Rule2021-25614
AWA Research Facility Registration Updates, Reviews, and Reports
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Published
November 24, 2021
Effective
December 27, 2021
Issuing agencies
Agriculture DepartmentAnimal and Plant Health Inspection Service
Abstract
We are amending the Animal Welfare Act (AWA) regulations governing facilities that conduct research, experimentation, teaching, and testing by removing duplicative and unnecessary reviews and requests for information. We are removing the requirement that registered research facilities update their registration information every 3 years because the information is already collected by other means. We are also removing a redundant requirement for the Institutional Animal Care and Use Committee at each facility to conduct a continuing review of research activities involving animals and instead requiring a complete resubmission and review of such activities at least every 3 years. We will also no longer require that research facilities request an inactive status if they no longer use, handle, or transport AWA covered animals. In addition, we are clarifying the duration of a registration and conditions for its cancellation and will no longer require that the Institutional Official or Chief Executive Officer sign the annual report. We are also making miscellaneous changes to improve readability. These changes will reduce duplicative requirements and administrative burden on facilities while continuing to ensure the integrity and credibility of research findings and the protection of research animals.
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[Federal Register Volume 86, Number 224 (Wednesday, November 24, 2021)]
[Rules and Regulations]
[Pages 66919-66926]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-25614]
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Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
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Federal Register / Vol. 86, No. 224 / Wednesday, November 24, 2021 /
Rules and Regulations
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 2, 3, and 4
[Docket No. APHIS-2019-0001]
RIN 0579-AE54
AWA Research Facility Registration Updates, Reviews, and Reports
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are amending the Animal Welfare Act (AWA) regulations
governing facilities that conduct research, experimentation, teaching,
and testing by removing duplicative and unnecessary reviews and
requests for information. We are removing the requirement that
registered research facilities update their registration information
every 3 years because the information is already collected by other
means. We are also removing a redundant requirement for the
Institutional Animal Care and Use Committee at each facility to conduct
a continuing review of research activities involving animals and
instead requiring a complete resubmission and review of such activities
at least every 3 years. We will also no longer require that research
facilities request an inactive status if they no longer use, handle, or
transport AWA covered animals. In addition, we are clarifying the
duration of a registration and conditions for its cancellation and will
no longer require that the Institutional Official or Chief Executive
Officer sign the annual report. We are also making miscellaneous
changes to improve readability. These changes will reduce duplicative
requirements and administrative burden on facilities while continuing
to ensure the integrity and credibility of research findings and the
protection of research animals.
DATES: This rule is effective December 27, 2021.
FOR FURTHER INFORMATION CONTACT: Dr. Lance H. Bassage, VMD, Director,
National Policy Staff, Animal Care, APHIS, 4700 River Road, Unit 84,
Riverdale, MD 20737; <a href="/cdn-cgi/l/email-protection#c5a9a4aba6a0ebadeba7a4b6b6a4a2a085b0b6a1a4eba2aab3"><span class="__cf_email__" data-cfemail="a2cec3ccc1c78cca8cc0c3d1d1c3c5c7e2d7d1c6c38cc5cdd4">[email protected]</span></a>.
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 regulations and sets forth institutional
responsibilities for regulated parties. Part 3 provides standards for
the humane handling, care, treatment, and transportation of covered
animals. Part 4 addresses rules of practice governing proceedings under
the AWA.
On September 17, 2020, APHIS announced in the Federal Register (85
FR 57998-58002, APHIS-2019-0001) \1\ proposed changes to 9 CFR part 2
in order to address reforms called for in Title II, Section 2034(d) of
the 21st Century Cures Act (21CCA). The 21CCA tasked the National
Institutes of Health (NIH), the USDA, and the U.S. Food and Drug
Administration (FDA) to identify inconsistent, overlapping, and
unnecessarily duplicative regulations and policies associated with
research using laboratory animals and to consider modifying,
streamlining, or repealing those that are unnecessary or impose
administrative burdens or excessive costs on regulated entities.\2\
These changes will reduce or remove redundant registration, reporting,
and review requirements of activities involving animals at AWA-
registered research facilities while ensuring that research animals
continue to receive humane care.
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\1\ <a href="https://www.federalregister.gov/documents/2020/09/17/2020-20512/awa-research-facility-registration-updates-reviews-and-reports">https://www.federalregister.gov/documents/2020/09/17/2020-20512/awa-research-facility-registration-updates-reviews-and-reports</a>.
\2\ Found at <a href="https://www.congress.gov/bill/114th-congress/house-bill/34/">https://www.congress.gov/bill/114th-congress/house-bill/34/</a>. An August 2019 report issued jointly by the NIH, the USDA,
and the FDA, titled ``Reducing Administrative Burden for
Researchers: Animal Care and Use in Research,'' is available at
<a href="https://olaw.nih.gov/sites/default/files/21CCA_final_report.pdf">https://olaw.nih.gov/sites/default/files/21CCA_final_report.pdf</a>. The
report identifies ways in which Agencies can reduce regulatory and
administrative burden consistent with requirements under the AWA.
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We solicited comments concerning our proposal for 60 days ending
November 16, 2020. We received 61 comments by that date.\3\ They were
from animal welfare organizations; public and private universities,
hospitals, and biomedical and other research institutions; a veterinary
association; and members of the public. They are discussed below by
topic.
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\3\ To view the proposal, supporting documents, and the comments
we received, go to <a href="http://www.regulations.gov">www.regulations.gov</a>. Enter APHIS-2019-0001 in the
Search field.
