Information Resources for Institutional Animal Care and Use Committees 1985-1999 *************************

United States Department of Agriculture

Research, Education, and Economics

 

ARS _ CSREES _ ERS _ NASS

Policies and Procedures


Number 130.4 - Animal Care and Use Committee

This document is available at http://www.afm.ars.usda.gov/ppweb/

 Title: Animal Care and Use Committee
 
 Number: 130.4
 
 Date: 8/29/90
 
 Originating Office: Office of the Deputy Administrator, National Program Staff
 
 This Replaces: Remove AM 130-4 Dated 6/1/77
 
 Distribution: Headquarters, Areas, and Locations
 
 This Directive states policy, responsibilities, committee membership, committee procedures, including reporting requirements for IACUCs.
 
 
 

Table of Contents


1. Reference
2. Summary
3. Abbreviations
4. Definitions
5. Forms
6. Authorities
7. Coverage
8. Policy
9. Responsibilities
        The Administrator through the NPS
        The AD's
        The IACUC
10. Committee Membership
11. IACUC Officers and Duties
        Chairperson
        Secretary
12. IACUC Meetings
13. Reports

1. Reference


For definitions of terms, regulations, animal coverage, and standards of care and use, see DIRECTIVE 635.1, Humane Animal Care and Use.

2. Summary

The amended Animal Welfare Act (AWA) regulations contained in 9 CFR Part 2, Subpart 2C, Section 2.37 (see Exhibit 1) require each Federal research facility that uses animals to establish an Institutional Animal Care and Use Committee (IACUC). Locations that receive extramural funds from the Public Health Service (PHS) for studies that use animals in biomedical research and testing require an IACUC. The specific requirements set forth by the AWA and PHS Policy are not identical.

It is ARS Policy for (a) all ARS Locations using ARS funds, personnel, or physical resources; (b) all non-ARS locations using either ARS funds, personnel or animals; or (c) ARS personnel using funds from non-ARS sources and engaging in research and testing that use vertebrate animals to have an IACUC. Although AWA legislation specifically excludes from AWA overview farm animals used or intended for use as food or fiber, or when used or intended for use in agricultural research, it is ARS Policy to include overview of all ARS vertebrate animals by IACUCs at ARS Locations or at non-ARS locations. It is also ARS Policy to include overview by ARS IACUCs of non-ARS animals at ARS Locations or non-ARS locations using either ARS funds or personnel.

The ARS Policy described herein fulfills the requirements of both the AWA and PHS Policy.

This Directive states policy, responsibilities, committee membership, committee procedures, including reporting requirements for IACUCs.

3. Abbreviations

AALAS - American Association for Laboratory Animal Science
AD - Area Director
Ag Guide - Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching
APHIS- Animal and Plant Health Inspection Service
AWA - Animal Welfare Act
CD - Center Director
CAD - Contracting and Assistance Division
CRIS - Current Research Information System
CFR - Code of Federal Regulations
IACUC- Institutional Animal Care and Use Committee
LERB - Labor and Employee Relations Branch, Personnel Division, ARS
NIH - National Institutes of Health
NIH Guide - NIH Guide for the Care and Use of Laboratory Animals
NPS - National Program Staff
OPRR - Office for the Protection from Research Risks, NIH
PD - Personnel Division
PHS - Public Health Service
PI - Principal Investigator
PL - Public Law
REAC - Regulatory Enforcement Animal Care, APHIS
VS - Veterinary Services, APHIS

4. Definitions

Activity. Each unique, related series of procedures done on an animal or group of animals addressed in a single Protocol Form.

Protocol Form. The form that contains descriptions of animal care and use activities for which IACUC approval is requested by the PI. Points which must be addressed in the Protocol Form are described in AWA, 9 CFR, Subpart 2C, Section 2.31[d] (see Exhibit 1).

Cooperator. AB used in this Directive, taken to mean any non-ARS personnel caring for or using any vertebrate animal at an ARS Location.

5. Forms

VS Form 18-1, USDA Interstate and International Certificate of Health Examination for Small Animals. See Exhibit 2 for model form. This form and other VS forms can be obtained from Sector Supervisor, REAC, APHIS at the addresses listed.

VS Form 18-5, Record of Dogs and Cats on Hand. See Exhibit 2 for model form.

VS Form 18-6, Record of Disposition of Dogs and Cats. See Exhibit 2 for model form.

