Anatomy of a Land Grant Institution Dorcas P. O’Rourke, D.V.M., M.S. Director, Office of Laboratory Animal Care The University of Tennessee AAALAC Council on Accreditation What is a land grant institution? Colleges and universities designated by Congress and state legislatures to receive federal support as defined in the Morrill Acts of 1862 and 1890 Rationale for LGI Development Need for broad-based educational systems LGIs to offer curricula in military tactics, agriculture, and mechanic arts Provide practical education to industrial classes First Morrill Act of 1862 Allowed public lands to be donated to states Proceeds from sale of these public lands supported the LGIs Hatch Act of 1887 Mandated creation of Agricultural Experiment Stations Stations affiliated with LGIs Scientific research to be conducted at experiment stations Federal and state funds appropriated annually to support research Smith-Lever Act of 1914 Provided federal monies for support of cooperative extension efforts Educational programs established to disseminate information obtained in experiment station research to local communities Other Landmark Decisions Six million dollar endowment to the University of Hawai’i in 1960 in lieu of federal land endowment University of Guam, College of the Virgin Islands, Community Colleges of American Samoa and Micronesia, and Northern Marianas College achieved land grant status in 1972 Other Landmark Decisions (cont.) Twenty-nine Native American colleges received land grant status and a 23 million dollar endowment in 1994 LGIs Today All states and territories have at least one LGI Total of 105 LGIs which receive over $550 million annually in federal funding Characteristics of Traditional LGIs Complex, decentralized animal care programs Varied, multiple funding sources, including Hatch and LGI appropriations Unique programs, such as veterinary medicine and agricultural sciences Separate programs with overlapping research focus Multiple lines of authority LGIs and AAALAC Accreditation Single vs. multiple accredited units ILAR Guide for most species Ag Guide and principles of the first three chapters of the ILAR Guide applicable to food and fiber animals The Ohio State University Single office for animal management and veterinary care for the accredited program Single IACUC (sub-IACUC for food and fiber animals) Single AAALAC accreditation (excluding food and fiber animals) University of Wisconsin Multiple animal care programs with multiple veterinarians, with compliance oversight in the institutional veterinarian’s office Multiple IACUCs Multiple AAALAC accredited programs (ag component not accredited) University of Missouri Multiple animal care programs, with many facility managers hired by and reporting to the institutional veterinarian’s office, and all veterinarians reporting to the institutional veterinarian (including ag) Single IACUC Multiple AAALAC accredited programs (ag component not accredited; soon to apply for single accreditation, including ag) University of Illinois Decentralized management of animal facilities and centralized oversight of all areas (including ag) through the institutional veterinarian’s office and IACUC Centralized veterinary care for lab animals; decentralized veterinary care (with institutional oversight) for food and fiber animals. Single IACUC Single AAALAC accreditation, including ag food and fiber animals Clemson University All veterinary care and oversight provided by institutional veterinarian’s office Single IACUC Single AAALAC accreditation Key to Successful AAALAC Accreditation in LGIs Ensure adequate veterinary care and compliance oversight Ensure clear lines of authority Ensure strong institutional commitment to the animal care and use program Accreditation for Agricultural Programs: Analysis of the Arguments For and Against Neal R. Merchen, Ph.D. Professor and Interim Head Department of Animal Sciences University of Illinois General Challenges – Agricultural Animal Programs Complex lines of accountability/authority Teaching activities - impact on H-H programs and biosecurity Decentralized management Faculty involved in management/oversight “Cultural resistance” to centralized oversight Disconnect between clinical veterinary service and oversight by IV Why Be Accredited? Arguments FOR AAALAC website Points from experience at U. of Illinois Why Be Accredited? Arguments FOR Symbol of quality Value in external validation of quality Demonstrates accountability Validates commitment to humane and ethical animal care and use Why Be Accredited? Arguments FOR (?) Enhances quality of agricultural research (?) Recruiting tool for faculty, students, researchers No discernable impact (?) Enhances funding opportunities. Limited impact for funding of ag production research Why Be Accredited? Arguments FOR Exercise in self-assessment Engage all participants Re-evaluation of practices Improves sensitivity to concerns of public Encourages standardization of practices Improves record-keeping Why Be Accredited? Arguments AGAINST Costs Funding, human resources Transaction costs for preparation Repair, renovation of facilities Ongoing costs University of Illinois – College of ACES Agricultural Animal Program Infrastructure