Federal, State And University Laws, Regulations, Guidelines And Policies
|Animal Welfare Act||Federal Law||USDA|
|Principles for the Care and Use of Animals Used in Testing, Research and Education||Principles endorsed by 9 federal agencies||Federal agencies including Health and Human Services(including PHS and NIH)|
|PHS Policy on Humane Care and Use of Laboratory Animals||PHS policy – applies to all PHS funded grants and contracts. PHS’s implementation of the above Principles||Office of Laboratory Animal Welfare (OLAW, formerly OPRR), NIH,PHS, HHS|
|Health Research Extension Act of 1985||Federal law – gives statutory basis for pre-existing PHS Policy||NIH|
|Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC)||Non-profit, "voluntary" accrediting organization||AAALAC|
|Guide for the Care and Use of Laboratory Animals||Guidelines used by PHS Policy and AAALAC. Revised 1996||Written by an NRCcommittee, used by NIHand other organizations|
|2000 Report of the AVMA Panel on Euthanasia||The Guide defers to the AVMAreport as the standard for acceptable methods of euthanasia||Used by AAALAC, NIH, IACUC’s, etc.|
|Institutional Animal Welfare Assurance of Compliance to PHS||Required by PHS Policy in order to receive PHS funds for animal research at Rutgers||OLAW for PHS.
ACFC at Rutgers
|Rutgers University Animal Welfare Policy||Internal policy||Animal Care and Facilities Committee (ACFC)|
The new era of the animal rights movement has meant a wide range of activities, from demonstrations to illegal break-ins, resulting in increased media attention and attendant activity in federal and state legislatures. Due to tremendous constituent pressure and in an effort to strike a proper social balance between scientific needs and animal welfare, the U.S. Congress passed two pieces of legislation in 1985 which directly affect the use of animals in research.
The intent of this chapter is to provide an overview of the laws and regulations governing animal research including the two new laws passed in 1985-the Health Research Extension Act of 1985 (P.L. 99-198) and the Improved Standards for Laboratory Animals Act amending theAnimal Welfare Act (P.L. 99-148). Every investigator and staff member who uses animals in research projects is governed by one or both of these laws. It is therefore essential that you have a sound understanding of both your rights and responsibilities in relation to the conduct of animal research.
Both the Public Health Service Policy and the amendments to the Animal Welfare Act stress increased self-regulation and greater public accountability. The ultimate responsibility for all animal research lies with the institution, but in both laws, the mandatory animal care committees are vested with oversight responsibility.
On September 1, 1985, the Executive Office of the President issued an Animal Welfare Policy Governing the Use of Animals in Research, Instruction and Demonstration.
The University Policy requires adherence to the Animal Welfare Act, the NIH Guide and thePHS Policy. Most importantly, the University Policy applies to all procedures using live vertebrate animals at the University regardless of funding source or species.
The Animal Welfare Act is the federal statutory authority for inspection of research facilities. It was originally passed in 1966 and subsequently amended in 1970, 1976 and 1985. The Act falls under the jurisdiction of the Secretary of Agriculture, with responsibility for administration delegated to the U.S. Department of Agriculture Animal and Plant Health Inspection Service(APHIS). APHIS is responsible for regulating not only research facilities but also animal dealers, exhibitors (including zoos, aquariums, circuses, etc.) and intermediate handlers of animals, including air and truck lines.
Whereas the PHS Policy affects only those institutions receiving Public Health Servicefunding, the Animal Welfare Act covers all research facilities in the U.S. that use laboratory animals in basic and biomedical research, education and product safety testing. Wild rats and mice are covered by the Act. Laboratory rats and mice, birds and some farm animals are not covered by the Animal Welfare Act regulations, and facilities using only those species do not have to be registered with the U.S. Department of Agriculture.
The Animal Welfare Act was historically concerned primarily with basic animal husbandry and veterinary care. The Guide, PHS and AAALAC are concerned not only about animal welfare, but the whole animal research environment, including personnel safety, and factors which although they might not adversely affect animal welfare, might interfere with the integrity of animal research projects. In this sense, regulations of the Animal Welfare Act are less rigorous than the guidelines set forth in the NIH Guide. As federal law, however, the Act allows little room for interpretation, whereas the recommendations of the Guide are meant to be used with professional judgement.
Major regulations of the Animal Welfare Act include:
- Animal dealers must be licensed before they can sell animals to research institutions. Research facilities must be registered before they can purchase animals for research.
- Research facilities must keep records regarding the purchase, sale, transportation, identification and disposition of dogs and cats.
- USDA has established standards and record keeping requirements affecting the purchase, handling, care and use of laboratory animals. The standards include minimum requirements for: restraint, housing, feeding, watering, sanitation, ventilation, separation by species, veterinary care and appropriate use of anesthetic, analgesic or tranquillizer drugs. The regulations include cage size and space requirements that differ in some cases from PHS recommendations (see The Guide Chapter 2 Sec 3).
