Questions and Answers Regarding Food Facility Registration (Seventh Edition)

Contains Nonbinding Recommendations

Questions and Answers Regarding

Food Facility Registration (Seventh

Edition): Guidance for Industry

You may submit electronic or written comments regarding this guidance at any time. Submit

electronic comments to https://www.regulations.gov/

. Submit written comments on the guidance

to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket

number FDA-2012-D-1002 listed in the notice of availability that publishes in the Federal

U.S. Department of Health and Human Services

Food and Drug Administration

Office of Foods and Veterinary Medicine

Center for Food Safety and Applied Nutrition

Center for Veterinary Medicine

Office of Regulatory Affairs

August 2018

Contains Nonbinding Recommendations

Table of Contents

I. INTRODUCTION .............................................................................................................. 3

II. QUESTIONS AND ANSWERS ...................................................................................... 4

A. Who Must Register? .................................................................................................... 4

B. Who is Exempt from Registration? ........................................................................... 4

C. Definitions .................................................................................................................. 21

D. When Must You Register or Renew Your Registration? ...................................... 36

E. How and Where Do You Register or Renew Your Registration? ........................ 38

F. What Information Is Required in the Registration? .............................................. 42

G. What Optional Items Are Included in the Registration? ...................................... 49

H. How and When Do You Update Your Facility's Registration Information? ...... 49

I. How and When Do You Cancel Your Facility's Registration Information? ....... 51

J. What Other Registration Requirements Apply? .................................................... 54

K. What Are the Consequences of Failing to Register, Renew, Update, or Cancel

Your Registration? ................................................................................................... 54

L. What Does Assignment of a Registration Number Mean? .................................... 55

M. Is Food Registration Information Available to the Public? .................................. 56

N. Waiver Request .......................................................................................................... 57

O. General Registration Questions ............................................................................... 59

P. Suspension of Registration ....................................................................................... 59

Q. Compliance Dates ...................................................................................................... 60

III. REFERENCES .................................................................................................... 61

Contains Nonbinding Recommendations

Questions and Answers Regarding Food

Facility Registration (Seventh Edition):

Guidance for Industry

This guidance represents the current thinking of the Food and Drug Administration (FDA or we) on this

topic. It does not establish any rights for any person and is not binding on FDA or the public. You can

use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To

discuss an alternative approach, contact FDA’s Technical Assistance Network by submitting your

information at https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm.

I. INTRODUCTION

On October 10, 2003, the Food and Drug Administration (FDA or we) issued an interim final

rule to implement amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made

by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

(Bioterrorism Act) (Pub. L. 107-188) (68 FR 58894). Section 415 of the FD&C Act (21 U.S.C.

350d) requires domestic and foreign facilities that manufacture, process, pack, or hold food for

human or animal consumption in the United States to register with FDA. This guidance was

developed to answer frequently asked questions relating to the registration requirements of

section 415 of the FD&C Act.

The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), enacted on January 4, 2011,

amended the food facility registration requirements in section 415 of the FD&C Act.

The first edition of this document was issued as Level 2 guidance pursuant to Title 21, Code of

Federal Regulations (CFR), Section 10.115 (21 CFR 10.115) and was made available on FDA's

website on December 4, 2003. The second, third, fourth, and fifth editions of this document

were issued as Level 1 guidance documents pursuant to 21 CFR 10.115 and were made available

on FDA’s website on January 12, 2004, February 17, 2004, August 2004, and December 2012,

respectively. The sixth edition was issued as Level 1 guidance and included one additional

question and answer relating to a proposed change to the “farm” definition in 21 CFR 1.227 (79

FR 58524; September 29, 2014). The new question and answer was identified with the date that

it was added to the guidance. The sixth edition was immediately effective because FDA had

determined that prior public participation was not feasible or appropriate.

This guidance has been jointly prepared by the Office of Compliance in the Center for Food Safety and Applied

Nutrition, the Office of Surveillance and Compliance in the Center for Veterinary Medicine, and the Office of

Regulatory Affairs at the U.S. Food and Drug Administration.

Contains Nonbinding Recommendations

This revision (Seventh Edition) is being issued as Level 1 guidance pursuant to 21 CFR

10.115 and includes additional questions and answers relating to issues regarding food facility

registration, including issues related to the following rulemakings: the Amendments to

Registration of Food Facilities final rule (Registration Final Rule) (81 FR 45912; July 14, 2016)

that revised FDA’s registration regulation; Current Good Manufacturing Practice, Hazard

Analysis, and Risk-Based Preventive Controls for Human Food (80 FR 55907; Sept. 17, 2015);

and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive

Controls for Food for Animals (80 FR 56170; Sept. 17, 2015). We also revised information in

existing questions and answers, deleted some questions and answers, and made editorial changes

(e.g., reorganized existing questions and answers) to improve clarity.

“I”, “you,” “your” or “registrant” are used in this guidance to refer to the owner, operator, or

agent in charge of a facility that manufacturers/processes, packs, or holds food for consumption

in the United States.

FDA’s guidance documents, including this guidance, do not establish legally enforceable

responsibilities. Instead, guidances describe our current thinking on a topic and should be

viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

The use of the word should in Agency guidances means that something is suggested or

recommended, but not required.

II. QUESTIONS AND ANSWERS

A. Who Must Register?

A.1 Who must register under the food facility registration requirements?

If you are the owner, operator, or agent in charge of either a domestic or foreign facility that is

engaged in manufacturing/processing, packing, or holding of food for human or animal

consumption in the United States, you must register with FDA, unless you are exempt under 21

CFR 1.226 from the requirement to register. If you are an owner, operator, or agent in charge

of a domestic facility, you must register your facility whether or not the food from the facility

enters interstate commerce (21 CFR 1.225(b)). If you are the owner, operator, or agent in

charge of a facility, you may authorize an individual to register your facility on your behalf (see

21 C

FR 1.225(c) and 1.230(a)). A foreign facility’s U.S. agent may, but is not required to,

B. Who is Exempt from Registration?

1. Farms

B.1.1 Are farms exempt from registration?

Under 21 CFR 1.226(b), farms are not required to register. “Farm” is defined in

21 CFR 1.227 as:

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(1) Primary production farm. A primary production farm is 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:

(i) Pack or hold raw agricultural commodities;

(ii) Pack or hold processed food, provided that all processed food used in such activities

is either consumed on that farm or another farm under the same management, or is processed

food identified in paragraph (1)(iii)(B)(1) of this definition; and

(iii) Manufacture/process food, provided that:

(A) All food used in such activities is consumed on that farm or another farm under the

same management; or

(B) Any manufacturing/processing of food that is not consumed on that farm or another

farm under the same management consists only of:

(1) 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 (an example of additional

manufacturing/processing is slicing);

(2) Treatment to manipulate the ripening of raw agricultural commodities (such as by

treating produce with ethylene gas), and packaging and labeling treated raw agricultural

commodities, without additional manufacturing/processing; and

(3) Packaging and labeling raw agricultural commodities, when these activities do not

involve additional manufacturing/processing (an example of additional

manufacturing/processing is irradiation); or

(2) Secondary activities farm. A secondary activities farm is 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) that

grows, harvests, and/or raises the majority of the raw agricultural commodities harvested,

packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in

the secondary activities farm. A secondary activities farm may also conduct those additional

activities allowed on a primary production farm as described in paragraph (1)(ii) and (iii) of this

definition.

Therefore, if your farm operation conducts activities that fall within the definition of “farm” in 21

CFR 1.227, the farm is exempt from registration. However, if your farm is a “farm mixed-type

facility,” you must register. The term “mixed-type facility” means an establishment that engages

in both activities that are exempt from registration and activities that require the establishment to

be registered. For a discussion of “farm mixed-type facility,” please see Question B.1.4 in this

document.

Note that in January 2018, FDA issued a guidance document in which we stated that we intend to

initiate a rulemaking that could change the definition of a “farm.” We also stated that we do not

anticipate that the rulemaking would result in an entity that currently is a “farm” becoming a

Contains Nonbinding Recommendations

“facility.” See “Policy Regarding Certain Entities Subject to the Current Good Manufacturing

Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification

Programs,” accessible at

https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm

590646.htm.”

For more information on activities that are within the “farm” definition, please see our draft

guidance entitled, “Classification of Activities as Harvesting, Packing, Holding, or

Manufacturing/Processing for Farms and Facilities” (81 FR 58421; August 25, 2016).

B.1.2 Is a farm that grows tomatoes and sells them directly to consumers from a roadside

stand located on the farm exempt from registration?

Yes. Assuming that the farm on which the tomatoes are grown otherwise satisfies the definition

of “farm” (21 CFR 1.227), it is exempt from registration. If the primary activity of the roadside

stand is selling food (including the tomatoes) directly to consumers, it is exempt as a “retail food

establishment” (see 21 CFR 1.227). The term “retail food establishment” is defined in 21 CFR

1.227 as “an establishment that sells food products directly to consumers as its primary function.

The term “retail food establishment” includes facilities that manufacture, process, pack, or hold

food if the establishment's primary function is to sell from that establishment food, including food

that it manufactures, processes, packs, or holds, directly to consumers. A retail food

establishment's primary function is to sell food directly to consumers if the annual monetary value

of sales of food products directly to consumers exceeds the annual monetary value of sales of

food products to all other buyers. The term “consumers” does not include businesses. A “retail

food establishment” includes grocery stores, convenience stores, and vending machine locations.

A “retail food establishment” also includes certain establishments located on farms and farm-

operated businesses selling food directly to consumers as their primary function. For a discussion

of “retail food establishments,” please see Section B.2 in this document.

B.1.3 If a farm located in a foreign country ships food directly to the United States, is it

required to register?

No. A farm located in a foreign country that ships food directly to the United States is exempt

from the registration requirements of section 415 of the FD&C Act (21 U.S.C. 350d; 21 CFR

1.227). However, if prior to shipping to the United States, the farm ships the food to a foreign

facility that manufactures/processes, packs, or holds the food, the second facility must register

unless the food subsequently undergoes further manufacturing/processing of more than a de

minimis nature at another foreign facility (21 CFR 1.226(a)). The de minimis provision (21 CFR

1.226) is discussed further in Question C.3.5 in this document.

B.1.4 Is a mixed-type facility, such as a farm that grows oranges and processes them into

orange juice for sale to a distributor, required to register?

Yes. The term “mixed-type facility” means an establishment that engages in both activities that

are exempt from registration and activities that require the establishment to be registered. An

Contains Nonbinding Recommendations

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 (21 CFR 1.227). In this example, the farm mixed-type facility is required to register

because its processing activities are not covered by the “farm” definition in 21 CFR 1.227.

B.1.5 Is use of chlorinated water to wash intact lettuce raw agricultural commodity (RACs)

on a farm considered "manufacturing/processing," necessitating registration of the farm?

RAC is defined in 21 CFR 112.2(a)(3) as any food in its raw or natural state, including all fruits

that are washed, colored or otherwise treated in their unpeeled natural form prior to marketing.

Washing RACs may be classified as “harvesting” on a farm but “manufacturing/processing”

when performed elsewhere. Washing RACs can also be classified as “packing” both on and off

farm when performed for the safe or effective packing of a food. If the farm is washing intact

lettuce (RACs) using water that has been chlorinated, FDA will consider this activity “harvesting”

or “packing” within the definition of “farm” in 21 CFR 1.227. Accordingly, a farm using

chlorinated water in this manner is not required to register on account of this activity.

B.1.6 Does placing stickers on a raw agricultural commodity (RAC), such as fruit on a

farm, amount to "manufacturing/processing" and, therefore, require registration of the

farm at which the application of the stickers occurs?

Placing labels (e.g., stickers) directly on raw agricultural commodities (RACs), on boxes or other

containers holding packed RACs, or on consumer packages containing RACs, is a

manufacturing/processing activity that is within the “farm” definition and does not result in a farm

having to register. (See “farm” definition in 21 CFR 1.227 at (1)(iii)(B)(3) and at B.1.1. of this

guidance).

B.1.7 Does a farm that packs fresh produce from other farms have to register? Does a farm

that packs its own produce have to register?

No. According to the definition of “farm” in 21 CFR 1.227, an establishment devoted to the

growing of crops, the harvesting of crops, the raising of animals, or any combination of these

activities, would remain within the “farm” definition if it packs or holds RACs, regardless of

whether the farm packs or holds RACs grown on that farm, RACs grown on another farm under

the same management, or RACs grown on another farm under different management. Any such

operation that meets the “farm” definition is not subject to the requirement to register under

section 415 of the FD&C Act.

B.1.8 Does a farm need to register if it grows its own produce, harvests it, wraps it, and

places it into cartons for the sole purpose of transporting the food off the farm?

No. The “farm” definition provides for farms to pack food (21 CFR 1.227 at (1)(i)). Wrapping

produce and placing it into cartons for transporting the food off the farm is packing and is within

the “farm” definition.

Contains Nonbinding Recommendations

B.1.9 Is a farm required to register if the owner of the farm transports workers out to the

field on a truck, where the workers pick strawberries from the field and place them into

plastic clamshells? The filled clamshells are then transported off the farm.

No. The farm in this example is exempt from registration. Moreover, the farm is exempt from

registration regardless of whether the clamshell is the container that the consumer receives. If the

strawberries are placed into clamshells that are not the containers that will be received by the

consumer, such activity is “packing” under 21 CFR 1.227. The definition of a “farm” in 21 CFR

1.227 includes farms that pack RACs, and so the farm would not have to register. Alternatively,

placing strawberries into a container that directly contacts the food and that the consumer receives

is “packaging” under 21 CFR 1.227, which is an example of manufacturing/processing.

However, the definition of “farm” provides that a farm may package and label RACs that are not

consumed on that farm or on another farm under the same management as long as the packaging

and labeling do not involve additional manufacturing/processing, so the farm in such case would

not have to register.

Furthermore, the truck that transports the workers and the filled containers off the farm is not a

facility that is required to register because it is holding the food only in its usual course of

business as a carrier (21 CFR 1.227, definition of “facility”).

B.1.10 On some farms, vegetables are removed from the ground, field trimmed, washed,

and then transferred to a truck in the field where they are placed in a consumer package,

cooled, and held before being moved off the farm by a transport vehicle. The truck (i.e.,

mobile operation) that packages and cools the RACs is a separate operation (i.e., is under

different management) from the operation that performs the other activities, and the truck

performs this function on multiple farms. Is the operation performing activities before the

vegetables are transferred to the truck for cooling and packaging or the truck operation

where the vegetables are cooled and packaged required to register with FDA?

The operation removing vegetables from the ground, field trimming, washing, and transferring

them to a truck is a primary production farm. All of these activities, as conducted by the

operation, are performed on RACs and can be classified as “harvesting” and/or “holding” within

the “farm” definition. Therefore, it is not required to register.

The mobile operation also is not required to register. The cooling conducted by the mobile

operation is considered to be a “harvesting” activity because it is performed on RACs in the same

general physical location where the RACs were grown or raised. This harvesting activity makes

the mobile operation a primary production farm, and primary production farms may also package

RACs (providing the packaging involves no additional manufacturing/processing) within the

“farm” definition.

B.1.11 Is a truck-mounted operation that removes carrots from the ground, chops them

into roughly 1-inch pieces, and then places them into consumer-ready bags before

transporting them off the farm for distribution required to register?

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The truck-mounted operation is a farm mixed-type facility because it is a farm, but it also

conducts activities outside the “farm” definition that require registration. Removing carrots from

the ground is considered harvesting and makes the operation a primary production farm.

Chopping the carrots into 1-inch pieces is a “manufacturing/processing” activity that is outside

the “farm” definition and triggers the registration requirement. Once chopped, the carrots are not

RACs and therefore placing them in consumer-ready bags is packaging processed food, another

“manufacturing/processing” activity outside of the “farm” definition.

B.1.12 Is a truck-mounted operation required to register if it travels from one vineyard to

another and bottles wine made from grapes grown and processed into wine at the vineyard?

Yes. A truck-mounted operation that travels from one vineyard to another and bottles wine is a

mobile facility that must be registered. Bottling wine is “packaging,” which is an activity

included in the definition of "manufacturing/processing" (21 CFR 1.227).

"Manufacturing/processing" is defined as "making food from one or more ingredients, or

synthesizing, preparing, treating, modifying or manipulating food, including food crops or

ingredients." Bottling wine involves manipulation of the wine because it is preserving the

manufactured condition of the wine by vacuum-sealing it and corking it. Thus, the truck-mounted

operation that bottles wine is a facility that is required to register. Furthermore, the exception in

21 CFR 1.227 for farms (both primary production farms and secondary activity farms) that

perform packaging and labeling without additional manufacturing/processing only applies to

packaging and labeling of RACs, and wine is a processed food.

