RegsPolicies&PrinciplesGoverningCare&UseLab Animals (2).ppsx

Regulations, Policies, and Principles Governing the Care and Use of Laboratory Animals Overview Numerous regulations, policies and guidelines impact the care and use of animals in research, teaching and testing. Institutions involved in animal use must follow federal regulations such as: The Animal...

Regulations, Policies, and Principles Governing the Care and Use of Laboratory Animals Overview Numerous regulations, policies and guidelines impact the care and use of animals in research, teaching and testing. Institutions involved in animal use must follow federal regulations such as: The Animal Welfare Act and Animal Welfare Regulations Public Health Service Policy on Humane Care and Use of Laboratory Animals Other regulations, policies, guidance documents and organizations, where applicable THE ANIMAL WELFARE ACT Animal Welfare Act (AWA) and Animal Welfare Regulations (AWR) Passed in 1966, the AWA was initially named the Laboratory Animal Welfare Act. It is the first law that regulated the sale, transport, and handling and protected nonfarm animals in the United States. It has been amended multiple times, most recently in 2018. Its requirements are set forth under Regulations and Standards in the Code of Federal Regulations. – Title 9, Chapter 1, Subchapter A – Animal Welfare AWA The US Department of Agriculture (USDA) is responsible for the administration and enforcement of the AWA. Within the USDA, this responsibility has been delegated to the Animal Care Program of the Animal and Plant Health Inspection Service (APHIS). USDA periodically issues Animal Care Policies to clarify intent and performs unannounced inspections at least annually. Animal Welfare Act Regulations apply to: – Animal research facilities – Animal dealers and exhibitors – Operators of animal auction sales – Carriers and transporters of animals  Must be licensed and/or registered by the USDA Retail pet stores are exempt – unless they sell animals to a research facility or a wholesale dealer. Animal Welfare Regulations (AWR) Regulations describe: – Humane handling of animals – Care – Identification – Recordkeeping – Treatment – Transportation AWR Mandatory minimal care standards were developed for dogs, cats, guinea pigs, hamsters, rabbits, nonhuman primates and marine mammals including: – Feeding and watering – Sanitation – Lighting and ventilation – Shelter from extremes of weather – Separation of species – Adequate veterinary care Animal Welfare Not covered by Act regulations – Birds, mice and rats specifically bred for research, teaching or testing – Horses not used for research purposes – Farm animals intended for use in improving:  Animal nutrition  Breeding  Management or production efficiency  Quality of food or fiber Laboratory Animal Welfare Act Original Act of 1966 Known as the Laboratory Animal Welfare Act Intended primarily to protect owners of dogs and cats from theft of their pets although hamsters, guinea pigs, rabbits and nonhuman primates were also mentioned The law required licensure of individuals or corporations buying and selling these animals as laboratory animals only if the animals were transported across state lines. Organizations that used dogs or cats in biomedical activities were required to register with the USDA if they received federal funding or purchased dogs or cats transported across state lines. This legislation applied only to animals being held before or after actual research and testing but not during their use. Animal Welfare Act (AWA) 1970 Amendment (Public Law (PL) 91‐579) Laboratory Animal Welfare Act was renamed the Animal Welfare Act (AWA) and amended to include all warm‐blooded laboratory animal species. Oversight was extended to intra‐ as well as interstate transportation of animals. Standards of care were extended to include the entire time animals are present in a research facility. Research facilities were also required to file an annual report which is still required to be submitted today: – Listing the number of animals used or held for research – Stating if the animals required or received anesthetics, analgesics or tranquilizers Animal Welfare Act 1976 Amendment (PL 94‐279) Redefined the regulation of animals during transportation – All carriers and intermediate handlers who were not required to be licensed under the AWA were required to register with the USDA Prohibited most animal fighting activities Regulations now specifically excluded rats & mice bred for use in research, Animal Welfare Act 1985 Amendment (PL 99‐198) “Improved Standards for Laboratory Animals Act” major changes to AWA Institutional Animal Care and Use Committee (IACUC) and Animal Welfare Information Center established Guidelines and requirements for: – Surgical (survival) procedures  Aseptic technique required  Multiple survival surgeries must be justified – Mandatory training of all personnel handling animals IACUC The IACUC is charged to act as an agent of the research facility to assure compliance with the AWA. Minimum of three members including: – DVM/VMD with experience in lab animal medicine – One “public member” not affiliated with the institution Inspect all animal facilities and study areas every 6 mos – To assure that the care and use of animals comply with regulations and standards; includes review of the institution's formal program of veterinary care Report findings to the research facility’s Institutional Official Investigate concerns involving care and use of research animals raised