The Catholic University of America

Summary of Federal Laws

Research

Animal Welfare Act

Compliance Partners

Associate Provost for Research

 

7 U.S.C. § 2131 to 2159; Title 9 CFR

This law governs the treatment of animals used for research: dogs, cats, monkeys, guinea pigs, hamsters, and other warm blooded animals.

Institutional Program for Animal Care and Use

The Public Health Service (PHS) requires institutions to use the 8th edition of the Guide for the Care and Use of Laboratory Animals (Guide) as a basis for developing and implementing an institutional program for activities involving animals.The program description must include the following:

a. a list of every branch and major component of the institution, as well as a list of every branch and major component of any other institution, which is to be included under the Assurance;

b. the lines of authority and responsibility for administering the program and ensuring compliance with this Policy;

c. the qualifications, authority, and responsibility of the veterinarian(s) who will participate in the program and the percent of time each will contribute to the program;

d. the membership list of the Institutional Animal Care and Use Committee(s) (IACUC) established in accordance with the requirements set forth in IV.A.3. of this Policy;3

e. the procedures which the IACUC will follow to fulfill the requirements set forth in this Policy;

f. the health program for personnel who work in laboratory animal facilities or have frequent contact with animals;

g. a synopsis of training or instruction in the humane practice of animal care and use, as well as training or instruction in research or testing methods that minimize the number of animals required to obtain valid results and minimize animal distress, offered to scientists, animal technicians, and other personnel involved in animal care, treatment, or use;

h. the gross square footage of each animal facility (including satellite facilities), the species housed therein and the average daily inventory, by species, of animals in each facility; and

i. any other pertinent information requested by OLAW.

Training

The USDA Animal Welfare Act Regulations and Public Health Service Policy make it clear that it is an institutional responsibility to provide training to personnel who work with laboratory animals to ensure that all personnel are qualified to do so. See resources for training below.

Animal Welfare Assurance

No activity involving animals may be conducted or supported by the PHS until the institution conducting the activity has provided a written Assurance acceptable to the PHS, setting forth compliance with this Policy. Assurances shall be submitted to the Office of Laboratory Animal Welfare (OLAW), Office of the Director, National Institutes of Health. The Assurance shall be signed by the Institutional Official. OLAW will provide the institution with necessary instructions and an example of an acceptable Assurance. All Assurances submitted to the PHS in accordance with this Policy will be evaluated by OLAW to determine the adequacy of the institution's proposed program for the care and use of animals in PHS-conducted or supported activities. On the basis of this evaluation OLAW may approve or disapprove the Assurance, or negotiate an approvable Assurance with the institution. Approval of an Assurance will be for a specified period of time (no longer than five years) after which time the institution must submit a new Assurance to OLAW.

Institutional Animal Care and Use Committee (IACUC)

The Chief Executive Officer shall appoint an Institutional Animal Care and Use Committee (IACUC), qualified through the experience and expertise of its members to oversee the institution's animal program, facilities, and procedures. The Assurance must include the names,position titles, and credentials of the IACUC chairperson and the members. The committee shall consist of not less than five members, and shall include at least:

(1) one Doctor of Veterinary Medicine, with training or experience in laboratory animal science and medicine, who has direct or delegated program authority and responsibility for activities involving animals at the institution

(2) one practicing scientist experienced in research involving animals;

(3) one member whose primary concerns are in a nonscientific area (for example, ethicist, lawyer, member of the clergy); and

(4) 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 of a person who is affiliated with the institution.

Recordkeeping Requirements

1. The awardee institution shall maintain:

a. a copy of the Assurance which has been approved by the PHS;

b. minutes of IACUC meetings, including records of attendance, activities of the committee, and committee deliberations;

c. records of applications, proposals, and proposed significant changes in the care and use of animals and whether IACUC approval was given or withheld;

d. records of semiannual IACUC reports and recommendations (including minority views) as forwarded to the Institutional Official; and

e. records of accrediting body determinations.

2. All records shall be maintained for at least three years; records that relate directly to applications, proposals, and proposed significant changes in ongoing activities reviewed and approved by the IACUC shall be maintained for the duration of the activity and for an additional three years after completion of the activity. All records shall be accessible for inspection and copying by authorized OLAW or other PHS representatives at reasonable times and in a reasonable manner.

