Editing Animal testing (section)

==Care and use of animals==
===Regulations and laws===
{{See also|Animal testing regulations|Institutional Animal Care and Use Committee|Animals (Scientific Procedures) Act 1986|European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes}}{{World laws on cosmetic animal testing}}The regulations that apply to animals in laboratories vary across species. In the U.S., under the [[Animal Welfare Act of 1966|Animal Welfare Act]] and the ''Guide for the Care and Use of Laboratory Animals'' (the ''Guide''), published by the National Academy of Sciences, any procedure can be performed on an animal if it can be successfully argued that it is scientifically justified. Researchers are required to consult with the institution's veterinarian and its [[Institutional Animal Care and Use Committee]] (IACUC), which every research facility is obliged to maintain.<ref name=Carbone68>Carbone, pp. 68–69.</ref> The IACUC must ensure that alternatives, including non-animal alternatives, have been considered, that the experiments are not unnecessarily duplicative, and [[Pain in animals|that pain relief is given]] unless it would interfere with the study. The IACUCs regulate all vertebrates in testing at institutions receiving federal funds in the USA. Although the Animal Welfare Act does not include purpose-bred rodents and birds, these species are equally regulated under Public Health Service policies that govern the IACUCs.<ref>[http://grants.nih.gov/grants/olaw/references/phspol.htm#AnimalWelfareAssurance Office of Laboratory Animal Welfare]. Public Health Service Policy on Humane Care and Use of Laboratory Animals. nih.gov</ref><ref>[http://edocket.access.gpo.gov/cfr_2008/janqtr/9cfr1.1.htm Title 9 – Animals and Animal Products]. Code of Federal Regulations. Vol. 1 (1 January 2008).</ref> The Public Health Service policy oversees the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).&nbsp;The CDC conducts infectious disease research on nonhuman primates, rabbits, mice, and other animals, while FDA requirements cover use of animals in pharmaceutical research.<ref name="aldf.org">{{cite web|url=http://aldf.org/resources/when-you-witness-animal-cruelty/animal-testing-and-the-law/?gclid=CJmh4vzmvdQCFUWCfgodqA8Hlg|title=Animal Testing and the Law – Animal Legal Defense Fund|website=Animal Legal Defense Fund|access-date=2017-06-14|archive-url=https://web.archive.org/web/20170823020847/http://aldf.org/resources/when-you-witness-animal-cruelty/animal-testing-and-the-law/?gclid=CJmh4vzmvdQCFUWCfgodqA8Hlg|archive-date=23 August 2017}}</ref> Animal Welfare Act (AWA) regulations are enforced by the USDA, whereas Public Health Service regulations are enforced by OLAW and in many cases by AAALAC.

According to the 2014 U.S. Department of Agriculture Office of the Inspector General (OIG) report—which looked at the oversight of animal use during a three-year period—"some Institutional Animal Care and Use Committees ...did not adequately approve, monitor, or report on experimental procedures on animals". The OIG found that "as a result, animals are not always receiving basic humane care and treatment and, in some cases, pain and distress are not minimized during and after experimental procedures". According to the report, within a three-year period, nearly half of all American laboratories with regulated species were cited for AWA violations relating to improper IACUC oversight.<ref>{{cite journal|last1=Harden|first1=Gil|title=USDA Inspector General Audit Report of APHIS Animal Care Program Inspection and Enforcement Activities|journal=United States Department of Agriculture Office of Inspector General|issue=Report No. 33601–0001–41|url=http://www.usda.gov/oig/webdocs/33601-0001-41.pdf|access-date=7 July 2015}}</ref> The USDA OIG made similar findings in a 2005 report.<ref>{{cite journal|date=September 2005|title=Audit Report: APHIS Animal Care Program Inspection and Enforcement Activities|url=http://www.usda.gov/oig/webdocs/33002-03-SF.pdf|journal=USDA Office of Inspector General Western Region|issue=Report No. 33002–3–SF|last1=Young|first1=Robert|access-date=7 July 2015}}</ref> With only a broad number of 120 inspectors, the United States Department of Agriculture&nbsp;(USDA) oversees more than 12,000 facilities involved in research, exhibition, breeding, or dealing of animals.<ref name="aldf.org" /> Others have criticized the composition of IACUCs, asserting that the committees are predominantly made up of animal researchers and university representatives who may be biased against animal welfare concerns.<ref>{{cite journal|last1=Hansen|first1=L|last2=Goodman|first2=J|last3=Chandna|first3=A|title=Analysis of animal research ethics committee membership at American institutions|journal=Animals|date=2012|volume=2|issue=1|pages=68–75|doi=10.3390/ani2010068|pmid=26486777|pmc=4494267|doi-access=free}}</ref>