Daily census 12 to 14,000 animals 10 livestock units at 3 locations 50 academic staff and animal caretakers 150 animal buildings Extensive documentation Why Be Accredited? Arguments AGAINST Difficulties in collaboration among principals IACUC Institutional veterinarian Clinical veterinarians Faculty Animal care staff “Complex lines of accountability and authority” - Build consensus opinions/agendas Why Be Accredited? Arguments AGAINST Poor relationship between ag animal care program to local oversight of animal care program Biggest reason for disinterest by ag animal units Lack of communication/mutual understanding Why Be Accredited? Arguments AGAINST (cont.) Poor relationship between ag animal care program to local oversight of animal care program Imbalance in institutional authority among IACUC, IV, IO Poor representation of ag animal programs on IACUC AAALAC used as a “club” Greatest Opportunities – AAALAC Accreditation of Ag Animal Programs Establishes independent seal of quality assurance Demonstrates accountability Self-assessment may improve practices Professionalism/pride/esprit de corps of animal caretakers Greatest Challenges - Institutions/AAALAC Resources Develop effective working groups among IV, IACUC, IO, ag animal programs Improve communication between AAALAC and ag animal professionals Clarify role of AAALAC to ag animal professionals Trends in Deficiencies Kathryn Bayne, M.S., Ph.D., D.V.M. Associate Director, AAALAC International Standards Used Farm Animal Position Statement AAALAC International uses the current edition of the Guide for the Care and Use of Laboratory Animals (NRC 1996) as its primary standard for evaluating animal care facilities and programs. The full range of programmatic criteria outlined in Sections I-III of the Guide are entirely applicable to farm animals, and in accredited facilities, the use of farm animals in research should be subject to the same general ethical considerations as the use of other animals in research. However, uses of farm animals are often separated into biomedical uses and agricultural uses, and different criteria for evaluating standards of housing and care for animals of the same species may be appropriate. Decisions on categorizing research uses of farm animals and defining standards for their care and use should be based on user goals, protocols, and concern for animal well-being and should be made by the Institutional Animal Care and Use Committee. For animals in an agricultural setting, AAALAC International takes the position that, in accredited facilities, the housing and care for farm animals should meet the standards that prevail on a high quality, well managed farm. The Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching (FASS 1999) is recognized by AAALAC International as a reference resource for individual farm animal species. Regardless of an investigator’s research objectives or funding source, institutions are expected to provide oversight of all research animals and ensure that their pain and distress is minimized. AAALAC International & Land Grant Institutions Approximately 28% are accredited Of those LGIs/State Universities that are accredited…. 38% have Campus-wide accreditation The Animal Care and Use Program Institutional Policies OHSP IACUC Adequate Veterinary Care Administrative Organization Animal Management Animal Space Provisions Support Service Sanitation Practices Caging/Housing System Aseptic surgery Husbandry Practices Identification/Record Keeping Vermin Control Veterinary Care Preventive Medicine Disease Diagnosis, Control, Treatment Surgical & Postsurgical Care Anesthesia/Analgesia Euthanasia Physical Plant HVAC Survival Surgery Support Facility Maintenance Personnel Safety Concerns General Storage Conditions Sanitation of Facilities Physical Plant (cont.) Illumination Emergency Power Physical Plant Design Security Trend Data Data extracted from January 1993 through January 2002 meetings of the Council on Accreditation, equating to the three most recent site visits for each institution (or less if they were new to the AAALAC program) Mandatory Deficiencies Identified Range of zero to nine mandatory items in a letter 59% of letters reviewed had no mandatory items for correction, i.e., institution granted Full Accreditation after site visit No significant correlation between number of mandatory items identified and whether program was Campus-wide or University-limited No correlation between number of mandatory items and whether institution had a medical school or health science center Suggestions for Improvement Identified Range of zero to 20 SFIs in a letter 24% of letters reviewed had no SFIs No significant correlation between number of SFIs identified and whether program was Campus-wide or University-limited No correlation between number of SFIs and whether institution had a medical school or health science center Mandatory Item vs. Suggestion For Improvement Mandatory Item = a deficiency which must be corrected for Full Accreditation to be awarded or continued Suggestion for Improvement (SFI) = items which the Council feels are desirable to upgrade an already acceptable or even commendable program Land Grant Institution Program Deficiencies 