19160 Federal Register / Vol. 80, No. 68 / Thursday, April 9, 2015 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 1 

[Docket No. FDA–2002–N–0323] 

Amendments to Registration of Food 

Facilities 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

proposing to amend its regulation for 

registration of food facilities that 

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 proposed rule would amend 

and update FDA’s registration 

regulations and is part of our 

implementation of the FDA Food Safety 

Modernization Act (FSMA), which 

added new provisions for the 

registration of food facilities. Moreover, 

a number of provisions in FSMA apply 

only to facilities required to register, 

including hazard analysis and riskbased preventive controls and 

mandatory recall authority. The 

proposed amendments will further 

enhance FDA’s capabilities with respect 

to responding to food safety issues, and 

in addition, provide FDA with 

information that we can use to focus 

and better utilize our limited inspection 

resources. 

DATES: Submit either electronic or 

written comments on the proposed rule 

by June 8, 2015. Submit comments on 

the information collection issues under 

the Paperwork Reduction Act of 1995 by 

May 11, 2015, (see the ‘‘Paperwork 

Reduction Act of 1995’’ section of this 

document). 

ADDRESSES: You may submit comments 

by any of the following methods, except 

that comments on the information 

collection issues under the Paperwork 

Reduction Act of 1995 must be 

submitted to the Office of Information 

and Regulatory Affairs, Office of 

Management and Budget (OMB) (see the 

‘‘Paperwork Reduction Act of 1995’’ 

section of this document). 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• Mail/Hand delivery/Courier (for 

paper submissions): Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Instructions: All submissions received 

must include the Docket No. FDA– 

2002–N–0323 for this rulemaking. All 

comments received may be posted 

without change to http://

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

With regard to the proposed rule: 

Monica Storozyszyn, Center for Food 

Safety and Applied Nutrition (HFS– 

615), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, 240–402–1367. With regard 

to the information collection: FDA PRA 

Staff, Office of Operations, Food and 

Drug Administration, 8455 Colesville 

Rd., COLE–14526, Silver Spring, MD 

20993–0002, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Executive Summary 

Purpose of the Proposed Rule 

This proposed regulation would 

implement certain provisions in section 

415 of the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) (21 U.S.C. 

350d), as amended by section 102 of the 

FDA Food Safety Modernization Act 

(FSMA), that relate to registration of 

food facilities. In addition, this 

proposed regulation would amend and 

update FDA’s registration regulations to 

further enhance FDA’s capabilities with 

respect to responding to food-related 

emergencies, and in addition, provide 

FDA with information that we can use 

to focus and better utilize our limited 

inspection resources. 

Summary of the Major Provisions of the 

Proposed Rule 

Section 102 of FSMA amends section 

415 of the FD&C Act by requiring that 

certain additional information be 

included in registrations. More 

specifically, section 102(a)(1)(A) of 

FSMA amends section 415 to provide 

that registrations for domestic food 

facilities are required to contain the 

email address for the contact person of 

the facility, and registrations for foreign 

food facilities are required to contain 

the email address of the U.S. agent for 

the facility. Further, section 102(a)(3) of 

FSMA amends section 415 to provide 

that food facilities required to register 

with FDA must renew their registrations 

with FDA every 2 years, between 

October 1 and December 31 of each 

even-numbered year, by submitting 

registration renewals to FDA. Also, 

section 102(b)(1)(A) of FSMA provides 

that all food facility registrations are 

required to 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. These 

FSMA amendments were selfimplementing and became effective 

upon enactment of FSMA. These FSMA 

amendments are being included in this 

proposed rule to codify the provisions 

in the food facility registration 

regulations in 21 CFR part 1, subpart H. 

In addition, section 102(b) of FSMA 

authorizes FDA to require that all food 

facility registrations be submitted to 

FDA in an electronic format; however, 

such requirement cannot take effect 

before the date that is 5 years after the 

date of enactment of FSMA (i.e., January 

4, 2016). We are proposing to 

implement this provision in this 

proposed rule. 

Section 102(c) of FSMA also directs 

FDA to amend the definition of the term 

‘‘retail food establishment’’ in 

§ 1.227(b)(11) of title 21, Code of Federal 

Regulations to clarify that, in 

determining the primary function of an 

establishment or a retail food 

establishment under such section, the 

sale of food products directly to 

consumers by such establishment and 

the sale of food directly to consumers by 

such retail food establishment include: 

(1) The sale of food products or food 

directly to consumers by such 

establishment at a roadside stand or 

farmers’ market where such stand or 

market is located other than where the 

food was manufactured or processed; (2) 

the sale and distribution of such food 

through a community supported 

agriculture program; and (3) the sale and 

distribution of such food at any other 

such direct sales platform as determined 

by the Secretary. We are proposing to 

implement these provisions in this 

proposed rule. 

Lastly, we are proposing changes to 

improve the utility of the food facility 

registration database. We are proposing, 

among other things, to: (1) Require 


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1The authorities of Treasury under section 701(b) 

of the FD&C Act (21 U.S.C. 371(b)) to jointly 

prescribe regulations with the Department of Health 

and Human Services for the efficient enforcement 

of section 801 of the FD&C Act were transferred to 

DHS when DHS was created by an act of Congress 

in 2002. 

certain additional data elements in food 

facility registrations; (2) employ 

additional measures to verify certain 

information submitted in registrations; 

and (3) take additional steps to ensure 

that our registration database is up-todate by identifying additional 

circumstances under which FDA will 

cancel registrations. 

Costs and Benefits 

Costs of meeting the proposed 

requirements of this rule will be 

incurred by both FDA and food facilities 

that are required to register. Table 1 

presents estimated costs associated with 

the provisions in this proposed rule. 

Estimated one-time costs to domestic 

and foreign facilities are about $22 

million. Annualized costs are calculated 

using a discount rate of 7 percent and 

3 percent over 20 years. Total 

annualized costs to food facilities, 

which include annualized one-time 

costs and annualized recurring costs, are 

approximately $5 million and $6 

million. Annualized recurring costs to 

FDA are approximately $1 million, 

using both discount rates. We expect 

that the benefits of the proposed rule 

would include aiding FDA’s ability to 

deter and limit the effects of foodborne 

outbreaks and other food-related 

emergencies. Although we are unable to 

quantify these and other benefits, we 

discuss the expected benefits 

qualitatively in the preliminary 

regulatory impact analysis (PRIA). 

TABLE 1—ANNUALIZED COST AND BENEFIT SUMMARY

[$Millions] 

Total one time 

costs 

Total 

annualized 

costs 7% 

Total 

annualized 

costs 3% 

Benefits 

Domestic Facilities .......................................... $9 $1 $1 Not Quantified. 

Foreign Facilities ............................................. 13 4 5 

Subtotal Facilities ..................................... 22 5 6 

Costs to FDA .................................................. ........................ 1 1 

Total .................................................. 22 6 7 

Table of Contents 

I. Background 

A. The Public Health Security and 

Bioterrorism Preparedness and Response 

Act of 2002 and FDA’s Current 

Regulations for Registration of Food 

Facilities 

B. The FDA Food Safety Modernization 

Act and Food Facility Registration 

C. Rulemaking Required by Section 103(c) 

of FSMA: On-Farm Activities 

II. Legal Authority 

III. The Proposed Rule 

A. Proposed Amendments to Registration 

of Food Facilities Under FSMA 

B. Other Proposed Amendments to 

Registration of Food Facilities 

C. Request for Comment on Establishment 

of a U.S. Agent Voluntary Identification 

System 

IV. Preliminary Regulatory Impact Analysis 

A. Overview 

B. Regulatory Flexibility Act 

C. Unfunded Mandates Reform Act of 1995 

D. Public Access to the Analyses 

V. Paperwork Reduction Act of 1995 

VI. Analysis of Environmental Impact 

VII. Federalism 

VIII. Request for Comments 

IX. References 

I. Background 

A. The Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 and FDA’s 

Current Regulations for Registration of 

Food Facilities 

After the events of September 11, 

2001, highlighted the need to enhance 

the security of the infrastructure of the 

United States, including the food 

supply, Congress responded by enacting 

the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 (the Bioterrorism 

Act) (Pub. L. 107–188), which was 

signed into law on June 12, 2002. The 

Bioterrorism Act included a provision 

in Title III (Protecting Safety and 

Security of Food and Drug Supply), 

Subtitle A—Protection of Food Supply, 

section 305, which required the 

Secretary of Health and Human Services 

(the Secretary) to develop a regulation to 

require domestic and foreign facilities 

that manufacture, process, pack, or hold 

food for consumption in the United 

States to register with FDA by December 

12, 2003. The provision created section 

415 and amended sections 301 and 801 

of the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 331 and 

381). Section 415 of the FD&C Act, as 

added by the Bioterrorism Act, generally 

requires food facilities to register with 

FDA by submitting certain information 

to the Agency and updating such 

information as necessary. Section 

301(dd) of the FD&C Act provides that 

failure to register in accordance with 

section 415 of the FD&C Act is a 

prohibited act. Section 801(l) of the 

FD&C Act, as added by the Bioterrorism 

Act, generally provides that an article of 

food imported or offered for import into 

the United States from a foreign facility 

for which a registration has not been 

submitted to FDA under section 415 

shall be held at the port of entry for the 

article. 

The Secretary and the Department of 

Treasury (Treasury) jointly issued a 

proposed rule for food facility 

registration (2003 proposed rule) in the 

Federal Register on October 10, 2003 

(68 FR 58894). On October 10, 2003, the 

Secretary and the Department of 

Homeland Security (DHS) jointly issued 

an interim final rule for registration of 

food facilities under the Bioterrorism 

Act.1 The interim final rule 

implemented section 305 of the 

Bioterrorism Act, and required domestic 

and foreign facilities to be registered 

with FDA by December 12, 2003 (68 FR 

58894). On October 3, 2005, FDA issued 

a final rule in the Federal Register (70 

FR 57505) that confirmed the interim 

final rule entitled ‘‘Registration of Food 

Facilities Under the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002.’’ FDA’s 

implementing regulation for section 415 

of the FD&C Act is codified in part 1 (21 

CFR part 1), subpart H. Highlights of 

FDA’s current registration of food 

facilities regulation are as follows: 

• The owner, operator, or agent in 

charge of a domestic or foreign facility 

engaged in manufacturing/processing, 

packing, or holding food for 

consumption by humans or animals in 


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the United States is required to register 

the facility with FDA. 

• The owner, operator, or agent in 

charge of a facility that is required to 

register may authorize an individual to 

register the facility on its behalf. 

• Facilities covered under the interim 

final rule had to be registered by 

December 12, 2003. 

• A foreign facility is exempt from 

registering if food from the facility 

undergoes further manufacturing/

processing (including packaging) by 

another facility outside the United 

States. The foreign facility is not exempt 

from registration if the further 

manufacturing/processing (including 

packaging) activities of the subsequent 

facility are limited to affixing a label to 

a package or other de minimis activity. 

• The following domestic and foreign 

facilities are also excluded from the 

registration requirement: Farms; retail 

food establishments; restaurants; 

nonprofit food establishments in which 

food is prepared for, or served directly 

to, the consumer; certain fishing vessels 

not engaged in processing; and facilities 

regulated exclusively, throughout the 

entire facility, by the U.S. Department of 

Agriculture (USDA) under the Federal 

Meat Inspection Act (21 U.S.C. 601, et 

seq.), the Poultry Products Inspection 

Act (21 U.S.C. 451, et seq.), or the Egg 

Products Inspection Act (21 U.S.C. 

1031, et seq.). 

• Registrants must use Form FDA 

3537 to register. This form is available 

either on the Internet or via mail or 

phone request. Registrants must use 

Form FDA 3537(a) to cancel their 

registrations. 

• FDA strongly encourages electronic 

registration, which is quicker and more 

convenient for both facilities and FDA 

than registration by mail. 

• To register electronically, a 

registrant may visit http://www.fda.gov/ 

furls, which is available for registration 

24 hours a day, 7 days a week. This Web 

site is available from wherever the 

Internet is accessible, including 

libraries, copy centers, schools, and 

Internet cafes, as well as through a 

foreign facility’s U.S. agent or other 

authorized individual if the facility 

makes such arrangements. 

• Regardless of the method of 

submission (paper or electronic), each 

registration must include the names, full 

addresses, and phone numbers for the 

facility, its parent company (if 

applicable), and the owner, operator and 

agent in charge; for a foreign facility, the 

name, address, and phone number, and, 

if no emergency contact is designated, 

the emergency contact phone number of 

the foreign facility’s U.S. agent; for a 

domestic facility, an emergency contact 

phone number; all trade names the 

facility uses; applicable food product 

categories as identified in § 170.3 (21 

CFR 170.3); and a statement certifying 

that the information submitted is true 

and accurate and, if the individual 

submitting the registration is not the 

owner, operator, or agent in charge of 

the facility, a statement in which the 

individual certifies that he/she is 

authorized to submit the registration. 

• No registration fee is required. 

• Updates to registration information 

or cancellation of registration must be 

submitted within 60 calendar days of 

any change to any of the required 

information previously submitted, 

except a change of the owner. 

• If a facility has a new owner, the 

former owner must cancel the facility’s 

registration within 60 calendar days of 

the change and the new owner must reregister the facility. 

• Failure of a domestic or foreign 

facility to register, update, or cancel its 

registration in accordance with the 

regulation is a prohibited act under 

section 301(dd) of the FD&C Act. 

• FDA will cancel a registration if the 

Agency independently verifies that the 

facility is no longer in business or has 

changed owners, and the owner, 

operator, or agent in charge of the 

facility fails to cancel the registration, or 

if FDA determines that the registration 

is for a facility that does not exist. 

• The disposition of food imported or 

offered for import from an unregistered 

foreign facility is governed by the 

procedures set out in subpart I of part 

1 (21 CFR part 1) (Prior Notice of 

Imported Food). 

• 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. 

• The list of registered facilities and 

registration documents submitted are 

not subject to public disclosure under 5 

U.S.C. 552 (the Freedom of Information 

Act). Information derived from this list 

or these documents is also not subject 

to such disclosure to the extent that it 

discloses the identity or location of a 

specific registered facility. 

B. The FDA Food Safety Modernization 

Act and Food Facility Registration 

The FDA Food Safety Modernization 

Act (FSMA) (Pub. L. 111–353), signed 

into law on January 4, 2011, enables 

FDA to better protect public health by 

helping to ensure the safety and security 

of the food supply. Section 102 of 

FSMA, entitled Registration of Food 

Facilities, amends section 415 of the 

FD&C Act regarding requirements for 

food facility registration along with 

other sections of the FD&C Act 

involving food facility registration. 

Further, other sections of FSMA include 

amendments that apply to facilities that 

are required to register under section 

415 of the FD&C Act. 

1. Section 102 of FSMA: Registration of 

Food Facilities 

Section 102 of FSMA includes a 

number of amendments to food facility 

registration requirements or sections of 

the FD&C Act involving food facility 

registration. First, section 102 of FSMA 

amends section 415 by requiring that 

certain additional information be 

included in registrations. More 

specifically, section 102(a)(1)(A) of 

FSMA amends section 415 to provide 

that registrations for domestic food 

facilities are required to contain the 

email address for the contact person of 

the facility, and registrations for foreign 

food facilities are required to contain 

the email address of the U.S. agent for 

the facility. Also, section 102(b)(1)(A) of 

FSMA provides that all food facility 

registrations are required to 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. 

These FSMA amendments were selfimplementing and became effective 

upon enactment of FSMA. These FSMA 

amendments are being included in this 

proposed rule to codify the provisions 

in the registration of food facilities 

regulations in 21 CFR part 1, subpart H. 

Second, section 102 of FSMA amends 

section 415 with respect to updating 

food product category information 

required in food facility registrations. 

Before FSMA was enacted, section 

415(a)(2) of the FD&C Act, as added by 

section 305 of the Bioterrorism Act, 

provided in relevant part that, when 

determined necessary by FDA ‘‘through 

guidance,’’ a registrant must submit a 

registration to FDA containing 

information necessary to notify FDA of 

the general food category (as identified 

in § 170.3) of food manufactured, 

processed, packed, or held at such 

facility. On July 17, 2003, FDA issued a 

guidance document stating that FDA 

had determined that the inclusion of 

food product categories in food facility 

registrations was necessary for a quick, 

accurate, and focused response to an 

actual or potential bioterrorist incident 

or other food-related emergency (see 68 

FR 42415). Section 102(a)(1)(B) of 

FSMA amends section 415(a)(2) of the 

FD&C Act with respect to food product 

category information by authorizing 

FDA to determine other food product 

categories, including those not 


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specifically identified in § 170.3. 

Specifically, section 415(a)(2) of the 

FD&C Act, as amended by section 

102(a)(1)(B) of FSMA, provides in 

relevant part that, when determined 

necessary by FDA ‘‘through guidance,’’ 

a registrant is required to submit a 

registration to FDA containing 

information necessary to notify FDA of 

the general food category (as identified 

in § 170.3 or any other food categories, 

as determined appropriate by FDA, 

including by guidance) of any food 

manufactured, processed, packed, or 

held at such facility. In October 2012, 

FDA issued a guidance entitled 

‘‘Guidance for Industry: Necessity of the 

Use of Food Product Categories in Food 

Facility Registrations and Updates to 

Food Product Categories.’’ This 

guidance represents FDA’s conclusion 

on the necessity of food product 

categories in food facility registrations 

and identifies other food product 

categories that are necessary and 

appropriate for food facility registration, 

as provided by section 415(a)(2) of the 

FD&C Act. 

Third, section 102(a)(3) of FSMA 

amends section 415 to provide that food 

facilities required to register with FDA 

must renew their registrations with FDA 

every 2 years, between October 1 and 

December 31 of each even-numbered 

year, by submitting registration 

renewals to FDA. Further, section 

102(a)(3) of FSMA directs FDA to 

provide for an abbreviated registration 

renewal process for any registrant that 

has not had any changes to such 

information since the registrant 

submitted the preceding registration or 

registration renewal for the facility. 

Fourth, section 102(b) of FSMA 

amends section 415(b) of the FD&C Act 

by adding new provisions authorizing 

FDA to suspend the registration of a 

food facility in certain circumstances. 

Specifically, if 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, FDA may 

by order suspend the registration of a 

facility that created, caused, or was 

otherwise responsible for such 

reasonable probability; or knew of, or 

had reason to know of, such reasonable 

probability and packed, received, or 

held such food. Under section 415(b)(4) 

of the FD&C Act, as amended by section 

102(b) of FSMA, if the registration of a 

food facility is suspended, no person 

can import or export, or offer to import 

or export, food from the facility into the 

United States, or otherwise introduce 

food from the facility into interstate or 

intrastate commerce in the United 

States. Under section 301(d) of the 

FD&C Act, as amended by section 102(b) 

of FSMA, the introduction or delivery 

for introduction into interstate 

commerce of an article of food in 

violation of section 415 is a prohibited 

act. Further, section 801(l) of the FD&C 

Act, as amended by section 102(b) of 

FSMA, provides, in relevant part, that 

an article of food being imported or 

offered for import into the United States 

that is from a foreign facility for which 

a registration has been suspended under 

section 415 must be held at the port of 

entry for the article of food, and may not 

be delivered to the importer, owner, or 

consignee of the article. FDA intends to 

address the suspension of registration 

provisions in section 102(b) of FSMA in 

a separate rulemaking. 

Section 102(b) of FSMA also 

authorizes FDA to require that all food 

facility registrations be submitted to 

FDA in an electronic format; however, 

such requirement cannot take effect 

before the date that is 5 years after the 

date of enactment of FSMA (i.e., January 

4, 2016). 

Lastly, section 102(c) of FSMA directs 

FDA to amend the definition of the term 

‘‘retail food establishment’’ in 

§ 1.227(b)(11) of title 21, Code of Federal 

Regulations to clarify that, in 

determining the primary function of an 

establishment or a retail food 

establishment under such section, the 

sale of food products directly to 

consumers by such establishment and 

the sale of food directly to consumers by 

such retail food establishment include: 

(1) The sale of food products or food 

directly to consumers by such 

establishment at a roadside stand or 

farmers’ market where such stand or 

market is located other than where the 

food was manufactured or processed; (2) 

the sale and distribution of such food 

through a community supported 

agriculture program; and (3) the sale and 

distribution of such food at any other 

such direct sales platform as determined 

by the Secretary. As discussed more 

fully in the paragraphs that follow, we 

are proposing to implement these 

provisions in this proposed rule. 

2. Other FSMA Amendments Involving 

Food Facilities Required To Register 

Under Section 415 of the FD&C Act 

In addition to amending section 415 

of the FD&C Act and the other related 

sections of the FD&C Act as discussed 

in the preceding section, FSMA also 

amended the FD&C Act such that 

section 415 functions in connection 

with other food safety provisions. For 

instance, FSMA added section 418 of 

the FD&C Act (21 U.S.C. 350g), which 

establishes certain preventive control 

requirements for food facilities that are 

required to register under section 415. 

In general, section 418(a) requires the 

owner, operator, or agent in charge of a 

‘‘facility’’ to evaluate the hazards that 

could affect food manufactured, 

processed, packed, or held by such 

facility, identify and implement 

preventive controls, monitor the 

performance of those controls, and 

maintain records of the monitoring. The 

term ‘‘facility’’ is defined in section 

418(o)(2) as ‘‘a domestic facility or a 

foreign facility that is required to 

register under section 415.’’ 