Reporting Requirements

1. At least once every 12 months, the IACUC, through the Institutional Official, shall report in writing to OLAW:

a. any change in the institution's program or facilities which would place the institution in a different category than specified in its Assurance (see IV.A.2.of this Policy);

b. any change in the description of the institution's program for animal care and use as required by IV.A.1.a.-i. of this Policy;

c. any changes in the IACUC membership;12 and

d. notice of the dates that the IACUC conducted its semiannual evaluations of the institution's program and facilities and submitted the evaluations to the Institutional Official.

2. At least once every 12 months, the IACUC, at an institution which has no changes to report as specified in IV.F.1.a.-c. of this Policy, shall report to OLAW in writing, through the Institutional Official, that there are no changes and inform OLAW of the dates of the required IACUC evaluations and submissions to the Institutional Official.

3. The IACUC, through the Institutional Official, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: a. any serious or continuing noncompliance with this Policy; b. any serious deviation from the provisions of the Guide;13 or c. any suspension of an activity by the IACUC.

4. Reports filed under IV.F. of this Policy shall include any minority views filed by members of the IACUC.

See 9 CFR 2.7 for the annual report by licensees.

Stay of Dec. 31, 2012 Final Rule, 78 Fed. Reg. 46255, Effective July 31, 2013.
The govt. intends to undertake a reveiw and analysis of the final rules that were to become effective as described in the rule below.


Final Rule, Handling of Animals, Contingency Plans, 77 Fed. Reg. 76815, Dec. 31, 2012

The final rule requires research facilities to develop contingency plans for response to and recovery from emergencies most likely to happen to their facilities and to train their employees on those plans. According to the rule, written contingency plans must be in place at all regulated facilities by July 26, 2013, all employees must be trained by September 27, 2013 and plans should be available upon request by APHIS inspectors after September 27, 2013. See the DOA web page with a FAQ on the Contingency Regulation, as well as an Animal Care Tech Note and other resources.

 

Laboratory Animal Welfare: Eighth Edition of the Guide for the Care and Use of Laboratory Animals, 76 Fed. Reg. 74803, Dec. 1, 2011
Effective January 1, 2012, institutions that receive Public Health Service (PHS) support for animal activities must base their animal care and use programs on the  8th edition of the Guide for the Care and Use of Laboratory Animals and must complete at least one semiannual program review and facilities inspection using the 8th Edition of the Guide as the basis for evaluation by December 31, 2012. It is not required that all necessary changes be completed by December 31, 2012, but rather that an evaluation must be conducted
and a plan and schedule for implementation of the standards in the 8th Edition of the Guide must be developed by 12-31-2012.
 
Institutions must verify to the Office of Laboratory Animal Welfare the organizational component of NIH that provides guidance and interpretation of the PHS Policy on Humane Care and Use of Laboratory
Animals, that they have met the required schedule. This will be done through the Annual Report to OLAW covering the 2012 reporting period due January 31, 2013.  In addition, institutions must document the
implementation of the 8th Edition of the Guide in their next Animal Welfare Assurance renewal.

 See the NIH Position Statements on use of the new Guide.

Memorandum of Understanding Between the FDA, the Animal and Plant Health Inspection Service, and NIH Concerning Laboratory Animal Welfare, 71 FR 26095, May 3, 2006

This memo sets forth the framework for reciprocal cooperation which will assist each agency in meeting its
responsibilities in promoting proper laboratory animal care and welfare. The agencies agree to share information on significant adverse findings regarding animal care at inspected organizations and other evidence of serious non-compliance with required standards or policies for care at organizations that fall under their respective authority; to coordinate successive evaluations and avoid redundant evaluations of the same entities.

Resources

Animal Care Policy Manual (Animal and Plant Health Inspection Service) issued March 2011

USDA Animal Welfare Act and Regulations Page

NIH Office of Laboratory Animal Welfare

Public Health Service Policy on Humane Care and Use of Laboratory Animals

Department of Veterans Affairs Training Modules

The Medical Research Service in the VA Headquarters Office of Research and Development has provided funding for the ResearchTraining.Org website to help VA research programs involving animal research. As a service to the research community, the web courses and documentation self-exams are also available free of charge to non-VA institutions. Passwords can be obtained from the VA if the institution does not already have them.

Of Interest
The Animal Enterprise Terrorism Act
This law (signed on Nov. 27, 2006) criminalizes the use of force, violence or threats for the purpose of damaging or interfering with operations of an animal enterprise. Education, testing and research at universities involving animals is thus protected from animal rights activists who cross the line into activity that is prohibited under the law.

 

 

updated 8/30/13 stay of final rule