[Federal Register Volume 80, Number 68 (Thursday, April 9, 2015)]
[Proposed Rules]
[Pages 19160-19188]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-08018]



[[Page 19159]]

Vol. 80

Thursday,

No. 68

April 9, 2015

Part III





Department of Health and Human Services





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Food and Drug Administration





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21 CFR Part 1





Amendments to Registration of Food Facilities; Proposed Rules

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

[[Page 19160]]


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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.

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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 risk-based 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, [email protected].

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 self-implementing 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 Sec.  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

[[Page 19161]]

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.

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]
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                                                             Total           Total
                                        Total one time    annualized      annualized            Benefits
                                             costs         costs 7%        costs 3%
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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
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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:
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    \1\ The 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.
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     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

[[Page 19162]]

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 Sec.  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 re-register 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 self-
implementing 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 Sec.  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

[[Page 19163]]

specifically identified in Sec.  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 Sec.  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 Sec.  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-high-risk 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 third-party 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

[[Page 19164]]

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 
reinspection-related 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 Risk-
Based 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 on-farm 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 
Risk-Based 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 even-numbered 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 
Sec.  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

[[Page 19165]]

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 
reinspection-related 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 self-
implementing 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 Sec.  1.227(b)(11) to mean an establishment that sells food 
products directly to consumers as its primary function. Under current 
Sec.  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 Sec.  1.227(b)(3)(ii)). If all sales from an on-farm 
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 Sec.  
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 on-farm establishment is a retail food establishment.
    a. Sale of food directly to consumers at a roadside stand or 
farmers' market. Under proposed Sec.  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 on-farm establishments at direct 
sales

[[Page 19166]]

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 Sec.  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 Sec.  1.227(b)(11) have the 
same meaning used for the term in 7 CFR 249.2. We note that, under 
proposed Sec.  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 Sec.  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-to-consumer 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 Sec.  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 Sec.  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 Sec.  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 Sec.  1.232 every other year, 
during the period beginning on October 1 and ending on December 31 of 
each even-numbered year. Under proposed Sec.  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 
Sec.  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 Sec.  
1.230(c) would provide for an abbreviated registration renewal process 
for registrations that do not have any changes to the information 
required under Sec.  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

[[Page 19167]]

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 Sec.  
1.231(a)(2).
    Proposed Sec.  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 Sec.  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 Sec.  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 Sec.  1.231(a)(2) would require mandatory electronic 
registration renewals beginning in the 2016 registration renewal 
period. Proposed Sec.  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 Sec.  1.232(b)(1) would require the email address for the 
contact person of a domestic facility be included in the registration. 
Proposed Sec.  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

[[Page 19168]]

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 Sec.  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 Sec.  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 Sec.  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 Sec.  1.232(a)(9) 
would codify such requirement in FDA's registration regulations. 
Specifically, proposed Sec.  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, Sec.  1.241 specifies the consequences of failing to 
register, update, or cancel a food facility registration. As described 
in current Sec.  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 Sec.  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 Sec.  1.241(a) would amend current Sec.  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 Sec.  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 Sec.  1.241(a), we 
are proposing to add proposed Sec.  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 Sec.  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 
Sec.  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 Sec.  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, Sec.  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, Sec.  
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, 
Sec.  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 Sec.  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 Sec.  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

[[Page 19169]]

communicating with FDA. (See Sec.  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.'' (Sec.  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.'' (Sec.  
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.'' (Sec.  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 Sec.  20.21 would 
not be triggered by FDA's proposed amendment to Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  1.231(a)(5) would apply this 
verification requirement to electronic registrations, and proposed 
Sec.  1.231(b)(7) would apply this requirement to registrations 
submitted by mail or fax. Under proposed Sec.  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 Sec.  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 Sec.  1.234(c)(2) would apply this verification requirement to 
electronic updates, and proposed Sec.  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 reinspection-related 
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

[[Page 19170]]