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Registration of Research Facilities
Section 2.30(a)(1) currently requires that each research facility
other than a Federal research facility register with the Secretary by
completing and filing an initial registration form.\4\ Facilities are
also required to update their registration every 3 years by filing a
registration update form \5\ with the registrant's name, address, and
contact information; USDA registration certificate numbers; and names
of partners, officers, and the Institutional Official (IO) as
applicable.
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\4\ APHIS Form 7011A: Application for Registration, New
Registration.
\5\ APHIS Form 7011: Application for Registration, Registration
Update.
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We proposed to eliminate the requirement in Sec. 2.30(a)(1) to
update the research facility registration every 3 years after the
facility's initial registration. We proposed this change because Sec.
2.30(c)(1) already requires such a facility to notify APHIS within 10
days of any change in the name, address, ownership, or any other change
in operations affecting its status as a research facility. We also
considered the registration update to be unnecessary
[[Page 66920]]
because name, address, contact information, and registration
certificate numbers are included in the annual report \6\ that
facilities are required to submit to APHIS in accordance with Sec.
2.36 of the regulations. Eliminating the registration update
requirement reduces administrative burden on institutions, removes
needless duplicative procedures for providing information, and is
consistent with the reforms mandated in the 21CCA.
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\6\ APHIS Form 7023: Annual Report of Research Facility.
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A commenter disagreed with eliminating the registration update and
asked that we provide data to help them assess the basis for this
proposed change, particularly how it addresses USDA's claim of needless
duplication. The commenter also questioned whether research facilities
were complying with the requirement to report changes in operations to
APHIS within 10 days and suggested that rather than being a redundant
requirement, the registration update is an opportunity for research
facilities to make up for changes that they had not otherwise reported
to APHIS.
The registration update is duplicative and therefore unnecessary
because a facility is already required under Sec. 2.30(c)(1) to
provide this information whenever there is a change in the name,
address, or ownership, or other change in operations affecting its
status as a research facility. Regarding the question of whether
facilities are complying with reporting requirements, our records
indicate consistent and substantial compliance with the requirement to
report changes to facility operations within 10 days of the changes. We
disagree with the commenter's implication that research facilities use
the registration update to report changes to operations, as the update
form does not include fields for such data and APHIS would consider any
such changes to be improperly submitted.
Notification of Change of Operation
As noted above, the current requirement in Sec. 2.30(c)(1) for
research facilities to notify the APHIS Animal Care Deputy
Administrator in writing \7\ of any change in the name, address, or
ownership, or other change in operations affecting its status as a
research facility within 10 days after making such a change would
remain in the regulations. We proposed to add language to the
requirement stating that a new Notification of Change form (APHIS Form
7033) \8\ may be used to provide that information. In addition, we
proposed to add a new provision to Sec. 2.30 that clarifies the
duration of a research facility's registration and conditions for its
cancellation.
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\7\ Send changes to USDA/APHIS/AC, 4700 River Road, Unit 84,
Riverdale, MD 20737-1234, or email <a href="/cdn-cgi/l/email-protection#e786898e8a868b84869582a792948386c9808891"><span class="__cf_email__" data-cfemail="05646b6c6864696664776045707661642b626a73">[email protected]</span></a>.
\8\ While APHIS recommends use of Form 7033 for licensees and
registrants, locally developed formats may also be used for
submitting a notification of change if desired.
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One commenter stated that eliminating the 3-year facility
registration update form (APHIS Form 7011) and instead relying on the
proposed APHIS Form 7033 risks losing certain information not required
by the latter form, such as the checklist for the types of animals used
at a facility. Other commenters stated that even though facilities are
already required to notify APHIS within 10 days of any change in the
name, address, or ownership, or any change in operations affecting its
status as a research facility, facilities are not specifically required
to let APHIS know of changes to types of animals used.
We disagree with the commenters. Neither the current registration
update form nor the new change notification form is intended to capture
changes to types of animals used. APHIS will continue to obtain
detailed information about the types of animals used at facilities from
the semiannual reviews and annual report, and through inspections of
facilities during business hours.
Two commenters asked that APHIS clarify what constitutes a ``change
of operations'' as the term appears in Sec. 2.30(c)(1). One commenter
added that it is unclear that any facility changes will compel the
facility to complete APHIS Form 7033 or otherwise submit the required
information without having more detail about what a change of
operations means.
A change of operations includes any change affecting a facility's
status as a research facility, including but not limited to whether the
facility is conducting teaching, testing, or research activities using
regulated species. Regarding the commenter's concern about research
facilities completing proposed APHIS Form 7033, we note that under
Sec. 2.30(c)(1) they are already required to report changes in
operations that affect their status as a research facility. The new
form is intended to make it easier for facilities to provide the
required information.
Duration of Registration and Conditions for Cancellation of a
Registration
We noted in the proposed rule that a small number of research
facilities become inactive each year. We determined that requiring
inactive facilities to request inactive status and continue filing
annual reports in accordance with Sec. 2.30(c)(2) constitutes an
unnecessary burden because these facilities are no longer using animals
covered under the AWA or otherwise functioning as a research facility
as the term is defined in Sec. 1.1. For this reason, we proposed to
remove the provisions requiring such facilities to request inactive
status and file an annual report. Under the proposed change, facilities
would no longer be identified as active or inactive, but instead be
registered or unregistered. Accordingly, under proposed Sec.
2.30(d)(1), a research facility that goes out of business or otherwise
ceases to function as a research facility can request to have its
registration canceled by writing to the Deputy Administrator.
