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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
2003 Changes or Proposed
Changes
- APHIS Divisions Moving from
USDA to DHS
On March 1st, 2003, APHIS' Agriculture
Quarantine and Inspection (AQI) force became
part of the Department of Homeland Security's
(DHS) Border and Transportation Security's
Bureau of Customs and Border Protection (BCBP).
On June 1st, 2003, the property and facilities
of USDA's Plum Island Animal Disease Center,
jointly run by APHIS and USDA's Agricultural
Research Service (ARS), were transferred to DHS;
all remaining components of APHIS, including
Animal Care (AC) will remain under the
USDA.
- FDA Issues Final Rule for
Records and Reports on Experiences with Animal
Drugs
On March 31st, 2003, the Food and Drug
Administration (FDA) issued a final rule that
reduces the agency's requirements for records
and reports on experiences with approved new
drugs for animals (68 FR No. 61, pages
15355-15369). The rule, which goes into effect
on June 30th, significantly reduces the previous
requirements of both reporting and record
keeping on experiences with New Animal Drug
Applications (NADA) and Abbreviated NADAs
(ANADA), as compared with current regulations,
and incorporates many of the industry comments
on earlier drafts. This final rule redefines the
kinds of information that must be maintained and
submitted by new animal drug applicants for a
NADA or ANADA. It revises the timing and content
of certain reports to enhance their usefulness,
provides for the protection of public and animal
health, and reduces the record keeping and
reporting requirements.
- Animal Welfare Act
On April 11th, 2003, the USDA, APHIS proposed
a rule (Federal Register Vol. 68, Number 70,
pages 17752-17755) to amend the Animal Welfare
Act regulations to require that research
facilities, dealers, and exhibitors maintain
medical records as a part of their program of
adequate veterinary care. Currently, the
maintenance of records is implied and certain
aspects of medical histories are required. The
proposed regulations, however, would
specifically require a detailed accounting of
certain aspects of medical histories. The
comment period for the proposed rule ended on
June 10th, 2003. A total of 9,821 comments were
received and reviewed as of 8/1/03. The USDA is
currently preparing a summary and
response.
- APHIS to Collaborate with
HSUS on Disaster Preparedness
On May 22nd, 2003, the U.S. Department of
Agriculture (USDA) Animal and Plant Health
Inspection Service (APHIS) announced the signing
of a Memorandum of Understanding with the Humane
Society of the United States (HSUS). APHIS and
HSUS agree to coordinate disaster preparedness
and response efforts involving animals by
exchanging information during disasters and
collaborating on disaster planning exercises,
operational procedures, equipment, and training.
These organizations expect their agreement to
promote standards for disaster preparedness
involving animals to the public, businesses,
disaster organizations, and emergency managers.
Currently, HSUS has formal agreements with The
American Red Cross and the Federal Emergency
Management Agency (FEMA) for disaster response
coordination and preparedness education.
Additional information about HSUS disaster
preparedness and response guidelines is
available on the HSUS website (http://www.hsus.org/disaster).
[USDA, APHIS, Press release: USDA
signs memorandum of understanding with the
Humane Society of the United States - 22 May
2003].
- FDA to Simplify
Regulations for Liquid and Free-Choice Medicated
Feed
On May 28th, 2003, the FDA proposed to change
the regulations for liquid medicated feed and
free-choice medicated feed. In doing so, it
hopes to clarify the following points: "What
data are required to demonstrate chemical and
physical stability of a drug in liquid feed; how
such data may be submitted for use in the new
animal drug approval process; and which liquid
medicated feeds may be manufactured in a feed
manufacturing facility that has not obtained a
medicated feed mill license from FDA." The FDA
wants to ensure that regulations for free-choice
medicated feed are "consistent with the
requirements for liquid medicated feed, and that
provisions for free-choice medicated feed and
liquid medicated feed comply with the terms of
the Animal Drug Availability Act (ADAA) of
1996." [FDA, Proposed rule: Requirements for
liquid medicated animal feed and free-choice
medicated animal feed. Federal Register 68, Vol.
102, pages 31645-31652 (28 May 2003).
