A Pithy Review of Laws and Regulations

1. A Pithy Review of Laws and Regulations Governing Animals in Biomedical Research Cynthia Pekow, DVM VA Puget Sound Health Care System

2. What does an IACUC member need to know about animal laws & regs? Which laws pertain to research animal use Varies with species, funding sources Who enforces the laws, who accredits What is the purpose and role of the IACUC Where to find good resources What all those acronyms mean�

3. Dull history lesson FDR 1935, Social Security Act: $2 million/year for disease research Surging economy post WW II Taxpayer funding for health-related research Explosive increase in biomedical research

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9. Guide for the Care and Use of Laboratory Animals Basis for PHS evaluation of animal care and use program Also used by AAALAC Available free on web Translated into many languages Government publication

10. The Guide for the Care and Use of Laboratory Animals Outlines and provides references for: Veterinary care Euthanasia Housing and environment Personnel qualifications Sanitation Surgical and post-operative care Facility construction

11. Professional Judgment The principles of the Guide are outcome-based and include professional judgment and performance standards

12. The Animal Welfare Act (AWA) Passed in 1966 �Pepper� the stolen Dalmation, Sports Illustrated Life Magazine feature

18. The Animal Welfare Act (AWA) Act applies to Animal research facilities Animal dealers and exhibitors Operators of auction sales Carriers and handlers of animals in shipment USDA role Writes specifics (CFR) Enforces: unannounced visits

19. The Animal Welfare Act Covers warm-blooded animals in research EXCEPT: Farm animals in agricultural research Purpose bred mice and rats, and birds

20. The Animal Welfare Act

21. AWA IACUC Specifics IACUC includes: Veterinarian Public Member At least 3 members Approves, monitors research Twice yearly facility & program review Prompt reporting of deficiencies Search for alternatives to painful procedures, duplication of work

22. Who else requires an IACUC? Public Health Service Part of US Dept of Health and Human Services Applies to institutions that accept PHS support ($$) Includes 27 NIH institutes

23. US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training Interagency Research Animal Committee 1983-4

24. Health Research Extension Act: 1985 Policy on animal use applies to any group receiving Public Health Service (PHS) $$ PHS includes: NIH, CDC, FDA, others Applies to all vertebrate animals PHS Policy implements the Act

25. Public Health Service Policy Covers all vertebrate animals (mice!) Mandates IACUC with At least 5 members Veterinarian Public member Practicing scientist Nonscientist member

26. Public Health Service Policy Assurance filed with the NIH OLAW Specifies: IACUC makeup, responsibilities Training Occupational Health Program Veterinary Care Guide basis for evaluation of program and facilities

27. More about that PHS Policy Institutional Official (IO) has ultimate responsibility for compliance (CEO appointed) IACUC responsibility to review and verify approval of all animal protocols Semi-annual facility/program reviews and training for all animal users must be described Prompt reporting of problems

28. Alternatives to Painful Experiments 1985- Animal Welfare Information Center (AWIC) at the National Agriculture Library in Beltsville, Maryland To check for alternatives and avoid unnecessary duplication

30. AAALAC, since 1965 Site visits every 3 years Council of experts evaluates report Full vs Probationary vs Revoked Association for Assessment and Accreditation of Laboratory Animal Care, International Voluntary Extensive program description Guide basis for evaluation

32. William Russell and Rex Burch The Principles of Humane Experimental Technique - 1959 Humanity vs. Inhumanity

33. The 3 R�s of Russell and Burch Replacement - a system that does not include the use of a living animal Reduction - any strategy that will result in the use of less animals Refinement - modifications that minimize pain and distress and enhance well-being

34. AVMA Guidelines on Euthanasia Basis for most IACUC determinations of humane or acceptable euthanasia Justification required if method is not recommended Most recent edition published in June 2007

35. Good Laboratory Practices Act 1974 FDA and EPA Testing of food, drugs, pesticides, medical devices Written Standard Operating Procedures Extensive record keeping Quality assurance

36. Freedom of Information Act 1966 If taxpayer $$ are used, public can access information USDA inspection reports on the web (off and now on again�) Spawned state �sunshine acts�

37. Additional Laws Convention on International Trade in Endangered Species (CITES) 1973 Endangered Species Act 1973 Pound Seizure Laws, state acts

39. Take Home Messages: Animal Welfare Act Warm-blooded animals, not mice/rats/birds Enforced by USDA, unannounced inspections Registration with USDA Annual report with animal numbers, pain categories Documented literature searches for alternatives to painful procedures and unnecessary duplication IACUC with at least 3 members Specifics in Code of Federal Regulations

40. Take Home Messages: Public Health Service Policy Applies if you accept PHS money Applies to vertebrate animals Enforced by OLAW Assurance document, annual update IACUC with at least 5 members Prompt reporting of deficiencies Guide basis for evaluation

41. Take Home Messages: Good Laboratory Practices Applies to preclinical studies where approval by FDA or EPA will be sought Requires a Quality Assurance Unit Requires extensive record keeping Enforced by FDA or EPA

42. Take Home Messages: AAALAC, International Voluntary Not part of government Extensive program description Site visit every 3 years, annual report Guide basis for evaluation

43. Take Home Messages: Freedom of Information Act Your records of USDA inspections, OLAW reports are open to the public State sunshine laws State Pet Protection or Pound Seizure laws

44. It all comes down to personal integrity