New Hire Orientation Health & Safety, 1/02 v.4 Incorporating USDA And AAALAC Requirements Into Your Overall Inspectional Practices Jordan Publico, B.S., RLATG, ILAM, RQAP-GLP Senior Quality Assurance Auditor Charles River, Insourcing Solutions (CRIS) “The Age of Auditing” February 2015 CRL: Contract Staffing Management Services

Presentation Objectives New Hire Orientation Health & Safety, 1/02 v.4 Presentation Objectives USDA mission and regulations USDA audit goals AAALAC mission and guidelines AAALAC accreditation program AAALAC inspection process Are you to be reviewed? “The Age of Auditing” February 2015 CRL: Contract Staffing Management Services

USDA The U.S. Congress passed the Animal Welfare Act (AWA) in 1966. New Hire Orientation Health & Safety, 1/02 v.4 USDA 1. THE U.S. DEPARTMENT OF AGRICULTURE (USDA) WAS CREATED IN 1862, AFTER PRESIDENT 1. 1. 1 1.ABRAHAM LINCOLN SIGNED THE AGRICULTURAL ACT THAT INCLUDED PROVISION FOR THE ESTABLISHMENT OF THE DEPARTMENT. THE USDA OVERSEES FARMING, NUTRITION, MARKETING, FOOD SAFETY AND COMMUNITY DEVELOPMENT. 2. (Congress discussed laboratory animal welfare in the early 1960s, but there was not enough interest to pass legislation. The tipping point happened after very revealing articles on the procurement process for finding and delivering dogs for biomedical research appeared in two popular magazines—Life and Sports Illustrated. The articles stimulated such a public outcry that Congress eventually wrote and passed the first Laboratory Animal Welfare Act in 1966. ) The U.S. Congress passed the Animal Welfare Act (AWA) in 1966. Since then, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) has vigilantly enforced this Act to ensure the well–being of animals used in laboratory research. 3. APHIS provides leadership for determining the standards of humane care and treatment of animals. APHIS implements those standards and achieves compliance through inspection, education, and cooperative efforts with the USDA Animal Care Program. 4. USDA and APHIS enforces standards for animal husbandry, recordkeeping, the review of research protocols, and veterinary care. The U.S. Congress passed the Animal Welfare Act (AWA) in 1966. United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) enforce this Act to ensure the well–being of animals used in laboratory research. “The Age of Auditing” February 2015 CRL: Contract Staffing Management Services

USDA regulating documents New Hire Orientation Health & Safety, 1/02 v.4 USDA regulating documents The AWA covers nearly all species of warm blooded animals used in research An amendment to the AWA in 2002 excluded birds, mice of the genus Mus, and rats of the genus Rattus bred for use in research The AWA does not regulate animals used in elementary or secondary education, or farm animals used in agricultural research, food, or fiber. “The Age of Auditing” February 2015 CRL: Contract Staffing Management Services

USDA Regulating Documents New Hire Orientation Health & Safety, 1/02 v.4 USDA Regulating Documents 1. Title 21 is the section of CFR that governs food and drugs within the Unites States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). 2. GLP is a quality system concerned with the organizational processing and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. Complete Traceability. 3. Preclinical trials on animals used in the United States follow these rules prior to clinical research in humans. Title 21 Food and Drug Act of the Code of Federal Regulations (CFR) Part 58 of Title 21, Good Laboratory Practices (GLP) “The Age of Auditing” February 2015 CRL: Contract Staffing Management Services

USDA Audit Goals Review research facilities using regulated animals. New Hire Orientation Health & Safety, 1/02 v.4 USDA Audit Goals 1. Responsible for any regulated animal business animal breeders such as dogs, cats, rabbits, and pocket pets, zoos, and animals used for entertainment such as circus’. 2. Review research facilities using regulated animals must register with APHIS and provide their animals with proper treatment and a healthy and safe environment. 3. Review nonhuman primate facilities to ensure that all animals are provided environmental enrichment, such as swings, toys, and regular interaction with other primates or a familiar caregiver. 4. Review facilities housing dogs, to ensure that animals are purchased from licensed vendors and have source documentation, as well as ensure that dogs are provided an opportunity for daily exercise. 5. Review of large animal facilities to ensure that guidelines for the care and use of farm animals in non–agricultural studies are in compliance. Review research facilities using regulated animals. Non-human primate facilities Facilities housing dogs Large animal non-agricultural facilities “The Age of Auditing” February 2015 CRL: Contract Staffing Management Services