- OLAW, APHIS Revise
Guidance Regarding IACUC Approval of Changes in
Personnel Involved in Animal Activities
On June 6th, 2003, the Office of Laboratory
Animal Welfare (OLAW), in consultation with the
USDA Animal and Plant Health Inspection Service
(APHIS), Animal Care, amended guidance provided
in 1995 to Public Health Service (PHS) awardee
institutions and IACUCs concerning approval of
changes in personnel involved in animal
activities. Such changes were considered major
by OLAW in the past and therefore required
full-committee or designated-member review under
the provisions of the PHS Policy and the USDA
animal welfare regulations. The revised guidance
allows such changes to be handled as follows:
"IACUCs may, by institutional policy, classify
certain proposed additions and changes in
personnel, other than the Principal
Investigator, as 'minor' provided that an
appropriate administrative review mechanism is
in place to ensure that all such personnel are
appropriately identified, adequately trained and
qualified, enrolled in applicable occupational
health and safety programs, and meet other
criteria as required by the IACUC. The IACUC
remains responsible for confirming that all
IACUC review criteria regarding personnel
training and qualifications are maintained and
documented (PHS Policy IV,C,1 and 9CFR 1,
chapter 1, Part 2, 2.31). Institutions will be
held accountable for ensuring the
performance-based outcome that all individuals
involved in animal-related activities are
competent to do so. This guidance is intended to
provide substantial reduction of burden on
IACUCs and research teams without diminishing
the crucial oversight of personnel training and
qualifications." [NIH. Office of Extramural
Research revised guidance regarding IACUC
approval of changes in personnel involved in
animal activities. Notice: NOT-OD-03-046. (6
June 2003). http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-046.html].
- European Commission
Proposes Radical Overhaul of Animal Transport
Rules
On July 16th, 2003, the European Commission
(EC) adopted a proposed Regulation that will
radically overhaul the animal transport rules in
Europe in an effort to minimize the stress that
animals experience during transportation. "To
improve enforcement, the Regulation identifies
the chain of all those involved in animal
transport and who is responsible for what, as
well as introducing efficient enforcement tools,
such as checks via the tachograph. It also
introduces much stricter rules for journeys of
more than 9 hours, including domestic transport
which mirror other EU legislation governing the
time that drivers can spend on the road. The
proposed Regulation recognizes that most of the
stress on the animals occurs around loading and
unloading and therefore introduces rules to deal
with situations before and after transport, for
example at slaughterhouses or at harbours. It
encourages Member States to develop guides of
good practice." The new regulation will reduce
the maximum travel times for all species and
will forbid the transportation of particularly
young or pregnant animals. It will also require
improved traveling conditions, including
species-appropriate temperatures, permanent
access to drinking water, and increased minimums
for space according to species and length of
journey. The proposed regulation will increase
the list of people responsible for animal
transportation conditions and increases personal
responsibility in case of infringement. The
regulation will have to be approved by the
Council of Ministers after consultation of the
European Parliament. It is expected to be in
effect by the end of 2005. [European
Commission: Commission proposes radical overhaul
of animal transport rule. (16 July 2003).
http://europa.eu.int/rapid/start/cgi/guesten.ksh?p_action.gettxt=gt&doc=IP/03/1023|0|RAPID&lg=EN&display].
- USDA Regulation of Birds,
Rats and Mice
USDA, APHIS, AC announced on July 30th, 2003
that a final rule that will place the new
language of the Animal Welfare Act (AWA) into
the definition of "animal" in the Code of
Federal Regulations (Title 9) and an Announced
Notice of Proposed Rulemaking (ANPR) were
submitted for final approval prior to
publishing. The ANPR will advise the public
about the plan to publish proposed standards for
rats, mice, and birds and will give the public a
chance to have their voice heard on this matter.
It is estimated that the regulatory process will
take 2 or more years before final standards can
be published and much of this time will be used
to conduct economic impact statements, as
required by law. [USDA, APHIS, AC: http://www.aphis.usda.gov/ac/rmbupdate.html].
- NIH to Report to Congress
Noncompliance with Federal Policy on Animal
Research
In last year's appropriations bill for the
Department Health and Human Services, Congress
has asked the National Institutes of Health
(NIH) to investigate noncompliance with federal
policy on animal research. The bill, which
encourages NIH to investigate allegations of
noncompliance with the Public Health Service
(PHS) Policy on Humane Care and Use of
Laboratory Animals and report its findings to
Congress, states, "The Committee is concerned
about allegations that several institutions
receiving NIH funding may not be in full
compliance with the Public Health Service Policy
on Humane Care and Use of Laboratory Animals.