Larry Carbone, a laboratory animal veterinarian, writes that, in his experience, IACUCs take their work very seriously regardless of the species involved, though the use of [[non-human primates]] always raises what he calls a "red flag of special concern".<ref>Carbone, p. 94.</ref> A study published in ''Science'' magazine in July 2001 confirmed the low reliability of IACUC reviews of animal experiments. Funded by the National Science Foundation, the three-year study found that animal-use committees that do not know the specifics of the university and personnel do not make the same approval decisions as those made by animal-use committees that do know the university and personnel. Specifically, blinded committees more often ask for more information rather than approving studies.<ref>{{cite journal | vauthors = Plous S, Herzog H | title = Animal Research: Reliability of Protocol Reviews for Animal Research | journal = Science | volume = 293 | issue = 5530 | pages = 608–09 | year = 2001 | pmid = 11474086 | doi = 10.1126/science.1061621 | s2cid = 33314019 }}</ref>

Scientists in India are protesting a recent guideline issued by the [[University Grants Commission (India)|University Grants Commission]] to ban the use of live animals in universities and laboratories.<ref>{{cite news|first =Jayashree|last =Nandi|url=http://articles.timesofindia.indiatimes.com/2012-04-27/science/31421085_1_animals-zoology-scientists |archive-url=https://web.archive.org/web/20121027144438/http://articles.timesofindia.indiatimes.com/2012-04-27/science/31421085_1_animals-zoology-scientists |archive-date=27 October 2012 |title=Scientists take on activists, want ban on live testing on animals lifted|date=27 April 2012 |newspaper =[[The Times of India]]|access-date=2012-07-13}}</ref>

On April 10, 2025, the FDA announced<ref>{{Cite web |last=Commissioner |first=Office of the |date=2025-04-10 |title=FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs |url=https://www.fda.gov/news-events/press-announcements/fda-announces-plan-phase-out-animal-testing-requirement-monoclonal-antibodies-and-other-drugs |archive-url=https://web.archive.org/web/20250410194347/https://www.fda.gov/news-events/press-announcements/fda-announces-plan-phase-out-animal-testing-requirement-monoclonal-antibodies-and-other-drugs |url-status=dead |archive-date=10 April 2025 |access-date=2025-05-13 |website=FDA |language=en}}</ref> a Roadmap to Reducing Animal Testing in Preclinical Safety Studies<ref>{{Cite web |title=Roadmap to Reducing Animal Testing in Preclinical Safety Studies |url=https://www.fda.gov/media/186092/download?attachment |website=FDA}}</ref> to reduce and phase out animal testing and promote alternatives such as advanced computer simulations and lab grown human "organoids" and organ-on-a-chip systems. Over 90% of drugs that appear safe and effective in animals do not go on to receive FDA approval in humans predominantly due to safety and/or efficacy issues.<ref>{{cite journal | vauthors = Marshall LJ, Bailey J, Cassotta M, Herrmann K, Pistollato F | title = Poor Translatability of Biomedical Research Using Animals - A Narrative Review | journal = Altern Lab Anim. | volume = 51 | issue = 2 | pages = 102–135 | date = March 2023 | pmid = 36883244 | doi = 10.1177/02611929231157756 | doi-access = free }}</ref>

===Numbers===
Accurate global figures for animal testing are difficult to obtain; it has been estimated that 100 million vertebrates are experimented on around the world every year,<ref>{{cite journal |last1=Taylor |first1=Katy |last2=Gordon |first2=Nicky |last3=Langley |first3=Gill |last4=Higgins |first4=Wendy |date=2008 |title=Estimates for worldwide laboratory animal use in 2005 |journal=ATLA |volume=36 |issue=3 |pages=327–42 |pmid=18662096|doi=10.1177/026119290803600310 |s2cid=196613886 |url=https://animalstudiesrepository.org/acwp_lab/14 |doi-access=free }}</ref> 10–11 million of them in the EU.<ref name="hunter2014">{{cite news | author=Hunter, Robert G. | title=Alternatives to animal testing drive market | quote=While growth has leveled off and there have been significant reductions in some countries, the number of animals used in research globally still totals almost 100 million a year. | work=[[Gen. Eng. Biotechnol. News]] | date=1 January 2014 | page=11 | issue=1 | volume=34 | url=http://www.genengnews.com/gen-articles/alternatives-to-animal-testing-drive-market/5095/ }}{{open access}}</ref> The [[Nuffield Council on Bioethics]] reports that global annual estimates range from 50 to 100 million animals. None of the figures include invertebrates such as shrimp and fruit flies.<ref name="nuffield45">{{cite web|url=http://www.nuffieldbioethics.org/fileLibrary/pdf/RIA_Report_FINAL-opt.pdf |title=The Ethics of research involving animals |publisher=Nuffield Council on Bioethics |archive-url=https://web.archive.org/web/20080625033250/http://www.nuffieldbioethics.org/fileLibrary/pdf/RIA_Report_FINAL-opt.pdf |archive-date=25 June 2008 }}</ref>[[File:Animaltesting.svg|thumb|356x356px|Number of animals under the Animal Welfare Act (A.W.A.) used or held for research, testing, teaching, experimentation, and/or surgery in U.S. research facilities in 2021]]The&nbsp;USDA/APHIS&nbsp;has&nbsp;published the 2016 animal research statistics. Overall, the number of animals (covered by the Animal Welfare Act) used in research in the US&nbsp;rose 6.9%&nbsp;from 767,622 (2015) to 820,812 (2016).<ref>{{cite news|url=https://speakingofresearch.com/2017/06/19/usda-publishes-2016-animal-research-statistics-7-rise-in-animal-use/|title=USDA publishes 2016 animal research statistics – 7% rise in animal use|date=2017-06-19|work=Speaking of Research|access-date=2017-12-10}}</ref> This includes both public and private institutions. By comparing with EU data, where all [[vertebrate]] species are counted, [[Speaking of Research]] estimated that around 12 million vertebrates were used in research in the US in 2016.<ref name="USDA2016">{{cite web|url=http://speakingofresearch.com/facts/statistics/|title=USDA Statistics for Animals Used in Research in the US|publisher=Speaking of Research|date=20 March 2008}}</ref> A 2015 article published in the ''[[Journal of Medical Ethics]]'', argued that the use of animals in the US has dramatically increased in recent years. Researchers found this increase is largely the result of an increased reliance on genetically modified mice in animal studies.<ref name="GoodmanChandnaRoe">{{cite journal|last1=Goodman|first1=J.|last2=Chandna|first2=A.|last3=Roe|first3=K.|date=2015|title=Trends in animal use at US research facilities|url=http://jme.bmj.com/content/early/2015/01/27/medethics-2014-102404.abstract|journal=Journal of Medical Ethics|volume=41|issue=7|pages=567–69|doi=10.1136/medethics-2014-102404|pmid=25717142|s2cid=46187262|access-date=7 July 2015}}</ref>