APHIS Form 7008 (Replaces Form VS Form 18-8), Inspection of Animal Facilities, Sites or Premises. The numbers on the refer to AWA, Standards section of 9 CFR 3. Obtain forms from REAC/APHIS. See Exhibit 2 for model Form and APHIS addresses.

VS Form 18-23, Annual Report of Research Facilities. Obtain Forms from REAC/APHIS. See Exhibit 2 for model Form and APHIS addresses.

ARS Form 605, Annual Report of Farm Animals Used in Agricultural Research (Exhibit 3).

ARS Form 606, IACUC Membership (Exhibit 3).

6. Authorities


7. Coverage

Use of all vertebrate animals for any purpose used at either any ARS Location, regardless of source of funds, or at another location using ARS funds or ARS personnel regardless of source of funds.

8. Policy

It is ARS policy:

To include all vertebrate animals used at either any ARS Location, regardless of source of funds, or at another location using ARS funds or ARS personnel regardless of source of funds under the IACUC overview provisions outlined in 9 CFR Part 2C (AWA). Further, the constitution of these IACUCs will conform to minimum membership and distribution characteristics stated in PHS Policy (i.e., at least five members). This statement formalizes Memoranda from ARS Administrator 1986, 1987, 1988, and 1989.

That all ARS Locations using vertebrate animals or other locations using ARS animals, personnel or funds for supporting any vertebrate animal use and also receive funds from any PHS agency, conform to the assurance requirements set out in PHS Policy Guidelines.

9. Responsibilities

The Administrator through the NPS administers the program and assures regulations and standards are enforced.

The AD's assure:


The IACUC:


10. Committee Membership

Consists of at least:

One Doctor of Veterinary Medicine, with training or experience with the care of the species in residence at the Location and who has direct or delegated program responsibility for activities involving animals at the Location.

One scientist experienced, and currently active, in research involving animals.

One member whose primary concerns are in a nonscientific area (e.g. ethicist, attorney, business person, clergy etc.).

One individual who is not affiliated with the institution in any way other than as a member of the IACUC and is not a member of the immediate family or a person who is affiliated with the institution.

NOTE: Furthermore, an individual who meets the requirements of more than one of the above categories may fulfill more than one requirement. However, no IACUC may have fewer than 5 members.

It is strongly recommended that all ARS IACUCs include, in addition to a senior scientist, an animal technician or caretaker.

Rotation of IACUC membership is encouraged.

11. IACUC Officers and Duties

Chairperson:

Secretary:


12. IACUC Meetings


13. Reports

Attending Veterinarian

On or before November 15 of each year, prepare original and three copies of VS Forms 18-5, 18-6, and 18-23 and ARS 605 covering the previous fiscal year ending September 30 and transmit the signed documents to IACUC secretary.

Secretary IACUC

On or before November 15 of each year, prepare original and three copies of report of activities of IACUC and also prepare IACUC membership form (ARS 606).

Only for locations that receive PHS funds and, therefore, have filed an Assurance with OPRR/NIH~ annually on or before December 1, prepare original and three copies of the annual report stipulated by PHS Policy.

Distribute documents:
Original and two copies to AD.

Retain documents: Retain one copy for file.

NOTE: Discard copies after 3 years.

AD

When documents are received, review for accuracy and compliance with ARS, AWA, and PHS policy. Accuracy is certified by AD signature.

Distribute documents:


Retain:
One certified copy for file.
NOTE: Discard copies after 3 years.

R. D. PLOWMAN
Administrator

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Number 635.1 - Humane Animal Care and Use This document is available at http://www.afm.ars.usda.gov/ppweb/

Title: Humane Animal Care and Use

Number: 635.1

Date: 8/29/90

Originating Office: Office of the Deputy Administrator National Program Staff

This Replaces: AM 535 dated 6/1/77

Distribution: ARS Headquarters, Areas, and Locations

This Directive states:
ARS Policy; lists coverage of animals under Public Laws, Polices and ARS practices; and assigns responsibilities for assuring humane animal care and use.



1. Reference
2. Abbreviations
3. Definition
4. Coverage
5. Authorities
6. Policy
7. Licensing and Registration
8. Responsibilities

1. Reference

For additional information see DIRECTIVE 130.4, Animal Care and Use Committee.

2. Abbreviations

AALAS - American Association for Laboratory Animal Science
AD - Area Director
AV - Attending Veterinarian
AWA - Animal Welfare Act
APHIS - Animal and Plant Health Inspection Service, USDA
CFR - Code of Federal Regulations
Ag Guide - Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching
IACUC - Institutional Animal Care and Use Committee
LERB - Labor and Employee Relations Branch, Personnel
PL - Public Law
REAC - Regulatory Enforcement Animal Care, APHIS
RL - Research Leader (ARS)
SY - Research Scientist (ARS)
VS - Veterinary Services, APHIS

3. Definition

Cooperator. As used in this Directive, taken to mean any non-ARS personnel caring for or using any vertebrate animal at an ARS Location.

