Manufacturers or Processors 

Packers 

Holding Facilities 

The Public Health Security and Bioterrorism 

Preparedness and Response Act of 2002 

November 2003 

Protecting the U.S. Food Supply 

FDA Food Security Information for Domestic and Foreign: 

FOOD FACILITIES 

REGISTRATION OF 

U.S. Food and Drug 

Administration U.S. Department of Health 

and Human Services 

What You Need to Know About 
U.S. Food and Drug U.S. Department of Health 

Administration and Human Services 

This guidance document is a restatement of the Food and Drug Administration’s (FDA’s) current requirements 

for registration of food facilities presented in simplified format and language. As guidance, it is not binding on 

either FDA or the public. FDA notes, however, that the regulation that is the basis for this pamphlet establishes 

requirements for all covered activities. For this reason, FDA strongly recommends that affected parties consult 

the regulation at 21 CFR Part 1, Subpart H, in addition to reading this pamphlet. 

The Food and Drug Administration has prepared this guidance to restate the legal requirements set forth in 

21 CFR 1.225 through 1.243 concerning registration of food facilities under the Public Health Security and 

Bioterrorism Preparedness and Response Act of 2002. This guide is intended to help any entity, regardless 

of size, to comply with the regulations that require 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 

document also serves as FDA’s Small Entity Compliance Guide (SECG), in accordance with section 212 of 

the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). 
INTRODUCTION 

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the 

Bioterrorism Act) directs the Food and Drug Administration (FDA), as the food regulatory agency 

of the Department of Health and Human Services, to take additional steps to protect the public from 

a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies. 

To carry out certain provisions of the Bioterrorism Act, FDA has established 

new regulations requiring that: 

• Food facilities are registered with FDA, and 

• FDA be given advance notice on shipments of imported food. 

These regulations go into effect on December 12, 2003. 

Purpose of this Booklet 

This booklet was created to inform domestic and foreign food facilities about the new food facility 

registration law and regulations. It contains important information that may affect your firm. 

The information in this booklet also appears online at 

http://www.fda.gov/oc/bioterrorism/bioact.html. 

3 
ABOUT REGISTRATION 

Food Facility Registration Requirement 

Domestic and foreign facilities that manufacture, process, pack, or hold food, as defined 

in the regulation, for human or animal consumption in the U.S. must register with FDA by 

December 12, 2003. 

Why Registration Is Required 

Food facility registration will help FDA to: 

• Determine the location and source of a potential bioterrorism incident or an outbreak of 

food-borne illness; and 

• Quickly notify facilities that may be affected. 

What It Costs 

There is no fee for registration or updates to a registration. 

HOW REGISTRATION AFFECTS YOU 

Which Facilities Must Register 

If your facility is in one of following food industry sectors, you must register your facility with 

FDA by December 12, 2003. 

Food Industry Sectors Affected 

• Domestic and foreign manufacturers or processors* 

• Domestic and foreign packers* 

• Domestic and foreign storage operations * 

Foods Handled by More Than One Foreign Facility 

If... Then... 

A foreign facility that manufactures, processes, packs, 

or holds food sends it to another foreign facility for 

further manufacturing/processing or packaging before 

the food is exported to the U.S. 

Only the second foreign facility 

is required to register. 

The second foreign facility performs only a minimal 

activity, such as putting on a label 

Both facilities must register. 

Any foreign facility packs or holds food after the last 

foreign manufacturer/processor of the food 

The foreign packer or holder 

must register. 

* Domestic facilities must register whether or not food from the facility enters interstate commerce. 

4 
Food Included in the Regulation 

Registration pertains only to facilities that manufacture/process, pack, or hold food, as defined in 

the regulation, for consumption by humans or animals in the U.S. 

The following chart gives examples of the types of food that are included in or excluded from 

the “food” definition in the facility registration regulation. If your facility handles ANY of the 

included foods, it must be registered. 