In 1995, researchers at Tufts University Center for Animals and Public Policy estimated that 14–21 million animals were used in American laboratories in 1992, a reduction from a high of 50 million used in 1970.<ref>Rowan, A., Loew, F., and Weer, J. (1995) "The Animal Research Controversy. Protest, Process and Public Policy: An Analysis of Strategic Issues." ''Tufts University'', North Grafton. cited in Carbone 2004, p. 26.</ref> In 1986, the U.S. Congress Office of Technology Assessment reported that estimates of the animals used in the U.S. range from 10 million to upwards of 100 million each year, and that their own best estimate was at least 17 million to 22 million.<ref>''Alternatives to Animal Use in Research, Testing and Education'', U.S. Congress Office of Technology Assessment, Washington, D.C.:Government Printing Office, 1986, p. 64. In 1966, the Laboratory Animal Breeders Association estimated in testimony before Congress that the number of mice, rats, guinea pigs, hamsters, and rabbits used in 1965 was around 60 million. (Hearings before the Subcommittee on Livestock and Feed Grains, Committee on Agriculture, U.S. House of Representatives, 1966, p. 63.)</ref> In 2016, the Department of Agriculture listed 60,979 dogs, 18,898 cats, 71,188 non-human primates, 183,237 guinea pigs, 102,633 hamsters, 139,391 rabbits, 83,059 farm animals, and 161,467 other mammals, a total of 820,812, a figure that includes all mammals except purpose-bred mice and rats. The use of dogs and cats in research in the U.S. decreased from 1973 to 2016 from 195,157 to 60,979, and from 66,165 to 18,898, respectively.<ref name=USDA2016 />

In the UK, Home Office figures show that 3.79 million procedures were carried out in 2017.<ref name="UK Home Office 2016">{{cite web|date=2017|url=http://www.understandinganimalresearch.org.uk/news/communications-media/animal-research-numbers-in-2017/ |title=Animal research numbers in 2017 |publisher=Understanding Animal Research}}</ref> 2,960 procedures used non-human primates, down over 50% since 1988. A "procedure" refers here to an experiment that might last minutes, several months, or years. Most animals are used in only one procedure: animals are frequently euthanized after the experiment; however death is the endpoint of some procedures.<ref name=nuffield45/>
The procedures conducted on animals in the UK in 2017 were categorised as: 43% (1.61 million) sub-threshold, 4% (0.14 million) non-recovery, 36% (1.35 million) mild, 15% (0.55 million) moderate, and 4% (0.14 million) severe.<ref name=SR2017>{{cite web|url=https://speakingofresearch.com/facts/uk-statistics/ |title=Home Office Statistics for Animals Used in Research in the UK |publisher=Speaking of Research|date=23 October 2012 }}</ref> A 'severe' procedure would be, for instance, any test where death is the end-point or fatalities are expected, whereas a 'mild' procedure would be something like a blood test or an MRI scan.<ref name="UK Home Office 2016" />

