Research animals are animals that humans use solely for scientific and product testing. They are used in medical and veterinary investigations and training; in the testing of drugs, cosmetics, and other consumer products; and in educational programs. The Scientific American (August 4, 2004) estimates that as many as one hundred million animals per year (mostly mice and rats) may be used in research, testing, and medical and veterinary training programs in the United States. Millions more research animals are kept as classroom pets or teaching aids to educate children in schools.
Living animals used as specimens to test drugs and products, practice medical and surgical procedures, and investigate diseases and bodily systems are called laboratory animals. Laboratory animals often die from these procedures or are euthanized by researchers after they are no longer needed. The plight of laboratory animals has been a major issue for animal rights advocates since the 1970s.
Increasingly, the use of dead animals to teach dissection skills to children is coming under fire. Dissection is a procedure in which an organism is cut apart for scientific examination. If the organism is alive at the time, the procedure is called vivisection. However, the term "vivisection" has come to be used to refer to all invasive research and testing performed on live animals for scientific purposes.
Live animals are used in modern medical research because some of their bodily systems mimic those of humans. This makes them useful test subjects for drugs, vaccines, and other products intended for humans. They are also useful training tools for doctors, surgeons, and veterinarians who need to practice medical procedures, such as inserting a catheter, administering anesthesia, or performing operations.
People who support the use of animals in research are passionate in their belief that the benefits to people far outweigh the consequences to animals. They point out the important medical and veterinary advances that have resulted. On the contrary, animal rights activists uniformly condemn this use. The most extreme activists have broken into laboratories, released animals, and physically harassed the researchers involved. Animal welfarists work to minimize the pain these animals experience during testing and to improve their living conditions.
The Gallup Organization includes a question about laboratory animals in the morality poll it conducts each year. (See Figure 5.1.) The poll conducted in May 2006 showed that 61% of Americans surveyed find "medical testing on animals" to be morally acceptable, whereas 32% find it morally wrong. Another 5% said the morality depends on the situation, and 2% had no opinion. These numbers were virtually unchanged from those obtained in annual polls conducted since 2001.
Science and Engineering Indicators is a report published by the National Science Board every two years. Each report includes polls and questionnaires conducted on public understanding and attitudes about various topics related to science and engineering. The 2002 report is the most recent of the reports to include public opinion polls on the use of animals in scientific research. Figure 5.2 and Figure 5.3 compare public opinion on the use of mice versus the use of dogs and chimpanzees in medical research that causes pain and injury to the animals but produces new information on human health problems. The results show that 67% of respondents approve of the use of mice in such a manner, whereas only 44% approve of the use of dogs and chimpanzees. This finding is not surprising, as people typically have more charitable feelings toward dogs and chimpanzees than they do toward mice. According to the Humane Society of the United States (HSUS), the National Science Board has found that approval for painful tests on dogs and chimpanzees has generally decreased since 1985, when 63% of those asked expressed approval for it. (See Table 5.1.)
This decrease may be the result in part of the fact that many people react emotionally to the thought of animals in distress. Scientists and researchers—those who work with the animals directly—use clinical terms to describe their work. They refer to laboratory animals as animal models and speak of them as specimens. Antivivisection groups gain support for their views by publicizing the gruesome details of experiments. Photographs of restrained animals with bolts through their brains or sores on their bodies can disturb the public, no matter how scientifically justified the experiments may be.
The modern antivivisection movement began in the nineteenth century. In Animals' Rights, Considered in Relation to Social Progress (1894), the humanitarian Henry S. Salt writes that "the practice of vivisection is revolting to the human conscience, even among the ordinary members of a not over-sensitive society." This was only seventy-six years after the publication of Mary Shelley's Frankenstein; or, The Modern Prometheus (1818), a story about a scientist who creates a mutant human from spare parts. The anthropologist Susan Sperling states in Animal Liberators: Research and Morality (1988) her beliefs that the antivivisectionists of the nineteenth century and the twenty-first century share a common fear: scientific manipulation of living beings.
Vivisection on animals and humans dates back to at least the ancient Greeks and Romans. During the third and second centuries BC human bodies were vivisected and dissected at the medical school in Alexandria, Egypt, by Herophilus and Erasistratus. Historians believe that more than six hundred living criminals were subjected to vivisection. Human dissection and vivisection were generally forbidden throughout the rest of Egypt and in the Roman Empire because of moral concerns.
Galen (circa 130–200 AD) was a Greek physician who moved to Rome and administered to gladiators and emperors. He frequently practiced vivisection on animals, particularly goats, pigs, monkeys, oxen, and dogs. Even though Galen made some important anatomical discoveries, he relied so heavily on animal models that he developed some misconceptions about human anatomy. However, his teachings formed the basis of Western medical science well into the Middle Ages. The Catholic Church frowned on human dissection and vivisection during this period, meaning that only animals were available for anatomical study, though some adventurous souls still used humans in their research.
|Public opinion on the use of chimpanzees and dogs in painful and injurious research, selected years 1985–2001|
|SCIENTISTS SHOULD BE ALLOWED TO DO RESEARCH THAT CAUSES PAIN AND INJURY TO ANIMALS LIKE DOGS AND CHIMPANZEES IF IT PRODUCES NEW INFORMATION.|
|Year||Supporting/strongly supporting animal research||Opposing/strongly opposing animal research|
|Source: Kathleen M. Conlee and Sarah T. Boysen, "Table 3. Public Opinion on Using Chimpanzees and Dogs in Painful and Injurious Research," in The State of the Animals III: 2005, Humane Society of the United States, December 31, 2005, http://www.hsus.org/web-files/PDF/hsp/SOA_3-2005_Chap9.pdf (accessed December 13, 2006)|
Few advances in medical science were made until the 1500s, when the Belgian doctor Andreas Vesalius challenged many of Galen's ideas. Vesalius began to uncover the mysteries of blood circulation after performing autopsies on human corpses. He also practiced vivisection on animals and wrote about its importance in the study of anatomy. Vesalius was followed by the British physician and anatomist William Harvey. By performing animal vivisection and dissecting the corpses of executed criminals, Harvey discovered the role of the heart in pumping blood throughout the body.
Seventeenth, Eighteenth, and Nineteenth Centuries
In the seventeenth century a new philosophy was introduced by the French philosopher René Descartes. Descartes and his followers believed that animals were unthinking, unfeeling machines. This allowed researchers to perform all manner of experiments on live animals without any moral concerns. In 1764 these practices and ideas were criticized by the French philosopher François-Marie Arouet de Voltaire. Voltaire noted that vivisection uncovered organs of feeling in animals, proving that animals were not machines, but sentient (feeling) beings. Later in the century the British philosopher and political scientist Jeremy Bentham summarized his thoughts on the subject in An Introduction to the Principles of Morals and Legislation (1789): "The question is not, Can they reason? Nor, Can they talk? but, Can they suffer?" (See Figure 5.4.)
|Major organizations devoted to issues involving animal research, by founding date, 1883–1992|
|Founding date||Organization||Stated mission|
|Source: Created by Kim Masters Evans for Thomson Gale|
|1883||American Anti-Vivisection Society (AAVS)||Devoted to legally and effectively ending the use of animals in science through education, advocacy, and the development of alternative methods to animal use.|
|1895||New England Anti-Vivisection Society (NEAVS)||Works to expose and replace animal experiments in laboratories and classrooms with ethically and scientifically responsible modern research methods.|
|1929||National Anti-Vivisection Society (NAVS)||Goals include ending the use of animals in research, product testing, and education; educating the public about the cruelty and waste of vivisection; and encouraging development of non-animal methodologies.|
|1950||American Association for Laboratory Animal Science (AALAS)||Advances responsible care and use of laboratory animals to benefit people and animals.|
|1965||American Association for Accreditation of Laboratory Animal Care (AAALAC)||Voluntary accreditation organization founded by veterinary and scientific groups to promote uniform animal-care standards.|
|1974||Public Responsibility in Medicine and Research (PRIM&R)||Group dedicated to furthering research and promoting ethical ideals within the research community.|
|1979||National Association for Biomedical Research (NABR)||Provides the collective voice for the scientific community on national policy involving animal use in research, education and product safety testing.|
|1981||Johns Hopkins University Center for Alternatives to Animal Testing (CAAT)||Funded by the Cosmetics, Toiletry, and Fragrance Association to research alternatives to animal testing.|
|1981||Michigan Society for Medical Research||Non-profit science education organization that supports biomedical research and the judicious use of animals in research.|
|1985||Physicians Committee for Responsible Medicine (PCRM)||Advocates alternatives to harming animals for educational or research purposes.|
|1986||The Scientists Center for Animal Welfare (SCAW)||A non-profit educational association of individuals and institutions involved in research. The group's goal is to promote the welfare of animals used in research, testing, and educational programs.|
|1991||Americans for Medical Progress (AMP)||Non-profit organization devoted to protecting society's investment in research by promoting public understanding of and support for the appropriate role of animals in biomedical research so that scientists are able to continue their quest for cures and improved methods of treatment for illness, injury and disease.|
|1991||Ethical Science & Education Coalition (ESEC)||Educational affiliate of the NEAVS that works to protect the rights of students who decide not to dissect or otherwise use animals in a harmful way.|
|1992||Center for Laboratory Animal Welfare (CLAW)||Affiliated with the Massachusetts SPCA, this organization advocates alternatives to animal testing.|
Throughout the eighteenth and nineteenth centuries philosophers debated the moral issues involved in animal vivisection. According to historians, the poor and working-class people of the time opposed animal vivisection because they associated it with the dissection of human corpses. The unclaimed bodies of poor people and criminals were often turned over to medical colleges for dissection. There were also well-publicized cases of grave robbing and body snatching to supply researchers with human corpses. These events horrified the common people and made them suspicious of scientists and doctors engaged in medical research.