INCLUDED Food EXCLUDED Food 

• Dietary supplements and dietary ingredients • Food contact substances

• Infant formula • Pesticides 

• Beverages (including alcoholic beverages 

and bottled water) 

• Fruits and vegetables 

• Fish and seafood 

• Dairy products and shell eggs 

• Raw agricultural commodities for use as 

food or components of food 

• Canned and frozen foods 

• Bakery goods, snack food, and candy 

(including chewing gum) 

• Live food animals 

• Animal feeds and pet food 

Note: A facility that manufactures/processes, packs, or holds a food contact substance or 

pesticide is NOT required to register with FDA. 

5 
Facilities That Do Not Have to Register 

If your facility is involved in one of the following activities, it does NOT have to register 

with FDA. 

These Facilities DON’T Have to Register 

• Private residences of individuals, even though food may be manufactured/processed, 

packed, or held in them. 

• Non-bottled water drinking water collection and distribution establishments and 

structures, such as municipal water systems. 

• Transport vehicles that hold food only in the usual course of their business as 

carriers. 

• Farms — i.e., facilities in one general location devoted to growing and harvesting crops 

(washing, trimming outer leaves, and cooling produce are part of harvesting) and/or 

raising animals (including seafood). The term “farm” also includes facilities that 

manufacture/process, pack, or hold food, provided that all food used in those activities 

is grown, raised, or consumed on that farm or another farm under the same ownership. 

• Restaurants — i.e., facilities that prepare and sell food directly to consumers for 

immediate consumption, including pet shelters, kennels, and veterinary facilities that 

provide food directly to animals. Facilities that provide food to interstate conveyances, 

such as commercial aircraft, or central kitchens that do not prepare and serve food 

directly to consumers, are not restaurants for purposes of the rule. 

• Retail food establishments, such as groceries, delis, and roadside stands, that sell food 

directly to consumers as their primary function, meaning that annual food sales directly 

to consumers are of greater dollar value than annual sales to other buyers. 

• Nonprofit food facilities, which are charitable entities that meet the terms of § 501(c)(3) 

of the Internal Revenue Code and that prepare or serve food directly to the consumer or 

otherwise provide food or meals for consumption by humans or animals in the U.S. This 

includes central food banks, soup kitchens, and nonprofit food delivery services. 

• Fishing vessels that harvest and transport fish. Such vessels may engage in practices 

such as heading, eviscerating, or freezing fish solely to prepare the fish for holding on 

board the vessel and remain exempt. 

• Facilities regulated exclusively and throughout the entire facility by the U.S. 

Department of Agriculture, that is, facilities handling only meat, poultry, or egg products. 

When Your Facility Must Register 

The deadline to register your facility with FDA is December 12, 2003. 

Facilities that go into business after December 12, 2003, must register before they begin 

manufacturing/processing, packing, or holding operations. 

How Often Your Facility Must Register 

Registration is required only once for each food facility. However, if required registration 

information about your facility changes, you must update the registration. 

Who May Register 

The owner, operator, or agent in charge of a facility, or an individual authorized by one of 

them, may register that facility. 

6 
Foreign facilities must designate a U.S. agent, who lives or maintains a place of business in the 

U.S. and is physically present in the U.S., for purposes of registration. The U.S. agent may be 

authorized to register the facility. 

What If Your Facility Fails to Register 

Failure to register your facility, update required elements, or cancel registration in accordance with 

this regulation is a prohibited act under the Federal Food, Drug, and Cosmetic Act. The Federal 

government can bring a civil action against persons who commit a prohibited act, or it can bring a 

criminal action in Federal court to prosecute persons who are responsible for the commission of a 

prohibited act, or both. 

If a foreign facility is required to register but fails to do so, food from that facility that is offered for 

import into the U.S. is subject to refusal. The food may be held within the port of entry, unless 

directed elsewhere by FDA or the Customs and Border Protection Service (CBP). 

FDA plans to issue enforcement guidance on the agency's policies regarding refusals of 

imported food or holds of imported food. This guidance document will be available to the 

public, and FDA will publish a notice of its availability in the Federal Register. 

