ANIMAL RESEARCH REQUIREMENTSCOMPARISON TABLEAs of October 11, 2001Requirement Animal Welfare Act - USDA Public Health Service Policy - PHS (DHHS)Regulatory Agency US Department of Agriculture (USDA) National Institutes of Health (NIH) Office of Laboratory AnimalWelfare (OLAW)Legislative Authority Statute: 7 USC 2131-2156Regulations: 9 CFRStatute: Health Research Extension Act of 1985 (PL 99-158) ("Law")• Policies: PHS Policy on Humane Care and Use of LaboratoryAnimals, ("Policy") which includes the "Guide for the Care andUse of Laboratory Animals" (the "Guide")Animals Covered Any live or dead warm-blooded animals used in research,teaching, testing, experimentation, except rats, mice, andbirds used in research.9 CFR 1.1Any live, vertebrate animal used or intended for use in research,research training, experimentation, or biological testing or for relatedpurposes.Policy III.A.Assurance/Registration Registration - updated every 3 years; signed by an officialwho has the legal authority to bind the University andsubmitted to the APHIS, REAC Supervisor (on agencyforms)9 CFR 2.30Assurance - typed on institution's letterhead and signed by the IO.Valid for a specified time, no longer than 5 years. The most recentsemi-annual report (below) must be submitted with the Assurance.Policy, IV.A.Institutional Official (IO) An individual authorized to legally commit on behalf ofthe facility that regulatory requirements will be met. 9CFR 1.1An individual who signs, and has the authority to sign the institution'sAssurance, stating that it will meet the requirements of the PHSPolicy.Policy, III.F.Animal Care Committee(IACUC) Appointed by CEO CEO Members Three (3) or more• 1 Veterinarian• 1 member not affiliated with the institution (or relatedto a person affiliated with the institution) representinggeneral community interests in proper care andtreatment of animals.• Where there are more than 3, not more than 3 shall befrom the same administrative unit of the institution.7 USC §2143(b) & 9 CFR §2.31Five (5) or more• 1 Veterinarian• 1 individual who is not affiliated with the institution or related to aperson affiliated with the institution.• 1 practicing scientist• 1 non scientist• An individual may meet more than one category of membership.Policy, IV.A.3 Quorum A majority of the Committee members. 7 USC§2132(m); 9 CFR 1.1A quorum is required for all formal actions, includingsemi-annual inspections.7 USC §2143(b)(2)A majority of members of the Committee.Policy, III.I Chair No statement/policy Strongly recommends against having the IO or Veterinarian oranyone else with a potential conflict of interest serve as Chair.PHS FAQAnimal Care Committee(IACUC), continuedAnimal Welfare Act - USDA Public Health Service Policy - PHSSemi-Annual Report• Review every 6 months the institution's program forhumane care and use of animals using Title 9, as abasis.• Inspect every 6 months all of the institution's animalfacilities using Title 9 as a basis.NOTE: May use subcommittees composed of at least 2members to conduct the above reviews and inspections.• Submit written report of semi-annual reviews &inspections to IO; such report must describe theinstitution's adherence to Title 9 and identify anysignificant departures from Title 9, to include areasonable and specific plan and schedule, with dates,for correcting deficiencies.• Report reviewed and signed by majority of Committeemembers, including minority views.• Report within 15 business days to APHIS and anyfederal funding agencies any failures to adhere tocorrective plan and schedule that results in a significantdeficiency remaining uncorrected.9 CFR 2.31(c)(1)-(3)• Review every 6 months the institution's program for humane careand use of animals using the "Guide" and USDA regulations.• Inspect every 6 months all of the institution's animal facilities usingthe "Guide" and USDA regulationsUSDA regulations override conflicting Guide policy.• Submit written report to IO, describing the institution's adherenceto the Guide and any significant departures from the Guide, toinclude a reasonable and specific plan and schedule for correctingeach deficiency.• Report reviewed and signed by a majority of the members,including any minority views.Policy IV.B.Annual Report• Written report, signed by IO or CEO, to the ACRegional Director for the State on or before 12/1 ofeach calendar year covering the previous federal fiscalyear (10/1 - 9/30); assuring compliance with the Act,location of all facilities where animals are housed/used,and specific animal information.9 CFR 2.36• Written report to OLAW, including minority views, describing anychanges to the institution's program or facilities that would place itin a different category; changes in IACUC membership (or statingthat there are no changes) and dates that the Committee conductedits semi-annual evaluations. Policy IV.FAnnually file with Director of NIH a certification that the semi-annual reviews have been conducted, reporting any violationsinvolving care and treatment of animals or assurances that havecontinued after notice to the institution of such violation(s).Law §495(a)(3)Animal Care Committee(IACUC), continuedAnimal Welfare Act - USDA Public Health Service Policy - PHS Other Reports• Report to APHIS and any federal funding agency anysuspension of an activity involving animal andappropriate corrective action taken.9 CFR 2.31(d)(7)• Prompt written notice to OLAW of circumstances and actions re:- Any serious or continuing noncompliance with this Policy- Any serious deviation from the Guide- Any suspension of an activity by the CommitteePolicy IV.F.3• Report to OLAW any suspension of an activity involving animaland appropriate corrective action taken.Policy IV.C.7 Suspension ofProtocols• IACUC may suspend any previously approved activityif it determines that the activity is not being conductedin accordance with the protocol approved by theIACUC.• Suspension requires a review at a convened meeting ofa quorum with a majority vote of the quorum.9 CFR 2.31(d)(6)• IACUC may suspend previously approved activity upondetermination that the activity is not conducted in accordance withthe Animal Welfare Act (7 USC2131-2156 and Title 9), the Guide,the Institution's Assurance or the Policy.• Suspension requires a review at a convened meeting of a quorumwith a majority vote of the quorum.Policy, IV.C.6Animal Care Committee(IACUC), continuedIACUC