Animal Welfare; Amendments to Licensing Provisions and to Requirements for Dogs, 28772-28799 [2020-07837]
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Federal Register / Vol. 85, No. 93 / Wednesday, May 13, 2020 / Rules and Regulations
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
9 CFR Parts 1, 2, and 3
[Docket No. APHIS–2017–0062]
RIN 0579–AE35
Animal Welfare; Amendments to
Licensing Provisions and to
Requirements for Dogs
Animal and Plant Health
Inspection Service, USDA.
ACTION: Final rule.
AGENCY:
We are amending the
licensing requirements in the Animal
Welfare Act (AWA) regulations to
promote compliance, reduce licensing
fees, and strengthen safeguards that
prevent individuals and businesses with
a history of noncompliance from
obtaining a license or working with
regulated animals. This action will
reduce regulatory burden with respect
to licensing and help ensure licensees’
sustained compliance with the AWA,
thus promoting animal welfare. We have
also revised the veterinary care and
watering standards for regulated dogs to
better align the regulations with the
humane care and treatment standards
set by the Animal Welfare Act.
DATES: Effective November 9, 2020.
FOR FURTHER INFORMATION CONTACT: Dr.
Barbara Kohn, Senior Staff Veterinarian,
APHIS, 4700 River Road, Unit 84,
Riverdale, MD 20737; (301) 851–3751;
barbara.a.kohn@usda.gov.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
Background
Under the Animal Welfare Act (AWA
or the Act, 7 U.S.C. 2131 et seq.), the
Secretary of Agriculture is authorized to
promulgate standards and other
requirements governing the humane
handling, care, treatment, and
transportation of certain animals by
dealers, exhibitors, operators of auction
sales, research facilities, and carriers
and intermediate handlers. The
Secretary has delegated responsibility
for administering the AWA to the
Administrator of the U.S. Department of
Agriculture’s (USDA’s) Animal and
Plant Health Inspection Service
(APHIS). Within APHIS, the
responsibility for administering the
AWA has been delegated to the Deputy
Administrator for Animal Care.
Definitions, regulations, and standards
established under the AWA are
contained in 9 CFR parts 1, 2, and 3
(referred to below as the regulations).
Part 1 contains definitions for terms
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used in parts 2 and 3. Part 2 provides
administrative requirements and sets
forth institutional responsibilities for
regulated parties, including licensing
requirements for dealers, exhibitors, and
operators of auction sales. Dealers,
exhibitors, and operators of auction
sales are required to comply in all
respects with the regulations and
standards (§ 2.100(a)) and to allow
APHIS officials access to their place of
business, facilities, animals, and records
to inspect for compliance (§ 2.126). Part
3 provides standards for the humane
handling, care, treatment, and
transportation of covered animals. Part
3 consists of subparts A through E,
which contain specific standards for
dogs and cats, guinea pigs and hamsters,
rabbits, nonhuman primates, and
marine mammals, respectively, and
subpart F, which sets forth general
standards for warmblooded animals not
otherwise specified in that part.
Under the current regulations, an
applicant for an initial license is
required to submit an application form,
an application fee, and an annual
license fee to Animal Care (§ 2.1(c)),
acknowledge receipt of a copy of the
regulations and agree to comply with
them by signing the application form
(§ 2.2(a)), and demonstrate compliance
with the AWA regulations and
standards, before APHIS can issue a
license (§ 2.3(a)). Once a person receives
a license, the licensee may renew his or
her license annually by submitting an
annual renewal form and license fee
(§ 2.1(d)(1)).
On March 22, 2019, we published in
the Federal Register (84 FR 10721–
10735, Docket No. APHIS–2017–0062) a
proposal to revise the AWA licensing
requirements to promote compliance,
reduce licensing fees and burdens, and
strengthen existing safeguards that
prevent individuals and businesses who
are unfit to hold a license (such as any
individual whose license has been
suspended or revoked or who has a
history of noncompliance) from
obtaining a license or from buying,
selling, transporting, exhibiting, or
delivering for transportation regulated
animals. We also proposed revisions to
the animal health and husbandry
standards of part 3, subpart A, to ensure
the adequate care and treatment of
regulated dogs. Prior to the proposed
rule, we published an advance notice of
proposed rulemaking (ANPR) in the
Federal Register on August 24, 2017,
(82 FR 40077–40078, Docket No.
APHIS–2017–0062), in which we
solicited comments from the public
regarding potential revisions to the
AWA regulations.
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We solicited comments on the
proposed rule for 60 days ending May
21, 2019. On May 28, 2019, we
published in the Federal Register (84
FR 24403, Docket No. APHIS–2017–
0062) a document 1 announcing a
reopening of the comment period for an
additional 15 days, to June 5, 2019, to
allow interested persons additional time
to prepare and submit comments.
We received approximately 110,600
comments on the proposed rule via
courier, U.S. mail, and Regulations.gov.
Of this total, 4,619 unique comments
were received via Regulations.gov, along
with approximately 600 unique paper
comments delivered to APHIS. Through
Regulations.gov we also received 25,400
comments in 629 distinct sets of
duplicate or near-duplicate comments.
An additional 79,978 comments we
received consisted of one of three
electronic form letters drafted by a
national animal welfare organization
and endorsed by its supporters, some of
whom added their views to the letter.
We received comments from members
of Congress, animal welfare
organizations, animal rescue and
sheltering organizations, licensed
animal dealers, breeders, and exhibitors,
kennel clubs, zoos and aquariums,
theme parks, animal reserves,
veterinarians and veterinary
organizations, and members of the
public. Issues raised by commenters are
discussed below by topic. We address
the issues in the order that they pertain
to the regulatory text of the proposed
rule.
Definitions
We proposed to amend § 1.1,
‘‘Definitions,’’ by removing the term AC
Regional Director, as Animal Care is no
longer organized under regions and
regional directors. We proposed
replacing references to the AC Regional
Director with Animal Care Deputy
Administrator and regional offices with
the appropriate Animal Care office.
One commenter opposed replacing
many tasks that have historically been
under the oversight of each Regional
Director and stated that placing them
under the oversight of the Deputy
Administrator would be contrary to
APHIS’ own strategic plan. A few
commenters stated that this proposed
change suggests that APHIS is
attempting to install an unqualified
third party lacking in veterinary
experience and credentials.
We disagree with the commenters.
The Deputy Administrator of Animal
1 To view the ANPR, proposed rule, supporting
documents, and the comments we received, go to
https://www.regulations.gov/#!docketDetail;
D=APHIS-2017-0062.
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Care has been delegated the authority by
the Administrator of APHIS to direct
activities to ensure compliance with,
and enforcement of, the AWA.2 The
replacement of the term AC Regional
Director with Deputy Administrator
reflects the current organizational
structure of Animal Care and not a
change in the authority of the Deputy
Administrator. The Deputy
Administrator of Animal Care is not
required to have veterinary experience
or credentials in order to be qualified.
Business Hours
We proposed to revise the definition
of business hours in § 1.1 of the
regulations so that the term no longer
limits inspection times to ‘‘Monday
through Friday, except for legal Federal
holidays.’’ We changed the definition to
mean ‘‘a reasonable number of hours
between 7 a.m. and 7 p.m. each week of
the year, during which inspections by
APHIS may be made.’’ We made this
change to accommodate persons who
are employed in other types of work and
are not usually available for inspections
during the day on Monday through
Friday.
One commenter disagreed with our
proposed change to business hours,
stating that it is unclear what USDA
means by ‘‘reasonable.’’ The commenter
considered ‘‘reasonable’’ to be a
minimum of 30 hours a week and not
just weekends, and noted that not being
present at the facility is a tactic on
which licensees have often relied to
avoid inspections.
The AWA authorizes USDA personnel
to have access, at all reasonable times,
to the places of business and the
facilities, animals, and records of
dealers, exhibitors, research facilities,
carriers, and intermediate handlers.3 As
discussed in the proposed rule, we have
observed a number of licensees who are
not available for a reasonable number of
hours between 7 a.m. and 7 p.m.
Monday through Friday because they
are employed full-time elsewhere
during the weekdays or because they
operate at reduced hours on weekdays
to allow customers to visit their
business on the weekends. We are
therefore making the change as
proposed to reflect these business
practices and to ensure that such
licensees are able to make their place of
business and facilities, animals, and
records available for inspection at all
reasonable times as required by the Act.
APHIS will continue to coordinate with
licensees and registrants who do not
maintain regular public business hours
2 See
37
7 CFR 371.7.
U.S.C. 2146(a).
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to establish optimal times for
inspection.
A commenter stated that removing the
business hour designation from Monday
through Friday may negatively impact
larger zoos and aquariums, as weekend
staffs at these businesses are usually
smaller than during the week.
A licensee or registrant that is
available a reasonable number of hours
only Monday through Friday would still
meet the definition of business hours for
the purpose of inspections. It is not our
intent to require that licensees and
registrants be available for a reasonable
number of hours on every day of the
week, but rather a reasonable number of
hours collectively during the course of
a week. Therefore, we are making no
changes to the rule in response to this
comment.
Additional Definitions
Several commenters asked that we
add definitions to § 1.1, including a
definition of ‘‘affirmative demonstration
of compliance,’’ to be defined as the
demonstration of compliance with the
Act, the regulations, and standards as
documented on inspection reports
created as part of the application or
inspection process for the current
period of licensure. In making this
request, a few commenters suggested
that without such a definition, APHIS
hinders licensing by subjectively
interpreting what constitutes
compliance. Some persons commenting
on the ANPR had also asked that we
provide such a definition.
We are making no changes to the rule
in response to these comments. The rule
already specifies that a license applicant
must demonstrate that his or her
location and any animals, facilities,
vehicles, equipment, and other locations
used or intended for use in the business
comply with the AWA and the
regulations. How APHIS inspectors
document noncompliances is
immaterial to whether the applicant
demonstrates compliance.
Several commenters asked that we
add a definition for ‘‘breeding female’’
to § 1.1. Some commenters also asked
that we define ‘‘puppy mill’’ in the
regulations.
We are making no changes to the rule
in response to these comments.
However, we note that USDA has
explained its thinking on the meaning of
the term ‘‘breeding female’’ in a
previous rulemaking: ‘‘While we
recognize that breeders have several
reasons for not breeding an intact
female, for the purposes of enforcement,
APHIS has to assume that a female that
is capable of breeding may be bred.
However, in determining whether an
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animal is capable of breeding, an APHIS
inspector will take into consideration a
variety of factors, including the animal’s
age, health, and fitness for breeding.’’ 4
As for the term ‘‘puppy mill,’’ we do not
use the term, nor will we define it, as
it does not appear in the Act or in our
regulations.
Licensing Requirements
In § 2.1, we proposed changes to the
information required to be submitted in
the licensing application, including
requiring applicants to indicate the
maximum number of animals on hand
at any one time, types of animals
anticipated to be held or exhibited,
information demonstrating that
applicants have adequate knowledge of
and experience with the animals, and
disclosure of any previous animal
welfare pleas of no contest or findings
of violations. We proposed these
changes to help strengthen compliance
with the AWA regulations.
Required Information on Application
A few commenters recommended that
the license form furnished by the
Deputy Administrator in § 2.1(a)(1) be
applicable to a person renewing a
license as well as a person seeking a
license.
We are making no changes in
response to this comment because this
rulemaking removes the license renewal
process from the regulations.
A commenter requested that we add
a planned business hours section to the
license application form to assist
inspectors in gaining entry to operation
on first contact. The commenter stated
that APHIS inspection reports indicate
that inspectors frequently have been
unable to enter a facility on arrival due
to no one being onsite, which removes
the benefit of the unannounced
inspection. The commenter asked if
more could be done to ensure the
unannounced inspection occurs on the
first attempt.
We do not believe requiring licensees
to put their business hours on the
application to be helpful to the
inspectors, nor is it necessary for
conducting unannounced inspections or
scheduling prelicense inspections. We
define business hours for inspections to
be a reasonable number of hours
between 7 a.m. and 7 p.m. each week of
the year to provide additional flexibility
for inspectors to gain entry on the first
contact. As noted above, we have
observed that a number of licensees are
employed full-time elsewhere during
4 78 FR 57227 (Sept. 18, 2013); https://
www.federalregister.gov/documents/2013/09/18/
2013-22616/animal-welfare-retail-pet-stores-andlicensing-exemptions.
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the weekdays or operate at reduced
hours on weekdays. We have additional
communication tools to ensure the
licensee is available for unannounced
inspections. If a licensee or registrant is
chronically unavailable for
unannounced inspections, we take steps
to remedy the situation, including
attempting inspections at different times
and days of the week. If necessary, we
will coordinate with the person to
establish an optimal inspection time
range that includes multiple blocks of
days of the week and multiple blocks of
time in which they are available for an
unannounced inspection. We will also
pursue enforcement and other remedial
actions if necessary. Accordingly, we
are making no changes to the rule in
response to this comment.
A commenter recommended that, in
order to ensure that disclosure
requirements have the intended impact,
APHIS should include warning
language on the license application that
clearly informs applicants of the
consequences of providing false
information, including penalty of
perjury.
We agree with the commenter.
Sections 2.11 and 2.12 of the regulations
state that a license applicant who has
made false or fraudulent statements or
provided false or fraudulent records to
USDA may have their application
denied or their license terminated, if
already issued. We will include this
information on the new license
application form.
A commenter supported our proposed
action to remove the ‘‘intention’’ to
operate as an exhibitor from § 2.1(a) to
make it more difficult for persons to
obtain licenses solely for the purpose of
circumventing State laws restricting the
private possession and sale of exotic
and wild animals (by only intending to
exhibit but not actually exhibiting
them). The commenter stated, however,
that APHIS should take even greater
steps to prevent this circumvention
from occurring by asking applicants
about insurance coverage, business
advertising, and exhibition travel
schedules on the application form in
order to identify licensees keeping
exotic animals only as pets.
We acknowledge the commenter’s
concerns but are making no changes to
the rule. Should we have concerns that
a person is holding an AWA license to
circumvent State laws restricting the
private possession and sale of exotic
and wild animals, we have the authority
under § 2.125 of the regulations to
request information concerning the
business to assess whether the person is
engaging in activities for which a
license is required.
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On the other hand, a commenter
opposing the rule said that APHIS’
attempt to prevent persons from
circumventing State law to keep exotic
and wild animals violates statutes
enforced by the Federal Trade
Commission, and that the Federal
Government is not allowed to
circumvent State laws.
We disagree with the commenter.
This change in the regulations supports,
rather than circumvents, State laws. The
AWA authorizes and encourages APHIS
to cooperate with State and other
officials in carrying out the purposes of
the AWA and any State, local, or
municipal legislation or ordinance on
the same subject. Finally, the
regulations in §§ 2.11 and 2.12 have
long stipulated that any license
applicant or holder who is violating or
circumventing State law may be subject
to the denial or termination of a license.
A commenter asked APHIS to require
that any applicant operating under the
name of a business disclose the business
name in addition to their legal name,
and to issue the license under the
business name. The commenter also
asked us to require disclosure of not
only the names of the individual and
business applying for a license, but also
the names of all business associates and
relatives involved in the business at the
time of application and after. Finally, a
few commenters requested that APHIS
add a new field on the application form
and require disclosure of any names
under which the business formerly
operated.
We are making no changes to the rule
in response to this comment. The
license application form requires that
applicants provide any previous USDA
license number(s) and any active license
numbers in which the applicant has an
interest. In addition, the applicant must
report any partners or officers, all
business names, and locations. Should
we require additional information, we
have the authority under § 2.125 of the
AWA regulations to request information
concerning the business.
In proposed § 2.1(a)(1)(v), we required
that license applicants disclose the
anticipated type of animals to be owned,
held, maintained, sold, or exhibited
during the period of licensure and
whether these include exotic or wild
animals. If exotic or wild animals are
included, we required that applicants
provide information and records
demonstrating they have adequate
knowledge of and experience with those
animals.
A commenter stated that it is unclear
why only applicants intending to hold
exotic or wild animals need to
demonstrate knowledge and experience
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in caring for those animals. The
commenter stated that all applicants
should be required to demonstrate
knowledge and experience with any
species they intend to obtain.
We agree with the commenter. In
establishing regulatory standards of
care 5 for all covered animals—wild,
exotic, or otherwise—APHIS requires
that all licensees demonstrate
knowledge and experience sufficient to
caring for their animals, regardless of
species, and we note there are many
ways that applicants can demonstrate
this. For this reason, we are amending
the proposed rule by removing the
additional information and records
requirement in paragraph (a)(1)(v).
In § 2.1(a)(1)(vii), we proposed
requiring license applicants to disclose
any plea of no contest or finding of
violation of Federal, State, or local laws
or regulations pertaining to animal
cruelty or the transportation, ownership,
neglect, or welfare of animals. A
substantial number of commenters
agreed with this provision. We noted in
the preamble to the proposed rule that
the current regulations already set forth
provisions for the denial of a license for
persons with animal cruelty convictions
and certain other violations of Federal,
State, or local laws pertaining to
animals, and that this rule further
supports this existing licensing
restriction by requiring disclosure of
such violations on the license
application.
A commenter agreed with this
provision and recommended that we
also require disclosure of animal- or
consumer-based legal violations (such
as illegal import or export of animals or
animal parts or products) and any
licensing denial, revocation, or similar
actions taken by any State, Federal, or
local authority for activity relating to
animal husbandry or sales. The
commenter also stated that any animal
cruelty conviction or plea, whether
incurred during the preceding 3 years or
otherwise, should disqualify an
applicant from obtaining a license. The
commenter asked that we include these
provisions in § 2.11.
Another commenter supporting
disclosure of pleas or convictions of
animal cruelty in proposed
§ 2.1(a)(1)(vii) stated that local cruelty
laws vary widely from one jurisdiction
to another and that some offenses, such
as failure to license an animal or certain
tethering violations, do not bear directly
on animal welfare or constitute cruelty.
For this reason, the commenter
5 The statutory bases for these standards are
located in section 2143 of the AWA, paragraphs
(a)(1) and (a)(4).
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suggested that the proposed language for
disclosing pleas and violations be
amended to include only activities like
those covered under the Act.
Under § 2.11(a)(5), APHIS will not
issue a license to any applicant who has
pled or been found to have violated any
Federal, State, or local laws or
regulations pertaining to animal cruelty
within 3 years of application, or after 3
years if the Administrator determines
that the circumstances render the
applicant unfit to be licensed. We will
apply this provision if the applicant
meets these conditions. Likewise, under
§ 2.11(a)(7), APHIS will not issue a
license to any applicant who pled or has
been found to have violated any
Federal, State, or local laws or
regulations pertaining to the
transportation, ownership, neglect, or
welfare of animals, or is otherwise unfit
to be licensed and the Administrator
determines that the issuance of a license
would be contrary to the purposes of the
Act. In order to make this
determination, we require the disclosure
of all such pleas and violations as
required under § 2.1(a)(1)(vii).
Accordingly, we do not consider it
necessary to make changes based on this
comment.
Locations, Numbers, and Types of
Animals
The current regulations do not require
a licensee to demonstrate compliance
when making changes to his or her
animals or locations, including
noteworthy changes to the numbers or
types of animals used in regulated
activity. This allows a licensee to
acquire substantially more or different
types of animals than what he or she
had when the license was originally
issued. Therefore, we proposed in
revised § 2.1(b)(1) to require licensees to
notify Animal Care no fewer than 90
days before making any changes to the
name, address, substantial control, or
ownership of the business or operation,
locations, activities, and number or type
of animals described in § 2.1(b)(2). After
the licensee demonstrates compliance
under the changes and fulfills all other
regulatory requirements, APHIS would
issue a new license with a new
certificate number.
A substantial number of commenters
supported this proposed requirement.
Among them, one commenter stated that
APHIS should also review patterns of
small changes not considered
noteworthy but which could have
significant cumulative impact on animal
welfare.
We are making no changes in
response to that comment. With respect
to evaluating facilities, we note and
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consider any change, regardless of size,
that may have an impact on animal
welfare.
On the other hand, some commenters
opposed the proposed requirement for
new licenses for facilities that change
their operations or the type or number
of animals they display, claiming that
the requirement is overly broad and
burdensome and would require facilities
that make even minor changes to their
facilities or collections of animals to
seek new licenses. Many of these
commenters supported requiring
licensees to notify APHIS of a change in
regulated activities only if the change
has an actual demonstrable impact on
the normal operating procedures of the
licensee. Similarly, a commenter
representing a zoological park stated
that the additional regulation of
obtaining a new license when making a
noteworthy change is excessive, as the
USDA license is for the functioning of
the entire zoo and not for one small part
of a facility that may have a
noncompliant issue. Another
commenter stated that slight changes to
regulated activities should need no
review, and specifically cited riding and
feeding animals, and animals used in
circus and movie work.
We are making no changes in
response to the comments. In
developing the list of conditions in
§ 2.1(b) that trigger the need for a new
license, we considered several factors,
including the complexity of care the
animals require, the varying regulations
and standards for different types of
animals, and the number of animals at
facilities. Our focus is on requiring
facilities to demonstrate compliance
when acquiring animals subject to
different standards or that have special
husbandry and care needs, or when
expanding the size of their animal
collection significantly from the time of
licensure. We believe this
demonstration is important for ensuring
that such facilities maintain compliance
with the AWA during their period of
licensure.
Several commenters stated that the
proposal to require a new license
whenever a facility makes any change in
substantial control or ownership is
vague and overly broad. One such
commenter asked that we state more
clearly when a new license is needed
under this type of change.
We appreciate the opportunity to
clarify the proposed rule in response to
these comments. Licenses are issued to
specific persons, which is defined in the
AWA regulations to mean, ‘‘individual,
partnership, firm, joint stock company,
corporation, association, trust, estate, or
other legal entity.’’ If the ownership of
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a licensed facility changes (i.e., if a new
‘‘person’’ or group of persons assumes
ownership 6), the new owner would
need to obtain a license.
A new license is also required if the
ownership structure is modified such
that it changes who has substantial
control of the business. For example, the
business’ ownership model may change
from an individual to a partnership or
corporation, or vice versa. If a business
is sold to another party, or if the
licensee passes away and a new owner
(including relatives) takes possession, a
new license is required. Licenses are
issued specific to certain activities (such
as exhibition), so a new license would
be required if, for example, a breeder
wants to begin operating as an exhibitor.
Because licenses are site-specific, any
change in location of the animals also
requires a new license. APHIS will
provide additional guidance on this
topic to include examples that indicate
when a new AWA license is needed.
A few commenters expressed the view
that requiring a new license whenever a
facility undergoes a change in
management is an unnecessary
intrusion into a licensee’s business
activities. One such commenter said
that if any management changes to a
facility are necessary, the Agency
should confine its role to simply
requiring advance notice of such
changes and allow the facility to keep
its existing license.
While a change in ownership would
require a new license under the
proposed regulations, changes in
operational management of a facility
typically would not. Accordingly, we
are revising proposed § 2.1(b)(1) to
exclude changes in management as
requiring a new license. Similarly, a
licensee that changes only the name of
the business would not require a new
license, unless the name change is
associated with a change in ownership.
Some commenters expressed concerns
about the minimum 90-day notice that
must be given to APHIS before any
change is made to the business or
operation as required in § 2.1(b)(1). The
commenters’ concerns focused on
situations where changes to the facility
would need to be made in a shorter
period due to unexpected circumstances
such as the death of an owner or
damages to the facility that affect the
welfare of the animals held by the
licensee.
We acknowledge that unexpected
situations (such as natural disasters) can
6 New ownership as described here typically
involves the facility being associated with a
different Internal Revenue Service-issued Employer
Identification Number (EIN). An EIN cannot be
transferred to another owner.
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arise and note that we have the
discretion to suspend enforcement in
such situations.
In § 2.1(b)(1), we proposed that any
person who intends to exhibit any
animal at any location other than the
person’s approved site must provide
that information on their application in
accordance with proposed § 2.1(a)(1)(iii)
and submit written itineraries in
accordance with § 2.126. We noted that
if the application did not provide such
information, then a new application
would have to be submitted and a new
license obtained before exhibiting at
locations other than the approved site.
A commenter operating as an
exhibitor asked us to explain how to
complete the license application with
respect to the location of animals. The
commenter asked whether licensees
should indicate on the application that
they exhibit at offsite locations and then
follow up with itinerary filings, or
whether each exhibition location would
need to be listed and approved upon
application for the license. The
commenter stated that it is unfair to
require licensees to know their entire
traveling itinerary for up to a year in
advance, much less 3 years.
We appreciate the opportunity to
clarify how this requirement will be
implemented. The applicant will need
only to specify on the application that
they intend to exhibit at off-site
locations, and then follow up with
submission of itineraries in accordance
with § 2.126.
Changes to Number of Animals Used in
Regulated Activities
We proposed in § 2.1(b)(2) that
licenses will authorize increments of 50
animals on hand at any single point in
time during the period of licensure, and
that licensees must obtain a new license
before any change resulting in more
than the authorized number of animals
on hand at any single point in time.
Licensees falling below de minimis are
still licensed and subject to the
regulations unless they choose to
terminate their license. If they terminate
their license then later exceed the de
minimis level and continue to conduct
regulated activity, they would need to
reapply for a license.
Several commenters suggested that
when licensed exhibitors obtain more
animals, they should have to seek
APHIS approval for the additional
animals regardless of number.
We are making no changes to the rule
in response to this comment. In
deciding on the range of the number of
animals we considered several factors,
including the impact on compliance and
the burdens associated with obtaining a
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new license. We do not believe that a
new license is necessarily required
every time a facility acquires an
additional animal.
A commenter recommended that
APHIS base the authorized number of
animals on a relative change in size
rather than on a flat threshold of 50
animals. The commenter added that this
determination should be made by
observing the actual number of animals
present during the prelicense inspection
rather than on the licensee’s reporting.
We are making no changes to the rule
based on this comment. The rule
requires applicants to provide the
anticipated maximum number of
animals on hand at any one time during
the period of licensure. This number
may not match the number of animals
on hand during the prelicense
inspection (although the number of
animals on hand during the prelicense
inspection should not exceed the
maximum number reported on the
application). During the prelicense
inspection, APHIS will determine
whether the animals, facilities, vehicles,
equipment, and locations are in
compliance, taking into account the
anticipated maximum number of
animals on hand.
Another commenter said that our
proposal to authorize increments of 50
animals is arbitrary and does not serve
its intended purpose. The commenter
added that an increase of 50 in one
species might require very little change
in facilities and resources, whereas an
increase of only a few of another species
might completely change the nature of
the operations. The commenter
recommended that APHIS not provide
licenses for increments of 50 animals,
but should instead provide licenses
based on the anticipated maximum
number of animals possessed during the
3-year period of licensure.
We are making no changes to the rule
in response to this comment. The
purpose of this requirement is to ensure
a licensee’s facilities are compliant with
the AWA regulations and standards for
the anticipated number and type of
animals to be held or used during the
period of licensure. Not all facilities will
have a static inventory of animals or
have all of their animals on-site for the
entire period of licensure. For example,
a dog breeding facility may have a large
number of animals over the course of 3
years, but a small number of animals on
hand at any single point in time. The
facility would need to demonstrate
compliance for the maximum
anticipated number of animals on hand
at any single point in time during the
period of licensure.
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A commenter stated that APHIS
should clarify the requirements for
disclosure of the anticipated number of
animals to account for potential
offspring (whether or not there is an
intention to breed), in order to account
for fraudulent disclosures. The
commenter cited the example of an
applicant who has 50 dogs, 40 of which
are unaltered females, who claims no
intention to breed those dogs yet could
have them produce 40 separate litters of
puppies. On the other hand, several
commenters stated that not all breeding
females are used for breeding. One such
commenter stated it is important to
define the term ‘‘breeding female’’ in a
clear and reasonable manner, adding
that just because a female dog is not
spayed does not mean she is a breeding
female.
We note that the prelicense
demonstration of compliance would
take into account the breed of dog, the
number of breeding female dogs, the
projected litter size, and the facility’s
business model for selling and placing
puppies and adult dogs who are no
longer used for breeding purposes. For
the purposes of enforcement, APHIS
assumes that a female dog that is
capable of breeding may be bred. If a
person uses animals for purposes
counter to what the license allows,
including breeding dogs that were
indicated during the inspection to be no
longer used for breeding, we will
investigate such instances and take
appropriate action.
A commenter stated that APHIS is
forcing people to circumvent the
burdens being placed on them by the
Agency and asked, by way of example,
if there is anything that would prohibit
his spouse or child from keeping 200
more animals outside the perimeter of
his licensed facility.
We note in response that this
rulemaking will actually relieve
paperwork burden and reduce fees for
many licensees. To answer the
commenter’s question, we reply that the
licensee, or any other person using or
maintaining animals in such a manner
that he or she requires a license, is
subject to the AWA regulations and any
prohibitions applicable to the situation
described.
Changes to Types of Animals Used in
Regulated Activities
Proposed § 2.1(b)(2) provides that
licenses will authorize specific numbers
and types of animals. Section
2.1(b)(2)(ii) specifically authorizes
licenses for using animals that are
subject to subparts A through F in part
3. However, with respect to licenses for
using animals subject to subparts D and
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F, licenses will separately authorize the
use of each of the following groups of
animals: (1) Group 5 and 6 nonhuman
primates, (2) big cats or large felids, (3)
wolves, (4) bears, and (5) megaherbivores. We noted that these groups
of animals would be separately
authorized because they are potentially
dangerous and have unique care needs.
We also included a provision requiring
licensees to obtain a new license before
using any animals beyond those animals
authorized for use under the existing
license for activities for which a license
is required. We proposed these changes
based on our experience with
administering and enforcing the AWA,
noting that licensees sometimes struggle
to achieve and maintain compliance
after making noteworthy changes to the
numbers or types of animals used in
regulated activity.
A commenter suggested that APHIS
should make it more clear in proposed
§ 2.1(b)(2)(ii) of the regulations that if a
licensee wishes to obtain any new
species, he or she is required to obtain
a new license.
We note in § 2.1(b)(1) that licensees
are required to notify Animal Care no
fewer than 90 days, and obtain a new
license, before making any change in the
number or type of animals described in
paragraph (b)(2).
A commenter supported the proposed
requirement for a new license for
dangerous and exotic animals with
unique care needs, but requested more
information as to what animals we
would include under such a license
beyond obvious ones such as elephants,
big cats, and bears. The commenter
noted, for instance, that servals are
potentially dangerous.
On the other hand, several
commenters opposed the proposal to
require a new license for each new
species acquired, and one such
commenter recommended that APHIS
set up several classes of animals based
on level of risk and complexity of care.
The commenter offered as an example a
class for domestic and farm animals, a
class for small exotics, and a class for
large exotics. Under this arrangement,
the commenter suggested, a licensee
could acquire any animal from the
animal class they are licensed for, or
any lesser class, without having to
reapply for a new license.
We agree that there are other
potentially dangerous animals that fall
under the general standards in subpart
F of part 3 that should be separately
authorized. Accordingly, we are revising
our proposed groups of animals that
require separate authorization as
follows: (1) Group 5 (baboons and
nonbrachiating species larger than 33
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pounds) and 6 (great apes over 55
pounds and brachiating species)
nonhuman primates; (2) exotic and wild
felids (including but not limited to
lions, tigers, leopards, cheetahs, jaguars,
cougars, lynx, servals, bobcats, and
caracals, and any hybrid cross thereof);
(3) hyenas and/or exotic and wild
canids (including but not limited to
wolves, coyotes, foxes, and jackals); (4)
bears, and (5) mega-herbivores
(elephants, rhinoceroses,
hippopotamuses, and giraffes).
A commenter recommended that we
include Category E, marine mammals,
under the considerations for licensing
along with large primates, large
carnivores, and mega-herbivores. The
commenter added that a facility that
passes a prelicense inspection to house
sea lions is not automatically prepared
to handle orcas, for example. This and
other commenters also noted that as
polar bears are considered a marine
mammal and bears are listed as a
Category F animal requiring special
considerations, Category E should be
listed under the considerations for
licensing so that polar bears do not fall
into a regulatory loophole.
We acknowledge the commenters’
concerns but are making no changes to
the rule on this topic. As a practical
matter, marine mammals are already
highly regulated animals with respect to
their welfare and species-specific needs.
In addition to protection under the
AWA, all species of marine mammals
are protected under the Marine Mammal
Protection Act (MMPA), and some are
also protected under the Endangered
Species Act and the Convention on
International Trade in Endangered
Species of Wild Fauna and Flora. These
animals include whales, dolphins,
porpoises, seals, sea lions, walruses,
polar bears, sea and marine otters,
dugongs, and manatees. Polar bears are
provided additional protection under
the International Agreement on the
Conservation of Polar Bears, an
agreement between the United States,
Canada, Denmark, Norway, and Russia,
which is implemented in the United
States by the provisions of the MMPA.
One commenter asked if a new license
is needed for adding other cetaceans if
the facility already has one kind of
cetacean.
If the species of cetacean being added
is different from the species authorized
under the existing license, a new license
would be required in accordance with
proposed § 2.1(b)(2)(ii).
Another commenter asked about the
impact of the proposed licensing
requirement for changes to numbers and
types of animals on the practice of
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rescuing and rehabilitating stranded
marine mammals.
Unless the rescued marine mammals
are exhibited (see the definition of
exhibitor in § 1.1) by the rescue or
rehabilitation facility, there is no impact
on such facilities. The animals are
regulated under the MMPA by the
National Oceanic and Atmospheric
Administration or the U.S. Fish and
Wildlife Service, depending on the
species involved.
A commenter asked APHIS to require
more specificity from licensees
regarding the types of animal they plan
on keeping. The commenter stated that
the categories of animals in part 3 are
typed too broadly for APHIS to ascertain
whether an applicant can properly care
for particular animals and suggested
that APHIS instead require disclosure
by species rather than type.
We appreciate the opportunity to
make clear that applicants would need
to specify the anticipated species or
common names of animals owned, held,
maintained, sold, or exhibited during
the period of licensure.
One commenter stated that licensees
acquiring nondomestic animals should
be required to indicate the type, weight,
and risk factor of the animal and that
APHIS should confirm that a suitable
secure enclosure is available to house
the new animal. The commenter also
recommended that the animals have an
assigned veterinary clinic.
We are making no changes to the rule
in response to this comment. During
prelicense inspections, Animal Care
inspectors assess facility compliance
with the AWA regulations, which
require animals to be in good health and
have adequate space. Each facility is
also required to have an attending
veterinarian with knowledge of and
experience with the animals at that
facility and a program of veterinary care
for those animals.
A commenter stated that if a licensee
has acquired animals that they are
incapable of caring for, this possibility
should be addressed more frequently
than every 3 years. The commenter also
questioned why a licensee with an
excellent compliance history needs to
reapply for a license every 3 years and
reasoned that a simple renewal would
be appropriate for such facilities and
consistent with APHIS’ risk-based
approach. Another commenter asked
APHIS to reconsider its proposal to
require new licenses and prelicense
inspections for zoological facilities in
good standing that make changes to the
species or number of animals they
display. The commenter stated that
APHIS’ policy objectives can easily be
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achieved during the already existing
inspection process.
We are making no changes to the rule
in response to these comments. If a
facility is in compliance, the process for
applying for a new license will be
simple, with less paperwork and
reduced fees by comparison with the
current license renewal process.
Similarly, facilities that wish to add
animals to their collection under a new
license class will be able to do so easily
by completing an application form,
paying the applicable fees, and
demonstrating compliance with the
AWA regulations. During this time, the
facility can continue to use the animals
authorized by their existing license for
regulated activity with no disruption to
business.
One commenter opposing the rule
stated that the number of animals a
licensee owns is not regulated under the
AWA and therefore should not be
considered in the regulations.
USDA’s authority to set criteria for
licensing comes from section 2133 of
the Act, which directs the Secretary to
issue licenses to dealers and exhibitors
upon application and payment of the
applicable fees, provided that the
applicant has demonstrated compliance
with the AWA regulations. The number
and type of animals that an applicant
intends to use for regulated purposes
has a direct bearing on compliance with
the AWA regulations. Moreover, section
2133 authorizes USDA to prescribe the
‘‘form and manner’’ of applications.
License Fees
In the ANPR, we asked for comment
on what fees would be reasonable to
assess for licenses. We received a wide
range of responses, including those from
commenters who suggested raising fees
as a way to discourage dog breeding, as
well as those from other commenters
who asked that we eliminate licensing
fees entirely to relieve burden on small
businesses. Many commenters suggested
sliding scales based on business size
and complexity that would allow APHIS
to recover its inspection costs. After
reviewing these comments on the
ANPR, we decided to propose amending
paragraph § 2.1(c)(2) of the regulations
by requiring a flat license fee of $120.
Several commenters responded to our
proposed changes to the license fees. A
commenter said that the USDA has not
raised licensing fees in 30 years and that
lowering the fees would be arbitrary,
capricious, and in violation of several
statutory requirements. The commenter
also stated that current license fees do
not cover the cost of issuing the license,
thus causing taxpayers to subsidize the
costs, and asked us not to reduce the
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fees. Another commenter stated that fees
should be raised to keep pace with
inflation and account for the Agency’s
enforcement burdens. The commenter
provided data to illustrate that annual
rates should be doubled to compensate
for inflation and stated that the lowest
fee to be paid every 3 years, when
adjusted for inflation, would be $180,
with the highest being $4,515 for the
largest facilities. Another commenter
stated that the proposed flat fee of $120
is contrary to the Act because it is
inequitable. The commenter cites a
passage in the Act stating that fees for
licenses ‘‘shall be adjusted on an
equitable basis taking into consideration
the type and nature of the operations to
be licensed,’’ and notes that a facility
that receives $1,000,000 in annual
income paying the same fee as a facility
that receives $10,000 annually is not an
equitable fee because it is neither
‘‘adjusted’’ nor considers the type and
nature of the operations as required by
the statute. The commenter stated that
USDA should instead scale fees based
on the numbers of animals and the
complexity involved in caring for and
inspecting the animals. Finally, a
commenter stated that APHIS is not
meeting the requirements of the
Independent Offices Appropriations
Act,7 which provides that Federal
agencies may set fees that are based on
costs to the Government and the value
of the permit to the recipient, among
other factors.
We appreciate the many comments
we received on license fees but are
making no changes to the proposed fee.
Under the AWA, the Secretary shall
charge, assess, and cause to be collected
reasonable fees for licenses issued. Such
fees shall be adjusted on an equitable
basis taking into consideration the type
and nature of the operations to be
licensed and shall be deposited and
covered into the Treasury as
miscellaneous receipts. These fees are
not user fees and are not used to cover
the cost of licensing, inspection,
enforcement, or other APHIS services.
Also, the Independent Offices
Appropriations Act does not apply to
AWA licensing fees, because USDA was
granted specific statutory authority to
assess them.8
As discussed in the proposed rule, we
took into account the type and nature of
operations to be licensed and conducted
a formal economic analysis. One
alternative to a flat fee that we
considered was to establish scaled fees,
similar to those in the current
regulations. However, we found it
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87
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difficult to do so in an equitable way.
For example, some dealers and
exhibitors with small numbers of
animals may derive significant income
from their regulated activities, while
other dealers and exhibitors with large
numbers of animals may derive more
modest incomes from their activities,
based on the types of animals, location
of their business, business model, and a
variety of other factors. Accordingly, we
are establishing the flat fee of $120 for
licensure, which represents a fee that is
comparable to, or in many cases
reduced from, existing fees for
licensure. In addition to being an
equitable fee for licenses that considers
the type and nature of the operations to
be licensed, the fee structure allows for
more efficient and streamlined business
processes for Animal Care and
simplifies the calculation of licensing
fees for applicants.
A lesser number of commenters asked
that we consider lowering or
eliminating license fees, with many
noting that any type of fee places an
unfair burden on smaller dog breeding
facilities.
We disagree with these commenters.