In addition, section 201(a) of FSMA 

created section 421 of the FD&C Act (21 

U.S.C. 350j), which also ties to section 

415. In particular, section 421 requires 

the Agency to identify high-risk 

‘‘facilities’’ and mandates more frequent 

inspections for domestic high-risk 

‘‘facilities’’ than for domestic non-highrisk facilities. Section 421 also includes 

an inspection mandate for foreign 

facilities. For the purposes of section 

421, the term ‘‘facility’’ refers to 

facilities that are required to register 

under section 415. (See section 421(e)). 

In addition, section 306 of FSMA added 

section 807(a)(1) of the FD&C Act (21 

U.S.C. 384c(a)(1)), which provides that 

FDA may enter into arrangements and 

agreements with foreign governments to 

facilitate the inspection of foreign 

facilities registered under section 415. 

FSMA also created section 423 of the 

FD&C Act (21 U.S.C. 350l), which 

provides a ‘‘responsible party’’ an 

opportunity to voluntarily cease 

distribution and recall a food under 

specified circumstances and also 

provides FDA with authority to mandate 

a recall under specified circumstances. 

The term ‘‘responsible party’’ is defined 

by reference to the definition in section 

417 of the FD&C Act (21 U.S.C. 350f), 

which in turn defines that term as a 

person that submits the registration 

under section 415(a) of the FD&C Act for 

a food facility that is required to register 

under section 415(a) of the FD&C Act, 

at which such article of food is 

manufactured, processed, packed, or 

held. (See section 417(a)(1) of the FD&C 

Act.) In addition, FSMA created section 

808 of the FD&C Act (21 U.S.C. 384d), 

which provides for the recognition of 

accreditation bodies that accredit thirdparty auditors to conduct food safety 

audits of foreign food entities, including 

foreign food facilities registered under 

section 415. 

Further, section 107 of FSMA 

amended the FD&C Act to provide FDA 

with the authority to collect fees related 

to reinspections of facilities required to 

register under section 415 of the FD&C 

Act. Specifically, section 107 of FSMA 


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added section 743(a)(1)(A) of the FD&C 

Act (21 U.S.C. 379j–31(a)(1)(A)), which 

provides FDA with the authority to 

assess and collect fees from domestic 

facilities (as defined in section 415(b) of 

the FD&C Act) and U.S. agents for 

foreign facilities (also as defined in 

section 415(b) of the FD&C Act) subject 

to reinspection to cover reinspectionrelated costs. 

FSMA is not the only act in which 

Congress has linked food facility 

registration to specific food safety 

requirements. The Food and Drug 

Administration Amendments Act of 

2007 (FDAAA) also tied food safety 

requirements to food facility 

registration. FDAAA amended the FD&C 

Act by creating section 417, which 

generally requires a ‘‘responsible party’’ 

to submit a report to FDA through the 

Reportable Food Registry after 

determining that an article of food is a 

reportable food as defined in section 

417(a)(2) and further defined in section 

201(ff) of the FD&C Act (21 U.S.C. 

321(ff))). As stated previously, section 

417 of the FD&C Act defines the term 

‘‘responsible party’’ as a person that 

submits the registration under section 

415(a) of the FD&C Act for a food 

facility that is required to register under 

section 415(a) of the FD&C Act, at which 

such article of food is manufactured, 

processed, packed, or held. (See section 

417(a)(1) of the FD&C Act.) 

As a result of these links between 

food facility registration and additional 

requirements in the FD&C Act, food 

facility registration now serves 

additional functions to those originally 

identified in the food facility 

registration regulations issued in 2003 

and finalized in 2005 (68 FR 58894; 70 

FR 57505). More specifically, the 

interim final rule noted that food facility 

registration would help FDA act quickly 

in responding to a threatened or actual 

bioterrorist attack on the U.S. food 

supply or to other food-related 

emergencies (68 FR 58894 at 58895). It 

also noted that registration would 

provide FDA with information about 

food facilities that would help FDA and 

other authorities determine the source 

and cause of an outbreak of foodborne 

illness, while also enabling FDA to 

notify more quickly the facilities that 

might be affected by the outbreak (68 FR 

58894 at 58895). While food facility 

registration continues to serve all of 

those functions, with the passage of 

FSMA and FDAAA, food facility 

registration now also serves to 

determine the applicability of 

provisions in other sections of the FD&C 

Act, including sections 417, 418, 421, 

423, 743, 807, and 808 of the FD&C Act. 

Thus, food facility registration now 

relates to many more food safety 

requirements than when the system was 

first implemented in 2003. 

C. Rulemaking Required by Section 

103(c) of FSMA: On-Farm Activities 

Section 103(c)(1)(A) of FSMA, 

regarding Hazard Analysis and RiskBased Preventive Controls, requires that 

the Secretary publish a notice of 

proposed rulemaking in the Federal 

Register to issue regulations with 

respect to ‘‘activities that constitute onfarm packing or holding of food that is 

not grown, raised, or consumed on such 

farm or another farm under the same 

ownership’’ and ‘‘activities that 

constitute on-farm manufacturing or 

processing of food that is not consumed 

on that farm or on another farm under 

common ownership’’ within the context 

of section 415 of the FD&C Act. Section 

103(c)(1)(B) of FSMA provides that such 

rulemaking will ‘‘enhance the 

implementation of . . . section 415 and 

clarify the activities that are included as 

part of the definition of the term 

‘facility’ under such section 415.’’ In the 

Federal Register of January 16, 2013 (78 

FR 3646), we published a proposed rule 

entitled ‘‘Current Good Manufacturing 

Practice and Hazard Analysis and RiskBased Preventive Controls for Human 

Food’’ to implement section 103 of 

FSMA and we discuss our proposal to 

revise the registration of food facilities 

regulations (part 1, subpart H) as 

specified by section 103(c)(1) of FSMA. 

In the Federal Register of September 29, 

2014 (79 FR 58524), we published a 

supplemental notice of proposed 

rulemaking to amend the 2013 

preventive controls proposed rule. That 

proposed rule is a separate rulemaking 

and not the subject of this rulemaking. 

II. Legal Authority 

We are issuing this proposed rule 

under the FD&C Act, FSMA, and the 

Bioterrorism Act. We are proposing to 

codify the requirements of section 102 

of FSMA that were self-implementing 

and effective upon enactment of FSMA, 

as discussed previously, in the 

Registration of Food Facilities 

Regulation (part 1, subpart H). In 

addition, we are proposing to 

implement other requirements of 

section 102 of FSMA, as discussed 

previously, including mandatory 

electronic registration submissions 

beginning in 2016 and amendments to 

the retail food establishment definition. 

Lastly, we are proposing other changes 

to improve the utility of the food facility 

registration database. 

FDA’s legal authority to implement 

requirements of section 102 of FSMA 

derives from section 102 of FSMA and 

sections 415, 301(dd), 801(l), and 701(a) 

of the FD&C Act. As discussed 

previously, section 415 of the FD&C Act 

requires food facilities that 

manufacture/process, pack, or hold food 

for consumption in the United States to 

register with FDA by submitting certain 

information to the Agency and updating 

such information as necessary. Section 

415(a)(2) of the FD&C Act, as amended 

by section 102 of FSMA, requires, in 

relevant part, food facility registrations 

to include additional information, 

including the email addresses of contact 

persons for domestic facilities and U.S. 

agents for foreign facilities; an assurance 

that FDA will be permitted to inspect 

the facility at the times and in the 

manner permitted by the FD&C Act; and 

updated food product category 

information, if determined necessary 

and appropriate by FDA. Further, 

section 415(a)(3) of the FD&C Act, as 

amended by section 102 of FSMA, 

requires, in relevant part, food facilities 

required to register to renew their 

registrations with FDA between October 

1 and December 1 of each evennumbered year, and directs FDA to 

provide for an abbreviated registration 

renewal process for registrants that have 

not had any changes to registration 

information since the registrant 

submitted the preceding registration or 

registration renewal for the facility 

involved. Section 301(dd) of the FD&C 

Act provides that failure to register in 

accordance with section 415 of the 

FD&C is a prohibited act. Section 801(l) 

of the FD&C Act provides that an article 

of food being imported or offered for 

import into the United States that is 

from a foreign facility for which a 

registration has not been submitted to 

FDA under section 415 (or for which a 

registration has been suspended under 

such section) must be held at the port 

of entry for the article of food, and may 

not be delivered to the importer, owner, 

or consignee of the article until the 

foreign facility is so registered. Section 

701(a) of the FD&C Act authorizes FDA 

to issue regulations for the efficient 

enforcement of the FD&C Act. As 

discussed previously, section 102(c) of 

FSMA also directs FDA to amend the 

definition of the term ‘‘retail food 

establishment’’ in FDA’s Registration of 

Food Facilities Regulation at 

§ 1.227(b)(11). 

As discussed in detail in the 

paragraphs that follow, FDA is 

proposing additional required data 

elements in food facility registrations to 

provide for more efficient and effective 

communications during a public health 

emergency and to provide FDA 

information that we can use to focus 


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and better deploy the Agency’s limited 

inspectional resources. FDA’s legal 

authority to implement these and other 

changes to improve the utility of the 

food facility registration database also 

derives from section 102 of FSMA and 

the sections of the FD&C Act described 

in the previous paragraph. Section 

415(a)(2) of the FD&C Act requires 

foreign facilities to submit registrations 

to FDA that include the name of the 

U.S. agent for the facility. Further, FDA 

is relying on section 107 of FSMA and 

sections 421 and 704 (21 U.S.C. 374) of 

the FD&C Act in issuing these proposed 

changes. Section 107 of FSMA amended 

the FD&C Act to provide FDA with the 

authority to assess and collect certain 

fees from, inter alia, U.S. agents for 

foreign facilities (as defined in section 

415(b) of the FD&C Act) subject to 

reinspection to cover reinspectionrelated costs. Section 704 gives FDA the 

authority to inspect factories, 

warehouses, and other establishments in 

which foods are manufactured, 

processed, packed, or held. Section 421 

of the FD&C Act requires the Agency to 

identify high-risk facilities and 

mandates more frequent inspections for 

domestic high-risk facilities than for 

domestic non-high-risk facilities. FDA is 

also relying on section 305(d) of the 

Bioterrorism Act (Pub. L. 107–188), 

which directs FDA, in relevant part, to 

ensure adequate authentication 

protocols are used to enable 

identification of the registrant and 

validation of the registration data, as 

appropriate, for registrations submitted 

to FDA electronically. Thus, FDA has 

the authority to issue this proposed rule 

under section 305 of the Bioterrorism 

Act, sections 102 and 107 of FSMA, and 

sections 301(dd), 415,701(a), and 704 of 

the FD&C Act. 

III. The Proposed Rule 

This proposed rule would revise 

FDA’s current regulations in part 1, 

subpart H, regarding registration of food 

facilities in two fundamental ways. 

First, it would add new provisions to 

the current regulations to implement 

certain provisions of section 102 of 

FSMA or otherwise codify amendments 

of section 102 of FSMA that were selfimplementing and effective upon 

enactment of FSMA, as discussed 

previously. Second, we are proposing 

changes to improve the utility of the 

food facility registration database. We 

are proposing to do this by proposing, 

among other things, to: (1) Require 

certain additional data elements in food 

facility registrations; (2) employ 

additional measures to verify certain 

information submitted in registrations; 

and (3) take additional steps to ensure 

that our registration database is up to 

date by identifying additional 

circumstances under which FDA will 

cancel registrations. The following 

description of the proposed rule 

describes both new provisions and 

changes to the existing regulations in 

part 1, subpart H. 

A. Proposed Amendments to 

Registration of Food Facilities Under 

FSMA 

1. Retail Food Establishment Definition 

Under section 415 of the FD&C Act 

and FDA’s registration regulation (21 

CFR 1.226(c)), a retail food 

establishment is not required to register 

with FDA. A ‘‘retail food establishment’’ 

is defined in current § 1.227(b)(11) to 

mean an establishment that sells food 

products directly to consumers as its 

primary function. Under current 

§ 1.227(b)(11), a retail food 

establishment may manufacture/

process, pack, or hold food if the 

establishment’s primary function is to 

sell from that establishment food, 

including food that it manufacturers/

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 definition of 

retail food establishment also provides 

that the term ‘‘consumers’’ does not 

include businesses, and a ‘‘retail food 

establishment’’ includes grocery stores, 

convenience stores, and vending 

machine locations. 

Section 102(c) of FSMA directs FDA 

to amend the definition of ‘‘retail food 

establishment’’ to clarify that, in 

determining the primary function of an 

establishment, the sale of food directly 

to consumers by such establishment 

includes: (1) The sale of food directly to 

consumers by such establishment at a 

roadside stand or farmers’ market where 

such stand or market is located other 

than where the food was manufactured 

or processed; (2) the sale and 

distribution of such food through a 

community supported agriculture 

program; and (3) the sale and 

distribution of such food at any other 

such direct sales platform as determined 

by the Secretary. 

The proposed amendment to the retail 

food establishment definition addresses 

off-farm sales by an establishment 

located on a farm. How these off-farm 

sales relate to an establishment’s status 

as a retail food establishment is 

significant because if manufacturing/

processing activities on a farm are part 

of a retail food establishment, they do 

not trigger the requirement to register. 

Otherwise, unless all food used in such 

activities is consumed on that farm or 

another farm under the same ownership, 

the manufacturing/processing operation 

is required to register (see 

§ 1.227(b)(3)(ii)). If all sales from an onfarm manufacturing/processing 

operation must be made on-farm for that 

operation to qualify as a retail food 

establishment, then an on-farm 

establishment that sells processed food 

at a direct sales platform such as a 

farmer’s market could not qualify as a 

retail food establishment and would be 

required to register. To prevent this, 

proposed § 1.227(b)(11) clarifies that all 

sales by an on-farm establishment do 

not have to be on the farm by 

specifically addressing how off-farm 

sales directly to consumers are to be 

counted in determining whether the onfarm establishment is a retail food 

establishment. 

a. Sale of food directly to consumers 

at a roadside stand or farmers’ market. 

Under proposed § 1.227(b)(11)(i), in 

determining the primary function of an 

establishment located on a farm, the sale 

of food directly to consumers from such 

establishment would include the sale of 

food directly to consumers by such 

establishment at a roadside stand or 

farmers’ market. The roadside stand or 

farmer’s market would not need to be on 

the farm where the establishment is 

located. For example, an establishment 

located on a farm that sells jams and 

jellies it manufacturers, along with 

produce it grows, directly to consumers 

at a farmers’ market would consider 

those sales in determining its primary 

function and thus whether it would 

meet the requirements to be considered 

a retail food establishment. Note that 

whether the farmers’ market would be a 

retail food establishment involves a 

separate primary function calculation 

involving only sales made at the 

farmers’ market and would not include, 

for example, sales at the farm. This 

analysis is not affected by the proposed 

amendment and is similar to how 

primary function would be determined 

at a grocery or convenience store. 

FDA is proposing that a farmers’ 

market is a location where one or more 

local farmers assemble to sell from their 

farms directly to consumers. FDA is 

proposing that a roadside stand is 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. These definitions are 

based on definitions found in 7 CFR 

249.2, with modifications to more 

specifically describe foods sold by onfarm establishments at direct sales 


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platforms such as roadside stands and 

farmers’ markets. We seek comments on 

this proposed amendment, and 

specifically, what, if any, limitations 

should be included such as distance of 

the roadside stand or farmers’ market 

from the farm, for example, not more 

than 275 miles from the farm. In 

addition, we seek comments on the 

proposed definitions for farmers’ market 

and roadside stand and if any of the 

terms within these proposed definitions 

should be further defined. 

b. Sale and distribution of food 

through a community supported 

agriculture program. Under proposed 

§ 1.227(b)(11)(ii), in determining the 

primary function of an establishment 

located on a farm, the sale of food 

directly to consumers from such 

establishment would also include the 

sale and distribution of such food 

through a community supported 

agriculture program. For example, an 

establishment located on a farm that 

sells apples it grows and apple pies it 

manufacturers directly to consumers 

through a CSA would consider those 

sales in determining its primary 

function and thus whether it would 

meet the requirements to be considered 

a retail food establishment. 

Section 102(c) of FSMA provides that 

for the purposes of the retail food 

establishment definition, ‘‘the term 

‘community supported agriculture 

program’ has the same meaning given 

the term ‘community supported 

agriculture (CSA) program’ in section 

249.2 of title 7, Code of Federal 

Regulations (or any successor 

regulation).’’ Under 7 CFR 249.2, a 

‘‘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. State agencies 

may purchase shares or subscribe to a 

community supported agriculture 

program on behalf of individual SFMNP 

[Senior Farmers’ Market Nutrition 

Program] participants.’’ Accordingly, we 

are proposing that the term ‘‘community 

supported agriculture program’’ in 

proposed § 1.227(b)(11) have the same 

meaning used for the term in 7 CFR 

249.2. We note that, under proposed 

§ 1.227(b)(11)(ii), a CSA program would 

include CSA programs in which a group 

of farmers consolidate their crops at a 

central location for distribution to 

shareholders or subscribers. 

c. Sale and distribution of food at any 

other direct-to-consumer sales 

platforms. Under proposed 

§ 1.227(b)(11)(iii), in determining the 

primary function of an establishment 

located on a farm, the sale of food 

directly to consumers from such 

establishment would include the sale 

and distribution of such food at other 

direct-to-consumer sales platforms, 

including door-to-door sales; mail, 

catalog and Internet orders, including 

online farmers markets and online 

grocery delivery; religious or other 

organization bazaars, and State and 

local fairs. The specified direct sales 

platforms are common platforms for 

direct-to-consumer sales of foods from 

farms, and to the extent that such 

platforms typically provide direct-toconsumer sales of food from local farms, 

they are similar to farmers’ markets and 

CSAs. We seek comments on the direct 

sales platforms we have specified and 

what, if any, other such direct sales 

platforms we should specify. 

d. Other issues. As proposed, this 

amendment to the retail food 

establishment definition would be 

limited to on-farm establishments. We 

believe such a limitation is consistent 

with section 102(c) of FSMA, which 

addresses the sale of foods directly to 

consumers at specific locations (i.e., 

roadside stands, farmers’ markets, and 

community supported agriculture 

programs) where the food for sale 

directly to consumers is sourced 

directly from farms. We request 

comment on whether such a limitation 

is appropriate. 

Further, proposed § 1.227(b)(11) 

provides for considering certain off-farm 

sales directly to consumers when 

determining an on-farm establishment’s 

primary function, but does not provide 

for considering off-farm sales to 

businesses in the primary function 

calculation. In doing so, the proposal 

reflected section 102(c) of FSMA, which 

addresses only sales to consumers. We 

request comment on whether, in 

addition to implementing the specific 

clarification in section 102(c), we 

should provide that off-farm sales to 

businesses also be considered in 

determining the primary function of an 

on-farm establishment. 

In addition, proposed § 1.227(b)(11) 

provides for, in determining the primary 

function of an on-farm establishment, 

considering the off-farm sales of ‘‘food’’ 

directly to consumers, which would 

include both food that has been 

manufactured/processed and food that 

has not (raw agricultural commodities). 

FDA requests comment on whether, in 

light of the reference to ‘‘other than 

where the food was manufactured or 

processed’’ in section 102(c)(1)(A) of 

FSMA or for other reasons, only the sale 

of processed foods off the farm should 

be considered in determining the 

primary function of an establishment 

located on a farm. 

2. Biennial Registration Renewal and 

Abbreviated Registration Renewal 

Process 

Section 415(a)(3) of the FD&C Act, as 

amended by section 102(a) of FSMA, 

requires that during the period 

beginning on October 1 and ending on 

December 31 of each even-numbered 

year, a registrant that has submitted a 

registration to FDA under section 

415(a)(1) of the FD&C Act must submit 

to FDA a renewal registration containing 

the information described in section 

415(a)(2) of the FD&C Act. This 

requirement went into effect upon 

enactment of FSMA. Food facilities 

were required to renew their 

registrations with FDA after the 

enactment of FSMA during the 2012 

registration renewal period. 

Proposed § 1.230(b) would require the 

owner, operator, or agent in charge of a 

facility to submit a registration renewal 

to FDA containing the information 

required under § 1.232 every other year, 

during the period beginning on October 

1 and ending on December 31 of each 

even-numbered year. Under proposed 

§ 1.230(b), the owner, operator, or agent 

in charge of a facility may authorize an 

individual to renew the facility’s 

registration on its behalf. As discussed 

in section III.B.12.b, we are proposing to 

replace ‘‘the owner, operator, or agent in 

charge of a facility’’ with ‘‘you’’ 

throughout the regulation because 

‘‘you’’ is defined in the regulation under 

current § 1.227(b)(14) to mean the 

owner, operator, or agent in charge of a 

facility that manufactures/processes, 

packs, or holds food for consumption in 

the United States. 