Some commenters suggested that we revise the heading of proposed
Sec. 2.30(d) to read, ``Cancellation and Resumption of a
Registration'' instead of ``Duration of a Registration and Conditions
for Cancellation of a Registration'' to reflect more accurately the
content of the paragraph.
We are making no changes in response to the commenters. The heading
of paragraph (d) appropriately emphasizes the main point of the
paragraph with respect to conditions of registration. We added the new
paragraph to clarify the duration of a research facility's registration
and conditions for its cancellation.
We proposed to add a provision in Sec. 2.30(d)(2) stating that the
Deputy Administrator may cancel a registration without a written
request from the research facility, if he or she has reason to believe
that a research facility has ceased to function as a research facility.
A commenter expressed concern about the provision that the Deputy
Administrator may initiate a cancellation of a research facility's
registration. The commenter noted that various reasons exist why a
facility may choose to remain in active status without having animals,
such as an inactive academic institution that has used non-covered
species at one time and anticipates using covered species again. The
commenter asked that we include language in the regulations explaining
how a facility would provide this information if they chose to remain
active.
We are making no changes in response to the commenter. Facilities
would no longer be identified as having active or inactive status, but
instead be either registered or unregistered. While facilities may have
their reasons for wishing to remain in active status, one
[[Page 66921]]
that ceases to function as a research facility, or has changed its
method of operation so that it no longer uses, handles, or transports
animals, does not need to be registered for regulatory purposes.
Whenever it plans to resume activities as a research facility, the
facility can submit a registration form in accordance with Sec.
2.30(c)(3) at least 10 days prior to using, handling, or transporting
animals again. We intend to provide for such a facility to be able to
retain its previous registration number upon registering.
One commenter recommended that APHIS define the term ``evidence of
business activity'' in greater detail.
We assume the commenter is referring to the phrase ``evidence of
business inactivity'' we used in the preamble to the proposed rule when
discussing duration of registration and conditions for cancellation. We
noted in the preamble that such evidence of inactivity could include
but not be limited to multiple unsuccessful attempts to contact the
facility by phone or mail, or no activity apparent at the physical
address listed in the registration.
A few commenters indicated that it is unclear how the USDA would
formally notify the facility that their registration was under
consideration to be cancelled or was actually cancelled. Another
commenter suggested that APHIS should attempt to notify the facility
with a letter stating that the registration will be canceled within a
certain timeframe if there is no response challenging the cancellation.
One commenter proposed that APHIS make at least four documented
attempts to contact the facility, with the fourth being by certified
mail, and allow four months for a response.
APHIS will make multiple attempts in writing and by phone during
business hours to establish contact with a research facility before
considering canceling its registration due to evidence of inactivity.
Once we have determined that a facility is no longer functioning as a
research facility as the term is defined in Sec. 1.1, there is no
regulatory need for the facility to remain registered.
Two commenters requested that the USDA provide a more tangible
standard for cancelling a registration than ``has reason to believe.''
One commenter recommended that a potential standard could be when the
Deputy Administrator ``has developed credible evidence that
demonstrates a research facility has ceased to function as a research
facility.''
In the preamble of the proposed rule, we explained that the Deputy
Administrator may cancel a registration if sufficient evidence exists
that a facility has ceased to function as a research facility. However,
in the regulatory text of proposed Sec. 2.30(d)(2), we used the words
``reason to believe.'' We agree with the commenter's suggestion that
the language should be more tangible and will amend paragraph (d)(2)
accordingly by replacing ``reason to believe'' with ``sufficient
evidence showing''.
The same commenter asked that we include a provision by which a
facility can contest or appeal the cancellation of a registration that
it believes has been made in error.
We are making no changes in response to the commenter. APHIS will
cancel a registration if the research facility requests it, or if we
have sufficient evidence showing that a facility has ceased to function
as a research facility. This evidence includes but is not limited to
failure to submit an annual report or respond to multiple contact
attempts. We note above that we will make several attempts in writing
and by phone during business hours to establish contact with a facility
before deciding to cancel its registration based on sufficient evidence
of inactivity, so accordingly we see no need to include a provision to
contest a cancellation. If a facility has questions about
cancellations, they are encouraged to contact APHIS Animal Care.\9\
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\9\ USDA/APHIS/AC, 4700 River Road, Unit 84, Riverdale, MD
20737-1234, or email <a href="/cdn-cgi/l/email-protection#187976717579747b796a7d586d6b7c79367f776e"><span class="__cf_email__" data-cfemail="82e3ecebefe3eee1e3f0e7c2f7f1e6e3ace5edf4">[email protected]</span></a>.
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We included in proposed paragraph (d)(3) the provision that if a
research facility registration has been canceled but the facility
wishes to resume operations or otherwise conduct regulated activities
in the future, it is responsible for submitting an application to
reregister at least 10 days prior to it using, handling, or
transporting animals. No fees would be associated with reregistration.
A commenter requested that the USDA streamline the registration
process so that it may be consistently completed within 10 business
days of receipt in order to ensure that reregistration does not
jeopardize funding or research plans.
We acknowledge the commenter's request but are making no changes to
the process. APHIS typically completes the process of registering a
facility within 10 business days of receiving the application for
registration and intends to continue doing so.
The commenter also asked that we outline the steps we will take to
provide flexible options for electronic registration and other measures
to ensure timely processing and notification of registration status.
We are currently developing an electronic registration option that
will provide greater flexibility and efficiency for stakeholders. We
will inform the regulated community when electronic registration is
available and where to access it.
