2016-16531 Amendments To Registration of Food Facilities FR

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
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45912 Federal Register / Vol. 81, No. 135 / Thursday July 14, 2016 / Rules and Regulations
DEPARTMENT OF HEALTH AND C. Proposed § 1.230(c)—Abbreviated FD&C Act) (21 U.S.C. 350d), as amended
HUMAN SERVICES Registration Renewal Process by section 102 of FSMA, that relate to
VI. Comments on Proposed Amendments to registration of food facilities.
Food and Drug Administration § 1.231—How and Where Do You Furthermore, this rule amends and
Register or Renew Your Registration?
A. Proposed § 1.231(a)—Electronic
updates FDA’s registration regulations
21 CFR Part 1 Registration and Registration Renewal and improves the utility of the food
[Docket No. FDA–2002–N–0323] B. Proposed § 1.231(b)—Registration or facility registration database to further
Registration Renewal by Mail or Fax enhance FDA’s capabilities with respect
RIN 0910–AG69 C. Proposed §§ 1.231(a)(3) and (b)(5) and to responding to food-related
1.234(c)(2) and (d)(5)—Unique Facility emergencies, and in addition, provide
Amendments to Registration of Food Identifier and Verification Procedures for FDA with information that we can use
Facilities FDA to focus and better utilize our limited
D. Proposed §§ 1.231(a)(4) and (b)(6), inspection resources.
AGENCY: Food and Drug Administration,
1.234(c)(3) and (d)(6), and 1.235(c)(3)
HHS. and (d)(6)—Verification Procedures for Summary of Major Provisions of the
ACTION: Final rule. Submissions Not Made by the Owner, Final Rule
Operator, or Agent in Charge of the
SUMMARY: The Food and Drug Facility
Section 102 of FSMA amends section
Administration (FDA or we) is E. Proposed §§ 1.231(a)(5) and (b)(7) and 415 of the FD&C Act by requiring that
amending its regulations for registration 1.234(c)(2) and (d)(5)—Verification certain additional information be
of food facilities that require domestic Procedures for U.S. Agents included in facility registrations. More
and foreign facilities that manufacture/ F. Proposed § 1.231(a)(6) and (b)(9)— specifically, section 102(a)(1)(A) of
process, pack, or hold food for human Requirement To Update Incorrect FSMA amends section 415 to provide
or animal consumption in the United Registration Information that registrations for domestic food
States to register with FDA. This rule VII. Comments on Proposed Amendments to facilities are required to contain the
§ 1.232—What Information Is Required email address for the contact person of
amends and updates FDA’s registration
in the Registration? the facility, and registrations for foreign
regulations and is part of our A. Requirement for Certain Email Address
implementation of the FDA Food Safety Information
food facilities are required to contain
Modernization Act (FSMA), which B. Requirement for a Unique Facility the email address of the U.S. agent for
added new provisions for the Identifier the facility. Further, section 102(a)(3) of
registration of food facilities. These C. Requirement To Include Food Product FSMA amends section 415 to provide
amendments will further enhance FDA’s Categories that food facilities required to register
capabilities with respect to responding D. Requirement To Identify Activity Type with FDA must renew their registrations
to food safety issues, and in addition, E. Requirement To Provide Assurance That with FDA every 2 years, between
FDA Will Be Permitted To Inspect October 1 and December 31 of each
provide FDA with information that we
VIII. Comments on Proposed Amendments to even-numbered year, by submitting
can use to focus and better utilize our § 1.233—Are There Optional Items
limited inspection resources. registration renewals to FDA. Also,
Included in the Registration Form?
DATES: This rule is effective September IX. Comments on Proposed Amendments to
section 102(b)(1)(A) of FSMA provides
12, 2016. § 1.234—How and When Do You Update that all food facility registrations are
Your Facility’s Registration Information? required to contain an assurance that
FOR FURTHER INFORMATION CONTACT:
X. Comments on Proposed Amendments to FDA will be permitted to inspect the
Courtney Buchanan, Center for Food facility at the times and in the manner
§ 1.235—How and When Do You Cancel
Safety and Applied Nutrition (HFS– Your Facility’s Registration Information? permitted by the FD&C Act. These
615), Food and Drug Administration, XI. Comments on Proposed Amendments to FSMA amendments were self-
5001 Campus Dr., College Park, MD § 1.241—What Are the Consequences of implementing and became effective
20740, 240–402–2487. Failing To Register, Update, Renew, or upon enactment of FSMA. These FSMA
SUPPLEMENTARY INFORMATION: Cancel Your Registration? amendments are included in this final
XII. Comments on Proposed Addition of
Table of Contents § 1.245—Waiver Request
rule to codify these provisions in 21
XIII. U.S. Agent Voluntary Identification CFR part 1, subpart H, the food facility
Executive Summary registration regulation.
Purpose and Coverage of the Final Rule System
XIV. Editorial Changes and Other Changes In addition, section 102(b) of FSMA
Summary of the Major Provisions of the Final
Rule A. Editorial Changes authorizes FDA to require that all food
Costs and Benefits B. CD–ROM Submissions facility registrations be submitted to
I. Background XV. Economic Analysis of Impacts FDA in an electronic format; however,
A. FDA Food Safety Modernization Act XVI. Paperwork Reduction Act of 1995 such requirement cannot take effect
B. Purpose of This Rulemaking XVII. Analysis of Environmental Impact before the date that is 5 years after the
C. Summary of the Major Provisions of the XVIII. Federalism date of enactment of FSMA (i.e., January
Proposed Rule XIX. References 4, 2016). We are implementing this
D. Public Comments
II. Legal Authority Executive Summary provision in the final rule. However, we
III. General Comments on the Proposed Rule are delaying the date for mandatory
Purpose and Coverage of the Final Rule electronic registration until January 4,
IV. Comments on Proposed Amendments to
§ 1.227—Definitions This rule is part of FDA’s 2020. Furthermore, we are including a
A. Retail Food Establishment implementation of FSMA (Pub. L. 111– waiver request provision in the rule to
B. U.S. Agent 353), which intends to better protect allow a registrant to submit a written
V. Comments on Proposed Amendments to public health by, among other things, request to FDA that explains why it is
§ 1.230—When Must You Register or not reasonable to submit the
adopting a modern, preventive, and
Renew Your Registration?
A. Proposed § 1.230(a)—When Must You risk-based approach to food safety registration, registration renewal,
Register? regulation. This rule implements certain update, or cancellation to FDA
B. Proposed § 1.230(b)—Registration provisions in section 415 of the Federal electronically or to explain why it is not
Renewal Food, Drug, and Cosmetic Act (the reasonable to provide the email address
Federal Register / Vol. 81, No. 135 / Thursday July 14, 2016 / Rules and Regulations 45913
of the owner, operator, or agent in Costs and Benefits granted the waiver). These costs are
charge of the facility. Costs of meeting the requirements of approximately $3 million.
Section 102(c) of FSMA also directs this final rule will be incurred by both Recurring biennial costs beginning in
FDA to amend the definition of the term FDA and food facilities that are required 2016 include costs from the requirement
‘‘retail food establishment’’ in § 1.227 of to register.
title 21, Code of Federal Regulations to for both domestic and foreign food
Table 1 presents estimated costs facilities to renew their registrations
clarify that, in determining the primary associated with the provisions in this
function of an establishment or a retail every 2 years and from requiring
final rule. These costs are similar to additional data elements in the
food establishment under such section, what we estimated the proposed rule
the sale of food products directly to registration form. Recurring costs for
would cost, but with the additional 2018 include costs from implementing
consumers by such establishment and implementation of a U.S. Agent
the sale of food directly to consumers by the U.S. agent VIS. As was the case
Voluntary Identification System (VIS) under Option 4 in the PRIA, these costs
such retail food establishment include: and reduced costs to facilities resulting
(1) The sale of food products or food are based on the supposition that the
from postponing the requirements to
directly to consumers by such U.S. agents for all foreign facilities will
provide a UFI and to submit
establishment at a roadside stand or choose to use the VIS. In the PRIA (see
registrations electronically. Estimated
farmers’ market where such stand or pages 51 to 53), we estimated that
one-time costs to domestic and foreign
market is located other than where the implementing the system by 2018 could
facilities are about $27 million. These
food was manufactured or processed; (2) reduce estimated costs for the U.S. agent
estimated costs include a small
the sale and distribution of such food information viewing and verification
reduction from the estimated one-time
through a community supported provisions in the proposed rule by one-
costs of provisions in the proposed rule.
agriculture program; and (3) the sale and half. We estimated that this would
As explained in the preliminary
distribution of such food at any other result in roughly $2 million of savings
such direct sales platform as determined regulatory impact analysis (PRIA), one-
time costs in the first year stem from the each year or about $4 million every 2
by the Secretary. We are revising the years. We no longer assess the costs of
definition of retail food establishment at self-implementing FSMA provisions
that are already effective, including requiring updates within 30 calendar
§ 1.227 in this final rule consistent with days because we are not finalizing our
section 102(c) of FSMA. learning costs (i.e., the administrative
In addition, we are making changes to costs incurred by domestic and foreign proposal to shorten the time period for
improve the utility of the food facility facilities in order to learn how to updates. The final rule does not change
registration database. We are making comply with any new regulation), first- the currently required time periods.
changes in 21 CFR part 1, subpart H to: time biennial registration renewal costs Thus, estimated recurring costs of this
(1) Require certain additional data from the 2012 registration renewal final rule are now approximately $8.8
elements in food facility registrations cycle, and costs that stem from million every 2 years. The $8.8 million
(e.g., a unique facility identifier (UFI) requirements for certain data elements in costs continue to accrue in each
for food facility registrations); (2) in the registration form such as the subsequent biennial registration renewal
employ measures to verify certain email address for a domestic facility’s cycle, and include costs associated with
information submitted in registrations; contact person and the email address for registration renewal activities and costs
and (3) take additional steps to ensure a foreign facility’s U.S. agent. These associated with other provisions of the
that our registration database is up-to- costs are approximately $20 million. final rule, such as certain verification
date by identifying additional Estimated one-time costs to domestic procedures.
circumstances under which FDA will and foreign facilities for the biennial
renewal cycle in 2016, by which time Annualized costs are calculated using
cancel registrations. a discount rate of 7 percent and 3
Further, we proposed to amend the the final rule will be effective, include
$4.6 million in one-time costs for percent over 20 years. Total annualized
regulation to shorten the timeframe for
submitting updates and cancellations entering additional data elements in the costs to food facilities, which include
from 60 calendar days to 30 calendar registration form and costs for U.S. annualized one-time costs and
days. In response to numerous agent verification procedures incurred annualized recurring costs, are
comments received on this issue, the in 2016. One-time costs in 2020 include approximately $4.7 million and $4.9
final rule does not shorten the the costs for the requirement to obtain million per year ($24 and $25 per
timeframes as proposed. The final rule a UFI plus the reduced costs associated facility) using a discount rate of 7
provides that updates to registration with the mandatory electronic percent and 3 percent, respectively, over
information or cancellation of submission requirement (because the a period of 20 years. Annualized
registration must be submitted within preamble to the final rule clarifies that recurring costs to FDA are
60 days of any change to any of the food facilities will not be required to approximately $0.9 and $1.2 million,
required information or the reason for resubmit waivers with each biennial also using a discount rate of 7 percent
the cancellation. registration renewal cycle once FDA has and 3 percent, respectively.
TABLE 1—ANNUALIZED COST AND BENEFIT SUMMARY

[$Millions]
Total Total
Total annualized annualized Benefits

one-time 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
TABLE 1—ANNUALIZED COST AND BENEFIT SUMMARY—Continued

[$Millions]
Total Total
Total annualized annualized Benefits
one-time costs costs 7% costs 3%
Costs to FDA ................................................................................................ ........................ 0.9 1.2
Total ....................................................................................................... 27 5.6 6.1
This analysis estimates costs and the total costs to manufacture, process, into law by President Obama on January
benefits of the provisions in this final pack, and hold foods for sale in the 4, 2011, is intended to allow FDA to
rule only, which are assumed to accrue United States. We expect that the better protect public health by helping
in addition to the estimated annual benefits of the final rule would include to ensure the safety and security of the
costs already incurred due to the aiding FDA’s ability to deter and limit food supply. FSMA enables us to focus
implementation of the provisions in the the effects of foodborne outbreaks and more on preventing food safety
2003 interim final rule issued jointly by other food-related emergencies. problems rather than relying primarily
the Secretary and the Department of Although we are unable to quantify on reacting to problems after they occur.
Homeland Security (DHS) jointly to these and other benefits, we discuss the The law also provides new enforcement
implement section 305 of the Public expected benefits qualitatively. (For a authorities to help achieve higher rates
Health Security and Bioterrorism more complete qualitative discussion of of compliance with risk-based,
Preparedness and Response Act of 2002 the benefits, see the PRIA) (Ref. 1). In
(the Bioterrorism Act) (Pub. L. 107–188) prevention-oriented safety standards
addition, we update in this analysis the
(68 FR 58894, October 10, 2003).1 Those and to better respond to and contain
monetized impact associated with
estimated costs were calculated in an problems when they do occur. In
different foodborne outbreak scenarios
economic impact analysis that from the PRIA in order to determine the addition, the law contains important
accompanied the interim final rule (68 amount of savings from illness new tools to better ensure the safety of
FR 58894 at 58932) (hereinafter referred reduction that would be required in imported foods and encourages
to as the ‘‘2003 economic impact order for the final rule to reduce costs partnerships with State, local, tribal,
analysis’’). For the final rule, the that result from foodborne illness by and territorial authorities. A top priority
economic impact analysis was modified approximately the same amount that the for FDA are those FSMA-required
slightly with respect to the costs compliance costs of the final rule would regulations that provide the framework
associated with the U.S. agent impose on food facilities. We expect the for industry’s implementation of
requirement at the final rule stage, final rule would have additional preventive controls and enhance our
which published in the Federal Register benefits that we are similarly unable to ability to oversee their implementation
on October 3, 2005 (70 FR 57505 at quantify, including providing for the for both domestic and imported food. To
57506). more efficient use of FDA’s inspectional that end, we proposed the seven
We also expect that at least some resources. foundational rules listed in Table 2 and
foreign food facilities could increase requested comments on all aspects of
prices as a result of the costs they would I. Background
these proposed rules.
have to incur as a result of the rule. Any A. FDA Food Safety Modernization Act
such potential price increases that could
occur as a result of compliance costs The FDA Food Safety Modernization
would likely be very small relative to Act (FSMA) (Pub. L. 111–353), signed
TABLE 2—PUBLISHED FOUNDATIONAL RULES FOR IMPLEMENTATION OF FSMA

Title Abbreviation Publication
Current Good Manufacturing Practice and Hazard Analysis and Risk- 2013 proposed human preventive 78 FR 3646, January 16, 2013.
Based Preventive Controls for Human Food. controls regulation.
Standards for the Growing, Harvesting, Packing, and Holding of 2013 proposed produce safety 78 FR 3504, January 16, 2013.
Produce for Human Consumption. regulation.
Current Good Manufacturing Practice and Hazard Analysis and Risk- 2013 proposed animal preventive 78 FR 64736, October 29, 2013.
Based Preventive Controls for Food for Animals. controls regulation.
Foreign Supplier Verification Programs (FSVP) or Importers of Food 2013 proposed FSVP regulation ... 78 FR 45730, July 29, 2013.
for Humans and Animals.
Accreditation of Third-Party Auditors/Certification Bodies to Conduct 2013 proposed third-party certifi- 78 FR 45782, July 29, 2013.
Food Safety Audits and to Issue Certifications. cation regulation.
Focused Mitigation Strategies To Protect Food Against Intentional 2013 proposed intentional adulter- 78 FR 78014, December 24, 2013.
Adulteration. ation regulation.
Sanitary Transportation of Human and Animal Food ............................. 2014 proposed sanitary transpor- 79 FR 7006, February 5, 2014.
tation regulation.
1 The authorities of Treasury under section 701(b) and Human Services for the efficient enforcement transferred to DHS when DHS was created by an act
of the FD&C Act (21 U.S.C. 371(b)) to jointly of section 801 of the FD&C Act (21 U.S.C. 381) were of Congress in 2002.
prescribe regulations with the Department of Health
We also issued a supplemental notice of in Table 3 and requested comments on supplemental notice of proposed
proposed rulemaking for the rules listed specific issues identified in each rulemaking.
TABLE 3—PUBLISHED SUPPLEMENTAL NOTICES OF PROPOSED RULEMAKING FOR THE FOUNDATIONAL RULES FOR
IMPLEMENTATION OF FSMA
Current Good Manufacturing Practice and Hazard Analysis and Risk- 2014 supplemental human preven- 79 FR 58524, September 29,
Based Preventive Controls for Human Food. tive controls notice. 2014.
Standards for the Growing, Harvesting, Packing, and Holding of 2014 supplemental produce safety 79 FR 58434, September 29,
Produce for Human Consumption. notice. 2014.
Current Good Manufacturing Practice and Hazard Analysis and Risk- 2014 supplemental animal preven- 79 FR 58476, September 29,
Based Preventive Controls for Food for Animals. tive controls notice. 2014.
Foreign Supplier Verification Programs (FSVP) for Importers of Food 2014 supplemental FSVP notice; 79 FR 58574, September 29,
for Humans and Animals. Supplemental Notice. 2014.
We finalized two of the foundational rules in November 2015. In April 2016, regulation. In May 2016, we finalized
rulemakings listed in Table 4 in we finalized the sanitary transportation the intentional adulteration regulation.
September 2015 and three additional
TABLE 4—PUBLISHED FOUNDATIONAL RULES FOR IMPLEMENTATION OF FSMA