The Committee encourages NIH to determine the
extent and scope of any such allegations and
notify the Committee of its findings."
[Making further continuing appropriations
for fiscal year 2003. Congressional Record S645
(15 January 2003). http://frwebgate.access.gpo.gov/cgi-bin/getpage.cgi?position=all&page=s645&dbname=2003_record.]
- Environmental Warning
Added to Animal Euthanasia Products
On July 21st, 2003, the FDA's Center for
Veterinary Medicine (CVM) added an environmental
warning to two FDA approved
pentobarbital-containing euthanasia solutions in
an attempt to protect wildlife from exposure to
toxic euthanasia solutions. CVM initiated this
label revision in response to reports of
wildlife dying as a result of barbiturate
intoxication. To help prevent or alleviate
future injury to wildlife, CVM is requiring that
manufacturers revise labels of
pentobarbital-containing euthanasia solutions to
include the following warning: "ENVIRONMENTAL
HAZARD: This product is toxic to wildlife. Birds
and mammals feeding on treated animals may be
killed. Euthanized animals must be properly
disposed of by deep burial, incineration, or
other method in compliance with state and local
laws, to prevent consumption of carcass material
by scavenging wildlife." [Food and Drug
Administration, HHS. Final Rule; Technical
Amendment. Injectable or implantable dosage form
new animal drugs; euthanasia solution; technical
amendment. Federal Register 68, No. 139,
42968-42969 (21 July 2003).]
- Airlines to Report on
Incidents Involving Pets During Transport
On August 11th 2003, the Department of
Transportation, Federal Aviation Administration
issued a final rule amending 14 CFR Part 119 to
"require air carriers that provide scheduled
passenger air transportation to submit monthly
to the Secretary of Transportation, through the
Animal and Plant Health Inspection Service,
reports (USDA), a report on any incidences
involving the loss, injury or death of an animal
during air transport provided by the air
carrier". The rule specifies the type and manner
of information that air carriers must submit to
APHIS to comply with Section 41721(a). APHIS
will process the reports and forward the
relevant information to the Office of Aviation
Enforcement and Proceedings (APE) for monthly
publication in the Air Travel Consumer Report."
This amendment to the Wendell H. Ford Aviation
Investment and Reform Act of the 21st Century
(AIR-21) followed public concerns about
commercial airline animal transportation. Unlike
the rule that was originally proposed, the final
rule exempts animals used in research. Section
119.72(c)(2) now defines 'animal' as "any warm
or cold blooded animal which, at the time of
transportation, is being kept as a pet in a
family household in the United States."
[Department of Transportation, Federal
Aviation Administration. Final Rule. Reports by
carriers on incidents involving animals during
air transport. Federal Register 68, No. 154,
47797-47800 (11 August 2003).]
- USDA to Apply Animal
Welfare Regulations to Foreign Air Carriers
On October 10th, 2003, the USDA announced and
requested comments on its "intent to begin
applying the Animal Welfare Act regulations and
standards for the humane transportation of
animals in commerce to all foreign air carriers
operating to or from any point within the United
States, its territories, possessions, or the
District of Columbia." The purpose of this
action was to include all foreign carriers in
the same regulations for animals covered by the
Animal Welfare Act, with which the US air
carriers must already comply. The comment period
ended on December 9th, 2003. This regulation
will take effect on April 7th, 2004, unless the
USDA received comments raising substantial
concerns related to its implementation. The US
Department of Transportation currently
authorizes about 517 foreign air carriers to
conduct air transportation to and from the
United States. Once this rule is finalized,
these carriers will have to meet the AWA
regulations' physical and record-keeping
requirements. They will be required to include a
copy of the consignor's written guarantee of
payment for transportation for C.O.D. shipments;
a shipping document; an animal health
certificate executed and issued by a licensed
veterinarian; as well as instructions for the
administration of drugs, medication, other
special care, food, and water. [USDA APHIS.
