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Association for Research in
Otolaryngology
Animal Research Committee
To inform members of changes or proposed
changes to federal regulations and policies
pertaining to the use of animals in
research
2002 Changes or Proposed Changes
- Animal Welfare Act
The AWA
was amended May 13th, 2002 [Pub.
Law 107-171], [the Farm Security and
Rural Investment Act of 2002]. One provision
of the Act clarifies Congressional intent
regarding the regulation of certain animals used
in biomedical research under the Animal Welfare
Act. The following is the actual wording
excerpted from the new law:
- Subtitle D—Animal Welfare
SEC. 10301. DEFINITION OF ANIMAL UNDER THE
ANIMAL WELFARE
ACT.
Section 2(g) of the Animal Welfare Act (7
U.S.C. 2132(g)) is amended in the first
sentence by striking ‘‘excludes
horses not used for research purposes
and’’ and inserting the following:
‘‘excludes (1) birds, rats of the
genus Rattus, and mice of the genus Mus, bred
for use in research, (2) horses not used for
research purposes, and (3)’’.
Additional information regarding the
status of USDA regulation of birds and
laboratory rats and mice is available at
http://www.aphis.usda.gov/ac/rmbupdate.html.
- PHS Policy on Humane Care
and Use of Laboratory Animals
The PHS
Policy on Humane Care and Use of Laboratory
Animals was amended August 8, 2002
(FR
Vo. 67, No. 152, pgs. 51289-51290) to permit
institutions with PHS Animal Welfare Assurances
to submit verification of IACUC approval for
competing applications subsequent to peer review
but prior to award, effective September 1, 2002
(i.e., for all applications submitted for the
May-June 2003 advisory council dates).
The PHS
Policy on Humane Care and Use of Laboratory
Animals was reprinted in August of 2002 and
in addition to the change in date required for
verification of IACUC approval for competing
applications (described above), other changes
included, (1) a provision allowing institutions
“the option of coding the names of IACUC
members in materials routinely submitted to the
Office of Laboratory Animal Welfare
(OLAW)”; (2) a provision allowing
institutions to electronically submit documents
to OLAW, eliminating the previous wording in the
Policy requiring that documents be submitted on
“institutional letterhead” or in
“letter form”; and (3) an update of
citations and addresses.
- Marine Mammals
An advance notice for proposed rulemaking and
a request for comments regarding animal welfare
regulations pertaining to marine mammals was
published by the USDA, APHIS on May 30th, 2002
(67
FR 104, pages 37731-37732).
- USDA Policy Manual
On August 26th, 2002, Policy
#23 (“Criteria for Licensing Hoofstock
Dealers) of the USDA/APHIS/AC
Policy Manual was modified. The USDA
regulates all hoofed animals when they are used
in biomedical research.
- Select Biological
Agents
On August 12th, 2002, in accordance with the
“Agricultural Bioterrorism Protection Act
of 2002” (PL 107-188, Public Health
Security and Bioterrorism Preparedness and
Response Act of 2002, June 12th, 2002),”
the US Department of Agriculture Animal and
Plant Health Inspection Service (USDA APHIS)
published an interim rule (Federal Register 67,
52383–52389) and request for comments
establishing an initial list of biological
agents and toxins it determined to “pose a
severe threat to animal or plant health, or to
animal or plant products.” All individuals
in possession of the listed agents and toxins
must notify the Secretary of Agriculture of such
possession within 60 days of the publication of
this rule. A list of the biological agents and
toxins and guidance on notification were
published by the USDA in new parts of the CFR,
entitled “Possession of Biological Agents
and Toxins” (7 CFR Part 331 and 9 CFR Part
121, for plant- and animal-related provisions,
respectively).
On December 13th, 2002, the USDA and
Department of Health and Human Services (DHHS)
established interim final rules (Federal
Register 67, 76908-76938 and 76886-76905,
respectively) that will take effect February
11th, 2003, establishing standards and
procedures governing the possession, use and
transfer of select biological agents and toxins.
Facilities possessing these agents are required
to register with the appropriate agency.
DHHS
regulations are administered by the CDC and
USDA
regulations are administered by APHIS.
Additional information may be found under the
AC
website.
- DEA Rescheduling of
Buprenorphine
On October 7th, 2002, the Drug Enforcement
Agency (DEA) rescheduled Buprenorphine, one of
the most commonly used analgesics for laboratory
animals, from Schedule V to Schedule III under
the Controlled Substances Act (CSA). The DEA
issued its final rule (Federal Register 67,
62354–62370) following a recommendation by
the Department of Health and Human Services
(DHHS) and a review by the DEA. As required by
21 USC 812 (b) for Schedule III control, the DEA
determined that (1) buprenorphine has a
potential for abuse less than the drugs or other
substances in Schedules I and II; (2)
buprenorphine has a currently accepted medical
use in treatment in the US; and (3) abuse of
buprenorphine may lead to moderate or low
physical dependence or high psychological
dependence.
- FAA Rule Regarding Animal
Incidents During Transport
On September 27th, 2002, the Federal Aviation
Administration (FAA) of the Department of
Transportation proposed a rule amending 14 CFR
Part 119 (Federal Register 67, 61238-61240) that
would require air carriers to report all
incidents involving the loss, injury or death of
an animal during air transport. Reports would be
submitted monthly to the Secretary of
Transportation, through APHIS of the
USDA.
- Institutional Animal Care
and Use Committee Guidebook
The Office of Laboratory Animal Welfare
(OLAW) and Applied Research Ethics National
Association (ARENA) announced the release of the
2nd edition of the Institutional
Animal Care and Use Committee Guidebook on
April 22nd, 2002. Although the Guidebook is not
a regulatory document, its recommendations
facilitate implementation of institutional
animal care and use committees and
interpretation of PHS Policy on Humane Care and
Use of Laboratory Animals.
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