20% Institutional Policies Animal Management Veterinary Care Physical Plant 7% 8% 65% Comparison Of LGIs with all Accredited Institutions Institutional Policies Animal Management Veterinary Care Physical Plant General Animal Care and Use Programs 70% 13% 12% 5% Land Grant Colleges & State Universities 65% 8% 7% 20% Land Grant Institution Suggestions for Improvement 20% 30% 13% 37% Institutional Policies Animal Management Veterinary Care Physical Plant Common Deficiencies 50 45 40 35 30 25 20 15 10 5 0 28.6 IACUC OHSP HVAC Program of Vet Care 19.8 13.5 9.5 Comparison Of LGIs with all Accredited Institutions IACUC OHSP HVAC Veterinary Care General Animal Care and Use Programs 25% 15% 9% 4% Land Grant Colleges & State Universities 28.6% 19.8% 13.5% 9.5% Identified Concerns 100 90 80 70 60 50 40 30 20 10 0 V A D C es & M ai nt H e V et .C ar A d. IA C U C O H SP Mandatory SFI's Accreditation Challenges IACUC Issues Christine M. Parks, D.V.M., Ph.D. Director, RARC University of Wisconsin-Madison AAALAC Council on Accreditation Emeriti Institutional Policies Lack of institutional commitment Institutional official not empowered to commit necessary resources Need to establish clear lines of authority and oversight of the program Inconsistencies in procedures and practices between centralized and satellite areas IACUC Participation Inadequate oversight of animals in satellite or study areas Inadequate program oversight Lack of participation of nonaffiliated member Organizational structure presented potential conflict of interest Policies, Training and Documentation Inadequate personnel training and documentation No policies for rodent surgery, analgesia/anesthesia, environmental enrichment, dog exercise No or inadequate IACUC training IACUC Semiannual Review Review did not include evaluation and inspection of all housing and laboratory areas Review did not include evaluation of programmatic issues No plan and schedule for correcting deficiencies IACUC Semiannual Review Inadequate oversight of farm units Inadequate evaluation of remote sites, and other sites such as slaughter house or feed mill Protocol Review Issues Inadequate intensity of protocol review including: pain and distress; exceptions from the Guide; euthanasia techniques; use of analgesia; justification of animal numbers; endpoints Need to ensure all animals covered by a protocol (holding, breeding, sentinels) Protocol Review Issues (cont.) Process errors, such as: protocol approval outside committee procedures; chair acting outside of authority; definition of major changes; documentation lapses Inadequate annual review Safety issues not addressed Failure to match numbers of animals approved with number used Occupational Health and Safety at Land Grant Institutions: An AAALAC Perspective Wendy J. Underwood, D.V.M., M.S. Attending Veterinarian Eli Lilly and Company AAALAC Council on Accreditation What mandates the creation of an OHS program? PHS Policy: The ILAR Guide The AG Guide OHSA: CFR 29 ILAR: “Occupation Health and Safety in the Care and Use of Research Animals”. What do the ‘Guides’ say? The ILAR Guide: “An occupational health and safety program must be part of an overall animal care and use program The Ag Guide: “An occupational health and safety program must be established for individuals who work with agricultural animals.” What are the required components of an OHSP? Risk Assessment and hazard identification Medical surveillance Training Personnel hygiene PPE Facilities Procedures and monitoring What are the ‘hallmarks’ of a good OHSP? Strong administrative support Sound implementation strategies Effective coordination of components OHS Findings at Land Grant Institutions Programatic PPE 16% Medical Surveillance 3% Programatic 20% Risk Assessment Training Study Hazards PPE Study Hazards Medical Surveillance 20% Risk Assessment Training 6% 35% Programmatic Issues 20% Inadequate: Oversight Implementation Notification Not offered to all Intensity Involvement by health specialists Need to ensure that the program conforms to the guide. Program does not reflect actual practices. Not applied to field study areas. Risk Assessment and Hazard Identification 35% Lack of risk assessment first aid kits identification of hazardous materials proper signage Potential health risks not identified (Q fever) Lack of confined space policy lone operator policy lock Out/Tag Out documentation of all personnel involved in program Allergen exposure Personnel Training 6% Inadequate training Need to provide training on Zoonoses Allergens Sharps disposal Heavy equipment Ergonomics Experimentation involving hazards 20% Lack of or inappropriate biohazard signs No mechanism to ensure people following policy Exhaust air not filtered Protocols not reviewed by safety committee Non filtered vacuums Lack of respirator use Inappropriate storage of volatile gases Inappropriate handling of medicated feeds Personnel Hygiene 16% Lack of water, sinks, towels, etc. to wash Uncertified safety showers, eye stations, or chemical hoods Washer and dryer for cleaning work clothing installed in soiled area No provision for cleaning work clothes PPE Not available Not offered Not used Inappropriate Lack of hearing protection respiratory protection Lack of monitoring mechanism for PPE use Policy not enforced Lack of policy Medical Surveillance 3% Tetanus immunization not offered No program to evaluate Q fever Broad OHSP Issues at Land Grant Institutions Lack of an OHS program for Ag facilities Lack of opportunity for inclusion Absence of safety professionals Industrial Hygienists Biosafety Officers Safety Officers More Common OHSP Issues at Land Grant Institutions PPE: No boots, safety glasses or work clothes in barn areas Confined Space Entry Zoonoses: ringworm, crypto, erysipelas, flue Heavy equipment training No tetanus immunization First aid kits Storage issues: gas, diesel, formalin, kerosene Physical injury and ergonomics Poor or no biohazard signage Lone Operator OHS Findings: Mandatory or Suggestions? 