“Well-trained and motivated personnel can often ensure high-quality animal care.…”

Training “hits” 64 Guide for the Care and Use of Laboratory Animals 36 Institutional Administrator’s Manual for Laboratory Animal Care and Use 35 Institutional Animal Care and Use Committee Guidebook 22 Biosafety in Microbiological and Biomedical Laboratories 17 Guidelines for Research Involving Recombinant DNA Molecules 3 PHS Policy on Humane Care and Use of Laboratory Animals 7 Animal Welfare Regulations, 9CFR, Part 3

AAALAC identified training deficiencies (mandatory/suggestion) Year IACUC OHSP Personnel 1998 9/6 3/2 1/1 1999 10/5 4/6 1/4 2000 5/4 7/3 0/4 2001 4/0 4/5 5/3 2002 3/3 4/2 1/4

Many deficiencies and suggestions for improvement in other areas are related to inadequate training.

Institutions should develop and embrace a culture of training, inclusive of administrators, compliance staff, IACUC, veterinary staff, animal care staff, and research staff.

The AAALAC International Program Description Describe the training, certification level and type, and experience of animal care personnel. Describe the continuing education opportunities provided to animal care personnel.

The AAALAC International Program Description Describe the personnel training for specific procedures: use of hazardous agents in animals educational program(s) to inform personnel about zoonoses, personal hygiene and other occupational health and safety considerations

The AAALAC International Program Description Describe the personnel training for specific procedures: training and experience of personnel performing surgery training and experience required to perform anesthesia training and experience of personnel carrying out euthanasia procedures

Animal care staff Husbandry personnel Supervisory personnel Management personnel

Animal care staff Veterinarians Veterinary technicians Surgical technicians and support staff

Animal care staff Technical support staff Research staff providing husbandry

Assignments may be specific, or one person may wear many hats.

Types of animal care programs Large versus small Focused versus diverse

Training requirements Regulations and guidelines Specific species training Specific task training

Continuing education/retraining important.

Mechanisms to implement training Condition of employment Prior to facility/animal access

Training development/documentation Training coordinator Facility management Veterinary staff Other specialists (biosafety officer, etc.)

Regulations/guidelines/ animal welfare basics Web-based training Generic (VA, etc) Institution specific Seminars Publications Videotapes

Specific species/task training AALAS classes and certifying exams (ALAT, LAT, LATG). AALAS Certified Manager of Animal Resources (CMAR) exams. Institute for Laboratory Animal Management (ILAM) educational program and certification.

Specific species/ task training Web based training Textbooks, videos Training manuals, SOPs On job training

A combination of methods often helps reinforce training and accommodates different types of learners.

Continuing education/retraining National, district and branch AALAS meetings. Other professional meetings and sponsored seminars (AAALAC, LAMA, SCAW, etc). Reviewing SOPs. Reviewing web-based training.

Case studies Immune compromised mice housed in sterile microisolator cages being changed by animal facility personnel on open bench. Animal care staff working in animal rooms in street clothes. Animal care staff dumping cages in dirty cagewash; no dump station in room and no PPE being worn.

Institutional responsibilities “Each institution should establish and provide resources for an animal care and use program that is managed in accord with this Guide and in compliance with applicable federal, state, and local laws and regulations” . . . Guide for Care & Use of Laboratory Animals

Organizational structure: research perspective

Organizational structure: university perspective

IACUC charge “AWRs and PHS Policy require institutions to ensure that people caring for or using animals are qualified to do so.” Guide for Care and Use of Laboratory Animals

Guide recommendations (personnel qualifications and training) There are a number of options for the training of technicians. Many states have colleges with accredited programs in veterinary technology (AVMA 1995); most are 2-year programs that result in associate of science degrees, and some are 4-year programs that result in bachelor of science degrees. Nondegree training, with certification programs for laboratory animal technicians and technologists, can be obtained from the American Association for Laboratory Animal Science (AALAS). There are commercially available training materials that are appropriate for self-study (Appendix B). Personnel using or caring for animals should also participate regularly in continuing-education activities relevant to their responsibilities. They are encouraged to be involved in local and national meetings of AALAS and other relevant professional organizations. On-the-job training should be part of every technician's job and should be supplemented with institution-sponsored discussion and training programs and with reference materials applicable to their jobs and the species with which they work (Kreger 1995). Coordinators of institutional training programs can seek assistance from the Animal Welfare Information Center (AWIC) and ILAR (NRC 1991). The Guide to the Care and Use of Experimental Animals by the Canadian Council on Animal Care (CCAC 1993) and guidelines of some other countries are valuable additions to the libraries of laboratory animal scientists (Appendix B).