Current Good Manufacturing Practice, Hazard Analysis and Risk- Final human preventive controls 80 FR 55908, September 17,
Based Preventive Controls for Human Food. regulation. 2015.
Current Good Manufacturing Practice and Hazard Analysis and Risk- Final animal preventive controls 80 FR 56170, September 17,
Based Preventive Controls for Food for Animals. regulation. 2015.
Standards for the Growing, Harvesting, Packing, and Holding of Final produce safety regulation ..... 80 FR 74354, November 27, 2015.
Produce for Human Consumption.
Foreign Supplier Verification Programs (FSVP) or Importers of Food Final FSVP regulation ................... 80 FR 74226, November 27, 2015.
for Humans and Animals.
Accreditation of Third-Party Auditors/Certification Bodies to Conduct Final third-party certification regu- 80 FR 74570, November 27, 2015.
Food Safety Audits and to Issue Certifications. lation.
Focused Mitigation Strategies To Protect Food Against Intentional Final intentional adulteration regu- 81 FR 34165, May 27, 2016.
Adulteration. lation.
Sanitary Transportation of Human and Animal Food ............................. Final sanitary transportation regu- 81 FR 20092, April 6, 2016.
lation.
Section 102 of FSMA, entitled 600 engagements on FSMA and the food facilities in the Federal Register on
Registration of Food Facilities, amends proposed rules, including public April 9, 2015 (80 FR 19160). We
section 415 of the FD&C Act regarding meetings, Webinars, listening sessions, received numerous comments submitted
requirements for food facility farm tours, and extensive presentations on the proposed rule.
registration along with other sections of and meetings with various stakeholder This rule is part of FDA’s
the FD&C Act involving food facility groups (Refs. 2 to 4). As a result of this implementation of FSMA, which
registration. Further, a number of stakeholder dialogue, FDA decided to intends to better protect public health
provisions in FSMA apply to only issue the four supplemental notices of by, among other things, adopting a
facilities that are required to register proposed rulemaking to share our modern, preventive, and risk-based
under section 415 of the FD&C Act, current thinking on key issues and get approach to food safety regulation. This
including hazard analysis and risk- additional stakeholder input on those regulation would implement certain
based preventive controls and issues. As we move forward into the provisions in section 415 of the FD&C
mandatory recall authority. next phase of FSMA implementation, Act, as amended by section 102 of
With the finalization of the seven we intend to continue this dialogue and FSMA, that relate to registration of food
foundational rulemakings, we are collaboration with our stakeholders, facilities. In addition, this regulation
putting in place a modern, risk-based through guidance, education, training, amends and updates FDA’s registration
framework for food safety that is based and assistance, to ensure that everyone regulations and improves the utility of
on the most recent science, that focuses understands and engages in their role in the food facility registration database to
effort where the hazards are reasonably food safety. FDA believes these seven further enhance FDA’s capabilities with
likely to occur, and that is flexible and foundational final rules, when respect to responding to food-related
practical given our current knowledge of implemented, will fulfill the paradigm emergencies, and in addition, provides
food safety practices. To achieve this, shift toward prevention that was FDA with information that we can use
FDA has engaged in a great deal of envisioned in FSMA and be a major step to focus and better utilize our limited
outreach to the stakeholder community forward for food safety that will help inspection resources.
to find the right balance in these protect consumers into the future.
regulations of flexibility and C. Summary of the Major Provisions of
accountability. B. Purpose of This Rulemaking the Proposed Rule
After FSMA was enacted in 2011, we We published the proposed rule Section 102 of FSMA, entitled
have been involved in approximately regarding amendments to registration of Registration of Food Facilities, amends
section 415 of the FD&C Act regarding category information by authorizing United States, or otherwise introduce
requirements for food facility FDA to determine other food product food from the facility into interstate or
registration along with other sections of categories, including those not intrastate commerce in the United
the FD&C Act involving food facility specifically identified in § 170.3. States. Under section 301(d) of the
registration. Further, other sections of Specifically, section 415(a)(2) of the FD&C Act (21 U.S.C. 331(d)), as
FSMA include amendments that apply FD&C Act, as amended by section amended by section 102(b) of FSMA,
to facilities that are required to register 102(a)(1)(B) of FSMA, provides in the introduction or delivery for
under section 415 of the FD&C Act. relevant part that, when determined introduction into interstate commerce of
necessary by FDA ‘‘through guidance,’’ an article of food in violation of section
1. Section 102 of FSMA: Registration of
a registrant is required to submit a 415 is a prohibited act. Further, section
Food Facilities
registration to FDA containing 801(l) of the FD&C Act, as amended by
Section 102 of FSMA includes a information necessary to notify FDA of section 102(b) of FSMA, provides, in
number of amendments to food facility the general food category (as identified relevant part, that an article of food
registration requirements or sections of in § 170.3 or any other food categories, being imported or offered for import
the FD&C Act involving food facility as determined appropriate by FDA, into the United States that is from a
registration. First, section 102 of FSMA including by guidance) of any food foreign facility for which a registration
amends section 415 by requiring that manufactured, processed, packed, or has been suspended under section 415
certain additional information be held at such facility. In October 2012, must be held at the port of entry for the
included in registrations. More FDA issued a guidance entitled article of food, and may not be delivered
specifically, section 102(a)(1)(A) of ‘‘Guidance for Industry: Necessity of the to the importer, owner, or consignee of
FSMA amends section 415 to provide Use of Food Product Categories in Food the article. FDA intends to address the
that registrations for domestic food Facility Registrations and Updates to suspension of registration provisions in
facilities are required to contain the Food Product Categories’’ (Ref. 5). This section 102(b) of FSMA in a separate
email address for the contact person of guidance represents FDA’s conclusion rulemaking.
the facility, and registrations for foreign on the necessity of food product Section 102(b) of FSMA also
food facilities are required to contain categories in food facility registrations authorizes FDA to require that all food
the email address of the U.S. agent for and identifies other food product facility registrations be submitted to
the facility. Also, section 102(b)(1)(A) of categories that are necessary and FDA in an electronic format; however,
FSMA provides that all food facility appropriate for food facility registration, such requirement cannot take effect
registrations are required to contain an as provided by section 415(a)(2) of the before the date that is 5 years after the
assurance that FDA will be permitted to FD&C Act. date of enactment of FSMA (i.e., January
inspect the facility at the times and in Third, section 102(a)(3) of FSMA 4, 2016). We proposed to add a waiver
the manner permitted by the FD&C Act. amends section 415 to provide that food request provision to allow a registrant to
These FSMA amendments were self- facilities required to register with FDA submit a written request to FDA that
implementing and became effective must renew their registrations with FDA explains why it is not reasonable to
upon enactment of FSMA. These FSMA every 2 years, between October 1 and submit the registration or registration
amendments were included in the December 31 of each even-numbered renewal to FDA electronically.
proposed rule to codify the provisions year, by submitting registration Lastly, section 102(c) of FSMA directs
in 21 CFR part 1, subpart H, the renewals to FDA. Further, section FDA to amend the definition of the term
registration of food facilities regulation. 102(a)(3) of FSMA directs FDA to ‘‘retail food establishment’’ in § 1.227 of
Second, section 102 of FSMA amends provide for an abbreviated registration title 21, Code of Federal Regulations to
section 415 with respect to updating renewal process for any registrant that clarify that, in determining the primary
food product category information has not had any changes to such function of an establishment or a retail
required in food facility registrations. information since the registrant food establishment under such section,
Before FSMA was enacted, section submitted the preceding registration or the sale of food products directly to
415(a)(2) of the FD&C Act, as added by registration renewal for the facility. consumers by such establishment and
section 305 of the Public Health Fourth, section 102(b) of FSMA the sale of food directly to consumers by
Security and Bioterrorism Preparedness amends section 415(b) of the FD&C Act such retail food establishment include:
and Response Act of 2002 (the by adding new provisions authorizing (1) The sale of food products or food
Bioterrorism Act) (Pub. L. 107–188), FDA to suspend the registration of a directly to consumers by such
provided in relevant part that, when food facility in certain circumstances. establishment at a roadside stand or
determined necessary by FDA ‘‘through Specifically, if FDA determines that farmers’ market where such stand or
guidance,’’ a registrant must submit a food manufactured, processed, packed, market is located other than where the
registration to FDA containing received, or held by a registered facility food was manufactured or processed; (2)
information necessary to notify FDA of has a reasonable probability of causing the sale and distribution of such food
the general food category (as identified serious adverse health consequences or through a community supported
in § 170.3) of food manufactured, death to humans or animals, FDA may agriculture program; and (3) the sale and
processed, packed, or held at such by order suspend the registration of a distribution of such food at any other
facility. On July 17, 2003, FDA issued a facility that created, caused, or was such direct sales platform as determined
guidance document stating that FDA otherwise responsible for such by the Secretary.
had determined that the inclusion of reasonable probability; or knew of, or
food product categories in food facility had reason to know of, such reasonable 2. Discussion of Other FSMA
registrations was necessary for a quick, probability and packed, received, or Amendments Involving Food Facilities
accurate, and focused response to an held such food. Under section 415(b)(4) Required To Register Under Section 415
actual or potential bioterrorist incident of the FD&C Act, as amended by section of the FD&C Act
or other food-related emergency (see 68 102(b) of FSMA, if the registration of a In addition to amending section 415
FR 42415). Section 102(a)(1)(B) of food facility is suspended, no person of the FD&C Act and the other related
FSMA amends section 415(a)(2) of the can import or export, or offer to import sections of the FD&C Act as discussed
FD&C Act with respect to food product or export, food from the facility into the in the preceding section, FSMA also
amended the FD&C Act such that Further, section 107 of FSMA registration now also serves to
section 415 functions in connection amended the FD&C Act to provide FDA determine the applicability of
with other food safety provisions. For with the authority to collect fees related provisions in other sections of the FD&C
instance, FSMA added section 418 of to reinspections of facilities required to Act, including sections 417, 418, 421,
the FD&C Act (21 U.S.C. 350g), which register under section 415 of the FD&C 423, 743, 807, and 808 of the FD&C Act.
establishes certain preventive control Act. Specifically, section 107 of FSMA Thus, food facility registration now
requirements for food facilities that are added section 743(a)(1)(A) of the FD&C relates to many more food safety
required to register under section 415. Act (21 U.S.C. 379j–31(a)(1)(A)), which requirements than when the system was
In general, section 418(a) requires the provides FDA with the authority to first implemented in 2003.
owner, operator, or agent in charge of a assess and collect fees from domestic
3. Rulemaking Required by Section
‘‘facility’’ to evaluate the hazards that facilities (as defined in section 415(b) of
103(c) of FSMA: On-Farm Activities
could affect food manufactured, the FD&C Act) and U.S. agents for
processed, packed, or held by such foreign facilities (also as defined in Section 103(c)(1)(A) of FSMA,
facility, identify and implement section 415(b) of the FD&C Act) subject regarding Hazard Analysis and Risk-
preventive controls, monitor the to reinspection to cover reinspection- Based Preventive Controls, requires that
performance of those controls, and related costs. the Secretary publish a notice of
maintain records of the monitoring. The FSMA is not the only act in which proposed rulemaking in the Federal
term ‘‘facility’’ is defined in section Congress has linked food facility Register to issue regulations with
418(o)(2) as ‘‘a domestic facility or a registration to specific food safety respect to ‘‘activities that constitute on-
foreign facility that is required to requirements. The Food and Drug farm packing or holding of food that is
register under section 415.’’ Administration Amendments Act of not grown, raised, or consumed on such
In addition, section 201(a) of FSMA 2007 (FDAAA) also tied food safety farm or another farm under the same
created section 421 of the FD&C Act (21 requirements to food facility ownership’’ and ‘‘activities that
U.S.C. 350j), which also ties to section registration. FDAAA amended the FD&C constitute on-farm manufacturing or
415. In particular, section 421 requires Act by creating section 417, which processing of food that is not consumed
the Agency to identify high-risk generally requires a ‘‘responsible party’’ on that farm or on another farm under
‘‘facilities’’ and mandates more frequent to submit a report to FDA through the common ownership’’ within the context
inspections for domestic high-risk Reportable Food Registry after of section 415 of the FD&C Act. Section
‘‘facilities’’ than for domestic non-high- determining that an article of food is a 103(c)(1)(B) of FSMA provides that such
risk facilities. Section 421 also includes reportable food as defined in section rulemaking will ‘‘enhance the
an inspection mandate for foreign 417(a)(2) and further defined in section implementation of . . . section 415 and
facilities. For the purposes of section 201(f) of the FD&C Act (21 U.S.C. clarify the activities that are included as
421, the term ‘‘facility’’ refers to 321(f)). As stated previously, section part of the definition of the term
facilities that are required to register 417 of the FD&C Act defines the term ‘facility’ under such section 415.’’ In the
under section 415. (See section 421(e)). ‘‘responsible party’’ as a person that Federal Register of January 16, 2013 (78
In addition, section 306 of FSMA added submits the registration under section FR 3646), we published a proposed rule
section 807(a)(1) of the FD&C Act (21 415(a) of the FD&C Act for a food entitled ‘‘Current Good Manufacturing
U.S.C. 384c(a)(1)), which provides that facility that is required to register under Practice and Hazard Analysis and Risk-
FDA may enter into arrangements and section 415(a) of the FD&C Act, at which Based Preventive Controls for Human
agreements with foreign governments to such article of food is manufactured, Food’’ to implement section 103 of
facilitate the inspection of foreign processed, packed, or held. (See section FSMA and we discuss our proposal to
facilities registered under section 415. 417(a)(1) of the FD&C Act.) revise the registration of food facilities
FSMA also created section 423 of the As a result of these links between regulations (part 1, subpart H) as
FD&C Act (21 U.S.C. 3501), which food facility registration and additional specified by section 103(c)(1) of FSMA.
provides a ‘‘responsible party’’ an requirements in the FD&C Act, food In the Federal Register of September 29,
opportunity to voluntarily cease facility registration now serves 2014 (79 FR 58524), we published a
distribution and recall a food under additional functions to those originally supplemental notice of proposed
specified circumstances and also identified in the food facility rulemaking to amend the 2013
provides FDA with authority to mandate registration regulations issued in 2003 preventive controls proposed rule. We
a recall under specified circumstances. and finalized in 2005 (68 FR 58894; 70 finalized the rulemaking on September
The term ‘‘responsible party’’ is defined FR 57505). More specifically, the 17, 2015. See ‘‘Current Good
by reference to the definition in section interim final rule noted that food facility Manufacturing Practice, Hazard
417 of the FD&C Act (21 U.S.C. 350f), registration would help FDA act quickly Analysis and Risk-Based Preventive
which in turn defines that term as a in responding to a threatened or actual Controls for Human Food,’’ 80 FR
person that submits the registration bioterrorist attack on the U.S. food 55908. That rule is a separate
under section 415(a) of the FD&C Act for supply or to other food-related rulemaking and not the subject of this
a food facility that is required to register emergencies (68 FR 58894 at 58895). It rulemaking.
under section 415(a) of the FD&C Act, also noted that registration would
at which such article of food is provide FDA with information about D. Public Comments
manufactured, processed, packed, or food facilities that would help FDA and We received over 1,000 submissions
held. (See section 417(a)(1) of the FD&C other authorities determine the source on the proposed amendments to food
Act.) In addition, FSMA created section and cause of an outbreak of foodborne facility registration rule by the close of
808 of the FD&C Act (21 U.S.C. 384d), illness, while also enabling FDA to the comment period, each containing
which provides for the recognition of notify more quickly the facilities that one or more comments on various
accreditation bodies that accredit third- might be affected by the outbreak (68 FR aspects of the proposal. We received
party auditors to conduct food safety 58894 at 58895). While food facility submissions from a wide array of
audits of foreign food entities, including registration continues to serve all of members of the public, including
foreign food facilities registered under those functions, with the passage of individual farmers; cooperatives;
section 415. FSMA and FDAAA, food facility coalitions; trade organizations;
consulting firms; law firms; academia; involved. Section 301(dd) of the FD&C enable identification of the registrant
public health organizations; public Act provides that failure to register in and validation of the registration data,
advocacy groups; consumers; consumer accordance with section 415 of the as appropriate, for registrations
groups; government agencies; and other FD&C is a prohibited act. Section 801(l) submitted to FDA electronically. Thus,
organizations. Some submissions of the FD&C Act provides that an article FDA has the authority to issue this rule
included signatures and statements from of food being imported or offered for under section 305 of the Bioterrorism
multiple individuals. Comments import into the United States that is Act, sections 102 and 107 of FSMA, and
addressed numerous provisions of the from a foreign facility for which a sections 301(dd), 415, 701(a), 704, and
proposed food facility registration rule, registration has not been submitted to 801 of the FD&C Act.
including our requests for comments on FDA under section 415 (or for which a We are including in this final rule the
various topics. Some comments registration has been suspended under requirements of section 102 of FSMA
addressed issues that are outside of the such section) must be held at the port that were self-implementing and
scope of this rule. We do not discuss of entry for the article of food, and may effective upon enactment of FSMA, as
such comments in this document. not be delivered to the importer, owner, discussed previously, in the Registration
In sections III through XIII of this or consignee of the article until the of Food Facilities regulation (21 CFR
document, we describe the comments foreign facility is so registered. Section part 1, subpart H). In addition, we are
we received on the rule, respond to 701(a) of the FD&C Act authorizes FDA including in this final rule other
them, and explain any changes we made to issue regulations for the efficient requirements of section 102 of FSMA,
to the proposed food facility registration enforcement of the FD&C Act. As such as mandatory electronic
rule. We discuss comments that ask us discussed previously, section 102(c) of registration submissions and
to clarify the proposed requirements or FSMA also directs FDA to amend the amendments to the definition of ‘‘retail
that disagree with, or suggest one or definition of the term ‘‘retail food food establishment’’ in § 1.227. Lastly,
more changes to, the proposed establishment’’ in FDA’s Registration of we are including in this final rule other
requirements. Our responses to the Food Facilities Regulation at § 1.227. changes to improve the utility of the
comments include our reasons for food facility registration database and
As discussed in this final rule, we are
determining whether to modify any of adding a waiver request provision to
revising our regulations to require
the proposed requirements. allow a facility to submit a written
additional data elements in food facility
request to FDA that explains why it is
II. Legal Authority registrations to provide for more not reasonable to submit the
We are issuing this final rule under efficient and effective communications registration, registration renewal,
the FD&C Act, FSMA, and the during a public health emergency and to updates, and cancellations to FDA
Bioterrorism Act. FDA’s legal authority provide FDA information that we can electronically or to explain why it is not
to implement requirements of section use to focus and better deploy the reasonable to provide the email address
102 of FSMA derives from section 102 Agency’s limited inspectional resources. of the owner, operator, or agent in
of FSMA and sections 415, 301(dd), FDA’s legal authority to implement charge of the facility.
801(l), and 701(a) of the FD&C Act. As these and other changes to improve the
discussed previously, section 415 of the utility of the food facility registration III. General Comments on the Proposed
FD&C Act requires food facilities that database also derives from section 102 Rule
manufacture/process, pack, or hold food of FSMA and the sections of the FD&C (Comment 1) Comments urge FDA to
for consumption in the United States to Act described in the previous exempt all facilities that make less than
register with FDA by submitting certain paragraph. Section 415(a)(2) of the $500,000 a year in sales who also sell
information to the Agency and updating FD&C Act requires foreign facilities to most of their food locally.
such information as necessary. Section submit registrations to FDA that include (Response 1) To the extent that the
415(a)(2) of the FD&C Act, as amended the name of the U.S. agent for the comment is asking that all facilities with
by section 102 of FSMA, requires, in facility. Further, FDA is relying on annual sales of less than $500,000 be
relevant part, food facility registrations section 107 of FSMA and sections 421 exempt from the registration
to include additional information, and 704 (21 U.S.C. 374) of the FD&C Act requirement, we do not agree. Neither
including the email addresses of contact in issuing these proposed changes. the Bioterrorism Act nor the FSMA
persons for domestic facilities and U.S. Section 107 of FSMA amended the amendments regarding food facility
agents for foreign facilities; an assurance FD&C Act to provide FDA with the registration exempt facilities from the
that FDA will be permitted to inspect authority to assess and collect certain requirement to register based on their
the facility at the times and in the fees from, inter alia, U.S. agents for size. Furthermore, facilities under this
manner permitted by the FD&C Act; and foreign facilities (as defined in section size may be linked to food-related
updated food product category 415(b) of the FD&C Act) subject to emergencies, and having registration
information, if determined necessary reinspection to cover reinspection- information for these facilities can
and appropriate by FDA. Further, related costs. Section 704 gives FDA the facilitate FDA’s response to such
section 415(a)(3) of the FD&C Act, as authority to inspect factories, emergencies.
amended by section 102 of FSMA, warehouses, and other establishments in (Comment 2) Several comments state
requires, in relevant part, food facilities which foods are manufactured, that small food producers or hobbyists
required to register to renew their processed, packed, or held. Section 421 who make food out of their home and
registrations with FDA between October of the FD&C Act requires the Agency to also sell the food at farmers’ markets
1 and December 31 of each even- identify high-risk facilities and and to other consumers should not be
numbered year, and directs FDA to mandates more frequent inspections for required to register.
provide for an abbreviated registration domestic high-risk facilities than for (Response 2) Under 21 CFR 1.227, a
renewal process for registrants that have domestic non-high-risk facilities. FDA is private residence is not a ‘‘facility’’ and
not had any changes to registration also relying on section 305(d) of the thus, is not required to be registered. A
information since the registrant Bioterrorism Act, which directs FDA, in private residence must meet customary
submitted the preceding registration or relevant part, to ensure adequate expectations for a private home and
registration renewal for the facility authentication protocols are used to does not otherwise include commercial
facilities in which a person also conditioning. The comment states that a relationship with a foreign authority,
happens to reside. Thus, a private establishments that are required to the foreign registration could be
residence that meets customary register are now subject to more accepted as assurance that foreign
expectations for a private residence that considerable regulatory requirements. businesses are in good standing with the
is also used to manufacture, process, (Response 3) FDA requires national competent authority. The
pack, or hold food need not be registration of any facility that comment also states that the
registered. Accordingly, if the activities manufactures/processes, packs, or holds requirement to register is particularly
of small food producers or hobbyists food for consumption in the United onerous for foreign businesses and that
meet customary expectations for a States. ‘‘Food’’ is defined in section many foreign businesses are not familiar
private residence, the producers or 201(f) of the FD&C Act to include with the norms of U.S. government
hobbyists would not be required to articles used for food or drink for man agencies.
register. or other animals. The comment states (Response 4) We disagree that a
(Comment 3) One comment requests that seed conditioning establishments foreign facility should not be required to
that FDA exclude seed conditioning should not be required to register register. Section 415(a)(1) of the FD&C
facilities that direct some seeds to because they do not intend to Act requires that each domestic and
animal food use from the requirement to manufacture, process, pack, or hold foreign facility be registered. ‘‘Facility’’
register. The comment describes seed food for animal consumption. We is defined as ‘‘any factory, warehouse,
conditioning facilities as facilities that decline to provide any specific or establishment (including a factory,
exclusions for seed conditioning warehouse, or establishment of an
clean, grade, size, disinfect, dry, sort,
establishments from the requirements importer) that manufactures, processes,
screen, fumigate, and/or blend seeds to
for registration. As we stated in the packs, or holds food’’ (21 U.S.C.
prepare seed intended for cultivation for
Agency’s ‘‘Guidance for Industry: 350d(c)(1)). In addition, ‘‘foreign
commercial sales. The comment states
Questions and Answers Regarding Food facility’’ is defined as a facility that
that these establishments do not intend
Facility Registration,’’ an establishment ‘‘manufactures, processes, packs, or
to manufacture, process, pack, or hold
that conditions seed for planting holds food, but only if food from such
food for consumption and are therefore
purposes is a facility that must be a facility is exported to the United
‘‘not in the animal food business.’’ The
registered if the owner, operator, or States for consumption in this country
comment states that such
agent in charge of the establishment without further processing or packaging
establishments instead intend to prepare reasonably believes that the seed is outside the United States’’ (21 U.S.C.
seed for planting purposes. The reasonably expected to be directed to 350d(c)(3)(A)). Therefore, food facilities
comment states that when some seeds food use, including animal food use or that are foreign facilities and do not
become cracked, damaged during the as an ingredient in animal food (Ref. 6). qualify for an exemption under § 1.226
process, or they may not be suitable for Whether a particular establishment is must register. Further, obtaining
cultivation, they cannot be used for required to register will depend on the registration information from other
planting. In those situations, the specific nature of the establishment. The foreign government agencies would not
establishment may direct the seeds for comment describes establishments that guarantee that FDA has all of the
use in animal food (or, alternatively, may direct cracked, damaged, culled, or required information for food facility
may direct the seeds for incineration excess seeds for use in animal food. If registration purposes for all foreign
and landfilling). The comment further an establishment that manufactures/ facilities. Foreign governments might
states that establishments may direct the process, packs, or holds the seed not require the same registration
seeds for animal food use if there is an reasonably believes that the seed is information as required in this final
oversupply of seeds that would reasonably expected to be directed to rule, in part because the registration
otherwise be cultivated. In addition, the such food use, the establishment must systems in foreign countries might serve
comment asks that FDA revise the be registered. The comment also states different purposes from FDA’s. The
Agency’s ‘‘Guidance for Industry: that some establishments may direct registration information required in this
Questions and Answers Regarding Food such cracked, damaged, culled, or final rule is designed to assist FDA in
Facility Registration (Fifth Edition)’’ to excess seeds for incineration and responding to bioterrorist or other food-
state that seed conditioning facilities are landfilling. If a seed conditioning related emergencies and to assist FDA in
not required to register. In that establishment directs the seeds only to better utilizing its limited inspection
guidance, FDA stated that an uses such as cultivation or to resources, among other purposes.
establishment that manufactures/ destruction (such as incineration or (Comment 5) Several comments
processes and sells seed to farmers is a landfill), the establishment would not recommend amending the definition of
facility that must be registered if the be required to register. retail food establishment to exclude
owner, operator, or agent in charge of Discussion on the application of the vending machines that manufacture
the establishment reasonably believes ‘‘Current Good Manufacturing Practice, food within the vending unit itself
that the seed is reasonably expected to Hazard Analysis, and Risk-Based before selling it directly to the
be directed to a food use, including Preventive Controls for Food for consumer. Comments state that vending
animal food use or as an ingredient in Animals’’ rule (80 FR 56170, September machines should have to register and
animal food. However, if the seed is 17, 2015) is outside the scope of this that self-serve ice vending machines are
reasonably expected only to be rule making. packaging ice and reselling packaged
cultivated, the guidance states that the (Comment 4) A comment suggests that food to retail clients. The comments
establishment is not required to be FDA should reconsider whether foreign state that an outbreak in foodborne
registered. The comment states that facilities should be required to register. illness linked to retail vending
because FSMA added certain preventive The comment states that most countries machines would have a devastating
control requirements under section 418 have an authorization or registration impact on the packaged ice industry as
of the FD&C Act for food facilities that system and businesses in those a whole.
are required to register under section countries will already be registered with (Response 5) Under § 1.227, a ‘‘retail
415, FDA should rethink the aspect of the relevant authority in their country. food establishment’’ includes grocery
the registration guidance regarding seed The comment states that where FDA has stores, convenience stores, and vending
machines. We disagree that we should submitting this form to FDA, or by share information derived from our
amend the definition of retail food authorizing an individual to submit this registration database with foreign
establishment to remove vending form to FDA, the owner, operator, or government officials consistent with
machines. Vending machines that sell agent in charge of the facility certifies FDA’s laws and procedures. Any
food products directly to consumers as that the registration information is true sharing of information with another
their primary function are properly and accurate. An individual (other than foreign government would typically be
exempt from registration as retail food the owner, operator, or agent in charge done under 21 CFR 20.89, which
establishments. This is consistent with of the facility) who submits the form to includes confidentiality provisions.
section 415(c)(1) of the FD&C Act, FDA also certifies that the registration
IV. Comments on Proposed
which provides that the term ‘‘facility’’ information is true and accurate and
Amendments to § 1.227—Definitions
does not include retail food that he/she is authorized to submit the
establishments. We acknowledge that registration on the facility’s behalf. We proposed to replace the phrase
outbreaks in any segment of industry Section 13 also provides for the ‘‘the owner, operator, or agent in charge
have a significant impact. We note, individual authorized by the owner, of a facility’’ with ‘‘you’’ throughout the
however, that while vending machines operator, or agent in charge to identify regulatory text in 21 CFR part 1, subpart
and other retail food establishments are the individual who authorized H, because ‘‘you’’ is defined in current
not required to register, they still have submission of the registration and to § 1.227 to mean the owner, operator, or
responsibility for ensuring the safety of provide specified contact information agent in charge of a facility that
their products. for that individual. With regard to the manufactures/processes, packs, or holds
(Comment 6) One comment electronic version of Form FDA 3537, food for consumption in the United
encourages FDA to require farms to section 13 of the form prepopulates with States. We are finalizing this change as
register to prevent what the comment information (as do the other fields). This proposed.
describes as a gap in oversight. is done to keep the process for Furthermore, we note that we have
(Response 6) FDA declines to require registration renewal or updates as redesignated all definitions in § 1.227 in
farms to register as food facilities under streamlined as possible. We understand 21 CFR part 1, subpart H, to eliminate
section 415 of the FD&C Act. The that some applicants will need to edit paragraph designations (such as (a) and
requirement in section 415 that a facility this section to indicate changes to who (b)). FDA made this change in the final
must register does not apply to farms. submits the form, while others may not. rule for ‘‘Current Good Manufacturing
See section 415(c) of the FD&C Act Therefore, we decline the Practice, Hazard Analysis and Risk-
(providing that the term ‘‘facility’’ does recommendation to not pre-populate Based Preventive Controls for Human
not include farms). The comment does this section for electronic registration Food’’ (80 FR 55908).
not explain how requiring farms to renewals or updates. In addition, we A. Retail Food Establishment
register would be consistent with decline the recommendation to require
section 415. the name of the individual associated Under section 415 of the FD&C Act
(Comment 7) One comment requests with the email address provided for the and FDA’s registration regulation (21
modifications to Form FDA 3537. In owner, operator, or agent in charge. We CFR 1.226(c)), a retail food
particular, the comment requests that currently believe that the final rule establishment is not required to register
the registration system should clear all already requires sufficient facility with FDA. A ‘‘retail food establishment’’
information from section 13 of the contact information. However, we will is defined in current § 1.227 to mean an
current Form FDA 3537 whenever a consider adding an optional field for an establishment that sells food products
registration is updated or renewed. The individual’s name associated with the directly to consumers as its primary
comment also states that many owners, required email address in a future function.
operators, or agents in charge of a version of Form FDA 3537. If we add A retail food establishment’s primary
facility may be corporations, not such a field, we will issue a guidance function is to sell food directly to
individuals, and therefore suggests that document in accordance with our good consumers if the annual monetary value
FDA add a field linked to the guidance practice (GGP) regulations in of sales of food products directly to
requirement that facilities provide the 21 CFR 10.115 describing this change. consumers exceeds the annual monetary
email address for the owner, operator, or With regard to the requested value of sales of food products to all
agent in charge. Specifically, the additional technical changes to the other buyers. The definition of retail
comment requests that facilities be able electronic version of the form, we will food establishment also provides that
to provide the name of the individual consider the recommendations and the term ‘‘consumers’’ does not include
associated with that email address. The make changes if appropriate. businesses, and a ‘‘retail food
comment also recommends making (Comment 8) A comment suggests that establishment’’ includes grocery stores,
technical edits to the electronic version FDA should share the list of registered convenience stores, and vending
of the form, such as changes to the pull- businesses with the authorities in the machine locations. Section 102(c) of
down selections in the Facility Name relevant third country. FSMA directs FDA to amend the
Suffix category (allowing facilities to (Response 8) FDA’s list of registered definition of ‘‘retail food establishment’’
indicate, for instance, whether they are facilities and registration documents are to clarify that, in determining the
cooperatives or limited liability not subject to disclosure under the primary function of an establishment,
corporations) and the automatically Freedom of Information Act (FOIA). In the sale of food directly to consumers by
populated telephone country codes. addition, any information derived from such establishment includes: (1) The
(Response 7) Section 13 of the current the list of facilities or registration sale of food directly to consumers by
Form FDA 3537 includes a certification documents that would disclose the such establishment at a roadside stand
statement providing that the owner, identity or location of a specific or farmers’ market where such stand or
operator, or agent in charge of the registered person also is not subject to market is located other than where the
facility, or an individual authorized by disclosure under FOIA (21 U.S.C. food was manufactured or processed; (2)
the owner, operator or agent in charge 350d(a)(5)). the sale and distribution of such food
of the facility, must submit the form. However, FDA believes that in certain through a community supported
The certification states that by circumstances it may be appropriate to agriculture program; and (3) the sale and
distribution of such food at any other We requested comment on what, if presented (Chevron step one)? (Chevron
such direct sales platform as determined any, limitations should be included in U.S.A., Inc., v. NRDC, Inc., 467 U.S.
by the Secretary. In addition, section the proposed definitions for roadside 837, 842 (1984)). If the ‘‘intent of
102(c) provides that the term stands and farmers’ markets, such as Congress is clear,’’ an Agency ‘‘must
‘‘consumer’’ does not include a distance of the roadside stand or give effect to the unambiguously
business. farmers’ market from the farm (80 FR expressed intent of Congress.’’ Id. at
We proposed to amend § 1.227 to 19160 at 19166). In addition, we 843. However, if ‘‘Congress has not
address off-farm sales by an requested comment on whether it is directly addressed the precise question
establishment located on a farm. appropriate to limit the amendment to at issue,’’ and the statute is ‘‘silent or
Specifically, we proposed to clarify that the retail food establishment definition ambiguous with respect to the specific
all sales by an on-farm establishment do to on-farm establishments, as we issue,’’ then our interpretation of the
not have to be on the farm by proposed (Id.). We also requested term ‘‘establishment’’ will be upheld as
specifically addressing how off-farm comment on whether we should provide long as it is based on a ‘‘permissible
sales directly to consumers are to be that off-farm sales to businesses also be construction of the statute’’ (Chevron
counted in determining whether the on- considered in determining an step two). Chevron, 467 U.S. at 842–43;
farm establishment is a retail food establishment’s primary function (Id.). FDA v. Brown & Williamson Tobacco
establishment. We proposed that, in 1. Applicability to On-Farm Corp, 529 U.S. 120, 132 (2000).) To find
determining the primary function of an Establishments no ambiguity, Congress must have
establishment located on a farm, the sale clearly manifested its intention with
of food directly to consumers from such (Comment 9) Numerous comments respect to the particular issue. See e.g.,
an establishment would include sales at state that the amendment to the retail Young v. Community Nutrition Institute,
food establishment definition should 476 U.S. 974, 980 (1986). We have
a roadside stand or farmer’s market, and
not be limited to on-farm determined that, in enacting section
that the roadside stand or farmers’
establishments. These comments 102(c) of FSMA, Congress did not speak
market would not need to be on the
maintain that it should not matter if an directly and precisely to the provision’s
farm where the establishment is located.
establishment is on a farm. Some scope. For instance, in section 102(c)(1)
In determining the primary function of
comments state that there is no statutory of FSMA, Congress provided that FDA
an establishment located on a farm, we
language directing or justifying the amend the definition of retail food
also proposed that the sale of food
proposal to limit the amendment of the establishment to clarify that, ‘‘in
directly to consumers would also
retail food establishment definition to
include the sale and distribution of such determining the primary function of an
on-farm establishments. Comments
food through a community supported establishment or a retail food
suggest that Congress intended the law
agriculture program (CSA). In addition, establishment under such section,’’ the
to apply equally to all direct-to-
we proposed that the sale of food sale of certain direct-to-consumer foods
consumer sales from farms, whether the
directly to consumers would include the should be counted (emphasis added).
sales occur on, or off, the farm. One
sale and distribution of such food at An ‘‘establishment’’ could be any
comment indicates that this definition
other direct-to-consumer platforms, number of types of businesses. An
should reflect the reality of modern
including door-to-door sales; mail, ‘‘establishment’’ could be any business
farming operations. One comment also
catalog and Internet orders; online that manufactures/processes, packs, or
states that local and regional food
farmers’ markets and online grocery entrepreneurs make use of shared holds food for consumption in the
deliveries; religious or other commercial kitchens and have no United States. Alternatively, an
organization bazaars; and state and local storefronts from which to make sales, ‘‘establishment’’ could be the type of
fairs. and that the limitation of the business that commonly sells foods at
We proposed to define ‘‘roadside amendment to on-farm establishments the direct-to-consumer platforms
stand’’, ‘‘farmers’ market’’, and would mean that these entities would enumerated in section 102(c) of FSMA
‘‘community supported agriculture have to register even if all of their sales (i.e., at roadside stands, farmers’
program’’ in § 1.227, based on are directly to consumers. markets, and CSAs).
definitions found in 7 CFR 249.2. (Response 9) We are convinced by the The language in section 102(c) of
Specifically, we proposed to specify that comments to expand the amendment to FSMA provides an express delegation of
a farmers’ market would mean a the retail food establishment definition authority to the Secretary to amend the
location where one or more local to include some non-farm definition of the term ‘‘retail food
farmers assemble to sell from their farms establishments. In particular, we agree establishment’’ in § 1.227 to provide for
directly to consumers and that a with the comments that we should the inclusion of certain specified sales
roadside stand would mean a stand revise the retail food establishment (i.e., farmers’ market, roadside stand,
situated on the side of or near a road or definition to reflect modern farming- and CSA sales) in determining an
thoroughfare at which a farmer sells related practices. We agree that limiting establishment’s primary function
food from his or her farm directly to the amendment to on-farm (FSMA section 102(c)(1)(A)-(B)), as well
consumers. establishments is overly simplistic, as other sales that the Agency may
Finally, we proposed that a CSA given the diverse ways farmers today determine (FSMA section 102(c)(1)(C)).
program would mean a program under engage in value-added processing of The decision to direct the Secretary to
which a farmer or group of farmers their raw agricultural commodities amend § 1.227, and the decision to
grows food for a group of shareholders (RACs). provide that certain sales may be
(or subscribers) who pledge to buy a The comments raise the question of included as determined by the
portion of the farmer’s crop(s) for that what type of businesses section 102(c) Secretary, contemplates the Secretary
season. Under our proposal, this would of FSMA is intended to address. In having certain discretion in effectuating
include CSA programs in which a group construing the scope of section 102(c) of the amendment. While Congress
of farmers consolidate their crops at a FSMA, FDA is confronted with two intended for certain specific sales (i.e.,
central location for distribution to questions. First, has Congress directly farmers’ market, roadside stand, and
shareholders or subscribers. spoken to the precise question CSA sales) to be counted in conducting
a primary function analysis, Congress to manufacture/process foods for sale at operation is a farm-operated business
did not specify to what kind of direct-to-consumer platforms, other and eligible for the retail food
businesses the new analysis would farmers conduct value-added processing establishment exemption from
apply. Instead, Congress left a gap for off of the farm, such as by renting space registration.
the Secretary to fill by regulation. at a shared kitchen. The clarification to In addition, we recognize that some
Because Congress left a gap for the the retail food establishment definition farms are members of cooperatives that
Secretary to fill, under Chevron step two that we included in the proposed rule pool RACs grown, harvested, or raised
FDA may interpret the scope of FSMA would have captured the on-farm by member farms for value-added
section 102(c)(1), provided that FDA’s operations, but not the off-farm processing. The phrase ‘‘one or more
interpretation is not arbitrary, operations. farms’’ in the explanation of the
capricious, or manifestly contrary to the Because farmers conduct meaning of ‘‘farm-operated business’’
statute. Chevron, 467 U.S. at 843 (noting manufacturing/processing in allows cooperatives comprised of
that if a statute is silent with respect to establishments located on farms and off multiple farms performing certain
an issue the Agency’s answer to the of farms, we conclude that it is manufacturing/processing activities to
issue should be based on a permissible reasonable to interpret section 102(c) of be eligible for the retail food
interpretation of the statute). FSMA to apply to on-farm establishment exemption from
The language in section 102(c) of establishments and certain off-farm registration.
FSMA does not specifically prescribe operations tied to farms. Accordingly, Regarding the example of shared
the provision’s scope, but it does we have finalized our proposal to commercial kitchens in the comment, if
provide examples of the kind of address off-farm sales by establishments an establishment is a retail food
circumstances in which Congress located on farms. In addition, in the establishment under § 1.227, a
intended the retail food establishment final rule, we have revised the retail commercial kitchen that is co-located
amendment applying. In directing the food establishment definition to also with, and thus, part of, the retail food
Secretary to include certain sales in state that the sale of food directly to establishment, is not required to be
determining the primary function, consumers by a farm-operated business registered.
section 102(c) directs the Secretary to includes the sale of food by that farm- 2. Sale of Food Directly to Consumers at
include sales at roadside stands and operated business directly to a Roadside Stand or Farmers’ Market
farmers’ markets located other than consumers: At a roadside stand or
where the food was manufactured or farmers market; through a CSA; and at (Comment 10) One comment states
processed, as well as CSAs (FSMA other such direct-to-consumer sales that farmers’ markets and roadside
section 102(c)(1)(A)–(B)). Sales platforms. By ‘‘farm-operated business,’’ stands should be considered retail food
platforms such as these are closely we mean a business that is managed by establishments, including those markets
associated with food produced by one or more farms and that conducts and stands that handle products or
farmers. Even in section 102(c)(1)(C) of manufacturing/processing not on the produce grown on a particular farmer’s
FSMA, Congress directed the Secretary farm(s). Thus, under the final rule, an property.
to include the sale and distribution of establishment located on a farm that (Response 10) We agree that farmers’
‘‘such food at any other such direct sales sells apples it grows and apple pies it markets and roadside stands may be
platform’’ as determined by the manufactures directly to consumers at a considered retail food establishments
Secretary (emphasis added). This farmer’s market would consider those even when they sell products not
suggests that the other platforms sales in determining its primary manufactured or grown on the property
Congress contemplated were platforms function. At the same time, if a farmer of the farmers selling those foods. The
that were akin to those listed in section manufactures or manages the test for whether such farmers’ markets
102(c)(1)(A)–(B) and involved food akin manufacturing of jellies from the apples and roadside stands are retail food
to that contemplated by section that he grows at an off-farm location, establishments is whether they sell food
102(c)(1)(A)–(B). Given that farmers such as an incubator kitchen, and sells directly to consumers as their primary
represent the overwhelming majority of those jellies at a farmer’s market, the function. The food sold directly to
businesses that commonly sell foods at jelly-making operation would be a farm- consumers can be produced by the
the direct-to-consumer platforms operated business and may consider farmers selling the food, but need not
enumerated in section 102(c) of FSMA those sales in determining its primary be.
(i.e., at roadside stands, farmers’ function. (Comment 11) One comment states
markets, and CSAs), it is reasonable to We recognize that some farmers rent that because farms may aggregate food
interpret section 102(c) of FSMA as space at off-farm manufacturing/ produced by other farms, the definition
applying to farmers and businesses processing facilities, like shared for farmers’ markets should not specify
closely tied to farms. Under this kitchens, to conduct value-added that the food sold by local farmers is
interpretation, section 102(c) allows processing. The ‘‘business’’ we are ‘‘from their farms.’’ Comments also
farmers to manufacture/process food for referring to in ‘‘farm-operated business’’ argue that the definition of roadside
sale without triggering registration, is the business entity conducting the stands and farmers’ markets should
provided that the primary function of manufacturing/processing operations. encompass stands at which any vendors
the farmer’s manufacturing/processing The ownership of the physical building, sell food directly to consumers, and that
operation is the sale of food directly to e.g., the ownership of the shared it should not be limited to stands at
consumers. kitchen, where the manufacturing/ which farmers sell food from their farms
Our proposal to clarify the retail food processing occurs is not relevant. Thus, directly to consumers as FDA proposed.
establishment definition recognized that if an apple grower leases space at an off- (Response 11) The definitions of
some farmers conduct manufacturing/ farm incubator kitchen to manufacture farmers’ markets and roadside stands
processing. However, our proposed apple jellies, ownership of the incubator are based on definitions found in 7 CFR
clarification would have only applied to kitchen building would not be relevant. 249.2, and we are wary of adopting
establishments located on farms. We Because the apple farmer manages the definitions of these terms that are
recognize that while some farmers have off-farm apple jelly manufacturing significantly different from the
the space and equipment on their farms operation, the apply jelly manufacturing definitions of the same terms held by
USDA. Moreover, we do not believe that to interact with and have more ready through a platform that resembles a CSA
changing the definitions as suggested by access to a larger customer base, and but does not sell crops could still be
the comments would have any practical that these metropolitan areas are used in determining the establishment’s
effect. That’s because the presence of removed from the rural areas where primary function in the final rule.
non-farmers at a farmers’ market or growing takes place. Comments also Paragraphs (1)(iii) and (2)(iii) of the
roadside stand would not mean that a state that grocery stores and other retail food establishment amendment
location that would otherwise meet the entities that identify as retail food are catchalls that include the sale of
definition of a farmers’ market or establishments have no mileage food at other direct-to-consumer
roadside stand would not be considered limitations connected to their platforms. Provided that the
a farmers’ market or roadside stand. headquarters, so there should be no requirements of those paragraphs are
Further, whether food is sold at reason to apply such a distinction to satisfied, an establishment could
farmers’ markets or roadside stands is similarly situated businesses. consider sales through that platform in