While the current regulations require an
annual license application and fees
ranging from $40 to $760 annually, this
rule only requires an application and a
flat $120 fee every 3 years, which would
be equivalent to the current lowest fee
of $40 (if applied annually over 3 years).
Accordingly, we do not believe that the
licensing component of this rule places
additional or undue burdens on license
holders or applicants and will in fact
reduce paperwork burdens on them, as
well as reduce licensing fees for many
of them. For these reasons, we are
making no changes to the rule in
response to this comment.
License Denial and Suspension
In proposed § 2.1(d), we reassigned an
existing provision from § 2.1(e) stating
that any failure to comply with the Act,
regulations, or standards would be
grounds for denial, suspension, or
revocation of a license as provided in
the AWA.
A few commenters recommended
revising § 2.1(d)(1) to read, ‘‘A licensee
who has a record of affirmative
demonstration of compliance and is
thus eligible for renewal must submit to
the appropriate Animal Care regional
office a completed application form and
the required license fee indicated in
§ 2.1(a)(2) by certified check, cashier’s
check, personal check, money order, or
credit card.’’
We are making no changes to the rule
in response to this comment. We have
revised § 2.1(d). Licenses are no longer
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renewable, and compliance as a
condition of licensure is already made
clear in other sections.
Demonstration of Compliance
Although an applicant for a license
renewal currently must also certify, to
the best of his or her knowledge and
belief, that he or she is in compliance
with all regulations and standards, we
noted in the proposed rule that the
regulations do not require the applicant
to actually demonstrate compliance
during an inspection before APHIS
renews his or her license.
Demonstration of compliance as a
condition of licensure was supported by
a majority of persons commenting on
the ANPR and proposed rule. As noted
above, many commenters also expressed
support for APHIS to require a new
license whenever noteworthy changes
are made to a facility, its management,
or its operation, or to the number, type,
or location of animals used in regulated
activities.
A substantial number of commenters
asked APHIS to stop ‘‘rubber stamping’’
licenses without requiring compliance
with the regulations.
We disagree with this characterization
and note that § 2.3 currently requires
that license applicants demonstrate
compliance with the AWA regulations
during an inspection before APHIS will
issue a new license to them. APHIS also
conducts regular inspections of licensed
facilities under a risk-based inspection
system that calls for frequent and indepth inspections at facilities with a
higher risk of animal welfare concerns,
and fewer at those that are consistently
in compliance. As we noted above, the
proposed changes eliminate the annual
license renewal and require instead
passing a prelicense compliance
inspection to obtain a new license every
3 years.
Many commenters called for a ‘‘zero
tolerance’’ approach to AWA violations
found during prelicensing inspections,
regardless of the degree of the
infraction.
Both current and proposed § 2.3
require that applicants demonstrate
compliance with the AWA and the
regulations before any new license is
issued. An applicant failing the first
inspection may request up to two more
inspections to demonstrate compliance.
If the first inspection reveals
noncompliant issues, APHIS will advise
the applicant of existing deficiencies
and the corrective measures that must
be completed to come into compliance.
In the subsequent inspection, we verify
that the applicant has taken any and all
prescribed corrective measures. Under
this approach, APHIS will not issue
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licenses to applicants with uncorrected
deficiencies. Accordingly, we see no
need to make changes in response to
these commenters.
A commenter asked that the USDA
put safeguards in place to ensure that it
does not continue renewing licenses
from facilities that it knows or should
know are not in compliance with the
AWA. Citing a lawsuit filed by the
commenter’s organization against the
USDA, the commenter stated that it
would be arbitrary and capricious for
the agency to renew the license of a
facility despite having ‘‘smoking gun’’
evidence of noncompliance at that
facility.
We are making no changes in
response to this comment because this
rule removes the license renewal
process from the regulations. Licensees
will have to demonstrate compliance
with the AWA before being issued a
license.
A commenter stated that the proposal
is deficient in that it still allows a
licensee with a history of
noncompliances to obtain a new license
every 3 years as long as they pass the
prelicense inspection by the third try.
The commenter urged APHIS to amend
its regulations to ensure that facilities
with a history of substantial
noncompliance, during either the
prelicense or license periods, are not
issued new licenses and are prohibited
from re-applying for new licenses for a
period of at least 3 years.
We are making no changes to the rule
in response to this comment. Under this
final rule, licenses are valid for 3 years
and applicants must demonstrate
compliance before obtaining a license. If
a previous licensee with a history of
repeat noncompliances wishes to obtain
a new license, they would need to
demonstrate compliance with the AWA
regulations before we will issue a
license to them. Separate from these
requirements, APHIS also has the
authority under the Act to deny and
terminate licenses when a person is
unfit to hold a license and to pursue
civil penalties and other sanctions for
violations after the person is given
notice and the opportunity for a hearing.
Several commenters recommended
that APHIS consider creating and using
a sliding scale or a tiered system of
noncompliances for greater fairness and
accuracy when determining a facility’s
compliance with the regulations.
Licensed facilities are expected to
comply with the AWA regulations and
standards. USDA conducts regular
inspections of licensed facilities under a
risk-based inspection system that calls
for frequent and in-depth inspections at
facilities with a higher risk of animal
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28779
welfare concerns, and fewer at those
that are consistently in compliance.
USDA currently identifies the
seriousness of each noncompliance to
determine the appropriate follow-up
action. We are therefore making no
changes in response to the
recommendation.
One commenter expressed concern
that forcing wildlife facilities with a
history of compliance to apply for a
license on equal footing with new
applicants fails to recognize the
experience of many wildlife
professionals and achievements of
superior facilities.
The purpose of this rule is to ensure
that licensees are compliant with the
AWA regulations. Although an
applicant for a license renewal under
the existing regulations must certify, to
the best of his or her knowledge and
belief, that he or she is in compliance
with all regulations and standards, those
regulations did not require the applicant
to demonstrate compliance before
APHIS renewed the license. Based on
our knowledge and experience with
administering and enforcing the AWA
and regulations, we are concerned that
even experienced licensees may
sometimes struggle to achieve and
maintain compliance after making
noteworthy changes to their animals
used in regulated activity. In addition,
we have observed licensees who have
been licensed for many years struggle
with compliance because they did not
have adequate programs for maintaining
compliance at aging facilities. For these
reasons, we believe that revisions to the
regulations set forth in this final rule are
necessary to ensure that dealers,
exhibitors, and operators of auction
sales demonstrate compliance with the
AWA regulations.
Several commenters said that USDA
is adding terminology to the regulations
that is not defined in the Act and allows
for broad interpretation by Agency
employees. These terms include
‘‘demonstrate’’, ‘‘unfit’’, ‘‘affirmatively’’,
and ‘‘sustained compliance’’. One
commenter said that Agency inspectors
interpret these terms unfairly to find
instances of noncompliance to the
detriment of the licensee, resulting in
more violations and subsequently more
elimination of licensees.
We disagree with the commenters.
The terms ‘‘demonstrate’’ and ‘‘unfit’’
have been in the AWA regulations for
decades, and the terms ‘‘affirmatively’’
and ‘‘sustained compliance’’ do not
appear in the regulations; they are
simply used as descriptive terms in this
rulemaking to help the reader
understand the Agency’s intent.
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‘‘Demonstrated’’ appears in the Act at 7
U.S.C. 2133.
Similarly, a commenter stated that
inspections of zoos are not conducted to
note those things that meet or exceed
compliance. The commenter said that
any decision about licensing status
made about a facility based only on
noncompliant issues is biased and does
not consider the state of the zoo overall,
which likely exceeds compliance.
We are making no changes in
response to this comment. The AWA
directs USDA to only issue licenses to
dealers and exhibitors that have
demonstrated compliance with the
AWA regulations. Although certain
aspects of a facility may meet or exceed
those requirements, we are not
authorized to issue licenses to dealers
and exhibitors who are not in full
compliance with the AWA regulations.
On the other hand, a commenter
stated that APHIS should increase the
frequency and rigor of inspections by
examining the full operation for
noncompliant issues and not limit
inspections in any way. The commenter
noted that in the Animal Care
Inspection Guide, APHIS distinguishes
between full or complete inspections on
one hand, and focused or limited
inspections on the other. The
commenter added that APHIS should
ensure that all prelicense inspections
are full rather than focused to ensure
that licenses are not issued to facilities
that fail to meet AWA standards as
required by 7 U.S.C. 2133.
We are making no changes to the rule
in response to this comment. During
prelicense inspections, USDA conducts
full and complete inspections of
applicant locations, animals, facilities,
vehicles, and equipment to assess
compliance with the AWA and
regulations. This process is not
changing under this final rule.
Several commenters supporting the
proposal disagreed with APHIS’ use of
‘‘teachable moments,’’ which, according
to commenters, are minor
noncompliances discovered during
inspections that APHIS does not
document on inspection reports. One
such commenter said that USDA has
implemented a variety of problematic
practices, including not recording
noncompliant items on any publicly
available reports. Another commenter
claimed that teachable moments were
developed to protect regulated entities
from public scrutiny for their
noncompliance and for this reason
licensing decisions are arbitrary and
capricious if based on documented
inspection reports only. The commenter
concluded that the USDA should
determine whether an applicant has
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demonstrated compliance based on the
full administrative record at the time of
the licensing application.
We are making no changes to the rule
in response to these comments because
what APHIS inspectors decide to
document as noncompliances during an
inspection is outside the scope of this
rulemaking. Furthermore, APHIS
inspectors do not use teachable
moments for prelicense inspections or
new site approval inspections. As noted
above, USDA conducts full inspections
of applicant locations, animals,
facilities, records, vehicles, and
equipment to assess compliance and
applicants must demonstrate
compliance with the Act and
regulations before a license will be
issued.
A few commenters stated that
prelicensing inspections should be
conducted without prior notification of
the facility to be inspected. One such
commenter expressed concern that
announced inspections may result in
the inspector having higher expectations
for a facility and not properly exercising
inspector discretion as referenced in the
inspection guide. Another commenter
noted that unannounced inspections are
common in other industries such as
restaurants.
We proposed no changes to the
requirement that prelicense inspections
must be scheduled during business
hours and at other times mutually
agreeable to the applicant and APHIS. In
addition to determining if an applicant
is in compliance with the AWA and
regulations, we wish to note that
interaction with APHIS staff during the
prelicense inspection is the best time for
applicants to learn more about
complying with the regulations. Also,
scheduled prelicense inspections allow
applicants to prepare files for review
and make personnel available for
prelicense inspections.
Several commenters opposed or
questioned the need for a prelicense
compliance inspection. One commenter
stated that APHIS already ensures
compliance through random inspections
as often as every 3 months for some
facilities, once a year for others, and
every 2 to 3 years for others. The
commenter added that for the small
number of facilities that are not in
compliance, APHIS already has the
authority to secure compliance through
a wide range of enforcement tools. The
commenter stated that conducting
prelicense inspections on top of its
existing random inspections for its
thousands of licensees is a waste of
limited resources and will strain the
Agency’s inspection capacity. One
commenter noted that if he is found to
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be in non-compliance, he is typically
provided a certain number of days to
correct the problem, after which his
premises are re-inspected to confirm
that the problem has been resolved. The
commenter asked why these
reinspections do not qualify as a
demonstration of compliance.
Other comments opposed the
prelicense compliance inspection on
grounds that it is unfair to facilities with
good histories of compliance. A
commenter suggested that businesses
with a continuous record of compliance
should receive fewer and fewer
inspections over time. Other
commenters cited a 2018 Animal Care
Impact Report showing that high
numbers of licensed sites have remained
in compliance and that there is no
significant burden posed by renewing
licenses annually. Another commenter
representing a marine mammal park
stated that APHIS has reported that 91
percent of the facilities accredited by
the Alliance of Marine Mammal Parks
and Aquariums were in compliance
with the AWA in 2018. Another
commenter noted that compliance is
checked through random inspections
and that the current methods are
successful at ensuring a zoological
facility’s compliance with the AWA
standards.
As we have noted previously, the
existing regulations did not require an
applicant for a license renewal to
demonstrate compliance before
renewing his or her license. The existing
regulations also did not require a
licensee to demonstrate compliance
when making any changes to his or her
animals or facilities, including
noteworthy changes in the number or
type of animals used in regulated
activity. However, based on our
experience with administering and
enforcing the Act and regulations, we
are concerned that licensees may
struggle to achieve and maintain
compliance after making such
noteworthy changes to their animals
used in regulated activity. In addition,
we have observed licensees who have
been licensed for many years may have
difficulties with compliance because
they did not have adequate programs for
maintaining compliance at aging
facilities. For these reasons, we consider
prelicense compliance inspections
important to ensuring animal welfare
under the AWA and regulations and are
adopting the changes as we proposed
them.
A commenter recommended that a
neutral review team, consisting of local
or State veterinarians, should be
included as part of the inspection
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process and review the conditions of
both the animals and animal housing.
We are making no changes to the rule
in response to this comment. The AWA
already authorizes the USDA to
cooperate with officials in various States
and subdivisions as necessary.9
Reinspections
In proposed § 2.3(b), we retained the
existing provision that an applicant who
fails the first inspection may request up
to two reinspections to demonstrate
compliance, but shortened the
timeframe in which the applicant must
request the second inspection, and if
applicable, the third inspection, to 60
days following the first inspection,
instead of the existing 90-day deadline.
Many commenters stated that license
applicants should receive two, not
three, chances to demonstrate
compliance with the law during
prelicense inspections. Several
commenters went further, stating that
two opportunities is excessive with
respect to existing license holders who
should have no uncertainties about
what the law requires. Another
commenter stated that the public
comments on the ANPR and the
proposed rule indicate that licensees are
taking advantage of the Agency’s
lenience, using both prelicense and
routine inspections as a means to learn
the animal husbandry standards
prescribed by the AWA gradually, at the
cost of both the animals and taxpayers.
The commenter recommended that we
provide only two prelicense inspection
opportunities, stating that this would
lessen the time and cost burdens on the
Agency and compel licensees to be more
responsive to addressing documented
noncompliances. Some commenters
asked us to not provide any second
chances to persons whose facilities are
not in compliance at the initial
inspection.
Our review of Animal Care records
indicates that few applicants actually
require three prelicensing inspections to
demonstrate compliance, but even those
applicants that require three
prelicensing inspections usually
complete the process within 90 days.
We encourage applicants to establish
contact and dialogue with their
inspector prior to requesting a
prelicensing inspection to make sure the
facility is in compliance. The AWA
regulations have long provided for three
prelicense inspections, and it will not
increase our regulatory burden to
maintain the availability of these
inspections. Therefore, we are making
no changes based on these comments.
97
U.S.C. 2145(b).
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Another commenter expressed
concern that there is no deadline for
APHIS to perform its first prelicense
inspection once it receives an
application for a new license. The
commenter noted that this lag could
cause the license application process to
stretch out indefinitely even if the
facility cannot demonstrate compliance
with the AWA.
Applicants for licenses have a strong
incentive to complete the prelicense
inspection process quickly so they can
obtain a license and engage in regulated
activity. Applicants who fail their first
prelicense inspection must request their
second inspection, and if applicable, the
third inspection, within 60 days
following the first inspection. Based on
our decades of experience in conducting
prelicensing inspections, we do not
anticipate the kind of delays envisioned
by the commenter.
To ensure that applicants can take full
advantage of the three prelicensing
inspections to demonstrate compliance
with the regulations and standards, we
stated in the preamble of the proposed
rule that we would encourage current
licensees to apply 4 months prior to the
expiration of their license.
A commenter requested that we
require, instead of ‘‘encourage,’’
reapplication filing 4 months prior to
current license expiration to allow for a
period of up to three inspections within
60 days and judicial appeal processing
of denials.
We are making no changes to the rule
in response to this comment. By
encouraging rather than requiring
reapplication 4 months prior to license
expiration, we are providing flexibility
to licensees without changing the
requirements for the inspection and
appeal processes.
We proposed in § 2.3(c) that should
applicants fail to demonstrate
compliance during the third prelicense
inspection, they can appeal the findings
of such inspection to the Deputy
Administrator within 7 days of
receiving the report. Should APHIS
reject an appeal, we would notify the
applicant of the Agency’s denial of the
license application. Within 30 days of
receiving such notice, an applicant may
request a hearing to contest the
Agency’s denial of the license
application. (Comments on hearings are
addressed under § 2.11 below.)
Citing animal welfare concerns, a
substantial number of commenters
disagreed with the provision to allow
applicants and license holders to
request a hearing if APHIS rejects an
appeal for the third failed inspection.
We are making no changes based on
the comments we received on this topic.
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As we noted in the proposed rule, we
included this provision to afford due
process protections for current
licensees.
A commenter recommended that the
last sentence of § 2.3(d) be changed to
state, ‘‘No license will be issued until an
affirmative demonstration of
compliance has been documented that
the applicant’s animals, premises,
facilities, vehicles, equipment,
locations, and records are in compliance
with all applicable requirements in the
Act and the regulations and standards in
this subchapter.’’
We are making no changes to the rule
in response to this comment. The
regulations already require that
applicants affirmatively demonstrate
compliance before a license will be
issued by APHIS.
Forfeiture of Application Fee
We proposed in § 2.3(d) that if an
applicant fails inspection or fails to
request reinspections within the 60-day
period noted in § 2.3(b), or if an
applicant fails to submit an appeal of
the third inspection report, the
applicant will forfeit the application fee
and cannot reapply for a license for 6
months from the date of the failed third
inspection or the expiration of the time
to request a third inspection.
One commenter noted that this
section indicates the failing applicant
will forfeit the application fee, but the
rest of the document indicates that there
will no longer be an application fee,
only a license fee. The commenter asked
us to clarify the application process
with regard to fees, particularly whether
the applicant pays the license fee at the
time of application.
In the proposed rule, we referred to
forfeiture of the application fee for
failure to pass the prelicensing
inspection or to request a reinspection
within 60 days. However, as we had
removed the application fee
requirement from § 2.1(c), our reference
to it was an oversight. We intended to
refer to forfeiture of the license fee and
will revise the section accordingly. The
applicant pays the license fee at the
time of application but forfeits the
license fee if he or she fails the
inspections, fails to request
reinspections within the 60-day period,
or fails to submit a timely appeal of the
third prelicense inspection report.
One commenter noted that proposed
§ 2.3(d) does not require applicants to
complete the inspection appeal process
before reapplying for a license, nor does
it require that they request all three
prelicense inspections. On the other
hand, the commenter noted that under
proposed § 2.11(b), applicants who have
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pursued all three prelicense inspections
and appeals but are still denied a
license may not be granted a license
within 1 year of their denial. The
commenter stated that if an applicant
intentionally fails to request additional
prelicense inspections and an appeal,
that applicant may reapply for a license
6 months sooner than a person who
after several efforts to remedy his or her
noncompliances was denied. The
commenter said that this discrepancy
would encourage persons with
significant noncompliances to forfeit the
license fee and reapply 6 months later,
instead of going through the appeals
process and working with APHIS to
address their violations. For this reason,
the commenter recommended that
APHIS change the waiting period for
reapplying for a license in § 2.3(d) from
6 months to 1 year from the date of the
failed third inspection or expiration of
the time to request a third inspection.
We appreciate the commenter’s
recommendation but are making no
changes to the rule in response. Every
applicant reapplying for a license must
demonstrate compliance with the Act
and regulations before a license is
issued.
Duration and Expiration of License
In the ANPR, we invited and received
a range of responses on whether we
should propose to establish a firm
expiration date for licenses (3 years, 5
years) and if so, what should that date
be and why. We noted in the proposed
rule that a large number of commenters
agreed with the example given in the
ANPR to have licenses expire with the
expectation that the issuance of a new
license would be contingent upon
affirmative demonstrations of
compliance with AWA regulations.
In the proposed rule, we included in
§ 2.5(a) the provision that licenses will
be valid and effective for a period of 3
years unless certain circumstances arise.
Consistent with the current regulations,
a license would not be valid if it has
been revoked or suspended, or if the
license is voluntarily terminated upon
request of the licensee.
A large number of commenters agreed
with our proposed action to eliminate
annual license renewals and to require
persons to apply for a new license every
3 years. However, many other
commenters with animal welfare
concerns considered a 3-year license
term to be too long, particularly for dog
breeders, arguing that 1 or 2 years
would be more appropriate. One
commenter stated that a longer
expiration window only works to assist
the chronically noncompliant facilities
in escaping consequences for their
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violations. Several commenters stated
that we should inspect premises
housing dangerous and exotic animals
annually to verify compliance, and that
once every 3 years is insufficient for
these premises. Another commenter
opposing a licensing period of 3 years
stated that such an approach would
allow a facility to fall out of compliance
between prelicense inspections,
resulting in dangerous conditions for all
animals at the facility while the licensee
continues to have applications approved
based on a show of compliance every 3
years. The commenter asked APHIS to
amend its regulations to ensure that
facilities with a history of substantial
noncompliance, during either the
prelicense or license periods, are not
issued new licenses and are prohibited
from re-applying for new licenses for a
period of at least 3 years.
We are making no changes to the rule
in response to these comments. In
addition to requiring that applicants
demonstrate compliance before
obtaining a 3-year license, APHIS
routinely conducts unannounced
inspections of licensees, as well as
complaint-based inspections and
inspections in which frequency is based
on determination of risk. If an APHIS
inspector identifies noncompliances
during these inspections, we may take a
number of actions in response to
promote compliance, including offering
enhanced compliance support, issuing
official warnings and other regulatory
correspondence, and pursuing penalties
and other sanctions after notice and the
opportunity for a hearing.
Many commenters opposed to the
proposal stated that APHIS lacks the
authority under the AWA to set an
expiration date on a license and that the
proposed rule is only an attempt to
bring about license removals. A
commenter asked how APHIS can
justify making someone start over in an
application process for a license for the
same facility and animals, even though
the facility is in compliance and has
been for several years. Similarly, other
commenters stated that placing a
permanent expiration date on current
licenses, then requiring licensees to go
through the entire initial licensing
procedure upon expiration would be
time-consuming and duplicative.
Several of these commenters noted that
there are current and successful license
renewal processes already in place.
As we noted in the proposed rule, all
licenses currently have expiration
dates—they expire 1 year after issuance,
and may be renewed annually. This rule
extends the period of licensure to 3
years but requires a license application
and demonstration of compliance prior
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to the issuance of a new license. We also
noted that the proposed rule is
consistent with section 2133 of the Act,
which prohibits the issuance of a
license until the dealer or exhibitor has
demonstrated that his facilities comply
with the standards promulgated by the
Secretary pursuant to section 2143 of
the Act. Section 2133 of the Act also
gives the Secretary the authority to issue
licenses to dealers and exhibitors upon
application in such form and manner as
he may prescribe, which includes the
authority to set expiration dates for
those licenses.
Some commenters opposing the rule
stated that setting a permanent
expiration date on a license and
requiring exhibitors to reapply 4 months
in advance would cause serious
hardships for traveling exhibitors. One
commenter said that exhibitors would
be forced to be at their home location in
order to have a prelicense inspection,
and that depending upon their renewal
date would incur costly travel expenses
to return home or to not book exhibits
for up to 4 months to accommodate this
process.
We are not making any changes to the
rule in response to this comment.
Although we encourage applicants to
take full advantage of the prelicense
inspection process by applying 4
months prior to the expiration date of
their license, it is not required, nor do
we anticipate that most applicants will
need the full time to complete the
process. A review of Animal Care
records indicates that few applicants
require three prelicensing inspections to
complete the process, but even those
applicants that require three
prelicensing inspections usually
complete the process within 90 days.
Finally, we also note that prelicense
inspections are scheduled at times that
are mutually agreeable to applicants and
APHIS.
Some commenters representing zoos
and aquariums stated that the proposal
to require exhibitors to apply for a new
license every 3 years would drastically
increase litigation costs borne by these
businesses. One such commenter said
that by proposing to switch from a
system of annual renewals to a new
license requirement, APHIS is enabling
litigation from activist groups that
disagree with the conclusions of APHIS
inspectors regarding prelicense
inspections and AWA compliance,
resulting in substantial legal costs for
both APHIS and exhibitors. The
commenter added that APHIS’
rulemaking proposal is unnecessary
because, as the Federal courts have
held, APHIS already has ample
authority under the AWA to bring
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enforcement actions against licensees
whose compliance performance slips.
As the commenter notes, APHIS has
authority under the AWA to enforce the
regulations on licensees in
noncompliance and will do so as
warranted. However, we disagree with
the commenter and consider the
proposed changes to licensing to be
necessary because the existing
regulations do not require an applicant
for a license renewal to demonstrate
compliance before renewing his or her
license, nor do they require a licensee
to demonstrate compliance when
making any changes to his or her
animals. APHIS has observed licensees
who have been licensed for many years
struggle with compliance because they
did not have adequate programs for
maintaining compliance at aging
facilities. We determined that in order
to reduce risks to animal welfare and
the public, licensees should be required
to demonstrate compliance and obtain a
new license to ensure that aging
facilities remain in compliance. For
applicants who have a history of
compliance, they should be able to
confidently demonstrate compliance
during the initial prelicense inspection,
generating a record that will be
defensible in any subsequent litigation.
In addition, APHIS already conducts
prelicensing inspections for new
applicants and risk-based inspections
for current licensees, and neither our
process for evaluating compliance nor
our goal of ensuring compliance with
the regulations has changed as a result
of the proposal. Substantial changes in
litigation rates or outcomes are not
anticipated. Therefore, we are making
no changes to the rule in response to
these comments and are adopting the
changes as proposed.
Some commenters representing
marine mammal exhibition facilities
stated that such facilities are
permanently situated and require an
extensive financial commitment to
develop and maintain, and that they are
inspected and approved by APHIS prior
to animals ever residing in them. One
commenter noted that the consequences
of a denial of a new license for an
existing licensee over what may be a
minor noncompliant item could be
devastating and far-reaching. The
commenters asked that we reconsider
our proposed requirement for new
licenses.
We are making no changes in
response to this comment. As noted
above, we encourage applicants to
initiate the application process 4
months prior to the expiration date of
their license to allow them the
opportunity to take full advantage of the
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prelicense inspection process. If a
noncompliance—especially a minor
noncompliance, as raised by the
commenters—is discovered during the
initial prelicense inspection, the
applicant will have two more
opportunities to correct the deficiency,
demonstrate compliance, and obtain a
license, thus ensuring continuity of
their business operations.
A commenter asked whether the
proposed changes would require new
licenses more often as a facility ages.
No, the period of licensure will be 3
years for all licensees in compliance,
regardless of the age of the facility.
Proposed § 2.5(a) states that licenses
will be valid and effective for 3 years,
with several exceptions. One exception,
in § 2.5(a)(1), is if the license has been
‘‘revoked or suspended pursuant to
section 19 of the Act.’’ A commenter
suggested that we add ‘‘or these
regulations’’ to the end of this
exception.
We are making no changes to the rule
in response to this comment. The
provisions of the rule regarding license
suspensions and revocations are
authorized by section 19 of the Act and
its implementing regulations.
In the proposed rule, we removed and
reserved § 2.6, which contained license
provisions. We received a comment
about the implications of removing
these provisions from the regulations.
The commenter noted that § 2.6
includes the statement that people
meeting the requirements for more than
one class of license are licensed for their
predominant business. The removed
section also includes a requirement for
both lessors and lessees to be licensed.
The commenter stated that if this
section is deleted, that information
needs to be addressed elsewhere in the
regulations.
We are not making any changes to the
rule in response to this comment. The
definitions Class ‘‘A’’ licensee (breeder),
Class ‘‘B’’ licensee, and Class ‘‘C’’
licensee (exhibitor) specify which
category of license a person should
apply for based on their business
activities. Lessors and lessees that meet
the definition of dealer, and do not fall
under one of the exemptions from the
licensing requirements, continue to
require a license under the AWA
regulations.
Temporary Licenses
We received numerous comments in
both the ANPR and the proposed rule
on the issuance of temporary licenses
for those licensees who may suffer a
lapse in licensure during the relicensing
process. We proposed in § 2.5(a)(3)(i) to
include flexibilities for issuing
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temporary licenses to licensees with
histories of compliance to ensure they
have ample time to apply for licenses
and demonstrate compliance prior to
the expiration of an existing license.
Substantial numbers of commenters
opposed our proposal to grant
temporary licenses on grounds that they
give licensees in noncompliance
additional time to operate. One such
commenter stated that the Act is clear
that USDA cannot provide for
temporary licenses unless it has a
process through which the facility
demonstrates compliance with the
AWA. The commenter stated that the
proposed rule presumably tries to
account for this problem by authorizing
temporary licenses for facilities showing
a ‘‘history of compliance’’ for the prior
licensing period. However, the
commenter said that this ‘‘history of
compliance’’ standard is inadequate
because facilities are not required to be
inspected every year, and noted that the
most recent inspection report may be
over 2 years old by the time the licensee
applies for a new license. Similarly,
another commenter stated that allowing
an applicant to remain in business
based solely on prior inspection reports
is an abuse of discretion.
We disagree with the commenters and
note that we base determinations of
compliance not only on the history of
compliance but on actual inspections.
We employ a risk-based inspection
system that calls for more frequent
inspections at facilities with a higher
risk of animal welfare concerns and
fewer inspections at those that
consistently demonstrate compliance.
Several commenters opposed to
temporary licensing said that USDA
lacks statutory authority to issue
temporary licenses.
The AWA authorizes USDA to issue
licenses to dealers and exhibitors upon
application in such form and manner as
he may prescribe and upon payment of
applicable fees, provided that no such
license shall be issued until the dealer
or exhibitor has demonstrated
compliance with the AWA regulations.
Under this rule, the Deputy
Administrator of Animal Care may issue
a temporary license that automatically
expires after 120 days to an applicant
whose immediately preceding 3-year
license has expired if the applicant
submits the appropriate application
form before the expiration date of the
preceding license and has had a history
of compliance with the AWA and
regulations during the preceding period
of licensure. These requirements are
authorized by the AWA and fall within
USDA’s authority to issue licenses.
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Another commenter expressed
concern that a temporary license would
be perceived as an indicator that the
facility under temporary licensure is
somehow inferior with respect to animal
welfare, and that this could have
negative consequences from a business
perspective.
Only licensees with extended
histories of compliance with the AWA
are eligible for a temporary license.
APHIS makes no distinction between a
3-year license certificate number and a
temporary license certificate number.
Several licensees who commented on
the rule expressed concern that their
license could expire before APHIS is
able to inspect their facility to verify
compliance for a new license. One such
commenter stated that it is unreasonable
to believe that APHIS will issue every
license prior to expiration and asked
what would happen in such a case.
We have considered the implications
of issuing new licenses to licensees as
their licenses expire and how to best
address the concerns expressed by
commenters. Accordingly, we have
adjusted the effective date of the rule for
the licensing provisions and will
conduct a gradual, phased-in
implementation based on license
expiration dates for current licensees.
We believe this approach will ensure
that adequate resources are
continuously available to conduct
prelicense and routine inspections
under the AWA. In the event that the
licensee submits a timely application
and has no noncompliances
documented in any inspection report
during the preceding period of
licensure, and APHIS does not conduct
the prelicense inspection before a lapse
in licensure, we have the ability to issue
a temporary license to that applicant.
One commenter asked if breeders
with lapsed licenses would be
prohibited from selling puppies until
the inspection for a new license is
completed, noting that such a lapse in
operations could result in them having
puppies that are too old to sell to
brokers and pet stores.
A person without a valid license is
prohibited from selling puppies or
engaging in any other activities
regulated under the Act until they
obtain a valid license. As mentioned
above, persons with an existing license
are encouraged to apply for a new
license up to 4 months prior to the
expiration of their license so they can
take full advantage of the prelicense
inspection process. The Deputy
Administrator would issue a temporary
license as long as the applicant meets
the criteria of submitting the application
for a new license before the preceding
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license expires and there are no
noncompliances cited during the period
of the preceding licensure. A temporary
license, valid for up to 120 days, would
be issued.
A commenter suggested that APHIS
consider multiple preceding periods of
licensure for purposes of granting
temporary conditional licenses in order
to strengthen the possibility that the
Agency is reviewing an accurate picture
of a facility’s compliance.
We are making no changes to the rule
in response to this comment. We believe
that a licensee that maintains
compliance with the regulations for a 3year period of licensure should be
eligible for a temporary license in the
event of an inadvertent lapse in
licensure. We note that the temporary
licenses are of limited duration and the
person would need to demonstrate
compliance before obtaining a new 3year license.
One commenter stated that for
licensees with a history of compliance
there is no need for developing new
regulations for a temporary license
process when the current regulation for
renewal could be amended to
accommodate licensees with a history of
compliance.
We are making no changes in
response to the rule in response to this
comment. As discussed above, the
existing regulations did not require an
applicant for a license renewal to
demonstrate compliance before
renewing his or her license. The existing
regulations also did not require a
licensee to demonstrate compliance
when the licensee makes any
subsequent changes to his or her
animals or facilities, including
noteworthy changes in the number or
type of animals used in regulated
activity. In addition, we have observed
licensees who have been licensed for
many years struggle with compliance
because they did not have adequate
programs for maintaining compliance at
aging facilities. For these reasons,
amending the current renewal process
to accommodate certain licensees would
not achieve the purpose of
demonstrating compliance as a
condition of licensure.
One commenter suggested that a
license extension could be allowed in
the case of a natural disaster, or when
a licensee has submitted the required
paperwork at least 3 months in advance
of expiration and whose past
inspections documented no
noncompliances.
We agree that a temporary license
may be issued to an applicant whose
immediately preceding 3-year license
has expired if the person submitted the
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application form before the expiration
date of a preceding license and the
applicant had no noncompliance with
the AWA and regulations documented
in an inspection report during the
preceding period of licensure. We do
not limit the causes for the inadvertent
lapse, and one such cause could be a
natural disaster.
A commenter asked whether ‘‘an’’
should actually be ‘‘any’’ in
§ 2.5(a)(3)(i)(B). The commenter pointed
out that the way the proposed provision
is worded, if an applicant had one
inspection report with no instances of
noncompliance, he or she would
qualify, even if he or she had two others
with critical noncompliances.
We agree with this comment and have
corrected the wording accordingly.
The same commenter observed that in
proposed § 2.5(a)(4), there ‘‘will not be
a refund of the license fee if a license
is denied, terminated, suspended, or
revoked prior to its expiration date,’’ but
noted that this language refers to a
license fee, not an application fee. The
commenter suggested adding ‘‘or’’ after
‘‘denied’’ in that sentence, explaining
that a license cannot be denied prior to
its expiration date because there is no
expiration date (i.e., no license to
expire) if the license is denied.
We agree that adding ‘‘or’’ after
‘‘denied’’ will clarify the sentence and
have made that change in this final rule.
As noted above, this final rule removes
the application fee, so we are making no
other changes in response to this
comment.
Suspensions and Revocations
In the ANPR, we asked for comment
on whether persons whose license has
been suspended or revoked should be
prohibited from engaging in other
activities involving animals regulated
under the AWA, such as working for
other AWA-regulated entities or using
other individual names or business
entities to apply for a license. We also
asked for comment on whether such
prohibitions should extend to officers,
agents, and employees of persons with
suspended or revoked licenses. A
majority of persons commenting on the
ANPR expressed strong support for the
suggested regulatory provision for
license applicants to disclose incidences
of violations and convictions involving
animal-related laws. Persons
commenting on the proposed rule also
supported disclosure of violations and
‘‘no contest’’ pleas as a requirement.
We proposed in § 2.9 that any person
who has been or is an officer, agent, or
employee of a licensee whose license
has been suspended or revoked and who
was responsible for or participated in
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the activity upon which the suspension
or revocation was based will not be
licensed, or registered as a carrier,
intermediate, handler, exhibitor, or
research facility within the period
during which the order of suspension or
revocation is in effect.
A commenter stated that additional
language is required to address the cited
licensees’ family members who may not
fall under the legal definition of
employee, agent, or officer.
We are making no changes to the rule
in response to this comment. Family
members who are authorized to act on
behalf of the licensee and who are
responsible for or participated in the
activity upon which the suspension or
revocation was based would fall within
the meaning of an ‘‘agent’’ and be
subject to this provision.
A commenter representing an animal
welfare advocacy organization suggested
that the Welfare of Our Friends Act, or
WOOF Act, which would amend the
AWA to prohibit the issuance of
licenses to immediate family members
and business partners of animal dealers
who had their licenses revoked,
provides clear and unambiguous
language that should be used in this
proposed provision.
The WOOF Act is proposed
legislation and has not been enacted.
The authority for this final rule is the
AWA. We note that § 2.9 already covers
immediate family members and
business partners of animal dealers who
may have been officers, agents, or
employees of the licensee. If these
persons have not participated in the
activity upon which the order of
revocation or suspension was based,
APHIS has no grounds to deny them a
license. Therefore, we believe that the
proposed rule language is sufficient and
are making no changes to the rule in
response to this comment.
One commenter supported this
provision but recommended carving out
exceptions for those with specialized
skills but may not have been directly
involved in prior violations of the AWA,
when their talents are needed due to
lack of other qualified individuals.
We are making no changes to the rule
in response to this comment. If a person
was not responsible for or did not
participate in the activity upon which
the suspension or revocation was based,
this provision would not apply to them.
A commenter agreed with the
proposed provision in § 2.9 to deny
licenses to officers, agents, and
employees of a licensee whose license
has been suspended or revoked and who
was responsible for or participated in
the activity upon which the suspension
or revocation was based. The
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commenter said that APHIS has the
authority to interpret what constitutes
‘‘participation,’’ such that if an officer,
agent, or employee somehow promoted,
aided in, or acted in furtherance of the
adverse activity, without actually
participating in the violation, APHIS
may still prevent that person from
getting their own license when
appropriate. To underscore this point,
the commenter encouraged APHIS to
strengthen § 2.9 by assessing each
participant’s non-eligible period on a
case-by-case basis and based on their
personal history, with the possibility of
that non-eligible period for that person
extending past the original licensee’s
period of suspension or revocation.
We are making no changes to the rule
in response to the comment. Periods of
suspension and revocation are assessed
by USDA administrative law judges
after notice and opportunity for a
hearing, or through a settlement
agreement. We do note that revocation
is permanent, so the period of
revocation is a person’s lifetime.
Accordingly, there is no longer period of
time that could be assessed for the
revocation of a license. In addition,
APHIS is authorized to deny a new
license when an applicant has been
determined to be unfit by the Secretary
as stated in § 2.11(a)(5) of the amended
regulations.
A commenter stated that APHIS must
ensure that existing licensees cannot
add, as an additional location on that
license, a facility or site associated with
a revoked or suspended license, and
that a licensee who seeks to do so
should not be found eligible for a new
license.
We are making no changes to the rule
in response to this comment. As noted
above, licenses are issued to specific
persons, and are issued for specific
activities, animals, and approved sites.
Under proposed § 2.1(b)(1), if an
existing licensee in good standing seeks
to acquire an additional location, he or
she would first need to notify APHISAnimal Care no fewer than 90 days
before the change and obtain a new
license. We note that seeking to add a
location associated with a license
revocation or suspension is not in itself
grounds for denying a license to a
person seeking such a location, but
rather depends on the specific terms of
a suspension or revocation associated
with a location. These terms are
contained in orders issued by
administrative law judges or settlement
agreements entered into by APHIS and
involved persons.
A commenter opposing the rule stated
that this provision violates the Equal
Employment Opportunity Act, as the
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government cannot prevent employers
from hiring who they wish to employ.
We are making no changes to the rule
in response to this comment. The Equal
Employment Opportunity Act is the act
which gives the Equal Employment
Opportunity Commission authority to
sue in Federal courts when it finds
reasonable cause to believe that there
has been employment discrimination
based on race, color, religion, sex, or
national origin. This rule in no way
discriminates based on these factors.
Licensees Whose Licenses Have Been
Suspended or Revoked
In the proposed rule, we revised
§ 2.10 to strengthen prohibitions against
licensees whose licenses have been
suspended or revoked from engaging in
AWA-regulated activities.
