Overview of Laboratory Animal Issues
Numbers and Species
It is estimated that at least 25-35 million vertebrate animals are used in laboratories in the United States, including approximately more than 1.5 million in Massachusetts. Worldwide, the number is thought to be well over 100 million. The most common species — listed from most to least often used — are mice, rats, rabbits, guinea pigs, hamsters, farm animals (such as sheep and pigs), dogs, primates, and cats.
It is impossible, however, to know exactly how many animals are being used in laboratories in the U.S. today. This is because the Animal Welfare Act (AWA), the law requiring records to be kept on laboratory animals, excludes mice, rats, and birds from its coverage. Because they are not covered by the AWA, the U.S. Department of Agriculture (USDA) does not usually inspect these species and does not currently include their numbers in its annual reports to Congress.
In fact, according to the 2007 USDA Animal Welfare Report, the total number of animals used in research in the U.S. was 1.02 million, largely inconsistent with the commonly held estimate of 25-35 million vertebrates used in research. This discrepancy is accounted for by the exclusion of mice, rats and birds from USDA totals, as these species comprise 95-98% of the animals used in research. In the last two decades, a number of legal challenges have been made, attempting to force the inclusion of these species under the coverage of the AWA. To date, these efforts have been only moderately successful, gaining support in the court system only to be obstructed legislatively.
History of Lab Animal Use
Vivisection (the act of cutting into a living animal, usually for the purpose of physiological and pathological knowledge) has been practiced since ancient Greek and Roman days, when live animals were cut open without anesthesia to study bodily functions. Similar practices continued throughout the Middle Ages, as people believed that man was the center of the universe and, therefore, that he could do anything he wanted with other animals. By the second half of the 1600s, however, following a dramatic rise in animal experimentation during the Renaissance, some philosophers began to object to the suffering of animals used for scientific research. Throughout the 1700s and early 1800s, this trend continued. The first organized protest against vivisection was led by British women in Florence, Italy in 1863, and the first Cruelty to Animals Act, mandating the use of anesthetics during vivisection, was passed in England in 1876.
In the mid-nineteenth century, however, the publication of Charles Darwin’s book Origin of Species increased scientific interest in species evolution and strongly reinforced the idea that animals could serve as models for humans in the study of biology and physiology. Additionally, Claude Bernard’s Introduction to the Study of Experimental Medicine popularized the idea of vivisection as the predominant mechanism for scientific research. During this period and through World War I, animal research was established as a significant method of laboratory investigation. This trend continued into the mid-twentieth century. An increase in laboratory animal use came after World War II, when the government began providing a significant amount of funding for research.
In 1966, Congress passed the first legislation aimed at regulating the care and use of animals in U.S. laboratories. Called the Laboratory Animal Welfare Act, it was enacted following a rise in public concern over the mistreatment of lost and stolen cats and dogs by laboratory animal dealers. Later strengthened through three major revisions and renamed the Animal Welfare Act, it now covers not only animals in laboratories but also in zoos, circuses, and aquaria and oversees animal transportation and animal fights.
Animal research reached its highest level in the United States in the mid-1980s following decades of public support for scientific research of all kinds. During this same time, animal activists were able to pressure cosmetics companies to reduce or eliminate animal use in the testing of their products; the development of new mechanisms for product safety testing that were not animal-based opened the door for this change. In the decade that followed, the number of animals being used in laboratories for research, testing, and education began to decline—some say by as much as 40-50%. Today, the use and maintenance of genetically engineered animals (those that have had their genetic code altered to produce a specific result), especially rats and mice, has greatly increased the number and suffering of laboratory animals.
Purpose of Lab Animals
Animals are used in laboratories today for one of three main purposes: biomedical research, testing drugs, vaccines, and consumer products, and for education.
Biomedical Research: About 60% of all animals in laboratories are used for biomedical research designed to further scientific understanding of how the body works and how disease affects bodily systems. Biomedical research is based on the idea that animals are similar enough to humans to serve as “models” for the study of human organ systems. Discoveries credited by scientists to the use of animals in research include penicillin, insulin, the polio vaccine, chemotherapy for childhood leukemia, hip replacement and heart bypass surgery. However, critics of biomedical animal research challenge the assumption that animals are appropriate models for humans, pointing to failures in extrapolating from one species to another. They cite examples of animal research that delayed the discovery of a cure or misled scientists into believing in the safety of a drug or vaccine that turned out to be harmful to humans.
Testing Efficacy of New Drugs and Vaccines: Approximately 17% of all animals in laboratories are used to evaluate the safety and effectiveness of new drugs and vaccines. Before new compounds can even be tested on small groups of humans, they are first tested extensively on animals. Only about 5 in 5,000 compounds tested receives Food and Drug Administration approval for use in humans.