Section 415(a)(3) of the FD&C Act, as 

amended by section 102(a)(3) of FSMA, 

directs FDA to provide for an 

abbreviated registration renewal process 

for any registrant that has not had any 

changes to its registration information 

since the registrant submitted the 

preceding registration or registration 

renewal for the facility. Proposed 

§ 1.230(c) would provide for an 

abbreviated registration renewal process 

for registrations that do not have any 

changes to the information required 

under § 1.232 since the registrant 

submitted the preceding registration or 

registration renewal for the facility to 

FDA. The abbreviated registration 

renewal process would require a 

registrant to confirm that no changes 

have been made to the information 

required in the registration since the 

registrant submitted the preceding 

registration or registration renewal, 

confirm that FDA will be permitted to 


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inspect the facility at the times and in 

the manner permitted by the FD&C Act, 

and certify that the information 

submitted is truthful and accurate. FDA 

is proposing that registrants must use 

Form FDA 3537 to submit abbreviated 

registration renewals to FDA. This form 

will be available electronically at 

www.fda.gov or via mail or phone 

request until mandatory electronic 

registration and registration renewals 

begin in the 2016 registration renewal 

period, as described in proposed 

§ 1.231(a)(2). 

Proposed § 1.230(b) would codify in 

FDA’s registration regulation the 

biennial registration renewal 

requirement of section 415(a)(3) of the 

FD&C Act (as added by section 102(a)(3) 

of FSMA), which is already in effect. 

Proposed § 1.230(c) would implement 

the provision of section 415(a)(3) of the 

FD&C Act providing for an abbreviated 

registration renewal process for 

registrants that have not had any 

changes to required registration 

information since such registrations 

submitted the preceding registration or 

registration renewal for the facility 

involved. The abbreviated registration 

renewal process was not available for 

the 2012 registration renewal period 

because section 102(a) of FSMA 

established new registration data 

elements, meaning all registrants would 

have had changes to their registration 

information since such registrations 

were previously submitted or updated. 

3. Mandatory Electronic Submission of 

Food Facility Registration and 

Registration Renewals 

Section 415(b)(5)(B) of the FD&C Act, 

as added by section 102(b) of FSMA, 

provides that FDA may require that 

registration under section 415 be 

submitted to FDA in an electronic 

format. However, section 415(b)(5)(B) 

specifies that such requirement may not 

take effect before the date that is 5 years 

after the date of enactment of FSMA, 

which is January 4, 2016. Proposed 

§ 1.231(a)(2) would provide that 

beginning January 4, 2016, electronic 

registration will be mandatory, unless a 

waiver has been granted for the 

registrant. In addition, proposed 

§ 1.231(a)(2) would require mandatory 

electronic registration renewals 

beginning in the 2016 registration 

renewal period. Proposed § 1.231(b) 

would also provide that beginning 

January 4, 2016, registration or 

registration renewals by mail or fax 

would no longer be permitted, unless a 

waiver has been granted for the 

registrant. Such waivers are further 

discussed in section III.B.11. 

FDA tentatively concludes that 

mandatory electronic submission of 

registration and registration renewals 

would provide a number of advantages 

over submission of registration and 

registration renewals on the FDA paper 

form, including the following: 

• The mandatory electronic system 

would improve the timeliness and 

accuracy of submissions. 

• The electronic transmission of 

information would be easier and more 

efficient for both industry and FDA than 

the use of paper forms. For example, a 

registrant would receive onscreen 

feedback if the information submitted 

was not complete, reducing errors and 

time and cost of communicating with 

FDA. Similarly, electronic transmission 

of the information would reduce 

significantly the time and cost 

associated with processing paper forms 

and communicating with industry 

concerning errors on those forms. 

• Information search and retrieval 

time would be reduced, allowing 

quicker access to the information in the 

database. 

• FDA has strongly encouraged 

electronic registration for the benefit of 

both FDA and the registrant. FDA 

tentatively concludes that the majority 

of facilities, both in the United States 

and abroad, have access to the Internet, 

either within their facilities or parent 

companies or through public libraries, 

copy centers, schools, or Internet cafes, 

as well as through a foreign facility’s 

U.S. agent if the facility makes such 

arrangements. If the U.S. agent does not 

have Internet access onsite, the agent 

may register the facility electronically 

from a local library or other public 

facility that offers Internet access. 

• FDA is able to accept electronic 

registrations from anywhere in the 

world where the Internet is available 24 

hours a day, 7 days a week. 

• Electronic registration also enables 

a facility to be registered more quickly 

than if registering by mail. Registration 

by mail can take several weeks to 

several months, depending on the 

efficiency of the mail system, the 

number of paper registrations that FDA 

would need to enter manually into the 

system, whether the Agency would have 

to return an incomplete or illegible form 

to a registrant, and because FDA would 

have to subsequently mail the 

registration number and receipt of 

registration to the registrant. 

We are seeking comments on the 

proposed requirements for mandatory 

electronic registration and registration 

renewals to begin in the year 2016. We 

are also requesting comments and data 

on the number of facilities, if any, that 

believe they would be unable to register 

or renew their registrations 

electronically, and the reasons for such 

belief, such as, no access to the Internet 

or for religious beliefs. In addition, as 

further discussed in section III.B.11, we 

are seeking comments on our proposal 

to allow for a waiver from the 

requirement for mandatory registration 

and registration renewals beginning in 

2016. 

4. Email Address for the Contact Person 

as Required Information 

Section 415(a)(2) of the FD&C Act, as 

amended by section 102(a) of FSMA, 

requires, among other things, that a 

registration for a domestic facility 

contain the email address for the contact 

person of the facility. This requirement 

went into effect upon enactment of 

FSMA. Proposed § 1.232(b)(1) would 

require the email address for the contact 

person of a domestic facility be 

included in the registration. Proposed 

§ 1.232(b)(1) would codify in FDA’s 

registration regulation the requirement 

of section 415(a)(2) of the FD&C Act that 

a registration for a domestic facility 

contain the email address for the contact 

person of the facility. 

FDA has received questions from 

some registrants related to the 

requirement that a registration for a 

domestic facility include the email 

address for the contact person of the 

facility. Specifically, some registrants 

have indicated that they are unable to 

obtain email addresses or otherwise use 

computers or similar electronic devices 

because of their religious beliefs. While 

section 415(a)(2) of the FD&C Act 

requires a registration for a domestic 

food facility to include the email 

address for the contact person of the 

facility, such contact person is not 

required to be the owner, operator, or 

agent in charge. Accordingly, a 

registrant can provide the email address 

of a third-party contact person in a 

registration (to be used for email 

communications between FDA and the 

facility), meaning that the registrant 

would not be required to obtain an 

email address or otherwise use a 

computer or similar electronic device 

within this context. 

As further discussed throughout this 

document, it is critical that FDA be able 

to contact facilities in a quick manner in 

the event of a threatened or actual 

terrorist attack, an outbreak of 

foodborne illness, or other food-related 

emergency. Moreover, section 415(a)(2) 

of the FD&C Act, as amended by FSMA, 

specifically requires domestic facilities 

to submit the email addresses of contact 

persons in food facility registrations. For 

these reasons, FDA tentatively 

concludes that all registrations for 


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domestic facilities are required to 

include the email addresses of a contact 

person of the facility. However, FDA 

recognizes that because of religious 

beliefs some registrants may disfavor the 

use of email communications between 

FDA and the facility in non-emergency 

situations, such as for routine 

communications, where the Agency can 

communicate with the facility by postal 

mail. We request comment on whether 

proposed § 1.232 should be modified to 

allow for registrants to request that the 

Agency only use email communications 

in emergency situations, such as during 

a terrorist attack, an outbreak of 

foodborne illness, or other food-related 

emergency. 

5. Email Address for the U.S. Agent as 

Required Information 

Section 415(a)(2) of the FD&C Act, as 

amended by section 102(a) of FSMA, 

requires, among other things, that a 

registration for a foreign facility contain 

the email address of the U.S. agent for 

the foreign facility. This requirement 

went into effect upon enactment of 

FSMA. Proposed § 1.232(c)(1) would 

require that a registration for a foreign 

facility include the email address of the 

foreign facility’s U.S. agent in addition 

to the U.S. agent’s name, full address, 

and phone number. Proposed 

§ 1.232(c)(1) would therefore codify in 

FDA’s registration regulation the 

requirement of section 415(a)(2) of the 

FD&C Act that a registration for a 

foreign facility contain the email 

address of the foreign facility’s U.S. 

agent. 

6. Assurance Statement That FDA Will 

Be Permitted To Inspect 

Section 415(a)(2) of the FD&C Act, as 

amended by section 102(b) of FSMA, 

also requires, among other things, that 

food facility registrations contain an 

assurance that the Secretary (and by 

delegation, FDA) will be permitted to 

inspect such facility at the times and in 

the manner permitted by the FD&C Act. 

This requirement went into effect upon 

enactment of FSMA. Proposed 

§ 1.232(a)(9) would codify such 

requirement in FDA’s registration 

regulations. Specifically, proposed 

§ 1.232(a)(9) would require a food 

facility registration to include 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. 

7. Consequences of Failing To Renew 

Registration 

Currently, § 1.241 specifies the 

consequences of failing to register, 

update, or cancel a food facility 

registration. As described in current 

§ 1.241(a), the failure of an owner, 

operator, or agent in charge of a food 

facility to register its facility, to update 

required elements of its facility’s 

registration, or to cancel its registration 

in accordance with part 1, subpart H is 

a prohibited action under section 

301(dd) of the FD&C Act. Accordingly, 

as further described in current 

§ 1.241(a), the consequences of failing to 

register, update, or cancel a food facility 

registration include civil injunction 

proceedings under section 302 of the 

FD&C Act (21 U.S.C. 332), criminal 

penalties under section 303 of the FD&C 

Act (21 U.S.C. 333), and debarment of 

a person who has been convicted of a 

felony relating to importation of food 

into the United States under section 306 

of the FD&C Act (21 U.S.C. 335a). 

Proposed § 1.241(a) would amend 

current § 1.241(a) by adding the failure 

to renew a food facility registration 

among the list of actions related to food 

facility registration that could subject a 

person to the consequences specified in 

§ 1.241(a). As discussed in section II, 

section 415(a)(3) of the FD&C Act, as 

amended by section 102(a) of FSMA, 

requires registrants to renew their 

facility registrations with FDA every 

other year. This requirement went into 

effect upon enactment of FSMA. 

Further, section 301(dd) of the FD&C 

Act provides that the failure to register 

in accordance with section 415 is a 

prohibited act. On June 2, 2014, FDA 

issued a guidance entitled ‘‘Compliance 

Policy Guide Sec. 100.250 Food Facility 

Registration—Human and Animal 

Food’’ stating that FDA will consider a 

registration to be expired if the 

registration is not renewed, as required 

by section 415(a)(3) of the FD&C Act, 

and the failure of a food facility to 

renew its registration with FDA, as 

required by section 415(a)(3) of the 

FD&C Act, means that the facility has 

failed to register in accordance with 

section 415 of the FD&C Act and thereby 

has committed a prohibited act under 

section 301(dd) of the FD&C Act (Ref. 1). 

Accordingly, in addition to proposing 

to amend § 1.241(a), we are proposing to 

add proposed § 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 § 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. In 

addition, as discussed more fully in 

section III.B.10, under proposed 

§ 1.241(c), FDA would cancel a 

registration that is expired for failure to 

renew if the facility has failed to renew 

its registration in accordance with 

proposed § 1.230(b). 

B. Other Proposed Amendments to 

Registration of Food Facilities 

1. U.S. Agent Information Sharing and 

Responsibilities 

Section 415(a)(1)(B) of the FD&C Act 

provides in relevant part that the 

registration of a foreign food facility 

must include the name of the U.S. agent 

for the facility. Currently, § 1.227(b)(13) 

defines a U.S. agent, in relevant part, as 

a person (as defined in section 201(e) of 

the FD&C Act) residing or maintaining 

a place of business in the United States 

whom a foreign facility designates as its 

agent for purposes of food facility 

registration. In addition, § 1.227(b)(13)(i) 

currently provides that the U.S. agent 

acts as a communications link between 

FDA and the foreign facility for both 

routine and emergency situations and 

that FDA will contact the U.S. agent 

when an emergency occurs, unless the 

registration specifies another emergency 

contact (see also 68 FR 58894 at 58915). 

Further, § 1.227(b)(13)(ii) currently 

provides that 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. 

Section 107 of FSMA amended the 

FD&C Act to provide U.S. agents with 

an additional role. Specifically, section 

107 of FSMA added section 743(a)(1)(A) 

of the FD&C Act, which provides FDA 

with the authority to assess and collect 

fees from the U.S. agent for each foreign 

facility subject to reinspection to cover 

reinspection-related costs. 

In order to further enable U.S. agents 

to serve their intended role, we are 

proposing to amend § 1.227(b)(13)(ii). 

Specifically, we are proposing to add 

that the U.S. agent of a foreign facility 

may view the information submitted in 

the foreign facility’s registration. Making 

registration information available to 

U.S. agents would allow agents to obtain 

the most current information contained 

in FDA’s registration database. U.S. 

agents could use such information to be 

in contact with foreign facilities, thereby 

enabling U.S. agents to more efficiently 

and effectively function as 

communications links between foreign 

food facilities and FDA. (See 

§ 1.227(b)(13)(i) (establishing that a U.S. 

agent ‘‘acts as a communications link 

between FDA and the foreign facility for 

both emergency and routine 

communications’’).) Further, U.S. agents 

could use such information to better 

represent foreign facilities when 


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communicating with FDA. (See 

§ 1.227(b)(13)(ii) (specifying that FDA 

will treat representations by the U.S. 

agent as those of the foreign facility).) 

The proposal is also consistent with the 

status of information and documents 

provided to U.S. agents. Indeed, FDA’s 

current regulations establish that 

‘‘information or documents provided to 

the U.S. agent [are] the equivalent of 

providing the information or documents 

to the foreign facility.’’ 

(§ 1.227(b)(13)(ii).) 

In proposing to make information 

submitted in a foreign facility’s 

registration available to the U.S. agent 

for that facility, we have considered 

FDA’s regulations governing public 

information (21 CFR part 20) among 

other factors. Section 20.21 (21 CFR 

20.21) provides that any record of FDA 

that is disclosed in an authorized 

manner to any member of the public is 

available for disclosure to all members 

of the public (subject to certain 

exceptions). If U.S. agents had the same 

status as any member of the public, 

making registration information 

available to U.S. agents for review likely 

would constitute disclosure to the 

public and obligate FDA to make the 

same records available to any person 

who requests them under the Freedom 

of Information Act (FOIA). FDA 

tentatively concludes, however, that 

U.S. agents for foreign facilities do not 

have the same status as any member of 

the public within the context of 

registration for such facilities. Indeed, 

FDA’s current registration regulations 

establish that U.S. agents function as 

stand-ins for foreign facilities with 

respect to communications and 

information sharing. Specifically, FDA’s 

regulations establish that a U.S. agent 

‘‘acts as a communications link between 

FDA and the foreign facility for both 

emergency and routine 

communications.’’ (§ 1.227(b)(13)(i).) 

Further, FDA’s regulations establish that 

‘‘information or documents provided to 

the U.S. agent [are] the equivalent of 

providing the information or documents 

to the foreign facility.’’ 

(§ 1.227(b)(13)(ii).) Put another way, 

making information or documents 

available to a U.S. agent has the same 

status as making information or 

documents available to a foreign facility. 

Thus, making registration information 

available for review to U.S. agents is the 

equivalent to making that information 

available for review to the U.S. agent’s 

foreign facility. FDA tentatively 

concludes, therefore, that the 

requirement for uniform access in 

§ 20.21 would not be triggered by FDA’s 

proposed amendment to 

§ 1.227(b)(13)(ii). FDA invites comments 

on this tentative conclusion. 

For this same reason, FDA also 

tentatively concludes that making 

foreign facilities’ registration 

information available to U.S. agents is 

consistent with the disclosure provision 

in section 415(a)(5) of the FD&C Act. 

That provision of the FD&C Act 

provides, in relevant part, that FDA’s 

list of registered food facilities and 

registration documents submitted to 

FDA under section 415 shall not be 

subject to disclosure under FOIA. That 

provision also provides that information 

derived from such list shall not be 

subject to disclosure under FOIA to the 

extent that it discloses the identity or 

location of a specific registered person. 

Because § 1.227(b)(13)(ii) establishes 

that ‘‘information or documents 

provided to the U.S. agent [are] the 

equivalent of providing the information 

or documents to the foreign facility,’’ 

FDA’s proposal to allow U.S. agents to 

view a foreign facility’s registration 

information would not result in any 

disclosures. That is, allowing U.S. 

agents to view foreign facilities’ 

registration information is the 

equivalent to allowing foreign facilities 

to view that information. Accordingly, 

FDA tentatively concludes that its 

proposal to amend § 1.227(b)(13)(ii) is 

consistent with the disclosure provision 

in section 415(a)(5) of the FD&C Act. 

2. Verification Procedures for U.S. 

Agent 

Proposed § 1.231(a)(5) and (b)(7) 

would provide that after a foreign 

facility completes its registration or 

updates its U.S. agent information as 

part of registration renewal, FDA will 

email the person identified as the U.S. 

agent for the foreign facility, using the 

email address for the person identified 

as the U.S. agent in the facility’s 

registration, to verify that the person has 

agreed to serve as the facility’s U.S. 

agent. FDA would not confirm the 

foreign facility’s registration or 

registration renewal until that person 

confirms that the person agreed to serve 

as the U.S. agent for the foreign facility. 

In addition, with respect to initial 

registrations, FDA will not provide the 

facility with a registration number until 

that person confirms that the person 

agreed to serve as the U.S. agent for the 

foreign facility. Proposed § 1.231(a)(5) 

would apply this verification 

requirement to electronic registrations, 

and proposed § 1.231(b)(7) would apply 

this requirement to registrations 

submitted by mail or fax. Under 

proposed § 1.234(c)(2) and (d)(5), this 

verification step would also take place 

when foreign facilities update U.S. agent 

information. Those proposed provisions 

provide that when updating U.S. agent 

information, FDA will email the person 

identified as the U.S. agent for the 

foreign facility, using the email address 

for the person identified as the U.S. 

agent in the facility’s registration, to 

verify that the person has agreed to 

serve as the U.S. agent. Under proposed 

§ 1.234(c)(2) and (d)(5), FDA would not 

provide an update confirmation until 

that person confirms that the person 

agreed to serve as the U.S. agent for the 

foreign facility. Proposed § 1.234(c)(2) 

would apply this verification 

requirement to electronic updates, and 

proposed § 1.234(d)(5) would apply this 

requirement to updates submitted by 

mail or fax. 

We are proposing this verification 

step for three reasons. First, we have 

learned that in some cases persons 

identified as U.S. agents in foreign food 

facility registrations were unaware that 

they had been so identified, and had not 

in fact agreed to serve as U.S. agents. 

Adding a verification step would help 

ensure that FDA’s registration database 

is accurate and up to date. Second, the 

verification step would allow FDA to 

more efficiently enforce section 743 of 

the FD&C Act. As stated elsewhere in 

this proposed rule, section 743(a)(1)(A) 

of the FD&C Act authorizes FDA to 

assess and collect fees from the U.S. 

agent for each foreign facility subject to 

reinspection to cover reinspectionrelated costs. Verifying that individuals 

identified as U.S. agents in foreign 

facilities’ registrations have actually 

agreed to serve as U.S. agents for those 

facilities would help ensure that FDA is 

assessing and collecting foreign facility 

reinspection fees from the appropriate 

individuals and allow for efficient 

enforcement of section 743 of the FD&C 

Act. Third, section 305(d) of the 

Bioterrorism Act (Pub. L. 107–188) 

directs FDA, in relevant part, to ensure 

adequate authentication protocols are 

used to enable identification of the 

registrant and validation of the 

registration data, as appropriate, for 

registrations submitted to FDA 

electronically. FDA tentatively 

concludes that a verification step for 

U.S. agent information would serve as 

an authentication protocol and help 

validate registration data concerning 

U.S. agents, including in those 

registrations submitted electronically. 

We seek comments on these proposed 

provisions, including on whether the 

proposed email verification step will be 

effective in preventing the unauthorized 

listing of persons as U.S. agents. 

Further, we seek comment on the 

effectiveness of this proposed email 

verification step in connection with two 


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19170 Federal Register / Vol. 80, No. 68 / Thursday, April 9, 2015 / Proposed Rules 

other ideas about which we request 

comment elsewhere in this document: 

The idea for a U.S. Agent Voluntary 

Identification System discussed in 

section III.C., and the idea to require 

Data Universal Numbering System (D– 

U–N–S®) numbers for U.S. agents 

discussed in section III.B.3. We also 

seek comments on what alternative 

approaches, if any, FDA should take to 

prevent unauthorized U.S. agent 

listings. 