less important for the purposes of this (Response 12) FDA agrees with the determining its primary function if
rule than whether the food is sold comments recommending against either the establishment is: (1) Located
directly to consumers. An establishment distance limitations in the definitions on a farm; or (2) is a farm-operated
is exempt from registration as a retail for farmers’ markets and roadside business and the requirements
food establishment if the stands. In enacting section 102(c) of applicable to farm-operated businesses
establishment’s primary function is to FSMA, Congress directed FDA to clarify are met.
sell food directly to consumers, that in determining the primary
regardless of whether the food is sold function of an establishment, the sale of 4. Sale and Distribution of Food at Any
through farmers’ markets, roadside food directly to consumers by such Other Direct-to-Consumer Sales
stands, or other direct-to-consumer establishments includes the sale of food Platforms
platforms. Farmers’ markets and at a roadside stand or farmers’ market, (Comment 14) Most comments agree
roadside stands are examples of direct- where such stand or market is located with the list of direct-to-consumer
to-consumer sales platforms that are other than where the food was platforms that we proposed. One
specifically mentioned in the manufactured or processed. Section comment, however, states that FDA
amendment to the definition of retail 102(c) of FSMA does not provide a should not consider as direct-to-
food establishment, but the catchall limitation on distance, and we decline consumer sales those sales by mail,
provisions in paragraphs (1)(iii) and to add such a limitation on our own catalog or Internet order, or through
(2)(iii) provide that the sale of food accord. online farmers’ markets or online
directly to consumers includes the sale grocery delivery. The comment states
3. Sale and Distribution of Food that allowing these types of sales creates
and distribution of food at other direct-
Through a Community Supported an opportunity for an on-farm
to-consumer platforms. As a result,
Agriculture Program manufacturing operation that sells large
changing the definitions of farmers’
market and roadside stand as the (Comment 13) One comment urges volumes of food in interstate commerce
comments suggest would have little, if FDA to define CSAs as involving the to fall within the retail food
any, impact on the scope of this rule. sale of ‘‘food’’ rather than ‘‘crops,’’ as establishment definition. The comment
Therefore, we decline the comments’ we proposed. The comment states that further states that a common feature of
suggestions and are finalizing CSAs may involve the distribution of sales at roadside stands, farmers’
definitions consistent with our food other than crops. markets, and CSAs listed in section
proposal. (Response 13) FDA agrees that CSA 102(c)(1) of FSMA is that they are
(Comment 12) One comment activities are not limited to only selling conducted face-to-face and it is likely
recommends that we specify that the ‘‘crops.’’ For example, a farm mixed- that Congress meant to provide FDA
‘‘local farmers’’ at a farmers’ market be type facility may sell strawberries it with flexibility to consider as direct-to-
from within the same state as the point grows and strawberry jam that it consumer sales other local face-to-face
of sale or within 275 miles of the point manufactures directly to consumers transactions that are similar to the
of sale. However, most of the comments through a CSA. Whether the on-farm specified exempt activities, but not
that addressed our request for comments manufacturing establishment is a retail platforms such as direct-to-consumer
on distance limitations for farmers’ food establishment, and thus exempt mail, catalog, or Internet sales that
markets and roadside stands expressed from registration, would depend on would allow for national sales.
concern about any such limitations. whether its primary function is to sell (Response 14) We agree that section
Some comments state there should be food directly to consumers. 102(c) of FSMA directs FDA to address
no distance limitation because the As to whether we should change the certain direct-to-consumer sales in
distance from a farm to a roadside stand proposed definition of CSAs to refer to clarifying the retail food establishment
or farmers’ market does not change the ‘‘food’’ instead of ‘‘crop(s),’’ we do not definition. However, we disagree with
fact that the food is being provided believe such a change is warranted. the objection to including the sale of
directly to consumers. Some comments Section 102(c) of FSMA provides that food through mail, catalog and Internet
state that there is no established public for the purposes of the retail food orders, including online farmers’
health risk related to the distance establishment definition, ‘‘the term markets and online grocery delivery, in
between a farm and sales locations such ‘community supported agriculture determining the primary function of an
as farmers’ markets and roadside stands. program’ has the same meaning given establishment that is either located on a
One comment states that there is no the term . . . in section 249.2 of title 7, farm or that is a farm-operated business.
risk-based justification for including Code of Federal Regulations (or any As discussed in the proposed rule (80
distance limitations in the definitions successor regulation).’’ Because 7 CFR FR 19160 at 19166), these direct sales
for farmers’ markets and roadside 249.2 refers to ‘‘crop(s),’’ not ‘‘food,’’ we platforms are common platforms for
stands. Comments also note it is not do not believe that the change suggested direct-to-consumer sales of foods from
uncommon for farms to locate stands or by the comments would be consistent farms. Although such sales might not be
take part in farmers’ markets in with section 102(c) of FSMA. However, face-to-face, direct-to-consumer sales of
metropolitan areas where they are likely the sale of food directly to consumers food from local farms and
establishments closely associated with understand that sales at produce and transfer produce and the food is not
farms are similar to farmers’ markets auctions can be to different types of stored, we do not consider such
and CSAs because they are direct-to- entities. In some cases, sales may be to facilities to be holding food and would
consumer. We think that including consumers. However, we understand not expect them to register.
these direct-to-consumer sales is that many sales at produce auctions are (Comment 17) Some comments
consistent with section 102(c) of FSMA sales to restaurants, wholesalers and request that we expand the list of direct-
because section 102(c) provides that the other businesses. An establishment’s to-consumer platforms that we proposed
sales of food directly to consumers for direct sales to individual consumers at to specify to also include food hubs,
the purposes of determining an an auction can be counted as sales to buying clubs, and non-farm community
establishment’s primary function may consumers. A direct sale to a business supported food distribution models.
be at ‘‘any other such direct sales at an auction, however, cannot be (Response 17) We decline to revise
platform as determined by the counted as sales to consumers. Further, the retail food establishment definition
Secretary.’’ Section 102(c) of FSMA a direct sale to a separate business that in § 1.227 to specifically discuss food
does not specify that direct-to-consumer runs a produce auction, rather than to hubs, buying clubs, and non-farm
sales be face-to-face in determining the specific buyers, would not be counted community supported distribution
primary function of an establishment. as sales to consumers because models. With respect to food hubs, the
Even if some establishments that use businesses (including businesses that comments do not explain why food
mail, catalog, and Internet orders in run produce auctions) are not hubs necessarily involve direct-to-
determining their primary function are consumers. Section 102(c)(2) of FSMA consumer sales that should be used in
larger establishments and can reach explicitly states that the term determining an establishment’s primary
consumers on a national level, we do ‘‘consumer’’ does not include a function. FDA discussed food hubs in
not believe that is inconsistent with business. the final preventive controls for human
section 102(c) of FSMA, which does not (Comment 16) Comments request that food regulation (see 80 FR 55908 at
specify that FDA’s amendment to the FDA specifically exempt produce 55992). As FDA noted in that
retail food establishment definition only auctions from the requirements of food rulemaking, USDA defines a regional
pertain to establishments of a specific facility registration. These comments food hub as ‘‘a business or organization
size. We believe that if an state that produce auctions are that actively manages the aggregation,
establishment’s annual monetary value frequently misunderstood to be ‘‘food distribution, and marketing of source-
of sales of food products directly to facilities,’’ but that they are in fact very identified food products primarily from
consumers exceeds the annual monetary similar to farmers’ markets in that the local and regional producers to
value of sales of food products directly auction does not take individual strengthen their ability to satisfy
to all other buyers, the establishment’s ownership of any products or wholesale, retail, and institutional
primary function is to sell food directly manufacture/process, hold, pack or demand’’ (Ref. 7). Some food hubs have
to consumers and that the establishment package food. The comments note that a farm-to-business model (e.g., selling to
should qualify as a retail food buyers represent a mix of direct food cooperatives, grocery stores,
establishment. Further, we note that, in consumers and commercial business institutional foodservice companies,
determining whether an establishment entities. and restaurants), while others have a
is a retail food establishment, our (Response 16) We decline the request farm-to-consumer model (i.e., selling
regulation has always allowed for to exempt produce auctions from the directly to the consumer, e.g., through a
establishments selling food directly to requirement to register. The registration CSA), and some are hybrids that do both
consumers via the Internet or mail order requirement applies to all facilities that (Ref. 7). Because all sales at food hubs
to be covered under the definition of manufacture/process, pack, or hold food are not necessarily direct-to-consumer,
‘‘retail food establishment,’’ provided for consumption in the United States, we do not agree that it is appropriate to
that they meet the other criteria of the and does not hinge on whether the include food hubs in the list of direct-
retail food establishment definition (see establishment in question actually owns to-consumer platforms that may be used
68 FR 58894 at 58914 to 58915). the food (see section 415(a)(1) of the in determining an establishment’s
(Comment 15) Some comments urge FD&C Act). We note, however, that not primary function. However, if an
FDA to include ‘‘produce auctions’’ in all produce auctions will necessarily be establishment located on a farm or an
the list of platforms where direct-to- required to register. Whether establishment described in paragraph
consumer sales take place. registration is required would depend (2) of the retail food establishment
(Response 15) Because the list of on the facts of a particular case. It is definition has food hub sales that are
direct-to-consumer sales platforms is possible that some produce auctions directly to consumers, we agree that, in
not exhaustive, we do not agree that it would qualify as retail food those circumstances, it would be
is necessary to include produce auctions establishments and therefore be exempt appropriate for those sales to be used in
in the list of direct-to-consumer from registration. Produce auctions determining the establishment’s primary
platforms that may be used in would qualify as retail food function. The catchall provisions in
determining an establishment’s primary establishments if their primary function paragraphs (1)(iii) and (2)(iii) of the
function. Provided that a sales platform is to sell food directly to consumers. definition provide that the sale of food
is direct-to-consumers, sales made Produce auctions with direct-to- directly to consumers includes the sale
through such platforms may help consumer sales that exceed sales to and distribution at other direct-to-
establish that an establishment’s businesses would be considered retail consumer platforms. For similar
primary function is to sell food directly food establishments. Further, as stated reasons, we do not agree that it is
to consumers (with an establishment in the final rule for ‘‘Current Good appropriate to amend the retail food
qualifying as a retail food establishment Manufacturing Practice, Hazard establishment definition to include
only if the annual monetary value of Analysis and Risk-Based Preventive buying clubs and non-farm community
sales of food products directly to Controls for Human Food’’ (80 FR 55908 supported food distribution models. The
consumers exceeds the annual monetary at 55992), to the extent that these comments have not provided
value of sales of food products to all operations are simply a location for information to allow FDA to assess
other buyers). Furthermore, we buyers and sellers to meet and to sell whether such platforms necessarily
involve direct-to-consumer sales. requirements for small and very small value of sales of food products to all
However, if on-farm establishments or businesses. In addition, the comment other buyers.
establishments described in paragraph recommends that the amendment to the (Comment 20) One comment states
(2) have sales at such platforms that are retail food establishment definition that our amendment to the retail food
directly to consumers, the sales may should only apply to small and very establishment definition should
also be used in determining those small farms, as defined in the proposed incorporate a method to evaluate
establishments’ primary function in regulation for produce safety. The potential risks to allow the Agency to
accordance with paragraphs (1)(iii) and comment states that Congress intended determine if the establishment has food
(2)(iii). for the retail food establishment safety issues or is subject to proper
amendment to only apply to small and oversight.
5. Other Issues Related to the Definition (Response 20) We decline this
of Retail Food Establishment very small farms, as evidenced by
request. The comment does not explain
certain statements made on the Senate
(Comment 18) One comment states how FDA would evaluate potential risks
floor regarding small farmers.
that there should not be any income or or what kind of food safety and/or
value limitation included in the retail (Response 19) Consistent with the oversight criteria the Agency would
food establishment definition. statutory direction in section 103(c) of apply. Further, the comment does not
(Response 18) We agree that there is FSMA, including the direction to explain how the request would be
no income limitation for establishments conduct a qualitative risk assessment, consistent with section 102(c) of FSMA.
to qualify as retail food establishments, FDA established exemptions for on-farm That provision, which directs FDA to
and we have not included one in the activity/food combinations conducted clarify the retail food establishment
final rule. As long as an establishment’s by farm-mixed-type facilities that are definition, does not state that the
primary function is to sell food directly small or very small businesses in the clarification to the definition should
to consumers, it is a retail food final rule for preventive controls for involve FDA performing any kind of
establishment. A retail food human food (§ 117.5(g) and (h)). We do risk evaluation of individual
establishment’s primary function is to not agree that section 102(c) of FSMA, establishments.
sell food directly to consumers if the which directed FDA to clarify the retail (Comment 21) One comment states
annual monetary value of sales of food food establishment definition, should be that our amendment to the retail food
products directly to consumers exceeds read to only apply to entities that establishment definition should
the annual monetary value of sales of qualify for the exemptions we consider off-farm sales to businesses in
food products to all other buyers. established in accordance with section the primary function calculation, and
(Comment 19) One comment urges 103(c) of FSMA. Congress’s direction in not just consumers. The comment states
FDA to recognize that even low-risk that similar to the determination for
section 102(c) of FSMA to amend the
activities can cause problems and whether an entity is a qualified farm
definition of retail food establishment
recommends limiting the application of under the produce safety regulation or
was separate and distinct from
section 102(c) of FSMA to the types of a qualified facility under the preventive
Congress’s direction in section 103(c) of
on-farm manufacturing activities that controls regulations, the determination
FSMA to establish exemptions and
the Agency tentatively identified as low- for whether an establishment is a retail
risk activities in proposed 21 CFR modifications for certain on-farm
food establishment should consider
117.5(g) and (h) in the proposed activities, and we are not aware of any
sales to ‘‘qualified end users.’’ Another
regulation for hazard analysis and risk- evidence that Congress intended for the
comment states that the amendment to
based preventive controls for human amendment to the retail food establish
the definition should only consider
food. This is based on the argument that definition to be limited by the entities sales at ‘‘the retail distribution level
section 102(c) of FSMA, which directed that qualify for exemptions in directly to consumers[.]’’
FDA to clarify the retail food accordance with section 103(c) of (Response 21) We disagree with the
establishment definition, should be read FSMA. As to the comment that the comment requesting that sales to
in connection with section 103(c)(1) of amendment to the retail food businesses be included in the primary
FSMA, which formed the basis for establishment definition should only function calculation, and agree with the
proposed § 117.5(g) and (h). apply to small and very small farms, we comment that the amendment should
Specifically, section 103(c)(1) of FSMA similarly do not agree. Section 102(c) of only consider sales ‘‘at the retail
directed FDA to conduct a science- FSMA does not provide that the distribution level directly to
based risk analysis of specific types of determination of the primary function consumers’’ to the extent that comment
on-farm packing or holding of food that be different for establishments of requests that the primary function
is not grown, raised, or consumed on particular sizes. Although there is some calculation only include direct-to-
such farm or another farm under the legislative history indicating that some consumer sales. Section 102(c)(2)(B) of
same ownership, as well as of specific legislators anticipated that the FSMA provides that the term
on-farm manufacturing and processing amendment would affect small ‘‘consumer’’ does not include a
activities as such activities relate to enterprises, we are not aware of business, and we think it is consistent
specific foods that are not consumed on evidence that Congress intended for the with that provision to establish that
that farm or on another farm under amendment to only apply to smaller sales to consumers do not include sales
common ownership. Section 103(c)(1) of enterprises, and there is no such to businesses for the purpose of
FSMA further directed FDA to consider limitation in the statutory provision. determining an establishment’s primary
the results of the science-based risk Moreover, we believe it is appropriate to function. It is true that the preventive
analysis and exempt certain facilities apply the same primary function controls and produce safety regulations
from the requirements in sections 418 of analysis to all establishments regardless provide for certain specified businesses
the FD&C Act (related to risk-based of size, with an establishment’s primary to be qualified end-users. Under the
preventive controls) and section 421 of function being to sell food directly to preventive controls regulations,
the FD&C Act (related to targeting of consumers if the annual monetary value qualified end-users include restaurants
inspection resources) for small and very of sales of food products directly to or retail food establishments located in
small businesses, or modify those consumers exceeds the annual monetary the same State as the qualified facility
that sold the food to such restaurant or not the same and must be designated ensuring the safety of imported food,
establishment or are not more than 275 through separate procedures. which is qualitatively different from
miles from such facility or farm and are (Response 22) We do not agree that serving as a communications link (80 FR
purchasing the food for sale directly to any amendments to the regulatory text 74226 at 74241; November 27, 2015).
consumers at such restaurant or retail of the final rule are necessary. Section Thus, we do not interpret the use of the
food establishment. Under the produce 805(a)(2)(B) of the FD&C Act (21 U.S.C. term ‘‘United States agent’’ under
safety regulation, a qualified end-user 384a(a)(2)(B)),which pertains to FSVP, section 805(a)(2)(B) to have the same
includes a restaurant or retail food provides that when there is no U.S. meaning as the U.S. agent that food
establishment that is located in the same owner or consignee with respect to an facilities are required to designate under
State or the same Indian reservation as article of food at the time of entry of the section 415(a)(1)(B) and FDA’s food
the farm that produced the food or not article into the United States, the term facility registration regulations. As we
more than 275 miles from such farm. ‘‘importer’’ for purposes of FSVP state in the FSVP final rule, however,
Whether a facility or farm sells food requirements means ‘‘the United States this interpretation does not prohibit a
directly to a qualified end-user is agent or representative of a foreign foreign owner or consignee from
significant under the preventive owner or consignee of the article of food designating a person who serves as a
controls and produce regulations at the time of entry of such article into U.S. agent under the food facility
because sales to qualified end-users may the United States’’ (emphasis added). regulations as the ‘‘importer’’ for
be used in determining whether Under the FSVP final rule, the purposes of FSVP (Id.).
facilities or farms are eligible for ‘‘importer’’ is responsible for verifying Because we do not interpret the use
qualified exemptions under those the safety of food imported into the of the terms to have the same meaning,
regulations. Although sales to qualified United States. In addition, section we do not think it is necessary to add
end-users are significant under those 415(a)(1)(B) of the FD&C Act provides regulatory text in this final rule stating
regulations, we do not agree that sales that foreign food facilities must submit that the U.S. agent for purposes of food
to such qualified end-users that are not the name of the ‘‘United States agent’’ facility registration is not the same as
consumers should be used in for the facility as part of the facility’s the U.S. agent for purposes of the FSVP
determining an establishment’s primary registration under section 415. FDA’s final rule. Additionally, we think such
function as a retail food establishment regulations implementing the food language could be confusing because
for the purposes of registration. facility registration requirements in there is no prohibition on the same
Congress specified that qualified end- section 415 of the FD&C Act require that person serving as both the U.S. agent for
users include certain restaurants and the registration for foreign facilities purposes of food facility registration and
retail food establishments for purposes must include the name of the U.S. agent the U.S. agent for purposes of satisfying
of the preventive controls and produce for the facility (21 CFR 1.232(c)(1)). The the FSVP ‘‘importer’’ requirements
safety regulations (see sections facility registration regulations also (provided that such person meets the
418(l)(4)(B) and 419(f)(4)(A) (21 U.S.C. define the term U.S. agent to mean a relevant requirements of each
350h(f)(4)(A)) of the FD&C Act), but person (as defined in section 201(e) of regulation).
specified that for purposes of amending the FD&C Act) residing or maintaining (Comment 23) Comments request FDA
the retail food establishment definition a place of business in the United States clarify that the communications link
the term ‘‘consumer’’ does not include whom a foreign facility designates as its between the U.S. agent and FDA goes
businesses (see section 102(c)(2)(B) of agent for purposes of food facility both ways and that FDA also clarify that
FSMA). registration (§ 1.227). The regulations communications to and from the U.S.
further specify that the U.S. agent ‘‘acts agent have the same legal effect as if
B. U.S. Agent as a communications link between FDA sent to or by the facility directly for both
We proposed to amend the definition and the foreign facility for both routine and emergency
of U.S. agent in § 1.227 to add that the emergency and routine communications.
U.S. agent of a foreign facility may view communications’’ (§ 1.227). (Response 23) As established in
the information submitted in the foreign Although Congress used the term current § 1.227, the U.S. agent acts as a
facility’s registration. ‘‘United States agent’’ in both section communications link between FDA and
In addition, we proposed to replace 805(a)(2)(B) and section 415(a)(1)(B) of a foreign facility for both routine and
the word ‘‘cannot’’ in the current the FD&C Act, we do not interpret the emergency communications. The U.S.
definition for U.S. agent in § 1.227 with use of the term ‘‘United States agent’’ in agent will be the person FDA contacts
‘‘may not.’’ Accordingly, the pertinent section 805(a)(2)(B) to mean the U.S. when an emergency occurs, unless the
sentence in that provision will provide agent for a foreign facility under section registration specifies another emergency
that, ‘‘A U.S. agent may not be in the 415(a)(1)(B). U.S. agents that foreign contact. In functioning as the
form of a mailbox, answering machine food facilities must designate for communications link with FDA, a U.S.
or service, or other place where an purposes of food facility registration agent may choose to initiate
individual acting as the foreign facility’s perform a very different role than the communications with FDA, and FDA
agent is not physically present’’ ‘‘United States agent’’ that a foreign may likewise choose to initiate
(emphasis added). owner or consignee may designate communications with the U.S. agent.
(Comment 22) Comments state that it under section 805(a)(2)(B) of the FD&C Further, as stated in § 1.227, FDA will
is confusing to distinguish the U.S. Act to serve as the ‘‘importer’’ for treat representations by the U.S. agent as
agent for food facility registration and purposes of the FSVP regulations. For those of the foreign facility, and will
the U.S. agent for purposes of the food facility registration, the ‘‘U.S. consider information or documents
foreign supplier verification program agent’’ acts as a communications link. provided to the U.S. agent the
(‘‘FSVP’’) requirements under 21 CFR For FSVP, however, an importer equivalent of providing the information
part 1, subpart L, and urge FDA to (whether a ‘‘United States agent’’ or or documents to the foreign facility. In
include language in the registration final otherwise) is responsible for the full that sense, information or documents
rule that clarifies that the U.S. agent for breadth of supplier verification provided to the U.S. agent has the same
purposes of food facility registration and activities required under the FSVP effect as if FDA provided the
the U.S. agent for purposes of FSVP are regulation. These activities involve information or documents to the foreign
facility, in that FDA will consider current § 1.230(a) and instead require must include the name of the individual
providing information or documents to that owners, operators, or agents in submitting the renewal. We have made
the U.S. agent the equivalent of charge must register before the facility this change because we believe that this
providing the information or documents begins to manufacture, process, pack, or information will aid our ability to verify
to the foreign facility. hold food for consumption in the that the individual submitting the
(Comment 24) One comment requests United States. We did not receive any registration information is authorized to
FDA outline and clarify the roles and comments on this change and are do so.
responsibilities of the U.S. agent. finalizing as proposed. (Comment 26) A comment states a
(Response 24) The roles and concern with the potential for a
B. Proposed § 1.230(b)—Registration bottleneck or system overload during
responsibilities of a U.S. agent are
Renewal the October 1 to December 31
outlined in current § 1.227. As stated
previously, the U.S. agent acts as a We proposed amending § 1.230 to registration renewal period. The
communications link between FDA and require biennial registration renewal comment asks if FDA would consider a
the foreign facility for both emergency and provide for an abbreviated biennial renewal expired if it was
and routine communications. registration renewal process. Proposed properly submitted on or prior to the
(Comment 25) Comments request that § 1.230(b) would require that during the December 31 deadline but was not
FDA clarify that the U.S. agent for a period beginning on October 1 and timely administered or accepted by FDA
foreign food facility may access the ending on December 31 of each even- on or prior to the December 31 deadline.
facility’s FDA Unified Registration and numbered year, the owner, operator, or The comment also requests that FDA
Listing Systems (FURLS) and help desk agent in charge of a facility would be consider extending the biennial
on behalf of the foreign facility, and that required to submit a registration registration deadline so that properly
the U.S. agent should have access to renewal to FDA containing the and timely submitted biennial renewals
Form FDA 483s and Establishment information required under § 1.232. are not considered expired if FDA has
Inspection Reports (EIR) pertaining to Under proposed § 1.230(b), the owner, not administered or accepted the
the foreign facility. operator, or agent in charge of a facility facility’s submission.
(Response 25) The final rule provides would be able authorize an individual (Response 26) Beginning with the first
that the U.S. agent of a foreign facility to renew the facility’s registration on its biennial registration renewal period in
may view the information submitted in behalf. We proposed that if the 2012, information technology (IT)
the foreign facility’s registration. The individual submitting the registration capabilities were added to support the
U.S. agent will be able to view the renewal is not the owner, operator, or system to help prevent any system
information electronically via FURLS agent in charge of the facility, the failure or overload. FDA will continue
Food Facility Registration Module, in registration renewal must also include a this protocol during all biennial
the interim, U.S. agents may contact statement in which the individual registration renewal periods to ensure
FDA’s help desk with questions about certifies that the information submitted that our IT systems can operate during
foreign facilities that they represent. In is true and accurate, certifies that he/she high-traffic times. Given these IT
addition, a U.S. agent may contact is authorized to submit the registration investments, FDA does not anticipate
FDA’s help desk on behalf of the foreign renewal, and identifies by name, that IT failures will cause problems with
facility. As to whether U.S. agents may address, email address, and telephone our registration system administering or
have access to any Form FDA 483s and number, the individual who authorized accepting submissions during the
EIRs related to the foreign facility, submission of the registration renewal. registration renewal period. However, if
certain information (such as We proposed that each registration any technical problems do arise during
confidential commercial information renewal must include the name of the the biennial registration renewal period,
and trade secret information) in such individual submitting the registration FDA may consider extending the time
records is protected from disclosure. renewal, and the individual’s signature period for biennial registration
(for the paper option). renewals, for instance by providing
FDA also generally does not proactively
We are finalizing these requirements, registrants at least the same number of
make available information related to
with two modifications. First, we have calendar days for biennial registration
FDA inspections of facilities, including modified the proposed requirement to renewal as allowed for under the FSMA
FDA Form 483s and EIRs, although it is provide the email address for the amendments to section 415 of the FD&C
possible that a U.S. agent could obtain individual who authorized submission Act. During the first biennial renewal
such information from the foreign of the registration renewal if the period in 2012, FDA took such an
facility or from FDA through a FOIA (5 individual submitting the registration approach. At that time, there was a
U.S.C. 552) request. Any confidential renewal is not the owner, operator, or delay with the registration renewal
commercial information, trade secret agent in charge of the facility. For period becoming operational and FDA
information, or other protected registration renewals not submitted by extended the deadline for facilities to
information in FDA Form 483s and EIRs the owner, operator, or agent in charge, complete renewals. As to the concerns
that we provide through a FOIA request final § 1.230(b) provides that the regarding expired registrations, as
would be redacted (i.e., deleted) in registration renewal must identify the discussed in section XI of this
accordance with the disclosure individual who authorized submission document, we are adding § 1.241(b) to
exemptions set forth in the FOIA and 21 of the registration renewal by email specify that FDA will consider a
CFR part 20. address, unless FDA has granted a registration for a food facility to be
V. Comments on Proposed Amendments waiver under § 1.245. Registration expired if the registration is not
to § 1.230—When Must You Register or renewals not submitted by the owner, renewed, as required by § 1.230(b). If a
Renew Your Registration? operator, or agent in charge must also food facility registration or renewal
identify by name, address, and registration is submitted (or postmarked
A. Proposed § 1.230(a)—When Must telephone number the individual who for paper submissions) on or before the
You Register? authorized the submission, as proposed. renewal deadline and includes all
We proposed to delete the reference to Second, we have added a requirement required information, we will not
the December 12, 2003, deadline in that each electronic registration renewal consider such a registration to be
expired. As described in section XI of renewals not submitted by the owner, (Response 27) We agree that
this document, § 1.241(c) provides that operator, or agent in charge of the registrants submitting abbreviated
FDA will cancel a registration if the facility, the abbreviated renewal must registration renewals need not confirm
facility’s registration has expired provide the email address of the that FDA will be permitted to inspect
because the facility has failed to renew individual who authorized submission the facility at the times and in the
its registration in accordance with of the abbreviated renewal, unless FDA manner permitted by the FD&C Act. We
§ 1.230(b). For registrations that we do has granted a waiver under § 1.245. We believe that the requirement in the final
not consider to be expired, we will not made this change in order to enable us rule in § 1.230(c) that registrants
cancel the registrations under § 1.241(c). to more efficiently perform the confirm that no changes have been
In addition, in the event that any IT verification process established in made to the information required under
problems complicate the submission § 1.231(a)(4) and (b)(6) for abbreviated § 1.232 since the preceding registration
and receipt of registration renewals, we renewals not submitted by the owner, or registration renewal encompasses a
would take that into account in operator, or agent in charge of the confirmation regarding FDA being
determining whether to consider any facility. Under those provisions, after permitted to inspect. Accordingly, we
registrations to have expired. submission of the abbreviated renewal have revised § 1.230(c) in the final rule
Prior to the beginning of the biennial (whether submitted electronically or by to no longer require that abbreviated
registration renewal period on October mail or fax), FDA will verify that the registration renewals provide
1, FDA intends to send an email to all individual identified as having confirmation regarding FDA being
registrants and U.S. agents notifying authorized submission of the permitted to inspect. However, we
them of the upcoming registration registration renewal in fact authorized continue to believe that it is appropriate
renewal period. In these emails, we plan the submission on behalf of the facility. for abbreviated registration renewals to
to provide information about the FDA will not provide a confirmation of certify that the information submitted is
deadline for registration renewal. Once the abbreviated renewal until that truthful and accurate. We believe such
the renewal period begins, if a registrant individual confirms that he or she certifications will help deter individuals
has not submitted a renewal, we plan to authorized the submission. Having the from submitting false information,
continue to send emails reminding email address for the individual who
registrations of the upcoming deadline including falsely certifying that no
authorized submission of the changes have been made to the required
through the end of the registration registration renewal will enable us to
renewal period on December 31. information. For the reasons discussed
more quickly and efficiently conduct in the previous paragraphs, we also
C. Proposed § 1.230(c)—Abbreviated the verification so that we can more believe it is appropriate for abbreviated
Registration Renewal Process quickly provide confirmation of the renewals to include the name of the
Under proposed § 1.230(c), we renewal. Finally, we have changed individual submitting the renewal and,
proposed to provide for an abbreviated § 1.230(c) to allow food facilities to for abbreviated renewals not submitted
registration renewal process for submit abbreviated registration renewals by the owner, operator, or agent in
registrations that do not have any if the information required in the charge of the facility, the email address
changes to the information required registration has not changed since the of the individual who authorized the
under § 1.232 since the submission of facility submitted an update or since the submission.
the preceding registration or registration facility submitted the preceding
registration or registration renewal. VI. Comments on Proposed
renewal. The abbreviated registration
Under the proposed rule, the Amendments to § 1.231—How and
renewal process that we proposed
abbreviated option would only have Where Do You Register or Renew Your
would require a registrant to confirm
been available if no information Registration?
that no changes have been made to the
information required in the registration changed since the facility submitted the
A. Proposed § 1.231(a)—Electronic
since the registrant submitted the preceding registration or registration
Registration and Registration Renewal
preceding registration or registration renewal. We made this change so that
renewal, confirm that FDA will be food facilities will not be required to In proposed § 1.231(a), we proposed
permitted to inspect the facility at the complete the standard renewal process to require mandatory electronic
times and in the manner permitted by if the required information is unchanged registration and registration renewals
the FD&C Act, and certify that the since the facility’s most recent beginning January 4, 2016, unless a
information submitted is truthful and registration update. We believe that this waiver has been granted under § 1.245.
accurate. FDA also proposed that change will make the renewal In the proposed rule, we proposed in
registrants must use Form FDA 3537 to requirement less burdensome for food § 1.245 to provide that to request a
submit abbreviated registration renewals facilities. waiver from the electronic registration
to FDA. In response to some comments, Furthermore, we note that we or renewal requirement, a registrant
we have made some changes to these consider abbreviated renewals to be must submit a written request to FDA
requirements. included as part of the registration that explains why it is not reasonable
In addition, on our own initiative, we renewal process explained in § 1.231 of for the registrant to submit a registration
have changed § 1.230(c) to require that the final rule. or registration renewal electronically to
each abbreviated renewal include the (Comment 27) Comments recommend FDA. In the proposed rule, FDA
name of the individual making the FDA simplify its proposal for tentatively concluded that reasons for
submission and the individual’s ‘‘abbreviated’’ renewals by requiring why it may not be reasonable for a
signature (for the paper option). We only that a box be checked to confirm registrant to submit a registration or
have made this change because we that there have not been any changes to registration renewal to FDA
believe that this information will aid the registration information previously electronically may include conflicting
our ability to verify that the individual submitted, including to the previously religious beliefs or where a registrant
submitting the registration information submitted certification regarding the does not have reasonable access to the
is authorized. We have also changed truthfulness and accuracy of the Internet (80 FR 19160 at 19177 to
§ 1.230(c) to require that for abbreviated registration information. 19178).
We requested comment on the revisions reflect our decision to delay proposed § 1.234(d)(5) would apply this
proposed requirements for mandatory the requirement to submit registrations requirement to updates submitted by
electronic registration and registration electronically until January 4, 2020, and mail or fax. As discussed more fully in
renewals to begin in the year 2016 and also to be consistent with § 1.245 in section VII.B of this document,
the proposal to allow for a waiver from making clear that waivers under § 1.245 § 1.232(a) of the final rule requires
these requirements. We also requested are granted by FDA. domestic and foreign facilities to submit
comment and data on the number of a UFI recognized as acceptable to FDA
C. Proposed §§ 1.231(a)(3) and (b)(5)
facilities, if any, that believe they would in the facility’s registration. We are not
and 1.234(c)(2) and (d)(5)—Unique
be unable to register or renew their finalizing the proposal to include a D–
Facility Identifier and Verification
registrations electronically, and the U–N–S number.
Procedures for FDA (Comment 29) Comments recommend
reasons for such belief.
(Comment 28) One comment states In proposed § 1.232(a)(2), we FDA verify registration information with
that small foreign facilities may not be proposed to require the D–U–N–S the U.S. agent for foreign facilities rather
able to submit registrations number of a domestic and foreign than using D–U–N–S numbers. The
electronically by 2016 because there is facility be included in the facility’s comments state that such a verification
no reliable access to the Internet. The registration. We proposed for this process would be less burdensome and
comment requests that paper requirement to function in connection complex.
submissions remain an option. with proposed § 1.231(a)(3) and (b)(5), (Response 29) We decline this
(Response 28) We recognize that there which would provide that after a facility suggestion. We believe that a
may be a need for additional flexibility completes its registration or updates its verification process that will function in
regarding the deadline for requiring D–U–N–S number as part of registration connection with a UFI will be more
electronic registrations and registration renewal, FDA would verify the accuracy efficient and effective than relying on
renewals. In response to this comment, of the facility’s D–U–N–S number and the U.S. agent. In addition, only foreign
we are revising § 1.231(a)(2) to replace would also verify that the facility- facilities have U.S. agents. Domestic
the proposed January 4, 2016, deadline specific address associated with the D– facilities do not have U.S. agents.
for electronic registrations and U–N–S number is the same address (Comment 30) Comments state that
registration renewals with a January 4, associated with the facility’s users should be given additional
2020, deadline. In addition, we are also registration. Under proposed attempts to input registration
revising § 1.231(a)(2) to state that § 1.231(a)(3) and (b)(5), FDA would not information if the verification step is
registrations or registration renewals confirm a food facility’s registration or unsuccessful. Comments also ask how
must be submitted electronically registration renewal until FDA verifies FDA will inform a facility of an
‘‘unless FDA has granted’’ a waiver. The the accuracy of its D–U–N–S number unsuccessful UFI verification step and
proposed provision would have stated and verifies that the facility-specific how facilities will be able to correct
that the electronic registration address associated with the D–U–N–S information.
requirement applies ‘‘unless you have number is the same address associated (Response 30) For electronic
been granted a waiver.’’ We believe that with the facility’s registration. With registration submissions, the registration
this change is consistent with § 1.245, respect to initial registrations, proposed screen would immediately notify the
which makes clear that the waivers are § 1.231(a)(3) and (b)(5) would also food facility if we are unable to verify
granted by FDA. Accordingly, final provide that FDA would not provide a the UFI or if the facility-specific address
§ 1.231(a)(2) provides that owners, facility with a registration number until associated with the UFI is the same
operators, or agents in charge must FDA verifies the accuracy of its D–U–N– address associated with the registration.
submit their registration or registration S number and verifies that the facility- For registration submissions by mail or
renewal to FDA electronically beginning specific address associated with the D– fax, FDA will use the contact
on January 4, 2020, unless FDA has U–N–S number is the same address information available for the facility to
granted a waiver under § 1.245. If FDA associated with the facility’s notify the facility of any such
has granted a waiver, registrations and registration. Proposed § 1.231(a)(3) occurrence. If FDA is unable to verify
registration renewals may be submitted would apply this verification the UFI or to verify that the facility-
through mail or fax. requirement to electronic registrations, specific address associated with the UFI
and proposed § 1.231(b)(5) would apply is the same address associated with the
B. Proposed § 1.231(b)—Registration or this requirement to registrations registration, the facility would have the
Registration Renewal by Mail or Fax submitted by mail or fax. We also opportunity to fix the information in the
In proposed § 1.231(b), we proposed proposed for the requirement to submit registration. However, if it turns out that
that, beginning January 4, 2016, we D–U–N–S numbers to function in FDA is unable to verify this information
would allow registrants to submit connection with proposed § 1.234(c)(2) because the UFI provider has incorrect
registration or registration renewals by and (d)(5), which proposed to provide information about the facility, the
mail or fax if a waiver has been granted that FDA would perform the same facility may contact the UFI provider to
under proposed § 1.245. As we verification step after facilities complete resolve the discrepancy. If verification
explained in Response 30, we are their registration updates. Under problems persist, the facility may
replacing the January 4, 2016, deadline proposed § 1.234(c)(2) and (d)(5), FDA contact FDA.
with a January 4, 2020, deadline. would not provide an update (Comment 31) One comment asks that
As revised, final § 1.231(b) states that confirmation until FDA verifies the FDA allow U.S. agents to ‘‘search for D–
beginning January 4, 2020, registrants accuracy of the food facility’s D–U–N– U–N–S numbers of facilities’’ before a
must submit their registrations or S number and also verifies that the facility registers. The comment states
registration renewals to FDA facility-specific address associated with that this will help ensure the accuracy
electronically, unless FDA has granted a the D–U–N–S number is the same of the registration information
waiver under § 1.245. If FDA has address associated with the facility’s submitted to FDA.
granted a waiver under § 1.245, the registration. Proposed § 1.234(c)(2) (Response 31) To the extent that the
registrant may register or renew a would apply this verification comment is asking that U.S. agents be
registration by mail or by fax. The requirement to electronic updates, and able to search the Dun and Bradstreet
database, we will consider this frequency needed to ensure that the D. Proposed §§ 1.231(a)(4) and (b)(6),
comment when we implement the UFI registration information for any 1.234(c)(3) and (d)(6), and 1.235(c)(3)
requirement. Whether U.S. agents may particular facility is accurate at any and (d)(6)—Verification Procedures for
search the database of the UFI system particular time. Information might Submissions Not Made by the Owner,
that FDA recognizes as acceptable may change in-between inspections, and Operator, or Agent in Charge of the
depend on a number of factors, inaccurate registration information Facility
including what database information, if could hinder FDA’s ability to locate We proposed in proposed
any, the UFI provider makes public. If facilities for inspection. We believe that § 1.231(a)(4) and (b)(6) that FDA would
U.S. agents wish to ensure the accuracy requiring a UFI recognized as acceptable email the individual identified as the
of foreign facilities’ registration owner, operator, or agent in charge who
to FDA is a more efficient and effective
information, they may wish to work
way to help ensure the accuracy and authorized submission of the
with the foreign facilities directly.
reliability of the registration information registration to verify that the individual
(Comment 32) Many comments state
that requiring the submission of D–U– and to help ensure that the registration in fact authorized submission of the
N–S numbers will not enhance the database is up-to-date. registration on behalf of the facility if
accuracy of FDA’s registration database. the registration or registration renewal
(Comment 34) Comments question the
A comment states that a D–U–N–S was not submitted by the owner,
capacity of the registration database to
number cross-check is an additional operator, or agent in charge of the
save registrations for completion at a facility. We further proposed that FDA
time-consuming step and is not effective later date so that the registrant can
at preventing inaccurate information would not confirm the registration or
obtain a D–U–N–S number. provide a registration number until that
from being submitted to FDA. One
comment states that discrepancies in the (Response 34) FDA’s registration individual confirms that he or she
FDA database and the Dun and system has the needed capacity to save authorized the registration submission.
Bradstreet database may cause registration information for completion With respect to registration renewals,
disruptions and delays in registration. at a later date. While FDA will not save under proposed § 1.231(a)(4) and (b)(6),
(Response 32) We disagree with the an incomplete registration on the server FDA would not provide a confirmation
comments asserting that the UFI indefinitely, the information will be of the registration renewal until the
verification step will not enhance the stored for a period of time greater than individual confirms that he or she
accuracy of FDA’s registration database. the maximum amount of time needed to authorized the registration renewal.
A UFI system such as D–U–N–S will acquire a UFI. Under proposed § 1.234(c)(3) and (d)(6),
allow the Agency to leverage the FDA would not confirm a registration
(Comment 35) One comment update until the individual identified as
information in the UFI system,
addresses ‘‘pharmaceutical wholesale the owner, operator, or agent in charge
providing assurance that the address
distributors’’ that hold only a small who authorized the update confirms
associated with the food facility is
accurate. For instance, FDA uses D–U– amount of food. For these facilities, the that he or she in fact authorized the
N–S numbers for drug establishment comment suggests that FDA verify the update on behalf of the facility. In
registration (Ref. 8). FDA has found that facility-specific address using means addition, under proposed § 1.235(c)(3)
the use of D–U–N–S numbers for drug other than a D–U–N–S number. The and (d)(6), FDA would not confirm a
establishment registration has been a comment states that the Agency can registration cancellation until the
useful resource for identifying and instead refer to facility-specific individual identified as the owner,
verifying certain business information. information collected by CDER and/or operator, or agent in charge who
Regarding concerns about disruptions information collected by State licensing authorized the cancellation confirms
and delays, we do not anticipate authorities. that he or she in fact authorized the
significant problems. We are postponing (Response 35) We do not think it is cancellation on behalf of the facility. We
the requirement for providing a UFI in appropriate to establish different proposed this verification step to
registrations until the registration address the problem with unauthorized
registration requirements for facilities of
renewal period beginning October 1, third party registration submissions
different sizes or for facilities that
2020, which should provide food discussed in the preamble to the
manufacture, process, pack, or hold
facilities sufficient time to obtain a UFI. proposed rule (80 FR 19160 at 19171).
If any facilities encounter delays different amounts of food. Food The unauthorized registrations have
associated with the UFI requirement or facilities of any size that handle any resulted both in duplicate registrations
verification step, they may contact FDA. amount of food may be linked to for food facilities and registrations for
(Comment 33) Comments recommend terrorism attacks or other food-related facilities that do not in fact
using inspection information obtained emergencies. In the event that any manufacture/process, pack, or hold food
by FDA investigators during inspections attacks or other emergencies occur, it for consumption in the United States.
to confirm and verify registration will be important for FDA to have (Comment 36) Comments state that it
information instead of requiring accurate and up-to-date information is not evident that use of email
information about D–U–N–S numbers. about all facilities. Even if FDA has verification will sufficiently prevent
(Response 33) To the extent possible, certain information about facilities unauthorized facility registrations, as an
FDA investigators do confirm the through other regulatory processes, we email address can be falsified.
accuracy of food facility registration expect that obtaining a UFI through food (Response 36) We have revised the
information when conducting facility registration will be a more regulatory text regarding the verification
inspections. However, FDA efficient way for FDA to verify the step in the final rule to no longer specify
investigators are not able to ensure the facility’s address. However, we may that FDA will email the owner, operator,
accuracy of FDA’s registration refer to information collected by other or agent in charge to conduct the
information in an efficient or FDA regulatory processes as verification. Instead, the final regulatory
comprehensive manner. Due to limited appropriate. text provides that FDA will verify that
