Orientation to the Use of Laboratory Animals at Touro University--California Joanne R. Blum, DVM, DACLAM Advanced Bioresources Inc. 7/9/2013
Laws, Policies and Standards Affecting the Care and Use of Animals International CITES (Convention on International Trade in Endangered Species of Wild Fauna and Flora) Export/Import and transportation regulations
Laws, Policies, and Regulations Affecting the Care and Use of Animals Federal level two primary regulatory documents: USDA s Animal Welfare Act Note: Currently Touro University-California (TU-C) is NOT a USDA registered research facility as there are no USDA regulated species in use at this site. ILAR Guide for the Care and Use of Laboratory Animals Note: Currently Touro University-California is mandated to abide by the Guide as the institution does receive federal funding for some animal research being conducted on site.
Federal Animal Welfare Act Laboratory Animal Welfare Act Established in 1966 Now known as Animal Welfare Act Established environmental, housing, and care requirements for USDA regulated species Mandates a minimum of once a year inspection of USDA registered facilities
Federal Animal Welfare Act Administered by USDA A regulated animal is currently defined as: any live or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or any other warm-blooded animal, which is being used for research, teaching, testing, experimentation...
USDA Excluded Animals Mice (Genus Mus) Rats (Genus Rattus) Birds (Poultry) Horses and livestock used for agricultural research purposes
Federal Animal Welfare Act USDA inspectors Must be given access to facility Given opportunity to document or photograph areas of noncompliance Can confiscate animals and/or call for police backup if facility is nonresponsive
Federal Animal Welfare Act Penalty for non-compliance Fines Cease and desist order All inspection reports and correspondence are available to public under Freedom of Information Act (FOIA) and are shared with other federal agencies
Public Health Service (PHS) Policy on the Humane Care and Use of Laboratory Animals In existence since 1971 Intended to ensure that institutions receiving federal funding for animal research care for and use animals humanely Requirements Compliance with ILAR Guide for the Care and Use of Laboratory Animals Institutional Assurance statements and annual reports IACUCs must be established Training and Occupational health program for animal users mandated
ILAR Guide for the Care and Use of Laboratory Animals Basis of compliance with Public Health Service Policy Basis for compliance with California Department of Health Services registered research facility program Major sections: Institutional Policies and Responsibilities Animal Environment, Housing and Management Veterinary Medical Care Physical Plant
ILAR Guide...laboratory animals include any vertebrate animal (e.g., traditional laboratory animals, farm animals, wildlife, and aquatic animals) used in research, teaching, or testing.
ILAR Guide The Guide does not specifically address: farm animals used in agricultural research or teaching wildlife and aquatic animals studied in natural settings invertebrate animals
Public Health Service (PHS) Policy on the Humane Care and Use of Laboratory Animals Penalty for noncompliance if PHS Assured Institution such as TU-C Revocation of Assurance Loss of PHS funding for entire institution Penalty for noncompliance if registered with California Department of Health Services Legal action resulting in fines and/or other penalties such as revocation of right to use/house research animals
Laws, Policies, and Regulations Affecting the Care and Use of Laboratory Animals Other Federal Agencies affecting research animal care and use: Drug Enforcement Administration (DEA) Note: TU-C is registered with DEA Food and Drug Administration (FDA) Note: TU-C does NOT currently conduct GLP studies Centers for Disease Control and Prevention (CDC) Note: TU-C does NOT currently conduct studies involving CDC regulated agents
Drug Enforcement Administration (DEA) Regulates research facilities using, storing and disposing of Scheduled drugs Schedules I V (most abusive to least abusive) Many of the anesthetics and analgesics used on animals are regulated substances Most regulated drugs marked with capital C (for federally Controlled) surrounding I, II, III, IV or V Requires licensing, recordkeeping and allows for inspections to assure compliance
Laws, Policies and Standards Affecting the Care and Use of Laboratory Animals Food and Drug Administration (FDA) Sets standards for testing of foods, drugs, other chemicals and medical devices Requires animal testing for toxicity or carcinogenicity Extensive documentation and quality assurance procedures Good Laboratory Practice Regulations (GLPs)
Centers for Disease Control and Prevention (CDC) Provides oversight for infectious/biohazardous substances Sets standards for packaging of materials containing etiologic agents and interstate shipment of certain agents