3. Proposed Requirement for D–U–N–S®

Number and Verification Procedures 

Proposed § 1.232(a)(2) would require 

the D–U–N–S® number of a domestic 

and foreign facility be included in the 

facility’s registration. This requirement 

would function in connection with 

proposed § 1.231(a)(3) and (b)(5), which 

provide that after a facility completes its 

registration or updates its D–U–N–S®

number as part of registration renewal, 

FDA will verify the accuracy of the food 

facility’s D–U–N–S® number and will 

also verify that the facility-specific 

address associated with the D–U–N–S®

number is the same address associated 

with the facility’s registration. Under 

proposed § 1.231(a)(3) and (b)(5), FDA 

would not confirm a food facility’s 

registration or registration renewal until 

FDA verifies the accuracy of its D–U–N– 

S® number and verifies that the facilityspecific address associated with the D– 

U–N–S® number is the same address 

associated with the facility’s 

registration. With respect to initial 

registrations, proposed § 1.231(a)(3) and 

(b)(5) would also provide that FDA 

would not provide a facility with a 

registration number until FDA verifies 

the accuracy of its D–U–N–S® number 

and verifies that the facility-specific 

address associated with the D–U–N–S®

number is the same address associated 

with the facility’s registration. Proposed 

§ 1.231(a)(3) would apply this 

verification requirement to electronic 

registrations, and proposed § 1.231(b)(5) 

would apply this requirement to 

registrations submitted by mail or fax. 

The requirement to submit D–U–N–S®

numbers would also function in 

connection with proposed § 1.234(c)(2) 

and (d)(5), which provide that FDA will 

perform the same verification step after 

facilities complete their registration 

updates. Under proposed § 1.234(c)(2) 

and (d)(5), FDA would not provide an 

update confirmation until FDA verifies 

the accuracy of the food facility’s D–U– 

N–S® number and also verifies that the 

facility-specific address associated with 

the D–U–N–S® number is the same 

address associated with the facility’s 

registration. Proposed § 1.234(c)(2) 

would apply this verification 

requirement to electronic updates, and 

proposed § 1.234(d)(5) would apply this 

requirement to updates submitted by 

mail or fax. 

Dun & Bradstreet assigns and 

maintains a database of the D–U–N–S®

numbers, which serve as unique 

identifiers (codes) of business entities. A 

D–U–N–S® number is a unique ninedigit sequence provided by Dun & 

Bradstreet that can be specific for each 

site. The site-specific number is a 

widely recognized business 

identification tool and serves as a useful 

resource for FDA in identifying and 

verifying certain business information 

submitted by a user. Upon application, 

each physical location of a business 

entity may be assigned a distinct sitespecific nine-digit D–U–N–S® number. 

D–U–N–S® Numbers are proprietary to 

and controlled by Dun & Bradstreet 

(D&B). 

If a food facility has not obtained a D– 

U–N–S® number, it may obtain one for 

no cost directly from Dun & Bradstreet 

(http://www.dnb.com). If a registrant 

does not include a D–U–N–S® number 

for its facility in a registration, FDA 

intends to make arrangements for 

obtaining a D–U–N–S® number for the 

facility by providing a direct link to Dun 

and Bradstreet in the registration 

system. FDA intends to allow a 

registrant attempting to register a facility 

without a D–U–N–S® number to 

temporarily save its registration 

information in the registration system 

and return to the registration system to 

complete its registration once the 

required D–U–N–S® number is 

obtained. Having registration 

information saved in the registration 

system, however, would not be 

equivalent to completing a registration. 

As discussed previously, under 

proposed § 1.231(a)(3) and (b)(5), FDA 

would not confirm a food facility’s 

registration or registration renewal until 

FDA verifies the accuracy of its D–U–N– 

S® number and verifies that the facilityspecific address associated with the D– 

U–N–S® number is the same address 

associated with the facility’s 

registration. 

FDA’s tentative decision to require 

and verify D–U–N–S® numbers is 

grounded in the statutory objective of 

efficiently enforcing the food safety and 

other requirements of the FD&C Act. By 

requiring D–U–N–S® numbers of 

facilities, FDA would be able to verify 

the facility-specific address information 

associated with those numbers. Such 

verification would increase the accuracy 

of FDA’s food facility registration 

database. As a consequence, FDA 

investigators would have access to more 

accurate food facility information, and 

would therefore be able to more 

efficiently identify and locate food 

facilities for inspection. As a result, 

FDA would be able to more efficiently 

conduct inspections under section 704 

to enforce the food safety and other 

requirements of the FD&C Act. 

FDA’s tentative decision to require D– 

U–N–S® numbers in food facility 

registration is also consistent with 

FDA’s mandate under section 415(a)(5) 

of the FD&C Act to compile and 

maintain an up-to-date list of registered 

food facilities, as well as the 

requirement in section 415(a)(2) of the 

FD&C Act that registrants submit 

information necessary to notify FDA of 

the name and address of each facility at 

which the registrant conducts business. 

Indeed, the verification that D–U–N–S®

numbers provides would help ensure 

that the food facility list is up to date 

and contains accurate information 

concerning the addresses of food 

facilities. Moreover, an up-to-date list 

that includes information necessary to 

notify FDA of the name and address of 

food facilities would aid FDA in 

efficiently responding to a terrorist 

threat or other food-related emergency. 

Finally, FDA’s tentative decision to 

require D–U–N–S® numbers is 

consistent with the direction contained 

in section 305(d) of the Bioterrorism Act 

(Pub. L. 107–188) to ensure adequate 

authentication protocols to enable 

identification of the registrant and 

validation of the registration data for 

registrations submitted to FDA 

electronically. FDA tentatively 

concludes that verifying information in 

connection with a D–U–N–S® number 

for a food facility would provide FDA 

with a protocol to enable FDA to 

identify food facilities and verify certain 

registration information for those 

facilities. We are seeking comment on 

these proposed provisions. 

In addition to requesting comment on 

the proposals related to requiring 

facility-specific D–U–N–S® numbers, 

we request comment on whether FDA 

should require use of a different facility 

identifier and, if so, what that identifier 

should be. If you recommend that FDA 

use a different identifier, we request 

comment on whether FDA should verify 

that identifier and whether FDA should 

verify facility-specific address 

information in connection with that 

identifier. We also request comment on 

whether FDA should also require that 

the registrations of foreign facilities also 

include a D–U–N–S® number or other 

identifier for the facility’s U.S. agent. To 

the extent FDA does pursue a D–U–N– 

S® number requirement, we seek 

comment on whether, as with the D–U– 

N–S® number for food facilities, FDA 


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should verify the accuracy of the U.S. 

agent D–U–N–S® numbers and whether 

FDA should verify that the contact 

information associated with the D–U– 

N–S® numbers is the same contact 

information submitted as part of the 

foreign food facilities’ registrations. In 

addition, we request comment on 

whether FDA should perform such 

verification after a facility completes or 

updates its registration, and whether 

FDA should verify this information 

prior to confirming a food facility’s 

registration, prior to confirming a 

registration renewal, prior to providing 

an update confirmation, and prior to 

providing the facility with a registration 

number when the facility first registers. 

If you recommend that FDA require that 

registrations of foreign facilities include 

an identifier other than a D–U–N–S®

number for their U.S. agents, we request 

comment on whether FDA should verify 

that identifier and whether FDA should 

verify contact information in connection 

with that identifier. 

We are requesting comment related to 

requiring D–U–N–S® numbers and other 

identifiers for U.S. agents because FDA 

has encountered instances in which 

foreign food facilities have included 

invalid U.S. agent information in their 

registrations. We are considering 

whether to require D–U–N–S® numbers 

or other identifiers for U.S. agents and 

verify the information associated with 

such numbers in order to increase the 

accuracy and reliability of the U.S. agent 

information. We also believe that more 

accurate U.S. agent information would 

allow FDA to more efficiently enforce 

section 743 of the FD&C Act, which 

authorizes FDA to assess and collect 

fees from the U.S. agent for each foreign 

facility subject to reinspection to cover 

reinspection-related costs. In addition, 

and as noted elsewhere in this proposed 

rule, section 305(d) of the Bioterrorism 

Act (Pub. L. 107–188) directs FDA, in 

relevant part, to ensure adequate 

authentication protocols are used to 

enable identification of the registrant 

and validation of the registration data, 

as appropriate, for registrations 

submitted to FDA electronically. FDA 

believes that requiring D–U–N–S®

numbers or other identifiers and 

verifying information associated with 

such numbers could serve as an 

authentication protocol and help 

validate registration data concerning 

U.S. agents, including in those 

registrations submitted electronically. 

We seek comment on whether the D–U– 

N–S® numbers or other identifiers for 

U.S. agents and verification of such 

numbers and related information would, 

in fact, increase the accuracy and 

reliability of the U.S. agent information. 

We also seek comment on any burdens 

that requiring D–U–N–S® numbers or 

other identifiers for U.S. agents would 

entail, both for foreign facilities and any 

persons registered as U.S. agents. 

4. Proposed Requirement for Email 

Address of Owner, Operator or Agent in 

Charge Who Authorized a Third Party 

To Act on Behalf of the Facility and 

Verification Procedure 

The only individuals permitted to 

register a facility are the owner, 

operator, or the agent in charge of the 

facility or an individual authorized to 

register the facility on behalf of the 

owner, operator, or agent in charge. 

(Section 415(a)(1) of the FD&C Act; 

§§ 1.225 and 1.232 (21 CFR 1.225 and 

1.232).) Currently, § 1.232(i) provides 

that if the individual submitting the 

registration form is not the owner, 

operator, or agent in charge of the 

facility, the registration must 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. We are proposing to 

recodify this provision at § 1.232(a)(10), 

and also to add the email address of the 

individual who authorized submission 

of the registration to the list of required 

information identifying the individual 

who authorized submission of such 

registrations. Proposed § 1.230(b) would 

apply this requirement to registration 

renewals. Thus, for registrations and 

registration renewals submitted by an 

individual who is not the owner, 

operator, or agent in charge, such 

submissions would be required to 

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, email address, and telephone 

number, the individual who authorized 

submission of the registration. In 

addition, proposed § 1.234(a) would 

provide that updates not submitted by 

the owner, operator, or agent in charge 

of the facility must include the email 

address of the owner, operator, or agent 

in charge who authorized submission of 

the update, and proposed § 1.235(b)(5) 

would provide this same email address 

requirement for cancellations not 

submitted by the owner, operator, or 

agent in charge of the facility. 

These requirements would function in 

connection with proposed §§ 1.231(a)(4) 

and (b)(6), 1.234(c)(3) and (d)(6), and 

1.235(c)(3) and (d)(6), which provide a 

verification step for electronic 

registrations and registration renewals, 

mail/fax registrations and registration 

renewals, electronic updates, mail/fax 

updates, electronic cancellations, and 

mail/fax cancellations not submitted by 

the owner, operator or agent in charge 

of the facility. Specifically, these 

proposals provide that after completion 

of such submissions, FDA will email the 

individual identified as the owner, 

operator, or agent in charge who 

authorized the submission to verify that 

the individual in fact authorized the 

submission on behalf of the facility. 

Under proposed § 1.231(a)(4) and (b)(6), 

FDA would not confirm the registration 

or provide a registration number until 

that individual confirms that he or she 

authorized the registration. With respect 

to registration renewals, proposed 

§ 1.231(a)(4) and (b)(6) provide that FDA 

would not provide a confirmation of the 

registration renewal until the individual 

confirms that he or she authorized the 

registration renewal. Under proposed 

§ 1.234(c)(3) and (d)(6), FDA would not 

confirm a registration update until the 

individual identified as the owner, 

operator, or agent in charge who 

authorized the update confirms that he 

or she in fact authorized the update on 

behalf of the facility. And under 

proposed § 1.235(c)(3) and (d)(6), FDA 

would not confirm a registration 

cancellation until the individual 

identified as the owner, operator, or 

agent in charge who authorized the 

update confirms that he or she in fact 

authorized the cancellation on behalf of 

the facility. Proposed § 1.231(a)(4) 

would apply this verification 

requirement to electronic registrations 

and registration renewals; proposed 

§ 1.231(b)(6) would apply the 

verification requirement to registration 

and registration renewals submitted by 

mail or fax; proposed § 1.234(c)(3) 

would apply the verification 

requirement to electronic updates; 

proposed § 1.234(d)(6) would apply the 

verification requirement to updates 

submitted by mail or fax; proposed 

§ 1.235(c)(3) would apply the 

verification requirement to electronic 

cancellations; and proposed 

§ 1.235(d)(6) would apply the 

verification requirement to cancellations 

submitted by mail or fax. 

We are proposing this email 

requirement and verification step to 

address a problem with unauthorized 

third party registration submissions that 

FDA has encountered in the course of 

implementing food facility registration. 

In some cases, this has resulted in 

duplicate registrations for foreign food 

facilities. In other cases, registrations 


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have been created for facilities that do 

not in fact manufacture/process, pack, 

or hold food for consumption in the 

United States. Unauthorized third party 

registrations threaten the accuracy of 

FDA’s food facility registration database, 

resulting in false entries that make it 

more difficult for the Agency to use its 

database to respond to food-related 

emergencies, as well as to identify food 

facilities for inspection. Such 

registrations also create potential 

problems for the facilities that are the 

subject of the unauthorized 

registrations. We tentatively conclude 

that the proposed email address and 

verification requirements are necessary 

to ensure the accuracy and truthfulness 

of food facility registrations. By 

requiring the email address of the 

owner, operator, or agent who 

authorizes third party registration 

submissions and using that email 

address to conduct a verification step, 

we believe that we would incentivize 

authorized, truthful registration 

submissions. As such, we tentatively 

conclude that these proposals would 

assist FDA in efficiently meeting its 

statutory obligation under section 

415(a)(5) of the FD&C Act to compile 

and maintain an up-to-date list of food 

facilities. We further tentatively 

conclude that these proposals would 

help in ensuring compliance with 

section 415(a)(1) of the FD&C Act. 

Under section 415(a)(1) of the FD&C Act 

and §§ 1.225 and 1.232, the only 

individuals permitted to register a 

facility are the owner, operator, or agent 

in charge of the facility or an individual 

authorized to register the facility on 

behalf of the owner, operator, or agent 

in charge. Registrations submitted by 

non-authorized individuals would not 

be in compliance with those provisions. 

In addition, we tentatively conclude 

that the proposed email address and 

verification step requirements would 

assist FDA in achieving the key 

objectives of food facility registration. 

Those objectives include using the 

registration database to prevent and 

respond to food-related emergencies, 

and meeting them requires an accurate 

and up-to-date list of registered 

facilities. Finally, we tentatively 

conclude that the proposals are 

consistent with section 305(d) of the 

Bioterrorism Act (Pub. L. 107–188), 

which directs FDA, in relevant part, to 

ensure adequate authentication 

protocols are used to enable 

identification of the registrant and 

validation of the registration data, as 

appropriate, for registrations submitted 

to FDA electronically. FDA tentatively 

concludes that the proposed verification 

step for registration submissions made 

by individuals other than the owner, 

operator, or agent in charge would serve 

as an authentication protocol and help 

validate registration data. 

We seek comment on these proposed 

provisions, including on whether the 

proposed email verification step will be 

effective in preventing the unauthorized 

submission of registrations, registration 

renewals, updates, and cancellations. 

We also seek comment on whether we 

should require any alternative or 

additional checks to ensure that the 

individual registering a facility is 

authorized to do so by the owner, 

operator, and agent in charge. For 

instance, should FDA require that 

owners, operators, or agents in charge 

create some type of authorization 

documentation to provide 

documentation for the fact that the 

owner, operator or agent in charge has 

authorized the individual to make a 

registration submission? If so, should 

such documentation be required to be 

submitted to FDA or maintained at the 

facility? Should such documentation 

include a letter signed by the owner, 

operator, or agent in charge authorizing 

the individual to make a registration 

submission? Are there other types of 

documentation that would provide 

another check that is necessary to 

ensure that the owner, operator, or agent 

in charge in fact provided 

authorization? 

5. Proposal To Require Certain 

Information in Food Facility 

Registration That Is Currently Optional 

a. Preferred mailing address 

information. Proposed § 1.232(a)(3) 

would require that domestic and foreign 

food facilities provide a preferred 

mailing address if such mailing address 

is different from the mailing address of 

the facility. We are proposing to require 

this information because we need to be 

able to efficiently contact food facilities 

with information regarding potential 

food-related emergencies and, when 

applicable, information regarding a 

suspension of a food facility’s 

registration. If food facilities provide 

preferred mailing addresses that are 

different from the mailing address of a 

food facility, FDA would be able to 

more efficiently contact food facilities 

and share such information. Proposed 

§ 1.232(a)(3) would therefore assist FDA 

in efficiently enforcing section 415 of 

the FD&C Act. We are seeking 

comments on this proposed provision. 

b. Email address for the owner, 

operator or agent in charge of the 

facility. Currently § 1.232(c) requires a 

food facility registration to include the 

name, address, and phone number of 

the owner, operator, or agent in charge 

of domestic and foreign facilities, but 

does not require that individual’s email 

address. Proposed § 1.232(a)(6) would 

add email address to the contact 

information required for the owner, 

operator, or agent in charge of the 

facility (for both domestic and foreign 

facilities). Although the FSMA 

amendments provide that registrations 

for domestic food facilities are now 

required to contain the email address for 

the contact person of the facility, often 

the contact person for the facility is not 

the same as the owner, operator, or 

agent in charge of the facility. We are 

proposing to require email addresses for 

the owner, operator, or agent in charge 

of food facilities in order to facilitate 

quick communications with those 

individuals. Such communications may 

be necessary in the event of food-related 

emergencies and, where applicable, 

suspensions of a food facility’s 

registration. Accordingly, we tentatively 

conclude that such information is 

necessary for FDA’s efficient 

enforcement of section 415 of the FD&C 

Act. 

We are proposing this requirement in 

addition to the requirements in 

§§ 1.232(a)(10), 1.230(b), 1.234(a), and 

1.235(b)(5) discussed earlier in this 

document with respect to registrations, 

registration renewals, updates, and 

cancellations submitted by individuals 

other than the owner, operator, or agent 

in charge of the facility. For such 

submissions, we are proposing in 

§§ 1.232(a)(10), 1.230(b), 1.234(a), and 

1.235(b)(5) to require the email address 

of the owner, operator, or agent in 

charge who authorized such 

submissions. We realize that in some 

cases the owner, operator, or agent in 

charge email address in proposed 

§ 1.232(a)(6) may be the same email 

address as the email address for the 

owner, operator, or agent in charge who 

authorized third party registration 

submissions in proposed 

§§ 1.232(a)(10), 1.230(b), 1.234(a), and 

1.235(b)(5). In some cases, however, the 

email addresses might differ. 

We are seeking comments on this 

proposed provision. Further, we are 

seeking comments on whether a waiver 

for this proposed requirement should be 

available in limited circumstances such 

as when and if the religious beliefs of an 

owner, operator or agent in charge 

prevent that individual from obtaining 

an email address. We are also seeking 

comments on how a food facility should 

request such a waiver, including 

whether such waivers should be 

requested in writing. 

c. Type of activity conducted at the 

facility. Proposed § 1.232(a)(8) would 


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require the type of activity conducted at 

the facility for each food product 

category identified. In addition, 

proposed § 1.232(a)(8) would require 

facilities to choose among the following 

activity types: (1) Ambient human food 

storage warehouse/holding facility; (2) 

Refrigerated human food warehouse/

holding facility; (3) Frozen human food 

warehouse/holding facility; (4) 

Interstate conveyance caterer/catering 

point; (5) Contract Sterilizer; (6) 

Labeler/Relabeler; (7) Manufacturer/

Processor; (8) Farm Mixed-Type 

Facility; (9) Packer/Repacker; (10) 

Salvage Operator (Reconditioner); (11) 

Animal food warehouse/holding 

facility; and (12) Other Activity. 

Facilities would be permitted to select 

more than one activity type for each 

food product category identified. The 

‘‘Other Activity’’ option would only be 

available if the facility engages in an 

activity that is not covered by the other 

options. Facilities that select ‘‘Other 

Activity’’ would be required to enter 

text onto the food facility registration 

form describing the activity. 

FDA believes that information 

regarding activity type is necessary to 

assist the Agency in using its limited 

resources efficiently, including with 

regard to inspectional oversight. Among 

other purposes, food facility registration 

was designed to provide FDA with a 

complete list of foreign and domestic 

facilities that manufacture/process, 

pack, or hold food for consumption into 

the United States. In the approximately 

10 years since food facility registration 

was originally implemented, the list of 

facilities has helped FDA accomplish 

one of its most important regulatory 

activities: Scheduling and planning 

inspections of establishments in which 

foods are manufactured/processed, 

packed, or held under section 704 of the 

FD&C Act. Specifically, FDA has used 

the food facility registration list to 

identify food facilities for inspection. 

Although the creation of food facility 

registration has led to improvements in 

FDA’s ability to identify food facilities 

for inspection, the limited nature of the 

information provided through food 

facility registration has meant that the 

information has not functioned as the 

most efficient tool for planning 

inspections. For instance, registrants 

have not been required to provide the 

Agency with such basic information as 

whether a facility manufactures/

processes or holds foods, or both. The 

difference between manufacturing/

processing and holding is important. 

FDA might prepare for inspections of 

manufacturing/processing and holding 

facilities quite differently, and might 

assign different personnel for the 

different types of inspections. With 

information about activity type, 

however, the Agency would be better 

able to prepare investigators for 

inspections and assign appropriate 

investigators. This would provide for 

more efficient use of the Agency’s 

limited inspectional resources, as 

sending appropriate, well-prepared 

investigators helps ensure that 

inspections are thorough and 

meaningful. Requiring information 

regarding activity type would therefore 

allow for the more efficient use of FDA’s 

inspectional authority under section 

704. 

The activity type requirement would 

serve additional purposes as well. 