===The Three Rs===
{{Main|Three Rs (animal research)}}
The Three Rs (3Rs) are guiding principles for more ethical use of animals in testing.  These were first described by W.M.S. Russell and R.L. Burch in 1959.<ref name="altweb.jhsph">{{cite book |url=http://altweb.jhsph.edu/pubs/books/humane_exp/het-toc |title=The principles of humane experimental technique |last1=Russell, W. M. S. (William Moy Stratton) |last2=Health |first2=JH Bloomberg School of Public |date=1992 |publisher=Universities Federation for Animal Welfare |isbn=0-900767-78-2 |edition=Special |location=South Mimms, Potters Bar, Herts, England |oclc=27347928 |access-date=16 August 2013 |archive-date=27 September 2011 |archive-url=https://web.archive.org/web/20110927060555/http://altweb.jhsph.edu/pubs/books/humane_exp/het-toc |url-status=dead }}</ref> The 3Rs state:
# Replacement which refers to the preferred use of non-animal methods over animal methods whenever it is possible to achieve the same scientific aims. These methods include computer modeling.
# Reduction which refers to methods that enable researchers to obtain comparable levels of information from fewer animals, or to obtain more information from the same number of animals.
# Refinement which refers to methods that alleviate or minimize potential pain, suffering or distress, and enhance [[animal welfare]] for the animals used. These methods include non-invasive techniques.<ref name="Badyal">{{cite journal |author=Badyal D. |author2=Desai C.|year=2014|title=Animal use in pharmacology education and research: The changing scenario|journal=Indian Journal of Pharmacology|volume=46|issue=3|pages=257–65|doi=10.4103/0253-7613.132153|pmc=4071700|pmid=24987170 |doi-access=free }}</ref>
The 3Rs have a broader scope than simply encouraging alternatives to animal testing, but aim to improve animal welfare and scientific quality where the use of animals can not be avoided.  These 3Rs are now implemented in many testing establishments worldwide and have been adopted by various pieces of legislation and regulations.<ref name="Ethical">{{cite journal |author1=Liguori, G.| display-authors=etal| year = 2017 | title = Ethical Issues in the Use of Animal Models for Tissue Engineering: Reflections on Legal Aspects, Moral Theory, 3Rs Strategies, and Harm-Benefit Analysis| journal = Tissue Engineering Part C: Methods | volume = 23 | issue = 12 | pages= 850–62 | doi=10.1089/ten.TEC.2017.0189| pmid=28756735| s2cid=206268293| url=https://pure.rug.nl/ws/files/51950145/ten.tec.2017.0189.pdf}}</ref>

Despite the widespread acceptance of the 3Rs, many countries—including Canada, Australia, Israel, South Korea, and Germany—have reported rising experimental use of animals in recent years with increased use of mice and, in some cases, fish while reporting declines in the use of cats, dogs, primates, rabbits, guinea pigs, and hamsters. Along with other countries<!-- which specific ''other" countries? -->, China has also escalated its use of [[Genetically modified animal|GM animals]], resulting in an increase in overall animal use.<ref>{{cite web |website=Canadian Council on Animal Care |title=2009 CCAC Survey of Animal Use |date=December 2010 |url=http://www.ccac.ca/Documents/Publications/Statistics/Survey_2009.pdf |access-date=7 July 2015 |archive-url=https://web.archive.org/web/20150607174417/http://www.ccac.ca/Documents/Publications/Statistics/Survey_2009.pdf |archive-date=7 June 2015 }}</ref><ref>{{cite news |last1=Merkes |first1=M. |last2=Buttrose |first2=R. |title=New code, same suffering: animals in the lab |url=http://www.abc.net.au/news/2013-08-01/merkes-and-buttrose-animal-testing/4857604 |access-date=7 July 2015 |agency=The Drum |publisher=ABC}}</ref><ref>{{cite news |last1=Even |first1=Dan |title=Number of animal experiments up for first time since 2008 |url=http://www.haaretz.com/news/national/number-of-animal-experiments-up-for-firsttime-since-2008.premium-1.526516 |access-date=7 July 2015 |agency=Haaretz |date=29 May 2013}}</ref><ref>{{cite web |title=Rise in animal research in South Korea in 2017 |website=Speaking of Research |date=20 April 2018 |url=https://speakingofresearch.com/2018/04/12/rise-in-animal-research-in-south-korea-in-2017/ |access-date=23 July 2017}}</ref><ref>{{cite web |title=Number of laboratory animals in Germany |url=http://www.mpg.de/286584/Numbers |website=Max-Planck-Gesellschaft |access-date=7 July 2015}}</ref><ref>{{cite journal |last1=Kong |first1=Q. |last2=Qin |first2=C. |title=Analysis of current laboratory animal science policies and administration in China |journal=ILAR |date=2009 |volume=51 |issue=1 |pages=e1–e11 |pmid=20075493 |doi=10.1093/ilar.51.1.e1|doi-access=free }}</ref>{{Excessive citations inline
| date = July 2020
}}