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[supreg]) 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[supreg] Number and Verification 
Procedures
    Proposed Sec.  1.232(a)(2) would require the D-U-N-S[supreg] number 
of a domestic and foreign facility be included in the facility's 
registration. This requirement would function in connection with 
proposed Sec.  1.231(a)(3) and (b)(5), which provide that after a 
facility completes its registration or updates its D-U-N-S[supreg] 
number as part of registration renewal, FDA will verify the accuracy of 
the food facility's D-U-N-S[supreg] number and will also verify that 
the facility-specific address associated with the D-U-N-S[supreg] 
number is the same address associated with the facility's registration. 
Under proposed Sec.  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[supreg] number and verifies that the 
facility-specific address associated with the D-U-N-S[supreg] number is 
the same address associated with the facility's registration. With 
respect to initial registrations, proposed Sec.  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[supreg] number and verifies that the facility-specific address 
associated with the D-U-N-S[supreg] number is the same address 
associated with the facility's registration. Proposed Sec.  1.231(a)(3) 
would apply this verification requirement to electronic registrations, 
and proposed Sec.  1.231(b)(5) would apply this requirement to 
registrations submitted by mail or fax. The requirement to submit D-U-
N-S[supreg] numbers would also function in connection with proposed 
Sec.  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 Sec.  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[supreg] number and also verifies that the 
facility-specific address associated with the D-U-N-S[supreg] number is 
the same address associated with the facility's registration. Proposed 
Sec.  1.234(c)(2) would apply this verification requirement to 
electronic updates, and proposed Sec.  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[supreg] numbers, which serve as unique identifiers (codes) of 
business entities. A D-U-N-S[supreg] number is a unique nine-digit 
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 site-specific nine-digit D-U-N-S[supreg] number. 
D-U-N-S[supreg] Numbers are proprietary to and controlled by Dun & 
Bradstreet (D&B).
    If a food facility has not obtained a D-U-N-S[supreg] 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[supreg] number 
for its facility in a registration, FDA intends to make arrangements 
for obtaining a D-U-N-S[supreg] 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[supreg] 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[supreg] 
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 Sec.  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[supreg] number and verifies that the facility-specific address 
associated with the D-U-N-S[supreg] number is the same address 
associated with the facility's registration.
    FDA's tentative decision to require and verify D-U-N-S[supreg] 
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[supreg] 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[supreg] 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[supreg] 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[supreg] 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[supreg] 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[supreg] 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[supreg] number or other 
identifier for the facility's U.S. agent. To the extent FDA does pursue 
a D-U-N-S[supreg] number requirement, we seek comment on whether, as 
with the D-U-N-S[supreg] number for food facilities, FDA

[[Page 19171]]

should verify the accuracy of the U.S. agent D-U-N-S[supreg] numbers 
and whether FDA should verify that the contact information associated 
with the D-U-N-S[supreg] 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[supreg] 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[supreg] 
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[supreg] 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[supreg] 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[supreg] 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[supreg] 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; 
Sec. Sec.  1.225 and 1.232 (21 CFR 1.225 and 1.232).) Currently, Sec.  
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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 
Sec. Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  1.231(a)(4) would apply this 
verification requirement to electronic registrations and registration 
renewals; proposed Sec.  1.231(b)(6) would apply the verification 
requirement to registration and registration renewals submitted by mail 
or fax; proposed Sec.  1.234(c)(3) would apply the verification 
requirement to electronic updates; proposed Sec.  1.234(d)(6) would 
apply the verification requirement to updates submitted by mail or fax; 
proposed Sec.  1.235(c)(3) would apply the verification requirement to 
electronic cancellations; and proposed Sec.  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

[[Page 19172]]

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 Sec. Sec.  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 Sec.  
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 Sec.  
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 Sec.  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 Sec.  
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 Sec. Sec.  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 Sec. Sec.  
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 Sec.  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 Sec. Sec.  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 Sec.  
1.232(a)(8) would

[[Page 19173]]

require the type of activity conducted at the facility for each food 
product category identified. In addition, proposed Sec.  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 food-
related 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 Sec.  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 [deg]C/70 [deg]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 [deg]C/ 40 [deg]F-0 [deg]C/
32 [deg]F).
     Frozen human food warehouse/holding facility: A facility 
that holds or stores food for human consumption at frozen temperatures 
(approximately 0 [deg]C/32 [deg]F or below).

