ALAT 2

What types of euthanasia methods are listed in the AVMA Guidelines for the Euthanasia of Animals?

Acceptable, conditionally acceptable, and unacceptable methods

Animal Welfare Regulations (AWR) are administered by

Animal and Plant Inspection Service (APHIS) of the United States Department of Agriculture (USDA).

1966, the United States Congress enacted the first federal law for laboratory animal welfare

Animal Welfare Act (AWA)

The Animal Welfare Regulations (AWR) are published each year in the

Code of Federal Regulations

Some research animals must be killed (euthanized) during or at the end of research studies. It is important that this step be taken with the highest degree of respect.

Efforts must be made to make the death as painless and distress-free as possible. The AVMA Guidelines for the Euthanasia of Animals list acceptable, conditionally acceptable, and unacceptable methods of euthanasia for different animal species. The Guide and the PHS Policy require that animal facilities follow the current euthanasia guidelines contained in this document

laws protect animals

The earliest law to protect animals from cruelty in America was passed in 1641 in the Massachusetts colony. The first federal anti-cruelty law was enacted in l873. It was specifically directed at the meat packing industry to limit the amount of time the animals could be confined during shipment. This law also mandated that animals be provided food, water, and the opportunity to rest during shipment. In the mid-19th century, the state of New York passed a law for the "more effectual prevention of animal cruelty." This law became the model for similar laws in other states. During the 20th century, anti-cruelty laws were extended to include the humane treatment of laboratory animals. • The foundation of the modern laboratory animal welfare guidelines and regulations can be traced to 1950. • The Animal Care Panel (ACP, which later became AALAS) published the first edition of the Guide in 1963. • In 1996, the Institute of Laboratory Animal Research (ILAR) produced the seventh edition of the Guide

PHS policy requires

all federal grant recipients to comply with the US Government Principles. These principles are described later in this section. Grant recipients must also follow the guidelines of the AWA, the Guide, and the AVMA Guidelines for the Euthanasia of Animals.

AWA and its later amendments govern the use in research of

all warm-blooded vertebrates (live or dead), with some exceptions. Not covered by the AWA are: •birds; rats, and mice bred exclusively for research; and •farm animals used or intended for use as food or fiber or for agricultural research. The AWA requires that minimum standards of care and treatment be provided for covered animals: •bred for commercial sale, •used in research, •transported commercially, or •exhibited to the public. Hamsters, guinea pigs, rabbits, cats, dogs, and nonhuman primates are examples of species covered by the AWA.

The purpose of the Guide

assist institutions in caring for and using animals in research. The Guide is the primary source of the standards and guidelines for laboratory animal care and use in the United States. The Guide's standards and guidelines support good science through the humane use of animals in animal facilities. The Guide describes standards for the following components of an animal care and use program: • Personnel qualifications and training •Occupational health and safety • Veterinary care •Animal environment, housing, and management •Animal procurement and transportation • Surgical and postsurgical care •Alleviation of pain and distress •Euthanasia techniques •Physical plant design and construction There is a related document called the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching (generally called the Ag Guide). It applies to research and teaching that have agricultural rather than biomedical objectives.

Public Health Service (PHS) oversees

many US federal agencies. Some of the major ones include: •Centers for Disease Control and Prevention (CDC) •Food and Drug Administration (FDA) •Indian Health Service (IHS) •National Institutes of Health (NIH) •Substance Abuse and Mental Health Services Administration

Which document is named by the Guide and PHS Policy as the one that must be followed when euthanizing research animals?

AVMA Guidelines for the Euthanasia of Animals

AAALAC

Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC).

regulations contained in the AWA and AWR.

Companies or institutions that sell, auction, exhibit, transport, breed, or conduct research with animals are subject to the regulations contained in the AWA and AWR. The regulations describe minimum acceptable standards in the areas of: •housing, •feeding, •watering, •handling, •sanitization, •ventilation, •transportation, •separation of species, and •veterinary care. The USDA also requires that animal suppliers and research facilities maintain records of animal acquisition and disposal. Laboratory animal facilities must submit the information in an annual report to the USDA.

PHS Policy has a requirement for

IACUC with the same responsibilities and functions as under the AWR. However, there are some administrative differences in how this committee is structured. Additionally, the PHS Policy requires that institutions have an occupational health and safety program for all personnel working with animals.

The Animal Research Environment (2009)