===Sources===
{{Main|Laboratory animal sources|International primate trade}}
Animals used by laboratories are largely supplied by specialist dealers. Sources differ for vertebrate and invertebrate animals. Most laboratories breed and raise flies and worms themselves, using strains and mutants supplied from a few main stock centers.<ref>[http://www.ncrr.nih.gov/comparative_medicine/resource_directory/invertebrates.asp Invertebrate Animal Resources] {{webarchive|url=https://web.archive.org/web/20071025061451/http://www.ncrr.nih.gov/comparative_medicine/resource_directory/invertebrates.asp |date=25 October 2007 }}. National Center for Research Resources. ncrr.nih.gov</ref> For vertebrates, sources include breeders and dealers including [[Fortrea]] and [[Charles River Laboratories]], which supply purpose-bred and wild-caught animals; businesses that trade in wild animals such as [[Nafovanny]]; and dealers who supply animals sourced from pounds, auctions, and newspaper ads. [[Animal shelter]]s also supply the laboratories directly.<ref>{{cite web|url=http://www.aesop-project.org/Oversight.htm |title=Who's Who of Federal Oversight of Animal Issues |publisher=Aesop-project.org |url-status=usurped |archive-url=https://web.archive.org/web/20070922123927/http://www.aesop-project.org/Oversight.htm |archive-date=22 September 2007 }}</ref> Large centers also exist to distribute strains of [[genetically modified animal]]s; the [[International Knockout Mouse Consortium]], for example, aims to provide [[knockout mouse|knockout mice]] for every gene in the mouse genome.<ref>{{cite journal |vauthors=Collins FS, Rossant J, Wurst W | title = A mouse for all reasons | journal = Cell | volume = 128 | issue = 1 | pages = 9–13 | year = 2007 | pmid = 17218247 | doi = 10.1016/j.cell.2006.12.018 | s2cid = 18872015 | doi-access = free }}</ref>
[[File:Muizenkooi met houten muizen (3).JPG|thumb|left|A laboratory mouse cage. Mice are either bred commercially, or raised in the laboratory.]]
In the U.S., Class A breeders are licensed by the U.S. Department of Agriculture (USDA) to sell animals for research purposes, while Class B dealers are licensed to buy animals from "random sources" such as auctions, pound seizure, and newspaper ads. Some Class B dealers have been accused of kidnapping pets and illegally trapping strays, a practice known as ''bunching''.<ref name=Gillham/><ref name="Class B dealers">[http://www.hsus.org/animals_in_research/class_b_dealers/ Class B dealers] {{Webarchive|url=https://web.archive.org/web/20100429102206/http://www.hsus.org/animals_in_research/class_b_dealers/ |date=29 April 2010 }}, Humane Society of the United States.</ref><ref>{{usurped|1=[https://web.archive.org/web/20070922123927/http://www.aesop-project.org/Oversight.htm "Who's Who of Federal Oversight of Animal Issues"]}}, Aesop Project.</ref><ref>Salinger, Lawrence and Teddlie, Patricia. [http://citation.allacademic.com/meta/p_mla_apa_research_citation/0/3/3/8/8/p33882_index.html "Stealing Pets for Research and Profit: The Enforcement (?) of the Animal Welfare Act"] {{Webarchive|url=https://archive.today/20130116184728/http://citation.allacademic.com/meta/p_mla_apa_research_citation/0/3/3/8/8/p33882_index.html |date=16 January 2013 }}, paper presented at the annual meeting of the American Society of Criminology, Royal York, Toronto, 15 October 2006</ref><ref>Reitman, Judith (1995) ''Stolen for Profit'', Zebra, {{ISBN|0-8217-4951-X}}.</ref><ref>Moran, Julio (12 September 1991) [https://www.latimes.com/archives/la-xpm-1991-09-12-me-3212-story.html "Three Sentenced to Prison for Stealing Pets for Research,"] L.A. Times.</ref> It was in part out of public concern over the sale of pets to research facilities that the 1966 Laboratory Animal Welfare Act was ushered in—the Senate Committee on Commerce reported in 1966 that stolen pets had been retrieved from Veterans Administration facilities, the Mayo Institute, the University of Pennsylvania, Stanford University, and Harvard and Yale Medical Schools.<ref>[[Gary L. Francione|Francione, Gary]]. ''Animals, Property, and the Law''. Temple University Press, 1995, p. 192; Magnuson, Warren G., Chairman. "Opening remarks in hearings prior to enactment of Pub. L. 89-544, the Laboratory Animal Welfare Act," U.S. Senate Committee on Commerce, 25 March 1966.</ref> The USDA recovered at least a dozen stolen pets during a raid on a Class B dealer in Arkansas in 2003.<ref name=HSUSBaird>{{usurped|1=[https://web.archive.org/web/20080325225027/http://www.hsus.org/animals_in_research/animals_in_research_news/animal_dealer_loses_license_and_pays_record_fine.html Notorious Animal Dealer Loses License and Pays Record Fine]}}, The Humane Society of the United States</ref>

Four states in the U.S.—[[Minnesota]], [[Utah]], [[Oklahoma]], and [[Iowa]]—require their shelters to provide animals to research facilities. Fourteen states explicitly prohibit the practice, while the remainder either allow it or have no relevant legislation.<ref name=ASPCAdealers>{{usurped|1=[https://web.archive.org/web/20080627163237/http://www.aspca.org/site/PageServer?pagename=kids_ri_animaltesting_comefrom Animal Testing: Where Do the Animals Come From?]}}. American Society for the Prevention of Cruelty to Animals. According to the ASPCA, the following states prohibit shelters from providing animals for research: Connecticut, Delaware, Hawaii, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, Vermont, and West Virginia.</ref>