Guide recommendations (personnel qualifications and training) There are a number of options for the training of technicians. Many states have colleges with accredited programs in veterinary technology (AVMA 1995); most are 2-year programs that result in associate of science degrees, and some are 4-year programs that result in bachelor of science degrees. Non-degree training, with certification programs for laboratory animal technicians and technologists, can be obtained from the American Association for Laboratory Animal Science (AALAS). There are commercially available training materials that are appropriate for self-study (Appendix B). Personnel using or caring for animals should also participate regularly in continuing-education activities relevant to their responsibilities. They are encouraged to be involved in local and national meetings of AALAS and other relevant professional organizations. On-the-job training should be part of every technician's job and should be supplemented with institution-sponsored discussion and training programs and with reference materials applicable to their jobs and the species with which they work (Kreger 1995). Coordinators of institutional training programs can seek assistance from the Animal Welfare Information Center (AWIC) and ILAR (NRC 1991). The Guide to the Care and Use of Experimental Animals by the Canadian Council on Animal Care (CCAC 1993) and guidelines of some other countries are valuable additions to the libraries of laboratory animal scientists (Appendix B).

Guide recommendations (occupational health & safety of personnel) Personnel should be trained regarding zoonoses, chemical safety, microbiologic and physical hazards (including those related to radiation and allergies), unusual conditions or agents that might be part of experimental procedures (including the use of genetically engineered animals and the use of human tissue in immunocompromised animals), handling of waste materials, personal hygiene, and other considerations (e.g., precautions to be taken during personnel pregnancy, illness, or decreased immunocompetence) as appropriate to the risk imposed by their workplace.

The organizational structure of universities can make compliance challenging IACUC Focus Group

Who trains the trainees?

Training tiers

Administration Research administrator Academic administrator Focus on compliance (regulatory perspective) Interested in education Academic administrator Focus on education Interested in compliance (academic integrity)

Principal investigator Professor Dedicated teacher Dedicated to research Believes in academic freedom Often believes that regulatory compliance is an obstruction to academic freedom

Research staff Laboratory manager Laboratory technicians Empowered by the P.I. Directs day to day operation of the lab Career employee Most knowledgeable of regulations Laboratory technicians Entry level position Frequently have other career aspirations Regulations learned from lab manager or PI Student assistants Gaining experience to increase competitiveness for professional school Need to work Follow directions Least knowledgeable of regulations Met the professor once

Trainees Postdoctoral fellows Graduate students Undergraduate students U.S. citizens & foreign nationals Well trained in research methodologies Highly motivated Moderately knowledgeable of regulations Graduate students U.S. citizens and foreign nationals Focus is on studies Learning the ropes and pushing the limits Marginally knowledgeable of regulations Undergraduate students Want to learn Naïve No knowledge of regulations

Gradients in training exist

Guide recommendations An occupational health and safety program must be part of the overall animal care and use program (CDC and NIH 1993; CFR 1984a,b,c; PHS Policy). The program must be consistent with federal, state, and local regulations and should focus on maintaining a safe and healthy workplace. The program will depend on the facility, research activities, hazards, and animal species involved. The National Research Council publication Occupational Health and Safety in the Care and Use of Research Animals (NRC In press) contains guidelines and references for establishing and maintaining an effective, comprehensive program (also see Appendix A). An effective program relies on strong administrative support and interactions among several institutional functions or activities, including the research program (as represented by the investigator), the animal care and use program (as represented by the veterinarian and the IACUC), the environmental health and safety program, occupational-health services, and administration (e.g., human resources, finance, and facility-maintenance personnel). Operational and day-to-day responsibility for safety in the workplace, however, resides with the laboratory or facility supervisor (e.g., principal investigator, facility director, or veterinarian) and depends on performance of safe work practices by all employees.