REGISTERING YOUR FACILITY 

How to Register Your Facility 

Registrants must use Form 3537 to register or update a registration. This form is available online 

and in paper form. A business with multiple facilities may also register on CD-ROM. FDA will 

process paper and CD-ROM submissions in the order received. 

Note: FDA does not allow registration in person. 

Online Registration 

You can save time by registering online at http://www.access.fda.gov/. This web site offers online 

help and operates 24 hours a day, seven days a week. You can access the site wherever the Internet 

is available — including libraries, copy centers, schools, and Internet cafes. 

An Online Registration Help Desk is available on business days, from 7:00 AM until 11:00 PM 

U.S. Eastern Standard Time to help you. 

To Contact the Online Registration Help Desk: 

By phone WITHIN THE U.S.: Call 1-800-216-7331 or 301-575-0156 

OUTSIDE THE U.S.: Call 301-575-0156 

By fax Fax questions to 301-436-2804 or 1-866-573-0846

By email Go to http://www.cfsan.fda.gov/~furls/helpf2.html and complete the form 

7 
Paper Registration FORM

3537 

If your facility does not have reasonable access to the Internet, you can request a copy of 

Form 3537 from FDA by mail or phone. The form can be mailed or faxed to you. 

To Request the Form: 

By mail Write to: 

U.S. Food and Drug Administration 

HFS-681 

5600 Fishers Lane 

Rockville, MD 20857 

USA 

By phone Call 1-800-216-7331 or 301-575-0156 

(7:00 a.m. to 11:00 p.m. U.S. Eastern Standard Time) 

Fill out the form completely and legibly and mail it to the above address, or fax it to 301-436-2804 



or 1-866-573-0846. 

Note: Paper registration is less efficient than online registration. It takes longer to receive 

confirmation for paper registration. And, if your form contains omissions or errors, FDA 

will return it for corrections without registering your facility — resulting in further delay. 

CD-ROM Registration 

If your business has a large number of food facilities, you may wish to submit multiple registrations 

on a CD-ROM by mail. You can do so, provided that each registration uses the same preferred 

mailing address. The CD-ROM you use must have ISO 9660 (CD-R or CD-RW) data format. 

To Register by CD-ROM: 

1. Go to http://www.cfsan.fda.gov/~furls/papercd.html and download the 

Portable Document Format (PDF) version of Form 3537. 

2. Fill in a separate copy of the form electronically for each facility. 

3. Use the same preferred mailing address for each facility. 

4. Save the form for each facility under a different file name: 

a. The file name can be up to 32 characters long. 

b. Use the first part of the file name to identify the parent company. 

5. Copy the files to a CD-ROM with ISO 9660 (CD-R or CD-RW) data format. 

6. Enclose one signed copy of the certification statement that appears on the 

registration form (Box 13). 

7. Mail the CD-ROM to: U.S. Food and Drug Administration 

HFS-681 

5600 Fishers Lane 

Rockville, MD 20857 

Note: If you send a CD-ROM that does not comply with the above specifications, FDA will 

return it without processing, which will delay registration. 

8 
Information Required for Registration 

FDA requires you to provide the following information for facility registration. 

Required Information 

• Facility name, address, phone number, and emergency contact phone number 

• Parent company name, address, and phone number (if applicable) 

• Name, address, and phone number of the owner, operator, or agent in charge 

• All trade names the facility uses 

• Applicable food product categories, as listed on the registration form 

• Name, address, and phone number of a foreign facility’s U.S. agent, and phone 

number of the facility’s emergency contact if it is someone other than the U.S. agent 

• Certification that the information submitted is true and accurate and that the person 

submitting it is authorized to do so 

Optional Registration Information 

FDA also requests optional registration information. Although you are not required by law to 

comply with this request, FDA encourages you to do so — particularly if your facility handles 

products such as infant formula, certain dietary supplements, and animal feed — as those 

products may be the target of a food-related emergency. 