25 20 15 10 5 0 eil rv Su x M E PP ds ar az H e ien yg H ng ni ai Tr SP H sk Ri O e nc SFI's la Mandatory Accreditation Challenges Animal Management Joy A. Mench, Ph.D. Professor of Animal Science University of California – Davis AAALAC Council on Accreditation The Guide A good management program provides the environment, housing and care that permit animals to grow, mature, reproduce and maintain good health; provides for their wellbeing; and minimizes variations that can affect research results” The Guide “Many factors should be considered in planning for adequate and appropriate physical and social environment, housing, space and management” Species, strain, breed and individual characteristics of animal; ability of animals to form social groups; availability and suitability of enrichments; design and construction of housing; project goals and experimental design Goal of housing to maximize species-typical behavior and minimize stress-induced ones Husbandry & Management Behavioral Management Husbandry Population management IACUC oversight of husbandry Role of IACUC in husbandry program Husbandry & Management Routine husbandry and management issues do not generally appear to pose significant challenges at Land-Grant Institutions Relatively rare as mandatory issues, but there are several common areas of suggested improvements Behavioral Management Provide opportunity for animal to express species-typical postures, behaviors, and activity Lack of social enrichment for social species Pair or group-housing; visual, olfactory, auditory contact Feed and Water Food quality Feed grade Feed storage times Feed storage conditions (vermin/contamination) Feed provision conditions (floor feeding) Water Automatic water lines Sanitation Cage sanitation schedules not in conformance with Guide No (or too infrequent) mechanism for ensuring effectiveness of sanitation (e.g., microbiological monitoring, other appropriate methods) Cluttered and dirty rooms Rusted equipment Other Husbandry Issues Lack of effective vermin control program A particular problem at farm locations, with bulk feed storage areas, open feed troughs No formal (or inadequate) Disaster Plan— most cited deficiency! Appropriate emergency contacts Posting of procedures Takes account of people and animals “Official responder” (vet or colony manager) IACUC Husbandry Issues Special Agricultural Practices Castration, dehorning, molting, etc If likely to cause pain or distress must be reviewed and approved by the IACUC, as per the Guide for the Care and Use of Agricultural Animals Accreditation Challenges Veterinary Care Issues Joseph D. Thulin, D.V.M., M.S. Institutional Veterinarian and Director Division of Animal Resources University of Illinois Urbana-Champaign AAALAC Council on Accreditation Categorizing Veterinary Concerns Program Organization Corresponds to Chapter 1 of NRC Guide Issues of institutional arrangements for veterinary care, responsibilities and authority of attending/institutional veterinarian, etc. Program Design and Implementation Corresponds to Chapter 3 of NRC Guide Preventive medicine (quarantine, surveillance, treatment, control, etc.), surgery, pain management, euthanasia Veterinary Care Concerns Summarized Major Category 100 90 80 70 60 50 40 30 20 10 0 53 16 Mandatory 91 1 SFI Design & Implementation Organization Summary of Mandatory Items 0% 3% 13% 23% Organization Preventive Medicine Surgical Care Pain Management Euthanasia 61% Summary of Suggestions for Improvement 11% 1% 9% 47% 32% Organization Preventive Medicine Surgical Care Pain Management Euthanasia Challenges in Organization of Veterinary Care Examples of Deficiencies Identified by Council Inadequate oversight to ensure adequate veterinary care. Institution needs to establish suitable arrangements for provision of vet care consistent with Guide, Ag Guide and institutional policy. Inadequate involvement of Attending Veterinarian in ag animal program. Examples of Deficiencies Identified by Council (cont.) Institution needs to implement an ag animal health program that delineates the lines of authority and responsibilities of veterinary care. No formal communication between PIveterinarians and Attending Veterinarian. PI-veterinarian not providing adequate vet care. Dairy manager initiating treatment w/o input from veterinarian. Who is the Attending Veterinarian? The veterinarian “…who has direct or delegated authority for activities involving animals at [the