A commenter recommended that APHIS place limitations on
reregistration by requiring that research facilities pay the costs of
their reregistration. The commenter suggested that without such a fee,
research facilities unable to comply consistently with the AWA could
use the cancellation and reregistration processes to avoid being cited
for noncompliance.
We are making no changes in response to the commenter's
recommendation. The AWA is silent on authorizing the Secretary to
charge a fee for registration. Regarding the commenter's concern, if a
facility is out of compliance with the regulations or otherwise has
pending citations, canceling its registration will neither cancel the
citations nor eliminate the possibility of APHIS taking enforcement
action, as enforcement is a process distinct from registration.
Proposed Sec. 2.30(d)(3) includes registration requirements for
formerly registered facilities wishing to resume regulated activity. A
few commenters recommended revising Sec. 2.30(d)(3) to read ``If a
research facility plans to resume activity,'' presumably to replace
``If a research facility resumes operation or otherwise wishes to
conduct regulated activities in the future . . . ''.
We did not intend to imply that formerly registered facilities
could resume operation of regulated activities prior to registering
again, so we agree with the language suggested by the commenters and
will replace the proposed wording with ``plans to resume regulated
activity'' in Sec. 2.30(d)(3). We emphasize that unregistered
facilities wishing to engage in regulated activities must submit APHIS
Form 7011A at least 10 days prior to using, handling, or transporting
animals. We intend to allow formerly registered facilities to retain
their original registration number if they are registering again.
IACUC Facility Reviews
We noted in the proposed rule that Sec. 2.31 requires the
Institutional Animal Care and Use Committee (IACUC) for each registered
research facility to assess the facility's animal program, facilities,
and procedures and evaluate proposed research activities or
[[Page 66922]]
significant changes in ongoing activities related to the care,
treatment, housing, and use of research animals. In accordance with
this section, the IACUC reviews the research facility's programs and
facilities to determine compliance with AWA and institutional
requirements. The IACUC also reviews proposed animal research
activities or significant changes to ongoing activities and notifies
the principal investigator (PI) and the research facility of its
decision to approve or withhold approval.
Section Sec. 2.31(c)(1) requires the IACUC of each research
facility to review, at least once every 6 months, the research
facility's program for humane care and use of animals using the AWA
regulations as a basis for evaluation. Under Sec. 2.31(c)(2), the
IACUC is also required to inspect all of the research facility's animal
facilities, including animal study areas, again using the AWA
regulations as a basis for evaluation. The IACUC reports the outcome of
these semiannual evaluations to the Institutional Official of the
research facility in accordance with requirements in Sec. 2.31(c)(3).
In addition, the IACUC's functions under Sec. 2.31(c)(4) include
reviewing and investigating reports of noncompliance received from
facility personnel, as well as public complaints, involving the care
and use of animals at the research facility. If noncompliance with the
AWA is found during these reviews and inspections, the IACUC is
authorized to require modifications or suspend an activity involving
animals in accordance with the specifications set forth in Sec.
2.31(d)(6).
In order to approve newly proposed research activities or proposed
significant changes in ongoing activities, the IACUC is also required
to conduct a review of components of the proposed activities or
significant changes related to the care and use of animals and
determine that they meet the requirements listed in Sec. 2.31(d)(1).
Once a research activity or a significant change to an ongoing activity
has been approved, paragraph (d)(5) of this section requires the IACUC
to conduct continuing reviews of activities covered under the
regulations at 9 CFR 1.1, et seq., at appropriate intervals as
determined by the IACUC, but not less than annually.
We proposed to amend Sec. 2.31(d)(5) by removing the continuing
review requirement and adding the requirement for a complete review of
activities at appropriate intervals as determined by the IACUC, but not
less than every 3 years. As we noted in the proposed rule, we made this
change in order to harmonize the USDA AWA regulations with the NIH
requirement for a complete review of IACUC-approved activities at 3-
year intervals.
Several commenters disagreed with our proposal to remove the
continuing review requirement in Sec. 2.31(d)(5) and add the
requirement for a complete review. One commenter stated that an annual
review of research activities and protocols is crucial to maintain
transparency and accountability in animal research, and many expressed
the view that these changes create too long of an interval between
reviews to ensure animal welfare oversight. Another commenter stated
that allowing IACUCs to conduct complete reviews ``at appropriate
intervals'' no less than every 3 years would give IACUCs far too much
leeway in reviewing activities and animal welfare oversight, and one
stated that we provided no data to support a 3-year complete review,
noting that it is unclear how the expanded review period comports with
annual and semiannual inspections. One commenter stated that APHIS does
not elucidate how it will ensure that the AWA standards of treatment
will be adhered to with a relaxed review standard.
We acknowledge the concerns expressed by these commenters over
whether IACUC reviews at research facilities are sufficiently frequent
and thorough to ensure animal welfare. However, we emphasize that the
two review types have different objectives, and that removing the
continuing review and adding a complete review, as we have proposed,
will actually enhance the thoroughness of review of animal activities
with no effect on frequency and oversight--we explain this point below.
The purpose of the continuing review required in paragraph (d)(5)
of the current regulations is not specified. In practice, however, it
has consisted of the IACUC determining whether significant changes
impacting animal welfare have occurred in a research activity since the
time it was originally approved or last reviewed. We consider the
continuing review to be redundant because, under Sec. 2.31(c) and (d),
any significant changes to an ongoing activity are already required to
be reviewed by the IACUC. Further, the semiannual review of a research
facility's program for humane care and use of animals covers animal use
in all facility research activities to ensure that the approved
activity continues to comply with regulatory and institutional
requirements, and under paragraph (c)(3) any departures from the
regulations found by the IACUC are required to be reported and
addressed appropriately. In addition, under Sec. 2.31(c)(4), the IACUC
is required to review, and, if warranted, investigate complaints by the
public or facility personnel involving the care and use of animals at
the research facility at any time. Finally, removing the continuing
review requirement has no effect on the IACUC approval process for new
activities and significant changes to animal activities.
