**Guidance for Industry**

**Questions and Answers Regarding Registration of Food Facilities**

**(Edition 2)**

Final Guidance

Comments and suggestions regarding this document may be submitted at any
time. Submit comments to Dockets Management Branch (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
All comments should be identified with the Docket Number 2003D-0545.

For questions regarding this document, contact Melissa S. Scales at the
Center for Food Safety and Applied Nutrition (CFSAN) at (Tel)
301-436-1720, (Fax) 301-436-2637, or e-mail
melissa.scales@cfsan.fda.gov.

Additional copies are available from:\
Office of Regulations and Policy, HFS-24\
Center for Food Safety and Applied Nutrition\
Food and Drug Administration, 5100 Paint Branch Parkway\
College Park, MD 20740\
[*http://www.cfsan.fda.gov/guidance.html*](http://www.cfsan.fda.gov/guidance.html )

**U.S. Department of Health and Human Services\
Food and Drug Administration\
Center for Food Safety and Applied Nutrition\
Revised December 30, 2003**

**This is a revision of the first edition of the FDA guidance
\"Questions and Answers Regarding Registration of Food Facilities,\"
which FDA issued on December 4, 2003.**

### Guidance for Industry[^1]

## Questions and Answers Regarding the Interim Final Rule on Registration of Food Facilities (Edition 2)

# 

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  This guidance represents the Food and Drug Administration\'s (FDA\'s)
  current thinking on this topic. It does not create or confer any rights
  for or on any person and does not operate to bind FDA or the public.
  You may use an alternative approach if the approach satisfies the
  requirements of the applicable statutes and regulations. If you want to
  discuss an alternative approach, contact the FDA staff responsible for
  implementing this guidance. If you cannot identify the appropriate FDA
  staff, call the appropriate number listed on the title page of this
  guidance.

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**I. INTRODUCTION**

On October 10, 2003, FDA issued an interim final regulation to implement
the Bioterrorism Act\'s requirement that domestic and foreign facilities
that manufacture, process, pack, or hold food for human or animal
consumption in the United States must register with FDA by December 12,
2003. ([See]{.underline} 68 FR 58894; October 10, 2003.) The interim
final rule implements section 305 of the Bioterrorism Act. Section 305
requires domestic and foreign facilities to register with FDA by
December 12, 2003, even in the absence of final regulations.

The first edition of this document was issued as Level 2 guidance
pursuant to 21 CFR 10.115 and was made available on FDA\'s website on
December 4, 2003. This revision (Edition 2) is being issued as Level 1
guidance and includes answers to new inquiries regarding the
implementation of the Registration of Food Facilities Interim Final Rule
(21 CFR Part 1, Subpart H). This guidance is immediately effective
because FDA has determined that prior public participation is not
feasible or appropriate. The revisions made by this edition (Edition 2)
are identified below by date.

FDA\'s guidance documents, including this guidance, do not establish
legally enforceable responsibilities. Instead, guidances describe the
Agency\'s 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?]{.underline}**

**Private Residences:**

1\. Q: If a person has a business in his/her home that involves

> manufacturing/processing, packing, or holding food, does that person
> need to register his residence as a food facility?
>
> A: No. A private residence is not a facility as defined in the Interim
> Final Rule (21 CFR 1.227(b)(2)) and thus, need not be registered.

2\. Q: 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?
>
> A: No. A private residence is not a facility as defined in the Interim
> Final Rule (21 CFR 1.227(b)(2)) and thus, need not be registered.

3\. Q: Is a private residence in which low acid canned food is produced

> exempt from the regulations for low acid canned food (21 CFR Part
> 113)?
>
> A: No. Although such a residence is not required to be registered as a
> food facility under 21 CFR Part 1, Subpart I, it is not exempt from
> any other requirements established by any other laws or regulations
> (21 CFR 1.240).