by members of the public or by animal care or research personnel Review and approve all proposed activities (protocols) IACUC Protocols (for research, teaching and product testing) must provide: – Species and approximate number of animals to be used – Rational for numbers and appropriateness of species – Detailed description of animal use – Description of procedures and drugs used to assure that discomfort and pain will be limited  Must provide assurance that animal discomfort, pain or distress will be avoided or minimized  Consultation with a veterinarian is required in planning any procedure that could cause pain to animals. – Description of the euthanasia method to be used – The principal investigator (PI) of the protocol must also assure the committee that the proposed work does not unnecessarily duplicate previous Animal Welfare Act 1990 Amendment (PL101‐624) “Protection of Pets” Mandated that animal pounds and shelters, public or private, hold all dogs and cats for a minimum period of 5 days (not including the day of acquisition) before euthanizing or releasing the animal to a Class B USDA‐ licensed dealer Animal Welfare Act 2002 Amendment (PL 107‐171) “Farm Security and Rural Investment Act” Changed the definition of “animal” –To specifically exclude birds, rats of the genus Rattus and mice of the genus Mus bred for research Addressed animal fighting (misdemeanor) 2007 Amendment (PL 110‐22) “Animal Fighting Prohibition Enforcement Act” Made violation of the animal fighting provisions of the AWA a felony, punishable by up to 3 years in prison Made it a felony to trade, sell or ship select equipment designed for use in animal fighting, or to promote an animal fighting venture Animal Welfare Act 2008 Amendment (PL 110‐246) “Food, Conservation and Energy Act” Strengthens definitions of and penalties for animal fighting activities Limits the transport and resale of dogs to animals that are least 6 months old, are in good health and that have all necessary vaccinations – Exemptions exist for research, veterinary treatment or imports into Hawaii from certain countries Animal Welfare Act 2014 Amendment (PL 113-79) “Agricultural Act” Imposes criminal penalties for attending animal fighting exhibitions or for causing a minor individual to attend Established a new ‘de minimis’ standard applicable to the entire AWA giving APHIS new discretionary authority to exclude licensing and registration requirements for animal dealers and exhibitors “if the size of the business is determined by the Secretary to be ‘de minimis’ (too trivial or minor to merit consideration)” so that APHIS could “focus its limited resources on situations that pose a higher risk to animal welfare and public safety” Animal Welfare Act 2018 Amendment (PL 115-334) “Agriculture Improvement Act” Extends the federal ban on animal fighting to US territories, in addition to US states (Parity in Animal Cruelty Enforcement (PACE) Act) Prohibits the slaughter of dogs and cats for human consumption and sets a $5,000 fine for each violation (Dog and Cat Meat Trade Prohibition Act) Expands domestic violence protections to include pets and directs USDA to make grants to provide temporary housing opportunities for domestic violence victims to shelter with their pets (PAWS Act) Animal Welfare Act Review Animal research facilities, animal dealers and exhibitors, operators of animal auction sales, and carriers and transporters of animals must be licensed and/or registered by the USDA. Retail pet stores are exempt unless they sell animals to research facility or wholesale dealer. AWA – Review A USDA veterinary medical officer performs unannounced compliance inspections at least annually: – Inspections include assessment of facilities, husbandry practices, programs of veterinary care, records and animal handling procedures. – Reports to the USDA of a suspected violation can trigger a visit “for cause”. To further clarify the intent of the AWA, and to help maintain consistency in application of the regulations, the USDA periodically issues Animal Care Policies https://www.aphis.usda.gov/aphis/ourfocus/animalwelfare/ Animal Welfare Regulations (AWR) Interprets the AWA into enforceable standards Describe: – Humane handling of animals – Care – Identification – Recordkeeping – Treatment – Transportation AWR - Review Mandatory minimal animal care standards are provided for select species (dogs, cats, guinea pigs, hamsters, rabbits, nonhuman primates and marine mammals) that address: – Feeding and watering – Sanitation – Lighting and ventilation – Shelter from extremes of weather – Separation of species – Adequate veterinary care Medical records must: – Be current, legible and sufficiently comprehensive to demonstrate delivery of adequate health care. – Be held for at least one year after an animal's disposition or euthanasia/death Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) PHS Policy The Health Research Extension Act of 1985 provides the legislative mandate for the PHS Policy. PHS Policy applies to: – Use of all live vertebrate animals in research and other biomedical activities – Wholly or partially funded by the US Public Health Service (PHS) agencies or US Department of Health and Human Services components – Activities performed at an institution with an Animal Welfare Assurance, regardless of the source of funding Governmental body, organizationally positioned within the National Institutes of Health (NIH), that is responsible for interpreting Office of and implementing the PHS Laboratory Animal Policy