Amendments to Registration of Food Facilities, 45911-45954 [2016-16531]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 81, Number 135 (Thursday, July 14, 2016)]
[Rules and Regulations]
[Pages 45911-45954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16531]



[[Page 45911]]

Vol. 81

Thursday

No. 135

July 14, 2016

Part VI





Department of Health and Human Services





-----------------------------------------------------------------------





Food and Drug Administration





-----------------------------------------------------------------------





21 CFR Part 1





Amendments to Registration of Food Facilities; Final Rule

Federal Register / Vol. 81 , No. 135 / Thursday July 14, 2016 / Rules 
and Regulations

[[Page 45912]]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2002-N-0323]
RIN 0910-AG69


Amendments to Registration of Food Facilities

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is amending its 
regulations for registration of food facilities that require domestic 
and foreign facilities that manufacture/process, pack, or hold food for 
human or animal consumption in the United States to register with FDA. 
This rule amends and updates 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. 
These 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: This rule is effective September 12, 2016.

FOR FURTHER INFORMATION CONTACT: Courtney Buchanan, Center for Food 
Safety and Applied Nutrition (HFS-615), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 240-402-2487.

SUPPLEMENTARY INFORMATION: 

Table of Contents

Executive Summary
Purpose and Coverage of the Final Rule
Summary of the Major Provisions of the Final Rule
Costs and Benefits
I. Background
    A. FDA Food Safety Modernization Act
    B. Purpose of This Rulemaking
    C. Summary of the Major Provisions of the Proposed Rule
    D. Public Comments
II. Legal Authority
III. General Comments on the Proposed Rule
IV. Comments on Proposed Amendments to Sec.  1.227--Definitions
    A. Retail Food Establishment
    B. U.S. Agent
V. Comments on Proposed Amendments to Sec.  1.230--When Must You 
Register or Renew Your Registration?
    A. Proposed Sec.  1.230(a)--When Must You Register?
    B. Proposed Sec.  1.230(b)--Registration Renewal
    C. Proposed Sec.  1.230(c)--Abbreviated Registration Renewal 
Process
VI. Comments on Proposed Amendments to Sec.  1.231--How and Where Do 
You Register or Renew Your Registration?
    A. Proposed Sec.  1.231(a)--Electronic Registration and 
Registration Renewal
    B. Proposed Sec.  1.231(b)--Registration or Registration Renewal 
by Mail or Fax
    C. Proposed Sec. Sec.  1.231(a)(3) and (b)(5) and 1.234(c)(2) 
and (d)(5)--Unique Facility Identifier and Verification Procedures 
for FDA
    D. 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)--Verification Procedures for 
Submissions Not Made by the Owner, Operator, or Agent in Charge of 
the Facility
    E. Proposed Sec. Sec.  1.231(a)(5) and (b)(7) and 1.234(c)(2) 
and (d)(5)--Verification Procedures for U.S. Agents
    F. Proposed Sec.  1.231(a)(6) and (b)(9)--Requirement To Update 
Incorrect Registration Information
VII. Comments on Proposed Amendments to Sec.  1.232--What 
Information Is Required in the Registration?
    A. Requirement for Certain Email Address Information
    B. Requirement for a Unique Facility Identifier
    C. Requirement To Include Food Product Categories
    D. Requirement To Identify Activity Type
    E. Requirement To Provide Assurance That FDA Will Be Permitted 
To Inspect
VIII. Comments on Proposed Amendments to Sec.  1.233--Are There 
Optional Items Included in the Registration Form?
IX. Comments on Proposed Amendments to Sec.  1.234--How and When Do 
You Update Your Facility's Registration Information?
X. Comments on Proposed Amendments to Sec.  1.235--How and When Do 
You Cancel Your Facility's Registration Information?
XI. Comments on Proposed Amendments to Sec.  1.241--What Are the 
Consequences of Failing To Register, Update, Renew, or Cancel Your 
Registration?
XII. Comments on Proposed Addition of Sec.  1.245--Waiver Request
XIII. U.S. Agent Voluntary Identification System
XIV. Editorial Changes and Other Changes
    A. Editorial Changes
    B. CD-ROM Submissions
XV. Economic Analysis of Impacts
XVI. Paperwork Reduction Act of 1995
XVII. Analysis of Environmental Impact
XVIII. Federalism
XIX. References

Executive Summary

Purpose and Coverage of the Final Rule

    This rule is part of FDA's implementation of FSMA (Pub. L. 111-
353), which intends to better protect public health by, among other 
things, adopting a modern, preventive, and risk-based approach to food 
safety regulation. This rule implements 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 FSMA, that relate to 
registration of food facilities. Furthermore, this rule amends and 
updates FDA's registration regulations and improves the utility of the 
food facility registration database 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 Major Provisions of the Final Rule

    Section 102 of FSMA amends section 415 of the FD&C Act by requiring 
that certain additional information be included in facility 
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 
included in this final rule to codify these provisions in 21 CFR part 
1, subpart H, the food facility registration regulation.
    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 implementing this provision in the final rule. However, 
we are delaying the date for mandatory electronic registration until 
January 4, 2020. Furthermore, we are including a waiver request 
provision in the rule to allow a registrant to submit a written request 
to FDA that explains why it is not reasonable to submit the 
registration, registration renewal, update, or cancellation to FDA 
electronically or to explain why it is not reasonable to provide the 
email address

[[Page 45913]]

of the owner, operator, or agent in charge of the facility.
    Section 102(c) of FSMA also directs FDA to amend the definition of 
the term ``retail food establishment'' in Sec.  1.227 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 revising the definition 
of retail food establishment at Sec.  1.227 in this final rule 
consistent with section 102(c) of FSMA.
    In addition, we are making changes to improve the utility of the 
food facility registration database. We are making changes in 21 CFR 
part 1, subpart H to: (1) Require certain additional data elements in 
food facility registrations (e.g., a unique facility identifier (UFI) 
for food facility registrations); (2) employ 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.
    Further, we proposed to amend the regulation to shorten the 
timeframe for submitting updates and cancellations from 60 calendar 
days to 30 calendar days. In response to numerous comments received on 
this issue, the final rule does not shorten the timeframes as proposed. 
The final rule provides that updates to registration information or 
cancellation of registration must be submitted within 60 days of any 
change to any of the required information or the reason for the 
cancellation.

Costs and Benefits

    Costs of meeting the requirements of this final 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 final rule. These costs are similar to what we estimated the 
proposed rule would cost, but with the additional implementation of a 
U.S. Agent Voluntary Identification System (VIS) and reduced costs to 
facilities resulting from postponing the requirements to provide a UFI 
and to submit registrations electronically. Estimated one-time costs to 
domestic and foreign facilities are about $27 million. These estimated 
costs include a small reduction from the estimated one-time costs of 
provisions in the proposed rule. As explained in the preliminary 
regulatory impact analysis (PRIA), one-time costs in the first year 
stem from the self-implementing FSMA provisions that are already 
effective, including learning costs (i.e., the administrative costs 
incurred by domestic and foreign facilities in order to learn how to 
comply with any new regulation), first-time biennial registration 
renewal costs from the 2012 registration renewal cycle, and costs that 
stem from requirements for certain data elements in the registration 
form such as the email address for a domestic facility's contact person 
and the email address for a foreign facility's U.S. agent. These costs 
are approximately $20 million. Estimated one-time costs to domestic and 
foreign facilities for the biennial renewal cycle in 2016, by which 
time the final rule will be effective, include $4.6 million in one-time 
costs for entering additional data elements in the registration form 
and costs for U.S. agent verification procedures incurred in 2016. One-
time costs in 2020 include the costs for the requirement to obtain a 
UFI plus the reduced costs associated with the mandatory electronic 
submission requirement (because the preamble to the final rule 
clarifies that food facilities will not be required to resubmit waivers 
with each biennial registration renewal cycle once FDA has granted the 
waiver). These costs are approximately $3 million.
    Recurring biennial costs beginning in 2016 include costs from the 
requirement for both domestic and foreign food facilities to renew 
their registrations every 2 years and from requiring additional data 
elements in the registration form. Recurring costs for 2018 include 
costs from implementing the U.S. agent VIS. As was the case under 
Option 4 in the PRIA, these costs are based on the supposition that the 
U.S. agents for all foreign facilities will choose to use the VIS. In 
the PRIA (see pages 51 to 53), we estimated that implementing the 
system by 2018 could reduce estimated costs for the U.S. agent 
information viewing and verification provisions in the proposed rule by 
one-half. We estimated that this would result in roughly $2 million of 
savings each year or about $4 million every 2 years. We no longer 
assess the costs of requiring updates within 30 calendar days because 
we are not finalizing our proposal to shorten the time period for 
updates. The final rule does not change the currently required time 
periods. Thus, estimated recurring costs of this final rule are now 
approximately $8.8 million every 2 years. The $8.8 million in costs 
continue to accrue in each subsequent biennial registration renewal 
cycle, and include costs associated with registration renewal 
activities and costs associated with other provisions of the final 
rule, such as certain verification procedures.
    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 $4.7 million and $4.9 million per year ($24 and $25 
per facility) using a discount rate of 7 percent and 3 percent, 
respectively, over a period of 20 years. Annualized recurring costs to 
FDA are approximately $0.9 and $1.2 million, also using a discount rate 
of 7 percent and 3 percent, respectively.

                                  Table 1--Annualized Cost and Benefit Summary
                                                   [$Millions]
----------------------------------------------------------------------------------------------------------------
                                                          Total           Total
                                     Total one-time    annualized      annualized              Benefits
                                          costs         costs 7%        costs 3%
----------------------------------------------------------------------------------------------------------------
Domestic Facilities................              $9            $1.4            $1.4  Not Quantified.
Foreign Facilities.................              18             3.3             3.5
                                    ------------------------------------------------
    Subtotal Facilities............              27             4.7             4.9

[[Page 45914]]

 
Costs to FDA.......................  ..............             0.9             1.2
                                    ------------------------------------------------
    Total..........................              27             5.6             6.1
----------------------------------------------------------------------------------------------------------------

    This analysis estimates costs and benefits of the provisions in 
this final rule only, which are assumed to accrue in addition to the 
estimated annual costs already incurred due to the implementation of 
the provisions in the 2003 interim final rule issued jointly by the 
Secretary and the Department of Homeland Security (DHS) jointly to 
implement section 305 of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 
107-188) (68 FR 58894, October 10, 2003).\1\ Those estimated costs were 
calculated in an economic impact analysis that accompanied the interim 
final rule (68 FR 58894 at 58932) (hereinafter referred to as the 
``2003 economic impact analysis''). For the final rule, the economic 
impact analysis was modified slightly with respect to the costs 
associated with the U.S. agent requirement at the final rule stage, 
which published in the Federal Register on October 3, 2005 (70 FR 57505 
at 57506).
---------------------------------------------------------------------------

    \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 (21 U.S.C. 381) were 
transferred to DHS when DHS was created by an act of Congress in 
2002.
---------------------------------------------------------------------------

    We also expect that at least some foreign food facilities could 
increase prices as a result of the costs they would have to incur as a 
result of the rule. Any such potential price increases that could occur 
as a result of compliance costs would likely be very small relative to 
the total costs to manufacture, process, pack, and hold foods for sale 
in the United States. We expect that the benefits of the final 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. (For a more complete qualitative discussion of 
the benefits, see the PRIA) (Ref. 1). In addition, we update in this 
analysis the monetized impact associated with different foodborne 
outbreak scenarios from the PRIA in order to determine the amount of 
savings from illness reduction that would be required in order for the 
final rule to reduce costs that result from foodborne illness by 
approximately the same amount that the compliance costs of the final 
rule would impose on food facilities. We expect the final rule would 
have additional benefits that we are similarly unable to quantify, 
including providing for the more efficient use of FDA's inspectional 
resources.

I. Background

A. FDA Food Safety Modernization Act

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), 
signed into law by President Obama on January 4, 2011, is intended to 
allow FDA to better protect public health by helping to ensure the 
safety and security of the food supply. FSMA enables us to focus more 
on preventing food safety problems rather than relying primarily on 
reacting to problems after they occur. The law also provides new 
enforcement authorities to help achieve higher rates of compliance with 
risk-based, prevention-oriented safety standards and to better respond 
to and contain problems when they do occur. In addition, the law 
contains important new tools to better ensure the safety of imported 
foods and encourages partnerships with State, local, tribal, and 
territorial authorities. A top priority for FDA are those FSMA-required 
regulations that provide the framework for industry's implementation of 
preventive controls and enhance our ability to oversee their 
implementation for both domestic and imported food. To that end, we 
proposed the seven foundational rules listed in Table 2 and requested 
comments on all aspects of these proposed rules.

    Table 2--Published Foundational Rules for Implementation of FSMA
------------------------------------------------------------------------
              Title                  Abbreviation         Publication
------------------------------------------------------------------------
Current Good Manufacturing        2013 proposed       78 FR 3646,
 Practice and Hazard Analysis      human preventive    January 16, 2013.
 and Risk-Based Preventive         controls
 Controls for Human Food.          regulation.
Standards for the Growing,        2013 proposed       78 FR 3504,
 Harvesting, Packing, and          produce safety      January 16, 2013.
 Holding of Produce for Human      regulation.
 Consumption.
Current Good Manufacturing        2013 proposed       78 FR 64736,
 Practice and Hazard Analysis      animal preventive   October 29, 2013.
 and Risk-Based Preventive         controls
 Controls for Food for Animals.    regulation.
Foreign Supplier Verification     2013 proposed FSVP  78 FR 45730, July
 Programs (FSVP) or Importers of   regulation.         29, 2013.
 Food for Humans and Animals.
Accreditation of Third-Party      2013 proposed       78 FR 45782, July
 Auditors/Certification Bodies     third-party         29, 2013.
 to Conduct Food Safety Audits     certification
 and to Issue Certifications.      regulation.
Focused Mitigation Strategies To  2013 proposed       78 FR 78014,
 Protect Food Against              intentional         December 24,
 Intentional Adulteration.         adulteration        2013.
                                   regulation.
Sanitary Transportation of Human  2014 proposed       79 FR 7006,
 and Animal Food.                  sanitary            February 5, 2014.
                                   transportation
                                   regulation.
------------------------------------------------------------------------


[[Page 45915]]

We also issued a supplemental notice of proposed rulemaking for the 
rules listed in Table 3 and requested comments on specific issues 
identified in each supplemental notice of proposed rulemaking.

 Table 3--Published Supplemental Notices of Proposed Rulemaking for the
              Foundational Rules for Implementation of FSMA
------------------------------------------------------------------------
              Title                  Abbreviation         Publication
------------------------------------------------------------------------
Current Good Manufacturing        2014 supplemental   79 FR 58524,
 Practice and Hazard Analysis      human preventive    September 29,
 and Risk-Based Preventive         controls notice.    2014.
 Controls for Human Food.
Standards for the Growing,        2014 supplemental   79 FR 58434,
 Harvesting, Packing, and          produce safety      September 29,
 Holding of Produce for Human      notice.             2014.
 Consumption.
Current Good Manufacturing        2014 supplemental   79 FR 58476,
 Practice and Hazard Analysis      animal preventive   September 29,
 and Risk-Based Preventive         controls notice.    2014.
 Controls for Food for Animals.
Foreign Supplier Verification     2014 supplemental   79 FR 58574,
 Programs (FSVP) for Importers     FSVP notice;        September 29,
 of Food for Humans and Animals.   Supplemental        2014.
                                   Notice.
------------------------------------------------------------------------

    We finalized two of the foundational rulemakings listed in Table 4 
in September 2015 and three additional rules in November 2015. In April 
2016, we finalized the sanitary transportation regulation. In May 2016, 
we finalized the intentional adulteration regulation.

    Table 4--Published Foundational Rules for Implementation of FSMA
------------------------------------------------------------------------
              Title                  Abbreviation         Publication
------------------------------------------------------------------------
Current Good Manufacturing        Final human         80 FR 55908,
 Practice, Hazard Analysis and     preventive          September 17,
 Risk-Based Preventive Controls    controls            2015.
 for Human Food.                   regulation.
Current Good Manufacturing        Final animal        80 FR 56170,
 Practice and Hazard Analysis      preventive          September 17,
 and Risk-Based Preventive         controls            2015.
 Controls for Food for Animals.    regulation.
Standards for the Growing,        Final produce       80 FR 74354,
 Harvesting, Packing, and          safety regulation.  November 27,
 Holding of Produce for Human                          2015.
 Consumption.
Foreign Supplier Verification     Final FSVP          80 FR 74226,
 Programs (FSVP) or Importers of   regulation.         November 27,
 Food for Humans and Animals.                          2015.
Accreditation of Third-Party      Final third-party   80 FR 74570,
 Auditors/Certification Bodies     certification       November 27,
 to Conduct Food Safety Audits     regulation.         2015.
 and to Issue Certifications.
Focused Mitigation Strategies To  Final intentional   81 FR 34165, May
 Protect Food Against              adulteration        27, 2016.
 Intentional Adulteration.         regulation.
Sanitary Transportation of Human  Final sanitary      81 FR 20092, April
 and Animal Food.                  transportation      6, 2016.
                                   regulation.
------------------------------------------------------------------------

    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, a number of provisions 
in FSMA apply to only facilities that are required to register under 
section 415 of the FD&C Act, including hazard analysis and risk-based 
preventive controls and mandatory recall authority.
    With the finalization of the seven foundational rulemakings, we are 
putting in place a modern, risk-based framework for food safety that is 
based on the most recent science, that focuses effort where the hazards 
are reasonably likely to occur, and that is flexible and practical 
given our current knowledge of food safety practices. To achieve this, 
FDA has engaged in a great deal of outreach to the stakeholder 
community to find the right balance in these regulations of flexibility 
and accountability.
    After FSMA was enacted in 2011, we have been involved in 
approximately 600 engagements on FSMA and the proposed rules, including 
public meetings, Webinars, listening sessions, farm tours, and 
extensive presentations and meetings with various stakeholder groups 
(Refs. 2 to 4). As a result of this stakeholder dialogue, FDA decided 
to issue the four supplemental notices of proposed rulemaking to share 
our current thinking on key issues and get additional stakeholder input 
on those issues. As we move forward into the next phase of FSMA 
implementation, we intend to continue this dialogue and collaboration 
with our stakeholders, through guidance, education, training, and 
assistance, to ensure that everyone understands and engages in their 
role in food safety. FDA believes these seven foundational final rules, 
when implemented, will fulfill the paradigm shift toward prevention 
that was envisioned in FSMA and be a major step forward for food safety 
that will help protect consumers into the future.

B. Purpose of This Rulemaking

    We published the proposed rule regarding amendments to registration 
of food facilities in the Federal Register on April 9, 2015 (80 FR 
19160). We received numerous comments submitted on the proposed rule.
    This rule is part of FDA's implementation of FSMA, which intends to 
better protect public health by, among other things, adopting a modern, 
preventive, and risk-based approach to food safety regulation. This 
regulation would implement certain provisions in section 415 of the 
FD&C Act, as amended by section 102 of FSMA, that relate to 
registration of food facilities. In addition, this regulation amends 
and updates FDA's registration regulations and improves the utility of 
the food facility registration database to further enhance FDA's 
capabilities with respect to responding to food-related emergencies, 
and in addition, provides FDA with information that we can use to focus 
and better utilize our limited inspection resources.

C. Summary of the Major Provisions of the Proposed Rule

    Section 102 of FSMA, entitled Registration of Food Facilities, 
amends

[[Page 45916]]

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 were included in the proposed rule to codify the provisions 
in 21 CFR part 1, subpart H, the registration of food facilities 
regulation.
    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 Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism 
Act) (Pub. L. 107-188), 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'' (Ref. 
5). 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 (21 U.S.C. 331(d)), 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). We 
proposed to add a waiver request provision to allow a registrant to 
submit a written request to FDA that explains why it is not reasonable 
to submit the registration or registration renewal to FDA 
electronically.
    Lastly, section 102(c) of FSMA directs FDA to amend the definition 
of the term ``retail food establishment'' in Sec.  1.227 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.
2. Discussion of 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

[[Page 45917]]

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. 3501), 
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(f) of 
the FD&C Act (21 U.S.C. 321(f)). 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.
3. 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. We finalized the 
rulemaking on September 17, 2015. See ``Current Good Manufacturing 
Practice, Hazard Analysis and Risk-Based Preventive Controls for Human 
Food,'' 80 FR 55908. That rule is a separate rulemaking and not the 
subject of this rulemaking.

D. Public Comments

    We received over 1,000 submissions on the proposed amendments to 
food facility registration rule by the close of the comment period, 
each containing one or more comments on various aspects of the 
proposal. We received submissions from a wide array of members of the 
public, including individual farmers; cooperatives; coalitions; trade 
organizations;

[[Page 45918]]

consulting firms; law firms; academia; public health organizations; 
public advocacy groups; consumers; consumer groups; government 
agencies; and other organizations. Some submissions included signatures 
and statements from multiple individuals. Comments addressed numerous 
provisions of the proposed food facility registration rule, including 
our requests for comments on various topics. Some comments addressed 
issues that are outside of the scope of this rule. We do not discuss 
such comments in this document.
    In sections III through XIII of this document, we describe the 
comments we received on the rule, respond to them, and explain any 
changes we made to the proposed food facility registration rule. We 
discuss comments that ask us to clarify the proposed requirements or 
that disagree with, or suggest one or more changes to, the proposed 
requirements. Our responses to the comments include our reasons for 
determining whether to modify any of the proposed requirements.

II. Legal Authority

    We are issuing this final rule under the FD&C Act, FSMA, and the 
Bioterrorism Act. 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 31 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.
    As discussed in this final rule, we are revising our regulations to 
require additional 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, 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 rule under 
section 305 of the Bioterrorism Act, sections 102 and 107 of FSMA, and 
sections 301(dd), 415, 701(a), 704, and 801 of the FD&C Act.
    We are including in this final rule 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 (21 CFR part 1, subpart H). In addition, we are including in 
this final rule other requirements of section 102 of FSMA, such as 
mandatory electronic registration submissions and amendments to the 
definition of ``retail food establishment'' in Sec.  1.227. Lastly, we 
are including in this final rule other changes to improve the utility 
of the food facility registration database and adding a waiver request 
provision to allow a facility to submit a written request to FDA that 
explains why it is not reasonable to submit the registration, 
registration renewal, updates, and cancellations to FDA electronically 
or to explain why it is not reasonable to provide the email address of 
the owner, operator, or agent in charge of the facility.

III. General Comments on the Proposed Rule

    (Comment 1) Comments urge FDA to exempt all facilities that make 
less than $500,000 a year in sales who also sell most of their food 
locally.
    (Response 1) To the extent that the comment is asking that all 
facilities with annual sales of less than $500,000 be exempt from the 
registration requirement, we do not agree. Neither the Bioterrorism Act 
nor the FSMA amendments regarding food facility registration exempt 
facilities from the requirement to register based on their size. 
Furthermore, facilities under this size may be linked to food-related 
emergencies, and having registration information for these facilities 
can facilitate FDA's response to such emergencies.
    (Comment 2) Several comments state that small food producers or 
hobbyists who make food out of their home and also sell the food at 
farmers' markets and to other consumers should not be required to 
register.
    (Response 2) Under 21 CFR 1.227, a private residence is not a 
``facility'' and thus, is not required to be registered. A private 
residence must meet customary expectations for a private home and does 
not otherwise include commercial

[[Page 45919]]

facilities in which a person also happens to reside. Thus, a private 
residence that meets customary expectations for a private residence 
that is also used to manufacture, process, pack, or hold food need not 
be registered. Accordingly, if the activities of small food producers 
or hobbyists meet customary expectations for a private residence, the 
producers or hobbyists would not be required to register.
    (Comment 3) One comment requests that FDA exclude seed conditioning 
facilities that direct some seeds to animal food use from the 
requirement to register. The comment describes seed conditioning 
facilities as facilities that clean, grade, size, disinfect, dry, sort, 
screen, fumigate, and/or blend seeds to prepare seed intended for 
cultivation for commercial sales. The comment states that these 
establishments do not intend to manufacture, process, pack, or hold 
food for consumption and are therefore ``not in the animal food 
business.'' The comment states that such establishments instead intend 
to prepare seed for planting purposes. The comment states that when 
some seeds become cracked, damaged during the process, or they may not 
be suitable for cultivation, they cannot be used for planting. In those 
situations, the establishment may direct the seeds for use in animal 
food (or, alternatively, may direct the seeds for incineration and 
landfilling). The comment further states that establishments may direct 
the seeds for animal food use if there is an oversupply of seeds that 
would otherwise be cultivated. In addition, the comment asks that FDA 
revise the Agency's ``Guidance for Industry: Questions and Answers 
Regarding Food Facility Registration (Fifth Edition)'' to state that 
seed conditioning facilities are not required to register. In that 
guidance, FDA stated that an establishment that manufactures/processes 
and sells seed to farmers is a facility that must be registered if the 
owner, operator, or agent in charge of the establishment reasonably 
believes that the seed is reasonably expected to be directed to a food 
use, including animal food use or as an ingredient in animal food. 
However, if the seed is reasonably expected only to be cultivated, the 
guidance states that the establishment is not required to be 
registered. The comment states that because FSMA added certain 
preventive control requirements under section 418 of the FD&C Act for 
food facilities that are required to register under section 415, FDA 
should rethink the aspect of the registration guidance regarding seed 
conditioning. The comment states that establishments that are required 
to register are now subject to more considerable regulatory 
requirements.
    (Response 3) FDA requires registration of any facility that 
manufactures/processes, packs, or holds food for consumption in the 
United States. ``Food'' is defined in section 201(f) of the FD&C Act to 
include articles used for food or drink for man or other animals. The 
comment states that seed conditioning establishments should not be 
required to register because they do not intend to manufacture, 
process, pack, or hold food for animal consumption. We decline to 
provide any specific exclusions for seed conditioning establishments 
from the requirements for registration. As we stated in the Agency's 
``Guidance for Industry: Questions and Answers Regarding Food Facility 
Registration,'' an establishment that conditions seed for planting 
purposes is a facility that must be registered if the owner, operator, 
or agent in charge of the establishment reasonably believes that the 
seed is reasonably expected to be directed to food use, including 
animal food use or as an ingredient in animal food (Ref. 6). Whether a 
particular establishment is required to register will depend on the 
specific nature of the establishment. The comment describes 
establishments that may direct cracked, damaged, culled, or excess 
seeds for use in animal food. If an establishment that manufactures/
process, packs, or holds the seed reasonably believes that the seed is 
reasonably expected to be directed to such food use, the establishment 
must be registered. The comment also states that some establishments 
may direct such cracked, damaged, culled, or excess seeds for 
incineration and landfilling. If a seed conditioning establishment 
directs the seeds only to uses such as cultivation or to destruction 
(such as incineration or landfill), the establishment would not be 
required to register.
    Discussion on the application of the ``Current Good Manufacturing 
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food 
for Animals'' rule (80 FR 56170, September 17, 2015) is outside the 
scope of this rule making.
    (Comment 4) A comment suggests that FDA should reconsider whether 
foreign facilities should be required to register. The comment states 
that most countries have an authorization or registration system and 
businesses in those countries will already be registered with the 
relevant authority in their country. The comment states that where FDA 
has a relationship with a foreign authority, the foreign registration 
could be accepted as assurance that foreign businesses are in good 
standing with the national competent authority. The comment also states 
that the requirement to register is particularly onerous for foreign 
businesses and that many foreign businesses are not familiar with the 
norms of U.S. government agencies.
    (Response 4) We disagree that a foreign facility should not be 
required to register. Section 415(a)(1) of the FD&C Act requires that 
each domestic and foreign facility be registered. ``Facility'' is 
defined as ``any factory, warehouse, or establishment (including a 
factory, warehouse, or establishment of an importer) that manufactures, 
processes, packs, or holds food'' (21 U.S.C. 350d(c)(1)). In addition, 
``foreign facility'' is defined as a facility that ``manufactures, 
processes, packs, or holds food, but only if food from such a facility 
is exported to the United States for consumption in this country 
without further processing or packaging outside the United States'' (21 
U.S.C. 350d(c)(3)(A)). Therefore, food facilities that are foreign 
facilities and do not qualify for an exemption under Sec.  1.226 must 
register. Further, obtaining registration information from other 
foreign government agencies would not guarantee that FDA has all of the 
required information for food facility registration purposes for all 
foreign facilities. Foreign governments might not require the same 
registration information as required in this final rule, in part 
because the registration systems in foreign countries might serve 
different purposes from FDA's. The registration information required in 
this final rule is designed to assist FDA in responding to bioterrorist 
or other food-related emergencies and to assist FDA in better utilizing 
its limited inspection resources, among other purposes.
    (Comment 5) Several comments recommend amending the definition of 
retail food establishment to exclude vending machines that manufacture 
food within the vending unit itself before selling it directly to the 
consumer. Comments state that vending machines should have to register 
and that self-serve ice vending machines are packaging ice and 
reselling packaged food to retail clients. The comments state that an 
outbreak in foodborne illness linked to retail vending machines would 
have a devastating impact on the packaged ice industry as a whole.
    (Response 5) Under Sec.  1.227, a ``retail food establishment'' 
includes grocery stores, convenience stores, and vending