Several commenters asked that APHIS
prevent persons with histories of
noncompliance from playing a ‘‘shell
game’’ of applying for new licenses
under different names or businesses.
We are making no changes to the rule
in response to this comment. Licenses
are issued to specific persons for
specific premises. If a person (for
example, a corporation) dissolves and
forms a new legal entity, the person
must apply for a new license. We
believe this commenter is concerned
about a licensee with a suspended or
revoked license applying for a new
license under a new name in order to
work around sanctions and resume
operations. However, a person may be
held liable for violations and subject to
penalties and other sanctions, even if
they no longer hold a license, or hold
a license in a different name.
Section 2.10(c) states that persons
with suspended or revoked licenses
shall not buy, sell, transport, exhibit, or
deliver for transportation, any animals
during the period of suspension or
revocation. A few commenters
recommended that we add ‘‘maintain’’
to the list of prohibited actions.
The maintenance of animals on the
property of a licensee whose license is
suspended or revoked depends on the
specific terms of a suspension or
revocation. These terms are contained in
orders issued by administrative law
judges or settlement agreements entered
into by APHIS and involved persons.
We are therefore making no changes to
the rule in response to this comment.
Denial of License Application
In the proposed rule, we discussed
responses to the ANPR from many
commenters expressing support for
streamlining procedures for denying,
terminating, and summarily suspending
a license. In proposed § 2.11(a), we
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added several grounds for denying a
license to an applicant, including failure
to comply with the Act or regulations,
license suspension or revocation, a no
contest plea or violation of laws or
regulations pertaining to animal cruelty,
or false statements to USDA pertaining
to animal welfare. A license may also be
denied if the Administrator determines
that circumstances render the applicant
unfit to be licensed or if issuance of a
license would be contrary to the
purposes of the AWA.
A commenter stated he does not
support streamlining the procedures for
denying a license application,
terminating a license, and summarily
suspending a license. The commenter
asked if there is an official definition for
‘‘streamlining’’ and whether it actually
involves revoking a license without due
process.
The AWA and this final rule provide
ample due process to persons whose
license has been denied, terminated,
summarily suspended, and revoked. For
example, a person whose license has
been revoked was provided with the
opportunity for a hearing. Therefore, we
are making no changes to the rule in
response to this comment.
A commenter proposed that APHIS
should automatically deny licenses to
applicants who have three or more
direct or critical violations during the
prior 3-year period, or have five or more
repeat violations during the prior 3-year
period, as defined in the Animal
Welfare Inspection Guide. The
commenter stated that whatever
standard APHIS adopts, it should result
in automatic denial of license
applications from facilities that have
accumulated dozens of repeat violations
that affect animal welfare over the last
3-year period. The commenter
additionally suggested that if a State
license was denied or rescinded then
the USDA license should be denied or
rescinded as well.
We believe the commenter is referring
to noncompliances rather than
violations, as noncompliances are based
on the observations and professional
judgments of inspectors. Section
2.11(a)(7) does provide grounds for
denying a license if an applicant is
determined to be unfit to be licensed
and the Administrator determines that
the issuance of a license would be
contrary to the purposes of the Act.
However, we realize that not every
noncompliance occurring during a
previous period of licensure makes a
person unfit to hold a license. For this
reason, we are making no changes to the
rule based on these comments.
In proposed § 2.11(a)(5), we
conformed with the proposed 3-year
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period of licensure the length of time
during which an applicant shall be
denied a license due to a nolo
contendere (no contest) plea or finding
of a violation of any Federal, State, or
local laws or regulations pertaining to
animal cruelty. We also continued to
retain the proviso that a license may
also be denied for such violations after
3 years if the Administrator determines
that the circumstances render the
applicant unfit to be licensed.
A commenter said that the proposal
does not go far enough to prevent
convicted animal abusers from
continuing to abuse animals and
recommended that we deny an
application if the applicant or licensee
has been convicted of an animal welfare
related law during the previous 10
years.
We are making no changes to the rule
in response to this comment because
proposed § 2.11(a)(5) already provides
APHIS with the authority to deny a
license if the applicant has been found
to have violated animal cruelty laws
within 3 years of application, as well as
after 3 years if the Administrator
determines the circumstances render the
applicant unfit to be licensed.
Appeal of License Denial
We proposed in § 2.11(b) to allow an
applicant without a license whose
initial application has been denied to
request a hearing for the purpose of
showing why the application for license
should not be denied. Should the denial
be upheld, we proposed that the
applicant may again apply for a license
1 year from the date of the final order
denying the application. We also
proposed allowing an applicant who
holds a valid license at the time he or
she submitted the application that has
been denied, and who submitted a
timely appeal of the inspection findings
from the third prelicense inspection as
indicated in § 2.3, to request an
expedited hearing before a USDA
Administrative Law Judge, with the
license remaining in effect until an
initial decision is rendered. We noted in
the proposal that this provision is
intended to afford adequate due process
protections to current license holders,
while maintaining proper regard for the
policy of Congress to ensure the humane
care and treatment of animals covered
under the Act.
A commenter noted that the USDA’s
administrative law judge system is
overburdened and can take years to
resolve AWA matters, and suggested
that the USDA not provide hearings for
the denial of license applications but
adopt informal hearing standards
similar to those for license suspension
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and revocation. The commenter added
that informal hearings would further the
purposes of the AWA and reduce
regulatory burdens. Other commenters
stated that the provision to allow
licensees whose applications have been
denied to seek a hearing will only
prolong animal suffering and delay
justice, and added that the law does not
require that they receive a hearing. One
such commenter stated that the AWA
does not call for a hearing ‘‘on the
record’’ and contains no other language
that would trigger the Administrative
Procedure Act’s formal adjudication
requirements. Other commenters stated
that licensees already have many
opportunities to challenge and correct
findings of noncompliance without
having to resort to a hearing.
We are making no changes to the rule
in response to these comments. As
noted above, we believe the provisions
will provide due process protections,
and are actually similar to those for
license termination, suspension, and
revocation, which also require notice
and the opportunity for a hearing before
a license can be terminated, suspended,
or revoked.
A commenter asked APHIS to revise
the language in 9 CFR part 4, ‘‘Rules of
Practice Governing Proceedings Under
the Animal Welfare Act,’’ to reflect the
full authority given to the Secretary by
the AWA and develop and implement a
process for promptly providing a notice
and opportunity for a hearing so
additional suspensions can be instituted
more quickly. The commenter noted
that while the Act provides the
Secretary with the authority to
temporarily suspend a license for up to
21 days and after notice and
opportunity for a hearing to suspend the
license for an additional period, the
current language in part 4, subpart B, of
the regulations only refers to a
temporary 21-day suspension and not to
the possibility of extending that
suspension. The commenter also asked
us to review our stipulation process
under ‘‘Subpart B—Supplemental Rules
of Practice,’’ to determine whether
agreed upon license forfeitures would
help ensure compliance and animal
welfare.
We appreciate the commenter’s
request but are making no changes in
response. We proposed no changes to
the regulations in part 4 or to the
USDA’s Rules of Practice governing
administrative enforcement
proceedings. Therefore, this comment
falls outside the scope of this
rulemaking.
A commenter stated that the last line
of proposed § 2.1(b)(2)(ii), which states
that ‘‘a licensee must obtain a new
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license before using any animal beyond
those animals authorized under the
existing license,’’ needs to be clarified.
We agree with the commenter that
this provision could more clearly
communicate our intent, which is that
licensees who wish to use animals not
authorized on their license will need to
obtain a new license before additional
types or numbers of animals may be
used for regulated purposes.
Accordingly, we are amending the last
line of § 2.1(b)(2)(ii) to read ‘‘A licensee
must obtain a new license before using
any animal beyond those types or
numbers of animals authorized under
the existing license.’’ Similarly, we are
amending proposed § 2.1(b)(1) to clarify
that licenses are issued for specific
types and numbers of animals.
One commenter stated that the right
of appeal for persons in noncompliance
with the AWA regulations is based on
an erroneous interpretation of the law
and the Constitution. The commenter
questioned our statement in the
proposed rule that allowing licensees
whose renewal applications are denied
for failure to demonstrate compliance to
keep their licenses pending a formal
hearing affords ‘‘constitutionally
mandated due process protections.’’
As we noted in the proposed rule, the
right to a hearing is intended to afford
due process protections to current
license holders, while ensuring the
humane care and treatment of covered
animals in accordance with the AWA.
By providing licensees with the
opportunity to appeal a noncompliance
documented on an inspection report, we
are able to consider facts that may not
have been available to the inspector at
the time of inspection and therefore to
ensure that the USDA has all available
information.
Several commenters asked that we
revoke the license of a person during
any ongoing appeals process. One such
commenter stated that animals should
not be permitted to remain with their
custodian when that person has violated
health and care requirements, and
should be sent to a sanctuary instead.
We are making no changes to the rule
in response to this comment, as a
license can only be revoked after notice
and opportunity for a hearing. A license
remains in effect until its expiration
date or a final decision is rendered by
an administrative law judge. We do note
that USDA has separate authority to
confiscate animals that are in a state of
suffering, after notifying the licensee
and providing him or her the
opportunity to correct the condition.
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Termination of License
Proposed § 2.12 states that, after a
hearing, a license may be terminated at
any time for any reason that a license
application may be denied pursuant to
§ 2.11. We proposed to remove a
reference to the license renewal process
in the current regulations because the
renewal option no longer exists.
A commenter expressed concern that
under proposed § 2.12, a teachable
moment reported as an instance of
noncompliance could result in license
termination. The commenter added that
although there are judicial safeguards in
the process, terminating a license under
those circumstances would be a gross
miscarriage of justice. Instead, the
commenter recommended amending
§§ 2.1(d) and 2.12 to specifically exempt
minor instances of noncompliance as
the basis of a license revocation unless
they are repeated.
Section 2.11(a)(7) provides grounds
for denying a license if an applicant is
determined to be unfit to be licensed
and the Administrator determines that
the issuance of a license would be
contrary to the purposes of the Act.
However, as the commenter notes,
APHIS inspectors do engage in
teachable moments with licensees, in
which inspectors point out minor
noncompliances and explain how they
can be corrected. Current and proposed
procedures do not require termination
of a license for these minor
noncompliances. For this reason, we see
no need to change the regulations as
requested by the commenter.
Appeal of Inspection Report
In proposed § 2.13, we noted that any
licensee or registrant may appeal
inspection findings in an inspection
report to the Deputy Administrator
within 21 days of the date the licensee
or registrant received the inspection
report.
One commenter, while not opposed to
this provision, suggested that when a
licensee’s inspection appeal is
successful, the public has the right to
know the nature of the disputed
violation and that an appeal was
undertaken. Accordingly, the
commenter stated that APHIS should
include assurances that we will publicly
disclose that the findings in an
inspection report have been appealed.
Additionally, the commenter stated that
all inspection reports that are corrected
based on appeals must be properly
labeled as such and shared with the
public.
We are making no changes to the rule
in response to this comment because it
falls outside the scope of this
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rulemaking. Separate Federal laws
govern the release of information and
documents to the public that are
controlled by the U.S. Government,
such as the Freedom of Information Act
(FOIA).
Another commenter observed that
§ 2.13 provides a right to a licensee or
applicant to appeal the individual
findings within an inspection report
distinct from an applicant’s ability to
appeal a denial of their license. The
commenter expressed concern that some
applicants may perceive these rights not
separately but as an additional step
within the appeals process, allowing
them to appeal inspection findings and
delay the license denial process. The
commenter suggested that APHIS add
language to § 2.13 stating that, ‘‘Under
no circumstances shall this section be
interpreted as tolling the period of time
by which a licensee or license applicant
must seek an appeal or request further
prelicense inspections.’’
We are making no changes to the rule
in response to this comment. The
procedures for appealing an inspection
report and requesting a hearing in
connection with the denial of a license
are distinctly separate processes.
Publication of Licensee Information
We proposed to amend § 2.38,
‘‘Miscellaneous,’’ by eliminating the
statement in paragraph (c) that we will
publish lists of research facilities in the
Federal Register and replacing it with
the statement that we will publish such
lists on the APHIS website instead.
A few commenters agreed with our
proposal to publish the lists of research
facilities online but suggested that
APHIS emphasize in the regulations that
the lists will be available on its website.
We believe the rule is sufficiently
clear that the lists will be published on
APHIS’ website and that copies of the
lists can also be obtained upon request
from the Deputy Administrator.
Therefore, we are making no changes to
the rule in response to this comment.
One commenter disagreed with our
proposal to remove the statement that
APHIS will publish lists of research
facilities in the Federal Register and
stated that APHIS is making it difficult
to locate the lists.
It is not APHIS’ intent to make the
lists difficult to locate. Indeed, we
believe making the lists available on our
website 10 makes them easier to find. As
is currently the case, interested parties
may continue to request the list from the
Deputy Administrator.
10 https://www.aphis.usda.gov/aphis/ourfocus/
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We also proposed to amend § 2.127,
‘‘Publication of names of persons
subject to the provisions of this part,’’
by replacing ‘‘names’’ in the section
heading with ‘‘lists,’’ and by removing
the statement that the list will be
published in the Federal Register. We
are making these changes to reflect
current business practices of publishing
information on public websites for ease
of access as well as our practice of
maintaining and updating a list of
registered research facilities on the
APHIS website.11
Substantial numbers of commenters
expressed concern about Agency
transparency with respect to making the
names of licensees, breeders, and
research facilities available to the
public, and many asked that we ensure
that licensee records are available for
public review. Some commenters
opposed the proposed change to § 2.127,
which would strike ‘‘names’’ and
replace it with ‘‘lists.’’ One such
commenter stated that the term ‘‘lists’’
is ambiguous and does not express how,
if at all, the Agency intends to identify
registrants or licensees.
As noted above, APHIS maintains a
list of licensees and registrants on its
website. By replacing the word ‘‘names’’
with ‘‘lists,’’ we are making clear that
the list may include additional
information beyond just the name of the
licensee and registrant, such as the city
and State where they are located and the
type of license or registration that
person holds. We are therefore making
no changes to the rule in response to
this comment.
One commenter stated that the final
rule should expressly state what
licensee information the USDA will
share with the public. Another
commenter requested that APHIS
continue to publish identifying
information for all persons licensed or
registered under the AWA, including
the following: Certificate/customer type,
legal name, doing business as (DBA)
name, city, and State, and to affirm this
in § 2.127.
APHIS is undertaking this change to
reflect both current business practices of
publishing information using public
websites for ease of access, and the
Agency’s practice of maintaining and
regularly updating a list of registered
research facilities on the APHIS website.
Currently, APHIS lists the legal name of
the licensee or registrant, any DBA
name associated with that person, the
city and State where they are located,
and the type of license or registration
the person holds. Therefore, we are
11 https://www.aphis.usda.gov/aphis/ourfocus/
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making no changes in response to these
comments.
A commenter asked APHIS to include
in its publication a disclosure
requirement for all ‘‘formerly known as’’
names associated with an existing
licensee or registrant to ensure full
transparency. The commenter,
representing an animal welfare
organization, added that it is necessary
to have access to unredacted inspection
reports so the organization can follow
up on complaints and incidents and
determine whether APHIS has
identified specific animal care
deficiencies at such locations.
We are making no changes to the rule
in response to this comment. We
publish the list of licensees and
registrants so that the public can know
who currently holds a license or
registration under the AWA. Whether a
person previously held a license, and
what name they held that license under,
is immaterial to this purpose. Members
of the public can request inspection
reports under FOIA by submitting a
request online at: https://
www.aphis.usda.gov/aphis/resources/
foia/ct_how_to_submit_a_foia_request.
All releases of information are subject to
applicable FOIA laws and appropriate
handling of protected personal
information. APHIS releases
information that meets all appropriate
FOIA and protected personal
information restrictions.
A commenter asked that we use and
retain a permanent identifying number
for each regulated entity regardless of
issuance of a new or subsequent license.
The commenter stated that use of an
assigned number not publicly linked to
any other identifying information will
mitigate any concerns the USDA has
about maintaining privacy interests. The
commenter stated that this number
should be included on all publicly
released AWA-related records in order
to allow public monitoring of the
USDA’s implementation of the Act,
including the ability to track whether
the USDA is following its own
inspection and enforcement policies.
This comment pertains to APHIS’
internal business processes and is
outside the scope of this rulemaking.
Therefore, we are making no changes to
the rule in response to this comment.
A commenter asked the USDA to stop
redacting licensee identities and
withholding records about enforcement
actions and adjudication proceedings.
The commenter said that the public
cannot determine whether USDA is
complying with the licensing
requirements if it redacts licensee
information from inspection reports.
Another commenter stated that APHIS
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needs to ensure that the additional
licensee information required by the
rule will be made public in accordance
with the precedent the Agency itself
persuaded the D.C. Circuit to establish
in Jurewicz v. U.S. Department of
Agriculture, 714 F. 3d 1326 (2014).
Public access to records held and
maintained by the U.S. Government is
outside the scope of this rulemaking,
but all released records meet all
applicable FOIA and personally
identifiable information restrictions.
Therefore, we are making no changes to
the rule in response to this comment.
Importation of Live Dogs
We proposed to amend the
regulations for importing live dogs in
§§ 2.150 through 2.153 in order to
harmonize the regulations with the
AWA and emphasize that dogs intended
for resale for research purposes, or dogs
intended for resale following veterinary
treatment, must be imported under a
permit and accompanying certifications.
Several commenters stated, without
providing specifics, that APHIS should
restrict importation of dogs because
imported dogs carry exotic diseases.
We are making no changes to the rule
in response to this comment. APHIS
does restrict the importation of dogs for
resale purposes to ensure they are in
good health, vaccinated, and meet the
minimum age requirement established
in the AWA.
One commenter stated that the
proposed changes will increase the
vulnerability of live dogs imported for
the purposes of experimentation.
Specifically, the commenter stated that
removal of the word ‘‘research’’ from
§§ 2.150(a) and 2.151(a) would exempt
from import permit requirements those
research entities with foreign sites that
import their own live dogs into the
United States, without reselling them,
for the purpose of research. The
commenter cited instances of research
companies obtaining animals from other
countries with weak records of animal
welfare and stated that, under our
proposed changes, they could import
dogs from their facilities in other
countries to use in their testing facilities
in the United States without securing a
permit from the USDA or preparing
certifications. Similarly, a commenter
stated that APHIS has provided no
reasoning for why this recordkeeping
requirement is proposed to be removed
for dogs imported for research or
veterinary treatment without subsequent
sale and noted that it is important that
all dogs imported for research or
veterinary treatment are accompanied
by a permit and certificate of veterinary
health to prevent the spread of disease.
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We are making no changes to the rule
in response to these comments. These
changes will harmonize the regulations
with the Act and make clear that dogs
intended for resale for research
purposes, or dogs intended for resale
following veterinary treatment, are
imported with an import permit and
accompanying certifications, except as
provided in § 2.151(b).
Animal Health and Husbandry
Standards
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Watering
We indicated in the proposed rule
that we were considering adding various
provisions pertaining to the care of dogs
in part 3, particularly in relation to
housing and access to water. We noted
that the current regulations require dogs
that do not have continual access to
water must be offered water not less
than twice daily for at least 1 hour each
time. While lack of continual access to
water is generally not a risk to healthy
dogs, lack of access to water may
exacerbate health problems when other
stresses are present, such as high heat or
illness. We considered amending the
AWA regulations to account for specific
watering needs for certain dogs, short of
requiring that all dogs have 24-hour
access to potable water for their wellbeing. However, in examining the issues
and accounting for the animal health
and well-being factors involved, we
determined that the most prudent
approach would be to include such a
provision requiring all dogs to have 24hour access to water. We therefore
proposed to amend § 3.10 to add a
provision that requires dogs to have
continual access to potable water,
unless restricted by the attending
veterinarian.12
A commenter agreed with ensuring
dogs have regular access to water but
noted that we stated in the proposed
rule that a lack of continual access to
water is generally not a risk to healthy
dogs. The commenter noted that
regulated facilities vary by type, size,
and the number of animals they
maintain. For this reason, the
commenter stated that APHIS should
allow for some flexibility in how
licensees, particularly smaller ones,
make water available to their animals
while still ensuring they are providing
appropriate care.
The rule requires that potable water
be continuously available to dogs,
12 In the proposed rule, we used the term
‘‘continual’’ access to water to mean constant,
uninterrupted access to potable water for dogs at all
times. However, we are substituting the more
accurate term ‘‘continuous’’ to mean the same thing
in this final rule.
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unless restricted by the attending
veterinarian. The rule does not prescribe
how the water is made continuously
available. With respect to flexibility in
how water is made available to dogs,
facilities may use a variety of watering
methods to comply with this
requirement. Most facilities at which the
dogs have 24-hour access to water use
a plumbed automatic watering system.
Automatic watering systems can be
connected either to a central water
supply line or a holding tank, which
then supplies a valve-tipped access
point through a pump or gravity-fed
system. Facilities that do not have an
automatic watering system may use
water-holding tanks filled by hand.
Water may also need to be hand-carried
to outdoor areas that house dogs.
Another commenter said that there
are no data or veterinary care
requirements described to support this
change for healthy dogs. The commenter
noted that healthy animals will play
with water bowls and spill water, and
that the lack of continuous access to
water in those cases should not be an
instance of noncompliance if the dog is
adequately hydrated. The commenter
added that the health and welfare of
animals is directly related to their
degree of hydration, not to the
frequency or duration of access to water,
and that the requirement for continuous
access to water for all is therefore an
arbitrary regulation based on ease of
enforcement rather than sound
veterinary judgment. The commenter
concluded that a better approach would
be to keep the current standard but
modify it to require that dogs be
adequately hydrated and have access to
water depending on conditions.
We are making no change to the rule
in response to this comment. The rule
as proposed will provide dogs with
continuous access to water so that the
dogs can adequately hydrate
themselves. We believe this standard
will be easier for facilities to follow and
for APHIS to enforce than the conditiondependent alternative proposed by the
commenter and will ensure the health
and well-being of the dogs.
Several commenters associated with
research institutions did not consider
the change to the watering requirements
to be necessary or practical. One
commenter stated that, according to his
organization’s records, for the past 5
years there have been 6,613 inspections
of research facilities resulting in 2,029
noncompliant items documented, of
which only 3 were for noncompliance
with the regulations in § 3.10. Another
commenter requested that the Agency
document the actual need for these
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expenditures before developing a final
rule requiring 24-hour access to water.
The commenter correctly points out
that a small fraction of inspections of
regulated facilities result in citations
related to inadequate watering, although
the number cited is lower than the
actual number for all facilities (there
were 11 such citations in FY 2016 and
2017 alone; in 2017, there were 12,243
active sites). Lack of continuous access
to drinkable water is generally not a risk
to healthy dogs, but lack of access can
escalate in dogs the health
consequences of other stress factors. We
note that the number of citations issued
for lack of water access does not reflect
the totality of problems that are either
caused or exacerbated by lack of access
to clean drinkable water. Ensuring this
access will directly benefit those dogs
that would otherwise have insufficient
access to drinkable water.
Moreover, we also proposed specific
veterinary care requirements for dogs.
We expect that these specific
requirements will strengthen
arrangements between licensees and
registrants and their attending
veterinarians and enhance preventative
and ongoing care for dogs. Accordingly,
we are making no changes to the rule in
response to this comment.
Other commenters questioned how
water can be provided continuously
when dogs are being removed from pens
for training or cleaning, or during
transport, and noted that there have
already been guidelines available for
providing adequate water supply for
dogs. Another commenter noted that
requiring 24 hour access to water
contradicts the current regulations,
which allow for the offering of water to
dogs before, during, and after transport
to be determined under a watering and
feeding plan, which may not necessarily
allow for 24 hour access. To resolve this
contradiction, the commenter
recommended that APHIS add an
exception to § 3.10(a) that states,
‘‘except during transport, in which the
dog must be offered water in accordance
with the standards set forth in § 3.14.’’
The transport watering requirements,
which do not require 24 hour access, are
actually detailed in § 3.16 (redesignated
as § 3.17), and not in § 3.14 as the
commenter indicated. However, we
agree with the substance of the
comment and will amend § 3.10(a) to
refer to the transportation requirements
in redesignated § 3.17.
Veterinary Care for Dogs
We proposed to amend the veterinary
care requirements for dogs in § 3.13.
The changes would expand existing
regulations in subpart D requiring
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dealers and exhibitors to establish and
maintain an adequate program of
veterinary care for regulated animals.
The expanded care requirements
include regularly scheduled veterinary
visits, an annual hands-on examination,
and husbandry requirements to help
ensure healthy eyes, skin, nails, hair,
and teeth.
We proposed in a new § 3.13(a)(1) to
require regularly scheduled visits by the
attending veterinarian, not less than
once every 12 months, to all premises
where animals are kept to assess
veterinary care and other aspects of care
and use. This requirement is expected to
be completed no later than 1 year after
the effective date.
Substantial numbers of commenters
supported this requirement. One
commenter supported the proposal but
expressed concern about the level of
oversight required by the attending
veterinarian in § 3.13(a), noting that it
places significant responsibility and
burden on the attending veterinarian to
draft policies tailored to all aspects of
the animals’ lives, despite the
veterinarian only being required to visit
the facility once a year. To ensure that
the animals at each facility receive
consistent and adequate veterinary care,
the commenter asked that we adopt
objective standards for medical,
preventative, and grooming care to
minimize inconsistent approaches to
care among attending veterinarians.
Furthermore, the commenter
recommended that APHIS add to the
regulations the requirement that the
program of veterinary care be drafted
and developed ‘‘in accordance with the
recommendations of a recognized and
objective veterinary association like the
American Veterinary Medical
Association.’’ Other commenters
recommended that APHIS include
additional requirements as part of the
scheduled visit, including pain
assessment and body condition scoring;
an oral examination; special exams for
breeding dogs; and administration of
medications for intestinal parasites,
heartworm, fleas, and ticks. A
commenter also recommended that dogs
receive preventative dental care, and
that specialized procedures such as
euthanasia and surgery only be
practiced by licensed veterinarians
using widely accepted techniques.
Some commenters opposed the
requirement for scheduling regular
veterinary visits. One such commenter
stated that the imposition of a
prescriptive program of veterinary care
is not consistent with APHIS’ stated
purpose to reduce regulatory burden on
licensees because the program of
veterinary care should be individually
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tailored to meet the needs of the animals
being maintained in each facility. Other
commenters representing research
organizations opposed the proposed
change and urged APHIS instead to
consider stronger enforcement of its
existing standards regarding veterinary
care, noting that their organizations are
rarely cited for veterinary care
violations.
We believe the requirement for
regular veterinary visits provides an
appropriate level of specificity to ensure
an adequate and balanced program of
veterinary care for dogs, and allows for
professional, individual judgment on
the part of the attending veterinarian.
Annual hands-on physical exams by the
attending veterinarian allow for the
evaluation of factors that could affect
the dogs’ health, well-being, and ability
to reproduce. A required husbandry
program will help ensure the overall
health of adult dogs and puppies,
thereby preventing avoidable disease
and injury. Required medical records
will help facilities keep track of
incidents, treatments and progress of
care, and allow facilities to track
individual health trends and the
frequency of illnesses and injuries for
the kennel as a whole. For these
reasons, we are making no changes to
the rule in response to the commenters.
A commenter asked that standards for
breeding, socialization, and exercise be
added to the regulations, as the lack of
concrete requirements may result in
inconsistent levels of oversight among
attending veterinarians and foster
uncertainty as to whether a licensee will
follow a veterinarian’s
recommendations for addressing
standards of care. Similarly, another
commenter stated that the veterinary
care plan should be required to include
current exercise and human interaction
and require greater life enrichment for
animals in the companion pet industry,
as well as placement strategies for dogs
after breeding age is passed and a cap
on the age of maturity for breeding.
The regulations pertaining to exercise
of dogs are contained in § 3.8 of the
regulations. Because we did not propose
any changes to these regulations or
propose any standards for breeding or
socialization of dogs, this comment falls
outside the scope of this rulemaking.
A commenter stated that this section
should be strengthened to require
veterinary care for animals, not only for
the obvious humane reasons, but also so
that unsuspecting consumers are not
saddled with unexpected health
problems after purchase.
USDA is authorized under the AWA
to issue standards governing the
humane handling, care, treatment, and
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transportation of animals. We lack
authority to promulgate regulations
pertaining to consumer protection.
A commenter stated that APHIS
should require that the veterinarian
signing the program of veterinary care
be in good standing with the applicable
State’s veterinary board and has
experience working with the species at
issue.
We are making no changes to the rule
in response to this comment. The AWA
authorizes USDA to require licensees to
comply with the Act, but not
veterinarians. We note that § 2.40(a)(2)
of the regulations requires licensees to
ensure that the attending veterinarian
has appropriate authority to ensure the
provision of adequate veterinary care
and to oversee the adequacy of other
aspects of animal care and use. The
appropriate authority may include but is
not limited to ensuring that the
veterinarian is in good standing with the
applicable State veterinary licensing
board. We also note that the definition
of attending veterinarian specifies that
the veterinarian ‘‘has received training
and/or experience in the care and
management of the species being
attended.’’
We also proposed in a new
§ 3.13(a)(2) to require that each dealer,
exhibitor, and research facility follow an
appropriate program of veterinary care
for dogs that is documented and signed
by an attending veterinarian, and
includes annual physical head-to-tail
examinations for adult dogs by the
attending veterinarian. We proposed
that these annual examinations be
required in addition to existing
requirements that provide for regularly
scheduled visits by the attending
veterinarian to premises where animals
are kept.
A substantial number of commenters
supported the proposal to require an
annual head-to-tail examination of each
adult dog at a facility. One commenter
recommended that we also require
hands-on veterinary examinations for
any dog showing visible signs of pain or
distress, emaciated body condition, or
other symptoms of potentially severe
illness or injury.
The requirements in proposed § 3.13
are in addition to the existing
requirements in subpart D, which
already require programs of adequate
veterinary care that include the use of
appropriate methods to diagnose and
treat diseases and injuries and direct
and frequent communication of
problems to the attending veterinarian.
We believe the regulations sufficiently
address the attending veterinarians’,
licensees’, and registrants’
responsibilities for sick animals and are
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making no changes to the rule as a result
of this comment.
Some commenters stated that the
proposed veterinary examination
requirement would cause financial
hardship on small breeders and noted
that many stakeholders do not live near
an affordable veterinarian.
We note that § 2.40 of the regulations
already requires dealers and exhibitors
to employ an attending veterinarian
under formal arrangements and to have
programs of adequate veterinary care.
A commenter stated that it is unclear
why the attending veterinarian would
need to conduct an annual physical
head-to-tail examination of every dog
for what are husbandry issues, when the
licensee is already required to observe
every animal on a daily basis.
We are making no changes to the rule
in response to this comment. A physical
examination of a dog by a veterinarian
may discover health issues that a
licensee may overlook, as the
veterinarian has more extensive
knowledge and expertise.
Several commenters stated that it is
not clear why APHIS does not already
have the authority under the current
language in § 2.40 to assure that such
care is provided. The commenter noted
that § 2.40 currently requires that for
licensees with a part-time or consulting
attending veterinarian there be a regular
schedule of visits and a written program
of veterinary care. The commenter said
that if APHIS finds that the number of
visits and written program is not
providing adequate care, the facility
should be cited and given a specific
timeline to come into compliance.
Under the current regulations in
§ 2.40, although a written program of
veterinary care is required for part-time
or consulting veterinarians, it is not
required for full-time attending
veterinarians. Similarly, although the
veterinarian must conduct regularly
scheduled visits, there is no
requirement for a physical, head-to-tail
annual examination for dogs. This rule
requires that dealers, exhibitors, and
research facilities keep and maintain a
written program of veterinary care for
dogs, regardless of their arrangement
with their attending veterinarian, and
require annual veterinary exams for
dogs in addition to the existing
veterinary care requirements that
provide for regularly scheduled visits of
the attending veterinarian to premises
where animals are kept to ensure the
adequacy of animal care.
Some commenters opposed a required
annual head-to-tail examination for
adult dogs on grounds that their animals
already receive adequate care. A few
research organizations stated that the
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proposed requirement for the head-totail examination will yield no additional
benefit and result in more regulatory
burden. They suggested that APHIS
focus specifically on those individuals
and businesses having a history of
noncompliance and prevent them from
obtaining a license or working with
regulated animals, while allowing
research institutions with strong
adherence to Federal requirements and
excellent veterinary care to perform
their duties following current accepted
practices.
APHIS believes that physical head-totail examinations and regularly
scheduled visits by attending
veterinarians to the premises where
animals are kept are necessary to ensure
adequate animal care and use,
regardless of the facility’s compliance
history. To address the commenters’
concerns, facilities that maintain high
levels of veterinary care likely meet or
exceed the veterinary care requirements
in this rule, meaning that such facilities
likely would not need to make any
changes to their practices. Therefore, we
are making no changes to the rule in
response to this comment.
With respect to the hands-on exam,
one commenter asked if APHIS had
considered facilities that exhibit wolfdogs (an animal that falls under USDA
dog regulations), noting that most
rescued wolf-dogs are not able to be
handled safely for this type of exam.
In § 1.1 of the regulations, dog-hybrid
crosses are considered dogs under the
definition of dog. Licensees and
registrants with dog-hybrid crosses must
comply with all applicable provisions of
the AWA regulations. Licensees and
registrants should work closely with
their attending veterinarian to
determine appropriate safe handling
practices for dogs (including hybrid
crosses) for hands-on examinations.
The commenter also suggested that
we require licensed veterinary
certification that the breeding animal is
free from detectable health or congenital
problems which can be identified using
accepted medical tests appropriate for
problems seen by breed, and is certified
healthy to breed.
We acknowledge the commenter’s
concern about breeding and breedspecific problems but are making no
changes in response. The veterinary
exam can determine whether a dog is
generally in good health, but any
additional testing to detect breedspecific issues would not be a
requirement, but rather a decision by
the dog owner.
We also included in proposed
§ 3.13(a)(3) a requirement for
vaccinations for rabies, parvovirus,
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distemper, and other dangerous diseases
of dogs.
One commenter opposed to the
vaccination requirements in the
proposed rule stated that the wording
‘‘contagious and deadly’’ used in the
proposed regulation could be
interpreted to mean that a disease must
be both contagious and deadly for a
vaccination to be required. The
commenter noted that vaccinations are
not always innocuous and should not be
given unless they are needed.
We appreciate the opportunity to
clarify our intent with respect to the
wording ‘‘contagious and deadly.’’ We
agree that vaccinations are required for
diseases that are contagious, or deadly,
or both, and are amending § 3.13(a)(3)
accordingly.
Other commenters opposed to the
vaccination requirement expressed a
concern that the proposed changes,
which include specific vaccination
requirements, would lead to overvaccinating of animals. A few
commenters stated that APHIS, through
this rulemaking, is requiring them to
excessively vaccinate their animals at
the expense of their dogs being
poisoned or having seizures. Another
commenter opposed to the proposal said
that mandatory vaccinations will result
in the deaths of millions of dogs.
We are making no changes to the
vaccination requirement in response to
these comments. Vaccinations are a
scientifically proven and critical
component in ensuring the health and
well-being of dogs. The regulations
require vaccinations for contagious and
deadly diseases of dogs, which
expressly includes but is not limited to
rabies, parvovirus, and distemper, in
accordance with a schedule approved
by the attending veterinarian. We note
that there are exceptions to this
requirement for research protocols
approved by the Institutional Animal
Care and Use Committee (IACUC) at
research facilities.
A commenter noted that the rule
allows exemptions from required
vaccinations for research facilities, but
not for dealers, and requested that the
exemption also be available to dealers
who provide dogs with higher health
status requirements (i.e., unvaccinated
dogs) for veterinary health research
purposes, providing the animals are
housed in barrier facilities suitable to
protect their health and well-being.
We noted that vaccinations would not
be a requirement if contraindicated for
health reasons for the individual animal
or unless otherwise required by a
research protocol approved by the
IACUC at research facilities. Therefore,
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we are making no changes to the rule in
response to this comment.
We proposed also that the veterinary
exam address husbandry issues for hair
coat, toenails, teeth, skin, eyes, and ears.
A commenter representing a research
organization recommended the
development of clear, objective criteria
to standardize what constitutes
adequate care and subsequently noncompliance regarding prevention and
treatment procedures for skin, nails,
teeth, eyes, ears, and hair coat. The
commenter expressed concern that
USDA inspectors may cite
noncompliance for the occurrence of
early signs of clinical conditions that are
considered mild and not in need of
immediate treatment. The commenter
asked that guidelines be developed and
made available to inspectors and
regulated facilities in the form of
additions to the Animal Welfare
Inspection Guide, rather than in the
proposed changes to the regulations,
and that they include examples of
appropriate written prevention and
treatment plans.
The rule requires a written program of
veterinary care that includes
preventative care and treatment to
ensure healthy and unmatted hair coats,
properly trimmed nails, and clean and
healthy eyes, ears, skin, and teeth,
unless otherwise required by a research
protocol approved by the IACUC at
research facilities. An adequate plan
would address these systems and
provide sufficient guidelines on when
and how the veterinarian will need to be
consulted on certain conditions.
Therefore, we are making no changes to
the rule in response to this comment.
We proposed in revised § 3.13(b) to
require licensees to keep and maintain
veterinary medical records and to make
them available for inspection by APHIS.
A few commenters stated that keeping
a medical record of every dog daily
would increase their recordkeeping
burden.
The rule does not require a daily
medical record for every dog. Rather,
the rule requires facilities to keep track
of incidents, treatments, and progress of
care, and to track individual health
trends and frequency of illnesses and
injuries for the kennel as a whole.
Regarding the proposed requirement
to maintain animal medical records, a
commenter questioned whether the
language in section 2140 of the AWA
gives the Secretary the authority to
require such records. The commenter
stated that under the Principles of
Veterinary Medical Ethics, a
veterinarian has a duty to maintain the
necessary records to provide
appropriate care, but does not agree that
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the AWA requires them to be
maintained.
Under section 2140 of the AWA,
‘‘[d]ealers and exhibitors shall make and
retain for such reasonable period of time
as the Secretary may prescribe, such
records with respect to the purchase,
sale, transportation, identification, and
previous ownership of animals as the
Secretary may prescribe.’’ This section
has similar language for research
facilities to maintain such records with
respect to live dogs and cats. However,
section 2151 grants the Secretary the
authority ‘‘to promulgate such rules,
regulations, and orders as he may deem
necessary in order to effectuate the
purposes of this Act.’’ Moreover, the
rule places the requirement to maintain
the medical records on the facility, not
on the veterinarian.
A commenter noted that § 3.13(b)(1),
which allows medical records for all
dogs kept in a group (or herd) to be
preserved on a single record (without
individual identifying marks noted for
each dog), will likely negate the positive
impact of this section as it will fail to
give inspectors a means of ensuring that
all dogs have received adequate care.
The commenter explained that the
justifications for allowing group records
for animals like cattle, sheep, and deer,
do not exist in the case of dogs, and that
licensees and attending veterinarians
should be able to safely and
productively identify each dog.
Accordingly, the commenter
recommended that we remove the
‘‘group’’ provision in paragraph (b)(1).
We disagree with this comment and
are making no changes in response. This
rule will allow routine husbandry, such
as vaccinations, preventive medical
procedures, and treatment that are
performed on a group of dogs to be kept
on a single record. All animals on the
record will have received the treatment
or care if they are listed on the record.
Therefore, we are making no changes to
the rule based on this comment.
Other Comments
One commenter stated that USDA
should develop and make available an
implementation plan.