The nineteenth century also witnessed organized efforts from animal welfare organizations to achieve legislation against animal cruelty in the United Kingdom and United States. The Cruelty to Animals Act was passed in Britain in 1849 and amended in 1876 to restrict the use of animals in research. In 1875 the Society for the Protection of Animals Liable to Vivisection was founded by Frances Power Cobbe. It was later called the Victorian Street Society. In 1898 Cobbe founded the British Union for the Abolition of Vivisection, an organization that is still active.
Vivisection was also fought by welfarists in the United States. In 1871 Harvard University founded one of the first vivisection laboratories in the country, despite opposition from the Massachusetts Society for the Prevention of Cruelty to Animals. Various antivivisection groups were founded, including the American Anti-Vivisection Society in 1883 and the New England Anti-Vivisection Society (NEAVS) in 1895. (Table 5.2 provides a list of some of the major U.S. organizations involved in advocating or opposing the use of animals in scientific research beginning in 1893.) The new antivivisection groups tried, unsuccessfully, to outlaw the practice of vivisection. Legislation was passed during the 1890s that outlawed repetition of painful animal experiments for the purpose of teaching or demonstrating well-known and accepted facts.
First Half of the Twentieth Century
In December 1903 American writer Mark Twain published the short story "A Dog's Tale" in Harper's Magazine. The story was written to protest cruelty to animals and their use in research. It is told from the viewpoint of a dog that lives with the family of a scientist. The dog saves the family's baby from a nursery fire but later sees her own puppy blinded and killed during an experiment performed by the scientist to impress his friends. Although some critics condemned the work as overly sentimental, animal welfarists of the time were pleased that it brought public attention to the issue of animal experimentation.
In 1906 Congress passed the Pure Food and Drug Act (PFDA). The original act did not require any type of testing to ensure that a product was safe or effective. This would change after some tragic events occurred. According to Susan E. Wilson-Sanders of the University of Arizona, in "Mrs. Brown's Sad Story: A History of the Food, Drug, and Cosmetic Act" (September 23, 2005, http://www.ahsc.arizona.edu/uac/notes/classes/Alternmethod/Fdapap03.htm), many Americans were injured, sickened, or even killed by unsafe potions, "snake oils," and patent medicines sold by entrepreneurs during the early decades of the twentieth century. Some of these products contained incredibly toxic substances, such as dinitrophenol, a compound used to make explosives.
During the 1920s and 1930s hair dyes containing an aniline compound called paraphenylenediamine became popular. Even though it was well known that aniline compounds were harmful to the eyes, a cosmetics company still chose to introduce a brand of mascara called Lash-Lure containing these chemicals. Doctors reported thousands of eye injuries caused by the product, and even a few deaths after patients suffered serious infections. Many states banned the use of aniline dyes in personal-care products. Wilson-Sanders reports that Lash-Lure contained twenty-five to thirty times more aniline than the amount commonly used in hair dyes.
Wilson-Sanders mentions several other popular cosmetic products of the time that caused injury, such as Anti-Mole, Berry's Freckle Ointment, Bleachodent (a teeth whitener), Dr. Dennis's Compound, Koremlu cream, and Dewsberry Hair Tonic. These products contained high concentrations of acids or other toxic chemicals. Whisker dyes marketed to men contained dangerous levels of silver or lead acetate. A popular depilatory (hair removal cream) contained rat poison.
According to Wilson-Sanders, doctors lobbied Congress throughout the 1930s to crack down on dangerous drugs and personal products sold to Americans, but they were opposed by powerful marketing groups. In 1937 nearly one hundred people (mostly children) died after drinking a product called Elixir of Sulfanilamide containing sulfa drugs dissolved in diethylene glycol (antifreeze). The public was outraged and pressured Congress to strengthen the original PFDA and include cosmetics. The Food, Drug, and Cosmetics Act (FDCA) was passed in 1938. It contained a requirement for animal testing.
Wilson-Sanders notes that the first tests were conducted on rats and could last less than one month. The testing requirements were gradually amended to include different species and to last for longer time periods. By 1957 drug testing had to be performed on rats or dogs for up to six months. By the 1980s testing was required to last twelve to eighteen months. Testing on pregnant animals was instituted in the 1960s following the thalidomide tragedy. Thalidomide is a drug that was widely prescribed in Canada and Europe during the late 1950s to treat nausea in pregnant women. More than ten thousand deformed babies resulted. Although the drug had been extensively tested on animals, it had not been tested on pregnant animals. New guidelines for testing the effects of drugs on animal reproduction and fetus development were incorporated into the FDCA.
Second Half of the Twentieth Century
Historians note that the antivivisection movement subsided with the advent of World War I (1914–18) and did not resurge until the 1960s. One of the driving forces behind the movement's rebirth was the story of Pepper, a Dalmatian who disappeared from her family's backyard in Pennsylvania in July 1965. The family tracked the dog to an animal dealer in New York, but he refused to return the dog. The family enlisted the help of the Animal Welfare Institute, the Pennsylvania State Police, and New York Congressman Joseph Resnick, but they were too late. Pepper had been sold to a hospital in New York City that conducted an experiment on her and euthanized her.
The story was widely publicized and led to public outrage. Bills were introduced in the U.S. House of Representatives and the U.S. Senate calling for animal dealers and laboratories to be licensed and inspected by the U.S. Department of Agriculture (USDA) and required to meet certain humane standards of care. During the debate, which took place between 1965 and 1966, Democratic Senator Warren Magnuson of Washington said, "We do not think we can allow the needs of research, great as they may be, to promote either the theft of a child's pet or the growth of unscrupulous animal dealers." The bills were opposed by strong lobbying groups and were in danger of failing, until a story ran in the February 4, 1966, issue of Life magazine.
"Concentration Camps for Dogs" was the story of a police raid on a dog dealer's facility in Maryland. The story included horrific photographs of abused dogs kept in filthy cages until they could be sold to research laboratories. According to the article, the dogs were to be sold at auction for thirty cents per pound. Letters flooded politicians' offices, and editorials appeared in major newspapers around the country calling for federal legislation.
A few months later Congress passed the Laboratory Animal Welfare Act of 1966. It called for the licensing of animal dealers and regulation of laboratory animals. The original act applied to dogs, cats, primates, guinea pigs, hamsters, and rabbits. In 1970 the act was renamed the Animal Welfare Act (AWA) and amended to cover several other warm-blooded animals. A year later the USDA decided to exclude rats, mice, and birds from coverage under the act, arguing that the department did not have the staff needed to regulate the huge numbers of such animals involved. It also noted that most of these small animals were used at research institutions that had other oversight protections in place to regulate their use.
The publication of Animal Liberation: A New Ethics for Our Treatment of Animals (1975) by the Australian philosopher Peter Singer brought more coverage to the use of animals in scientific research. The book includes disturbing photographs and descriptions of animals being subjected to all sorts of painful procedures for questionable purposes. Singer argues that the pain and suffering inflicted on the animals is too high a moral price to pay for scientific research.
In 1976 the animal activist Henry Spira led a campaign protesting the American Museum of Natural History's research on the effects of castration and mutilation on cats' sexual behavior. The campaign was hailed as a success by activists after the museum halted the research a year later. Spira then turned his attention to the testing of cosmetics on animals, particularly the Draize eye test, in which chemicals are put into the eyes of restrained animals.