Information about a facility’s activity 

type would provide FDA with important 

information regarding a facility’s role in 

the U.S. food supply system. This 

would allow FDA to better assess the 

facility’s potential impact in cases of 

bioterrorist incidents or other foodrelated emergencies. Better information 

about a facility’s impact would assist 

FDA in using its limited resources 

efficiently during such incidents, for 

instance helping the Agency identify 

manufacturers/processors that may 

receive contaminated ingredients or 

frozen storage facilities impacted by 

power outages. The improved 

information would also allow FDA to 

communicate more quickly and 

efficiently on various non-emergency 

issues, such as new regulatory 

requirements or policies. 

In addition, the activity type 

information would aid FDA in 

implementing FSMA’s mandate to 

determine inspectional frequency based 

on safety risks. Specifically, section 

201(a) of FSMA created section 421 of 

the FD&C Act, which requires the 

Agency to identify high-risk facilities 

and mandates more frequent inspections 

for domestic high-risk facilities than for 

domestic non-high-risk facilities. For 

the purposes of section 421, the term 

‘‘facility’’ refers to facilities that are 

required to register under section 415. 

(See section 421(e).) Section 421(a)(1) 

sets forth the factors for FDA to use in 

identifying high-risk facilities, which 

include ‘‘[a]ny . . . criteria deemed 

necessary and appropriate by the 

Secretary for purposes of allocating 

inspection resources.’’ (Section 

421(a)(1)(F).) Among the criteria the 

Agency has deemed necessary and 

appropriate for this purpose are type of 

activity conducted at the facility 

(manufacturer/processor, packer/

repacker, etc.). Because section 421’s 

risk-based inspection mandate applies 

to facilities registered under section 415, 

and because the Agency has identified 

information about the type of activity 

conducted at a facility as an important 

factor to consider when identifying 

high-risk facilities under section 421, 

FDA tentatively concludes that the 

proposed activity type requirement for 

registration would allow the Agency to 

more efficiently enforce section 421. 

For all of these reasons, FDA 

tentatively concludes that section 415 of 

the FD&C Act, along with sections 421, 

701(a), and 704, authorize FDA to 

require the submission of the activity 

type information specified in this 

proposed rulemaking. 

Although proposed § 1.232(a)(8) lists 

the specific activity types that food 

facilities must select, the proposed 

provision does not define those activity 

types. FDA is requesting comments on 

whether it should define the specified 

activity types in FDA’s food facility 

registration regulations. To the extent 

that FDA does define the activity types, 

FDA anticipates that the Agency would 

model the activity type definitions from 

the definitions for establishment types 

contained in the Agency’s Field 

Management Directive (Ref. 2), while 

also modifying the Field Management 

Directive definitions to reflect the 

nature of activities conducted by 

registered food facilities and the 

information required on other parts of 

the food facility registration form. FDA 

tentatively concludes that modeling the 

activity type definitions from the Field 

Management Directive definitions 

would allow for the efficient use of FDA 

inspectional resources. FDA 

investigators are already familiar with 

the Field Management Directive, and 

consistency between the food facility 

registration and Field Management 

Directive definitions would minimize 

confusion about the nature of activities 

performed at food facilities. FDA’s 

tentative definitions for food facility 

activity types for food facilities that are 

required to register under section 415 of 

the FD&C Act are as follows: 

• 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–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). 


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• 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 sterilization or irradiation of 

foods or components of foods. 

• 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 nonfarm facility that makes food from one 

or more ingredients, or synthesizes, 

prepares, treats, modifies, or 

manipulates food, including food crops 

or ingredients. For purposes of this 

activity type option, examples of 

manufacturing/processing activities are 

cutting, peeling, trimming, washing, 

waxing, eviscerating, rendering, 

cooking, baking, freezing, cooling, 

pasteurizing, homogenizing, mixing, 

formulating, bottling, milling, grinding, 

extracting juice, distilling, or packaging. 

• Farm Mixed-Type Facility: An 

establishment that grows and harvests 

crops or raises animals and may 

conduct other activities within the farm 

definition in § 1.227, but also conducts 

activities that require the establishment 

to be registered. 

• 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. 

FDA requests comment on whether 

the above definitions provide sufficient 

information for food facilities to select 

from the activity type options. To the 

extent that the definitions do not 

provide sufficient information, FDA 

requests comment on how the activity 

type definitions should be amended. In 

addition to seeking comment on 

whether and how to define the above 

activity types, FDA seeks comment on 

whether the activity types listed in 

proposed § 1.232(a)(8) encompass the 

full range of activities conducted by 

registered food facilities and whether 

they are otherwise appropriate. FDA 

selected the list of activity types in 

proposed § 1.232(a)(8) because that list 

largely reflects the optional activity 

types on current Form FDA 3537. At the 

same time, we are proposing several 

modifications to the current optional list 

of activity types. The modifications are 

designed to help FDA communicate 

more quickly with food facilities in the 

case of food-related emergencies, as well 

as to more accurately reflect the types of 

activities conducted at human and 

animal food facilities. Such 

modifications include dividing the 

optional activity type of ‘‘warehouse/

holding facility’’ for facilities that hold 

food for human consumption into three 

subcategories. Those three subcategories 

would be ‘‘ambient human food 

temperature warehouse/holding 

facility,’’ ‘‘refrigerated human food 

warehouse/holding facility,’’ and 

‘‘frozen human food warehouse/holding 

facility.’’ These additional subcategories 

would enable FDA to more quickly alert 

facilities potentially affected by an 

emergency food incident if FDA 

receives information indicating the type 

of facility affected. For example, if FDA 

receives information indicating that 

refrigerated or frozen warehouses/

holding facilities could be affected by 

power outages, FDA would be able to 

communicate with such facilities about 

the incident. For animal food 

warehouse/holding facilities, however, 

FDA is not proposing to modify the 

activity types (that are currently 

optional) on current Form FDA 3537. 

FDA has tentatively concluded that the 

nature of animal food warehouse/

holding facilities differs from human 

food warehouse/holding facilities, and 

that the current list of activity types— 

which has only one option for 

warehouse/holding—sufficiently 

enables FDA to respond quickly in the 

case of emergencies related to animal 

food. Indeed, animal food warehouse/

holding facilities typically hold or store 

animal food at ambient temperature, 

negating the need for FDA to have 

information about the temperature 

storage conditions at animal food 

facilities. 

In addition, FDA is proposing to add 

a ‘‘farm mixed-type facility’’ activity 

type option. FDA is proposing to add 

this activity type option in order to help 

the Agency efficiently inspect farm 

mixed-type facilities. The expertise 

required to inspect such facilities may 

differ from the expertise required to 

inspect non-farm manufacturing/

processing facilities. Information about 

whether a facility is a farm mixed-type 

facility would therefore allow FDA to 

identify appropriate investigators to 

conduct such inspections. 

Another change FDA is proposing to 

make from the optional activity types on 

current Form FDA 3537 is to eliminate 

the ‘‘commissary’’ activity type option. 

FDA is proposing this change because 

the Agency has tentatively concluded 

that the other activity type options 

listed in proposed § 1.232(a)(8)(i) 

through (a)(8)(xi) sufficiently address 

the types of activities conducted by 

facilities that identify as commissaries 

and that are required to register under 

section 415 of the FD&C Act. 

Finally, FDA seeks comment on 

whether low-acid and acidified food 

processing should be treated as activity 

types, or whether there should be food 

product category options related to lowacid canned foods and acidified foods, 

or both. Currently, low-acid food and 

acidified food processing are optional 

activity types on current Form FDA 

3537. In addition, FDA identified lowacid canned food products and acidified 

foods as food product categories in the 

October 2012 guidance the Agency 

issued concerning food product 

categories. (See ‘‘Necessity of the Use of 

Food Product Categories in Food 

Facility Registrations and Updates to 

Food Product Categories.’’) As a result 

of the October 2012 guidance, low-acid 

foods and acidified foods have been 

listed on Form FDA 3537 as food 

product categories, while also being 

included as optional activity types. FDA 

recognizes that it may be confusing and 

redundant for there to be both food 

product categories and activity type 

categories related to low-acid canned 

foods and acidified foods. FDA also 

recognizes that the food product 

categories for low-acid canned foods 

and acidified foods may be broad in 

certain circumstances and may 

encompass a number of foods for which 

there may also be other applicable food 

categories. For example, a low-acid food 

might also be a baby food, which is 

another food product category option. 

And an acidified food might also be a 

fruit or fruit product, which is also 

another food product category option. A 

facility that manufactures/processes, 

packs, or holds low-acid food that is a 

baby food or an acidified food that is 

fruit or fruit product might therefore be 

confused about which food product 

categories to select. Accordingly, FDA 

seeks comment on whether low-acid 

and acidified foods should be included 

in only one portion of Form FDA 3537. 

We further seek comment on whether to 

include these products in the activity 

type section or the food product 

category section of Form FDA 3537. We 

also seek comment on all aspects of our 

proposal related to requiring food 

facilities to identify the type of activity 

conducted at the facility for each food 

product category identified. 

d. Email address of the emergency 

contact of a domestic facility. Proposed 


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§ 1.232(b)(2) would add an email 

address to the emergency contact 

information registrants are required to 

provide for a domestic facility. Thus, in 

addition to the emergency contact 

phone number required under current 

§ 1.232(e), registrants would also be 

required to provide an emergency 

contact email address. This proposed 

change would not affect the role of the 

emergency contact information. The 

emergency contact information would 

continue to be used in the event that we 

need to correspond with the facility 

during a terrorist threat or other foodrelated emergency. The purpose of 

requiring an email address is that such 

information would provide an efficient 

method of reaching the emergency 

contact in addition to the already 

required emergency contact phone 

number. We realize that in some cases 

the emergency contact email address 

may be the same email address as the 

email address for the facility contact 

person required in proposed 

§ 1.232(b)(1) for domestic facilities. 

Consequently, proposed § 1.232(b)(2) 

would require an emergency contact 

email address to be provided only if that 

email address is different from the 

facility contact person email address 

required in proposed § 1.232(b)(1). 

Accordingly, the email address for the 

facility contact person required in 

proposed § 1.232(b)(1) would serve as 

the default emergency contact email 

address unless a facility provides a 

different emergency contact email 

address. We are seeking comments on 

this proposed provision. 

6. Proposal To Identify and Update 

Food Product Categories 

Proposed § 1.232(a)(7) would retain 

the requirement in current § 1.232(g) 

that food facilities provide information 

regarding food product categories, but 

would change that requirement to be 

consistent with the changes FDA has 

made to food product categories in 

response to the FSMA amendments. 

Section 415(a)(2) of the FD&C Act, as 

added by section 305 of the Bioterrorism 

Act, provided in relevant part that, 

when determined necessary by FDA 

‘‘through guidance,’’ a registrant must 

submit a registration to FDA containing 

information necessary to notify FDA of 

the general food category (as identified 

in § 170.3) of food manufactured, 

processed, packed, or held at such 

facility. On July 17, 2003, FDA issued a 

guidance document stating that FDA 

had determined that the inclusion of 

food product categories in food facility 

registrations was necessary for a quick, 

accurate, and focused response to an 

actual or potential bioterrorist incident 

or other food-related emergency (see 68 

FR 42415). On October 10, 2003, FDA 

issued an interim final rule that also 

required facilities to submit registrations 

to FDA containing information 

regarding applicable food product 

categories as identified in § 170.3. 

Specifically, current § 1.232(g) provides 

that food facility registrations include 

applicable food product categories as 

defined in § 170.3, unless facilities 

check either ‘‘most/all human food 

product categories,’’ according to 

§ 1.233(j), or ‘‘none of the above 

mandatory categories’’ because a facility 

manufactures/processes, packs, or holds 

a food that is not identified in § 170.3. 

On October 3, 2005, FDA issued a final 

rule for food facility registration, which 

generally confirmed the interim final 

rule (70 FR 57505). 

As discussed previously, section 102 

of FSMA amends section 415(a)(2) of 

the FD&C Act, to now provide, in 

relevant part, that, when determined 

necessary by FDA ‘‘through guidance,’’ 

a registrant is required to submit a 

registration to FDA containing 

information necessary to notify FDA of 

the general food category (as identified 

in § 170.3 or any other food categories, 

as determined appropriate by FDA, 

including by guidance) of any food 

manufactured, processed, packed, or 

held at such facility. In October 2012, 

FDA issued a guidance document 

entitled ‘‘Guidance for Industry: 

Necessity of the Use of Food Product 

Categories in Food Facility Registrations 

and Updates to Food Product 

Categories’’ (Ref. 3). This guidance 

document represents FDA’s conclusion 

on the necessity of food product 

categories in food facility registrations 

and identifies additional food product 

categories, as provided by section 

415(a)(2) of the FD&C Act. In the 

guidance document, FDA explained that 

because of Congress’s explicit statutory 

authorization to effectuate a binding 

requirement based on findings in a 

guidance, the document is not subject to 

the usual restrictions in FDA’s good 

guidance practice (GGP) regulations, 

such as the requirements that guidances 

not establish legally enforceable 

responsibilities and that they 

prominently display a statement of the 

document’s nonbinding effect (21 CFR 

10.115(d) and (i)). 

Proposed § 1.232(a)(7) would be 

consistent with FDA’s October 2012 

guidance and the FSMA amendments. 

Specifically, the proposed provision 

would require that a food facility 

registration include applicable food 

product categories of any food 

manufactured/processed, packed, or 

held at the facility, as identified on 

Form FDA 3537. FDA intends to address 

any further amendments of the food 

product categories contained on FDA 

Form 3537, if necessary and 

appropriate, through updates to the 

guidance document ‘‘Guidance for 

Industry: Necessity of the Use of Food 

Product Categories in Food Facility 

Registrations and Updates to Food 

Product Categories.’’ We are seeking 

comments on this proposed provision. 

7. Proposal To Remove List of Optional 

Items Included in the Registration 

Proposed § 1.233 would provide that 

FDA encourages, but does not require, 

registrants to submit items that are 

indicated as optional on the Form FDA 

3537. This proposed amendment would 

remove the list of optional items 

currently codified in § 1.233. We are 

proposing this change for two reasons. 

First, we are proposing elsewhere in this 

document to convert several of the 

optional items in current § 1.233 into 

required items in proposed § 1.232. 

Second, we believe FDA 

recommendations for optional items to 

include in food facility registrations are 

better addressed in guidance documents 

that follow our GGP regulations in 21 

CFR 10.115. We are seeking comments 

on this proposed amendment. 

8. Proposal To Require Immediate 

Updates to Incorrect Registration 

Information 

Proposed § 1.231(a)(6) would require 

a food facility to immediately update 

any previously submitted registration 

information that was incorrect at the 

time of submission of an electronic 

registration or registration renewal. This 

proposal is consistent with the current 

requirement in § 1.231(b)(6) for 

registrations submitted by mail or fax, as 

well as with the current requirement in 

§ 1.231(c)(10) for registrations submitted 

by CD–ROM. Under current 

§ 1.231(b)(6) and (c)(10), any 

information that was incorrect at the 

time of submission of a registration 

submitted by mail or fax or CD–ROM 

must be immediately updated. Under 

the proposed rule, § 1.231(b)(6) would 

be recodified as § 1.231(b)(9). (Current 

§ 1.231(c)(10) would not be recodified, 

as FDA is proposing to no longer allow 

registration submissions to be submitted 

by CD–ROM.) That requirement would 

also apply to registration renewals 

submitted by mail or fax, as we are 

proposing for all of the requirements in 

§ 1.231(b) to apply to both registrations 

and registration renewals submitted by 

mail or fax. 

We are proposing to require the 

immediate update of incorrect 

information submitted in electronic 


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registrations and registration renewals 

so that the requirement to immediately 

update incorrect information applies 

equally to registration submissions that 

are made electronically and by mail or 

fax. When FDA first implemented food 

facility registration in 2003, the Agency 

was concerned that a requirement for 

immediate updates of electronically 

submitted incorrect information would 

burden the food facility registration data 

system. Now, however, we have no such 

concerns. Due to advances in 

technology, we are confident in the 

ability of our data systems to maintain 

functionality while frequent updates are 

made in the system. Additionally, the 

majority of registrants now submit their 

registrations electronically, and FDA is 

proposing to require electronic 

registration beginning in 2016. With so 

many electronic registrations, the 

accuracy of the registration database 

depends on food facilities providing 

correct information. We tentatively 

conclude that the requirement for 

immediate updates of incorrect 

information submitted in electronic 

registrations and registration renewals 

would help ensure that FDA’s 

registration database is accurate and up 

to date. Such an outcome would be 

consistent with FDA’s mandate under 

section 415(a)(5) of the FD&C Act to 

compile and maintain an up-to-date list 

of food facilities. It would also be 

consistent with the requirement in 

section 415(a)(2) of the FD&C Act that 

registrants notify FDA ‘‘in a timely 

manner’’ of changes to the registration 

information they submit under that 

provision. Importantly, a more accurate 

and up-to-date registration database 

would help FDA more efficiently and 

effectively prevent and respond to foodrelated emergencies. To the extent that 

any incorrect information is relevant to 

FDA in planning for inspections, the 

proposed requirement would also aid 

the Agency in more efficiently and 

effectively locating and identifying food 

facilities for inspection. We request 

comments on this proposed provision. 

9. Proposal To Change Requirement To 

Update and Cancel Registration Within 

60 Calendar Days 

Proposed § 1.234(a) and § 1.235(a) 

would shorten the time period for a food 

facility to update or cancel its 

registration from 60 calendar days to 30 

calendar days. Specifically, proposed 

§ 1.234(a) would require facilities to 

update their registration information, 

previously submitted under § 1.232, 

within 30 calendar days, replacing the 

60-calendar-day requirement in current 

§ 1.234(a). Proposed § 1.234(a) would 

not amend the other requirements in 

current § 1.234(a). For instance, it would 

not amend the requirement that such 

updates occur when there is any change 

to any of the information previously 

submitted under § 1.232 (e.g., change of 

operator, agent in charge, or U.S. agent), 

except a change of the owner. It would 

similarly not amend the provision that 

owners, operators, or agents in charge 

may authorize an individual to update 

a facility’s registration. Proposed 

§ 1.235(a) would also replace a 60- 

calendar-day requirement with a 30- 

calendar-day requirement, providing 

that facilities cancel their registrations 

within 30 calendar days of the reason 

for cancellation (e.g., facility ceases 

operations, ceases providing food for 

consumption in the United States, or is 

sold to a new owner) instead of the 60 

calendar days in current § 1.235(a). 

We are proposing to shorten the time 

period for updates and cancellations 

because we have learned over the past 

10 years of food facility registration that: 

(1) We need registration information to 

be accurate and (2) for such information 

to be accurate, it needs to be more 

timely. For instance, we need to know 

as soon as possible when vital contact 

information has changed and when a 

facility has changed the food products it 

manufactures/processes, packs, or 

holds. We also need to know as soon as 

possible when a facility ceases 

operations or has been sold to a new 

owner. This information is important in 

both scheduling inspections and in 

responding to actual or threatened 

terrorist attacks and other food-related 

emergencies. Furthermore, the proposed 

timeframe is consistent with FDA’s 

requirement under section 415(a)(5) of 

the FD&C Act to maintain an up-to-date 

list of facilities that are registered, as 

well as with registrants’ obligation 

under section 415(a)(2) of the FD&C Act 

to notify FDA ‘‘in a timely manner’’ of 

changes to registration information. For 

these reasons, we tentatively conclude 

that the expedited receipt of updates to 

registration information and 

cancellations would help promote the 

efficient enforcement of section 415 of 

the FD&C Act. 

10. Proposal To Cancel Registrations in 

Additional Circumstances 

Currently, § 1.241(b) provides that 

FDA will cancel a registration if FDA 

independently verifies that the facility 

is no longer in business or has changed 

owners, and the owner, operator, or 

agent in charge of the facility fails to 

cancel the registration, or if FDA 

determines that the registration is for a 

facility that does not exist. Proposed 

§ 1.241(c) would amend the regulation 

by also providing that FDA will cancel 

a registration if the Agency 

independently verifies that the facility 

is not required to register, if information 

about the facility’s address was not 

updated in a timely manner in 

accordance with § 1.234(a), or if the 

registration was submitted to the 

Agency by a person not authorized to 

submit the registration under § 1.225. 

Proposed § 1.241(c) would further 

amend the regulation by also providing 

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 

§ 1.230(b). 

FDA is proposing to cancel 

registrations in these additional 

circumstances based on our experiences 

with invalid registrations during the 

approximately 10 years we have spent 

administering food facility registration, 

as well as to improve the utility of the 

food facility registration database and to 

make registration cancellations more 

consistent with the FSMA amendments. 

Examples of such invalid registrations 

have included instances in which an 

importer has registered a foreign food 

facility and listed himself as the U.S. 

agent as well as the owner, operator, or 

agent in charge for the facility without 

the facility’s authorization. There have 

also been instances in which other third 

parties have created duplicate 

registrations for foreign food facilities, 

without authorization from the foreign 

facilities. Such registrations do not 

comply with food facility registration 

requirements and undermine the main 

objectives of food facility registration. 

The only individuals permitted to 

register a facility are the owner, 

operator, or the agent in charge of the 

facility or an individual authorized to 

register the facility on behalf of the 

owner, operator, or agent in charge. 