The plan for implementing the rule
includes a 3-year schedule for
converting the current 1-year licenses to
a 3-year new license based on the
expiration day and month listed on the
license. Prior to the license expiration
date, USDA will notify current licensees
of the month and date on which their
license will need to be converted to the
3-year license and licensees will need to
submit an application for the new
license. Until the license is converted to
the 3-year schedule, the licensee must
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pay a $40 license fee and renew the
current license for 1 year. After the
effective date of the rule, new applicants
that demonstrate compliance with the
AWA, regulations, and standards will be
issued a 3-year license. We believe this
approach will ensure that adequate
resources are continuously available to
conduct prelicense and routine
inspections under the AWA.
A few commenters stated that USDA
should require online education classes
on compliance that need to be
completed by the licensee between
licensing or annually.
We agree that applicants, licensees,
and registrants need to learn about the
AWA regulations and how to achieve
and maintain compliance with them.
APHIS provides a variety of learning
opportunities, including online modules
and in person trainings, and plans to
continue these after the publication of
this rule.
Some commenters expressed concerns
that APHIS is understaffed and therefore
unable to conduct inspections for
compliance under the existing
regulations, let alone new ones.
We affirm that APHIS has adequate
resources for conducting inspections to
ensure compliance with the AWA. We
employ a risk-based inspection system
that calls for more frequent inspections
at facilities with a higher risk of animal
welfare concerns and fewer inspections
at those that are consistently in
compliance.
Some commenters objected to
allowing members of the public to
comment on the rule, particularly
animal welfare advocates, stating that
the general public lacks any technical
expertise that can be offered on these
issues. One such commenter
representing a wild animal preserve
stated that only individuals who own
animals as their business should be
voting on changes in regulations with
USDA.
The Administrative Procedure Act,
which applies to all agencies of the
Federal government, provides the
general procedures for various types of
rulemaking. For informal rulemakings
such as this one, agencies are required
to provide the public with adequate
notice of a proposed rule followed by a
meaningful opportunity to comment on
the rule’s content. Accordingly, we are
not authorized to limit the opportunity
to comment to only certain individuals
or businesses. We also note that
comments do not constitute ‘‘votes.’’
Some commenters stated that
licensees were not consulted in the
development of these changes: A
commenter stated that ‘‘those authoring
these proposed amendments did not
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solicit the input of seasoned and
respected licensees prior to doing so.’’
On August 24, 2017, we published an
ANPR to solicit input from licensees
and all other members of the public on
potential revisions to the licensing
requirements under the AWA
regulations.13 We received over 47,000
comments in response to the ANPR,
including comments from licensees.
After carefully reviewing those
comments, we published a proposed
rule for public comment, to which we
received over 100,000 comments from
licensees and other members of the
public. We believe that we have
adequately solicited input from
licensees before publishing this final
rule, and are accordingly making no
changes in response to this comment.
Several thousand commenters asked
USDA to end the practice of keeping
dogs in stacked cages with wire flooring,
to ban cage stacking, and to require
facilities to provide animals with more
cage and living space. A letter signed by
several members of Congress supported
the rule but also called for the
elimination of wire flooring in dog
enclosures, as well as a prohibition on
stacking cages and an increase in space
requirements for dogs. An animal
welfare organization commented that
APHIS’ failure to address wire flooring
in the proposed rule is unacceptable
and APHIS should add a requirement
that all primary enclosures in
commercial breeding facilities have
solid floors, or flooring that is slatted if
the slats are at least 3.5 inches in width
with no more than half-inch gaps
between slats.
We acknowledge the concerns of the
public and members of Congress on this
subject. However, we are making no
changes in response to these comments
because enclosure flooring and space
requirements are outside the scope of
this rulemaking.
A few commenters stated that the
proposed rule change is contrary to the
intent of reducing burden as mandated
by the 21st Century Cures Act, which
requires the National Institutes of
Health, the U.S. Department of
Agriculture, and the Food and Drug
Administration to complete a review of
applicable regulations and policies for
the care and use of laboratory animals
and make revisions as appropriate, to
reduce administrative burden on
investigators, while maintaining the
integrity and credibility of research
13 82 FR 40077 (Aug. 24, 2017) and 82 FR 48938
(Oct. 23, 2017); https://www.federalregister.gov/
documents/2017/10/23/2017-22940/animalwelfare-procedures-for-applying-for-licenses-andrenewals.
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findings and protection of research
animals.
The changes to the licensing
requirements do not apply to research
facilities. In addition, the amendments
to the veterinary care and watering
standards are necessary to ensure the
humane treatment and care of dogs, and
are not the kind of inconsistent,
overlapping, or unnecessarily
duplicative regulations that are targeted
for review by section 2034 of the 21st
Century Cures Act.
Several commenters, without
providing specifics, disagreed with the
rule in that it imposes economic and
recordkeeping burdens on breeders. One
commenter generally stated that the
proposed changes are unfair to zoos and
will burden APHIS with paperwork,
enforcement, and legal challenges.
We believe that changes to the
licensing fees would not be unfair to
zoos, but could result in significant
savings for many exhibitors. Under
existing licensing fees, exhibitors pay
between $30 and $300 per year, with an
additional $10 per year renewal
application or new application fee. The
licensees need to submit the renewal
application each year. Under the
proposed and final rule, each licensee
pays only $40 per year ($120 for a 3 year
license) and has to apply for the license
only once every 3 years. This saves each
licensee anywhere from $0 dollars (no
change in cost) to $780 for an exhibitor
with over 500 animals over the course
of the 3 year licensing period. The new
rule also saves the licensee two-thirds of
the time filling out and filing the
paperwork for the license over the 3
year period.
We anticipate an increase in animal
welfare due to the requirement that
licensees must apply for a license every
3 years and demonstrate compliance
with the regulations and standards.
Based on our knowledge and experience
with administering and enforcing the
AWA and regulations, we are concerned
that even experienced licensees may
struggle to achieve and maintain
compliance after making noteworthy
changes to their animals used in
regulated activity. In addition, we have
observed licensees who have been
licensed for many years struggle with
compliance because they did not have
adequate programs for maintaining
compliance at aging facilities. For these
reasons, we believe that revisions to the
regulations set forth in this final rule are
necessary to ensure that dealers,
exhibitors, and operators of auction
sales demonstrate compliance with the
AWA regulations.
We received many other comments
that made general statements about the
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28793
rule or addressed subjects that are
outside the scope of this rulemaking.
Therefore, for the reasons given in the
proposed rule and in this document, we
are adopting the proposed rule as a final
rule, with the changes discussed in this
document.
Executive Orders 12866, 13563, 13771
and Regulatory Flexibility Act
This final rule has been determined to
be significant for the purposes of
Executive Order 12866 and, therefore,
has been reviewed by the Office of
Management and Budget. This final rule
is an Executive Order 13771 regulatory
action. Details on the estimated costs of
this final rule can be found in the rule’s
economic analysis.
We have prepared an economic
analysis for this rule. The economic
analysis provides a cost-benefit analysis,
as required by Executive Orders 12866
and 13563, which direct agencies to
assess all costs and benefits of available
regulatory alternatives and, if regulation
is necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, and equity). Executive Order
13563 emphasizes the importance of
quantifying both costs and benefits, of
reducing costs, of harmonizing rules,
and of promoting flexibility. The
economic analysis also provides a final
regulatory flexibility analysis that
examines the potential economic effects
of this rule on small entities, as required
by the Regulatory Flexibility Act. The
economic analysis is summarized
below. Copies of the full analysis are
available on the Regulations.gov website
(see footnote 1 in this document for a
link to Regulations.gov) or by contacting
the person listed under FOR FURTHER
INFORMATION CONTACT.
APHIS is making revisions to the
licensing requirements to promote
compliance with the AWA, as well as to
strengthen existing safeguards that
prevent individuals and businesses that
are unfit to hold a license from
obtaining a license or from working
with regulated animals. Licensees will
be required to renew their certification
of regulatory compliance and pay the
associated license fee once every 3 years
rather than every year. In addition, the
fee will be changed to a flat rate rather
than a set of tiered rates. This action
will promote AWA compliance by
requiring that regulated businesses
affirmatively demonstrate regulatory
compliance when applying for or
renewing a license. It will reduce the
license fee for most regulated entities
and will reduce the compliance
paperwork burden for all licensees.
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APHIS is also amending the
veterinary care requirements for dogs
that are under the care of entities
covered by the AWA. Facilities with
dogs will be required to have an
expanded Program of Veterinary Care
(PVC) that includes annual, hands-on
veterinary exams for adult dogs by the
attending veterinarian and addresses
husbandry issues for hair coat, toenails,
teeth, skin, eyes, and ears. Facilities will
also be required to create and maintain
medical records of preventive health
care measures and the treatment of ill
and injured dogs.
The expanded PVC will guide the
facilities in practicing a minimum level
of acceptable husbandry and in
maintaining records of preventive care
and the treatment of ill or injured dogs.
Annual hands-on physical exams by the
attending veterinarian will allow for
evaluation of factors that could affect
the dogs’ health, well-being, and ability
to reproduce. Health problems that are
detected early could receive timely and
appropriate veterinary care. A required
husbandry program will help ensure the
overall health of adult dogs and
puppies, thereby preventing avoidable
disease, illness, and injury. Required
medical records will help facilities keep
track of incidents, treatments, and
progress of care. They also will enable
facilities to track individual health
trends and the frequency of illnesses
and injuries for the kennel as a whole.
This rule will also amend the AWA
standard for dogs with respect to access
to clean, drinkable water. The current
regulations state that if potable water is
not continuously available to a facility’s
dogs, it must be offered as often as
necessary to ensure the animals’ health
and well-being, and not less than twice
daily for at least 1 hour each time,
unless restricted by the attending
veterinarian. The standard will require
that facilities make potable water
continuously available.
All businesses covered under the
AWA will be affected by the licensing
requirements, including animal dealers,
exhibitors, retail pet stores, brokers, and
breeders. The number of these entities
varies from year to year, but has tended
to be around 6,000 in recent years.
Based on reported revenue data and
Small Business Administration (SBA)
small-entity standards, the majority of
the entities affected by this rule can be
considered small. About one-half of
these businesses are licensees and
registrants with dogs, including about
2,240 dog breeder facilities.
The licensing requirements will result
in annual cost savings expected to range
from about $627,000 to $2,106,300. The
veterinary care requirements for
facilities having dogs will result in
annual costs ranging from about
$726,200 to about $1,390,200, and the
water access requirement for these
facilities will result in annual costs
ranging from about $1,020,800 to
$2,460,000. Net costs, as shown in table
A, are therefore expected to range from
annual cost savings of $359,300 (the
higher licensing cost savings estimate
plus the lower veterinary care and water
access cost estimates) to annual costs of
$3,223,200 (the lower licensing cost
savings estimate plus the higher
veterinary care and water access cost
estimates).
TABLE A—ESTIMATED NET COSTS OF THE RULE, 2016 DOLLARS
Low estimate
Licensing cost savings .............................................................................................................................................
Veterinary care costs ...............................................................................................................................................
Water access costs .................................................................................................................................................
Net costs ..................................................................................................................................................................
Based on the costs in the table and in
accordance with guidance on complying
with Executive Order 13771, the single
primary estimate of the costs of this rule
is $1,432,000, the mid-point estimate of
net costs annualized in perpetuity using
a 7 percent discount rate.
Executive Order 12372
This program/activity is listed in the
Catalog of Federal Domestic Assistance
under No. 10.025 and is subject to
Executive Order 12372, which requires
intergovernmental consultation with
State and local officials. (See 2 CFR
chapter IV.)
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Executive Order 12988
This final rule has been reviewed
under Executive Order 12988, Civil
Justice Reform. It is not intended to
have retroactive effect. The Act does not
provide administrative procedures
which must be exhausted prior to a
judicial challenge to the provisions of
this rule.
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Executive Order 13175
This rule has been reviewed in
accordance with the requirements of
Executive Order 13175, Consultation
and Coordination with Indian Tribal
Governments. Executive Order 13175
requires Federal agencies to consult and
coordinate with Tribes on a
government-to-government basis on
policies that have Tribal implications,
including regulations, legislative
comments or proposed legislation, and
other policy statements or actions that
have substantial direct effects on one or
mare Indian Tribes, on the relationship
between the Federal Government and
Indian Tribes or on the distribution of
power and responsibilities between the
Federal Government and Indian Tribes.
The USDA’s Office of Tribal Relations
(OTR) has assessed the impact of this
rule on Indian Tribes and concluded
that this rule does not have substantial
direct effects on one or more Indian
Tribes, on the relationship between the
Federal Government and Indian Tribes
or on the distribution of power and
responsibilities between the Federal
Government and Indian Tribes.
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($2,106,300)
726,200
1,020,800
(359,300)
High estimate
($627,000)
1,390,200
2,460,000
3,223,200
OTR has determined that Tribal
consultation under Executive Order
13175 is not required at this time. If
consultation is requested, OTR will
work with the APHIS to ensure quality
consultation is provided.
Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), the Office of
Information and Regulatory Affairs
designated this rule as not a major rule,
as defined by 5 U.S.C. 804(2).
Paperwork Reduction Act
In accordance with section 3507(d) of
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.), some of the
information collection requirements
included in this final rule have been
approved under Office of Management
and Budget (OMB) control number
0579–0036 and some of the information
collection requirements were filed
under OMB comment-filed number
0579–0470, which has been submitted
to OMB for approval. When OMB
notifies us of its decision, if approval is
denied, we will publish a document in
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the Federal Register providing notice of
what action we plan to take.
E-Government Act Compliance
The Animal and Plant Health
Inspection Service is committed to
compliance with the EGovernment Act
to promote the use of the internet and
other information technologies, to
provide increased opportunities for
citizen access to Government
information and services, and for other
purposes. For information pertinent to
E-Government Act compliance related
to this rule, please contact Mr. Joseph
Moxey, APHIS’ Information Collection
Coordinator, at (301) 851–2483.
List of Subjects
9 CFR Parts 1 and 2
Animal welfare, Pets, Reporting and
recordkeeping requirements, Research.
9 CFR Part 3
Animal welfare, Marine mammals,
Pets, Reporting and recordkeeping
requirements, Research, Transportation.
Accordingly, we are amending 9 CFR
parts 1, 2, and 3 as follows:
PART 1—DEFINITION OF TERMS
1. The authority citation for part 1
continues to read as follows:
■
Authority: 7 U.S.C. 2131–2159; 7 CFR 2.22,
2.80, and 371.7.
2. Section 1.1 is amended by
removing the definition for AC Regional
Director and revising the definition for
Business hours to read as follows:
■
§ 1.1
Definitions.
*
*
*
*
*
Business hours means a reasonable
number of hours between 7 a.m. and 7
p.m. each week of the year, during
which inspections by APHIS may be
made.
*
*
*
*
*
PART 2—REGULATIONS
3. The authority citation for part 2
continues to read as follows:
■
Authority: 7 U.S.C. 2131–2159; 7 CFR
2.22, 2.80, and 371.7.
4. Section 2.1 is amended as follows:
a. By revising paragraphs (a)(1) and
(2), (b), and (c);
■ b. By removing paragraph (d) and
redesignating paragraph (e) as paragraph
(d); and
■ c. By revising newly redesignated
paragraph (d) and the OMB citation at
the end of the section.
The revisions read as follows:
■
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■
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§ 2.1
Requirements and application.
(a)(1) No person shall operate as a
dealer, exhibitor, or operator of an
auction sale, without a valid license,
except persons who are exempt from the
licensing requirements under paragraph
(a)(3) of this section. A person must be
18 years of age or older to obtain a
license. A person seeking a license shall
apply on a form which will be furnished
by the Deputy Administrator. The
applicant shall provide the information
requested on the application form,
including, but not limited to:
(i) The name of the person applying
for the license;
(ii) A valid mailing address through
which the applicant can be reached at
all times;
(iii) Valid addresses for all locations,
facilities, premises, or sites where
animals, animal facilities, equipment,
and records are held, kept, or
maintained;
(iv) The anticipated maximum
number of animals on hand at any one
time during the period of licensure;
(v) The anticipated type of animals
described in paragraph (b)(2)(ii) of this
section to be owned, held, maintained,
sold, or exhibited, including those
animals leased, during the period of
licensure;
(vi) If the person is seeking a license
as an exhibitor, whether the person
intends to exhibit any animal at any
location other than the person’s
location(s) listed pursuant to paragraph
(a)(1)(iii) of this section; and
(vii) Disclosure of any plea of nolo
contendere (no contest) or finding of
violation of Federal, State, or local laws
or regulations pertaining to animal
cruelty or the transportation, ownership,
neglect, or welfare of animals.
(2) The completed application form,
along with a $120 license fee, shall be
submitted to the appropriate Animal
Care office.
*
*
*
*
*
(b)(1) No person shall have more than
one license. Licenses are issued to
specific persons, and are issued for
specific activities, types and numbers of
animals, and approved sites. A new
license must be obtained upon change
of ownership, location, activities, or
animals. A licensee shall notify Animal
Care no fewer than 90 days and obtain
a new license before any change in the
name, address, substantial control or
ownership of his business or operation,
locations, activities, and number or type
of animals described in paragraph (b)(2)
of this section. Any person who is
subject to the regulations in this
subchapter and who intends to exhibit
any animal at any location other than
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28795
the person’s approved site must provide
that information on their application
form in accordance with paragraph (a)
of this section and submit written
itineraries in accordance with § 2.126.
(2) Licenses authorize a specific
number and specific type(s) of animals,
as follows:
(i) Licenses authorize increments of
50 animals on hand at any single point
in time during the period of licensure.
A licensee must obtain a new license
before any change resulting in more
than the authorized number of animals
on hand at any single point in time
during the period of licensure.
(ii) Licenses authorize the use of
animals subject to subparts A through F
in part 3 of this subchapter, except that,
for animals subject to subparts D and F,
licenses must specifically authorize the
use of each of the following groups of
animals: Group 5 (baboons and
nonbrachiating species larger than 33
pounds) and Group 6 (great apes over 55
pounds and brachiating species)
nonhuman primates; exotic and wild
felids (including but not limited to
lions, tigers, leopards, cheetahs, jaguars,
cougars, lynx, servals, bobcats, and
caracals, and any hybrid cross thereof);
hyenas and/or exotic and wild canids
(including but not limited to wolves,
coyotes, foxes, and jackals); bears; and
mega-herbivores (including but not
limited to elephants, rhinoceroses,
hippopotamuses, and giraffes). A
licensee must obtain a new license
before using any animal beyond those
types or numbers of animals authorized
under the existing license.
(c) A license will be issued to any
applicant, except as provided in §§ 2.9
through 2.11, when:
(1) The applicant has met the
requirements of this section and §§ 2.2
and 2.3; and
(2) The applicant has paid a $120
license fee to the appropriate Animal
Care office. The applicant may pay the
fee by certified check, cashier’s check,
personal check, money order, or credit
card. An applicant whose check is
returned by a bank will be charged a fee
of $20 for each returned check. If an
applicant’s check is returned,
subsequent fees must be paid by
certified check, cashier’s check, money
order, or credit card.
(d) The failure of any person to
comply with any provision of the Act,
or any of the provisions of the
regulations or standards in this
subchapter, shall constitute grounds for
denial of a license or for its suspension
or revocation by the Secretary, as
provided in the Act.
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(Approved by the Office of Management and
Budget under control numbers 0579–0036
and 0579–0470)
5. Section 2.2 is revised to read as
follows:
■
§ 2.2 Acknowledgement of regulations and
standards.
Animal Care will supply a copy of the
Act and the regulations and standards in
this subchapter to an applicant upon
request. Signing the application form is
an acknowledgement that the applicant
has reviewed the Act and the
regulations and standards and agrees to
comply with them.
(Approved by the Office of Management and
Budget under control numbers 0579–0036
and 0579–0470)
6. Section 2.3 is revised to read as
follows:
■
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§ 2.3 Demonstration of compliance with
standards and regulations.
(a) Each applicant for a license must
demonstrate that his or her location(s)
and any animals, facilities, vehicles,
equipment, or other locations used or
intended for use in the business comply
with the Act and the regulations and
standards set forth in parts 2 and 3 of
this subchapter. Each applicant must
make his or her animals, locations,
facilities, vehicles, equipment, and
records available for inspection during
business hours and at other times
mutually agreeable to the applicant and
APHIS, to ascertain the applicant’s
compliance with the Act and the
regulations and standards.
(b) Each applicant for a license must
be inspected by APHIS and demonstrate
compliance with the Act and the
regulations and standards, as required
in paragraph (a) of this section, before
APHIS will issue a license. If the first
inspection reveals that the applicant’s
animals, premises, facilities, vehicles,
equipment, locations, or records do not
meet the applicable requirements of this
subchapter, APHIS will advise the
applicant of existing deficiencies and
the corrective measures that must be
completed to come into compliance
with the regulations and standards. An
applicant who fails the first inspection
may request up to two more inspections
by APHIS to demonstrate his or her
compliance with the Act and the
regulations and standards. The
applicant must request the second
inspection, and if applicable, the third
inspection, within 60 days following the
first inspection.
(c) Any applicant who fails the third
and final prelicense inspection may
appeal all or part of the inspection
findings to the Deputy Administrator.
To appeal, the applicant must send a
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written statement contesting the
inspection finding(s) and include any
documentation or other information in
support of the appeal. To receive
consideration, the appeal must be
received by the Deputy Administrator
within 7 days of the date the applicant
received the third prelicense inspection
report. Within 7 days of receiving a
timely appeal, the Deputy Administrator
will issue a written response to notify
the applicant whether APHIS will issue
a license or deny the application.
(d) If an applicant fails inspection or
fails to request reinspections within the
60-day period, or fails to submit a
timely appeal of the third prelicense
inspection report as described in
paragraph (c) of this section, the
applicant cannot reapply for a license
for a period of 6 months from the date
of the failed third inspection or the
expiration of the time to request a third
inspection. No license will be issued
until the applicant pays the license fee
and demonstrates upon inspection that
the animals, premises, facilities,
vehicles, equipment, locations, and
records are in compliance with all
applicable requirements in the Act and
the regulations and standards in this
subchapter.
(Approved by the Office of Management and
Budget under control number 0579–0036)
7. Section 2.5 is revised to read as
follows:
■
§ 2.5 Duration of license and termination
of license.
(a) A license issued under this part
shall be valid and effective for 3 years
unless:
(1) The license has been revoked or
suspended pursuant to section 19 of the
Act or terminated pursuant to § 2.12.
(2) The license is voluntarily
terminated upon request of the licensee,
in writing, to the Deputy Administrator.
(3) The license has expired, except
that:
(i) The Deputy Administrator may
issue a temporary license, which
automatically expires after 120 days, to
an applicant whose immediately
preceding 3-year license has expired, if:
(A) The applicant submits the
appropriate application form before the
expiration date of a preceding license;
and
(B) The applicant had no
noncompliances with the Act and the
regulations and standards in parts 2 and
3 of this subchapter documented in any
inspection report during the preceding
period of licensure.
(ii) For expedited hearings occurring
under § 2.11(b)(2), a license will remain
valid and effective until the
administrative law judge issues his or
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her initial decision. Should the
administrative law judge’s initial
decision affirm the denial of the license
application, the applicant’s license shall
terminate immediately.
(4) There will not be a refund of the
license fee if a license is denied, or
terminated, suspended, or revoked prior
to its expiration date.
(b) Any person who seeks the
reinstatement of a license that has
expired or been terminated must follow
the procedure applicable to new
applicants for a license set forth in § 2.1.
(c) A license which is invalid under
this part shall be surrendered to the
Deputy Administrator. If the license
cannot be found, the licensee shall
provide a written statement so stating to
the Deputy Administrator.
§§ 2.6 through 2.8
Reserved]
[Removed and
8. Sections 2.6 through 2.8 are
removed and reserved.
■ 9. Section 2.9 is revised to read as
follows:
■
§ 2.9 Officers, agents, and employees of
licensees whose licenses have been
suspended or revoked.
Any person who has been or is an
officer, agent, or employee of a licensee
whose license has been suspended or
revoked and who was responsible for or
participated in the activity upon which
the order of suspension or revocation
was based will not be licensed, or
registered as a carrier, intermediate
handler, dealer, exhibitor, or research
facility, within the period during which
the order of suspension or revocation is
in effect.
■ 10. Section 2.10 is revised to read as
follows:
§ 2.10 Licensees whose licenses have
been suspended or revoked.
(a) Any person whose license or
registration has been suspended for any
reason shall not be licensed, or
registered, in his or her own name or in
any other manner, within the period
during which the order of suspension is
in effect. No partnership, firm,
corporation, or other legal entity in
which any such person has a substantial
interest, financial or otherwise, will be
licensed or registered during that
period. Any person whose license has
been suspended for any reason may
apply to the Deputy Administrator, in
writing, for reinstatement of his or her
license or registration.
(b) Any person whose license has
been revoked shall not be licensed or
registered, in his or her own name or in
any other manner, and no partnership,
firm, corporation, or other legal entity in
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which any such person has a substantial
interest, financial or otherwise, will be
licensed or registered.
(c) Any person whose license has
been suspended or revoked shall not
buy, sell, transport, exhibit, or deliver
for transportation, any animal during
the period of suspension or revocation,
under any circumstances, whether on
his or her behalf or on the behalf of
another licensee or registrant.
■ 11. Section 2.11 is revised to read as
follows:
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§ 2.11
Denial of license application.
(a) A license will not be issued to any
applicant who:
(1) Has not complied with the
requirements of §§ 2.1 through 2.4 and
has not paid the fees indicated in § 2.1;
(2) Is not in compliance with the Act
or any of the regulations or standards in
this subchapter;
(3) Has had a license revoked or
whose license is suspended, as set forth
in § 2.1(d);
(4) Was an officer, agent, or employee
of a licensee whose license has been
suspended or revoked and who was
responsible for or participated in the
activity upon which the order of
suspension or revocation was based, as
set forth in § 2.9;
(5) Has pled nolo contendere (no
contest) or has been found to have
violated any Federal, State, or local laws
or regulations pertaining to animal
cruelty within 3 years of application, or
after 3 years if the Administrator
determines that the circumstances
render the applicant unfit to be
licensed;
(6) Is or would be operating in
violation or circumvention of any
Federal, State, or local laws; or
(7) Has made any false or fraudulent
statements or provided any false or
fraudulent records to the Department or
other government agencies, or has pled
nolo contendere (no contest) or has been
found to have violated any Federal,
State, or local laws or regulations
pertaining to the transportation,
ownership, neglect, or welfare of
animals, or is otherwise unfit to be
licensed and the Administrator
determines that the issuance of a license
would be contrary to the purposes of the
Act.
(b)(1) An applicant whose initial
license application has been denied may
request a hearing in accordance with the
applicable rules of practice in 7 CFR
part 1 for the purpose of showing why
the application for license should not be
denied. The denial of an initial license
application shall remain in effect until
the final decision has been rendered.
Should the license denial be upheld, the
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20:23 May 12, 2020
Jkt 250001
applicant may again apply for a license
1 year from the date of the final order
denying the application, unless the
order provides otherwise.
(2) An applicant who submitted a
timely appeal of a third prelicense
inspection as described in § 2.3(c), and
whose appeal results in the denial of the
license application, may request an
expedited hearing if the applicant held
a valid license when he or she
submitted the license application that
has been denied and the Deputy
Administrator received such license
application no fewer than 90 days prior
to the expiration of the valid license. If
the applicant meets the criteria in this
paragraph (b)(2), and notwithstanding
the timeframes of the proceedings set
forth in the applicable rules of practice
(7 CFR 1.130 through 1.151):
(i) The applicant must submit the
request for an expedited hearing within
30 days of receiving notice from the
Deputy Administrator that the license
application has been denied;
(ii) The administrative law judge shall
set the expedited hearing so that it
occurs within 30 days of receiving a
timely request for expedited hearing as
described in paragraph (b)(2)(i) of this
section; and
(iii) The administrative law judge
must issue an initial decision no later
than 30 days after the expedited
hearing.
(iv) The applicant’s license will
remain valid until the administrative
law judge issues his or her initial
decision. Should the administrative law
judge’s initial decision affirm the denial
of the license application, the
applicant’s license shall terminate
immediately.
(c) No partnership, firm, corporation,
or other legal entity in which a person
whose license application has been
denied has a substantial interest,
financial or otherwise, will be licensed
within 1 year of the license denial.
(d) No license will be issued under
circumstances that the Administrator
determines would circumvent any
order, stipulation, or settlement
agreement suspending, revoking,
terminating, or denying a license or
disqualifying a person from engaging in
activities under the Act.
■ 12. Section 2.12 is revised to read as
follows:
§ 2.12
Termination of a license.
A license may be terminated at any
time for any reason that a license
application may be denied pursuant to
§ 2.11 after a hearing in accordance with
the applicable rules of practice in 7 CFR
part 1.
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28797
13. Section 2.13 is added to read as
follows:
■
§ 2.13
Appeal of inspection report.
Except as otherwise provided in
§ 2.3(c), any licensee or registrant may
appeal all or part of the inspection
findings in an inspection report to the
Deputy Administrator. To appeal, the
licensee or registrant must send a
written statement contesting the
inspection finding(s) and include any
documentation or other information in
support of the appeal. To receive
consideration, the appeal must be
received by the Deputy Administrator
within 21 days of the date the licensee
or registrant received the inspection
report that is the subject of the appeal.
§ 2.25
[Amended]
14. In § 2.25, paragraph (a) is amended
by removing the words ‘‘AC Regional
Director’’ each time they appear and
adding the words ‘‘Deputy
Administrator’’ in their place.
■
§ 2.26
[Amended]
15. Section 2.26 is amended by
removing the words ‘‘AC Regional
Director’’ and adding the words
‘‘Deputy Administrator’’ in their place.
■
§ 2.27
[Amended]
16. Section 2.27 is amended by
removing the words ‘‘AC Regional
Director’’ each time they appear and
adding the words ‘‘Deputy
Administrator’’ in their place.
■
§ 2.30
[Amended]
17. Section 2.30 is amended by
removing the words ‘‘AC Regional
Director’’ each time they appear and
adding the words ‘‘Deputy
Administrator’’ in their place.
■
§ 2.35
[Amended]
18. In § 2.35, the OMB citation at the
end of the section is amended by
removing the number ‘‘0579–0254’’ and
adding the number ‘‘0579–0036’’ in its
place.
■
§ 2.36
[Amended]
19. In § 2.36, paragraph (a) is amended
by removing the words ‘‘AC Regional
Director’’ and adding the words
‘‘Deputy Administrator’’ in their place.
■ 20. Section 2.38 is amended as
follows:
■ a. By revising paragraph (c);
■ b. In paragraph (g)(1) introductory
text, by removing the period between
the words ‘‘acquired’’ and ‘‘sold’’ and
adding a comma in its place;
■ c. In paragraph (g)(7), footnote 1, by
removing the words ‘‘AC Regional
Director’’ and adding the words
■
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Federal Register / Vol. 85, No. 93 / Wednesday, May 13, 2020 / Rules and Regulations
‘‘Deputy Administrator’’ in their place;
and
■ d. In paragraph (i) introductory text,
by removing the words ‘‘AC Regional
Director’’ and adding the words
‘‘Deputy Administrator’’ in their place.
The revision reads as follows:
§ 2.38
Miscellaneous.
*
*
*
*
*
(c) Publication of lists of research
facilities subject to the provisions of this
part. APHIS will publish on its website
lists of research facilities registered in
accordance with the provisions of this
subpart. The lists may also be obtained
upon request from the Deputy
Administrator.
*
*
*
*
*
§ 2.52
[Amended]
21. In § 2.52, footnote 4 is amended by
removing the words ‘‘AC Regional
Director’’ and adding the words
‘‘Deputy Administrator’’ in their place.
■
§ 2.75
[Amended]
22. In § 2.75, paragraphs (a)(3) and
(b)(2) are amended by removing the
citation ‘‘§ 2.79’’ and adding the citation
‘‘§ 2.78’’ in its place.
■
§ 2.77
[Amended]
23. In § 2.77, paragraph (b) is amended
by removing the citation ‘‘§ 2.79’’ and
adding the citation ‘‘§ 2.78’’ in its place.
■
§ 2.102
[Amended]
24. In § 2.102, paragraphs (a) and (b)
introductory text are amended by
removing the words ‘‘AC Regional
Director’’ and adding the words
‘‘Deputy Administrator’’ in their place.
■
§ 2.126
[Amended]
25. In § 2.126, paragraph (c) is
amended by removing the words ‘‘AC
Regional Director’’ each time they
appear and adding the words ‘‘Deputy
Administrator’’ in their place.
■ 26. Section 2.127 is revised to read as
follows:
■
§ 2.127 Publication of lists of persons
subject to the provisions of this part.
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[Amended]
27. In § 2.132, the OMB citation at the
end of the section is amended by
removing the number ‘‘0579–0254’’ and
adding the number ‘‘0579–0036’’ in its
place.
■
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20:23 May 12, 2020
Jkt 250001
[Amended]
§ 3.10
28. Section 2.150 is amended as
follows:
■ a. By removing the words
‘‘continental United States or Hawaii’’
each time they appear and adding the
word ‘‘States’’ in their place;
■ b. In paragraph (a), by removing the
words ‘‘, research, or veterinary
treatment’’; and
■ c. In paragraph (c)(8), by adding the
words ‘‘resale for’’ immediately before
the words ‘‘research purposes’’.
■
§ 2.151
[Amended]
29. Section 2.151 is amended as
follows:
■ a. By removing the words
‘‘continental United States or Hawaii’’
each time they appear and adding the
word ‘‘States’’ in their place;
■ b. In paragraph (a) introductory text,
by removing the words ‘‘, research, or
veterinary treatment’’;
■ c. In paragraph (b)(1), by adding the
words ‘‘resale for’’ immediately before
the words ‘‘use in research, tests, or
experiments at a research facility’’; and
■ d. In paragraph (b)(2) introductory
text, by adding the words ‘‘and
subsequent resale’’ immediately after
the words ‘‘for veterinary treatment by
a licensed veterinarian’’.
■
§ 2.152
[Amended]
30. Section 2.152 is amended by
removing the words ‘‘continental United
States or Hawaii’’ and adding the word
‘‘States’’ in their place.
■
§ 2.153
[Amended]
31. Section 2.153 is amended as
follows:
■ a. By removing the words
‘‘continental United States or Hawaii’’
both times they appear and adding the
word ‘‘States’’ in their place; and
■ b. By adding the words ‘‘or the Act’’
immediately after the words ‘‘this
subpart’’.
■
PART 3—STANDARDS
32. The authority citation for part 3
continues to read as follows:
■
APHIS will publish on its website
lists of persons licensed or registered in
accordance with the provisions of this
part. The lists may also be obtained
upon request from the Deputy
Administrator.
§ 2.132
§ 2.150
Authority: 7 U.S.C. 2131–2159; 7 CFR
2.22, 2.80, and 371.7.
§ 3.6
[Amended]
33. In § 3.6, paragraphs (b)(5) and
(c)(3) are amended by removing the
citations ‘‘§ 3.14 of this subpart’’ and
‘‘§ 3.14(a)(6) of this subpart’’ and adding
the citations ‘‘§ 3.15’’ and ‘‘§ 3.15(a)(6)’’
in their places, respectively.
■ 34. Section 3.10 is revised to read as
follows:
■
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Fmt 4701
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Watering.
(a) Potable water must be
continuously available to the dogs,
unless restricted by the attending
veterinarian or except as provided in
§ 3.17(a).
(b) If potable water is not
continuously available to the cats, it
must be offered to the cats as often as
necessary to ensure their health and
well-being, but not less than twice daily
for at least 1 hour each time, unless
restricted by the attending veterinarian.
(c) Water receptacles must be kept
clean and sanitized in accordance with
§ 3.11(b) and before being used to water
a different dog or cat or a different social
grouping of dogs or cats.
§§ 3.13 through 3.19 [Redesignated as
§§ 3.14 through 3.20]
35. Sections 3.13 through 3.19 are
redesignated as §§ 3.14 through 3.20,
respectively.
■ 36. New § 3.13 is added to read as
follows:
■
§ 3.13
Veterinary care for dogs.
(a) Each dealer, exhibitor, and
research facility must follow an
appropriate program of veterinary care
for dogs that is developed, documented
in writing, and signed by the attending
veterinarian. Dealers, exhibitors, and
research facilities must keep and
maintain the written program and make
it available for APHIS inspection. The
written program of veterinary care must
address the requirements for adequate
veterinary care for every dealer and
exhibitor in § 2.40 of this subchapter
and every research facility in § 2.33 of
this subchapter, and must also include:
(1) Regularly scheduled visits, not less
than once every 12 months, by the
attending veterinarian to all premises
where animals are kept, to assess and
ensure the adequacy of veterinary care
and other aspects of animal care and
use;
(2) A complete physical examination
from head to tail of each dog by the
attending veterinarian not less than
once every 12 months;
(3) Vaccinations for contagious and/or
deadly diseases of dogs (including
rabies, parvovirus and distemper) and
sampling and treatment of parasites and
other pests (including fleas, worms,
coccidia, giardia, and heartworm) in
accordance with a schedule approved
by the attending veterinarian, unless
otherwise required by a research
protocol approved by the Committee at
research facilities; and
(4) Preventative care and treatment to
ensure healthy and unmatted hair coats,
properly trimmed nails, and clean and
healthy eyes, ears, skin, and teeth,
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unless otherwise required by a research
protocol approved by the Committee at
research facilities.
(b) Dealers, exhibitors, and research
facilities must keep copies of medical
records for dogs and make the records
available for APHIS inspection. These
records must include:
(1) The identity of the animal,
including identifying marks, tattoos, or
tags on the animal and the animal’s
breed, sex, and age; Provided, however,
that routine husbandry, such as
vaccinations, preventive medical
procedures, or treatments, performed on
all animals in a group (or herd), may be
kept on a single record;
(2) If a problem is identified (such as
a disease, injury, or illness), the date
and a description of the problem,
examination findings, test results, plan
for treatment and care, and treatment
procedures performed, when
appropriate;
(3) The names of all vaccines and
treatments administered and the dates
of administration; and
(4) The dates and findings/results of
all screening, routine, or other required
or recommended test or examination.
(c) Medical records for dogs shall be
kept for the following periods:
(1) The medical records for dogs shall
be kept and maintained by the research
facility for the duration of the research
activity and for an additional 3 years
after the dog is euthanized or disposed
of, and for any period in excess of 3
years as necessary to comply with any
applicable Federal, State, or local law.
(2) The medical records for dogs shall
be kept and maintained by the dealer or
exhibitor for at least 1 year after the dog
is euthanized or disposed of and for any
period in excess of 1 year as necessary
to comply with any applicable Federal,
State, or local law.
(3) Whenever the Administrator
notifies a research facility, dealer, or
exhibitor in writing that specified
records shall be retained pending
completion of an investigation or
proceeding under the Act, the research
facility, dealer, or exhibitor shall hold
those records until their disposition is
authorized by the Administrator.
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(Approved by the Office of Management and
Budget under control number 0579–0470)
§ 3.14
[Amended]
(d) Removal during transportation in
commerce prohibited. * * *
*
*
*
*
*
37. Newly redesignated § 3.14 is
amended as follows:
■ a. In paragraph (c) introductory text,
by removing the citation ‘‘§ 3.16 of this
subpart’’ and adding the citation
‘‘§ 3.17’’ in its place;
■ b. In paragraph (d), by removing the
citation ‘‘§ 3.14 of this subpart’’ and
adding the citation ‘‘§ 3.15’’ in its place;
and
■ c. In paragraph (e) introductory text:
■ i. In the first sentence, by removing
the citation ‘‘§§ 3.18 and 3.19 of this
subpart’’ both times it appears and
adding the citation ‘‘§§ 3.19 and 3.20’’
in its place; and
■ ii. In the second sentence, by
removing the citations ‘‘§ 3.18’’ and
‘‘§ 3.19’’ and adding the citations
‘‘§ 3.19’’ and ‘‘§ 3.20’’ in their place,
respectively.