[[Page 45920]]

machines. We disagree that we should amend the definition of retail 
food establishment to remove vending machines. Vending machines that 
sell food products directly to consumers as their primary function are 
properly exempt from registration as retail food establishments. This 
is consistent with section 415(c)(1) of the FD&C Act, which provides 
that the term ``facility'' does not include retail food establishments. 
We acknowledge that outbreaks in any segment of industry have a 
significant impact. We note, however, that while vending machines and 
other retail food establishments are not required to register, they 
still have responsibility for ensuring the safety of their products.
    (Comment 6) One comment encourages FDA to require farms to register 
to prevent what the comment describes as a gap in oversight.
    (Response 6) FDA declines to require farms to register as food 
facilities under section 415 of the FD&C Act. The requirement in 
section 415 that a facility must register does not apply to farms. See 
section 415(c) of the FD&C Act (providing that the term ``facility'' 
does not include farms). The comment does not explain how requiring 
farms to register would be consistent with section 415.
    (Comment 7) One comment requests modifications to Form FDA 3537. In 
particular, the comment requests that the registration system should 
clear all information from section 13 of the current Form FDA 3537 
whenever a registration is updated or renewed. The comment also states 
that many owners, operators, or agents in charge of a facility may be 
corporations, not individuals, and therefore suggests that FDA add a 
field linked to the requirement that facilities provide the email 
address for the owner, operator, or agent in charge. Specifically, the 
comment requests that facilities be able to provide the name of the 
individual associated with that email address. The comment also 
recommends making technical edits to the electronic version of the 
form, such as changes to the pull-down selections in the Facility Name 
Suffix category (allowing facilities to indicate, for instance, whether 
they are cooperatives or limited liability corporations) and the 
automatically populated telephone country codes.
    (Response 7) Section 13 of the current Form FDA 3537 includes a 
certification statement providing that the owner, operator, or agent in 
charge of the facility, or an individual authorized by the owner, 
operator or agent in charge of the facility, must submit the form. The 
certification states that by submitting this form to FDA, or by 
authorizing an individual to submit this form to FDA, the owner, 
operator, or agent in charge of the facility certifies that the 
registration information is true and accurate. An individual (other 
than the owner, operator, or agent in charge of the facility) who 
submits the form to FDA also certifies that the registration 
information is true and accurate and that he/she is authorized to 
submit the registration on the facility's behalf. Section 13 also 
provides for the individual authorized by the owner, operator, or agent 
in charge to identify the individual who authorized submission of the 
registration and to provide specified contact information for that 
individual. With regard to the electronic version of Form FDA 3537, 
section 13 of the form prepopulates with information (as do the other 
fields). This is done to keep the process for registration renewal or 
updates as streamlined as possible. We understand that some applicants 
will need to edit this section to indicate changes to who submits the 
form, while others may not. Therefore, we decline the recommendation to 
not pre-populate this section for electronic registration renewals or 
updates. In addition, we decline the recommendation to require the name 
of the individual associated with the email address provided for the 
owner, operator, or agent in charge. We currently believe that the 
final rule already requires sufficient facility contact information. 
However, we will consider adding an optional field for an individual's 
name associated with the required email address in a future version of 
Form FDA 3537. If we add such a field, we will issue a guidance 
document in accordance with our good guidance practice (GGP) 
regulations in 21 CFR 10.115 describing this change.
    With regard to the requested additional technical changes to the 
electronic version of the form, we will consider the recommendations 
and make changes if appropriate.
    (Comment 8) A comment suggests that FDA should share the list of 
registered businesses with the authorities in the relevant third 
country.
    (Response 8) FDA's list of registered facilities and registration 
documents are not subject to disclosure under the Freedom of 
Information Act (FOIA). In addition, any information derived from the 
list of facilities or registration documents that would disclose the 
identity or location of a specific registered person also is not 
subject to disclosure under FOIA (21 U.S.C. 350d(a)(5)).
    However, FDA believes that in certain circumstances it may be 
appropriate to share information derived from our registration database 
with foreign government officials consistent with FDA's laws and 
procedures. Any sharing of information with another foreign government 
would typically be done under 21 CFR 20.89, which includes 
confidentiality provisions.

IV. Comments on Proposed Amendments to Sec.  1.227--Definitions

    We proposed to replace the phrase ``the owner, operator, or agent 
in charge of a facility'' with ``you'' throughout the regulatory text 
in 21 CFR part 1, subpart H, because ``you'' is defined in current 
Sec.  1.227 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. We are finalizing this change as 
proposed.
    Furthermore, we note that we have redesignated all definitions in 
Sec.  1.227 in 21 CFR part 1, subpart H, to eliminate paragraph 
designations (such as (a) and (b)). FDA made this change in the final 
rule for ``Current Good Manufacturing Practice, Hazard Analysis and 
Risk-Based Preventive Controls for Human Food'' (80 FR 55908).

A. Retail Food Establishment

    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 to mean an establishment that sells food products 
directly to consumers as its primary function.
    A retail food establishment's primary function is to sell food 
directly to consumers if the annual monetary value of sales of food 
products directly to consumers exceeds the annual monetary value of 
sales of food products to all other buyers. 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

[[Page 45921]]

distribution of such food at any other such direct sales platform as 
determined by the Secretary. In addition, section 102(c) provides that 
the term ``consumer'' does not include a business.
    We proposed to amend Sec.  1.227 to address off-farm sales by an 
establishment located on a farm. Specifically, we proposed to clarify 
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. We proposed that, in 
determining the primary function of an establishment located on a farm, 
the sale of food directly to consumers from such an establishment would 
include sales at a roadside stand or farmer's market, and that the 
roadside stand or farmers' market would not need to be on the farm 
where the establishment is located. In determining the primary function 
of an establishment located on a farm, we also proposed that the sale 
of food directly to consumers would also include the sale and 
distribution of such food through a community supported agriculture 
program (CSA). In addition, we proposed that the sale of food directly 
to consumers would include the sale and distribution of such food at 
other direct-to-consumer platforms, including door-to-door sales; mail, 
catalog and Internet orders; online farmers' markets and online grocery 
deliveries; religious or other organization bazaars; and state and 
local fairs.
    We proposed to define ``roadside stand'', ``farmers' market'', and 
``community supported agriculture program'' in Sec.  1.227, based on 
definitions found in 7 CFR 249.2. Specifically, we proposed to specify 
that a farmers' market would mean a location where one or more local 
farmers assemble to sell from their farms directly to consumers and 
that a roadside stand would mean 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.
    Finally, we proposed that a CSA program would mean 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. Under our proposal, this would 
include CSA programs in which a group of farmers consolidate their 
crops at a central location for distribution to shareholders or 
subscribers.
    We requested comment on what, if any, limitations should be 
included in the proposed definitions for roadside stands and farmers' 
markets, such as distance of the roadside stand or farmers' market from 
the farm (80 FR 19160 at 19166). In addition, we requested comment on 
whether it is appropriate to limit the amendment to the retail food 
establishment definition to on-farm establishments, as we proposed 
(Id.). We also requested comment on whether we should provide that off-
farm sales to businesses also be considered in determining an 
establishment's primary function (Id.).
1. Applicability to On-Farm Establishments
    (Comment 9) Numerous comments state that the amendment to the 
retail food establishment definition should not be limited to on-farm 
establishments. These comments maintain that it should not matter if an 
establishment is on a farm. Some comments state that there is no 
statutory language directing or justifying the proposal to limit the 
amendment of the retail food establishment definition to on-farm 
establishments. Comments suggest that Congress intended the law to 
apply equally to all direct-to-consumer sales from farms, whether the 
sales occur on, or off, the farm. One comment indicates that this 
definition should reflect the reality of modern farming operations. One 
comment also states that local and regional food entrepreneurs make use 
of shared commercial kitchens and have no storefronts from which to 
make sales, and that the limitation of the amendment to on-farm 
establishments would mean that these entities would have to register 
even if all of their sales are directly to consumers.
    (Response 9) We are convinced by the comments to expand the 
amendment to the retail food establishment definition to include some 
non-farm establishments. In particular, we agree with the comments that 
we should revise the retail food establishment definition to reflect 
modern farming-related practices. We agree that limiting the amendment 
to on-farm establishments is overly simplistic, given the diverse ways 
farmers today engage in value-added processing of their raw 
agricultural commodities (RACs).
    The comments raise the question of what type of businesses section 
102(c) of FSMA is intended to address. In construing the scope of 
section 102(c) of FSMA, FDA is confronted with two questions. First, 
has Congress directly spoken to the precise question presented (Chevron 
step one)? (Chevron U.S.A., Inc., v. NRDC, Inc., 467 U.S. 837, 842 
(1984)). If the ``intent of Congress is clear,'' an Agency ``must give 
effect to the unambiguously expressed intent of Congress.'' Id. at 843. 
However, if ``Congress has not directly addressed the precise question 
at issue,'' and the statute is ``silent or ambiguous with respect to 
the specific issue,'' then our interpretation of the term 
``establishment'' will be upheld as long as it is based on a 
``permissible construction of the statute'' (Chevron step two). 
Chevron, 467 U.S. at 842-43; FDA v. Brown & Williamson Tobacco Corp, 
529 U.S. 120, 132 (2000).) To find no ambiguity, Congress must have 
clearly manifested its intention with respect to the particular issue. 
See e.g., Young v. Community Nutrition Institute, 476 U.S. 974, 980 
(1986). We have determined that, in enacting section 102(c) of FSMA, 
Congress did not speak directly and precisely to the provision's scope. 
For instance, in section 102(c)(1) of FSMA, Congress provided that FDA 
amend the definition of retail food establishment to clarify that, ``in 
determining the primary function of an establishment or a retail food 
establishment under such section,'' the sale of certain direct-to-
consumer foods should be counted (emphasis added). An ``establishment'' 
could be any number of types of businesses. An ``establishment'' could 
be any business that manufactures/processes, packs, or holds food for 
consumption in the United States. Alternatively, an ``establishment'' 
could be the type of business that commonly sells foods at the direct-
to-consumer platforms enumerated in section 102(c) of FSMA (i.e., at 
roadside stands, farmers' markets, and CSAs).
    The language in section 102(c) of FSMA provides an express 
delegation of authority to the Secretary to amend the definition of the 
term ``retail food establishment'' in Sec.  1.227 to provide for the 
inclusion of certain specified sales (i.e., farmers' market, roadside 
stand, and CSA sales) in determining an establishment's primary 
function (FSMA section 102(c)(1)(A)-(B)), as well as other sales that 
the Agency may determine (FSMA section 102(c)(1)(C)). The decision to 
direct the Secretary to amend Sec.  1.227, and the decision to provide 
that certain sales may be included as determined by the Secretary, 
contemplates the Secretary having certain discretion in effectuating 
the amendment. While Congress intended for certain specific sales 
(i.e., farmers' market, roadside stand, and CSA sales) to be counted in 
conducting

[[Page 45922]]

a primary function analysis, Congress did not specify to what kind of 
businesses the new analysis would apply. Instead, Congress left a gap 
for the Secretary to fill by regulation.
    Because Congress left a gap for the Secretary to fill, under 
Chevron step two FDA may interpret the scope of FSMA section 102(c)(1), 
provided that FDA's interpretation is not arbitrary, capricious, or 
manifestly contrary to the statute. Chevron, 467 U.S. at 843 (noting 
that if a statute is silent with respect to an issue the Agency's 
answer to the issue should be based on a permissible interpretation of 
the statute).
    The language in section 102(c) of FSMA does not specifically 
prescribe the provision's scope, but it does provide examples of the 
kind of circumstances in which Congress intended the retail food 
establishment amendment applying. In directing the Secretary to include 
certain sales in determining the primary function, section 102(c) 
directs the Secretary to include sales at roadside stands and farmers' 
markets located other than where the food was manufactured or 
processed, as well as CSAs (FSMA section 102(c)(1)(A)-(B)). Sales 
platforms such as these are closely associated with food produced by 
farmers. Even in section 102(c)(1)(C) of FSMA, Congress directed the 
Secretary to include the sale and distribution of ``such food at any 
other such direct sales platform'' as determined by the Secretary 
(emphasis added). This suggests that the other platforms Congress 
contemplated were platforms that were akin to those listed in section 
102(c)(1)(A)-(B) and involved food akin to that contemplated by section 
102(c)(1)(A)-(B). Given that farmers represent the overwhelming 
majority of businesses that commonly sell foods at the direct-to-
consumer platforms enumerated in section 102(c) of FSMA (i.e., at 
roadside stands, farmers' markets, and CSAs), it is reasonable to 
interpret section 102(c) of FSMA as applying to farmers and businesses 
closely tied to farms. Under this interpretation, section 102(c) allows 
farmers to manufacture/process food for sale without triggering 
registration, provided that the primary function of the farmer's 
manufacturing/processing operation is the sale of food directly to 
consumers.
    Our proposal to clarify the retail food establishment definition 
recognized that some farmers conduct manufacturing/processing. However, 
our proposed clarification would have only applied to establishments 
located on farms. We recognize that while some farmers have the space 
and equipment on their farms to manufacture/process foods for sale at 
direct-to-consumer platforms, other farmers conduct value-added 
processing off of the farm, such as by renting space at a shared 
kitchen. The clarification to the retail food establishment definition 
that we included in the proposed rule would have captured the on-farm 
operations, but not the off-farm operations.
    Because farmers conduct manufacturing/processing in establishments 
located on farms and off of farms, we conclude that it is reasonable to 
interpret section 102(c) of FSMA to apply to on-farm establishments and 
certain off-farm operations tied to farms. Accordingly, we have 
finalized our proposal to address off-farm sales by establishments 
located on farms. In addition, in the final rule, we have revised the 
retail food establishment definition to also state that the sale of 
food directly to consumers by a farm-operated business includes the 
sale of food by that farm-operated business directly to consumers: At a 
roadside stand or farmers market; through a CSA; and at other such 
direct-to-consumer sales platforms. By ``farm-operated business,'' we 
mean a business that is managed by one or more farms and that conducts 
manufacturing/processing not on the farm(s). Thus, under the final 
rule, an establishment located on a farm that sells apples it grows and 
apple pies it manufactures directly to consumers at a farmer's market 
would consider those sales in determining its primary function. At the 
same time, if a farmer manufactures or manages the manufacturing of 
jellies from the apples that he grows at an off-farm location, such as 
an incubator kitchen, and sells those jellies at a farmer's market, the 
jelly-making operation would be a farm-operated business and may 
consider those sales in determining its primary function.
    We recognize that some farmers rent space at off-farm 
manufacturing/processing facilities, like shared kitchens, to conduct 
value-added processing. The ``business'' we are referring to in ``farm-
operated business'' is the business entity conducting the 
manufacturing/processing operations. The ownership of the physical 
building, e.g., the ownership of the shared kitchen, where the 
manufacturing/processing occurs is not relevant. Thus, if an apple 
grower leases space at an off-farm incubator kitchen to manufacture 
apple jellies, ownership of the incubator kitchen building would not be 
relevant. Because the apple farmer manages the off-farm apple jelly 
manufacturing operation, the apply jelly manufacturing operation is a 
farm-operated business and eligible for the retail food establishment 
exemption from registration.
    In addition, we recognize that some farms are members of 
cooperatives that pool RACs grown, harvested, or raised by member farms 
for value-added processing. The phrase ``one or more farms'' in the 
explanation of the meaning of ``farm-operated business'' allows 
cooperatives comprised of multiple farms performing certain 
manufacturing/processing activities to be eligible for the retail food 
establishment exemption from registration.
    Regarding the example of shared commercial kitchens in the comment, 
if an establishment is a retail food establishment under Sec.  1.227, a 
commercial kitchen that is co-located with, and thus, part of, the 
retail food establishment, is not required to be registered.
2. Sale of Food Directly to Consumers at a Roadside Stand or Farmers' 
Market
    (Comment 10) One comment states that farmers' markets and roadside 
stands should be considered retail food establishments, including those 
markets and stands that handle products or produce grown on a 
particular farmer's property.
    (Response 10) We agree that farmers' markets and roadside stands 
may be considered retail food establishments even when they sell 
products not manufactured or grown on the property of the farmers 
selling those foods. The test for whether such farmers' markets and 
roadside stands are retail food establishments is whether they sell 
food directly to consumers as their primary function. The food sold 
directly to consumers can be produced by the farmers selling the food, 
but need not be.
    (Comment 11) One comment states that because farms may aggregate 
food produced by other farms, the definition for farmers' markets 
should not specify that the food sold by local farmers is ``from their 
farms.'' Comments also argue that the definition of roadside stands and 
farmers' markets should encompass stands at which any vendors sell food 
directly to consumers, and that it should not be limited to stands at 
which farmers sell food from their farms directly to consumers as FDA 
proposed.
    (Response 11) The definitions of farmers' markets and roadside 
stands are based on definitions found in 7 CFR 249.2, and we are wary 
of adopting definitions of these terms that are significantly different 
from the definitions of the same terms held by

[[Page 45923]]

USDA. Moreover, we do not believe that changing the definitions as 
suggested by the comments would have any practical effect. That's 
because the presence of non-farmers at a farmers' market or roadside 
stand would not mean that a location that would otherwise meet the 
definition of a farmers' market or roadside stand would not be 
considered a farmers' market or roadside stand.
    Further, whether food is sold at farmers' markets or roadside 
stands is less important for the purposes of this rule than whether the 
food is sold directly to consumers. An establishment is exempt from 
registration as a retail food establishment if the establishment's 
primary function is to sell food directly to consumers, regardless of 
whether the food is sold through farmers' markets, roadside stands, or 
other direct-to-consumer platforms. Farmers' markets and roadside 
stands are examples of direct-to-consumer sales platforms that are 
specifically mentioned in the amendment to the definition of retail 
food establishment, but the catchall provisions in paragraphs (1)(iii) 
and (2)(iii) provide that the sale of food directly to consumers 
includes the sale and distribution of food at other direct-to-consumer 
platforms. As a result, changing the definitions of farmers' market and 
roadside stand as the comments suggest would have little, if any, 
impact on the scope of this rule. Therefore, we decline the comments' 
suggestions and are finalizing definitions consistent with our 
proposal.
    (Comment 12) One comment recommends that we specify that the 
``local farmers'' at a farmers' market be from within the same state as 
the point of sale or within 275 miles of the point of sale. However, 
most of the comments that addressed our request for comments on 
distance limitations for farmers' markets and roadside stands expressed 
concern about any such limitations. Some comments state there should be 
no distance limitation because the distance from a farm to a roadside 
stand or farmers' market does not change the fact that the food is 
being provided directly to consumers. Some comments state that there is 
no established public health risk related to the distance between a 
farm and sales locations such as farmers' markets and roadside stands. 
One comment states that there is no risk-based justification for 
including distance limitations in the definitions for farmers' markets 
and roadside stands. Comments also note it is not uncommon for farms to 
locate stands or take part in farmers' markets in metropolitan areas 
where they are likely to interact with and have more ready access to a 
larger customer base, and that these metropolitan areas are removed 
from the rural areas where growing takes place. Comments also state 
that grocery stores and other entities that identify as retail food 
establishments have no mileage limitations connected to their 
headquarters, so there should be no reason to apply such a distinction 
to similarly situated businesses.
    (Response 12) FDA agrees with the comments recommending against 
distance limitations in the definitions for farmers' markets and 
roadside stands. In enacting section 102(c) of FSMA, Congress directed 
FDA to clarify that in determining the primary function of an 
establishment, the sale of food directly to consumers by such 
establishments includes the sale of food at a roadside stand or 
farmers' market, where such stand or market is located other than where 
the food was manufactured or processed. Section 102(c) of FSMA does not 
provide a limitation on distance, and we decline to add such a 
limitation on our own accord.
3. Sale and Distribution of Food Through a Community Supported 
Agriculture Program
    (Comment 13) One comment urges FDA to define CSAs as involving the 
sale of ``food'' rather than ``crops,'' as we proposed. The comment 
states that CSAs may involve the distribution of food other than crops.
    (Response 13) FDA agrees that CSA activities are not limited to 
only selling ``crops.'' For example, a farm mixed-type facility may 
sell strawberries it grows and strawberry jam that it manufactures 
directly to consumers through a CSA. Whether the on-farm manufacturing 
establishment is a retail food establishment, and thus exempt from 
registration, would depend on whether its primary function is to sell 
food directly to consumers.
    As to whether we should change the proposed definition of CSAs to 
refer to ``food'' instead of ``crop(s),'' we do not believe such a 
change is warranted. 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 . . . in section 249.2 of title 7, Code of Federal Regulations 
(or any successor regulation).'' Because 7 CFR 249.2 refers to 
``crop(s),'' not ``food,'' we do not believe that the change suggested 
by the comments would be consistent with section 102(c) of FSMA. 
However, the sale of food directly to consumers through a platform that 
resembles a CSA but does not sell crops could still be used in 
determining the establishment's primary function in the final rule. 
Paragraphs (1)(iii) and (2)(iii) of the retail food establishment 
amendment are catchalls that include the sale of food at other direct-
to-consumer platforms. Provided that the requirements of those 
paragraphs are satisfied, an establishment could consider sales through 
that platform in determining its primary function if either the 
establishment is: (1) Located on a farm; or (2) is a farm-operated 
business and the requirements applicable to farm-operated businesses 
are met.
4. Sale and Distribution of Food at Any Other Direct-to-Consumer Sales 
Platforms
    (Comment 14) Most comments agree with the list of direct-to-
consumer platforms that we proposed. One comment, however, states that 
FDA should not consider as direct-to-consumer sales those sales by 
mail, catalog or Internet order, or through online farmers' markets or 
online grocery delivery. The comment states that allowing these types 
of sales creates an opportunity for an on-farm manufacturing operation 
that sells large volumes of food in interstate commerce to fall within 
the retail food establishment definition. The comment further states 
that a common feature of sales at roadside stands, farmers' markets, 
and CSAs listed in section 102(c)(1) of FSMA is that they are conducted 
face-to-face and it is likely that Congress meant to provide FDA with 
flexibility to consider as direct-to-consumer sales other local face-
to-face transactions that are similar to the specified exempt 
activities, but not platforms such as direct-to-consumer mail, catalog, 
or Internet sales that would allow for national sales.
    (Response 14) We agree that section 102(c) of FSMA directs FDA to 
address certain direct-to-consumer sales in clarifying the retail food 
establishment definition. However, we disagree with the objection to 
including the sale of food through mail, catalog and Internet orders, 
including online farmers' markets and online grocery delivery, in 
determining the primary function of an establishment that is either 
located on a farm or that is a farm-operated business. As discussed in 
the proposed rule (80 FR 19160 at 19166), these direct sales platforms 
are common platforms for direct-to-consumer sales of foods from farms. 
Although such sales might not be face-to-face, direct-to-consumer sales 
of food from local farms and

[[Page 45924]]

establishments closely associated with farms are similar to farmers' 
markets and CSAs because they are direct-to-consumer. We think that 
including these direct-to-consumer sales is consistent with section 
102(c) of FSMA because section 102(c) provides that the sales of food 
directly to consumers for the purposes of determining an 
establishment's primary function may be at ``any other such direct 
sales platform as determined by the Secretary.'' Section 102(c) of FSMA 
does not specify that direct-to-consumer sales be face-to-face in 
determining the primary function of an establishment. Even if some 
establishments that use mail, catalog, and Internet orders in 
determining their primary function are larger establishments and can 
reach consumers on a national level, we do not believe that is 
inconsistent with section 102(c) of FSMA, which does not specify that 
FDA's amendment to the retail food establishment definition only 
pertain to establishments of a specific size. We believe that if an 
establishment's annual monetary value of sales of food products 
directly to consumers exceeds the annual monetary value of sales of 
food products directly to all other buyers, the establishment's primary 
function is to sell food directly to consumers and that the 
establishment should qualify as a retail food establishment. Further, 
we note that, in determining whether an establishment is a retail food 
establishment, our regulation has always allowed for establishments 
selling food directly to consumers via the Internet or mail order to be 
covered under the definition of ``retail food establishment,'' provided 
that they meet the other criteria of the retail food establishment 
definition (see 68 FR 58894 at 58914 to 58915).
    (Comment 15) Some comments urge FDA to include ``produce auctions'' 
in the list of platforms where direct-to-consumer sales take place.
    (Response 15) Because the list of direct-to-consumer sales 
platforms is not exhaustive, we do not agree that it is necessary to 
include produce auctions in the list of direct-to-consumer platforms 
that may be used in determining an establishment's primary function. 
Provided that a sales platform is direct-to-consumers, sales made 
through such platforms may help establish that an establishment's 
primary function is to sell food directly to consumers (with an 
establishment qualifying as a retail food establishment only 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). Furthermore, we understand that sales at produce 
auctions can be to different types of entities. In some cases, sales 
may be to consumers. However, we understand that many sales at produce 
auctions are sales to restaurants, wholesalers and other businesses. An 
establishment's direct sales to individual consumers at an auction can 
be counted as sales to consumers. A direct sale to a business at an 
auction, however, cannot be counted as sales to consumers. Further, a 
direct sale to a separate business that runs a produce auction, rather 
than to specific buyers, would not be counted as sales to consumers 
because businesses (including businesses that run produce auctions) are 
not consumers. Section 102(c)(2) of FSMA explicitly states that the 
term ``consumer'' does not include a business.
    (Comment 16) Comments request that FDA specifically exempt produce 
auctions from the requirements of food facility registration. These 
comments state that produce auctions are frequently misunderstood to be 
``food facilities,'' but that they are in fact very similar to farmers' 
markets in that the auction does not take individual ownership of any 
products or manufacture/process, hold, pack or package food. The 
comments note that buyers represent a mix of direct consumers and 
commercial business entities.
    (Response 16) We decline the request to exempt produce auctions 
from the requirement to register. The registration requirement applies 
to all facilities that manufacture/process, pack, or hold food for 
consumption in the United States, and does not hinge on whether the 
establishment in question actually owns the food (see section 415(a)(1) 
of the FD&C Act). We note, however, that not all produce auctions will 
necessarily be required to register. Whether registration is required 
would depend on the facts of a particular case. It is possible that 
some produce auctions would qualify as retail food establishments and 
therefore be exempt from registration. Produce auctions would qualify 
as retail food establishments if their primary function is to sell food 
directly to consumers. Produce auctions with direct-to-consumer sales 
that exceed sales to businesses would be considered retail food 
establishments. Further, as stated in the final rule for ``Current Good 
Manufacturing Practice, Hazard Analysis and Risk-Based Preventive 
Controls for Human Food'' (80 FR 55908 at 55992), to the extent that 
these operations are simply a location for buyers and sellers to meet 
and to sell and transfer produce and the food is not stored, we do not 
consider such facilities to be holding food and would not expect them 
to register.
    (Comment 17) Some comments request that we expand the list of 
direct-to-consumer platforms that we proposed to specify to also 
include food hubs, buying clubs, and non-farm community supported food 
distribution models.
    (Response 17) We decline to revise the retail food establishment 
definition in Sec.  1.227 to specifically discuss food hubs, buying 
clubs, and non-farm community supported distribution models. With 
respect to food hubs, the comments do not explain why food hubs 
necessarily involve direct-to-consumer sales that should be used in 
determining an establishment's primary function. FDA discussed food 
hubs in the final preventive controls for human food regulation (see 80 
FR 55908 at 55992). As FDA noted in that rulemaking, USDA defines a 
regional food hub as ``a business or organization that actively manages 
the aggregation, distribution, and marketing of source-identified food 
products primarily from local and regional producers to strengthen 
their ability to satisfy wholesale, retail, and institutional demand'' 
(Ref. 7). Some food hubs have a farm-to-business model (e.g., selling 
to food cooperatives, grocery stores, institutional foodservice 
companies, and restaurants), while others have a farm-to-consumer model 
(i.e., selling directly to the consumer, e.g., through a CSA), and some 
are hybrids that do both (Ref. 7). Because all sales at food hubs are 
not necessarily direct-to-consumer, we do not agree that it is 
appropriate to include food hubs in the list of direct-to-consumer 
platforms that may be used in determining an establishment's primary 
function. However, if an establishment located on a farm or an 
establishment described in paragraph (2) of the retail food 
establishment definition has food hub sales that are directly to 
consumers, we agree that, in those circumstances, it would be 
appropriate for those sales to be used in determining the 
establishment's primary function. The catchall provisions in paragraphs 
(1)(iii) and (2)(iii) of the definition provide that the sale of food 
directly to consumers includes the sale and distribution at other 
direct-to-consumer platforms. For similar reasons, we do not agree that 
it is appropriate to amend the retail food establishment definition to 
include buying clubs and non-farm community supported food distribution 
models. The comments have not provided information to allow FDA to 
assess whether such platforms necessarily