[[Page 19174]]

     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 non-farm facility that makes 
food from one or more ingredients, or synthesizes, prepares, treats, 
modifies, or manipulates food, including food crops or ingredients. For 
purposes of this activity type option, examples of 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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 low-acid 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 low-acid 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

[[Page 19175]]

Sec.  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 Sec.  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 food-related 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 
Sec.  1.232(b)(1) for domestic facilities. Consequently, proposed Sec.  
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 Sec.  1.232(b)(1). 
Accordingly, the email address for the facility contact person required 
in proposed Sec.  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 Sec.  1.232(a)(7) would retain the requirement in current 
Sec.  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 Sec.  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 Sec.  170.3. Specifically, current Sec.  1.232(g) 
provides that food facility registrations include applicable food 
product categories as defined in Sec.  170.3, unless facilities check 
either ``most/all human food product categories,'' according to Sec.  
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 Sec.  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 
Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  
1.233 into required items in proposed Sec.  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 Sec.  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 Sec.  1.231(b)(6) for registrations 
submitted by mail or fax, as well as with the current requirement in 
Sec.  1.231(c)(10) for registrations submitted by CD-ROM. Under current 
Sec.  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, Sec.  
1.231(b)(6) would be recodified as Sec.  1.231(b)(9). (Current Sec.  
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 Sec.  
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

[[Page 19176]]

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 food-
related 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 Sec.  1.234(a) and Sec.  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 Sec.  
1.234(a) would require facilities to update their registration 
information, previously submitted under Sec.  1.232, within 30 calendar 
days, replacing the 60-calendar-day requirement in current Sec.  
1.234(a). Proposed Sec.  1.234(a) would not amend the other 
requirements in current Sec.  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 Sec.  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 Sec.  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 Sec.  
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, Sec.  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 Sec.  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 Sec.  1.234(a), or if the registration was 
submitted to the Agency by a person not authorized to submit the 
registration under Sec.  1.225. Proposed Sec.  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 Sec.  
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; Sec. Sec.  1.225 and 1.232.) Registration information 
submitted to FDA must be true and accurate. (Sec.  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 food-related emergency. Moreover, such registrations could hinder 
the Agency's

[[Page 19177]]

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 Sec.  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 Sec.  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 Sec.  
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 un-updated 
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 Sec.  1.241(c) would maintain the requirement in current 
Sec.  1.241(b) that FDA will cancel registrations in the specified 
circumstances if the Agency ``independently verifies'' those 
circumstances. Specifically, proposed Sec.  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 Sec.  1.234(a) or the registration was 
submitted by a person not authorized to submit the registration under 
Sec.  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 Sec.  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 Sec.  1.241(c) would maintain the requirement in 
current Sec.  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 Sec.  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 Sec.  1.231(a)(2) would 
provide that beginning January 4, 2016,

[[Page 19178]]

electronic registration will be mandatory, unless a waiver has been 
granted for the registrant. Proposed Sec.  1.245 would allow a 
registrant to request a waiver from the electronic registration 
requirement. Specifically, proposed Sec.  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 Sec.  1.230(a)--When must you 
register? Current Sec.  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 Sec.  1.230(a). Thus, proposed 
Sec.  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 Sec.  1.230(a) would retain the provision in 
current Sec.  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 Sec.  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 Sec.  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 
Sec.  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 
Sec.  1.231(c), as well as the option to use CD-ROM for updates of 
multiple submissions in current Sec.  1.234(e) and for cancellations of 
multiple registrations in current Sec.  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

[[Page 19179]]

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 Sec.  
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 Sec.  1.231(b)(6). Because the 
use of an identification number would constitute verification for 
purposes of proposed Sec.  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,

[[Page 19180]]

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 FSMA-
related emergency OMB approval and subsequent 3-year approval, we have 
refined our estimates for the time required to comply with the self-
implementing 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 one-time burden of the FSMA-related 
provisions of the proposed rule on registered facilities as follows:

[[Page 19181]]