§ 3.19
§ 3.15
■
■
[Amended]
38. In newly redesignated § 3.15,
paragraph (h) is amended by removing
the citation ‘‘§ 3.13(c)’’ and adding the
citation ‘‘§ 3.14(c)’’ in its place.
■
§ 3.17
[Amended]
39. In newly redesignated § 3.17,
paragraph (a) is amended by removing
the citation
‘‘§ 3.13(c) of this subpart’’ both times
it appears and adding the citation
‘‘§ 3.14(c)’’ in its place.
■ 40. Newly redesignated § 3.18 is
amended as follows:
■ a. In paragraph (a), by removing the
citation ‘‘§ 3.15(e)’’ and adding the
citation ‘‘§ 3.16(e)’’ in its place;
■ b. In paragraph (b), by removing the
citation ‘‘§ 3.15(d)’’ and adding the
citation ‘‘§ 3.16(d)’’ in its place; and
■ c. In paragraph (d), by adding a
paragraph heading and removing the
citations ‘‘§ 3.14(b) of this subpart’’ and
‘‘§ 3.6 or § 3.14 of this subpart’’ and
adding the citations ‘‘§ 3.15(b)’’ and
‘‘§ 3.6 or § 3.15’’ in their places,
respectively.
The addition reads as follows:
■
§ 3.18
*
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*
*
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*
Fmt 4701
28799
[Amended]
41. In newly redesignated § 3.19,
paragraph (f) is amended by removing
the citation ‘‘§ 3.13(f) of this subpart’’
and adding the citation ‘‘§ 3.14(f)’’ in its
place.
■
§ 3.20
[Amended]
42. Newly redesignated § 3.20 is
amended as follows:
■ a. In paragraph (a)(1), by removing the
citation ‘‘§ 3.18(d) of this subpart’’ and
adding the citation ‘‘§ 3.19(d)’’ in its
place; and
■ b. In paragraph (a)(3), by removing the
citations ‘‘§ 3.13(e)’’ and ‘‘§ 3.18(d) of
this subpart’’ and adding the citations
‘‘§ 3.14(e)’’ and ‘‘§ 3.19(d)’’ in their
places, respectively.
■
§ 3.61
[Amended]
43. Section 3.61 is amended as
follows:
■ a. In paragraph (b), by removing the
word ‘‘specie’’ and adding the word
‘‘species’’ in its place; and
■ b. In paragraph (f), by removing the
word ‘‘works’’ and adding the word
‘‘words’’ in its place.
■ 44. Section 3.78 is amended by
revising the section heading to read as
follows:
§ 3.78
*
Outdoor housing facilities.
*
§ 3.110
*
*
*
[Amended]
45. In § 3.110, paragraph (a) is
amended by removing the words ‘‘it is
determined that’’.
■
§ 3.111
[Amended]
46. Section 3.111 is amended by
removing the word ‘‘regional’’ in
footnote 14.
■
Done in Washington, DC, this 9th day of
April 2020.
Lorren Walker,
Acting Under Secretary for Marketing and
Regulatory Programs.
[FR Doc. 2020–07837 Filed 5–12–20; 8:45 am]
*
Sfmt 9990
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Agencies
[Federal Register Volume 85, Number 93 (Wednesday, May 13, 2020)]
[Rules and Regulations]
[Pages 28772-28799]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07837]
[[Page 28771]]
Vol. 85
Wednesday,
No. 93
May 13, 2020
Part IV
Department of Agriculture
-----------------------------------------------------------------------
Animal and Plant Health Inspection Service
-----------------------------------------------------------------------
9 CFR Parts 1, 2 and 3
Animal Welfare; Amendments to Licensing Provisions and to Requirements
for Dogs; Final Rule
Federal Register / Vol. 85 , No. 93 / Wednesday, May 13, 2020 / Rules
and Regulations
[[Page 28772]]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 1, 2, and 3
[Docket No. APHIS-2017-0062]
RIN 0579-AE35
Animal Welfare; Amendments to Licensing Provisions and to
Requirements for Dogs
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: We are amending the licensing requirements in the Animal
Welfare Act (AWA) regulations to promote compliance, reduce licensing
fees, and strengthen safeguards that prevent individuals and businesses
with a history of noncompliance from obtaining a license or working
with regulated animals. This action will reduce regulatory burden with
respect to licensing and help ensure licensees' sustained compliance
with the AWA, thus promoting animal welfare. We have also revised the
veterinary care and watering standards for regulated dogs to better
align the regulations with the humane care and treatment standards set
by the Animal Welfare Act.
DATES: Effective November 9, 2020.
FOR FURTHER INFORMATION CONTACT: Dr. Barbara Kohn, Senior Staff
Veterinarian, APHIS, 4700 River Road, Unit 84, Riverdale, MD 20737;
(301) 851-3751; [email protected].
SUPPLEMENTARY INFORMATION:
Background
Under the Animal Welfare Act (AWA or the Act, 7 U.S.C. 2131 et
seq.), the Secretary of Agriculture is authorized to promulgate
standards and other requirements governing the humane handling, care,
treatment, and transportation of certain animals by dealers,
exhibitors, operators of auction sales, research facilities, and
carriers and intermediate handlers. The Secretary has delegated
responsibility for administering the AWA to the Administrator of the
U.S. Department of Agriculture's (USDA's) Animal and Plant Health
Inspection Service (APHIS). Within APHIS, the responsibility for
administering the AWA has been delegated to the Deputy Administrator
for Animal Care. Definitions, regulations, and standards established
under the AWA are contained in 9 CFR parts 1, 2, and 3 (referred to
below as the regulations). Part 1 contains definitions for terms used
in parts 2 and 3. Part 2 provides administrative requirements and sets
forth institutional responsibilities for regulated parties, including
licensing requirements for dealers, exhibitors, and operators of
auction sales. Dealers, exhibitors, and operators of auction sales are
required to comply in all respects with the regulations and standards
(Sec. 2.100(a)) and to allow APHIS officials access to their place of
business, facilities, animals, and records to inspect for compliance
(Sec. 2.126). Part 3 provides standards for the humane handling, care,
treatment, and transportation of covered animals. Part 3 consists of
subparts A through E, which contain specific standards for dogs and
cats, guinea pigs and hamsters, rabbits, nonhuman primates, and marine
mammals, respectively, and subpart F, which sets forth general
standards for warmblooded animals not otherwise specified in that part.
Under the current regulations, an applicant for an initial license
is required to submit an application form, an application fee, and an
annual license fee to Animal Care (Sec. 2.1(c)), acknowledge receipt
of a copy of the regulations and agree to comply with them by signing
the application form (Sec. 2.2(a)), and demonstrate compliance with
the AWA regulations and standards, before APHIS can issue a license
(Sec. 2.3(a)). Once a person receives a license, the licensee may
renew his or her license annually by submitting an annual renewal form
and license fee (Sec. 2.1(d)(1)).
On March 22, 2019, we published in the Federal Register (84 FR
10721-10735, Docket No. APHIS-2017-0062) a proposal to revise the AWA
licensing requirements to promote compliance, reduce licensing fees and
burdens, and strengthen existing safeguards that prevent individuals
and businesses who are unfit to hold a license (such as any individual
whose license has been suspended or revoked or who has a history of
noncompliance) from obtaining a license or from buying, selling,
transporting, exhibiting, or delivering for transportation regulated
animals. We also proposed revisions to the animal health and husbandry
standards of part 3, subpart A, to ensure the adequate care and
treatment of regulated dogs. Prior to the proposed rule, we published
an advance notice of proposed rulemaking (ANPR) in the Federal Register
on August 24, 2017, (82 FR 40077-40078, Docket No. APHIS-2017-0062), in
which we solicited comments from the public regarding potential
revisions to the AWA regulations.
We solicited comments on the proposed rule for 60 days ending May
21, 2019. On May 28, 2019, we published in the Federal Register (84 FR
24403, Docket No. APHIS-2017-0062) a document \1\ announcing a
reopening of the comment period for an additional 15 days, to June 5,
2019, to allow interested persons additional time to prepare and submit
comments.
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\1\ To view the ANPR, proposed rule, supporting documents, and
the comments we received, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2017-0062.
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We received approximately 110,600 comments on the proposed rule via
courier, U.S. mail, and Regulations.gov. Of this total, 4,619 unique
comments were received via Regulations.gov, along with approximately
600 unique paper comments delivered to APHIS. Through Regulations.gov
we also received 25,400 comments in 629 distinct sets of duplicate or
near-duplicate comments. An additional 79,978 comments we received
consisted of one of three electronic form letters drafted by a national
animal welfare organization and endorsed by its supporters, some of
whom added their views to the letter. We received comments from members
of Congress, animal welfare organizations, animal rescue and sheltering
organizations, licensed animal dealers, breeders, and exhibitors,
kennel clubs, zoos and aquariums, theme parks, animal reserves,
veterinarians and veterinary organizations, and members of the public.
Issues raised by commenters are discussed below by topic. We address
the issues in the order that they pertain to the regulatory text of the
proposed rule.
Definitions
We proposed to amend Sec. [thinsp]1.1, ``Definitions,'' by
removing the term AC Regional Director, as Animal Care is no longer
organized under regions and regional directors. We proposed replacing
references to the AC Regional Director with Animal Care Deputy
Administrator and regional offices with the appropriate Animal Care
office.
One commenter opposed replacing many tasks that have historically
been under the oversight of each Regional Director and stated that
placing them under the oversight of the Deputy Administrator would be
contrary to APHIS' own strategic plan. A few commenters stated that
this proposed change suggests that APHIS is attempting to install an
unqualified third party lacking in veterinary experience and
credentials.
We disagree with the commenters. The Deputy Administrator of Animal
[[Page 28773]]
Care has been delegated the authority by the Administrator of APHIS to
direct activities to ensure compliance with, and enforcement of, the
AWA.\2\ The replacement of the term AC Regional Director with Deputy
Administrator reflects the current organizational structure of Animal
Care and not a change in the authority of the Deputy Administrator. The
Deputy Administrator of Animal Care is not required to have veterinary
experience or credentials in order to be qualified.
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\2\ See 7 CFR 371.7.
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Business Hours
We proposed to revise the definition of business hours in Sec. 1.1
of the regulations so that the term no longer limits inspection times
to ``Monday through Friday, except for legal Federal holidays.'' We
changed the definition to mean ``a reasonable number of hours between 7
a.m. and 7 p.m. each week of the year, during which inspections by
APHIS may be made.'' We made this change to accommodate persons who are
employed in other types of work and are not usually available for
inspections during the day on Monday through Friday.
One commenter disagreed with our proposed change to business hours,
stating that it is unclear what USDA means by ``reasonable.'' The
commenter considered ``reasonable'' to be a minimum of 30 hours a week
and not just weekends, and noted that not being present at the facility
is a tactic on which licensees have often relied to avoid inspections.
The AWA authorizes USDA personnel to have access, at all reasonable
times, to the places of business and the facilities, animals, and
records of dealers, exhibitors, research facilities, carriers, and
intermediate handlers.\3\ As discussed in the proposed rule, we have
observed a number of licensees who are not available for a reasonable
number of hours between 7 a.m. and 7 p.m. Monday through Friday because
they are employed full-time elsewhere during the weekdays or because
they operate at reduced hours on weekdays to allow customers to visit
their business on the weekends. We are therefore making the change as
proposed to reflect these business practices and to ensure that such
licensees are able to make their place of business and facilities,
animals, and records available for inspection at all reasonable times
as required by the Act. APHIS will continue to coordinate with
licensees and registrants who do not maintain regular public business
hours to establish optimal times for inspection.
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\3\ 7 U.S.C. 2146(a).
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A commenter stated that removing the business hour designation from
Monday through Friday may negatively impact larger zoos and aquariums,
as weekend staffs at these businesses are usually smaller than during
the week.
A licensee or registrant that is available a reasonable number of
hours only Monday through Friday would still meet the definition of
business hours for the purpose of inspections. It is not our intent to
require that licensees and registrants be available for a reasonable
number of hours on every day of the week, but rather a reasonable
number of hours collectively during the course of a week. Therefore, we
are making no changes to the rule in response to this comment.
Additional Definitions
Several commenters asked that we add definitions to Sec. 1.1,
including a definition of ``affirmative demonstration of compliance,''
to be defined as the demonstration of compliance with the Act, the
regulations, and standards as documented on inspection reports created
as part of the application or inspection process for the current period
of licensure. In making this request, a few commenters suggested that
without such a definition, APHIS hinders licensing by subjectively
interpreting what constitutes compliance. Some persons commenting on
the ANPR had also asked that we provide such a definition.
We are making no changes to the rule in response to these comments.
The rule already specifies that a license applicant must demonstrate
that his or her location and any animals, facilities, vehicles,
equipment, and other locations used or intended for use in the business
comply with the AWA and the regulations. How APHIS inspectors document
noncompliances is immaterial to whether the applicant demonstrates
compliance.
Several commenters asked that we add a definition for ``breeding
female'' to Sec. 1.1. Some commenters also asked that we define
``puppy mill'' in the regulations.
We are making no changes to the rule in response to these comments.
However, we note that USDA has explained its thinking on the meaning of
the term ``breeding female'' in a previous rulemaking: ``While we
recognize that breeders have several reasons for not breeding an intact
female, for the purposes of enforcement, APHIS has to assume that a
female that is capable of breeding may be bred. However, in determining
whether an animal is capable of breeding, an APHIS inspector will take
into consideration a variety of factors, including the animal's age,
health, and fitness for breeding.'' \4\ As for the term ``puppy mill,''
we do not use the term, nor will we define it, as it does not appear in
the Act or in our regulations.
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\4\ 78 FR 57227 (Sept. 18, 2013); https://www.federalregister.gov/documents/2013/09/18/2013-22616/animal-welfare-retail-pet-stores-and-licensing-exemptions.
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Licensing Requirements
In Sec. 2.1, we proposed changes to the information required to be
submitted in the licensing application, including requiring applicants
to indicate the maximum number of animals on hand at any one time,
types of animals anticipated to be held or exhibited, information
demonstrating that applicants have adequate knowledge of and experience
with the animals, and disclosure of any previous animal welfare pleas
of no contest or findings of violations. We proposed these changes to
help strengthen compliance with the AWA regulations.
Required Information on Application
A few commenters recommended that the license form furnished by the
Deputy Administrator in Sec. 2.1(a)(1) be applicable to a person
renewing a license as well as a person seeking a license.
We are making no changes in response to this comment because this
rulemaking removes the license renewal process from the regulations.
A commenter requested that we add a planned business hours section
to the license application form to assist inspectors in gaining entry
to operation on first contact. The commenter stated that APHIS
inspection reports indicate that inspectors frequently have been unable
to enter a facility on arrival due to no one being onsite, which
removes the benefit of the unannounced inspection. The commenter asked
if more could be done to ensure the unannounced inspection occurs on
the first attempt.
We do not believe requiring licensees to put their business hours
on the application to be helpful to the inspectors, nor is it necessary
for conducting unannounced inspections or scheduling prelicense
inspections. We define business hours for inspections to be a
reasonable number of hours between 7 a.m. and 7 p.m. each week of the
year to provide additional flexibility for inspectors to gain entry on
the first contact. As noted above, we have observed that a number of
licensees are employed full-time elsewhere during
[[Page 28774]]
the weekdays or operate at reduced hours on weekdays. We have
additional communication tools to ensure the licensee is available for
unannounced inspections. If a licensee or registrant is chronically
unavailable for unannounced inspections, we take steps to remedy the
situation, including attempting inspections at different times and days
of the week. If necessary, we will coordinate with the person to
establish an optimal inspection time range that includes multiple
blocks of days of the week and multiple blocks of time in which they
are available for an unannounced inspection. We will also pursue
enforcement and other remedial actions if necessary. Accordingly, we
are making no changes to the rule in response to this comment.
A commenter recommended that, in order to ensure that disclosure
requirements have the intended impact, APHIS should include warning
language on the license application that clearly informs applicants of
the consequences of providing false information, including penalty of
perjury.
We agree with the commenter. Sections 2.11 and 2.12 of the
regulations state that a license applicant who has made false or
fraudulent statements or provided false or fraudulent records to USDA
may have their application denied or their license terminated, if
already issued. We will include this information on the new license
application form.
A commenter supported our proposed action to remove the
``intention'' to operate as an exhibitor from Sec. 2.1(a) to make it
more difficult for persons to obtain licenses solely for the purpose of
circumventing State laws restricting the private possession and sale of
exotic and wild animals (by only intending to exhibit but not actually
exhibiting them). The commenter stated, however, that APHIS should take
even greater steps to prevent this circumvention from occurring by
asking applicants about insurance coverage, business advertising, and
exhibition travel schedules on the application form in order to
identify licensees keeping exotic animals only as pets.
We acknowledge the commenter's concerns but are making no changes
to the rule. Should we have concerns that a person is holding an AWA
license to circumvent State laws restricting the private possession and
sale of exotic and wild animals, we have the authority under Sec.
2.125 of the regulations to request information concerning the business
to assess whether the person is engaging in activities for which a
license is required.
On the other hand, a commenter opposing the rule said that APHIS'
attempt to prevent persons from circumventing State law to keep exotic
and wild animals violates statutes enforced by the Federal Trade
Commission, and that the Federal Government is not allowed to
circumvent State laws.
We disagree with the commenter. This change in the regulations
supports, rather than circumvents, State laws. The AWA authorizes and
encourages APHIS to cooperate with State and other officials in
carrying out the purposes of the AWA and any State, local, or municipal
legislation or ordinance on the same subject. Finally, the regulations
in Sec. Sec. 2.11 and 2.12 have long stipulated that any license
applicant or holder who is violating or circumventing State law may be
subject to the denial or termination of a license.
A commenter asked APHIS to require that any applicant operating
under the name of a business disclose the business name in addition to
their legal name, and to issue the license under the business name. The
commenter also asked us to require disclosure of not only the names of
the individual and business applying for a license, but also the names
of all business associates and relatives involved in the business at
the time of application and after. Finally, a few commenters requested
that APHIS add a new field on the application form and require
disclosure of any names under which the business formerly operated.
We are making no changes to the rule in response to this comment.
The license application form requires that applicants provide any
previous USDA license number(s) and any active license numbers in which
the applicant has an interest. In addition, the applicant must report
any partners or officers, all business names, and locations. Should we
require additional information, we have the authority under Sec. 2.125
of the AWA regulations to request information concerning the business.
In proposed Sec. 2.1(a)(1)(v), we required that license applicants
disclose the anticipated type of animals to be owned, held, maintained,
sold, or exhibited during the period of licensure and whether these
include exotic or wild animals. If exotic or wild animals are included,
we required that applicants provide information and records
demonstrating they have adequate knowledge of and experience with those
animals.
A commenter stated that it is unclear why only applicants intending
to hold exotic or wild animals need to demonstrate knowledge and
experience in caring for those animals. The commenter stated that all
applicants should be required to demonstrate knowledge and experience
with any species they intend to obtain.
We agree with the commenter. In establishing regulatory standards
of care \5\ for all covered animals--wild, exotic, or otherwise--APHIS
requires that all licensees demonstrate knowledge and experience
sufficient to caring for their animals, regardless of species, and we
note there are many ways that applicants can demonstrate this. For this
reason, we are amending the proposed rule by removing the additional
information and records requirement in paragraph (a)(1)(v).
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\5\ The statutory bases for these standards are located in
section 2143 of the AWA, paragraphs (a)(1) and (a)(4).
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In Sec. 2.1(a)(1)(vii), we proposed requiring license applicants
to disclose any plea of no contest or finding of violation of Federal,
State, or local laws or regulations pertaining to animal cruelty or the
transportation, ownership, neglect, or welfare of animals. A
substantial number of commenters agreed with this provision. We noted
in the preamble to the proposed rule that the current regulations
already set forth provisions for the denial of a license for persons
with animal cruelty convictions and certain other violations of
Federal, State, or local laws pertaining to animals, and that this rule
further supports this existing licensing restriction by requiring
disclosure of such violations on the license application.
A commenter agreed with this provision and recommended that we also
require disclosure of animal- or consumer-based legal violations (such
as illegal import or export of animals or animal parts or products) and
any licensing denial, revocation, or similar actions taken by any
State, Federal, or local authority for activity relating to animal
husbandry or sales. The commenter also stated that any animal cruelty
conviction or plea, whether incurred during the preceding 3 years or
otherwise, should disqualify an applicant from obtaining a license. The
commenter asked that we include these provisions in Sec. 2.11.
Another commenter supporting disclosure of pleas or convictions of
animal cruelty in proposed Sec. 2.1(a)(1)(vii) stated that local
cruelty laws vary widely from one jurisdiction to another and that some
offenses, such as failure to license an animal or certain tethering
violations, do not bear directly on animal welfare or constitute
cruelty. For this reason, the commenter
[[Page 28775]]
suggested that the proposed language for disclosing pleas and
violations be amended to include only activities like those covered
under the Act.
Under Sec. 2.11(a)(5), APHIS will not issue a license to any
applicant who has pled or been found to have violated any Federal,
State, or local laws or regulations pertaining to animal cruelty within
3 years of application, or after 3 years if the Administrator
determines that the circumstances render the applicant unfit to be
licensed. We will apply this provision if the applicant meets these
conditions. Likewise, under Sec. 2.11(a)(7), APHIS will not issue a
license to any applicant who pled or has been found to have violated
any Federal, State, or local laws or regulations pertaining to the
transportation, ownership, neglect, or welfare of animals, or is
otherwise unfit to be licensed and the Administrator determines that
the issuance of a license would be contrary to the purposes of the Act.
In order to make this determination, we require the disclosure of all
such pleas and violations as required under Sec. 2.1(a)(1)(vii).
Accordingly, we do not consider it necessary to make changes based on
this comment.
Locations, Numbers, and Types of Animals
The current regulations do not require a licensee to demonstrate
compliance when making changes to his or her animals or locations,
including noteworthy changes to the numbers or types of animals used in
regulated activity. This allows a licensee to acquire substantially
more or different types of animals than what he or she had when the
license was originally issued. Therefore, we proposed in revised Sec.
2.1(b)(1) to require licensees to notify Animal Care no fewer than 90
days before making any changes to the name, address, substantial
control, or ownership of the business or operation, locations,
activities, and number or type of animals described in Sec. 2.1(b)(2).
After the licensee demonstrates compliance under the changes and
fulfills all other regulatory requirements, APHIS would issue a new
license with a new certificate number.
A substantial number of commenters supported this proposed
requirement. Among them, one commenter stated that APHIS should also
review patterns of small changes not considered noteworthy but which
could have significant cumulative impact on animal welfare.
We are making no changes in response to that comment. With respect
to evaluating facilities, we note and consider any change, regardless
of size, that may have an impact on animal welfare.
On the other hand, some commenters opposed the proposed requirement
for new licenses for facilities that change their operations or the
type or number of animals they display, claiming that the requirement
is overly broad and burdensome and would require facilities that make
even minor changes to their facilities or collections of animals to
seek new licenses. Many of these commenters supported requiring
licensees to notify APHIS of a change in regulated activities only if
the change has an actual demonstrable impact on the normal operating
procedures of the licensee. Similarly, a commenter representing a
zoological park stated that the additional regulation of obtaining a
new license when making a noteworthy change is excessive, as the USDA
license is for the functioning of the entire zoo and not for one small
part of a facility that may have a noncompliant issue. Another
commenter stated that slight changes to regulated activities should
need no review, and specifically cited riding and feeding animals, and
animals used in circus and movie work.
We are making no changes in response to the comments. In developing
the list of conditions in Sec. 2.1(b) that trigger the need for a new
license, we considered several factors, including the complexity of
care the animals require, the varying regulations and standards for
different types of animals, and the number of animals at facilities.
Our focus is on requiring facilities to demonstrate compliance when
acquiring animals subject to different standards or that have special
husbandry and care needs, or when expanding the size of their animal
collection significantly from the time of licensure. We believe this
demonstration is important for ensuring that such facilities maintain
compliance with the AWA during their period of licensure.
Several commenters stated that the proposal to require a new
license whenever a facility makes any change in substantial control or
ownership is vague and overly broad. One such commenter asked that we
state more clearly when a new license is needed under this type of
change.
We appreciate the opportunity to clarify the proposed rule in
response to these comments. Licenses are issued to specific persons,
which is defined in the AWA regulations to mean, ``individual,
partnership, firm, joint stock company, corporation, association,
trust, estate, or other legal entity.'' If the ownership of a licensed
facility changes (i.e., if a new ``person'' or group of persons assumes
ownership \6\), the new owner would need to obtain a license.
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\6\ New ownership as described here typically involves the
facility being associated with a different Internal Revenue Service-
issued Employer Identification Number (EIN). An EIN cannot be
transferred to another owner.
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A new license is also required if the ownership structure is
modified such that it changes who has substantial control of the
business. For example, the business' ownership model may change from an
individual to a partnership or corporation, or vice versa. If a
business is sold to another party, or if the licensee passes away and a
new owner (including relatives) takes possession, a new license is
required. Licenses are issued specific to certain activities (such as
exhibition), so a new license would be required if, for example, a
breeder wants to begin operating as an exhibitor. Because licenses are
site-specific, any change in location of the animals also requires a
new license. APHIS will provide additional guidance on this topic to
include examples that indicate when a new AWA license is needed.
A few commenters expressed the view that requiring a new license
whenever a facility undergoes a change in management is an unnecessary
intrusion into a licensee's business activities. One such commenter
said that if any management changes to a facility are necessary, the
Agency should confine its role to simply requiring advance notice of
such changes and allow the facility to keep its existing license.
While a change in ownership would require a new license under the
proposed regulations, changes in operational management of a facility
typically would not. Accordingly, we are revising proposed Sec.
2.1(b)(1) to exclude changes in management as requiring a new license.
Similarly, a licensee that changes only the name of the business would
not require a new license, unless the name change is associated with a
change in ownership.
Some commenters expressed concerns about the minimum 90-day notice
that must be given to APHIS before any change is made to the business
or operation as required in Sec. 2.1(b)(1). The commenters' concerns
focused on situations where changes to the facility would need to be
made in a shorter period due to unexpected circumstances such as the
death of an owner or damages to the facility that affect the welfare of
the animals held by the licensee.
We acknowledge that unexpected situations (such as natural
disasters) can
[[Page 28776]]
arise and note that we have the discretion to suspend enforcement in
such situations.
In Sec. 2.1(b)(1), we proposed that any person who intends to
exhibit any animal at any location other than the person's approved
site must provide that information on their application in accordance
with proposed Sec. 2.1(a)(1)(iii) and submit written itineraries in
accordance with Sec. 2.126. We noted that if the application did not
provide such information, then a new application would have to be
submitted and a new license obtained before exhibiting at locations
other than the approved site.
A commenter operating as an exhibitor asked us to explain how to
complete the license application with respect to the location of
animals. The commenter asked whether licensees should indicate on the
application that they exhibit at offsite locations and then follow up
with itinerary filings, or whether each exhibition location would need
to be listed and approved upon application for the license. The
commenter stated that it is unfair to require licensees to know their
entire traveling itinerary for up to a year in advance, much less 3
years.
We appreciate the opportunity to clarify how this requirement will
be implemented. The applicant will need only to specify on the
application that they intend to exhibit at off-site locations, and then
follow up with submission of itineraries in accordance with Sec.
2.126.
Changes to Number of Animals Used in Regulated Activities
We proposed in Sec. 2.1(b)(2) that licenses will authorize
increments of 50 animals on hand at any single point in time during the
period of licensure, and that licensees must obtain a new license
before any change resulting in more than the authorized number of
animals on hand at any single point in time. Licensees falling below de
minimis are still licensed and subject to the regulations unless they
choose to terminate their license. If they terminate their license then
later exceed the de minimis level and continue to conduct regulated
activity, they would need to reapply for a license.
Several commenters suggested that when licensed exhibitors obtain
more animals, they should have to seek APHIS approval for the
additional animals regardless of number.
We are making no changes to the rule in response to this comment.
In deciding on the range of the number of animals we considered several
factors, including the impact on compliance and the burdens associated
with obtaining a new license. We do not believe that a new license is
necessarily required every time a facility acquires an additional
animal.
A commenter recommended that APHIS base the authorized number of
animals on a relative change in size rather than on a flat threshold of
50 animals. The commenter added that this determination should be made
by observing the actual number of animals present during the prelicense
inspection rather than on the licensee's reporting.
We are making no changes to the rule based on this comment. The
rule requires applicants to provide the anticipated maximum number of
animals on hand at any one time during the period of licensure. This
number may not match the number of animals on hand during the
prelicense inspection (although the number of animals on hand during
the prelicense inspection should not exceed the maximum number reported
on the application). During the prelicense inspection, APHIS will
determine whether the animals, facilities, vehicles, equipment, and
locations are in compliance, taking into account the anticipated
maximum number of animals on hand.
Another commenter said that our proposal to authorize increments of
50 animals is arbitrary and does not serve its intended purpose. The
commenter added that an increase of 50 in one species might require
very little change in facilities and resources, whereas an increase of
only a few of another species might completely change the nature of the
operations. The commenter recommended that APHIS not provide licenses
for increments of 50 animals, but should instead provide licenses based
on the anticipated maximum number of animals possessed during the 3-
year period of licensure.
We are making no changes to the rule in response to this comment.
The purpose of this requirement is to ensure a licensee's facilities
are compliant with the AWA regulations and standards for the
anticipated number and type of animals to be held or used during the
period of licensure. Not all facilities will have a static inventory of
animals or have all of their animals on-site for the entire period of
licensure. For example, a dog breeding facility may have a large number
of animals over the course of 3 years, but a small number of animals on
hand at any single point in time. The facility would need to
demonstrate compliance for the maximum anticipated number of animals on
hand at any single point in time during the period of licensure.
A commenter stated that APHIS should clarify the requirements for
disclosure of the anticipated number of animals to account for
potential offspring (whether or not there is an intention to breed), in
order to account for fraudulent disclosures. The commenter cited the
example of an applicant who has 50 dogs, 40 of which are unaltered
females, who claims no intention to breed those dogs yet could have
them produce 40 separate litters of puppies. On the other hand, several
commenters stated that not all breeding females are used for breeding.
One such commenter stated it is important to define the term ``breeding
female'' in a clear and reasonable manner, adding that just because a
female dog is not spayed does not mean she is a breeding female.
We note that the prelicense demonstration of compliance would take
into account the breed of dog, the number of breeding female dogs, the
projected litter size, and the facility's business model for selling
and placing puppies and adult dogs who are no longer used for breeding
purposes. For the purposes of enforcement, APHIS assumes that a female
dog that is capable of breeding may be bred. If a person uses animals
for purposes counter to what the license allows, including breeding
dogs that were indicated during the inspection to be no longer used for
breeding, we will investigate such instances and take appropriate
action.
A commenter stated that APHIS is forcing people to circumvent the
burdens being placed on them by the Agency and asked, by way of
example, if there is anything that would prohibit his spouse or child
from keeping 200 more animals outside the perimeter of his licensed
facility.
We note in response that this rulemaking will actually relieve
paperwork burden and reduce fees for many licensees. To answer the
commenter's question, we reply that the licensee, or any other person
using or maintaining animals in such a manner that he or she requires a
license, is subject to the AWA regulations and any prohibitions
applicable to the situation described.
Changes to Types of Animals Used in Regulated Activities
Proposed Sec. 2.1(b)(2) provides that licenses will authorize
specific numbers and types of animals. Section 2.1(b)(2)(ii)
specifically authorizes licenses for using animals that are subject to
subparts A through F in part 3. However, with respect to licenses for
using animals subject to subparts D and
[[Page 28777]]
F, licenses will separately authorize the use of each of the following
groups of animals: (1) Group 5 and 6 nonhuman primates, (2) big cats or
large felids, (3) wolves, (4) bears, and (5) mega-herbivores. We noted
that these groups of animals would be separately authorized because
they are potentially dangerous and have unique care needs. We also
included a provision requiring licensees to obtain a new license before
using any animals beyond those animals authorized for use under the
existing license for activities for which a license is required. We
proposed these changes based on our experience with administering and
enforcing the AWA, noting that licensees sometimes struggle to achieve
and maintain compliance after making noteworthy changes to the numbers
or types of animals used in regulated activity.
A commenter suggested that APHIS should make it more clear in
proposed Sec. 2.1(b)(2)(ii) of the regulations that if a licensee
wishes to obtain any new species, he or she is required to obtain a new
license.
We note in Sec. 2.1(b)(1) that licensees are required to notify
Animal Care no fewer than 90 days, and obtain a new license, before
making any change in the number or type of animals described in
paragraph (b)(2).
A commenter supported the proposed requirement for a new license
for dangerous and exotic animals with unique care needs, but requested
more information as to what animals we would include under such a
license beyond obvious ones such as elephants, big cats, and bears. The
commenter noted, for instance, that servals are potentially dangerous.
On the other hand, several commenters opposed the proposal to
require a new license for each new species acquired, and one such
commenter recommended that APHIS set up several classes of animals
based on level of risk and complexity of care. The commenter offered as
an example a class for domestic and farm animals, a class for small
exotics, and a class for large exotics. Under this arrangement, the
commenter suggested, a licensee could acquire any animal from the
animal class they are licensed for, or any lesser class, without having
to reapply for a new license.
We agree that there are other potentially dangerous animals that
fall under the general standards in subpart F of part 3 that should be
separately authorized. Accordingly, we are revising our proposed groups
of animals that require separate authorization as follows: (1) Group 5
(baboons and nonbrachiating species larger than 33 pounds) and 6 (great
apes over 55 pounds and brachiating species) nonhuman primates; (2)
exotic and wild felids (including but not limited to lions, tigers,
leopards, cheetahs, jaguars, cougars, lynx, servals, bobcats, and
caracals, and any hybrid cross thereof); (3) hyenas and/or exotic and
wild canids (including but not limited to wolves, coyotes, foxes, and
jackals); (4) bears, and (5) mega-herbivores (elephants, rhinoceroses,
hippopotamuses, and giraffes).
A commenter recommended that we include Category E, marine mammals,
under the considerations for licensing along with large primates, large
carnivores, and mega-herbivores. The commenter added that a facility
that passes a prelicense inspection to house sea lions is not
automatically prepared to handle orcas, for example. This and other
commenters also noted that as polar bears are considered a marine
mammal and bears are listed as a Category F animal requiring special
considerations, Category E should be listed under the considerations
for licensing so that polar bears do not fall into a regulatory
loophole.
We acknowledge the commenters' concerns but are making no changes
to the rule on this topic. As a practical matter, marine mammals are
already highly regulated animals with respect to their welfare and
species-specific needs. In addition to protection under the AWA, all
species of marine mammals are protected under the Marine Mammal
Protection Act (MMPA), and some are also protected under the Endangered
Species Act and the Convention on International Trade in Endangered
Species of Wild Fauna and Flora. These animals include whales,
dolphins, porpoises, seals, sea lions, walruses, polar bears, sea and
marine otters, dugongs, and manatees. Polar bears are provided
additional protection under the International Agreement on the
Conservation of Polar Bears, an agreement between the United States,
Canada, Denmark, Norway, and Russia, which is implemented in the United
States by the provisions of the MMPA.
One commenter asked if a new license is needed for adding other
cetaceans if the facility already has one kind of cetacean.
If the species of cetacean being added is different from the
species authorized under the existing license, a new license would be
required in accordance with proposed Sec. 2.1(b)(2)(ii).
Another commenter asked about the impact of the proposed licensing
requirement for changes to numbers and types of animals on the practice
of rescuing and rehabilitating stranded marine mammals.
Unless the rescued marine mammals are exhibited (see the definition
of exhibitor in Sec. 1.1) by the rescue or rehabilitation facility,
there is no impact on such facilities. The animals are regulated under
the MMPA by the National Oceanic and Atmospheric Administration or the
U.S. Fish and Wildlife Service, depending on the species involved.
A commenter asked APHIS to require more specificity from licensees
regarding the types of animal they plan on keeping. The commenter
stated that the categories of animals in part 3 are typed too broadly
for APHIS to ascertain whether an applicant can properly care for
particular animals and suggested that APHIS instead require disclosure
by species rather than type.
We appreciate the opportunity to make clear that applicants would
need to specify the anticipated species or common names of animals
owned, held, maintained, sold, or exhibited during the period of
licensure.
One commenter stated that licensees acquiring nondomestic animals
should be required to indicate the type, weight, and risk factor of the
animal and that APHIS should confirm that a suitable secure enclosure
is available to house the new animal. The commenter also recommended
that the animals have an assigned veterinary clinic.
We are making no changes to the rule in response to this comment.
During prelicense inspections, Animal Care inspectors assess facility
compliance with the AWA regulations, which require animals to be in
good health and have adequate space. Each facility is also required to
have an attending veterinarian with knowledge of and experience with
the animals at that facility and a program of veterinary care for those
animals.
A commenter stated that if a licensee has acquired animals that
they are incapable of caring for, this possibility should be addressed
more frequently than every 3 years. The commenter also questioned why a
licensee with an excellent compliance history needs to reapply for a
license every 3 years and reasoned that a simple renewal would be
appropriate for such facilities and consistent with APHIS' risk-based
approach. Another commenter asked APHIS to reconsider its proposal to
require new licenses and prelicense inspections for zoological
facilities in good standing that make changes to the species or number
of animals they display. The commenter stated that APHIS' policy
objectives can easily be
[[Page 28778]]
achieved during the already existing inspection process.
We are making no changes to the rule in response to these comments.
If a facility is in compliance, the process for applying for a new
license will be simple, with less paperwork and reduced fees by
comparison with the current license renewal process. Similarly,
facilities that wish to add animals to their collection under a new
license class will be able to do so easily by completing an application
form, paying the applicable fees, and demonstrating compliance with the
AWA regulations. During this time, the facility can continue to use the
animals authorized by their existing license for regulated activity
with no disruption to business.
One commenter opposing the rule stated that the number of animals a
licensee owns is not regulated under the AWA and therefore should not
be considered in the regulations.
USDA's authority to set criteria for licensing comes from section
2133 of the Act, which directs the Secretary to issue licenses to
dealers and exhibitors upon application and payment of the applicable
fees, provided that the applicant has demonstrated compliance with the
AWA regulations. The number and type of animals that an applicant
intends to use for regulated purposes has a direct bearing on
compliance with the AWA regulations. Moreover, section 2133 authorizes
USDA to prescribe the ``form and manner'' of applications.
License Fees
In the ANPR, we asked for comment on what fees would be reasonable
to assess for licenses. We received a wide range of responses,
including those from commenters who suggested raising fees as a way to
discourage dog breeding, as well as those from other commenters who
asked that we eliminate licensing fees entirely to relieve burden on
small businesses. Many commenters suggested sliding scales based on
business size and complexity that would allow APHIS to recover its
inspection costs. After reviewing these comments on the ANPR, we
decided to propose amending paragraph Sec. 2.1(c)(2) of the
regulations by requiring a flat license fee of $120.
Several commenters responded to our proposed changes to the license
fees. A commenter said that the USDA has not raised licensing fees in
30 years and that lowering the fees would be arbitrary, capricious, and
in violation of several statutory requirements. The commenter also
stated that current license fees do not cover the cost of issuing the
license, thus causing taxpayers to subsidize the costs, and asked us
not to reduce the fees. Another commenter stated that fees should be
raised to keep pace with inflation and account for the Agency's
enforcement burdens. The commenter provided data to illustrate that
annual rates should be doubled to compensate for inflation and stated
that the lowest fee to be paid every 3 years, when adjusted for
inflation, would be $180, with the highest being $4,515 for the largest
facilities. Another commenter stated that the proposed flat fee of $120
is contrary to the Act because it is inequitable. The commenter cites a
passage in the Act stating that fees for licenses ``shall be adjusted
on an equitable basis taking into consideration the type and nature of
the operations to be licensed,'' and notes that a facility that
receives $1,000,000 in annual income paying the same fee as a facility
that receives $10,000 annually is not an equitable fee because it is
neither ``adjusted'' nor considers the type and nature of the
operations as required by the statute. The commenter stated that USDA
should instead scale fees based on the numbers of animals and the
complexity involved in caring for and inspecting the animals. Finally,
a commenter stated that APHIS is not meeting the requirements of the
Independent Offices Appropriations Act,\7\ which provides that Federal
agencies may set fees that are based on costs to the Government and the
value of the permit to the recipient, among other factors.