4. Coverage

1. ARS Policy:

a. Includes: All vertebrate animals in all ARS Locations, or other locations in which ARS funds or ARS personnel are involved.

b. Excludes: Invertebrate animals.


2. AWA:

a. Includes: Any live or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or any other warmblooded animal, used or intended for use in research, teaching, testing, experimentation, or exhibition purposes, or as a pet.

b. Excludes: Birds, rats of the genus Rattus and mice of the genus Mus bred for use in research, and horses and other farm animals, such as, but not limited to livestock and poultry used or intended for use as food or fiber, or livestock or poultry used or intended for use for improving animal nutrition, breeding, management, or production efficiency, or for improving the quality of food or fiber.


3. PHS Policy:

a. Includes: Any animal (including farm animals) used in biomedical research and testing funded by a PHS Agency or in any institution that receives funds from a PHS Agency.

b. Excludes: Livestock and poultry used or intended for use that also is excluded from coverage by the AWA.


4. Ag Guide:

a. Includes: Livestock and poultry used in agricultural research and teaching.

b. Excludes: Animals covered by AWA or PHS.


5. Authorities


6. Policy

It is ARS policy to assure that all ARS research animals are treated humanely. Allegations of animal abuse must be reported promptly, in writing, to the Chairperson, IACUC, and the AD. It is ARS Policy to assure that all ARS research facilities and other facilities using ARS animals, funds or personnel for any animal use comply with the following:

1. The AWA, for animals used in biomedical research, testing or teaching and covered by the AWA including:

a. The AWA, its amendments, regulations, and standards concerning procurement, transportation, care, handling, and treatment of animals, training of personnel, and employee health programs (Exhibit 1).
b. Requirement to maintain IACUCs in all ARS Locations that have animals covered by the AWA (except that ARS requires a minimum of five members whereas AWA requires a minimum of three). See also Directive 130.4, Animal Care and Use Committee.
c. Assurance that animals not covered under the AWA receive the same level of humane animal care and treatment.
d. Review, and, if warranted, investigate concerns involving care and use of animals resulting from complaints or reports of noncompliance.


2. PHS Policy, for ARS facilities receiving funds from any PHS agency including:

a. "PHS Policy, and also NIH Guide concerning procurement, transportation, care, handling, and treatment of animals, training of personnel, and employee health programs (Exhibit 2).
b. Maintain IACUCs that comply with PHS Policy in all ARS Locations that use animals. Note that ARS and PHS Policy concerning IACUC size and composition are identical. See also Directive 130.4, Animal Care and Use Committee.
c. Assurance that animals not covered under PHS Policy receive the same level of humane animal care and treatment.


3. Ag Guide, for ARS facilities or facilities receiving ARS funds and using farm animals for any purpose with the following stipulations:

Ag Guide chapters 5-11 outlining appropriate husbandry practices for various species of farm animals (Exhibit 3).


7. Licensing and Registration

1. Not required for Federal agencies under the AWA.

2. Filing of an annual PHS Assurance with OPRR/NIH is required for all ARS Locations that receive funds from any PHS agency. Many other public and private funding entities also require filing of a PHS Assurance as a condition of grant/contract completion.


8. Responsibilities

1
. The Administrator, where applicable, through the NPS, assures compliance with ANA, PHS Policy and NIH Guide, Ag Guide, and
ARS Policy concerning humane care and use of all vertebrate \1-1/
animals.

2. AD's assure:

a. IACUCs are established where required and maintained in operation.
b. IACUC members and Chairpeople are appointed and function according to Directive 130.4, Animal Care and Use Committee.
c. That all employees who work with animals are appropriately trained.
d. Regulations, standards, and policies are enforced.
e. Reporting requirements for AWA, PHS Policy (where applicable), and ARS are met in a timely manner.
f. Deficiencies, including those involving physical facilities, are corrected promptly.
g. Procurement of all vertebrate animals in Areas/Centers/Locations is covered by an IACUC approval for the stipulated number of animals.
h. Consultation to IACUC, Attending Veterinarians, and/or other employees concerning animal care and welfare is provided.
i. That upon request of APHIS representatives, information required under the AWA is furnished.
j. That, if needed, assistance is requested from APHIS and/or OPRR/NIH concerning attainment of policy goals.
k. Funds and time are provided for employees to receive training required under the AWA.
l. Reported noncompliances with ARS Policy, the AWA and/or PHS Policy are investigated promptly and resolved.
m. That prompt disciplinary action is taken regarding any employee or cooperator found to have abused animals.