B.1.13 Are maple syrup producers “farms” and, thus, exempt from registering?

The response to this question depends upon the activities of the maple syrup producer. The

activities of maple syrup producers customarily consist of two types: gathering sap from sugar

maple trees and concentrating the sap through the application of heat to make syrup. Gathering

sap is "harvesting," which is included in the definition of “farm” (21 CFR 1.227). Therefore, the

farm is exempt from registration. However, making maple syrup by concentrating sugar maple

sap (i.e., by evaporation using heat) is a form of “manufacturing/processing” (21 CFR 1.227).

Accordingly, a facility that concentrates sugar maple sap is performing a

“manufacturing/processing” activity and is required to register, unless all of the concentrated sap

is consumed on the farm or another farm under the same management or is exempt from

registration as a retail food establishment, as discussed in Question B.2.11 (21 CFR 1.227).

B.1.14 Does a farm need to register if it grows a crop, harvests it, and holds it for a period

of time before shipping it to a distributor (e.g., grain elevator) or manufacturer/processor?

No. Holding a harvested crop for a period of time before providing it to a distributor or

manufacturer/processor does not result in the farm being required to register. (For a full

discussion of what constitutes a farm, see Question B.1.1).

B.1.15 If a farm grows hay and sells the hay as animal food to a dairy farm that is not

under the same management, does the hay farm need to register? Does the dairy farm need

to register? Is registration dependent on how long the farm holds the hay before it sells it?

Contains Nonbinding Recommendations

No. The farm growing and selling the hay is a “farm” because the associated activities are

considered part of either growing, harvesting, or holding a RAC, which are activities that fall

within the “farm” definition in 21 CFR 1.227. Therefore, the farm is not required to register.

(See Question B.1.1). The dairy farm would not be required to register solely on the basis of

buying or receiving the hay, but for more information on dairy farms specifically, see Question

B.1.20. Registration is not dependent on how long the farm holds the hay before it sells because

the duration of holding the hay does not affect whether the operation is a farm.

B.1.16 A farmer sells his potato crop to a manufacturer/processor that manufactures frozen

potato products and the processor takes ownership but does not harvest the potatoes

immediately. The processor in effect stores the potatoes in the ground and removes them

when ready to process. Must the processor register the farm as a storage warehouse

facility?

Even though the potato crop has been sold to a potato processor, until the potatoes are removed

from the farm and stored at an off-farm facility, there is no requirement that the farmer or

processor register the farm as a food facility.

B.1.17 A peppermint farmer harvests his crops by cutting, trimming, and washing the

leaves, and then places the harvested crop in a barn to allow it to dehydrate. The entire

crop is sold to a manufacturer. Do any of these activities constitute

manufacturing/processing, thus necessitating registration for this farm?

No. Cutting (or otherwise separating) the edible portion of a RAC from the crop plant and

removing or trimming part of the RAC (e.g., foliage, husks, roots or stems) are harvesting

activities that are traditionally performed on farms for the purpose of removing RACs from the

place they were grown or raised and preparing them for use as food. Washing the leaves in this

context would be considered part of harvesting. Drying/dehydrating a RAC (e.g., fresh

peppermint) to create a distinct commodity (e.g., dried peppermint) is a manufacturing/processing

activity; however, it is provided for in the “farm” definition, as long as there is no additional

manufacturing/processing (e.g., chopping) done to the RAC. Therefore, if the peppermint farmer

cuts, trims, and washes the leaves, and then places the harvested leaves in a barn to allow them to

dehydrate, and no additional manufacturing/processing is conducted on the peppermint, the farm

would not be required to register.

B.1.18 Am I required to register my farm if I sell grain stored on my farm to a neighboring

farm, and the grain could be used by the neighboring farm as animal food?

No. A farm that grows grain, stores it on the farm, and then sells that grain to a neighboring farm

or another person is acting within the definition of “farm” in 21 CFR 1.227. The farm would still

be exempt from registration even if the neighboring farm or other person uses the grain as human

or animal food at a later time.

B.1.19 Am I required to register if I extract and bottle honey produced on my farm (i.e.,

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remove the wax seal and spin the honey out of the honeycomb, then bottle the honey)?

No. Many activities associated with beekeeping and honey production are within the “farm”

definition and therefore do not require registration. In this case, extracting honey is considered

harvesting and bottling honey is packaging a RAC, which is a type of manufacturing/processing

included within the “farm” definition.

B.1.20 If cows are milked on a farm and the milk is then picked up from the farm and

transported by tanker to a cooperative, is the farm required to register?

If the cows are milked, and the milk is stored in refrigerated storage tanks at the dairy farm to be

picked up by a milk tanker for processing, the dairy farm is not required to register, because the

milking of cows and storing of milk are activities that fall within the definition of “farm” in 21

CFR 1.227. FDA considers milking of cows to be “harvesting” when applied to animals, because

it is akin to harvesting crops. However, if the dairy farm manufactures/processes the milk, for

example, by pasteurizing it, and all milk used in such activities is not consumed on that farm or

another farm under the same management, the dairy farm would be a mixed-type facility and

would have to register.

B.1.21 Does a farm that mills and bags animal food for sale have to register?

An on-farm operation that manufactures and processes food for livestock or poultry (e.g., a feed

mill) does not remain within the definition of “farm” in 21 CFR 1.227 if the sale of that food is to

a farm under different management, even if the raw ingredients are grown on the farm that has the

feed mill. The establishment is a farm mixed-type facility and required to register. (See Question

B.1.4).

However, a farm that includes an operation that manufactures/processes and packs animal food

(e.g., mills and bags animal food) can be within the definition of “farm” in 21 CFR 1.227 as long

as all of that animal food is consumed on that farm or another farm under the same management.

Because it is a farm, it is not required to register.

B.1.22 If a farm accumulates animal carcasses and sends the carcasses to a rendering plant

to be added to animal food, is the farm required to register?

No. A farm may hold RACs and remain within the “farm” definition. Unprocessed animal

carcasses destined for rendering into animal food are a RAC. The definition of “farm” in 21 CFR

1.227 allows holding of one’s own RACs and others’ RACs. Therefore, even if a farm is

accumulating carcasses from other farms, that fact would not require it to register.

B.1.23 Am I required to register if I grow vegetable/fruit crops and send the oversupply

from these crops to animal food without further manufacturing or processing?

No. The farm is not required to register, because these activities–growing, harvesting, and

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holding unprocessed fruits and vegetables for food use (human and/or animal)–fall within the

definition of “farm” in 21 CFR 1.227.

B.1.24 Does an agricultural feed cooperative that manufactures animal food (e.g., operates

a feed mill) and is recognized as a cooperative under U.S. laws have to register?

Whether the agricultural feed cooperative manufacturing operation has to register depends on

whether the operation meets one of the exemptions in 21 CFR 1.226, such as being a farm.

Example 1: A cooperative consists of member farms that own and manage a feed mill, and the

feed mill sells animal food to the member farms and other non-member farms. The cooperative

feed mill would not meet the “retail food establishment” exemption because it is selling to farms

(businesses) rather than to consumers. It would not meet the definition of a “farm” because the

manufactured/processed food is not consumed on farms under the same management, since the

feed mill is not under one management with the various individual farms that are purchasing the

animal food from the feed mill. The feed mill would be required to register

Example 2: A cooperative manages a feed mill and also manages an operation in the same

general (but not necessarily contiguous) physical location as the feed mill, devoted to raising

animals that are eating all the food produced by the feed mill. The feed mill does not sell the

manufactured/processed food to any other buyers. The operation managed by the cooperative

would meet the definition of a “farm” in 21 CFR 1.227 and the feed mill that is part of that

operation would not be required to register.

B.1.25 Algae may be grown in shallow outdoor ponds, inside greenhouses, or in

fermentation-type vessels. Do such facilities have to register? Does an operation that both

grows and processes algae have to register?

An operation that grows algae for use in human or animal food and that is under one management

in one general (but not necessarily contiguous) physical location, whether the algae is grown

outdoors or indoors, is growing a crop and would be considered a primary production farm (see

the definition of “farm” in 21 CFR 1.227). A farm that also processes algae would be a farm

mixed-type facility, an establishment that engages in both activities that are exempt from

registration under section 415 of the FD&C Act and activities that require the establishment to

A farm is exempt from registration. As noted in Question B.1.4, a farm mixed-type facility is

required to register.

2. Retail Food Establishments

B.2.1 Does a warehouse club that sells to both consumers and businesses need to register?

A warehouse club is exempt from registration as a retail food establishment if it sells food

products directly to consumers as its primary function. A retail food establishment's primary

function is to sell food directly to consumers if the annual monetary value of sales of food

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products directly to consumers exceeds the annual monetary value of sales of food products to all

other buyers. Businesses are not considered consumers. Thus, if the annual monetary value of

sales of food products directly to businesses exceeds the annual monetary value of sales of food

products to consumers, the warehouse club must register (21 CFR 1.227).

B.2.2 If a supermarket has a bakery on the premises that bakes bread and sells it to other

stores in the same chain, is the supermarket required to register?

The supermarket is exempt from registration as a “retail food establishment” (21 CFR 1.227) if its

primary function is to sell food products directly to consumers from the supermarket. A retail

food establishment's primary function is to sell food directly to consumers if the annual monetary

value of sale of all food products directly to consumers exceeds the annual monetary value of

sales of food products to all other buyers.

B.2.3 Are retail food establishment storerooms, distribution centers, or warehouses

considered "holding facilities" that are required to register?

If a facility is a "retail food establishment" under 21 CFR 1.227, storerooms for the retail food

establishment that are under the same ownership and at the same general location and thus, part

of, the retail food establishment, are not required to register. However, a distribution center or

warehouse that is not at the same general physical location as the retail food establishment does

not meet the definition of "retail food establishment" in 21 CFR 1.227 because it does not sell

food from the facility directly to consumers. Thus, such a distribution center or warehouse is

required to register.

B.2.4 If a retail food reaches its shelf life and is stored at the retail facility pending return to

the manufacturing facility, does the retail store become a holding facility that must be

registered?

No. A “retail food establishment” may manufacture/process, pack, or hold food if the

establishment’s primary function is to sell food from that establishment directly to consumers (see

definition of “retail food establishment” in 21 CFR 1.227).

B.2.5 If a bakery primarily sells its food directly to consumers, but 40% of its annual sales

are to wholesale facilities, does the bakery have to register?

No. The bakery is a “retail food establishment” and does not need to register. A retail food

establishment is exempt from registration if the annual monetary value of sales of food products

directly to consumers exceeds the annual monetary value of sales of food products to all other

buyers (21 CFR 1.226(c) and 1.227).

B.2.6 Are self-service ice vending machines required to register?

No. Under 21 CFR 1.227, a “retail food establishment” includes grocery stores, convenience

stores, and vending machines. Therefore, vending machines that sell food products directly to

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consumers as their primary function are exempt from registration as retail food establishments.

B.2.7 How did the Registration Final Rule amend the definition of “retail food

establishment?”

As a result of section 102 of FSMA, the Registration Final Rule published on July 14, 2016,

amended the definition of “retail food establishment” in 21 CFR 1.227 to clarify that:

• Sale of food directly to consumers by a farm-operated business or from an establishment

located on a farm includes sales by those establishments directly to consumers:

o At a roadside stand (a stand situated on the side of or near a road or thoroughfare at

which a farmer sells food from his or her farm directly to consumers) or farmers’

market (a location where one or more local farmers assemble to sell food from their

farms directly to consumers);

o Through a community supported agriculture program. Community supported

agriculture (CSA) program means a program under which a farmer or group of

farmers grows food for a group of shareholders (or subscribers) who pledge to buy

a portion of the farmer’s crop(s) for that season. This includes CSA programs in

which a group of farmers consolidate their crops at a central location for

distribution to shareholders or subscribers; and

o At other such direct-to-consumer sales platforms, including door-to-door sales;

mail, catalog and Internet order, including online farmers markets and online

grocery delivery; religious or other organization bazaars; and State and local fairs.

• A “farm-operated business” means a business that is managed by one or more farms and

conducts manufacturing/processing not on the farm(s).

For example, an establishment located on a farm that sells apples it grows and apple pies it

manufactures directly to consumers at a farmer’s market would consider those sales in

determining its primary function. At the same time, if a farmer manufactures or manages the

manufacturing of jellies at an off-farm location, such as an incubator kitchen from the apples that

he grows, and sells those jellies directly to consumers at a farmer’s market, the jelly-making

operation would be a farm-operated business and may consider those sales in determining its

primary function.

We recognize that some farmers rent space at off-farm manufacturing/processing facilities, like

shared kitchens, to conduct value-added processing. The “business” we are referring to in “farm-

operated business” is the business entity conducting the manufacturing/processing operations.

The ownership of the physical building, e.g., the ownership of the shared kitchen, where the

manufacturing/processing occurs is not relevant. Thus, if an apple grower leases space at an off-

farm incubator kitchen to manufacture apple jellies, ownership of the incubator kitchen building

would not be relevant. Because the apple farmer manages the off-farm apple jelly manufacturing

operation, the apply jelly manufacturing operation is a farm-operated business and eligible for the

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retail food establishment exemption from registration.

In addition, we recognize that some farms are members of cooperatives that pool RACs grown,

harvested, or raised by member farms for value-added processing. The phrase “one or more

farms” in the explanation of the meaning of “farm-operated business” allows cooperatives

comprised of multiple farms performing certain manufacturing/processing activities to be eligible

for the retail food establishment exemption from registration (see Comment 9 in the Registration

Final Rule; 81 FR 45912 at 45921 to 45922).

B.2.8 Are farmers’ markets and roadside stands considered retail food establishments,

including those markets and stands that sell food not manufactured or grown on the farm

selling those foods?

Farmers’ markets and roadside stands may be retail food establishments even when they sell food

products not manufactured or grown on the farm that is selling those foods. The test for whether

such farmers’ markets and roadside stands are retail food establishments is whether they sell food

directly to consumers as their primary function. The food sold directly to consumers can be

produced by the farmers selling the food, but need not be (see Comment 10 in the Registration

Final Rule; 81 FR 45912 at 45922).

B.2.9 Is there a limitation on the distance of roadside stands or farmers’ markets from the

farms on which the food is produced?

No. For purposes of the definitions for farmers’ markets and roadside stands, as used in the

definition of “retail food establishment” in 21 CFR 1.227, there is no limitation on the distance

between the farmers’ market or roadside stand and the farms on which the food is produced (see

Comment 12 in the Registration Final Rule; 81 FR 45912 at 45923).

B.2.10 What does “CSA program” mean for purposes of the “retail food establishment”

definition?

The term “CSA program,” which is used in the definition of “retail food establishment” in 21

CFR 1.227, means a program under which a farmer or group of farmers grows food for a group of

shareholders (or subscribers) who pledge to buy a portion of the farmer's crop(s) for that season.

This includes CSA programs in which a group of farmers consolidates their crops at a central

location for distribution to shareholders or subscribers.

B.2.11 For purposes of the “retail food establishment” definition, can CSAs sell food other

than crops?

Yes. CSA activities are not limited to only selling “crops.” For example, a farm mixed-type

facility may sell strawberries it grows and strawberry jam that it manufactures directly to

consumers through a CSA. Whether the on-farm manufacturing establishment is a retail food

establishment, and thus exempt from registration, would depend on whether its primary function

is to sell food directly to consumers. The sale of food directly to consumers through a platform

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that resembles a CSA but does not sell crops could still be used in determining the

establishment’s primary function. It may be possible for an establishment to consider sales

through that platform in determining its primary function if the establishment either: (1) is

located on a farm; or (2) is a farm-operated business and the requirements applicable to farm-

operated businesses are met (see Comment 13 in the Registration Final Rule; 81 FR 45912 at

45923).

B.2.12 Can sales from my on-farm manufacturing operation that are made via mail,

catalog or Internet order, or through online farmers’ markets or online grocery delivery be

considered sales of food directly to consumers?

Yes. Sales of food directly to consumers from an establishment located on a farm or from a farm-

operated business includes sales by such establishments directly to consumers at such direct-to-

consumer platforms as mail, catalog, and Internet order, including online farmers markets and

online grocery delivery.

B.2.13 If I supply food directly to consumers via the Internet or mail-order, am I a retail

food establishment?

Maybe. Facilities that sell food directly to consumers via the Internet or mail-order may be retail

food establishments, provided they meet the other criteria of the “retail food establishment”

definition in 21 CFR 1.227 (see Comment 82 in the Interim Final Rule; 68 FR 58894 at 58914 to

58915).

B.2.14 For purposes of the “retail food establishment” definition, can sales at produce

auctions, food hubs, and buying clubs be considered sales that are directly to consumers?