- Research facilities must demonstrate annually that professionally acceptable standards governing the care, treatment and use of animals are being followed. Rutgers must file an annual report that states the number of animals used each year, categorized by species and the level of pain and distress the animals experienced.
- USDA inspectors (veterinarians) must inspect each registered research facility at least annually. Inspectors are accompanied by Laboratory Animal Services personnel when they inspect University facilities. They have access to all animal facilities housing animals covered by the Act.
- Inspectors may confiscate or destroy animals found to be suffering as a result of failure to comply with any provisions of the Act, if the animals are not on experiment at the time.
- Inspectors may take photographs of animal facilities.
- Inspection of research facilities by law enforcement agencies is permitted, at reasonable hours, to search for lost animals. In New Jersey, state and municipal police have such authority. Animal control officers and humane society representatives do not.
- Violations of any provisions of the Act or of any of the rules, regulations or standards established by USDA under the Act are subject to a civil fines for each offense and each day such violations continue.
Existing statutory language prohibiting promulgation of rules or regulations with regard to "design, outlines, guidelines or performance of actual research" was revised to make exceptions for certain of the new standards.
- Research facilities are required to have an Institutional Animal Committee. (This was required of Rutgers by PHS Policy.)
- Research facilities shall provide training for scientists, technicians and others involved with animal care. [Hence this manual.] The National Agriculture Library, with the National Library of Medicine shall establish an information service to provide information on employee training, prevention of unintended duplication of research, and improved methods of reducing or replacing animal use and minimizing pain. The National Agricultural Library also maintains the Animal Welfare Information Center.
- Federal agencies will suspend or revoke funds when it is determined that conditions of animal care, treatment or practice in a particular project are not in compliance despite notification and an opportunity for corrections. Monetary fines for violations of the Animal Welfare Act were also increased.
- Nothing in the Act shall be construed to require a research facility to disclose publicly or to the Institutional Animal Committee during its inspection, trade secrets or commercial or financial information which is privileged or confidential." In addition, penalties for release of trade secrets are established.
- Standards for animal care, treatment, and practices in experimental procedures to ensure that animal pain and distress are minimized, including adequate veterinary care with the appropriate use of anesthetics, analgesics, tranquilizing drugs, and euthanasia must be established.
- Investigators must assure in writing that alternatives to painful procedures were considered. A veterinarian must be consulted in any practice which could cause pain to animals (PHS Policy).
- No animal may be used in more than one major operative experiment from which it is allowed to recover except in cases of scientific necessity.
- Exceptions to such standards may be made only when specified by research protocol and any such exception must be detailed and explained in a report filed with the Institutional Animal Committee.
As of August 15, 1990, all of the above regulations implementing the 1985 amendments were finalized. New regulations for Part 3, "Standards", were finalized at a later date. These new regulations include :
- Standards for exercise of dogs.
- Standards for a physical environment adequate to promote the psychological well-being of primates.
The principles below were prepared by the Interagency Research Animal Committee. This committee, which was established in 1983, serves as a focal point for federal agencies' discussions of issues involving all animal species needed for biomedical research and testing. The committee's principal concerns are the conservation, use, care, and welfare of research animals. Its responsibilities include information exchange, program coordination, and contributions to policy development.
The development of knowledge necessary for the improvement of the health and well-being of humans as well as other animals requires in vivo experimentation with a wide variety of animal species. Whenever U.S. Government agencies develop requirements for testing, research or training procedures involving the use of vertebrate animals, the principles shall be considered; and whenever these agencies actually perform or sponsor such procedures the responsible institutional official shall ensure that these principles are adhered to:
- The transportation, care, and use of animals should be in accordance with the Animal Welfare Act and other applicable Federal laws, guidelines, and policies.
- Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society.
- The animals selected for a procedure should be of an appropriate species and quality and number required to obtain valid results. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered.
- Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals.
- Procedures with animals that may cause more than momentary or slight pain and distress should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures should not be performed on unanesthetized animals paralyzed by chemical agents.
- Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure or, if appropriate, during the procedure.
- The living conditions of animals should be appropriate for their species and contribute to their health and comfort. Normally, the housing, feeding, and care of all animals used for biomedical purposes must be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied. In any case, veterinary care shall be provided as indicated.
- Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their in-service training, including the proper and humane care and use of laboratory animals.
- Where exceptions are required in relation to the provisions of these Principles, the decisions should not rest with the investigators directly concerned but should be made, with due regard to Principle II, by an appropriate review group such as an institutional animal care and use committee. Such exceptions should not be made solely for the purposes of teaching or demonstration.
