Current Regulations and Emerging Issues in the US

Transcription

1 Current Regulations and Emerging Issues in the US B. Taylor Bennett DVM, PHD, DACLAM Senior Scientific Advisor National Association for Biomedical Research

2 Guide for the Care and Use of Page 12 Regulations, Policies and Principles The use of laboratory animals is governed by an interrelated, dynamic system of regulations, policies, guidelines, and procedures.

3 Current Oversight and Emerging Issues in the US B. Taylor Bennett DVM, PHD, DACLAM Senior Scientific Advisor National Association for Biomedical Research

4 Involuntary mandated by law or exist as a condition of funding. Voluntary those that an individual/institution adheres to as part of their overall commitment to research and academic excellence.

5 Involuntary Animal Welfare Act(AWA) United States Dept. of Agriculture (USDA) PHS Policy on the Humane Care and Use of NIH Office of Laboratory Animal Welfare(OLAW) Good Laboratory Practice Regulations (GLPs) Food and Drug Administration (FDA) Private Funding Agencies

6 Voluntary Accreditation Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC) Individual Users

7 Animal Welfare Act first passed in 1966, amended in 1970, 1976, 1985,1990, 2002, 2008 Enabling Legislation Definitions, Regulations and Standards; 1985 harmonization with PHS Policy Animal warm blooded mammal except birds, mice and rats raised for research, and farm animals used for agricultural research Functions license dealers, register research institutions (1100), records, reports, power of enforcement unannounced inspections

8 Animal Welfare Act The Act prohibits the promulgation of rules, regulations, or orders which would interfere with the conduct of actual research. Determination of what constitutes actual research is left to the discretion of the research facility Exceptions for those areas covered by the program of adequate veterinary care for those areas which assure that professionally acceptable standards governing the care, treatment and use of animals are being followed by the research facility during actual research or experimentation

9 Laboratory Animals Regulatory Process Amendment to the Animal Welfare Act Secretary of Agriculture proposes additions or changes to existing regulations Publication of the proposed rule Public comment period Publication of final rule with explanations Implementation This process took 4 6 years following the 1985 amendment NABR s role advocate for sound public policy in support of ethical and essential animal research

10 Animal Welfare Regulations (AWR) Institutional Responsibilities Institutional Animal Care and Use Committee (IACUC) Personnel qualifications Attending Veterinarian & Program of Adequate Veterinary Care Record Keeping Requirements Annual Report

11 Institutional Responsibilities Institutional Animal Care and Use Committee (IACUC) Semi annual inspections and reviews prepare reports both facilities and management practices including PI s labs Review concerns Make recommendations Review, approve and require modification of proposed activities involving the use of animals adherence to the 3 Rs, properly trained personnel, proper assurances Authorized to suspend report to regulatory and funding agencies

12 Institutional Responsibilities Attending Veterinarian and Adequate Veterinary Care Employ an attending veterinarian under formal arrangements Provide the attending veterinarian with the appropriate authority to ensure the provision of adequate veterinary care and to oversee the adequacy of other aspects of animal care and use Voting member of the IACUC

13 Institutional Responsibilities Attending Veterinarian and Adequate Veterinary Care Each research facility shall provide the attending veterinarian with the necessary resources to manage an effective program of adequate veterinary care Appropriate facilities, personnel, equipment, and services Appropriate methods to prevent, control, diagnose, and treat diseases and injuries, and the availability of emergency, weekend, and holiday care Daily observation of all animals to assess their health and well being

14 Institutional Responsibilities Attending Veterinarian and Adequate Veterinary Care Each research facility shall provide the attending veterinarian with the necessary resources to manage an effective program of adequate veterinary care Guidance to PIs and other personnel regarding handling, immobilization, anesthesia, analgesia, tranquilization, and euthanasia Adequate pre procedural and post procedural care in accordance with current established veterinary medical and nursing procedures

