Report highlights. Animal testing as also often called “pre-clinical testing” or “pre-clinical trials.” Animal testing is controversial for many reasons. The National Research Council recommends an end to animal research in lieu of human testing. Many critics of animal research also cite the pain and suffering research animals may undergo.
- Animal testing costs taxpayers $14 billion annually.
- Animal research has been deemed ineffective by government health agencies.
- Most research animals are not protected by any animal welfare laws.
- Over 30% of animal experiments involve moderate-to-severe suffering.
- Over 98% of drugs tested on animals are never sold in stores.
- 22 million research animals are estimated to populate U.S. laboratories.
- Worldwide, there are over 192 million research animals.
- Americans are starkly divided in their opinions of animal testing.
Use of Animals in Experiments
Experimentation on animals is ancient. The earliest examples dating to the 4th century BC, when animals were dissected to study their anatomy and practice surgeries prior to attempting the procedures on humans. In modern research and scientific experimentation, animals serve a similar purpose.
- Test subjects are purposefully exposed to infectious diseases in order to study progression and treatment.
- Other tests include forced ingestion, such as forced feeding or forced inhalation of a toxic substance.
- Animals may be deprived of food and water as part of an experiment.
- Wounds, burns, or other physical damage may be inflicted to study healing.
- Animals are used to study the physiological effects of pain.
- Behavioral studies may induce stress, fear, and panic.
- Genetic manipulation/engineering leaves some animals born with genetic deficiencies, deformities, and potentially fatal disorders.
- Multiple industries use animals in experimentation for varying reasons.
- Animals are used to test cosmetics.
- Biomedical research on animals is common in the pharmaceutical and academic industries.
- Departments and agencies under the federal government use animal testing to predict how new chemicals and technologies might affect humans and/or the environment.
Animal Research in Pharmaceuticals
The pharmaceutical industry is a $1.3 trillion business, commanding 4% of the United States’ Gross Domestic Product. Companies are willing to invest in years of research in order to put out a viable product. Experimentation reveals how a product may work in multiple scenarios, at multiple concentrations or doses, with a range of test subjects, thereby reducing the risk of an expensive recall later on.
- 10-15 years is the average time it takes for a drug to complete the development process and be made available to consumers.
- On average, The Food and Drug Administration (FDA) approves 37.75 new drugs per year out of hundreds of applications.
- The number of drugs released to the market increases each year by an average of 14%.
- Toxicity levels almost always differ across species, making test results unreliable.
- 92% of drugs tested on animals are deemed ineffective for humans.
- 0.02% of animal-tested drugs are ever made available to the public.
- Animals used in pharmaceutical testing are typically euthanized once the experiment is complete.
Animal Research in the Federal Government
A number of departments and institutions regulated by the United States Federal Government make use of animal testing in their facilities. U.S. Agencies use animals in testing for many of the same reasons public organizations and private companies do.
- 1.6 million animals, protected and unprotected, are estimated to populate federal laboratories.
- The Department of Agriculture (DOA) researches the health and quality of livestock.
- The Department of Defense (DOD) conducts experiments using technologies and/or chemicals for use in the armed forces.
- The Department of Energy (DOE) tests the effect of new technologies on the health of living creatures.
- The Department of Health and Human Services (DHHS) oversees multiple agencies where testing is done, including the FDA and the National Institute on Drug Abuse (NIDA)
- The Department of the Interior (DOI) uses animal experiments to improve fish and wildlife resource management.
- The Department of Transportation (DOT) conducts research on safe transport of potentially hazardous material and its effect on living creatures.
- The Consumer Product Safety Commission (CPSC) uses animals to test the safety of consumer products.
- The Environmental Protection Agency (EPA) tests the effects of toxic substances on living creatures.
- The National Aeronautics and Space Administration (NASA) experiments on animals to study the effects of flight and space travel on living creatures.
- The Veterans Administration (VA) uses research animals to study treatments for veteran health as well as for education programs.
- Animal testing is a federal requirement for certain research: the FDA, EPA, CPSC, and the Occupational Safety and Health Administration (OSHA) all have processes that explicitly call for animal testing.
Academic Animal Research
Biomedical research in universities and academic institutions account for a large percentage of experiments using animal test subjects. In academia, ethics of animal research and viability of testing are constantly under question.
- 4% of U.S. medical schools use animal testing.
- Many top universties do not allow animal testing, including Yale, Duke, Harvard, and Tufts.