**[B. Who is Exempt from Registration?]{.underline}**

**Farms:**

4\. Q: Is a facility that manufactures/processes and sells seed to
farmers required

> to be registered if the seed is intended for cultivation? What if the
> seed is an ingredient that will be included in animal feed?
>
> A: FDA requires registration of any facility that
> manufactures/processes, packs, or holds food for consumption in the
> U.S. As noted in a response to a comment in the Interim Final Rule
> (Comment 62), FDA will consider a product as one that will be used for
> food if the owner, operator, or agent in charge of the facility
> reasonably believes that the substance is reasonably expected to be
> directed to a food use. Therefore, if the owner, operator, or agent in
> charge of the facility in this question reasonably believes that the
> seed is reasonably expected to be used as an ingredient for animal
> feed, the seed is considered \"food\" and thus, the facility is
> required to be registered. However, if the seed is reasonably expected
> only to be cultivated, the facility is not required to be registered.

5\. Q: Is a farm that grows tomatoes and sells them directly to
consumers from a

roadside stand located on the farm exempt from registration?

A: Yes. Assuming that the farm on which the tomatoes are grown otherwise
satisfies the definition of farm (21 CFR 1.227(b)(3)), 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 (21 CFR 1.227(b)(11).

6\. Q: If a farm located in a foreign country ships food directly to the
U.S., is it

required to register?

> A: No. Assuming that the farm otherwise satisfies the definition of
> farm (21 CFR 1.227(b)(3)), the farm is exempt from registration if it
> ships food directly to the U.S. However, if prior to export to the
> U.S., food grown on the farm is shipped 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 is
> discussed further in question 21 of this guidance and in the preamble
> to the Interim Final Rule (responses to comment 17, 21, 25, and 26).

7\. Q: 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?
>
> A: Yes. FDA uses the term \"mixed-type facility\" in the preamble to
> the Interim Final Rule (response to Comment 46) to refer to an
> establishment that engages in both activities that are exempt from
> registration and activities that require the establishment to be
> registered. In this example, the farm is required to be registered
> because its processing activities are not covered by the farm
> definition (21 CFR 1.227(b)(3)).

8\. Q: \[Added December 30, 2003\] Is applying pesticides on a farm
considered a \"traditional farming activity\" within the scope of the
farm definition and exemption? Does this include applying a pesticide,
for example, on bananas in the field or in the packing station just
prior to packing?

> A: Whether the application of a pesticide to a crop is an activity
> covered by the farm definition depends upon whether the application is
> prior to or post-harvest. Section 1.227(b)(3) defines a farm as "a
> facility in one general location devoted to the growing and harvesting
> of crops, the raising of animals (including seafood), or both." FDA
> considers application of pesticides to a crop prior to harvest as an
> integral part of growing crops. Such application generally does not
> involve close manipulation of the food being grown because the
> application is usually directed at the entire plant. Therefore, an
> establishment devoted to the growing and harvesting of crops that
> applies a pesticide to its crops prior to harvest is a \"farm\" within
> the meaning of the Interim Final Rule. However, post-harvest
> application is necessarily directed at the food, not the entire plant,
> and thus, is considered to be manufacturing/processing under
> §1.227(b)(6). Therefore, a farm that treats a crop against pests
> post-harvest must register with FDA unless it satisfies the conditions
> of § 1.227(b)(3)(ii).

9\. Q: \[Added December 30, 2003\] Is use of chlorinated water to wash
lettuce on a farm considered \"processing,\" necessitating registration
of a farm?

> A: If the farm is using water directly from a public or other water
> supply that is chlorinated for other purposes, FDA will consider this
> activity "washing\" within the meaning of 21 CFR 1.227(b)(3).
> Accordingly, an establishment using chlorinated water in this manner
> is a \"farm\" and is not required to be registered. In addition, FDA's
> Good Agricultural Practices guidance document (section 2.2)
> ([[http://www.foodsafety.gov/\~dms/prodguid.html]{.underline}](http://www.foodsafety.gov/~dms/prodguid.html))
> notes that chlorine is commonly added to water at 50-200 parts per
> million (ppm) total chlorine, at a pH of 6.0 -7.5, for post harvest
> treatment of fresh produce, with a contact time of 1-2 minutes. FDA
> recognizes that chlorination at these levels is the only way many
> growers and packers can raise the microbiological quality of the water
> they use to a level that is safe and suitable. Addition of chlorine to
> water at these levels, therefore, does not constitute
> "manufacturing/processing" within the meaning of 21 CFR
> 1.227(b)(3)(ii).
>
> In contrast, if water used as a wash on harvested foods on a farm
> contains added chlorine above levels of 200 ppm to create a specific
> wash, FDA considers this activity as \"treating\" food within the
> meaning of 21 CFR 1.227(c)(6), which is a manufacturing/processing
> activity that would require the farm to register, unless it falls
> under another exemption (e.g., foreign facility exemption).