resources, FDA is not able to inspect the individual identified as having
every registered facility with the authorized the submission in fact
authorized the applicable submission on provide guidance about how we will In the final rule, we are continuing to
behalf of the facility. We have made this conduct this verification step, which require a verification step for U.S. agent
change in final §§ 1.231(a)(4) and (b)(6) may provide for emailing the individual information. However, we have revised
(for registrations and registration identified as having authorized the the regulatory text regarding the
renewals), 1.234(c)(3) and (d)(6) (for submission. Any such process that we verification step to no longer specify
updates), and 1.235(c)(3) and (d)(6) (for outline in guidance will be aimed at that FDA will email the person listed as
cancellations). We plan to issue ensuring the accuracy of the verification the U.S. agent to conduct the
guidance providing more detailed process, while also being efficient and verification. Instead, the final regulatory
information about how FDA will not unduly resource-intensive. text provides that FDA will verify that
conduct this verification step. It is Conducting across-the-board the person identified as the U.S. agent
possible that the guidance will provide surveillance of each registration, by for the foreign facility agreed to serve as
for using email, phone, U.S. mail, or contrast, would demand extensive the U.S. agent. We have made this
other methods, as appropriate. In resources. However, FDA will continue change in final §§ 1.231(a)(5) and (b)(6)
determining what methods are its current practice of individually (for registrations and registration
appropriate for conducting the contacting facilities if specific questions renewals) and 1.234(c)(2) and (d)(5) (for
verification, FDA will consider the arise regarding the facility’s registration. updates). We plan to issue guidance
effectiveness of the method for Regarding the request to conduct the providing more detailed information
preventing unauthorized registrations. verification later in the registration about how FDA will conduct this
The final rule continues to provide in process, we decline that request. We verification step. It is possible that the
§§ 1.231(a)(4) and (b)(6) that FDA will believe that delaying confirmation of the guidance will provide for using email.
not confirm a registration or registration registration submission until after we The final rule continues to provide in
renewal or provide a registration complete the verification will help deter § 1.231(a)(5) and (b)(7) that FDA will not
number until the individual confirms individuals from submitting confirm a registration or registration
that he or she authorized the unauthorized registrations. renewal or provide a registration
submission. For updates and (Comment 38) Several comments number until the person identified as
cancellations, the final rule continues to suggest that FDA provide the owner, the U.S. agent for the foreign facility
provide in §§ 1.234(c)(3) and (d)(6) (for operator, or agent in charge an confirms that the person agreed to serve
updates), and 1.235(c)(3) and (d)(6) (for identification number that they can give as the U.S. agent. For updates, the final
cancellations) that FDA will not provide to authorized personnel submitting rule continues to provide in
a confirmation of the registration update registration, renewals, updates, and § 1.234(c)(2) and (d)(5) that FDA will
or cancellation until the individual cancellations, similar to the VIS for U.S. not provide a confirmation of the
confirms that he or she authorized the agents. registration update until the person
submission. identified as the U.S. agent for the
(Comment 37) Comments suggest that (Response 38) We will consider in the
foreign facility confirms that the person
instead of the proposed verifications future whether to create an
agreed to serve as the U.S. agent.
step, FDA run cross-checks in the food identification number to provide to the (Comment 39) One comment suggests
facility registration database to owner, operator, or agent in charge as that the verification email sent to the
determine if a facility is registered suggested in the comments. U.S. agent should include a statement
multiple times. These comments argue E. Proposed §§ 1.231(a)(5) and (b)(7) where the U.S. agent affirmatively
that contacting the owner, operator, or and 1.234(c)(2) and (d)(5)—Verification acknowledges that the U.S. agent may
agent in charge of a facility to verify a Procedures for U.S. Agents be liable for fees for reinspection costs.
registration can be burdensome, (Response 39) The U.S. agent acts as
especially for owners, operators, or We proposed in § 1.231(a)(5) and a communications link between FDA
agents in charge of multiple facilities. (b)(7) that FDA will email the person and the foreign facility for both
Comments further suggest FDA run identified as the U.S. agent for the emergency and routine
cross-checks in the database to identify foreign facility, using the email address communications. See 21 CFR 1.227. The
submissions for companies with for the person identified as the U.S. U.S. agent will be the person FDA
information that does not appear agent, to verify that the person agreed to contacts when an emergency occurs,
consistent (e.g., different email suffix serve as the U.S. agent. We further unless the registration specifies another
used, different phone numbers) to proposed that FDA would not confirm emergency contact. See id. Under the
identify fraudulent third-party the registration or provide a registration final rule, FDA will verify that the
registrations. Other comments number until that person confirms that person identified as the U.S. agent for
encourage FDA to conduct the the person agreed to serve as the U.S. foreign facilities has agreed to serve in
verification process only after the agent for the facility. In addition, we that role. FDA will not confirm the
registration has been submitted. The proposed a similar process for emailing registration or provide the facility with
comments state that this will prevent the U.S. agent when foreign facilities a registration number until that person
delays in the registration process. update U.S. agent information in confirms that the person agreed to serve
(Response 37) Due to a large number proposed § 1.234(c)(2) and (d)(5). as the U.S. agent. See 21 CFR
of registrations and limited resources, it Specifically, we proposed that when 1.231(a)(5); 21 CFR 1.231(b)(7). In
is not possible for FDA to individually foreign facilities update the U.S. agent addition, for registration updates, FDA
monitor every registration and contact information as part of registration will not provide an update confirmation
every facility outside of the processes renewal, FDA would not confirm the until the person identified as the U.S.
provided in the final rule. Under the registration renewal until the person agent confirms that the person agreed to
final rule, if the registration submission confirms having agreed to serve as the serve as the U.S. agent for the foreign
is not made by the owner, operator, or U.S. agent. We also proposed that for facility. See 21 CFR 1.234(c)(2); 21 CFR
agent in charge, we will confirm that the registration updates, we would not 1.234(d)(5). We have revised the
individual identified as having provide an update confirmation until regulatory text for the final rule to no
authorized a registration submission in that person confirms having agreed to longer specify that FDA will email the
fact authorized the submission. We will serve as the U.S. agent. person listed as the U.S. agent to
conduct the verification. Instead, we (reconditioner); (11) Animal food contact phone number and an email
plan to issue guidance with information warehouse/holding facility; (12) Other address if the email address is different
about how FDA will verify that the activity. Facilities would be permitted from the facility contact person email
person identified as the U.S. agent to select more than one activity type for address required in proposed
agreed to serve in that role. We have not each food product category identified. § 1.232(b)(1). For foreign facilities, we
decided on what language we will use The ‘‘Other Activity’’ option would only proposed to require (in § 1.232(c)(2))
in any communications to the person be available if the facility engages in an that the foreign facility provide an
identified as the U.S. agent, whether activity that is not covered by the other emergency contact number and email
those communications are conducted options. Facilities that select ‘‘Other address. Further, we proposed to retain
using email or through other means. We Activity’’ would be required to enter the requirement in current § 1.232(g)
will consider this comment as we work text onto the food facility registration (proposed § 1.232(a)(7)) that food
to implement the U.S. agent verification form describing the activity. Although facilities provide information regarding
step. we proposed to specify the specific food product categories, but to change
activity types that food facilities must that requirement to be consistent with
F. Proposed § 1.231(a)(6) and (b)(9)—
select, we did not propose to define the changes FDA has made to food
Requirement to Update Incorrect
those activity types. Instead, we product categories in response to the
Registration Information
requested comments on whether we FSMA amendments.
We proposed in § 1.231(a)(6) and should do so, and also requested
(b)(9) that if any information previously A. Requirement for Certain Email
comments on possible definitions. We
submitted was incorrect at the time of Address Information
further sought comment on whether
submission, the registrant must processing of thermally processed low- (Comment 40) Comments state that
immediately update the facility’s acid foods packaged in hermetically requiring email addresses for the
registration as specified in § 1.234. We sealed containers (‘‘LACF’’) and emergency contact of a domestic facility
did not receive any comments on these acidified foods should be treated as and a foreign facility will not be
provisions and are finalizing the activity types, or whether there should effective if the email address is for a
provisions as proposed. be food product category options related third party other than the facility. Some
to low-acid canned foods and acidified comments recommend that the rule
VII. Comments on Proposed
foods, or both. should be amended so that food
Amendments to § 1.232—What
We further proposed to update the facilities can indicate their preferred
Information Is Required in the
registration regulation regarding food means of contact in an emergency on
Registration?
product categories. the registration form, whether by email,
We proposed in § 1.232(b)(1) to codify The rule also proposed to codify in phone, fax or other.
in FDA’s registration regulation the FDA’s registration regulation the (Response 40) We believe that having
requirement of section 415(a)(2) of the requirement for food facility the required email addresses will assist
FD&C Act that a registration for a registrations to include a statement in FDA in responding to food-related
domestic facility contain the email which the owner, operator, or agent in emergencies even when the email
address for the contact person of the charge provides an assurance that FDA address is for a third party, and
facility. This requirement went into will be permitted to inspect the facility therefore disagree with the comments
effect upon enactment of FSMA. In at the times and in the manner suggesting otherwise. Email is a fast and
proposed § 1.232(c)(1), we also permitted by the FD&C Act. This efficient method to communicate, and
proposed to codify the requirement of requirement went into effect upon we anticipate that having the email
section 415(a)(2) of the FD&C Act that enactment of FSMA. address for the emergency contact for a
a registration for a foreign facility The rule further proposed certain domestic facility and foreign facility
contain the email address of the U.S. changes related to registrations not will assist us in reaching those contacts.
agent for the foreign facility. This submitted by the owner, operator, or Regarding the request to allow facilities
requirement also went into effect upon agent in charge of the facility. Currently, to indicate their preferred means of
enactment of FSMA. § 1.232(i) provides that if the individual contact during an emergency (e.g.,
In addition, we also proposed to submitting the registration form is not email, phone, fax, or other), we will
require that a food facility registration the owner, operator, or agent in charge consider whether to add an optional
include the email address of the owner, of the facility, the registration must field on Form FDA 3537 that would
operator, or agent in charge, and that include a statement in which the allow facilities to indicate this. If we
registrations include the D–U–N–S individual certifies that the information add any such optional field, we will
number of a domestic and foreign submitted is true and accurate, certifies issue guidance in accordance with our
facility be included in the facility’s that he/she is authorized to submit the GGP regulations in 21 CFR 10.115.
registration. We further proposed to registration, and identifies by name, (Comment 41) A comment opposes
require the type of activity conducted at address, and telephone number, the having to provide an email address for
the facility for each food product individual who authorized submission the U.S. agent in addition to the name,
category defined. We proposed that of the registration. We proposed to full address, and phone number of the
facilities choose among the following recodify this provision in proposed U.S. agent. The comment states that a
activity types: (1) Ambient human food § 1.232(a)(10), and also to add the email U.S. agent’s email address will be of
storage warehouse/holding facility; (2) address of the individual who little assistance to FDA during an
Refrigerated human food warehouse/ authorized submission of the emergency because once submitted, the
holding facility; (3) Frozen human food registration to the list of required contact information could change and
warehouse/holding facility; (4) information identifying the individual may never be updated.
Interstate conveyance caterer/catering who authorized submission of such (Response 41) Section 415(a)(2) of the
point; (5) Contract sterilizer; (6) Labeler/ registrations. FD&C Act, as amended by section 102(a)
relabeler; (7) Manufacturer/processor; In addition, we proposed to require of FSMA, requires, among other things,
(8) Farm mixed-type facility; (9) Packer/ domestic facilities (proposed that a registration for a foreign facility
repacker; (10) Salvage operator § 1.232(b)(2)) provide an emergency contain the email address of the U.S.
agent for the foreign facility. This To account for these circumstances, we the FD&C Act that registrants submit
requirement went into effect upon are providing in final § 1.232(a)(6) that information necessary to notify FDA of
enactment of FSMA. Section 1.232(c)(1) the email address be added to the the name and address of each facility at
of the final rule will codify the information required regarding the which the registrant conducts business.
requirement in FDA’s registration owner, operator, or agent in charge of Indeed, the verification that UFIs
regulation. Further, FDA disagrees that the facility, except when FDA has provide will help ensure that the food
the email address for the U.S. agent will granted a waiver under § 1.245. facility list is up-to-date and contains
not be useful for the Agency. We plan Consequently, under final § 1.232(a)(6), accurate information concerning the
to use the email address information to a food facility registration must include addresses of food facilities. Moreover,
assist us in routine and emergency the name, address, and phone number an up-to-date list that includes
communications with the U.S. agent. In of the owner, operator or agent in information necessary to notify FDA of
addition, we plan to use the email charge. In addition, the email address of the name and address of food facilities
address information to help us verify the owner, operator, or agent in charge will aid FDA in efficiently responding
that the person identified as a U.S. agent is required, unless FDA has granted a to a terrorist threat or other food-related
in a facility’s registration has agreed to waiver under § 1.245. emergency. Finally, FDA’s decision to
serve in that role. As described require unique facility identifiers is
B. Requirement for a Unique Facility
elsewhere in this Federal Register
Identifier consistent with the direction contained
document, after a foreign facility
(Comment 43) Comments state that in section 305(d) of the Bioterrorism Act
completes its registration or updates its
FDA does not have express legal (Pub. L. 107–188, 116 Stat. 594, 668–69)
U.S. agent information (including as
part of registration renewal), FDA will authority to require a D–U–N–S number. to ensure adequate authentication
verify that the person identified as the The comments state that Congress protocols to enable identification of the
U.S. agent for the foreign facility has amended the registration requirements registrant and validation of the
agreed to serve as the facility’s U.S. in section 415 of the FD&C Act as part registration data for registrations
agent (see §§ 1.231(a)(5) and (b)(7) and of FSMA, and that Congress could have, submitted to FDA electronically.
1.234(c)(2) and (d)(5)). In addition, as but did not, require the submission of Verifying information in connection
described in section IX of this D–U–N–S numbers. with a UFI for a food facility will
document, facilities must submit (Response 43) We have replaced the provide FDA with a protocol to enable
updates within 60 calendar days of any proposed requirement that registrations FDA to identify food facilities and verify
change to any of the registration include a D–U–N–S number with a certain registration information for those
information previously submitted, requirement that they include a UFI facilities.
including information about the U.S. recognized as acceptable to FDA. We (Comment 44) Comments suggest
agent. believe that we have adequate legal obtaining a D–U–N–S number is a
(Comment 42) Comments recommend authority for this requirement in the duplicative effort for facilities and
that FDA create an exemption from the final rule. As to the comments’ would not provide assurance of the
requirement that facilities provide an statement that Congress could have, but
most up-to-date and accurate
email address for the owner, operator, or chose not to, include a UFI requirement
information for a facility considering
agent in charge of a facility for facilities in FSMA, we do not believe that the
that information in both databases is
that do not have email addresses or lack of such a requirement in FSMA
voluntarily entered by the facility. One
Internet access. One comment requests indicates that Congress did not
comment states that use of an
that providing the email address of the authorize FDA to require such
identifiers. As we stated in the proposed identification number such as a D–U–
owner, operator, or agent in charge be N–S number would not lead to
optional. rule, the UFI requirement is grounded in
the statutory objective of efficiently increased accuracy because with both a
(Response 42) Although section
enforcing the food safety and other D–U–N–S number and food facility
102(a)(1)(A) of FSMA requires
requirements of the FD&C Act. By registration, facilities self-report
submission of email address
information for the contact person of requiring UFIs, FDA will be able to information. Comments urge FDA to
domestic facilities and the U.S. agent of verify the facility-specific address allow multiple identifiers for facilities
foreign facilities, often these persons are information associated with those as opposed to solely relying on D–U–N–
not the same as the owner, operator, or identifiers. Such verification should S. Some comments recommend FDA
agent in charge of the facility. We are increase the accuracy of FDA’s food utilize the U.S. Customs and Border
requiring email addresses for the owner, facility registration database. As a Protection’s (CBP) identification number
operator, or agent in charge of food consequence, FDA investigators will system and/or the Prior Notice (PN)
facilities in § 1.232(a)(6) in order to have access to more accurate food system for foreign registration
facilitate quick communications with facility information, and will therefore verification as opposed to a D–U–N–S
those individuals. Such be able to more efficiently identify and number. Comments encourage FDA to
communications may be necessary in locate food facilities for inspection. As allow facilities other options for a
the event of food-related emergencies a result, FDA will be able to more specific facility identifier that include
and, where applicable, suspensions of a efficiently conduct inspections under using certifications and identifiers from
food facility’s registration. However, we section 704 to enforce the food safety State agencies. Comments state that
understand that there may be and other requirements of the FD&C programs for use of identifying traders
circumstances in which an owner, Act. are best dealt with at an international
operator or agent in charge of a facility FDA’s decision to require UFIs in level by the World Customs
is not able to obtain an email address. food facility registration is also Organization. This comment states that
We expect that these circumstances will consistent with FDA’s mandate under no one identification system is better
the same or similar to the circumstances section 415(a)(5) of the FD&C Act to than another and that FDA should not
that may cause a facility to receive a compile and maintain an up-to-date list impose this particular system
waiver from the electronic registration of registered food facilities, as well as worldwide. One comment encourages
requirement in accordance with § 1.245. the requirement in section 415(a)(2) of FDA to work with State, local, and tribal
agencies to develop a UFI without would be adequate UFIs because any U–N–S requirement optional for foreign
relying on a third-party system. such certifications and identifiers would facilities. They state that this would
(Response 44) As stated previously in likely differ State by State, and States help alleviate the burden for foreign
this Federal Register document, the might not develop UFIs for foreign facilities because they state that it can
final rule requires that registrations facilities. For these reasons, we do not take up to 2 weeks for foreign facilities
include UFIs, not D–U–N–S numbers. agree that using the alternative to obtain D–U–N–S numbers. One
We believe that this change provides identifiers suggested by the comments comment states that facilities need time
additional flexibility. We anticipate that would allow FDA to accurately identify to implement the D–U–N–S number
we will issue guidance specifying which food facilities. Consequently, they requirement, especially foreign facilities
UFIs or identifiers FDA recognizes as would not allow FDA to efficiently that may be unfamiliar with the process
acceptable, and we expect to recognize enforce section 415 of the FD&C Act. of obtaining a D–U–N–S number. The
D–U–N–S numbers as acceptable With respect to the comment stating comment is also concerned that Dun
identifiers. that programs for use of identifying and Bradstreet will be inundated with
We disagree with the comments traders are best dealt with at an requests during the next biennial
stating that UFIs will be duplicative and international level by the World renewal period. In addition, comments
will not assist FDA in obtaining up-to- Customs Organization and that FDA state that it would be burdensome for
date information about food facilities. should not impose this particular facilities to maintain both food facility
We anticipate that UFIs will help ensure system worldwide, FDA is responsible registration numbers and D–U–N–S
that the identified facility is, in fact, the for administering the requirements of numbers. One comment suggests that
food facility in the food facility section 415 of the FD&C Act. Those FDA should work with Dun and
registration submission. The D–U–N–S requirements include the responsibility Bradstreet to make the iUpdate system
number system, for instance, is an to maintain an accurate and up-to-date available to facilities and make it clear
internationally recognized unique registration database. Our database to food facilities that they have access
number system that is updated on a needs are specific to the laws and to the iUpdate system when obtaining a
regular basis. D–U–N–S numbers also regulations we implement, and we D–U–N–S number. One comment states
provide for site-specific identification of believe that we are in the best position that the Dun and Bradstreet Web site for
business entities. Although business to determine what UFIs should be obtaining D–U–N–S numbers is not
establishments may provide information acceptable. In addition, by requiring the reliable, and facilities may be prompted
about themselves to Dun and Bradstreet, submission of an acceptable UFI, we are to request D–U–N–S number by
Dun and Bradstreet does not rely on not requiring worldwide adoption of telephone (at a large cost).
self-reported information alone. The any particular identification system.
company independently verifies certain The requirement would only apply to (Response 46) As stated in the
information associated with food facilities that are required to previous paragraphs, we conclude that
establishments. The ability to verify the register with FDA (i.e., food facilities it is appropriate to require that food
accuracy of this information will that manufacture/process, pack, or hold facilities, including foreign facilities,
increase the accuracy of the registration food for consumption in the United submit UFIs in their registrations. Use of
database and, as a consequence, help States). a UFI, such as a D–U–N–S number,
provide FDA investigators with more Regarding the comment encouraging provides additional information than
accurate food facility information that FDA to work with State, local, and tribal that provided by food facility
they can use to more efficiently identify agencies to develop a UFI without registration numbers, because UFIs such
and locate food facilities for inspection. relying on a third-party system, we may as D–U–N–S numbers allow FDA to
In addition, we expect that the UFI consider whether such an approach verify certain information submitted in
verification process will make it more would be appropriate. However, we registrations. Such verification is
difficult for unauthorized individuals to expect that undertaking the important for both domestic and foreign
submit registrations on behalf of development of a new UFI system could food facilities. As to the concern about
facilities because unauthorized entail significant resources. the burden of this requirement, we do
individuals may not know a particular (Comment 45) One comment states not agree that the process of applying
facility’s UFI, or may be unable to that a U.S. Government Accountability for a UFI is unreasonably burdensome,
provide an accurate facility-specific Office report stated that the U.S. General including for foreign facilities.
address. Services Administration has concerns Nevertheless, in response to the
To the extent that the comments are regarding reliance on D–U–N–S comments, we are delaying the
concerned about the burden of the numbers and has been looking into requirement to submit a UFI until the
requirement, we note that Dun and alternatives that would encourage registration renewal period beginning
Bradstreet makes D–U–N–S numbers competition (Ref. 10). The comment October 1, 2020. We believe that this
available at no cost. Further, as of mid- urges FDA not to require a D–U–N–S will provide adequate time for domestic
2013, approximately 70 percent of number for food facility registration. and foreign facilities to obtain
domestic facilities required to register (Response 45) As stated previously, D–U–N–S numbers without cost and for
with FDA and 64 percent of foreign the final rule does not require the facilities (both domestic and foreign) to
facilities required to register with FDA, submissions of D–U–N–S numbers; become familiar with the process for
have D–U–N–S numbers (Ref. 9). instead it requires the submission of obtaining D–U–N–S numbers. In
As to the comments suggesting we use UFIs recognized as acceptable to FDA. addition, a D–U–N–S number can be
CBP or PN systems, we do not agree that We will consider recognizing as acquired at any time, not only within
such identification systems would be acceptable UFIs other than D–U–N–S the biennial registration renewal period.
appropriate. Not all food facilities numbers. We do not anticipate that facilities will
import food, and therefore not all food (Comment 46) Comments state that have difficulty obtaining UFIs as a result
facilities will necessarily have access to the proposed requirement to obtain a D– of the UFI provider being overburdened
any CBP or PN system. Furthermore, we U–N–S number would be burdensome or its Web site being unreliable. But if
do not believe that any certifications and unfamiliar to many. Comments such difficulties do arise, facilities
and identifiers from State agencies recommend FDA make the proposed D– should contact us so that we can look
into the matter. Regarding the request in process of applying for a UFI is facilities to provide information about
the comment that FDA work with Dun reasonable and that it will not be any products other than the food
and Bradstreet to make the iUpdate unduly burdensome. manufactured/processed, packed, or
system available to food facilities, we (Comment 49) Comments express held by the food facilities, and, as
will look into the possibility and concern over the confidentiality of previously stated, information derived
determine whether the system is D–U–N–S numbers. Comments state from the registration list or registration
appropriate for food facility registration. that FDA should confirm and clarify documents are not subject to disclosure
(Comment 47) Comments state that that D–U–N–S numbers as well as under FOIA if they would disclose the
the food facility registration number facility names, addresses, and other identity or location of a specific
will serve as an adequate facility information submitted in registrations registered person.
identifier. Comments state that there are not subject to public disclosures. With regard to concerns raised about
does not appear to be a problem with One comment states that disclosure of foreign country privacy standards, we
inaccurate data in the food facility D–U–N–S numbers could allow third requested comment on the proposed
registration database and state that parties to obtain the address of requirements, and a wide range of
requiring an additional identifier is ‘‘pharmaceutical distribution entities had the chance to provide us
therefore not necessary. warehouses’’ that also hold food, and feedback. We are not aware of
(Response 47) FDA will not that disclosure would allow criminals to information, nor did we receive
discontinue the use of registration identify large quantities of drugs. The information from comments, that a UFI
numbers. However, since FDA comment also expresses concern about requirement would violate a European
implemented the registration inadvertent disclosure of D–U–N–S Union privacy law. If an entity finds
requirement in 2003, we have identified numbers by FDA FOIA staff. Comments that a UFI requirement conflicts with
a number of accuracy-related problems ask that FDA consult with the State specific local laws, they should contact
in the registration database. One such Department and Foreign Governments FDA.
problem involves incorrect facility ‘‘since mandating the collection of We also believe that finalizing a UFI
address information. Accurate address private data might run afoul of requirement, as opposed to a D–U–N–S
information is critical to scheduling European privacy laws.’’ number requirement, will help foster
inspections efficiently, and without it (Response 49) With respect to potential competition with other UFI
FDA often faces the problem of concerns about use of UFIs, including providers and encourage better
‘‘inspectional washouts,’’ where an FDA D–U–N–S numbers, leading to the customer service from providers
investigator arrives for an unannounced disclosure of confidential information, recognized as acceptable to FDA.
inspection at a listed address only to we take appropriate measures to secure (Comment 50) Comments request
find that the facility has gone out of all data and records provided to the clarity regarding facilities that require a
business or is otherwise not located at Agency, including data contained in D–U–N–S number (i.e. headquarters
the listed address. In fiscal year 2015, food facility registrations. Furthermore, and/or sub sites). Other comments
FDA experienced 629 inspectional we note that under section 415(a)(5) of encourage FDA to allow the use of the
washouts for foreign and domestic food the FD&C Act, FDA’s list of registered parent company’s D–U–N–S number for
facilities. We believe that requiring UFIs facilities and registration documents are separate facilities that a company may
in registrations and verifying the not subject to disclosure under FOIA. In own so that companies that own
facility-specific address associated with addition, any information derived from multiple facilities need only use one D–
those numbers will help increase the such list or registration documents that U–N–S number. Comments also state
accuracy of the address information would disclose the identity or location that many companies’ D–U–N–S
contained in FDA’s food facility of a specific registered person also is not numbers are typically handled by
registration database. subject to disclosure under FOIA. With headquarters personnel who may be
(Comment 48) Numerous comments respect to public disclosure, FDA located at a different address than the
state that it does not make sense for intends to treat information about facility itself.
small businesses or hobbyists who facilities’ UFIs the same as it treats other (Response 50) Under the final rule,
operate out of their homes to obtain information derived from registration each facility must provide a UFI
D–U–N–S numbers for the sole reason of submissions. It should also be noted recognized as acceptable by FDA.
registering with FDA. that no registration information will be Requiring identifiers that are unique to
(Response 48) Under § 1.227, a private disclosed to a UFI provider, such as Dun individual facilities is necessary to
residence is not a ‘‘facility.’’ Thus, a and Bradstreet, as part of the enable FDA to verify the facility-specific
private residence that meets customary verification process. Dun and Bradstreet address information associated with
expectations for a private residence that could disclose the identity or location those identifiers. Such verification will
is also used to manufacture, process, associated with a D–U–N–S number in allow FDA to more efficiently identify
pack, or hold food need not be some circumstances (such as for persons and locate food facilities for inspection
registered. Accordingly, if the activities that pay for Dun and Bradstreet and to maintain an accurate and up-to-
of small businesses or hobbyists who services), but any information that Dun date registration database. Accordingly,
operate out of their homes meet and Bradstreet could disclose would not FDA declines the suggestions to allow
customary expectations for a private indicate whether a facility is registered identifiers that are specific to parent
residence, they would not have to or include any information provided to companies instead of individual
register and therefore would not be FDA as part of the registration process. facilities.
required to obtain a UFI under this final Regarding the concern expressed in (Comment 51) Comments ask if the
rule. If, however, their activities do not one comment about the security of requirement to supply a D–U–N–S
meet customary expectations for a facilities that store both foods and number will apply to all facilities
private residence, the small businesses drugs, it is unclear how the submission immediately, or if it will only apply to
or hobbyists would be required to of a UFI for purposes of food facility facilities not currently registered.
register as food facilities and obtain a registration places the facility at any (Response 51) The requirement to
UFI. For the reasons outlined in the additional risk. The food facility provide a UFI will apply to all
previous paragraphs, we believe that the registration regulations do not require registrants, new and existing. For all
registrants, as we stated previously in FDA should add an optional D–U–N–S accessible for each facility and are
this document, we are delaying the number field to Form FDA 3537. directly linked to a facility’s physical
compliance date for the requirement to (Response 54) We disagree that location.
submit a UFI recognized as acceptable foreign facilities should have 30 days to (Response 57) FDA declines to
to FDA until the registration renewal update their registrations with a UFI. implement this recommendation. While
period beginning October 1, 2020. After For all registrants, we are delaying the geographical coordinates can provide
a food facility provides a UFI, it will be requirement to submit a UFI recognized longitude and latitude information
required to update its registration with as acceptable by FDA until the about a facility, geographical
any changes to the identifier in registration renewal period beginning coordinates may not always provide the
accordance with § 1.234 of the final October 1, 2020, and we believe that same relevant and detailed information
rule. this delay will provide all facilities, as a UFI. For instance, multiple,
(Comment 52) Comments ask if including foreign facilities, with separate facilities may operate from a
facilities will have to provide a new sufficient time to obtain a UFI location with the same geographical
D–U–N–S numbers if they change recognized as acceptable by FDA. We coordinates, and geographical
ownership. also believe that it would be coordinate information may not reveal
(Response 52) If a facility comes administratively difficult to implement the complete address of a facility.
under new ownership, the former owner the comment’s suggestion that different (Comment 58) Comments state that
must cancel the old registration in registration information be submitted at some individuals will have religious
accordance with § 1.235 of the final different times. The Agency will objections to the D–U–N–S number
rule, and the new owner must submit a consider adding an optional UFI field to requirement because D–U–N–S numbers
new registration for the facility as allow facilities to voluntarily submit involve a mandatory universal
specified in § 1.231 (see 21 CFR UFI information in advance of the numbering system.
1.234(b)). If a facility cancels its October 1, 2020, date.
(Response 58) If a registrant has
(Comment 55) Comments express
registration due to a change in religious beliefs that conflict with
concern over the availability of the D–
ownership, the new owner, operator, or obtaining a UFI, they should contact
U–N–S system to small facilities that do
agent in charge must provide the FDA and explain why they are not able
not have reliable access to the Internet.
appropriate UFI when registering the (Response 55) Our understanding is to comply with the requirement in the
facility under new ownership. that access to the Internet is not final rule.
(Comment 53) A comment states that required for D–U–N–S numbers, and
FDA should prominently display on the C. Requirement To Include Food
that a D–U–N–S number can be Product Categories
registration Web site that a D–U–N–S obtained by phone. If any food facilities
number can be obtained at no cost and have difficulty obtaining a UFI We proposed to amend § 1.232 to be
within a reasonable timeframe. In recognized as acceptable by FDA due to consistent with FDA’s October 2012
addition, the comment suggests that lack of access to the Internet or phone, guidance document entitled ‘‘Guidance
FDA provide a link on the FURLS Web they may contact FDA. for Industry: Necessity of the Use of
page that facilities can use to contact (Comment 56) Comments state that Food Product Categories in Food
FDA if they are asked to pay for a Dun and Bradstreet does not appear to Facility Registrations and Updates to
D–U–N–S number or to purchase account for additions or deletions to the Food Product Categories’’ (Food Product
additional D–U–N–S services, or if they Specially Designated Nationals (SDN) Categories Guidance) (Ref. 5) and the
cannot obtain a number within a List. These comments suggest FDA FSMA amendments. Specifically, the
reasonable time. establish an ongoing monitoring process proposed provision would require that a
(Response 53) We will consider that routinely verifies the food facility food facility registration include
making changes to the registration Web registration database against the current applicable food product categories of
site and the FURLS Web page to clarify SDN list. any food manufactured/processed,
which UFIs are recognized as acceptable (Response 56) The U.S. Treasury packed, or held at the facility, as
to FDA and how to obtain a UFI. If Department’s Office of Foreign Assets identified on Form FDA 3537. We stated
facilities have difficulty obtaining a UFI, Control publishes a list of individuals that we intend to address any further
they are welcome to contact FDA at any and companies owned or controlled by, amendments of the food product
time. We will consider providing further or acting for or on behalf of, targeted categories contained on Form FDA
instructions regarding how to contact countries. It also lists individuals, 3537, if necessary and appropriate,
FDA on the FURLS Web page as well. groups, and entities, such as terrorists through updates to the guidance
(Comment 54) One comment states and narcotics traffickers designated document ‘‘Guidance for Industry:
that foreign facilities should be able to under programs that are not country- Necessity of the Use of Food Product
submit registrations without a specific. Collectively, such individuals Categories in Food Facility Registrations
D–U–N–S number, and then have 30 and companies are called ‘‘Specially and Updates to Food Product
days to update the registration with the Designated Nationals’’ or ‘‘SDNs’’ (Ref. Categories.’’
D–U–N–S number. The comment 11). The comment has not identified a (Comment 59) Comments state that it
suggests that FDA conduct the compelling reason why we should is confusing to update required food
verification step at that time. establish an ongoing monitoring process product categories by guidance since the
Furthermore, the comment recommends that routinely verifies the facility guidance document is binding and, the
that FDA can maintain a log of instances registration database against the SDN comments say, looks indistinguishable
involving registrations that were list, and we decline to do so. from other guidance documents that are
cancelled because a foreign facility did (Comment 57) Comments recommend not binding. Comments recommend that
not have a D–U–N–S number and that FDA require that each facility’s the Food Product Category guidance
FDA place those facilities on Import registration include its geographical document be called something other
Alert. Furthermore, the comment coordinates instead of D–U–N–S than ‘‘Guidance,’’ such as ‘‘Binding
suggests that in the 12 months prior to numbers. Comments state that Guidance,’’ to set it apart. Comments
the next biennial registration period, geographical coordinates are more easily encourage FDA to consider amending
the food product categories through a include food product category category, replace the ‘‘food processing
mechanism other than guidance. information in their registrations. That byproducts’’ category with a ‘‘human
(Response 59) We disagree with these said, it may not be necessary for food by-products not otherwise listed’’
comments. Section 102 of FSMA warehouse facilities to ‘‘constantly category, and replace the ‘‘recycled
amends section 415(a)(2) of the FD&C update’’ their registrations. For animal waste products’’ category with a
Act, to now provide, in relevant part, warehouse facilities engaged in ongoing ‘‘processed animal waste products’’
that, when determined necessary by operations that frequently change food category. We will update Form FDA
FDA ‘‘through guidance,’’ a registrant is product categories, these facilities may 3537 to reflect changes that we make to
required to submit a registration to FDA select all of the food product categories the Food Product Categories guidance.
containing information necessary to that are normally part of their If facilities have specific questions
notify FDA of the general food category operations. If the warehouse has any about the food product categories for
(as identified in § 170.3 or any other updates to the food product categories animal food, they may contact FDA.
food categories, as determined that it handles, it is required to update (Comment 62) Comments propose
appropriate by FDA, including by its registration in accordance with utilizing FDA Product Codes instead of
guidance) of any food manufactured, § 1.234. The Agency will consider the food product categories currently on
processed, packed, or held at such possible IT solutions to reduce the Form FDA 3537. Comments state FDA
facility. We therefore believe it is burden associated with selection of food Product Codes ‘‘more specifically
appropriate to establish food product product category information. identify foods and thus allow FDA to
categories using guidance, and also to (Comment 61) Comments question more accurately assess risk,’’ and note
use the term ‘‘guidance’’ in describing whether FDA is proposing to remove that FDA’s draft guidance for industry
the document. Because of Congress’s animal feed product categories from on the voluntary qualified importer
explicit statutory authorization to Form FDA 3537 and, if not, request program (VQIP) recommends use of the
effectuate a binding requirement based clarity on the definitions of each of the product codes.
on findings in guidance, the Food animal food product category listed on (Response 62) FDA’s product code is
Product Categories guidance document the form. a unique alpha-numeric code used by
is not subject to the usual restrictions in (Response 61) This final rule does not FDA and customs brokers and self-filers
FDA’s GGP regulations, such as the remove animal food product categories to describe food products, as well as
requirements that guidances not from Form FDA 3537, and registrants other products regulated by FDA. FDA
establish legally enforceable will continue to be required to provide requires submission of this data element
responsibilities and that they information about food product for prior notice (21 CFR 1.281(a)(5)(i)),
prominently display a statement of the categories for animal food. As to the in part because the specificity provided
document’s nonbinding effect (see 21 comment’s request for guidance on the by the FDA product code helps facilitate
CFR 10.115(d) and (i)). Although we meaning of the different food product risk-based screening of imported
appreciate the comments’ concern that categories for animal food, we do not products. The use of FDA product codes
this causes the Food Product Categories agree that such guidance is necessary. is also part of the application process for
Guidance to differ from other guidance We believe that many of the food VQIP, as explained in the VQIP draft
documents, we think that the guidance product categories on Form FDA 3537 guidance (Ref. 12). At the same time,
document itself makes this difference do not require elaboration. For instance, FDA requires the submission of food
clear. In particular, we stated in the we believe that registrants understand product category information for
Food Product Categories guidance that the meaning of the term ‘‘pet food,’’ registration. Food product categories are
we did not include the standard which is one of the food product for the most part more general and are
language regarding the ‘‘nonbinding categories for animal food. To the extent tailored to food facility registration.
effect of guidance’’ in the guidance that the comment seeks clarification on FDA may use the food product
because it is not an accurate description the categories that pertain to animal categories in connection with product
of the effect of the guidance (Ref. 5). food ingredients, we believe that these codes at the time of import. Specifically,
(Comment 60) Comments suggest that categories are well understood in the FDA is able to use the information about
FDA should not require warehouses and animal food industry. For instance, food product categories to screen food
storage facilities to identify food every year the Association of American imports because the Agency is able to
product categories that they handle Feed Control Officials (AAFCO) issues match a registrant’s food product
because this information constantly the Official Publication (OP) that category with the product code and
changes. The comments state that it includes categories for various animal common or usual market name
would therefore be burdensome for food ingredients, many of which overlap submitted as part of prior notice.
these facilities to be required to with the food product categories listed However, food product categories
‘‘constantly update’’ their food product on Form FDA 3537 for animal food. In provide certain information that the
category information. order to provide even greater product codes do not provide. For
(Response 60) Information about the consistency with the categories used by example, the fruit and vegetable
categories of food a facility handles the animal food industry, FDA plans to categories include separate sub-
helps FDA conduct investigations and update the Food Product Categories categories for fresh-cut fruits and
surveillance operations in response to guidance to add several additional food vegetables, raw agricultural
food-related emergencies and to quickly product categories for animal food. commodities, and other fruit and
alert facilities affected by such an Those categories are: Botanicals and vegetable products. Because fresh-cut
incident if FDA receives information herbs; direct fed microbials; forage fruit and vegetables present different
indicating the type of food affected. This products; and technical additives. In risks from other fruits and vegetables,
is true for warehouse and storage addition, we plan to revise the Food this information helps FDA target
facilities, as well as other facilities that Product Categories Guidance to replace communications with facilities. The
manufacture/process, pack, or hold certain food product categories. product codes do not distinguish fresh-
food. We therefore disagree with the Specifically, we plan to replace the cut from other fruit or vegetable
suggestion to exempt warehouses and ‘‘animal derived products’’ category products. For all of these reasons, we
storage facilities from the requirement to with an ‘‘animal protein products’’ believe it is appropriate to continue to
require food product categories for activity type information. One comment that will make it less burdensome to
registration, and not FDA product states that the requirement will reduce provide this information, such as drop
codes. Further, we note that food facility the need for FDA to reach out to down menus or ‘‘Select all’’ options.
registration and VQIP serve different facilities to gather this same Regarding the request that FDA obtain
purposes. information. One comment suggests that activity type information through a
(Comment 63) One comment suggests FDA obtain activity type information in written text field, we decline that
that we modify Form FDA 3537 to allow a written text field on the registration request. We do not believe that using
facilities to write in the type of food that form instead of using a matrix similar to written text fields would easily enable
is being held at the facility in order to that currently used on Form FDA 3537, facilities to match the activity type
minimize the content of sections 10a which matches activity type information information with the food product
and 10b on the form. with food product category information. category information. Also, the
(Response 63) We decline the The comment is concerned that comment does not explain why written
suggestion to modify sections 10a warehouses that hold a number of text fields would be less burdensome
(general product categories for human different foods would be required to than the matrix used on current Form
consumption) and 10b (general product make frequent updates. FDA 3537, which allows facilities to
categories for animal consumption) to a check boxes indicating applicable
(Response 65) We disagree with the
blank column for the facility to write in activity types. (Currently, the activity
comments suggesting that we not
a food category. We believe that it type information on Form FDA 3537 is
require activity type information. As
makes the registration process easier for optional.)
stated in the proposed rule (80 FR 19160
facilities if there are designated food (Comment 66) One comment asks
at 19173), information about activity
product categories from which they can whether foreign facilities must provide
type will provide FDA with important
choose. We also believe that the specific activity type information about all foods
food product categories currently on information regarding a facility’s role in
associated with the facility, or only
Form FDA 3537 are necessary and the U.S. food supply system, allowing
about foods exported for consumption
appropriate for food facility registration, us to better assess the facility’s potential
in the United States.
as indicated in the Food Product impact in cases of bioterrorist incidents (Response 66) Facilities are only
Categories Guidance. or other food-related emergencies. required to provide activity type
(Comment 64) One comment agrees Improved information about activity information about food that the facility
with the designation of ‘‘Bakery types will also allow us to better prepare manufactures/processes, packs, or holds
products, dough mixes, or icings [21 investigators for inspections and assign for consumption in the United States.
CFR 170.3(n)(1),(9)]’’ as a food product appropriate investigators, and allow FDA is requiring information about
category, provided that the food product FDA to communicate more quickly and activity types to help FDA better assess
category is intended to encompass all of efficiently on various non-emergency the facility’s potential impact in cases of
the foods covered by § 170.3(n)(1) and issues, such as new regulatory bioterrorist incidents or other food-
(9). The comment would alternatively requirements or policies. In addition, related emergencies, and to help the
support separate food product categories the activity type information will aid Agency identify facilities with which to
for the products covered by § 170.3(n)(1) FDA in implementing section 421 of the communicate on various issues, among
and (9) if the different products covered FD&C Act, which requires FDA to the other reasons discussed in the
by the two different provisions have identify high-risk facilities and previous paragraphs. We anticipate that
unique risk profiles. mandates more frequent inspections for we will only need to assess facilities
(Response 64) The food product domestic high-risk facilities than for and communicate with facilities with
category ‘‘Bakery products, dough domestic non-high-risk facilities. respect to foods that are consumed in
mixes, or icings [21 CFR Section 421(a)(1) of the FD&C Act sets the United States.
170.3(n)(1),(9)]’’ is intended to forth the factors for FDA to use in (Comment 67) A comment suggests
encompass all of the foods covered by identifying high-risk facilities, which that FDA provide definitions for the
§ 170.3(n)(1) and (9). If we make include ‘‘[a]ny . . . criteria deemed following activity types: Ambient
changes to the food product categories, necessary and appropriate by the human food storage warehouse/holding
we will update the Food Product Secretary for purposes of allocating facility; refrigerated human food
Categories Guidance. inspection resources’’ (see section warehouse/holding facility; and frozen
421(a)(1)(F) of the FD&C Act). Among human food warehouse/holding facility.
D. Requirement To Identify Activity the criteria we have deemed necessary (Response 67) In the proposed rule,
Type and appropriate for this purpose are we provided tentative definitions for the
(Comment 65) Some comments state type of activity conducted at the facility activity types required in § 1.232 (80 FR
that requiring activity type information (manufacturer/processor, packer/ 19160 at 19173 to 19174) and we