[[Page 45925]]

involve direct-to-consumer sales. However, if on-farm establishments or 
establishments described in paragraph (2) have sales at such platforms 
that are directly to consumers, the sales may also be used in 
determining those establishments' primary function in accordance with 
paragraphs (1)(iii) and (2)(iii).
5. Other Issues Related to the Definition of Retail Food Establishment
    (Comment 18) One comment states that there should not be any income 
or value limitation included in the retail food establishment 
definition.
    (Response 18) We agree that there is no income limitation for 
establishments to qualify as retail food establishments, and we have 
not included one in the final rule. As long as an establishment's 
primary function is to sell food directly to consumers, it is a retail 
food establishment. 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.
    (Comment 19) One comment urges FDA to recognize that even low-risk 
activities can cause problems and recommends limiting the application 
of section 102(c) of FSMA to the types of on-farm manufacturing 
activities that the Agency tentatively identified as low-risk 
activities in proposed 21 CFR 117.5(g) and (h) in the proposed 
regulation for hazard analysis and risk-based preventive controls for 
human food. This is based on the argument that section 102(c) of FSMA, 
which directed FDA to clarify the retail food establishment definition, 
should be read in connection with section 103(c)(1) of FSMA, which 
formed the basis for proposed Sec.  117.5(g) and (h). Specifically, 
section 103(c)(1) of FSMA directed FDA to conduct a science-based risk 
analysis of specific types of on-farm packing or holding of food that 
is not grown, raised, or consumed on such farm or another farm under 
the same ownership, as well as of specific on-farm manufacturing and 
processing activities as such activities relate to specific foods that 
are not consumed on that farm or on another farm under common 
ownership. Section 103(c)(1) of FSMA further directed FDA to consider 
the results of the science-based risk analysis and exempt certain 
facilities from the requirements in sections 418 of the FD&C Act 
(related to risk-based preventive controls) and section 421 of the FD&C 
Act (related to targeting of inspection resources) for small and very 
small businesses, or modify those requirements for small and very small 
businesses. In addition, the comment recommends that the amendment to 
the retail food establishment definition should only apply to small and 
very small farms, as defined in the proposed regulation for produce 
safety. The comment states that Congress intended for the retail food 
establishment amendment to only apply to small and very small farms, as 
evidenced by certain statements made on the Senate floor regarding 
small farmers.
    (Response 19) Consistent with the statutory direction in section 
103(c) of FSMA, including the direction to conduct a qualitative risk 
assessment, FDA established exemptions for on-farm activity/food 
combinations conducted by farm-mixed-type facilities that are small or 
very small businesses in the final rule for preventive controls for 
human food (Sec.  117.5(g) and (h)). We do not agree that section 
102(c) of FSMA, which directed FDA to clarify the retail food 
establishment definition, should be read to only apply to entities that 
qualify for the exemptions we established in accordance with section 
103(c) of FSMA. Congress's direction in section 102(c) of FSMA to amend 
the definition of retail food establishment was separate and distinct 
from Congress's direction in section 103(c) of FSMA to establish 
exemptions and modifications for certain on-farm activities, and we are 
not aware of any evidence that Congress intended for the amendment to 
the retail food establish definition to be limited by the entities that 
qualify for exemptions in accordance with section 103(c) of FSMA. As to 
the comment that the amendment to the retail food establishment 
definition should only apply to small and very small farms, we 
similarly do not agree. Section 102(c) of FSMA does not provide that 
the determination of the primary function be different for 
establishments of particular sizes. Although there is some legislative 
history indicating that some legislators anticipated that the amendment 
would affect small enterprises, we are not aware of evidence that 
Congress intended for the amendment to only apply to smaller 
enterprises, and there is no such limitation in the statutory 
provision. Moreover, we believe it is appropriate to apply the same 
primary function analysis to all establishments regardless of size, 
with an establishment's primary function being 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.
    (Comment 20) One comment states that our amendment to the retail 
food establishment definition should incorporate a method to evaluate 
potential risks to allow the Agency to determine if the establishment 
has food safety issues or is subject to proper oversight.
    (Response 20) We decline this request. The comment does not explain 
how FDA would evaluate potential risks or what kind of food safety and/
or oversight criteria the Agency would apply. Further, the comment does 
not explain how the request would be consistent with section 102(c) of 
FSMA. That provision, which directs FDA to clarify the retail food 
establishment definition, does not state that the clarification to the 
definition should involve FDA performing any kind of risk evaluation of 
individual establishments.
    (Comment 21) One comment states that our amendment to the retail 
food establishment definition should consider off-farm sales to 
businesses in the primary function calculation, and not just consumers. 
The comment states that similar to the determination for whether an 
entity is a qualified farm under the produce safety regulation or a 
qualified facility under the preventive controls regulations, the 
determination for whether an establishment is a retail food 
establishment should consider sales to ``qualified end users.'' Another 
comment states that the amendment to the definition should only 
consider sales at ``the retail distribution level directly to 
consumers[.]''
    (Response 21) We disagree with the comment requesting that sales to 
businesses be included in the primary function calculation, and agree 
with the comment that the amendment should only consider sales ``at the 
retail distribution level directly to consumers'' to the extent that 
comment requests that the primary function calculation only include 
direct-to-consumer sales. Section 102(c)(2)(B) of FSMA provides that 
the term ``consumer'' does not include a business, and we think it is 
consistent with that provision to establish that sales to consumers do 
not include sales to businesses for the purpose of determining an 
establishment's primary function. It is true that the preventive 
controls and produce safety regulations provide for certain specified 
businesses to be qualified end-users. Under the preventive controls 
regulations, qualified end-users include restaurants or retail food 
establishments located in the same State as the qualified facility

[[Page 45926]]

that sold the food to such restaurant or establishment or are not more 
than 275 miles from such facility or farm and are purchasing the food 
for sale directly to consumers at such restaurant or retail food 
establishment. Under the produce safety regulation, a qualified end-
user includes a restaurant or retail food establishment that is located 
in the same State or the same Indian reservation as the farm that 
produced the food or not more than 275 miles from such farm. Whether a 
facility or farm sells food directly to a qualified end-user is 
significant under the preventive controls and produce regulations 
because sales to qualified end-users may be used in determining whether 
facilities or farms are eligible for qualified exemptions under those 
regulations. Although sales to qualified end-users are significant 
under those regulations, we do not agree that sales to such qualified 
end-users that are not consumers should be used in determining an 
establishment's primary function as a retail food establishment for the 
purposes of registration. Congress specified that qualified end-users 
include certain restaurants and retail food establishments for purposes 
of the preventive controls and produce safety regulations (see sections 
418(l)(4)(B) and 419(f)(4)(A) (21 U.S.C. 350h(f)(4)(A)) of the FD&C 
Act), but specified that for purposes of amending the retail food 
establishment definition the term ``consumer'' does not include 
businesses (see section 102(c)(2)(B) of FSMA).

B. U.S. Agent

    We proposed to amend the definition of U.S. agent in Sec.  1.227 to 
add that the U.S. agent of a foreign facility may view the information 
submitted in the foreign facility's registration.
    In addition, we proposed to replace the word ``cannot'' in the 
current definition for U.S. agent in Sec.  1.227 with ``may not.'' 
Accordingly, the pertinent sentence in that provision will provide 
that, ``A U.S. agent may not be in the form of a mailbox, answering 
machine or service, or other place where an individual acting as the 
foreign facility's agent is not physically present'' (emphasis added).
    (Comment 22) Comments state that it is confusing to distinguish the 
U.S. agent for food facility registration and the U.S. agent for 
purposes of the foreign supplier verification program (``FSVP'') 
requirements under 21 CFR part 1, subpart L, and urge FDA to include 
language in the registration final rule that clarifies that the U.S. 
agent for purposes of food facility registration and the U.S. agent for 
purposes of FSVP are not the same and must be designated through 
separate procedures.
    (Response 22) We do not agree that any amendments to the regulatory 
text of the final rule are necessary. Section 805(a)(2)(B) of the FD&C 
Act (21 U.S.C. 384a(a)(2)(B)),which pertains to FSVP, provides that 
when there is no U.S. owner or consignee with respect to an article of 
food at the time of entry of the article into the United States, the 
term ``importer'' for purposes of FSVP requirements means ``the United 
States agent or representative of a foreign owner or consignee of the 
article of food at the time of entry of such article into the United 
States'' (emphasis added). Under the FSVP final rule, the ``importer'' 
is responsible for verifying the safety of food imported into the 
United States. In addition, section 415(a)(1)(B) of the FD&C Act 
provides that foreign food facilities must submit the name of the 
``United States agent'' for the facility as part of the facility's 
registration under section 415. FDA's regulations implementing the food 
facility registration requirements in section 415 of the FD&C Act 
require that the registration for foreign facilities must include the 
name of the U.S. agent for the facility (21 CFR 1.232(c)(1)). The 
facility registration regulations also define the term U.S. agent to 
mean 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 (Sec.  1.227). The regulations further specify that the 
U.S. agent ``acts as a communications link between FDA and the foreign 
facility for both emergency and routine communications'' (Sec.  1.227).
    Although Congress used the term ``United States agent'' in both 
section 805(a)(2)(B) and section 415(a)(1)(B) of the FD&C Act, we do 
not interpret the use of the term ``United States agent'' in section 
805(a)(2)(B) to mean the U.S. agent for a foreign facility under 
section 415(a)(1)(B). U.S. agents that foreign food facilities must 
designate for purposes of food facility registration perform a very 
different role than the ``United States agent'' that a foreign owner or 
consignee may designate under section 805(a)(2)(B) of the FD&C Act to 
serve as the ``importer'' for purposes of the FSVP regulations. For 
food facility registration, the ``U.S. agent'' acts as a communications 
link. For FSVP, however, an importer (whether a ``United States agent'' 
or otherwise) is responsible for the full breadth of supplier 
verification activities required under the FSVP regulation. These 
activities involve ensuring the safety of imported food, which is 
qualitatively different from serving as a communications link (80 FR 
74226 at 74241; November 27, 2015). Thus, we do not interpret the use 
of the term ``United States agent'' under section 805(a)(2)(B) to have 
the same meaning as the U.S. agent that food facilities are required to 
designate under section 415(a)(1)(B) and FDA's food facility 
registration regulations. As we state in the FSVP final rule, however, 
this interpretation does not prohibit a foreign owner or consignee from 
designating a person who serves as a U.S. agent under the food facility 
regulations as the ``importer'' for purposes of FSVP (Id.).
    Because we do not interpret the use of the terms to have the same 
meaning, we do not think it is necessary to add regulatory text in this 
final rule stating that the U.S. agent for purposes of food facility 
registration is not the same as the U.S. agent for purposes of the FSVP 
final rule. Additionally, we think such language could be confusing 
because there is no prohibition on the same person serving as both the 
U.S. agent for purposes of food facility registration and the U.S. 
agent for purposes of satisfying the FSVP ``importer'' requirements 
(provided that such person meets the relevant requirements of each 
regulation).
    (Comment 23) Comments request FDA clarify that the communications 
link between the U.S. agent and FDA goes both ways and that FDA also 
clarify that communications to and from the U.S. agent have the same 
legal effect as if sent to or by the facility directly for both routine 
and emergency communications.
    (Response 23) As established in current Sec.  1.227, the U.S. agent 
acts as a communications link between FDA and a foreign facility for 
both routine and emergency communications. The U.S. agent will be the 
person FDA contacts when an emergency occurs, unless the registration 
specifies another emergency contact. In functioning as the 
communications link with FDA, a U.S. agent may choose to initiate 
communications with FDA, and FDA may likewise choose to initiate 
communications with the U.S. agent. Further, as stated in Sec.  1.227, 
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. In that sense, information or 
documents provided to the U.S. agent has the same effect as if FDA 
provided the information or documents to the foreign

[[Page 45927]]

facility, in that FDA will consider providing information or documents 
to the U.S. agent the equivalent of providing the information or 
documents to the foreign facility.
    (Comment 24) One comment requests FDA outline and clarify the roles 
and responsibilities of the U.S. agent.
    (Response 24) The roles and responsibilities of a U.S. agent are 
outlined in current Sec.  1.227. As stated previously, the U.S. agent 
acts as a communications link between FDA and the foreign facility for 
both emergency and routine communications.
    (Comment 25) Comments request that FDA clarify that the U.S. agent 
for a foreign food facility may access the facility's FDA Unified 
Registration and Listing Systems (FURLS) and help desk on behalf of the 
foreign facility, and that the U.S. agent should have access to Form 
FDA 483s and Establishment Inspection Reports (EIR) pertaining to the 
foreign facility.
    (Response 25) The final rule provides that the U.S. agent of a 
foreign facility may view the information submitted in the foreign 
facility's registration. The U.S. agent will be able to view the 
information electronically via FURLS Food Facility Registration Module, 
in the interim, U.S. agents may contact FDA's help desk with questions 
about foreign facilities that they represent. In addition, a U.S. agent 
may contact FDA's help desk on behalf of the foreign facility. As to 
whether U.S. agents may have access to any Form FDA 483s and EIRs 
related to the foreign facility, certain information (such as 
confidential commercial information and trade secret information) in 
such records is protected from disclosure. FDA also generally does not 
proactively make available information related to FDA inspections of 
facilities, including FDA Form 483s and EIRs, although it is possible 
that a U.S. agent could obtain such information from the foreign 
facility or from FDA through a FOIA (5 U.S.C. 552) request. Any 
confidential commercial information, trade secret information, or other 
protected information in FDA Form 483s and EIRs that we provide through 
a FOIA request would be redacted (i.e., deleted) in accordance with the 
disclosure exemptions set forth in the FOIA and 21 CFR part 20.

V. Comments on Proposed Amendments to Sec.  1.230--When Must You 
Register or Renew Your Registration?

A. Proposed Sec.  1.230(a)--When Must You Register?

    We proposed to delete the reference to the December 12, 2003, 
deadline in current Sec.  1.230(a) and instead require that owners, 
operators, or agents in charge must register before the facility begins 
to manufacture, process, pack, or hold food for consumption in the 
United States. We did not receive any comments on this change and are 
finalizing as proposed.

B. Proposed Sec.  1.230(b)--Registration Renewal

    We proposed amending Sec.  1.230 to require biennial registration 
renewal and provide for an abbreviated registration renewal process. 
Proposed Sec.  1.230(b) would require that during the period beginning 
on October 1 and ending on December 31 of each even-numbered year, the 
owner, operator, or agent in charge of a facility would be required to 
submit a registration renewal to FDA containing the information 
required under Sec.  1.232. Under proposed Sec.  1.230(b), the owner, 
operator, or agent in charge of a facility would be able authorize an 
individual to renew the facility's registration on its behalf. We 
proposed that if the individual submitting the registration renewal is 
not the owner, operator, or agent in charge of the facility, the 
registration renewal must also include a statement in which the 
individual certifies that the information submitted is true and 
accurate, certifies that he/she is authorized to submit the 
registration renewal, and identifies by name, address, email address, 
and telephone number, the individual who authorized submission of the 
registration renewal. We proposed that each registration renewal must 
include the name of the individual submitting the registration renewal, 
and the individual's signature (for the paper option).
    We are finalizing these requirements, with two modifications. 
First, we have modified the proposed requirement to provide the email 
address for the individual who authorized submission of the 
registration renewal if the individual submitting the registration 
renewal is not the owner, operator, or agent in charge of the facility. 
For registration renewals not submitted by the owner, operator, or 
agent in charge, final Sec.  1.230(b) provides that the registration 
renewal must identify the individual who authorized submission of the 
registration renewal by email address, unless FDA has granted a waiver 
under Sec.  1.245. Registration renewals not submitted by the owner, 
operator, or agent in charge must also identify by name, address, and 
telephone number the individual who authorized the submission, as 
proposed. Second, we have added a requirement that each electronic 
registration renewal must include the name of the individual submitting 
the renewal. We have made this change because we believe that this 
information will aid our ability to verify that the individual 
submitting the registration information is authorized to do so.
    (Comment 26) A comment states a concern with the potential for a 
bottleneck or system overload during the October 1 to December 31 
registration renewal period. The comment asks if FDA would consider a 
biennial renewal expired if it was properly submitted on or prior to 
the December 31 deadline but was not timely administered or accepted by 
FDA on or prior to the December 31 deadline. The comment also requests 
that FDA consider extending the biennial registration deadline so that 
properly and timely submitted biennial renewals are not considered 
expired if FDA has not administered or accepted the facility's 
submission.
    (Response 26) Beginning with the first biennial registration 
renewal period in 2012, information technology (IT) capabilities were 
added to support the system to help prevent any system failure or 
overload. FDA will continue this protocol during all biennial 
registration renewal periods to ensure that our IT systems can operate 
during high-traffic times. Given these IT investments, FDA does not 
anticipate that IT failures will cause problems with our registration 
system administering or accepting submissions during the registration 
renewal period. However, if any technical problems do arise during the 
biennial registration renewal period, FDA may consider extending the 
time period for biennial registration renewals, for instance by 
providing registrants at least the same number of calendar days for 
biennial registration renewal as allowed for under the FSMA amendments 
to section 415 of the FD&C Act. During the first biennial renewal 
period in 2012, FDA took such an approach. At that time, there was a 
delay with the registration renewal period becoming operational and FDA 
extended the deadline for facilities to complete renewals. As to the 
concerns regarding expired registrations, as discussed in section XI of 
this document, we are adding 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). If a food 
facility registration or renewal registration is submitted (or 
postmarked for paper submissions) on or before the renewal deadline and 
includes all required information, we will not consider such a 
registration to be

[[Page 45928]]

expired. As described in section XI of this document, Sec.  1.241(c) 
provides that FDA will cancel a registration if the facility's 
registration has expired because the facility has failed to renew its 
registration in accordance with Sec.  1.230(b). For registrations that 
we do not consider to be expired, we will not cancel the registrations 
under Sec.  1.241(c). In addition, in the event that any IT problems 
complicate the submission and receipt of registration renewals, we 
would take that into account in determining whether to consider any 
registrations to have expired.
    Prior to the beginning of the biennial registration renewal period 
on October 1, FDA intends to send an email to all registrants and U.S. 
agents notifying them of the upcoming registration renewal period. In 
these emails, we plan to provide information about the deadline for 
registration renewal. Once the renewal period begins, if a registrant 
has not submitted a renewal, we plan to continue to send emails 
reminding registrations of the upcoming deadline through the end of the 
registration renewal period on December 31.

C. Proposed Sec.  1.230(c)--Abbreviated Registration Renewal Process

    Under proposed Sec.  1.230(c), we proposed to 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 submission of the preceding registration or registration renewal. 
The abbreviated registration renewal process that we proposed 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 also proposed that registrants 
must use Form FDA 3537 to submit abbreviated registration renewals to 
FDA. In response to some comments, we have made some changes to these 
requirements.
    In addition, on our own initiative, we have changed Sec.  1.230(c) 
to require that each abbreviated renewal include the name of the 
individual making the submission and the individual's signature (for 
the paper option). We have made this change because we believe that 
this information will aid our ability to verify that the individual 
submitting the registration information is authorized. We have also 
changed Sec.  1.230(c) to require that for abbreviated renewals not 
submitted by the owner, operator, or agent in charge of the facility, 
the abbreviated renewal must provide the email address of the 
individual who authorized submission of the abbreviated renewal, unless 
FDA has granted a waiver under Sec.  1.245. We made this change in 
order to enable us to more efficiently perform the verification process 
established in Sec.  1.231(a)(4) and (b)(6) for abbreviated renewals 
not submitted by the owner, operator, or agent in charge of the 
facility. Under those provisions, after submission of the abbreviated 
renewal (whether submitted electronically or by mail or fax), FDA will 
verify that the individual identified as having authorized submission 
of the registration renewal in fact authorized the submission on behalf 
of the facility. FDA will not provide a confirmation of the abbreviated 
renewal until that individual confirms that he or she authorized the 
submission. Having the email address for the individual who authorized 
submission of the registration renewal will enable us to more quickly 
and efficiently conduct the verification so that we can more quickly 
provide confirmation of the renewal. Finally, we have changed Sec.  
1.230(c) to allow food facilities to submit abbreviated registration 
renewals if the information required in the registration has not 
changed since the facility submitted an update or since the facility 
submitted the preceding registration or registration renewal. Under the 
proposed rule, the abbreviated option would only have been available if 
no information changed since the facility submitted the preceding 
registration or registration renewal. We made this change so that food 
facilities will not be required to complete the standard renewal 
process if the required information is unchanged since the facility's 
most recent registration update. We believe that this change will make 
the renewal requirement less burdensome for food facilities.
    Furthermore, we note that we consider abbreviated renewals to be 
included as part of the registration renewal process explained in Sec.  
1.231 of the final rule.
    (Comment 27) Comments recommend FDA simplify its proposal for 
``abbreviated'' renewals by requiring only that a box be checked to 
confirm that there have not been any changes to the registration 
information previously submitted, including to the previously submitted 
certification regarding the truthfulness and accuracy of the 
registration information.
    (Response 27) We agree that registrants submitting abbreviated 
registration renewals need not confirm that FDA will be permitted to 
inspect the facility at the times and in the manner permitted by the 
FD&C Act. We believe that the requirement in the final rule in Sec.  
1.230(c) that registrants confirm that no changes have been made to the 
information required under Sec.  1.232 since the preceding registration 
or registration renewal encompasses a confirmation regarding FDA being 
permitted to inspect. Accordingly, we have revised Sec.  1.230(c) in 
the final rule to no longer require that abbreviated registration 
renewals provide confirmation regarding FDA being permitted to inspect. 
However, we continue to believe that it is appropriate for abbreviated 
registration renewals to certify that the information submitted is 
truthful and accurate. We believe such certifications will help deter 
individuals from submitting false information, including falsely 
certifying that no changes have been made to the required information. 
For the reasons discussed in the previous paragraphs, we also believe 
it is appropriate for abbreviated renewals to include the name of the 
individual submitting the renewal and, for abbreviated renewals not 
submitted by the owner, operator, or agent in charge of the facility, 
the email address of the individual who authorized the submission.

VI. Comments on Proposed Amendments to Sec.  1.231--How and Where Do 
You Register or Renew Your Registration?

A. Proposed Sec.  1.231(a)--Electronic Registration and Registration 
Renewal

    In proposed Sec.  1.231(a), we proposed to require mandatory 
electronic registration and registration renewals beginning January 4, 
2016, unless a waiver has been granted under Sec.  1.245. In the 
proposed rule, we proposed in Sec.  1.245 to provide that to request a 
waiver from the electronic registration or renewal requirement, a 
registrant must submit a written request to FDA that explains why it is 
not reasonable for the registrant to submit a registration or 
registration renewal electronically to FDA. In the proposed rule, FDA 
tentatively concluded that reasons for why it may not be reasonable for 
a registrant to submit a registration or registration renewal to FDA 
electronically may include conflicting religious beliefs or where a 
registrant does not have reasonable access to the Internet (80 FR 19160 
at 19177 to 19178).

[[Page 45929]]

    We requested comment on the proposed requirements for mandatory 
electronic registration and registration renewals to begin in the year 
2016 and the proposal to allow for a waiver from these requirements. We 
also requested comment 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.
    (Comment 28) One comment states that small foreign facilities may 
not be able to submit registrations electronically by 2016 because 
there is no reliable access to the Internet. The comment requests that 
paper submissions remain an option.
    (Response 28) We recognize that there may be a need for additional 
flexibility regarding the deadline for requiring electronic 
registrations and registration renewals. In response to this comment, 
we are revising Sec.  1.231(a)(2) to replace the proposed January 4, 
2016, deadline for electronic registrations and registration renewals 
with a January 4, 2020, deadline. In addition, we are also revising 
Sec.  1.231(a)(2) to state that registrations or registration renewals 
must be submitted electronically ``unless FDA has granted'' a waiver. 
The proposed provision would have stated that the electronic 
registration requirement applies ``unless you have been granted a 
waiver.'' We believe that this change is consistent with Sec.  1.245, 
which makes clear that the waivers are granted by FDA. Accordingly, 
final Sec.  1.231(a)(2) provides that owners, operators, or agents in 
charge must submit their registration or registration renewal to FDA 
electronically beginning on January 4, 2020, unless FDA has granted a 
waiver under Sec.  1.245. If FDA has granted a waiver, registrations 
and registration renewals may be submitted through mail or fax.

B. Proposed Sec.  1.231(b)--Registration or Registration Renewal by 
Mail or Fax

    In proposed Sec.  1.231(b), we proposed that, beginning January 4, 
2016, we would allow registrants to submit registration or registration 
renewals by mail or fax if a waiver has been granted under proposed 
Sec.  1.245. As we explained in Response 30, we are replacing the 
January 4, 2016, deadline with a January 4, 2020, deadline.
    As revised, final Sec.  1.231(b) states that beginning January 4, 
2020, registrants must submit their registrations or registration 
renewals to FDA electronically, unless FDA has granted a waiver under 
Sec.  1.245. If FDA has granted a waiver under Sec.  1.245, the 
registrant may register or renew a registration by mail or by fax. The 
revisions reflect our decision to delay the requirement to submit 
registrations electronically until January 4, 2020, and also to be 
consistent with Sec.  1.245 in making clear that waivers under Sec.  
1.245 are granted by FDA.