Sales at such platforms can be to different types of entities. In some cases, sales may be to

consumers. However, sales may also be to restaurants, wholesalers, and other businesses. An

establishment’s direct sales to individual consumers at these platforms can be counted as sales to

consumers. However, a direct sale to a business at these platforms cannot be counted as sales to

consumers. Furthermore, a direct sale to a separate business that runs these platforms, rather than

to specific buyers, would not be counted as sales to consumers because businesses (including

businesses that run produce auctions) are not consumers (see Comments 15 and 17 in the

Registration Final Rule; 81 FR 45912 at 45924).

B.2.15 Is there an income limitation included in the “retail food establishment” definition?

No. There is no income limitation for establishments to qualify as retail food establishments. As

long as an establishment’s primary function is to sell food directly to consumers, it is a retail food

establishment. A retail food establishment’s primary function is to sell food directly to

consumers if the annual monetary value of sales of food products directly to consumers exceeds

the annual monetary value of sales of food products to all other buyers (21 CFR 1.227).

B.2.16 What types of facilities that sell animal food would be considered retail food

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establishments?

A “retail food establishment” is an establishment that sells food products directly to consumers as

its primary function. A retail food establishment’s primary function is to sell food directly to

consumers if the annual monetary value of sales of food products directly to consumers exceeds

the annual monetary value of sales of food products to all other buyers (see 21 CFR 1.227). A pet

store that sells animal food directly to consumers is an example of a type of animal food

establishment that may be a retail food establishment. In some instances, a farm supply store,

specialty bakery, hobby store, or other retail store that sells animal food, such as pet treats (and

also may sell human food), may be a retail food establishment if the annual monetary value of

sales of food products directly to consumers (such as pet owners or other individuals) exceeds the

annual monetary value of sales of food products to all other buyers (such as farms, which are

considered businesses). (See also Comment 79 in the Interim Final Rule; 68 FR 58894 at

58914.)

B.2.17 Do off-farm feed mills that sell all their animal food to the public need to register or

do they qualify for a retail food establishment exemption?

Feed mills that manufacture/process, pack, or hold animal food for consumption in the United

States are required to register, unless an exemption in 21 CFR 1.226 applies (e.g., the retail food

establishment or farm exemptions). To be considered a “retail food establishment,” the annual

monetary value of sales of food products directly to consumers must exceed the annual monetary

value of sales of food products to all other buyers. In most instances, off-farm feed mills selling

food to the public would not meet the retail food establishment definition because they typically

sell most of their animal food to farms, which are considered businesses, and not consumers.

B.2.18 I have a farm supply store that sells to both farms (i.e., businesses) and pet owners

(i.e., consumers). What percentage of animal food sales to farms would require my store to

To be considered a “retail food establishment” as defined in 21 CFR 1.227, the establishment’s

primary function must be to sell food directly to consumers. A retail food establishment’s

primary function is to sell food directly to consumers if the annual monetary value of sales of

food directly to consumers exceeds the annual monetary value of sales of food to all other buyers

(see 21 CFR 1.227). The term “consumers” does not include businesses, such as farms.

Therefore, if more than 50% of a farm supply store’s annual monetary value of sales of food is to

consumers, such as pet owners and other individuals, then the farm supply store would meet the

definition of a “retail food establishment” and would not be required to register. However, if

more than 50% of a farm supply store’s annual monetary value of sales of food is to other buyers,

such as farms, then the farm supply store would not meet the definition of a “retail food

establishment” and would be required to register.

B.2.19 Can I manufacture/process some of the animal food I sell at retail, in addition to

selling prepackaged or bulk animal food and still be considered a retail food establishment?

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A retail food establishment may manufacture/process food and remain within the “retail food

establishment” definition of 21 CFR 1.227 if the establishment’s primary function is to sell food,

including food it manufactures/processes, directly to consumers. A retail food establishment’s

primary function is to sell food directly to consumers if the annual monetary value of sales of

food directly to consumers exceeds the annual monetary value of sales of food to all other buyers

(such as to farms, which are considered businesses).

B.2.20 Do meal-kit type services have to register?

If the meal-kit type service meets the definition of a retail food establishment, it is exempt from

registration (see 21 CFR 1.227). A meal-kit type service is a retail food establishment if it sells

food directly to consumers as its primary function. A retail food establishment’s primary

function is to sell food directly to consumers if the annual monetary value of sales of food

products directly to consumers exceeds the annual monetary value of sales of food products to all

other buyers. The definition of retail food establishment also provides that the term ‘‘consumers’’

does not include businesses. Establishments selling food directly to consumers via the Internet or

mail order may be retail food establishments provided that they meet the other criteria of the

retail food establishment definition (21 CFR 1.227).

3. Restaurants

B.3.1 Are central kitchens that prepare food for a chain of restaurants considered to be

restaurants and, therefore, exempt from registration?

Under 21 CFR 1.226(d), restaurants are not required to register. Central kitchens that do not sell

the food they prepare directly to consumers for immediate consumption are not “restaurants,” as

defined in 21 CFR 1.227. Thus, they are not exempt, as restaurants, from registration.

B.3.2 Are pet shelters, kennels, and veterinary facilities in which food is provided to

animals exempt from registration?

The definition of “restaurant” includes pet shelters, kennels, and veterinary facilities in which

food is provided to animals (21 CFR 1.227). Therefore, these facilities are not required to

4. Nonprofit Food Establishments

B.4.1 Are exporters of food for charity exempt from the registration requirements?

Yes. An establishment, including a non-profit facility, is not required to register if all food

manufactured/processed, packed, or held at the facility is not for consumption in the United

States (21 CFR 1.225 and 1.227).

B.4.2 Is an establishment operated by a public or other not-for-profit organization in which

food is prepared, such as food for a school lunch program, including the National School

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Lunch Program (NSLP), or for a food service program, including the Summer Food Service

Program (SFSP) and the Child and Adult Care Food Program (CACFP), required to

Establishments such as those identified in the question are exempt from the food facility

registration requirements if they are “nonprofit food establishments” (21 CFR 1.226(e)).

“Nonprofit food establishment” is defined in 21 CFR 1.227 as “a charitable entity that prepares or

serves food directly to the consumer or otherwise provides food or meals for consumption by

humans or animals in the United States. The term includes central food banks, soup kitchens, and

nonprofit food delivery services. To be considered a nonprofit food establishment, the

establishment must meet the terms of section 501(c)(3) of the U.S. Internal Revenue Code (26

U.S.C. 501(c)(3)).”

To qualify under 26 U.S.C. 501(c)(3), an entity (such as a corporation, community chest, fund, or

foundation) must satisfy the following four criteria: (1) it must be organized and operated

exclusively for religious, charitable, or educational purposes (among others); (2) no part of the

net earnings of the entity may inure to the benefit of any private individual; (3) no substantial

part of the entity's activities may be for the purpose of influencing legislation; and (4) the entity

cannot participate in any political campaign of any candidate for public office (26 U.S.C.

501(c)(3)). The requirement in the definition of "nonprofit food establishment" in 21 CFR

1.226(e) to "meet the terms of section 501(c)(3)" means that the institution or organization that

runs a food service program under which the establishment operates must satisfy the criteria of 26

U.S.C. 501(c)(3). However, the public institution or organization need not be formally

designated as a 26 U.S.C. 501(c)(3) institution or organization.

FDA is aware that certain lunch and food service programs are sponsored by private nonprofit

institutions or organizations that have been granted tax-exempt status under 26 U.S.C. 501(c)(3)

of the Internal Revenue Code. An establishment operating under a food service program that is

conducted by such an institution or organization is exempt from registration under 21 CFR

1.226(e) if, in addition to the institution or organization having 26 U.S.C. 501(c)(3) status, the

establishment satisfies the remaining elements of the "nonprofit food establishment" definition in

21 CFR 1.227.

FDA is also aware that many food service programs are conducted by public institutions or

organizations, such as public school systems, that do not have formal 26 U.S.C. 501(c)(3) status.

If a public institution or other organization that runs a food service program satisfies the four 26

U.S.C. 501(c)(3) criteria listed in a previous paragraph in this answer, an establishment operating

under a food service program of such an institution or organization is exempt from registration

under 21 CFR 1.226(e) if, in addition to the institution or organization satisfying the 26 U.S.C.

501(c)(3) criteria, the establishment satisfies the remaining elements of the "nonprofit food

establishment" definition in 21 CFR 1.227.

In addition, a "restaurant" (21 CFR 1.227) that is part of a school lunch or other food service

program is exempt from registration, regardless of whether it is a "nonprofit food establishment."

Also, a "retail food establishment" (21 CFR 1.227) that is part of a school lunch or other food

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service program is exempt from registration, regardless of whether it is a "nonprofit food

establishment."

B.4.3 If I prepare food for organizations like “Meals on Wheels,” am I required to

If your facility meets the definition of “nonprofit food establishment” in 21 CFR 1.227, then you

do not have to register. The exemption from registration for nonprofit food establishments can

extend to a wide range of charitable entities, including those that prepare meals for consumption

through partner organizations, such as “Meals on Wheels” programs and soup kitchens,

regardless of whether the organization preparing the meal is the same organization that is

delivering or serving the meal to the consumer. The definition of “nonprofit food establishment”

in 21 CFR 1.227 includes central food banks, food pantries and meal delivery services. However,

an entity that does not satisfy the criteria of 26 U.S.C. 501(c)(3) would not meet the definition of

“nonprofit food establishment.” For instance, an entity that prepares meals at its facility and sells

them to other unaffiliated businesses or organizations (including non-profit organizations) that

subsequently offer/deliver those meals to individual consumers would not be a “nonprofit food

establishment” if the net earnings of the entity inure to the benefit of a private individual (such

that the entity does not meet the criteria of 26 U.S.C. 501(c)(3)). Such an entity would be

required to register, provided that none of the other exemptions in 21 CFR 1.226 apply.

B.4.4 Are food banks required to register?

If a food bank meets the definition of “nonprofit food establishment,” as defined in 21 CFR

1.227, the food bank does not have to register. “Nonprofit food establishment” is defined as “a

charitable entity that prepares or serves food directly to the consumer or otherwise provides food

or meals for consumption by humans or animals in the United States. The term includes central

food banks, soup kitchens, and nonprofit food delivery services. To be considered a nonprofit

food establishment, the establishment must meet the terms of section 501(c)(3) of the U.S.

Internal Revenue Code (26 U.S.C. 501(c)(3)).” Distributing donated or rescued food, either

directly to the consumer or to other charitable organizations, such as food pantries, soup kitchens

or meal delivery services, are activities within the definition of non-profit food establishment

because the food is provided for consumption by humans or animals.

In addition, some food pantries where individuals can visit to obtain food may also be considered

non-profit food establishments, provided they meet the definition in 21 CFR 1.227.

5. Fishing Vessels

B.5.1 Are fishing vessels that catch, head and eviscerate, and then hold fish in cold storage

until it can be off-loaded for delivery to a processor required to register?

Under 21 CFR 1.226(f), fishing vessels are exempt from registration unless processing is done on

board the ship. “Processing,” relating to fish and fishery products, means, “Handling, storing,

preparing, heading, eviscerating, shucking, freezing, changing into different market forms,

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manufacturing, preserving, packing, labeling, dockside unloading, or holding.” However, a

fishing vessel that “engages in harvesting or transporting fish or fishery products, without

otherwise engaging in processing, or that engages in practices such as heading, eviscerating, or

freezing, intended solely to prepare a fish for holding on board a harvest vessel,” is exempt from

registration (21 CFR 1.226(f)).

6. Facilities Regulated Exclusively by the United States Department of Agriculture (USDA)

B.6.1 Are facilities that process rabbits, deer, elk, and bison required to register with

FDA?

Yes. Facilities that process species that are not amenable (in other words, they are not subject

to the USDA-administered mandatory inspection requirements under the Federal Meat

Inspection Act and the Poultry Products Inspection Act) are required to register as food

facilities with FDA. Examples of species that are not amenable are rabbit, deer, elk, and bison.

Rabbits, deer, elk, and bison are species that are foods under FDA’s jurisdiction. A facility

that processes rabbit, deer, elk, or bison, as well as meat or poultry products under USDA

jurisdiction, would not be exempt from registration because it is not regulated exclusively,

throughout the entire facility, by USDA (21 CFR 1.226(g)).

B.6.2 Are facilities that process fish of the order Siluriformes and products derived from

these fish required to register as food facilities with FDA?

No. On December 2, 2015, the United States Department of Agriculture’s Food Safety

Inspection Service (FSIS) amended its regulations to establish a mandatory inspection program

for fish of the order Siluriformes and products derived from these fish (see 80 FR 75590;

December 2, 2015). Siluriformes include catfish, tra, swai and basa. Effective March 1, 2016,

FSIS assumed primary responsibility for the regulation of domestic and imported Siluriformes

(fish), and products derived from these fish. A facility that processes only Siluriformes would be

exempt from registration because it is regulated exclusively, throughout the entire facility, by

USDA (21 CFR 1.226(g)). However, a facility that processes other fish, as well as Siluriformes

under USDA jurisdiction, would not be exempt from registration because it is not regulated

exclusively, throughout the entire facility, by USDA (21 CFR 1.226(g)).

B.6.3 Are establishments that operate under USDA FSIS inspection and also produce

finished pet food required to register?

Yes. Facilities that manufacture, process, pack, or hold finished pet food must be registered as a

food facility with FDA. Pet food is regulated by FDA. A facility that manufactures, processes,

packs, or holds finished pet food, as well as meat or poultry products under USDA jurisdiction,

would not be exempt from registration because it is not regulated exclusively, throughout the

entire facility, by USDA (21 CFR 1.226(g)).

C. Definitions

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1. Facility

C.1.1 If a person has a business in his or her home that involves manufacturing, processing,

packing, or holding food, does that person need to register that private residence as a food

facility?

No. A private residence is not a “facility” as defined in 21 CFR 1.227. Thus, a private residence

that meets customary expectations for a private residence that is also used to manufacture,

process, pack, or hold food need not be registered. For example, if a person uses their home to

store food that is to be sold as a school activity or for a youth organization such as Girl Scouts or

to prepare food for a bake sale, FDA considers that these activities meet customary expectations

for a private residence.

C.1.2 Are small food producers or hobbyists who make food out of their home and also sell

the food at farmers’ markets or to other consumers required to register?

Under 21 CFR 1.227, a private residence is not a “facility” and thus, is not required to register. A

private residence must meet customary expectations for a private home and does not otherwise

include commercial facilities in which a person also happens to reside. Thus, a private residence

that meets customary expectations for a private residence that is also used to manufacture,

process, pack, or hold food need not be registered. Accordingly, if the activities of small food

producers or hobbyists meet customary expectations for a private residence, the producers or

hobbyists would not be required to register.

C.1.3 If berries are harvested, then made into jam at a private residence for sale at

markets and to retail stores, does the producer have to register the private residence as a

facility?

Under 21 CFR 1.227, a private residence is not a “facility” and thus, is not required to register. A

private residence must meet customary expectations for a private home and does not otherwise

include commercial facilities in which a person also happens to reside. Thus, a private residence

that meets customary expectations for a private residence that is also used to manufacture,

process, pack, or hold food need not be registered. Accordingly, if the activities of the jam

producer meet customary expectations for a private residence, the producer would not be required

to register.

C.1.4 If a person is selling food from his or her private residence through the Internet, does

that person need to register his residence as a food facility?

No. A private residence from which a person also sells food through the Internet is not a

“facility” as defined in 21 CFR 1.227 and, thus, would not have to register.

C.1.5 A number of maple sugar makers operate from their own property, on which their

private residence is also located. Are these maple sugar makers required to register the

facility that is on their property and used for maple sugar production?

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Under 21 CFR 1.227, a private residence is not a “facility” and thus, is not required to register. A

private residence must meet customary expectations for a private home and does not otherwise

include commercial facilities in which a person also happens to reside. A private residence

includes the parcel of real property on which the residence is located. Accordingly, if the maple

sugar production occurs in the private home or in a detached building that meets customary

expectations for use as part of the private home, such as a detached garage that has not been

modified for manufacturing and processing so that it can no longer practically be used as

customary for a garage, the home or building would not have to register. If, however, a separate

building located on the real property of the private residence site is used as a maple sugar

manufacturing or processing facility and does not have a use as customarily expected for a private

residence, that facility must be registered, unless that facility qualifies for another exemption

(e.g., as a farm or retail food establishment; see 21 CFR 1.227).