10\. Q: \[Added December 30, 2003\] Does placing stickers on fruit on a
farm amount to \"manufacturing/processing\" and therefore require
registration of the facility in which the application of the stickers
occurs?

> A: A farm that places stickers on produce grown or consumed on the
> farm is not required to register as long as the farm otherwise
> satisfies the definition of farm (21 CFR 1.227(b)(3).) Under
> §1.227(b)(3)(i), FDA considers on-farm facilities that pack or hold
> food as meeting the farm definition, if all food used in such packing
> or holding is grown, raised, or consumed on that farm or another farm
> under the same ownership. As stated in the response to comment 41 in
> the Interim Final Rule, FDA considers certain activities to be
> "packing," such as sorting, grading, wrapping, or boxing harvested
> food for the sole purpose of transporting this food off the farm. FDA
> also considers placing stickers on produce grown or consumed on a farm
> part of "packing."

**Retail Facilities:**

11\. Q: Does a warehouse club that sells to both consumers and
businesses need

> to be registered?
>
> A: A warehouse club is exempt from registration as a retail food
> establishment (21 CFR 1.227(b)(11)) 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 products directly to consumers exceeds
> the annual monetary value of sales of food products to all other
> buyers. Businesses are not considered consumers.

12\. Q: 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 be
> registered?
>
> A: The supermarket is exempt from registration as a retail food
> establishment (21 CFR 1.227(b)(11)) if its primary function is to sell
> food products directly to consumers from the supermarket. As noted, an
> 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.

**Nonprofit Food Facilities:**

13\. Q: Are exporters of food for charity exempt from the registration

> requirements?
>
> A: Yes. A facility, including a non-profit facility, is not required
> to be registered if all food manufactured/processed, packed, or held
> at the facility is not for consumption in the U.S. (21 CFR 1.225 and
> 1.227(b)(7)).

**Facilities Regulated Exclusively, Throughout the Entire Facility, by
USDA:**

14\. Q: Are facilities that process deer, elk, and bison required to
register with

> FDA?
>
> A: Yes. These facilities are required to be registered with FDA
> because they are not regulated [exclusively]{.underline} by the United
> States Department of Agriculture (USDA) (21 CFR 1.226(g).)

**[C. Definitions:]{.underline}**

**Holding:**

15\. Q: Are local collecting facilities for grains exempt from the
registration

requirement?

> A: All establishments at which food is manufactured/processed, packed,
> or held are required to be registered, unless otherwise exempt. FDA
> understands the term "collecting facilities" to refer to facilities
> that store or hold food, such as silos or grain elevators. Such a
> facility must be registered with FDA because food (grain) is held by
> the facility (21 CFR 1.225; 1.227(b)(5)).

16\. Q: If a facility receives packaged produce for shipping and holds
it in cold

> storage, is it required to register?
>
> A: Yes. The facility in this example is holding food and therefore,
> must be registered (21 CFR 1.225; 21 CFR 1.227(b)(5)).

17\. Q: If finished food products for consumption in the U.S. are held
at a third

> party facility before consolidation for import into the U.S., must
> this facility be registered?
>
> A: Yes, if the finished products are held at a third party facility
> prior to export to the U.S., the facility is required to be registered
> (21 CFR 1.225; 1.227(b)(5))**.**

18\. Q. \[Added December 30, 2003\] In a lessor-lessee relationship,
such as a food-producing business that rents space from a landlord, who
is legally obligated to register the facility?