The complete review required by NIH at federally funded facilities
involves a full evaluation of each new animal research activity--
including all elements pertaining to animal welfare listed under Sec.
2.31(d) and (e)--with resubmission and complete review of that activity
every 3 years thereafter as if it were a new activity. The NIH requires
the complete review of the entire activity protocol even if no
significant changes have been made to it in that 3-year period, the
rationale being that regulations or scientific developments germane to
the activity may have changed during the period between reviews. The
complete review does not affect the IACUC's authority under Sec.
2.31(c)(3) to determine the best means of conducting the evaluations
required by paragraphs (c)(1) and (2) of the facility's programs and
facilities. A facility's programs include the animal activities, and
the IACUC's evaluations required by paragraphs (c)(1) and (2) include
monitoring after approval.
Based on the results of the complete review, the IACUC grants or
withholds approval, or requires modifications to the activity. The
purpose of the complete review is to ensure that all elements of animal
use in a research activity, or changes to an ongoing activity, are
humane and designed to minimize animal distress, and that alternatives
to painful and distressing procedures have been considered and
implemented to the extent possible.
We proposed harmonizing our review requirements with NIH by adding
the complete review requirement because it ensures that every component
in a research activity that uses animals is thoroughly evaluated. We
note that under the current AWA regulations, no such equivalent review
requirement exists. In other words, once approved, an animal research
activity using AWA species that is not funded by the Public Health
Service \10\ can continue
[[Page 66923]]
indefinitely without ever being fully revisited to ensure its
underlying design or foundational assumptions are in step with current
science and regulatory policy relating to animal welfare. The
continuous review was never intended to serve this purpose, as it
involves only periodic checks sufficiently covered by other reviews
discussed above.
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\10\ The Public Health Service is a collection of agencies with
the Department of Health and Human Services that includes NIH. NIH
requires that a complete IACUC review of research protocols be
conducted at least once every 3 years for facilities conducting
research funded by the Public Health Service.
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For the complete review, the PI will provide the IACUC with a
written description of all current activities that involve the care and
use of animals for review and approval. Changes such as but not limited
to personnel, species, study objectives, and frequency of sample
collections may be reviewed by the IACUC as frequently as necessary,
but not less than every 3 years.
A commenter expressed concern that any violation of IACUC-approved
protocols, such as performing procedures on animals beyond what was
initially approved or experiencing more animal mortalities than was
initially approved, would not necessarily be brought to the attention
of the IACUC until the 3-year review, by which time it could be too
late to take appropriate action.
We note the commenter's concern but reiterate that, under Sec.
2.31(c), the IACUC is required to review the research facility's
program for humane care and use of animals at least once every 6
months, which includes animal use in all facility research activities,
and under paragraph (c)(3) any departures from the regulations found by
the IACUC at any time are required to be reported and addressed
appropriately. The IACUC may approve, require modifications, or
withhold approval of such changes, using the AWA regulations as the
basis for its decision. Requirements for submitting a proposal to make
significant changes to an ongoing activity are listed in Sec. 2.31(e).
Furthermore, the IACUC may review animal use in an ongoing activity at
any time if there are indications that it deviates from initially
approved procedures.
One commenter stated that an annual review is essential for
ensuring that when new alternatives in animal use become available, the
IACUC and the PI can promptly consider them. Similarly, several
commenters noted that advances in scientific knowledge are emerging so
quickly that refinements for improving the humane treatment of animals
in research activities may go unused in the long period between
reviews.
In the interim 3-year period before a complete review occurs, the
semiannual review, and the IACUC review and approval process for
significant changes, remain in place for raising concerns about changes
in a scientific method or the existence of alternatives that reduce or
replace live animal use. In addition, the Animal Welfare Information
Center remains a resource for the PI to consult regarding the latest
alternatives. The AWA regulations under Sec. 2.32(c)(5) require
training of PIs and other facility staff in using this resource or that
of the National Library of Medicine. If the PI decides to implement an
alternative in a research activity based on new knowledge, then he or
she can submit an amendment to the IACUC for review and approval at any
time.
Two commenters cited a 2014 audit report by the USDA Office of
Inspector General (OIG) that found a substantial number of research
facilities reviewed in fiscal years 2009-2011 misreported animal use
and that IACUCs did not approve, monitor, or report adequately on
experimental procedures on animals. Citing these issues in the OIG
audit, the commenters indicated that a full IACUC continuing review on
at least an annual basis is needed to ensure compliance and protect
animals.
We acknowledge the conclusions of the audit report, in which USDA-
OIG recommended that APHIS provide research facilities with training or
best practice guidelines for IACUC protocol reviews and approvals
regarding experimental procedures. As noted in the audit report, APHIS
agreed with the OIG recommendation and has since developed guidance for
research facilities on protocol review and approval, including updating
the Animal Care Inspection Guide with additional guidance on IACUC best
practices. In addition, NIH and APHIS formed the Interagency
Collaborative Animal Research Education Project, which involves
frequent trainings to empower IACUCs and their institutions to improve
animal welfare and increase compliance with Federal standards.
We reiterate that eliminating the continuing review does not affect
the frequency or depth of reviews required to ensure the humane care
and use of animals, and that addition of the complete review further
addresses the commenter's concerns.