would be burdensome for facilities that repacker, etc.). Because the risk-based requested comment on whether to
hold many products (i.e., warehouses) inspection mandate in section 421of the define the specified activity types. We
and perform various activities. FD&C Act applies to facilities registered conclude that it is not necessary to
Comments also state that this under section 415, and because we have provide definitions in the regulatory
information is irrelevant to FDA’s identified information about the type of text, considering that we provided
mission and operations, including activity conducted at a facility as an tentative definitions in the proposed
inspection planning, determining important factor to consider when rule and that we understand the activity
inspection frequency, and responding to identifying high-risk facilities under type terms to be generally well-
food-related emergencies. These section 421 of the FD&C Act, the activity understood by industry. If additional
comments suggest that activity type type information will allow us to more clarification is needed, we will consider
information should remain optional, as efficiently enforce section 421. providing guidance on the activity type
it is under the current food facility Therefore, we decline the definitions, as appropriate. We believe
registration regulation. Other comments, recommendation to keep the activity that any such clarification will be better
however, state that they support the types as optional data elements. We will provided in a guidance document that
requirement that facilities provide consider IT and formatting solutions follows our GGP regulations in 21 CFR
10.115 because we will be better able to definition in § 1.227 so that it no longer packaged food not exposed to the
provide clarification quickly as the need limits establishments that fall within the environment. The comment states that
may arise. ‘‘farm’’ definition to those that pack or this information will assist FDA in
(Comment 68) One comment hold food grown, raised, or consumed setting inspection priorities and
recommends that FDA divide the on that farm or another farm under the conducting inspections at storage
‘‘ambient human food warehouse/ same ownership. Under the revised facilities. The comment states that such
holding facility,’’ ‘‘refrigerated human ‘‘farm’’ definition in § 1.227, an facilities pose a very limited, if any,
food warehouse/holding facility’’, and establishment devoted to the growing of food-safety risk. The comment also
‘‘frozen human food warehouse/holding crops, the raising of animals, or both, mentions that a citizen petition
facility’’ activity types into two sub- would remain within the ‘‘farm’’ submitted for FDA review requests an
categories: ‘‘Ambient human food definition if it packs and holds RACs exemption from certain FSMA
warehouse/holding facility’’, and grown on that farm or another farm requirements for storage facilities that
‘‘refrigerated/frozen human food under the same ownership, and also if are solely engaged in the storage of
warehouse/holding facility.’’ The it packs and holds RACs grown on packaged food not exposed to the
comment states that three sub-categories another farm. Any such establishment environment.
are not useful and may lead to that meets the ‘‘farm’’ definition is not (Response 71) FDA declines this
confusion. subject to the requirement to register suggestion. We agree that different food
(Response 68) We disagree with this under section 415 and therefore is not safety requirements should apply to
comment. Information distinguishing required to provide FDA with activity facilities solely engaged in the storage of
whether a facility is engaged in type information in accordance with unexposed packaged food, and in the
refrigerated or frozen warehousing/ this final rule. However, if the farm final rule for preventive controls for
holding is important to the Agency engages in other activities that require human food we have exempted such
when responding to food-related the establishment to be registered, it is facilities from 21 CFR part 117, subparts
emergencies. Generally speaking, the required to provide FDA with activity C (hazard analysis and risk-based
closer a refrigerated or frozen food gets type information in accordance with preventive controls) and G (supply-
to ambient temperature, the more § 1.232(a)(8) and select farm mixed-type chain program), and provided for
potential there is for spoilage and facility. modified requirements if the food
foodborne illness to occur. Refrigerated (Comment 70) One comment asks requires time/temperature control for
foods have a more narrow window FDA to clarify what it means by farm safety. However, for purposes of food
before they reach a temperature where mixed-type facility as a facility type and facility registration, we do not agree that
spoilage occurs. Facilities that to develop a plan for on-farm it is necessary for facilities to separately
warehouse such foods would therefore inspections and to train investigators on identify whether they are solely engaged
be of most concern to FDA in an conducting such inspections.
in the storage of packaged food not
emergency involving power outages. For Furthermore, the comment requests that
exposed to the environment. In the final
example, during a response to a natural FDA develop outreach and education
disaster in which power outages occur, rule, we are dividing the (previously
plans to help farms understand the
the Agency might choose to first focus optional) activity type of ‘‘warehouse/
registration process, in particular farms
on refrigerated warehouses to ensure holding facility’’ for facilities that hold
that have to register because they are
proper handling of foods that are at risk food for human consumption into three
mixed-type facilities.
of spoilage and foodborne illness. (Response 70) In § 1.227 of our sub-categories. Those three sub-
(Comment 69) A comment requests regulations, we explain that a mixed- categories are ‘‘ambient human food
that FDA provide clarification regarding type facility means an establishment temperature warehouse/holding
the ‘‘farm mixed-type facility’’ activity that engages in both activities that are facility,’’ ‘‘refrigerated human food
type. Specifically, the comment asks exempt from registration under section warehouse/holding facility,’’ and
FDA to confirm whether it is acceptable 415 of the FD&C Act and activities that ‘‘frozen human food warehouse/holding
for a farm that packs fresh produce from require the establishment to be facility.’’ We anticipate that the
other farms to register as a ‘‘farm mixed- registered. An example of such a facility information that we will gather from
type facility.’’ The comment also asks is a ‘‘farm mixed-type facility,’’ which is these sub-categories will be sufficient to
FDA to confirm that a farm that packs an establishment that is a farm, but also allow us to more efficiently respond to
its own produce should not register. conducts activities outside the farm food-related emergencies. For example,
(Response 69) In § 1.227 of our definition that require the establishment if FDA receives information indicating
regulations, we define a mixed-type to be registered. We will consider that refrigerated or frozen warehouses/
facility as an establishment that engages appropriate ways to train and prepare holding facilities could be affected by
in both activities that are exempt from investigators for inspections of mixed- power outages, FDA would be able to
registration under section 415 of the type facilities. As to the request that communicate with such facilities about
FD&C Act and activities that require the FDA provide education and outreach to the incident. We do not anticipate that
establishment to be registered. An help farms understand the registration information about whether a facility is
example of such a facility is a ‘‘farm process, we agree with comments that solely engaged in the storage of
mixed-type facility,’’ which is an stress the importance of education and unexposed packaged food will be of
establishment that is a farm, but also outreach. Within the Agency, we are much additional utility in responding to
conducts activities outside the ‘‘farm’’ establishing a Food Safety Technical an emergency food incident.
definition that require the establishment Assistance Network and we plan to Regarding the citizen petition
to be registered. FDA added the provide updated guidance concerning submitted to FDA (Docket No. FDA
definition in § 1.227 for mixed-type the registration requirements. 2011–P–0561–CP), the Agency will
facilities in the final rule for ‘‘Current (Comment 71) Comments encourage respond to the citizen petition in
Good Manufacturing Practice, Hazard FDA to allow the activity type for accordance with 21 CFR part 10.
Analysis and Risk-Based Preventive facilities that warehouse/hold food to (Comment 72) A comment encourages
Controls for Human Food.’’ Also in that indicate that their storage facilities are FDA to leave sections 8 and 9 on form
rulemaking, we revised the ‘‘farm’’ solely engaged in the storage of FDA 3537. The comment states that
these sections contain important E. Requirement To Provide Assurance converts several of the optional items in
information about food facilities. That FDA Will Be Permitted To Inspect current § 1.233 into required items in
(Response 72) We do not plan to (Comment 74) One comment revised § 1.232. Second, we believe FDA
disagrees with the requirement that recommendations for optional items to
remove sections 8 (‘‘Seasonal facility
facilities provide assurance that FDA include in food facility registrations are
date’’) from Form FDA 3537. In that
will be permitted to inspect the facility better addressed in guidance documents
section, we provide an optional field for that follow our GGP regulations in 21
facilities to give the approximate dates at the times and in the manner
permitted by the FD&C Act. The CFR 10.115.
that they are open for business, if their
operations are on a seasonal basis. We comment states that this requirement IX. Comments on Proposed
plan to retain seasonal facility dates as violates a country’s sovereignty and that Amendments to § 1.234—How and
an optional field. Section 1.233 of the facilities are subject to the national laws When Do You Update Your Facility’s
final rule provides that FDA encourages, of the country in which they are located, Registration Information?
but does not require, registrants to and should therefore not be required to We proposed to amend § 1.234(a) to
agree to inspection by FDA without the shorten the time period for a food
submit items that are indicated as
permission of their country’s facility to update its registration from 60
optional on Form FDA 3537.
government. to 30 calendar days. We also proposed
Regarding section 9 (‘‘Types of (Response 74) Section 415(a)(2) of the to amend § 1.234(b) to provide that
storage’’) on Form FDA 3537, we are FD&C Act, as amended by section 102(b) when the reason for the update is a
removing this section from the form. In of FSMA, requires that food facility change in owner, the former owner must
that section, which is for facilities that registrations contain an assurance that cancel the registration in 30 calendar
are primarily holders, we make it FDA will be permitted to inspect the days instead of the 60 calendar days
optional for facilities to identify facility at the times and in the manner allotted in current § 1.234(b). As
whether the facility’s type of storage is permitted by the FD&C Act. We do not discussed in the paragraphs that follow,
ambient storage, refrigerated storage, or agree that requiring this assurance we are not finalizing these proposals.
frozen storage. Because facilities are violates the sovereignty of countries in In addition, we proposed to amend
now required to provide this which foreign facilities are located. The § 1.234(a) to require that for updates not
information as part of the activity type assurance is required for food facilities submitted by the owner, operator, or
requirement in § 1.232(a)(8) of the final in order to complete their food facility agent in charge of the facility, the
rule, it would be duplicative to provide registration. The assurance does not update must provide the email address
facilities with the option of completing require foreign facilities to disregard the of the owner, operator, or agent in
this information in a separate section of laws of the countries in which they are charge who authorized submission of
the registration form. located, nor does it require the foreign the update. We are finalizing this
countries to relinquish any sovereignty. requirement in the final rule, with
(Comment 73) Comments recommend When FDA selects foreign food facilities modifications. Final § 1.234(a) provides
that LACF and acidified food processing for inspection that have registered with that for updates not submitted by the
be treated as an activity type, not a food FDA because they manufacture/process, owner, operator, or agent in charge, the
product category. Comments state that pack, or hold food for consumption in update must include the email address
there are many foods that are LACF or the United States, FDA involves the of the individual who authorized the
acidified foods that also fall within foreign governments by generally update, unless FDA has granted a
other food product categories (such as sending an advance notification to the waiver under § 1.245. We are allowing
baby food, cheese, and salad dressings). Competent Authority responsible for for a waiver for the same reasons as
Comments state that FDA investigators food safety in the country where FDA those discussed in Response 44.
would be able to better prepare for will be conducting an inspection. Under Further, we proposed to amend
inspections if facilities select the the FSMA amendments to the FD&C § 1.234(d) to provide that beginning
activity type ‘‘low-acid and acidified Act, FDA has the authority to take January 4, 2016, electronic updates will
food processing’’ in conjunction with action if the Agency encounters be mandatory unless a waiver under
the applicable food product category inspection refusals. Specifically, FDA § 1.245 has been granted. For the
(e.g., cheese) for the food produced at may refuse admission of food into the reasons discussed in section VI.A of this
the facility. United States when that food is from a document, final § 1.234(d) delays the
(Response 73) We agree with these foreign factory, warehouse, or other requirement for electronic submission of
establishment of which the owner, cancellations. Specifically, final
comments. The final rule includes
operator, or agent in charge, or the § 1.234(d) provides that updates must be
acidified food and low-acid food
government of the foreign country, that submitted electronically beginning
processing in the list of activity type
refuses to allow inspection (see section January 4, 2020. Final § 1.234(d) also
options. In addition, we will update the
807(b) of the FD&C Act). provides that if FDA has granted a
Food Product Categories Guidance to waiver under § 1.245, cancellations may
remove acidified foods and LACF as VIII. Comments on Proposed § 1.233— be made by mail or fax.
food product categories. We also plan to Are There Optional Items Included in (Comment 75) Comments oppose
update the Food Product Categories the Registration Form? shortening the time period for
Guidance to list molluscan shellfish as We proposed to amend § 1.233 to registration updates. Comments state
a food product category. Previously, provide that FDA encourages, but does that FDA did not provide any examples
Form FDA 3537 included ‘‘molluscan not require, registrants to submit items of when a shortened time period for
shellfish establishment’’ as an optional that are indicated as optional on the updates would have better enabled FDA
activity type. However, the list of Form FDA 3537. We proposed for this to schedule inspections or more
activity types in this final rule does not amendment to remove the optional effectively respond to food safety issues.
include molluscan shellfish items currently listed § 1.233. We are Comments state that a shortened time
establishments. We are revising Form finalizing this amendment as proposed, period would increase the regulatory
FDA 3537 to reflect these changes. for two reasons. First, the final rule burden on food facilities. One comment
encourages FDA to consider the Specifically, final § 1.235(d) provides period for submitting cancellations
difference in public holidays as well as that cancellations must be submitted would strike an appropriate balance.
time and language differences between electronically beginning January 4, Current § 1.235 provides 60 calendar
the United States and foreign countries. 2020. Final § 1.235(d) also provides that days to cancel, and we are not aware of
The comment states that facilities in if FDA has granted a waiver under any specific instances in which facilities
foreign countries may need a longer § 1.245, cancellations may be made by have found this time period to cause
amount of time to update the mail or fax. Also in the proposed rule, difficulties.
information and suggests keeping 60 we proposed to amend § 1.235(b)(5) to
XI. Comments on Proposed
calendar days for submitting updates. require that for cancellations not
Amendments to § 1.241—What Are the
Some comments state that, given the submitted by the owner, operator, or
Consequences of Failing To Register,
potential for criminal penalties for agent in charge of the facility, the
Update, Renew, or Cancel Your
committing prohibited acts under the cancellation must include the email
Registration?
FD&C Act, the shortened time period address of the owner, operator, or agent
does not provide a reasonable amount of in charge who authorized the Proposed § 1.241(c) proposed to
time for compliance, particularly for cancellation. We are finalizing this amend the registration regulation to
businesses that are in the midst of requirement in the final rule, with provide that FDA may cancel
reorganizations. modifications. Final § 1.235(b)(5) registrations in certain additional
(Response 75) In response to these provides that cancellations not circumstances in addition to those
comments, we are not shortening the submitted by the owner, operator, or currently specified in current § 1.241.
time period for the submission of agent in charge must include the email Specifically, we proposed to amend
updates in § 1.234(a). Consequently, we address for the individual who § 1.241(c) to provide that FDA will
will continue to allow owners, authorized the cancellation, unless FDA cancel a registration if FDA
operators, or agents in charge of a has granted a waiver under § 1.245 of independently verifies that the facility
facility 60 calendar days to submit the final rule. We are allowing for is not required to register, if information
updates to any changes of the required waivers for the same reasons discussed about the facility’s address was not
registration elements previously in Response 44. updated in a timely manner in
submitted. We believe that this strikes In addition, we are deleting proposed accordance with § 1.234(a), or if the
an appropriate balance between the § 1.235(d)(7) of the final rule, because it registration was submitted to FDA by a
concerns expressed in the comments is not applicable for cancellations. person not authorized to submit the
and FDA’s need to maintain an accurate Furthermore, we have redesignated registration under § 1.225. In addition,
and up-to-date registration database. In proposed § 1.235(d)(8) to § 1.235(d)(7) in proposed § 1.241(c) proposed to further
addition, we are not shortening the time the final rule and are making edits to amend the registration regulation by
period in § 1.234(b). Consequently, clarify the process FDA will use to also providing that FDA will cancel a
when the reason for the update is a confirm cancellations submitted registration if the facility’s registration
change in owner, the former owner will through mail or fax. We state in has expired because the facility has
continue to have 60 calendar days to § 1.235(d)(7) of the final rule that the failed to renew the registration in
cancel the registration, as is currently registration will be considered cancelled accordance with § 1.230(b). Similarly,
provided in current § 1.234(b). once FDA enters the facility’s we proposed to add § 1.241(b) to the
cancellation data into the registration registration regulation to specify that
X. Comments on Proposed Amendments FDA will consider a registration for a
system. FDA will send the registrant a
To § 1.235—How and When Do You food facility to be expired if the
cancellation confirmation.
Cancel Your Facility’s Registration (Comment 76) Comments disagree registration is not renewed, as required
Information? with FDA’s proposal to shorten the time by § 1.230(b), and FDA will consider a
We proposed to amend § 1.235 to period for cancellations from 60 food facility with an expired registration
shorten the time period for cancelling calendar days to 30 calendar days. to have failed to register in accordance
registrations from 60 calendar days to 30 Comments state that reducing the time with section 415 of the FD&C Act.
calendar days. Specifically, proposed period for cancellations would be FDA proposed to cancel registrations
§ 1.235(a) would replace a 60-calendar- burdensome without providing any in these additional circumstances based
day requirement with a 30-calendar-day commensurate benefit to public health. on our experiences with invalid
requirement, providing that facilities Additionally, some comments suggest registrations during the approximately
cancel their registrations within 30 that the time period should be 10 years we have spent administering
calendar days of the reason for increased, not decreased, to 90 days. food facility registration, as well as to
cancellation (e.g., facility ceases (Response 76) In response to these improve the accuracy and utility of the
operations, ceases providing food for comments, we are not shortening the food facility registration database such
consumption in the United States, or is time period for the submission of that FDA would be able to maintain a
sold to a new owner) instead of the 60 cancellations in § 1.235(a) of the final more up-to-date list of registered
calendar days in current § 1.235(a). As rule. Consequently, owners, operators, facilities in accordance with section
discussed in the following paragraphs, and agents in charge will continue to be 415(a)(5) of the FD&C Act. A more
we are not finalizing this proposal. required to cancel registrations within accurate and up-to-date list will enable
In addition, we proposed to amend 60 calendar days of the reason for investigators to more efficiently locate
§ 1.235 to require in § 1.235(d) that cancellation. Just as with our decision to food facilities for inspection and will
beginning January 4, 2016, owners, not shorten the time period for the better enable FDA to act quickly in
operators, or agents in charge must submission of updates in § 1.234(a) of responding to a threatened or actual
cancel their registrations electronically, the final rule, we believe that this terrorist attack on the U.S. food supply
unless a waiver under § 1.245 has been strikes an appropriate balance between or other food-related emergency. In
granted. For the reasons discussed in the concerns expressed in the comments addition, our proposal to cancel
section VI.A of this document, final and FDA’s need to maintain an accurate registrations when a facility has failed to
§ 1.235(d) delays the requirement for and up-to-date registration database. We renew its registration in accordance
electronic submission of cancellations. do not believe that lengthening the time with § 1.230(b) was designed to respond
to the FSMA amendments. FSMA stated that we anticipate that if facilities we plan to notify registrants that we will
amended section 415 of the FD&C Act do not respond within 30 days, or if consider a food facility with an expired
to require food facilities that are corrective action is otherwise not taken registration to have failed to register in
required to register with FDA to renew within that time period, we would accordance with section 415 of the
their registrations with FDA every other determine that we conducted an FD&C Act. Because facilities will
year. Cancelling the registrations of independent verification and would already receive notice of their obligation
facilities that have failed to do so will then cancel the registration. If a facility to renew throughout this process, we do
allow FDA to efficiently enforce the believes its registration was cancelled in not agree that it is necessary to provide
renewal requirement. It will also allow error, the facility would be able to an additional 30-day notice before
FDA to efficiently implement its contact FDA. We also stated in the cancelling registrations that expired
obligation under section 415(a)(5) of the proposed rule that we anticipated that it because the facility has failed to renew
FD&C Act to maintain an up-to-date list would not be appropriate to provide the its registration in accordance with
of facilities. The proposal is also 30-day window for corrective action if § 1.230(b).
consistent with the requirement in the basis for cancellation is an expired (Comment 79) Comments recommend
section 415(a)(2) of the FD&C Act that registration due to failure to renew a that FDA provide similar procedures
facilities notify FDA in a ‘‘timely registration in accordance with when cancelling a registration to those
manner’’ as to changes in their § 1.230(b). In those circumstances, a that the Agency provides when
registration information, including their facility would have already received suspending a facility’s registration, such
address information. We are finalizing notice of its obligation to renew (80 FR as providing an opportunity for a
the amendments to § 1.241 as proposed, 19160 at 19177). FDA understands the hearing and an opportunity to reinstate
with one modification. We are revising serious nature of cancelling a the registration.
§ 1.241(c) of the final rule to state that registration, and we plan to provide (Response 79) We disagree. As
if we cancel a facility’s registration, we appropriate notice to facilities facing specified in section 415(b)(2) regarding
will send a confirmation of the cancellation consistent with our registration suspensions, FDA will
cancellation using contact information statements in the proposed rule. provide a registrant subject to a
submitted by the facility in the However, we decline the request to suspension order with an opportunity
registration database. We are making amend the regulatory text to specify the for an informal hearing on the actions
these edits to clarify the process FDA specific notice we will provide. The required for reinstatement of registration
will use to confirm cancellations in facts in each scenario involving a and why the registration that is subject
these additional circumstances. potential cancellation are likely to be to suspension should be reinstated.
(Comment 77) Comments request that unique, and we do not think it would Suspensions involve a factual
the final rule include safeguards for be appropriate to follow a single determination by FDA that there is a
when inadvertent technical mistake are procedure for each cancellation. In reasonable probability of serious
the basis for cancellation, such as a addition, we decline to commit to adverse health consequences or death.
period of time during which facilities providing registrants 60 days after See section 415(b)(1) of the FD&C Act
may make corrections or a response notice is provided before cancelling (providing that the Secretary may
process initiated by FDA. Comments registrations. We believe that 30 days suspend a facility’s registration if the
also state the final regulations should will generally provide registrants with Secretary determines that food
specifically state that FDA will send sufficient time to respond to any manufactured, processed, packed,
notice to facilities facing potential questions or concerns raised by FDA received, or held by a registered facility
cancellations indicating the Agency’s and take corrective action if appropriate. has a reasonable probability of causing
intent to cancel the registration and the If FDA cancels a facility’s registration, serious adverse health consequences or
basis for the cancellation. Comments FDA will mail a confirmation of the death to humans or animals). We do not
state that wrongful cancellations could cancellation to the facility at the address believe that the same procedures used
cause significant hardship. Some provided in the facility’s registration. for registration suspensions are
comments also state that facilities We believe that this approach will necessary for registration cancellations
should have 60 days to take corrective provide adequate due process to because registration cancellations are
action before FDA cancels a registration. facilities. unlikely to present the kind of factual
Some comments state that registrants (Comment 78) Other comments urge issues involved in registration
should have due process prior to FDA FDA to provide a 30-day notice before suspensions.
cancelling a registration. a registration is considered expired, to Registration cancellations under
(Response 77) Our amendments to ensure due process, and to allow § 1.241 do not involve determinations
§ 1.241(c) will maintain the requirement facilities to respond. The comments made by FDA regarding the probability
in current § 1.241(b) that FDA will state that facilities should have the of food safety hazards. They are instead
cancel registrations if the Agency opportunity to allow potential gaps in based on a facility’s failure to itself
‘‘independently verifies’’ that the communication or misunderstandings to comply with certain requirements for
specified circumstances are satisfied. In be resolved. food facility registration. Those
the proposed rule, we stated that we (Response 78) We do not agree that it requirements are administrative in
anticipate that in many cases it would is necessary to provide a 30-day notice nature. Further, we believe that the
be appropriate for FDA to send notices before a registration is considered procedures in § 1.241 are adequate to
to facilities facing potential cancellation expired. Leading up to and throughout ensure fairness. FDA will cancel
indicating our intent to cancel their the registration renewal period, we plan registrations if it independently verifies
registrations and the basis for such to notify registrants of their obligation to that the facility is no longer in business
cancellations. We also stated that we renew their registrations and the or has changed owners, and the owner,
anticipated that, when appropriate, if deadline for doing so. We also plan to operator, or agent in charge of the
the circumstances meriting possible notify registrants that failure to renew facility fails to cancel the registration, or
cancellation are corrected within 30 their registrations in accordance with if FDA determines that the registration
days after notice is provided, we would § 1.230(b) will cause FDA to consider is for a facility that does not exist, is not
not cancel the registration. We further the registrations expired. Additionally, required to register, or where the
information about the facility’s address FD&C Act, FDA’s practice is to take registrations, stating that keeping this
was not updated in a timely manner in enforcement action based on the facts of additional information on file could
accordance with § 1.234(a) of the final the case and the seriousness of the prove useful to FDA.
rule or the registration was submitted by violations. (Response 84) FDA will archive
a person not authorized to submit the (Comment 82) Comments state that information from inactive food facility
registration under § 1.225. FDA will not some establishments, such as farms, registrations as appropriate.
cancel registrations in these have registered with FDA even though
XII. Comments on Proposed Addition of
circumstances if it does not they are not required to. The comments
§ 1.245—Waiver Request
independently verify the relevant facts. state that FDA should not cancel the
In addition, for registrations that FDA registrations for such establishments. In In the proposed rule, we proposed for
cancels as a result of the facility’s failure addition, some comments urge FDA to § 1.245 to provide that to request a
to renew the registration, the facility allow entities to register that are not waiver from the requirement to submit
will have received multiple notices from required to register, stating that FDA registrations and registration renewals
FDA reminding it of the registration may find it useful to have information electronically, a registrant must submit
renewal requirement. If we nevertheless about such entities. a written request to FDA that explains
cancel a registration in error, facilities (Response 82) We disagree. Not all why it is not reasonable for the
should contact FDA so that we can look food-related establishments are required registrant to submit a registration or
into the matter. to register under section 415 of the registration renewal electronically to
(Comment 80) Comments recommend FD&C Act. Only food facilities not FDA. In the proposed rule, FDA
that FDA annually review imports to exempt under § 1.266 are required to tentatively concluded that reasons for
determine whether registered foreign register, and farms are not food why it may not be reasonable for a
facilities have imported food into the facilities. See section 415(c)(1) registrant to submit a registration or
United States during the preceding year (providing that the term ‘‘facility’’ does registration renewal to FDA
and cancelling registrations for facilities not include farms); 21 CFR 1.226 electronically may include conflicting
that have not done so. (establishing that the registration religious beliefs or where a registrant
(Response 80) We decline to conduct requirements in 21 CFR part 1, subpart does not have reasonable access to the
such a review of registrations. The H, do not apply to farms); 21 CFR 1.227 Internet (80 FR 19160 at 19177 to
comment does not explain why such a (establishing separate definitions for 19178).
use of FDA resources would be ‘‘facility’’ and ‘‘farm’’). FDA uses In the final rule, we are finalizing the
warranted, especially in light of the registration information to identity option of a waiver. However, we are
effect that the biennial registration facilities for inspection and for revising § 1.245 of the final rule to
renewal requirement has helped to communications on both routine and clarify that FDA must have already
routinely remove inactive registrations. emergency matters. A registration granted the waiver in order for the
(Comment 81) One comment states database that includes establishments electronic submission requirement to
that criminal and civil liability for lack registered as food facilities but that are not apply. We believe that this
of compliance with the registration not, in fact, food facilities hinders these requirement was implicit in proposed
requirements would be a efforts, compromising FDA’s ability to § 1.245, but we have revised the
disproportionate response from FDA. strategically target inspections and regulatory text to avoid any possible
The comment states that the possibility communications. We therefore believe it confusion. We are also revising § 1.245
of such liability may ‘‘result in a lack of is appropriate for FDA to cancel the of the final rule to provide that a waiver
willingness by U.S.-based agents to take registrations for such establishments. In is available not only from the
responsibility’’ for foreign entities. addition, we do not believe that the requirement to submit registrations and
(Response 81) Under section 415 of comment has identified reasons why it registration renewals (which also
the FD&C Act, owners, operators, and would be useful to have entities includes abbreviated renewals)
agents in charge of facilities are required participate in food facility registration electronically, but also from the
to register with FDA. In addition, under under section 415 of the FD&C Act that requirement to submit updates and
section 301(dd) of the FD&C Act, the are not required to register under cancellations electronically. In addition,
failure to register in accordance with section 415. we are also expanding the waiver option
section 415 is a prohibited act. Further, (Comment 83) A comment so that waivers are also available from
the causing of a prohibited act and being recommends that FDA conduct broad the requirement in § 1.232(a)(6) to
responsible for the commission of a education and outreach regarding provide the email address of the owner,
prohibited act are subject to civil and registration requirements, before seeking operator, or agent in charge of the
criminal sanction under the FD&C Act civil or criminal penalties on entities facility, and also from the requirement
(see sections 301, 302 (21 U.S.C. 332), that are newly subject to registration in §§ 1.230(b) and (c), 1.232(a)(10),
and 303 (21 U.S.C. 333) of the FD&C requirements, and that therefore may be 1.234(a), and 1.235(b)(5) to provide the
Act). We believe that it is consistent unfamiliar with the requirements. email address for the individual who
with the FD&C Act for the registration (Response 83) We recognize that there authorized submission of a registration
regulation to specify in § 1.241 that the will be questions about registration renewal, registration, update, or
United States can bring a civil action in requirements. We agree that education cancellation, respectively, when such
Federal court to enjoin a person who and outreach are important, and we submissions are not made by the owner,
commits a prohibited act and a criminal plan to develop additional education operator, or agent in charge of the
action in Federal court to prosecute a and outreach strategies as appropriate. facility. Finally, we are revising
person who is responsible for the In addition, we are establishing a Food proposed § 1.245 to no longer refer to
commission of a prohibited act. Indeed, Safety Technical Assistance Network to January 4, 2016, as the date on which
the registration regulation has specified allow us to respond in a timely and electronic registration submissions will
this since 2003. To the extent that the consistent way to industry questions. begin to be required. Instead of January
comment is concerned about liability for (Comment 84) Some comments urge 4, 2016, we now refer to January 4,
a foreign facility’s violations of FDA not to dispose of registration 2020. Accordingly, final § 1.245
requirements under section 415 of the information from cancelled provides that under §§ 1.231(a)(2) and
(b), 1.234(d), and 1.235(d), beginning renewal to FDA electronically may We sought comments on the creation
January 4, 2020, the owner, operator, or include conflicting religious beliefs or of this voluntary system and whether it
agent in charge must submit where a registrant does not have is likely to increase the accuracy of U.S.
registrations, registration renewals, reasonable access to the Internet. agent contact information and reduce
updates, and cancellations to FDA However, we do not intend to limit the number of unauthorized and/or
electronically unless FDA has granted a waivers only to those facilities that fraudulent U.S. agent listings.
waiver from such requirement. Section identify a religious reason for seeking a (Comment 87) Numerous comments
1.245 of the final rule also provides that waiver or that point to lack of access to state the creation of a VIS would be
under § 1.232(a)(6), the registration must the Internet. beneficial.
include the email address of the owner, We will consider whether it would be (Response 87) We agree, and we plan
operator, or agent in charge of the helpful to provide additional guidance to implement a voluntary U.S. agent
facility, unless FDA has granted a on the process for requesting waivers identification system as described in the
waiver from such requirement. In under § 1.245 of the final rule. proposed rule. As we stated in the
addition, § 1.245 provides that under (Comment 86) Comments request that proposed rule, we will follow our GGP
§§ 1.230(b) and (c), 1.232(a)(10), registrants not be required to submit regulations in 21 CFR 10.115 when we
1.234(a), and 1.235(b)(5), registration additional waiver requests after a implement this system (80 FR 19160 at
renewals, registrations, updates, and request has already been granted. 19179).
cancellations not submitted by the (Response 86) We agree that if a (Comment 88) Comments request that
owner, operator, or agent in charge must waiver has been requested and granted, the system provide a mechanism for
include the email address for the the facility should not be required to electronic resignation by the U.S. agent,
individual who authorized the submit future waiver requests each time as well as notice of changes to the
submission, unless FDA has granted a the facility submits a renewal or updates foreign facility’s registration, including
waiver. Section 1.245 of the final rule the facility’s registration information. when the registration is cancelled.
further provides that to request a waiver Accordingly, once FDA grants a waiver, (Response 88) Under § 1.234(a) of the
from these requirements, the registrant we will consider the waiver to be in final rule, the owner, operator, or agent
must submit a written request to FDA effect for as long as the reasons for the in charge of a facility may authorize an
that explains why it is not reasonable to waiver remain unchanged and the individual to update a facility’s
submit the registration, registration registration has not been cancelled. registration. The authorized individual
renewal, update, or cancellation to FDA XIII. U.S. Agent Voluntary may be, but is not required to be, the
electronically or to provide the email Identification System U.S. agent for the facility. If the
address of the owner, operator, or agent authorized individual is the U.S. agent
in charge of the facility. We requested comment on whether to
for the facility, the U.S. agent may
(Comment 85) Comments support the issue a future guidance document to
update the information in the
proposed waiver provision, but some provide for the establishment of a U.S.
Agent Voluntary Identification System registration about who serves in that
comments request that we clarify the role. In addition, FDA plans to allow
grounds for granting waivers from the (VIS or the system), or to otherwise
create such a system. As envisioned, the U.S. agents to electronically notify FDA
electronic registration requirement. that they no longer serve as the U.S.
Some comments request that FDA system would be designed to ensure the
accuracy of U.S. agent information and agent for a foreign facility. We also
consider reasons for why a registrant anticipate that the system will notify the
would request a waiver from electronic enable U.S. agents to independently
identify the facility or facilities for U.S. agent if the registration for the
submission of food facility registration foreign facility is cancelled. We plan to
in addition to those discussed in the which the agent has agreed to serve.
Specifically, the system would allow a provide further information and details
proposed rule. Comments state that about the system in a future guidance
conflicting religious beliefs are not U.S. agent to directly provide FDA with
the agent’s contact information (that is, document.
necessarily the only beliefs that lead an
individual or entity to decide not to use the same contact information required XIV. Editorial Changes and Other
technology. Comments state that there for foreign food facility registration) and Changes
may be other reasons, such as the name of the facility or facilities for
which the agent has agreed to serve. A. Editorial Changes
philosophical or political reasons. Other
comments state that the regulatory text Currently, FDA only receives U.S. agent Proposed § 1.231 would provide that
should specifically recognize religious contact information through foreign beginning January 4, 2016, electronic
objections and lack of reasonable access food facility registrations, many of registration will be mandatory,
to the Internet as reasons to grant a which are submitted and updated by the including registration renewals, unless a
waiver from the electronic registration facility, rather than the U.S. agent for waiver has been granted for the
requirement. the facility. The new system would registrant. Proposed § 1.231 would also
(Response 85) We do not believe it is allow agents to provide information provide that beginning on January 4,
necessary to provide examples in the about themselves, including their name, 2016, registration or registration
regulatory text for when FDA would mailing address, phone number, email renewals by mail or fax would no longer
grant a waiver because we believe that address, and emergency contact phone be permitted, unless a waiver has been
each waiver request should provide an number, as well as the name of the granted for the registrant. Proposed
explanation as to why it is not facility or facilities for which the agent § 1.234 would require updates to be
reasonable for the particular facility to agrees to serve. After a U.S. agent has submitted electronically after January 4,
submit a registration or registration provided such information to FDA 2016, unless a waiver has been granted
renewal electronically to FDA, and we through the system, the Agency would in § 1.245. Proposed § 1.235 would
intend to consider each waiver request provide the U.S. agent with an require cancellations to be submitted
on a case-by-case basis. FDA stated in identification number. The U.S. agent electronically after January 4, 2016,
the proposed rule that reasons for why could then provide the identification unless a waiver has been granted in
it may not be reasonable for a registrant number to foreign facilities that the U.S. § 1.245. Proposed § 1.245 also mentions
to submit a registration or registration agent agrees to represent as a U.S. agent. January 4, 2016. Because the final rule
is being published after January 4, 2016, inadvertently retained the option to an estimate of the annual reporting
we are finalizing §§ 1.231, 1.234, 1.235, submit multiple cancellations using burden. Included in the estimate is the
and 1.245 without a reference to CD–ROM in § 1.235(e). That was an time for reviewing instructions,
‘‘January 4, 2016.’’ Furthermore, we error, and this final rule removes searching existing data sources,
note that for reasons stated elsewhere in § 1.235(e) from § 1.235. gathering and maintaining the data
this Federal Register document, we are needed, and completing and reviewing
XV. Economic Analysis of Impacts
replacing ‘‘January 4, 2016’’ with each collection of information.
‘‘January 4, 2020’’ in §§ 1.231, 1.234, FDA has examined the impacts of this Title: Registration of Food Facilities
1.235, and 1.245 of the final rule. final rule under Executive Order 12866, (OMB Control Number 0910–0502)—
We are making other changes in Executive Order 13563, the Regulatory Revision.
§§ 1.231, 1.232, 1.234, and 1.235 of the Flexibility Act (5 U.S.C. 601–612), and Description of Respondents:
final rule to improve clarity. The the Unfunded Mandates Reform Act of Respondents to this collection of
changes are as follows: 1995 (Pub. L. 104–4). Executive Orders information are owners, operators, or
• Using ‘‘submit’’ or ‘‘submission’’ 12866 and 13563 direct Agencies to agents in charge of domestic or foreign
instead of ‘‘complete’’ or ‘‘completion’’ assess all costs and benefits of available facilities that manufacture, process,
in §§ 1.231, 1.234, and 1.235 of the final regulatory alternatives and, when pack, or hold food for human or animal
rule; regulation is necessary, to select consumption in the United States.
• Using ‘‘sends’’ instead of regulatory approaches that maximize Description: In the Federal Register of
‘‘transmits’’ in §§ 1.231 and 1.234 of the net benefits (including potential April 9, 2015 (80 FR 19159), we
final rule; economic, environmental, public health published a notice of proposed
• Adding ‘‘you’’ in §§ 1.231, 1.232, and safety, and other advantages; rulemaking including a Paperwork
and 1.234 of the final rule to clarify that distributive impacts; and equity). The Reduction Act (PRA) analysis of the
we are referring to the registrant; Agency believes that this final rule is information collection provisions found
• Deleting language that mentions the not a significant regulatory action under in the proposed regulation. In the
registrant not having ‘‘reasonable access Executive Order 12866. analysis we invited comments on these
to the Internet’’ in §§ 1.231, 1.234, and The Regulatory Flexibility Act topics: (1) Whether the proposed
1.235 of the final rule; requires Agencies to analyze regulatory collection of information is necessary
• Deleting ‘‘electronic’’ and options that would minimize any for the proper performance of FDA’s
‘‘automatically’’ in §§ 1.231 and 1.235, significant impact of a rule on small functions, including whether the
respectively, in the final rule. entities. Because the additional costs information will have practical utility;
Furthermore, we stated in proposed per entity of this rule are small, the (2) the accuracy of FDA’s estimate of the
§§ 1.231, 1.234, 1.235, and 1.245 that Agency also believes that this final rule burden of the proposed collection of
the zip code for our College Park, will not have a significant economic information, including the validity of
Maryland address is ‘‘20993.’’ In impact on a substantial number of small the methodology and assumptions used;
§§ 1.231, 1.234, 1.235, and 1.245 of the entities. (3) ways to enhance the quality, utility,
final rule, we are correcting the zip code Section 202(a) of the Unfunded and clarity of the information to be
to ‘‘20740.’’ In addition, the street has Mandates Reform Act of 1995 requires collected; and (4) ways to minimize the
been renamed from ‘‘Paint Branch that Agencies prepare a written burden of the collection of information
Parkway’’ to ‘‘Campus Drive’’ and the statement, which includes an on respondents, including through the
street number has been changed from assessment of anticipated costs and use of automated collection techniques,
‘‘5100’’ to ‘‘5001.’’ Therefore, in the benefits, before issuing ‘‘any rule that when appropriate, and other forms of
final rule, we are changing the street includes any Federal mandate that may information technology.
name and number to ‘‘5001 Campus result in the expenditure by State, local, FSMA (Pub. L. 111–353), enacted on
Drive.’’ and tribal governments, in the aggregate, January 4, 2011, amended section 415 of
or by the private sector, of $100,000,000 the FD&C Act to require, among other
B. CD–ROM Submissions things, that registrants for food facilities
or more (adjusted annually for inflation)
We proposed to delete the option to in any one year.’’ The current threshold renew registrations biennially (section
submit and update multiple after adjustment for inflation is $146 415(a)(3) of the FD&C Act). FSMA also
registrations by CD–ROM. Specifically, million, using the most current (2015) amended section 415 of the FD&C Act
we proposed to remove the option to Implicit Price Deflator for the Gross to require that food facility registrations
use CD–ROM for multiple registration Domestic Product. FDA does not expect include the email address for the
submissions in § 1.231(c) as well as the this final rule to result in any 1-year contact person of a domestic facility and
option to use CD–ROM for updates of expenditure that would meet or exceed the email address of the United States
multiple submissions in § 1.234(e). FDA this amount. agent for a foreign facility, as well as an
stated that it proposed to make this The final analyses conducted in assurance that FDA will be permitted to
change because we tentatively accordance with these Executive Orders inspect the facility (section 415(a)(2) of
concluded that this method of and statutes will be made available in the FD&C Act). These requirements
submitting, updating, and canceling the docket for this rulemaking (Ref. 13). went into effect upon enactment of
registrations is outdated and obsolete. FSMA. In addition, section 415(a)(2) of
We did not receive comments on this XVI. Paperwork Reduction Act of 1995 the FD&C Act, as amended by FSMA,
issue and we are finalizing these This final rule contains information also provides that, when determined
changes as proposed. collection requirements that are subject necessary by FDA ‘‘through guidance,’’
In addition, in the preamble to the to review by the Office of Management a food facility is required to submit to
proposed rule, we stated that we were and Budget (OMB) under the Paperwork FDA information about the general food
proposing to remove the option to use Reduction Act of 1995 (44 U.S.C. 3501– category of a food manufactured,
CD–ROM in § 1.235(e) (i.e., the option 3520). The title, description, and processed, packed, or held at such
for cancellations of multiple respondent description of the facility, as determined appropriate by
registrations). In our proposed information collection provisions are FDA, including by guidance. FDA
regulatory text, however, we shown in the following paragraphs with issued a guidance document entitled
‘‘Guidance for Industry: Necessity of the reporting burden for food facility analysis that accompanied the proposed
Use of Food Product Categories in Food registration under the final rule is rule.
Facility Registrations and Updates to 278,382 hours, a decrease of 189,735 Although FDA is making some
Food Product Categories’’ in October hours. This decrease is due in large part generally minor revisions to the
2012. to a reduction in the number of proposed rule, we are finalizing most of
To comply with the statutory deadline registered food facilities, which we the key aspects of the proposed rule.
under the provisions of FSMA, FDA believe is reflective of the fact that the The following three changes are
initially obtained a 6-month OMB 2012 biennial registration renewal cycle substantial enough to require us to
approval of these self-implementing appear to have had the effect of revise the estimates in the PRA for the
FSMA reporting burdens under the removing many out-of-date registrations proposed rule: (1) We are clarifying that
emergency processing provisions of the from the registration system. As if a waiver under § 1.245 has been
PRA, and subsequently obtained a 3- discussed in the PRA for the proposed granted from the electronic submission
year approval of these requirements rule, we are making additional changes requirement, the facility is not required
under the same assigned OMB control to the currently approved reporting to submit future waiver requests each
number 0910–0502. OMB extended the burden as well. Since obtaining the time the facility submits a renewal or
approval for an additional 3 years in FSMA-related emergency OMB approval update; (2) we will continue to allow 60
2013. The current expiration date of the and subsequent 3-year approval, we calendar days to submit updates to
information collection is August 31, have refined our estimates for the time registrations in § 1.234, instead of
2016. required to comply with the self- shortening the time period to 30
The final rule will require food implementing FSMA provisions. As we calendar days as we proposed; and
facilities to submit certain additional explain in detail in the preliminary finally (3) we plan to implement a VIS
registration information to FDA with economic impact analysis, this is in part for U.S. agents.
initial registrations, updates, and because we no longer assume that it will These revisions are necessary to
biennial renewals. The final rule will address changes to the proposed
take domestic and foreign facilities
also require mandatory electronic regulation included in this final rule, as
different amounts of time to comply
registration submissions beginning in discussed in the following paragraphs.
with the provisions of the proposed
2020, which we estimate would cause For more information on our original
rule. It is also in part because the option
some food facilities to submit a request calculations of the information
to submit abbreviated registration
for a waiver from that requirement. collection burden associated with this
Finally, the final rule will establish renewals did not previously exist and in rulemaking, you may refer to the PRA
certain verification procedures. These part because we have revised additional analyses found under Docket No. FDA–
requirements are discussed in depth in assumptions. 2002–N–0323 at http://
the preamble to the final rule. We received many comments www.regulations.gov.
The currently approved reporting regarding requirements of this rule, but FDA revises its estimate of the one-
burden for food facility registration none of the comments specifically time burden of the FSMA-related
under OMB control number 0910–0502 addressed the four topics about which provisions of this final rule on
is 468,117 hours. The estimated we invited comments in the PRA registered facilities as follows:
TABLE 5—ESTIMATED ONE TIME REPORTING BURDEN 1