Spira formed a coalition of animal welfare and antivivisection groups to educate the public about animal testing of cosmetics. In full-page advertisements in major newspapers, Spira accused major cosmetics companies of being cruel to animals. Public response was immediate. Several companies, including Revlon and Avon, announced their intention to cease animal testing and find new alternatives. In 1981 the Cosmetics, Toiletries, and Fragrance Association funded the founding of the Center for Alternatives to Animal Testing (CAAT) at Johns Hopkins University in Baltimore, Maryland. By the end of the 1980s Revlon and Avon had ceased animal testing.
In 1985 Congress amended the AWA to require that researchers minimize animal pain and distress whenever possible through use of anesthesia, analgesics (painkillers), and humane euthanasia. New requirements were added regarding the physical and psychological well-being of dogs and primates used in research work. Throughout the 1980s and 1990s animal welfare groups petitioned and sued the USDA to add mice, rats, and birds to the animals covered under the AWA but were unsuccessful. In 1990 AWA coverage was extended to horses and other farm animals.
Scientists engaged in animal research watched with concern as animal welfare and antivivisection groups launched aggressive publicity campaigns against them. In 1979 the National Association for Biomedical Research (January 21, 2005, http://www.nabr.org/about.html) was founded in Washington, D.C., with the mission of "advocating sound public policy that recognizes the vital role of humane animal use in biomedical research, higher education and product safety testing." In 1981 the Foundation for Biomedical Research and the Michigan Society for Medical Research (MISMR) were founded with similar goals.
|Medical advances achieved through animal research, selected years 1796–2003|
|Year||Advance (type of animal)|
|*Denotes Nobel Prize-winning work.|
|Source: "Historically, What Have Been the Tangible Benefits of Animal Research?" in CDC News: Overview of Animals in Scientific Research Fact Sheet, U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, November 16, 2006, http://www.cdc.gov/about/news/2006_11/animal_care/factsheet_ar_general.htm (accessed December 28, 2006)|
|1796||Vaccine for smallpox developed (cow)|
|1881||Vaccine for anthrax developed (sheep)|
|1885||Vaccine for rabies developed (dog, rabbit)|
|1902||Malarial life cycle discovered (pigeon)*|
|1905||Pathogenesis of tuberculosis discovered (cow, sheep)*|
|1919||Mechanisms of immunity discovered (guinea pig, horse, rabbit)*|
|1921||Insulin discovered (dog, fish)*|
|1928||Pathogenesis of typhus discovered (guinea pig, rat, mouse)*|
|1929||Vitamins supporting nerve growth discovered (chicken)*|
|1932||Function of neurons discovered (cat, dog)*|
|1933||Vaccine for tetanus developed (horse)|
|1939||Anticoagulants developed (cat)|
|1942||The Rh factor discovered (monkey)|
|1943||Vitamin K discovered (rat, dog, chick, mouse)*|
|1945||Penicillin tested (mouse)*|
|1954||Polio vaccine developed (mouse, monkey)*|
|1956||Open heart surgery and cardiac pacemakers developed (dog)|
|1964||Regulation of cholesterol discovered (rat)*|
|1968||Rubella vaccine developed (monkey)|
|1970||Lithium approved (rat, guinea pig)|
|1973||Animal social and behavior patterns discovered (bee, fish, bird)*|
|1975||Interaction between tumor viruses and genetic material discovered (monkey, horse, chicken, mouse)*|
|1982||Treatment for leprosy developed (armadillo)|
|1984||Monoclonal antibodies developed (mouse)*|
|1990||Organ transplantation techniques advanced (dog, sheep, cow, pig)*|
|1992||Laproscopic surgical techniques advanced (pig)|
|1995||Gene transfer for cystic fibrosis developed (mouse, nonhuman primate)|
|1997||Prions discovered and characterized (hamster, mouse)*|
|1998||Nitric oxide as signaling molecule in cardiovascular system discovered (rabbit)*|
|2000||Brain signal transduction discovered (mouse, rat, sea slug)*|
|2002||Mechanism of cell death discovered (worm)*|
|2003||Non-invasive imaging methods (MRI) for medical diagnosis developed (clam, rat)*|
These organizations work to counter claims by animal rights activists that animal research and testing are cruel practices with little to no scientific value. Table 5.3 is a listing provided by the Foundation for Biomedical Research of medical advances achieved through animal research. RDS: Understanding Animal Research in Medicine is an organization based in the United Kingdom that represents the interests of British researchers conducting animal research. The RDS (2007, http://www.rds-online.org.uk/pages/page.asp?i_ToolbarID=3&i_PageID=37) maintains a timeline of the major medical and veterinary breakthroughs of each decade that have been achieved through animal testing.
PEOPLE FOR THE ETHICAL TREATMENT OF ANIMALS (PETA) AND THE SILVER SPRINGS MONKEY CASE
In 1981 a little-known organization called People for the Ethical Treatment of Animals (PETA) gained national prominence through an exposé on paralysis experiments on monkeys at the Institute of Behavioral Research in Silver Springs, Maryland. The research was funded by the National Institutes of Health (NIH) and led by Edward Taub. It involved depriving monkeys of sensory input into their spinal cords to give them denervated arms, or arms in which the nerves were not active. The monkeys gnawed and licked their arms, producing wounds. Taub hired Alex Pacheco to work as a laboratory assistant. Unbeknownst to Taub, Pacheco had cofounded PETA the year before. Pacheco photographed the monkeys, then reported the lab to authorities. A subsequent raid led to the filing of animal cruelty charges against Taub.
The incident came to be known as the Silver Springs Monkey Case. Even though the charges against Taub were eventually dropped, the publicity made PETA famous. The monkeys were confiscated, and Congress forced the NIH to cease the research. This was viewed as a major triumph by people involved in antivivisection and the growing animal rights movement.
The Animal Enterprise Protection Act of 1992 was enacted against "animal enterprise terrorism." The law prohibits "causing physical disruption to the functioning of an animal enterprise." Three types of animal enterprises are defined:
- Commercial or academic enterprises using animals to produce food or fiber or for agriculture, research, or testing
- Zoos, aquariums, circuses, rodeos, and other legal sporting events
- Fairs and similar events designed to advance agricultural arts and sciences
Offenses that can be charged under the act include using the mail to cause physical disruption at animal enterprises and stealing, damaging, or causing the loss of property used by animal enterprises. Property includes animals and records. People who cause or who conspire to cause economic damages more than $10,000 can be fined and/or imprisoned for up to one year. Aggravated offenses include causing serious bodily injury or death to another person during physical disruption to an animal enterprise. These offenses have penalties ranging from ten years to life in prison. The act also states that restitution can be demanded to cover any loss of food production or farm income associated with an offense and the cost of repeating any experiments that were interrupted or ruined.
HUNTINGDON LIFE SCIENCES BECOMES A TARGET
PETA continued to use infiltration and secretly obtained photographs and videotapes to publicize the realities of animal research. In 1996 and 1997 the group conducted an eight-month undercover investigation at a Huntingdon Life Sciences (HLS) facility in New Jersey. The HLS is a major target of antivivisection groups because it is one of the largest contract companies conducting animal research. A PETA member began working at the HLS and secretly collected documents, photographs, and videotapes that PETA used to file a formal complaint against the HLS with the USDA. PETA also released some of the material to the media.
The HLS countersued PETA, claiming that the materials were obtained by illegal means and that PETA had violated the Economic Espionage Act and the Animal Enterprise Protection Act. In December 1997 a mutual settlement was reached in which PETA agreed to turn over all records taken from the HLS and cease trying to infiltrate HLS property for five years, and the HLS agreed to drop its lawsuit against PETA. A gag order was put into place forbidding PETA from publicly discussing information it collected during the case, excluding the information that it had already released to the media.
In 1999 Stop Huntingdon Animal Cruelty (SHAC), a new animal rights group, began using radical and violent means against HLS headquarters in the United Kingdom. Cars were firebombed and company executives were assaulted outside their homes. Several activists were arrested and jailed for violent crimes.
SHAC began targeting companies providing the HLS with services, funding, and equipment. Banks, brokerage houses, and investment companies with ties to the HLS were picketed and flooded with threatening letters, faxes, and e-mails. Employees were harassed and sometimes assaulted. Their homes were vandalized. The intimidation tactics were effective, as many companies decided to sever their business ties with the HLS. By 2002 no commercial bank in the United Kingdom would loan money to the company. According to Alan Cowell, in "Scene Shifts in Fight against British Testing Lab" (New York Times, January 22, 2002), the company's stock dropped in value from $3 per share in 1993 to $0.06 a share in 2002, even though the company was making a modest profit.