> A: Either the lessor or the lessee may register the facility as
> follows. The Bioterrorism Act and the Registration Interim Final Rule
> place the duty to register a facility on the owner, operator,
> [or]{.underline} agent-in-charge of the facility. Each of these
> persons has an independent obligation to comply with the registration
> requirement, and any one of them may satisfy the obligation for the
> other two. On the other hand, if a facility is not registered, FDA
> could proceed with an enforcement action against one or all of the
> three. A facility is defined as "any establishment, structure, or
> structures under one ownership at one general physical location, or,
> in the case of a mobile facility, traveling to multiple locations,
> that manufactures/processes, packs, or holds food for consumption in
> the United States." Thus, for a public warehouse, either the owner of
> the entire warehouse may register the warehouse and satisfy the
> obligation for all lessees, or an individual lessee, functioning as
> the operator or agent-in-charge of the portion of the warehouse he/she
> leases, may register that portion of the facility.

19\. Q: \[Added December 30, 2003\] Post offices and similar facilities
owned or operated by express couriers may have packages containing food
on their premises as part of the shipment process. Are these types of
establishments required to be registered with FDA as food facilities?

A: No. For purposes of the registration Interim Final Rule, post offices
and express courier facilities are not required to be registered with
FDA as food facilities. The activities of both 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 the Interim
Final Rule (21 CFR 1.226(b)(2)) does not include transportation vehicles
"if they hold food only in the usual course of business as carriers.\"
Although the registration Interim Final Rule does not define
"transportation vehicles," the proposed rule on the establishment and
maintenance of records (68 FR 25188 at 25238; May 9, 2003) defines
"transporter" as "a person who has possession, custody, or control of an
article of food ... 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 house 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(b)(2). Thus, for the purpose of the registration Interim Final
Rule, post offices and express courier facilities operating in a manner
comparable to post offices that are part of the transportation network
and have possession, custody, or control of food for the sole purpose of
transporting it are not required to be registered with FDA.

20\. Q: \[Added December 30, 2003\] Truck terminals and freight
forwarders may have food on their premises as part of the shipment
process. Are these types of establishments required to be registered
with FDA as food facilities?

> A: No. Truck terminals and other stationary facilities that serve
> merely to assist transportation vehicles in the process of
> transporting food are not required to be registered with FDA. The
> analysis for post offices and similar facilities is also applicable
> here. Thus, for the purpose of the registration Interim Final Rule,
> 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 be registered with FDA.
>
> FDA acknowledges that this response is not completely consistent with
> certain prior guidance (Response to Comment 36; 68 Fed. Reg. 58894 at
> 58904; October 10, 2003). The agency has further considered this
> issue, as well as related ones, resulting in a revision of the earlier
> guidance.

**Manufacturing/Processing:**

21\. Q: Is fumigation (such as of bagged cocoa beans) considered *de
minimis*

> processing?
>
> A: No. The Interim Final Rule states that \"treating\" food is a
> manufacturing/processing activity (21 CFR 1.227(b)(6); also see the
> response to Comment 41 in the rule). Therefore, a foreign facility
> that performs fumigation of food that is for consumption in the U.S.,
> is required to be registered [unless]{.underline} another foreign
> facility conducts further manufacturing/processing of more than a *de
> minimis* nature before the food is shipped to the U.S. FDA notes that
> even if fumigation were considered to be a *de minimis* activity, the
> facility at which the fumigation occurs would be required to be
> registered. The Bioterrorism Act *de minimis* provision is relevant to
> whether a particular foreign facility that manufactures/processes,
> packs, or holds food prior to the \"*de minimis* facility\" is
> required to be registered. The response to comment 17 in the preamble
> of the Interim Final Rule also discusses fumigation of cocoa beans.

