# Presentation: 498863

## Acquisition Management Committee SymposiumOctober 24, 2006ANIMAL WELFARE REQUIREMENTS

- Axel Wolff, M.S., D.V.M
- Director, Division of Compliance Oversight

## PHS Policy on Humane Care and Use of Laboratory Animals

- An Overview

## Authorizing Legislation and  Implementing Policy

**Health Research Extension Act of 1985**
**Public Law 99-158 "Animals In Research****”**
- November 20, 1985
**Public Health Service Policy on**
**Humane Care and Use of **
**Laboratory Animals**
- Revised August, 2002

## Health Research Extension Act of 1985, Public Law 99-158 11/20/85, “Animals in Research”

- Applicable to contracts
- Requires Institutional Animal Care and Use Committees, training of staff on humane animal use, reason for using animals
- Allows for correction of noncompliance by contractor
- Allows revocation of grant if problems not corrected

## Standards for Animal Care and Use PHS Policy 

- Guide for the Care and Use of Laboratory Animals
- U.S. Government Principles
- AVMA Panel on Euthanasia
-  USDA Animal Welfare Regulations

## Guide for the Care and Use of Laboratory Animals

- National Academy of Sciences’ Institute for Laboratory Animal Research
- Performance Standards
- Published data
- Expert opinion and experience
- Scientific principles

## US Govt Principles for the Utilization and Care of Vertebrate Animals

- Basic tenets of animal care and use
- PHS Policy – implements and supplements
- Institutional commitment in assurance
- IACUC incorporation into review of protocols

## US Govt Principles in a Nutshell

- Transportation
- Relevance to health, advance of knowledge
- Appropriate species, quality and numbers, alternatives considered
- Minimization of discomfort, distress and pain

- Appropriate sedation, analgesia or anesthesia
- Humane endpoints and euthanasia
- Appropriate living conditions and provision of veterinary care
- Trained personnel
- Exceptions reviewed by IACUC

## Additional standards

- 2000 Report of the AVMA Panel on Euthanasia, JAVMA, Vol 218, No. 5, 5/1/2001, **unless** deviation justified for scientific reasons in writing by PI and approved by IACUC
- USDA Animal Welfare Regulations
- Pain and distress categories
- Consideration of alternatives

## Other Federal Animal Regulators

**USDA** – certain warm-blooded animals used in research, exhibition; includes vendors
**US Fish and Wildlife Service** – wildlife imports, exports, and research, and certain wild marine mammals
**US Customs** – animal imports under inhumane conditions – Lacey Act
**National Marine Fisheries Service** – certain wild marine mammals
**CDC** – importation of nonhuman primates and certain other animals
**FDA** – Good Laboratory Practices (GLPs)

## OLAW Responsibilities 

- PHS Policy interpretation and implementation
- Animal Welfare Assurance negotiation and approvals
- Compliance evaluation
- Education

## Key Elements of the PHS Policy

- Enforced self-regulation
- Animal Welfare Assurance
- Institutional Animal Care and Use Committee
- Record keeping requirements
- Reporting requirements

## Enforced Self-regulation

- Performance standards
- Flexibility
- Self-monitoring
- Self-correcting
- Self-reporting
- OLAW oversight

## Animal Welfare Assurance

- Contract with federal government
- Documentation of institutional commitment
- Description of institutional programs and procedures
- Principal method for compliance oversight

## Program of Animal Care and Use

- Applicability
- Lines of authority and responsibility
- Institutional Animal Care and Use Committee
- Procedures to implement the PHS Policy
- Veterinary care
- Occupational safety and health
- Training
- Facilities
- Species

## IACUC Membership

- Minimum of Five Members
- Veterinarian
- Scientist experienced in animal research
- Nonscientist
- Member unaffiliated with the institution
- One other

## IACUC Responsibilities

- Oversight of animal care and use program
- Semiannual evaluation/inspection and report to Institutional Official
- Review protocols and procedures
- Review concerns
- Advise Institutional Official
- Suspend PHS-supported activity if necessary

## Record Keeping

- Animal Welfare Assurance
- Minutes of IACUC meetings
- Records of IACUC review of protocols
- Semiannual reports, including dissenting views
- Accrediting body determinations

## Annual Reporting

- Program or facility changes
- IACUC membership changes
- Dates of semiannual program evaluations and facility inspections
- Dissenting views
- Gain or loss of AAALAC accreditation

## Prompt Reporting

- Serious or continuing noncompliance with the PHS Policy
- Serious deviations from the *Guide*
- Any suspension of an activity by the IACUC

## Five Points of the Research  Plan – Vertebrate Animals

- Number and species
- Rationale
- Description of use
- Procedures to minimize pain
- Method of euthanasia

## IACUC approval

- Contract proposals covered by PHS Policy from Assured institutions must include verification of IACUC approval, including most recent date.
- Verification may be filed any time prior to award.

## Which study should be checked “yes” for vertebrate animal?

- Embryonated egg
- Tadpole
- Zebrafish
- Cow spleen from slaughterhouse
- Antibodies from goat
- Chimpanzee behavior study
- Octopus nerve study
- Mosquito malaria study (host?)

## Institutional Accountability

- The institution is accountable for:
- financial and administrative aspects of the award
- the animal care and use program (IACUC)
- The investigator is accountable for:
- the research
- compliance with the animal care and use program
- The IACUC, together with the Institutional Official, exercises oversight over institutional animal care and use

## Animal References in RFP Handbook- 8/4/06 version

- Schedule item #45- deliverable of animal in specific containers
- #115- Animal Welfare: research with live vertebrates must comply w/ PHS Policy
- #116- Introduction of rodents/products: requires permit before shipping to NIH
- #117- Protection of personnel who work w/ nonhuman primates: contract personnel must comply with NIH intramural policy

## RFP Handbook continued:

- Contract clause item 223a- requires Assurance of contractor using vertebrates and compliance with AWA, PHS Policy, Guide, establish IACUC
- 223b- identify species, numbers, rationale, description, analgesics, euthanasia
- 223c- Assurance #, date of Assurance, AAALAC accreditation if required by SOW

## RFP continued:

- 227, 271-Model organisms (mammalian models, amphibians, fish, worms, flies) developed with NIH funds must have plan for sharing so other researchers can benefit.
*Thanks to Jackie Holden for information on the RFP Handbook.*

## OLAW guidance

- OLAW will be working with contract officials on updating the portions of the RFP handbook dealing with animal related issues

## Implications of Noncompliance

- Corrective actions & improved systems
- Restrict/withdraw approval of Assurance
- Special terms/conditions of awards
- Cost disallowance
- Suspension/termination of award
- Criminal prosecution

## NIH Expectations

- Institutional climate that promotes compliance
- Institutional policies
- Institutional training
- Checks and balances
- Communication, internal and with NIH

## Electronic Access - OLAW

**E-mail**:  olaw@od.nih.gov
- _[grants.nih.gov/grants/olaw/olaw.htm](http://grants.nih.gov/grants/olaw/olaw.htm)_
**ListServ**: announcements, notices, policy interpretations, etc.

## QUESTIONS

- 				PLEASE ASK!