3.
Area/Center/Location Procurement Officer and Area/Center Location Property Office will assure that all orders for acquisition and disposition of all vertebrate animals comply with the AWA and ARS Directives concerning approved sources, and assurance that appropriate documentation accompanies all acquisitions and dispositions of animals.

4. RLs/SYs assure:

a. Acquisition of all animals comply with the AWA and ARS Policy.
b. Recordkeeping complies with the AWA, including the special recordkeeping required for dogs and cats that is described in Subpart 2C, Section 2.35.
c. Compliance with all special requirements concerning dogs and cats (Directive 130.4, Animal Care and Use Committee) that are delegated to RLs/SYs.
d. Dogs and cats obtained from sources other than dealers, exhibitors, and exempt persons are held for at least 5 full days before they are used.
e. All animals held or used for any purpose are covered by IACUC approval.
f. Recordkeeping provisions of the AWA, Subpart 2C, Section 2.35 concerning dogs and cats are followed and forms/records are forwarded to the appropriate Area IACUC (the official Area Record).
g. They personally, as well as their technicians, caretakers, students, and others are aware of and follow regulations and standards for humane care of animals used in any manner by them and/or their subordinates.
h. Any inadequacies in care, handling, or environmental conditions concerning animals are promptly reported and corrected.
i. Maintenance of training on regulatory requirements and humane care and use of animals.
j. Disposition of all healthy surplus animals comply with ARS property disposal procedures for disposition of surplus government animals. In addition, disposition of all dogs and cats also must comply with the AWA concerning recordkeeping (Subpart 2C, Section 2.35), euthanasia, sale, or transportation.

5. Attending Veterinarian:

a. Serves on the IACUC
b. Assures that:
i. All vertebrate animals receive adequate veterinary care in compliance with the AWA, NIH Guide, and Ag Guide.
ii. Guidance is provided to appropriate research and care personnel concerning, including but not limited to, care and use of animals regarding humane handling, immobilization, anesthesia, analgesia, euthanasia, tranquilization, as well as pre-and post-procedural care in accordance with established veterinary and nursing procedures and the AWA.
iii. VS Form 18-23 covering the previous fiscal year ending September 30 is accurately completed, receives concurrence by IACUC, and forwarded to AD for transmission to REAC/APHIS and NPS/ARS in a timely manner.
iv. ARS Form 605 covering the previous fiscal year ending September 30 is accurately completed, receives concurrence by IACUC, and forwarded to AD for transmission to NPS/ARS in a timely manner.
v. Animal caretakers receive an adequate level of training to provide optimum care of animals.
vi. Chairperson, IACUC, RL, Center Director, and AD are promptly notified about all failures to comply with provisions of AWA, NIH Guide, and Ag Guide concerning regulations and standards.
vii. Knowledge of new veterinary medical developments and regulatory requirements is maintained through a continuing program of training.

6. Consulting Veterinarian assume same responsibilities as attending veterinarian.


7. Animal Caretakers assure:

a. All animals under their responsibility receive care consistent with the AWA, NIH Guide, and Ag Guide on a daily basis, except for free ranging animals where Location IACUCs set the appropriate frequency.
b. All management and environmental requirements for animals are met in a timely manner.
c. Maintenance of current knowledge of all aspects of care for the species in their charge through a continuing program of training.
d. That during the first year of employment as animal caretaker, they take a course leading to certification given by AALAS (for laboratory animal caretakers) or by another organization/institution (for caretakers of species for which AALAS training is inappropriate). This course must contain training in current animal care practices and regulatory requirements relevant to the species in use. Lists of appropriate training courses leading to employee certification may be obtained from the IACUC. Employee certifications will be updated periodically to assure that they reflect current animal care practices, regulatory requirements, and relevance to the species being cared for.
e. On or before the first year of employment as animal caretaker, receive certification in the appropriate training course (described in H.7.d above). Failure to meet the certification requirement within a year after entering on duty will be grounds for dismissal.


8. IACUCs will fulfill all of the requirements in Directive 130.4, Animal Care and Use Committee.

R. D. PLOWMAN
Administrator


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Last updated February 22, 2001