C.1.6 Are facilities that import food into the United States solely for export from a bonded

warehouse required to register? Does the bonded warehouse that holds the food have to

No. Facilities that manufacture/process, pack, or hold food entering the United States solely for

the purpose of exportation or trans-shipment to another country (i.e., none of the food is for

consumption in the Unites States) are not required to register (see 21 CFR 1.225). The intent of

the Food Facility Registration regulation is to identify facilities that manufacture/process, pack,

or hold food for consumption in the United States. However, food entering the United States

solely for future export is subject to the Prior Notice of Imported Food regulation (see 21 CFR

part 1, subpart I).

C.1.7 A university research facility may sell some of its animals into commercial channels

for food use. Does the facility have to register?

A university research facility that sells live animals for human or animal consumption is required

to register unless the facility meets one or more of the exemptions from registration in 21 CFR

1.226 (e.g., farm, exclusive regulation by USDA).

C.1.8 A company has a physically separate central storage building for holding food prior

to use in a restaurant operated by the company. The central storage building is located

within the same general area as the restaurant that it supplies (i.e., on the same property as

the restaurant). Is the storage building exempt from registration?

“Facility” is defined to include structures under one ownership at one general physical location

(21 CFR 1.227). Since the storage building and restaurant are owned by the same company and

are located on the same property, the storage building is exempt from registration. However, if

the storage building was at a separate location or owned by a different person, it would be a

distinct facility that is required to register.

C.1.9 Are distribution/warehouse facilities that supply animal food products to retail food

establishments (e.g., farm supply stores and pet shops) required to register?

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The distribution/warehouse facilities would be required to register because these facilities hold

animal food for consumption in the United States, unless one of the exemptions in 21 CFR 1.226

applies. Generally, the retail food establishment exemption would not be applicable because the

distributor/warehouse's primary function is not selling directly to consumers. The

distributor/warehouse is distributing the animal food to retail food establishments, which are

considered businesses and not consumers.

For situations where a retail food establishment has a co-located storage building, see Question

B.2.3.

C.1.10 If I operate a feed mill that manufactures, warehouses, and distributes animal food

in packaged form and/or in bulk, does my facility have to register?

Yes. The feed mill would be required to register because the feed mill manufactures, processes,

packs, or holds animal food for consumption in the United States, unless the feed mill meets one

of the exemptions in 21 CFR 1.226 (see also sections II.B.1 Farms and II.B.2 Retail Food

Establishments).

C.1.11 I am an animal food distributor that stores and distributes bagged livestock and pet

food. Does my facility have to register?

Yes. The animal food distribution facility would be required to register because the facility holds

animal food for consumption in the United States, unless the facility meets one of the exemptions

in 21 CFR 1.226 (see also Question B.2.18).

C.1.12 Are facilities that manufacture food additives and color additives for food use

required to register as a food facility?

Food additives and color additives for food use are “food” as defined in section 201(f) of the

FD&C Act (21 U.S.C. 321(f)). Therefore, many food additive and color additive facilities are

required to register because these facilities manufacture/process, pack, or hold food for

consumption in the United States. However, if a food additive is not intended to have a technical

effect in or on the food and meets the definition of a food contact substance in section 409(h)(6)

of the FD&C Act (21 U.S.C. 348(h)(6)), it is excluded from the definition of “food” for purposes

of food facility registration (see 21 CFR 1.227). (See, for example, Questions C.2.5, C. 2.6,

C.2.10, and C.2.12.). Consequently, facilities that manufacture food contact substances are not

required to register.

C.1.13 Are human and animal food brokers required to register?

If you are a broker who does not manufacture, process, pack, or hold human or animal food, you

are not required to register. FDA’s understanding is that most brokers do not engage in

manufacturing, processing, packing, or holding and furthermore, never take possession of the

food. If you do manufacture, process, pack, or hold human or animal food for consumption in the

United States, you would be required to register your facility.

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2. Food

C.2.1 Are facilities that manufacture/process, pack, or hold fertilizers required to register?

Fertilizers are not food for consumption. Thus, facilities that manufacture/process, pack, or hold

fertilizers are not required to register.

C.2.2 Are pharmaceuticals considered "food" for purposes of the food facility registration

requirement?

Pharmaceuticals are not “food,” as defined in section 201(f) of the FD&C Act (21 U.S.C. 321(f)),

because they are not used for food or drink or for components of food or drink. Therefore,

facilities that manufacture, process, pack, or hold such products are not required to register as

food facilities under section 415 of the FD&C Act. However, such facilities may be subject to

registration under other statutory provisions. Pharmaceutical manufacturers may wish to consult

with FDA's Center for Drug Evaluation and Research regarding facility registration. You may

email the eDRLS team at [email protected]. Animal drug manufacturers may wish to consult

with FDA’s Center for Veterinary Medicine regarding drug establishment registration by

emailing [email protected] .

C.2.3 Are dietary supplements and components of dietary supplements considered "food"

for purposes of the food facility registration requirement?

Under section 201(ff) of the FD&C Act (21 U.S.C. 321(ff)), a dietary supplement and a

component of a dietary supplement are “foods.” Accordingly, a facility that

manufactures/processes, packs, or holds a dietary supplement or a component of a dietary

supplement is required to register as a food facility unless it qualifies for an exemption from

registration (21 CFR 1.226).

Products marketed as nutritional supplements or feed supplements for animals are considered to

be “foods” or “new animal drugs” depending on the intended use. Facilities

manufacturing/processing, packing, or holding animal food for consumption in the United States

must register.

C.2.4 Are pet rawhide chew manufacturing facilities required to register?

Yes. These facilities are required to register because rawhide chews are consumed by animals

and thus are "food," as defined in 21 CFR 1.227.

C.2.5 In terms of food facility registration, what is the responsibility of a manufacturer of a

chemical, substance X, if the manufacturer sells the substance to a customer who uses

substance X to produce an indirect food additive?

The term indirect food additive is not defined in the FD&C Act or FDA regulations, but is

generally used to refer to a food contact substance. For the purposes of food facility registration,

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the definition of "food" in 21 CFR 1.227 excludes food contact substances, as defined in

section 409(h)(6) of the FD&C Act (21 U.S.C. 348(h)(6)), but includes food additives (see 21

U.S.C. 321(f)). Consequently, facilities that manufacture chemicals used in the production of

food contact substances are not required to register with FDA. However, if substance X is

intended to have a technical effect in or on the food, it is "food" (i.e., a food additive), as defined

in 21 CFR 1.227 and section 201(f) of the FD&C Act, and the facility that manufactures

substance X must be registered. In addition, if an owner, operator, or agent in charge of a

manufacturing facility for substance X reasonably believes that the substance is reasonably

expected to be directed to food use, the owner, operator, or agent in charge must register the

facility with FDA.

C.2.6 We produce enzymes that can be used to manufacture food additives. Are the

facilities in which these enzymes are manufactured/processed, packed or held subject to

these regulations?

The answer to this question depends upon the use of the enzymes in question. As explained in

Question C.2.5 in this document, for the purposes of food facility registration, the definition of

“food” excludes food contact substances (21 CFR 1.227). If an enzyme produced by the facility

is added to food and is intended to have a technical effect in the food, the facility is required to

contact substance (or component of a food contact substance), the facility is not required to

C.2.7 Are facilities that manufacture gum base substances, such as polyvinyl acetate used to

produce chewing gum base, required to register?

Yes. Chewing gum is "food" (section 201(f)(2) of the FD&C Act; 21 CFR 1.227). Because

polyvinyl acetate chewing gum base is an ingredient (component) of chewing gum, a facility that

manufactures/processes, packs, or holds it is required to register, unless the facility is exempt

from registration under 21 CFR 1.226.

C.2.8 Are facilities that manufacture products that are not considered to be for

consumption, but are partially consumed because of the way they are used (e.g., lip balms

and toothpaste) required to register?

No. Products such as lip balms and toothpaste are cosmetics and are not "food," as defined in

section 201(f) of the FD&C Act (21 U.S.C. 321(f)), because they are not consumed for their taste,

aroma, or nutritive value (Nutrilab v. Schweiker, 713 F.2d 335, 338 (7th Circ. 1983)).

Accordingly, a facility that manufactures/processes, packs, or holds these cosmetics is not

required to register as a food facility.

C.2.9 Does a facility need to register if it manufactures raw materials for dietary

supplements?

Yes. Dietary supplements and dietary supplement components are "food" (sections 201(f) and

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201(ff) of the FD&C Act and 21 CFR 1.227). Accordingly, a facility that

manufactures/processes, packs, or holds a dietary supplement or a component of dietary

supplement (i.e., a raw material) is required to register as a food facility.

C.2.10 Are facilities that manufacture food packaging required to register as food

facilities?

No. The definition of "food" in 21 CFR 1.227, for the purposes of food facility registration,

excludes food contact substances as defined in section 409(h)(6) of the FD&C Act (21 U.S.C.

348(h)(6)). Consequently, a facility that manufactures/processes, packs, or holds food contact

substances, including food packaging or bottled water containers or closures, is not required to

C.2.11 Are facilities that manufacture/process, pack, or hold food used in research and

development or as food samples required to register with FDA?

Yes. Food used in research and development or as product samples is "food" for purposes of the

food facility registration requirements of section 415 of the FD&C Act. Accordingly, a facility

that manufactures/processes, packs, or holds food used in research and development or as product

samples is required to register with FDA. However, if the food is not for consumption in the

United States by humans or animals, the facility is not required to register.

C.2.12 Are the "secondary direct additives" listed in 21 CFR part 173 considered "food

contact substances" as defined in section 409(h)(6) of the FD&C Act? Are facilities that

manufacture/process, pack, or hold secondary direct additives required to register?

The answer to these questions depends upon the specific use of the secondary direct additive. The

regulations in 21 CFR part 173 stipulate the conditions of safe use for certain additives that are

added directly to food (such as enzyme preparations) as well as additives that are food contact

substances (such as ion exchange resins). A facility that manufactures/processes, packs, or holds

a substance approved in 21 CFR part 173 is exempt from registration only if the substance

satisfies the definition of "food contact substance" in section 409(h)(6) of the FD&C Act (21

U.S.C. 348(h)(6)). Otherwise, a facility that manufactures/processes, packs, or holds a substance

approved in 21 CFR part 173 is required to register.

3. Holding

C.3.1 If finished food products for consumption in the United States are held at a third

party facility before consolidation for import into the United States, must this facility

Yes. The facility is holding food for consumption in the United States, and therefore is required

to register, unless an exemption applies (21 CFR 1.225 and 1.226).

C.3.2 Post offices and similar facilities owned or operated by express couriers may have

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packages containing food on their premises as part of the shipment process. Are these types

of establishments required to register with FDA as food facilities?

No. Post offices and express courier facilities are not required to register as food facilities. The

activities of postal services and express courier services are focused on the transport of goods.

Their facilities generally serve only as a point of transfer of packages and other freight, including

packages containing food. Thus, it is appropriate to view both types of facilities as part of the

transportation process. The definition of "facility" in 21 CFR 1.227 provides that transport

vehicles are not facilities "if they hold food only in the usual course of business as carriers."

Although FDA did not define "transport vehicle" for the purpose of food facility registration, the

Agency’s definition of “transporter” in 21 CFR 1.328, relating to the establishment and

maintenance of records, is relevant. "Transporter" is defined as "a person who has possession,

custody, or control of an article of food in the United States for the sole purpose of transporting

the food…" FDA believes that it is appropriate to apply this same rationale to exclude from

registration facilities that hold food only because they are part of the process of transporting it

from one location to another. This analysis is also consistent with the definition of "facility" in 21

CFR 1.227. Thus, because post offices and express courier facilities operating in a manner

comparable to post offices are part of the transportation network and have possession, custody, or

control of food for the sole purpose of transporting, they are not required to register as food

facilities.

C.3.3 Truck terminals and freight forwarders may have food on their premises as part of

the shipment process. Are these types of establishments required to register with FDA as

food facilities?

No. Truck terminals and other stationary facilities that serve merely to assist transportation

vehicles in the process of transporting food are not required to register with FDA. As with post

offices and similar facilities discussed in Question C.3.2 in this document, truck terminals and

freight forwarders that are part of the transportation network and have possession, custody, or

control of food for the sole purpose of facilitating its transport are not required to register as food

facilities. FDA acknowledges that this response is not completely consistent with certain prior

guidance (see Comment 36 in the preamble to the Interim Final Rule; 68 FR 58894 at 58904).

However, FDA further considered this issue, as well as related ones, and determined that the

earlier guidance should be revised.

C.3.4 Is a vessel carrier that only transports food from one facility to another considered to

be a facility that must be registered?

No. A vessel carrier that holds food only in its usual course of business as a carrier is a transport

vehicle. A transport vehicle is not a “facility,” as defined in 21 CFR 1.227. Therefore, a vessel

carrier is not a facility that must be registered.

C.3.5 Are foreign storage facilities that hold finished food products prior to export to the

United States required to register?

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Yes. 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.

C.3.6 Do the facilities of both the exporter and the importer of food for consumption in the

United States need to register if they each hold food?

Yes. The facilities of both the exporter and the importer are required to register if they hold food

for consumption in the United States. However, as indicated in the response to Question C.3.5 in

this document, 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 (21 CFR 1.226(a)).

C.3.7 Does a cruise ship have to register if it is holding food for consumption for passengers

and returns to the United States with food not consumed on the cruise?

Restaurants are not required to register (21 CFR 1.226(d)). “Restaurant” is defined in 21 CFR

1.227 as an establishment that "prepares and sells food directly to consumers for immediate

consumption." A food service establishment on a cruise ship is exempt as a restaurant. The

remainder of the ship is not required to register because it is not manufacturing/processing,

packing, or holding food for consumption in the United States. In addition, even if a cruise ship

carries food as cargo, it is not required to register because, in such circumstances, it would be

considered a transport vehicle (21 CFR 1.227).

C.3.8 Is a stockyard or livestock market required to register?

Yes. A stockyard or livestock market would be required to register (unless an exemption in 21

CFR 1.226 applies) if they are holding live animals for human or animal consumption.

Generally, stockyards and livestock markets consist of a series of pens or yards where market

animals are collected and held. These animals are either sold to feedlots/veal finishing farms or

purchased by packing houses for slaughter. Neither a livestock market nor a stockyard is a

“farm” as defined in 21 CFR 1.227, because they do not raise animals.

C.3.9 Must I register my facility as a warehouse if we only hold food for a short period of

time (i.e., a few hours to one day before food is transported)?

There is no timeframe (maximum or minimum) associated with holding. Consequently, a facility

that holds food for consumption in the United States is not exempt from food facility registration

requirements based on how long it holds food.

C.3.10 Do I have to register if my establishment fumigates food?

The definition of “holding” provides that holding includes “activities performed incidental to

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storage of a food (e.g., activities performed for the safe or effective storage of that food, such as

fumigating food during storage, and drying/dehydrating raw agricultural commodities when the

drying/dehydrating does not create a distinct commodity) . . . but does not include activities that

transform a raw agricultural commodity into a processed food as defined in section 201(gg) of the

Federal Food, Drug, and Cosmetic Act” (see definition of “holding” in 21 CFR 1.227).

Generally, a facility that fumigates food is manufacturing/processing, packing, or holding food

and therefore is required to register. However, if the fumigation is performed on a farm for the

safe or effective storage of a RAC, this activity would not be one that requires the farm to register

because fumigation is considered a “holding” activity and holding RACs is within the “farm”

definition.

4. Manufacturing/Processing

C.4.1 Do all manufacturing/processing sites under one ownership have to register, even if

only one is involved with foods for consumption in the United States?

No. Only facilities that manufacture/process, pack, or hold food for consumption in the United

States are required to register. Thus, facilities that manufacture/process, pack, or hold food that

will be consumed outside of the United States do not need to register.

C.4.2 Am I required to register my facility if my facility manufactures/processes human

food that results in human food by-products that we pack or hold for processing by

another facility that manufactures/processes animal food?

Yes. Your facility is required to register because you manufacture/process, pack, or hold food for

consumption by humans and animals in the United States. There is not a separate registration

process for human and animal food. (See also Question F.3.4).

C.4.3 Am I required to register if I use heat to pasteurize the honey I produce on my farm?

Under 21 CFR 1.227, heating honey for pasteurization is considered manufacturing/processing.

Therefore, if you use heat to pasteurize the honey you produce on your farm, you must register

unless: (1) all the honey that has undergone manufacturing/processing is consumed on your farm

or another farm under the same management, or (2) your manufacturing/processing operation

meets the definition of a retail food establishment.

C.4.4 If I bottle water from a spring, must I register?

Bottling water from a spring is considered manufacturing/processing under 21 CFR 1.227.

Facilities engaged in manufacturing/processing, packing, or holding bottled water from a spring

are required to register, including those located at or near the spring site. However, the bottler

would not have to register the actual spring location as a facility.