registered] facility…” (Animal Welfare Regs) The veterinarian “…who has direct or delegated program authority and responsibility for activities involving animals at the institution…” (PHS Policy) The veterinarian who is responsible for the program of adequate veterinary care. (AWR, NRC Guide, Ag Guide) Attending Veterinarian (cont.) The Attending (Institutional) Veterinarian ideally should report to the Institutional Official. An institution might have more than one AV; however, the lines of accountability and responsibilities among the veterinarians need to be clearly delineated. PI-veterinarians pose special considerations such as conflict of interest and relationship to the AV. Challenges in Design and Implementation of the Veterinary Care Program Examples of Deficiencies Identified by Council Inadequate notification of the veterinary staff about ill animals. (Most frequent deficiency.) Daily observation of animals not conducted. Inadequate treatment of health problems (e.g., feather picking in poultry). Examples of Deficiencies Identified by Council (cont.) Inadequate routine health care (e.g., dental work, physical exams, hoof trimming, etc.). Medical records at farm units did not conform with Ag Guide. Inadequate documentation of health problems and treatments. Indiscriminate use of antibiotics. Examples of Deficiencies Identified by Council (cont.) 15% death rate of cows in a barn due to mastitis which had not been aggressively investigated. Records of veterinary care provided by PIveterinarians inadequate. Malnourished/moribund piglet observed; had intended to leave with sow for next day or two. Examples of Deficiencies Identified by Council (cont.) Diagnostics services not used to ensure adequate veterinary care. Inadequate aseptic techniques (sterilized instruments, hair removal, disinfection of site, sterile gloves, survival surgeries). Inadequate documentation of surgical and postoperative care. Adequate Veterinary Care NRC Guide requires effective programs for: Preventive medicine. Surveillance, diagnosis, treatment, and control of disease, including zoonosis control. Management of protocol-associated disease, disability, or other sequelae. Anesthesia and analgesia. Surgery and postsurgical care. Assessment of animal well-being. Euthanasia. Adequate Veterinary Care (cont.) Under AWR also includes availability of appropriate facilities, personnel, equipment, and services. Ag Guide requires a written and implemented program for disease prevention (including biosecurity), surveillance, diagnosis, treatment, and end point resolution, and has stringent requirements for health and production record keeping. Challenges in Implementation of Veterinary Care Poorly organized programs typically have problems with implementation. All personnel involved in veterinary care must be knowledgeable of institutional responsibilities. Be cognizant of the relationships among the various standards/regulations, i.e., NRC Guide, Ag Guide, AWR, PHS Policy. The Physical Plant in an AAALAC International Accredited Agricultural Facility John J. McGlone, Ph.D. Professor, Department of Animal Science Texas Tech University AAALAC Council on Accreditation Emeriti Outline Physical Plant Considerations (Sections of the Guide): The physical environment Physical Plant considerations Problem areas Opportunities The Physical Environment Microenvironment & Macroenvironment Housing Primary enclosures Sheltered or outdoor housing Naturalistic environment Space Temperature & Humidity Ventilation Illumination Noise Physical Plant Considerations In general, the building, room and pens or cages The Physical Environment p. 22-36 of the Guide The Physical Plant Ch 4, pp 71-80 of the Guide Physical Plant (Ch 4) Functional areas Construction guidelines Corridors Animal room doors Exterior windows Floors, drainage, walls, ceilings HVAC Power and lighting, storage areas, noise control, facilities for sanitizing materials Facilities for aseptic surgery Physical Plant Problem Areas Physical plant issues represented 10% of all mandatory items (32/320) 15% of all suggestions for improvements (112/759) Physical Plant Problem Areas All other issues were 3 or less and they were scattered over nearly every category and sub-category Physical Plant Problem Areas – The big 4 Issues Flooring should be refurbished, resealed, or replaced to provide smooth, impervious sanitizable surfaces (n=17) Unsealed animal room surfaces (n=4) Fencing in need of repair (n=4) Temperatures not monitored/recorded regularly (n=4) Physical Plant Problem Areas – Summary Problem Areas Flooring Walls Fencing Temperature & humidity monitoring Physical Plant Problem Areas – What is not a major concern A farm setting Outdated facilities Natural ventilation Non-controlled photoperiod (as in open barns) Lack of temperature control Physical Plant Problem Areas – Opportunities Agricultural facilities can be accredited for what they are A farm setting, as in a modern, wellmanaged farm A hybrid between a farm and a laboratory A biomedical facility that uses farm animals Ag facilities can be accredited, too! The End For more information: AAALAC International Booth # 607 accredit@aaalac.org accredit_europe@aaalac.org www.aaalac.org