In 2002 the company moved its stock market listing to the United States. Cowell reports that the HLS was taken over "on paper" by Life Sciences Research, a company set up by the HLS and incorporated in Maryland. This arrangement allows the HLS to take advantage of U.S. privacy laws that protect the identity of certain investors. An American arm of SHAC known as SHAC USA was formed to lead an intimidation campaign against the HLS and companies that do business with it. SHAC USA (October 27, 2006, http://colorado.indymedia.org/newswire/display/7294/index.php) states that the group uses an array of tactics "from protests, to letter writing, to phone blockades, publicity stunts, and direct action." SHAC USA also notes that underground activists associated with the Animal Liberation Front support SHAC USA by conducting "economic sabotage and live liberations from the HLS and the lab's breeders."
SHAC USA lists a number of "direct actions" taken against HLS employees, its suppliers, and customers. During late January and early February 2005 these actions included splattering homes with paint, filling locks with glue, breaking windows, setting off smoke bombs in offices, and harassing company executives on vacation and at church. Activists claim they followed the son of the chief executive officer of one of the HLS's pharmaceutical clients to school and handed out leaflets to the boy's classmates accusing the HLS of torturing animals.
In May 2004 SHAC USA and seven individuals associated with it were indicted in New Jersey under federal charges for violating the Animal Enterprise Protection Act, stalking, and conspiracy to commit terrorism. The case went to trial in February 2006, and the organization and six of the individuals were found guilty. They were sentenced to various prison terms ranging up to six years. SHAC USA officially ceased to exist; however, animal activists developed a new Web site at http://www.shac7.com that publicizes the case and seeks to raise money and moral support for the imprisoned individuals. The Web site summarizes the details of the case and continues to accuse the HLS of abusing animals by "punching 4-month-old beagle puppies in the face, dissecting a live monkey, falsifying scientific data, and violating Good Laboratory Practice laws over 600 times" (November 16, 2006, http://www.shac7.com/hls.htm).
The HLS (2007, http://www.huntingdon.com/index.php?currentNumber=3¤tIsExpanded=0) defends its practices, stating that it is "committed to providing the highest levels of animal husbandry and welfare." It also notes that in 2003 it was accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) and is one of only a few contract research organizations in the world to be accredited. The AAALAC is an independent nonprofit organization founded in 1965 by scientists and veterinarians engaged in animal research. The AAALAC (2007, http://www.aaalac.org/accreditation/benefits.cfm) notes that accreditation "demonstrates a willingness to go above and beyond the minimums required by law. It tells the public that the institution is committed to the responsible care and use of animals in science."
Mainstream antivivisection and welfarist groups condemn the violent tactics used by radical activists and instead wage public relations and political campaigns against the use of research animals.
FEDERAL LEGISLATION AND OVERSIGHT
Facilities that use certain species of live laboratory animals for research purposes must abide by laws and policies governing their use. Even though there are a few state laws that also apply, most of the applicable legislation and oversight is provided by federal agencies.
Animal Welfare Act
Animal Welfare Act (AWA) regulations are enforced by the Animal Care unit of the USDA's Animal and Plant Health Inspection Service (APHIS). The regulations govern the housing and care of the animals and include licensing, registration, veterinary, and record-keeping requirements. Covered facilities must register with the USDA.
The AWA does not apply to cold-blooded animals, rats, mice, or birds. According to the law, these animals do not fall under the definition of animal. This condition was made permanent in May 2002 as part of new federal legislation. The AWA does cover dogs, cats, rabbits, primates, guinea pigs, hamsters, marine mammals, and "other warm-blooded animals."
Under the AWA each research facility must have an attending veterinarian who is required to provide adequate veterinary care to the facility's animals. The law defines adequate veterinary care as "what is currently the accepted professional practice or treatment for that particular circumstance or condition." Each research facility must have an institutional officer who is responsible for legally committing the facility to meet AWA requirements. This officer or the chief executive officer of the facility must appoint an institutional animal care and use committee (IACUC) to assess the research facility's animal program, buildings, and procedures. The IACUC must include at least three members—a chairperson, a veterinarian, and a person not affiliated with the institute—to represent "general community interests." IACUC members have to be qualified based on their experience and expertise.
The IACUC is responsible for reviewing a research facility's animal use program and inspecting the facilities in which animals are housed and studied. These evaluations must be done at least once every six months. Written reports are required and must be made available to APHIS and to any federal agencies that provide funding to the facility. The IACUC is also responsible for investigating any complaints lodged against the facility regarding the care and use of the animals. This includes complaints from the general public. The IACUC has the power to approve or disapprove proposed animal care and use activities and to ask for modifications in these activities. It can also suspend particular animal activities if it believes they are not being conducted in accordance with its wishes.
Under the AWA any proposed activities must meet certain criteria. Some of the major requirements include:
- Procedures must "avoid or minimize discomfort, distress, and pain to the animals."
- Researchers must consider alternative procedures that will not cause more than momentary or slight pain and provide reasons in cases where alternatives cannot be used.
- Researchers must provide written assurance that the activities "do not unnecessarily duplicate previous experiments."
Any procedures that may cause more than momentary or slight pain or distress require that pain-relieving drugs be administered, unless withholding the drugs is "scientifically justified." Animals cannot be administered paralyzing drugs unless they are also given anesthesia. Those that experience severe or chronic pain or distress that cannot be relieved are required to be painlessly euthanized as soon as possible, unless researchers seek and receive an exemption from the IACUC.
According to APHIS, in September 2006 there were 1,120 registered research facilities in the United States. (See Table 5.4.) California had the most facilities (161), followed by New York (78), Massachusetts (76), Texas (74), and Pennsylvania (62). APHIS (January 24, 2007, http://www.aphis.usda.gov/ac/publications/reports/R_cert_holders.pdf) maintains a list of the research institutions that includes the names and addresses of the facilities, which are mostly colleges and universities, pharmaceutical companies, hospitals, and biotechnology laboratories.
All research facilities are required to comply with AWA regulations. Federal facilities are not required to register with the USDA and are not subject to USDA inspections, though they are required to comply with USDA standards for animal care established under the AWA and must submit annual reports to the USDA regarding their use of regulated laboratory animals. The AWA requires that nonfederal research facilities receive at least one inspection per year to determine compliance with the law.
All registered research facilities must submit annual reports to the USDA listing the number and species of animals used in research, testing, and experimentation and indicating whether pain-relieving drugs were administered. If the drugs were not administered for procedures that caused pain or distress, the report must explain why their use would have interfered with the research or experiment.
|USDA-licensed research facilities|
|[As of September 7, 2006]|
|Source: Adapted from "Research," in Facility Lists: Research, U.S. Department of Agriculture, Animal and Plant Health Inspection Service, September 7, 2006, http://www.aphis.usda.gov/ac/publications/reports/R_cert_holders.txt (accessed December 6, 2006)|
|District of Columbia||6|
Health Research Extension Act
In 1985 the Health Research Extension Act (HREA) was passed. This act requires that facilities conducting animal research, training, and testing activities that receive funding from the Public Health Service (PHS) follow an animal welfare policy called the Public Health Service Policy on the Humane Care and Use of Laboratory Animals (PHSP). The PHS includes government agencies such as the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration (FDA), and the NIH. The NIH is the main public source of funding for biomedical research in the United States.
Affected animal research facilities must follow the recommendations given in the PHS's Guide for the Care and Use of Laboratory Animals (1996, http://books.nap.edu/readingroom/books/labrats/) regarding housing, cleanliness, husbandry, veterinary care, and use of measures to alleviate pain and distress. The standards are similar to those found in the AWA, but the HREA applies to all vertebrates, including mice, rats, and birds.
The HREA requires facilities to file annual reports that describe their animal care and use programs and how they comply with the AWA and the PHSP. The PHSP is administered by the NIH Office for Protection from Research Risks. Research facilities that receive funding from the NIH must have at least five people on their IACUC. The NIH also reviews planned animal studies to ensure that animal models are appropriate and that no more animals than necessary are used.
Food, Drug, and Cosmetic Act
Another major piece of federal legislation that affects laboratory animals is the Food, Drug, and Cosmetic Act (FDCA). The FDCA defines drugs as follows:
- Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease
- Articles (other than food) intended to affect the structure or any function of the body of man or other animals
Drugs must receive FDA approval before they can be sold in the United States. Although the FDA does not specify the tests that must be done, the agency does not allow human testing to occur if animal safety testing is considered inadequate or incomplete.
Cosmetics are defined as articles other than soap that are applied to the human body for "cleansing, beautifying, promoting attractiveness, or altering the appearance." Soaps are specifically excluded from the regulatory definition of cosmetics and so do not fall under the FDCA.
Cosmetic products and their ingredients (except for color additives) are not subject to premarket FDA approval. However, it is illegal to distribute cosmetics that contain substances that could harm consumers under normal use. Although animal testing is not required by the law, it is recommended by the FDA to ensure product safety. Cosmetic products that are not adequately tested for safety must have a warning statement on their front label reading "WARNING—The safety of this product has not been determined."