Building a culture of compliance Administration IACUC Professors Staff Trainees

Building a culture of compliance: administrative “buy-in” Research Officer & Academic Officers must understand the importance of compliance. IACUC can be instrumental in educating the administration.

Building a culture of compliance: IACUC facilitation IACUC should be knowledgeable of the regulations & responsible for advocating best practices to both administrators and professors. “Educate” rather than “Train.”

Building a culture of compliance: IACUC facilitation

Building a culture of compliance: professorial “buy-in” Let the Professor Teach. “Educate” rather than “Train.”

Building a culture of compliance: encouraging professorial “buy-in” Get the students to ask the Professor to teach a course. “Educate” rather than “Train.”

Building a culture of compliance: encouraging academic administrative “buy-in” Academic affairs will support course development and delivery. “Educate” rather than “Train.”

Building a culture of compliance: closing the loop Use the Chief Academic Officer to gain support of the President “Educate” rather than “Train.”

Take home messages Strict interpretation of the Guide may be not always capture students among those who require training. Goal of training animal users may be accomplished under the academic affairs mission of the university. Resources for training may not have to come from the research office.

Roadmap Why is IACUC training important? What needs to be included in the training? How do we go about training the IACUC? Resources.

Why is IACUC training important? Understand responsibilities and importance of the role of the IACUC. Facilitate conduct of required functions. Ensure checks and balances. Distribute responsibilities in the animal care program. Limit regulatory burden. Enhance interactions with investigators. It is required.

The regulations “It shall be the responsibility of the research facility to ensure that all scientists, research technicians, animal technicians, and other personnel involved in animal care, treatment, and use are qualified to perform their duties…” USDA 2.32(a)

The regulations “… This responsibility shall be fulfilled in part through the provision of training and instructions to those personnel.” USDA 2.32(a)

The Guide “Personnel caring for animals should be appropriately trained … and the institution should provide for formal or on-the-job training to facilitate effective implementation of the program and humane care and use of animals.” The Guide, p. 13

The Guide “It is the institution’s responsibility to provide suitable orientation, background materials, access to appropriate resources, and, if necessary, specific training to assist IACUC members in understanding and evaluating issues brought before the committee.” The Guide, p. 9

Roadmap Why is IACUC training important? What needs to be included in the training? How do we go about training the IACUC? Resources.

What should be included in the training? IACUC Procedures Expectations and responsibilities Description of the Animal Care Program Processes Regulations and Policies Semi-annual review Protocol review Review of concerns Suspend activities Specific Issues Humane Endpoints Pain and Distress Justification of numbers of animals Many others

Roadmap Why is IACUC training important? What needs to be included in the training? How do we go about training the IACUC? Resources.

Approaches to training Orientation On-going E options Publications Conferences Customized workshops

Orientation for new members Overview of requirements and expectations. Provide copies of The Guide, Animal Welfare Act and Regulations, PHS Policy, & US Government Principles. Institutional policies. Institutional protocol form and written description of this process. Review role of the attending veterinarian, IACUC staff, institutional official, and faculty.

A continuous process On-going Review specific requirements for both the IACUC and animal welfare concerns Inspections Environmental enrichment Review institutional policies You should have some They should be reviewed periodically Use scenarios Lab Animal IACUC 101

Electronic materials E options OLAW tutorial grants1.nih.gov/grants/olaw/tutorial/index.htm VA Office of Research and Development www.researchtraining.org www.iacuc.org List-servs: IACUC-Forum, CompMed, IACUC Talk E-newsletters: AMP Digest, NABR E-clips

Publications Lab Animal Contemporary Topics ILAR Journal Animal Lab News

Conferences IACUC 101 PRIM&R ARENA spring conference AALAS National meeting SCAW’s IACUC-Advanced SCAW December conference State society conferences: NJABR, MiSMR, NCABR, TSBR, and others

Custom workshops Tailored to your facility. Optimal if a major upheaval in your program.