C. Proposed Sec. Sec.  1.231(a)(3) and (b)(5) and 1.234(c)(2) and 
(d)(5)--Unique Facility Identifier and Verification Procedures for FDA

    In proposed Sec.  1.232(a)(2), we proposed to require the D-U-N-S 
number of a domestic and foreign facility be included in the facility's 
registration. We proposed for this requirement to function in 
connection with proposed Sec.  1.231(a)(3) and (b)(5), which would 
provide that after a facility completes its registration or updates its 
D-U-N-S number as part of registration renewal, FDA would verify the 
accuracy of the facility's D-U-N-S number and would also verify that 
the facility-specific address associated with the D-U-N-S number is the 
same address associated with the facility's registration. Under 
proposed 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 number and verifies that the facility-specific 
address associated with the D-U-N-S number is the same address 
associated with the facility's registration. 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 number and verifies that the 
facility-specific address associated with the D-U-N-S number is the 
same address associated with the facility's registration. Proposed 
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. We also 
proposed for the requirement to submit D-U-N-S numbers to function in 
connection with proposed Sec.  1.234(c)(2) and (d)(5), which proposed 
to provide that FDA would 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 number 
and also verifies that the facility-specific address associated with 
the D-U-N-S number is the same address associated with the facility's 
registration. Proposed 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. As 
discussed more fully in section VII.B of this document, Sec.  1.232(a) 
of the final rule requires domestic and foreign facilities to submit a 
UFI recognized as acceptable to FDA in the facility's registration. We 
are not finalizing the proposal to include a D-U-N-S number.
    (Comment 29) Comments recommend FDA verify registration information 
with the U.S. agent for foreign facilities rather than using D-U-N-S 
numbers. The comments state that such a verification process would be 
less burdensome and complex.
    (Response 29) We decline this suggestion. We believe that a 
verification process that will function in connection with a UFI will 
be more efficient and effective than relying on the U.S. agent. In 
addition, only foreign facilities have U.S. agents. Domestic facilities 
do not have U.S. agents.
    (Comment 30) Comments state that users should be given additional 
attempts to input registration information if the verification step is 
unsuccessful. Comments also ask how FDA will inform a facility of an 
unsuccessful UFI verification step and how facilities will be able to 
correct information.
    (Response 30) For electronic registration submissions, the 
registration screen would immediately notify the food facility if we 
are unable to verify the UFI or if the facility-specific address 
associated with the UFI is the same address associated with the 
registration. For registration submissions by mail or fax, FDA will use 
the contact information available for the facility to notify the 
facility of any such occurrence. If FDA is unable to verify the UFI or 
to verify that the facility-specific address associated with the UFI is 
the same address associated with the registration, the facility would 
have the opportunity to fix the information in the registration. 
However, if it turns out that FDA is unable to verify this information 
because the UFI provider has incorrect information about the facility, 
the facility may contact the UFI provider to resolve the discrepancy. 
If verification problems persist, the facility may contact FDA.
    (Comment 31) One comment asks that FDA allow U.S. agents to 
``search for D-U-N-S numbers of facilities'' before a facility 
registers. The comment states that this will help ensure the accuracy 
of the registration information submitted to FDA.
    (Response 31) To the extent that the comment is asking that U.S. 
agents be able to search the Dun and Bradstreet

[[Page 45930]]

database, we will consider this comment when we implement the UFI 
requirement. Whether U.S. agents may search the database of the UFI 
system that FDA recognizes as acceptable may depend on a number of 
factors, including what database information, if any, the UFI provider 
makes public. If U.S. agents wish to ensure the accuracy of foreign 
facilities' registration information, they may wish to work with the 
foreign facilities directly.
    (Comment 32) Many comments state that requiring the submission of 
D-U-N-S numbers will not enhance the accuracy of FDA's registration 
database. A comment states that a D-U-N-S number cross-check is an 
additional time-consuming step and is not effective at preventing 
inaccurate information from being submitted to FDA. One comment states 
that discrepancies in the FDA database and the Dun and Bradstreet 
database may cause disruptions and delays in registration.
    (Response 32) We disagree with the comments asserting that the UFI 
verification step will not enhance the accuracy of FDA's registration 
database. A UFI system such as D-U-N-S will allow the Agency to 
leverage the information in the UFI system, providing assurance that 
the address associated with the food facility is accurate. For 
instance, FDA uses D-U-N-S numbers for drug establishment registration 
(Ref. 8). FDA has found that the use of D-U-N-S numbers for drug 
establishment registration has been a useful resource for identifying 
and verifying certain business information. Regarding concerns about 
disruptions and delays, we do not anticipate significant problems. We 
are postponing the requirement for providing a UFI in registrations 
until the registration renewal period beginning October 1, 2020, which 
should provide food facilities sufficient time to obtain a UFI. If any 
facilities encounter delays associated with the UFI requirement or 
verification step, they may contact FDA.
    (Comment 33) Comments recommend using inspection information 
obtained by FDA investigators during inspections to confirm and verify 
registration information instead of requiring information about D-U-N-S 
numbers.
    (Response 33) To the extent possible, FDA investigators do confirm 
the accuracy of food facility registration information when conducting 
inspections. However, FDA investigators are not able to ensure the 
accuracy of FDA's registration information in an efficient or 
comprehensive manner. Due to limited resources, FDA is not able to 
inspect every registered facility with the frequency needed to ensure 
that the registration information for any particular facility is 
accurate at any particular time. Information might change in-between 
inspections, and inaccurate registration information could hinder FDA's 
ability to locate facilities for inspection. We believe that requiring 
a UFI recognized as acceptable to FDA is a more efficient and effective 
way to help ensure the accuracy and reliability of the registration 
information and to help ensure that the registration database is up-to-
date.
    (Comment 34) Comments question the capacity of the registration 
database to save registrations for completion at a later date so that 
the registrant can obtain a D-U-N-S number.
    (Response 34) FDA's registration system has the needed capacity to 
save registration information for completion at a later date. While FDA 
will not save an incomplete registration on the server indefinitely, 
the information will be stored for a period of time greater than the 
maximum amount of time needed to acquire a UFI.
    (Comment 35) One comment addresses ``pharmaceutical wholesale 
distributors'' that hold only a small amount of food. For these 
facilities, the comment suggests that FDA verify the facility-specific 
address using means other than a D-U-N-S number. The comment states 
that the Agency can instead refer to facility-specific information 
collected by CDER and/or information collected by State licensing 
authorities.
    (Response 35) We do not think it is appropriate to establish 
different registration requirements for facilities of different sizes 
or for facilities that manufacture, process, pack, or hold different 
amounts of food. Food facilities of any size that handle any amount of 
food may be linked to terrorism attacks or other food-related 
emergencies. In the event that any attacks or other emergencies occur, 
it will be important for FDA to have accurate and up-to-date 
information about all facilities. Even if FDA has certain information 
about facilities through other regulatory processes, we expect that 
obtaining a UFI through food facility registration will be a more 
efficient way for FDA to verify the facility's address. However, we may 
refer to information collected by other FDA regulatory processes as 
appropriate.

D. 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)--Verification Procedures for Submissions Not 
Made by the Owner, Operator, or Agent in Charge of the Facility

    We proposed in proposed Sec.  1.231(a)(4) and (b)(6) that FDA would 
email the individual identified as the owner, operator, or agent in 
charge who authorized submission of the registration to verify that the 
individual in fact authorized submission of the registration on behalf 
of the facility if the registration or registration renewal was not 
submitted by the owner, operator, or agent in charge of the facility. 
We further proposed that FDA would not confirm the registration or 
provide a registration number until that individual confirms that he or 
she authorized the registration submission. With respect to 
registration renewals, under proposed Sec.  1.231(a)(4) and (b)(6), 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. In 
addition, 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 cancellation 
confirms that he or she in fact authorized the cancellation on behalf 
of the facility. We proposed this verification step to address the 
problem with unauthorized third party registration submissions 
discussed in the preamble to the proposed rule (80 FR 19160 at 19171). 
The unauthorized registrations have resulted both in duplicate 
registrations for food facilities and registrations for facilities that 
do not in fact manufacture/process, pack, or hold food for consumption 
in the United States.
    (Comment 36) Comments state that it is not evident that use of 
email verification will sufficiently prevent unauthorized facility 
registrations, as an email address can be falsified.
    (Response 36) We have revised the regulatory text regarding the 
verification step in the final rule to no longer specify that FDA will 
email the owner, operator, or agent in charge to conduct the 
verification. Instead, the final regulatory text provides that FDA will 
verify that the individual identified as having authorized the 
submission in fact

[[Page 45931]]

authorized the applicable submission on behalf of the facility. We have 
made this change in final Sec. Sec.  1.231(a)(4) and (b)(6) (for 
registrations and registration renewals), 1.234(c)(3) and (d)(6) (for 
updates), and 1.235(c)(3) and (d)(6) (for cancellations). We plan to 
issue guidance providing more detailed information about how FDA will 
conduct this verification step. It is possible that the guidance will 
provide for using email, phone, U.S. mail, or other methods, as 
appropriate. In determining what methods are appropriate for conducting 
the verification, FDA will consider the effectiveness of the method for 
preventing unauthorized registrations. The final rule continues to 
provide in Sec. Sec.  1.231(a)(4) and (b)(6) that FDA will not confirm 
a registration or registration renewal or provide a registration number 
until the individual confirms that he or she authorized the submission. 
For updates and cancellations, the final rule continues to provide in 
Sec. Sec.  1.234(c)(3) and (d)(6) (for updates), and 1.235(c)(3) and 
(d)(6) (for cancellations) that FDA will not provide a confirmation of 
the registration update or cancellation until the individual confirms 
that he or she authorized the submission.
    (Comment 37) Comments suggest that instead of the proposed 
verifications step, FDA run cross-checks in the food facility 
registration database to determine if a facility is registered multiple 
times. These comments argue that contacting the owner, operator, or 
agent in charge of a facility to verify a registration can be 
burdensome, especially for owners, operators, or agents in charge of 
multiple facilities. Comments further suggest FDA run cross-checks in 
the database to identify submissions for companies with information 
that does not appear consistent (e.g., different email suffix used, 
different phone numbers) to identify fraudulent third-party 
registrations. Other comments encourage FDA to conduct the verification 
process only after the registration has been submitted. The comments 
state that this will prevent delays in the registration process.
    (Response 37) Due to a large number of registrations and limited 
resources, it is not possible for FDA to individually monitor every 
registration and contact every facility outside of the processes 
provided in the final rule. Under the final rule, if the registration 
submission is not made by the owner, operator, or agent in charge, we 
will confirm that the individual identified as having authorized a 
registration submission in fact authorized the submission. We will 
provide guidance about how we will conduct this verification step, 
which may provide for emailing the individual identified as having 
authorized the submission. Any such process that we outline in guidance 
will be aimed at ensuring the accuracy of the verification process, 
while also being efficient and not unduly resource-intensive. 
Conducting across-the-board surveillance of each registration, by 
contrast, would demand extensive resources. However, FDA will continue 
its current practice of individually contacting facilities if specific 
questions arise regarding the facility's registration. Regarding the 
request to conduct the verification later in the registration process, 
we decline that request. We believe that delaying confirmation of the 
registration submission until after we complete the verification will 
help deter individuals from submitting unauthorized registrations.
    (Comment 38) Several comments suggest that FDA provide the owner, 
operator, or agent in charge an identification number that they can 
give to authorized personnel submitting registration, renewals, 
updates, and cancellations, similar to the VIS for U.S. agents.
    (Response 38) We will consider in the future whether to create an 
identification number to provide to the owner, operator, or agent in 
charge as suggested in the comments.

E. Proposed Sec. Sec.  1.231(a)(5) and (b)(7) and 1.234(c)(2) and 
(d)(5)--Verification Procedures for U.S. Agents

    We proposed in Sec.  1.231(a)(5) and (b)(7) that 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, to verify 
that the person agreed to serve as the U.S. agent. We further proposed 
that FDA would not confirm the registration or provide a registration 
number until that person confirms that the person agreed to serve as 
the U.S. agent for the facility. In addition, we proposed a similar 
process for emailing the U.S. agent when foreign facilities update U.S. 
agent information in proposed Sec.  1.234(c)(2) and (d)(5). 
Specifically, we proposed that when foreign facilities update the U.S. 
agent information as part of registration renewal, FDA would not 
confirm the registration renewal until the person confirms having 
agreed to serve as the U.S. agent. We also proposed that for 
registration updates, we would not provide an update confirmation until 
that person confirms having agreed to serve as the U.S. agent.
    In the final rule, we are continuing to require a verification step 
for U.S. agent information. However, we have revised the regulatory 
text regarding the verification step to no longer specify that FDA will 
email the person listed as the U.S. agent to conduct the verification. 
Instead, the final regulatory text provides that FDA will verify that 
the person identified as the U.S. agent for the foreign facility agreed 
to serve as the U.S. agent. We have made this change in final 
Sec. Sec.  1.231(a)(5) and (b)(6) (for registrations and registration 
renewals) and 1.234(c)(2) and (d)(5) (for updates). We plan to issue 
guidance providing more detailed information about how FDA will conduct 
this verification step. It is possible that the guidance will provide 
for using email. The final rule continues to provide in Sec.  
1.231(a)(5) and (b)(7) that FDA will not confirm a registration or 
registration renewal or provide a registration number until the person 
identified as the U.S. agent for the foreign facility confirms that the 
person agreed to serve as the U.S. agent. For updates, the final rule 
continues to provide in Sec.  1.234(c)(2) and (d)(5) that FDA will not 
provide a confirmation of the registration update until the person 
identified as the U.S. agent for the foreign facility confirms that the 
person agreed to serve as the U.S. agent.
    (Comment 39) One comment suggests that the verification email sent 
to the U.S. agent should include a statement where the U.S. agent 
affirmatively acknowledges that the U.S. agent may be liable for fees 
for reinspection costs.
    (Response 39) The U.S. agent acts as a communications link between 
FDA and the foreign facility for both emergency and routine 
communications. See 21 CFR 1.227. The U.S. agent will be the person FDA 
contacts when an emergency occurs, unless the registration specifies 
another emergency contact. See id. Under the final rule, FDA will 
verify that the person identified as the U.S. agent for foreign 
facilities has agreed to serve in that role. FDA will not confirm the 
registration or provide the facility with a registration number until 
that person confirms that the person agreed to serve as the U.S. agent. 
See 21 CFR 1.231(a)(5); 21 CFR 1.231(b)(7). In addition, for 
registration updates, FDA will not provide an update confirmation until 
the person identified as the U.S. agent confirms that the person agreed 
to serve as the U.S. agent for the foreign facility. See 21 CFR 
1.234(c)(2); 21 CFR 1.234(d)(5). We have revised the regulatory text 
for the final rule to no longer specify that FDA will email the person 
listed as the U.S. agent to

[[Page 45932]]

conduct the verification. Instead, we plan to issue guidance with 
information about how FDA will verify that the person identified as the 
U.S. agent agreed to serve in that role. We have not decided on what 
language we will use in any communications to the person identified as 
the U.S. agent, whether those communications are conducted using email 
or through other means. We will consider this comment as we work to 
implement the U.S. agent verification step.

F. Proposed Sec.  1.231(a)(6) and (b)(9)--Requirement to Update 
Incorrect Registration Information

    We proposed in Sec.  1.231(a)(6) and (b)(9) that if any information 
previously submitted was incorrect at the time of submission, the 
registrant must immediately update the facility's registration as 
specified in Sec.  1.234. We did not receive any comments on these 
provisions and are finalizing the provisions as proposed.

VII. Comments on Proposed Amendments to Sec.  1.232--What Information 
Is Required in the Registration?

    We proposed in Sec.  1.232(b)(1) to 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. This requirement went into effect upon 
enactment of FSMA. In proposed Sec.  1.232(c)(1), we also proposed to 
codify 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 
U.S. agent for the foreign facility. This requirement also went into 
effect upon enactment of FSMA.
    In addition, we also proposed to require that a food facility 
registration include the email address of the owner, operator, or agent 
in charge, and that registrations include the D-U-N-S number of a 
domestic and foreign facility be included in the facility's 
registration. We further proposed to require the type of activity 
conducted at the facility for each food product category defined. We 
proposed that facilities 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; 
(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. 
Although we proposed to specify the specific activity types that food 
facilities must select, we did not propose to define those activity 
types. Instead, we requested comments on whether we should do so, and 
also requested comments on possible definitions. We further sought 
comment on whether processing of thermally processed low-acid foods 
packaged in hermetically sealed containers (``LACF'') and acidified 
foods 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.
    We further proposed to update the registration regulation regarding 
food product categories.
    The rule also proposed to codify in FDA's registration regulation 
the requirement for food facility registrations 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. This requirement went into effect 
upon enactment of FSMA.
    The rule further proposed certain changes related to registrations 
not submitted by the owner, operator, or agent in charge of the 
facility. 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 
proposed to recodify this provision in proposed 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.
    In addition, we proposed to require domestic facilities (proposed 
Sec.  1.232(b)(2)) provide an emergency contact phone number and an 
email address if the email address is different from the facility 
contact person email address required in proposed Sec.  1.232(b)(1). 
For foreign facilities, we proposed to require (in Sec.  1.232(c)(2)) 
that the foreign facility provide an emergency contact number and email 
address. Further, we proposed to retain the requirement in current 
Sec.  1.232(g) (proposed Sec.  1.232(a)(7)) that food facilities 
provide information regarding food product categories, but to change 
that requirement to be consistent with the changes FDA has made to food 
product categories in response to the FSMA amendments.

A. Requirement for Certain Email Address Information

    (Comment 40) Comments state that requiring email addresses for the 
emergency contact of a domestic facility and a foreign facility will 
not be effective if the email address is for a third party other than 
the facility. Some comments recommend that the rule should be amended 
so that food facilities can indicate their preferred means of contact 
in an emergency on the registration form, whether by email, phone, fax 
or other.
    (Response 40) We believe that having the required email addresses 
will assist FDA in responding to food-related emergencies even when the 
email address is for a third party, and therefore disagree with the 
comments suggesting otherwise. Email is a fast and efficient method to 
communicate, and we anticipate that having the email address for the 
emergency contact for a domestic facility and foreign facility will 
assist us in reaching those contacts. Regarding the request to allow 
facilities to indicate their preferred means of contact during an 
emergency (e.g., email, phone, fax, or other), we will consider whether 
to add an optional field on Form FDA 3537 that would allow facilities 
to indicate this. If we add any such optional field, we will issue 
guidance in accordance with our GGP regulations in 21 CFR 10.115.
    (Comment 41) A comment opposes having to provide an email address 
for the U.S. agent in addition to the name, full address, and phone 
number of the U.S. agent. The comment states that a U.S. agent's email 
address will be of little assistance to FDA during an emergency because 
once submitted, the contact information could change and may never be 
updated.
    (Response 41) 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.

[[Page 45933]]

agent for the foreign facility. This requirement went into effect upon 
enactment of FSMA. Section 1.232(c)(1) of the final rule will codify 
the requirement in FDA's registration regulation. Further, FDA 
disagrees that the email address for the U.S. agent will not be useful 
for the Agency. We plan to use the email address information to assist 
us in routine and emergency communications with the U.S. agent. In 
addition, we plan to use the email address information to help us 
verify that the person identified as a U.S. agent in a facility's 
registration has agreed to serve in that role. As described elsewhere 
in this Federal Register document, after a foreign facility completes 
its registration or updates its U.S. agent information (including as 
part of registration renewal), FDA will verify that the person 
identified as the U.S. agent for the foreign facility has agreed to 
serve as the facility's U.S. agent (see Sec. Sec.  1.231(a)(5) and 
(b)(7) and 1.234(c)(2) and (d)(5)). In addition, as described in 
section IX of this document, facilities must submit updates within 60 
calendar days of any change to any of the registration information 
previously submitted, including information about the U.S. agent.
    (Comment 42) Comments recommend that FDA create an exemption from 
the requirement that facilities provide an email address for the owner, 
operator, or agent in charge of a facility for facilities that do not 
have email addresses or Internet access. One comment requests that 
providing the email address of the owner, operator, or agent in charge 
be optional.
    (Response 42) Although section 102(a)(1)(A) of FSMA requires 
submission of email address information for the contact person of 
domestic facilities and the U.S. agent of foreign facilities, often 
these persons are not the same as the owner, operator, or agent in 
charge of the facility. We are requiring email addresses for the owner, 
operator, or agent in charge of food facilities in Sec.  1.232(a)(6) 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. However, we understand that there may be circumstances in 
which an owner, operator or agent in charge of a facility is not able 
to obtain an email address. We expect that these circumstances will the 
same or similar to the circumstances that may cause a facility to 
receive a waiver from the electronic registration requirement in 
accordance with Sec.  1.245. To account for these circumstances, we are 
providing in final Sec.  1.232(a)(6) that the email address be added to 
the information required regarding the owner, operator, or agent in 
charge of the facility, except when FDA has granted a waiver under 
Sec.  1.245. Consequently, under final Sec.  1.232(a)(6), a food 
facility registration must include the name, address, and phone number 
of the owner, operator or agent in charge. In addition, the email 
address of the owner, operator, or agent in charge is required, unless 
FDA has granted a waiver under Sec.  1.245.

B. Requirement for a Unique Facility Identifier

    (Comment 43) Comments state that FDA does not have express legal 
authority to require a D-U-N-S number. The comments state that Congress 
amended the registration requirements in section 415 of the FD&C Act as 
part of FSMA, and that Congress could have, but did not, require the 
submission of D-U-N-S numbers.
    (Response 43) We have replaced the proposed requirement that 
registrations include a D-U-N-S number with a requirement that they 
include a UFI recognized as acceptable to FDA. We believe that we have 
adequate legal authority for this requirement in the final rule. As to 
the comments' statement that Congress could have, but chose not to, 
include a UFI requirement in FSMA, we do not believe that the lack of 
such a requirement in FSMA indicates that Congress did not authorize 
FDA to require such identifiers. As we stated in the proposed rule, the 
UFI requirement is grounded in the statutory objective of efficiently 
enforcing the food safety and other requirements of the FD&C Act. By 
requiring UFIs, FDA will be able to verify the facility-specific 
address information associated with those identifiers. Such 
verification should increase the accuracy of FDA's food facility 
registration database. As a consequence, FDA investigators will have 
access to more accurate food facility information, and will therefore 
be able to more efficiently identify and locate food facilities for 
inspection. As a result, FDA will 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 decision to require UFIs 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 UFIs provide will 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 will aid FDA in efficiently 
responding to a terrorist threat or other food-related emergency. 
Finally, FDA's decision to require unique facility identifiers is 
consistent with the direction contained in section 305(d) of the 
Bioterrorism Act (Pub. L. 107-188, 116 Stat. 594, 668-69) to ensure 
adequate authentication protocols to enable identification of the 
registrant and validation of the registration data for registrations 
submitted to FDA electronically. Verifying information in connection 
with a UFI for a food facility will provide FDA with a protocol to 
enable FDA to identify food facilities and verify certain registration 
information for those facilities.
    (Comment 44) Comments suggest obtaining a D-U-N-S number is a 
duplicative effort for facilities and would not provide assurance of 
the most up-to-date and accurate information for a facility considering 
that information in both databases is voluntarily entered by the 
facility. One comment states that use of an identification number such 
as a D-U-N-S number would not lead to increased accuracy because with 
both a D-U-N-S number and food facility registration, facilities self-
report information. Comments urge FDA to allow multiple identifiers for 
facilities as opposed to solely relying on D-U-N-S. Some comments 
recommend FDA utilize the U.S. Customs and Border Protection's (CBP) 
identification number system and/or the Prior Notice (PN) system for 
foreign registration verification as opposed to a D-U-N-S number. 
Comments encourage FDA to allow facilities other options for a specific 
facility identifier that include using certifications and identifiers 
from State agencies. Comments state that programs for use of 
identifying traders are best dealt with at an international level by 
the World Customs Organization. This comment states that no one 
identification system is better than another and that FDA should not 
impose this particular system worldwide. One comment encourages FDA to 
work with State, local, and tribal

[[Page 45934]]

agencies to develop a UFI without relying on a third-party system.
    (Response 44) As stated previously in this Federal Register 
document, the final rule requires that registrations include UFIs, not 
D-U-N-S numbers. We believe that this change provides additional 
flexibility. We anticipate that we will issue guidance specifying which 
UFIs or identifiers FDA recognizes as acceptable, and we expect to 
recognize D-U-N-S numbers as acceptable identifiers.
    We disagree with the comments stating that UFIs will be duplicative 
and will not assist FDA in obtaining up-to-date information about food 
facilities. We anticipate that UFIs will help ensure that the 
identified facility is, in fact, the food facility in the food facility 
registration submission. The D-U-N-S number system, for instance, is an 
internationally recognized unique number system that is updated on a 
regular basis. D-U-N-S numbers also provide for site-specific 
identification of business entities. Although business establishments 
may provide information about themselves to Dun and Bradstreet, Dun and 
Bradstreet does not rely on self-reported information alone. The 
company independently verifies certain information associated with 
establishments. The ability to verify the accuracy of this information 
will increase the accuracy of the registration database and, as a 
consequence, help provide FDA investigators with more accurate food 
facility information that they can use to more efficiently identify and 
locate food facilities for inspection. In addition, we expect that the 
UFI verification process will make it more difficult for unauthorized 
individuals to submit registrations on behalf of facilities because 
unauthorized individuals may not know a particular facility's UFI, or 
may be unable to provide an accurate facility-specific address.
    To the extent that the comments are concerned about the burden of 
the requirement, we note that Dun and Bradstreet makes D-U-N-S numbers 
available at no cost. Further, as of mid-2013, approximately 70 percent 
of domestic facilities required to register with FDA and 64 percent of 
foreign facilities required to register with FDA, have D-U-N-S numbers 
(Ref. 9).
    As to the comments suggesting we use CBP or PN systems, we do not 
agree that such identification systems would be appropriate. Not all 
food facilities import food, and therefore not all food facilities will 
necessarily have access to any CBP or PN system. Furthermore, we do not 
believe that any certifications and identifiers from State agencies 
would be adequate UFIs because any such certifications and identifiers 
would likely differ State by State, and States might not develop UFIs 
for foreign facilities. For these reasons, we do not agree that using 
the alternative identifiers suggested by the comments would allow FDA 
to accurately identify food facilities. Consequently, they would not 
allow FDA to efficiently enforce section 415 of the FD&C Act.
    With respect to the comment stating that programs for use of 
identifying traders are best dealt with at an international level by 
the World Customs Organization and that FDA should not impose this 
particular system worldwide, FDA is responsible for administering the 
requirements of section 415 of the FD&C Act. Those requirements include 
the responsibility to maintain an accurate and up-to-date registration 
database. Our database needs are specific to the laws and regulations 
we implement, and we believe that we are in the best position to 
determine what UFIs should be acceptable. In addition, by requiring the 
submission of an acceptable UFI, we are not requiring worldwide 
adoption of any particular identification system. The requirement would 
only apply to food facilities that are required to register with FDA 
(i.e., food facilities that manufacture/process, pack, or hold food for 
consumption in the United States).
    Regarding the comment encouraging FDA to work with State, local, 
and tribal agencies to develop a UFI without relying on a third-party 
system, we may consider whether such an approach would be appropriate. 
However, we expect that undertaking the development of a new UFI system 
could entail significant resources.
    (Comment 45) One comment states that a U.S. Government 
Accountability Office report stated that the U.S. General Services 
Administration has concerns regarding reliance on D-U-N-S numbers and 
has been looking into alternatives that would encourage competition 
(Ref. 10). The comment urges FDA not to require a D-U-N-S number for 
food facility registration.
    (Response 45) As stated previously, the final rule does not require 
the submissions of D-U-N-S numbers; instead it requires the submission 
of UFIs recognized as acceptable to FDA. We will consider recognizing 
as acceptable UFIs other than D-U-N-S numbers.
    (Comment 46) Comments state that the proposed requirement to obtain 
a D-U-N-S number would be burdensome and unfamiliar to many. Comments 
recommend FDA make the proposed D-U-N-S requirement optional for 
foreign facilities. They state that this would help alleviate the 
burden for foreign facilities because they state that it can take up to 
2 weeks for foreign facilities to obtain D-U-N-S numbers. One comment 
states that facilities need time to implement the D-U-N-S number 
requirement, especially foreign facilities that may be unfamiliar with 
the process of obtaining a D-U-N-S number. The comment is also 
concerned that Dun and Bradstreet will be inundated with requests 
during the next biennial renewal period. In addition, comments state 
that it would be burdensome for facilities to maintain both food 
facility registration numbers and D-U-N-S numbers. One comment suggests 
that FDA should work with Dun and Bradstreet to make the iUpdate system 
available to facilities and make it clear to food facilities that they 
have access to the iUpdate system when obtaining a D-U-N-S number. One 
comment states that the Dun and Bradstreet Web site for obtaining D-U-
N-S numbers is not reliable, and facilities may be prompted to request 
D-U-N-S number by telephone (at a large cost).
    (Response 46) As stated in the previous paragraphs, we conclude 
that it is appropriate to require that food facilities, including 
foreign facilities, submit UFIs in their registrations. Use of a UFI, 
such as a D-U-N-S number, provides additional information than that 
provided by food facility registration numbers, because UFIs such as D-
U-N-S numbers allow FDA to verify certain information submitted in 
registrations. Such verification is important for both domestic and 
foreign food facilities. As to the concern about the burden of this 
requirement, we do not agree that the process of applying for a UFI is 
unreasonably burdensome, including for foreign facilities. 
Nevertheless, in response to the comments, we are delaying the 
requirement to submit a UFI until the registration renewal period 
beginning October 1, 2020. We believe that this will provide adequate 
time for domestic and foreign facilities to obtain D-U-N-S numbers 
without cost and for facilities (both domestic and foreign) to become 
familiar with the process for obtaining D-U-N-S numbers. In addition, a 
D-U-N-S number can be acquired at any time, not only within the 
biennial registration renewal period. We do not anticipate that 
facilities will have difficulty obtaining UFIs as a result of the UFI 
provider being overburdened or its Web site being unreliable. But if 
such difficulties do arise, facilities should contact us so that we can 
look