and evaluating whether Welfare (OLAW) institutions are in compliance Provides instruction to institutions and researchers who receive PHS support OLAW and PHS Policy PHS Policy –Institutions must submit an Animal Welfare Assurance document to OLAW: Describing the program of animal care and use Assuring commitment to following the “US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training” (US Government Principles), https://olaw.nih.gov/policies‐laws/phs‐ policy.htm#USGovPrinciples) and complying with the PHS Policy, the Guide for the Care and Use of Laboratory Animals (the Guide; ILAR, 2011) and the AWR Voluntary accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International) is suggested as it strongly demonstrates this commitment. Listing names, position titles and credentials of IACUC members PHS Policy Requirements IACUC must have a minimum of five members, including: – DVM with lab animal training or experience – Practicing scientist experienced in research involving animals – Nonscientist – Individual not affiliated with the institution IACUC must conduct de novo (anew) review of animal use protocols at least once every 3 years Institutions must have an occupational health program to safeguard the health of individuals associated with the conduct of animal research PHS Policy Requirements Institutions must: – Provide instruction on the responsible conduct of research – Establish a mechanism for the semiannual review of animal facilities and procedures for conformance with the Guide – Provide OLAW with an annual update to their Animal Welfare Assurance document, describing any changes to their animal care and use program, including changes in select personnel (e.g., IO, IACUC members) https://olaw.nih.gov/guidance/topic‐index/animal‐ welfare.htm Other Regulations, Policies, Guidance Documents and Organizations Guide for the Care and Use of Laboratory Animals Published by the Institute for Laboratory Animal Research (ILAR) in 1963 and last updated in 2011 Assists institutions in caring for and using animals in ways judged to be scientifically, technically and humanely appropriate Assists investigators in fulfilling their obligation to plan and conduct animal experiments in accord with the highest scientific, humane and ethical principles The Guide defines laboratory animals as “any vertebrate (e.g., traditional laboratory animals, farm animals, wildlife and aquatic animals) used in research, testing, or education.” Guide for the Care and Use of Laboratory Animals Outlines and references major components of the animal care and use program: –Institutional policies and responsibilities –Animal housing and environment –Management –Veterinary medical care –Physical plant –Personnel qualifications and training –Occupational health and safety of personnel –Preventative medicine –Surgery and postsurgical care –Euthanasia Guide for the Care and Use of Laboratory Animals Unless otherwise justified, euthanasia method must be consistent with AVMA Guidelines for Euthanasia. The Guide's recommendations carry the force of law based on the Health Research Extension Act passed by Congress in 1985. Encourages programs to adhere to: – US Government Principles – PHS Policy – Other applicable federal, state and local laws, regulations, and policies Emphasizes use of performance-oriented standards – Directs user to achieve a goal – Does not specify method to reach the goal Guide for the Care and Use of Agricultural Animals in Research and Teaching The Ag Guide - first published in 1988 and last updated in 2010 Maintained by a joint committee of the American Dairy Science Association (ADSA), the American Society of Animal Science (ASAS) and the Poultry Science Association (PSA) Supplements applicable federal & state laws, regulations and policies, and the “Guide” –Agricultural animals used in research or teaching It is science-based and provides guidelines for husbandry, veterinary care, facility construction and maintenance and for institutional policies for agricultural animals. Guide for the Care and Use of Agricultural Animals in Research and Teaching Endorses the US Government Principles and emphasizes the use of performance‐oriented standards in place of more rigid and less‐adaptable engineering standards Not intended to pertain to animals produced on farms and ranches for commercial purposes AAALAC International uses the Ag Guide for relevant program assessment and accreditation purposes. https://www.asas.org/ag_guide_3rded/HTML5/ind ex.ht Good Laboratory Practice Regulations (GLP) Provide framework for performing high-quality, welldocumented, and repeatable safety studies – Food and Drug Administration (1978) – Environmental Protection Agency (1983) – Both the FDA and the EPA have the legal authority to inspect study records and the facilities where studies are conducted. Specifically address and define standards for research facilities engaged in product safety testing designed for human and veterinary applications Important components – Quality assurance – Adherence to standard operating procedures – Extensive recordkeeping Chimpanzee Health Improvement, Maintenance and Protection Act CHIMP Act (PL 106‐551) of 2000 – Created a sanctuary retirement system for chimpanzees previously used, bred, or purchased for use in medical research supported by the agencies of the federal government – Also mandates that standards of care for chimpanzees in the sanctuary be developed to ensure the well‐being and the health and safety of the chimpanzees – originally