---------------------------------------------------------------------------
\7\ 31 U.S.C. 9701.
---------------------------------------------------------------------------
We appreciate the many comments we received on license fees but are
making no changes to the proposed fee. Under the AWA, the Secretary
shall charge, assess, and cause to be collected reasonable fees for
licenses issued. Such fees shall be adjusted on an equitable basis
taking into consideration the type and nature of the operations to be
licensed and shall be deposited and covered into the Treasury as
miscellaneous receipts. These fees are not user fees and are not used
to cover the cost of licensing, inspection, enforcement, or other APHIS
services. Also, the Independent Offices Appropriations Act does not
apply to AWA licensing fees, because USDA was granted specific
statutory authority to assess them.\8\
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\8\ 7 U.S.C. 2153.
---------------------------------------------------------------------------
As discussed in the proposed rule, we took into account the type
and nature of operations to be licensed and conducted a formal economic
analysis. One alternative to a flat fee that we considered was to
establish scaled fees, similar to those in the current regulations.
However, we found it difficult to do so in an equitable way. For
example, some dealers and exhibitors with small numbers of animals may
derive significant income from their regulated activities, while other
dealers and exhibitors with large numbers of animals may derive more
modest incomes from their activities, based on the types of animals,
location of their business, business model, and a variety of other
factors. Accordingly, we are establishing the flat fee of $120 for
licensure, which represents a fee that is comparable to, or in many
cases reduced from, existing fees for licensure. In addition to being
an equitable fee for licenses that considers the type and nature of the
operations to be licensed, the fee structure allows for more efficient
and streamlined business processes for Animal Care and simplifies the
calculation of licensing fees for applicants.
A lesser number of commenters asked that we consider lowering or
eliminating license fees, with many noting that any type of fee places
an unfair burden on smaller dog breeding facilities.
We disagree with these commenters. While the current regulations
require an annual license application and fees ranging from $40 to $760
annually, this rule only requires an application and a flat $120 fee
every 3 years, which would be equivalent to the current lowest fee of
$40 (if applied annually over 3 years). Accordingly, we do not believe
that the licensing component of this rule places additional or undue
burdens on license holders or applicants and will in fact reduce
paperwork burdens on them, as well as reduce licensing fees for many of
them. For these reasons, we are making no changes to the rule in
response to this comment.
License Denial and Suspension
In proposed Sec. 2.1(d), we reassigned an existing provision from
Sec. 2.1(e) stating that any failure to comply with the Act,
regulations, or standards would be grounds for denial, suspension, or
revocation of a license as provided in the AWA.
A few commenters recommended revising Sec. 2.1(d)(1) to read, ``A
licensee who has a record of affirmative demonstration of compliance
and is thus eligible for renewal must submit to the appropriate Animal
Care regional office a completed application form and the required
license fee indicated in Sec. 2.1(a)(2) by certified check, cashier's
check, personal check, money order, or credit card.''
We are making no changes to the rule in response to this comment.
We have revised Sec. 2.1(d). Licenses are no longer
[[Page 28779]]
renewable, and compliance as a condition of licensure is already made
clear in other sections.
Demonstration of Compliance
Although an applicant for a license renewal currently must also
certify, to the best of his or her knowledge and belief, that he or she
is in compliance with all regulations and standards, we noted in the
proposed rule that the regulations do not require the applicant to
actually demonstrate compliance during an inspection before APHIS
renews his or her license.
Demonstration of compliance as a condition of licensure was
supported by a majority of persons commenting on the ANPR and proposed
rule. As noted above, many commenters also expressed support for APHIS
to require a new license whenever noteworthy changes are made to a
facility, its management, or its operation, or to the number, type, or
location of animals used in regulated activities.
A substantial number of commenters asked APHIS to stop ``rubber
stamping'' licenses without requiring compliance with the regulations.
We disagree with this characterization and note that Sec. 2.3
currently requires that license applicants demonstrate compliance with
the AWA regulations during an inspection before APHIS will issue a new
license to them. APHIS also conducts regular inspections of licensed
facilities under a risk-based inspection system that calls for frequent
and in-depth inspections at facilities with a higher risk of animal
welfare concerns, and fewer at those that are consistently in
compliance. As we noted above, the proposed changes eliminate the
annual license renewal and require instead passing a prelicense
compliance inspection to obtain a new license every 3 years.
Many commenters called for a ``zero tolerance'' approach to AWA
violations found during prelicensing inspections, regardless of the
degree of the infraction.
Both current and proposed Sec. 2.3 require that applicants
demonstrate compliance with the AWA and the regulations before any new
license is issued. An applicant failing the first inspection may
request up to two more inspections to demonstrate compliance. If the
first inspection reveals noncompliant issues, APHIS will advise the
applicant of existing deficiencies and the corrective measures that
must be completed to come into compliance. In the subsequent
inspection, we verify that the applicant has taken any and all
prescribed corrective measures. Under this approach, APHIS will not
issue licenses to applicants with uncorrected deficiencies.
Accordingly, we see no need to make changes in response to these
commenters.
A commenter asked that the USDA put safeguards in place to ensure
that it does not continue renewing licenses from facilities that it
knows or should know are not in compliance with the AWA. Citing a
lawsuit filed by the commenter's organization against the USDA, the
commenter stated that it would be arbitrary and capricious for the
agency to renew the license of a facility despite having ``smoking
gun'' evidence of noncompliance at that facility.
We are making no changes in response to this comment because this
rule removes the license renewal process from the regulations.
Licensees will have to demonstrate compliance with the AWA before being
issued a license.
A commenter stated that the proposal is deficient in that it still
allows a licensee with a history of noncompliances to obtain a new
license every 3 years as long as they pass the prelicense inspection by
the third try. The commenter urged APHIS to amend its regulations to
ensure that facilities with a history of substantial noncompliance,
during either the prelicense or license periods, are not issued new
licenses and are prohibited from re-applying for new licenses for a
period of at least 3 years.
We are making no changes to the rule in response to this comment.
Under this final rule, licenses are valid for 3 years and applicants
must demonstrate compliance before obtaining a license. If a previous
licensee with a history of repeat noncompliances wishes to obtain a new
license, they would need to demonstrate compliance with the AWA
regulations before we will issue a license to them. Separate from these
requirements, APHIS also has the authority under the Act to deny and
terminate licenses when a person is unfit to hold a license and to
pursue civil penalties and other sanctions for violations after the
person is given notice and the opportunity for a hearing.
Several commenters recommended that APHIS consider creating and
using a sliding scale or a tiered system of noncompliances for greater
fairness and accuracy when determining a facility's compliance with the
regulations.
Licensed facilities are expected to comply with the AWA regulations
and standards. USDA conducts regular inspections of licensed facilities
under a risk-based inspection system that calls for frequent and in-
depth inspections at facilities with a higher risk of animal welfare
concerns, and fewer at those that are consistently in compliance. USDA
currently identifies the seriousness of each noncompliance to determine
the appropriate follow-up action. We are therefore making no changes in
response to the recommendation.
One commenter expressed concern that forcing wildlife facilities
with a history of compliance to apply for a license on equal footing
with new applicants fails to recognize the experience of many wildlife
professionals and achievements of superior facilities.
The purpose of this rule is to ensure that licensees are compliant
with the AWA regulations. Although an applicant for a license renewal
under the existing regulations must certify, to the best of his or her
knowledge and belief, that he or she is in compliance with all
regulations and standards, those regulations did not require the
applicant to demonstrate compliance before APHIS renewed the license.
Based on our knowledge and experience with administering and enforcing
the AWA and regulations, we are concerned that even experienced
licensees may sometimes struggle to achieve and maintain compliance
after making noteworthy changes to their animals used in regulated
activity. In addition, we have observed licensees who have been
licensed for many years struggle with compliance because they did not
have adequate programs for maintaining compliance at aging facilities.
For these reasons, we believe that revisions to the regulations set
forth in this final rule are necessary to ensure that dealers,
exhibitors, and operators of auction sales demonstrate compliance with
the AWA regulations.
Several commenters said that USDA is adding terminology to the
regulations that is not defined in the Act and allows for broad
interpretation by Agency employees. These terms include
``demonstrate'', ``unfit'', ``affirmatively'', and ``sustained
compliance''. One commenter said that Agency inspectors interpret these
terms unfairly to find instances of noncompliance to the detriment of
the licensee, resulting in more violations and subsequently more
elimination of licensees.
We disagree with the commenters. The terms ``demonstrate'' and
``unfit'' have been in the AWA regulations for decades, and the terms
``affirmatively'' and ``sustained compliance'' do not appear in the
regulations; they are simply used as descriptive terms in this
rulemaking to help the reader understand the Agency's intent.
[[Page 28780]]
``Demonstrated'' appears in the Act at 7 U.S.C. 2133.
Similarly, a commenter stated that inspections of zoos are not
conducted to note those things that meet or exceed compliance. The
commenter said that any decision about licensing status made about a
facility based only on noncompliant issues is biased and does not
consider the state of the zoo overall, which likely exceeds compliance.
We are making no changes in response to this comment. The AWA
directs USDA to only issue licenses to dealers and exhibitors that have
demonstrated compliance with the AWA regulations. Although certain
aspects of a facility may meet or exceed those requirements, we are not
authorized to issue licenses to dealers and exhibitors who are not in
full compliance with the AWA regulations.
On the other hand, a commenter stated that APHIS should increase
the frequency and rigor of inspections by examining the full operation
for noncompliant issues and not limit inspections in any way. The
commenter noted that in the Animal Care Inspection Guide, APHIS
distinguishes between full or complete inspections on one hand, and
focused or limited inspections on the other. The commenter added that
APHIS should ensure that all prelicense inspections are full rather
than focused to ensure that licenses are not issued to facilities that
fail to meet AWA standards as required by 7 U.S.C. 2133.
We are making no changes to the rule in response to this comment.
During prelicense inspections, USDA conducts full and complete
inspections of applicant locations, animals, facilities, vehicles, and
equipment to assess compliance with the AWA and regulations. This
process is not changing under this final rule.
Several commenters supporting the proposal disagreed with APHIS'
use of ``teachable moments,'' which, according to commenters, are minor
noncompliances discovered during inspections that APHIS does not
document on inspection reports. One such commenter said that USDA has
implemented a variety of problematic practices, including not recording
noncompliant items on any publicly available reports. Another commenter
claimed that teachable moments were developed to protect regulated
entities from public scrutiny for their noncompliance and for this
reason licensing decisions are arbitrary and capricious if based on
documented inspection reports only. The commenter concluded that the
USDA should determine whether an applicant has demonstrated compliance
based on the full administrative record at the time of the licensing
application.
We are making no changes to the rule in response to these comments
because what APHIS inspectors decide to document as noncompliances
during an inspection is outside the scope of this rulemaking.
Furthermore, APHIS inspectors do not use teachable moments for
prelicense inspections or new site approval inspections. As noted
above, USDA conducts full inspections of applicant locations, animals,
facilities, records, vehicles, and equipment to assess compliance and
applicants must demonstrate compliance with the Act and regulations
before a license will be issued.
A few commenters stated that prelicensing inspections should be
conducted without prior notification of the facility to be inspected.
One such commenter expressed concern that announced inspections may
result in the inspector having higher expectations for a facility and
not properly exercising inspector discretion as referenced in the
inspection guide. Another commenter noted that unannounced inspections
are common in other industries such as restaurants.
We proposed no changes to the requirement that prelicense
inspections must be scheduled during business hours and at other times
mutually agreeable to the applicant and APHIS. In addition to
determining if an applicant is in compliance with the AWA and
regulations, we wish to note that interaction with APHIS staff during
the prelicense inspection is the best time for applicants to learn more
about complying with the regulations. Also, scheduled prelicense
inspections allow applicants to prepare files for review and make
personnel available for prelicense inspections.
Several commenters opposed or questioned the need for a prelicense
compliance inspection. One commenter stated that APHIS already ensures
compliance through random inspections as often as every 3 months for
some facilities, once a year for others, and every 2 to 3 years for
others. The commenter added that for the small number of facilities
that are not in compliance, APHIS already has the authority to secure
compliance through a wide range of enforcement tools. The commenter
stated that conducting prelicense inspections on top of its existing
random inspections for its thousands of licensees is a waste of limited
resources and will strain the Agency's inspection capacity. One
commenter noted that if he is found to be in non-compliance, he is
typically provided a certain number of days to correct the problem,
after which his premises are re-inspected to confirm that the problem
has been resolved. The commenter asked why these reinspections do not
qualify as a demonstration of compliance.
Other comments opposed the prelicense compliance inspection on
grounds that it is unfair to facilities with good histories of
compliance. A commenter suggested that businesses with a continuous
record of compliance should receive fewer and fewer inspections over
time. Other commenters cited a 2018 Animal Care Impact Report showing
that high numbers of licensed sites have remained in compliance and
that there is no significant burden posed by renewing licenses
annually. Another commenter representing a marine mammal park stated
that APHIS has reported that 91 percent of the facilities accredited by
the Alliance of Marine Mammal Parks and Aquariums were in compliance
with the AWA in 2018. Another commenter noted that compliance is
checked through random inspections and that the current methods are
successful at ensuring a zoological facility's compliance with the AWA
standards.
As we have noted previously, the existing regulations did not
require an applicant for a license renewal to demonstrate compliance
before renewing his or her license. The existing regulations also did
not require a licensee to demonstrate compliance when making any
changes to his or her animals or facilities, including noteworthy
changes in the number or type of animals used in regulated activity.
However, based on our experience with administering and enforcing the
Act and regulations, we are concerned that licensees may struggle to
achieve and maintain compliance after making such noteworthy changes to
their animals used in regulated activity. In addition, we have observed
licensees who have been licensed for many years may have difficulties
with compliance because they did not have adequate programs for
maintaining compliance at aging facilities. For these reasons, we
consider prelicense compliance inspections important to ensuring animal
welfare under the AWA and regulations and are adopting the changes as
we proposed them.
A commenter recommended that a neutral review team, consisting of
local or State veterinarians, should be included as part of the
inspection
[[Page 28781]]
process and review the conditions of both the animals and animal
housing.
We are making no changes to the rule in response to this comment.
The AWA already authorizes the USDA to cooperate with officials in
various States and subdivisions as necessary.\9\
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\9\ 7 U.S.C. 2145(b).
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Reinspections
In proposed Sec. 2.3(b), we retained the existing provision that
an applicant who fails the first inspection may request up to two
reinspections to demonstrate compliance, but shortened the timeframe in
which the applicant must request the second inspection, and if
applicable, the third inspection, to 60 days following the first
inspection, instead of the existing 90-day deadline.
Many commenters stated that license applicants should receive two,
not three, chances to demonstrate compliance with the law during
prelicense inspections. Several commenters went further, stating that
two opportunities is excessive with respect to existing license holders
who should have no uncertainties about what the law requires. Another
commenter stated that the public comments on the ANPR and the proposed
rule indicate that licensees are taking advantage of the Agency's
lenience, using both prelicense and routine inspections as a means to
learn the animal husbandry standards prescribed by the AWA gradually,
at the cost of both the animals and taxpayers. The commenter
recommended that we provide only two prelicense inspection
opportunities, stating that this would lessen the time and cost burdens
on the Agency and compel licensees to be more responsive to addressing
documented noncompliances. Some commenters asked us to not provide any
second chances to persons whose facilities are not in compliance at the
initial inspection.
Our review of Animal Care records indicates that few applicants
actually require three prelicensing inspections to demonstrate
compliance, but even those applicants that require three prelicensing
inspections usually complete the process within 90 days. We encourage
applicants to establish contact and dialogue with their inspector prior
to requesting a prelicensing inspection to make sure the facility is in
compliance. The AWA regulations have long provided for three prelicense
inspections, and it will not increase our regulatory burden to maintain
the availability of these inspections. Therefore, we are making no
changes based on these comments.
Another commenter expressed concern that there is no deadline for
APHIS to perform its first prelicense inspection once it receives an
application for a new license. The commenter noted that this lag could
cause the license application process to stretch out indefinitely even
if the facility cannot demonstrate compliance with the AWA.
Applicants for licenses have a strong incentive to complete the
prelicense inspection process quickly so they can obtain a license and
engage in regulated activity. Applicants who fail their first
prelicense inspection must request their second inspection, and if
applicable, the third inspection, within 60 days following the first
inspection. Based on our decades of experience in conducting
prelicensing inspections, we do not anticipate the kind of delays
envisioned by the commenter.
To ensure that applicants can take full advantage of the three
prelicensing inspections to demonstrate compliance with the regulations
and standards, we stated in the preamble of the proposed rule that we
would encourage current licensees to apply 4 months prior to the
expiration of their license.
A commenter requested that we require, instead of ``encourage,''
reapplication filing 4 months prior to current license expiration to
allow for a period of up to three inspections within 60 days and
judicial appeal processing of denials.
We are making no changes to the rule in response to this comment.
By encouraging rather than requiring reapplication 4 months prior to
license expiration, we are providing flexibility to licensees without
changing the requirements for the inspection and appeal processes.
We proposed in Sec. 2.3(c) that should applicants fail to
demonstrate compliance during the third prelicense inspection, they can
appeal the findings of such inspection to the Deputy Administrator
within 7 days of receiving the report. Should APHIS reject an appeal,
we would notify the applicant of the Agency's denial of the license
application. Within 30 days of receiving such notice, an applicant may
request a hearing to contest the Agency's denial of the license
application. (Comments on hearings are addressed under Sec. 2.11
below.)
Citing animal welfare concerns, a substantial number of commenters
disagreed with the provision to allow applicants and license holders to
request a hearing if APHIS rejects an appeal for the third failed
inspection.
We are making no changes based on the comments we received on this
topic. As we noted in the proposed rule, we included this provision to
afford due process protections for current licensees.
A commenter recommended that the last sentence of Sec. 2.3(d) be
changed to state, ``No license will be issued until an affirmative
demonstration of compliance has been documented that the applicant's
animals, premises, facilities, vehicles, equipment, locations, and
records are in compliance with all applicable requirements in the Act
and the regulations and standards in this subchapter.''
We are making no changes to the rule in response to this comment.
The regulations already require that applicants affirmatively
demonstrate compliance before a license will be issued by APHIS.
Forfeiture of Application Fee
We proposed in Sec. 2.3(d) that if an applicant fails inspection
or fails to request reinspections within the 60-day period noted in
Sec. 2.3(b), or if an applicant fails to submit an appeal of the third
inspection report, the applicant will forfeit the application fee and
cannot reapply for a license for 6 months from the date of the failed
third inspection or the expiration of the time to request a third
inspection.
One commenter noted that this section indicates the failing
applicant will forfeit the application fee, but the rest of the
document indicates that there will no longer be an application fee,
only a license fee. The commenter asked us to clarify the application
process with regard to fees, particularly whether the applicant pays
the license fee at the time of application.
In the proposed rule, we referred to forfeiture of the application
fee for failure to pass the prelicensing inspection or to request a
reinspection within 60 days. However, as we had removed the application
fee requirement from Sec. 2.1(c), our reference to it was an
oversight. We intended to refer to forfeiture of the license fee and
will revise the section accordingly. The applicant pays the license fee
at the time of application but forfeits the license fee if he or she
fails the inspections, fails to request reinspections within the 60-day
period, or fails to submit a timely appeal of the third prelicense
inspection report.
One commenter noted that proposed Sec. 2.3(d) does not require
applicants to complete the inspection appeal process before reapplying
for a license, nor does it require that they request all three
prelicense inspections. On the other hand, the commenter noted that
under proposed Sec. 2.11(b), applicants who have
[[Page 28782]]
pursued all three prelicense inspections and appeals but are still
denied a license may not be granted a license within 1 year of their
denial. The commenter stated that if an applicant intentionally fails
to request additional prelicense inspections and an appeal, that
applicant may reapply for a license 6 months sooner than a person who
after several efforts to remedy his or her noncompliances was denied.
The commenter said that this discrepancy would encourage persons with
significant noncompliances to forfeit the license fee and reapply 6
months later, instead of going through the appeals process and working
with APHIS to address their violations. For this reason, the commenter
recommended that APHIS change the waiting period for reapplying for a
license in Sec. 2.3(d) from 6 months to 1 year from the date of the
failed third inspection or expiration of the time to request a third
inspection.
We appreciate the commenter's recommendation but are making no
changes to the rule in response. Every applicant reapplying for a
license must demonstrate compliance with the Act and regulations before
a license is issued.
Duration and Expiration of License
In the ANPR, we invited and received a range of responses on
whether we should propose to establish a firm expiration date for
licenses (3 years, 5 years) and if so, what should that date be and
why. We noted in the proposed rule that a large number of commenters
agreed with the example given in the ANPR to have licenses expire with
the expectation that the issuance of a new license would be contingent
upon affirmative demonstrations of compliance with AWA regulations.
In the proposed rule, we included in Sec. 2.5(a) the provision
that licenses will be valid and effective for a period of 3 years
unless certain circumstances arise. Consistent with the current
regulations, a license would not be valid if it has been revoked or
suspended, or if the license is voluntarily terminated upon request of
the licensee.
A large number of commenters agreed with our proposed action to
eliminate annual license renewals and to require persons to apply for a
new license every 3 years. However, many other commenters with animal
welfare concerns considered a 3-year license term to be too long,
particularly for dog breeders, arguing that 1 or 2 years would be more
appropriate. One commenter stated that a longer expiration window only
works to assist the chronically noncompliant facilities in escaping
consequences for their violations. Several commenters stated that we
should inspect premises housing dangerous and exotic animals annually
to verify compliance, and that once every 3 years is insufficient for
these premises. Another commenter opposing a licensing period of 3
years stated that such an approach would allow a facility to fall out
of compliance between prelicense inspections, resulting in dangerous
conditions for all animals at the facility while the licensee continues
to have applications approved based on a show of compliance every 3
years. The commenter asked APHIS to amend its regulations to ensure
that facilities with a history of substantial noncompliance, during
either the prelicense or license periods, are not issued new licenses
and are prohibited from re-applying for new licenses for a period of at
least 3 years.
We are making no changes to the rule in response to these comments.
In addition to requiring that applicants demonstrate compliance before
obtaining a 3-year license, APHIS routinely conducts unannounced
inspections of licensees, as well as complaint-based inspections and
inspections in which frequency is based on determination of risk. If an
APHIS inspector identifies noncompliances during these inspections, we
may take a number of actions in response to promote compliance,
including offering enhanced compliance support, issuing official
warnings and other regulatory correspondence, and pursuing penalties
and other sanctions after notice and the opportunity for a hearing.
Many commenters opposed to the proposal stated that APHIS lacks the
authority under the AWA to set an expiration date on a license and that
the proposed rule is only an attempt to bring about license removals. A
commenter asked how APHIS can justify making someone start over in an
application process for a license for the same facility and animals,
even though the facility is in compliance and has been for several
years. Similarly, other commenters stated that placing a permanent
expiration date on current licenses, then requiring licensees to go
through the entire initial licensing procedure upon expiration would be
time-consuming and duplicative. Several of these commenters noted that
there are current and successful license renewal processes already in
place.
As we noted in the proposed rule, all licenses currently have
expiration dates--they expire 1 year after issuance, and may be renewed
annually. This rule extends the period of licensure to 3 years but
requires a license application and demonstration of compliance prior to
the issuance of a new license. We also noted that the proposed rule is
consistent with section 2133 of the Act, which prohibits the issuance
of a license until the dealer or exhibitor has demonstrated that his
facilities comply with the standards promulgated by the Secretary
pursuant to section 2143 of the Act. Section 2133 of the Act also gives
the Secretary the authority to issue licenses to dealers and exhibitors
upon application in such form and manner as he may prescribe, which
includes the authority to set expiration dates for those licenses.
Some commenters opposing the rule stated that setting a permanent
expiration date on a license and requiring exhibitors to reapply 4
months in advance would cause serious hardships for traveling
exhibitors. One commenter said that exhibitors would be forced to be at
their home location in order to have a prelicense inspection, and that
depending upon their renewal date would incur costly travel expenses to
return home or to not book exhibits for up to 4 months to accommodate
this process.
We are not making any changes to the rule in response to this
comment. Although we encourage applicants to take full advantage of the
prelicense inspection process by applying 4 months prior to the
expiration date of their license, it is not required, nor do we
anticipate that most applicants will need the full time to complete the
process. A review of Animal Care records indicates that few applicants
require three prelicensing inspections to complete the process, but
even those applicants that require three prelicensing inspections
usually complete the process within 90 days. Finally, we also note that
prelicense inspections are scheduled at times that are mutually
agreeable to applicants and APHIS.
Some commenters representing zoos and aquariums stated that the
proposal to require exhibitors to apply for a new license every 3 years
would drastically increase litigation costs borne by these businesses.
One such commenter said that by proposing to switch from a system of
annual renewals to a new license requirement, APHIS is enabling
litigation from activist groups that disagree with the conclusions of
APHIS inspectors regarding prelicense inspections and AWA compliance,
resulting in substantial legal costs for both APHIS and exhibitors. The
commenter added that APHIS' rulemaking proposal is unnecessary because,
as the Federal courts have held, APHIS already has ample authority
under the AWA to bring
[[Page 28783]]
enforcement actions against licensees whose compliance performance
slips.
As the commenter notes, APHIS has authority under the AWA to
enforce the regulations on licensees in noncompliance and will do so as
warranted. However, we disagree with the commenter and consider the
proposed changes to licensing to be necessary because the existing
regulations do not require an applicant for a license renewal to
demonstrate compliance before renewing his or her license, nor do they
require a licensee to demonstrate compliance when making any changes to
his or her animals. APHIS has observed licensees who have been licensed
for many years struggle with compliance because they did not have
adequate programs for maintaining compliance at aging facilities. We
determined that in order to reduce risks to animal welfare and the
public, licensees should be required to demonstrate compliance and
obtain a new license to ensure that aging facilities remain in
compliance. For applicants who have a history of compliance, they
should be able to confidently demonstrate compliance during the initial
prelicense inspection, generating a record that will be defensible in
any subsequent litigation. In addition, APHIS already conducts
prelicensing inspections for new applicants and risk-based inspections
for current licensees, and neither our process for evaluating
compliance nor our goal of ensuring compliance with the regulations has
changed as a result of the proposal. Substantial changes in litigation
rates or outcomes are not anticipated. Therefore, we are making no
changes to the rule in response to these comments and are adopting the
changes as proposed.
Some commenters representing marine mammal exhibition facilities
stated that such facilities are permanently situated and require an
extensive financial commitment to develop and maintain, and that they
are inspected and approved by APHIS prior to animals ever residing in
them. One commenter noted that the consequences of a denial of a new
license for an existing licensee over what may be a minor noncompliant
item could be devastating and far-reaching. The commenters asked that
we reconsider our proposed requirement for new licenses.
We are making no changes in response to this comment. As noted
above, we encourage applicants to initiate the application process 4
months prior to the expiration date of their license to allow them the
opportunity to take full advantage of the prelicense inspection
process. If a noncompliance--especially a minor noncompliance, as
raised by the commenters--is discovered during the initial prelicense
inspection, the applicant will have two more opportunities to correct
the deficiency, demonstrate compliance, and obtain a license, thus
ensuring continuity of their business operations.
A commenter asked whether the proposed changes would require new
licenses more often as a facility ages.
No, the period of licensure will be 3 years for all licensees in
compliance, regardless of the age of the facility.
Proposed Sec. 2.5(a) states that licenses will be valid and
effective for 3 years, with several exceptions. One exception, in Sec.
2.5(a)(1), is if the license has been ``revoked or suspended pursuant
to section 19 of the Act.'' A commenter suggested that we add ``or
these regulations'' to the end of this exception.
We are making no changes to the rule in response to this comment.
The provisions of the rule regarding license suspensions and
revocations are authorized by section 19 of the Act and its
implementing regulations.
In the proposed rule, we removed and reserved Sec. 2.6, which
contained license provisions. We received a comment about the
implications of removing these provisions from the regulations. The
commenter noted that Sec. 2.6 includes the statement that people
meeting the requirements for more than one class of license are
licensed for their predominant business. The removed section also
includes a requirement for both lessors and lessees to be licensed. The
commenter stated that if this section is deleted, that information
needs to be addressed elsewhere in the regulations.
We are not making any changes to the rule in response to this
comment. The definitions Class ``A'' licensee (breeder), Class ``B''
licensee, and Class ``C'' licensee (exhibitor) specify which category
of license a person should apply for based on their business
activities. Lessors and lessees that meet the definition of dealer, and
do not fall under one of the exemptions from the licensing
requirements, continue to require a license under the AWA regulations.
Temporary Licenses
We received numerous comments in both the ANPR and the proposed
rule on the issuance of temporary licenses for those licensees who may
suffer a lapse in licensure during the relicensing process. We proposed
in Sec. 2.5(a)(3)(i) to include flexibilities for issuing temporary
licenses to licensees with histories of compliance to ensure they have
ample time to apply for licenses and demonstrate compliance prior to
the expiration of an existing license.
Substantial numbers of commenters opposed our proposal to grant
temporary licenses on grounds that they give licensees in noncompliance
additional time to operate. One such commenter stated that the Act is
clear that USDA cannot provide for temporary licenses unless it has a
process through which the facility demonstrates compliance with the
AWA. The commenter stated that the proposed rule presumably tries to
account for this problem by authorizing temporary licenses for
facilities showing a ``history of compliance'' for the prior licensing
period. However, the commenter said that this ``history of compliance''
standard is inadequate because facilities are not required to be
inspected every year, and noted that the most recent inspection report
may be over 2 years old by the time the licensee applies for a new
license. Similarly, another commenter stated that allowing an applicant
to remain in business based solely on prior inspection reports is an
abuse of discretion.
We disagree with the commenters and note that we base
determinations of compliance not only on the history of compliance but
on actual inspections. We employ a risk-based inspection system that
calls for more frequent inspections at facilities with a higher risk of
animal welfare concerns and fewer inspections at those that
consistently demonstrate compliance.
Several commenters opposed to temporary licensing said that USDA
lacks statutory authority to issue temporary licenses.
The AWA authorizes USDA to issue licenses to dealers and exhibitors
upon application in such form and manner as he may prescribe and upon
payment of applicable fees, provided that no such license shall be
issued until the dealer or exhibitor has demonstrated compliance with
the AWA regulations. Under this rule, the Deputy Administrator of
Animal Care may issue a temporary license that automatically expires
after 120 days to an applicant whose immediately preceding 3-year
license has expired if the applicant submits the appropriate
application form before the expiration date of the preceding license
and has had a history of compliance with the AWA and regulations during
the preceding period of licensure. These requirements are authorized by
the AWA and fall within USDA's authority to issue licenses.
[[Page 28784]]
Another commenter expressed concern that a temporary license would
be perceived as an indicator that the facility under temporary
licensure is somehow inferior with respect to animal welfare, and that
this could have negative consequences from a business perspective.
Only licensees with extended histories of compliance with the AWA
are eligible for a temporary license. APHIS makes no distinction
between a 3-year license certificate number and a temporary license
certificate number.
Several licensees who commented on the rule expressed concern that
their license could expire before APHIS is able to inspect their
facility to verify compliance for a new license. One such commenter
stated that it is unreasonable to believe that APHIS will issue every
license prior to expiration and asked what would happen in such a case.
We have considered the implications of issuing new licenses to
licensees as their licenses expire and how to best address the concerns
expressed by commenters. Accordingly, we have adjusted the effective
date of the rule for the licensing provisions and will conduct a
gradual, phased-in implementation based on license expiration dates for
current licensees. We believe this approach will ensure that adequate
resources are continuously available to conduct prelicense and routine
inspections under the AWA. In the event that the licensee submits a
timely application and has no noncompliances documented in any
inspection report during the preceding period of licensure, and APHIS
does not conduct the prelicense inspection before a lapse in licensure,
we have the ability to issue a temporary license to that applicant.
One commenter asked if breeders with lapsed licenses would be
prohibited from selling puppies until the inspection for a new license
is completed, noting that such a lapse in operations could result in
them having puppies that are too old to sell to brokers and pet stores.
A person without a valid license is prohibited from selling puppies
or engaging in any other activities regulated under the Act until they
obtain a valid license. As mentioned above, persons with an existing
license are encouraged to apply for a new license up to 4 months prior
to the expiration of their license so they can take full advantage of
the prelicense inspection process. The Deputy Administrator would issue
a temporary license as long as the applicant meets the criteria of
submitting the application for a new license before the preceding
license expires and there are no noncompliances cited during the period
of the preceding licensure. A temporary license, valid for up to 120
days, would be issued.
A commenter suggested that APHIS consider multiple preceding
periods of licensure for purposes of granting temporary conditional
licenses in order to strengthen the possibility that the Agency is
reviewing an accurate picture of a facility's compliance.
We are making no changes to the rule in response to this comment.
We believe that a licensee that maintains compliance with the
regulations for a 3-year period of licensure should be eligible for a
temporary license in the event of an inadvertent lapse in licensure. We
note that the temporary licenses are of limited duration and the person
would need to demonstrate compliance before obtaining a new 3-year
license.
One commenter stated that for licensees with a history of
compliance there is no need for developing new regulations for a
temporary license process when the current regulation for renewal could
be amended to accommodate licensees with a history of compliance.
We are making no changes in response to the rule in response to
this comment. As discussed above, the existing regulations did not
require an applicant for a license renewal to demonstrate compliance
before renewing his or her license. The existing regulations also did
not require a licensee to demonstrate compliance when the licensee
makes any subsequent changes to his or her animals or facilities,
including noteworthy changes in the number or type of animals used in
regulated activity. In addition, we have observed licensees who have
been licensed for many years struggle with compliance because they did
not have adequate programs for maintaining compliance at aging
facilities. For these reasons, amending the current renewal process to
accommodate certain licensees would not achieve the purpose of
demonstrating compliance as a condition of licensure.
One commenter suggested that a license extension could be allowed
in the case of a natural disaster, or when a licensee has submitted the
required paperwork at least 3 months in advance of expiration and whose
past inspections documented no noncompliances.
We agree that a temporary license may be issued to an applicant
whose immediately preceding 3-year license has expired if the person
submitted the application form before the expiration date of a
preceding license and the applicant had no noncompliance with the AWA
and regulations documented in an inspection report during the preceding
period of licensure. We do not limit the causes for the inadvertent
lapse, and one such cause could be a natural disaster.
A commenter asked whether ``an'' should actually be ``any'' in
Sec. 2.5(a)(3)(i)(B). The commenter pointed out that the way the
proposed provision is worded, if an applicant had one inspection report
with no instances of noncompliance, he or she would qualify, even if he
or she had two others with critical noncompliances.
We agree with this comment and have corrected the wording
accordingly.
The same commenter observed that in proposed Sec. 2.5(a)(4), there
``will not be a refund of the license fee if a license is denied,
terminated, suspended, or revoked prior to its expiration date,'' but
noted that this language refers to a license fee, not an application
fee. The commenter suggested adding ``or'' after ``denied'' in that
sentence, explaining that a license cannot be denied prior to its
expiration date because there is no expiration date (i.e., no license
to expire) if the license is denied.
We agree that adding ``or'' after ``denied'' will clarify the
sentence and have made that change in this final rule. As noted above,
this final rule removes the application fee, so we are making no other
changes in response to this comment.
Suspensions and Revocations
In the ANPR, we asked for comment on whether persons whose license
has been suspended or revoked should be prohibited from engaging in
other activities involving animals regulated under the AWA, such as
working for other AWA-regulated entities or using other individual
names or business entities to apply for a license. We also asked for
comment on whether such prohibitions should extend to officers, agents,
and employees of persons with suspended or revoked licenses. A majority
of persons commenting on the ANPR expressed strong support for the
suggested regulatory provision for license applicants to disclose
incidences of violations and convictions involving animal-related laws.
Persons commenting on the proposed rule also supported disclosure of
violations and ``no contest'' pleas as a requirement.
We proposed in Sec. 2.9 that any person who has been or is an
officer, agent, or employee of a licensee whose license has been
suspended or revoked and who was responsible for or participated in
[[Page 28785]]
the activity upon which the suspension or revocation was based will not
be licensed, or registered as a carrier, intermediate, handler,
exhibitor, or research facility within the period during which the
order of suspension or revocation is in effect.
A commenter stated that additional language is required to address
the cited licensees' family members who may not fall under the legal
definition of employee, agent, or officer.
We are making no changes to the rule in response to this comment.
Family members who are authorized to act on behalf of the licensee and
who are responsible for or participated in the activity upon which the
suspension or revocation was based would fall within the meaning of an
``agent'' and be subject to this provision.
A commenter representing an animal welfare advocacy organization
suggested that the Welfare of Our Friends Act, or WOOF Act, which would
amend the AWA to prohibit the issuance of licenses to immediate family
members and business partners of animal dealers who had their licenses
revoked, provides clear and unambiguous language that should be used in
this proposed provision.
The WOOF Act is proposed legislation and has not been enacted. The
authority for this final rule is the AWA. We note that Sec. 2.9
already covers immediate family members and business partners of animal
dealers who may have been officers, agents, or employees of the
licensee. If these persons have not participated in the activity upon
which the order of revocation or suspension was based, APHIS has no
grounds to deny them a license. Therefore, we believe that the proposed
rule language is sufficient and are making no changes to the rule in
response to this comment.
One commenter supported this provision but recommended carving out
exceptions for those with specialized skills but may not have been
directly involved in prior violations of the AWA, when their talents
are needed due to lack of other qualified individuals.
We are making no changes to the rule in response to this comment.
If a person was not responsible for or did not participate in the
activity upon which the suspension or revocation was based, this
provision would not apply to them.
A commenter agreed with the proposed provision in Sec. 2.9 to deny
licenses to officers, agents, and employees of a licensee whose license
has been suspended or revoked and who was responsible for or
participated in the activity upon which the suspension or revocation
was based. The commenter said that APHIS has the authority to interpret
what constitutes ``participation,'' such that if an officer, agent, or
employee somehow promoted, aided in, or acted in furtherance of the
adverse activity, without actually participating in the violation,
APHIS may still prevent that person from getting their own license when
appropriate. To underscore this point, the commenter encouraged APHIS
to strengthen Sec. 2.9 by assessing each participant's non-eligible
period on a case-by-case basis and based on their personal history,
with the possibility of that non-eligible period for that person
extending past the original licensee's period of suspension or
revocation.
We are making no changes to the rule in response to the comment.
Periods of suspension and revocation are assessed by USDA
administrative law judges after notice and opportunity for a hearing,
or through a settlement agreement. We do note that revocation is
permanent, so the period of revocation is a person's lifetime.
Accordingly, there is no longer period of time that could be assessed
for the revocation of a license. In addition, APHIS is authorized to
deny a new license when an applicant has been determined to be unfit by
the Secretary as stated in Sec. 2.11(a)(5) of the amended regulations.
A commenter stated that APHIS must ensure that existing licensees
cannot add, as an additional location on that license, a facility or
site associated with a revoked or suspended license, and that a
licensee who seeks to do so should not be found eligible for a new
license.
We are making no changes to the rule in response to this comment.
As noted above, licenses are issued to specific persons, and are issued
for specific activities, animals, and approved sites. Under proposed
Sec. 2.1(b)(1), if an existing licensee in good standing seeks to
acquire an additional location, he or she would first need to notify
APHIS-Animal Care no fewer than 90 days before the change and obtain a
new license. We note that seeking to add a location associated with a
license revocation or suspension is not in itself grounds for denying a
license to a person seeking such a location, but rather depends on the
specific terms of a suspension or revocation associated with a
location. These terms are contained in orders issued by administrative
law judges or settlement agreements entered into by APHIS and involved
persons.