[[Page 45935]]

into the matter. Regarding the request in the comment that FDA work 
with Dun and Bradstreet to make the iUpdate system available to food 
facilities, we will look into the possibility and determine whether the 
system is appropriate for food facility registration.
    (Comment 47) Comments state that the food facility registration 
number will serve as an adequate facility identifier. Comments state 
that there does not appear to be a problem with inaccurate data in the 
food facility registration database and state that requiring an 
additional identifier is therefore not necessary.
    (Response 47) FDA will not discontinue the use of registration 
numbers. However, since FDA implemented the registration requirement in 
2003, we have identified a number of accuracy-related problems in the 
registration database. One such problem involves incorrect facility 
address information. Accurate address information is critical to 
scheduling inspections efficiently, and without it FDA often faces the 
problem of ``inspectional washouts,'' where an FDA investigator arrives 
for an unannounced inspection at a listed address only to find that the 
facility has gone out of business or is otherwise not located at the 
listed address. In fiscal year 2015, FDA experienced 629 inspectional 
washouts for foreign and domestic food facilities. We believe that 
requiring UFIs in registrations and verifying the facility-specific 
address associated with those numbers will help increase the accuracy 
of the address information contained in FDA's food facility 
registration database.
    (Comment 48) Numerous comments state that it does not make sense 
for small businesses or hobbyists who operate out of their homes to 
obtain D-U-N-S numbers for the sole reason of registering with FDA.
    (Response 48) Under Sec.  1.227, a private residence is not a 
``facility.'' Thus, a private residence that meets customary 
expectations for a private residence that is also used to manufacture, 
process, pack, or hold food need not be registered. Accordingly, if the 
activities of small businesses or hobbyists who operate out of their 
homes meet customary expectations for a private residence, they would 
not have to register and therefore would not be required to obtain a 
UFI under this final rule. If, however, their activities do not meet 
customary expectations for a private residence, the small businesses or 
hobbyists would be required to register as food facilities and obtain a 
UFI. For the reasons outlined in the previous paragraphs, we believe 
that the process of applying for a UFI is reasonable and that it will 
not be unduly burdensome.
    (Comment 49) Comments express concern over the confidentiality of 
D-U-N-S numbers. Comments state that FDA should confirm and clarify 
that D-U-N-S numbers as well as facility names, addresses, and other 
information submitted in registrations are not subject to public 
disclosures. One comment states that disclosure of D-U-N-S numbers 
could allow third parties to obtain the address of ``pharmaceutical 
distribution warehouses'' that also hold food, and that disclosure 
would allow criminals to identify large quantities of drugs. The 
comment also expresses concern about inadvertent disclosure of D-U-N-S 
numbers by FDA FOIA staff. Comments ask that FDA consult with the State 
Department and Foreign Governments ``since mandating the collection of 
private data might run afoul of European privacy laws.''
    (Response 49) With respect to concerns about use of UFIs, including 
D-U-N-S numbers, leading to the disclosure of confidential information, 
we take appropriate measures to secure all data and records provided to 
the Agency, including data contained in food facility registrations. 
Furthermore, we note that under section 415(a)(5) of the FD&C Act, 
FDA's list of registered facilities and registration documents are not 
subject to disclosure under FOIA. In addition, any information derived 
from such list or registration documents that would disclose the 
identity or location of a specific registered person also is not 
subject to disclosure under FOIA. With respect to public disclosure, 
FDA intends to treat information about facilities' UFIs the same as it 
treats other information derived from registration submissions. It 
should also be noted that no registration information will be disclosed 
to a UFI provider, such as Dun and Bradstreet, as part of the 
verification process. Dun and Bradstreet could disclose the identity or 
location associated with a D-U-N-S number in some circumstances (such 
as for persons that pay for Dun and Bradstreet services), but any 
information that Dun and Bradstreet could disclose would not indicate 
whether a facility is registered or include any information provided to 
FDA as part of the registration process.
    Regarding the concern expressed in one comment about the security 
of facilities that store both foods and drugs, it is unclear how the 
submission of a UFI for purposes of food facility registration places 
the facility at any additional risk. The food facility registration 
regulations do not require facilities to provide information about any 
products other than the food manufactured/processed, packed, or held by 
the food facilities, and, as previously stated, information derived 
from the registration list or registration documents are not subject to 
disclosure under FOIA if they would disclose the identity or location 
of a specific registered person.
    With regard to concerns raised about foreign country privacy 
standards, we requested comment on the proposed requirements, and a 
wide range of entities had the chance to provide us feedback. We are 
not aware of information, nor did we receive information from comments, 
that a UFI requirement would violate a European Union privacy law. If 
an entity finds that a UFI requirement conflicts with specific local 
laws, they should contact FDA.
    We also believe that finalizing a UFI requirement, as opposed to a 
D-U-N-S number requirement, will help foster potential competition with 
other UFI providers and encourage better customer service from 
providers recognized as acceptable to FDA.
    (Comment 50) Comments request clarity regarding facilities that 
require a D-U-N-S number (i.e. headquarters and/or sub sites). Other 
comments encourage FDA to allow the use of the parent company's D-U-N-S 
number for separate facilities that a company may own so that companies 
that own multiple facilities need only use one D-U-N-S number. Comments 
also state that many companies' D-U-N-S numbers are typically handled 
by headquarters personnel who may be located at a different address 
than the facility itself.
    (Response 50) Under the final rule, each facility must provide a 
UFI recognized as acceptable by FDA. Requiring identifiers that are 
unique to individual facilities is necessary to enable FDA to verify 
the facility-specific address information associated with those 
identifiers. Such verification will allow FDA to more efficiently 
identify and locate food facilities for inspection and to maintain an 
accurate and up-to-date registration database. Accordingly, FDA 
declines the suggestions to allow identifiers that are specific to 
parent companies instead of individual facilities.
    (Comment 51) Comments ask if the requirement to supply a D-U-N-S 
number will apply to all facilities immediately, or if it will only 
apply to facilities not currently registered.
    (Response 51) The requirement to provide a UFI will apply to all 
registrants, new and existing. For all

[[Page 45936]]

registrants, as we stated previously in this document, we are delaying 
the compliance date for the requirement to submit a UFI recognized as 
acceptable to FDA until the registration renewal period beginning 
October 1, 2020. After a food facility provides a UFI, it will be 
required to update its registration with any changes to the identifier 
in accordance with Sec.  1.234 of the final rule.
    (Comment 52) Comments ask if facilities will have to provide a new 
D-U-N-S numbers if they change ownership.
    (Response 52) If a facility comes under new ownership, the former 
owner must cancel the old registration in accordance with Sec.  1.235 
of the final rule, and the new owner must submit a new registration for 
the facility as specified in Sec.  1.231 (see 21 CFR 1.234(b)). If a 
facility cancels its registration due to a change in ownership, the new 
owner, operator, or agent in charge must provide the appropriate UFI 
when registering the facility under new ownership.
    (Comment 53) A comment states that FDA should prominently display 
on the registration Web site that a D-U-N-S number can be obtained at 
no cost and within a reasonable timeframe. In addition, the comment 
suggests that FDA provide a link on the FURLS Web page that facilities 
can use to contact FDA if they are asked to pay for a D-U-N-S number or 
to purchase additional D-U-N-S services, or if they cannot obtain a 
number within a reasonable time.
    (Response 53) We will consider making changes to the registration 
Web site and the FURLS Web page to clarify which UFIs are recognized as 
acceptable to FDA and how to obtain a UFI. If facilities have 
difficulty obtaining a UFI, they are welcome to contact FDA at any 
time. We will consider providing further instructions regarding how to 
contact FDA on the FURLS Web page as well.
    (Comment 54) One comment states that foreign facilities should be 
able to submit registrations without a D-U-N-S number, and then have 30 
days to update the registration with the D-U-N-S number. The comment 
suggests that FDA conduct the verification step at that time. 
Furthermore, the comment recommends that FDA can maintain a log of 
instances involving registrations that were cancelled because a foreign 
facility did not have a D-U-N-S number and that FDA place those 
facilities on Import Alert. Furthermore, the comment suggests that in 
the 12 months prior to the next biennial registration period, FDA 
should add an optional D-U-N-S number field to Form FDA 3537.
    (Response 54) We disagree that foreign facilities should have 30 
days to update their registrations with a UFI. For all registrants, we 
are delaying the requirement to submit a UFI recognized as acceptable 
by FDA until the registration renewal period beginning October 1, 2020, 
and we believe that this delay will provide all facilities, including 
foreign facilities, with sufficient time to obtain a UFI recognized as 
acceptable by FDA. We also believe that it would be administratively 
difficult to implement the comment's suggestion that different 
registration information be submitted at different times. The Agency 
will consider adding an optional UFI field to allow facilities to 
voluntarily submit UFI information in advance of the October 1, 2020, 
date.
    (Comment 55) Comments express concern over the availability of the 
D-U-N-S system to small facilities that do not have reliable access to 
the Internet.
    (Response 55) Our understanding is that access to the Internet is 
not required for D-U-N-S numbers, and that a D-U-N-S number can be 
obtained by phone. If any food facilities have difficulty obtaining a 
UFI recognized as acceptable by FDA due to lack of access to the 
Internet or phone, they may contact FDA.
    (Comment 56) Comments state that Dun and Bradstreet does not appear 
to account for additions or deletions to the Specially Designated 
Nationals (SDN) List. These comments suggest FDA establish an ongoing 
monitoring process that routinely verifies the food facility 
registration database against the current SDN list.
    (Response 56) The U.S. Treasury Department's Office of Foreign 
Assets Control publishes a list of individuals and companies owned or 
controlled by, or acting for or on behalf of, targeted countries. It 
also lists individuals, groups, and entities, such as terrorists and 
narcotics traffickers designated under programs that are not country-
specific. Collectively, such individuals and companies are called 
``Specially Designated Nationals'' or ``SDNs'' (Ref. 11). The comment 
has not identified a compelling reason why we should establish an 
ongoing monitoring process that routinely verifies the facility 
registration database against the SDN list, and we decline to do so.
    (Comment 57) Comments recommend FDA require that each facility's 
registration include its geographical coordinates instead of D-U-N-S 
numbers. Comments state that geographical coordinates are more easily 
accessible for each facility and are directly linked to a facility's 
physical location.
    (Response 57) FDA declines to implement this recommendation. While 
geographical coordinates can provide longitude and latitude information 
about a facility, geographical coordinates may not always provide the 
same relevant and detailed information as a UFI. For instance, 
multiple, separate facilities may operate from a location with the same 
geographical coordinates, and geographical coordinate information may 
not reveal the complete address of a facility.
    (Comment 58) Comments state that some individuals will have 
religious objections to the D-U-N-S number requirement because D-U-N-S 
numbers involve a mandatory universal numbering system.
    (Response 58) If a registrant has religious beliefs that conflict 
with obtaining a UFI, they should contact FDA and explain why they are 
not able to comply with the requirement in the final rule.

C. Requirement To Include Food Product Categories

    We proposed to amend Sec.  1.232 to be consistent with FDA's 
October 2012 guidance document entitled ``Guidance for Industry: 
Necessity of the Use of Food Product Categories in Food Facility 
Registrations and Updates to Food Product Categories'' (Food Product 
Categories Guidance) (Ref. 5) 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. We stated that we intend to address any further amendments of the 
food product categories contained on Form FDA 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.''
    (Comment 59) Comments state that it is confusing to update required 
food product categories by guidance since the guidance document is 
binding and, the comments say, looks indistinguishable from other 
guidance documents that are not binding. Comments recommend that the 
Food Product Category guidance document be called something other than 
``Guidance,'' such as ``Binding Guidance,'' to set it apart. Comments 
encourage FDA to consider amending

[[Page 45937]]

the food product categories through a mechanism other than guidance.
    (Response 59) We disagree with these comments. 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. We therefore believe it is 
appropriate to establish food product categories using guidance, and 
also to use the term ``guidance'' in describing the document. Because 
of Congress's explicit statutory authorization to effectuate a binding 
requirement based on findings in guidance, the Food Product Categories 
guidance document is not subject to the usual restrictions in FDA's 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 (see 21 CFR 10.115(d) 
and (i)). Although we appreciate the comments' concern that this causes 
the Food Product Categories Guidance to differ from other guidance 
documents, we think that the guidance document itself makes this 
difference clear. In particular, we stated in the Food Product 
Categories guidance that we did not include the standard language 
regarding the ``nonbinding effect of guidance'' in the guidance because 
it is not an accurate description of the effect of the guidance (Ref. 
5).
    (Comment 60) Comments suggest that FDA should not require 
warehouses and storage facilities to identify food product categories 
that they handle because this information constantly changes. The 
comments state that it would therefore be burdensome for these 
facilities to be required to ``constantly update'' their food product 
category information.
    (Response 60) Information about the categories of food a facility 
handles helps FDA conduct investigations and surveillance operations in 
response to food-related emergencies and to quickly alert facilities 
affected by such an incident if FDA receives information indicating the 
type of food affected. This is true for warehouse and storage 
facilities, as well as other facilities that manufacture/process, pack, 
or hold food. We therefore disagree with the suggestion to exempt 
warehouses and storage facilities from the requirement to include food 
product category information in their registrations. That said, it may 
not be necessary for warehouse facilities to ``constantly update'' 
their registrations. For warehouse facilities engaged in ongoing 
operations that frequently change food product categories, these 
facilities may select all of the food product categories that are 
normally part of their operations. If the warehouse has any updates to 
the food product categories that it handles, it is required to update 
its registration in accordance with Sec.  1.234. The Agency will 
consider possible IT solutions to reduce the burden associated with 
selection of food product category information.
    (Comment 61) Comments question whether FDA is proposing to remove 
animal feed product categories from Form FDA 3537 and, if not, request 
clarity on the definitions of each of the animal food product category 
listed on the form.
    (Response 61) This final rule does not remove animal food product 
categories from Form FDA 3537, and registrants will continue to be 
required to provide information about food product categories for 
animal food. As to the comment's request for guidance on the meaning of 
the different food product categories for animal food, we do not agree 
that such guidance is necessary. We believe that many of the food 
product categories on Form FDA 3537 do not require elaboration. For 
instance, we believe that registrants understand the meaning of the 
term ``pet food,'' which is one of the food product categories for 
animal food. To the extent that the comment seeks clarification on the 
categories that pertain to animal food ingredients, we believe that 
these categories are well understood in the animal food industry. For 
instance, every year the Association of American Feed Control Officials 
(AAFCO) issues the Official Publication (OP) that includes categories 
for various animal food ingredients, many of which overlap with the 
food product categories listed on Form FDA 3537 for animal food. In 
order to provide even greater consistency with the categories used by 
the animal food industry, FDA plans to update the Food Product 
Categories guidance to add several additional food product categories 
for animal food. Those categories are: Botanicals and herbs; direct fed 
microbials; forage products; and technical additives. In addition, we 
plan to revise the Food Product Categories Guidance to replace certain 
food product categories. Specifically, we plan to replace the ``animal 
derived products'' category with an ``animal protein products'' 
category, replace the ``food processing byproducts'' category with a 
``human food by-products not otherwise listed'' category, and replace 
the ``recycled animal waste products'' category with a ``processed 
animal waste products'' category. We will update Form FDA 3537 to 
reflect changes that we make to the Food Product Categories guidance.
    If facilities have specific questions about the food product 
categories for animal food, they may contact FDA.
    (Comment 62) Comments propose utilizing FDA Product Codes instead 
of the food product categories currently on Form FDA 3537. Comments 
state FDA Product Codes ``more specifically identify foods and thus 
allow FDA to more accurately assess risk,'' and note that FDA's draft 
guidance for industry on the voluntary qualified importer program 
(VQIP) recommends use of the product codes.
    (Response 62) FDA's product code is a unique alpha-numeric code 
used by FDA and customs brokers and self-filers to describe food 
products, as well as other products regulated by FDA. FDA requires 
submission of this data element for prior notice (21 CFR 
1.281(a)(5)(i)), in part because the specificity provided by the FDA 
product code helps facilitate risk-based screening of imported 
products. The use of FDA product codes is also part of the application 
process for VQIP, as explained in the VQIP draft guidance (Ref. 12). At 
the same time, FDA requires the submission of food product category 
information for registration. Food product categories are for the most 
part more general and are tailored to food facility registration. FDA 
may use the food product categories in connection with product codes at 
the time of import. Specifically, FDA is able to use the information 
about food product categories to screen food imports because the Agency 
is able to match a registrant's food product category with the product 
code and common or usual market name submitted as part of prior notice. 
However, food product categories provide certain information that the 
product codes do not provide. For example, the fruit and vegetable 
categories include separate sub-categories for fresh-cut fruits and 
vegetables, raw agricultural commodities, and other fruit and vegetable 
products. Because fresh-cut fruit and vegetables present different 
risks from other fruits and vegetables, this information helps FDA 
target communications with facilities. The product codes do not 
distinguish fresh-cut from other fruit or vegetable products. For all 
of these reasons, we believe it is appropriate to continue to

[[Page 45938]]

require food product categories for registration, and not FDA product 
codes. Further, we note that food facility registration and VQIP serve 
different purposes.
    (Comment 63) One comment suggests that we modify Form FDA 3537 to 
allow facilities to write in the type of food that is being held at the 
facility in order to minimize the content of sections 10a and 10b on 
the form.
    (Response 63) We decline the suggestion to modify sections 10a 
(general product categories for human consumption) and 10b (general 
product categories for animal consumption) to a blank column for the 
facility to write in a food category. We believe that it makes the 
registration process easier for facilities if there are designated food 
product categories from which they can choose. We also believe that the 
specific food product categories currently on Form FDA 3537 are 
necessary and appropriate for food facility registration, as indicated 
in the Food Product Categories Guidance.
    (Comment 64) One comment agrees with the designation of ``Bakery 
products, dough mixes, or icings [21 CFR 170.3(n)(1),(9)]'' as a food 
product category, provided that the food product category is intended 
to encompass all of the foods covered by Sec.  170.3(n)(1) and (9). The 
comment would alternatively support separate food product categories 
for the products covered by Sec.  170.3(n)(1) and (9) if the different 
products covered by the two different provisions have unique risk 
profiles.
    (Response 64) The food product category ``Bakery products, dough 
mixes, or icings [21 CFR 170.3(n)(1),(9)]'' is intended to encompass 
all of the foods covered by Sec.  170.3(n)(1) and (9). If we make 
changes to the food product categories, we will update the Food Product 
Categories Guidance.

D. Requirement To Identify Activity Type

    (Comment 65) Some comments state that requiring activity type 
information would be burdensome for facilities that hold many products 
(i.e., warehouses) and perform various activities. Comments also state 
that this information is irrelevant to FDA's mission and operations, 
including inspection planning, determining inspection frequency, and 
responding to food-related emergencies. These comments suggest that 
activity type information should remain optional, as it is under the 
current food facility registration regulation. Other comments, however, 
state that they support the requirement that facilities provide 
activity type information. One comment states that the requirement will 
reduce the need for FDA to reach out to facilities to gather this same 
information. One comment suggests that FDA obtain activity type 
information in a written text field on the registration form instead of 
using a matrix similar to that currently used on Form FDA 3537, which 
matches activity type information with food product category 
information. The comment is concerned that warehouses that hold a 
number of different foods would be required to make frequent updates.
    (Response 65) We disagree with the comments suggesting that we not 
require activity type information. As stated in the proposed rule (80 
FR 19160 at 19173), information about activity type will provide FDA 
with important information regarding a facility's role in the U.S. food 
supply system, allowing us to better assess the facility's potential 
impact in cases of bioterrorist incidents or other food-related 
emergencies. Improved information about activity types will also allow 
us to better prepare investigators for inspections and assign 
appropriate investigators, and 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 
will aid FDA in implementing section 421 of the FD&C Act, which 
requires FDA to identify high-risk facilities and mandates more 
frequent inspections for domestic high-risk facilities than for 
domestic non-high-risk facilities. Section 421(a)(1) of the FD&C Act 
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'' (see section 421(a)(1)(F) of the FD&C Act). Among the 
criteria we have deemed necessary and appropriate for this purpose are 
type of activity conducted at the facility (manufacturer/processor, 
packer/repacker, etc.). Because the risk-based inspection mandate in 
section 421of the FD&C Act applies to facilities registered under 
section 415, and because we have 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 of the FD&C 
Act, the activity type information will allow us to more efficiently 
enforce section 421. Therefore, we decline the recommendation to keep 
the activity types as optional data elements. We will consider IT and 
formatting solutions that will make it less burdensome to provide this 
information, such as drop down menus or ``Select all'' options. 
Regarding the request that FDA obtain activity type information through 
a written text field, we decline that request. We do not believe that 
using written text fields would easily enable facilities to match the 
activity type information with the food product category information. 
Also, the comment does not explain why written text fields would be 
less burdensome than the matrix used on current Form FDA 3537, which 
allows facilities to check boxes indicating applicable activity types. 
(Currently, the activity type information on Form FDA 3537 is 
optional.)
    (Comment 66) One comment asks whether foreign facilities must 
provide activity type information about all foods associated with the 
facility, or only about foods exported for consumption in the United 
States.
    (Response 66) Facilities are only required to provide activity type 
information about food that the facility manufactures/processes, packs, 
or holds for consumption in the United States. FDA is requiring 
information about activity types to help FDA better assess the 
facility's potential impact in cases of bioterrorist incidents or other 
food-related emergencies, and to help the Agency identify facilities 
with which to communicate on various issues, among the other reasons 
discussed in the previous paragraphs. We anticipate that we will only 
need to assess facilities and communicate with facilities with respect 
to foods that are consumed in the United States.
    (Comment 67) A comment suggests that FDA provide definitions for 
the following activity types: Ambient human food storage warehouse/
holding facility; refrigerated human food warehouse/holding facility; 
and frozen human food warehouse/holding facility.
    (Response 67) In the proposed rule, we provided tentative 
definitions for the activity types required in Sec.  1.232 (80 FR 19160 
at 19173 to 19174) and we requested comment on whether to define the 
specified activity types. We conclude that it is not necessary to 
provide definitions in the regulatory text, considering that we 
provided tentative definitions in the proposed rule and that we 
understand the activity type terms to be generally well-understood by 
industry. If additional clarification is needed, we will consider 
providing guidance on the activity type definitions, as appropriate. We 
believe that any such clarification will be better provided in a 
guidance document that follows our GGP regulations in 21 CFR

[[Page 45939]]

10.115 because we will be better able to provide clarification quickly 
as the need may arise.
    (Comment 68) One comment recommends that FDA divide the ``ambient 
human food warehouse/holding facility,'' ``refrigerated human food 
warehouse/holding facility'', and ``frozen human food warehouse/holding 
facility'' activity types into two sub-categories: ``Ambient human food 
warehouse/holding facility'', and ``refrigerated/frozen human food 
warehouse/holding facility.'' The comment states that three sub-
categories are not useful and may lead to confusion.
    (Response 68) We disagree with this comment. Information 
distinguishing whether a facility is engaged in refrigerated or frozen 
warehousing/holding is important to the Agency when responding to food-
related emergencies. Generally speaking, the closer a refrigerated or 
frozen food gets to ambient temperature, the more potential there is 
for spoilage and foodborne illness to occur. Refrigerated foods have a 
more narrow window before they reach a temperature where spoilage 
occurs. Facilities that warehouse such foods would therefore be of most 
concern to FDA in an emergency involving power outages. For example, 
during a response to a natural disaster in which power outages occur, 
the Agency might choose to first focus on refrigerated warehouses to 
ensure proper handling of foods that are at risk of spoilage and 
foodborne illness.
    (Comment 69) A comment requests that FDA provide clarification 
regarding the ``farm mixed-type facility'' activity type. Specifically, 
the comment asks FDA to confirm whether it is acceptable for a farm 
that packs fresh produce from other farms to register as a ``farm 
mixed-type facility.'' The comment also asks FDA to confirm that a farm 
that packs its own produce should not register.
    (Response 69) In Sec.  1.227 of our regulations, we define a mixed-
type facility as an establishment that engages in both activities that 
are exempt from registration under section 415 of the FD&C Act and 
activities that require the establishment to be registered. An example 
of such a facility is a ``farm mixed-type facility,'' which is an 
establishment that is a farm, but also conducts activities outside the 
``farm'' definition that require the establishment to be registered. 
FDA added the definition in Sec.  1.227 for mixed-type facilities in 
the final rule for ``Current Good Manufacturing Practice, Hazard 
Analysis and Risk-Based Preventive Controls for Human Food.'' Also in 
that rulemaking, we revised the ``farm'' definition in Sec.  1.227 so 
that it no longer limits establishments that fall within the ``farm'' 
definition to those that pack or hold food grown, raised, or consumed 
on that farm or another farm under the same ownership. Under the 
revised ``farm'' definition in Sec.  1.227, an establishment devoted to 
the growing of crops, the raising of animals, or both, would remain 
within the ``farm'' definition if it packs and holds RACs grown on that 
farm or another farm under the same ownership, and also if it packs and 
holds RACs grown on another farm. Any such establishment that meets the 
``farm'' definition is not subject to the requirement to register under 
section 415 and therefore is not required to provide FDA with activity 
type information in accordance with this final rule. However, if the 
farm engages in other activities that require the establishment to be 
registered, it is required to provide FDA with activity type 
information in accordance with Sec.  1.232(a)(8) and select farm mixed-
type facility.
    (Comment 70) One comment asks FDA to clarify what it means by farm 
mixed-type facility as a facility type and to develop a plan for on-
farm inspections and to train investigators on conducting such 
inspections. Furthermore, the comment requests that FDA develop 
outreach and education plans to help farms understand the registration 
process, in particular farms that have to register because they are 
mixed-type facilities.
    (Response 70) In Sec.  1.227 of our regulations, we explain that a 
mixed-type facility means an establishment that engages in both 
activities that are exempt from registration under section 415 of the 
FD&C Act and activities that require the establishment to be 
registered. An example of such a facility is a ``farm mixed-type 
facility,'' which is an establishment that is a farm, but also conducts 
activities outside the farm definition that require the establishment 
to be registered. We will consider appropriate ways to train and 
prepare investigators for inspections of mixed-type facilities. As to 
the request that FDA provide education and outreach to help farms 
understand the registration process, we agree with comments that stress 
the importance of education and outreach. Within the Agency, we are 
establishing a Food Safety Technical Assistance Network and we plan to 
provide updated guidance concerning the registration requirements.
    (Comment 71) Comments encourage FDA to allow the activity type for 
facilities that warehouse/hold food to indicate that their storage 
facilities are solely engaged in the storage of packaged food not 
exposed to the environment. The comment states that this information 
will assist FDA in setting inspection priorities and conducting 
inspections at storage facilities. The comment states that such 
facilities pose a very limited, if any, food-safety risk. The comment 
also mentions that a citizen petition submitted for FDA review requests 
an exemption from certain FSMA requirements for storage facilities that 
are solely engaged in the storage of packaged food not exposed to the 
environment.
    (Response 71) FDA declines this suggestion. We agree that different 
food safety requirements should apply to facilities solely engaged in 
the storage of unexposed packaged food, and in the final rule for 
preventive controls for human food we have exempted such facilities 
from 21 CFR part 117, subparts C (hazard analysis and risk-based 
preventive controls) and G (supply-chain program), and provided for 
modified requirements if the food requires time/temperature control for 
safety. However, for purposes of food facility registration, we do not 
agree that it is necessary for facilities to separately identify 
whether they are solely engaged in the storage of packaged food not 
exposed to the environment. In the final rule, we are dividing the 
(previously optional) activity type of ``warehouse/holding facility'' 
for facilities that hold food for human consumption into three sub-
categories. Those three sub-categories are ``ambient human food 
temperature warehouse/holding facility,'' ``refrigerated human food 
warehouse/holding facility,'' and ``frozen human food warehouse/holding 
facility.'' We anticipate that the information that we will gather from 
these sub-categories will be sufficient to allow us to more efficiently 
respond to food-related emergencies. 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. We do not 
anticipate that information about whether a facility is solely engaged 
in the storage of unexposed packaged food will be of much additional 
utility in responding to an emergency food incident.
    Regarding the citizen petition submitted to FDA (Docket No. FDA 
2011-P-0561-CP), the Agency will respond to the citizen petition in 
accordance with 21 CFR part 10.
    (Comment 72) A comment encourages FDA to leave sections 8 and 9 on 
form FDA 3537. The comment states that

[[Page 45940]]

these sections contain important information about food facilities.
    (Response 72) We do not plan to remove sections 8 (``Seasonal 
facility date'') from Form FDA 3537. In that section, we provide an 
optional field for facilities to give the approximate dates that they 
are open for business, if their operations are on a seasonal basis. We 
plan to retain seasonal facility dates as an optional field. Section 
1.233 of the final rule provides that FDA encourages, but does not 
require, registrants to submit items that are indicated as optional on 
Form FDA 3537.
    Regarding section 9 (``Types of storage'') on Form FDA 3537, we are 
removing this section from the form. In that section, which is for 
facilities that are primarily holders, we make it optional for 
facilities to identify whether the facility's type of storage is 
ambient storage, refrigerated storage, or frozen storage. Because 
facilities are now required to provide this information as part of the 
activity type requirement in Sec.  1.232(a)(8) of the final rule, it 
would be duplicative to provide facilities with the option of 
completing this information in a separate section of the registration 
form.
    (Comment 73) Comments recommend that LACF and acidified food 
processing be treated as an activity type, not a food product category. 
Comments state that there are many foods that are LACF or acidified 
foods that also fall within other food product categories (such as baby 
food, cheese, and salad dressings). Comments state that FDA 
investigators would be able to better prepare for inspections if 
facilities select the activity type ``low-acid and acidified food 
processing'' in conjunction with the applicable food product category 
(e.g., cheese) for the food produced at the facility.
    (Response 73) We agree with these comments. The final rule includes 
acidified food and low-acid food processing in the list of activity 
type options. In addition, we will update the Food Product Categories 
Guidance to remove acidified foods and LACF as food product categories. 
We also plan to update the Food Product Categories Guidance to list 
molluscan shellfish as a food product category. Previously, Form FDA 
3537 included ``molluscan shellfish establishment'' as an optional 
activity type. However, the list of activity types in this final rule 
does not include molluscan shellfish establishments. We are revising 
Form FDA 3537 to reflect these changes.