New Hire Orientation Health & Safety, 1/02 v.4 USDA Audit Goals 1. To ensure that research facilities provide their animals with proper veterinary care, APHIS requires that they employ an attending veterinarian who is located on the premises or who makes regularly scheduled visits. 2. To ensure that a program of veterinary care outlines procedures such as the administration of vaccines, regular examinations, and the care of sick animals. And ensuring that animals in pain or distress receive immediate care. 3. To ensure that the veterinary care program includes provisions for the humane euthanasia of animals, in accordance with the American Veterinary Medical Association (AVMA 2007). To ensure that research facilities provide their animals with proper veterinary care To ensure that a veterinary program outlines procedures such as the administration of vaccines, regular examinations, and the care of sick animals To ensure provisions for humane euthanasia is provided in accordance with the American Veterinary Medical Association (AVMA 2007) “The Age of Auditing” February 2015 CRL: Contract Staffing Management Services

New Hire Orientation Health & Safety, 1/02 v.4 USDA Audit Goals 1. Review the facilities Institutional Animal Care and Use Committee (IACUC) who oversee the humane care and use of regulated animals. 2. Review IACUC oversight on research protocols to ensure that they comply with AWA requirements, and utilize the 3 R’s (Replace, Reduce, Refine), to ensure that activities do not duplicate previous experiments. 3. Review IACUC oversight to ensure that researchers on protocols have sufficient documentation to ensure that any employee who has contact with laboratory animals have received adequate training with the procedures they are performing as well as training on the animal that they are using in their protocol. Review the facilities Institutional Animal Care and Use Committee (IACUC) Ensure AWA compliance, and utilize the 3 R’s (Replace, Reduce, Refine) Ensure that staff have adequate training and education “The Age of Auditing” February 2015 CRL: Contract Staffing Management Services

New Hire Orientation Health & Safety, 1/02 v.4 AAALAC 1. Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) is a private nonprofit organization that has been working since its inception in 1965. In 1996, AAALAC changed its name AAALAC International to include global institutions. AAALACs mission is to promote the humane treatment of animals in science through a voluntary accreditation program called a Program Status Evaluation (PSE). 2. The PSE is a completely confidential peer review that helps assess the quality of all aspects of your animal research program, including animal husbandry, veterinary care, institutional policies, and the facilities where animals are housed and used. 3. This type of evaluation promotes the well-being of laboratory animals, and serves as the first step toward achieving AAALAC Accreditation, a distinction earned by hundreds of institutions that have achieved excellence in animal care and use. Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) was in incepted in 1965 Promotes humane treatment of laboratory animals through a voluntary accreditation program called a Program Status Evaluation (PSE) The PSE is a confidential peer review that helps assess the quality of all aspects of your animal research program “The Age of Auditing” February 2015 CRL: Contract Staffing Management Services

Why seek AAALAC Accreditation? New Hire Orientation Health & Safety, 1/02 v.4 Why seek AAALAC Accreditation? 1. Quality and Commitment to Excellence in Animal Care. 2. Scientific Validity that results in improved animal welfare and better research practices and outcomes. 3. Accountability and tells the public that the institution is committed to the responsible care and use of animals in science. 4. Assurance in a Global Market that harmonizes animal care and use practices, and provide assurance to diverse stakeholders. 5. Recruiting tool to attract the best and brightest researchers and professors. NOTE: Any animal facility receiving government funding requires AAALAC Accreditation. AAALAC Accreditation Ensures: Quality and Commitment to Animal Care Excellence Scientific Validity Public Accountability Global Market Harmonization Recruiting Tool Note: Any public health service funded research facility is required to seek and maintain AAALAC accreditation. “The Age of Auditing” February 2015 CRL: Contract Staffing Management Services