A commenter opposing the rule stated that this provision violates
the Equal Employment Opportunity Act, as the government cannot prevent
employers from hiring who they wish to employ.
We are making no changes to the rule in response to this comment.
The Equal Employment Opportunity Act is the act which gives the Equal
Employment Opportunity Commission authority to sue in Federal courts
when it finds reasonable cause to believe that there has been
employment discrimination based on race, color, religion, sex, or
national origin. This rule in no way discriminates based on these
factors.
Licensees Whose Licenses Have Been Suspended or Revoked
In the proposed rule, we revised Sec. 2.10 to strengthen
prohibitions against licensees whose licenses have been suspended or
revoked from engaging in AWA-regulated activities.
Several commenters asked that APHIS prevent persons with histories
of noncompliance from playing a ``shell game'' of applying for new
licenses under different names or businesses.
We are making no changes to the rule in response to this comment.
Licenses are issued to specific persons for specific premises. If a
person (for example, a corporation) dissolves and forms a new legal
entity, the person must apply for a new license. We believe this
commenter is concerned about a licensee with a suspended or revoked
license applying for a new license under a new name in order to work
around sanctions and resume operations. However, a person may be held
liable for violations and subject to penalties and other sanctions,
even if they no longer hold a license, or hold a license in a different
name.
Section 2.10(c) states that persons with suspended or revoked
licenses shall not buy, sell, transport, exhibit, or deliver for
transportation, any animals during the period of suspension or
revocation. A few commenters recommended that we add ``maintain'' to
the list of prohibited actions.
The maintenance of animals on the property of a licensee whose
license is suspended or revoked depends on the specific terms of a
suspension or revocation. These terms are contained in orders issued by
administrative law judges or settlement agreements entered into by
APHIS and involved persons. We are therefore making no changes to the
rule in response to this comment.
Denial of License Application
In the proposed rule, we discussed responses to the ANPR from many
commenters expressing support for streamlining procedures for denying,
terminating, and summarily suspending a license. In proposed Sec.
2.11(a), we
[[Page 28786]]
added several grounds for denying a license to an applicant, including
failure to comply with the Act or regulations, license suspension or
revocation, a no contest plea or violation of laws or regulations
pertaining to animal cruelty, or false statements to USDA pertaining to
animal welfare. A license may also be denied if the Administrator
determines that circumstances render the applicant unfit to be licensed
or if issuance of a license would be contrary to the purposes of the
AWA.
A commenter stated he does not support streamlining the procedures
for denying a license application, terminating a license, and summarily
suspending a license. The commenter asked if there is an official
definition for ``streamlining'' and whether it actually involves
revoking a license without due process.
The AWA and this final rule provide ample due process to persons
whose license has been denied, terminated, summarily suspended, and
revoked. For example, a person whose license has been revoked was
provided with the opportunity for a hearing. Therefore, we are making
no changes to the rule in response to this comment.
A commenter proposed that APHIS should automatically deny licenses
to applicants who have three or more direct or critical violations
during the prior 3-year period, or have five or more repeat violations
during the prior 3-year period, as defined in the Animal Welfare
Inspection Guide. The commenter stated that whatever standard APHIS
adopts, it should result in automatic denial of license applications
from facilities that have accumulated dozens of repeat violations that
affect animal welfare over the last 3-year period. The commenter
additionally suggested that if a State license was denied or rescinded
then the USDA license should be denied or rescinded as well.
We believe the commenter is referring to noncompliances rather than
violations, as noncompliances are based on the observations and
professional judgments of inspectors. Section 2.11(a)(7) does provide
grounds for denying a license if an applicant is determined to be unfit
to be licensed and the Administrator determines that the issuance of a
license would be contrary to the purposes of the Act. However, we
realize that not every noncompliance occurring during a previous period
of licensure makes a person unfit to hold a license. For this reason,
we are making no changes to the rule based on these comments.
In proposed Sec. 2.11(a)(5), we conformed with the proposed 3-year
period of licensure the length of time during which an applicant shall
be denied a license due to a nolo contendere (no contest) plea or
finding of a violation of any Federal, State, or local laws or
regulations pertaining to animal cruelty. We also continued to retain
the proviso that a license may also be denied for such violations after
3 years if the Administrator determines that the circumstances render
the applicant unfit to be licensed.
A commenter said that the proposal does not go far enough to
prevent convicted animal abusers from continuing to abuse animals and
recommended that we deny an application if the applicant or licensee
has been convicted of an animal welfare related law during the previous
10 years.
We are making no changes to the rule in response to this comment
because proposed Sec. 2.11(a)(5) already provides APHIS with the
authority to deny a license if the applicant has been found to have
violated animal cruelty laws within 3 years of application, as well as
after 3 years if the Administrator determines the circumstances render
the applicant unfit to be licensed.
Appeal of License Denial
We proposed in Sec. 2.11(b) to allow an applicant without a
license whose initial application has been denied to request a hearing
for the purpose of showing why the application for license should not
be denied. Should the denial be upheld, we proposed that the applicant
may again apply for a license 1 year from the date of the final order
denying the application. We also proposed allowing an applicant who
holds a valid license at the time he or she submitted the application
that has been denied, and who submitted a timely appeal of the
inspection findings from the third prelicense inspection as indicated
in Sec. 2.3, to request an expedited hearing before a USDA
Administrative Law Judge, with the license remaining in effect until an
initial decision is rendered. We noted in the proposal that this
provision is intended to afford adequate due process protections to
current license holders, while maintaining proper regard for the policy
of Congress to ensure the humane care and treatment of animals covered
under the Act.
A commenter noted that the USDA's administrative law judge system
is overburdened and can take years to resolve AWA matters, and
suggested that the USDA not provide hearings for the denial of license
applications but adopt informal hearing standards similar to those for
license suspension and revocation. The commenter added that informal
hearings would further the purposes of the AWA and reduce regulatory
burdens. Other commenters stated that the provision to allow licensees
whose applications have been denied to seek a hearing will only prolong
animal suffering and delay justice, and added that the law does not
require that they receive a hearing. One such commenter stated that the
AWA does not call for a hearing ``on the record'' and contains no other
language that would trigger the Administrative Procedure Act's formal
adjudication requirements. Other commenters stated that licensees
already have many opportunities to challenge and correct findings of
noncompliance without having to resort to a hearing.
We are making no changes to the rule in response to these comments.
As noted above, we believe the provisions will provide due process
protections, and are actually similar to those for license termination,
suspension, and revocation, which also require notice and the
opportunity for a hearing before a license can be terminated,
suspended, or revoked.
A commenter asked APHIS to revise the language in 9 CFR part 4,
``Rules of Practice Governing Proceedings Under the Animal Welfare
Act,'' to reflect the full authority given to the Secretary by the AWA
and develop and implement a process for promptly providing a notice and
opportunity for a hearing so additional suspensions can be instituted
more quickly. The commenter noted that while the Act provides the
Secretary with the authority to temporarily suspend a license for up to
21 days and after notice and opportunity for a hearing to suspend the
license for an additional period, the current language in part 4,
subpart B, of the regulations only refers to a temporary 21-day
suspension and not to the possibility of extending that suspension. The
commenter also asked us to review our stipulation process under
``Subpart B--Supplemental Rules of Practice,'' to determine whether
agreed upon license forfeitures would help ensure compliance and animal
welfare.
We appreciate the commenter's request but are making no changes in
response. We proposed no changes to the regulations in part 4 or to the
USDA's Rules of Practice governing administrative enforcement
proceedings. Therefore, this comment falls outside the scope of this
rulemaking.
A commenter stated that the last line of proposed Sec.
2.1(b)(2)(ii), which states that ``a licensee must obtain a new
[[Page 28787]]
license before using any animal beyond those animals authorized under
the existing license,'' needs to be clarified.
We agree with the commenter that this provision could more clearly
communicate our intent, which is that licensees who wish to use animals
not authorized on their license will need to obtain a new license
before additional types or numbers of animals may be used for regulated
purposes. Accordingly, we are amending the last line of Sec.
2.1(b)(2)(ii) to read ``A licensee must obtain a new license before
using any animal beyond those types or numbers of animals authorized
under the existing license.'' Similarly, we are amending proposed Sec.
2.1(b)(1) to clarify that licenses are issued for specific types and
numbers of animals.
One commenter stated that the right of appeal for persons in
noncompliance with the AWA regulations is based on an erroneous
interpretation of the law and the Constitution. The commenter
questioned our statement in the proposed rule that allowing licensees
whose renewal applications are denied for failure to demonstrate
compliance to keep their licenses pending a formal hearing affords
``constitutionally mandated due process protections.''
As we noted in the proposed rule, the right to a hearing is
intended to afford due process protections to current license holders,
while ensuring the humane care and treatment of covered animals in
accordance with the AWA. By providing licensees with the opportunity to
appeal a noncompliance documented on an inspection report, we are able
to consider facts that may not have been available to the inspector at
the time of inspection and therefore to ensure that the USDA has all
available information.
Several commenters asked that we revoke the license of a person
during any ongoing appeals process. One such commenter stated that
animals should not be permitted to remain with their custodian when
that person has violated health and care requirements, and should be
sent to a sanctuary instead.
We are making no changes to the rule in response to this comment,
as a license can only be revoked after notice and opportunity for a
hearing. A license remains in effect until its expiration date or a
final decision is rendered by an administrative law judge. We do note
that USDA has separate authority to confiscate animals that are in a
state of suffering, after notifying the licensee and providing him or
her the opportunity to correct the condition.
Termination of License
Proposed Sec. 2.12 states that, after a hearing, a license may be
terminated at any time for any reason that a license application may be
denied pursuant to Sec. 2.11. We proposed to remove a reference to the
license renewal process in the current regulations because the renewal
option no longer exists.
A commenter expressed concern that under proposed Sec. 2.12, a
teachable moment reported as an instance of noncompliance could result
in license termination. The commenter added that although there are
judicial safeguards in the process, terminating a license under those
circumstances would be a gross miscarriage of justice. Instead, the
commenter recommended amending Sec. Sec. 2.1(d) and 2.12 to
specifically exempt minor instances of noncompliance as the basis of a
license revocation unless they are repeated.
Section 2.11(a)(7) provides grounds for denying a license if an
applicant is determined to be unfit to be licensed and the
Administrator determines that the issuance of a license would be
contrary to the purposes of the Act. However, as the commenter notes,
APHIS inspectors do engage in teachable moments with licensees, in
which inspectors point out minor noncompliances and explain how they
can be corrected. Current and proposed procedures do not require
termination of a license for these minor noncompliances. For this
reason, we see no need to change the regulations as requested by the
commenter.
Appeal of Inspection Report
In proposed Sec. 2.13, we noted that any licensee or registrant
may appeal inspection findings in an inspection report to the Deputy
Administrator within 21 days of the date the licensee or registrant
received the inspection report.
One commenter, while not opposed to this provision, suggested that
when a licensee's inspection appeal is successful, the public has the
right to know the nature of the disputed violation and that an appeal
was undertaken. Accordingly, the commenter stated that APHIS should
include assurances that we will publicly disclose that the findings in
an inspection report have been appealed. Additionally, the commenter
stated that all inspection reports that are corrected based on appeals
must be properly labeled as such and shared with the public.
We are making no changes to the rule in response to this comment
because it falls outside the scope of this rulemaking. Separate Federal
laws govern the release of information and documents to the public that
are controlled by the U.S. Government, such as the Freedom of
Information Act (FOIA).
Another commenter observed that Sec. 2.13 provides a right to a
licensee or applicant to appeal the individual findings within an
inspection report distinct from an applicant's ability to appeal a
denial of their license. The commenter expressed concern that some
applicants may perceive these rights not separately but as an
additional step within the appeals process, allowing them to appeal
inspection findings and delay the license denial process. The commenter
suggested that APHIS add language to Sec. 2.13 stating that, ``Under
no circumstances shall this section be interpreted as tolling the
period of time by which a licensee or license applicant must seek an
appeal or request further prelicense inspections.''
We are making no changes to the rule in response to this comment.
The procedures for appealing an inspection report and requesting a
hearing in connection with the denial of a license are distinctly
separate processes.
Publication of Licensee Information
We proposed to amend Sec. [thinsp]2.38, ``Miscellaneous,'' by
eliminating the statement in paragraph (c) that we will publish lists
of research facilities in the Federal Register and replacing it with
the statement that we will publish such lists on the APHIS website
instead.
A few commenters agreed with our proposal to publish the lists of
research facilities online but suggested that APHIS emphasize in the
regulations that the lists will be available on its website.
We believe the rule is sufficiently clear that the lists will be
published on APHIS' website and that copies of the lists can also be
obtained upon request from the Deputy Administrator. Therefore, we are
making no changes to the rule in response to this comment.
One commenter disagreed with our proposal to remove the statement
that APHIS will publish lists of research facilities in the Federal
Register and stated that APHIS is making it difficult to locate the
lists.
It is not APHIS' intent to make the lists difficult to locate.
Indeed, we believe making the lists available on our website \10\ makes
them easier to find. As is currently the case, interested parties may
continue to request the list from the Deputy Administrator.
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\10\ https://www.aphis.usda.gov/aphis/ourfocus/animalwelfare.
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[[Page 28788]]
We also proposed to amend Sec. [thinsp]2.127, ``Publication of
names of persons subject to the provisions of this part,'' by replacing
``names'' in the section heading with ``lists,'' and by removing the
statement that the list will be published in the Federal Register. We
are making these changes to reflect current business practices of
publishing information on public websites for ease of access as well as
our practice of maintaining and updating a list of registered research
facilities on the APHIS website.\11\
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\11\ https://www.aphis.usda.gov/aphis/ourfocus/animalwelfare.
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Substantial numbers of commenters expressed concern about Agency
transparency with respect to making the names of licensees, breeders,
and research facilities available to the public, and many asked that we
ensure that licensee records are available for public review. Some
commenters opposed the proposed change to Sec. 2.127, which would
strike ``names'' and replace it with ``lists.'' One such commenter
stated that the term ``lists'' is ambiguous and does not express how,
if at all, the Agency intends to identify registrants or licensees.
As noted above, APHIS maintains a list of licensees and registrants
on its website. By replacing the word ``names'' with ``lists,'' we are
making clear that the list may include additional information beyond
just the name of the licensee and registrant, such as the city and
State where they are located and the type of license or registration
that person holds. We are therefore making no changes to the rule in
response to this comment.
One commenter stated that the final rule should expressly state
what licensee information the USDA will share with the public. Another
commenter requested that APHIS continue to publish identifying
information for all persons licensed or registered under the AWA,
including the following: Certificate/customer type, legal name, doing
business as (DBA) name, city, and State, and to affirm this in Sec.
2.127.
APHIS is undertaking this change to reflect both current business
practices of publishing information using public websites for ease of
access, and the Agency's practice of maintaining and regularly updating
a list of registered research facilities on the APHIS website.
Currently, APHIS lists the legal name of the licensee or registrant,
any DBA name associated with that person, the city and State where they
are located, and the type of license or registration the person holds.
Therefore, we are making no changes in response to these comments.
A commenter asked APHIS to include in its publication a disclosure
requirement for all ``formerly known as'' names associated with an
existing licensee or registrant to ensure full transparency. The
commenter, representing an animal welfare organization, added that it
is necessary to have access to unredacted inspection reports so the
organization can follow up on complaints and incidents and determine
whether APHIS has identified specific animal care deficiencies at such
locations.
We are making no changes to the rule in response to this comment.
We publish the list of licensees and registrants so that the public can
know who currently holds a license or registration under the AWA.
Whether a person previously held a license, and what name they held
that license under, is immaterial to this purpose. Members of the
public can request inspection reports under FOIA by submitting a
request online at: https://www.aphis.usda.gov/aphis/resources/foia/ct_how_to_submit_a_foia_request. All releases of information are
subject to applicable FOIA laws and appropriate handling of protected
personal information. APHIS releases information that meets all
appropriate FOIA and protected personal information restrictions.
A commenter asked that we use and retain a permanent identifying
number for each regulated entity regardless of issuance of a new or
subsequent license. The commenter stated that use of an assigned number
not publicly linked to any other identifying information will mitigate
any concerns the USDA has about maintaining privacy interests. The
commenter stated that this number should be included on all publicly
released AWA-related records in order to allow public monitoring of the
USDA's implementation of the Act, including the ability to track
whether the USDA is following its own inspection and enforcement
policies.
This comment pertains to APHIS' internal business processes and is
outside the scope of this rulemaking. Therefore, we are making no
changes to the rule in response to this comment.
A commenter asked the USDA to stop redacting licensee identities
and withholding records about enforcement actions and adjudication
proceedings. The commenter said that the public cannot determine
whether USDA is complying with the licensing requirements if it redacts
licensee information from inspection reports. Another commenter stated
that APHIS needs to ensure that the additional licensee information
required by the rule will be made public in accordance with the
precedent the Agency itself persuaded the D.C. Circuit to establish in
Jurewicz v. U.S. Department of Agriculture, 714 F. 3d 1326 (2014).
Public access to records held and maintained by the U.S. Government
is outside the scope of this rulemaking, but all released records meet
all applicable FOIA and personally identifiable information
restrictions. Therefore, we are making no changes to the rule in
response to this comment.
Importation of Live Dogs
We proposed to amend the regulations for importing live dogs in
Sec. Sec. 2.150 through 2.153 in order to harmonize the regulations
with the AWA and emphasize that dogs intended for resale for research
purposes, or dogs intended for resale following veterinary treatment,
must be imported under a permit and accompanying certifications.
Several commenters stated, without providing specifics, that APHIS
should restrict importation of dogs because imported dogs carry exotic
diseases.
We are making no changes to the rule in response to this comment.
APHIS does restrict the importation of dogs for resale purposes to
ensure they are in good health, vaccinated, and meet the minimum age
requirement established in the AWA.
One commenter stated that the proposed changes will increase the
vulnerability of live dogs imported for the purposes of
experimentation. Specifically, the commenter stated that removal of the
word ``research'' from Sec. Sec. 2.150(a) and 2.151(a) would exempt
from import permit requirements those research entities with foreign
sites that import their own live dogs into the United States, without
reselling them, for the purpose of research. The commenter cited
instances of research companies obtaining animals from other countries
with weak records of animal welfare and stated that, under our proposed
changes, they could import dogs from their facilities in other
countries to use in their testing facilities in the United States
without securing a permit from the USDA or preparing certifications.
Similarly, a commenter stated that APHIS has provided no reasoning for
why this recordkeeping requirement is proposed to be removed for dogs
imported for research or veterinary treatment without subsequent sale
and noted that it is important that all dogs imported for research or
veterinary treatment are accompanied by a permit and certificate of
veterinary health to prevent the spread of disease.
[[Page 28789]]
We are making no changes to the rule in response to these comments.
These changes will harmonize the regulations with the Act and make
clear that dogs intended for resale for research purposes, or dogs
intended for resale following veterinary treatment, are imported with
an import permit and accompanying certifications, except as provided in
Sec. 2.151(b).
Animal Health and Husbandry Standards
Watering
We indicated in the proposed rule that we were considering adding
various provisions pertaining to the care of dogs in part 3,
particularly in relation to housing and access to water. We noted that
the current regulations require dogs that do not have continual access
to water must be offered water not less than twice daily for at least 1
hour each time. While lack of continual access to water is generally
not a risk to healthy dogs, lack of access to water may exacerbate
health problems when other stresses are present, such as high heat or
illness. We considered amending the AWA regulations to account for
specific watering needs for certain dogs, short of requiring that all
dogs have 24-hour access to potable water for their well-being.
However, in examining the issues and accounting for the animal health
and well-being factors involved, we determined that the most prudent
approach would be to include such a provision requiring all dogs to
have 24-hour access to water. We therefore proposed to amend Sec.
[thinsp]3.10 to add a provision that requires dogs to have continual
access to potable water, unless restricted by the attending
veterinarian.\12\
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\12\ In the proposed rule, we used the term ``continual'' access
to water to mean constant, uninterrupted access to potable water for
dogs at all times. However, we are substituting the more accurate
term ``continuous'' to mean the same thing in this final rule.
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A commenter agreed with ensuring dogs have regular access to water
but noted that we stated in the proposed rule that a lack of continual
access to water is generally not a risk to healthy dogs. The commenter
noted that regulated facilities vary by type, size, and the number of
animals they maintain. For this reason, the commenter stated that APHIS
should allow for some flexibility in how licensees, particularly
smaller ones, make water available to their animals while still
ensuring they are providing appropriate care.
The rule requires that potable water be continuously available to
dogs, unless restricted by the attending veterinarian. The rule does
not prescribe how the water is made continuously available. With
respect to flexibility in how water is made available to dogs,
facilities may use a variety of watering methods to comply with this
requirement. Most facilities at which the dogs have 24-hour access to
water use a plumbed automatic watering system. Automatic watering
systems can be connected either to a central water supply line or a
holding tank, which then supplies a valve-tipped access point through a
pump or gravity-fed system. Facilities that do not have an automatic
watering system may use water-holding tanks filled by hand. Water may
also need to be hand-carried to outdoor areas that house dogs.
Another commenter said that there are no data or veterinary care
requirements described to support this change for healthy dogs. The
commenter noted that healthy animals will play with water bowls and
spill water, and that the lack of continuous access to water in those
cases should not be an instance of noncompliance if the dog is
adequately hydrated. The commenter added that the health and welfare of
animals is directly related to their degree of hydration, not to the
frequency or duration of access to water, and that the requirement for
continuous access to water for all is therefore an arbitrary regulation
based on ease of enforcement rather than sound veterinary judgment. The
commenter concluded that a better approach would be to keep the current
standard but modify it to require that dogs be adequately hydrated and
have access to water depending on conditions.
We are making no change to the rule in response to this comment.
The rule as proposed will provide dogs with continuous access to water
so that the dogs can adequately hydrate themselves. We believe this
standard will be easier for facilities to follow and for APHIS to
enforce than the condition-dependent alternative proposed by the
commenter and will ensure the health and well-being of the dogs.
Several commenters associated with research institutions did not
consider the change to the watering requirements to be necessary or
practical. One commenter stated that, according to his organization's
records, for the past 5 years there have been 6,613 inspections of
research facilities resulting in 2,029 noncompliant items documented,
of which only 3 were for noncompliance with the regulations in Sec.
3.10. Another commenter requested that the Agency document the actual
need for these expenditures before developing a final rule requiring
24-hour access to water.
The commenter correctly points out that a small fraction of
inspections of regulated facilities result in citations related to
inadequate watering, although the number cited is lower than the actual
number for all facilities (there were 11 such citations in FY 2016 and
2017 alone; in 2017, there were 12,243 active sites). Lack of
continuous access to drinkable water is generally not a risk to healthy
dogs, but lack of access can escalate in dogs the health consequences
of other stress factors. We note that the number of citations issued
for lack of water access does not reflect the totality of problems that
are either caused or exacerbated by lack of access to clean drinkable
water. Ensuring this access will directly benefit those dogs that would
otherwise have insufficient access to drinkable water.
Moreover, we also proposed specific veterinary care requirements
for dogs. We expect that these specific requirements will strengthen
arrangements between licensees and registrants and their attending
veterinarians and enhance preventative and ongoing care for dogs.
Accordingly, we are making no changes to the rule in response to this
comment.
Other commenters questioned how water can be provided continuously
when dogs are being removed from pens for training or cleaning, or
during transport, and noted that there have already been guidelines
available for providing adequate water supply for dogs. Another
commenter noted that requiring 24 hour access to water contradicts the
current regulations, which allow for the offering of water to dogs
before, during, and after transport to be determined under a watering
and feeding plan, which may not necessarily allow for 24 hour access.
To resolve this contradiction, the commenter recommended that APHIS add
an exception to Sec. 3.10(a) that states, ``except during transport,
in which the dog must be offered water in accordance with the standards
set forth in Sec. 3.14.''
The transport watering requirements, which do not require 24 hour
access, are actually detailed in Sec. 3.16 (redesignated as Sec.
3.17), and not in Sec. 3.14 as the commenter indicated. However, we
agree with the substance of the comment and will amend Sec. 3.10(a) to
refer to the transportation requirements in redesignated Sec. 3.17.
Veterinary Care for Dogs
We proposed to amend the veterinary care requirements for dogs in
Sec. [thinsp]3.13. The changes would expand existing regulations in
subpart D requiring
[[Page 28790]]
dealers and exhibitors to establish and maintain an adequate program of
veterinary care for regulated animals. The expanded care requirements
include regularly scheduled veterinary visits, an annual hands-on
examination, and husbandry requirements to help ensure healthy eyes,
skin, nails, hair, and teeth.
We proposed in a new Sec. 3.13(a)(1) to require regularly
scheduled visits by the attending veterinarian, not less than once
every 12 months, to all premises where animals are kept to assess
veterinary care and other aspects of care and use. This requirement is
expected to be completed no later than 1 year after the effective date.
Substantial numbers of commenters supported this requirement. One
commenter supported the proposal but expressed concern about the level
of oversight required by the attending veterinarian in Sec. 3.13(a),
noting that it places significant responsibility and burden on the
attending veterinarian to draft policies tailored to all aspects of the
animals' lives, despite the veterinarian only being required to visit
the facility once a year. To ensure that the animals at each facility
receive consistent and adequate veterinary care, the commenter asked
that we adopt objective standards for medical, preventative, and
grooming care to minimize inconsistent approaches to care among
attending veterinarians. Furthermore, the commenter recommended that
APHIS add to the regulations the requirement that the program of
veterinary care be drafted and developed ``in accordance with the
recommendations of a recognized and objective veterinary association
like the American Veterinary Medical Association.'' Other commenters
recommended that APHIS include additional requirements as part of the
scheduled visit, including pain assessment and body condition scoring;
an oral examination; special exams for breeding dogs; and
administration of medications for intestinal parasites, heartworm,
fleas, and ticks. A commenter also recommended that dogs receive
preventative dental care, and that specialized procedures such as
euthanasia and surgery only be practiced by licensed veterinarians
using widely accepted techniques.
Some commenters opposed the requirement for scheduling regular
veterinary visits. One such commenter stated that the imposition of a
prescriptive program of veterinary care is not consistent with APHIS'
stated purpose to reduce regulatory burden on licensees because the
program of veterinary care should be individually tailored to meet the
needs of the animals being maintained in each facility. Other
commenters representing research organizations opposed the proposed
change and urged APHIS instead to consider stronger enforcement of its
existing standards regarding veterinary care, noting that their
organizations are rarely cited for veterinary care violations.
We believe the requirement for regular veterinary visits provides
an appropriate level of specificity to ensure an adequate and balanced
program of veterinary care for dogs, and allows for professional,
individual judgment on the part of the attending veterinarian. Annual
hands-on physical exams by the attending veterinarian allow for the
evaluation of factors that could affect the dogs' health, well-being,
and ability to reproduce. A required husbandry program will help ensure
the overall health of adult dogs and puppies, thereby preventing
avoidable disease and injury. Required medical records will help
facilities keep track of incidents, treatments and progress of care,
and allow facilities to track individual health trends and the
frequency of illnesses and injuries for the kennel as a whole. For
these reasons, we are making no changes to the rule in response to the
commenters.
A commenter asked that standards for breeding, socialization, and
exercise be added to the regulations, as the lack of concrete
requirements may result in inconsistent levels of oversight among
attending veterinarians and foster uncertainty as to whether a licensee
will follow a veterinarian's recommendations for addressing standards
of care. Similarly, another commenter stated that the veterinary care
plan should be required to include current exercise and human
interaction and require greater life enrichment for animals in the
companion pet industry, as well as placement strategies for dogs after
breeding age is passed and a cap on the age of maturity for breeding.
The regulations pertaining to exercise of dogs are contained in
Sec. 3.8 of the regulations. Because we did not propose any changes to
these regulations or propose any standards for breeding or
socialization of dogs, this comment falls outside the scope of this
rulemaking.
A commenter stated that this section should be strengthened to
require veterinary care for animals, not only for the obvious humane
reasons, but also so that unsuspecting consumers are not saddled with
unexpected health problems after purchase.
USDA is authorized under the AWA to issue standards governing the
humane handling, care, treatment, and transportation of animals. We
lack authority to promulgate regulations pertaining to consumer
protection.
A commenter stated that APHIS should require that the veterinarian
signing the program of veterinary care be in good standing with the
applicable State's veterinary board and has experience working with the
species at issue.
We are making no changes to the rule in response to this comment.
The AWA authorizes USDA to require licensees to comply with the Act,
but not veterinarians. We note that Sec. 2.40(a)(2) of the regulations
requires licensees to ensure that the attending veterinarian has
appropriate authority to ensure the provision of adequate veterinary
care and to oversee the adequacy of other aspects of animal care and
use. The appropriate authority may include but is not limited to
ensuring that the veterinarian is in good standing with the applicable
State veterinary licensing board. We also note that the definition of
attending veterinarian specifies that the veterinarian ``has received
training and/or experience in the care and management of the species
being attended.''
We also proposed in a new Sec. 3.13(a)(2) to require that each
dealer, exhibitor, and research facility follow an appropriate program
of veterinary care for dogs that is documented and signed by an
attending veterinarian, and includes annual physical head-to-tail
examinations for adult dogs by the attending veterinarian. We proposed
that these annual examinations be required in addition to existing
requirements that provide for regularly scheduled visits by the
attending veterinarian to premises where animals are kept.
A substantial number of commenters supported the proposal to
require an annual head-to-tail examination of each adult dog at a
facility. One commenter recommended that we also require hands-on
veterinary examinations for any dog showing visible signs of pain or
distress, emaciated body condition, or other symptoms of potentially
severe illness or injury.
The requirements in proposed Sec. 3.13 are in addition to the
existing requirements in subpart D, which already require programs of
adequate veterinary care that include the use of appropriate methods to
diagnose and treat diseases and injuries and direct and frequent
communication of problems to the attending veterinarian. We believe the
regulations sufficiently address the attending veterinarians',
licensees', and registrants' responsibilities for sick animals and are
[[Page 28791]]
making no changes to the rule as a result of this comment.
Some commenters stated that the proposed veterinary examination
requirement would cause financial hardship on small breeders and noted
that many stakeholders do not live near an affordable veterinarian.
We note that Sec. 2.40 of the regulations already requires dealers
and exhibitors to employ an attending veterinarian under formal
arrangements and to have programs of adequate veterinary care.
A commenter stated that it is unclear why the attending
veterinarian would need to conduct an annual physical head-to-tail
examination of every dog for what are husbandry issues, when the
licensee is already required to observe every animal on a daily basis.
We are making no changes to the rule in response to this comment. A
physical examination of a dog by a veterinarian may discover health
issues that a licensee may overlook, as the veterinarian has more
extensive knowledge and expertise.
Several commenters stated that it is not clear why APHIS does not
already have the authority under the current language in Sec. 2.40 to
assure that such care is provided. The commenter noted that Sec. 2.40
currently requires that for licensees with a part-time or consulting
attending veterinarian there be a regular schedule of visits and a
written program of veterinary care. The commenter said that if APHIS
finds that the number of visits and written program is not providing
adequate care, the facility should be cited and given a specific
timeline to come into compliance.
Under the current regulations in Sec. 2.40, although a written
program of veterinary care is required for part-time or consulting
veterinarians, it is not required for full-time attending
veterinarians. Similarly, although the veterinarian must conduct
regularly scheduled visits, there is no requirement for a physical,
head-to-tail annual examination for dogs. This rule requires that
dealers, exhibitors, and research facilities keep and maintain a
written program of veterinary care for dogs, regardless of their
arrangement with their attending veterinarian, and require annual
veterinary exams for dogs in addition to the existing veterinary care
requirements that provide for regularly scheduled visits of the
attending veterinarian to premises where animals are kept to ensure the
adequacy of animal care.
Some commenters opposed a required annual head-to-tail examination
for adult dogs on grounds that their animals already receive adequate
care. A few research organizations stated that the proposed requirement
for the head-to-tail examination will yield no additional benefit and
result in more regulatory burden. They suggested that APHIS focus
specifically on those individuals and businesses having a history of
noncompliance and prevent them from obtaining a license or working with
regulated animals, while allowing research institutions with strong
adherence to Federal requirements and excellent veterinary care to
perform their duties following current accepted practices.
APHIS believes that physical head-to-tail examinations and
regularly scheduled visits by attending veterinarians to the premises
where animals are kept are necessary to ensure adequate animal care and
use, regardless of the facility's compliance history. To address the
commenters' concerns, facilities that maintain high levels of
veterinary care likely meet or exceed the veterinary care requirements
in this rule, meaning that such facilities likely would not need to
make any changes to their practices. Therefore, we are making no
changes to the rule in response to this comment.
With respect to the hands-on exam, one commenter asked if APHIS had
considered facilities that exhibit wolf-dogs (an animal that falls
under USDA dog regulations), noting that most rescued wolf-dogs are not
able to be handled safely for this type of exam.
In Sec. 1.1 of the regulations, dog-hybrid crosses are considered
dogs under the definition of dog. Licensees and registrants with dog-
hybrid crosses must comply with all applicable provisions of the AWA
regulations. Licensees and registrants should work closely with their
attending veterinarian to determine appropriate safe handling practices
for dogs (including hybrid crosses) for hands-on examinations.
The commenter also suggested that we require licensed veterinary
certification that the breeding animal is free from detectable health
or congenital problems which can be identified using accepted medical
tests appropriate for problems seen by breed, and is certified healthy
to breed.
We acknowledge the commenter's concern about breeding and breed-
specific problems but are making no changes in response. The veterinary
exam can determine whether a dog is generally in good health, but any
additional testing to detect breed-specific issues would not be a
requirement, but rather a decision by the dog owner.
We also included in proposed Sec. 3.13(a)(3) a requirement for
vaccinations for rabies, parvovirus, distemper, and other dangerous
diseases of dogs.
One commenter opposed to the vaccination requirements in the
proposed rule stated that the wording ``contagious and deadly'' used in
the proposed regulation could be interpreted to mean that a disease
must be both contagious and deadly for a vaccination to be required.
The commenter noted that vaccinations are not always innocuous and
should not be given unless they are needed.
We appreciate the opportunity to clarify our intent with respect to
the wording ``contagious and deadly.'' We agree that vaccinations are
required for diseases that are contagious, or deadly, or both, and are
amending Sec. 3.13(a)(3) accordingly.
Other commenters opposed to the vaccination requirement expressed a
concern that the proposed changes, which include specific vaccination
requirements, would lead to over-vaccinating of animals. A few
commenters stated that APHIS, through this rulemaking, is requiring
them to excessively vaccinate their animals at the expense of their
dogs being poisoned or having seizures. Another commenter opposed to
the proposal said that mandatory vaccinations will result in the deaths
of millions of dogs.
We are making no changes to the vaccination requirement in response
to these comments. Vaccinations are a scientifically proven and
critical component in ensuring the health and well-being of dogs. The
regulations require vaccinations for contagious and deadly diseases of
dogs, which expressly includes but is not limited to rabies,
parvovirus, and distemper, in accordance with a schedule approved by
the attending veterinarian. We note that there are exceptions to this
requirement for research protocols approved by the Institutional Animal
Care and Use Committee (IACUC) at research facilities.
A commenter noted that the rule allows exemptions from required
vaccinations for research facilities, but not for dealers, and
requested that the exemption also be available to dealers who provide
dogs with higher health status requirements (i.e., unvaccinated dogs)
for veterinary health research purposes, providing the animals are
housed in barrier facilities suitable to protect their health and well-
being.
We noted that vaccinations would not be a requirement if
contraindicated for health reasons for the individual animal or unless
otherwise required by a research protocol approved by the IACUC at
research facilities. Therefore,
[[Page 28792]]
we are making no changes to the rule in response to this comment.
We proposed also that the veterinary exam address husbandry issues
for hair coat, toenails, teeth, skin, eyes, and ears.
A commenter representing a research organization recommended the
development of clear, objective criteria to standardize what
constitutes adequate care and subsequently non-compliance regarding
prevention and treatment procedures for skin, nails, teeth, eyes, ears,
and hair coat. The commenter expressed concern that USDA inspectors may
cite noncompliance for the occurrence of early signs of clinical
conditions that are considered mild and not in need of immediate
treatment. The commenter asked that guidelines be developed and made
available to inspectors and regulated facilities in the form of
additions to the Animal Welfare Inspection Guide, rather than in the
proposed changes to the regulations, and that they include examples of
appropriate written prevention and treatment plans.
The rule requires a written program of veterinary care that
includes preventative care and treatment to ensure healthy and unmatted
hair coats, properly trimmed nails, and clean and healthy eyes, ears,
skin, and teeth, unless otherwise required by a research protocol
approved by the IACUC at research facilities. An adequate plan would
address these systems and provide sufficient guidelines on when and how
the veterinarian will need to be consulted on certain conditions.
Therefore, we are making no changes to the rule in response to this
comment.
We proposed in revised Sec. 3.13(b) to require licensees to keep
and maintain veterinary medical records and to make them available for
inspection by APHIS.
A few commenters stated that keeping a medical record of every dog
daily would increase their recordkeeping burden.
The rule does not require a daily medical record for every dog.
Rather, the rule requires facilities to keep track of incidents,
treatments, and progress of care, and to track individual health trends
and frequency of illnesses and injuries for the kennel as a whole.
Regarding the proposed requirement to maintain animal medical
records, a commenter questioned whether the language in section 2140 of
the AWA gives the Secretary the authority to require such records. The
commenter stated that under the Principles of Veterinary Medical
Ethics, a veterinarian has a duty to maintain the necessary records to
provide appropriate care, but does not agree that the AWA requires them
to be maintained.
Under section 2140 of the AWA, ``[d]ealers and exhibitors shall
make and retain for such reasonable period of time as the Secretary may
prescribe, such records with respect to the purchase, sale,
transportation, identification, and previous ownership of animals as
the Secretary may prescribe.'' This section has similar language for
research facilities to maintain such records with respect to live dogs
and cats. However, section 2151 grants the Secretary the authority ``to
promulgate such rules, regulations, and orders as he may deem necessary
in order to effectuate the purposes of this Act.'' Moreover, the rule
places the requirement to maintain the medical records on the facility,
not on the veterinarian.
A commenter noted that Sec. 3.13(b)(1), which allows medical
records for all dogs kept in a group (or herd) to be preserved on a
single record (without individual identifying marks noted for each
dog), will likely negate the positive impact of this section as it will
fail to give inspectors a means of ensuring that all dogs have received
adequate care. The commenter explained that the justifications for
allowing group records for animals like cattle, sheep, and deer, do not
exist in the case of dogs, and that licensees and attending
veterinarians should be able to safely and productively identify each
dog. Accordingly, the commenter recommended that we remove the
``group'' provision in paragraph (b)(1).
We disagree with this comment and are making no changes in
response. This rule will allow routine husbandry, such as vaccinations,
preventive medical procedures, and treatment that are performed on a
group of dogs to be kept on a single record. All animals on the record
will have received the treatment or care if they are listed on the
record. Therefore, we are making no changes to the rule based on this
comment.
Other Comments
One commenter stated that USDA should develop and make available an
implementation plan.
The plan for implementing the rule includes a 3-year schedule for
converting the current 1-year licenses to a 3-year new license based on
the expiration day and month listed on the license. Prior to the
license expiration date, USDA will notify current licensees of the
month and date on which their license will need to be converted to the
3-year license and licensees will need to submit an application for the
new license. Until the license is converted to the 3-year schedule, the
licensee must pay a $40 license fee and renew the current license for 1
year. After the effective date of the rule, new applicants that
demonstrate compliance with the AWA, regulations, and standards will be
issued a 3-year license. We believe this approach will ensure that
adequate resources are continuously available to conduct prelicense and
routine inspections under the AWA.
A few commenters stated that USDA should require online education
classes on compliance that need to be completed by the licensee between
licensing or annually.