- Other universities, such as Stanford, have pledged to minimize their use of animal testing.
- Academic animal research may include surgery practices, system examinations, pharmacological testing, psychological tests, and studies of growth.
- 95% of animals used for academic biomedical research are rodents.
Animal Research in Cosmetics
Experimenting on animals for the purposes of developing cosmetics is the most likely form of animal research to face a ban. Some animal experiments with cosmetics are fatal.
- More than 500,000 animals are used in cosmetic research.
- 250 U.S. companies have petitioned the federal government to put an end to unnecessary cosmetics animal testing.
- 39 countries have banned the use of cosmetics animal testing altogether.
- Animal testing is not a legal requirement for cosmetics approval.
- Common experiments include skin and eye irritation tests, force-feeding, and determination of a product’s “lethal dose.”
Research Animal Populations
Laboratories are required to report federally-protected animals to the U.S. government; this accounts for a relatively small percentage of the total estimated population.
- 5%-15% of research animals are protected by law.
- Most recently, institutions nationwide reported 902,787 laboratory animals.
- As many as 100 million animals may be used in laboratory testing each year.
- Massachusetts reported the highest number of research animals with 89,910.
- Wyoming reported the fewest with 434 federally-protected research animals.
- Arizona reported holding the most protected animals in facilities without using them in research.
Use of Different Species
Pre-clinical trials involved animal experimentation require the use of multiple species in order to be considered viable. Research scientists select species based on what they know of the animal’s physiology, how the animal’s physiology may compare to a human’s, what effect they believe the experiment may have on the animal, etc. The animal’s size, metabolism, and medical history are all potential factors when selecting an animal for experimentation.
- For pre-clinical trials to be viable, a minimum of 2 species must be used in experimentation.
- Among reported animals, guinea pigs are the most widely used, with 171,406 undergoing experimentation every year.
- Rabbits are the second-most used in experiments, followed by Non-human primates.
- The United States uses more primates in experiments than any other country.
- Non-human primates are the most likely species to be held in a research facility without participation in any experiment.
- When used in experiments, non-human primates are most likely to be used to test gastrointestinal disorders.
- Rats are most likely to be used in general and preliminary testing.
Pain and Treatment
Animal experimentation is for illnesses or conditions that are painful; these experiments require the animal to experience pain while still others require the animal’s death. If animals are legally protected, research facilities are required to report how many of those protected animals experienced pain, on a scale of mild-to-severe, as part of the experimental process.
- 471,037 animals reportedly experienced no pain in the course of experimentation.
- 253,002 animals experienced pain and were given pain-killing drugs.
- 56,031 animals experienced pain but were not given any pain-relieving treatment.
- Massachusetts reported the highest rate of pain-free experimentation with 65.3%.
- California reported the highest number of animals given an anesthetic for pain.
- Michigan reported the highest rate of pain and distress among animals during experimentation.
- 21.9% of painful and/or distressing animal experimentation reportedly occurs in Michigan facilities.
Animal Welfare and Research Laws
Federal and state governments specify regulations for use of animals in science and research laboratories. At the federal level, conduct in research and science laboratories is regulated by multiple departments. Animal rights groups, public health officials, universities and private companies also publish reports and guidelines for scientists and researchers in the course of dealing with animals.
Animal Welfare Act
The Animal Welfare Act (AWA) is enforced by the Animal and Plant Health Inspection Service (APHIS) under the United States Department of Agriculture (USDA). Under the AWA, pets have the most rights, whereas some animals have none at all. In research labs, enforcing the AWA is especially difficult.
- The AWA applies to hospitals, colleges and universities, diagnostic laboratories, pharmaceutical and biotechnology companies, and private research facilities.
- Research facilities are required to form their own Institutional Animal Care and Use Committee to oversee research animal welfare.
- The AWA prohibits researchers from duplicating experiments unnecessarily.
- Critics of the AWA cite its vague language.
- Facilities are required to provide “basic standards of veterinary care and animal husbandry” with little mention of specifics.
- Cages and enclosures must be cleaned every two weeks.
- Potable water must be available twice daily for one hour.
- A caretaker must observe the animals daily.
- Dogs are singled out to be given “the opportunity for exercise.”
- Laboratories are required to “promote the psychological well-being of nonhuman primates.”
- Researchers are obligated to minimize animal suffering “unless withholding such methods is scientifically justified.”
- Still more critics argue the AWA is insufficient for preventing animal suffering.