A few commenters indicated that reducing the frequency of protocol
review will diminish efforts to follow the ``Three R's''--reduction,
refinement, replacement--thus undermining the spirit and intent of the
independent policing inherent to the current AWA enforcement structure
and limiting the IACUC's role.
We are making no changes in response to the comment. The IACUC's
role is not limited or diminished as the result of removing the
continuous review requirement, and addition of the complete review
provides the committee with an additional strategy for ensuring animal
welfare. We add that the IACUC has the authority to review the humane
care and use of animals and all the research facility's animal
facilities whenever deemed necessary to ensure compliance with the AWA.
A commenter stated that the proposed changes in review hamstring
Congressional review and related agency reporting, as both reporting
and funding may rely upon outdated data.
The annual continuing review is distinct from the annual report
that facilities will still be required to submit to APHIS. The annual
report provides data about the animals used by species and the level of
pain and distress experienced during the annual reporting period.
Furthermore, agency funding is not dependent on the annual report of
animal use by research facilities.
One commenter stated that revising the review requirements lies
outside the scope of the statutory source, explaining that APHIS does
not explain whether the protection of animals would be adversely
affected by reducing administrative burden in accordance with 2034(d)
of the 21CCA.
We disagree with the commenter. The 21CCA tasked the NIH, in
collaboration with the USDA and the FDA, to review regulations and
policies for the care and use of laboratory animals and revise them
appropriately to reduce administrative burden on investigators while
maintaining the integrity and credibility of research findings and
protection of research animals. The reduction in administrative burden
will have no effect on animal welfare in research facilities, as there
will be no change in the degree of IACUC and APHIS oversight.
A few commenters stated that harmonizing the IACUC review
requirement with NIH requirements is insufficient to ensure animal
welfare at research facilities, with one noting that serious animal
welfare violations have been documented at NIH facilities in the past
few years. Another commenter suggested that, instead of changing the
USDA review, the NIH should conform to USDA's stronger annual review
requirement. Another commenter stated that the proposal to align with
the NIH review timeframe is based purely on convenience and is an
inadequate reason to put animals in harm's way.
We reiterate that APHIS' addition of the complete review as a
regulatory requirement ensures a thorough evaluation of research
activity design and development with respect to
[[Page 66924]]
maintaining animal welfare and is independent of NIH oversight
activities. Together with semiannual inspections, monitoring of animal
activities at an interval deemed necessary for each facility, and
investigation of complaints as warranted, the level of animal welfare
oversight at facilities will not be diminished by this change.
Another commenter suggested changing the requirement to a 2-year or
less review interval, explaining that it would relieve burden while
matching the NIH requirement of a complete review of IACUC-approved
activities.
We are making no changes in response to the commenter. In keeping
with the reforms of the 21CCA, our proposed changes eliminate the
redundancy of the continuous review while retaining the semiannual
review. Regarding the complete review, we reiterate that the IACUC may
choose to review ongoing activities more frequently than 3 years as
part of a program review.
In the proposed rule, we noted that the complete review would
result in approval of an activity using animals for an interval
approved by the IACUC, not to exceed 3 years after the review, unless
the IACUC suspends the activity for nonconformance with the description
of that activity as provided by the PI and approved by the IACUC under
Sec. 2.31(d)(6).
A commenter stated that in addition to a protocol expiring after 3
years or being terminated, it is likely that research facilities have
methods to terminate an approved IACUC protocol other than those cited
in the regulations. The commenter noted as one example a voluntary
termination by the PI or the IACUC for a reason other than that
described in Sec. 2.31(d)(6), or suspension by the IO.
We are making no changes in response to the comment. However, we
acknowledge the commenter's point that a facility may choose to
terminate a research activity voluntarily for reasons not included in
the regulations.
A commenter suggested we consider the way protocols are renewed on
an annual basis in Canada following a full review.
We are making no changes in response to the commenter. We note that
under the regulations, research facilities are currently required to
submit an annual report and under the proposed regulatory changes will
undertake the 3-year complete review. Consistent with the aims of the
21CCA, this change harmonizes our review requirements with NIH
requirements for Public Health Service-funded studies.
As a final note on our proposed addition of the complete review to
Sec. 2.31(d)(5), we are amending the language we originally proposed
to read ``all activities'' instead of ``proposed activities''
pertaining to requirements for submitting written descriptions of
activities to the IACUC involving the care and use of animals. This
change more accurately reflects what we intended and reinforces
commenter concerns that both proposed and ongoing activities involving
animal care and use fall under the review requirement.
Annual Report Signature
We proposed to amend Sec. 2.36(a) to eliminate the requirement for
Chief Executive Officer (CEO) and IO signatures on a paper copy of the
annual report. We noted that this guards against identity theft and
allows for the facility representative to electronically submit the
annual report on behalf of the CEO or IO while maintaining requirements
for the facility annual report and practices. We also proposed to
modify Sec. 2.36(a) to inform registered research facilities and
Federal research facilities that APHIS Forms 7023, 7023A, and 7023B may
be used to submit the annual report information required in Sec.
2.36(b).
Several commenters indicated that requiring the CEO or IO to sign
the annual report makes them legally accountable and connected to the
IACUC process and recommended against eliminating the requirement. One
such commenter advised against eliminating the requirement for a signed
paper copy of the report. Another commenter stated that, since the CEO
or IO is ultimately responsible for making modifications to a facility
and for ensuring that research protocols are modified as necessary for
animal welfare purposes, his or her signature on the report confirms
the awareness that such modifications are needed. The commenter added
that if the annual report was submitted by the facility representative
electronically, the CEO or IO may not be aware that modifications are
needed for the facility to conform with the AWA. The commenter
supported digital signature and electronic submission of the report but
asked that we require CEO or IO signature.