Number of
Number of Total annual Average burden
Activity/21 CFR section responses per Total hours
respondents responses per response
respondent
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 of the 2012 registration renewal cycle. We also estimate the one-time burden
in table 5, we assume that some of the As such, we estimate that 88 percent of from the new data elements in this final
participants in the 2012 biennial currently registered food facilities, or rule. We estimate an increase in the
registration renewal cycle were new 172,274 facilities, were already average burden per response due to the
registrants. We do not consider those registered in 2012. new data elements required by this final
new registrations in estimating the total Using our updated estimates for the rule. FDA believes that the new
burden associated with the FSMA time required to comply with the self- information will be readily available to
requirements. FDA used the Small implementing FSMA provisions, we the firms. We estimate that entering the
Business Administration’s (SBA’s) now estimate that the requirement for four additional pieces of information
estimate that 12 percent of all an email address for a domestic that are currently optional will require,
businesses are new. Although SBA’s facility’s contact person and a foreign on average, an additional minute for
estimate does not necessarily mean that facility’s U.S. agent will take 1 minute. each new data element per response.
12 percent of all food facilities are new, We also now estimate that the assurance The four additional pieces of
we nevertheless find the SBA’s estimate statement required by FSMA will take 5 information that are currently optional
sufficiently relevant to apply to food minutes to provide, and that the post- are: (1) Preferred mailing address, (2)
facilities. We therefore estimate that 12 FSMA changes to food product email address for the owner operator or
percent of currently registered food categories will not result in any agent in charge, (3) type of activity or
facilities were not registered at the time additional burden for facilities. type of storage conducted at the facility,
and (4) email address of the emergency elements will require a total of 5 electronically submit their registration.
contact of a domestic facility. As additional minutes. We estimate that the We estimate that it will take a
explained in the preamble to the final submission of the FSMA data elements respondent 10 minutes to prepare the
rule, we revised the final rule and no and new data elements will jointly waiver request submission and attach it
longer require facilities to use increase the one-time burden from those to their paper Form FDA 3537
D–U–N–S numbers. Instead, the final activities by a total of 11 minutes (0.18 registration submission. Thus, the one-
rule requires the use of a UFI recognized hour). The estimated one-time burden time burden of submitting waiver
as acceptable by FDA. We are also for currently registered facilities is requests is estimated to be 361 hours
postponing the requirement to submit a 172,274 facilities × 0.18 hours = 31,009 (2,121 × 0.17 hours), as reported in table
UFI until the registration renewal period hours. According to 2014 registration 5. The estimated total one-time burden
beginning October 1, 2020. We estimate data, 2,121 registrations were from
for currently registered facilities is
that entering a unique facility identifier facilities that submitted paper
therefore 31,370 hours.
requires, on average, an additional registrations. We believe these same
minute per response. Thus, we estimate facilities are more likely to request a We estimate the annual burden for
that entering these five new data waiver from the requirement to this information collection as follows:
TABLE 6—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of Average
Number of Total annual
Activity/21 CFR section responses per burden per Total
respondents responses
respondent response
New domestic facility registrations (1.230–1.233) ............... 9,795 1 9,795 2.7 26,447
New foreign facility registrations (1.230–1.233) .................. 13,697 1 13,697 8.7 119,164
Updates (1.234) ................................................................... 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 verification procedure ..................... 41,256 1 41,256 0.25 10,314
U.S. Agent verification procedure with VIS ......................... 57,070 1 57,070 0.25 14,268
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 number of active registrations in the the burden for the proposed 30-day
reporting burden for food facility food facility registration database. update requirement, we estimated that
registration under OMB control number Prior to FSMA, FDA estimated that 68,518 respondents (70 percent of
0910–0502 is 468,117 hours. The the average burden associated with new facilities) would submit updates each
estimated reporting burden for food domestic and foreign facility year. For a 60-day update requirement,
facility registration under this final rule registrations was a respective 2.5 and we estimated that the number of
is 278,382 hours, a decrease of 189,735 8.5 hours. (See 75 FR 30033.) We expect respondents was 53,836 per year (55
hours. This decrease is due to the that this final rule will add an percent of facilities). The average
recently reduced number of active additional 11 minutes to that burden as burden per response for updates
registrations in the food facility a result of the required new data remains unchanged as 1.2 hours, as
registration database. elements. Based on estimates by SBA reported in table 6 row 3. In the
that 12 percent of all businesses are proposed rule, we also proposed to
Our estimates of the number of new, we estimate that all new facilities shorten the time period to submit
facilities that will submit new facility each year will be equal to 12 percent of cancellations from 60 calendar days to
registrations are based on estimates by the total number of registered facilities. 30 calendar days. Although we are not
SBA that 12 percent of all businesses Thus, we estimate that each year there finalizing that proposal, we have not
each year are new. As such, we estimate will be 9,795 new domestic and 13,697 changed our estimate of the average
that 12 percent of registrations (or new foreign facility registrations, and burden per response for cancellations
23,500 registrations) are from new that the average burden for those new because this final rule does not add new
facilities entering the market. We are registrations will be of 2.7 hours (2.5 data elements for cancellations.
making additional changes to the hours plus 11 minutes) for new This final rule also establishes an
currently approved reporting burden as domestic facility registrations and 8.7 abbreviated renewal process, which
well. As discussed previously, FDA hours (8.5 hours plus 11 minutes) for modifies our previous estimate that on
obtained a 6-month emergency OMB new foreign facility registrations, as average it will take 0.5 hours per
approval of the self-implementing reported in table 6, rows 1 and 2. renewal. With the option for an
FSMA reporting burdens, and This final rule does not shorten the abbreviated renewal process, we
subsequently obtained a 3-year approval time period for updates from 60 estimate that half the facilities will take
of these requirements. As described in calendar days to 30 calendar days as 15 minutes per renewal using the
the preliminary economic impact originally proposed. We are not abbreviated renewal process and that
analysis, we estimate that on an finalizing our proposal to change the half of facilities will take 30 minutes.
annualized basis 97,833 respondents current requirement that updates take This alters our previous estimate of 0.5
will file biennial renewals, a decrease places within 30 calendar days; instead, hours to submit a renewal to an average
from the estimated number of 224,930 we are continuing to allow 60 calendar of 0.38 hours (23 minutes) to submit a
respondents reported in the 2013 days for updates, as provided in current renewal, as reported in table 6, row 5.
request for extension. These decreases § 1.234. In the PRA analysis for the This estimate takes into account that
are due to recent reductions in the proposed rule, in which we estimated some registered firms will be able to
take advantage of the abbreviated identification number that the agent determined that the rule does not
renewal process, while other firms will could provide to foreign facilities it has contain policies that have substantial
take more time to prepare and submit agreed to represent as a U.S. agent. If a direct effects on the States, on the
the renewal, as discussed in the foreign facility uses a U.S. agent relationship between the National
preliminary economic impact analysis. identified in the system, the facility will Government and the States, or on the
Furthermore, this final rule also have the option of providing the name distribution of power and
establishes a verification procedure for and identification number for the U.S. responsibilities among the various
registrations submitted by individuals agent in its registration rather than the levels of government. Accordingly, we
other than the owner, operator, or agent specific U.S. agent’s contact information conclude that the rule does not contain
in charge (third party registrations), as required for food facility registrations policies that have federalism
well as a verification procedure for U.S. (e.g., address, email address, phone implications as defined in the Executive
agents. In connection with requiring this number). After using the identification Order and, consequently, a federalism
verification process, this final rule adds number, and if the foreign facility name summary impact statement is not
email address to the list of required matches a facility name the U.S. agent required.
information identifying the individual identified in the system, the U.S. agent
who authorized submission of contact information in the system will XIX. References
registrations submitted by individuals then be linked and automatically The following references are on
other than the owner, operator, or agent populated in the foreign facility display in the Division of Dockets
in charge. As described in the registration. When the confirmation Management (HFA–305), Food and Drug
preliminary economic impact analysis, copy of a foreign facility registration is Administration, 5630 Fishers Lane, Rm.
we estimate that it takes 15 minutes sent to the U.S. agent, it will be sent to 1061, Rockville, MD 20852, and are
(0.25 hour) to participate in FDA’s the contact information provided by the available for viewing by interested
verification procedure. We have not U.S. agent to ensure that the U.S. agent persons between 9 a.m. and 4 p.m.,
changed this estimate. We further is aware of the connection with each Monday through Friday; they are also
estimate that 82,513 registrations will be foreign facility registration. available electronically at http://
affected once every other year, or 41,256 We expect that when a foreign facility www.regulations.gov. FDA has verified
annually. Thus, the total annual burden uses an identification number for a the Web site addresses, as of the date
of these verifications is estimated to be registered U.S. agent and the name of this document publishes in the Federal
10,314 hours (41,256 × 0.25 hour = the facility matches the facility name Register, but Web sites are subject to
10,314 hours), as reported in table 6, the agent has identified, that we will change over time.
row 6. consider the use of that identification a
For the U.S. agent verification 1. FDA, Amendments to Registration of Food
verification of U.S. agent information for Facilities—Preliminary Regulatory
process, in the PRIA we estimated a purposes of the U.S. agent verification Impact Analysis FDA–2002–N–0323,
resulting burden from the verification step. Thus, we estimate the total annual (http://www.fda.gov/downloads/
procedure to be about 30 minutes (0.5 burden of the foreign facility U.S. agent AboutFDA/ReportsManualsForms/
hours) by 114,139 affected registrations verifications to be 14,268 hours (57,070 Reports/EconomicAnalyses/UCM
once every 2 years, or 57,070 facility × 0.25 hour = 14,268), as reported in 444325.pdf), April 2015.
registrations annually. However, this table 6, row 7. 2. FDA Memorandum, ‘‘FDA Memorandum
final rule also provides for the creation The information collection provisions to Dockets on Records of Outreach,’’
of a U.S. agent VIS, which we estimate in this final rule have been submitted to 2013. See Reference 7 to the 2014
will cut the time for verification OMB for review as required by section supplemental human preventive controls
procedures for U.S. agents in half (from notice.
3507(d) of the Paperwork Reduction Act 3. FDA Memorandum, ‘‘Memoranda of
30 minutes to 15 minutes). As currently of 1995. Before the effective date of this Outreach,’’ 2015.
envisioned, the system is designed to final rule, FDA will publish a notice in 4. FDA, ‘‘Food CGMP Modernization—A
ensure the accuracy of U.S. agent the Federal Register announcing OMB’s Focus on Food Safety,’’ (http://
information and enable U.S. agents to decision to approve, modify, or www.fda.gov/Food/GuidanceRegulation/
independently identify the facility or disapprove the information collection CGMP/ucm207458.htm), November 2,
facilities for which the agent has agreed provisions in this final rule. 2005. Accessed and printed on March
to serve. Specifically, the system will An Agency may not conduct or 20, 2015. See Reference 1 to the 2013
allow a U.S. agent to directly provide sponsor, and a person is not required to proposed human preventive controls
their contact information (that is, the respond to, a collection of information rule.
same contact information required for 5. FDA, ‘‘Guidance for Industry: Necessity of
unless it displays a currently valid OMB the Use of Food Product Categories in
foreign food facility registration) and the control number. Food Facility Registrations and Updates
name of the facility or facilities for
XVII. Analysis of Environmental to Food Product Categories’’ (http://
which the agent has agreed to serve. www.fda.gov/Food/GuidanceRegulation/
Currently, FDA only receives U.S. agent Impact
GuidanceDocumentsRegulatory
contact information through foreign We have determined under 21 CFR Information/ucm324778.htm), October
food facility registrations, many of 25.30(j) that this action is of a type that 2012. Accessed and printed on April 5,
which are created and updated by the does not individually or cumulatively 2016.
facility, rather than the U.S. agent for have a significant effect on the human 6. FDA, ‘‘Guidance for Industry: Questions
the facility. We expect that the system environment. Therefore, neither an and Answers Regarding Food Facility
will allow agents to provide their name, environmental assessment nor an Registration (Sixth Edition),’’ (http://
full mailing address, phone number, www.fda.gov/downloads/Food/Guidance