Remember Assess the level of need –individualize. Keep training on the front burner. Assess the level of need –individualize. Don’t forget the community representative. Make it easy.

Roadmap Why is IACUC training important? What needs to be included in the training? How do we go about training the IACUC? Resources.

Core materials for IACUC training Institute of Laboratory Animal Resources, National Research Council. Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC, 1996). Animal Welfare Act as Amended (7 USC, 2131 et.seq.).http://www.aphis.usda.gov/ac/awapdf.pdf. Animal Welfare Regulations, 9 CFR Ch. 1, Subchapter A (1999 edn). Animal and Plant Health inspection Service, USDA. http://www.aphis.usda.gov/ac/9CFR99.html. Public Health Service. Policy on Humane Care and Use of Laboratory Animals (Washington, DC, 1986). USDA Animal and Plant Health Inspection Animal Care Policy Manual. http://www.aphis.usda.gov/ac/polman.pdf.html.

Core materials for IACUC training Health Research Extension Act of 1985 (P.L. 99-158), November 20, 1985-Animals in Research. http://grants1.nih.gov/grants/olaw/references/hrea1985.htm. Interagency Research Animal Committees. U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training (Office of Science and Technology Policy, Washington, DC, 1985). Federation of Animal Science Societies. Guide for the Care and Use of Agriculture Animals in Agricultural Research and Teaching (Savoy, IL, 1999).

Core materials for IACUC training Beaver, B.V. et al. 2000 Report of the AVMA Panel on Euthanasia. J. Am. Vet. Med. Assoc. 218, 669-696 (2001). Institute of Laboratory Animal Resources, National Research Council. Occupational Health and Safety in the Care and Use of Research Animals (National Academy Press, Washington, DC, 1997). ARENA/OLAW Institutional Animal Care and Use Committee Guidebook, 2nd edn (2002).

Thanks! Molly Greene Mary Lou James

Other resources AAALAC International www.aaalac.org The Connection (Winter/Spring 2002 Seeds for a Successful Program: IACUC Training) American Association for Laboratory Animal Science www.aalas.org Animal and Plant Health Inspection Service – Animal Care http://www.aphis.usda.gov/ac Animal Welfare Information Center www.nal.usda.gov/awic Information Resources for Institutional Animal Care and Use Committees 1985 – 1999, AWIC Resource Series No. 7, http://www.nal.usda.gov/awic/pubs/IACUC/iacuc.htm CompMed E-mail listserv@listservaalas.org IACUC 101 Sponsored by the Office of Laboratory Animal Welfare and the Applied Research Ethics National Association in conjunction with other partners. Visit http://grants.nih.gov/grants/olaw/workshop.htm

Other resources IACUC-Forum IACUC-Forum, a closed listserv where issues relating to laboratory animal research may be discussed privately among members of the listserv. Visit www.iacuc.org for details. IACUC Talk http://www.scaw.com/forum.html IACUC.ORG www.iacuc.org IACUC Resource Page www.labanimal.com/iacuc/iacuc.htm OLAW conferences http://grants.nih.gov/grants/olaw/worshop.htm OLAW’s IACUC Guidebook http://grants.nih.gov/grants/olaw/iacuc_guidebook/iacuc_guidebook.htm OLAW’s PHS Policy Tutorial http://grants.nih.gov/grants/olaw/tutorial/index.htm

Other resources PRIM&R / ARENA annual meeting Public Responsibility in Medicine and Research (PRIM&R) and Applied Research Ethics National Association (ARENA) annual IACUC meeting. Visit http://www.primr.org/conferences.html “Protocol Review” A monthly column n Lab Animal magazine edited by Jerald Silverman, www.labanimal.com Articles IACUC Training: From New-Member Orientation to Continuing Education. Lab Animal 31: 26, 2002 The IACUC Handbook April 2000, Jerald Silverman, Mark A. Suckow, Sreekant Murthy, CRC Press. $59.95. Visit www.crcpress.com to order. ResearchTraining.org, www.researchtraining.org

Agenda Characteristics of ag programs The “Three Tier” approach Ag specific training Examples of training materials Case Studies

Characteristics of ag programs Most Land Grant Universities & some Pharma Veterinary schools, animal science depts Experimental stations: remote, isolated Autonomous, independent Highly skilled technicians and herdsmen Most have ‘been around’ a long time Students

The training approach The Three Tier approach Another tier? #1 Overview Laws and regs and institutional responsibilities #2 Species specific training #3 “Hands On” training Another tier? … Ag specific training needs

The objective of Tier 1: overview of ‘Laws and Regs’ Provide a basic understanding … That many laws and regulations exist wrt to research animals. That some of them apply to research agricultural animals. That an appropriate “Animal Care and Use Program” is important!