(Section 415 (a)(2) of the FD&C Act; 

§§ 1.225 and 1.232.) Registration 

information submitted to FDA must be 

true and accurate. (§ 1.232(i).) Where a 

registration is submitted to the Agency 

by an unauthorized person, the 

registration is not submitted in 

accordance with section 415 of the 

FD&C Act and FDA’s registration 

regulations. Further, such registrations 

are less likely to be accurate or complete 

because unauthorized persons generally 

do not have access to a facility’s 

information. Registrations containing 

false, inaccurate, or incomplete 

information hinder the Agency’s ability 

to act quickly in responding to a 

threatened or actual terrorist attack on 

the U.S. food supply or other foodrelated emergency. Moreover, such 

registrations could hinder the Agency’s 


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ability to enforce or implement other 

provisions of the FD&C Act, including 

conducting facility inspections. Finally, 

such registrations could adversely 

impact food facilities as such facilities 

may not be aware that a person is falsely 

submitting information to the Agency 

on the facility’s behalf. 

As to our proposal to cancel 

registrations when a facility has failed to 

renew its registration in accordance 

with § 1.230(b), this proposal is 

designed to respond to the FSMA 

amendments. As discussed elsewhere in 

this document, FSMA amended section 

415 of the FD&C Act to require food 

facilities that are required to register 

with FDA to renew their registrations 

with FDA every other year. Cancelling 

the registrations of facilities that have 

failed to do so would allow FDA to 

efficiently enforce the renewal 

requirement. It would also allow FDA to 

efficiently implement its obligation 

under section 415(a)(5) of the FD&C Act 

to maintain an up-to-date list of 

facilities that are registered—as would 

the proposals to cancel registrations for 

facilities that are not required to register 

and registrations submitted to the 

Agency by unauthorized officials. A 

registration database that includes 

unnecessary, un-updated, or 

unauthorized entries would not be an 

up-to-date list of food facilities required 

to register with FDA under section 415 

of the FD&C Act. 

As to our proposal to cancel 

registrations when information about 

the facility’s address was not updated in 

a timely manner in accordance with 

proposed § 1.234(a), this proposal is 

designed to assist FDA in using its 

limited inspectional resources 

efficiently. Inaccurate address 

information makes it difficult for FDA 

investigators to efficiently inspect food 

facilities, as investigators may invest 

time traveling to a particular address 

location only to find that the facility is 

not located there. FDA tentatively 

concludes that canceling registrations 

where a food facility has failed to 

update its address information in a 

timely manner in accordance with 

proposed § 1.234(a) would increase the 

accuracy of the address information 

contained in FDA’s food facility 

registration database, and would 

therefore enable FDA investigators to 

more efficiently locate food facilities for 

inspection. FDA also tentatively 

concludes that such cancellations 

would allow FDA to efficiently 

implement its obligation under section 

415(a)(5) to maintain an up-to-date list 

of facilities that are registered and 

would be consistent with the 

requirement in section 415(a)(2) of the 

FD&C Act that facilities notify FDA in 

a ‘‘timely manner’’ as to changes in their 

registration information, including their 

address information. We have also 

tentatively concluded that canceling 

registrations where a facility has failed 

to update its address information would 

supplement the requirement in FSMA 

that food facilities participate in 

biennial registration. Biennial 

registration renewal serves as a general 

mechanism to ensure all registrations 

are accurate and up to date, while 

cancellations based on failure to update 

allow FDA to respond to specific 

facilities that have failed to update 

address information. In addition, in 

enacting biennial registration renewal, 

Congress did not eliminate the 

requirement in section 415(a)(2) of the 

FD&C Act that registrants provide 

updates to their registration information 

in a ‘‘timely manner.’’ Instead, Congress 

added biennial renewal as a 

supplemental requirement. Thus, 

biennial renewal and the proposal to 

cancel registrations based on unupdated address information would 

both operate to improve the accuracy of 

FDA’s food facility registration database, 

but would provide different 

mechanisms for doing so. 

Proposed § 1.241(c) would maintain 

the requirement in current § 1.241(b) 

that FDA will cancel registrations in the 

specified circumstances if the Agency 

‘‘independently verifies’’ those 

circumstances. Specifically, proposed 

§ 1.241(c) would provide that FDA will 

cancel registrations if it ‘‘independently 

verifies’’ that the facility is no longer in 

business or has changed owners, and 

the owner, operator, or agent in charge 

of the facility fails to cancel the 

registration, or if FDA determines that 

the registration is for a facility that does 

not exist, is not required to register, or 

where the information about the 

facility’s address was not updated in a 

timely manner in accordance with 

§ 1.234(a) or the registration was 

submitted by a person not authorized to 

submit the registration under § 1.225. In 

maintaining the ‘‘independently 

verif[y]’’ requirement, we realize that 

each potential cancellation is likely to 

present unique facts, and thus may 

require the Agency to take an 

individualized approach in 

independently verifying the 

circumstances that merit registration 

cancellation. Nevertheless, we believe 

that in many cases it would be 

appropriate for us to send notices to 

facilities facing potential cancellation 

indicating our intent to cancel their 

registrations and the basis for such 

cancellations. We anticipate that we 

would send such notices prior to 

canceling registrations. We also 

anticipate that, when appropriate, if the 

circumstances meriting possible 

cancellation are corrected within 30 

days after notice is provided, we would 

not cancel the registration. We 

anticipate that it would 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 

§ 1.230(b). In such circumstances, we 

anticipate that a facility would have 

already received notice of its obligation 

to renew its registration, and therefore 

would have already have had the 

amount of time specified in section 

415(a)(3) of the FD&C Act—the period 

beginning on October 1 and ending on 

December 31 of each even-numbered 

year—to renew its registration. 

Accordingly, when a facility’s 

registration has expired due to failure to 

renew, we do not anticipate that FDA 

would need to provide the facility with 

additional time to take corrective action 

prior to canceling that facility’s 

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 would 

determine that we conducted an 

independent verification and would 

then cancel the registration. If a facility 

believes its registration was cancelled in 

error, the facility would be able to 

contact the FDA Industry Systems Help 

Desk via telephone at 1–800–216–7331 

or 301–575–0156. 

Finally, proposed § 1.241(c) would 

maintain the requirement in current 

§ 1.241(b) that if FDA cancels a facility’s 

registration, FDA will mail a 

confirmation of the cancellation to the 

facility at the address provided in the 

facility’s registration. 

We are seeking comments on 

proposed § 1.241(c), as well as the 

Agency’s approach to independently 

verifying the circumstances that may 

merit registration cancellation. 

11. Proposal To Provide for a Waiver 

Request From Submitting Your 

Registration Electronically 

As discussed previously, section 

415(b)(5)(B) of the FD&C Act, as added 

by section 102(b) of FSMA, provides 

that FDA may require that registrations 

under section 415 be submitted to FDA 

in an electronic format. Section 

415(b)(5)(B) specifies that such 

requirement may not take effect before 

the date that is 5 years after the date of 

enactment of FSMA, which is January 4, 

2016. Proposed § 1.231(a)(2) would 

provide that beginning January 4, 2016, 


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electronic registration will be 

mandatory, unless a waiver has been 

granted for the registrant. Proposed 

§ 1.245 would allow a registrant to 

request a waiver from the electronic 

registration requirement. Specifically, 

proposed § 1.245 would provide that a 

registrant may request such a waiver by 

submitting a written request to FDA 

explaining why it is not reasonable for 

the registrant to submit a registration or 

registration renewal electronically to 

FDA. FDA tentatively concludes that 

reasons for why it may not be 

reasonable for a registrant to submit a 

registration or registration renewal to 

FDA electronically may include 

conflicting religious beliefs or where a 

registrant does not have reasonable 

access to the Internet. We are seeking 

comments on this proposed provision 

and what, if any, other such reason 

should be considered for granting a 

waiver from the mandatory electronic 

registration and email requirements. We 

are also seeking comments on what 

information should be provided in a 

written request for a waiver from the 

electronic registration requirement. 

12. Other Proposed Modifications to 

Registration of Food Facilities 

Regulations 

a. Proposal to delete date from 

§ 1.230(a)—When must you register? 

Current § 1.230(a) provides that the 

owner, operator, or agent in charge of a 

facility that manufactures/processes, 

packs, or holds food for consumption in 

the United States must register the 

facility no later than December 12, 2003. 

It also provides that 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 on or after December 12, 

2003, must register before the facility 

begins such activities. The regulation 

contains the December 12, 2003, 

deadline because the Bioterrorism Act 

required facilities subject to food facility 

registration requirements to register 

with FDA no later than December 12, 

2003. Because the December 12, 2003, 

deadline has now passed and is no 

longer relevant, we are proposing to 

delete the reference to that deadline in 

proposed § 1.230(a). Thus, proposed 

§ 1.230(a) would contain no deadline, 

and would instead provide that owners, 

operators, or agents in charge must 

register before the facility begins to 

manufacture, process, pack, or hold 

food for consumption in the United 

States. We are seeking comments on this 

proposed modification. 

In addition, proposed § 1.230(a) 

would retain the provision in current 

§ 1.230(a) that owners, operators and 

agents in charge may authorize an 

individual to register the facility on 

their behalf. Currently, registrations 

submitted by such authorized 

individuals must include a statement 

from such individuals certifying that the 

information submitted is truthful and 

accurate and the individual is 

authorized to submit the registrations on 

the facility’s behalf, and the individual 

must identify by name, address, and 

telephone number the individual who 

authorized submission of the 

registration. (21 CFR 1.232(i).) The 

certification statement also states that 

anyone who makes a materially false, 

fictitious, or fraudulent statement to the 

U.S. Government is subject to criminal 

penalties under 18 U.S.C. 1001. (Under 

the proposed rule, this certification 

provision would be recodified at 

§ 1.232(a)(10)). Further, as discussed in 

section III.B.4., for registrations 

submitted by individuals other than the 

owner, operator, or agent in charge, we 

are proposing to add the email address 

to the information required for 

identifying the individual who 

authorized submission of the 

registration on behalf of the facility. In 

addition, we are proposing that FDA 

will email the individual identified as 

the owner, operator, or agent in charge 

who authorized submission of the 

registration to verify that the individual 

in fact authorized submission of the 

registration on behalf of the facility. 

Further, we are proposing that FDA will 

not confirm the registration or provide 

a registration number until that 

individual confirms that he or she 

authorized the registration submission. 

b. Proposal to replace ‘‘owner, 

operator, or agent in charge of a 

facility’’ with ‘‘you’’ and make other 

minor changes. We are proposing to 

replace the phrase ‘‘owner, operator, or 

agent in charge of a facility’’ throughout 

the codified at part 1, subpart H, with 

the term ‘‘you’’ as defined in current 

§ 1.227(b)(14) as ‘‘you or registrant 

means the owner, operator, or agent in 

charge of a facility that manufactures/

processes, packs, or holds food for 

consumption in the United States.’’ We 

are seeking comments on this proposed 

modification. In addition, we are 

proposing to replace the word ‘‘cannot’’ 

in current § 1.227(b)(13) with the term 

‘‘may not.’’ Accordingly, the pertinent 

sentence in that provision would 

provide that, ‘‘A U.S. agent may not be 

in the form of a mailbox, answering 

machine or service, or other place where 

an individual acting as the foreign 

facility’s agent is not physically 

present’’ (emphasis added). We are 

proposing this change to make clear that 

we are not concerned about a U.S. 

agent’s ability to be in the form of a 

mailbox, answering machine, or service, 

or other place where a U.S. agent is not 

physically present, but rather that we do 

not authorize a U.S. agent to be in such 

forms or locations. We are also seeking 

comments on this proposed 

modification. 

c. Proposal to delete option for CD– 

ROM submissions. We are proposing to 

delete the option to submit, update, and 

cancel multiple registrations by CD– 

ROM. Specifically, we are proposing to 

remove the option to use CD–ROM for 

multiple registration submissions in 

current § 1.231(c), as well as the option 

to use CD–ROM for updates of multiple 

submissions in current § 1.234(e) and 

for cancellations of multiple 

registrations in current § 1.235(e). FDA 

is proposing to make these changes 

because the Agency has tentatively 

concluded that this method of 

submitting, updating, and canceling 

registrations is outdated and obsolete. 

The Agency has only received 11 CD– 

ROM submissions since the registration 

requirements took effect. We are seeking 

comments on this proposal. 

C. Request for Comment on 

Establishment of a U.S. Agent Voluntary 

Identification System 

We are requesting comments on 

whether we should issue a future 

guidance document to provide for the 

creation of a U.S. Agent Voluntary 

Identification System (VIS or the 

system), or otherwise create such a 

system. As currently envisioned, the 

system would be designed to ensure the 

accuracy of U.S. agent information and 

enable U.S. agents to independently 

identify the facility or facilities for 

which the agent has agreed to serve. 

Specifically, the system would allow a 

U.S. agent to directly provide FDA with 

the agent’s contact information (that is, 

the same contact information required 

for foreign food facility registration) and 

the name of the facility or facilities for 

which the agent has agreed to serve. 

Currently, FDA only receives U.S. agent 

contact information through foreign 

food facility registrations, many of 

which are submitted and updated by the 

facility, rather than the U.S. agent for 

the facility. The new system would 

allow agents to provide information 

about themselves, including their name, 

mailing address, phone number, email 

address, and emergency contact phone 

number, as well as the name of the 

facility or facilities for which the agent 

agrees to serve. After a U.S. agent has 

provided such information to FDA 

through the system, the Agency would 

provide the U.S. agent with an 


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identification number. The U.S. agent 

could then provide the identification 

number to foreign facilities that the U.S. 

agent agrees to represent as a U.S. agent. 

The foreign facilities, in turn, would 

have the option of providing the 

identification number for the U.S. agent 

in its registration rather than the 

specific U.S. agent’s contact information 

required for food facility registrations 

(e.g., address, email address, phone 

number). After using the identification 

number, and if the foreign facility name 

matches a facility name the U.S. agent 

identified in the system, the U.S. agent 

contact information in the system would 

then be linked and automatically 

populated in the foreign facility 

registration. When the confirmation 

copy of a foreign facility registration is 

sent to the U.S. agent, the confirmation 

copy would be sent to the contact 

information provided by the U.S. agent 

to ensure that the U.S. agent is aware of 

the connection with each foreign facility 

registration. 

As we envision the voluntary system, 

U.S. agents would have discretion as to 

whom they provide their U.S. agent 

identification numbers. Because U.S. 

agents would be notified any time a 

foreign facility registers with FDA using 

their U.S. agent identification numbers, 

U.S. agents would have the opportunity 

to contact FDA in the event the U.S. 

agent is falsely identified in a food 

facility registration. U.S. agents would 

also have the ability to directly update 

or correct their contact information 

themselves. If we implement the 

voluntary U.S. agent verification system, 

we anticipate that we would also create 

update requirements that would mirror 

the update requirements for food facility 

registration (i.e., 30 calendar days from 

any of the information previously 

submitted, as proposed elsewhere in 

this document). When a foreign facility 

uses an identification number for a 

registered U.S. agent and the name of 

the facility matches the facility name 

the agent has identified, we would 

consider the use of that identification a 

verification for purposes of proposed 

§ 1.231(b)(6), and would therefore 

provide the facility with a registration 

number without FDA taking any 

additional steps to verify the U.S. agent 

as provided in proposed § 1.231(b)(6). 

Because the use of an identification 

number would constitute verification 

for purposes of proposed § 1.231(b)(6), 

foreign facilities would have an 

incentive to use U.S. agents registered in 

the system. Additionally, because U.S. 

agents would have direct access to a list 

of facilities listing them as U.S. agent, 

they would have an incentive to use the 

identification system, which we 

anticipate will limit the number of 

unauthorized and/or fraudulent U.S. 

agent listings. We would consider the 

use by a foreign facility of a U.S. agent 

identification number to be 

confirmation that the U.S. agent agrees 

to serve in that capacity for that foreign 

facility. If, however, the person 

designated as the U.S. agent then 

contacts FDA to state that the person 

did not agree to serve as the U.S. agent 

or declines the assignment, FDA would 

provide the facility with 30 calendar 

days to correct the U.S. agent 

information. If the facility does not take 

correction action, FDA would then take 

appropriate action. 

We are seeking comment on creating 

this voluntary system because we find 

merit in the notion that a system that 

allows U.S. agents to provide their own 

contact information is likely to increase 

the accuracy of U.S. agent contact 

information and reduce the number of 

unauthorized and/or fraudulent U.S. 

agent listings. 

If we pursue this system, we would 

follow our Good Guidance Practice 

regulations in 21 CFR 10.115. We are 

seeking comments on the proposed U.S. 

Agent Voluntary Identification System. 

IV. Preliminary Regulatory Impact 

Analysis 

A. Overview 

FDA has examined the impacts of this 

proposed rule under Executive Order 

12866, Executive Order 13563, the 

Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4). 

Executive Orders 12866 and 13563 

direct Agencies to assess all costs and 

benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety, 

and other advantages; distributive 

impacts; and equity). FDA has 

developed a PRIA that presents the 

benefits and costs of this proposed rule 

(Ref. 4). FDA believes that the proposed 

rule will not be a significant regulatory 

action as defined by Executive Order 

12866. 

For interested persons, the detailed 

PRIA (Ref. 4) is available at http://

www.regulations.gov (enter Docket No. 

FDA–2002–N–0323), and is also 

available on FDA’s Web site at http://

www.fda.gov/AboutFDA/

ReportsManualsForms/Reports/

EconomicAnalyses/ucm440616.htm. 

B. Regulatory Flexibility Act 

The Regulatory Flexibility Act 

requires Agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. We expect compliance costs 

generated by this proposed rule to be 

small. Nevertheless, we are unsure 

whether this proposed rule would have 

a significant economic impact on a 

substantial number of small entities and 

have analyzed various regulatory 

options to examine the impact on small 

entities. 

C. Unfunded Mandates Reform Act of 

1995 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that Agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $141 

million, using the most current (2013) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this proposed rule to result in any 1- 

year expenditure that would meet or 

exceed this amount. 

D. Public Access to the Analyses 

The analyses that FDA has performed 

in order to examine the impacts of this 

proposed rule under Executive Order 

12866, Executive Order 13563, the 

Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4), are 

available to the public in the docket for 

this proposed rule (Ref. 4). 

V. Paperwork Reduction Act of 1995 

This proposed rule contains 

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(the PRA) (44 U.S.C. 3501–3520). A 

description of these provisions is given 

in the Description section of this 

document with an estimate of the 

annual reporting burden. Included in 

the burden estimate is the time for 

reviewing instructions, searching 

existing data sources, gathering and 

maintaining the data needed, and 

completing and reviewing each 

collection of information. 

FDA invites comment on these topics: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of FDA’s functions, 


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including whether the information will 

have practical utility; (2) the accuracy of 

FDA’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Title: Registration of Food Facilities 

(OMB Control Number 0910–0502)— 

Revision. 

Description of Respondents: 

Respondents to this collection of 

information are owners, operators, or 

agents-in-charge of domestic or foreign 

facilities that manufacture, process, 

pack, or hold food for human or animal 

consumption in the United States. 

Description: FDA is proposing to 

amend its regulations governing food 

facility registration. We are proposing to 

codify the requirements of section 102 

of FSMA that were self-implementing 

and effective upon enactment of FSMA. 

In addition, we are proposing to 

implement other requirements of 

section 102 of FSMA, as discussed 

previously, including mandatory 

electronic registration submissions 

beginning in 2016 and amendments to 

the retail food establishment definition. 

Lastly, we are proposing other changes 

to improve the utility of the food facility 

registration database. As discussed in 

the preamble to the proposed rule, FDA 

has the authority to issue this proposed 

rule under section 305(d) of the 

Bioterrorism Act, sections 102 and 107 

of FSMA, and sections 301(dd), 415, 

421, 701(a) 704 and 801(l) of the FD&C 

Act. 

The FDA Food Safety Modernization 

Act (FSMA) (Pub. L. 111–353), enacted 

on January 4, 2011, amended section 

415 of the FD&C Act to require, among 

other things, that registrants for food 

facilities renew registrations biennially 

(section 415(a)(3) of the FD&C Act). 

FSMA also amended section 415 of the 

FD&C Act to require that food facility 

registrations include the email address 

for the contact person of a domestic 

facility and the email address of the 

United States agent for a foreign facility, 

as well as an assurance that FDA will be 

permitted to inspect the facility (section 

415(a)(2) of the FD&C Act). These 

requirements went into effect upon 

enactment of FSMA. In addition, section 

415(a)(2) of the FD&C Act, as amended 

by FSMA, also provides that, when 

determined necessary by FDA ‘‘through 

guidance,’’ a food facility is required to 

submit to FDA information about the 

general food category of a food 

manufactured, processed, packed, or 

held at such facility, as determined 

appropriate by FDA, including by 

guidance. FDA issued a guidance 

document entitled ‘‘Guidance for 

Industry: Necessity of the Use of Food 

Product Categories in Food Facility 

Registrations and Updates to Food 

Product Categories’’ in October 2012. 