We agree that applicants, licensees, and registrants need to learn
about the AWA regulations and how to achieve and maintain compliance
with them. APHIS provides a variety of learning opportunities,
including online modules and in person trainings, and plans to continue
these after the publication of this rule.
Some commenters expressed concerns that APHIS is understaffed and
therefore unable to conduct inspections for compliance under the
existing regulations, let alone new ones.
We affirm that APHIS has adequate resources for conducting
inspections to ensure compliance with the AWA. We employ a risk-based
inspection system that calls for more frequent inspections at
facilities with a higher risk of animal welfare concerns and fewer
inspections at those that are consistently in compliance.
Some commenters objected to allowing members of the public to
comment on the rule, particularly animal welfare advocates, stating
that the general public lacks any technical expertise that can be
offered on these issues. One such commenter representing a wild animal
preserve stated that only individuals who own animals as their business
should be voting on changes in regulations with USDA.
The Administrative Procedure Act, which applies to all agencies of
the Federal government, provides the general procedures for various
types of rulemaking. For informal rulemakings such as this one,
agencies are required to provide the public with adequate notice of a
proposed rule followed by a meaningful opportunity to comment on the
rule's content. Accordingly, we are not authorized to limit the
opportunity to comment to only certain individuals or businesses. We
also note that comments do not constitute ``votes.''
Some commenters stated that licensees were not consulted in the
development of these changes: A commenter stated that ``those authoring
these proposed amendments did not
[[Page 28793]]
solicit the input of seasoned and respected licensees prior to doing
so.''
On August 24, 2017, we published an ANPR to solicit input from
licensees and all other members of the public on potential revisions to
the licensing requirements under the AWA regulations.\13\ We received
over 47,000 comments in response to the ANPR, including comments from
licensees. After carefully reviewing those comments, we published a
proposed rule for public comment, to which we received over 100,000
comments from licensees and other members of the public. We believe
that we have adequately solicited input from licensees before
publishing this final rule, and are accordingly making no changes in
response to this comment.
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\13\ 82 FR 40077 (Aug. 24, 2017) and 82 FR 48938 (Oct. 23,
2017); https://www.federalregister.gov/documents/2017/10/23/2017-22940/animal-welfare-procedures-for-applying-for-licenses-and-renewals.
---------------------------------------------------------------------------
Several thousand commenters asked USDA to end the practice of
keeping dogs in stacked cages with wire flooring, to ban cage stacking,
and to require facilities to provide animals with more cage and living
space. A letter signed by several members of Congress supported the
rule but also called for the elimination of wire flooring in dog
enclosures, as well as a prohibition on stacking cages and an increase
in space requirements for dogs. An animal welfare organization
commented that APHIS' failure to address wire flooring in the proposed
rule is unacceptable and APHIS should add a requirement that all
primary enclosures in commercial breeding facilities have solid floors,
or flooring that is slatted if the slats are at least 3.5 inches in
width with no more than half-inch gaps between slats.
We acknowledge the concerns of the public and members of Congress
on this subject. However, we are making no changes in response to these
comments because enclosure flooring and space requirements are outside
the scope of this rulemaking.
A few commenters stated that the proposed rule change is contrary
to the intent of reducing burden as mandated by the 21st Century Cures
Act, which requires the National Institutes of Health, the U.S.
Department of Agriculture, and the Food and Drug Administration to
complete a review of applicable regulations and policies for the care
and use of laboratory animals and make revisions as appropriate, to
reduce administrative burden on investigators, while maintaining the
integrity and credibility of research findings and protection of
research animals.
The changes to the licensing requirements do not apply to research
facilities. In addition, the amendments to the veterinary care and
watering standards are necessary to ensure the humane treatment and
care of dogs, and are not the kind of inconsistent, overlapping, or
unnecessarily duplicative regulations that are targeted for review by
section 2034 of the 21st Century Cures Act.
Several commenters, without providing specifics, disagreed with the
rule in that it imposes economic and recordkeeping burdens on breeders.
One commenter generally stated that the proposed changes are unfair to
zoos and will burden APHIS with paperwork, enforcement, and legal
challenges.
We believe that changes to the licensing fees would not be unfair
to zoos, but could result in significant savings for many exhibitors.
Under existing licensing fees, exhibitors pay between $30 and $300 per
year, with an additional $10 per year renewal application or new
application fee. The licensees need to submit the renewal application
each year. Under the proposed and final rule, each licensee pays only
$40 per year ($120 for a 3 year license) and has to apply for the
license only once every 3 years. This saves each licensee anywhere from
$0 dollars (no change in cost) to $780 for an exhibitor with over 500
animals over the course of the 3 year licensing period. The new rule
also saves the licensee two-thirds of the time filling out and filing
the paperwork for the license over the 3 year period.
We anticipate an increase in animal welfare due to the requirement
that licensees must apply for a license every 3 years and demonstrate
compliance with the regulations and standards. Based on our knowledge
and experience with administering and enforcing the AWA and
regulations, we are concerned that even experienced licensees may
struggle to achieve and maintain compliance after making noteworthy
changes to their animals used in regulated activity. In addition, we
have observed licensees who have been licensed for many years struggle
with compliance because they did not have adequate programs for
maintaining compliance at aging facilities. For these reasons, we
believe that revisions to the regulations set forth in this final rule
are necessary to ensure that dealers, exhibitors, and operators of
auction sales demonstrate compliance with the AWA regulations.
We received many other comments that made general statements about
the rule or addressed subjects that are outside the scope of this
rulemaking.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, with the
changes discussed in this document.
Executive Orders 12866, 13563, 13771 and Regulatory Flexibility Act
This final rule has been determined to be significant for the
purposes of Executive Order 12866 and, therefore, has been reviewed by
the Office of Management and Budget. This final rule is an Executive
Order 13771 regulatory action. Details on the estimated costs of this
final rule can be found in the rule's economic analysis.
We have prepared an economic analysis for this rule. The economic
analysis provides a cost-benefit analysis, as required by Executive
Orders 12866 and 13563, which direct agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, and equity). Executive Order 13563 emphasizes the importance
of quantifying both costs and benefits, of reducing costs, of
harmonizing rules, and of promoting flexibility. The economic analysis
also provides a final regulatory flexibility analysis that examines the
potential economic effects of this rule on small entities, as required
by the Regulatory Flexibility Act. The economic analysis is summarized
below. Copies of the full analysis are available on the Regulations.gov
website (see footnote 1 in this document for a link to Regulations.gov)
or by contacting the person listed under FOR FURTHER INFORMATION
CONTACT.
APHIS is making revisions to the licensing requirements to promote
compliance with the AWA, as well as to strengthen existing safeguards
that prevent individuals and businesses that are unfit to hold a
license from obtaining a license or from working with regulated
animals. Licensees will be required to renew their certification of
regulatory compliance and pay the associated license fee once every 3
years rather than every year. In addition, the fee will be changed to a
flat rate rather than a set of tiered rates. This action will promote
AWA compliance by requiring that regulated businesses affirmatively
demonstrate regulatory compliance when applying for or renewing a
license. It will reduce the license fee for most regulated entities and
will reduce the compliance paperwork burden for all licensees.
[[Page 28794]]
APHIS is also amending the veterinary care requirements for dogs
that are under the care of entities covered by the AWA. Facilities with
dogs will be required to have an expanded Program of Veterinary Care
(PVC) that includes annual, hands-on veterinary exams for adult dogs by
the attending veterinarian and addresses husbandry issues for hair
coat, toenails, teeth, skin, eyes, and ears. Facilities will also be
required to create and maintain medical records of preventive health
care measures and the treatment of ill and injured dogs.
The expanded PVC will guide the facilities in practicing a minimum
level of acceptable husbandry and in maintaining records of preventive
care and the treatment of ill or injured dogs. Annual hands-on physical
exams by the attending veterinarian will allow for evaluation of
factors that could affect the dogs' health, well-being, and ability to
reproduce. Health problems that are detected early could receive timely
and appropriate veterinary care. A required husbandry program will help
ensure the overall health of adult dogs and puppies, thereby preventing
avoidable disease, illness, and injury. Required medical records will
help facilities keep track of incidents, treatments, and progress of
care. They also will enable facilities to track individual health
trends and the frequency of illnesses and injuries for the kennel as a
whole.
This rule will also amend the AWA standard for dogs with respect to
access to clean, drinkable water. The current regulations state that if
potable water is not continuously available to a facility's dogs, it
must be offered as often as necessary to ensure the animals' health and
well-being, and not less than twice daily for at least 1 hour each
time, unless restricted by the attending veterinarian. The standard
will require that facilities make potable water continuously available.
All businesses covered under the AWA will be affected by the
licensing requirements, including animal dealers, exhibitors, retail
pet stores, brokers, and breeders. The number of these entities varies
from year to year, but has tended to be around 6,000 in recent years.
Based on reported revenue data and Small Business Administration (SBA)
small-entity standards, the majority of the entities affected by this
rule can be considered small. About one-half of these businesses are
licensees and registrants with dogs, including about 2,240 dog breeder
facilities.
The licensing requirements will result in annual cost savings
expected to range from about $627,000 to $2,106,300. The veterinary
care requirements for facilities having dogs will result in annual
costs ranging from about $726,200 to about $1,390,200, and the water
access requirement for these facilities will result in annual costs
ranging from about $1,020,800 to $2,460,000. Net costs, as shown in
table A, are therefore expected to range from annual cost savings of
$359,300 (the higher licensing cost savings estimate plus the lower
veterinary care and water access cost estimates) to annual costs of
$3,223,200 (the lower licensing cost savings estimate plus the higher
veterinary care and water access cost estimates).
Table A--Estimated Net Costs of the Rule, 2016 Dollars
------------------------------------------------------------------------
Low estimate High estimate
------------------------------------------------------------------------
Licensing cost savings.................. ($2,106,300) ($627,000)
Veterinary care costs................... 726,200 1,390,200
Water access costs...................... 1,020,800 2,460,000
Net costs............................... (359,300) 3,223,200
------------------------------------------------------------------------
Based on the costs in the table and in accordance with guidance on
complying with Executive Order 13771, the single primary estimate of
the costs of this rule is $1,432,000, the mid-point estimate of net
costs annualized in perpetuity using a 7 percent discount rate.
Executive Order 12372
This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 2 CFR chapter IV.)
Executive Order 12988
This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. It is not intended to have retroactive effect.
The Act does not provide administrative procedures which must be
exhausted prior to a judicial challenge to the provisions of this rule.
Executive Order 13175
This rule has been reviewed in accordance with the requirements of
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments. Executive Order 13175 requires Federal agencies to consult
and coordinate with Tribes on a government-to-government basis on
policies that have Tribal implications, including regulations,
legislative comments or proposed legislation, and other policy
statements or actions that have substantial direct effects on one or
mare Indian Tribes, on the relationship between the Federal Government
and Indian Tribes or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes.
The USDA's Office of Tribal Relations (OTR) has assessed the impact
of this rule on Indian Tribes and concluded that this rule does not
have substantial direct effects on one or more Indian Tribes, on the
relationship between the Federal Government and Indian Tribes or on the
distribution of power and responsibilities between the Federal
Government and Indian Tribes.
OTR has determined that Tribal consultation under Executive Order
13175 is not required at this time. If consultation is requested, OTR
will work with the APHIS to ensure quality consultation is provided.
Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
the Office of Information and Regulatory Affairs designated this rule
as not a major rule, as defined by 5 U.S.C. 804(2).
Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), some of the information collection
requirements included in this final rule have been approved under
Office of Management and Budget (OMB) control number 0579-0036 and some
of the information collection requirements were filed under OMB
comment-filed number 0579-0470, which has been submitted to OMB for
approval. When OMB notifies us of its decision, if approval is denied,
we will publish a document in
[[Page 28795]]
the Federal Register providing notice of what action we plan to take.
E-Government Act Compliance
The Animal and Plant Health Inspection Service is committed to
compliance with the EGovernment Act to promote the use of the internet
and other information technologies, to provide increased opportunities
for citizen access to Government information and services, and for
other purposes. For information pertinent to E-Government Act
compliance related to this rule, please contact Mr. Joseph Moxey,
APHIS' Information Collection Coordinator, at (301) 851-2483.
List of Subjects
9 CFR Parts 1 and 2
Animal welfare, Pets, Reporting and recordkeeping requirements,
Research.
9 CFR Part 3
Animal welfare, Marine mammals, Pets, Reporting and recordkeeping
requirements, Research, Transportation.
Accordingly, we are amending 9 CFR parts 1, 2, and 3 as follows:
PART 1--DEFINITION OF TERMS
0
1. The authority citation for part 1 continues to read as follows:
Authority: 7 U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371.7.
0
2. Section 1.1 is amended by removing the definition for AC Regional
Director and revising the definition for Business hours to read as
follows:
Sec. 1.1 Definitions.
* * * * *
Business hours means a reasonable number of hours between 7 a.m.
and 7 p.m. each week of the year, during which inspections by APHIS may
be made.
* * * * *
PART 2--REGULATIONS
0
3. The authority citation for part 2 continues to read as follows:
Authority: 7 U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371.7.
0
4. Section 2.1 is amended as follows:
0
a. By revising paragraphs (a)(1) and (2), (b), and (c);
0
b. By removing paragraph (d) and redesignating paragraph (e) as
paragraph (d); and
0
c. By revising newly redesignated paragraph (d) and the OMB citation at
the end of the section.
The revisions read as follows:
Sec. 2.1 Requirements and application.
(a)(1) No person shall operate as a dealer, exhibitor, or operator
of an auction sale, without a valid license, except persons who are
exempt from the licensing requirements under paragraph (a)(3) of this
section. A person must be 18 years of age or older to obtain a license.
A person seeking a license shall apply on a form which will be
furnished by the Deputy Administrator. The applicant shall provide the
information requested on the application form, including, but not
limited to:
(i) The name of the person applying for the license;
(ii) A valid mailing address through which the applicant can be
reached at all times;
(iii) Valid addresses for all locations, facilities, premises, or
sites where animals, animal facilities, equipment, and records are
held, kept, or maintained;
(iv) The anticipated maximum number of animals on hand at any one
time during the period of licensure;
(v) The anticipated type of animals described in paragraph
(b)(2)(ii) of this section to be owned, held, maintained, sold, or
exhibited, including those animals leased, during the period of
licensure;
(vi) If the person is seeking a license as an exhibitor, whether
the person intends to exhibit any animal at any location other than the
person's location(s) listed pursuant to paragraph (a)(1)(iii) of this
section; and
(vii) Disclosure of any plea of nolo contendere (no contest) or
finding of violation of Federal, State, or local laws or regulations
pertaining to animal cruelty or the transportation, ownership, neglect,
or welfare of animals.
(2) The completed application form, along with a $120 license fee,
shall be submitted to the appropriate Animal Care office.
* * * * *
(b)(1) No person shall have more than one license. Licenses are
issued to specific persons, and are issued for specific activities,
types and numbers of animals, and approved sites. A new license must be
obtained upon change of ownership, location, activities, or animals. A
licensee shall notify Animal Care no fewer than 90 days and obtain a
new license before any change in the name, address, substantial control
or ownership of his business or operation, locations, activities, and
number or type of animals described in paragraph (b)(2) of this
section. Any person who is subject to the regulations in this
subchapter and who intends to exhibit any animal at any location other
than the person's approved site must provide that information on their
application form in accordance with paragraph (a) of this section and
submit written itineraries in accordance with Sec. 2.126.
(2) Licenses authorize a specific number and specific type(s) of
animals, as follows:
(i) Licenses authorize increments of 50 animals on hand at any
single point in time during the period of licensure. A licensee must
obtain a new license before any change resulting in more than the
authorized number of animals on hand at any single point in time during
the period of licensure.
(ii) Licenses authorize the use of animals subject to subparts A
through F in part 3 of this subchapter, except that, for animals
subject to subparts D and F, licenses must specifically authorize the
use of each of the following groups of animals: Group 5 (baboons and
nonbrachiating species larger than 33 pounds) and Group 6 (great apes
over 55 pounds and brachiating species) nonhuman primates; exotic and
wild felids (including but not limited to lions, tigers, leopards,
cheetahs, jaguars, cougars, lynx, servals, bobcats, and caracals, and
any hybrid cross thereof); hyenas and/or exotic and wild canids
(including but not limited to wolves, coyotes, foxes, and jackals);
bears; and mega-herbivores (including but not limited to elephants,
rhinoceroses, hippopotamuses, and giraffes). A licensee must obtain a
new license before using any animal beyond those types or numbers of
animals authorized under the existing license.
(c) A license will be issued to any applicant, except as provided
in Sec. Sec. 2.9 through 2.11, when:
(1) The applicant has met the requirements of this section and
Sec. Sec. 2.2 and 2.3; and
(2) The applicant has paid a $120 license fee to the appropriate
Animal Care office. The applicant may pay the fee by certified check,
cashier's check, personal check, money order, or credit card. An
applicant whose check is returned by a bank will be charged a fee of
$20 for each returned check. If an applicant's check is returned,
subsequent fees must be paid by certified check, cashier's check, money
order, or credit card.
(d) The failure of any person to comply with any provision of the
Act, or any of the provisions of the regulations or standards in this
subchapter, shall constitute grounds for denial of a license or for its
suspension or revocation by the Secretary, as provided in the Act.
[[Page 28796]]
(Approved by the Office of Management and Budget under control
numbers 0579-0036 and 0579-0470)
0
5. Section 2.2 is revised to read as follows:
Sec. 2.2 Acknowledgement of regulations and standards.
Animal Care will supply a copy of the Act and the regulations and
standards in this subchapter to an applicant upon request. Signing the
application form is an acknowledgement that the applicant has reviewed
the Act and the regulations and standards and agrees to comply with
them.
(Approved by the Office of Management and Budget under control
numbers 0579-0036 and 0579-0470)
0
6. Section 2.3 is revised to read as follows:
Sec. 2.3 Demonstration of compliance with standards and regulations.
(a) Each applicant for a license must demonstrate that his or her
location(s) and any animals, facilities, vehicles, equipment, or other
locations used or intended for use in the business comply with the Act
and the regulations and standards set forth in parts 2 and 3 of this
subchapter. Each applicant must make his or her animals, locations,
facilities, vehicles, equipment, and records available for inspection
during business hours and at other times mutually agreeable to the
applicant and APHIS, to ascertain the applicant's compliance with the
Act and the regulations and standards.
(b) Each applicant for a license must be inspected by APHIS and
demonstrate compliance with the Act and the regulations and standards,
as required in paragraph (a) of this section, before APHIS will issue a
license. If the first inspection reveals that the applicant's animals,
premises, facilities, vehicles, equipment, locations, or records do not
meet the applicable requirements of this subchapter, APHIS will advise
the applicant of existing deficiencies and the corrective measures that
must be completed to come into compliance with the regulations and
standards. An applicant who fails the first inspection may request up
to two more inspections by APHIS to demonstrate his or her compliance
with the Act and the regulations and standards. The applicant must
request the second inspection, and if applicable, the third inspection,
within 60 days following the first inspection.
(c) Any applicant who fails the third and final prelicense
inspection may appeal all or part of the inspection findings to the
Deputy Administrator. To appeal, the applicant must send a written
statement contesting the inspection finding(s) and include any
documentation or other information in support of the appeal. To receive
consideration, the appeal must be received by the Deputy Administrator
within 7 days of the date the applicant received the third prelicense
inspection report. Within 7 days of receiving a timely appeal, the
Deputy Administrator will issue a written response to notify the
applicant whether APHIS will issue a license or deny the application.
(d) If an applicant fails inspection or fails to request
reinspections within the 60-day period, or fails to submit a timely
appeal of the third prelicense inspection report as described in
paragraph (c) of this section, the applicant cannot reapply for a
license for a period of 6 months from the date of the failed third
inspection or the expiration of the time to request a third inspection.
No license will be issued until the applicant pays the license fee and
demonstrates upon inspection that the animals, premises, facilities,
vehicles, equipment, locations, and records are in compliance with all
applicable requirements in the Act and the regulations and standards in
this subchapter.
(Approved by the Office of Management and Budget under control
number 0579-0036)
0
7. Section 2.5 is revised to read as follows:
Sec. 2.5 Duration of license and termination of license.
(a) A license issued under this part shall be valid and effective
for 3 years unless:
(1) The license has been revoked or suspended pursuant to section
19 of the Act or terminated pursuant to Sec. 2.12.
(2) The license is voluntarily terminated upon request of the
licensee, in writing, to the Deputy Administrator.
(3) The license has expired, except that:
(i) The Deputy Administrator may issue a temporary license, which
automatically expires after 120 days, to an applicant whose immediately
preceding 3-year license has expired, if:
(A) The applicant submits the appropriate application form before
the expiration date of a preceding license; and
(B) The applicant had no noncompliances with the Act and the
regulations and standards in parts 2 and 3 of this subchapter
documented in any inspection report during the preceding period of
licensure.
(ii) For expedited hearings occurring under Sec. 2.11(b)(2), a
license will remain valid and effective until the administrative law
judge issues his or her initial decision. Should the administrative law
judge's initial decision affirm the denial of the license application,
the applicant's license shall terminate immediately.
(4) There will not be a refund of the license fee if a license is
denied, or terminated, suspended, or revoked prior to its expiration
date.
(b) Any person who seeks the reinstatement of a license that has
expired or been terminated must follow the procedure applicable to new
applicants for a license set forth in Sec. 2.1.
(c) A license which is invalid under this part shall be surrendered
to the Deputy Administrator. If the license cannot be found, the
licensee shall provide a written statement so stating to the Deputy
Administrator.
Sec. Sec. 2.6 through 2.8 [Removed and Reserved]
0
8. Sections 2.6 through 2.8 are removed and reserved.
0
9. Section 2.9 is revised to read as follows:
Sec. 2.9 Officers, agents, and employees of licensees whose licenses
have been suspended or revoked.
Any person who has been or is an officer, agent, or employee of a
licensee whose license has been suspended or revoked and who was
responsible for or participated in the activity upon which the order of
suspension or revocation was based will not be licensed, or registered
as a carrier, intermediate handler, dealer, exhibitor, or research
facility, within the period during which the order of suspension or
revocation is in effect.
0
10. Section 2.10 is revised to read as follows:
Sec. 2.10 Licensees whose licenses have been suspended or revoked.
(a) Any person whose license or registration has been suspended for
any reason shall not be licensed, or registered, in his or her own name
or in any other manner, within the period during which the order of
suspension is in effect. No partnership, firm, corporation, or other
legal entity in which any such person has a substantial interest,
financial or otherwise, will be licensed or registered during that
period. Any person whose license has been suspended for any reason may
apply to the Deputy Administrator, in writing, for reinstatement of his
or her license or registration.
(b) Any person whose license has been revoked shall not be licensed
or registered, in his or her own name or in any other manner, and no
partnership, firm, corporation, or other legal entity in
[[Page 28797]]
which any such person has a substantial interest, financial or
otherwise, will be licensed or registered.
(c) Any person whose license has been suspended or revoked shall
not buy, sell, transport, exhibit, or deliver for transportation, any
animal during the period of suspension or revocation, under any
circumstances, whether on his or her behalf or on the behalf of another
licensee or registrant.
0
11. Section 2.11 is revised to read as follows:
Sec. 2.11 Denial of license application.
(a) A license will not be issued to any applicant who:
(1) Has not complied with the requirements of Sec. Sec. 2.1
through 2.4 and has not paid the fees indicated in Sec. 2.1;
(2) Is not in compliance with the Act or any of the regulations or
standards in this subchapter;
(3) Has had a license revoked or whose license is suspended, as set
forth in Sec. 2.1(d);
(4) Was an officer, agent, or employee of a licensee whose license
has been suspended or revoked and who was responsible for or
participated in the activity upon which the order of suspension or
revocation was based, as set forth in Sec. 2.9;
(5) Has pled nolo contendere (no contest) or has been found to have
violated any Federal, State, or local laws or regulations pertaining to
animal cruelty within 3 years of application, or after 3 years if the
Administrator determines that the circumstances render the applicant
unfit to be licensed;
(6) Is or would be operating in violation or circumvention of any
Federal, State, or local laws; or
(7) Has made any false or fraudulent statements or provided any
false or fraudulent records to the Department or other government
agencies, or has pled nolo contendere (no contest) or has been found to
have violated any Federal, State, or local laws or regulations
pertaining to the transportation, ownership, neglect, or welfare of
animals, or is otherwise unfit to be licensed and the Administrator
determines that the issuance of a license would be contrary to the
purposes of the Act.
(b)(1) An applicant whose initial license application has been
denied may request a hearing in accordance with the applicable rules of
practice in 7 CFR part 1 for the purpose of showing why the application
for license should not be denied. The denial of an initial license
application shall remain in effect until the final decision has been
rendered. Should the license denial be upheld, the applicant may again
apply for a license 1 year from the date of the final order denying the
application, unless the order provides otherwise.
(2) An applicant who submitted a timely appeal of a third
prelicense inspection as described in Sec. 2.3(c), and whose appeal
results in the denial of the license application, may request an
expedited hearing if the applicant held a valid license when he or she
submitted the license application that has been denied and the Deputy
Administrator received such license application no fewer than 90 days
prior to the expiration of the valid license. If the applicant meets
the criteria in this paragraph (b)(2), and notwithstanding the
timeframes of the proceedings set forth in the applicable rules of
practice (7 CFR 1.130 through 1.151):
(i) The applicant must submit the request for an expedited hearing
within 30 days of receiving notice from the Deputy Administrator that
the license application has been denied;
(ii) The administrative law judge shall set the expedited hearing
so that it occurs within 30 days of receiving a timely request for
expedited hearing as described in paragraph (b)(2)(i) of this section;
and
(iii) The administrative law judge must issue an initial decision
no later than 30 days after the expedited hearing.
(iv) The applicant's license will remain valid until the
administrative law judge issues his or her initial decision. Should the
administrative law judge's initial decision affirm the denial of the
license application, the applicant's license shall terminate
immediately.
(c) No partnership, firm, corporation, or other legal entity in
which a person whose license application has been denied has a
substantial interest, financial or otherwise, will be licensed within 1
year of the license denial.
(d) No license will be issued under circumstances that the
Administrator determines would circumvent any order, stipulation, or
settlement agreement suspending, revoking, terminating, or denying a
license or disqualifying a person from engaging in activities under the
Act.
0
12. Section 2.12 is revised to read as follows:
Sec. 2.12 Termination of a license.
A license may be terminated at any time for any reason that a
license application may be denied pursuant to Sec. 2.11 after a
hearing in accordance with the applicable rules of practice in 7 CFR
part 1.
0
13. Section 2.13 is added to read as follows:
Sec. 2.13 Appeal of inspection report.
Except as otherwise provided in Sec. 2.3(c), any licensee or
registrant may appeal all or part of the inspection findings in an
inspection report to the Deputy Administrator. To appeal, the licensee
or registrant must send a written statement contesting the inspection
finding(s) and include any documentation or other information in
support of the appeal. To receive consideration, the appeal must be
received by the Deputy Administrator within 21 days of the date the
licensee or registrant received the inspection report that is the
subject of the appeal.
Sec. 2.25 [Amended]
0
14. In Sec. 2.25, paragraph (a) is amended by removing the words ``AC
Regional Director'' each time they appear and adding the words ``Deputy
Administrator'' in their place.
Sec. 2.26 [Amended]
0
15. Section 2.26 is amended by removing the words ``AC Regional
Director'' and adding the words ``Deputy Administrator'' in their
place.
Sec. 2.27 [Amended]
0
16. Section 2.27 is amended by removing the words ``AC Regional
Director'' each time they appear and adding the words ``Deputy
Administrator'' in their place.
Sec. 2.30 [Amended]
0
17. Section 2.30 is amended by removing the words ``AC Regional
Director'' each time they appear and adding the words ``Deputy
Administrator'' in their place.
Sec. 2.35 [Amended]
0
18. In Sec. 2.35, the OMB citation at the end of the section is
amended by removing the number ``0579-0254'' and adding the number
``0579-0036'' in its place.
Sec. 2.36 [Amended]
0
19. In Sec. 2.36, paragraph (a) is amended by removing the words ``AC
Regional Director'' and adding the words ``Deputy Administrator'' in
their place.
0
20. Section 2.38 is amended as follows:
0
a. By revising paragraph (c);
0
b. In paragraph (g)(1) introductory text, by removing the period
between the words ``acquired'' and ``sold'' and adding a comma in its
place;
0
c. In paragraph (g)(7), footnote 1, by removing the words ``AC Regional
Director'' and adding the words
[[Page 28798]]
``Deputy Administrator'' in their place; and
0
d. In paragraph (i) introductory text, by removing the words ``AC
Regional Director'' and adding the words ``Deputy Administrator'' in
their place.
The revision reads as follows:
Sec. 2.38 Miscellaneous.
* * * * *
(c) Publication of lists of research facilities subject to the
provisions of this part. APHIS will publish on its website lists of
research facilities registered in accordance with the provisions of
this subpart. The lists may also be obtained upon request from the
Deputy Administrator.
* * * * *
Sec. 2.52 [Amended]
0
21. In Sec. 2.52, footnote 4 is amended by removing the words ``AC
Regional Director'' and adding the words ``Deputy Administrator'' in
their place.
Sec. 2.75 [Amended]
0
22. In Sec. 2.75, paragraphs (a)(3) and (b)(2) are amended by removing
the citation ``Sec. 2.79'' and adding the citation ``Sec. 2.78'' in
its place.
Sec. 2.77 [Amended]
0
23. In Sec. 2.77, paragraph (b) is amended by removing the citation
``Sec. 2.79'' and adding the citation ``Sec. 2.78'' in its place.
Sec. 2.102 [Amended]
0
24. In Sec. 2.102, paragraphs (a) and (b) introductory text are
amended by removing the words ``AC Regional Director'' and adding the
words ``Deputy Administrator'' in their place.
Sec. 2.126 [Amended]
0
25. In Sec. 2.126, paragraph (c) is amended by removing the words ``AC
Regional Director'' each time they appear and adding the words ``Deputy
Administrator'' in their place.
0
26. Section 2.127 is revised to read as follows:
Sec. 2.127 Publication of lists of persons subject to the provisions
of this part.
APHIS will publish on its website lists of persons licensed or
registered in accordance with the provisions of this part. The lists
may also be obtained upon request from the Deputy Administrator.
Sec. 2.132 [Amended]
0
27. In Sec. 2.132, the OMB citation at the end of the section is
amended by removing the number ``0579-0254'' and adding the number
``0579-0036'' in its place.
Sec. 2.150 [Amended]
0
28. Section 2.150 is amended as follows:
0
a. By removing the words ``continental United States or Hawaii'' each
time they appear and adding the word ``States'' in their place;
0
b. In paragraph (a), by removing the words ``, research, or veterinary
treatment''; and
0
c. In paragraph (c)(8), by adding the words ``resale for'' immediately
before the words ``research purposes''.
Sec. 2.151 [Amended]
0
29. Section 2.151 is amended as follows:
0
a. By removing the words ``continental United States or Hawaii'' each
time they appear and adding the word ``States'' in their place;
0
b. In paragraph (a) introductory text, by removing the words ``,
research, or veterinary treatment'';
0
c. In paragraph (b)(1), by adding the words ``resale for'' immediately
before the words ``use in research, tests, or experiments at a research
facility''; and
0
d. In paragraph (b)(2) introductory text, by adding the words ``and
subsequent resale'' immediately after the words ``for veterinary
treatment by a licensed veterinarian''.
Sec. 2.152 [Amended]
0
30. Section 2.152 is amended by removing the words ``continental United
States or Hawaii'' and adding the word ``States'' in their place.
Sec. 2.153 [Amended]
0
31. Section 2.153 is amended as follows:
0
a. By removing the words ``continental United States or Hawaii'' both
times they appear and adding the word ``States'' in their place; and
0
b. By adding the words ``or the Act'' immediately after the words
``this subpart''.
PART 3--STANDARDS
0
32. The authority citation for part 3 continues to read as follows:
Authority: 7 U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371.7.
Sec. 3.6 [Amended]
0
33. In Sec. 3.6, paragraphs (b)(5) and (c)(3) are amended by removing
the citations ``Sec. 3.14 of this subpart'' and ``Sec. 3.14(a)(6) of
this subpart'' and adding the citations ``Sec. 3.15'' and ``Sec.
3.15(a)(6)'' in their places, respectively.
0
34. Section 3.10 is revised to read as follows:
Sec. 3.10 Watering.
(a) Potable water must be continuously available to the dogs,
unless restricted by the attending veterinarian or except as provided
in Sec. 3.17(a).
(b) If potable water is not continuously available to the cats, it
must be offered to the cats as often as necessary to ensure their
health and well-being, but not less than twice daily for at least 1
hour each time, unless restricted by the attending veterinarian.
(c) Water receptacles must be kept clean and sanitized in
accordance with Sec. 3.11(b) and before being used to water a
different dog or cat or a different social grouping of dogs or cats.
Sec. Sec. 3.13 through 3.19 [Redesignated as Sec. Sec. 3.14 through
3.20]
0
35. Sections 3.13 through 3.19 are redesignated as Sec. Sec. 3.14
through 3.20, respectively.
0
36. New Sec. 3.13 is added to read as follows:
Sec. 3.13 Veterinary care for dogs.
(a) Each dealer, exhibitor, and research facility must follow an
appropriate program of veterinary care for dogs that is developed,
documented in writing, and signed by the attending veterinarian.
Dealers, exhibitors, and research facilities must keep and maintain the
written program and make it available for APHIS inspection. The written
program of veterinary care must address the requirements for adequate
veterinary care for every dealer and exhibitor in Sec. 2.40 of this
subchapter and every research facility in Sec. 2.33 of this
subchapter, and must also include:
(1) Regularly scheduled visits, not less than once every 12 months,
by the attending veterinarian to all premises where animals are kept,
to assess and ensure the adequacy of veterinary care and other aspects
of animal care and use;
(2) A complete physical examination from head to tail of each dog
by the attending veterinarian not less than once every 12 months;
(3) Vaccinations for contagious and/or deadly diseases of dogs
(including rabies, parvovirus and distemper) and sampling and treatment
of parasites and other pests (including fleas, worms, coccidia,
giardia, and heartworm) in accordance with a schedule approved by the
attending veterinarian, unless otherwise required by a research
protocol approved by the Committee at research facilities; and
(4) Preventative care and treatment to ensure healthy and unmatted
hair coats, properly trimmed nails, and clean and healthy eyes, ears,
skin, and teeth,
[[Page 28799]]
unless otherwise required by a research protocol approved by the
Committee at research facilities.
(b) Dealers, exhibitors, and research facilities must keep copies
of medical records for dogs and make the records available for APHIS
inspection. These records must include:
(1) The identity of the animal, including identifying marks,
tattoos, or tags on the animal and the animal's breed, sex, and age;
Provided, however, that routine husbandry, such as vaccinations,
preventive medical procedures, or treatments, performed on all animals
in a group (or herd), may be kept on a single record;
(2) If a problem is identified (such as a disease, injury, or
illness), the date and a description of the problem, examination
findings, test results, plan for treatment and care, and treatment
procedures performed, when appropriate;
(3) The names of all vaccines and treatments administered and the
dates of administration; and
(4) The dates and findings/results of all screening, routine, or
other required or recommended test or examination.
(c) Medical records for dogs shall be kept for the following
periods:
(1) The medical records for dogs shall be kept and maintained by
the research facility for the duration of the research activity and for
an additional 3 years after the dog is euthanized or disposed of, and
for any period in excess of 3 years as necessary to comply with any
applicable Federal, State, or local law.
(2) The medical records for dogs shall be kept and maintained by
the dealer or exhibitor for at least 1 year after the dog is euthanized
or disposed of and for any period in excess of 1 year as necessary to
comply with any applicable Federal, State, or local law.
(3) Whenever the Administrator notifies a research facility,
dealer, or exhibitor in writing that specified records shall be
retained pending completion of an investigation or proceeding under the
Act, the research facility, dealer, or exhibitor shall hold those
records until their disposition is authorized by the Administrator.
(Approved by the Office of Management and Budget under control
number 0579-0470)
Sec. 3.14 [Amended]
0
37. Newly redesignated Sec. 3.14 is amended as follows:
0
a. In paragraph (c) introductory text, by removing the citation ``Sec.
3.16 of this subpart'' and adding the citation ``Sec. 3.17'' in its
place;
0
b. In paragraph (d), by removing the citation ``Sec. 3.14 of this
subpart'' and adding the citation ``Sec. 3.15'' in its place; and
0
c. In paragraph (e) introductory text:
0
i. In the first sentence, by removing the citation ``Sec. Sec. 3.18
and 3.19 of this subpart'' both times it appears and adding the
citation ``Sec. Sec. 3.19 and 3.20'' in its place; and
0
ii. In the second sentence, by removing the citations ``Sec. 3.18''
and ``Sec. 3.19'' and adding the citations ``Sec. 3.19'' and ``Sec.
3.20'' in their place, respectively.
Sec. 3.15 [Amended]
0
38. In newly redesignated Sec. 3.15, paragraph (h) is amended by
removing the citation ``Sec. 3.13(c)'' and adding the citation ``Sec.
3.14(c)'' in its place.
Sec. 3.17 [Amended]
0
39. In newly redesignated Sec. 3.17, paragraph (a) is amended by
removing the citation
``Sec. 3.13(c) of this subpart'' both times it appears and adding
the citation ``Sec. 3.14(c)'' in its place.
0
40. Newly redesignated Sec. 3.18 is amended as follows:
0
a. In paragraph (a), by removing the citation ``Sec. 3.15(e)'' and
adding the citation ``Sec. 3.16(e)'' in its place;
0
b. In paragraph (b), by removing the citation ``Sec. 3.15(d)'' and
adding the citation ``Sec. 3.16(d)'' in its place; and
0
c. In paragraph (d), by adding a paragraph heading and removing the
citations ``Sec. 3.14(b) of this subpart'' and ``Sec. 3.6 or Sec.
3.14 of this subpart'' and adding the citations ``Sec. 3.15(b)'' and
``Sec. 3.6 or Sec. 3.15'' in their places, respectively.
The addition reads as follows:
Sec. 3.18 Care in transit.
* * * * *
(d) Removal during transportation in commerce prohibited. * * *
* * * * *
Sec. 3.19 [Amended]
0
41. In newly redesignated Sec. 3.19, paragraph (f) is amended by
removing the citation ``Sec. 3.13(f) of this subpart'' and adding the
citation ``Sec. 3.14(f)'' in its place.
Sec. 3.20 [Amended]
0
42. Newly redesignated Sec. 3.20 is amended as follows:
0
a. In paragraph (a)(1), by removing the citation ``Sec. 3.18(d) of
this subpart'' and adding the citation ``Sec. 3.19(d)'' in its place;
and
0
b. In paragraph (a)(3), by removing the citations ``Sec. 3.13(e)'' and
``Sec. 3.18(d) of this subpart'' and adding the citations ``Sec.
3.14(e)'' and ``Sec. 3.19(d)'' in their places, respectively.
Sec. 3.61 [Amended]
0
43. Section 3.61 is amended as follows:
0
a. In paragraph (b), by removing the word ``specie'' and adding the
word ``species'' in its place; and
0
b. In paragraph (f), by removing the word ``works'' and adding the word
``words'' in its place.
0
44. Section 3.78 is amended by revising the section heading to read as
follows:
Sec. 3.78 Outdoor housing facilities.
* * * * *
Sec. 3.110 [Amended]
0
45. In Sec. 3.110, paragraph (a) is amended by removing the words ``it
is determined that''.
Sec. 3.111 [Amended]
0
46. Section 3.111 is amended by removing the word ``regional'' in
footnote 14.
Done in Washington, DC, this 9th day of April 2020.
Lorren Walker,
Acting Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2020-07837 Filed 5-12-20; 8:45 am]
BILLING CODE 3410-34-P