Optional Information Requested 

• Facility fax number and email address 

• Preferred mailing address, if different from that of the facility 

• Fax number and email address of the owner, operator, or agent in charge of the 

facility 

• Fax number and email address of the parent company (if applicable) 

• For a foreign facility: the fax number and email address of its U.S. agent 

• Type of activity conducted at the facility (i.e., processing, packing, etc.) 

• Food categories not included in the required information; these are listed in section 

11a of Form 3537 (where they are marked optional), or in section 11b (where all 

food categories listed are optional) 

• Type of storage (if it's a holding facility) 

• Whether the facility manufactures/processes, packs, or holds most or all of the 

product categories identified in 21 CFR 170.3 

• Approximate dates of operation (if the facility’s business is seasonal) 

9 
Facility Registration Screen 

Here is a sample screen from the FDA registration web site (http://www.access.fda.gov/). 

10 
How Registration Is Confirmed 

After you register your facility, FDA will confirm the registration and assign a registration number. 

If You Register... You Will Receive Confirmation 

Online Immediately — electronically 

By fax By fax 

By surface mail By surface mail 

or CD-ROM 

Note: Assignment of a registration number means only that the facility is registered. It does 

NOT convey FDA approval or endorsement of the facility or its products. 

Confidentiality of Registration Information 

The list of registered facilities and submitted registration documents are not subject to disclosure 

under the Freedom of Information Act. This confidentiality does not apply to information 

obtained by other meansor that has previously been disclosed to the public. 

How to Update Registration Information 

If any of the required information on your registration form changes — for example, if there is a 

new operator, agent in charge, or U.S. agent — the owner, operator, or agent in charge, or an 

individual authorized by one of them, must notify FDA within 60 days. 

You can submit information changes online (regardless of how you originally registered), by 

paper, or on CD-ROM. 

To Update Your Registration: 

Online Go to http://www.access.fda.gov/* 

By paper Use the paper registration process described on page 8 

By CD-ROM Enter the changes on CD-ROM (see page 8) 

In the case of new ownership, the former owner must cancel the facility’s registration 

within 60 days and the new owner must register the facility before beginning operations. 

How to Cancel Registration 

If your facility goes out of business or comes under new ownership, you must cancel its 

registration within 60 days using Form 3537a. You can do this electronically at 

http://www.access.fda.gov/, or you can request the form from FDA and use the paper 

registration process described on page 8. 

* Use the PIN that was issued with your facility’s registration number. If you originally registered by paper 

or CD-ROM, you will need to follow the online instructions to set up an account. 

11 
FIND OUT MORE 

How to Comment on the Regulation 

The registration regulation is currently an interim final rule. This means the regulation has the 

full force of law, but FDA is providing a 75-day comment period (ending December 24, 2003) 

on specific issues related to it. In addition, to ensure that those commenting on this interim final 

rule have had the benefit of FDA's outreach and educational efforts and have had experience 

with the systems, timeframes, and data elements of this interim final rule, the agency intends to 

reopen the comment period for an additional 30 days, beginning in March, 2004. 

How to Get More Information 

Additional information is available at http://www.fda.gov/oc/bioterrorism/bioact.html. 

For more details and information on the specific requirements of the facility registration 

regulation, please refer to the Fact Sheet on FDA’s New Food Bioterrorism Regulation: 

Interim Final Rule — Registration of Food Facilities. This fact sheet is available online at 

http://www.cfsan.fda.gov/~dms/fsbtac12.html. 

12 
FDA’s FOOD FACILITY REGISTRATION REGULATION AT-A-GLANCE 

WHAT It Is: Domestic and foreign facilities that manufacture, process, pack, or hold food, as 

defined in the regulation, for human or animal consumption in the U.S. must register with FDA by 

December 12, 2003. 

WHY It’s Required: To help FDA to determine the location and source of a potential or actual 

bioterrorism incident or an outbreak of food-borne illness, and permit the agency to notify quickly 

facilities that may be affected. 

WHICH Facilities Must Register: Domestic and foreign manufacturers/processors, packers, and 

storage operations that handle foods included in the regulation. 