                                                    Table 2--Estimated One-Time Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                      Activity/21 CFR section                           Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
All facility registrations (1.230-1.233)...........................         172,274                1          172,274   0.18 (11 mins)           31,584
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There 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 self-implementing 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 post-FSMA 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[supreg] 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 x 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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
     Activity/21 CFR section         Number of     responses per   Total annual   Average burden       Total
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
New domestic facility                      9,795               1           9,795             2.7          26,447
 registrations (1.230-1.233)....
New foreign facility                      13,697               1          13,697             8.7         119,164
 registrations (1.230-1.233)....
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          37,196
                                                                                    (23 minutes)
Waiver requests (1.245).........           1,061               1           1,061            0.17             180
                                                                                    (10 minutes)
Third party registration                  41,256               1          41,256            0.25          10,314
 verification procedure.........                                                    (15 minutes)
U.S. Agent verification                   57,070               1          57,070             0.5          28,535
 procedure......................                                                    (30 minutes)
                                 -------------------------------------------------------------------------------
    Total Hours.................  ..............  ..............  ..............  ..............         331,002
----------------------------------------------------------------------------------------------------------------
\1\ There 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

[[Page 19182]]

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 x 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 x 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 x 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 [email protected]. 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.

[[Page 19183]]

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/ComplianceManuals/CompliancePolicyGuidanceManual/UCM399369.pdf), 
accessed on March 27, 2015.
2. FDA, ``Field Management Directives,'' (http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/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/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/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

0
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.

0
2. Revise Sec.  1.227 (b)(11) and (13) to read as follows:


Sec.  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.
* * * * *
0
3. Revise Sec.  1.230 to read as follows:


Sec.  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 Sec.  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

[[Page 19184]]

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 Sec.  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 Sec.  
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.
0
4. Revise Sec.  1.231 to read as follows:


Sec.  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 Sec.  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[supreg] number) and will also verify that the facility-
specific address associated with the D-U-N-S[supreg] 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[supreg] number and 
verifies that the facility-specific address associated with the D-U-N-
S[supreg] 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[supreg] number as part of your electronic 
registration renewal, FDA will verify the accuracy of your facility's 
D-U-N-S[supreg] number and will also verify that the facility-specific 
address associated with the D-U-N-S[supreg] 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[supreg] number and verifies that the 
facility-specific address associated with the D-U-N-S[supreg] 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 Sec.  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 Sec.  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[supreg] number and will also verify 
that the

[[Page 19185]]

facility-specific address associated with the D-U-N-S[supreg] 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[supreg] 
number and verifies that the facility-specific address associated with 
the D-U-N-S[supreg] 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[supreg] number as part of your registration renewal, 
FDA will verify the accuracy of your facility's D-U-N-S[supreg] number 
and will also verify that the facility-specific address associated with 
the D-U-N-S[supreg] 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[supreg] number and verifies that the facility-specific address 
associated with the D-U-N-S[supreg] 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 Sec.  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.
0
5. Revise Sec.  1.232 to read as follows:


Sec.  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[supreg] 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:

[[Page 19186]]

    (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.
0
6. Revise Sec.  1.233 to read as follows:


Sec.  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.
0
7. Revise Sec.  1.234 to read as follows:


Sec.  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 Sec.  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 Sec.  1.235 within 
30 calendar days of the change and the new owner must submit a new 
registration for the facility as specified in Sec.  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[supreg] number information, FDA will verify the accuracy of your 
facility's D-U-N-S[supreg] number and will also verify that the 
facility-specific address associated with the D-U-N-S[supreg] 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[supreg] 
number and verifies that the facility-specific address associated with 
the D-U-N-S[supreg] 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 Sec.  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 Sec.  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[supreg] number and will also 
verify that the facility-specific address associated with the D-U-N-
S[supreg] 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[supreg] number and 
verifies that the facility-specific address associated with the D-U-N-
S[supreg] 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.
0
8. Revise Sec.  1.235 to read as follows:


Sec.  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;

[[Page 19187]]

    (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 Sec.  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 Sec.  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 Sec.  1.231(a), you may cancel your 
facilities' registrations using a CD-ROM.
0
9. Revise Sec.  1.241 to read as follows:


Sec.  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 Sec.  
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 Sec.  1.234(a) or the registration was 
submitted by a person not authorized to submit the registration under 
Sec.  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 Sec.  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.

[[Page 19188]]

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10. Add Sec.  1.245 to subpart H to read as follows:


Sec.  1.245  Waiver request.

    Under Sec.  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