We note that under the definition in Sec. 1.1, the IO is the
individual at a research facility who is authorized to legally commit
on behalf of the research facility that the requirements of 9 CFR parts
1, 2, and 3 will be met. The IACUC is required to prepare a report of
findings from the semiannual inspections to be given to the IO. The CEO
and IO of the facility are legally responsible for facility and
activity conformance with the AWA regardless of whether they actually
sign the annual report.
Another commenter stated that changing the signature requirement is
arbitrary and recommended against it, as APHIS does not consider its
costs or alternatives to the revision.
We disagree that it is arbitrary because the change is consistent
with the reforms called for in the 21CCA to reduce administrative
burden. The costs of this change to the regulations are considered in
the supporting economic analysis (see footnote 3 for a link to the
analysis).
Other Comments
One commenter stated that IACUCs at taxpayer-funded State
universities should open their meetings to the public.
This comment is beyond the scope of the rulemaking as we proposed
no changes to IACUC meetings.
A commenter stated that we failed to show the cost savings to
facilities of the proposed changes.
Information about costs can be found in the economic analysis
prepared for this rulemaking.
Another commenter stated that cost savings and relief from
regulatory burden would be achieved by moving away from animal
experiments toward human-relevant research.
The comment is beyond the scope of this rulemaking as we did not
address the topic of whether animal experimentation should be
eliminated.
A commenter questioned whether the Secretary of Agriculture has the
authority to delegate administration of the AWA to the APHIS
Administrator. The commenter also stated that while the Administrative
Procedure Act requires a ``reasoned explanation'' for finalizing
proposed changes, the proposed rule does not explain how reducing
duplicative requirements and administrative burden on research
facilities, maintaining research integrity and oversight, and ensuring
that research animals continue to receive humane care would result from
the proposed provisions in the rule.
The delegation authority of the USDA Secretary is established by
statute.\11\ As for the relationship between reducing administrative
burden while maintaining oversight and humane animal care, we respond
that the reduction in burden does not impede current processes in place
to ensure oversight, such as evaluating, at least
[[Page 66925]]
semiannually, the research facility's program for humane care and use
of animals, conducting reviews as determined necessary, and
investigating public complaints as warranted.
---------------------------------------------------------------------------
\11\ 5 U.S.C. 302--Delegation of authority.
---------------------------------------------------------------------------
Miscellaneous
In parts 2, 3, and 4 of the current regulations, we proposed and
are making minor corrections in punctuation and wording to improve
readability. In paragraphs (f)(6) and (7) of Sec. 3.111, we are
removing extraneous punctuation and wording. In Sec. Sec. 4.10 and
4.11, we are adding pronouns that are more inclusive.
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 Order 12866 and Regulatory Flexibility Act
This final rule has been determined to be not significant for the
purposes of Executive Order 12866 and, therefore, has not been reviewed
by the Office of Management and Budget.
In accordance with the Regulatory Flexibility Act, we have analyzed
the potential economic effects of this action on small entities.The
analysis is summarized below. Copies of the full analysis are available
on the <a href="http://Regulations.gov">Regulations.gov</a> website (see footnote 3 in this document for a
link to <a href="http://Regulations.gov">Regulations.gov</a>) or by contacting the person listed under FOR
FURTHER INFORMATION CONTACT.
APHIS is amending five requirements in the following three sections
of the Animal Welfare Regulations. The five amendments in these three
sections are summarized as follows:
Section 2.30--Registration
<bullet> Paragraph (a)(1): Eliminate the requirement for research
facility registration updates at 3-year intervals;
<bullet> Paragraph (c): Eliminate the requirement for a research
facility to request being placed on inactive status if the facility has
not used, handled, or transported animals for a period of at least 2
years;
<bullet> Paragraph (d): Clarify the duration of a registration and
conditions for cancellation of a registration;
Section 2.31--IACUC
<bullet> Paragraph (d)(5): Replace continuing annual reviews of
activities involving animals approved by the IACUC with reviews and
approval by the IACUC at intervals not exceeding 3 years; and
Section 2.36--Annual Report
<bullet> Paragraph (a): Eliminate the requirement for Chief
Executive Officer and Institutional Official signatures on the
reporting facility annual report.
APHIS solicited public comments concerning these amendments for 60
days ending November 16, 2020 and received 61 comments. Three
commenters raised concerns that were specific and relevant to the
Initial Regulatory Flexibility Analysis (IRFA). The commenters
expressed concern that the changes could compromise humane animal care
at research facilities. Processes in place under the regulations by
which IACUC monitors animal activities will not be affected by the
changes. These processes include semiannual inspections and the
authority to investigate any complaints where warranted under 9 CFR
2.31.
APHIS has quantified annual savings for facilities that total
approximately $80,000 from the changes in Sec. 2.30(a)(1) and
approximately $11,000 from the change in Sec. 2.36(a). APHIS also
expects that the changes to Sec. 2.30(c)(2) and (3) will reduce
administrative burden of certain inactive research facilities. APHIS
expects that the change in Sec. 2.31(d)(5) will be cost neutral; no
quantifiable public information is available to show expected net cost
savings from the change.
These changes are intended to reduce administrative burden on
investigators, IACUC members, attending veterinarians, and other
related facility staff, and will not affect the Animal Welfare
regulations that ensure humane animal care during research, testing,
experiments, or teaching. Facilities covered by this final rule include
small entities.