To comply with the statutory deadline 

under the provisions of FSMA, FDA 

initially obtained a 6-month OMB 

approval of these self-implementing 

FSMA reporting burdens under the 

emergency processing provisions of the 

PRA, and subsequently obtained a 3- 

year approval of these requirements 

under the same assigned OMB control 

number 0910–0502. OMB extended the 

approval for an additional 3 years in 

2013. The current expiration date of the 

information collection is August 31, 

2016. 

The proposed rule would require food 

facilities to submit additional 

registration information to FDA with 

initial registrations, updates, and 

biennial renewals. The proposed rule 

would make the submission of the 

following currently optional 

information mandatory: (1) Preferred 

mailing address; (2) email address for 

the owner, operator, or agent in charge; 

(3) type of activity conducted at the 

facility; and (4) email address of the 

emergency contact of a domestic 

facility. In addition, the proposed rule 

would require food facilities to submit 

a D–U–N–S Number and, for 

registrations submitted by individuals 

other than the owner, operator, or agent 

in charge, the email address for the 

owner, operator, or agent in charge who 

authorized the registration submission 

on behalf of the facility. The proposed 

rule would also require mandatory 

electronic registration submissions 

beginning in 2016, which we estimate 

would cause some food facilities to 

submit a request for a waiver from that 

requirement. Finally, the proposed rule 

would establish a verification procedure 

for registration submissions made by 

individuals other than the owner, 

operator, or agent in charge, as well as 

a verification procedure for U.S. Agents. 

Registration is one of several tools 

implemented under the Bioterrorism 

Act that enables FDA to act quickly in 

responding to a threatened or actual 

terrorist attack on the U.S. food supply 

or other food-related emergency by 

giving FDA information about facilities 

that manufacture/process, pack, or hold 

food for consumption in the United 

States. Further, in the event of an 

outbreak of foodborne illness, such 

information helps FDA determine the 

source and cause of the event. In 

addition, registration information 

enables FDA to quickly notify food 

facilities that might be affected by an 

outbreak, terrorist attack, threat, or other 

emergency. The proposed amendments 

will further enhance FDA’s capabilities 

with respect to responding to food 

safety issues, and in addition, provide 

FDA with information that we can use 

to focus and better utilize our limited 

inspection resources. 

The currently approved reporting 

burden for food facility registration 

under OMB control number 0910–0502 

is 468,117 hours. The estimated 

reporting burden for food facility 

registration under the proposed rule is 

413,153 hours, a decrease of 54,964 

hours. This decrease is due in large part 

to a reduction in the number of 

registered food facilities, which we 

believe is reflective of the fact that the 

2012 biennial registration renewal cycle 

appears to have had the effect of 

removing many out-of-date registrations 

from the registration system. We are 

proposing to make additional changes to 

the currently approved reporting burden 

as well. Since obtaining the FSMArelated emergency OMB approval and 

subsequent 3-year approval, we have 

refined our estimates for the time 

required to comply with the selfimplementing FSMA provisions. As we 

explain in detail in the preliminary 

economic impact analysis, this is in part 

because we no longer assume that it will 

take domestic and foreign facilities 

different amounts of time to comply 

with the provisions of the proposed 

rule. It is also in part because the option 

to submit abbreviated registration 

renewals did not previously exist and in 

part because we have revised additional 

assumptions. 

FDA revises its estimate of the onetime burden of the FSMA-related 

provisions of the proposed rule on 

registered facilities as follows: 


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TABLE 2—ESTIMATED ONE-TIME REPORTING BURDEN 1

Activity/21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

All facility registrations (1.230–1.233) .................................. 172,274 1 172,274 0.18 (11 mins) 31,584 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

To determine the number of facilities 

in table 2, we assume that some of the 

participants in the 2012 biennial 

registration renewal cycle were new 

registrants. We do not consider those 

new registrations in estimating the total 

burden associated with the FSMA 

requirements. FDA used the the Small 

Business Administraiton’s (SBA’s) 

estimate that 12 percent of all 

businesses are new. Although SBA’s 

estimate does not necessarily mean that 

12 percent of all food facilities are new, 

we nevertheless find the SBA’s estimate 

sufficiently relevant to apply to food 

facilities. We therefore estimate that 12 

percent of currently registered food 

facilities were not registered at the time 

of the 2012 registration renewal cycle. 

As such, we estimate that 88 percent of 

currently registered food facilities, or 

172,274 facilities, were registered in 

2012. 

Using our updated estimates for the 

time required to comply with the selfimplementing FSMA provisions, we 

now estimate that the requirement for 

an email address for a domestic 

facility’s contact person and a foreign 

facility’s U.S. Agent will take 1 minute. 

We also now estimate that the assurance 

statement required by FSMA will take 5 

minutes to provide and that the postFSMA changes to food product 

categories will not result in any 

additional burden for facilities. 

We also estimate the one-time burden 

from the new data elements in the 

proposed rule. We estimate that the 

average burden per response would be 

increased by the new data elements in 

the proposed rule. FDA believes that the 

new information will be readily 

available to the firms. We estimate that 

entering the four additional pieces of 

information that are currently optional 

would require, on average, an additional 

minute for each new data element per 

response. The four additional pieces of 

information that are currently optional 

are: (1) Preferred mailing address; (2) 

email address for the owner, operator, or 

agent in charge; (3) type of activity or 

type of storage conducted at the facility; 

and (4) email address of the emergency 

contact of a domestic facility. In 

addition, we estimate that entering a D– 

U–N–S® Number would require, on 

average, an additional minute per 

response. Thus, we estimate that these 

five proposed new data elements will 

require a total of 5 additional minutes. 

We estimate that the submission of the 

FSMA data elements and proposed new 

data elements would jointly increase the 

one-time burden from those activities by 

a total of 11 minutes (0.18 hour). The 

estimated one-time burden for currently 

registered facilities is therefore 172,274 

facilities × 0.18 hours = 31,584 hours. 

FDA estimates the annual burden of 

the proposed rule’s revision of this 

information collection as follows: 

TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity/21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total 

New domestic facility registrations (1.230–1.233) ............... 9,795 1 9,795 2.7 26,447 

New foreign facility registrations (1.230–1.233) .................. 13,697 1 13,697 8.7 119,164 

Updates (1.234) ................................................................... 68,518 1 68,518 1.5 102,777 

Cancellations (1.235) ........................................................... 6,390 1 6,390 1 6,390 

Biennial renewals (1.235) .................................................... 97,883 1 97,883 0.38 

(23 minutes) 

37,196 

Waiver requests (1.245) ...................................................... 1,061 1 1,061 0.17 

(10 minutes) 

180 

Third party registration verification procedure ..................... 41,256 1 41,256 0.25 

(15 minutes) 

10,314 

U.S. Agent verification procedure ........................................ 57,070 1 57,070 0.5 

(30 minutes) 

28,535 

Total Hours ................................................................... ........................ ........................ ........................ ........................ 331,002 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The currently approved annual 

reporting burden for food facility 

registration under OMB control number 

0910–0502 is 468,117 hours. The 

estimated reporting burden for food 

facility registration under the proposed 

rule is 332,971 hours, a decrease of 

135,146 hours. This decrease is due to 

the recently reduced number of active 

registrations in the food facility 

registration database. 

Our estimates of the number of 

facilities that will submit new facility 

registrations are based on estimates by 

SBA that 12 percent of all businesses 

each year are new. As such, we estimate 

that 12 percent of registrations (or 

23,500 registrations) are from new 

facilities entering the market. We are 

proposing to make additional changes to 

the currently approved reporting burden 

as well. As discussed previously, FDA 

obtained a 6-month emergency OMB 

approval of the self-implementing 

FSMA reporting burdens, and 

subsequently obtained a 3-year approval 

of these requirements. As described in 

the preliminary economic impact 

analysis, we estimate that 68,518 

respondents will file updates, a decrease 

from the estimated number of 118,530 

respondents reported in the 2013 

request for extension, and we estimate 

that 97,883 respondents will file 

biennial renewals, a decrease from the 


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estimated number of 224,930 

respondents reported in the 2013 

request for extension. These decreases 

are due to recent reductions in the 

number of active registrations in the 

food facility registration database. 

Prior to FSMA, FDA estimated that 

the average burden associated with new 

domestic and foreign facility 

registrations was a respective 2.5 and 

8.5 hours. (See 75 FR 30033, May 28, 

2010.) We expect that the proposed rule 

would add an additional 11 minutes to 

that burden as a result of the proposed 

new data elements. Based on estimates 

by SBA that 12 percent of all businesses 

are new, we estimate that all new 

facilities each year will be equal to 12 

percent of the total number of registered 

facilities. Thus, we estimate that each 

year there will be 9,795 new domestic 

and 13,697 new foreign facility 

registrations, and that the average 

burden for those new registrations will 

be of 2.7 hours (2.5 hours plus 11 

minutes) for new domestic facility 

registrations and 8.7 hours (8.5 hours 

plus 11 minutes) for new foreign facility 

registrations, as reported in table 28, 

rows 1 and 2) (p. 64 of Ref. 4). 

The proposed rule would also shorten 

the time period for updates from 60 

calendar days to 30 calendar days. The 

average burden per response for updates 

would increase from 1.2 hours to 1.54 

hours (difference of 0.34 hours, or about 

20 minutes), as reported in table 28, row 

3 (p. 64 of Ref. 4). 

This proposed rule would also 

establish an abbreviated renewal 

process, which modifies our previous 

estimate that on average it would take 

0.5 hours per renewal. With the option 

for an abbreviated renewal process, we 

estimate that half the facilities will take 

15 minutes per renewal using the 

abbreviated renewal process and that 

half of facilities will take 30 minutes. 

This alters our previous estimate of 0.5 

hours to submit a renewal to an average 

of 0.38 hours (23 minutes) to submit a 

renewal, as reported in table 28, row 5 

(p. 64 of Ref. 4). This estimate takes into 

account that some registered firms 

would be able to take advantage of the 

abbreviated renewal process, while 

other firms would take more time to 

prepare and submit the renewal, as 

discussed in the preliminary economic 

impact analysis. We have not changed 

our estimate of the average burden per 

response for cancellations because the 

proposed rule does not add new data 

elements for cancellations. 

If the rule is finalized as proposed, it 

would mandate the electronic 

submission of food facility registrations, 

while also allowing respondents to 

submit a request for waiver of the 

requirement to electronically submit 

their registration. As described in the 

preliminary economic impact analysis, 

we estimate that, on average, 1,061 

facilities will seek a waiver each year. 

We also estimate that it would take a 

respondent 10 minutes to prepare the 

proposed waiver request submission 

and attach it to their paper Form FDA 

3537 registration submission. Thus, the 

total annual burden of submitting 

waiver requests is estimated to be 180 

hours (1,061 × 0.17 hours), as reported 

in table 28, row 6 (p. 64 of Ref. 4). 

If the rule is finalized as proposed, it 

would establish a verification procedure 

for registrations submitted by 

individuals other than the owner, 

operator, or agent-in-charge (third party 

registrations), as well as a verification 

procedure for U.S. Agents. To verify 

third-party registrations, FDA would 

send an email to the owner, operator, or 

agent in charge with a link allowing the 

owner, operator, or agent in charge to 

either confirm or deny that he or she 

authorized the registration submission 

on behalf of the facility. In connection 

with requiring his verification process, 

the proposed rule would add email 

address to the list of required 

information identifying the individual 

who authorized submission of 

registrations submitted by individuals 

other than the owner, operator, or agent 

in charge. As described in the 

preliminary economic impact analysis, 

we estimate that it would take an owner, 

operator, or agent in charge 15 minutes 

(0.25 hour) to participate in FDA’s 

verification procedure. This estimate 

includes the time required to enter the 

email address of the owner, operator, or 

agent in charge who authorized the 

submission. We further estimate that 

82,513 registrations would be affected 

once every other year, or 41,257 

annually. Thus, the total annual burden 

of these verifications is estimated to be 

10,314 hours (41,257 × 0.25 hour = 

10,314 hours), as reported in table 28, 

row 7 (p. 64 of Ref. 4). 

To verify the U.S. Agent, FDA would 

send an email to the U.S. Agent at the 

email address provided by the 

registrant. The email address would 

include a link that would connect the 

U.S. Agent to FDA’s food facility 

registration module, allowing the U.S. 

Agent to either accept or decline 

assignment with the facility. If the U.S. 

Agent accepts the assignment, FDA 

would also email the facility of the U.S. 

Agent’s acceptance. If, however, a U.S. 

Agent declines the assignment, the 

issuance of the registration number 

could be delayed. We estimate that the 

burden that will result from the 

verification procedure would be about 

30 minutes (0.5 hours). We also estimate 

that 114,139 registrations would be 

affected once every 2 years, or 57,070 

facility registrations annually. Thus, the 

total annual burden of these 

verifications is estimated to be 28,535 

hours (57,070 × 0.5 hour = 28,535 

hours), as reported in table 28, row 8 (p. 

64 of Ref. 4). 

In compliance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 

3407(d)), the Agency has submitted the 

information collection provisions of this 

proposed rule to OMB for review. 

Interested persons are requested to send 

comments regarding information 

collection to the Office of Information 

and Regulatory Affairs, OMB. 

To ensure that comments on 

information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

title ‘‘Registration of Food Facilities.’’ 

These requirements will not be effective 

until FDA obtains OMB approval. FDA 

will publish a notice concerning OMB 

approval of these requirements in the 

Federal Register. 

VI. Analysis of Environmental Impact 

We have determined under 21 CFR 

25.30(h) that this action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

VII. Federalism 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. We 

have determined that the proposed rule, 

if finalized, would not contain policies 

that would have substantial direct 

effects on the States, on the relationship 

between the National Government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government. 

Accordingly, we tentatively conclude 

that the proposed rule does not contain 

policies that have federalism 

implications as defined in the Executive 

order and, consequently, a federalism 

summary impact statement is not 

required. 

VIII. Request for Comments 

We invite public comment on the 

matters specified in this document as 

well as any other matters concerning 

this proposed rule that are of interest. 


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Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

IX. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday, and are available 

electronically at http://

www.regulations.gov. (We have verified 

the Web site addresses, but we are not 

responsible for any subsequent changes 

to the Web sites after this document 

publishes in the Federal Register.) 

1. FDA, ‘‘Compliance Policy Guide Sec. 

100.250 Food Facility 

Registration—Human and Animal 

Food’’ (http://www.fda.gov/

downloads/ICECI/Compliance

Manuals/CompliancePolicy

GuidanceManual/UCM399369.pdf), 

accessed on March 27, 2015. 

2. FDA, ‘‘Field Management Directives,’’ 

(http://www.fda.gov/ICECI/

Inspections/FieldManagement

Directives/ucm096034.htm), 

accessed on March 27, 2015. 

3. FDA, ‘‘Guidance for Industry: 

Necessity of the Use of Food 

Product Categories in Food Facility 

Registrations and Updates to Food 

Product Categories,’’ (http://

www.fda.gov/Food/Guidance

Regulation/GuidanceDocuments

RegulatoryInformation/

FoodDefense/ucm324778.htm), 

accessed on March 27, 2015. 

4. FDA, ‘‘Preliminary Regulatory Impact 

Analysis,’’ 2014. 

List of Subjects in 21 CFR Part 1 

Cosmetics, Drugs, Exports, Food 

labeling, Imports, Labeling, Reporting 

and recordkeeping requirements. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, it is proposed that 

21 CFR part 1 be amended as follows: 

PART 1—GENERAL ENFORCEMENT 

REGULATIONS 

■ 1. The authority citation for 21 CFR 

part 1 is revised to read as follows: 

Authority: 15 U.S.C. 1333, 1453, 1454, 

1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 

321, 331, 332, 333, 334, 335a, 343, 350c, 

350d, 350j, 352, 355, 360b, 362, 371, 374, 

379j–31, 381, 382, 387, 387a, 387c, 393; 42 

U.S.C. 216, 241, 243, 262, 264; Pub. L. 107– 

188, 116 Stat. 594, 668–69. 

■ 2. Revise § 1.227 (b)(11) and (13) to 

read as follows: 

§ 1.227 What definitions apply to this 

subpart? 

* * * * * 

(b) * * * 

(11) Retail food establishment means 

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. Sale of food directly 

to consumers from an establishment 

located on a farm includes sales by that 

establishment directly to consumers: 

(i) 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); 

(ii) 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 

(iii) 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. 

* * * * * 

(13) U.S. agent means a person (as 

defined in section 201(e) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

321(e))) residing or maintaining a place 

of business in the United States whom 

a foreign facility designates as its agent 

for purposes of this subpart. A U.S. 

agent may not be in the form of a 

mailbox, answering machine or service, 

or other place where an individual 

acting as the foreign facility’s agent is 

not physically present. 

(i) The U.S. agent acts as a 

communications link between FDA and 

the foreign facility for both emergency 

and routine communications. The U.S. 

agent will be the person FDA contacts 

when an emergency occurs, unless the 

registration specifies another emergency 

contact. 

(ii) 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. FDA will consider the U.S. 

agent the equivalent of the registrant for 

purposes of sharing information and 

communications. The U.S. agent of a 

foreign facility may view the 

information submitted in the foreign 

facility’s registration. 

(iii) Having a single U.S. agent for the 

purposes of this subpart does not 

preclude facilities from having multiple 

agents (such as foreign suppliers) for 

other business purposes. A firm’s 

commercial business in the United 

States need not be conducted through 

the U.S. agent designated for purposes 

of this subpart. 

* * * * * 

■ 3. Revise § 1.230 to read as follows: 

§ 1.230 When must you register or renew 

your registration? 

(a) Registration. You must register 

before your facility begins to 

manufacture, process, pack, or hold 

food for consumption in the United 

States. You may authorize an individual 

to register the facility on your behalf. 

(b) Registration renewal. You must 

submit a registration renewal containing 

the information required under § 1.232 

every other year, during the period 

beginning on October 1 and ending on 

December 31 of each even-numbered 

year. You may authorize an individual 

to renew a facility’s registration on your 

behalf. If the individual submitting the 

registration renewal is not the owner, 

operator, or agent in charge of the 

facility, the registration renewal 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 renewal, and identifies by 

name, address, email address, and 


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telephone number, the individual who 

authorized submission of the 

registration renewal. Each registration 

renewal must include the name of the 

individual submitting the registration 

renewal, and the individual’s signature 

(for the paper option). 

(c) Abbreviated registration renewal 

process. If you do not have any changes 

to the information required under 

§ 1.232 since you submitted the 

preceding registration or registration 

renewal for your facility, you may use 

the abbreviated registration renewal 

process. If you use the abbreviated 

registration renewal process, you must 

confirm that no changes have been 

made to the information required under 

§ 1.232 since you submitted the 

preceding registration or registration 

renewal, confirm that FDA will be 

permitted to inspect the facility at the 

times and in the manner permitted by 

the Federal Food, Drug, and Cosmetic 

Act, and certify that the information 

submitted is truthful and accurate. You 

must use Form FDA 3537 to submit 

abbreviated registration renewals to 

FDA. 

■ 4. Revise § 1.231 to read as follows: 

§ 1.231 How and where do you register or 

renew your registration? 

(a) Electronic registration and 

registration renewal. (1) To register or 

renew a registration electronically, you 

must go to http://www.fda.gov/furls, 

which is available for registration 24 

hours a day, 7 days a week. This Web 

site is available from wherever the 

Internet is accessible, including 

libraries, copy centers, schools, and 

Internet cafes. An individual authorized 

by the owner, operator, or agent in 

charge of a facility may also register a 

facility electronically. 

(2) Beginning on January 4, 2016, you 

must submit your registration or 

registration renewal to FDA 

electronically, unless you have been 

granted a waiver under § 1.245. 

(3) After you complete your electronic 

registration, FDA will verify the 

accuracy of your facility’s Data 

Universal Numbering System (D–U–N– 

S® number) and will also verify that the 

facility-specific address associated with 

the D–U–N–S® number 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 D–U–N– 

S® number and verifies that the facilityspecific address associated with the D– 

U–N–S® number is the same address 

associated with your registration. With 

respect to electronic registration 

renewals, after you complete your 

electronic registration renewal, FDA 

will provide you with an electronic 

confirmation of your registration 

renewal. When you update your 

facility’s D–U–N–S® number as part of 

your electronic registration renewal, 

FDA will verify the accuracy of your 

facility’s D–U–N–S® number and will 

also verify that the facility-specific 

address associated with the D–U–N–S®

number is the same address associated 

with your registration. FDA will not 

provide you with an electronic 

confirmation of your registration 

renewal until FDA verifies the accuracy 

of your D–U–N–S® number and verifies 

that the facility-specific address 

associated with the D–U–N–S® number 

is the same address associated with your 

registration. 

(4) For electronic registrations not 

submitted by the owner, operator, or 

agent in charge of the facility, after 

completion of the electronic 

registration, FDA will email the 

individual identified as the owner, 

operator, or agent in charge who 

authorized submission of the 

registration to verify that the individual 

in fact authorized submission of the 

registration on behalf of the facility. 

FDA will not confirm the registration or 

provide a registration number until that 

individual confirms that he or she 

authorized the registration submission. 

With respect to electronic registration 

renewals, after completion of the 

electronic registration renewal, FDA 

will provide an electronic confirmation 

of the registration renewal. For 

electronic registration renewals not 

submitted by the owner, operator, or 

agent in charge of the facility, FDA will 

email the individual identified as the 

owner, operator, or agent in charge who 

authorized submission of the 

registration renewal to verify that the 

individual in fact authorized 

submission of the registration renewal 

on behalf of the facility. FDA will not 

provide an electronic confirmation of 

the registration renewal until that 

individual confirms that he or she 

authorized the registration renewal. 

