-acid food processor	Farm mixed-type facility	Salvage operator (reconditioner)	Animal food warehouse/holding facility	Other activity (must specify)

Exempt Facilities & Businesses

The following are examples of operations and businesses that are exempt from registering their facility with the FDA. It is not an exhaustive list, but here to serve as the most common exemptions. Many of these definitions can be found in 21 CFR 1.227, unless otherwise noted.

Qualified facilities (also known as very small businesses), as outlined in 21 CFR 117.3
Farms, see Glossary below for definition of farm operations
Retail food establishments
- Grocery & warehouse stores
- Restaurants
Home processors, those under Cottage Food Laws
Apiary and beekeeping operations
Non-profit food establishments and operations
Fishing vessels that aren't processing seafood onboard
Food packaging manufacturers

DUNS Number Requirement: Your Unique Facility Identifier

In addition to a facility registration number, the FDA now requires a unique facility identifier (UFI) to be entered onto applications when facilities are registering or renewing their facility registration (21 CFR 1.232(a)(2)). The UFI is not a substitution for FDA registration numbers. A UFI is required for each address registered with the FDA. As of 2022, data universal numbering system numbers, or DUNS numbers as they are commonly called, are the only FDA-recognized UFI. This 9-digit unique identifying number are used to verify food processing facilities.

Registration with DUNS numbers began during the last biannual period, ending December 31, 2020. However, this required registration date has been extended to December, 31, 2022. Food processing facilities must include this number when registrering or renewing their facility to avoid having their FDA registration cancelled.

DUNS numbers can be obtained, free of charge from Dunn & Bradstreet. It can take up to thirty (30) days after your request to receive a DUNS number. Dunn & Bradstreet also offers expedited requests for a fee.

Registration Renewal, Updates and Cancellation

Facilities must have their registration renewed by the owner, operator, or agent in charge of the facility between October 1 and December 31 of every even-numbered year. As of January 4, 2020, the FDA requires all renewals to be submitted electronically on their FURLS database website. The FDA offers an abbreviated registration for operations that do not have changes to their registration; the owner, operator or agent in charge will need to verify information and data before submitting the abbreviated registration.

If a company needs to submit their renewal via fax or the mail, a waiver must be previously granted by the FDA. More information on waivers can be found in Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition).

Updates and cancellation of registration must be communicated to the FDA via the FURLS database within 60 days of changes; this includes changes of ownership

Glossary of Terms

Farm (two types):

Primary production farm – an operation under one management in one general (but not necessarily contiguous) physical location devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities. The term “farm” includes operations that, in addition to these activities:
1. Pack or hold raw agricultural commodities;
2. Pack or hold processed food, as long as the food is either consumed on that farm or another farm under the same management;
3. Manufacture/process food, as long as:
  1. The food is consumed on that farm or another farm under the same management; or
  2. Manufactured/processed food intended for sale consists only of:
4. Drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), and packaging and labeling such commodities, without additional manufacturing/processing (e.g., slicing)
5. Treatment to manipulate the ripening of raw agricultural commodities (e.g., ethylene gas), and packaging and labeling without additional manufacturing/processing.
6. Packaging and labeling raw agricultural commodities, when these activities do not involve additional manufacturing/processing.
Secondary activities farm – an operation, not located on a primary production farm, devoted to harvesting (such as hulling or shelling), packing, and/or holding of raw agricultural commodities, provided that the primary production farm(s):
1. Grows, harvests, and/or raises the majority of the raw agricultural commodities handled at the secondary activities farm (e.g., packinghouse)
2. Owns, or jointly owns, a majority interest in the secondary activities farm.
3. A secondary activities farm may also conduct those additional activities allowed on a primary production farm as described above.

Harvesting – applies to farms and farm mixed-type facilities and means activities that are traditionally performed on farms for the purpose of removing raw agricultural commodities from the place they were grown or raised and preparing them for use as food. Harvesting is limited to activities performed on raw agricultural commodities, or on processed foods created by drying/dehydrating a raw agricultural commodity without additional manufacturing/processing, on a farm. Harvesting does not include activities that transform a raw agricultural commodity into a processed food.

Examples of harvesting include cutting (or otherwise separating) the edible portion of the raw agricultural commodity from the crop plant and removing or trimming part of the raw agricultural commodity (e.g., foliage, husks, roots or stems), cooling, field coring, filtering, gathering, hulling, shelling, sifting, threshing, trimming of outer leaves of, and washing raw agricultural commodities grown on a farm.

Holding – storing of food, including warehouses, cold storage, silos, grain elevators, and liquid storage tanks.

Home Processor - As defined by NC food laws & regulations. An inspected, low-risk food manufacturer who is processing in a residential home.

Manufacturing/processing – Making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients. Examples include cutting (other than the cutting of outer leaves associated with harvesting), peeling, trimming, cooking, freezing, cooling, pasteurizing, homogenizing, milling, grinding, extracting juice, labeling, or packaging. Manufacturing/processing does not include harvesting (see below).

Mixed-type facility - an establishment that engages in both activities that are exempt from FDA registration (i.e., farm) and activities that require the establishment to be registered (manufacturing/processing). An example of such a facility is a "farm mixed-type facility," which is an establishment that is a farm, but also conducts activities outside the farm definition that require the establishment to be registered.

Packaging – Placing food in a container that directly contacts with the food and that the consumer receives.

Packing – 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 (e.g., activities performed for the safe or effective packing or re-packing of that food (such as sorting, culling, grading, and weighing or conveying incidental to packing or re-packing).

Retail Food Establishment - an establishment that sells food products directly to consumers as its primary function.