Laws and Regulations

What high-profile incident prompted the regulation of animal research in the US?

Pepper the dalmation was stolen for research and sold to a “concentration camp for dogs”

What are the nine foundational ethical guidelines ensuring humane care, scientific justification, and proper oversight of research animals?

U.S. Government Principles

What are the nine U.S. Government Principles?

1. Transportation, care, and use of animals should be in accordance with the AWA

2. Procedures involving animals should be designed with consideration of their relevance to human/animal health

3. Animals selected should be of appropriate species and quality and the minimum number required

4. Avoidance/minimization of discomfort, distress, and pain

5. Procedures that cause more than momentary/slight pain should be performed with appropriate sedation; surgeries should not be performed on unanesthetized animals paralyzed by chemical agents

6. Animals that suffer pain that cannot be relieved should be painlessly killed at the end of the procedure

7. Appropriate living conditions for animals; directed by veterinarian or other trained scientist

8. Personnel should be experienced/trained in procedures

9. Exceptions to principles should not be approved by the investigator (need IACUC permission)

According to US Government Principle IV, unless the contrary is established, investigators should consider that…

Procedures that cause pain in humans also cause pain in animals

According to US Government Principle VII, the housing, feeding, and care of all animals used for biomedical purposes must be directed by…

A veterinarian or other trained scientist

When was the Animal Welfare Act enacted?

1966

What is the name of the list of USDA animal welfare regulations?

The Blue Book

What organization administers the Animal Welfare Act (and Horse Protection Act)?

USDA, Animal and Plant Health Inspection Service (APHIS), Animal Care

The Animal Welfare Act covers warm-blooded animals except:

• Mice of genus Mus

• Rats of genus Rattus

• Birds bred in captivity and used in research

• Livestock used in agricultural research

• (cold-blooded animals)

What is biomedical research?

Intended to benefit human health or animal health

What is agricultural research?

Conducted on agricultural species and is intended to improve production of food or fiber

What is wildlife research?

Conducted on wildlife, usually in the animal’s natural habitat

In addition to research, the Animal Welfare Act covers…

• Exhibitions (zoos, circuses)

• Breeding

• Animal dealers

• Transportation

What does IACUC stand for?

Institutional Animal Care and Use Committee

Who appoints members of an IACUC?

Chief Executive Officer

What are the responsibilities of an IACUC?

• Review and approve, require modifications of, or withhold approval of all animal projects

• Review programs for humane care/use of animals (at least once every six months)

• Inspections of animal facilities (at least once every six months)

• Prepare reports of evaluations and submit to Institutional Official

• Investigate adverse events/noncompliance

Who does an IACUC report to?

Institutional Official

What are the three required members of an IACUC as per the Animal Welfare Act?

• Chair

• Veterinarian

• Community member (not associated with the institute)

What are the two additional required members of an IACUC as per the PHS?

Scientist and non-scientist

As required by the Animal Welfare Act, institutions must submit an annual report to the USDA that includes:

• Names and numbers of animals used

• Pain/distress categorization

• Exceptions

• Location of all facilities

What category involves no pain, distress, or use of pain-relieving drugs in a study?

Category C

What category involves pain/distress to animals for which anesthesia was used?

Category D

Which category involves pain/distress to animals for which no anesthesia was used because it would have affected the results of the study?

Category E

According to USDA regulations, how do you calculate the minimum amount of floor space per dog?

(dog length + 6 inches)²/144

Besides IACUC, what are some examples of USDA regulations?

• Each research facility shall allow police officers to enter for the purpose of seeking missing animals

• Dog minimum amount of floor space

• Dealers/research facilities must follow a plan to exercise dogs; dog researchers must have written program of veterinary care

• Shipping containers for dogs have “Live Animals” 1 inch high

• Dealers/research facilities must follow a plan to provide environment enhancement for NHPs

How is the Animal Welfare Act enforced?

Unannounced inspections by Veterinary Medical Officers and Animal Care Inspectors

What are enforcement actions that can be taken if an instutition is in violation of the Animal Welfare Act?

• Citations

• Increased inspection frequency

• Warning letters

• Fines

• Revocation of licensure

• Confiscation of animals

What are example regulations from the Animal Welfare Act?

• Each research facility shall have an Attending Veterinarian who shall provide adequate veterinary care to its animals

• Each research facility shall allow police officers to enter its place of business to inspect animals and records for the purpose of seeking animals that are missing

What does OLAW stand for?

Office of Laboratory Animal Welfare

What organization administers Public Health Service policy?

OLAW (division of NIH)

What is the PHS?

Collection of agencies within the Department of Health and Human Services, including: NIH, FDA, CDC

The PHS Policy on Humane Care and Use of Laboratory Animals applies to…

All vertebrate animals when research is funded by PHS

What does the PHS Policy on Humane Care and Use of Laboratory Animals require?

Funded institutions to follow the Guide

What can noncompliance with the PHS Policy on Humane Care and Use of Laboratory Animals result in?

Loss of future funding; institution required to give back or repay money already spent

Institutions that obtain funding for animal research through PHS of NSF must prepare which legal document agreeing to follow standards in the Guide?

Animal Welfare Assurance

What are some of OLAW’s interpretations of the Guide listed in their FAQs?

• Real time monitoring of temp. and humidity with alarm systems

• FCR (full committee review) vs. DMR (designated member review)

• Proposals must include rationale for number of animals used

• Cost cannot be overriding factor in decisions related to animal welfare

What are the two methods of IACUC review?

Full-committee review and designated member review

What decisions may a full-committee IACUC review result in?

Approval, modifications, or withholding of approval

What decisions may a designated member IACUC review result in?

Approval, modifications, or referral to full committee

What document provides comprehensive guidelines for animals used in biomedical research and teaching?

Guide for the Care and Use of Laboratory Animals

What are the three action words in The Guide?

Must, should, and may

What are some guidelines in the Guide?

• Attending veterinarian must have access to all animals

• Institutions must have an occupational health and safety program

• All animals should be observed daily

• Institution must report/investigate animal welfare concerns

• 30-70% humidity range

• 10-15 room air changes/hour

• Light levels

• Single housing of social species should be the exception

• Toe clipping of small rodents

• Physical separation of animals by species

• Procedures must be in place to provide emergency veterinary care

Why does the Guide require 10-15 air changes per hour (very high) in animal rooms?

Reduce allergens in air

When do FDA regulations apply to animal research?

When submitting animal research data to FDA to gain approval to market new drug

What is the name of the regulations for animal research put out by the FDA?

Good Laboratory Practices (GLPs)

What can failure to follow FDA standards result in?

Disqualification for submitting data for review

What form is filled out when an FDA inspection finds noncompliance?

483

USDA, OLAW, and FDA have a ________________ agreeing to share inspection findings.

Memorandum of understanding

*What are the three primary standards used by AAALAC International?

• Guide

• Ag Guide

• ETS 123

What are some example AAALAC position statements?

• Social housing is default method of housing

• Macaques should be presumed to have herpesvirus

• No glue boards

• Daily checks of snap traps

What is ETS 123?

European standards for laboratory animal care

When can ETS 123 affect research in the US?

International companies do work in the US and in Europe

What are some examples of things regulated by state laws?

• Mandatory adoption

• Swine gestation crates

• Cat declawing

• Dog debarking

What is the goal of PA Senate Bill 381?

Ban all dog/cat research in PA

What are two towns with local animal research laws?

Davis, CA and Cambridge, MA

What are sunshine laws/Freedom of Information Act?

Requires public agencies to hold open meetings/federal agencies to disclose records upon request

From what organizations can you not request information via the FoIA?

Private organizations