The objective of Tier 1: overview of ‘Laws and Regs’ To do: Let them know that training is required (regardless of level of expertise). Set the stage for an environment of compliance. Let them know why compliance is important.

The Regs! Animal Welfare Act 9CFR USDA/APHIS History: Pepper the Dalmatian! Does not cover rats & mice (bred for research) or farm animals used for food or fiber Does cover farm animals used for teaching or for biomedical research Institutional responsibilities Code of Federal Regulations Administered by USDA, Animal Plant and Health Inspection Service

Overview: the Regs! Public Health Service Policy Make sure herdsmen understand that: the ‘Policy’ applies to any research institution receiving funding from NIH the ‘Policy’ applies to all vertebrate animals.

Overview: the regs! AAALAC Not ‘regulatory’ but ‘voluntary’ Covers all animals in a “Program” But what the heck is a Program???

The overview: The ‘program’ of animal care and use Provide information on exactly what a “Program” is! Institutional Policies Stress the importance of Institutional Oversight for animal care and use! Animal Environment, Housing Most Ag folks know about this Traditional Approach How does this apply to Ag Programs?

The overview: The program of animal care and use Veterinary Care Tell them about the roles and responsibilities of the AV! Discuss the importance of teamwork Physical Plant May or may not apply Traditional Approach How does this apply to Ag Programs?

The overview: the “Guides” What are the standards? They need to know that there are two “Guides”: The ILAR Guide and the AG Guide The ILAR Guide: PHS and AAALAC use as a primary reference! Contains guidance on the 4 components of an Animal Care and Use Program mentioned earlier. If get NIH grants, then must be PHS Assured and must follow the ‘Guide’ The AG Guide: more formally entitled Guide for Care and Use of Ag Animals in Ag Research and Teaching” Put out by FASS Follows same relative outline as ILAR Guide wrt Institutional Policies Then provides species specific guidance, e.g chapters on Beef, Swine, Dairy, Sheep and Goats etc.

Tier #2 Species specific training

Tier #2 Species specific training Swine Dairy Beef Sheep and Goats Poultry

Tier #2 species modules: content Breeds Classification (species, genus) Nomenclature (freemartin) Uses in research Main biological characteristics Behavior General husbandry Space requirements Procurement ‘On Arrival’ examination Technician responsibilities Nutrition Basic handling and restraint Identification Animal Health/Common Diseases Euthanasia

Tier #2 species modules: the trainer Identified most qualified technician/herdsman per species. Asked him/her to develop the module. Provided presentation skills. That technician became the trainer for that particular species. Trainer presentation skills and efforts were recognized by supervision and reflected on ‘performance management’.

Tier #3 “Hands On” training

Tier #3: “Hands On” training Herd health SOP’s Dehorning Piglet processing Foot Trimming (all species) Castration Euthanasia (captive bolt) Heat check for dairy Artificial insemination Routine health treatments Mastitis Hypocalcemia Anemia For each module, there is a didactic and a hands on portion. Individuals must demonstrate proficiency in hands on tasks.

Tier #3: “Hands On” training Research techniques Handling and restraint Bleeding and injection techniques Anesthesia and analgesia Aseptic technique Surgical principles Specific surgical procedures Rumen cannulation Abomasal cannulation Vascular access For each module, there is a didactic and a hands on portion. Individuals must demonstrate proficiency in hands on tasks.