In the European Union, animal sources are governed by ''Council Directive 86/609/EEC'', which requires lab animals to be specially bred, unless the animal has been lawfully imported and is not a wild animal or a stray. The latter requirement may also be exempted by special arrangement.<ref name=direct1>{{CELEX|31986L0609|text=Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes}}</ref> In 2010 the Directive was revised with [[EU Directive 2010/63/EU]].<ref>{{CELEX|32010L0063|text=Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes}}</ref> In the UK, most animals used in experiments are bred for the purpose under the 1988 Animal Protection Act, but wild-caught primates may be used if exceptional and specific justification can be established.<ref>[http://www.ukcites.gov.uk/pdf_files/Sep05GN9%20Primate%20imports.pdf Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES)] {{webarchive|url=https://web.archive.org/web/20070731082707/http://www.ukcites.gov.uk/pdf_files/Sep05GN9%20Primate%20imports.pdf |date=31 July 2007 }} Department for Environment, Food and Rural Affairs</ref><ref name=HOStats>{{cite web|url=http://www.official-documents.gov.uk/document/cm67/6713/6713.pdf |title="Statistics of Scientific Procedures on Living Animals", Statistics of Scientific Procedures on Living Animals, Home Office|year= 2004| page=87 }}</ref> The United States also allows the use of wild-caught primates; between 1995 and 1999, 1,580 wild baboons were imported into the U.S. Most of the primates imported are handled by [[Charles River Laboratories]] or by [[Fortrea]], which are very active in the [[international primate trade]].<ref>{{usurped|1=[https://web.archive.org/web/20070708204056/http://www.ippl.org/04-25-07c.html U.S. Primate Imports Spike]}} ''International Primate Protection League'' April 2007</ref>

===Pain and suffering===
{{Further|Animal cognition|Pain in animals|Pain in fish|Pain in amphibians|Pain in invertebrates|Pain in cephalopods}}
[[File:Frog vivisection.jpg|thumb|right|Prior to dissection for educational purposes, [[chloroform]] was administered to this [[Common Sand Frog|common sand frog]] to induce [[anesthesia]] and death.]]
The extent to which animal testing causes [[pain]] and [[suffering]], and the capacity of animals to experience and comprehend them, is the subject of much debate.<ref>{{cite journal |vauthors=Duncan IJ, Petherick JC | title = The implications of cognitive processes for animal welfare | journal = Journal of Animal Science | volume = 69 | issue = 12 | pages = 5017–22 | year = 1991 | pmid = 1808195 | doi=10.2527/1991.69125017x}}</ref><ref>{{cite journal |vauthors=Curtis SE, Stricklin WR | title = The importance of animal cognition in agricultural animal production systems: an overview | journal = Journal of Animal Science | volume = 69 | issue = 12 | pages = 5001–07 | year = 1991 | pmid = 1808193 | doi=10.2527/1991.69125001x}}</ref>

According to the USDA, in 2016 501,560 animals (61%) (not including rats, mice, birds, or invertebrates) were used in procedures that did not include more than momentary pain or distress. 247,882 (31%) animals were used in procedures in which pain or distress was relieved by anesthesia, while 71,370 (9%) were used in studies that would cause pain or distress that would not be relieved.<ref name="USDA2016" />

The idea that animals might not feel pain as human beings feel it traces back to the 17th-century French philosopher, [[René Descartes]], who argued that animals do not experience pain and suffering because they lack [[consciousness]].<ref name=nuffield45/><ref name=Carbone149>Carbone, p. 149.</ref> [[Bernard Rollin]] of [[Colorado State University]], the principal author of two U.S. federal laws regulating pain relief for animals,<ref>Rollin drafted the 1985 Health Research Extension Act and an animal welfare amendment to the 1985 Food Security Act: see Rollin, Bernard. [http://www.nature.com/embor/journal/v8/n6/full/7400996.html "Animal research: a moral science. Talking Point on the use of animals in scientific research"], EMBO Reports 8, 6, 2007, pp. 521–25</ref> writes that researchers remained unsure into the 1980s as to whether animals experience pain, and that veterinarians trained in the U.S. before 1989 were simply taught to ignore animal pain.<ref name=Rollin117>Rollin, Bernard. ''The Unheeded Cry: Animal Consciousness, Animal Pain, and Science''. New York: Oxford University Press, 1989, pp. xii, 117–18, cited in Carbone 2004, p. 150.</ref> In his interactions with scientists and other veterinarians, he was regularly asked to "prove" that animals are conscious, and to provide "scientifically acceptable" grounds for claiming that they feel pain.<ref name=Rollin117/> Carbone writes that ''the view that animals feel pain differently is now a minority view.'' Academic reviews of the topic are more equivocal, noting that although the argument that [[Animal consciousness|animals have at least simple conscious thoughts and feelings]] has strong support,<ref>{{cite journal |vauthors=Griffin DR, Speck GB | title = New evidence of animal consciousness | journal = Animal Cognition | volume = 7 | issue = 1 | pages = 5–18 | year = 2004 | pmid = 14658059 | doi = 10.1007/s10071-003-0203-x | s2cid = 8650837 }}</ref> some critics continue to question how reliably animal mental states can be determined.<ref name=nuffield45/><ref>{{cite journal | author = Allen C | title = Assessing animal cognition: ethological and philosophical perspectives | journal = Journal of Animal Science | volume = 76 | issue = 1 | pages = 42–47 | year = 1998 | pmid = 9464883 | doi = 10.2527/1998.76142x }}</ref> However, some canine experts are stating that, while intelligence does differ animal to animal, dogs have the intelligence of a two to two-and-a-half-year old. This does support the idea that dogs, at the very least, have some form of consciousness.<ref>{{cite web |url=https://www.apa.org/news/press/releases/2009/08/dogs-think |title=Smarter Than You Think: Renowned Canine Researcher Puts Dogs' Intelligence on Par with 2-Year-Old Human |access-date=2023-05-05 |website=www.apa.org}}</ref> The ability of invertebrates to experience pain and suffering is less clear, however, legislation in several countries (e.g. U.K., [[Regulation of animal research in New Zealand|New Zealand]],<ref>{{cite web|url=http://www.legislation.govt.nz/act/public/1999/0142/latest/DLM49664.html|title=Animal Welfare Act 1999|publisher=Parliamentary Counsel Office|year=2015|access-date=23 January 2016}}</ref> Norway<ref name="Norway">{{cite web |title=Norwegian animal welfare act |url=https://www.animallaw.info/statute/noway-cruelty-norwegian-animal-welfare-act-2010#s1|access-date=25 January 2016|website=Animal Legal and Historical Center |year=2011}}</ref>) protects some invertebrate species if they are being used in animal testing.