New Hire Orientation Health & Safety, 1/02 v.4 AAALAC guidelines 1. AAALAC references the ‘Guide for the Care and Use of Laboratory Animals’ (NRC 2011), as its primary standard for evaluating laboratory animal care and use programs through internationally accepted best practices. 2. Reference Resources are used for animal use specifics that ‘The Guide’ does not address such as; Biosafety, Health Monitoring, Euthanasia, Occupational Health, and Education. 3. Specialty publications are also referenced and designated as Reference Resources.  These were first established by AAALAC in 1975, and are intended to serve as additional references and guidelines for laboratory animal care and use programs. 4. Reference Resources also include research specifics including DNA research, Neoplasia and Animal Surgery, and specie specifics including Non-human primates, Agricultural and Wild animals. The ‘Guide for the Care and Use of Laboratory Animals’ (National Academy of Sciences 2011) Reference resources are used for specifics that ‘The Guide’ does not address such as; Biosafety, Health Monitoring, Euthanasia, Occupational Health, and Education “The Age of Auditing” February 2015 CRL: Contract Staffing Management Services

AAALAC Inspection Process New Hire Orientation Health & Safety, 1/02 v.4 AAALAC Inspection Process 1. Once PSE is obtained and reviewed by the AAALAC office, a Senior Director of AAALAC is identified as inspection team lead. 2. Inspection starts with an in-briefing meeting to review the overall animal use program. 3. Facility walk-through is conducted to ensure program and regulation compliance. 4. Additional comprehensive meetings with animal care and research staff, representatives from oversight committees, and the Institutional Official. A Senior Director of AAALAC is identified as inspection team lead Inspection starts with an in-briefing meeting Facility walk-through is conducted Meetings scheduled with care and research staff, representatives from oversight committees, and the Institutional Official “The Age of Auditing” February 2015 CRL: Contract Staffing Management Services

AAALAC Inspection Process New Hire Orientation Health & Safety, 1/02 v.4 AAALAC Inspection Process Review of Institutional policies including study protocols and standard operating procedures. Review of the animal housing and support areas ensuring they protect the animals from environmental extremes. Walls, ceiling and flooring is in tact and the proper condition to be sanitized regularly. 3. Ensure that caging requirements are met per specie, proper ventilation and illumination is provided, as well as behavioral and environmental enrichment is provided. 4. Review of individual and batch records of treatment and surgical procedures. Review of IACUC Policies and SOP’s Assessment of Physical Plant Review of Lab Animal Management Micro and Macro Environment - Space Recommendations - Ventilation - Illumination Behavioral Management Structural and Social Environment Treatment and surgical records “The Age of Auditing” February 2015 CRL: Contract Staffing Management Services

AAALAC Inspection Process New Hire Orientation Health & Safety, 1/02 v.4 AAALAC Inspection Process 1. On-site inspection ends with an out-briefing meeting to review the overall program again and provide specific guidance on how to improve deficient program areas with recommendations provided. 2. The review team will meet with the AAALAC council to accept and/or reject inspection findings, and makes the final decision on accreditation. 3. The final report should be received in 6 – 10 weeks post inspection with areas for corrective action if required. On-site inspection ends with an out-brief meeting. Review team will convene with the AAALAC council to accept and/or reject inspection findings, and makes the final decision on accreditation. The final report should be received in 6 – 10 weeks post inspection with areas for corrective action if required. “The Age of Auditing” February 2015 CRL: Contract Staffing Management Services

New Hire Orientation Health & Safety, 1/02 v.4 Corrective Action Mandatory Item = deficiency which must be corrected for Full Accreditation to be awarded or continued. Suggestion for Improvement (SFI) = item which the Council feels is desirable to upgrade an already acceptable or even commendable program. Mandatory Item = deficiency which must be corrected for Full Accreditation to be awarded or continued Suggestion for Improvement (SFI) = item which the Council feels is desirable to upgrade an already acceptable or even commendable program “The Age of Auditing” February 2015 CRL: Contract Staffing Management Services

Receiving Accreditation New Hire Orientation Health & Safety, 1/02 v.4 Receiving Accreditation 1. Initial and full approval is good for three years 2. Provisional approval is good for one year Note: If you receive commendations that means that you are exceeding quality objectives in certain areas of your overall program. Initial and full approval is good for three years Provisional approval is good for one year “The Age of Auditing” February 2015 CRL: Contract Staffing Management Services