Critics of animal use in drug and vaccine development raise concerns about the possibility of rejecting compounds that might prove to be miracle drugs in people even though they are toxic to certain animals. If penicillin had been tested only in guinea pigs, they say, humans might never have benefited from this lifesaving antibiotic. Additionally, the benefit of a treatment to humans is not fully known or able to be reliably measured until it is tested clinically on a human population; thus, despite having been tested on and costing the lives of thousands of animals (and costing perhaps millions of dollars) the ultimate efficacy a drug or vaccine is still largely unknown until it is tested on a human population.
Consumer Product Safety Testing: U.S. government agencies require an extensive array of animal tests to assure the safety of items such as shampoo, food packaging, and household cleaners. These products are tested for their toxicity to the eyes and skin, for their potential to cause internal organ damage, and for their safety for use by pregnant women. In some cases, animal tests are specifically required by a federal regulatory agency. In other cases, only the "best available" safety information is requested. Many American regulatory agencies, however, still believe that traditional animal tests are the "best available." And for some products and ingredients, traditional animal tests are still the only ones available.
While there is still much progress to be made, many manufacturers have dramatically reduced their reliance on animal use in product safety testing in the last two decades. Two crucial components of this change have been the sharing of information about the safety of ingredients and product formulations, as well as the utilization of computers in facilitating searches of databanks containing this information. While truly reliable figures are not available, it is estimated that the number of animals used to test the safety of personal care products in the U.S. is probably fewer than 5% of all animals used in U.S. laboratories. This represents nearly a 90% reduction since 1980, when a public outcry arose over animal use in product safety testing.
Animals in Education: Less than 10% of laboratory animals are used each year in the teaching of science at colleges and medical and veterinary schools. These are generally comprised of animal labs in medical schools, dog and other animal laboratories in veterinary schools, and rats and pigeons used in psychology labs for behavioral research.
Medical schools have made great progress in recent years: only 10 medical schools currently use animal laboratories (this number is down from 100 schools 20 years ago) and as of late 2008, dogs are no longer used in medical education at any U.S. school. Interestingly, most veterinary schools still use dog and animal labs in their educational programs. Many of these are anesthetized healthy dogs used for surgical training. However, some vet schools are also beginning to offer alternatives to traditional dog labs, instead providing their students with surgical experience on organ models, in spay/neuter clinics, or via Educational Memorial Programs (EMPs) where pet owners can donate the bodies of their deceased animals to veterinary schools for surgical and anatomical training.
In addition to laboratory animals used in higher education, millions of additional animals are killed each year for use in dissection classes in elementary and secondary schools. Frogs are most common, but cats, fetal pigs, rats, and snakes are also used, despite the fact that a wide variety of alternatives are available to provide students with equivalent learning experiences. These alternatives include interactive software programs, other electronic media, virtual reality programs, as well as non-living animal models, which can be used instead of live animals to study anatomy. Fifteen states have upheld (through state law, resolution, or Board of Education policy) a student’s right to choose humane alternatives to dissection without being penalized.
Sources of Lab Animals
There are three primary sources of laboratory animals: wild, purpose-bred, and stray or unwanted animals. Most are purpose-bred — that is, they are bred in a laboratory specifically for use in research, testing, or education. The federal government identifies those who breed and sell these animals as Class A animal dealers.
Random source, or Class B dealers, also supply animals to laboratories. These dealers are those licensed to collect laboratory animals from “random sources”: stray or otherwise unwanted dogs, cats, and other animals off the streets, from animal auctions, and from city pounds and local animal shelters. While “pound seizure,” the practice of acquiring laboratory animals from pounds and shelters, is prohibited by law in some states (in 1986, Massachusetts was the first state to make this practice illegal), other states –Minnesota, Oklahoma and Utah- require animals in pounds to be turned over to research laboratories. Class B dealers are licensed and regulated by the USDA.
Trends show that the demand for laboratory animals acquired from random sources is on the decline. In 2014, five Class B random-source dog and cat dealers were licensed to sell animals for experimentation in the United States. That number is down from 11 in 2009 and is a significant reduction from the early 1990s, when there were more than 100 such dealers selling dogs and cats. A 2009 report by the National Academies of Sciences concluded that animals from random-source dealers are not necessary for National Institutes of Health (NIH) supported research. As a result, the NIH has since phased out funding for research that uses cats and dogs from Class B dealers. The policy went into full effect in 2012 for cats and in October 2015 for dogs.
Although there are only a few random-source Class B dealers still licensed in theU.S., they remain a concern. Kenneth Schroeder, a Class B dealer, had his license revoked when he was accused of having “willfully violated the Animal Welfare Act” by obtaining seven dogs illegally, failing to provide proper housing, and refusing to allow USDA inspectors access to his records and facilities.