environmental impact statement is Regulation/UCM332460.pdf), November
email address, and an emergency required. 2014. Accessed on May 2, 2016.
contact phone number, as well as the 7. USDA Agricultural Marketing Service,
name of the facility or facilities for XVIII. Federalism
‘‘Regional Food Hub Resource Guide,’’
which the agent agrees to serve. After a We have analyzed the final rule in (https://www.ams.usda.gov/sites/default/
U.S. agent provides this information, accordance with the principles set forth files/media/Regional%20Food%20
FDA will provide the agent with an in Executive Order 13132. We have Hub%20Resource%20Guide.pdf), April
2012. Accessed and printed on April 6, Retail food establishment means an (ii) Through a community supported
2016. establishment that sells food products agriculture program. Community
8. FDA, ‘‘Specification of the Unique Facility directly to consumers as its primary supported agriculture (CSA) program
Identifier (UFI) System for Drug function. The term ‘‘retail food means a program under which a farmer
Establishment Registration,’’ Guidance
for Industry, (http://www.fda.gov/
establishment’’ includes facilities that or group of farmers grows food for a
downloads/drugs/guidancecompliancere manufacture, process, pack, or hold group of shareholders (or subscribers)
gulatoryinformation/guidances/ucm food if the establishment’s primary who pledge to buy a portion of the
421827.pdf), November 2014. Accessed function is to sell from that farmer’s crop(s) for that season. This
and printed on April 6, 2016. establishment food, including food that includes CSA programs in which a
9. FDA Memorandum, ‘‘D–U–N–S and it manufactures, processes, packs, or group of farmers consolidate their crops
Registered Facilities,’’ July 9, 2014, from holds, directly to consumers. A retail at a central location for distribution to
John Gardner, MD, MPH Senior food establishment’s primary function is shareholders or subscribers; and
Technical Advisor, Medical Informatics, to sell food directly to consumers if the (iii) At other such direct-to-consumer
Office of Informatics and Technology annual monetary value of sales of food
Innovation, Office of Information
sales platforms, including door-to-door
Management and Technology, Office of
products directly to consumers exceeds sales; mail, catalog and Internet order,
Operations. the annual monetary value of sales of including online farmers markets and
10. U.S. Government Accountability Office, food products to all other buyers. The online grocery delivery; religious or
‘‘Government Is Analyzing Alternatives term ‘‘consumers’’ does not include other organization bazaars; and State
for Contractor Identification Numbers,’’ businesses. A ‘‘retail food and local fairs.
(http://www.gao.gov/assets/600/ establishment’’ includes grocery stores, (3) For the purposes of this definition,
591551.pdf), June 2012. Accessed and convenience stores, and vending ‘‘farm-operated business’’ means a
printed on April 5, 2016. machine locations. A ‘‘retail food business that is managed by one or more
11. Specially Designated Nationals List (SDN) establishment’’ also includes certain farms and conducts manufacturing/
(https://www.treasury.gov/resource- farm-operated businesses selling food
center/sanctions/SDN-List/Pages/ processing not on the farm(s).
default.aspx). Accessed on April 5, 2016.
directly to consumers as their primary * * * * *
12. FDA, ‘‘FDA’s Voluntary Qualified function. U.S. agent means a person (as defined
Importer Program,’’ Draft Guidance for (1) Sale of food directly to consumers in section 201(e) of the Federal Food,
Industry, (http://www.fda.gov/ from an establishment located on a farm Drug, and Cosmetic Act (21 U.S.C.
downloads/Food/GuidanceRegulation/ includes sales by that establishment 321(e))) residing or maintaining a place
GuidanceDocumentsRegulatory directly to consumers: of business in the United States whom
Information/UCM448558.pdf), June (i) At a roadside stand (a stand
a foreign facility designates as its agent
2015. Accessed and printed on April 6, situated on the side of or near a road or
2016. for purposes of this subpart. A U.S.
thoroughfare at which a farmer sells
13. FDA, ‘‘Amendments to Registration of food from his or her farm directly to agent may not be in the form of a
Food Facilities: Final Regulatory Impact consumers) or farmers’ market (a mailbox, answering machine or service,
Analysis, Final Regulatory Flexibility
location where one or more local or other place where an individual
Analysis, and Final Unfunded Mandates acting as the foreign facility’s agent is
Reform Act Analysis,’’ 2016. farmers assemble to sell food from their
farms directly to consumers); not physically present.
List of Subjects in 21 CFR Part 1 (ii) Through a community supported (1) The U.S. agent acts as a
agriculture program. Community communications link between FDA and
Cosmetics, Drugs, Exports, Food the foreign facility for both emergency
labeling, Imports, Labeling, Reporting supported agriculture (CSA) program
means a program under which a farmer and routine communications. The U.S.
and recordkeeping requirements. agent will be the person FDA contacts
or group of farmers grows food for a
Therefore, under the Federal Food, group of shareholders (or subscribers) when an emergency occurs, unless the
Drug, and Cosmetic Act and under who pledge to buy a portion of the registration specifies another emergency
authority delegated to the Commissioner farmer’s crop(s) for that season. This contact.
of Food and Drugs, 21 CFR part 1 is includes CSA programs in which a (2) FDA will treat representations by
amended to read as follows: group of farmers consolidate their crops the U.S. agent as those of the foreign
at a central location for distribution to facility, and will consider information
PART 1—GENERAL ENFORCEMENT or documents provided to the U.S. agent
REGULATIONS shareholders or subscribers; and
(iii) At other such direct-to-consumer the equivalent of providing the
sales platforms, including door-to-door information or documents to the foreign
■ 1. The authority citation for part 1 is facility. FDA will consider the U.S.
revised to read as follows: sales; mail, catalog and Internet order,
including online farmers markets and agent the equivalent of the registrant for
Authority: 15 U.S.C. 1333, 1453, 1454, purposes of sharing information and
1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C.
online grocery delivery; religious or
other organization bazaars; and State communications. The U.S. agent of a
321, 331, 332, 333, 334, 335a, 343, 350c, foreign facility may view the
350d, 350j, 352, 355, 360b, 360ccc, 360ccc– and local fairs.
(2) Sale of food directly to consumers information submitted in the foreign
1, 360ccc–2, 362, 371, 374, 379j–31, 381, 382,
384a, 384b, 384d, 387, 387a, 387c, 393; 42 by a farm-operated business includes facility’s registration.
U.S.C. 216, 241, 243, 262, 264, 271; Pub. L. the sale of food by that farm-operated (3) Having a single U.S. agent for the
107–188, 116 Stat. 594, 668–69; Pub. L. 111– business directly to consumers: purposes of this subpart does not
353, 124 Stat. 3885, 3889. (i) At a roadside stand (a stand preclude facilities from having multiple
situated on the side of or near a road or agents (such as foreign suppliers) for
■ 2. In § 1.227, revise the definitions for
thoroughfare at which a farmer sells other business purposes. A firm’s
‘‘Retail food establishment’’ and ‘‘U.S.
food from his or her farm directly to commercial business in the United
agent’’ to read as follows:
consumers) or farmers’ market (a States need not be conducted through
§ 1.227 What definitions apply to this location where one or more local the U.S. agent designated for purposes
subpart? farmers assemble to sell food from their of this subpart.
* * * * * farms directly to consumers); * * * * *
■ 3. Revise § 1.230 to read as follows: abbreviated renewal must provide the registration in fact authorized the
email address of the individual who submission on behalf of the facility.
§ 1.230 When must you register or renew authorized submission of the FDA will not confirm the registration or
your registration?
abbreviated renewal, unless FDA has provide a registration number until that
(a) Registration. You must register granted a waiver under § 1.245. You individual confirms that he or she
before your facility begins to must use Form FDA 3537 to submit authorized the submission. With respect
manufacture, process, pack, or hold abbreviated registration renewals to to electronic registration renewals, after
food for consumption in the United FDA. completion of the electronic registration
States. You may authorize an individual renewal, FDA will provide an electronic
■ 4. Revise § 1.231 to read as follows:
to register the facility on your behalf. confirmation of the registration renewal.
(b) Registration renewal. You must § 1.231 How and where do you register or For electronic registration renewals not
submit a registration renewal containing renew your registration? submitted by the owner, operator, or
the information required under § 1.232 (a) Electronic registration and agent in charge of the facility, FDA will
every other year, during the period registration renewal. (1) To register or verify that the individual identified as
beginning on October 1 and ending on renew a registration electronically, you having authorized submission of the
December 31 of each even-numbered must go to http://www.fda.gov/furls, registration renewal in fact authorized
year. You may authorize an individual which is available for registration 24 the submission on behalf of the facility.
to renew a facility’s registration on your hours a day, 7 days a week. This Web FDA will not provide an electronic
behalf. If the individual submitting the site is available from wherever the confirmation of the registration renewal
registration renewal is not the owner, Internet is accessible, including until that individual confirms that he or
operator, or agent in charge of the libraries, copy centers, schools, and she authorized the submission.
facility, the registration renewal must Internet cafes. An individual authorized (5) For a foreign facility, after you
also include a statement in which the by the owner, operator, or agent in submit your electronic registration, FDA
individual certifies that the information charge of a facility may also register a will verify that the person identified as
submitted is true and accurate, certifies facility electronically. the U.S. agent for your foreign facility
that he/she is authorized to submit the (2) Beginning on January 4, 2020, you has agreed to serve as your U.S. agent.
registration renewal, and identifies by must submit your registration or FDA will not confirm your registration
name, address, and telephone number, registration renewal to FDA or provide you with a registration
the individual who authorized electronically, unless FDA has granted number until that person confirms that
submission of the registration renewal. you a waiver under § 1.245. the person agreed to serve as your U.S.
In addition, the registration renewal (3) After you submit your electronic agent. With respect to electronic
must also identify the individual who registration, FDA will verify the registration renewals, after you
authorized submission of the accuracy of your unique facility complete your electronic registration
registration renewal by email address, identifier (UFI) recognized as acceptable renewal, FDA will provide you with an
unless FDA has granted a waiver under by FDA and will also verify that the electronic confirmation of your
§ 1.245. Each registration renewal must facility-specific address associated with registration renewal. When you update
include the name of the individual the UFI is the same address associated information about your U.S. agent as
submitting the registration renewal, and with your registration. FDA will not part of your electronic registration
the individual’s signature (for the paper confirm your registration or provide you renewal, FDA will verify that the person
option). Each electronic registration with a registration number until FDA identified as the U.S. agent for your
renewal must include the name of the verifies the accuracy of your facility’s foreign facility has agreed to serve as
individual submitting the renewal. UFI and verifies that the facility-specific your U.S. agent. FDA will not provide
(c) Abbreviated registration renewal address associated with the UFI is the you with an electronic confirmation of
process. If you do not have any changes same address associated with your your registration renewal until that
to the information required under registration. With respect to electronic person confirms that the person agreed
§ 1.232 since you submitted the registration renewals, after you submit to serve as your U.S. agent.
preceding registration, registration your electronic registration renewal, (6) If any information you previously
renewal, or update for your facility, you FDA will provide you with an electronic submitted was incorrect at the time of
may use the abbreviated registration confirmation of your registration submission, you must immediately
renewal process. If you use the renewal. When you update your update your facility’s registration as
abbreviated registration renewal facility’s UFI as part of your electronic specified in § 1.234.
process, you must confirm that no registration renewal, FDA will verify the (7) You will be considered registered
changes have been made to the accuracy of your facility’s UFI and will once FDA electronically sends you your
information required under § 1.232 also verify that the facility-specific confirmation and registration number.
since you submitted the preceding address associated with the UFI is the (b) Registration or registration renewal
registration, registration renewal or same address associated with your by mail or fax. Beginning January 4,
update, and you must certify that the registration. FDA will not provide you 2020, you must submit your registration
information submitted is truthful and with a confirmation of your registration or registration renewal to FDA
accurate. Each abbreviated registration renewal until FDA verifies the accuracy electronically, unless FDA has granted
renewal must include the name of the of your UFI and verifies that the facility- you a waiver under § 1.245. If FDA has
individual submitting the abbreviated specific address associated with the UFI granted you a waiver under § 1.245, you
renewal, and the individual’s signature is the same address associated with your may register or renew a registration by
(for the paper option). Each electronic registration. mail or by fax.