E. Requirement To Provide Assurance That FDA Will Be Permitted To 
Inspect

    (Comment 74) One comment disagrees with the requirement that 
facilities provide assurance that FDA will be permitted to inspect the 
facility at the times and in the manner permitted by the FD&C Act. The 
comment states that this requirement violates a country's sovereignty 
and that facilities are subject to the national laws of the country in 
which they are located, and should therefore not be required to agree 
to inspection by FDA without the permission of their country's 
government.
    (Response 74) Section 415(a)(2) of the FD&C Act, as amended by 
section 102(b) of FSMA, requires that food facility registrations 
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. We do not 
agree that requiring this assurance violates the sovereignty of 
countries in which foreign facilities are located. The assurance is 
required for food facilities in order to complete their food facility 
registration. The assurance does not require foreign facilities to 
disregard the laws of the countries in which they are located, nor does 
it require the foreign countries to relinquish any sovereignty. When 
FDA selects foreign food facilities for inspection that have registered 
with FDA because they manufacture/process, pack, or hold food for 
consumption in the United States, FDA involves the foreign governments 
by generally sending an advance notification to the Competent Authority 
responsible for food safety in the country where FDA will be conducting 
an inspection. Under the FSMA amendments to the FD&C Act, FDA has the 
authority to take action if the Agency encounters inspection refusals. 
Specifically, FDA may refuse admission of food into the United States 
when that food is from a foreign factory, warehouse, or other 
establishment of which the owner, operator, or agent in charge, or the 
government of the foreign country, that refuses to allow inspection 
(see section 807(b) of the FD&C Act).

VIII. Comments on Proposed Sec.  1.233--Are There Optional Items 
Included in the Registration Form?

    We proposed to amend Sec.  1.233 to provide that FDA encourages, 
but does not require, registrants to submit items that are indicated as 
optional on the Form FDA 3537. We proposed for this amendment to remove 
the optional items currently listed Sec.  1.233. We are finalizing this 
amendment as proposed, for two reasons. First, the final rule converts 
several of the optional items in current Sec.  1.233 into required 
items in revised 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.

IX. Comments on Proposed Amendments to Sec.  1.234--How and When Do You 
Update Your Facility's Registration Information?

    We proposed to amend Sec.  1.234(a) to shorten the time period for 
a food facility to update its registration from 60 to 30 calendar days. 
We also proposed to amend Sec.  1.234(b) to provide that when the 
reason for the update is a change in owner, the former owner must 
cancel the registration in 30 calendar days instead of the 60 calendar 
days allotted in current Sec.  1.234(b). As discussed in the paragraphs 
that follow, we are not finalizing these proposals.
    In addition, we proposed to amend Sec.  1.234(a) to require that 
for updates not submitted by the owner, operator, or agent in charge of 
the facility, the update must provide the email address of the owner, 
operator, or agent in charge who authorized submission of the update. 
We are finalizing this requirement in the final rule, with 
modifications. Final Sec.  1.234(a) provides that for updates not 
submitted by the owner, operator, or agent in charge, the update must 
include the email address of the individual who authorized the update, 
unless FDA has granted a waiver under Sec.  1.245. We are allowing for 
a waiver for the same reasons as those discussed in Response 44.
    Further, we proposed to amend Sec.  1.234(d) to provide that 
beginning January 4, 2016, electronic updates will be mandatory unless 
a waiver under Sec.  1.245 has been granted. For the reasons discussed 
in section VI.A of this document, final Sec.  1.234(d) delays the 
requirement for electronic submission of cancellations. Specifically, 
final Sec.  1.234(d) provides that updates must be submitted 
electronically beginning January 4, 2020. Final Sec.  1.234(d) also 
provides that if FDA has granted a waiver under Sec.  1.245, 
cancellations may be made by mail or fax.
    (Comment 75) Comments oppose shortening the time period for 
registration updates. Comments state that FDA did not provide any 
examples of when a shortened time period for updates would have better 
enabled FDA to schedule inspections or more effectively respond to food 
safety issues. Comments state that a shortened time period would 
increase the regulatory burden on food facilities. One comment

[[Page 45941]]

encourages FDA to consider the difference in public holidays as well as 
time and language differences between the United States and foreign 
countries. The comment states that facilities in foreign countries may 
need a longer amount of time to update the information and suggests 
keeping 60 calendar days for submitting updates. Some comments state 
that, given the potential for criminal penalties for committing 
prohibited acts under the FD&C Act, the shortened time period does not 
provide a reasonable amount of time for compliance, particularly for 
businesses that are in the midst of reorganizations.
    (Response 75) In response to these comments, we are not shortening 
the time period for the submission of updates in Sec.  1.234(a). 
Consequently, we will continue to allow owners, operators, or agents in 
charge of a facility 60 calendar days to submit updates to any changes 
of the required registration elements previously submitted. We believe 
that this strikes an appropriate balance between the concerns expressed 
in the comments and FDA's need to maintain an accurate and up-to-date 
registration database. In addition, we are not shortening the time 
period in Sec.  1.234(b). Consequently, when the reason for the update 
is a change in owner, the former owner will continue to have 60 
calendar days to cancel the registration, as is currently provided in 
current Sec.  1.234(b).

X. Comments on Proposed Amendments To Sec.  1.235--How and When Do You 
Cancel Your Facility's Registration Information?

    We proposed to amend Sec.  1.235 to shorten the time period for 
cancelling registrations from 60 calendar days to 30 calendar days. 
Specifically, proposed Sec.  1.235(a) would 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). 
As discussed in the following paragraphs, we are not finalizing this 
proposal.
    In addition, we proposed to amend Sec.  1.235 to require in Sec.  
1.235(d) that beginning January 4, 2016, owners, operators, or agents 
in charge must cancel their registrations electronically, unless a 
waiver under Sec.  1.245 has been granted. For the reasons discussed in 
section VI.A of this document, final Sec.  1.235(d) delays the 
requirement for electronic submission of cancellations. Specifically, 
final Sec.  1.235(d) provides that cancellations must be submitted 
electronically beginning January 4, 2020. Final Sec.  1.235(d) also 
provides that if FDA has granted a waiver under Sec.  1.245, 
cancellations may be made by mail or fax. Also in the proposed rule, we 
proposed to amend Sec.  1.235(b)(5) to require that for cancellations 
not submitted by the owner, operator, or agent in charge of the 
facility, the cancellation must include the email address of the owner, 
operator, or agent in charge who authorized the cancellation. We are 
finalizing this requirement in the final rule, with modifications. 
Final Sec.  1.235(b)(5) provides that cancellations not submitted by 
the owner, operator, or agent in charge must include the email address 
for the individual who authorized the cancellation, unless FDA has 
granted a waiver under Sec.  1.245 of the final rule. We are allowing 
for waivers for the same reasons discussed in Response 44.
    In addition, we are deleting proposed Sec.  1.235(d)(7) of the 
final rule, because it is not applicable for cancellations. 
Furthermore, we have redesignated proposed Sec.  1.235(d)(8) to Sec.  
1.235(d)(7) in the final rule and are making edits to clarify the 
process FDA will use to confirm cancellations submitted through mail or 
fax. We state in Sec.  1.235(d)(7) of the final rule that the 
registration will be considered cancelled once FDA enters the 
facility's cancellation data into the registration system. FDA will 
send the registrant a cancellation confirmation.
    (Comment 76) Comments disagree with FDA's proposal to shorten the 
time period for cancellations from 60 calendar days to 30 calendar 
days. Comments state that reducing the time period for cancellations 
would be burdensome without providing any commensurate benefit to 
public health. Additionally, some comments suggest that the time period 
should be increased, not decreased, to 90 days.
    (Response 76) In response to these comments, we are not shortening 
the time period for the submission of cancellations in Sec.  1.235(a) 
of the final rule. Consequently, owners, operators, and agents in 
charge will continue to be required to cancel registrations within 60 
calendar days of the reason for cancellation. Just as with our decision 
to not shorten the time period for the submission of updates in Sec.  
1.234(a) of the final rule, we believe that this strikes an appropriate 
balance between the concerns expressed in the comments and FDA's need 
to maintain an accurate and up-to-date registration database. We do not 
believe that lengthening the time period for submitting cancellations 
would strike an appropriate balance. Current Sec.  1.235 provides 60 
calendar days to cancel, and we are not aware of any specific instances 
in which facilities have found this time period to cause difficulties.

XI. Comments on Proposed Amendments to Sec.  1.241--What Are the 
Consequences of Failing To Register, Update, Renew, or Cancel Your 
Registration?

    Proposed Sec.  1.241(c) proposed to amend the registration 
regulation to provide that FDA may cancel registrations in certain 
additional circumstances in addition to those currently specified in 
current Sec.  1.241. Specifically, we proposed to amend Sec.  1.241(c) 
to provide that FDA will cancel a registration if FDA independently 
verifies that the facility is not required to register, if information 
about the facility's address was not updated in a timely manner in 
accordance with Sec.  1.234(a), or if the registration was submitted to 
FDA by a person not authorized to submit the registration under Sec.  
1.225. In addition, proposed Sec.  1.241(c) proposed to further amend 
the registration regulation by also providing that FDA will cancel a 
registration if the facility's registration has expired because the 
facility has failed to renew the registration in accordance with Sec.  
1.230(b). Similarly, we proposed to add Sec.  1.241(b) to the 
registration regulation 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.
    FDA proposed to cancel registrations in these additional 
circumstances based on our experiences with invalid registrations 
during the approximately 10 years we have spent administering food 
facility registration, as well as to improve the accuracy and utility 
of the food facility registration database such that FDA would be able 
to maintain a more up-to-date list of registered facilities in 
accordance with section 415(a)(5) of the FD&C Act. A more accurate and 
up-to-date list will enable investigators to more efficiently locate 
food facilities for inspection and will better enable FDA to act 
quickly in responding to a threatened or actual terrorist attack on the 
U.S. food supply or other food-related emergency. In addition, our 
proposal to cancel registrations when a facility has failed to renew 
its registration in accordance with Sec.  1.230(b) was designed to 
respond

[[Page 45942]]

to the FSMA amendments. FSMA amended section 415 of the FD&C Act to 
require food facilities that are required to register with FDA to renew 
their registrations with FDA every other year. Cancelling the 
registrations of facilities that have failed to do so will allow FDA to 
efficiently enforce the renewal requirement. It will also allow FDA to 
efficiently implement its obligation under section 415(a)(5) of the 
FD&C Act to maintain an up-to-date list of facilities. The proposal is 
also consistent with the requirement in section 415(a)(2) of the FD&C 
Act that facilities notify FDA in a ``timely manner'' as to changes in 
their registration information, including their address information. We 
are finalizing the amendments to Sec.  1.241 as proposed, with one 
modification. We are revising Sec.  1.241(c) of the final rule to state 
that if we cancel a facility's registration, we will send a 
confirmation of the cancellation using contact information submitted by 
the facility in the registration database. We are making these edits to 
clarify the process FDA will use to confirm cancellations in these 
additional circumstances.
    (Comment 77) Comments request that the final rule include 
safeguards for when inadvertent technical mistake are the basis for 
cancellation, such as a period of time during which facilities may make 
corrections or a response process initiated by FDA. Comments also state 
the final regulations should specifically state that FDA will send 
notice to facilities facing potential cancellations indicating the 
Agency's intent to cancel the registration and the basis for the 
cancellation. Comments state that wrongful cancellations could cause 
significant hardship. Some comments also state that facilities should 
have 60 days to take corrective action before FDA cancels a 
registration. Some comments state that registrants should have due 
process prior to FDA cancelling a registration.
    (Response 77) Our amendments to Sec.  1.241(c) will maintain the 
requirement in current Sec.  1.241(b) that FDA will cancel 
registrations if the Agency ``independently verifies'' that the 
specified circumstances are satisfied. In the proposed rule, we stated 
that we anticipate that in many cases it would be appropriate for FDA 
to send notices to facilities facing potential cancellation indicating 
our intent to cancel their registrations and the basis for such 
cancellations. We also stated that we anticipated that, when 
appropriate, if the circumstances meriting possible cancellation are 
corrected within 30 days after notice is provided, we would not cancel 
the registration. We further stated that we anticipate that if 
facilities do not respond within 30 days, or if corrective action is 
otherwise not taken within that time period, we would determine that we 
conducted an independent verification and would then cancel the 
registration. If a facility believes its registration was cancelled in 
error, the facility would be able to contact FDA. We also stated in the 
proposed rule that we anticipated that it would not be appropriate to 
provide the 30-day window for corrective action if the basis for 
cancellation is an expired registration due to failure to renew a 
registration in accordance with Sec.  1.230(b). In those circumstances, 
a facility would have already received notice of its obligation to 
renew (80 FR 19160 at 19177). FDA understands the serious nature of 
cancelling a registration, and we plan to provide appropriate notice to 
facilities facing cancellation consistent with our statements in the 
proposed rule. However, we decline the request to amend the regulatory 
text to specify the specific notice we will provide. The facts in each 
scenario involving a potential cancellation are likely to be unique, 
and we do not think it would be appropriate to follow a single 
procedure for each cancellation. In addition, we decline to commit to 
providing registrants 60 days after notice is provided before 
cancelling registrations. We believe that 30 days will generally 
provide registrants with sufficient time to respond to any questions or 
concerns raised by FDA and take corrective action if appropriate. If 
FDA cancels a facility's registration, FDA will mail a confirmation of 
the cancellation to the facility at the address provided in the 
facility's registration. We believe that this approach will provide 
adequate due process to facilities.
    (Comment 78) Other comments urge FDA to provide a 30-day notice 
before a registration is considered expired, to ensure due process, and 
to allow facilities to respond. The comments state that facilities 
should have the opportunity to allow potential gaps in communication or 
misunderstandings to be resolved.
    (Response 78) We do not agree that it is necessary to provide a 30-
day notice before a registration is considered expired. Leading up to 
and throughout the registration renewal period, we plan to notify 
registrants of their obligation to renew their registrations and the 
deadline for doing so. We also plan to notify registrants that failure 
to renew their registrations in accordance with Sec.  1.230(b) will 
cause FDA to consider the registrations expired. Additionally, we plan 
to notify registrants that we will consider a food facility with an 
expired registration to have failed to register in accordance with 
section 415 of the FD&C Act. Because facilities will already receive 
notice of their obligation to renew throughout this process, we do not 
agree that it is necessary to provide an additional 30-day notice 
before cancelling registrations that expired because the facility has 
failed to renew its registration in accordance with Sec.  1.230(b).
    (Comment 79) Comments recommend that FDA provide similar procedures 
when cancelling a registration to those that the Agency provides when 
suspending a facility's registration, such as providing an opportunity 
for a hearing and an opportunity to reinstate the registration.
    (Response 79) We disagree. As specified in section 415(b)(2) 
regarding registration suspensions, FDA will provide a registrant 
subject to a suspension order with an opportunity for an informal 
hearing on the actions required for reinstatement of registration and 
why the registration that is subject to suspension should be 
reinstated. Suspensions involve a factual determination by FDA that 
there is a reasonable probability of serious adverse health 
consequences or death. See section 415(b)(1) of the FD&C Act (providing 
that the Secretary may suspend a facility's registration if the 
Secretary 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). We do not believe that the same procedures used for 
registration suspensions are necessary for registration cancellations 
because registration cancellations are unlikely to present the kind of 
factual issues involved in registration suspensions.
    Registration cancellations under Sec.  1.241 do not involve 
determinations made by FDA regarding the probability of food safety 
hazards. They are instead based on a facility's failure to itself 
comply with certain requirements for food facility registration. Those 
requirements are administrative in nature. Further, we believe that the 
procedures in Sec.  1.241 are adequate to ensure fairness. FDA will 
cancel registrations if it independently verifies that the facility is 
no longer in business or has changed owners, and the owner, operator, 
or agent in charge of the facility fails to cancel the registration, or 
if FDA determines that the registration is for a facility that does not 
exist, is not required to register, or where the

[[Page 45943]]

information about the facility's address was not updated in a timely 
manner in accordance with Sec.  1.234(a) of the final rule or the 
registration was submitted by a person not authorized to submit the 
registration under Sec.  1.225. FDA will not cancel registrations in 
these circumstances if it does not independently verify the relevant 
facts. In addition, for registrations that FDA cancels as a result of 
the facility's failure to renew the registration, the facility will 
have received multiple notices from FDA reminding it of the 
registration renewal requirement. If we nevertheless cancel a 
registration in error, facilities should contact FDA so that we can 
look into the matter.
    (Comment 80) Comments recommend that FDA annually review imports to 
determine whether registered foreign facilities have imported food into 
the United States during the preceding year and cancelling 
registrations for facilities that have not done so.
    (Response 80) We decline to conduct such a review of registrations. 
The comment does not explain why such a use of FDA resources would be 
warranted, especially in light of the effect that the biennial 
registration renewal requirement has helped to routinely remove 
inactive registrations.
    (Comment 81) One comment states that criminal and civil liability 
for lack of compliance with the registration requirements would be a 
disproportionate response from FDA. The comment states that the 
possibility of such liability may ``result in a lack of willingness by 
U.S.-based agents to take responsibility'' for foreign entities.
    (Response 81) Under section 415 of the FD&C Act, owners, operators, 
and agents in charge of facilities are required to register with FDA. 
In addition, under section 301(dd) of the FD&C Act, the failure to 
register in accordance with section 415 is a prohibited act. Further, 
the causing of a prohibited act and being responsible for the 
commission of a prohibited act are subject to civil and criminal 
sanction under the FD&C Act (see sections 301, 302 (21 U.S.C. 332), and 
303 (21 U.S.C. 333) of the FD&C Act). We believe that it is consistent 
with the FD&C Act for the registration regulation to specify in Sec.  
1.241 that the United States can bring a civil action in Federal court 
to enjoin a person who commits a prohibited act and a criminal action 
in Federal court to prosecute a person who is responsible for the 
commission of a prohibited act. Indeed, the registration regulation has 
specified this since 2003. To the extent that the comment is concerned 
about liability for a foreign facility's violations of requirements 
under section 415 of the FD&C Act, FDA's practice is to take 
enforcement action based on the facts of the case and the seriousness 
of the violations.
    (Comment 82) Comments state that some establishments, such as 
farms, have registered with FDA even though they are not required to. 
The comments state that FDA should not cancel the registrations for 
such establishments. In addition, some comments urge FDA to allow 
entities to register that are not required to register, stating that 
FDA may find it useful to have information about such entities.
    (Response 82) We disagree. Not all food-related establishments are 
required to register under section 415 of the FD&C Act. Only food 
facilities not exempt under Sec.  1.266 are required to register, and 
farms are not food facilities. See section 415(c)(1) (providing that 
the term ``facility'' does not include farms); 21 CFR 1.226 
(establishing that the registration requirements in 21 CFR part 1, 
subpart H, do not apply to farms); 21 CFR 1.227 (establishing separate 
definitions for ``facility'' and ``farm''). FDA uses registration 
information to identity facilities for inspection and for 
communications on both routine and emergency matters. A registration 
database that includes establishments registered as food facilities but 
that are not, in fact, food facilities hinders these efforts, 
compromising FDA's ability to strategically target inspections and 
communications. We therefore believe it is appropriate for FDA to 
cancel the registrations for such establishments. In addition, we do 
not believe that the comment has identified reasons why it would be 
useful to have entities participate in food facility registration under 
section 415 of the FD&C Act that are not required to register under 
section 415.
    (Comment 83) A comment recommends that FDA conduct broad education 
and outreach regarding registration requirements, before seeking civil 
or criminal penalties on entities that are newly subject to 
registration requirements, and that therefore may be unfamiliar with 
the requirements.
    (Response 83) We recognize that there will be questions about 
registration requirements. We agree that education and outreach are 
important, and we plan to develop additional education and outreach 
strategies as appropriate. In addition, we are establishing a Food 
Safety Technical Assistance Network to allow us to respond in a timely 
and consistent way to industry questions.
    (Comment 84) Some comments urge FDA not to dispose of registration 
information from cancelled registrations, stating that keeping this 
additional information on file could prove useful to FDA.
    (Response 84) FDA will archive information from inactive food 
facility registrations as appropriate.

XII. Comments on Proposed Addition of Sec.  1.245--Waiver Request

    In the proposed rule, we proposed for Sec.  1.245 to provide that 
to request a waiver from the requirement to submit registrations and 
registration renewals electronically, a registrant must submit a 
written request to FDA that explains why it is not reasonable for the 
registrant to submit a registration or registration renewal 
electronically to FDA. In the proposed rule, FDA tentatively concluded 
that reasons for why it may not be reasonable for a registrant to 
submit a registration or registration renewal to FDA electronically may 
include conflicting religious beliefs or where a registrant does not 
have reasonable access to the Internet (80 FR 19160 at 19177 to 19178).
    In the final rule, we are finalizing the option of a waiver. 
However, we are revising Sec.  1.245 of the final rule to clarify that 
FDA must have already granted the waiver in order for the electronic 
submission requirement to not apply. We believe that this requirement 
was implicit in proposed Sec.  1.245, but we have revised the 
regulatory text to avoid any possible confusion. We are also revising 
Sec.  1.245 of the final rule to provide that a waiver is available not 
only from the requirement to submit registrations and registration 
renewals (which also includes abbreviated renewals) electronically, but 
also from the requirement to submit updates and cancellations 
electronically. In addition, we are also expanding the waiver option so 
that waivers are also available from the requirement in Sec.  
1.232(a)(6) to provide the email address of the owner, operator, or 
agent in charge of the facility, and also from the requirement in 
Sec. Sec.  1.230(b) and (c), 1.232(a)(10), 1.234(a), and 1.235(b)(5) to 
provide the email address for the individual who authorized submission 
of a registration renewal, registration, update, or cancellation, 
respectively, when such submissions are not made by the owner, 
operator, or agent in charge of the facility. Finally, we are revising 
proposed Sec.  1.245 to no longer refer to January 4, 2016, as the date 
on which electronic registration submissions will begin to be required. 
Instead of January 4, 2016, we now refer to January 4, 2020. 
Accordingly, final Sec.  1.245 provides that under Sec. Sec.  
1.231(a)(2) and

[[Page 45944]]

(b), 1.234(d), and 1.235(d), beginning January 4, 2020, the owner, 
operator, or agent in charge must submit registrations, registration 
renewals, updates, and cancellations to FDA electronically unless FDA 
has granted a waiver from such requirement. Section 1.245 of the final 
rule also provides that under Sec.  1.232(a)(6), the registration must 
include the email address of the owner, operator, or agent in charge of 
the facility, unless FDA has granted a waiver from such requirement. In 
addition, Sec.  1.245 provides that under Sec. Sec.  1.230(b) and (c), 
1.232(a)(10), 1.234(a), and 1.235(b)(5), registration renewals, 
registrations, updates, and cancellations not submitted by the owner, 
operator, or agent in charge must include the email address for the 
individual who authorized the submission, unless FDA has granted a 
waiver. Section 1.245 of the final rule further provides that to 
request a waiver from these requirements, the registrant must submit a 
written request to FDA that explains why it is not reasonable to submit 
the registration, registration renewal, update, or cancellation to FDA 
electronically or to provide the email address of the owner, operator, 
or agent in charge of the facility.
    (Comment 85) Comments support the proposed waiver provision, but 
some comments request that we clarify the grounds for granting waivers 
from the electronic registration requirement. Some comments request 
that FDA consider reasons for why a registrant would request a waiver 
from electronic submission of food facility registration in addition to 
those discussed in the proposed rule. Comments state that conflicting 
religious beliefs are not necessarily the only beliefs that lead an 
individual or entity to decide not to use technology. Comments state 
that there may be other reasons, such as philosophical or political 
reasons. Other comments state that the regulatory text should 
specifically recognize religious objections and lack of reasonable 
access to the Internet as reasons to grant a waiver from the electronic 
registration requirement.
    (Response 85) We do not believe it is necessary to provide examples 
in the regulatory text for when FDA would grant a waiver because we 
believe that each waiver request should provide an explanation as to 
why it is not reasonable for the particular facility to submit a 
registration or registration renewal electronically to FDA, and we 
intend to consider each waiver request on a case-by-case basis. FDA 
stated in the proposed rule that reasons for why it may not be 
reasonable for a registrant to submit a registration or registration 
renewal to FDA electronically may include conflicting religious beliefs 
or where a registrant does not have reasonable access to the Internet. 
However, we do not intend to limit waivers only to those facilities 
that identify a religious reason for seeking a waiver or that point to 
lack of access to the Internet.
    We will consider whether it would be helpful to provide additional 
guidance on the process for requesting waivers under Sec.  1.245 of the 
final rule.
    (Comment 86) Comments request that registrants not be required to 
submit additional waiver requests after a request has already been 
granted.
    (Response 86) We agree that if a waiver has been requested and 
granted, the facility should not be required to submit future waiver 
requests each time the facility submits a renewal or updates the 
facility's registration information. Accordingly, once FDA grants a 
waiver, we will consider the waiver to be in effect for as long as the 
reasons for the waiver remain unchanged and the registration has not 
been cancelled.