Institutions such as Rutgers which conduct U.S. Public Health Service (PHS) - supported animal research must comply with the Policy on Humane Care and Use of Laboratory Animals. The Policy, administered through the National Institutes of Health, Office of Protection from Research Risks, has evolved over the last twenty years. The Health Research Extension Act of 1985 Section 495 "Animals in Research," put a statutory foundation under the Policy.
As revised to meet new legal requirements effective in September 1986, following are the key elements of the Policy.
Written documentation of Rutgers's commitment to animal welfare is required in the form of detailed information on the animal care and use program. Institutions are required to designate clear lines of authority and responsibility for those involved. Each institution must identify an official who is ultimately responsible for the institution's animal program and a veterinarian qualified in laboratory animal medicine who will participate in implementation. The program description must also give details concerning veterinary care, animal husbandry and all animal facilities. A synopsis of mandatory training or instruction in the humane practice of animal care and use as well as the occupational health program for all personnel involved with animals must also be included in the assurance statement. Rutgers must ensure that the laboratory animal facilities meet the requirements outlined in the Guide for the Care and Use of Laboratory Animals. At Rutgers, the function of the Institutional Animal Care and Use Committee is delegated to two committees, the Animal Care and Facilities Committee and the Institutional Review Board for the Use and Care of Animals.
Rutgers has an Animal Welfare Assurance on file with OPRR. The effective date is April 27, 1987. The Assurance Number is A-3262-01.
The centerpiece of each research facility's animal research program is the mandatory Institutional Animal Care and Use Committee (IACUC). At Rutgers, the functions of the IACUC are delegated to two committees, the Animal Care and Facilities Committee and the Institutional Review Board for the Use and Care of Animals.
The research institution must keep on file the Animal Welfare Assurance, the minutes of IACUC meetings, records of IACUC review of research projects, and semi-annual IACUC reports and recommendations and records of determinations of accrediting bodies. Annual reporting requirements must include gain or loss of AAALAC accreditation, program or facility changes, IACUC membership changes, the dates of the semiannual IACUC reports and any minority views. If there are no changes, a statement indicating such must be submitted.
All PHS awarding units must have an Animal Welfare Assurance verification of IACUC review and approval on file.
The University is required to conduct a semi-annual self-assessment of its animal research program and facilities based on the Guide for the Care and Use of Laboratory Animals. Deficiencies in the program or facilities are reported to the responsible institutional official along with a timetable for correction of the deficiencies.
In addition to the Animal Welfare Act and the Public Health Service Policy, several other federal laws and regulations govern the acquisition and care of animals used in research and product safety testing.
The Guide for the Care and Use of Laboratory Animals, prepared by the Institute of Laboratory Animal Resources, Commission on Life Sciences, National Research Council, is a companion piece to the PHS policy and should be referred to regularly when developing grant proposals and research design as well as in the actual care and treatment of research animals. The Guide specifically addresses institutional policies, laboratory animal husbandry, veterinary care and facility requirements. The Guide is used by AAALAC in its accreditation program. The Guide includes cage size and space recommendations for various animal species. It also contains an excellent bibliography on many aspects of animal research.
The entire text of the Guide is available on-line at:http://www.nap.edu/readingroom/books/labrats/. Individuals may obtain one free copy by contacting OPRR at (301) 496-7163. Greater quantities can be purchased from National Academy Press, (800) 624-6242.
F. GUIDE FOR THE CARE AND USE OF AGRICULTURAL ANIMALS IN AGRICULTURAL RESEARCH AND TEACHING
The ILAR Guide (above) is fully applicable to "farm" animals when they are used in a biomedical research setting (e.g. the use of calves to test artificial hearts), but has never dealt extensively with these species when housed in an agricultural setting. The agricultural Guide was first published in 1988 in recognition of the need for guidelines for the care and use of agricultural animals maintained in production-type facilities. Sponsored by a consortium of animal science and agricultural organizations, the agricultural Guide has been accepted byAAALAC as the basis for evaluating agricultural animal care programs. Specifically, AAALAC has adopted the individual chapters (5 through 11) that deal with husbandry of the various species. Neither the Public Health Service nor USDA has formally recognized these guidelines.
Copies of the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching may be obtained at a cost of $5.00 per copy from Association Headquarters, 309 West Clark Street, Champaign, IL 61820, (217) 356-3182.
G. ASSOCIATION FOR THE ASSESSMENT AND ACCREDITATION OF LABORATORY ANIMAL CARE INTERNATIONAL (AAALAC)
AAALAC is a non-governmental, non-profit organization established in 1965 to encourage optimal care of laboratory animals by providing a mechanism for peer evaluation of animal care programs by the scientific community. Humane treatment of laboratory animals, protection of personnel from hazards associated with the use of animals and control of variables that could affect animal research adversely are among the principal concern of the accreditation program. Institutions are accredited only after a thorough review of all aspects of their animal care program and an on-site facility inspection. AAALAC uses the recommendations of the Guide for the Care and Use of Laboratory Animals as a standard. While AAALAC has no legal standing, AAALAC is the only accrediting body recognized by the Public Health Service for demonstrating compliance with the standards of the Guide as required in the Public Health Service Policy.