15 (PHS) PHS Policy intended to implement and supplement the US Government Principles Implementation by Awardee Institution Institutional Program Guide for the Care and Use of (NAP 1996) Institutional Status AAALAC accreditation Animal Welfare Assurance 1373/1009

16 USDA Regulations and Standards Animal excludes rats, mice and birds Registration IACUC 3 Unannounced inspections PHS PHS Policy, US Principles & Guide All vertebrate animals Animal Welfare Assurance Self regulation IACUC 5 Inspection for cause

17 Food and Drug Administration (FDA) Good Laboratory Practice Regulations (1978) regulates the use of animals in nonclinical laboratory studies. GLP Requirements 1. Protocols 2. SOP'S 3. QA 4. Archives

18 Private Funding agencies Proof of Assurance AAALAC accreditation Special Requirements Copies of USDA inspections Approved protocol at time of submission

19 AAALAC Association for the Assessment and Accreditation of Laboratory Animal Care International Peer review program with progressive standards Uses the Guide for the Care and Use of Laboratory Animals (NAS 2011) 688 accredited institutions in the US

20 Individual Users should provide the impetus for setting and maintaining high standards. Reducing Non experimental Variability good care = good science. Maintain the integrity of the Scientific Process self regulation prevents costly regulatory oversight.

21 Key components of an Institutional Animal Care and Use Program (ACUP) Institutional Official Institutional Animal Care and Use Committee (IACU) Attending veterinarian

22 Key functions of an Institutional Animal Care and Use Program (ACUP) Assuring institutional compliance Facilitating research Optimizing the welfare of the animals Four legged ones Two legged ones

23 Optimizing animal welfare The four legged ones Should be relatively easy The two legged ones Do not have as much control over either their primary enclosures or ambient environment We do have a lot of control over providing an environment that enhances their psychological wellbeing

24 Optimizing animal welfare User friendly research support service that is designed to minimize the ever growing regulatory burden that PIs must deal with to manage their laboratories Seen as part of the solution and not part of the problem

25 Optimizing animal welfare Effective day to day research support service Positive communication environment that encourages people to interact Solutions to issues and not reasons why something cannot be done An environment that makes compliance easy for the user Create a culture of compliance

26 Emerging ( Evolving) Issues Increasing Administrative Burden Regulatory burden Institutional down streaming Age of Enforcement Use (misuse) FOIA Assuring compliance with declining resources

27 Emerging Issues Increasing Administrative Burden PHS Assurances and certifications 12 pages of instructions Institutional organization Senior laboratory technician Program administrator

28 Emerging Issues Age of Enforcement May of 2010 Shift from an education focus to an enforcement focus Change in emphasis on repeat non compliant items 669 NCI s in 1679 inspections Review of the top 10 citations 289 NCI s Citations for corrected items discovered in the institutions own records

29 Emerging Issues Use (misuse) FOIA Some activists post the information they receive to internet sites labeling investigators as animal abusers. Some sites encourage harassment of PIs and a few facilitate or suggest the use of illegal actions. Animal rights extremists intent on taking direct action against researchers use websites to identify a target. Time and effort associated with blanket requests

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31 Laboratory Animals SCAW Dec 2010

32 Showing primate vivisectors/primate vivisection grants in the U.S total results/grants. 920 distinct vivisectors (show only distinct vivisectors). SCAW Dec 2010

33 Emerging Issues Assuring compliance with declining resources Funding not keeping up with increasing cost Cost passed on to the investigators in the form of increased per diems and service charges Reducing the resources available for the research itself The facilitating function becomes harder to maintain Compromises the positive communication environment that encourages people to interact Compromises the culture of compliance

34 Laboratory Animals Summary The use of laboratory animals is governed by an interrelated, dynamic system of regulations, policies, guidelines, and procedures. IACUC and attending veterinarian are key to the system at the institutional level Maintaining a positive communication environment that encourages people to interact is critical

35 Laboratory Animals Summary The emerging issues will make maintaining that environment more difficult