Some consumer products are considered both a drug and a cosmetic under the law, such as dandruff shampoos, fluoride-containing toothpastes, combination antiperspirants/deodorants, and makeup products or moisturizers that contain sunscreens. These products are subject to provisions of the laws that apply to both drugs and cosmetics.
Other Federal Legislation
The Federal Hazardous Substances Labeling Act was passed in 1960. The Consumer Product Safety Commission administers the law as it applies to household products. This law affects animals because household products (such as cleaners) that contain hazardous chemicals must warn consumers about their potential hazards. A hazardous substance is defined as one that is toxic, corrosive, flammable, or combustible; that is extremely irritating or sensitizing; or that generates pressure through heat, decomposition, or other means. Toxicity tests are required to determine these conditions.
Other laws governing chemicals that must be tested for toxicity include the Toxic Substances Control Act and the Federal Insecticide, Fungicide, and Rodenticide Act. Both of these laws are administered by the Environmental Protection Agency. Animals are commonly used to test the products regulated by all of this legislation.
In 2000 the Chimpanzee Health Improvement, Maintenance, and Protection (CHIMP) Act was passed, calling for the creation of a national sanctuary system for chimpanzees no longer needed in research programs conducted or supported by federal agencies. In 2002 the NIH awarded a contract to Chimp Haven Inc. to establish and operate a sanctuary under the CHIMP Act in Shreveport, Louisiana. Construction began in 2003, and the facility was dedicated in 2004. Table 5.5 shows a timeline compiled by the HSUS of major events in the formation of the national sanctuary system for chimpanzees. Most chimpanzees involved in federal research programs were bred or captured from the wild to be used in hepatitis and acquired immune deficiency syndrome research. (See Figure 5.5 for the percentage breakdown of federal research grants involving chimpanzee research between 2000 and September 2004.) The CHIMP Act is extremely controversial because it allows the animals to be recalled for research purposes if there is a "public health need." Because the act does not call for permanent retirement of chimpanzees, many animal activist groups have called for its repeal.
|National chimpanzee sanctuary system timeline of events, April 15, 1999–June 28, 2006|
|Source: Adapted from Kathleen M. Conlee and Sarah T. Boysen, "Table 4. National Chimpanzee Sanctuary System: Timeline of Events," in The State of the Animals III: 2005, Humane Society of the United States, December 31, 2005, http://www.hsus.org/web-files/PDF/hsp/SOA_3-2005_Chap9.pdf (accessed December 13, 2006)|
|April 15, 1999||A coalition that includes representatives from the research, animal-protection, zoo, and sanctuary communities writes a letter regarding the issue of chimpanzee "retirement" and submits it to U.S. Rep. J.E. Porter (R-IL) and U.S. Sen. A. Specter (R-PA).|
|November 22, 1999||H.R. 3514, the Chimpanzee Health Improvement, Maintenance, and Protection (CHIMP) Act, is introduced in the U.S. House of Representatives by Rep. J. Greenwood (R-PA). This bill will require the federal government to provide for permanent "retirement" of chimpanzees who are identified as no longer needed for research.|
|May 18, 2000||The House Committee on Commerce holds a hearing on H.R. 3514. Those presenting testimony include J. Goodall (Jane Goodall Institute), J. Strandberg (NIH), T. Nelson (National Chimpanzee Research Retirement Task Force), and A. Prince (New York Blood Center).|
|June 14, 2000||S. 2725, the Chimpanzee Health Improvement Maintenance and Protection (CHIMP) Act, is introduced in the U.S. Senate by Sens. R. Smith (R-NH) and R. Durbin (D-IL).|
|September 20, 2000||S. 2725 gains approval by the Senate Health, Education, Labor, and Pensions Committee.|
|October 24, 2000||The House passes H.R. 3514 with the Bliley amendments.|
|December 6, 2000||The Senate passes S. 2725 unanimously.|
|December 20, 2000||President Clinton signs the CHIMP Act into public law (P.L. 106-551).|
|April 16, 2001||The National Center for Research Resources (NCRR), part of the National Institutes of Health (NIH), publishes a "source sought" notice to determine whether there is an existing nonprofit that fulfills the requirements of the CHIMP Act and is interested in serving as the "contractor" of the sanctuary system.|
|September 28, 2001||NIH publishes a request for proposal for an entity to operate and maintain a sanctuary system via the CHIMP Act.|
|December 20, 2001||The departments of Labor, Education, Health and Human Services and related agencies' 2002 Appropriations Act (H.R. 3061) allocates $5 million to begin construction of the national chimpanzee sanctuary facilities.|
|January 10, 2002||President G.W. Bush signs H.R. 3061 into public law, including $5 million toward construction of the national sanctuary system.|
|September 30, 2002||NIH announces the award of a contract to Chimp Haven to establish and operate a chimpanzee sanctuary, pursuant to the CHIMP Act.|
|May 1, 2003||Chimp Haven, the contractor of the national chimpanzee sanctuary system, breaks ground on its Shreveport, La., facility.|
|January 11, 2005||NIH publishes a notice of proposed rule making regarding standards of care for chimpanzees held in the national chimpanzee sanctuary system.|
|June 28, 2006||Chimp Haven receives full accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care International.|
LABORATORY ANIMALS AND THEIR USES
Determining the number of animals used for research in the United States is extremely difficult, because rats, mice, birds, and cold-blooded animals are not regulated by the AWA and do not have to be counted. It is widely agreed that rats and mice make up a huge majority of research animals. The National Research Council notes in National Need and Priorities for Veterinarians in Biomedical Research (2004) that approximately twenty-three million rats and mice were used in biomedical research during 1998 and that the number was expected to increase by 10% to 20% annually through 2010. If this prediction held true, as many as ninety-nine million rats and mice were needed during 2006 for biomedical research. Some estimates place the total number even higher. In 2002 Jonathan Knight and Alison Abbott estimated in "Mouse Genetics: Full House" (Nature, June 20, 2002) that sixty million mice would be needed just to complete the mouse genome (a study of the genetic makeup of the mouse with the function of every gene identified). The Scientific American (August 4, 2004) estimates that close to one hundred million mice are "consumed" annually in U.S. laboratories.
As shown in Table 5.6, there were 1,101,958 AWA-registered animals used in live research during fiscal year 2004. California laboratories used the most regulated animals (116,395), followed by Massachusetts (89,031), Pennsylvania (79,273), Ohio (70,245), and New Jersey (65,180). Together, these five states accounted for more than one-third of all regulated research animals.
Figure 5.6 shows the breakdown of regulated research animals by species in 2004. Rabbits made up the largest portion (23%), and guinea pigs made up 22%. Hamsters made up 16% of the total. Pigs, sheep, and other farm animals totaled 10%. Together, dogs, cats, and nonhuman primates constituted 13% of all regulated animals. These species are the ones that arouse the most public concern in the research animal debate. Other covered species constituted 16% of the total.
The total number of regulated research animals used annually over the thirty-two-year period from 1973 to 2004 is shown in Figure 5.7. Over the first twenty years of this period (1973 to 1992), the average was 1.8 million animals per year. For the twelve-year period from 1993 to 2004 the average dropped to 1.3 million per year.
The vast majority of research animals are used in biomedical research. Biomedicine is a medical discipline based on principles of the natural sciences, particularly biology and biochemistry.
The NIH maintains the Computer Retrieval of Information on Scientific Projects (CRISP; http://www.crisp.cit.nih.gov/), a database of biomedical research projects that have received funding from federal agencies dating back to 1972. The CRISP database can be searched to find information about the use of animals in federally funded research projects at universities, hospitals, and other research institutions. For example, a search conducted in February 2007 using the search term dogs returned 179 projects in which dogs played a role. Information supplied about each project includes the name of the principal investigator, the name and address of the research institution, the starting and ending dates of the project, the federal agency providing funding, and a description of the project.
According to the FDA, in "The Beginnings: Laboratory and Animal Studies" (January 30, 2006, http://www.fda.gov/fdac/special/testtubetopatient/studies.html), drug companies typically test new drugs on at least two different animal species to see if they are affected differently. Animal testing is performed to determine specific characteristics, such as:
- How much of the drug is absorbed into the bloodstream
- Any toxic side effects
- Appropriate dosage levels
- How the drug is metabolized (broken down) by the body
- How quickly the drug is excreted from the body
The results from animal tests tell researchers if and how new drugs should then be tested on humans.