Determination to regulate and request for
comments. Animal welfare; transportation of
animals on foreign air carriers. Federal
Register 68, No. 197, 58575-58577 (10 October
2003)].
- DEA Establishes
Registration Fees for Using Controlled
Substance
On October 10th 2003, the Drug Enforcement
Administration (DEA) announced a final rule
establishing a fee schedule, effective December
1st, 2003, for registration and reregistration
fees "relating to the registration and control
of the manufacture, distribution and the
dispensing of controlled substances. DEA is
required to adequately recover necessary costs
associated with the Diversion Control Program
(DCP) as mandated by the Departments of
Commerce, Justice, and State, the Judiciary, and
Related Agencies Appropriations Act of 1993."
Registration for the use of controlled
substances, such as barbiturates, opioids, and
other drugs for anesthesia, analgesia, and
euthanasia required for research on animals must
be accompanied by payment using the new fee
schedule. [DOJ DEA. Final rule. Controlled
substances registration and registration
application fees. Federal Register 68, No. 197,
58587-58600 (10 October 2003)].
- OLAW Answers Frequently
Asked Questions About the Public Health Service
Policy on Humane Care and Use of Laboratory
Animals
In the October 2003 issue of Lab Animal, the
Office of Laboratory Animal Welfare (OLAW) of
the NIH, Office of Extramural Research (OER)
published its interpretation of PHS Policy on
Human Care and Use of Laboratory Animals,
regarding eight questions that are frequently
asked by institutions. [Lab Animal
32(9):33-36, 2003. http://www.labanimal.com/iacuc/feature1003.pdf].
In the same issue, OLAW, as well as the USDA,
APHIS, Animal Care division provide commentary
in the Protocol Review column regarding the use
of unapproved species of animals [Lab Animal
32(9):17-19, 2003. http://www.labanimal.com/col/prot1003.htm]
- European Commission
Proposes New Regulations for the European
Chemical Industry
On October 29th 2003, the European Commission
proposed a new regulation system in order to
increase the protection of human health and the
environment from exposure to chemicals, and to
reduce the number of animals used to test the
safety of chemicals, while maintaining and
enhancing the competitiveness and innovative
capability of the European Union's chemical
industry. The proposed system, called REACH
(Registration, Evaluation and Authorisation of
Chemicals), would cover all scientific research
and development, laboratory-scale research and
development, and work supporting reference
standards. It will require that animal testing
be kept to a minimum, and that companies share
existing data in order to reduce the number of
animals used and the costs associated with their
testing. Companies that manufacture or import
more than one ton of any chemical substance a
year will have to register in a database. The
Commission advocates the use of non-animal
testing methods, including refined exposure
information, computer models, and cell culture
tests. [European Commission Press Room.
Chemicals: commission presents proposal to
modernize EU legislation. IP/03/1477. (29
October 2003). http://europa.eu.int/rapid/start/cgi/guesten.ksh?p_action.gettxt=gt&doc=IP/03/1477|0|RAPID&lg=EN&dislay;
European Commission Press Room. Chemicals:
research key to new EU chemical policy.
IP/03/1631. (1 December 2003). http://europa.eu.int/rapid/start/cgi/guesten.ksh?p_action.gettxt=gt&doc=IP/03/1631%7C0%7CRAPID&lg=EN&display;
European Commission Press Room. REACH-new
chemicals legislation. http://europa.eu.int/comm/press_room/presspacks/reach/pp_reach_en.htm.]
- CDC Amends 'Select Agent'
Regulations
On November 3rd, 2003, the Depart of Health
and Human Services, Centers for Disease Control
and Prevention (CDC) issued an amendment to an
interim final rule published December 13, 2002,
and request for comments regarding the
possession, use, and transfer of select agents
and toxins. Under the "select agent rule",
researchers needing access to select agents must
undergo security risk assessments by the FBI and
a separate lab inspection by either the CDC or
the USDA. The FBI background checks were to have
been completed by June 12, 2003 and the rules
fully implemented by November 12, 2003. However,
the FBI Criminal Justice Information Services
(CJIS) Division stated that while they had
finalized over 5000 security risk assessments,
many of the 8000 or so background check requests
have not yet been completed and they could not
complete all assessments by the November 12
deadline. As a result, researchers working with
select agents prior to February 7, 2003, when
the law went into effect, have been allowed to
continue working while the new rule is
implemented. ["Possession, use, and transfer
of select biological agents and toxins," Federal
Register, 68, No. 212, 62245-62247, November 3,
2003 (http://www.cdc.gov/od/sap/docs/42cfr73a.pdf)].