abbreviated registration renewal must (4) For electronic registrations not (1) You must register or renew a
include the name of the individual submitted by the owner, operator, or registration (including abbreviated
submitting the abbreviated renewal. For agent in charge of the facility, after registration renewals) using Form FDA
abbreviated registration renewals not submission of the registration, FDA will 3537. You may obtain a copy of this
submitted by the owner, operator, or verify that the individual identified as form by writing to the U.S. Food and
agent in charge of the facility, the having authorized submission of the Drug Administration, Center for Food
Safety and Applied Nutrition, 5001 completion of the registration renewal § 1.232 What information is required in the
Campus Dr. (HFS–681), College Park, by mail or fax, FDA will provide a registration?
MD 20740 or by requesting the form by confirmation of the registration renewal. (a) For a domestic and foreign facility,
phone at 1–800–216–7331 or 301–575– For registration renewals not submitted the following information is required:
0156. by the owner, operator, or agent in (1) The name, full address, and phone
(2) When you receive the form, you charge of the facility, FDA will verify number of the facility;
must fill it out completely and legibly that the individual identified as having (2) Beginning October 1, 2020, the
and either mail it to the address in authorized submission of the facility’s UFI recognized as acceptable
paragraph (b)(1) of this section or fax it registration renewal in fact authorized by FDA;
to 301–436–2804. the submission on behalf of the facility. (3) The preferred mailing address, if
(3) If any required information on the FDA will not provide a confirmation of different from that of the facility;
form is incomplete or illegible when the registration renewal until that (4) The name, full address, and phone
FDA receives it, FDA will return the individual confirms that he or she number of the parent company, if the
form to you for revision, provided that authorized the submission. facility is a subsidiary of the parent
your mailing address or fax number is (7) For a foreign facility, after you company;
legible and valid. When returning a submit your registration by mail or fax, (5) All trade names the facility uses;
registration form for revision, FDA will FDA will verify that the person (6) The name, full address, and phone
use the means by which the form was identified as the U.S. agent for your number of the owner, operator, or agent
received by the Agency (i.e., by mail or foreign facility has agreed to serve as in charge of the facility. In addition, the
fax). your U.S. agent. FDA will not confirm email address of the owner, operator, or
(4) FDA will enter complete and your registration or provide you with a agent in charge is required, unless FDA
legible mailed and faxed registration registration number until that person has granted you a waiver under § 1.245;
submissions into its registration system, (7) The applicable food product
confirms that the person agreed to serve
as soon as practicable, in the order FDA categories of any food manufactured/
as your U.S. agent. With respect to
receives them. processed, packed, or held at the facility
(5) After you submit your registration, registration renewals, after you
complete your registration renewal by as identified on Form FDA 3537;
FDA will verify the accuracy of your (8) The type of activity conducted at
facility’s UFI and will also verify that mail or fax, FDA will provide you with
a confirmation of your registration the facility for each food product
the facility-specific address associated category identified. You may select
with the UFI is the same address renewal. When you update information
about your U.S. agent as part of your more than one activity type for each
associated with your registration. FDA food product category identified. The
will not confirm your registration or registration renewal, FDA will verify
that the person identified as the U.S. activity type options are as follows:
provide you with a registration number (i) Ambient human food storage
until FDA verifies the accuracy of your agent for your foreign facility has agreed
to serve as your U.S. agent. FDA will not warehouse/holding facility;
facility’s UFI and verifies that the (ii) Refrigerated human food
facility-specific address associated with provide you with a confirmation of your
registration renewal until that person warehouse/holding facility;
the UFI is the same address associated (iii) Frozen human food warehouse/
with your registration. With respect to confirms that the person agreed to serve
as your U.S. agent. holding facility;
registration renewals, after you submit (iv) Interstate conveyance caterer/
your registration renewal by mail or fax, (8) FDA will mail or fax you a copy
catering point;
FDA will provide you with a of the registration as entered,
(v) Contract sterilizer;
confirmation of your registration confirmation of registration, and your (vi) Labeler/relabeler;
renewal. When you update your registration number. When responding (vii) Manufacturer/processor;
facility’s UFI as part of your registration to a registration submission, FDA will (viii) Acidified food processor;
renewal, FDA will verify the accuracy of use the means by which the registration (ix) Low-acid food processor;
your facility’s UFI and will also verify was received by the Agency (i.e., by (x) Farm mixed-type facility;
that the facility-specific address mail or fax). (xi) Packer/repacker;
associated with the UFI is the same (9) If any information you previously (xii) Salvage operator (reconditioner);
address associated with your submitted was incorrect at the time of (xiii) Animal food warehouse/holding
registration. FDA will not provide you submission, you must immediately facility;
with a confirmation of your registration update your facility’s registration as (xiv) Other activity.
renewal until FDA verifies the accuracy specified in § 1.234. (9) A statement in which the owner,
of your UFI and verifies that the facility- (10) Your facility is considered operator, or agent in charge provides an
specific address associated with the UFI registered once FDA enters your assurance that FDA will be permitted to
is the same address associated with your facility’s registration data into the inspect the facility at the times and in
registration. registration system and the system the manner permitted by the Federal
(6) For registrations not submitted by generates a registration number. Food, Drug, and Cosmetic Act;
the owner, operator, or agent in charge (c) Fees. No registration fee is (10) A statement in which the owner,
of the facility, after submission of the required. operator, or agent in charge certifies that
registration by mail or fax, FDA will (d) Language. You must submit all the information submitted is true and
verify that the individual identified as registration information in the English accurate. If the individual submitting
having authorized submission of the language except an individual’s name, the form is not the owner, operator, or
registration in fact authorized the the name of a company, the name of a agent in charge of the facility, the
submission on behalf of the facility. street, and a trade name may be registration must also include a
FDA will not confirm the registration or submitted in a foreign language. All statement in which the individual
provide a registration number until that information, including these items, certifies that the information submitted
individual confirms that he or she must be submitted using the Latin is true and accurate, certifies that he/she
authorized the submission. With respect (Roman) alphabet. is authorized to submit the registration,
to registration renewals, after ■ 5. Revise § 1.232 to read as follows: and identifies by name, address, and
telephone number, the individual who (2) After you submit your electronic form for revision, FDA will use the
authorized submission of the update, FDA will provide you with an means by which the registration was
registration. In addition, the registration electronic confirmation of your update. received by the Agency (i.e., by mail or
must identify the individual who When updating UFI information, FDA fax).
authorized submission of the will verify the accuracy of your facility’s (4) FDA will enter complete and
registration by email address, unless UFI and will also verify that the facility- legible updates into its registration
FDA has granted a waiver under § 1.245. specific address associated with the UFI system as soon as practicable, in the
Each registration must include the name is the same address associated with your order FDA receives them.
of the individual submitting the registration. FDA will not provide you (5) FDA will then mail to the address
registration, and the individual’s with an electronic confirmation of your or fax to the fax number on the
signature (for the paper option). registration update until FDA verifies registration form a copy of the update as
(b) For a domestic facility, the the accuracy of your facility’s UFI and entered and confirmation of the update.
following additional information is verifies that the facility-specific address When responding to an update
required: associated with the UFI is the same submission, FDA will use the means by
(1) The email address for the contact address associated with your which the form was received by the
person of the facility; registration. For foreign facilities, when Agency (i.e., by mail or fax). After you
(2) An emergency contact phone updating information about your U.S. submit your update by mail or fax, FDA
number and email address if different agent, FDA will verify that the person will verify the accuracy of your facility’s
from the email address for the contact identified as the U.S. agent for your UFI and will also verify that the facility-
person in paragraph (b)(1) of this foreign facility has agreed to serve as
section. specific address associated with the UFI
your U.S. agent. FDA will not provide is the same address associated with your
(c) For a foreign facility, the following you with an electronic confirmation of
additional information is required: registration. FDA will not provide a
your registration update until that confirmation of your registration update
(1) The name, full address, phone person confirms that the person agreed
number, and email address of the until FDA verifies the accuracy of your
to serve as your U.S. agent. facility’s UFI and verifies that the
foreign facility’s U.S. agent; (3) For electronic updates not
(2) An emergency contact phone facility-specific address associated with
submitted by the owner, operator, or
number and email address. the UFI is the same address associated
agent in charge of the facility, after
■ 6. Revise § 1.233 to read as follows: with your registration. For foreign
submission of the electronic update,
facilities, when updating information
§ 1.233 Are there optional items included FDA will verify that the individual
about your U.S. agent, FDA will verify
in the registration form? identified as having authorized
that the person identified as the U.S.
Yes. FDA encourages, but does not submission of the update in fact
agent for your foreign facility has agreed
require, you to submit items that are authorized the submission on behalf of
to serve as your U.S. agent. FDA will not
indicated as optional on the Form FDA the facility. FDA will not confirm the
provide you with a confirmation of your
3537 that you submit. update to the registration until that
registration update until that person
■ 7. Revise § 1.234 to read as follows: individual confirms that he or she
confirms that the person agreed to serve
authorized the submission.
§ 1.234 How and when do you update your (4) Your registration will be as your U.S. agent.
facility’s registration information? considered updated once FDA sends (6) For registration updates not
(a) Update requirements. You must you your update confirmation, unless submitted by the owner, operator, or
update a facility’s registration within 60 notified otherwise. agent in charge of the facility, after
calendar days of any change to any of (d) Update by mail or fax. Beginning submission of the registration update by
the information previously submitted January 4, 2020, you must submit your mail or fax, FDA will verify that the
under § 1.232 (e.g., change of operator, update electronically, unless FDA has individual identified as having
agent in charge, or U.S. agent), except a granted you a waiver under § 1.245. If authorized submission of the update in
change of the owner. You may authorize FDA has granted you a waiver under fact authorized the submission on behalf
an individual to update a facility’s § 1.245, you may update your facility’s of the facility. FDA will not confirm the
registration on your behalf. For updates registration by mail or by fax. registration update until that individual
not submitted by the owner, operator, or (1) You must update your registration confirms that he or she authorized the
agent in charge of the facility, the using Form FDA 3537. You may obtain update.
update must provide the email address a copy of this form by writing to the (7) If any update information you
of the individual who authorized U.S. Food and Drug Administration, previously submitted was incorrect at
submission of the update, unless FDA Center for Food Safety and Applied the time of submission, you must
has granted a waiver under § 1.245. Nutrition, 5001 Campus Dr. (HFS–681), immediately resubmit your update.
(b) Cancellation due to ownership College Park, MD 20740 or by requesting (8) Your registration will be
changes. If the reason for the update is the form by phone at 1–800–216–7331 considered updated once FDA enters
that the facility has a new owner, the or 301–575–0156. your facility’s update data into the
former owner must cancel the facility’s (2) When you receive the form, you registration system and the system
registration as specified in § 1.235 must legibly fill out the sections of the generates an update confirmation.
within 60 calendar days of the change form reflecting your updated ■ 8. Revise § 1.235 to read as follows:
and the new owner must submit a new information and either mail it to the
registration for the facility as specified address in paragraph (d)(1) of this § 1.235 How and when do you cancel your
in § 1.231. The former owner may section or fax it to 301–436–2804. facility’s registration information?
authorize an individual to cancel a (3) If the information on the form is (a) Notification of registration
facility’s registration. incomplete or illegible when FDA cancellation. You must cancel a
(c) Electronic update. (1) To update receives it, FDA will return the form to registration within 60 calendar days of
your registration electronically, you you for revision, provided that your the reason for cancellation (e.g., your
must update at http://www.fda.gov/ mailing address or fax number is legible facility ceases operations, ceases
furls. and valid. When returning a registration providing food for consumption in the
United States, or is sold to a new paragraph (d)(1) of this section or fax it agent in charge of a domestic or foreign
owner). to 301–436–2804. facility to register its facility, renew the
(b) Cancellation requirements. The (3) If the information on the form is registration of its facility, update
cancellation of a facility’s registration incomplete or illegible when FDA required elements of its facility’s
must include the following information: receives it, FDA will return the form to registration, or cancel its registration in
(1) The facility’s registration number; you for revision, provided that your accordance with the requirements of
(2) Whether the facility is domestic or mailing address or fax number is legible this subpart is a prohibited act under
foreign; and valid. When returning a section 301(dd) of the Federal Food,
(3) The facility name and address; cancellation form for revision, FDA will Drug, and Cosmetic Act.
(4) The name, address, and email use the means by which the cancellation (b) FDA will consider a registration
address (if available) of the individual was received by the Agency (i.e., by for a food facility to be expired if the
submitting the cancellation; mail or fax). registration is not renewed, as required
(5) For registration cancellations not (4) FDA will enter complete and by § 1.230(b). Thus, if you previously
submitted by the owner, operator, or legible mailed and faxed cancellations submitted a registration to FDA, but do
agent in charge of the facility, the email into its registration system as soon as not submit a registration renewal to
address of the individual who practicable, in the order FDA receives FDA during the period beginning on
authorized submission of the them. October 1 and ending on December 31
registration cancellation, unless FDA (5) FDA will mail to the address or fax of each even-numbered year, FDA will
has granted a waiver under § 1.245; and to the fax number on the cancellation consider the registration for the facility
(6) A statement certifying that the form a copy of the cancellation as to be expired. FDA will consider a food
information submitted is true and entered and confirmation of the facility with an expired registration to
accurate, and that the person submitting cancellation. When responding to a have failed to register in accordance
the cancellation is authorized by the cancellation, FDA will use the means by with section 415 of the Federal Food,
facility to cancel its registration. which the form was received by the Drug, and Cosmetic Act.
Agency (i.e., by mail or fax). (c) FDA will cancel a registration if
(c) Electronic cancellation. (1) To
(6) For registration cancellations not FDA independently verifies that the
cancel your registration electronically,
submitted by the owner, operator, or facility is no longer in business or has
you must cancel at http://www.fda.gov/
agent in charge of the facility, after changed owners, and the owner,
furls.
submission of the registration operator, or agent in charge of the
(2) Once you complete your electronic
cancellation by mail or fax, FDA will facility fails to cancel the registration, or
cancellation, FDA will provide you with
verify that the individual identified as if FDA determines that the registration
an electronic confirmation of your
having authorized submission of the is for a facility that does not exist, is not
cancellation.
cancellation in fact authorized the required to register, or where the
(3) For registration cancellations not
submission on behalf of the facility. information about the facility’s address
submitted by the owner, operator, or
FDA will not confirm the registration was not updated in a timely manner in
agent in charge of the facility, after
cancellation until that individual accordance with § 1.234(a) or the
submission of the registration
confirms that he or she authorized the registration was submitted by a person
cancellation, FDA will verify that the
registration cancellation. not authorized to submit the registration
individual identified as having
(7) Your registration will be under § 1.225. Also, FDA will cancel a
authorized submission of the
considered cancelled once FDA enters registration if the facility’s registration
cancellation in fact authorized the
your facility’s cancellation data into the has expired because the facility has
submission on behalf of the facility.
registration system. FDA will send you failed to renew its registration in
FDA will not confirm the registration
your cancellation confirmation. accordance with § 1.230(b). If FDA
cancellation until that individual
■ 9. Revise § 1.241 to read as follows: cancels a facility’s registration, FDA will
confirms that he or she authorized the
send a confirmation of the cancellation
registration cancellation. § 1.241 What are the consequences of
using contact information submitted by
(4) Your registration will be failing to register, update, renew, or cancel
your registration? the facility in the registration database.
considered cancelled once FDA sends (d) If an article of food is imported or
you your cancellation confirmation. (a) Section 301 of the Federal Food, offered for import into the United States
(d) Cancellation by mail or fax. Drug, and Cosmetic Act (21 U.S.C. 331) and a foreign facility that manufactured/
Beginning January 4, 2020, you must prohibits the doing of certain acts or processed, packed, or held that article of
cancel your registration electronically, causing such acts to be done. Under food has not registered in accordance
unless FDA has granted you a waiver section 302 of the Federal Food, Drug, with this subpart, the disposition of the
under § 1.245. If FDA has granted a and Cosmetic Act (21 U.S.C. 332), the article of food shall be governed by the
waiver under § 1.245, you may cancel United States can bring a civil action in procedures set out in subpart I of this
your facility’s registration by mail or Federal court to enjoin a person who part.
fax. commits a prohibited act. Under section ■ 10. Add § 1.245 to subpart H to read
(1) You must cancel your registration 303 of the Federal Food, Drug, and as follows:
using Form FDA 3537a. You may obtain Cosmetic Act (21 U.S.C. 333), the
a copy of this form by writing to the United States can bring a criminal § 1.245 Waiver request.
U.S. Food and Drug Administration, action in Federal court to prosecute a Under §§ 1.231(a)(2) and (b), 1.234(d),
Center for Food Safety and Applied person who is responsible for the and 1.235(d), beginning January 4, 2020,
Nutrition, 5001 Campus Dr. (HFS–681), commission of a prohibited act. Under you must submit your registration,
College Park, MD 20740 or by requesting section 306 of the Federal Food, Drug, registration renewal, updates, and
the form by phone at 1–800–216–7331 and Cosmetic Act (21 U.S.C. 335a), FDA cancellations to FDA electronically
or 301–575–0156. can seek debarment of any person who unless FDA has granted a waiver from
(2) When you receive the form, you has been convicted of a felony relating such requirement. Under § 1.232(a)(6),
must completely and legibly fill out the to importation of food into the United you must provide the email address of
form and either mail it to the address in States. Failure of an owner, operator, or the owner, operator, or agent in charge
of the facility unless FDA has granted a authorized the submission, unless FDA facility. You must submit your request
waiver from such requirement. In has granted a waiver. To request a to: U.S. Food and Drug Administration,
addition, under §§ 1.230(b) and (c), waiver from these requirements, you Center for Food Safety and Applied
1.232(a)(10), 1.234(a), and 1.235(b)(5), must submit a written request to FDA Nutrition, 5001 Campus Dr. (HFS–681),
registration renewals, abbreviated that explains why it is not reasonable College Park, MD 20740.
registration renewals, registrations, for you to submit your registration, Dated: July 7, 2016.
updates, and cancellations not registration renewal, update, or Leslie Kux,
submitted by the owner, operator, or cancellation to FDA electronically or to Associate Commissioner for Policy.
agent in charge must include the email provide the email address of the owner, [FR Doc. 2016–16531 Filed 7–13–16; 8:45 am]
address for the individual who operator, or agent in charge of the BILLING CODE 4164–01–P

2016-16531 Amendments To Registration of Food Facilities FR

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2016-16531 Amendments To Registration of Food Facilities FR

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TABLE 1—ANNUALIZED COST AND BENEFIT SUMMARY

Total annualized annualized Benefits

Domestic Facilities ........................................................................................ $9 $1.4 $1.4 Not Quantified.

Subtotal Facilities ................................................................................... 27 4.7 4.9

TABLE 1—ANNUALIZED COST AND BENEFIT SUMMARY—Continued

Costs to FDA ................................................................................................ ........................ 0.9 1.2

Total ....................................................................................................... 27 5.6 6.1

TABLE 2—PUBLISHED FOUNDATIONAL RULES FOR IMPLEMENTATION OF FSMA

TABLE 4—PUBLISHED FOUNDATIONAL RULES FOR IMPLEMENTATION OF FSMA

TABLE 5—ESTIMATED ONE TIME REPORTING BURDEN 1

TABLE 6—ESTIMATED ANNUAL REPORTING BURDEN 1

Total Hours ................................................................... ........................ ........................ ........................ ........................ 278,382

full mailing address, phone number, www.fda.gov/downloads/Food/Guidance

(for the paper option). Each electronic registration. mail or by fax.

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