Laws, Policies and Standards Affecting the Care and Use of Animals State California Department of Health Services Requires registration of research facilities that utilize mice, rats or birds and are not registered with the USDA or PHS assured Regulates importation of nonhuman primates into state
Laws, Policies and Standards Affecting the Care and Use of Laboratory Animals State California Department of Fish and Game Regulates importation of prohibited species into the state Requires special permits to house and use prohibited species Sets standards for housing and use of prohibited species Requires inspections to assure compliance Note: TU-C is licensed to house/use Xenopus laevis
Laws, Policies and Standards Affecting the Care and Use of Animals Local County and city ordinances/agencies Dictate animal carcass and regular as well as hazardous waste disposal Regulate building and use permits institutions MUST be licensed to house/use research animals Can inspect to assure compliance with Fire Codes and other city/county ordinances
Laws, Policies and Standards Affecting the Care and Use of Animals Institutional Standard Operating Procedures, Guidelines and Policies TU-C requires orientation training for all personnel entering/using the animal facility Includes Rodent Surgery Guidelines established by TU-C No photography allowed unless prior approval from IACUC has been granted Only trained, authorized personnel allowed access to the vivarium Policy on Reporting Animal Care and Use Concerns
Laws, Policies and Standards Affecting the Care and Use of Laboratory Animals Other Standards AVMA Panel on Euthanasia
Partners in a Quality Animal Care and Use Program Institutional Official (IO) IACUC Attending Veterinarian Principal Investigator Everyone! Foundation of an Institution s Compliance Program
Role of the Institutional Official Legal representative of the institution with ultimate authority of the animal care and use program CEO or President of institution or their appointed designee Be informed about the animal care and use program Provide sustained and visible support Assure allocation of sufficient monetary and personnel resources to ensure compliance with applicable rules and regulations, provide for education of employees Influence institutional priorities
Role of the Institutional Official (IO) Appoints Institutional Animal Care and Use Committee (IACUC) to oversee the animal care and use program, assists in developing plans to correct program deficiencies and to address concerns that may arise regarding animal care and use Regulatory documents (e.g., animal welfare Assurance, reports of noncompliance) are submitted by the IACUC through the IO and must bear his/her signature as the official responsible for animal welfare
The Institutional Animal Care and Use Committee (IACUC) The establishment of IACUCs is mandated by: USDA Animal Welfare Act Public Health Service Policy on the Humane Care and Use of Laboratory Animals ILAR Guide for the Care and Use of Laboratory Animals
IACUC Membership: Public Health Service Policy A minimum composition of 5 members Chairperson Veterinarian with training or experience in laboratory animal science and medicine Public member not otherwise affiliated with the institution Practicing scientist with experience in animal research Person whose primary concerns are in a nonscientific area One person may fulfill more than one of the above requirements but must have at least five members
IACUC Functions IACUC is charged with reviewing and approving, requiring modifications in (to secure approval) or withholding approval of animal care and use activities (protocols) or changes to previously approved animal activities (amendments) IACUC MUST approve of all procedures prior to initiating animal studies Written notification must be provided by the IACUC to the principal investigator of decisions on protocol submissions
Protocols Further Review Proposed activities and proposed changes in ongoing activities that have been approved by the IACUC may be subject to further review and approval by institutional management the IO MAY overrule IACUC approval of animal research related activities Institutional Officials may NOT approve of an activity involving the care and use of animals if it has not been approved by the IACUC
ILAR Guide Protocol Review Topics Rationale and purpose of proposed animal use Justification of species and numbers of animals Availability and appropriateness of alternatives Adequacy of training and experience of personnel Unusual housing and husbandry requirements Appropriate sedation, analgesia, and anesthesia Avoidance of unnecessary duplication of experiments
ILAR Guide: Protocol Review Topics Criteria and process for timely intervention, removal of animals from a study or euthanasia Conduct of major survival surgical procedures Post procedural care Method of euthanasia and disposal of animals Safety of working environment for personnel