contained a clause that allowed, under special circumstances, further use of the chimpanzees in research – That portion of the original law was repealed by the passage of the Chimp Haven is Home Act (PL 110‐170) in December 2007 – Removal of chimpanzees from the sanctuary system for all research purposes, except for noninvasive behavioral studies, is prohibited – Chimp Haven in Louisiana selected as sanctuary The 21st Century Cures Act (PL 114–255) - became law in December 2016 Intended to reduce unnecessary, inconsistent, overlapping, or duplicative policies and regulations that hinder the conduct of animal In part “to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently ???? Animal Welfare Information Center (AWIC) Part of the USDA National Agricultural Library Mandated by 1985 AWA amendment to provide information on improved animal care and use in research, teaching and testing Provides specific information on employee training and identification of improved research methods that could reduce or replace animal use and minimize pain and distress to animals Assists with literature searches designed to identify animal alternatives and prevent unintended duplication of animal experimentation Provides educational opportunities through workshops, publications, and public exhibits https://www.nal.usda.gov/awic State Regulations All 50 states and the District of Columbia have laws that protect animals. Some states have public health and agriculture regulations that specifically cover animals used in research. Also, several states, cities and towns regulate the release of impounded animals for research as well as the adoption of retired research animals. Most animal laws address: – Prevention of cruel treatment – Provision of food and water – Provision of shelter and protection from extreme weather Assessment and Accreditation of Laboratory Animal Care, International (AAALAC Nonprofit organization International) established in 1965 Promotes the humane treatment of animals in science – Encourages high standards of animal care, use, and well-being through use of voluntary accreditation and assessment programs AAALAC‐accredited institutions are now present in over 47 countries worldwide. Supported by over 60 prestigious member organizations (delegate from each are advisors) AAALAC International AAALAC accreditation – Voluntary – Considered “gold standard” of industry Institution prepares program description and performs self-assessment Site visits – Occur once every 3 years – Performed by council members and consultants – Council is composed of professionals from around the world with expertise in the fields of veterinary medicine, laboratory animal science and animal research AAALAC International Site visit – Three documents are used in evaluation of animal care and use program Guide for the Care and Use of Laboratory Animals Guide for the Care and Use of Agricultural Animals in Research and Teaching European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes www.aaalac.org Table 2.1. US law, regulation, policy and guidelines for the care and use of animals in research. Document Animals covered Agency Comments Create general and species-specific standards: AWR provide more specific details on how to achieve compliance. Warm-blooded animals, live Animal Welfare Act Require that all research facilities or dead, except birds, rats, (AWA)and amendments establish an IACUC, which must submit an and mice bred for research USDA-APHIS Animal Welfare annual report to USDA-APHIS. Require and agricultural animals used Regulations(AWR) licensing and registration. USDA-APHIS for food or fiber inspectors perform unannounced visits at least once a year. Violations can result in penalties. Live vertebrates used or intended for use in research, Public Health Service Policy Requires all federal grant recipients to research training, on Humane Care and Use comply with the US Principles, the AWA, experimentation, biological OLAW of Laboratory Animals (PHS and the Guide. Requires an IACUC and an testing, or for related Policy) Occupational health and safety program. purposes. Includes rats, mice, and birds. Presents overarching principles for the US Government Principles humane care of animals in these for the Utilization and Care All vertebrates, includes rats, activities and the relevance of animal use of Vertebrate Animals used mice , birds, farm animals, OLAW to the good of Society. Covers humane in Testing, Research, and wild life, and aquatic animals transportation, minimization of Training(US Government discomfort, appropriate husbandry, and Principles) methods of euthanasia. Provides guidelines and standards for a variety of areas such as justification for species and number used, availability of National Research less-invasive alternatives, training of Guide for the Care and Use All vertebrates. Includes rats, Council (NRC); Institute personnel, anesthesia and analgesia, of Laboratory Animals (the mice, birds, farm animals, of Laboratory Animal euthanasia and disposal of animals, and "Guide") wild life and aquatic animals. Research (ILAR) 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. Applies to nonclinical studies (safety data) in support of applications to the Does not cover specific FDA for food or drug research or Good Laboratory Practice animal species but is directed FDA and EPA marketing permits or to EPA for research Regulations (GLPs) to the type of research or marketing permits for pesticides and conducted. toxic products. Requires staff training and