Table 2.1. US law, regulation, policy and guidelines for the care and use of animals in research. Document Animals covered Agency Comments Animal Welfare Act (AWA)and amendments Animal Welfare Regulations(AWR) Warm-blooded animals, live or dead, except birds, rats, and mice bred for research and agricultural animals used for food or fiber USDA-APHIS Provides general and species-specific standards: AWR provide more specific details on how to achieve compliance. Require that all research facilities establish an IACUC, which must submit an annual report to USDA-APHIS. Require licensing and registration. USDA-APHIS inspectors perform unannounced visits at least once a year. Violations can result in penalties. Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) Live vertebrates used or intended for use in research, research training, experimentation, biological testing, or for related purposes. Includes rats, mice, and birds. OLAW Requires all federal grant recipients to comply with the US Principles, the AWA, and the Guide. Requires an IACUC and an Occupational health and safety program. US Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training(US Government Principles) All vertebrates, includes rats, mice , birds, farm animals, wild life, and aquatic animals OLAW Presents overarching principles for the humane care of animals in these activities and the relevance of animal use to the good of Society. Covers humane transportation, minimization of discomfort, appropriate husbandry, and methods of euthanasia. Guide for the Care and Use of Laboratory Animals (the "Guide") All vertebrates. Includes rats, mice, birds, farm animals, wild life and aquatic animals. National Research Council (NRC); Institute of Laboratory Animal Research (ILAR) Provides guidelines and standards for a variety of areas such as justification for species and number used, availability of less-invasive alternatives, training of personnel, anesthesia and analgesia, euthanasia and disposal of animals, and the safety of the working environment for personnel. The Guide identifies the outcomes that need to be achieved but does not specify how to achieve them. Good Laboratory Practice Regulations (GLPs) Does not cover specific animal species but is directed to the type of research conducted. FDA and EPA Applies to nonclinical studies (safety data) in support of applications to the FDA for food or drug research or marketing permits or to EPA for research or marketing permits for pesticides and toxic products. Requires staff training and SOPs and the establishment of a QA unit

Office of Laboratory Animal Welfare (OLAW) at NIH is responsible for the general administration and coordination of the PHS Policy

The IO must submit a document called the Animal Welfare Assurance of Compliance Statement to OLAW. •This document, usually referred to as the PHS Assurance, describes the institution's program for the care and use of animals. •The IACUC has the responsibility to prepare an annual report for OLAW to show compliance with PHS Policy.

The use of animals in research is heavily regulated at the federal level and by state and local agencies. All individuals who work with laboratory animals should be aware of and comply with the regulations and guidelines of the field. This chapter describes some of the most important regulations and guidelines that affect a laboratory animal technician's daily duties

These mandates are: 1.Guide for the Care and Use of Laboratory Animals (often referred to as the Guide) 2.Animal Welfare Act and the Animal Welfare Regulations 3.Public Health Service Policy 4.US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training 5.American Veterinary Medical Association Guidelines on Euthanasia

USDA Animal and Plant Health Inspection Service (APHIS) is

charged with administering and enforcing the AWR. •To ensure compliance, an APHIS inspector conducts unannounced site visits at least annually to inspect the facility. •The inspector looks at the animal species covered under the AWA and the relevant animal records. • The inspector also reviews the IACUC's semi-annual facility inspection reports and the records of its program reviews. •The inspector then issues a report. •Any violation noted on the inspector's report must be corrected. The USDA has the authority to stop the research being conducted at the facility if the violations are not corrected in a timely fashion. The APHIS inspectors' reports are available to the general public in accordance with the federal law called the Freedom of Information Act (FOIA).

1985 amendment to the AWA requires

each registered institution have an Institutional Animal Care and Use Committee (IACUC). The amendment states that this committee is responsible for ensuring that animal care at the facility conforms to the AWR. Over time, the IACUC has become responsible for ensuring that the animal research program is in compliance with all applicable laws, regulations, policies, and guidelines. According to the AWR, the IACUC must have a chairman and at least two other members. •One member must be a veterinarian with experience in laboratory animal care. •Another member must be a public member and represent the community. The public member cannot be affiliated with the facility. •No more than three of the members may be from the same administrative unit. •The IACUC membership must also include a practicing scientist experienced in research involving animals. The IACUC reports to a senior administrator known as the Institutional Official (IO), sometimes known as the Chief Executive Officer (CEO). The IO must have the authority to provide resources to ensure compliance. The IACUC oversees and evaluates the animal care and use program at the institution. It reviews the methods of animal care in all animal study protocols, and verifies that the methods are appropriate and in compliance with federal regulations and institutional policies. The IACUC must perform semi-annual inspections of the facility and report its findings to the IO. The report advises the IO of the facility's compliance or the plan and timetable for any necessary corrective actions. The report also makes recommendations regarding the animal care program.

requirements of the AWA and AWR

•Register with the USDA. •Appoint an Institutional Animal Care and Use Committee to oversee the animal care and use program. •Provide training for all animal technicians and animal users. •Maintain individual animal records, including their source and use. •Show that they provide adequate housing for each species and meet requirements for housing dimensions and environmental controls. • Meet or exceed the sanitization standards for the cages and the facility. •Provide adequate veterinary care. •Provide dogs with the opportunity to exercise. •Provide psychological enrichment to nonhuman primates. •Provide for the relief of animal pain and distress. •Consider alternatives to experiments likely to cause pain and distress. •Perform no more than one major surgery on an animal unless scientifically justified or medically necessary. •Submit an annual report that includes the number of covered species used and the "pain category" under which they were used

PHS Policy on Humane Care and Use of Laboratory Animals is another federal mandate that applies to federally funded research projects. The PHS Policy requires institutions to ensure the appropriate care and use of all animals involved in PHS-conducted or supported research.

•The PHS Policy covers all live vertebrates used or intended for use in research, research training, experimentation, biological testing, or for related purposes. •Note that the birds, rats and mice bred for research that are not covered under the AWA are covered under the PHS Policy. •Cold-blooded vertebrates such as fish, amphibians, and reptiles are also covered by the PHS policy