[Federal Register Volume 80, Number 68 (Thursday, April 9, 2015)]
[Proposed Rules]
[Pages 19159-19188]
[FR Doc No: 2015-08018]

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

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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,<PHONE_NUMBER>. 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_ADDRESS>
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

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

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

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

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

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

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

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

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

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

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

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

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

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).

     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

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

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