(5) For a foreign facility, after you 

complete your electronic registration, 

FDA will email the person identified as 

the U.S. agent for your foreign facility, 

using the email address for the person 

identified as your U.S. agent, to verify 

that the person 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 agreed to serve 

as your U.S. agent. With respect to 

electronic registration renewals, after 

you complete your electronic 

registration renewal, FDA will provide 

you with an electronic confirmation of 

your registration renewal. When you 

update information about your U.S. 

agent as part of your electronic 

registration renewal, FDA will email the 

person identified as the U.S. agent for 

your foreign facility, using the email 

address for the person identified as your 

U.S. agent, to verify that the person has 

agreed to serve as your U.S. agent. FDA 

will not provide you with an electronic 

confirmation of your registration 

renewal until that person confirms that 

the person agreed to serve as your U.S. 

agent. 

(6) If any information you previously 

submitted was incorrect at the time of 

submission, you must immediately 

update your facility’s registration as 

specified in § 1.234. 

(7) You will be considered registered 

once FDA electronically transmits your 

confirmation and registration number. 

(b) Registration or registration renewal 

by mail or fax. Before January 4, 2016, 

if you do not have reasonable access to 

the Internet through any of the methods 

described in paragraph (a) of this 

section, you may register or renew a 

registration by mail or by fax. Beginning 

January 4, 2016, you must submit your 

registration or registration renewal to 

FDA electronically, unless you have 

been granted a waiver under § 1.245. 

(1) You must register or renew a 

registration (including abbreviated 

registration renewals) using Form FDA 

3537. You may obtain a copy of this 

form by writing to the U.S. Food and 

Drug Administration, Center for Food 

Safety and Applied Nutrition, 5100 

Paint Branch Pkwy. (HFS–681), College 

Park, MD 20993, or by requesting the 

form by phone at 1–800–216–7331 or 

301–575–0156. 

(2) When you receive the form, you 

must fill it out completely and legibly 

and either mail it to the address in 

paragraph (b)(1) of this section or fax it 

to 301–436–2804. 

(3) If any required information on the 

form is incomplete or illegible when 

FDA receives it, FDA will return the 

form to you for revision, provided that 

your mailing address or fax number is 

legible and valid. When returning a 

registration form for revision, FDA will 

use the means by which the form was 

received by the Agency (i.e., by mail or 

fax). 

(4) FDA will enter complete and 

legible mailed and faxed registration 

submissions into its registration system, 

as soon as practicable, in the order FDA 

receives them. 

(5) After you complete your 

registration, FDA will verify the 

accuracy of your facility’s D–U–N–S®

number and will also verify that the 


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facility-specific address associated with 

the D–U–N–S® number 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 D–U–N– 

S® number and verifies that the facilityspecific address associated with the D– 

U–N–S® number is the same address 

associated with your registration. With 

respect to registration renewals, after 

you complete your registration renewal 

by mail or fax, FDA will provide you 

with a confirmation of your registration 

renewal. When you update your 

facility’s D–U–N–S® number as part of 

your registration renewal, FDA will 

verify the accuracy of your facility’s D– 

U–N–S® number and will also verify 

that the facility-specific address 

associated with the D–U–N–S® number 

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 D–U–N–S® number and verifies 

that the facility-specific address 

associated with the D–U–N–S® number 

is the same address associated with your 

registration. 

(6) For registrations not submitted by 

the owner, operator, or agent in charge 

of the facility, after completion of the 

registration by mail or fax, FDA will 

email the individual identified as the 

owner, operator, or agent in charge who 

authorized submission of the 

registration to verify that the individual 

in fact authorized submission of the 

registration on behalf of the facility. 

FDA will not confirm the registration or 

provide a registration number until that 

individual confirms that he or she 

authorized the registration submission. 

With respect to registration renewals, 

after completion of the registration 

renewal by mail or fax, FDA will 

provide a confirmation of the 

registration renewal. For registration 

renewals not submitted by the owner, 

operator, or agent in charge of the 

facility, FDA will email the individual 

identified as the owner, operator or 

agent in charge who authorized 

submission of the registration renewal 

to verify that the individual in fact 

authorized the submission of the 

registration renewal on behalf of the 

facility. FDA will not provide a 

confirmation of the registration renewal 

until that individual confirms that he or 

she authorized the registration renewal. 

(7) For a foreign facility, after you 

complete your registration by mail or 

fax, FDA will email the person 

identified as the U.S. agent for your 

foreign facility, using the email address 

for the person identified as the U.S. 

agent in your registration, to verify that 

the person 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 agreed to serve 

as your U.S. agent. With respect to 

registration renewals, after you 

complete your registration renewal by 

mail or fax, FDA will provide you with 

a confirmation of your registration 

renewal. When you update information 

about your U.S. agent as part of your 

registration renewal, FDA will email the 

person identified as the U.S. agent for 

your foreign facility, using the email 

address for the person identified as your 

U.S. agent, to verify that the person has 

agreed to serve as your U.S. agent. FDA 

will not provide you with a 

confirmation of your registration 

renewal until that person confirms that 

the person agreed to serve as your U.S. 

agent. 

(8) FDA will mail or fax a copy of the 

registration as entered, confirmation of 

registration, and your registration 

number. When responding to a 

registration submission, FDA will use 

the means by which the registration was 

received by the Agency (i.e., by mail or 

fax). 

(9) If any information you previously 

submitted was incorrect at the time of 

submission, you must immediately 

update your facility’s registration as 

specified in § 1.234. 

(10) Your facility is considered 

registered once FDA enters your 

facility’s registration data into the 

registration system and the system 

generates a registration number. 

(c) Fees. No registration fee is 

required. 

(d) Language. You must submit all 

registration information in the English 

language except an individual’s name, 

the name of a company, the name of a 

street, and a trade name may be 

submitted in a foreign language. All 

information, including these items, 

must be submitted using the Latin 

(Roman) alphabet. 

■ 5. Revise § 1.232 to read as follows: 

§ 1.232 What information is required in the 

registration? 

(a) For a domestic and foreign facility, 

the following information is required: 

(1) The name, full address, and phone 

number of the facility; 

(2) The D–U–N–S® number of the 

facility; 

(3) The preferred mailing address, if 

different from that of the facility; 

(4) The name, full address, and phone 

number of the parent company, if the 

facility is a subsidiary of the parent 

company; 

(5) All trade names the facility uses; 

(6) The name, full address, phone 

number, and email address of the 

owner, operator, or agent in charge of 

the facility; 

(7) The applicable food product 

categories of any food manufactured/

processed, packed, or held at the facility 

as identified on Form FDA 3537; 

(8) The type of activity conducted at 

the facility for each food product 

category identified. You may select 

more than one activity type for each 

food product category identified. The 

activity type options are as follows: 

(i) Ambient human food storage 

warehouse/holding facility; 

(ii) Refrigerated human food 

warehouse/holding facility; 

(iii) Frozen human food warehouse/

holding facility; 

(iv) Interstate conveyance caterer/

catering point; 

(v) Contract Sterilizer; 

(vi) Labeler/Relabeler; 

(vii) Manufacturer/Processor; 

(viii) Farm Mixed-Type Facility; 

(ix) Packer/Repacker; 

(x) Salvage Operator (Reconditioner); 

(xi) Animal food warehouse/holding 

facility; 

(xii) Other Activity. 

(9) 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 Federal 

Food, Drug, and Cosmetic Act; 

(10) 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, email 

address and telephone number, the 

individual who authorized submission 

of the registration. Each registration 

must include the name of the individual 

registering the facility submitting the 

registration, and the individual’s 

signature (for the paper option). 

(b) For a domestic facility, the 

following additional information is 

required: 

(1) The email address for the contact 

person of the facility; 

(2) An emergency contact phone 

number and email address if different 

from the email address for the contact 

person in paragraph (b)(1) of this 

section. 

(c) For a foreign facility, the following 

additional information is required: 


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(1) The name, full address, phone 

number, and email address of the 

foreign facility’s U.S. agent; 

(2) An emergency contact phone 

number and email address. 

■ 6. Revise § 1.233 to read as follows: 

§ 1.233 Are there optional items included 

in the registration form? 

Yes. FDA encourages, but does not 

require, you to submit items that are 

indicated as optional on the Form FDA 

3537 that you submit. 

■ 7. Revise § 1.234 to read as follows: 

§ 1.234 How and when do you update your 

facility’s registration information? 

(a) Update requirements. You must 

update a facility’s registration within 30 

calendar days of any change to any of 

the information previously submitted 

under § 1.232 (e.g., change of operator, 

agent in charge, or U.S. agent), except a 

change of the owner. You may authorize 

an individual to update a facility’s 

registration on your behalf. For updates 

not submitted by the owner, operator, or 

agent in charge of the facility, the 

update must provide the email address 

of the owner, operator, or agent in 

charge who authorized submission of 

the update. 

(b) Cancellation due to ownership 

changes. If the reason for the update is 

that the facility has a new owner, the 

former owner must cancel the facility’s 

registration as specified in § 1.235 

within 30 calendar days of the change 

and the new owner must submit a new 

registration for the facility as specified 

in § 1.231. The former owner may 

authorize an individual to cancel a 

facility’s registration. 

(c) Electronic update. (1) To update 

your registration electronically, you 

must update at http://www.fda.gov/

furls. 

(2) After you complete your electronic 

update, FDA will provide you with an 

electronic confirmation of your update. 

When updating D–U–N–S® number 

information, FDA will verify the 

accuracy of your facility’s D–U–N–S®

number and will also verify that the 

facility-specific address associated with 

the D–U–N–S® number is the same 

address associated with your 

registration. FDA will not provide you 

with an electronic confirmation of your 

registration update until FDA verifies 

the accuracy of your facility’s D–U–N– 

S® number and verifies that the facilityspecific address associated with the D– 

U–N–S® number is the same address 

associated with your registration. For 

foreign facilities, when updating 

information about your U.S. agent, FDA 

will email the person identified as the 

U.S. agent for your foreign facility, using 

the email address for the person 

identified as your U.S. agent, to verify 

that the person has agreed to serve as 

your U.S. agent. FDA will not provide 

you with an electronic confirmation of 

your registration update until that 

person confirms that the person agreed 

to serve as your U.S. agent. 

(3) For electronic updates not 

submitted by the owner, operator, or 

agent in charge of the facility, after 

completion of the electronic update, 

FDA will email the individual identified 

as the owner, operator, or agent in 

charge who authorized submission of 

the update to verify that the individual 

in fact authorized submission of the 

update on behalf of the facility. FDA 

will not confirm the update to the 

registration until that individual 

confirms that he or she authorized the 

update. 

(4) Your registration will be 

considered updated once FDA transmits 

your update confirmation, unless 

notified otherwise. 

(d) Update by mail or fax. Before 

January 4, 2016, if you do not have 

reasonable access to the Internet 

through any of the methods described in 

§ 1.231(a), you may update your 

facility’s registration by mail or by fax. 

Beginning January 4, 2016, electronic 

updates will be mandatory, unless a 

waiver under § 1.245 has been granted. 

(1) You must update your registration 

using Form FDA 3537. You may obtain 

a copy of this form by writing to the 

U.S. Food and Drug Administration, 

Center for Food Safety and Applied 

Nutrition, 5100 Paint Branch Pkwy. 

(HFS–681), College Park, MD 20993 or 

by requesting the form by phone at 1– 

800–216–7331 or 301–575–0156. 

(2) When you receive the form, you 

must legibly fill out the sections of the 

form reflecting your updated 

information and either mail it to the 

address in paragraph (d)(1) of this 

section or fax it to 301–436–2804. 

(3) If the information on the form is 

incomplete or illegible when FDA 

receives it, FDA will return the form to 

you for revision, provided that your 

mailing address or fax number is legible 

and valid. When returning a registration 

form for revision, FDA will use the 

means by which the registration was 

received by the Agency (i.e., by mail or 

fax). 

(4) FDA will enter complete and 

legible updates into its registration 

system as soon as practicable, in the 

order FDA receives them. 

(5) FDA will then mail to the address 

or fax to the fax number on the 

registration form a copy of the update as 

entered and confirmation of the update. 

When responding to an update 

submission, FDA will use the means by 

which the form was received by the 

Agency (i.e., by mail or fax). After you 

complete your update by mail or fax, 

FDA will verify the accuracy of your 

facility’s D–U–N–S® number and will 

also verify that the facility-specific 

address associated with the D–U–N–S®

number is the same address associated 

with your registration. FDA will not 

provide a confirmation of your 

registration update until FDA verifies 

the accuracy of your facility’s D–U–N– 

S® number and verifies that the facilityspecific address associated with the D– 

U–N–S® number is the same address 

associated with your registration. For 

foreign facilities, when updating 

information about your U.S. agent, FDA 

will email the person identified as the 

U.S. agent for your foreign facility, using 

the email address for the person 

identified as your U.S. agent, to verify 

that the person has agreed to serve as 

your U.S. agent. FDA will not provide 

you with a confirmation of your 

registration update until that person 

confirms that the person agreed to serve 

as your U.S. agent. 

(6) For registration updates not 

submitted by the owner, operator, or 

agent in charge of the facility, after 

completion of the registration update by 

mail or fax, FDA will email the 

individual identified as the owner, 

operator, or agent in charge who 

authorized submission of the 

registration update to verify that the 

individual in fact authorized 

submission of the update on behalf of 

the facility. FDA will not confirm the 

registration update until that individual 

confirms that he or she authorized the 

update. 

(7) If any update information you 

previously submitted was incorrect at 

the time of submission, you must 

immediately resubmit your update. 

(8) Your registration will be 

considered updated once FDA enters 

your facility’s update data into the 

registration system and the system 

generates an update confirmation. 

■ 8. Revise § 1.235 to read as follows: 

§ 1.235 How and when do you cancel your 

facility’s registration information? 

(a) Notification of registration 

cancellation. You must cancel a 

registration within 30 calendar days of 

the reason for cancellation (e.g., your 

facility ceases operations, ceases 

providing food for consumption in the 

United States, or is sold to a new 

owner). 

(b) Cancellation requirements. The 

cancellation of a facility’s registration 

must include the following information: 

(1) The facility’s registration number; 


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(2) Whether the facility is domestic or 

foreign; 

(3) The facility name and address; 

(4) The name, address, and email 

address (if available) of the individual 

submitting the cancellation; 

(5) For registration cancellations not 

submitted by the owner, operator, or 

agent in charge of the facility, the email 

address of the owner, operator, or agent 

in charge who authorized submission of 

the registration cancellation; and 

(6) 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. 

(c) Electronic cancellation. (1) To 

cancel your registration electronically, 

you must cancel at http://www.fda.gov/ 

furls. 

(2) Once you complete your electronic 

cancellation, FDA will automatically 

provide you with an electronic 

confirmation of your cancellation. 

(3) For registration cancellations not 

submitted by the owner, operator, or 

agent in charge of the facility, after 

completion of the registration 

cancellation, FDA will email the 

individual identified as the owner, 

operator, or agent in charge who 

authorized submission of the 

registration cancellation to verify that 

the individual in fact authorized 

submission of the registration 

cancellation on behalf of the facility. 

FDA will not confirm the registration 

cancellation until that individual 

confirms that he or she authorized the 

registration cancellation. 

(4) Your registration will be 

considered cancelled once FDA 

transmits your cancellation 

confirmation. 

(d) Cancellation by mail or fax. Before 

January 4, 2016, if you do not have 

reasonable access to the Internet 

through any of the methods described in 

§ 1.231(a), you may cancel your 

facility’s registration by mail or fax. 

Beginning January 4, 2016, you must 

cancel your registration electronically 

unless a waiver under § 1.245 has been 

granted. 

(1) You must cancel your registration 

using Form FDA 3537a. You may obtain 

a copy of this form by writing to the 

U.S. Food and Drug Administration, 

Center for Food Safety and Applied 

Nutrition, 5100 Paint Branch Pkwy. 

(HFS–681), College Park, MD 20993 or 

by requesting the form by phone at 1– 

800–216–7331 or 301–575–0156. 

(2) When you receive the form, you 

must completely and legibly fill out the 

form and either mail it to the address in 

paragraph (d)(1) of this section or fax it 

to 301–436–2804. 

(3) If the information on the form is 

incomplete or illegible when FDA 

receives it, FDA will return the form to 

you for revision, provided that your 

mailing address or fax number is legible 

and valid. When returning a 

cancellation form for revision, FDA will 

use the means by which the cancellation 

was received by the Agency (i.e., by 

mail or fax). 

(4) FDA will enter complete and 

legible mailed and faxed cancellations 

into its registration system as soon as 

practicable, in the order FDA receives 

them. 

(5) FDA will mail to the address or fax 

to the fax number on the cancellation 

form a copy of the cancellation as 

entered and confirmation of the 

cancellation. When responding to a 

cancellation, FDA will use the means by 

which the form was received by the 

Agency (i.e., by mail or fax). 

(6) For registration cancellations not 

submitted by the owner, operator, or 

agent in charge of the facility, after 

completion of the registration 

cancellation by mail or fax, FDA will 

email the individual identified as the 

owner, operator, or agent in charge who 

authorized submission of the 

registration cancellation to verify that 

the individual in fact authorized 

submission of the registration 

cancellation on behalf of the facility. 

FDA will not confirm the registration 

cancellation until that individual 

confirms that he or she authorized the 

registration cancellation. 

(7) If any information you previously 

submitted was incorrect at the time of 

submission, you must immediately 

resubmit your cancellation. 

(8) Your registration will be 

considered cancelled once FDA enters 

your facility’s cancellation data into the 

registration system and the system 

generates a confirmation. 

(e) Cancellation by CD–ROM for 

multiple submissions. If, for example, 

you do not have reasonable access to the 

Internet through any of the methods 

described in § 1.231(a), you may cancel 

your facilities’ registrations using a CD– 

ROM. 

■ 9. Revise § 1.241 to read as follows: 

§ 1.241 What are the consequences of 

failing to register, update, renew, or cancel 

your registration? 

(a) Section 301 of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 331) 

prohibits the doing of certain acts or 

causing such acts to be done. Under 

section 302 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 332), the 

United States can bring a civil action in 

Federal court to enjoin a person who 

commits a prohibited act. Under section 

303 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 333), the 

United States can bring a criminal 

action in Federal court to prosecute a 

person who is responsible for the 

commission of a prohibited act. Under 

section 306 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 335a), FDA 

can seek debarment of any person who 

has been convicted of a felony relating 

to importation of food into the United 

States. Failure of an owner, operator, or 

agent in charge of a domestic or foreign 

facility to register its facility, renew the 

registration of its facility, update 

required elements of its facility’s 

registration, or cancel its registration in 

accordance with the requirements of 

this subpart is a prohibited act under 

section 301(dd) of the Federal Food, 

Drug, and Cosmetic Act. 

(b) FDA will consider a registration 

for a food facility to be expired if the 

registration is not renewed, as required 

by § 1.230(b). Thus, if you previously 

submitted a registration to FDA, but do 

not submit a registration renewal to 

FDA during the period beginning on 

October 1 and ending on December 31 

of each even-numbered year, FDA will 

consider the registration for the facility 

to be expired. FDA will consider a food 

facility with an expired registration to 

have failed to register in accordance 

with section 415 of the Federal Food, 

Drug, and Cosmetic Act. 

(c) FDA will cancel a registration if 

FDA independently verifies that the 

facility is no longer in business or has 

changed owners, and the owner, 

operator, or agent in charge of the 

facility fails to cancel the registration, or 

if FDA determines that the registration 

is for a facility that does not exist, is not 

required to register, or where the 

information about the facility’s address 

was not updated in a timely manner in 

accordance with § 1.234(a) or the 

registration was submitted by a person 

not authorized to submit the registration 

under § 1.225. Also, FDA will cancel a 

registration if the facility’s registration 

has expired because the facility has 

failed to renew its registration in 

accordance with § 1.230(b). If FDA 

cancels a facility’s registration, FDA will 

mail a confirmation of the cancellation 

to the facility at the address provided in 

the facility’s registration. 

(d) If an article of food is imported or 

offered for import into the United States 

and a foreign facility that manufactured/ 

processed, packed, or held that article of 

food has not registered in accordance 

with this subpart, the disposition of the 

article of food shall be governed by the 

procedures set out in subpart I of this 

part. 


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■ 10. Add § 1.245 to subpart H to read 

as follows: 

§ 1.245 Waiver request. 

Under § 1.231(a)(2) and (b), beginning 

January 4, 2016, you must submit your 

registration or registration renewal to 

FDA electronically unless FDA grants a 

waiver from such requirement. To 

request a waiver from such requirement, 

you must submit a written request to 

FDA that explains why it is not 

reasonable for you to submit your 

registration or registration renewal to 

FDA electronically. You must submit 

your request to: U.S. Food and Drug 

Administration, Center for Food Safety 

and Applied Nutrition, 5100 Paint 

Branch Pkwy. (HFS–681), College Park, 

MD 20993. 

Dated: April 1, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08018 Filed 4–8–15; 8:45 am] 

BILLING CODE 4164–01–P 


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