Animal Welfare Regulations
Last updated on June 17, 2001
These regulations are contained in the Code of Federal Regulations (CFR),
Subchapter A - Animal Welfare. They represent the regulations promulgated by the
USDA to enforce the Animal Welfare Act. The text of 9CFR
was downloaded from USDA on 6/16/01 and is divided into:
Part 1. Definitions
Part 2. Regulations
Part 3. Standards
Part 4. Rules of Practice
On this page, some
notable parts of 9CFR are described, particularly as they differ from other
legal requirements, i.e. the PHS Policy and the Guide.
Part 2. Subpart C. Research Facilities
2.31 IACUC
2.32 Personnel training
2.33 Attending veterinarian and adequate veterinary care
2.35 Record-keeping
2.36 Annual report
2.38 Miscellaneous
The IACUC (§2.31)
The Institutional Animal Care and Use Committee (IACUC) must be appointed by
the Chief Executive Officer of the research facility (note vocabulary difference
from the Guide).
There must be at least three members: the Chair, a DVM with training or
experience, and a non-affiliated member. PHS
Policy requires at least 5 members.
IACUC functions include:
1. Review the program for humane care and use of animals
2. Inspect the facilities at least every 6 months
3. Prepare reports of the evaluation and submit them to the
Institutional Official (IO).
 | Reports must be signed by the majority of the committee and include
minority views. |
| They must be maintained by the facility and be available for inspection. |
| They must contain a description of the nature and extent of
adherence to 9CFR, identify any departures from 9 CFR and state why. |
| They must distinguish "significant" (i.e. resulting in a threat
to animal health or safety) from "minor" deficiencies. There must
be a plan and schedule for correction of each deficiency, and if they remain
uncorrected, the IO must report this to APHIS. |
4. Review and investigate concerns involved animal care and
use
5. Make recommendations to the IO regarding the animal
program, facilities or personnel training
6. Review and approve, require modifications in, or withhold
approval of proposed activities using animals; and do the same thing for changes
in proposed use of animals
7. Be authorized to suspend activities involving animals
IACUC review determines that the following requirements will be met:
- Field studies (conducted on free-living animals in their natural habitat,
not involving invasive procedures, and not harming or altering their
behavior) are exempt
- Procedures will avoid or minimize distress, discomfort and pain
- The PI must consider alternatives to procedures that may cause more than
momentary or slight pain or distress and provide a written narrative of the
methods and sources used to determine that alternatives were not available
(see Animal Care Policy 11
and Policy 12)
- PI provides assurance that the activities are not duplicative
- Procedures that do cause more than momentary or slight pain or distress
must: be performed with sedatives, analgesics or anesthetics; involve
consultation with a DVM during planning; not use paralytics without
anesthesia
- Ensure euthanasia of animals whose pain/distress can't be relieved
- Animals' living conditions must be in accordance with 9 CFR part 3
- Medical care must be available and provided
- Personnel conducting procedures must be trained
- Surgical procedures must include pre- and post-operative plans. Survival
surgery must be aseptically performed. Major procedures on non-rodents will
be performed in a dedicated facility. Non-major procedures and rodent
surgery (and also field surgery) doesn't have to be in a dedicated facility,
but must use aseptic techniques.
- No animal will receive more than one major operative procedure (that which
penetrates and exposes a body cavity, or one that produces permanent
impairment of physical or psychological functions), unless either justified
for the science, performed as part of routine veterinary care or to protect
the animal's health or well-being
- Euthanasia must be in accordance with the 9 CFR definition: humane
destruction of an animal accomplished by a method producing rapid
unconsciousness and subsequent death without evidence of pain or distress
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Personnel Qualifications (§2.32)
This aspect includes five categories of training that must be provided to
scientists, research technicians, animal technicians and others involved in
animal care, treatment, and use:
- Human methods of animal maintenance and experimentation: (a) basic needs
of each species; (b) proper handling and care; (c) pre-procedural and
post-procedural care; (d) aseptic surgical methods
- Concept, availability and use of research/testing methods that limit
animal use or minimize distress
- Proper use of anesthetics, analgesics and tranquilizers for different
species
- How to report deficiencies in animal care and treatment
- Use of services to provide information on methods, alternatives,
duplication, and the AWA
The training program should be evaluated as part of the semi-annual IACUC
evaluation. PHS Policy VIII addresses
training in a similar way.
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Attending veterinarian and adequate veterinary care
(§2.33)
The Guide, ACLAM,
and 9 CFR all have similar suggestions for the provision of veterinary care.
Although several of the US Government Principles address medical concerns, only policy
VII mentions the need for a veterinarian to oversee animal care. Provision
of medical care is one of the aspects of a PHS grant that the IACUC must review.
Requirements in 9CFR for an attending veterinarian are:
- Each institution must have an attending veterinarian; if this is a
consultant position there must also be a written program of veterinary care
- The AV must have the authority to oversee the program
- The AV (or other designated vet) must be a voting member of the IACUC
Each research
facility shall establish and maintain programs of adequate veterinary
care that include:
-
The availability of appropriate facilities, personnel, equipment, and
services
- The use of appropriate methods to prevent, control, diagnose, and treat
diseases and injuries, and the availability of emergency, weekend, and
holiday care;
- Daily observation of all animals to assess their health and well-being.
Daily observation of animals may be accomplished
by someone other than the attending veterinarian. A mechanism of direct and frequent communication is required...
- Guidance to principal investigators and other personnel involved in the
care and use of animals regarding handling, immobilization, anesthesia,
analgesia, tranquilization, and euthanasia;
(Also refer to Policy
11, Painful Procedures);
- Adequate pre-procedural and post-procedural care in accordance with current
established veterinary medical and nursing procedures.
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Record-keeping (§2.35)
IACUC records to be kept by the research facility include minutes of the
meetings, records of protocols, and the semi-annual evaluations.
For each dog and cat, including any of their offspring, the facility must
keep records of who they got it from (name, address, USDA license number or
vehicle license number), date of acquisition, description of the animal,
official USDA tag number and the number assigned to the animal by the facility.
If a facility transfers ownership of a dog or cat, records must indicate the
name and address of the new owner, date, and vehicle information. APHIS form
7006 is useful for this purpose.
All records and reports should be kept for 3 years, and made available to the
APHIS inspector if requested.
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The annual report is due at the Regional Director's office no later than
December 1 of each year, and covers the previous Federal fiscal year. The report
(which is put on a standard form) must include:
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Assurance that professionally acceptable standards governing the care, treatment,
and use of animals, including appropriate use of anesthetic, analgesic,
and tranquilizing drugs, prior to, during, and following actual research,
teaching, testing, surgery, or experimentation were followed by the research
facility;
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Assurance that each principal investigator has considered alternatives to
painful procedures;
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Assurance that the facility is adhering to the standards and regulations
under the Act, and that it has required that exceptions to the standards
and regulations be specified and explained by the principal investigator
and approved by the IACUC. A summary of all such exceptions must be attached
to the facility's annual report...
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State the location of all facilities where animals were housed or used
in actual research, testing, teaching, or experimentation, or held for
these purposes;
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and give an accounting of the number and species of animals used in each pain
category
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This section describes how the facility must comply with the APHIS inspector
when he/she comes, the methods of identifying dogs and cats, and health
certificates for dogs, cats and NHPs.
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