Millions of research animals are used to test products intended for industrial and consumer markets in the United States. Product safety testing exposes animals to chemicals to determine factors such as eye and skin irritancy. Common product safety tests conducted with animals include:
- Acute toxicity tests determine the immediate effects of chemical exposure. The LD-50 test is an example. In this test animals are exposed to chemicals through ingestion, inhalation, or skin contact to determine the concentration necessary to kill 50% of the test group within a specific time period.
- Skin and eye irritancy tests determine the effects on skin and eyes of chemical exposure. One example is the Draize eye test. Rabbits are commonly used because they cannot blink and wash out the chemicals.
- Subchronic and chronic toxicity tests determine the effects of long-term chemical exposure.
- Genetic toxicity tests determine the effects of chemical exposure on reproductive organs.
|Animals used at USDA-registered research facilities, by state, fiscal year 2004|
|[Total reported = 1,101,958]|
|States||All other covered species||Cats||Dogs||Guinea pigs||Hamsters||Nonhuman primates||Other farm animals||Pig||Rabbits||Sheep||Total by state:|
|Animals used at USDA-registered research facilities, by state, fiscal year 2004 [continued]|
|[Total reported = 1,101,958]|
|States||All other covered species||Cats||Dogs||Guinea pigs||Hamsters||Nonhuman primates||Other farm animals||Pig||Rabbits||Sheep||Total by state:|
|Source: "Animals Used in Research," in Animal Care Reports: Annual Reports of Enforcement by Fiscal Year: 2004, U.S. Department of Agriculture, Animal and Plant Health Inspection Service, 2004, http://www.aphis.usda.gov/ac/awreports/awreport2004.pdf (accessed November 28, 2006)|
- Birth defects tests determine the effects of chemical exposure on offspring.
- Cancer potential tests determine the potential of chemical exposures for causing cancer.
Some companies selling consumer products, such as cosmetics and household cleaners, advertise that they do not conduct animal testing on their products or that their products are "cruelty-free." In some cases this statement may be somewhat misleading. For example, according to the CAAT (January 29, 2007, http://altweb.jhsph.edu/faqs.htm#13), such claims can mean various things, including:
- Animal testing has not been performed on the products and/or their ingredients in the previous five years.
- Animal testing was performed on the products and/or ingredients by another company (for example, a supplier).
- Nonanimal testing was performed on finished products made from ingredients already known to be safe because of previous animal testing.
CAAT points out that the vast majority of cosmetic ingredients used by the industry have been tested on animals at some point in time, or are known to be safe based on decades of use. It notes that smaller cosmetics companies tend to produce final products made from purchased ingredients, rather than from ingredients developed in-house. Larger companies that develop new ingredients for cosmetics must use animal testing or viable alternatives to prove that the ingredients are safe for consumer use.
The National Anti-Vivisection Society's Personal Care for People Who Care (2005) lists hundreds of companies that produce personal care (for example, bath products, deodorants, and antiperspirants), household (for example, bathroom and kitchen cleaners and furniture polishes), pet care, and cosmetic products and tells whether they do or do not test their products on animals.
In addition, the book identifies companies that do not use any animal-derived ingredients in their products. Other animal rights organizations, such as PETA, maintain similar types of lists. Some provide a seal that compliant companies can use to mark their products for easy identification by shoppers.
In February 2003 the Council of the European Union and the European Parliament approved the Seventh Amendment of Council Directive 76/768/EEC (the Cosmetics Directive). It will place a ban on the testing of cosmetics on animals in Europe in 2009. In addition, in 2009 the sale and import of new cosmetics tested on animals using eleven specific tests will be banned. Another ban will be implemented in 2013 on the sale and import of cosmetics tested on animals for three toxicity tests (assuming that valid alternative tests have been established by that time).
Dead animals used for dissection in schools make up a small portion of all research animals. The HSUS states in "Back to School Shouldn't Mean Back to Dissection Says the HSUS" (September 23, 2004, http://www.hsus.org/press_and_publications/press_releases/back_to_school_shouldnt_mean_back_to_dissection_says_the_hsus.html) that an estimated six million animals—mostly frogs, pig fetuses, and cats—are dissected by U.S. schoolchildren each year. Dissection has been considered a staple of biology classes since the 1960s, when the National Science Foundation urged schools to implement a more hands-on science curriculum.
The first legal challenge against school dissection lodged by a student occurred in California in 1987. A high school student sued her school for not allowing her to perform an alternative to dissection. California and Florida became the first states to allow students to opt out of dissection in the mid- to late 1980s. According to "Dissection Laws" (August 30, 2006, http://www.hsus.org/animals_in_research/animals_in_education/dissection_laws.html), the HSUS notes that other states have since followed suit with choice-in-dissection laws or policies: Illinois, Louisiana, Maine, Maryland, Massachusetts, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Rhode Island, and Virginia.
By the early twenty-first century many students were expressing ethical and moral concerns about the practice of dissection in the classroom. Some school districts now offer students alternatives, such as computer models. The National Science Teachers Association defends dissection as a valuable learning tool for children, but urges teachers to be flexible in offering alternatives.
Surgical/Medical Training and Behavior Research
It is estimated that the use of laboratory animals for surgical/medical training and behavior research makes up only a small part of the number of research animals used. However, this category is one that is particularly criticized by antivivisection groups. In the past, surgeons training to operate on humans and animals almost always practiced on live animals. Many of these surgeries were terminal surgeries, meaning that the animals are not allowed to regain consciousness. The animals are euthanized while they are under the effects of anesthesia.
The Physicians Committee for Responsible Medicine (PCRM) reports in "Alternatives to Animal Labs in Medical Schools" (January 30, 2007, http://www.pcrm.org/resch/anexp/alertliveanimallabs.html) that more than 85% of all U.S. medical schools have eliminated live animal labs to train medical students. Many veterinary schools are limiting the number of terminal surgeries required of their students. Some veterinary schools conduct dissection labs. According to the PCRM, many schools now use animal cadavers donated by people whose pets or livestock have died of natural causes or have been humanely euthanized because of illness or injury.
SOURCES OF RESEARCH ANIMALS
Research animals are obtained by laboratories from animal breeders and brokers licensed by the USDA. These licenses fall into two types:
- Class A—Breeders who sell animals that they have bred and raised on their own premises and who buy animals only to replenish their breeding stock
- Class B—Breeders, dealers, brokers, and operators of auction sales that purchase and/or resell live or dead animals, often obtained from city or county animal shelters
Breeders who sell fewer than twenty-five dogs and/or cats per year that were born and raised on their own premises, for research, teaching, or testing purposes, are exempt.
APHIS (http://www.aphis.usda.gov/ac/publications.html) reports that in September 2006 there were 4,974 Class A breeders and 1,185 Class B breeders/dealers/brokers in the United States. Note that not all these licensees sell animals to research laboratories. Some sell animals to pet stores and other animal enterprises.
Lab animal suppliers advertise their animals in the Lab Animal Buyer's Guide (http://guide.labanimal.com/guide/). It lists more than five hundred companies and over eight hundred products and services. Animals available include frogs, toads, salamanders, newts, cats, dogs, ferrets, chickens, ducks, cattle, goats, sheep, swine, rabbits, nonhuman primates (monkeys, chimpanzees, and so on), birds, fish, opossums, woodchucks, exotic animals, invertebrates, and a wide assortment of rodents.
The vast majority of laboratory research animals are purpose-bred, meaning that they are born and raised under controlled conditions and may be genetically manipulated. Purpose-breeding of laboratory animals is becoming more and more common as researchers demand animals with particular genetic makeups. For example, researchers investigating narcolepsy use dogs bred to be born with the condition. Charles River Laboratories in Wilmington, Massachusetts, is a leading breeder and supplier of purpose-bred animals.
Live animals for research can also be purchased from random sources. For example, dogs and cats obtained from animal shelters are considered random-source animals. Researchers acquire these animals from dealers with USDA Class B licenses or directly from shelters. Class B dealers can acquire random-source dogs and cats for resale, but only from the following sources:
- Other USDA licensed dealers
- State-, county-, or city-owned and operated animal pounds or shelters
- Humane groups and contract pounds organized as legal entities under the laws of their state
- People who have bred and raised the animals on their own premises
Class B dealers are prohibited from obtaining dogs and cats from private individuals who did not breed and raise the animal on their own premises.