- FDA to Collect Fees for
Improving Animal Drug Reviews
On November 18th 2003, President Bush signed
into law the 'Animal Drug User Fee Act of 2003'
(ADUFA), which provides user fees to the Food
and Drug Administration (FDA) to fund FDA's
system for reviewing new animal drugs. This
legislation is similar to the legislation
established more than a decade ago by the FDA
for reviewing human drugs. [Animal Drug User
Fee Act of 2003. 108th Congress, 1st Session, S
313. (4 November 2003). http://www.fda.gov/cvm/index/adufa/PublicLaw108-130.pdf.]
The Act will substantially reduce the review
time for new animal drugs by providing funding
to increase the number of FDA Center for
Veterinary Medicine employees and for improving
the management system. The Act allows for the
waiving or reduction of fees for small
businesses and in circumstances where payment of
the fees would impede innovation. [FDA.
President signs new law providing user fees to
improve animal drug review. FDA News (19
November 2003). http://www.fda.gov/bbs/topics/NEWS/2003/NEW00978.html.]
- National Veterinary
Medical Service Act
The "National Veterinary Medical Service Act"
was signed into law on December 6th, 2003 by
President Bush and authorizes the Secretary of
Agriculture "to conduct a loan repayment program
regarding the provision of veterinary services
in shortage situations, and for other purposes."
The Act establishes a program to pay the
principal and interest of qualifying educational
loans of veterinarians who provide veterinary
services in 'veterinarian shortage situations',
or provide service to the federal government in
emergency situations. The Secretary of
Agriculture is to develop regulations for the
amounts and repayment schedules. According to
the Act, the Secretary may consider the
following to determine veterinarian shortage
situations:
- "Urban or rural areas that the Secretary
determines have a shortage of veterinarians."
- "Areas of veterinary practice that the
Secretary determines have a shortage of
veterinarians, such as public health,
epidemiology, and food safety."
- "Areas of veterinary need in the Federal
Government."
- "Other factors that the Secretary
considers to be relevant."
Qualifying loans include those made to cover
tuition, books and laboratory expenses, and
living expenses for individuals receiving a DVM
or equivalent degree from an accredited college
of veterinary medicine. Veterinarians will
receive salaries commensurate with their duties,
travel and appropriate per diem reimbursements,
and will not be required to serve more than 60
working days for each year of service. [HR
1367. National Veterinary Medical Service Act.
108th Congress, 1st Session.]
- Captive Wildlife Safety
Act
The "Captive Wildlife Safety Act" was signed
into law on December 19th, 2003 by President
Bush to ban the interstate commerce of certain
species of wild cats bound for the exotic pet
trade. The Act, which amends the Lacey Act
Amendments of 1981 to further the conservation
of certain wildlife species, prohibits
interstate commerce of any lion, tiger, leopard,
cheetah, jaguar, or cougar species, or any
hybrid of such a species. This ban does not
apply to importation, exportation,
transportation, sale, receipt, acquisition, or
purchase of an animal of a prohibited wildlife
species, by a person that: "(A) is licensed and
inspected by the Animal and Plant Health
Inspection Service with respect to that species;
(B) is a State college, university, or agency,
State-licensed wildlife rehabilitator, or State-
licensed veterinarian; (C) is an accredited
wildlife sanctuary that cares for prohibited
wildlife species and (i) is a corporation that
is exempt from taxation under section 501(a) of
the Internal Revenue Code 1986 and described in
sections 501(c)(3) and 170(b)(1)(A)(vi) of such
Code; (ii) does not commercially trade
[these wild cat species], including
offspring, parts, and byproducts of such
animals; (iii) does not propagate animals; and
(iv) does not allow direct contact between the
public and animals; or (D) has custody of the
animal solely for the purpose of expeditiously
transporting the animal to a person described in
this paragraph with respect to the species".
[HR 1006. Captive Wildlife Safety Act. 108th
Congress, 1st Session]
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