Based on our review of available information, the APHIS
Administrator has determined that this action will not have a
significant economic impact on a substantial number of small entities.
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 rule has been reviewed under Executive Order 12988, Civil
Justice Reform. It is not intended to have retroactive effect. The Act
provides administrative procedures which must be exhausted prior to a
judicial challenge to the provisions of this rule.
Paperwork Reduction Act
This rule contains no new information collection or recordkeeping
requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.). The information collection activities in this rule are
approved under the Office of Management and Budget control number 0579-
0036.
E-Government Act Compliance
The Animal and Plant Health Inspection Service is committed to
compliance with the E-Government 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' Paperwork Reduction Act Coordinator, at (301) 851-2483.
List of Subjects
9 CFR Part 2
Animal welfare, Pets, Reporting and recordkeeping requirements,
Research.
9 CFR Part 3
Animal welfare, Marine mammals, Pets, Reporting and recordkeeping
requirements, Research, Transportation.
9 CFR Part 4
Administrative practice and procedure, Animal welfare.
Accordingly, we are amending 9 CFR parts 2, 3, and 4 as follows:
PART 2--REGULATIONS
0
1. 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
2. Section 2.30 is amended as follows:
0
a. By revising paragraphs (a)(1) and (c);
0
b. By redesignating paragraph (d) as paragraph (e);
0
c. By adding a new paragraph (d); and
0
d. By adding a heading for newly redesignated paragraph (e).
The revisions and addition read as follows:
Sec. 2.30 Registration.
(a) * * *
(1) Each research facility, other than a Federal research facility,
shall register with the Secretary by completing and filing a properly
executed form which will be furnished, upon request, by the Deputy
Administrator. The registration form shall be filed with the Deputy
Administrator. Except as provided in
[[Page 66926]]
paragraph (a)(2) of this section, where a school or department of a
university or college uses or intends to use live animals for research,
tests, experiments, or teaching, the university or college rather than
the school or department will be considered the research facility and
will be required to register with the Secretary. An official who has
the legal authority to bind the parent organization shall sign the
registration form.
* * * * *
(c) Notification of change of operation. A research facility shall
notify the Deputy Administrator in writing of any change in the name,
address, or ownership, or other change in operations affecting its
status as a research facility, within 10 days after making such change.
The Notification of Change form (APHIS Form 7033) may be used to
provide the information.
(d) Duration of a registration and conditions for cancellation of a
registration. (1) A research facility that goes out of business or
ceases to function as a research facility, or that changes its method
of operation so that it no longer uses, handles, or transports animals,
and does not plan to use, handle, or transport animals at any time in
the future, may have its registration canceled by making a written
request to the Deputy Administrator.
(2) If the Deputy Administrator has sufficient evidence showing
that a research facility has ceased to function as a research facility,
then the Deputy Administrator may cancel the registration on its own,
without a written request from the research facility.
(3) If a research facility plans to resume regulated activity, the
facility is responsible for submitting a form (APHIS Form 7011A) to
reregister at least 10 days prior to it using, handling, or
transporting animals. There are no fees associated with such
reregistration.
(e) Non-interference with APHIS officials. * * *
0
3. In Sec. 2.31, paragraph (d)(5) is revised to read as follows:
Sec. 2.31 Institutional Animal Care and Use Committee (IACUC).
* * * * *
(d) * * *
(5) The IACUC shall conduct complete reviews of activities covered
by this subchapter at appropriate intervals as determined by the IACUC,
but not less than every 3 years. The complete review shall address all
requirements related to the care and use of animals under paragraphs
(d) and (e) of this section. The IACUC shall be provided a written
description of all activities that involve the care and use of animals
for review and approval at the end of the term.
* * * * *
0
4. In Sec. 2.36, paragraph (a) is revised to read as follows:
Sec. 2.36 Annual report.
(a) The reporting facility shall be that segment of the research
facility, or that department, agency, or instrumentality of the United
States that uses or intends to use live animals in research, tests,
experiments, or for teaching. Each reporting facility shall submit an
annual report to the Deputy Administrator on or before December 1 of
each calendar year. The report shall cover the previous Federal fiscal
year. The Annual Report of Research Facility (APHIS Form 7023),
Continuation Sheet for Annual Report of Research Facility (APHIS Form
7023A), and Annual Report of Research Facility Column E Explanation
(APHIS Form 7023B) are forms which may be used to submit the
information required by paragraph (b) of this section.
* * * * *
PART 3--STANDARDS
0
5. 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. 3.111 [Amended]
0
6. Section 3.111 is amended in paragraphs (f)(6) and (7) by removing
``, which''.
PART 4--RULES OF PRACTICE GOVERNING PROCEEDINGS UNDER THE ANIMAL
WELFARE ACT
0
7. The authority citation for part 4 continues to read as follows:
Authority: 7 U.S.C. 2149 and 2151; 7 CFR 2.22, 2.80, and 371.7.
Sec. 4.10 [Amended]
0
8. In Sec. 4.10, paragraph (a) is amended by removing the words ``he''
and ``his'' and adding the words ``he or she'' and ``his or her'' in
its places, respectively.
Sec. 4.11 [Amended]
0
9. In Sec. 4.11, paragraph (a) introductory text is amended by
removing the word ``his'' and adding the words ``his or her'' in its
place.
Done in Washington, DC, this 18th day of November 2021.
Mark Davidson,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2021-25614 Filed 11-23-21; 8:45 am]
BILLING CODE 3410-34-P
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