In the U.S., the defining text on animal welfare regulation in animal testing is the ''Guide for the Care and Use of Laboratory Animals''.<ref>[http://www.nap.edu/openbook.php?record_id=5140 "Guide for the Care and Use of Laboratory Animals"], ILAR, National Research Council, National Academies Press, 1996, p. 64, {{ISBN|0-309-05377-3}}.</ref> This defines the parameters that govern animal testing in the U.S. It states "The ability to experience and respond to pain is widespread in the animal kingdom...Pain is a stressor and, if not relieved, can lead to unacceptable levels of stress and distress in animals." The Guide states that the ability to recognize the symptoms of pain in different species is vital in efficiently applying pain relief and that it is essential for the people caring for and using animals to be entirely familiar with these symptoms. On the subject of analgesics used to relieve pain, the Guide states "The selection of the most appropriate analgesic or anesthetic should reflect professional judgment as to which best meets clinical and humane requirements without compromising the scientific aspects of the research protocol". Accordingly, all issues of animal pain and distress, and their potential treatment with analgesia and anesthesia, are required regulatory issues in receiving animal protocol approval.<ref>{{cite web|url=https://ori.hhs.gov/education/products/ncstate/iacuc.htm|title=How to Work With Your Institutional Animal Care and Use Committee (IACUC)|website=ori.hhs.gov}}</ref> Currently, traumatic methods of marking laboratory animals are being replaced with non-invasive alternatives.<ref>{{cite journal |last1=Klabukov |first1=Ilya |last2=Shestakova |first2=Victoria |last3=Krasilnikova |first3=Olga |last4=Smirnova |first4=Anna |last5=Abramova |first5=Olga |last6=Baranovskii |first6=Denis |last7=Atiakshin |first7=Dmitri |last8=Kostin |first8=Andrey A. |last9=Shegay |first9=Peter |last10=Kaprin |first10=Andrey D. |date=2023 |title=Refinement of Animal Experiments: Replacing Traumatic Methods of Laboratory Animal Marking with Non-Invasive Alternatives |journal=Animals |volume=13 |issue=22 |pages=3452 |doi=10.3390/ani13223452 |doi-access=free |issn=2076-2615 |pmc=10668729 |pmid=38003070}}</ref><ref>{{cite journal |last1=Lindner |first1=Elke |last2=Fuelling |first2=Olaf |date=2002 |title=Marking methods in small mammals: ear-tattoo as an alternative to toe-clipping |url=https://zslpublications.onlinelibrary.wiley.com/doi/10.1017/S0952836902000195 |journal=Journal of Zoology |language=en |volume=256 |issue=2 |pages=159–163 |doi=10.1017/S0952836902000195 |issn=0952-8369}}</ref>

In 2019, Katrien Devolder and Matthias Eggel proposed [[Genetically modified animal|gene editing research animals]] to [[eradication of suffering|remove the ability to feel pain]]. This would be an intermediate step towards eventually stopping all experimentation on animals and adopting [[alternatives to animal testing|alternatives]].<ref>{{cite journal |last1=Devolder |first1=Katrien |last2=Eggel |first2=Matthias |title=No Pain, No Gain? In Defence of Genetically Disenhancing (Most) Research Animals |journal=Animals |date=2019 |volume=9 |issue=4 |page=154 |doi=10.3390/ani9040154 |pmc=6523187 |pmid=30970545 |doi-access=free }}</ref> Additionally, this would not stop research animals from experiencing psychological harm.