5. Packing

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See Questions and Answers B.1.7 – B.1.10 under section II.B.1 in this document.

6. Trade Names

C.6.1 Does a distributor of food products need to register the trade names of all products it

distributes, or repacks and then distributes, or only the trade names of those products

manufactured at its facility?

Under 21 CFR 1.227, a "trade name" is a name under which a facility conducts business, as

opposed to a "brand name," which is a name associated with a product. A distributor is required

to include in a facility's registration all trade names under which the facility conducts business (21

CFR 1.232(a)(5)). A facility's registration is not required to include all brand names for products

manufactured/processed, packed, or held at the facility.

7. U.S. Agent

C.7.1 Who can be a U.S. agent and what are the roles and responsibilities of the U.S. agent?

A U.S. agent may be an individual, partnership, corporation, or association. A U.S. agent must

have a place of business or residence in the United States and be physically present in the United

States. For example, a foreign facility may use its U.S. importer as its U.S. agent. As established

in 21 CFR 1.227, the U.S. agent acts as a communications link between FDA and a foreign

facility for both routine and emergency communications. The U.S. agent will be the person FDA

contacts when an emergency occurs, unless the registration specifies another emergency contact.

In functioning as the communications link with FDA, a U.S. agent may choose to initiate

communications with FDA, and FDA may likewise choose to initiate communications with the

U.S. agent. Further, as stated in the definition for “U.S. agent” in 21 CFR 1.227, FDA will treat

representations by the U.S. agent as those of the foreign facility, and will consider information or

documents provided to the U.S. agent the equivalent of providing the information or documents

to the foreign facility.

C.7.2 For foreign facilities, may the U.S. agent for the facility also serve as the facility's

emergency contact?

Yes. The U.S. agent will be considered the emergency contact for a registered foreign facility

unless another name is provided in the facility's registration as the emergency contact (21 CFR

1.227 and 1.232(c)).

C.7.3 Some U.S. law firms are charging fees to serve as a foreign facility's U.S. agent. Some

of these firms have the word "FDA" in their name. Must a foreign facility use one of these

firms as its U.S. agent?

No. FDA does not recommend or endorse any particular firm, organization, person, or company

to serve as a foreign facility's U.S. agent. FDA is not affiliated with any firm offering its services

as a U.S. agent. As we stated in Question C.7.1 in this document, a U.S. agent may be an

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individual, partnership, corporation, or association. The U.S. agent must have a place of business

or residence in the United States and be physically present in the United States.

C.7.4 May a foreign government official residing in the United States, such as a

representative from the foreign country's embassy, act as a foreign facility's U.S. agent for

purposes of food facility registration?

FDA is concerned that acting as a U.S. agent may conflict with the duties of foreign government

representatives (see Comment 90 in the preamble to the Interim Final Rule; 68 FR 58894 at

58916). Whether it is proper for a foreign government representative to act as a U.S. agent is a

fact-specific inquiry, depending on the title and status of the foreign government representative

and the functions that the representative assumes as a U.S. agent. FDA will consider such

situations on a case-by-case basis in consultation with the U.S. State Department.

C.7.5 I am a foreign facility that does business with several different brokers. May I use

more than one of these as my U.S. agent?

No. Under 21 CFR 1.227, each foreign facility is required to have only one U.S. agent for food

facility registration purposes. However, having a single U.S. agent for FDA registration purposes

does not preclude a facility from having multiple brokers for other business purposes. A foreign

facility is not required to conduct all of its business in the U.S. through the U.S. agent designated

for purposes of registration (see 21 CFR 1.227 and Comment 86 in the preamble to the Interim

Final Rule; 68 FR 58894 at 58915).

C.7.6 Is a power of attorney required for a U.S. agent to work on behalf of the facility?

A facility's U.S. agent, as defined in 21 CFR 1.227, may have a power of attorney arrangement

from the facility however, a power of attorney arrangement from the facility is not required.

C.7.7 May a foreign food processor change U.S. agents after registration?

Yes. A foreign facility may change its U.S. agent at any time. Under 21 CFR 1.234(a), updates

to required information, including the U.S. agent designation by foreign facilities, must be made

within 60 calendar days of the change. At this time, updates may be submitted electronically at

https://www.access.fda.gov . If you do not have access to the Internet, you also may update the

U.S. agent information through the paper system, as explained in section II.E.3 in this document.

After January 4, 2020, you must submit updates electronically, unless FDA has granted a waiver

under 21 CFR 1.245 (see also section II.N of this document for a discussion on waivers).

C.7.8 May the emergency contact for a foreign facility have a phone number outside the

United States?

Yes. A foreign facility's emergency contact may have a phone number outside the United States.

However, the facility is also required to identify a U.S. agent who resides or maintains a place of

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business in the United States and is physically located in the United States. The U.S. agent must

have a U.S. phone number. In addition, 21 CFR 1.232(c) requires an e-mail address for the U.S.

agent be provided in the foreign facility’s registration.

C.7.9 What information must the U.S. agent have on the foreign facility? For example,

does the U.S. agent need to know and understand the company and product? Or is it

sufficient for the U.S. agent to be able to contact the manufacturer quickly in case of

emergency, as well as serve as a conduit for the general information flow to and from

FDA?

Under 21 CFR 1.227, there are two qualifications for a U.S. agent. The agent: (1) must reside or

maintain a place of business in the United States; and (2) must be physically present in the United

States. Although the U.S. agent is not required to know and understand the facility's company

and product, the U.S. agent must be able to serve as the communication link between FDA and

the foreign facility because FDA will contact the foreign facility's U.S. agent when an emergency

occurs (unless the registration specifies another emergency contact). Thus, at a minimum, the

U.S. agent needs to know whom to contact at the facility if any emergency arises.

C.7.10 How does a foreign facility "authorize" someone in the United States to be their

agent (e.g., letter to FDA, notarized document)?

From FDA's perspective, for registration purposes, listing the name and contact information for

the U.S. agent in the registration is sufficient to "authorize" the agent, as long as the U.S. agent

has agreed to serve as the U.S. agent for the foreign facility. For its own business reasons,

however, a facility may want to formalize its relationship with the agent with some sort of written

agreement. Regardless of whether there is a formalized relationship between the facility and its

U.S. agent, FDA will verify that the person identified as the U.S. agent for the foreign facility has

agreed to serve as the U.S. agent (see 21 CFR 1.231). (See also section II.E.6 of this document

for a discussion of the verification procedures for U.S. agents).

C.7.11 May a foreign facility appoint one U.S. agent for part of the year and another U.S.

agent for the rest of the year?

Yes. However, any change in a facility's U.S. agent must be communicated to FDA through an

update of the registration information within 60 days of the change (21 CFR 1.234).

C.7.12 May foreign facilities belonging to the same parent company use different U.S.

agents for registration purposes?

Yes. Each foreign facility must identify, as part of the registration process, its U.S. agent, and

there is no requirement that facilities belonging to the same parent company utilize the same U.S.

agent. Also, any or all facilities belonging to the same parent company may designate the same

U.S. agent for registration purposes.

C.7.13 Traditionally, a U.S. broker has been utilized for routine and emergency

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communications with respect to the disposition of a particular shipment. Will that continue

or will only the designated U.S. agent be the facilitator for communications between a

shipping facility, carrier, broker, and importer?

Routine registration and emergency communications under the registration regulation relate to

facilities, not to specific shipments. FDA expects that food facility registration requirements will

have no impact on customary communications regarding the disposition of a particular food

shipment. A firm's commercial business in the United States need not be conducted exclusively

through the U.S. agent designated for registration purposes (21 CFR 1.227). Ordinarily, for

example, for questions relating to an imported food shipment subject to the prior notice

requirements (21 CFR part 1, subpart I), FDA will contact the transmitter or submitter of the prior

notice, rather than the U.S. agent for the facility associated with the shipment.

C.7.14 If someone agrees to be the U.S. agent for a foreign facility and later wishes to be

removed as the U.S. agent, how would this be accomplished? What is the status of the

facility’s registration?

To ensure that FDA is aware of the U.S. agent's intention of being removed from the facility's

registration, the U.S. agent may notify FDA of its intention by sending an e-mail to

[email protected]. This e-mail should include the information previously provided on the

registration form regarding the U.S. agent (i.e., name, address, phone number, email address) and

the name(s) and either address(es) or registration number(s) of the facility or facilities from which

the U.S. agent wishes to be removed. The owner, operator, or agent in charge of the foreign

facility, or an individual authorized by one of them (e.g., the U.S. agent), must update the

information identifying the facility's U.S. agent in the facility's registration (21 CFR 1.234). FDA

will then notify the facility (through its owner, operator, or agent in charge) within 60 calendar

days of the removal and request that the facility amend the registration to designate another U.S.

agent who has in fact agreed to serve as the facility’s U.S. agent.

C.7.15 How can the U.S. agent be accessible 24 hours a day, 7 days a week? How can a

small company make such an assurance?

The foreign facility is responsible for making arrangements with the person designated as its U.S.

agent or its designated emergency contact. A U.S. agent may be an individual, partnership,

corporation, or association. Because the role of the U.S. agent is to act as a communications link

between the facility and FDA, FDA intends to communicate through the U.S. agent in both

routine registration matters and emergency situations. This means that the U.S. agent must be

accessible to FDA 24 hours a day, 7 days a week, unless the foreign facility opts to designate a

different person other than the facility's U.S. agent as the facility's emergency contact by

providing the information specified in 21 CFR 1.232(c)(2) in the facility's registration. In terms

of ensuring such accessibility, FDA suggests that the foreign facility may wish to specify the

terms of availability in any written agreement it has with its U.S. agent or emergency contact.

C.7.16 Can a person in the United States, who has not been designated as the U.S. agent for

a foreign facility, perform the registration function for that facility?

Contains Nonbinding Recommendations

Registration must be performed by the owner, operator, or agent in charge of a facility, or an

individual authorized to register the facility by one of them (21 CFR 1.225 and 1.230). The

authorized individual may be, but is not required to be, the U.S. agent for the facility.

C.7.17 Under 21 CFR 1.232(c), the registration for a foreign facility is required to include

the "name, full address, phone number, and e-mail address of the foreign facility’s U.S.

agent. . . ." "U.S. agent" is defined in 21 CFR 1.227 as a "person . . . residing or

maintaining a place of business in the United States whom a foreign facility designates as its

agent" for purposes of registration of food facilities. As used in this definition, what does a

facility need to do to "designate" a person as a U.S. agent?

A foreign facility's U.S. agent must reside or maintain a place of business in the United States and

must be physically present in the United States (21 CFR 1.227). FDA expects the facility

management to contact the person and confirm that the person is willing and able to serve as the

facility's U.S. agent. The facility should "designate" a person as the facility's U.S. agent only if

the person has affirmatively agreed to serve in that capacity. The person's name and other

identifying information must be given in section 7 of Form FDA 3537 or in response to the

appropriate prompt when a facility is registered electronically. As previously stated in our

response to Question C.7.10, FDA will verify that the person identified as the U.S. agent for the

foreign facility has agreed to serve as the U.S. agent (see 21 CFR 1.231).

C.7.18 What will happen to an article of food that is offered for import into the United

States from a facility that does not provide a U.S. agent?

When FDA determines a foreign food facility has not registered in accordance with section 415

of the FD&C Act because it does not provide a U.S. agent, FDA may hold shipments offered for

import from that facility at the U.S. port of arrival until the facility amends their registration to

list a U.S. agent who has affirmatively agreed to serve as such.

C.7.19 Are the U.S. agent for food facility registration and the U.S. agent for purposes of

the foreign supplier verification program (FSVP) the same?

No. Although Congress used the term “United States agent” in both section 805(a)(2)(B)

(pertaining to who serves as the “importer” for purposes of fulfilling FSVP requirements) and

section 415(a)(1)(B) of the FD&C Act (pertaining to food facility registration), we do not

interpret the use of the term “United States agent” in section 805(a)(2)(B) to mean the U.S. agent

for a foreign facility under section 415(a)(1)(B) (see Comment 22 in the Registration Final Rule;

81 FR 45912 at 45926).

C.7.20 Can the U.S. agent for food facility registration and the U.S. agent for purposes of

the FSVP be the same person?

Yes. There is no prohibition on the same person serving as both the U.S. agent for purposes of

food facility registration and the U.S. agent for purposes of satisfying the FSVP “importer”

requirements–provided that such person meets the relevant requirements of both the FSVP

Contains Nonbinding Recommendations

regulation (21 CFR part 1, subpart L) and the food facility registration regulation.

C.7.21 Can the U.S. agent for a foreign food facility access the facility’s registration via

FDA Unified Registration and Listing Systems (FURLS)/Food Facility Registration Module

(FFRM) and help desk on behalf of the foreign facility?

Yes. The U.S. agent of a foreign facility can view the information submitted in the foreign

facility’s registration (21 CFR 1.227). The U.S. agent will be able to view the information

electronically via FURLS/FFRM. U.S. agents can contact FDA’s help desk with questions about

foreign facilities that they represent. In addition, a U.S. agent may contact FDA’s help desk on

behalf of the foreign facility (see Comment 25 in the Registration Final Rule; 81 FR 45912 at

45927).

8. Other Definitions

C.8.1 How does FDA define "owner," "operator," and "agent in charge?"

The owner, operator, or agent in charge is a person (as defined in section 201(e) of the FD&C

Act; 21 U.S.C. 321(e)) who has an ownership interest in, or management authority of, a facility or

a portion of a facility (e.g., a lessee of a part of a public warehouse).

C.8.2 How does FDA define "parent company?"

The term "parent company" is used in 21 CFR 1.232(a)(4) and is intended to have the meaning it

has in the corporate context. If a facility is part of a company that is owned by another

corporation, then the corporation would be the parent company. For example, if a facility is

owned by Company X, and Company X is a subsidiary of Corporation Y, then the owner of the

facility is Company X and the parent company is Corporation Y.

D. When Must You Register or Renew Your Registration?

1. When Must You Register?

D.1.1 When must you register initially under the food facility registration requirements?

If you are required to register with FDA, you must register before your facility begins

manufacturing/processing, packing, or holding operations.

2. Biennial Registration Renewal

D.2.1 When does a facility that is required to register with FDA need to submit a

registration renewal to FDA?

Section 415(a)(3) of the FD&C Act requires facilities that are required to register with FDA to

renew their registrations every other year, during the period beginning on October 1 and ending

Contains Nonbinding Recommendations

on December 31 of each even-numbered year.

FDA will consider a registration for a food facility to be expired if the registration is not renewed

as required (21 CFR 1.241(b)). FDA will consider a food facility with an expired registration to

have failed to register in accordance with section 415 (21 CFR 1.241(b)). The failure to register a

food facility in accordance with section 415 is a prohibited act under section 301(dd) of the

FD&C Act (21 U.S.C. 331(dd)).

D.2.2 Do new food facilities need to wait until October 1 of a biennial renewal year to

No. The owner, operator, or agent in charge of a facility that begins to manufacture/process,

pack, or hold food for consumption in the United States must register before the facility begins

such activities (21 CFR 1.230). An owner, operator, or agent in charge of a facility may

authorize an individual to register the facility on its behalf (21 CFR 1.230). If the initial

registration is submitted prior to October 1 of a biennial renewal year, a renewal still must be

submitted for the facility during the period beginning on October 1 and ending on December 31.

D.2.3 Does FDA intend to inform food facilities about the registration renewal

period?

Prior to the beginning of the biennial registration renewal (or “registration renewal”) period on

October 1, FDA intends to communicate with all registered facilities and U.S. agents for the

facilities notifying them of the upcoming registration renewal period. In these communications,

we plan to provide general information about the registration renewal process, including the

deadline for renewals. Once the renewal period begins, if a facility has not submitted a renewal,

we plan to continue to send communications reminding the facility of the upcoming deadline

through the end of the registration renewal period on December 31.

D.2.4 Will a food facility be issued a new registration number during the registration

renewal process?

No. A food facility will not be issued a new registration number when it renews a current

registration.

D.2.5 Am I required to provide my registration number and pin number when I submit

my registration renewal?

When you submit a registration renewal via mail or fax, you are asked to provide your facility

registration number and pin number (or PIN). For electronic submissions, Account holders in

FURLS will not need to provide a registration number or pin because that information is linked

to the Account.

D.2.6 Does FDA consider a registration renewal expired if it was properly submitted

on or prior to the December 31 deadline but was not timely administered or accepted

by FDA on or prior to the December 31 deadline?