Are you ready to be reviewed? New Hire Orientation Health & Safety, 1/02 v.4 Are you ready to be reviewed? Inspect physical plant and make recommendations with time allowed for maintenance to make any necessary repairs such as lights out, cracks in wall and/or flooring, and broken door locks. Inspect all animal support areas for adequate sanitation, proper feed and water storage and delivery, cage requirements, proper identification and enrichment. This also includes safety checks such as eye wash stations and showers, and adequate pest management. Inspect all animal and veterinary records for documentation deviations to allow management time for appropriate corrective action. This also includes checking for expired veterinary supplies and accountable documentation in regards to controlled substances. Inspect all equipment for current certifications/calibrations such as safety hoods, rack blower units, and isoflurane vaporizers. This also includes documentation for equipment usage as per facility SOPs. Inspect physical plant and cleanliness Inspect ALL animal support areas and supplies Review ALL animal and veterinary records and supplies Check ALL support equipment for current certifications/calibration “The Age of Auditing” February 2015 CRL: Contract Staffing Management Services

New Hire Orientation Health & Safety, 1/02 v.4 Quality is doing the right thing the first time when no one is looking! How much does accreditation cost? Organizations seeking and maintaining accreditation are asked to pay a one-time application fee and subsequent annual fees. Both of these fees are based on a sliding scale that generally correlates with the size of an institution’s animal facility. An institution that has very few animals will pay much smaller fees than one that maintains a large vivarium and extensive support areas. The fees cover the cost of periodic site visits and administrative expenses. References: www.fda.gov www.usda.gov www.aaalac.org www.sqa.org www.aalas.org Contact information: Jordan Publico, B.S., RLATG, ILAM, RQAP-GLP jordan.publico@crl.com National Capital Area Regional Chapter Society of Quality Assurance NCARSQA President 2015, Past President 2016. SQA AHSS “The Age of Auditing” February 2015 CRL: Contract Staffing Management Services

Society of Quality Assurance (SQA) New Hire Orientation Health & Safety, 1/02 v.4 Society of Quality Assurance (SQA) SQA is an association of over 2,200 QA professionals who are dedicated to implementing industry, governments, academia requirements, information sharing, and consulting. Good Clinical Practices (GCPs) Good Laboratory Practices (GLPs) Good Manufacturing Practices (GMPs) “The Age of Auditing” February 2015 CRL: Contract Staffing Management Services

SQA Chapters “The Age of Auditing” February 2015 New Hire Orientation Health & Safety, 1/02 v.4 SQA Chapters “The Age of Auditing” February 2015 CRL: Contract Staffing Management Services

National Capital Area Regional Society of Quality Assurance (NCARSQA) New Hire Orientation Health & Safety, 1/02 v.4 National Capital Area Regional Society of Quality Assurance (NCARSQA) 1• Education Programs. 2• Dexter Goldman Memorial Scholarship Award eligibility. 3• NCARSQA Educational Scholarship Award eligibility. 4• Leadership Training and Networking Opportunities. 5• Newsletters. 6• Company profiles and job postings advertised on website and newsletters. 7• NEW BRAND! NEW WEBSITE! COMING SPRING 2015! www.NCARSQA.org “The Age of Auditing” February 2015 CRL: Contract Staffing Management Services

American Association for Laboratory Animal Science (AALAS) New Hire Orientation Health & Safety, 1/02 v.4 American Association for Laboratory Animal Science (AALAS) AALAS is an association of professionals that advances responsible laboratory animal care and use to benefit people and animals. AALAS provides educational materials to laboratory animal care professionals and researchers, administers certification programs for laboratory animal technicians and managers, publishes scholarly journals, supports laboratory animal science research, and serves as the premier forum for the exchange of information and expertise in the care and use of laboratory animals.  “The Age of Auditing” February 2015 CRL: Contract Staffing Management Services

AALAS Districts 1: Northern Mountain 2: Central PA. New Hire Orientation Health & Safety, 1/02 v.4 AALAS Districts 1: Northern Mountain 2: Central PA. 3: National Capital Area Branch (NCAB) 4: Appalachian 5: Central OH. 6: Central IL. 7: Mile-High 8: Western Mountain “The Age of Auditing” February 2015 CRL: Contract Staffing Management Services

New Hire Orientation Health & Safety, 1/02 v.4 philosophy.com The headlines you make in this life will be based on the difference you made in the lives of others. “The Age of Auditing” February 2015 CRL: Contract Staffing Management Services