===Euthanasia===
{{Further|Euthanasia|Animal euthanasia}}
Regulations require that scientists use as few animals as possible, especially for terminal experiments.<ref name=Flecknell/> However, while policy makers consider suffering to be the central issue and see animal euthanasia as a way to reduce suffering, others, such as the [[RSPCA]], argue that the lives of laboratory animals have intrinsic value.<ref>[http://www.apc.gov.uk/reference/costbenefit.pdf Animal Procedures Committee: review of cost-benefit assessment in the use of animals in research] {{webarchive |url=https://web.archive.org/web/20080227041442/http://www.apc.gov.uk/reference/costbenefit.pdf |date=27 February 2008 }} The Animal Procedures Committee, June 2003 p46-7</ref> Regulations focus on whether particular methods cause [[pain]] and [[suffering]], not whether their death is undesirable in itself.<ref name=Carbone2>Carbone, Larry. "Euthanasia," in Bekoff, M. and Meaney, C. ''Encyclopedia of Animal Rights and Welfare''. Greenwood Publishing Group, pp. 164–66, cited in Carbone 2004, pp. 189–90.</ref> The animals are euthanized at the end of studies for sample collection or [[Autopsy|post-mortem examination]]; during studies if their pain or suffering falls into certain categories regarded as unacceptable, such as depression, infection that is unresponsive to treatment, or the failure of large animals to eat for five days;<ref>{{cite web|first =Dale |last =Cooper |url=http://www.ahc.umn.edu/rar/euthanasia.html |title="Euthanasia Guidelines", Research animal resources|publisher=University of Minnesota|date=11 June 2017 }}</ref> or when they are unsuitable for breeding or unwanted for some other reason.<ref>{{cite journal |vauthors=Close B, Banister K, Baumans V, Bernoth EM, Bromage N, Bunyan J, Erhardt W, Flecknell P, Gregory N, Hackbarth H, Morton D, Warwick C | title = Recommendations for euthanasia of experimental animals: Part 1 | journal = Laboratory Animals | volume = 30 | issue = 4 | pages = 293–316 (295) | year = 1996 | pmid = 8938617 | doi = 10.1258/002367796780739871| doi-access = free }}</ref>

Methods of euthanizing laboratory animals are chosen to induce rapid unconsciousness and death without pain or distress.<ref>[http://www.nap.edu/openbook.php?record_id=5140 "Guide for the Care and Use of Laboratory Animals"], ILAR, National Research Council, National Academies Press, 1996, p. 65, {{ISBN|0-309-05377-3}}.</ref> The methods that are preferred are those published by councils of veterinarians. The animal can be made to inhale a gas, such as [[carbon monoxide]] and [[carbon dioxide]], by being placed in a chamber, or by use of a face mask, with or without prior sedation or anesthesia. [[Sedative]]s or [[anesthetic]]s such as [[barbiturate]]s can be given [[Intravenous therapy|intravenously]], or inhalant anesthetics may be used. Amphibians and fish may be immersed in water containing an anesthetic such as [[tricaine]]. Physical methods are also used, with or without sedation or anesthesia depending on the method. Recommended methods include [[decapitation]] (beheading) for small rodents or rabbits. [[Cervical dislocation]] (breaking the neck or spine) may be used for birds, mice, rats, and rabbits depending on the size and weight of the animal.<ref>{{cite journal |last=Diaz |first=Silvina L. |date=2020 |title=Conducting and reporting animal experimentation: Quo vadis? |url=https://onlinelibrary.wiley.com/doi/10.1111/ejn.14091 |journal=European Journal of Neuroscience |language=en |volume=52 |issue=6 |pages=3493–3498 |doi=10.1111/ejn.14091 |pmid=30058230 |s2cid=51865025 |issn=0953-816X|hdl=11336/88084 |hdl-access=free }}</ref>  High-intensity microwave [[irradiation]] of the brain can preserve brain tissue and induce death in less than 1 second, but this is currently only used on rodents. [[Captive bolt]]s may be used, typically on dogs, ruminants, horses, pigs and rabbits. It causes death by a concussion to the brain. Gunshot may be used, but only in cases where a penetrating captive bolt may not be used. Some physical methods are only acceptable after the animal is unconscious. [[electric shock|Electrocution]] may be used for cattle, sheep, swine, foxes, and mink after the animals are unconscious, often by a prior electrical stun. [[Pithing]] (inserting a tool into the base of the brain) is usable on animals already unconscious. Slow or rapid freezing, or inducing [[air embolism]] are acceptable only with prior anesthesia to induce unconsciousness.<ref>{{cite web|url=http://www.avma.org/resources/euthanasia.pdf |title=AVMA Guidelines on Euthanasia, June 2007 edition, Report of the AVMA Panel on Euthanasia |publisher=Avma.org |archive-url=https://web.archive.org/web/20110815114956/http://www.avma.org/resources/euthanasia.pdf |archive-date=15 August 2011 }}</ref><!--add subsections on cage sizes; use versus care-->