The rules that Class B dealers must follow when acquiring animals are primarily intended to prevent them from selling pets to research facilities. USDA regulations also require Class B dealers to hold live dogs and cats for specific time periods before reselling them, and the dealers have to keep records, including physical information about each animal (age, color, sex, species, and breed) and the names and addresses of the seller and buyer of each animal. (See Table 5.7.) This gives pet owners a chance to track down lost pets that were sold to Class B dealers by animal shelters. Random-source dealers are listed in the Lab Animal Buyer's Guide. Some animal protection groups also maintain lists of Class B dealers they believe sell random-source dogs and cats to laboratories.
|Holding periods required for dogs and cats held by USDA-licensed "B" dealers|
|IF the source is||AND the dog/cat's age is||THEN the holding period is|
|Source: "Licensed 'B' Dealer," in Random Source Dog and Cat Dealer Inspection Guide, U.S. Department of Agriculture, Animal and Plant Health Inspection Service, April 2000, http://www.aphis.usda.gov/ac/dealer/randomsource.pdf (accessed January 3, 2007)|
|a private pound, contract pound or shelter||any age||10 full days, not including the day of acquisition and the time in transit|
|a state, city, or county operated pound or shelter||any age||5 full days, not including the day of acquisition and the time in transit|
|a private individual who bred and raised the dog/cat on his/her premises||< or = 120 days||24 hours, not including the time in transit|
|a private individual who bred and raised the dog/cat on his/her premises||>120 days||5 full days, not including the day of acquisition and the time in transit|
|another USDA licensed dealer or exhibitor who has already held the dog/cat for the required holding period||any age||24 hours, not including the time in transit|
|another USDA licensed dealer or exhibitor who has not held the dog/cat for the required holding period||any age||5 full days, not including the day of acquisition and the time in transit|
Random-source animals are used in research where genetic diversity is important. According to the MISMR, in "The Use of Pound Animals in Biomedical Research" (2006, http://www.mismr.org/educational/pound.html), random-source animals are primarily used in biomedical research on cardiovascular diseases, cancer, diabetes, arthritis, lung disorders, orthopedics, birth defects, hearing loss, and blindness. Dogs are the subject of choice for heart and kidney disease research. Cats are frequently used in research devoted to the central nervous system, strokes, and disorders of the brain, eyes, and ears. The MISMR (2006, http://www.mismr.org/about/) notes that use of these animals in research benefits not only human medicine but also veterinary medicine.
Random-source dogs and cats are far less expensive than those that are purpose-bred. The MISMR reports in "Use of Pound Animals in Biomedical Research" that in 2006 the cost of a shelter dog or cat was $60 to $200, compared with $422 to $580 for a purpose-bred one. It also claims that less than 2% of the ten million animals that reside in shelters each year are used for medical research. The organization claims that these animals would be euthanized in the shelters anyway because of the pet overpopulation problem.
Animal welfare organizations disagree, however, noting that neither municipal animal shelters nor Class B dealers all follow the regulations. Many fail to keep animals for the assigned period, and dealers often do not keep detailed records of the animals they sell. Despite regulations of the industry, lost family pets do periodically become the subjects of experiments when they are not held for the entire waiting period. In addition, there has been much controversy over Class B dealers, some of whom have been known to steal pets from homes and yards. Welfarists and animal rights activists often criticize the NIH for funding research projects that use shelter dogs and cats. The NIH leaves source decisions to individual research institutions. Although some people are pushing for legislation to outlaw the use of shelter animals in medical research, the MISMR argues in "Use of Pound Animals in Biomedical Research" that this would drive up the cost of research and costs to local communities that must house and euthanize unwanted animals. Those involved in the animal welfare and rights movement respond with evidence that more and more animal shelters are adopting a "no-kill" policy—meaning they will euthanize only in cases of severe illness or temperament problems but not because of overpopulation—so shelter animals will not necessarily be euthanized and may instead be adopted.
CLASS B DEALER BUSTED BY THE USDA
In August 2003 federal authorities raided Martin Creek Kennels in Williford, Arkansas, and confiscated more than one hundred dogs and one cat. The facility had a USDA Class B license to purchase and resell animals. The raid resulted from an undercover videotape obtained by the animal protection group Last Chance for Animals. The videotape documented many cases of abuse and neglect at the facility and several incidences of dogs being shot to death and thrown into mass graves. Brenda Shoss reports in "Pet Theft Thugs: They're Real. They're Nearby" (March 24, 2005, http://www.kinshipcircle.org/columns_articles/0052.html) that the kennel purchased stolen pets from bunchers (people who steal pets, pick up strays, and take in dogs and cats given away for free and sell them to Class B dealers). The kennel bought stolen pets for $5 to $30 per animal and sold them using falsified paperwork to research laboratories for $150 to $700 per dog and $50 to $200 per cat.
Shoss notes that the kennel had been in business for sixteen years, and during that time it sold thousands of animals to research laboratories. In February 2005 C. C. Baird, the owner of the kennel, and his family were fined $262,700 by the USDA and had their Class B licenses revoked permanently.
Because of cases such as this, those in the animal rights and welfare community, as well as veterinarians, frequently warn against placing "free to good home" advertisements, fearing that the animals offered will end up in the hands of bunchers or Class B dealers.
REDUCTION, REFINEMENT, AND REPLACEMENT
In 1959 William Russell and Rex Burch published Principles of Humane Experimental Technique, which advocated three principles for the animal research industry: reduction, refinement, and replacement. Russell and Burch called these principles "the three R's for the removal of inhumanity" in the scientific community.
The book was largely ignored until the 1980s, when public protest against the use of animals in laboratory testing became more widespread. Scientists and animal welfare organizations then embraced the three Rs as scientifically reasonable and humane goals for the industry. The three Rs, however, are guiding principles, not legal requirements.
The three Rs are defined as follows:
- Reduction is a goal to reduce the number of animals used in research overall by reducing the number required for individual experiments or areas of study without sacrificing the statistical validity of the results. In other words, researchers are urged to use statistics to determine the minimum number of animals that can be used in an experiment and still provide valid data. Another goal is to reduce the number of procedures that require whole animals. For example, tissues from an animal used in one experiment could be used in other experiments in place of live whole animals.
- Refinement is a goal to refine experimental and care practices to reduce animal suffering and distress and encourage well-being. Such practices include the use of painkillers during and after experiments, the use of humane euthanasia techniques, and improvements in animals' living environments.
- Replacement is a goal to replace live laboratory animals with suitable alternatives (for example, computer simulations) and to replace higher animal species with lower species.
Search for Alternatives to Animal Tests
In 1993 the National Institutes of Health Revitalization Act was passed, requiring formation of an agency to oversee validation of alternatives to toxicological animal testing. The result was the Interagency Coordinating Committee for the Validation of Alternative Methods (ICCVAM) and the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM).
The ICCVAM is responsible for establishing validation criteria and for encouraging government agencies that regulate toxicity testing to accept validated methods. The NICEATM facilitates information sharing among all the parties involved.
|Alternative test methods submitted to the ICCVAM for evaluation|
|[As of November 30, 2005]|
|Test method||Toxicity category|
|Note: ICCVAM is the Interagency Coordinating Committee on the Validation of Alternative Methods, a division of the National Institute of Environmental Health Sciences.|
|Source: "Test Method Evaluations," in Activities and Publications: Test Methods, National Institutes of Health, National Institute of Environmental Health Sciences, The Interagency Coordinating Committee on the Validation of Alternative Methods, November 30, 2005, http://iccvam.niehs.nih.gov/methods/review.htm (accessed December 14, 2006)|
|Up-and-Down Procedure (UDP)||Acute toxicity|
|In Vitro Methods for Assessing Acute Systemic Toxicity|
|Botulinum Toxin Testing||Biologics and vaccines|
|Corrositex ® Assay||Dermal corrosivity and irritation|
|EpiDerm™, Episkin™ and Rat Skin Transcutaneous Electrical Resistance (TER) Assays|
|Frog Embryo Teratogenesis Assay—Xenopus (FETAX)||Developmental toxicity|
|In Vitro Endocrine Disruptor Screening Assays||Endocrine disruptor|
|Murine Local Lymph Node Assay (LLNA)||Immunotoxicity|
|In Vitro Test Methods for Detecting Ocular Corrosives and Severe Irritants||Ocular toxicity|
|In Vitro 3T3 NRU Phototoxicity Test Method||Phototoxicity|
|In Vitro Pyrogenicity Test Methods||Pyrogenicity|
Table 5.8 lists the alternative test methods that have been submitted to the ICCVAM for review and evaluation. Two of the tests are considered particularly promising: the local lymph node assay (LLNA) and Corrositex. The LLNA is a mouse-based test for determining if new chemicals cause allergic contact dermatitis (skin reactions). The traditional test for this condition used guinea pigs. The LLNA is reported to use fewer animals and cause much less pain and distress than the traditional test. It is also much faster. CAAT reports in "New Alternative Test Should Save Thousands of Guinea Pigs" (January 2000, http://altweb.jhsph.edu/news/2000/20000110.htm) that the LLNA has been accepted by the U.S. Environmental Protection Agency, the FDA, the Occupational Safety and Health Administration, and the Consumer Product Safety Commission as an alternative test method for assessing allergic contact dermatitis.