- APHIS is prohibited from interrupting the conduct of actual research or experimentation.
- Laboratories are not required to report unprotected animals.
- Some animals have no federal protection only if they were bred specifically for research:
- Rats of the genus Rattus
- Mice of the genus Mus
- Some animals have no protection under the AWA in any case:
- Coldblooded species
Health Research Extension Act
The Public Health Service (PHS) Policy on Humane Care and Use of Animals (PHCUA) is a result of the Health Research Extension Act of 1985. This law established guidelines for proper care of animals used in biomedical and behavioral research funded by PHS. The policy itself makes reference to the AWA, noting that PHS regulations are to be considered in conjunction with the rules of the AWA.
Some states have created laws to fill in gaps left by federal policy. States have recently placed limits on or banned animal testing. Most state anti-cruelty laws exempt research animals, though some supplement these exemptions with additional regulations just for animals involved in laboratory tests.
- 349 state laws regulate use and treatment of animals in research facilities.
- Each state has an average of 7 regulations affecting research animals.
- Michigan offers the most legal protection to research animals with 23 regulations.
- 2 states have zero additional legal protections: Wyoming and Pennsylvania.
- 4 states have banned animal testing for cosmetics: California, New Jersey, New York, and Virginia.
Alternatives to Animal Research
An increasing number of specialists and institutions call animal testing ineffective and unnecessary. The National Research Council (NRC) of the National Academies of Sciences, Engineers, and Medicine (NASEM) published their official position that animal testing should be discontinued.
- Scientists already use simulated human organs and tissues as substitutes for human experimentation; these are considered more reliable than testing animals with completely different physiologies.
- Tissue-on-Chips or Organs-on-Chips are human cells that have been manipulated to function as organs and organ systems.
- Computer modeling can simulate chemical effects on a human body based on known parameters, such as toxicity of like-substances.
- Human volunteers are typically given extremely small doses of experimental drugs.
- State-of-the-art scanning and technology can view the inside of the human body with no dissection necessary.
International Law and Trends
Worldwide, more countries are placing restrictions on or outright banning animal testing. Industries still make the argument for animal testing in certain cases, however, and some governmental bodies actually require animal testing prior to approval for market release.
- China is estimated to use the highest number of research animals, with 20.5 million test subjects.
- Japan is the only other country besides China and the United States to test animals in the tens of millions.
- Brussels has banned experiments on cats, dogs, and primates.
- The European Union estimates that only 20% of animal experiments are regulatory requirements.
- 50% of all animal testing in the United Kingdom (UK) is conducted in universities.
- 49% of all animal tests in the UK involved the creation or breeding of genetically altered animals.
- The Chinese government requires animal testing on all cosmetics.
The general public is divided when it comes to animal experimentation and research. Political preferences don’t seem to affect opinion, but the level of education a person received does.
- 52% of Americans oppose the use of animals in research laboratories.
- 21% of Americans oppose genetic engineering of animals due to the potential for suffering.
- Men are 46.8% more likely to support animal research than women.
- People with advanced degrees are 38.4% more accepting of animal research than those with a high school degree as their highest level of educational attainment.
- USDA Animal Welfare Act
- USDA Animal Welfare Fact Sheet
- Animal Welfare Act Program Information
- ALDF Glossary of Legal Terms
- Animals Used In Research
- Toxicity Testing in the 21st Century: A Vision and a Strategy
- The FDA’s Drug Review Process: Ensuring Drugs are Safe and Effective
- USDA Annual Report Animal Usage in Research 2018
- Preclinical Development
- US Statistics
- Most Americans Accept Genetic Engineering of Animals that Benefits Human Health…
- What is Animal Testing?
- Public Health Service Policy on Humane Care and Use of Laboratory Animals
- Government of Brussels-Capital Bans Animal Tests On Primates, Dogs, And Cats
- Biopharmaceutical Spotlight: The Biopharmaceutical Industry in the United States
- Trends in FDA Drug Approvals Over Last 2 Decades: An Observational Study
- The NIH Microphysiological Systems Program: Tissue-on-Chips for Safety and Efficacy…
- Animal Testing and Medicine
- HSI: About Animal Testing
- Alternatives to Animal Testing
- Use of Laboratory Animals in Biomedical and Behavioral Research
- The Use of Animals in Universities
- Facts and Figures on Animal Testing
- Americans are Divided Over the Use of Animals in Scientific Research
- Cosmetic Testing FAQ
- Ending Cosmetics Animal Testing