Expanding US Laboratory Animal Laws to Other Species

Transcription

1 Steven M. Niemi, DVM, DACLAM 26 January 2018 Cambridge MA Expanding US Laboratory Animal Laws to Other Species Future Directions for Laboratory Animal Law in the United States

2 For the Record The opinions expressed in this presentation are mine alone and may not reflect those of current or past employers, professional affiliations, colleagues, family, or anyone else I ever met. I have no commercial or financial conflicts to declare. Any commercial entities mentioned are named only for example purposes, and does not imply an endorsement of any products or services. 2

3 Overview Species covered under the AWA today What s excluded? Is a change indicated? If so, how could we get there?

4 How This Began

5 Definition The term animal means any live or dead dog, cat, monkey (nonhuman primate mammal), guinea pig, hamster, rabbit, or such other warmblooded animal, as the Secretary may determine is being used, or is intended for use, for research, testing, experimentation, or exhibition purposes, or as a pet; but such term excludes (1) birds, rats of the genus Rattus, and mice of the genus Mus, bred for use in research, (2) horses not used for research purposes, and (3) other farm animals, such as, but not limited to livestock or poultry, used or intended for use as food or fiber, or livestock or poultry used or intended for use for improving animal nutrition, breeding, management, or production efficiency, or for improving the quality of food or fiber. With respect to a dog, the term means all dogs including those used for hunting, security, or breeding purposes. 9 CFR AWA, 2132(g) 9 CFR AWA Regulations, Part 1, 1.1

6 Definition The term animal means any live or dead dog, cat, monkey (nonhuman primate mammal), guinea pig, hamster, rabbit, or such other warmblooded animal, as the Secretary may determine is being used, or is intended for use, for research, testing, experimentation, or exhibition purposes, or as a pet; but such term excludes (1) birds, rats of the genus Rattus, and mice of the genus Mus, bred for use in research, (2) horses not used for research purposes, and (3) other farm animals, such as, but not limited to livestock or poultry, used or intended for use as food or fiber, or livestock or poultry used or intended for use for improving animal nutrition, breeding, management, or production efficiency, or for improving the quality of food or fiber. With respect to a dog, the term means all dogs including those used for hunting, security, or breeding purposes. 9 CFR AWA, 2132(g) 9 CFR AWA Regulations, Part 1, 1.1

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8 III. Definitions A. Animal Any live, vertebrate animal used or intended for use in research, research training, experimentation, or biological testing or for related purposes. II. Applicability This Policy is applicable to all PHS-conducted or supported activities involving animals (*) (* and beyond, e.g.,

9 Why It Matters Home Office Great Britain # procedures in 2016 Mice m (72.8%) Fish m (13.6%) Rats m (6.3%) Birds m (3.8%)

10 Why It Matters

11 Why It Matters Species (search title & abstract) # Publications WW Rabbit (any part of any word) 168,255 Pig 122,716 Cat 91,909 Dog 86,344 Monkey or Primate (sum) 72,680 Guinea Pig 66,404 Hamster 55,885

12 Why It Matters Species (search title & abstract) # Publications WW Rabbit (any part of any word) 168,255 Pig 122,716 Cat 91,909 Dog 86,344 Monkey or Primate (sum) 72,680 Guinea Pig 66,404 Hamster 55,885 Mouse or Mice (sum) 1,101,653 Rat 818,580 Frog 29,577 Zebrafish or Zebra fish (sum) 27,780 Bird 19,604

13 Why It Matters 2015: In U.S., More Say Animals Should Have Same Rights as People

14 Why It Matters 2017: Americans Hold Record Liberal Views on Most Moral Issues Medical testing on animals is another issue showing substantial change over the past 16 years, with the percentage finding it morally acceptable dropping from 65% in when it ranked among the most acceptable issues -- to 51% today. Unlike the shifts in attitudes about marriage, young adults are driving attitudinal changes on animal medical testing. Fifty-nine percent of Americans aged 50 and older believe medical testing on animals is morally acceptable, compared with 45% of those younger than 50.

15 Now s the Time

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17 How Could We Get There? 1. Reduction/Replacement Combine 2 federal oversight bodies 1 Single set of laws and regulations Include all vertebrate species Regardless of funding source Regardless of end-use scope of species coverage redundant or conflicting regulations confusion, risk of non-compliance wasteful spending of diminishing $

18 July 27,

19 Recommendation # 5.7 assess the feasibility and utility of developing a unified federal approach for the development, promulgation, and management of policies and regulations pertaining to the care and use of research animals. (page 115)

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21 1 st Recommendation The Executive Office of the President (EOP) and the Office of Management and Budget (OMB) should explore whether regulatory efficiencies could be gained, and burden reduced, by consolidating animal research oversight under a single Federal office or entity with one primary set of regulations and guidance documents.

22 How Could We Get There? 2. Refinement inspector education inspector training Augment learning modules with guided tours, wet labs # inspectors? ($?) Specialist inspectors? ($?)

23 How Could We Get There? 3. Refinement Emphasize performance standards (evidence-based outcomes) over engineering standards (quantitative inputs)

24 How Could We Get There? Refinement to Performance Standards JD Bailoo, et al. (2017). Evaluation of the effects of space allowance on measures of animal welfare in laboratory mice. Sci Rprts. DOI: /s

25 How Could We Get There? Refinement to Performance Standards (b) Sanitation of enclosures cages, rooms, and hard-surfaced pens or runs shall be sanitized either by washing them with hot water (180 F. at source) and soap or detergent, as in a mechanical washer, or by washing all soiled surfaces with a detergent solution followed by a safe and effective disinfectant, or by cleaning all soiled surfaces with saturated live steam under pressure. (AWA Regs Part 3, Subpart F, 3.131)

26 How Could We Get There? ILAR Roundtable s Workshop on Performance Standards April 2015 Washington, DC

27 How Could We Get There? 5. Refinement Establish scientific advisory council(s) Researchers, veterinarians, protectionists Public meeting agendas, minutes Useful model = Scientific Advisory Committee on Alternative Toxicological Methods (SACATM)

28 How Could We Get There? (Reduce/Replace/Refine) It must comprise the entire package

29 In Closing "It's never too late be what you might have been." Mary Ann Evans (pen name - George Eliot)

30 Steven M. Niemi, DVM, DACLAM 26 January 2018 Cambridge MA Expanding US Laboratory Animal Laws to Other Species Future Directions for Laboratory Animal Law in the United States