Examples of WHICH Foods Require Facility Registration: 

• Dietary supplements and dietary ingredients 

• Infant formula 

• Beverages (including alcoholic beverages and bottled water) 

• Fruits and vegetables 

• Fish and seafood 

• Dairy products and eggs 

• Raw agricultural commodities for use as food or components of food 

• Canned and frozen foods 

• Bakery goods, snack food, and candy (including chewing gum) 

• Live food animals 

• Animal feeds and pet food 

WHEN Facilities Must Register: By December 12, 2003. 

WHO May Register: The owner, operator, or agent in charge of a facility, or an individual 

authorized by one of them, may register that facility. 

Foreign facilities must designate a U.S. agent, who lives or maintains a place of business in the 

U.S. and is physically present in the U.S., for purposes of registration. The U.S. agent may be 

authorized to register the facility. 

HOW to Register: 

Online Go to http://www.access.fda.gov/ (24 hours a day, 7 days a week). 

By Mail or Fax 1. Request Form 3537 from FDA (1-800-216-7331 or 301-575-0156). 

2. Mail or fax the completed form to: 

U.S. Food and Drug Administration 

HFS-681 

5600 Fishers Lane 

Rockville, MD 20857 

U.S.A. 

Fax: 301-436-2804 or 1-866-573-0846

On CD-ROM 

(For multiple facilities 

using the same mailing 

address) 

1. Download Form 3537 at http://www.cfsan.fda.gov/~furls/papercd.html. 

2. Create separate electronic files for each facility. 

3. Submit files on CD-ROM (ISO 9660 CD-R or CD-RW format). 

4. Include a signed certification statement. 

5. Send to the above address. 13 
Get HELP: (business days, 7:00 AM to 11:00 PM U.S. EST) 

By phone WITHIN THE U.S.: Call 1-800-216-7331 or 301-575-0156 

OUTSIDE THE U.S.: Call 301-575-0156 

By fax Fax questions to 301-436-2804 or 1-866-573-0846

By email Go to http://www.cfsan.fda.gov/~furls/helpf2.html and complete the form 

WHAT Information is Required: 

• Facility name, address, phone number, and emergency contact phone number 

• Parent company name, address, and phone number (if applicable) 

• Name, address, and phone number of the owner, operator or agent in charge 

• All trade names the facility uses 

• Applicable food product categories, as specified in FDA regulation 21 CFR 170.3 

• Name, address, phone number, and emergency contact phone number of a foreign facility’s 

U.S. agent 

• Certification that the information submitted is true and accurate and that the person 

submitting it is authorized to do so 

HOW Registration Is Confirmed: FDA confirms the registration either electronically (online 

registration) or by mail (paper or CD-ROM registration), and assigns a registration number. 

What If . . . 

IF... Then... 

Required registration You must notify FDA within 60 days (online or by mail or fax). 

info changes 

There’s a change in The former owner must cancel registration within 60 days and 

ownership the new owner must re-register. 

Your facility goes You must cancel registration. 

out of business 

A domestic facility The Federal government can bring a civil or criminal action against the 

owner, operator, or agent in charge. However, FDA will use discretion 

in enforcing the regulation during the comment period (see below). 

fails to register 

A foreign facility fails The food will be held at the port of entry, unless otherwise directed 

to register and then by FDA or CBP. 

tries to import food 

into the U.S. 

Comments and Compliance 

FDA will provide a 75-day comment period (ending December 24, 2003) on issues related to this 

regulation. For the 4 months following December 12, 2003, FDA plans to focus on education and 

training to assist facilities required to register to comply with the rule. FDA will use discretion in 

enforcing the regulation, while at the same time ensuring public health protection. 

Get More Info: For more information, go to http://www.fda.gov/oc/bioterrorism/bioact.html. 14 
U.S. Department of Health and Human Services 

U.S. Food and Drug Administration 
For more information, go to 

http://www.fda.gov/oc/bioterrorism/bioact.html 

U.S. Food and Drug U.S. Department of Health 

Administration and Human Services