Corrositex is an in vitro (outside the body) test in which synthetic skin is used to test chemical irritancy. In vitro tests are commonly conducted in test tubes. The traditional test for skin irritancy relied on rabbits and could take several weeks. The new one takes just a few minutes or hours. Corrositex and other in vitro skin corrosion tests could be used to satisfy corrositivity testingrequired by various agencies. The new tests would replace the current testing protocol in which corrosive substances are placed on the skin of living animals (usually rabbits) for specific lengths of time, as shown in Table 5.9. The extent of tissue damage in the animals is assessed after the exposure time to determine the corrositivity of the chemicals. The ICCVAM notes in Recommended Performance Standards for In Vitro Test Methods for Skin Corrosion (May2004, http://iccvam.niehs.nih.gov/methods/ps/ps044510.pdf) that use of the new tests could "avoid pain and distress that may result from the application of corrosive substances to animals."
|Traditional skin corrositivity testing performed on the skin of living animals, by exposure and observation times|
|Corrosive category (category 1) (applies to authorities not using subcategories)||Potential corrosive subclassesa(UN packing group classificationb)||Corrosive in at least 1 of 3 animals|
|aClassifications designated by the United Nations (UN) Globally Harmonised System for the Classification and Labelling of Chemical Substances and Mixtures (GHS).|
|bCorresponding UN packing group classifications to be used for the transport of dangerous goods.|
|Source: "Table 1.1. Skin Corrosive Category and Subcategories," in Recommended Performance Standards for In Vitro Test Methods for Skin Corrosion, National Institutes of Health, National Institute of Environmental Health Sciences, Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), May 2004, http://iccvam.niehs.nih.gov/methods/ps/ps044510.pdf (accessed January 3, 2007)|
|Corrosive subcategory 1A (I)||≤3 minutes||≤1 hour|
|Corrosive||Corrosive subcategory 1B (II)||>3 minutes/≤1 hour||≤14 days|
|Corrosive subcategory 1C (III)||>1 hour/≤4 hours||≤14 days|
Pain and Distress
One of the goals of refinement is to relieve animal pain and distress. APHIS tracks the occurrence of pain and distress in regulated animals, as shown in Table 5.10. These numbers are based on reports by research institutions to APHIS for fiscal year 2004. As shown in Figure 5.8, 56% of the regulated animals experienced no pain or distress, 36% experienced pain or distress but were administered drugs for relief, and 8% suffered pain and distress but were not given drugs for relief. Hamsters and guinea pigs were the species most involved in experiments in which pain and distress were not relieved. More than sixty-seven thousand of them fell into this category during 2004. In addition, nearly twenty-seven hundred dogs, cats, and primates also suffered pain and distress that was not relieved.
Animal welfare groups express doubts about the validity of APHIS pain and distress numbers, saying that these numbers are greatly underreported by research institutions. In 1998 the HSUS launched a Pain and Distress Initiative to focus attention on issues involved in assessing and relieving pain in laboratory animals. The HSUS publishes the quarterly newsletter Pain and Distress Report to publicize these issues. The goal of the initiative is to eliminate pain and distress in research animals by 2020.
|Animals used in research at facilities registered with the U.S. Department of Agriculture (USDA), by species, and pain/distress and relief measures, fiscal year 2004|
|No pain and/or distress—no drugs were needed for relief||Pain and/or distress—drugs were used for relief||Pain and/or distress—no drugs could be used for relief||Total animals used|
|Source: Adapted from "Animals Used in Research: No Pain and/or Distress—No Drugs Were Needed for Relief (Category C)," "Animals Used in Research: Pain and/or Distress—Drugs Were Used for Relief (Category D)," and "Animals Used in Research: Pain and/or Distress—No Drugs Could Be Used for Relief (Category E)," in Animal Care Reports: Annual Reports of Enforcement by Fiscal Year, 2004, U.S. Department of Agriculture, Animal and Plant Health Inspection Service, 2004, http://www.aphis.usda.gov/ac/awreports/awreport2004.pdf (accessed November 28, 2006)|
|All other covered species||106,471||56,568||8,273||171,312|
|Other farm animals||23,564||8,224||168||31,956|
|Total number of animals||615,410||399,800||86,748||1,101,958|
The HSUS acknowledges that animal rights advocates want to eliminate animal testing, not reform it. The organization states, "The HSUS would like to see the day when animals are no longer used in harmful research. However, we believe the most urgent public priority is eliminating pain and distress among laboratory animals" (October 26, 2006, http://www.hsus.org/animals_in_research/pain_distress/pain_distress_campaign/).
Scientists recognize that eliminating pain and distress in laboratory animals is not only humane but also good scientific practice. The animal use policy at Vanderbilt University, for example, acknowledges that experimental results can be compromised by a physical or mental state of distress in the subject and recommends relieving pain and distress in animal subjects.
One concept embraced by the HSUS is the use of humane endpoints. This means that test animals can be humanely euthanized after exhibiting specific symptoms of a disease rather than dying of the disease itself.
Genetic engineering is the scientific manipulation of genetic material. Animals have been the subject of genetic engineering research and experiments for several decades. Transgenic animals are animals that carry a foreign gene that has been deliberately inserted through genetic engineering. They are widely used in biomedical research and pharmaceutical development. Most of these animals are farm animals. Raising these transgenic animals for the cultivation of pharmaceutical products is known as pharming. For example, scientists have pharmed transgenic sheep and goats that produce foreign proteins in their milk. Production of these proteins could have enormous medical and industrial benefits for humans. As of early 2007, pharmed substances were still in the development stage and had not yet been commercialized.
Another growing area of genetic engineering is xenotransplantation. The term xeno comes from the Greek word xenos, meaning "foreign" or "strange." In xenotransplantation organs from animals are transplanted into humans. Research continues on the genetic engineering of pigs so that they can grow organs that will not be rejected by human bodies. Scientists believe that harvesting organs from transgenic pigs could one day solve the human organ shortage that at present exists, saving millions of human lives. The technology is almost to the point of making this possible. Some people consider this to be medical progress, but others see it as another injustice perpetrated against animals for the sake of humans, noting that there would not be an organ shortage if more people were willing to become organ donors.
Cloning is a form of genetic manipulation in which a later-born genetic twin can be produced. In July 1996 the first mammal cloned from adult cells was born, a product of research at the Roslin Institute in Edinburgh, Scotland. Dolly was cloned from an udder cell taken from a six-year-old sheep. She was a fairly healthy clone and produced six lambs of her own. Before she was euthanized by lethal injection on February 14, 2003, Dolly had been suffering from lung cancer and arthritis. An autopsy (postmortem examination) of Dolly revealed that, other than her cancer and arthritis, she was anatomically like other sheep. (See Figure 5.9.) Between 1996 and 2007 other animals were cloned, including sheep, mice, cows, a gaur (an endangered Asian ox), goats, pigs, rabbits, dogs, and cats. Not all the animals have survived, and most have been born with compromised immunity and genetic disorders. Cloning is still new technology, and the success rate is low.
The company Genetic Savings and Clone financed the first successful cat cloning in 2001. It resulted in a cat that did not exactly duplicate the cat from which it was cloned. The company refined its cloning technique and in December 2004 made its first sale, receiving $50,000 for a cloned kitten named Little Nicky. The kitten was a twin to a Maine Coon cat named Nicky that died during early 2004. In February 2005 the company sold its second cloned cat (Little Gizmo) to an owner whose cat had died in 2004. However, lack of customers forced Genetic Savings and Clone to close at the end of 2006. Another company, ViaGen, banks tissue collected from pets for future cloning. Although ViaGen did not clone pets as of February 2007, it has successfully cloned livestock. The idea of pet cloning becoming commonplace is enormously disturbing to those in the animal rights and welfare movement, who note that the pet overpopulation problem in the United States has already meant homelessness for billions of pets.
Besides the pet market, cloning also holds potential in other animal fields. Farmers may be able to vastly increase meat, milk, and egg production by cloning their best-producing animals. The scientific implications of cloning are impressive. It could benefit millions of people. Yet, the ethical questions are troubling to some.
A Gallup poll conducted in May 2006 found that 29% of those asked believed that cloning of animals was morally acceptable. (See Figure 5.10.) Lydia Saad reports in "Cloning Humans Is a Turn Off to Most Americans" (Gallup News Service, May 16, 2002) that in 2002, 38% of respondents favored the cloning of endangered species to keep them from becoming extinct. Only 15% favored the cloning of pets. Therefore, public support does not seem to be fully behind animal cloning, even though the practice proceeds in the laboratory.