Alternatives Protocols must include a written narrative description of the methods and sources used to determine that alternatives to procedures that may cause more than momentary or slight pain or distress to the animals have been considered by the principal investigator Principal investigators must provide written assurance that the activities do not unnecessarily duplicate previous experiments
Alternatives Protocols must address the 3 R s Replacement Reduction Refinement
Replacement The substitution of insentient material for conscious, whole, living, phylogenetically-higher animals e.g., use computer simulation rather than animal; use cell culture rather than an animal
Reduction Decreasing number of animals used to obtain information Strategies Use statistics to determine appropriate animal numbers Use quality animals and methods so research does not require unnecessary repetition Maximize use of any one animal (Within humane limits)
Refinement Utilizing methods that minimize the level of pain or distress experienced by experimental animals Assuring use of the most advanced techniques/procedures Assure personnel are appropriately trained in the proper handling and use of the species they are working with in research
Protocols Suspensions IACUCs may suspend previously approved activities if it determines that the activity is not being conducted in accordance with the approved protocol specifications Suspensions must be reported to the Institutional Official and, after review and possible corrective actions, the suspension must be reported to USDA and other federal agencies, as applicable Noncompliance with the IACUC approved protocol procedures, or conducting procedures without prior IACUC approval is reportable to regulatory agencies and may result in a loss of the privilege to use animals in research
IACUC Functions Inspect all animal facilities at least once every 6 months Areas where animals are housed >12 hours Animal housing and support areas Cagewash Procedure areas Non-survival surgeries Laboratories Rodent surgeries
IACUC Functions Review animal care and use program at least once every 6 months IACUC membership and functions IACUC records and reporting requirements Veterinary care Personnel qualifications and training Occupational health and safety of personnel
IACUC Functions Prepare reports and make recommendations to Institutional Official regarding any aspect of the facility s animal program, facilities or personnel training Review complaints/concerns involving animal care and use Reporting policy is posted in vivarium, along with current contact information
Reporting Procedures Regarding Concerns About the Touro University-California Vivarium and Practices Within This vivarium facility, the medical research conducted within it, and all other aspects of the care and use of animals on campus are overseen by the Touro University- California, Institutional Animal Care and Use Committee (TU-C IACUC) that includes members of the scientific faculty, a consulting veterinarian and a member representing the general interests of the community. If anyone has any concerns regarding the standards of the facility or the care and use of animals at this institution, they are requested to notify (anonymously, if so desired) the chair of the TU-C IACUC or the TU-C Institutional Official.
Role of the Attending Veterinarian Regulatory agencies require that the Attending Veterinarian have direct or delegated authority for activities involving animals. Work in concert with the Institutional Animal Care and Use Committee (IACUC) and research staff Assure health care programs for animals Assure adequate anesthesia/analgesia Assure post-procedural care and surgical care Assure proper euthanasia Oversee husbandry and facilities Assure compliance with applicable rules and regulations
Role of the Principal Investigator (PI) Plan research in the context of quality animal care Accept responsibility Know the regulations Cooperate with the IACUC Ensure protocols are current and accurate Ensure staff are trained/qualified and compliant and have training files for all individuals involved in the care and use of animals on their protocols Maintain adequate records/documentation of research activities
Role of the Research Staff Read and follow all IACUC protocol procedures, standard operating procedures and vivarium practices Assure appropriate training in conducting all husbandry and research activities involving animals Maintain appropriate records that document training, procedure and vivarium activities
Laws, Policies and Standards Affecting the Care and Use of Animals Research utilizing animals is a privilege, not a right. Institutional Animal Care and Use Committee approval must be granted prior to utilizing animals in research or making changes to a previously approved protocol... A single incident of serious non-compliance with animal welfare regulations or guidelines can jeopardize the entire institution s privilege of conducting animal research. Say what you do and do what you say