Ag specific training!!! Zoonoses and biosafety Recognition of pain and distress in ag animals Ag animal environmental enrichment Necropsy room safety

Readily available training FASS Training Federation of Animal Science Societies (www.fass.org) Beef Cattle Dairy Cattle Swine Training Horse Training Ag Guide

Available video tapes National Institute Animal Agriculture (NIAA) Swine Handling and Transport Cattle Handling and Transport Understanding Dairy Cattle Behavior to Improve Handling and Transport

Lots of other sources of training material … AAALAS National Practitioner Organizations AABP, AASV, AADP…. National Producer Organizations National Cattleman’s Beef Association Temple Grandin (www.grandin.com) American Farm Bureau AVMA AWIC Land Grant University agricultural program websites Practitioner Org’s AABP: Mastitis, Bovine Euthanasia AASP: Practical Euthanasia, Foreign Animal Disease, Guidelines for Tx use of antimicrobial, Swine Diseases NCBA: Animal Welfare, Food Safety

Case study #1 Large Land Grant University, USA Mandatory: inadequate veterinary care Problem: an inadequate understanding of: the role of the veterinarian in research, the regulations and how they are applied to agricultural research and what constitutes an ‘animal care and use program” Solution (in part): Tier #1 training

Case study #2: Large Land Grant University, USA Mandatory: lack of or inadequate personnel training Problem: long term very experienced herdsmen who do not understand the need for training Solution: Tier #1 training Tier #2 training Herdsman as “the trainer”

Case study #3 Land Grant University, USA Mandatory: inappropriate euthanasia (swine, cattle) Problem: lack of understanding of appropriate euthanasia techniques Solution Tier #3: SOP discussion and hands on training for euthanasia techniques (electrocution, carbon dioxide, captive bolt..)

Questions?

Industry’s unique challenges Slides prepared by: Michael Ballinger, DVM, DACLAM Director, Global Animal Resources, Amgen President, Council on Accreditation, AAALAC International

What is “industry” Vendors Contract Research Organizations (CRO) Biotech companies Pharmaceutical/vaccine companies The challenges vary with various industry sectors

Industry environment/challenges Generally risk averse. Business model includes regulatory compliance (FDA, EPA, OECD, ISO, DOD). Business model includes accreditation, (AAALAC International). Cost/benefit ratio analysis evaluated for programs. Must have business case for education & training.

Business case for training Is it mandated by law or regulation? Will it protect the company’s resources? Will it make us more competitive? Will it improve the data? How important is it for the company to project competence? How important is it to convey that animal welfare is important?

Training by job category IACUC member training. Animal care staff training. Research & science staff training. Personnel at risk for research hazards. Awareness/training of the companies “rank and file.”

IACUC training Animal Welfare Act compliance sells need. 1996 Guide provides specific expectation. Support for regular travel to IACUC conferences is generally available. Many organizations now “bring the trainers in” to maximize return on investment.

Animal care staff training Well defined training programs are common. Documentation often excellent, especially if GLP. AALAS certification often endorsed and financially supported. May be requirement for advancement. ILAM & CMAR support is common.

Training for science staff Business case not as obvious. “Qualified” versus “Trained.” Who is ultimately responsible for qualification of research staff? What cost center should support it? IACUC may demand “demonstration of proficiency” but should they require training?

Environmental health and safety training Strong business case for adequate occupational health & safety resources. Strong business case for hazard abatement. Formal courses readily available. Combining animal use training with other required training (i.e. EHS) will increase efficiency and may increase effectiveness.

GLP versus non-GLP GLP animal users take training very seriously, but focus is not animal welfare. Well-documented. Humane issues not always a key component. FDA assumes adequate animal care/welfare. USDA focus on welfare, not on study design. Mandate and oversight comes from GLP compliance (QA) organization, not IACUC.

Research and non-GLP Company culture may hinder new demands for mandated training and especially “needless documentation.” Perhaps an over reaction to “GLP’s don’t apply here.” Procedural training with humane focus evolved long after GLP’s in most companies.

Industry examples of approaches Risk-based prioritization for hands-on training and/or proficiency demonstration. Concentrate on recognizing pain/distress and reporting problems. Track proficiencies in a central training record. Internal awareness programs for “rank and file” “culture of care” (Aventis, Charles River). Integrated Needs-Based Training Programs— Attend Seminar tomorrow 8:00 am!!