The entire laboratory animal care program at Rutgers and the Cook Agricultural Research Farm are AAALAC accredited.
A number of New Jersey state laws are applicable to the use of animals in research and teaching.
1. Use of Pound Animals for Research
New Jersey law prohibits pounds and animal shelters from releasing dogs and cats for use in research. Random-source dogs and cats may be purchased from USDA licensed dealers who obtain animals from out of state. A list of licensed dealers is available from the USDA.
2. The Use of the Drug T-61 for Euthanasia
New Jersey law prohibits the use of neuromuscular blocking agents for euthanasia. The effect of this law is make illegal the use of the drug T-61 for euthanasia of animals.
3. Medical Waste Disposal
New Jersey's Comprehensive Regulated Medical Waste Management Act was signed into law in March of 1989 following widely publicized beach closings due to syringes and other medical waste washing ashore during the height of the tourist season. These regulations are amongst the strictest in the world. A key concept behind the regulations is that it is not sufficient to render medical waste sterile, but that it must be rendered unrecognizable. REHS administers the medical waste disposal program at Rutgers.
4. Right-to-Know Law
As a public employer, Rutgers is subject to the New Jersey Worker and Community Right to Know Act. This law is similar to, but stricter than, the federal Hazard Communication Standard enforced by OSHA. While final responsibility for safety matters at Rutgers rests with REHS, Laboratory Animal Services is particularly concerned about, and monitors the use of hazardous substances in animal studies, conducted in animal facilities or in research labs, to the extent that personnel and animals may be exposed. Chapter Error! Bookmark not defined. discusses the procedures for use of hazardous substances in animal studies.
I. Controlled Substances
In New Jersey, both a federal and state registration is required to obtain and store controlled substances. Faculty or departments who register with state and federal agencies as a "Researcher" may obtain controlled substances for their lab or building under their own registration. A professional medical degree (e.g. M.D., D.V.M., etc.) is not required.
In 1997, ketamine hydrochloride (e.g. Ketaset) was designated a controlled substance in New Jersey
LAS can provide application forms for both state and federal registration.
The recognized authority on acceptable methods of euthanasia is the 1993 Report of the AVMA Panel on Euthanasia. The 1986 revision updated the 1978 version and devoted considerably more attention to research animals than did previous editions. Both the Guide and the Animal Welfare Act defer to the recommendations of the AVMA Panel in matters related to euthanasia. Recommendations of this report are discussed in more detail in the chapter on euthanasia in this manual.
K. Good Laboratory Practices
In 1978, the Food and Drug Administration (FDA) adopted Good Laboratory Practices (GLP) rules and implemented a laboratory audit and inspection program. The Environmental Protection Agency (EPA), in 1983, issued its own GLP rules for its toxic substances control and pesticides programs. Studies which require submission of data to either FDA or EPA must confirm to GLP rules.
The GLP's for FDA and EPA are similar. Both address all areas of laboratory operations, not limited to, but including conduct of animal studies.
Provisions relating to care and housing of test animals are identical in both agencies' GLP rules. They require the use of written standard operating procedures for housing, feeding, handling and care with additional standards on species separation, disease control and treatment, identification, sanitation, feed and water inspection, bedding and pest control.
GLP's were implemented in response to fraudulent practices conducted by some laboratories in the 1970's. Few studies at Rutgers will be covered by the rules. Although they are very stringent, much can be learned about proper documentation of research findings by reading the GLP's.
It is difficult to conduct GLP animal studies at Rutgers. If you intend to conduct a GLP animal study at Rutgers, you should consult with LAS well in advance.
L. THE FREEDOM OF INFORMATION ACT
The Federal Freedom of Information Act (FOIA) provides for public access to government information. The FOIA has increasingly been used in recent years by animal rights organizations to obtain records such as inspection reports maintained by USDA and evaluations and recommendations on research projects funded by the NIH. This information is sometimes misused, distorted or taken out of context. Government agencies are not required to notify submitters, grant recipients for example, that disclosure of their data is being considered. NIH generally does notify grant submitters that a FOIA request for their information is being reviewed.
LAS periodically requests from USDA a list of all FOIA requests made by others for information about Rutgers. LAS also requests a copy of all information on file about Rutgers so that we know what information would be disclosed to others. Investigators may wish to make similar requests of funding agencies about funded grants.
It is important to note that only funded projects, not pending grant applications, are available under FOIA.