XIII. U.S. Agent Voluntary Identification System

    We requested comment on whether to issue a future guidance document 
to provide for the establishment of a U.S. Agent Voluntary 
Identification System (VIS or the system), or to otherwise create such 
a system. As envisioned, the system would be designed to ensure the 
accuracy of U.S. agent information and enable U.S. agents to 
independently identify the facility or facilities for which the agent 
has agreed to serve. Specifically, the system would allow a U.S. agent 
to directly provide FDA with the agent's contact information (that is, 
the same contact information required for foreign food facility 
registration) and the name of the facility or facilities for which the 
agent has agreed to serve. Currently, FDA only receives U.S. agent 
contact information through foreign food facility registrations, many 
of which are submitted and updated by the facility, rather than the 
U.S. agent for the facility. The new system would allow agents to 
provide information about themselves, including their name, mailing 
address, phone number, email address, and emergency contact phone 
number, as well as the name of the facility or facilities for which the 
agent agrees to serve. After a U.S. agent has provided such information 
to FDA through the system, the Agency would provide the U.S. agent with 
an identification number. The U.S. agent could then provide the 
identification number to foreign facilities that the U.S. agent agrees 
to represent as a U.S. agent.
    We sought comments on the creation of this voluntary system and 
whether it is likely to increase the accuracy of U.S. agent contact 
information and reduce the number of unauthorized and/or fraudulent 
U.S. agent listings.
    (Comment 87) Numerous comments state the creation of a VIS would be 
beneficial.
    (Response 87) We agree, and we plan to implement a voluntary U.S. 
agent identification system as described in the proposed rule. As we 
stated in the proposed rule, we will follow our GGP regulations in 21 
CFR 10.115 when we implement this system (80 FR 19160 at 19179).
    (Comment 88) Comments request that the system provide a mechanism 
for electronic resignation by the U.S. agent, as well as notice of 
changes to the foreign facility's registration, including when the 
registration is cancelled.
    (Response 88) Under Sec.  1.234(a) of the final rule, the owner, 
operator, or agent in charge of a facility may authorize an individual 
to update a facility's registration. The authorized individual may be, 
but is not required to be, the U.S. agent for the facility. If the 
authorized individual is the U.S. agent for the facility, the U.S. 
agent may update the information in the registration about who serves 
in that role. In addition, FDA plans to allow U.S. agents to 
electronically notify FDA that they no longer serve as the U.S. agent 
for a foreign facility. We also anticipate that the system will notify 
the U.S. agent if the registration for the foreign facility is 
cancelled. We plan to provide further information and details about the 
system in a future guidance document.

XIV. Editorial Changes and Other Changes

A. Editorial Changes

    Proposed Sec.  1.231 would provide that beginning January 4, 2016, 
electronic registration will be mandatory, including registration 
renewals, unless a waiver has been granted for the registrant. Proposed 
Sec.  1.231 would also provide that beginning on 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. 
Proposed Sec.  1.234 would require updates to be submitted 
electronically after January 4, 2016, unless a waiver has been granted 
in Sec.  1.245. Proposed Sec.  1.235 would require cancellations to be 
submitted electronically after January 4, 2016, unless a waiver has 
been granted in Sec.  1.245. Proposed Sec.  1.245 also mentions January 
4, 2016. Because the final rule

[[Page 45945]]

is being published after January 4, 2016, we are finalizing Sec. Sec.  
1.231, 1.234, 1.235, and 1.245 without a reference to ``January 4, 
2016.'' Furthermore, we note that for reasons stated elsewhere in this 
Federal Register document, we are replacing ``January 4, 2016'' with 
``January 4, 2020'' in Sec. Sec.  1.231, 1.234, 1.235, and 1.245 of the 
final rule.
    We are making other changes in Sec. Sec.  1.231, 1.232, 1.234, and 
1.235 of the final rule to improve clarity. The changes are as follows:
     Using ``submit'' or ``submission'' instead of ``complete'' 
or ``completion'' in Sec. Sec.  1.231, 1.234, and 1.235 of the final 
rule;
     Using ``sends'' instead of ``transmits'' in Sec. Sec.  
1.231 and 1.234 of the final rule;
     Adding ``you'' in Sec. Sec.  1.231, 1.232, and 1.234 of 
the final rule to clarify that we are referring to the registrant;
     Deleting language that mentions the registrant not having 
``reasonable access to the Internet'' in Sec. Sec.  1.231, 1.234, and 
1.235 of the final rule;
     Deleting ``electronic'' and ``automatically'' in 
Sec. Sec.  1.231 and 1.235, respectively, in the final rule.
    Furthermore, we stated in proposed Sec. Sec.  1.231, 1.234, 1.235, 
and 1.245 that the zip code for our College Park, Maryland address is 
``20993.'' In Sec. Sec.  1.231, 1.234, 1.235, and 1.245 of the final 
rule, we are correcting the zip code to ``20740.'' In addition, the 
street has been renamed from ``Paint Branch Parkway'' to ``Campus 
Drive'' and the street number has been changed from ``5100'' to 
``5001.'' Therefore, in the final rule, we are changing the street name 
and number to ``5001 Campus Drive.''

B. CD-ROM Submissions

    We proposed to delete the option to submit and update multiple 
registrations by CD-ROM. Specifically, we proposed to remove the option 
to use CD-ROM for multiple registration submissions in Sec.  1.231(c) 
as well as the option to use CD-ROM for updates of multiple submissions 
in Sec.  1.234(e). FDA stated that it proposed to make this change 
because we tentatively concluded that this method of submitting, 
updating, and canceling registrations is outdated and obsolete. We did 
not receive comments on this issue and we are finalizing these changes 
as proposed.
    In addition, in the preamble to the proposed rule, we stated that 
we were proposing to remove the option to use CD-ROM in Sec.  1.235(e) 
(i.e., the option for cancellations of multiple registrations). In our 
proposed regulatory text, however, we inadvertently retained the option 
to submit multiple cancellations using CD-ROM in Sec.  1.235(e). That 
was an error, and this final rule removes Sec.  1.235(e) from Sec.  
1.235.

XV. Economic Analysis of Impacts

    FDA has examined the impacts of this final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The Agency believes that this final rule is not a significant 
regulatory action under Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because the additional costs per entity of this rule 
are small, the Agency also believes that this final rule will not have 
a significant economic impact on a substantial number of small 
entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before issuing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $146 million, using the most current (2015) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.
    The final analyses conducted in accordance with these Executive 
Orders and statutes will be made available in the docket for this 
rulemaking (Ref. 13).

XVI. Paperwork Reduction Act of 1995

    This final rule contains information collection requirements that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
title, description, and respondent description of the information 
collection provisions are shown in the following paragraphs with an 
estimate of the annual reporting burden. Included in the estimate is 
the time for reviewing instructions, searching existing data sources, 
gathering and maintaining the data needed, and completing and reviewing 
each collection of information.
    Title: Registration of Food Facilities (OMB Control Number 0910-
0502)--Revision.
    Description of Respondents: Respondents to this collection of 
information are owners, operators, or agents in charge of domestic or 
foreign facilities that manufacture, process, pack, or hold food for 
human or animal consumption in the United States.
    Description: In the Federal Register of April 9, 2015 (80 FR 
19159), we published a notice of proposed rulemaking including a 
Paperwork Reduction Act (PRA) analysis of the information collection 
provisions found in the proposed regulation. In the analysis we invited 
comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
    FSMA (Pub. L. 111-353), enacted on January 4, 2011, amended section 
415 of the FD&C Act to require, among other things, that registrants 
for food facilities renew registrations biennially (section 415(a)(3) 
of the FD&C Act). FSMA also amended section 415 of the FD&C Act to 
require that food facility registrations include the email address for 
the contact person of a domestic facility and the email address of the 
United States agent for a foreign facility, as well as an assurance 
that FDA will be permitted to inspect the facility (section 415(a)(2) 
of the FD&C Act). These requirements went into effect upon enactment of 
FSMA. In addition, section 415(a)(2) of the FD&C Act, as amended by 
FSMA, also provides that, when determined necessary by FDA ``through 
guidance,'' a food facility is required to submit to FDA information 
about the general food category of a food manufactured, processed, 
packed, or held at such facility, as determined appropriate by FDA, 
including by guidance. FDA issued a guidance document entitled

[[Page 45946]]

``Guidance for Industry: Necessity of the Use of Food Product 
Categories in Food Facility Registrations and Updates to Food Product 
Categories'' in October 2012.
    To comply with the statutory deadline under the provisions of FSMA, 
FDA initially obtained a 6-month OMB approval of these self-
implementing FSMA reporting burdens under the emergency processing 
provisions of the PRA, and subsequently obtained a 3-year approval of 
these requirements under the same assigned OMB control number 0910-
0502. OMB extended the approval for an additional 3 years in 2013. The 
current expiration date of the information collection is August 31, 
2016.
    The final rule will require food facilities to submit certain 
additional registration information to FDA with initial registrations, 
updates, and biennial renewals. The final rule will also require 
mandatory electronic registration submissions beginning in 2020, which 
we estimate would cause some food facilities to submit a request for a 
waiver from that requirement. Finally, the final rule will establish 
certain verification procedures. These requirements are discussed in 
depth in the preamble to the final rule.
    The currently approved reporting burden for food facility 
registration under OMB control number 0910-0502 is 468,117 hours. The 
estimated reporting burden for food facility registration under the 
final rule is 278,382 hours, a decrease of 189,735 hours. This decrease 
is due in large part to a reduction in the number of registered food 
facilities, which we believe is reflective of the fact that the 2012 
biennial registration renewal cycle appear to have had the effect of 
removing many out-of-date registrations from the registration system. 
As discussed in the PRA for the proposed rule, we are making additional 
changes to the currently approved reporting burden as well. Since 
obtaining the FSMA-related emergency OMB approval and subsequent 3-year 
approval, we have refined our estimates for the time required to comply 
with the self-implementing FSMA provisions. As we explain in detail in 
the preliminary economic impact analysis, this is in part because we no 
longer assume that it will take domestic and foreign facilities 
different amounts of time to comply with the provisions of the proposed 
rule. It is also in part because the option to submit abbreviated 
registration renewals did not previously exist and in part because we 
have revised additional assumptions.
    We received many comments regarding requirements of this rule, but 
none of the comments specifically addressed the four topics about which 
we invited comments in the PRA analysis that accompanied the proposed 
rule.
    Although FDA is making some generally minor revisions to the 
proposed rule, we are finalizing most of the key aspects of the 
proposed rule. The following three changes are substantial enough to 
require us to revise the estimates in the PRA for the proposed rule: 
(1) We are clarifying that if a waiver under Sec.  1.245 has been 
granted from the electronic submission requirement, the facility is not 
required to submit future waiver requests each time the facility 
submits a renewal or update; (2) we will continue to allow 60 calendar 
days to submit updates to registrations in Sec.  1.234, instead of 
shortening the time period to 30 calendar days as we proposed; and 
finally (3) we plan to implement a VIS for U.S. agents.
    These revisions are necessary to address changes to the proposed 
regulation included in this final rule, as discussed in the following 
paragraphs. For more information on our original calculations of the 
information collection burden associated with this rulemaking, you may 
refer to the PRA analyses found under Docket No. FDA-2002-N-0323 at 
https://www.regulations.gov.
    FDA revises its estimate of the one-time burden of the FSMA-related 
provisions of this final rule on registered facilities as follows:

                                                    Table 5--Estimated One Time Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
           Activity/21 CFR section               Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
All facility registrations (1.230-1.233)....         172,274               1         172,274  0.18 (11 minutes).........................          31,009
Waiver requests (1.245).....................           2,121               1           2,121  0.17 (10 minutes).........................             361
                                             -----------------------------------------------------------------------------------------------------------
    Total One Time Reporting Burden.........  ..............  ..............  ..............  ..........................................          31,370
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operations and maintenance costs associated with one-time recordkeeping burden.

    To determine the number of facilities in table 5, we assume that 
some of the participants in the 2012 biennial registration renewal 
cycle were new registrants. We do not consider those new registrations 
in estimating the total burden associated with the FSMA requirements. 
FDA used the Small Business Administration's (SBA's) estimate that 12 
percent of all businesses are new. Although SBA's estimate does not 
necessarily mean that 12 percent of all food facilities are new, we 
nevertheless find the SBA's estimate sufficiently relevant to apply to 
food facilities. We therefore estimate that 12 percent of currently 
registered food facilities were not registered at the time of the 2012 
registration renewal cycle. As such, we estimate that 88 percent of 
currently registered food facilities, or 172,274 facilities, were 
already registered in 2012.
    Using our updated estimates for the time required to comply with 
the self-implementing FSMA provisions, we now estimate that the 
requirement for an email address for a domestic facility's contact 
person and a foreign facility's U.S. agent will take 1 minute. We also 
now estimate that the assurance statement required by FSMA will take 5 
minutes to provide, and that the post-FSMA changes to food product 
categories will not result in any additional burden for facilities.
    We also estimate the one-time burden from the new data elements in 
this final rule. We estimate an increase in the average burden per 
response due to the new data elements required by this final rule. FDA 
believes that the new information will be readily available to the 
firms. We estimate that entering the four additional pieces of 
information that are currently optional will require, on average, an 
additional minute for each new data element per response. The four 
additional pieces of information that are currently optional are: (1) 
Preferred mailing address, (2) email address for the owner operator or 
agent in charge, (3) type of activity or type of storage conducted at 
the facility,

[[Page 45947]]

and (4) email address of the emergency contact of a domestic facility. 
As explained in the preamble to the final rule, we revised the final 
rule and no longer require facilities to use D-U-N-S numbers. Instead, 
the final rule requires the use of a UFI recognized as acceptable by 
FDA. We are also postponing the requirement to submit a UFI until the 
registration renewal period beginning October 1, 2020. We estimate that 
entering a unique facility identifier requires, on average, an 
additional minute per response. Thus, we estimate that entering these 
five new data elements will require a total of 5 additional minutes. We 
estimate that the submission of the FSMA data elements and new data 
elements will jointly increase the one-time burden from those 
activities by a total of 11 minutes (0.18 hour). The estimated one-time 
burden for currently registered facilities is 172,274 facilities x 0.18 
hours = 31,009 hours. According to 2014 registration data, 2,121 
registrations were from facilities that submitted paper registrations. 
We believe these same facilities are more likely to request a waiver 
from the requirement to electronically submit their registration. We 
estimate that it will take a respondent 10 minutes to prepare the 
waiver request submission and attach it to their paper Form FDA 3537 
registration submission. Thus, the one-time burden of submitting waiver 
requests is estimated to be 361 hours (2,121 x 0.17 hours), as reported 
in table 5. The estimated total one-time burden for currently 
registered facilities is therefore 31,370 hours.
    We estimate the annual burden for this information collection as 
follows:

                                 Table 6--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
     Activity/21 CFR section         Number of     responses per   Total annual     burden per         Total
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
New domestic facility                      9,795               1           9,795             2.7          26,447
 registrations (1.230-1.233)....
New foreign facility                      13,697               1          13,697             8.7         119,164
 registrations (1.230-1.233)....
Updates (1.234).................          53,836               1          53,836             1.2          64,603
Cancellations (1.230(b))........           6,390               1           6,390               1           6,390
Biennial renewals (1.235).......          97,883               1          97,883            0.38          37,196
Third party registration                  41,256               1          41,256            0.25          10,314
 verification procedure.........
U.S. Agent verification                   57,070               1          57,070            0.25          14,268
 procedure with VIS.............
                                 -------------------------------------------------------------------------------
    Total Hours.................  ..............  ..............  ..............  ..............         278,382
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The currently approved annual reporting burden for food facility 
registration under OMB control number 0910-0502 is 468,117 hours. The 
estimated reporting burden for food facility registration under this 
final rule is 278,382 hours, a decrease of 189,735 hours. This decrease 
is due to the recently reduced number of active registrations in the 
food facility registration database.
    Our estimates of the number of facilities that will submit new 
facility registrations are based on estimates by SBA that 12 percent of 
all businesses each year are new. As such, we estimate that 12 percent 
of registrations (or 23,500 registrations) are from new facilities 
entering the market. We are making additional changes to the currently 
approved reporting burden as well. As discussed previously, FDA 
obtained a 6-month emergency OMB approval of the self-implementing FSMA 
reporting burdens, and subsequently obtained a 3-year approval of these 
requirements. As described in the preliminary economic impact analysis, 
we estimate that on an annualized basis 97,833 respondents will file 
biennial renewals, a decrease from the estimated number of 224,930 
respondents reported in the 2013 request for extension. These decreases 
are due to recent reductions in the number of active registrations in 
the food facility registration database.
    Prior to FSMA, FDA estimated that the average burden associated 
with new domestic and foreign facility registrations was a respective 
2.5 and 8.5 hours. (See 75 FR 30033.) We expect that this final rule 
will add an additional 11 minutes to that burden as a result of the 
required new data elements. Based on estimates by SBA that 12 percent 
of all businesses are new, we estimate that all new facilities each 
year will be equal to 12 percent of the total number of registered 
facilities. Thus, we estimate that each year there will be 9,795 new 
domestic and 13,697 new foreign facility registrations, and that the 
average burden for those new registrations will be of 2.7 hours (2.5 
hours plus 11 minutes) for new domestic facility registrations and 8.7 
hours (8.5 hours plus 11 minutes) for new foreign facility 
registrations, as reported in table 6, rows 1 and 2.
    This final rule does not shorten the time period for updates from 
60 calendar days to 30 calendar days as originally proposed. We are not 
finalizing our proposal to change the current requirement that updates 
take places within 30 calendar days; instead, we are continuing to 
allow 60 calendar days for updates, as provided in current Sec.  1.234. 
In the PRA analysis for the proposed rule, in which we estimated the 
burden for the proposed 30-day update requirement, we estimated that 
68,518 respondents (70 percent of facilities) would submit updates each 
year. For a 60-day update requirement, we estimated that the number of 
respondents was 53,836 per year (55 percent of facilities). The average 
burden per response for updates remains unchanged as 1.2 hours, as 
reported in table 6 row 3. In the proposed rule, we also proposed to 
shorten the time period to submit cancellations from 60 calendar days 
to 30 calendar days. Although we are not finalizing that proposal, we 
have not changed our estimate of the average burden per response for 
cancellations because this final rule does not add new data elements 
for cancellations.
    This final rule also establishes an abbreviated renewal process, 
which modifies our previous estimate that on average it will take 0.5 
hours per renewal. With the option for an abbreviated renewal process, 
we estimate that half the facilities will take 15 minutes per renewal 
using the abbreviated renewal process and that half of facilities will 
take 30 minutes. This alters our previous estimate of 0.5 hours to 
submit a renewal to an average of 0.38 hours (23 minutes) to submit a 
renewal, as reported in table 6, row 5. This estimate takes into 
account that some registered firms will be able to

[[Page 45948]]

take advantage of the abbreviated renewal process, while other firms 
will take more time to prepare and submit the renewal, as discussed in 
the preliminary economic impact analysis.
    Furthermore, this final rule also establishes a verification 
procedure for registrations submitted by individuals other than the 
owner, operator, or agent in charge (third party registrations), as 
well as a verification procedure for U.S. agents. In connection with 
requiring this verification process, this final rule adds email address 
to the list of required information identifying the individual who 
authorized submission of registrations submitted by individuals other 
than the owner, operator, or agent in charge. As described in the 
preliminary economic impact analysis, we estimate that it takes 15 
minutes (0.25 hour) to participate in FDA's verification procedure. We 
have not changed this estimate. We further estimate that 82,513 
registrations will be affected once every other year, or 41,256 
annually. Thus, the total annual burden of these verifications is 
estimated to be 10,314 hours (41,256 x 0.25 hour = 10,314 hours), as 
reported in table 6, row 6.
    For the U.S. agent verification process, in the PRIA we estimated a 
resulting burden from the verification procedure to be about 30 minutes 
(0.5 hours) by 114,139 affected registrations once every 2 years, or 
57,070 facility registrations annually. However, this final rule also 
provides for the creation of a U.S. agent VIS, which we estimate will 
cut the time for verification procedures for U.S. agents in half (from 
30 minutes to 15 minutes). As currently envisioned, the system is 
designed to ensure the accuracy of U.S. agent information and enable 
U.S. agents to independently identify the facility or facilities for 
which the agent has agreed to serve. Specifically, the system will 
allow a U.S. agent to directly provide their contact information (that 
is, the same contact information required for foreign food facility 
registration) and the name of the facility or facilities for which the 
agent has agreed to serve. Currently, FDA only receives U.S. agent 
contact information through foreign food facility registrations, many 
of which are created and updated by the facility, rather than the U.S. 
agent for the facility. We expect that the system will allow agents to 
provide their name, full mailing address, phone number, email address, 
and an emergency contact phone number, as well as the name of the 
facility or facilities for which the agent agrees to serve. After a 
U.S. agent provides this information, FDA will provide the agent with 
an identification number that the agent could provide to foreign 
facilities it has agreed to represent as a U.S. agent. If a foreign 
facility uses a U.S. agent identified in the system, the facility will 
have the option of providing the name and identification number for the 
U.S. agent in its registration rather than the specific U.S. agent's 
contact information required for food facility registrations (e.g., 
address, email address, phone number). After using the identification 
number, and if the foreign facility name matches a facility name the 
U.S. agent identified in the system, the U.S. agent contact information 
in the system will then be linked and automatically populated in the 
foreign facility registration. When the confirmation copy of a foreign 
facility registration is sent to the U.S. agent, it will be sent to the 
contact information provided by the U.S. agent to ensure that the U.S. 
agent is aware of the connection with each foreign facility 
registration.
    We expect that when a foreign facility uses an identification 
number for a registered U.S. agent and the name of the facility matches 
the facility name the agent has identified, that we will consider the 
use of that identification a verification of U.S. agent information for 
purposes of the U.S. agent verification step. Thus, we estimate the 
total annual burden of the foreign facility U.S. agent verifications to 
be 14,268 hours (57,070 x 0.25 hour = 14,268), as reported in table 6, 
row 7.
    The information collection provisions in this final rule have been 
submitted to OMB for review as required by section 3507(d) of the 
Paperwork Reduction Act of 1995. Before the effective date of this 
final rule, FDA will publish a notice in the Federal Register 
announcing OMB's decision to approve, modify, or disapprove the 
information collection provisions in this final rule.
    An Agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number.

XVII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(j) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

XVIII. Federalism

    We have analyzed the final rule in accordance with the principles 
set forth in Executive Order 13132. We have determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, we conclude that the rule 
does not contain policies that have federalism implications as defined 
in the Executive Order and, consequently, a federalism summary impact 
statement is not required.

XIX. References

    The following references are on display in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, and are available for viewing by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday; 
they are also available electronically at https://www.regulations.gov. 
FDA has verified the Web site addresses, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.

1. FDA, Amendments to Registration of Food Facilities--Preliminary 
Regulatory Impact Analysis FDA-2002-N-0323, (https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM444325.pdf), April 2015.
2. FDA Memorandum, ``FDA Memorandum to Dockets on Records of 
Outreach,'' 2013. See Reference 7 to the 2014 supplemental human 
preventive controls notice.
3. FDA Memorandum, ``Memoranda of Outreach,'' 2015.
4. FDA, ``Food CGMP Modernization--A Focus on Food Safety,'' (https://www.fda.gov/Food/GuidanceRegulation/CGMP/ucm207458.htm), November 
2, 2005. Accessed and printed on March 20, 2015. See Reference 1 to 
the 2013 proposed human preventive controls rule.
5. FDA, ``Guidance for Industry: Necessity of the Use of Food 
Product Categories in Food Facility Registrations and Updates to 
Food Product Categories'' (https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm324778.htm), October 2012. Accessed and printed on April 5, 2016.
6. FDA, ``Guidance for Industry: Questions and Answers Regarding 
Food Facility Registration (Sixth Edition),'' (https://www.fda.gov/downloads/Food/GuidanceRegulation/UCM332460.pdf), November 2014. 
Accessed on May 2, 2016.
7. USDA Agricultural Marketing Service, ``Regional Food Hub Resource 
Guide,'' (https://www.ams.usda.gov/sites/default/files/media/Regional%20Food%20Hub%20Resource%20Guide.pdf), April

[[Page 45949]]

2012. Accessed and printed on April 6, 2016.
8. FDA, ``Specification of the Unique Facility Identifier (UFI) 
System for Drug Establishment Registration,'' Guidance for Industry, 
(https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm421827.pdf), 
November 2014. Accessed and printed on April 6, 2016.
9. FDA Memorandum, ``D-U-N-S and Registered Facilities,'' July 9, 
2014, from John Gardner, MD, MPH Senior Technical Advisor, Medical 
Informatics, Office of Informatics and Technology Innovation, Office 
of Information Management and Technology, Office of Operations.
10. U.S. Government Accountability Office, ``Government Is Analyzing 
Alternatives for Contractor Identification Numbers,'' (https://www.gao.gov/assets/600/591551.pdf), June 2012. Accessed and printed 
on April 5, 2016.
11. Specially Designated Nationals List (SDN) (https://www.treasury.gov/resource-center/sanctions/SDN-List/Pages/default.aspx). Accessed on April 5, 2016.
12. FDA, ``FDA's Voluntary Qualified Importer Program,'' Draft 
Guidance for Industry, (https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM448558.pdf), June 2015. Accessed and printed on April 6, 2016.
13. FDA, ``Amendments to Registration of Food Facilities: Final 
Regulatory Impact Analysis, Final Regulatory Flexibility Analysis, 
and Final Unfunded Mandates Reform Act Analysis,'' 2016.

List of Subjects in 21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, 
Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
1 is amended to read as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for part 1 is revised to read as follows:

    Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 
350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 
374, 379j-31, 381, 382, 384a, 384b, 384d, 387, 387a, 387c, 393; 42 
U.S.C. 216, 241, 243, 262, 264, 271; Pub. L. 107-188, 116 Stat. 594, 
668-69; Pub. L. 111-353, 124 Stat. 3885, 3889.


0
2. In Sec.  1.227, revise the definitions for ``Retail food 
establishment'' and ``U.S. agent'' to read as follows:


Sec.  1.227  What definitions apply to this subpart?