22\. Q: Is it necessary for a facility housing cotton gins to register
if the cotton

> gins separate cotton from its seeds and hulls and the facility then
> sells these seeds or hulls to a manufacturer who then further
> processes the seeds and hulls into feed for sale to livestock
> operations?
>
> A: FDA notes that the answer to this question depends in part on
> whether the cotton by-products are \"food\" as defined in the interim
> final rule (21 CFR 1.227(b)(4)) and whether the establishment housing
> the cotton gins is domestic or foreign.
>
> In the preamble to the Interim Final Rule, FDA responded to a comment
> (Comment 62) regarding facilities that manufacture/process, pack, or
> hold multi-use substances. (68 Fed. Reg. 58894 at 58910; October 10,
> 2003.) The agency believes that discussion is relevant to this
> question. In the Interim Final Rule, the agency stated that \"a
> product is one that will be used for food if the owner, operator, or
> agent in charge of the facility reasonably believes that the substance
> in question is reasonably expected to be directed to a food use.\" In
> this example, the facility containing the cotton gins is a food
> facility because the owner, operator, or agent in charge of the
> facility knows or should know that the cotton by-products are
> reasonably likely to be used as components of animal feed.
>
> If the cotton gin establishment is located in the U.S., the
> establishment is required to be registered because it is
> manufacturing/processing food (components of animal feed), and the
> facility does not appear to satisfy any exemption from registration.
> FDA notes that any subsequent facility that processes the cotton seed
> and hulls into animal feed is also required to be registered.
>
> However, if the cotton gin establishment and the establishment that
> processes the cotton seed and hulls into animal feed are both located
> in a foreign country, the cotton gin establishment would not required
> to be registered because a subsequent foreign facility (the feed
> manufacturer) conducts further manufacturing/processing of the cotton
> by-products prior to export to the U.S. The foreign feed
> manufacturing/processing facility must be registered unless, before
> the feed is exported to the U.S., the feed undergoes further
> manufacturing/processing of more than a *de* *minimis* nature at a
> third foreign facility (21 CFR 1.226(a)).

**US Agent:**

23\. Q: For foreign facilities, may the U.S. agent for the facility also
serve as the

> facility\'s emergency contact?
>
> A: 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(b)(13); 1.233(e)).

24\. Q: 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?
>
> A: No. A foreign facility\'s U.S. agent may be an individual,
> partnership, corporation, or association; the only requirement for
> such an agent is that the agent must have a place of business or
> residence in the U.S. and be physically present in the U.S. For
> example, a foreign facility may use its U.S. importer as its U.S.
> agent. FDA does not recommend or endorse any particular firm,
> organization, persons, or company to serve as a foreign facility\'s
> U.S. agent. FDA is [not]{.underline} affiliated with any firm offering
> its services as a U.S. agent.

25\. Q: May a foreign government official residing in the U.S., 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?
>
> A: In the preamble to the Interim Final Rule (Comment 90), FDA noted
> that the agency has concerns that acting as a U.S. agent may conflict
> with the duties of foreign government representatives. 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.

26\. Q: 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?
>
> A: No. The Interim Final Rule requires that each foreign facility 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. FDA notes that 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. 21 CFR 1.227(b)(13)(iii) and the response to
> comment 86 in the preamble to the Interim Final Rule further discuss
> this issue.

27\. Q: Is the U.S. agent legally liable in the event something goes
wrong with

> food manufactured/processed, packed, or held at the foreign facility
> for which he serves as U.S. agent?
>
> A: FDA generally does not intend to hold a foreign facility\'s U.S.
> agent responsible for violations of the Bioterrorism Act that are
> committed by the foreign facility. FDA, however, would consider legal
> action against a U.S. agent where the agent knowingly submits false
> information to FDA or the U.S. agent and the foreign facility are
> effectively the same entity. Liability issues between the facility and
> its U.S. agent must be resolved between the private parties (i.e., the
> facility and its U.S. agent), most likely through the terms of their
> contractual relationship.

[Other Definitions]{.underline}

28\. Q: \[Added December 30, 2003\] How does FDA define "owner,"
"operator," and "agent in charge?"

> A: The owner, operator, or agent in charge is a person (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).

29\. Q: \[Added December 30, 2003\] How does FDA define "parent
company?"

> A: The term \"parent company\" is used in 21 CFR 1.232(b) 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.

[^1]: This guidance has been prepared by the Center for Food Safety and
    Applied Nutrition (CFSAN) at the U.S. Food and Drug Administration.