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In the Registration Final Rule, we added 21 CFR 1.241(b) to specify that FDA will consider a

registration for a food facility to be expired if the registration is not renewed, as required by 21

CFR 1.230(b). If a food facility registration or renewal registration is submitted (or

postmarked, for paper submissions) on or before the renewal deadline and includes all required

information, we will not consider such a registration to be expired. Furthermore, 21 CFR

1.241(c) provides that FDA will cancel a registration if the facility’s registration has expired

because the facility has failed to renew its registration in accordance with 21 CFR 1.230(b).

For registrations that we do not consider to be expired, we will not cancel the registrations

under 21 CFR 1.241(c) (see Comment 26 in the Registration Final Rule; 81 FR 45912 at 45927

to 45928).

3. Abbreviated Registration Renewal Process

D.3.1 Will I have to resubmit all of my registration information when I renew my

registration?

FDA is providing an abbreviated registration renewal process for facilities that do not have

information changes under 21 CFR 1.232 since the submission of the preceding registration,

registration renewal, or update (see 21 CFR 1.230(c)).

If you use the abbreviated registration renewal process, you must confirm that no changes have

been made to the information required under 21 CFR 1.232 since you submitted the preceding

registration, registration renewal, or update, and you must certify that the information submitted

is truthful and accurate. Each electronic abbreviated registration renewal must include the name

of the individual submitting the abbreviated renewal. For registrations submitted by mail or fax,

each abbreviated registration renewal must also include the individual’s signature (see 21 CFR

1.230(c)).

For abbreviated registration renewals not submitted by the owner, operator, or agent in charge of

the facility, the abbreviated renewal must provide the email address of the individual who

authorized submission of the abbreviated renewal, unless FDA has granted a waiver under 21

CFR 1.245 (21 CFR 1.230(c)).

E. How and Where Do You Register or Renew Your Registration?

1. General Questions

E.1.1 How can registration be submitted?

Currently, you, or an individual you authorize, can submit a facility's registration or

registration renewal electronically or by U.S. mail or fax.

However, FDA regulations require that owners, operators, or agents in charge must submit

their registration to FDA electronically beginning on January 4, 2020, unless FDA has

granted a waiver under 21 CFR 1.245 (21 CFR 1.231(a)(2); 21 CFR 1.234(d); 21 CFR

Contains Nonbinding Recommendations

1.235(d)).

E.1.2 Does FDA require registration to be submitted in an electronic format?

No. Registration by a paper system is still available. FDA regulations require that owners,

operators, or agents in charge must submit their registration, registration renewal, update, and

cancellation to FDA electronically beginning on January 4, 2020, unless FDA has granted a

waiver under 21 CFR 1.245 (21 CFR 1.231(a)(2); 21 CFR 1.234(d); 21 CFR 1.235(d)). If FDA

has granted a waiver, registrations and registration renewals may be submitted through mail or

fax (see 21 CFR 1.231(a)(2); 21 CFR 1.234(d); 21 CFR 1.235(d)). However, FDA continues to

encourage use of the electronic format because it is more efficient and provides for immediate

submission of the registration information.

2. Electronic Registration and Registration Renewal

E.2.1 How can I submit my registration or registration renewal electronically?

You, or an individual you authorize, can submit a facility’s registration or registration

renewal electronically via FURLS Food Facility Registration Module (FFRM) at

https://www.access.fda.gov. You will need an FDA Industry Systems (FIS) account ID

and password in order to access the electronic system. More information is available about

the FIS at

https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration.

You may also use the electronic system to update your registration information or submit a

cancellation (e.g., due to change in ownership or going out of business).

3. Registration or Registration Renewal by Mail or Fax

E.3.1 How can I submit my registration or registration renewal by mail or fax?

Beginning January 4, 2020, registrants must submit their registration or registration renewal to

FDA electronically, unless FDA has granted a waiver under 21 CFR 1.245 (see 21 CFR 1.231). If

FDA has granted a waiver under 21 CFR 1.245, the registrant may register or renew by mail or by

fax. If you submit a registration or registration renewal by mail or fax, you must use the paper

version of Form FDA 3537. That version is available for download at

https://www.fda.gov/food/guidanceregulation/foodfacilityregistration/ucm073728.htm.

You can request the paper form and submit the completed form by fax to 301-436-2804 or by

mail to:

U.S. Food and Drug Administration

Food Facility Registration (HFS-681)

5001 Campus Dr.

College Park, MD 20740

Contains Nonbinding Recommendations

You also may request the paper form by phone at 1-800-216-7331 or 240-247-8804.

You may also use the paper form to update or cancel your registration information, if FDA has

granted a waiver under 21 CFR 1.245 (see 21 CFR 1.234(d); 21 CFR 1.235(d)).

4. Unique Facility Identifier and Verification Procedures for FDA

E.4.1 How will FDA conduct the verification process for the unique facility identifier

(UFI) required in the facility’s registration?

Under 21 CFR 1.232(a)(2), domestic and foreign facilities must submit a unique facility

identifier (UFI) recognized as acceptable to FDA in the facility’s registration (see also section

F.2 of this document for further discussion of the UFI requirement).

Please note, however, that the requirement for providing a UFI in food facility registration

submissions will not begin until October 1, 2020.

As outlined in 21 CFR 1.231(a)(3) and (b)(5), beginning October 1, 2020, FDA intends to

conduct the verification process for the UFI as follows:

•

For electronic registrations, after you submit your registration, FDA will verify the

accuracy of your UFI recognized as acceptable by FDA and will also verify that the

facility-specific address associated with the UFI is the same address associated with your

registration. FDA will not confirm your registration or provide you with a registration

number until FDA verifies the accuracy of your facility’s UFI and verifies that the

facility-specific address associated with the UFI is the same address associated with your

registration.

•

For electronic registration renewals, after you submit your electronic registration renewal,

FDA will provide you with an electronic confirmation of your registration renewal. When

you add or update your facility’s UFI as part of the registration renewal, FDA will verify

the accuracy of your facility’s UFI and will also verify that the facility-specific address

associated with the UFI is the same address associated with your registration. FDA will

not provide you with a confirmation of your registration renewal until FDA verifies the

accuracy of your UFI and verifies that the facility-specific address associated with the

UFI is the same address associated with your registration.

•

For registrations submitted by mail or fax, after you submit your registration, FDA will

verify the accuracy of your facility’s UFI and will also verify that the facility-specific

address associated with the UFI is the same address associated with your registration.

FDA will not confirm your registration or provide you with a registration number until

FDA verifies the accuracy of your facility’s UFI and verifies that the facility-specific

address associated with the UFI is the same address associated with your registration.

•

For registration renewals submitted by mail or fax, after you submit your registration

renewal, FDA will provide you with a confirmation of your registration renewal. When

you add or update your facility’s UFI as part of your registration renewal, FDA will

Contains Nonbinding Recommendations

verify the accuracy of your facility’s UFI and will also verify that the facility-specific

address associated with the UFI is the same address associated with your registration.

FDA will not provide you with a confirmation of your registration renewal until FDA

verifies the accuracy of your UFI and verifies that the facility-specific address associated

with the UFI is the same address associated with your registration.

5. Verification Procedures for Submissions Not Made by the Owner, Operator, or Agent in

Charge of the Facility

E.5.1 How will FDA conduct the verification process for submissions not made

by the owner, operator, or agent in charge of the facility?

For registrations or registration renewals not submitted by the owner, operator, or agent in charge

of the facility, FDA will verify that the individual identified as having authorized the submission

in fact authorized the submission on behalf of the facility. FDA will not confirm a registration,

provide a registration number, or provide confirmation of a registration renewal until that

individual confirms that he or she authorized the submission (see 21 CFR 1.231(a)(4) and (b)(6)).

In most circumstances, FDA will conduct this verification step by sending an email to the

individual identified as having authorized the submission. In some circumstances, however,

FDA may determine that it is appropriate to use other methods to conduct the verification step,

such as U.S. mail or phone.

For updates and cancellations, FDA will not provide a confirmation of the registration update or

cancellation until the individual confirms that he or she authorized the submission (21 CFR

1.234(c)(3) and (d)(6) (for updates) and 1.235(c)(3) and (d)(6) (for cancellations)). We will

provide the owner, operator, or agent in charge of the facility 30 calendar days to respond to our

verification request.

If we do not receive a response to our verification request within that time, the registration,

registration renewal, update, or cancellation submission will be removed from our database and a

new submission will be required. For registration renewals, updates, or cancellations, if FDA has

previously verified that the authorizing individual has authorized the individual submitting the

renewal to make registration submissions on behalf of the facility, FDA will not re-verify that the

authorizing individual in fact authorized the submission.

FDA will continue its current practice of individually contacting facilities if specific questions

arise regarding the facility’s registration.

6. Verification Procedures for U.S. Agents

E.6.1 How will FDA conduct the verification process for U.S. agents?

For registrations, registration renewals, and updates to information about U.S. agents, FDA will

verify that the person identified as the U.S. agent for the foreign facility agreed to serve as the

U.S. agent (see 21 CFR 1.231(a)(5) and (b)(7) (for registrations and registration renewals) and

1.234(c)(2) and (d)(5) (for updates)). FDA will not confirm a registration or registration

Contains Nonbinding Recommendations

renewal or provide a registration number until the person identified as the U.S. agent for the

foreign facility confirms that the person agreed to serve as the U.S. agent (21 CFR 1.231(a)(5)

and (b)(6)). For updates, FDA will not provide a confirmation of the registration update until

the person identified as the U.S. agent for the foreign facility confirms that the person agreed to

serve as the U.S. agent (21 CFR 1.234(c)(2) and (d)(5)).

In most circumstances, FDA will conduct this verification step by sending an email to the person

identified as the U.S. agent. In some circumstances, however, FDA may determine that it is

appropriate to use other methods to conduct the verification step, such as U.S. mail or phone.

If the individual listed as the U.S. agent informs FDA that he has not agreed to serve as the

facility’s U.S. agent, FDA will inform the facility (through its owner, operator, or agent in

charge) of that fact and request that the facility amend the registration to designate an individual

who has agreed to serve as the facility’s U.S. agent. For registration renewals, if FDA has

previously verified that the U.S. agent has agreed to serve as the U.S. agent for the facility, FDA

will not re-verify that the U.S. agent has agreed to serve as the U.S. agent for the foreign facility.

We will provide the person identified as the U.S. agent 30 calendar days to respond to our

verification request. If we do not receive a response to our verification request within that time,

the registration, registration renewal, or update submission will be removed from our database

and a new submission will be required.

E.6.2 What will happen when the person listed as the U.S. agent for the facility does not

agree to serve as the facility's U.S. agent?

After you submit your registration, FDA will verify that the person identified as the U.S. agent

for your foreign facility has agreed to serve as your U.S. agent. FDA will not confirm your

registration or provide you with a registration number until that person confirms that the

person has agreed to serve as your U.S. agent (see 21 CFR 1.231(a)(5) and (b)(7)).

If the person listed as the U.S. agent informs FDA that the person has not agreed to serve as the

facility's U.S. agent, FDA will inform the facility (through its owner, operator, or agent in

charge) of that fact and request that the facility amend the registration to designate a person that

has in fact agreed to serve as the facility's U.S. agent.

7. Requirement to Update Incorrect Registration Information

E.7.1 If I provide incorrect information at the time I submit my registration or

registration renewal, do I have to immediately update my submission?

Yes. If any information previously submitted was incorrect at the time of submission, you must

immediately update your facility’s registration as specified in 21 CFR 1.234 (21 CFR 1.231(a)(6)

and (b)(9)).

F. What Information Is Required in the Registration?

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1. General questions

F.1.1 What information is required in the registration of a food facility?

As outlined in 21 CFR 1.232, the following information is required for domestic and foreign

food facility registrations:

•

Facility name, address, phone number, and emergency contact phone number;

•

Preferred mailing address, if different from that of the facility;

•

Parent company name, address, and phone number (if the facility is a subsidiary of the

parent company);

•

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, unless FDA has granted a

waiver under 21 CFR 1.245;

•

Applicable food product categories of any food manufactured/processed, packed, or held

at the facility, as identified on Form FDA 3537;

•

The type(s) of activity at the facility for each food product category, as provided in 21

CFR 1.232(a)(8);

•

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. If the individual submitting the form is not the owner,

operator, or agent in charge of the facility, the registration must also include a statement

in which the individual certifies that the information submitted is true and accurate,

certifies that he/she is authorized to submit the registration, and identifies by name,

address, and telephone number, the individual who authorized submission of the

registration. In addition, the registration must identify the individual who authorized

submission of the registration by email address, unless FDA has granted a waiver under

21 CFR 1.245.

In addition, beginning October 1, 2020, the facility’s UFI recognized as acceptable by FDA will

be required to be submitted with the registration information (21 CFR 1.232(a)(2)). Each

registration submission must include the name of the individual submitting the registration. For

the paper option, the registration must also include the individual’s signature (see 21 CFR

1.230).

For a domestic facility, the registration must also include:

•

The email address for the contact person of the facility;

•

An emergency contact phone number and email address if different from the email

address for the contact person.

For a foreign facility, the registration must also include:

Contains Nonbinding Recommendations

•

The name, full address, phone number, and email address of the foreign facility’s U.S.

agent;

•

An emergency contact phone number and email address.

F.1.2 If a mobile facility (e.g., a truck-mounted operation) is required to register, what

address should it use?

When registering, the owner, operator, or agent in charge of the mobile facility must provide FDA

with the information required in 21 CFR 1.232. A fixed address for the owner, operator, or agent

in charge of the mobile facility may be used. Addresses of mobile facilities are discussed in the

preamble to the Interim Final Rule (see Comment 38; 68 FR 58894 at 58904).

2. Unique Facility Identifier (UFI)

F.2.1 When will I be required to submit a UFI in my registration submission?

As previously stated in the answer to Question F.1.1 in this document, beginning October 1, 2020,

the facility’s UFI recognized as acceptable by FDA will be required to be submitted with the

registration information (21 CFR 1.232(a)(2)). After a food facility provides a UFI, it will be

required to update its registration with any changes to the identifier in accordance with 21 CFR

1.234.

F.2.2 If I have a UFI recognized as acceptable by FDA, may I include it in my registration

submission before October 1, 2020?

At this time, Form FDA 3537 does not provide a data field to include UFI information. We will

consider adding an optional UFI data field on Form FDA 3537 in advance of the October 1, 2020

date to allow facilities to voluntarily submit UFI information.

F.2.3 Which UFI or UFIs are recognized as acceptable to FDA for food facility registration

purposes?

At this time, FDA recognizes the Data Universal Numbering System D-U-N-S (DUNS) number

as an acceptable UFI. DUNS numbers are assigned and managed by Dun & Bradstreet.

However, as stated previously in this document, the requirement to submit a UFI will not begin

until October 1, 2020. If FDA recognizes as acceptable any additional UFIs before the October

1, 2020 date, we will update the response to this question.

F.2.4 How do I obtain a UFI recognized as acceptable by FDA?

At this time, the DUNS number is the preferred UFI recognized as acceptable to FDA for food

facility registration. The DUNS number is assigned and managed by Dun & Bradstreet and is

available free of charge. Information on how to obtain a DUNS number will be available on the

FDA Web site.

https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm2006832.htm

Contains Nonbinding Recommendations

You can obtain a DUNS number through the Internet or by phone.

However, as stated previously in this document, the requirement to submit a UFI will not begin

until October 1, 2020. If FDA recognizes as acceptable additional UFIs before the October 1,

2020 date, we will update the response to this question.

F.2.5 Who can I contact if I want to use a different UFI than the one(s) FDA recognizes

as acceptable?

If you would like FDA to consider the use of an alternative identifier for food facility registration

other than the one(s) FDA recognizes as acceptable in this document, you may contact FDA at

the FURLS Helpdesk (email to FURL[email protected] or by phone at 1-800-216-7331 or 240-247-

8804).

F.2.6 If I provide a UFI with my registration submission, do I also have to include my food

facility registration number?

Yes. If you submit an update or a registration renewal, you are also asked to provide your

facility registration number on Form FDA 3537

F.2.7 If I am the owner, operator, or agent in charge of multiple food facilities, do I have

to provide separate UFIs for each of my facilities?

Yes. The registration for each facility must include a UFI recognized as acceptable by FDA (see

21 CFR 1.232(a)(2)).

F.2.8 Do I have to provide a new UFI for the facility if there is a change in ownership?

If a facility comes under new ownership, the former owner must cancel the old registration in

accordance with 21 CFR 1.235, and the new owner must submit a new registration for the

facility as specified in 21 CFR 1.231 (see 21 CFR 1.234(b)). If a facility cancels its registration

due to a change in ownership, the new owner, operator, or agent in charge must provide the

appropriate UFI when registering the facility under the new ownership (see 21 CFR 1.232).

3. Food Product Categories

F.3.1 Am I required to provide information about food product categories in my

registration submission?

