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===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). 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 (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>
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