* * * * *
    Retail food establishment means an establishment that sells food 
products directly to consumers as its primary function. The term 
``retail food establishment'' includes facilities that manufacture, 
process, pack, or hold food if the establishment's primary function is 
to sell from that establishment food, including food that it 
manufactures, processes, packs, or holds, directly to consumers. A 
retail food establishment's primary function is to sell food directly 
to consumers if the annual monetary value of sales of food products 
directly to consumers exceeds the annual monetary value of sales of 
food products to all other buyers. The term ``consumers'' does not 
include businesses. A ``retail food establishment'' includes grocery 
stores, convenience stores, and vending machine locations. A ``retail 
food establishment'' also includes certain farm-operated businesses 
selling food directly to consumers as their primary function.
    (1) Sale of food directly to consumers from an establishment 
located on a farm includes sales by that establishment directly to 
consumers:
    (i) At a roadside stand (a stand situated on the side of or near a 
road or thoroughfare at which a farmer sells food from his or her farm 
directly to consumers) or farmers' market (a location where one or more 
local farmers assemble to sell food from their farms directly to 
consumers);
    (ii) Through a community supported agriculture program. Community 
supported agriculture (CSA) program means a program under which a 
farmer or group of farmers grows food for a group of shareholders (or 
subscribers) who pledge to buy a portion of the farmer's crop(s) for 
that season. This includes CSA programs in which a group of farmers 
consolidate their crops at a central location for distribution to 
shareholders or subscribers; and
    (iii) At other such direct-to-consumer sales platforms, including 
door-to-door sales; mail, catalog and Internet order, including online 
farmers markets and online grocery delivery; religious or other 
organization bazaars; and State and local fairs.
    (2) Sale of food directly to consumers by a farm-operated business 
includes the sale of food by that farm-operated business directly to 
consumers:
    (i) At a roadside stand (a stand situated on the side of or near a 
road or thoroughfare at which a farmer sells food from his or her farm 
directly to consumers) or farmers' market (a location where one or more 
local farmers assemble to sell food from their farms directly to 
consumers);
    (ii) Through a community supported agriculture program. Community 
supported agriculture (CSA) program means a program under which a 
farmer or group of farmers grows food for a group of shareholders (or 
subscribers) who pledge to buy a portion of the farmer's crop(s) for 
that season. This includes CSA programs in which a group of farmers 
consolidate their crops at a central location for distribution to 
shareholders or subscribers; and
    (iii) At other such direct-to-consumer sales platforms, including 
door-to-door sales; mail, catalog and Internet order, including online 
farmers markets and online grocery delivery; religious or other 
organization bazaars; and State and local fairs.
    (3) For the purposes of this definition, ``farm-operated business'' 
means a business that is managed by one or more farms and conducts 
manufacturing/processing not on the farm(s).
* * * * *
    U.S. agent means a person (as defined in section 201(e) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(e))) residing or 
maintaining a place of business in the United States whom a foreign 
facility designates as its agent for purposes of this subpart. A U.S. 
agent may not be in the form of a mailbox, answering machine or 
service, or other place where an individual acting as the foreign 
facility's agent is not physically present.
    (1) The U.S. agent acts as a communications link between FDA and 
the foreign facility for both emergency and routine communications. The 
U.S. agent will be the person FDA contacts when an emergency occurs, 
unless the registration specifies another emergency contact.
    (2) FDA will treat representations by the U.S. agent as those of 
the foreign facility, and will consider information or documents 
provided to the U.S. agent the equivalent of providing the information 
or documents to the foreign facility. FDA will consider the U.S. agent 
the equivalent of the registrant for purposes of sharing information 
and communications. The U.S. agent of a foreign facility may view the 
information submitted in the foreign facility's registration.
    (3) Having a single U.S. agent for the purposes of this subpart 
does not preclude facilities from having multiple agents (such as 
foreign suppliers) for other business purposes. A firm's commercial 
business in the United States need not be conducted through the U.S. 
agent designated for purposes of this subpart.
* * * * *

[[Page 45950]]


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


Sec.  1.230  When must you register or renew your registration?

    (a) Registration. You must register before your facility begins to 
manufacture, process, pack, or hold food for consumption in the United 
States. You may authorize an individual to register the facility on 
your behalf.
    (b) Registration renewal. You must submit a registration renewal 
containing the information required under Sec.  1.232 every other year, 
during the period beginning on October 1 and ending on December 31 of 
each even-numbered year. You may authorize an individual to renew a 
facility's registration on your behalf. If the individual submitting 
the registration renewal is not the owner, operator, or agent in charge 
of the facility, the registration renewal must also include a statement 
in which the individual certifies that the information submitted is 
true and accurate, certifies that he/she is authorized to submit the 
registration renewal, and identifies by name, address, and telephone 
number, the individual who authorized submission of the registration 
renewal. In addition, the registration renewal must also identify the 
individual who authorized submission of the registration renewal by 
email address, unless FDA has granted a waiver under Sec.  1.245. Each 
registration renewal must include the name of the individual submitting 
the registration renewal, and the individual's signature (for the paper 
option). Each electronic registration renewal must include the name of 
the individual submitting the renewal.
    (c) Abbreviated registration renewal process. If you do not have 
any changes to the information required under Sec.  1.232 since you 
submitted the preceding registration, registration renewal, or update 
for your facility, you may use the abbreviated registration renewal 
process. If you use the abbreviated registration renewal process, you 
must confirm that no changes have been made to the information required 
under Sec.  1.232 since you submitted the preceding registration, 
registration renewal or update, and you must certify that the 
information submitted is truthful and accurate. Each abbreviated 
registration renewal must include the name of the individual submitting 
the abbreviated renewal, and the individual's signature (for the paper 
option). Each electronic abbreviated registration renewal must include 
the name of the individual submitting the abbreviated renewal. For 
abbreviated registration renewals not submitted by the owner, operator, 
or agent in charge of the facility, the abbreviated renewal must 
provide the email address of the individual who authorized submission 
of the abbreviated renewal, unless FDA has granted a waiver under Sec.  
1.245. You must use Form FDA 3537 to submit abbreviated registration 
renewals to FDA.

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


Sec.  1.231  How and where do you register or renew your registration?

    (a) Electronic registration and registration renewal. (1) To 
register or renew a registration electronically, you must go to https://www.fda.gov/furls, which is available for registration 24 hours a day, 
7 days a week. This Web site is available from wherever the Internet is 
accessible, including libraries, copy centers, schools, and Internet 
cafes. An individual authorized by the owner, operator, or agent in 
charge of a facility may also register a facility electronically.
    (2) Beginning on January 4, 2020, you must submit your registration 
or registration renewal to FDA electronically, unless FDA has granted 
you a waiver under Sec.  1.245.
    (3) After you submit your electronic registration, FDA will verify 
the accuracy of your unique facility identifier (UFI) recognized as 
acceptable by FDA and will also verify that the facility-specific 
address associated with the UFI is the same address associated with 
your registration. FDA will not confirm your registration or provide 
you with a registration number until FDA verifies the accuracy of your 
facility's UFI and verifies that the facility-specific address 
associated with the UFI is the same address associated with your 
registration. With respect to electronic registration renewals, after 
you submit your electronic registration renewal, FDA will provide you 
with an electronic confirmation of your registration renewal. When you 
update your facility's UFI as part of your electronic registration 
renewal, FDA will verify the accuracy of your facility's UFI and will 
also verify that the facility-specific address associated with the UFI 
is the same address associated with your registration. FDA will not 
provide you with a confirmation of your registration renewal until FDA 
verifies the accuracy of your UFI and verifies that the facility-
specific address associated with the UFI is the same address associated 
with your registration.
    (4) For electronic registrations not submitted by the owner, 
operator, or agent in charge of the facility, after submission of the 
registration, FDA will verify that the individual identified as having 
authorized submission of the registration in fact authorized the 
submission on behalf of the facility. FDA will not confirm the 
registration or provide a registration number until that individual 
confirms that he or she authorized the submission. With respect to 
electronic registration renewals, after completion of the electronic 
registration renewal, FDA will provide an electronic confirmation of 
the registration renewal. For electronic registration renewals not 
submitted by the owner, operator, or agent in charge of the facility, 
FDA will verify that the individual identified as having authorized 
submission of the registration renewal in fact authorized the 
submission on behalf of the facility. FDA will not provide an 
electronic confirmation of the registration renewal until that 
individual confirms that he or she authorized the submission.
    (5) For a foreign facility, after you submit your electronic 
registration, FDA will verify that the person identified as the U.S. 
agent for your foreign facility has agreed to serve as your U.S. agent. 
FDA will not confirm your registration or provide you with a 
registration number until that person confirms that the person agreed 
to serve as your U.S. agent. With respect to electronic registration 
renewals, after you complete your electronic registration renewal, FDA 
will provide you with an electronic confirmation of your registration 
renewal. When you update information about your U.S. agent as part of 
your electronic registration renewal, FDA will verify that the person 
identified as the U.S. agent for your foreign facility has agreed to 
serve as your U.S. agent. FDA will not provide you with an electronic 
confirmation of your registration renewal until that person confirms 
that the person agreed to serve as your U.S. agent.
    (6) If any information you previously submitted was incorrect at 
the time of submission, you must immediately update your facility's 
registration as specified in Sec.  1.234.
    (7) You will be considered registered once FDA electronically sends 
you your confirmation and registration number.
    (b) Registration or registration renewal by mail or fax. Beginning 
January 4, 2020, you must submit your registration or registration 
renewal to FDA electronically, unless FDA has granted you a waiver 
under Sec.  1.245. If FDA has granted you a waiver under Sec.  1.245, 
you may register or renew a registration by mail or by fax.
    (1) You must register or renew a registration (including 
abbreviated registration renewals) using Form FDA 3537. You may obtain 
a copy of this form by writing to the U.S. Food and Drug 
Administration, Center for Food

[[Page 45951]]

Safety and Applied Nutrition, 5001 Campus Dr. (HFS-681), College Park, 
MD 20740 or by requesting the form by phone at 1-800-216-7331 or 301-
575-0156.
    (2) When you receive the form, you must fill it out completely and 
legibly and either mail it to the address in paragraph (b)(1) of this 
section or fax it to 301-436-2804.
    (3) If any required information on the form is incomplete or 
illegible when FDA receives it, FDA will return the form to you for 
revision, provided that your mailing address or fax number is legible 
and valid. When returning a registration form for revision, FDA will 
use the means by which the form was received by the Agency (i.e., by 
mail or fax).
    (4) FDA will enter complete and legible mailed and faxed 
registration submissions into its registration system, as soon as 
practicable, in the order FDA receives them.
    (5) After you submit your registration, FDA will verify the 
accuracy of your facility's UFI and will also verify that the facility-
specific address associated with the UFI is the same address associated 
with your registration. FDA will not confirm your registration or 
provide you with a registration number until FDA verifies the accuracy 
of your facility's UFI and verifies that the facility-specific address 
associated with the UFI is the same address associated with your 
registration. With respect to registration renewals, after you submit 
your registration renewal by mail or fax, FDA will provide you with a 
confirmation of your registration renewal. When you update your 
facility's UFI as part of your registration renewal, FDA will verify 
the accuracy of your facility's UFI and will also verify that the 
facility-specific address associated with the UFI is the same address 
associated with your registration. FDA will not provide you with a 
confirmation of your registration renewal until FDA verifies the 
accuracy of your UFI and verifies that the facility-specific address 
associated with the UFI is the same address associated with your 
registration.
    (6) For registrations not submitted by the owner, operator, or 
agent in charge of the facility, after submission of the registration 
by mail or fax, FDA will verify that the individual identified as 
having authorized submission of the registration in fact authorized the 
submission on behalf of the facility. FDA will not confirm the 
registration or provide a registration number until that individual 
confirms that he or she authorized the submission. With respect to 
registration renewals, after completion of the registration renewal by 
mail or fax, FDA will provide a confirmation of the registration 
renewal. For registration renewals not submitted by the owner, 
operator, or agent in charge of the facility, FDA will verify that the 
individual identified as having authorized submission of the 
registration renewal in fact authorized the submission on behalf of the 
facility. FDA will not provide a confirmation of the registration 
renewal until that individual confirms that he or she authorized the 
submission.
    (7) For a foreign facility, after you submit your registration by 
mail or fax, FDA will verify that the person identified as the U.S. 
agent for your foreign facility has agreed to serve as your U.S. agent. 
FDA will not confirm your registration or provide you with a 
registration number until that person confirms that the person agreed 
to serve as your U.S. agent. With respect to registration renewals, 
after you complete your registration renewal by mail or fax, FDA will 
provide you with a confirmation of your registration renewal. When you 
update information about your U.S. agent as part of your registration 
renewal, FDA will verify that the person identified as the U.S. agent 
for your foreign facility has agreed to serve as your U.S. agent. FDA 
will not provide you with a confirmation of your registration renewal 
until that person confirms that the person agreed to serve as your U.S. 
agent.
    (8) FDA will mail or fax you a copy of the registration as entered, 
confirmation of registration, and your registration number. When 
responding to a registration submission, FDA will use the means by 
which the registration was received by the Agency (i.e., by mail or 
fax).
    (9) If any information you previously submitted was incorrect at 
the time of submission, you must immediately update your facility's 
registration as specified in Sec.  1.234.
    (10) Your facility is considered registered once FDA enters your 
facility's registration data into the registration system and the 
system generates a registration number.
    (c) Fees. No registration fee is required.
    (d) Language. You must submit all registration information in the 
English language except an individual's name, the name of a company, 
the name of a street, and a trade name may be submitted in a foreign 
language. All information, including these items, must be submitted 
using the Latin (Roman) alphabet.
0
5. Revise Sec.  1.232 to read as follows:


Sec.  1.232  What information is required in the registration?

    (a) For a domestic and foreign facility, the following information 
is required:
    (1) The name, full address, and phone number of the facility;
    (2) Beginning October 1, 2020, the facility's UFI recognized as 
acceptable by FDA;
    (3) The preferred mailing address, if different from that of the 
facility;
    (4) The name, full address, and phone number of the parent company, 
if the facility is a subsidiary of the parent company;
    (5) All trade names the facility uses;
    (6) The name, full address, and phone number of the owner, 
operator, or agent in charge of the facility. In addition, the email 
address of the owner, operator, or agent in charge is required, unless 
FDA has granted you a waiver under Sec.  1.245;
    (7) The applicable food product categories of any food 
manufactured/processed, packed, or held at the facility as identified 
on Form FDA 3537;
    (8) The type of activity conducted at the facility for each food 
product category identified. You may select more than one activity type 
for each food product category identified. The activity type options 
are as follows:
    (i) Ambient human food storage warehouse/holding facility;
    (ii) Refrigerated human food warehouse/holding facility;
    (iii) Frozen human food warehouse/holding facility;
    (iv) Interstate conveyance caterer/catering point;
    (v) Contract sterilizer;
    (vi) Labeler/relabeler;
    (vii) Manufacturer/processor;
    (viii) Acidified food processor;
    (ix) Low-acid food processor;
    (x) Farm mixed-type facility;
    (xi) Packer/repacker;
    (xii) Salvage operator (reconditioner);
    (xiii) Animal food warehouse/holding facility;
    (xiv) Other activity.
    (9) A statement in which the owner, operator, or agent in charge 
provides an assurance that FDA will be permitted to inspect the 
facility at the times and in the manner permitted by the Federal Food, 
Drug, and Cosmetic Act;
    (10) A statement in which the owner, operator, or agent in charge 
certifies that the information submitted is true and accurate. If the 
individual submitting the form is not the owner, operator, or agent in 
charge of the facility, the registration must also include a statement 
in which the individual certifies that the information submitted is 
true and accurate, certifies that he/she is authorized to submit the 
registration, and identifies by name, address, and

[[Page 45952]]

telephone number, the individual who authorized submission of the 
registration. In addition, the registration must identify the 
individual who authorized submission of the registration by email 
address, unless FDA has granted a waiver under Sec.  1.245. Each 
registration must include the name of the individual submitting the 
registration, and the individual's signature (for the paper option).
    (b) For a domestic facility, the following additional information 
is required:
    (1) The email address for the contact person of the facility;
    (2) An emergency contact phone number and email address if 
different from the email address for the contact person in paragraph 
(b)(1) of this section.
    (c) For a foreign facility, the following additional information is 
required:
    (1) The name, full address, phone number, and email address of the 
foreign facility's U.S. agent;
    (2) An emergency contact phone number and email address.
0
6. Revise Sec.  1.233 to read as follows:


Sec.  1.233  Are there optional items included in the registration 
form?

    Yes. FDA encourages, but does not require, you to submit items that 
are indicated as optional on the Form FDA 3537 that you submit.
0
7. Revise Sec.  1.234 to read as follows:


Sec.  1.234  How and when do you update your facility's registration 
information?

    (a) Update requirements. You must update a facility's registration 
within 60 calendar days of any change to any of the information 
previously submitted under Sec.  1.232 (e.g., change of operator, agent 
in charge, or U.S. agent), except a change of the owner. You may 
authorize an individual to update a facility's registration on your 
behalf. For updates not submitted by the owner, operator, or agent in 
charge of the facility, the update must provide the email address of 
the individual who authorized submission of the update, unless FDA has 
granted a waiver under Sec.  1.245.
    (b) Cancellation due to ownership changes. If the reason for the 
update is that the facility has a new owner, the former owner must 
cancel the facility's registration as specified in Sec.  1.235 within 
60 calendar days of the change and the new owner must submit a new 
registration for the facility as specified in Sec.  1.231. The former 
owner may authorize an individual to cancel a facility's registration.
    (c) Electronic update. (1) To update your registration 
electronically, you must update at https://www.fda.gov/furls.
    (2) After you submit your electronic update, FDA will provide you 
with an electronic confirmation of your update. When updating UFI 
information, FDA will verify the accuracy of your facility's UFI and 
will also verify that the facility-specific address associated with the 
UFI is the same address associated with your registration. FDA will not 
provide you with an electronic confirmation of your registration update 
until FDA verifies the accuracy of your facility's UFI and verifies 
that the facility-specific address associated with the UFI is the same 
address associated with your registration. For foreign facilities, when 
updating information about your U.S. agent, FDA will verify that the 
person identified as the U.S. agent for your foreign facility has 
agreed to serve as your U.S. agent. FDA will not provide you with an 
electronic confirmation of your registration update until that person 
confirms that the person agreed to serve as your U.S. agent.
    (3) For electronic updates not submitted by the owner, operator, or 
agent in charge of the facility, after submission of the electronic 
update, FDA will verify that the individual identified as having 
authorized submission of the update in fact authorized the submission 
on behalf of the facility. FDA will not confirm the update to the 
registration until that individual confirms that he or she authorized 
the submission.
    (4) Your registration will be considered updated once FDA sends you 
your update confirmation, unless notified otherwise.
    (d) Update by mail or fax. Beginning January 4, 2020, you must 
submit your update electronically, unless FDA has granted you a waiver 
under Sec.  1.245. If FDA has granted you a waiver under Sec.  1.245, 
you may update your facility's registration by mail or by fax.
    (1) You must update your registration using Form FDA 3537. You may 
obtain a copy of this form by writing to the U.S. Food and Drug 
Administration, Center for Food Safety and Applied Nutrition, 5001 
Campus Dr. (HFS-681), College Park, MD 20740 or by requesting the form 
by phone at 1-800-216-7331 or 301-575-0156.
    (2) When you receive the form, you must legibly fill out the 
sections of the form reflecting your updated information and either 
mail it to the address in paragraph (d)(1) of this section or fax it to 
301-436-2804.
    (3) If the information on the form is incomplete or illegible when 
FDA receives it, FDA will return the form to you for revision, provided 
that your mailing address or fax number is legible and valid. When 
returning a registration form for revision, FDA will use the means by 
which the registration was received by the Agency (i.e., by mail or 
fax).
    (4) FDA will enter complete and legible updates into its 
registration system as soon as practicable, in the order FDA receives 
them.
    (5) FDA will then mail to the address or fax to the fax number on 
the registration form a copy of the update as entered and confirmation 
of the update. When responding to an update submission, FDA will use 
the means by which the form was received by the Agency (i.e., by mail 
or fax). After you submit your update by mail or fax, FDA will verify 
the accuracy of your facility's UFI and will also verify that the 
facility-specific address associated with the UFI is the same address 
associated with your registration. FDA will not provide a confirmation 
of your registration update until FDA verifies the accuracy of your 
facility's UFI and verifies that the facility-specific address 
associated with the UFI is the same address associated with your 
registration. For foreign facilities, when updating information about 
your U.S. agent, FDA will verify that the person identified as the U.S. 
agent for your foreign facility has agreed to serve as your U.S. agent. 
FDA will not provide you with a confirmation of your registration 
update until that person confirms that the person agreed to serve as 
your U.S. agent.
    (6) For registration updates not submitted by the owner, operator, 
or agent in charge of the facility, after submission of the 
registration update by mail or fax, FDA will verify that the individual 
identified as having authorized submission of the update in fact 
authorized the submission on behalf of the facility. FDA will not 
confirm the registration update until that individual confirms that he 
or she authorized the update.
    (7) If any update information you previously submitted was 
incorrect at the time of submission, you must immediately resubmit your 
update.
    (8) Your registration will be considered updated once FDA enters 
your facility's update data into the registration system and the system 
generates an update confirmation.
0
8. Revise Sec.  1.235 to read as follows:


Sec.  1.235  How and when do you cancel your facility's registration 
information?

    (a) Notification of registration cancellation. You must cancel a 
registration within 60 calendar days of the reason for cancellation 
(e.g., your facility ceases operations, ceases providing food for 
consumption in the

[[Page 45953]]

United States, or is sold to a new owner).
    (b) Cancellation requirements. The cancellation of a facility's 
registration must include the following information:
    (1) The facility's registration number;
    (2) Whether the facility is domestic or foreign;
    (3) The facility name and address;
    (4) The name, address, and email address (if available) of the 
individual submitting the cancellation;
    (5) For registration cancellations not submitted by the owner, 
operator, or agent in charge of the facility, the email address of the 
individual who authorized submission of the registration cancellation, 
unless FDA has granted a waiver under Sec.  1.245; and
    (6) A statement certifying that the information submitted is true 
and accurate, and that the person submitting the cancellation is 
authorized by the facility to cancel its registration.
    (c) Electronic cancellation. (1) To cancel your registration 
electronically, you must cancel at https://www.fda.gov/furls.
    (2) Once you complete your electronic cancellation, FDA will 
provide you with an electronic confirmation of your cancellation.
    (3) For registration cancellations not submitted by the owner, 
operator, or agent in charge of the facility, after submission of the 
registration cancellation, FDA will verify that the individual 
identified as having authorized submission of the cancellation in fact 
authorized the submission on behalf of the facility. FDA will not 
confirm the registration cancellation until that individual confirms 
that he or she authorized the registration cancellation.
    (4) Your registration will be considered cancelled once FDA sends 
you your cancellation confirmation.
    (d) Cancellation by mail or fax. Beginning January 4, 2020, you 
must cancel your registration electronically, unless FDA has granted 
you a waiver under Sec.  1.245. If FDA has granted a waiver under Sec.  
1.245, you may cancel your facility's registration by mail or fax.
    (1) You must cancel your registration using Form FDA 3537a. You may 
obtain a copy of this form by writing to the U.S. Food and Drug 
Administration, Center for Food Safety and Applied Nutrition, 5001 
Campus Dr. (HFS-681), College Park, MD 20740 or by requesting the form 
by phone at 1-800-216-7331 or 301-575-0156.
    (2) When you receive the form, you must completely and legibly fill 
out the form and either mail it to the address in paragraph (d)(1) of 
this section or fax it to 301-436-2804.
    (3) If the information on the form is incomplete or illegible when 
FDA receives it, FDA will return the form to you for revision, provided 
that your mailing address or fax number is legible and valid. When 
returning a cancellation form for revision, FDA will use the means by 
which the cancellation was received by the Agency (i.e., by mail or 
fax).
    (4) FDA will enter complete and legible mailed and faxed 
cancellations into its registration system as soon as practicable, in 
the order FDA receives them.
    (5) FDA will mail to the address or fax to the fax number on the 
cancellation form a copy of the cancellation as entered and 
confirmation of the cancellation. When responding to a cancellation, 
FDA will use the means by which the form was received by the Agency 
(i.e., by mail or fax).
    (6) For registration cancellations not submitted by the owner, 
operator, or agent in charge of the facility, after submission of the 
registration cancellation by mail or fax, FDA will verify that the 
individual identified as having authorized submission of the 
cancellation in fact authorized the submission on behalf of the 
facility. FDA will not confirm the registration cancellation until that 
individual confirms that he or she authorized the registration 
cancellation.
    (7) Your registration will be considered cancelled once FDA enters 
your facility's cancellation data into the registration system. FDA 
will send you your cancellation confirmation.
0
9. Revise Sec.  1.241 to read as follows:


Sec.  1.241  What are the consequences of failing to register, update, 
renew, or cancel your registration?

    (a) Section 301 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 331) prohibits the doing of certain acts or causing such acts to 
be done. Under section 302 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 332), the United States can bring a civil action in Federal 
court to enjoin a person who commits a prohibited act. Under section 
303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333), the 
United States can bring a criminal action in Federal court to prosecute 
a person who is responsible for the commission of a prohibited act. 
Under section 306 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 335a), FDA can seek debarment of any person who has been 
convicted of a felony relating to importation of food into the United 
States. Failure of an owner, operator, or agent in charge of a domestic 
or foreign facility to register its facility, renew the registration of 
its facility, update required elements of its facility's registration, 
or cancel its registration in accordance with the requirements of this 
subpart is a prohibited act under section 301(dd) of the Federal Food, 
Drug, and Cosmetic Act.
    (b) FDA will consider a registration for a food facility to be 
expired if the registration is not renewed, as required by Sec.  
1.230(b). Thus, if you previously submitted a registration to FDA, but 
do not submit a registration renewal to FDA during the period beginning 
on October 1 and ending on December 31 of each even-numbered year, FDA 
will consider the registration for the facility to be expired. FDA will 
consider a food facility with an expired registration to have failed to 
register in accordance with section 415 of the Federal Food, Drug, and 
Cosmetic Act.
    (c) FDA will cancel a registration if FDA independently verifies 
that the facility is no longer in business or has changed owners, and 
the owner, operator, or agent in charge of the facility fails to cancel 
the registration, or if FDA determines that the registration is for a 
facility that does not exist, is not required to register, or where the 
information about the facility's address was not updated in a timely 
manner in accordance with Sec.  1.234(a) or the registration was 
submitted by a person not authorized to submit the registration under 
Sec.  1.225. Also, FDA will cancel a registration if the facility's 
registration has expired because the facility has failed to renew its 
registration in accordance with Sec.  1.230(b). If FDA cancels a 
facility's registration, FDA will send a confirmation of the 
cancellation using contact information submitted by the facility in the 
registration database.
    (d) If an article of food is imported or offered for import into 
the United States and a foreign facility that manufactured/processed, 
packed, or held that article of food has not registered in accordance 
with this subpart, the disposition of the article of food shall be 
governed by the procedures set out in subpart I of this part.
0
10. Add Sec.  1.245 to subpart H to read as follows:


Sec.  1.245  Waiver request.

    Under Sec. Sec.  1.231(a)(2) and (b), 1.234(d), and 1.235(d), 
beginning January 4, 2020, you must submit your registration, 
registration renewal, updates, and cancellations to FDA electronically 
unless FDA has granted a waiver from such requirement. Under Sec.  
1.232(a)(6), you must provide the email address of the owner, operator, 
or agent in charge

[[Page 45954]]

of the facility unless FDA has granted a waiver from such requirement. 
In addition, under Sec. Sec.  1.230(b) and (c), 1.232(a)(10), 1.234(a), 
and 1.235(b)(5), registration renewals, abbreviated registration 
renewals, registrations, updates, and cancellations not submitted by 
the owner, operator, or agent in charge must include the email address 
for the individual who authorized the submission, unless FDA has 
granted a waiver. To request a waiver from these requirements, you must 
submit a written request to FDA that explains why it is not reasonable 
for you to submit your registration, registration renewal, update, or 
cancellation to FDA electronically or to provide the email address of 
the owner, operator, or agent in charge of the facility. You must 
submit your request to: U.S. Food and Drug Administration, Center for 
Food Safety and Applied Nutrition, 5001 Campus Dr. (HFS-681), College 
Park, MD 20740.

    Dated: July 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16531 Filed 7-13-16; 8:45 am]
BILLING CODE 4164-01-P