Yes. Your food facility registration must include the applicable food product categories of any

food manufactured/processed, packed, or held at the facility as identified on Form FDA 3537 (21

CFR 1.232(a)(7)). See the 2016 Edition of the “Necessity of the Use of Food Categories in Food

Facility Registrations and Updates to Food Categories: Guidance for Industry,” issued in

September 2016, for the updated food product categories.

F.3.2 If my facility is a warehouse/holding facility, do I have to constantly update the

Contains Nonbinding Recommendations

food product categories in my registration if this information frequently changes?

For warehouse facilities engaged in ongoing operations that frequently change food product

categories, these facilities may select all of the food product categories that are normally part of

their operations. If the warehouse has updates to the food product categories it handles, the

facility is required to update its registration in accordance with 21 CFR 1.234 (see Comment 60

in the Registration Final Rule; 81 FR 45912 at 45937).

F.3.3 Do I submit registration information about the ingredients used at my facility for

manufacturing finished foods, or the finished products that I manufacture?

You are required to provide the applicable food product categories of any food

manufactured/processed, packed, or held at the facility, as identified on Form FDA 3537 (21

CFR 1.232(a)(7)). If you are a manufacturer/processor, you should provide food product

category information about the foods that you manufacture/process, not the ingredients that

you use in your manufacturing/processing. For example, if you manufacture chocolate chip

cookies and you use butter as one of the ingredients for the cookies, you should not provide

food product category information about the butter. Instead, you should provide food

product category information about the cookies. Specifically, you should select the food

product category of bakery products, dough mixes, or icings. (See also the Food Product

Categories Guidance at

https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation

/ucm324778.htm for more information and updates to the food product categories identified

on Form FDA 3537.)

F.3.4 If my facility is subject to FDA’s human food Current Good Manufacturing

Practice regulations in subpart B of 21 CFR part 117 and manufactures/processes

human food that results in human food by-products that we pack or hold and then send

either to another facility that manufactures/processes animal food or to a farmer for use

as animal food, do I provide animal food product category information in my

registration?

Yes. Your food facility registration must include applicable food product categories of any food

manufactured/processed, packed, or held at the facility as identified on Form FDA 3537 (21 CFR

1.232(a)(7)). If your facility’s human food manufacturing results in by-product that you pack or

hold for distribution as animal food, you must select the applicable animal food product

categories for the by-products that you pack or hold.

4. Activity Type Information

F.4.1 Am I required to provide activity type information in my registration

submission?

Yes. Your food facility registration must include information about the types of activities

conducted at your facility for each food product category identified (21 CFR 1.232(a)(8)). The

activity type options are as follows:

Contains Nonbinding Recommendations

•

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;

•

Manufacturer/processor;

•

Acidified food processor;

•

Low-acid food processor;

•

Farm mixed-type facility;

•

Packer/repacker;

•

Salvage operator (reconditioner);

•

Animal food warehouse/holding facility;

•

Other activity (must specify).

F.4.2 What does FDA consider the different activity types specified in 21 CFR

1.232(a)(8) to mean?

FDA’s considers the activity types to have the following meanings:

• Ambient human food storage warehouse/holding facility: A facility that holds or stores

food for human consumption at ambient air temperatures (approximately 21° C/70° F).

Examples include storage tanks and grain elevators.

• Refrigerated human food warehouse/holding facility: A facility that holds or stores food

products for human consumption at refrigerated temperatures (approximately 4° C/40° F

to 0° C/32° F).

• Frozen human food warehouse/holding facility: A facility that holds or stores food for

human consumption at frozen temperatures (approximately 0° C/32° F or below).

• Interstate conveyance caterer/catering point: A facility that prepares complete or partial

meals or drinks from raw or partially processed materials for service to passengers or

crew aboard an interstate conveyance or for consumption by these groups at a location

other than where prepared.

• Contract Sterilizer: A facility that performs contract operations such as sterilization or

irradiation of foods or components of foods, or that provides other microbial reduction

treatments such as steam treatment or propylene oxide (PPO) treatment.

• 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

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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.

• Acidified food processor: An establishment that manufactures/processes acidified foods as

defined in 21 CFR 114.3(b) and is subject to the requirements of 21 CFR parts 108 and 114.

• Low-acid food processor: An establishment that manufactures/processes thermally

processed low-acid food (as defined in 21 CFR 113.3(n)) packaged in a hermetically

sealed container (as defined in 21 CFR 113.3(j)) and is subject to the requirements of 21

CFR parts 108 and 113.

• Farm Mixed-Type Facility: An establishment that is a farm, but also conducts activities

outside the farm definition that require the establishment to be registered under section

415 of the FD&C Act.

• Packer/Repacker: A facility that packs a food product or products into different

containers without making any change in the form of the product.

• Salvage Operator (Reconditioner): A facility that deals in the resale and reconditioning

of damaged foods.

• Animal food warehouse/holding facility (e.g., storage facilities, including storage tanks,

grain elevators): A facility that holds or stores food for animal consumption at any

temperature.

• Other activity: Any other activity conducted at the facility not otherwise specified in 21

CFR 1.232(a)(8).

F.4.3 When do I select both low-acid food processor and acidified food processor as

activity types on the registration form?

The low-acid food processor and acidified food processor activity types should both be selected

if the facility manufactures acidified foods subject to the requirements in 21 CFR parts 108 and

114, as well as thermally processed low-acid foods packaged in hermetically sealed containers

that are subject to the requirements of 21 CFR parts 108 and 113. For example, a facility that

processes a thermally processed low-acid food such as green beans in water in a can and an

acidified food such as pearl onions in brine in a glass jar would select both the low-acid food

processor and acidified food processor activity types on the food facility registration form. The

facility is engaging in both acidified food and low-acid food processing.

F.4.4 Do foreign facilities have to provide activity type information about all foods

associated with the facility, or only about foods exported for consumption in the United

States?

Foreign facilities that are required to register are only required to provide activity type

information about food that the facility manufactures/processes, packs, or holds for consumption

in the United States (see Comment 66 in the Registration Final Rule; 81 FR 45912 at 45938).

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5. Requirement to Provide Assurance that FDA Will Be Permitted to Inspect

F.5.1 Is a foreign facility required to provide assurance that FDA will be permitted to

inspect the facility?

Yes. Section 415(a)(2) of the FD&C Act, as amended by section 102(b) of FSMA, requires that

food facility registrations contain an assurance that FDA will be permitted to inspect the facility

at the times and in the manner permitted by the FD&C Act. The assurance is required for food

facilities in order to complete their food facility registration.

G. What Optional Items Are Included in the Registration?

G.1 What optional information may be provided in the registration?

As stated in 21 CFR 1.233, FDA encourages, but does not require, registrants to submit items

that are indicated as optional on Form FDA 3537.

The following information is optional, but may be provided when submitting a food facility

registration:

•

Facility fax number;

•

Fax number and e-mail address for the preferred mailing address, if different from that of

the facility;

•

Fax number of the owner, operator, or agent in charge of the facility;

•

Fax number and e-mail address of the parent company (if applicable);

•

Individual name and title for the facility emergency contact;

•

For a foreign facility: Title and fax number of its U.S. agent;

•

Fax number of the authorizing individual; and

•

Approximate dates of operation (if the facility’s business is seasonal).

H. How and When Do You Update Your Facility's Registration Information?

H.1 When must I update the information submitted in a food facility’s registration?

You, or an individual you authorize, must submit an update to the facility's registration within 60

calendar days of any change to any of the required information (21 CFR 1.234(a)). If the reason

for an update is a change in ownership, the former owner must cancel the facility’s registration

within 60 calendar days. The new owner must submit a new registration for the facility before

the facility begins to manufacture/process, pack, or hold food for consumption in the United

States (21 CFR 1.234(b)).

H.2 I have changes to my registration information. Must I update my registration now,

or can I wait until the beginning of the biennial registration renewal period beginning on

October 1 of each even-numbered year?

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The owner, operator, or agent in charge of a facility is required to submit an update to a facility’s

registration to FDA within 60 calendar days of a change to any of the required registration

information previously submitted under 21 CFR 1.232 (21 CFR 1.234(a)). If a change occurs to

a facility’s previously submitted required registration information before the start of or during the

biennial registration renewal period, a registrant may submit an update for such change as part of

the facility’s registration renewal by including the update information in the registration renewal,

provided that such update is submitted within 60 calendar days of the change. If a facility

submits an update to FDA before the start of the next biennial registration renewal period, which

takes place from October 1 – December 31 of each even-numbered year, the facility will still be

required to submit a registration renewal to FDA during the biennial registration renewal period.

H.3 If I am the owner, operator, or agent in charge of a facility, may I authorize another

individual to update the facility’s registration?

Yes. Under 21 CFR 1.234(a), the owner, operator, or agent in charge of a facility may authorize

an individual to update a facility’s registration. The authorized individual may be, but is not

required to be, the U.S. agent for the facility. For updates not submitted by the owner, operator,

or agent in charge, the update must include the email address of the individual who authorized

the update, unless FDA has granted a waiver under 21 CFR 1.235 (21 CFR 1.234(a)). FDA

will verify that the individual identified as having authorized submission of the update in fact

authorized the submission on behalf of the facility and will not confirm the registration update

until that individual confirms that he or she authorized the update (21 CFR 1.234(c)(3); 21 CFR

1.234(d)(6)).

H.4 Am I required to include the email address of the individual who authorized the

update in my registration update?

For updates not submitted by the owner, operator, or agent in charge, the update must include the

email address of the individual who authorized the update, unless FDA has granted a waiver

under 21 CFR 1.245 (see 21 CFR 1.234).

H.5 When must I submit my update to FDA electronically?

Updates must be submitted electronically to FDA beginning January 4, 2020, unless FDA has

granted a waiver under 21 CFR 1.245. If FDA has granted a waiver, you may submit your

update by mail or fax (see 21 CFR 1.234(d)).

H.6 Am I required to provide my registration number and pin number when I update

my registration?

If you submit an update to your registration via mail or fax, you are asked to provide your

facility registration number and pin number (or PIN) on Form FDA 3537. For electronic

submissions, account holders in FURLS will not need to provide a registration number or pin

because that information is linked to the Account.

H.7 What do I do if I don’t know my facility’s registration number or pin number?

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If a registrant does not know their registration number and/or pin number, the owner, operator,

or agent in charge should mail or fax a letter requesting that information, on company

letterhead including the company’s name, address, email address (if available), and facility

telephone number to:

U.S. Food and Drug Administration

Food Facility Registration (HFS-681)

5001 Campus Dr.

College Park, MD 20740

You may send the fax to (301) 436-2804. Alternatively, the owner, operator, or agent in charge

may send an email to FURL[email protected] to request their registration number and/or pin number.

The email should include the company’s name, address, and facility telephone number. We will

verify that the individual requesting the registration number and/or pin number is the owner,

operator, or agent in charge of the facility. Upon successful verification of the requester, the

registration number and/or pin number will be sent to the owner, operator, or agent in charge of

the facility by email, or U.S. mail, as appropriate.

During the biennial registration renewal period, there may be a delay in this process due to

increased industry queries. We encourage registrants requesting their registration number and/or

pin number to contact us in advance of the biennial registration renewal period.

I. How and When Do You Cancel Your Facility's Registration Information?

I.1 How and when must a facility cancel its registration?

The owner, operator, or agent in charge of the facility, or an individual authorized by one of them,

must cancel the registration within 60 calendar days of the reason for the cancellation (e.g., if a

facility goes out of business or comes under new ownership, the owner, operator, or agent in

charge must cancel the registration within 60 days (21 CFR 1.235)).

The owner, operator, or agent in charge of the facility, or an individual authorized by one of

them, can submit the cancellation electronically at https://www.fda.gov/furls

. Alternatively, you

can obtain a paper copy of the cancellation form, Form FDA 3537a, and use the paper process to

fax or mail the cancellation to FDA. Beginning January 4, 2020, you must submit your

cancellation electronically, unless FDA has granted a waiver under 21 CFR 1.245 (21 CFR

1.235(d)). If FDA has granted a waiver, you may submit your cancellation by mail or fax.

You can request the paper form and submit the completed form by fax to 301-436-2804 or by

mail to:

U.S. Food and Drug Administration

Food Facility Registration (HFS-681)

5001 Campus Dr.

College Park, MD 20740

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I.2 What information must be submitted in a cancellation?

As specified in 21 CFR 1.235(b), the cancellation for a facility’s registration must include the

following information:

•

The facility’s registration number;

•

Whether the facility is domestic or foreign;

•

The facility name and address;

•

The name, address, and email address (if available) of the individual submitting the

cancellation;

•

For registration cancellations not submitted by the owner, operator, or agent in charge of

the facility, the email address of the individual who authorized submission of the

registration cancellation, unless FDA has granted a waiver under 21 CFR 1.245; and

•

A statement certifying that the information submitted is true and accurate, and that the

person submitting the cancellation is authorized by the facility to cancel its registration.

I.3 When will my registration be considered canceled?

For electronic cancellations, once you complete your electronic cancellation, FDA will provide

you with an electronic confirmation of your cancellation (21 CFR 1.235(c)(2)). Your

registration will be considered cancelled once FDA sends you your cancellation confirmation (21

CFR 1.235(c)(4)). For cancellations submitted by mail or fax, the registration will be considered

cancelled once FDA enters the facility’s cancellation data into the registration system (21 CFR

1.235(d)(7)). FDA will send the registrant a cancellation confirmation (21 CFR 1.235(d)(7)).

As we stated in the answer to Question E.5.1 of this document, for registration cancellations not

submitted by the owner, operator, or agent in charge of the facility, after submission of the

registration cancellation, FDA will verify that the individual identified as having authorized

submission of the cancellation in fact authorized the submission on behalf of the facility (21 CFR

1.235(c)(3); 21 CFR 1.235(d)(6)). FDA will not confirm the registration cancellation until that

individual confirms that he or she authorized the registration cancellation (21 CFR 1.235(c)(3);

21 CFR 1.235(d)(6)).

I.4 Can FDA cancel my registration?

Yes. As described in 21 CFR 1.241(c), FDA may cancel registrations in certain circumstances.

Specifically, 21 CFR 1.241(c) provides that FDA will cancel a registration if FDA independently

verifies:

•

the facility is no longer in business;

•

the facility has changed owners, and the owner, operator, or agent in charge of the

facility fails to cancel the registration;

•

the registration is for a facility that does not exist;

•

the facility is not required to register;

•

the information about the facility’s address was not updated in a timely manner in

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accordance with 21 CFR 1.234(a); or

•

the registration was submitted to FDA by a person not authorized to submit the

registration under 21 CFR 1.225.

In addition, FDA will consider a registration for a food facility to be expired if the registration is

not renewed, as required by 21 CFR 1.230(b), and FDA will consider a food facility with an

expired registration to have failed to register in accordance with section 415 of the FD&C Act

(21 CFR 1.241(b)). Furthermore, 21 CFR 1.241(c) provides that FDA will cancel a registration

if the facility’s registration has expired because the facility has failed to renew the registration in

accordance with 21 CFR 1.230(b).

21 CFR 1.241(c) states that if we cancel a facility’s registration, we will send a confirmation of

the cancellation using contact information submitted by the facility in the registration database.

I.5 If FDA cancels my registration, will I be informed before the registration is canceled?

We anticipate that in many cases it will be appropriate for FDA to send notices to facilities

facing potential cancellation indicating our intent to cancel their registrations and the basis for

such cancellations. We also anticipate that, when appropriate, if the circumstances meriting

possible cancellation are corrected within 30 days after notice is provided, we will not cancel the

registration. We further anticipate that if facilities do not respond within 30 days, or if corrective

action is otherwise not taken within that time period, we will consider the lack of response or

lack of corrective action as independent verification that the facility should no longer be

registered and will then cancel the registration. If a facility believes its registration was cancelled

in error, the fac

ility may contact FDA. We also anticipate that it will generally not be

appropriate to provide the 30-day window for corrective action if the basis for cancellation is an

expired registration due to failure to renew a registration in accordance with 21 CFR 1.230(b). In

those circumstances, a facility would have already received notice of its obligation to renew.

Leading up to and throughout the registration renewal period, we plan to notify registrants of

their obligation to renew registrations and the deadline for doing so. We also plan to notify

registrants that failure to renew their registrations in accordance with 21 CFR 1.230(b) will cause

FDA to consider the registrations expired. Additionally, we plan to notify registrants that we

will consider a food facility with an expired registration to have failed to register in accordance

with section 415 of the FD&C Act.

If FDA cancels a facility’s registration, FDA will send a confirmation of the cancellation to the

facility (see 21 CFR 1.241(c)).