Health and Safety Concerns in the Vivarium Physical hazards Animal bites; Needle sticks; Ergonomic issues; Slips/Trips Chemical hazards Cleaning agents; Experimental drugs; Anesthetics Biological hazards Animal allergens; Experimental agents (e.g., tumor cell lines); Zoonotic agents
General Safety in the Vivarium Vivarium is a restricted access facility authorized entry for trained personnel only Wear proper PPE (personal protective equipment) Gloves whenever handling animals or animal equipment Latex gloves for handling aqueous solutions and blood/serum Chemical resistant gloves (i.e., nitrile) as needed No open toed shoes allowed in vivarium Develop good work habits.clean up BEFORE and AFTER you do work in vivarium
General Safety in the Vivarium Know location of emergency contact numbers posted in vivarium Report any workplace concerns or risks to your supervisor ALWAYS wash hands after handling animals/animal equipment Assure you are properly trained to perform tasks No eating or drinking or applying cosmetics or adjusting contact lenses in vivarium or when working with animals in labs
Physical Hazards in the Vivarium Animal bites/scratches Learning proper handling/restraint of animals is key to prevention Assure current tetanus vaccination prophylaxis Report any injuries to your supervisor and seek medical assistance Needle sticks Never recap needles Use proper sharps disposal containers Do NOT overfill sharps disposal containers
Physical Hazards in the Vivarium Ergonomic issues Heavy equipment, bags of feed/bedding Practice proper lifting; ask for assistance Slips/trips One of most frequently reported hazards in workplace Use caution around wet floors
Chemical Hazards in the Vivarium All chemicals used in the vivarium should have MSDS (material safety data sheets) in vivarium binder that detail toxicity data, how to treat exposures Assure proper use of chemicals read labels and follow instructions for proper storage, handling, dilution and disposal Assure proper labeling of secondary container list chemical agent, dilution/concentration, date of expiration
Chemical Hazards in the Vivarium Assure proper maintenance of inhalant anesthesia machines discard charcoal canisters (e.g., Vaporguard or F-AIR ) when they weigh 50 grams over starting weight Wear proper PPE (personal protective equipment) such as eye protection, gloves, lab coats when using chemicals Know location of emergency showers and eye wash stations and how to use them
Biological Hazards in the Vivarium Animal allergens 10 to 40% of staff in contact with animals will develop allergies with symptoms of runny nose, eye irritation, hives up to asthma and, rarely, anaphylaxis Source of allergens: proteins excreted in saliva, urine, and glands associated with animal s skin Exposure through inhalation or direct skin or eye contact Practice exposure control to reduce risk of developing allergies to lab animals practice prevention!
Exposure Controls for Animal Allergens Maintain clean environment Wear appropriate PPE (personal protective equipment) gloves and lab coat at a minimum face masks or respirators, hair bonnets, shoe covers may be needed; remember, you can carry animal hair and other allergenic proteins from animals on your hands/clothing/shoes ALWAYS wash hands after handling animals/leaving the vivarium Seek medical attention for any allergy symptoms
Animal User Occupational Health Program All animal users should participate in the animal user occupational health program Complete baseline medical questionnaire Always alert your supervisor and seek medical care for any allergy symptoms, animal bites/scratches or other injuries or any health concerns
Biological Hazards in the Vivarium Zoonotic diseases Some bacteria, fungal and parasitic organisms can be transmitted from animals to humans and vice versa Wear appropriate PPE (personal protective equipment) such as gloves and lab coats when handling animals/animal equipment ALWAYS wash hands after handling animals/animal equipment Report any injuries/wounds and seek medical assistance
Biological Hazards in the Vivarium Biological materials (e.g., tumor cell lines) used in some research studies may pose a risk Personnel handling any human biologic materials should have current blood borne pathogen training, have Hepatitis B vaccination, and practice Universal precautions Wear appropriate PPE (personal protective equipment) such as gloves, eye protection, lab coats Practice safe work habits: No recapping of needles, proper sharps disposal, clean work environment and ALWAYS wash hands after handling materials
Touro University-California Vivarium Know and understand applicable rules, regulations and policies Comply with procedures as described in the IACUC approved protocols Ensure proper training on all applicable aspects of animal handling and husbandry, experimental manipulations, facility and equipment sanitation Use proper chemical handling, storage, use and disposal practices For any concerns or when in doubt ASK!