Laboratory Animal Care and Use
The Animal Welfare Act (AWA) is the most significant law governing the care and use of laboratory animals in the United States. The AWA passed in 1966 and was amended in 1970, 1976, 1985, and 1989. The AWA covers all warm-blooded animals except mice, rats, and birds. The AWA’s regulations spell out requirements for veterinary care, adequate food and water, protection from temperature extremes, shelter from outdoor elements, sanitation, and record keeping.
A separate piece of legislation, called the Health Research Extension Act, passed in 1985, covers all vertebrates—including mice, rats, and birds—used in research, testing, and education if the work is funded by the Public Health Service (PHS). The PHS Guide for the Care and Use of Laboratory Animals sets the standards for care and housing that must be provided to animals in PHS-funded studies.
Almost all animals in laboratories suffer to one degree or another from the stress of confinement, but they do not all experience pain or even distress as a result of experimental procedures. In 2007 the USDA reported that 38% of warm-blooded animals in laboratories covered by the AWA experienced no pain or distress, 54% experienced moderate to severe pain or distress that was relieved by anesthesia or analgesia (pain-killing medication), and the remaining 8% experienced unrelieved pain or distress. The USDA reported that 68,136 animals were used in research in Massachusetts in 2007. Of those, 62% were reported to have no pain and no drugs, 34% had pain and drugs, and 4% had pain without drugs. Of course, these figures do not include rats, mice, and birds, which are not covered by the AWA. While some laboratory animals die as a result of experimental procedures, most are euthanized for postmortem examination or when they are no longer needed.
According to the AWA, facilities using animals for research, testing, or education must form an Institutional Animal Care and Use Committee (IACUC) to oversee their animal programs. IACUCs are composed of scientists, veterinarians, and at least one member of the general public who is not affiliated with the institution in any way. IACUCs not only inspect the institution’s laboratories, they must also review and approve all research protocols before any animals can be used. They also look for evidence that the investigator has made a concerted effort to find alternatives to research that might cause pain and distress, and if animals must be used, that there is a plan for alleviating that pain and distress. The amount of time and effort put into these efforts, however, varies widely. There are approximately 1,400 IACUCs associated with research, testing, and education laboratories across the United States today. A report by the Office of the Inspector General in 2014 showed that in FY 2009-2011, 531 of 1,117 research facilities were cited with 1,379 IACUC-related violations regarding lack of oversight. Unfortunately, the USDA has only 57 veterinary medical officers (VMOs) and 68 inspectors (as of FY 2010) responsible for enforcing the Animal Welfare Act in over 8,656 facilities.
Alternatives to Animals in Research
While laboratory animals are the primary vehicle for research in the United States, an increasing number of alternatives to animal research now offer new hope for the welfare of millions of these animals used in biomedical research, product safety testing, and education. While the use of alternatives doesn't always mean eliminating animals altogether, the number of animals being used has been dramatically reduced in recent years, and the lives of many others have been significantly improved. The words now used almost universally by the research community and by animal protection advocates to describe alternatives are the Three Rs - Replacement, Reduction, and Refinement.
The widely-applied concept of the Three Rs was originally introduced in the 1950s by William Russell and Rex Burch, British biologists who sought to lessen the suffering of laboratory animals. Replacement means substituting other systems for whole animal use. Reduction means decreasing the number of animals to the minimum needed to yield accurate data. Refinement means using modern medicine to minimize or eliminate pain and distress and employing housing and husbandry techniques to enrich the captive environment to reduce boredom and promote natural behavior. Please see the Center for Lab Animal Welfare’s publication, "Laboratory Animal Alternatives – The Three Rs", for more information.
What Can You Do?
While the sheer scope of the issues impacting laboratory animals may seem daunting, individuals can make a positive impact on the welfare of laboratory animals in several ways:
· Be in the know. Public pressure has been the primary force behind all the improvements that have been made over the years in the laws and regulations protecting animals in laboratories. Join groups that promote laboratory animal welfare such as the MSPCA and its affiliate, the Center for Laboratory Animal Welfare. These organizations send e-newsletters and alerts to educate members about lab animal issues and let them know when their voice can help laboratory and other animals.
· Be an educated and conscientious consumer. Consider purchasing products made by companies that are doing the most to develop and promote alternatives to animals in testing their products’ safety. When making investments, consider those companies that don’t test on animals, don’t support animal-based research, or have committed to minimizing the number of animals used to test their products.
· Be an educated learner. If you or members of your family are an educator or student of any level, educate yourself, your family, and your institution about alternatives to the harmful or invasive use of animals in the classroom.