I.6 What must I do if FDA cancels my registration because FDA considers it to be expired?

If FDA cancels your registration because FDA considers it to be expired and you continue to

manufacture/process, pack, or hold food for consumption in the United States and are

subject to section 415 of the FD&C Act, you must re- register according to 21 CFR 1.230,

and you must include all the information specified in 21 CFR 1.232.

I.7 If I have registered with FDA but am not required to do so, do I have to cancel the

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registration, or will FDA cancel the registration?

Yes, you must cancel your registration within 60 calendar days of the reason for cancellation (see

21 CFR 1.235(a)). However, as specified in 21 CFR 1.241(c), we will cancel registrations if we

independently verify that a facility is not required to register.

I.8 If FDA cancels a registration, what will FDA do with the information about those

facilities that have previously registered?

We will archive information from inactive food facility registrations as appropriate.

J. What Other Registration Requirements Apply?

J.1 What other registration requirements apply to foods?

In addition to the food facility registration requirements under section 415 of the FD&C Act and

21 CFR part 1, subpart H, commercial processors of low-acid canned foods and acidified foods

must register as required in 21 CFR part 108. Food facilities that are required to register must

also comply with any other applicable Federal, State, or local registration requirements.

Also, shell egg producers with 3,000 or more laying hens at a particular farm that does not sell all

their eggs directly to consumers and that produces shell eggs for the table market are required to

In addition, section 412(c)(1)(A) of the FD&C Act requires a person who introduces or delivers

for introduction any new infant formula into interstate commerce to register with FDA the name

of the person and their place of business, and all establishments at which the person intends to

manufacture the new infant formula.

In addition, certain medicated feed mills are required to be licensed with FDA and registered as a

drug establishment. For more information about which medicated feed mills must meet these

requirements and how to become licensed and registered as a drug establishment, please see:

https://www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/MedicatedFeed/default.htm.

K. What Are the Consequences of Failing to Register, Renew, Update, or Cancel Your

Registration?

K.1 What are the consequences if an owner, operator, or agent in charge of a facility does

not register, renew, update, or cancel the facility’s registration, as required in section 415

of the FD&C Act and 21 CFR part 1, subpart H?

If a facility is required to register under section 415 of the FD&C Act, then the failure of an

owner, operator, or agent in charge of a facility to register its facility, renew the registration of its

facility, update required registration elements of its facility’s registration, or to cancel its

registration in accordance with the requirements in 21 CFR part 1, subpart H is a prohibited act

under section 301(dd) of the FD&C Act (21 U.S.C. 331(dd)). See 21 CFR 1.241(a). The United

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States can bring a civil action in Federal court to enjoin a person who commits a prohibited act.

The United States also can bring a criminal action in Federal court to prosecute a person who is

responsible for the commission of a prohibited act (21 CFR 1.241(a)). In addition, under section

306 of FD&C Act, FDA can seek debarment of any person who has been convicted of a felony

relating to importation of food into the United States.

If food being imported or offered for import into the United States is from a foreign facility for

which registration has not been submitted, the food must be held at the port of entry and may not

be delivered to the importer, owner, or consignee of the food until the foreign facility is

registered. However, the food may be directed to a secure facility by FDA and/or U.S. Customs

and Border Protection (CBP) (section 801(l) of the FD&C Act).

K.2 If a foreign facility has not renewed its registration by December 31 of a biennial

renewal period, will the facility still be able to import food into the United States?

If a foreign facility required to register does not renew its registration by December 31 of a

biennial renewal period, the registration for the facility will be considered expired and FDA will

cancel the registration. FDA will enforce the registration requirements of section 415 of the

FD&C Act and implementing regulations in 21 CFR part 1, subpart H as appropriate in each

situation. FDA’s prior notice for imported foods system is the agency’s primary tool for

ensuring that foreign facilities that offer food for import into the United States are registered

under section 415 of the FD&C Act. (See 21 CFR 1.285 and CPG Sec. 110.310 Prior Notice of

Imported Food Under the Public Health Security and Bioterrorism Prepare

dness Response Act

of 2002). If FDA determines that a foreign food facility is not registered in accordance with

section 415 and 21 CFR part 1, subpart H, including because the facility has failed to renew its

registration as required, the food being imported or offered for import into the United States

from the foreign facility is subject to being held at the port of entry (as defined in 19 CFR

101.1), in accordance with section 801(l) of the FD&C Act, unless CBP concurrence is obtained

for the export of the food and the food is immediately exported from the port of arrival (as

defined in 21 CFR 1.276(b)(11) (see 21 CFR 1.285(b)). Food held in this circumstance shall not

be entered and shall not be delivered to the importer, owner, or ultimate consig

nee until the

foreign facility is registered in accordance with section 415 and 21 CFR part 1, subpart H, and

the appropriate registration number is provided in prior notice as specified in 21 CFR 1.285(i).

FDA may allow the food held at the port of entry to be moved to a secure facility, as appropriate

(21 CFR 1.285(c)(2)). However, FDA ordinarily will not allow the food to be transferred by

any person from the port of entry into the United States or from the secure facility.

K.3 If a foreign facility has not renewed its registration by December 31 of a biennial

renewal period, will the facility’s designated U.S. agent continue to be designated as the

U.S. agent for the facility?

Once a registration expires for failure to renew the registration, FDA will cancel the registration

(see 21 CFR 1.241(c)). Once the registration is cancelled, the U.S agent no longer serves as the

U.S. agent (as defined in 21 CFR 1.227) for that facility.

L. What Does Assignment of a Registration Number Mean?

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L.1 When is a food facility registration number assigned?

FDA assigns a registration number to confirm that a food facility is registered. A facility’s

registration is not confirmed until after we verify certain information included in the registration.

Specifically, we will not confirm a registration until we verify a facility’s UFI and facility-

specific address, that the person identified as the U.S. agent agreed to serve as the U.S. agent (for

foreign facility registrations), and that registrations not submitted by an owner, operator, or agent

in charge were in fact authorized by the individual identified as having authorized the

submission. See 21 CFR 1.231. Upon successful verification of this information, the

registration number is assigned, and the registrant is notified of the registration number and pin

number for the facility either in an email or a letter sent through U.S. mail.

L.2 What does assignment of a registration number mean?

Assignment of a registration number to a facility means that the facility is registered with FDA.

Assignment of a registration number does not in any way convey FDA’s approval or

endorsement of a facility or its products.

M. Is Food Registration Information Available to the Public?

M.1 Is the information included in a food facility’s registration or relating to such

registrations (e.g., list of registered facilities) available to the public?

Section 415(a)(5) of the FD&C Act provides that the list of registered facilities and registration

documents, including information provided in those documents, that is submitted under 21 CFR

part 1, subpart H, are not subject to public disclosure under the Freedom of Information Act

(FOIA) (5 U.S.C. 552). In addition, any information derived from such list or registration

documents that would disclose the identity or location of a specific registered person is not

subject to disclosure under 5 U.S.C. 552.

M.2 Is a registered facility responsible for ensuring that the companies with which they

deal are registered?

There are no direct penalties for doing business with a company that is not registered. However,

if a company offers food for import into the United States and the food is from a foreign

manufacturing facility that is not registered, the company may be unable to complete the prior

notice for the shipment (21 CFR 1.281(a)(6)), which is required to import the shipment.

M.3 Is a facility required to provide its food facility registration number, assigned by FDA

when the registration is submitted, to customers or other businesses who request the

number? Is a facility prohibited from revealing its registration number?

Section 415(a)(5) of the FD&C Act provides that certain registration-related information,

including the registration number, is not subject to disclosure under FOIA. However, this does

not prevent a facility itself from disclosing such information. In fact, for imports, a facility will

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likely need to provide its registration number to any downstream commercial entity who will be

submitting prior notice for a food manufactured by the facility (see 21 CFR part 1, subpart I).

The FD&C Act does not prevent a foreign facility from entering into an agreement with its

customers to limit the circumstances in which the facility’s registration number may be disclosed

to third parties.

M.4 FDA’s list of facilities and registration documents are not subject to public disclosure.

How do we know that a supplier, for instance, is registered?

Section 415(a)(5) of the FD&C Act provides that certain food facility registration information is

not subject to disclosure under FOIA. However, disclosure of such information by the facility

itself is not prohibited. FDA expects that generally, suppliers and their customers will resolve

this question as part of their agreement to buy and sell food for consumption in the United

States.

M.5 Will FDA require the food facility registration number to be displayed as part of a

food label?

No. There is no requirement to list on the food label the registration number (or numbers) for the

facility (or facilities) associated with manufacturing/processing, packing, or holding the food.

FDA actually discourages food facilities from including their registration numbers on the food

label to prevent others from using the registration number for improper purposes.

N. Waiver Request

N.1 What is the process for submitting a waiver from electronic submission for my

registration, registration renewal, update, or cancellation?

Beginning January 4, 2020, registrants must submit registrations, registration renewals, updates,

or cancellations to FDA electronically, unless FDA has granted a waiver under 21 CFR 1.245

(see 21 CFR 1.231(a)(2) and (b), 1.234(d), and 1.235(d)).

If you are submitting a waiver from electronic submission of your registration, registration

renewal, update, or cancellation, you must submit a written request to FDA that explains why it

is not reasonable for you to submit a registration, registration renewal, update, or cancellation

electronically to FDA. Possible reasons for why it may not be reasonable will depend on the

circumstances, but in some cases may include conflicting religious beliefs or lack of reasonable

access to the Internet.

We encourage registrants seeking a waiver to submit their request in advance of the biennial

registration renewal because we experience an increased volume of industry queries during this

timeframe.

N.2 What is the process for submitting a waiver from providing the email address of the

owner, operator, or agent in charge of the facility, or the individual who authorized the

submission, in my registration, registration renewal, update, or cancellation?

Contains Nonbinding Recommendations

Under 21 CFR 1.232(a)(6), you must provide the email address of the owner, operator, or agent

in charge of the facility unless FDA has granted a waiver from such requirement. In addition,

under 21 CFR 1.230(b) and (c), 1.232(a)(10), 1.234(a), and 1.235(b)(5), registration renewals,

abbreviated registration renewals, registrations, updates, and cancellations not submitted by the

owner, operator, or agent in charge must include the email address for the individual who

authorized the submission, unless FDA has granted a waiver under 21 CFR 1.245.

If you are submitting a waiver from the email requirement, you must submit a written request to

FDA that explains why it is not reasonable for you to submit the required email address

information (21 CFR 1.245).

N.3 Who must submit the waiver request to FDA?

The owner, operator, or agent in charge of the facility or the U.S. agent for a foreign facility may

submit the waiver request to FDA.

N.4 How and where can I submit my waiver request?

The waiver request must be submitted in writing to the following address:

U.S. Food and Drug Administration

Center for Food Safety and Applied Nutrition

5001 Campus Dr. (HFS-681)

College Park, MD 20740

You may also submit your request by email to FURL[email protected]. The waiver request should

include the facility name(s) and address(es) and the name of the owner, operator, or agent in

charge of the facility. In addition, if the waiver request is being submitted by a U.S. agent on

behalf of a foreign facility, the request should include the name of the U.S. agent authorized by

the owner, operator, or agent in charge of the facility to submit the waiver request. Once FDA

receives and reviews the request, we will notify you if the waiver has been granted or denied.

For requests regarding a waiver from submitting a registration, registration renewal, update, or

cancellation to FDA electronically, if we grant your waiver, we will send you a paper copy of

Form FDA 3537 or Form FDA 3537a, if requested.

N.5 If I have multiple facilities, may I submit one waiver request for all of my facilities?

Yes. You may submit one waiver request for all of your facilities if you have multiple facilities.

You should include the facility names, addresses, and the name of the owner, operator, or agent

in charge of each facility in your waiver request. If the waiver request is being submitted by a

U.S. agent on behalf of a foreign facility, the request should include the name of the U.S agent

authorized by the owner, operator, or agent in charge of the facility to submit the waiver request.

N.6 How will FDA review my waiver request?

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FDA will consider whether to grant or deny your waiver based on the information you include in

your request. We will consider each request on a case-by-case basis.

N.7 Do I have to submit additional waiver requests after a request has already been

granted?

No. Once FDA grants a waiver, we will consider the waiver to be in effect for as long as the

reasons for the waiver remain unchanged and the registration has not been cancelled, unless you

have informed FDA that the waiver is no longer needed. If the registration for the facility has

been cancelled, a new waiver request should be submitted.

O. General Registration Questions

O.1 Will the food facility regulations be published in other languages?

No. FDA has no plans to publish the Amendments to Registration of Food Facilities Final Rule

or the regulations at 21 CFR part 1, subpart H in any language other than English.

O.2 Is there a fee for registration, updating a registration, renewing a registration,

or canceling a registration?

No. There is no fee associated with initial registration, updating a registration, renewing a

registration, or canceling a registration.

O.3 Do I have to use a third-party service when submitting a registration?

No. FDA does not require a food facility to use a third party to make registration submissions.

A food facility owner, operator, or agent in charge of the facility is responsible for meeting the

registration requirements (see section 415(a) of the FD&C Act; and 21 CFR part 1, subpart H).

The owner, operator, or agent in charge may authorize an individual to make registration

submissions on behalf of the facility (see, e.g., 21 CFR 1.230(a)). The authorized individual

may be, but is not required to be, the U.S. agent for a foreign facility. Although third parties

such as U.S. agents may charge a fee for their registration-related services, there is no fee

assessed by FDA for registrations.

O.4 Are qualified facilities that are exempt from the Preventive Controls for Human Food

or Animal Food final rules still required to register?

Yes. Qualified facilities, as defined in 21 CFR 117.3 (human food) or 21 CFR 507.3 (animal

food), are food facilities that are required to register under section 415 of the FD&C Act.

P. Suspension of Registration

P.1 Can FDA suspend the registration of a food facility?

Contains Nonbinding Recommendations

Yes. Section 415(b) of the FD&C Act, as amended by FSMA, provides FDA the authority

to suspend by order the registration of a facility registered under section 415.

P.2 When can FDA suspend the registration of a facility registered under section 415 of the

FD&C Act?

FDA can order suspension of a food facility’s registration when:

1. FDA determines that food manufactured, processed, packed, received, or held by a

registered facility has a reasonable probability of causing serious adverse health

consequences or death to humans or animals (SAHCODHA); and

2. That facility:

a. Created, caused, or was otherwise responsible for that reasonable probability of

SAHCODHA; or

b. Knew of, or had reason to know of, the reasonable probability of SAHCODHA, and

packed, received, or held such food (section 415(b) of the FD&C Act).

P.3 When are registered food facilities subject to the suspension of registration provisions

of section 415 of the FD&C Act?

Registered facilities became subject to the suspension of registration provisions in section 415(b)

of the FD&C Act on July 3, 2011, which was 180 days after the January 4, 2011 enactment of

FSMA (section 415(b)(6)(B) of the FD&C Act).

Q. Compliance Dates

Q.1 When must I comply with the requirements of the Amendments to Registration of Food

Facilities final rule?

You must comply with the requirements of the Registration Final Rule on September 12, 2016,

unless otherwise stated in the final rule.

Q.2 When must I comply with the UFI requirement?

Beginning October 1, 2020, you must provide the facility’s UFI recognized as acceptable by FDA

in your registration submission, as specified in 21 CFR 1.232(a)(2).

Q.3 When must I comply with the electronic submission requirement?

Beginning January 4, 2020, you must submit your registration, registration renewal, updates, and

cancellations to FDA electronically unless FDA has granted a waiver from such requirement (see

21 CFR 1.231(a)(2) and (b), 1.234(d), and 1.235(d)). Furthermore, as we stated in the

Contains Nonbinding Recommendations

Registration Final Rule, FDA must have already granted a waiver in order for the electronic

submission requirement to not apply (see 81 FR 45912 at 45943 to 45944).

III. REFERENCES

We have placed the following references on display at the Dockets Management Staff, Food

and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You may see

them at that location between 9 a.m. and 4 p.m., Monday through Friday. As of December 1,

2016, FDA had verified the Web site address for the references it makes available as hyperlinks

from the Internet copy of this guidance, but FDA is not responsible for any subsequent changes

to Non-FDA Web site references after December 1, 2016.

1. U.S. Food and Drug Administration. 2016. “Classification of Activities as

Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and

Facilities.” Accessed online at

https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinfor

mation/ucm517567.htm.

2. U.S. Food and Drug Administration. 2016. “Necessity of the Use of Food Categories in

Food Facility Registrations and Updates to Food Categories: Guidance for Industry.”

Accessed online at

https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformati

on/ucm324778.htm

3. U.S. Food and Drug Administration. 2016. Information on Medicated Feeds. Accessed

online at

https://www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/MedicatedFeed/defa

ult.htm.