Product Safety Testing
What is the role of animals in product safety testing? Learn more about the growing number of alternatives to animal tests, the need for validation of these alternatives, and government's role in ensuring their acceptance for widespread use.
Animals have been used to test the safety and effectiveness of drugs and vaccines in the U.S. since the early 1920s. After World War II, animals also came into widespread use for testing the safety of consumer products-on the theory that their responses could predict the potential for harm to humans and other animals.
Because test results from one species don't always apply perfectly to others, this theory has come under increasing scientific criticism in recent years. In addition, many consumers have raised serious concerns about the ethics of using animals to test product safety, especially for cosmetics. But for a variety of reasons, scientists in government and industry continue to make widespread use of laboratory animal tests in an effort to limit the risk of harm to the consumer.
The Ethical Dilemma
The public has become increasingly aware of the potential of some chemicals to harm humans, wildlife, and the environment - and lawmakers have pushed hard for strict product safety standards. At the same time, many people have grown increasingly concerned about the potential for animal suffering in product testing laboratories.
The Center for Laboratory Animal Welfare believes that this dilemma can be resolved through the development of alternative test methods that dramatically reduce the number of animals used in laboratories today-and perhaps someday lead to their complete elimination-while providing the public with vital product safety assurances.
The Role of Animals
Because all laboratory animal use is not required to be reported in the U.S., exact numbers are impossible to obtain. But it has been estimated that about 4 million animals per year are used to test the safety of cosmetics, household cleaners, pesticides, industrial chemicals, food additives, packing materials, and fabric treatments, as well as drugs and vaccines for both people and animals. This represents about 13 percent of all animals used in U.S. laboratories today. The other 87 percent are used in education and in basic biomedical research, including the development of new drugs and vaccines.
About 95 percent of the 4 million animals used in testing are mice, rats, and other rodents such as guinea pigs and hamsters; but rabbits, dogs, cats, nonhuman primates, birds, fish, and amphibians are also used. During a product test, a group of test animals is exposed to a substance by application to an eye or a patch of shaved skin, in their food or drinking water, by inhalation, or by addition to the water in which they live. Another group of the same species, left unexposed to the test substance, is often studied as the control group. The condition of the exposed animals is then compared with this control group.
Some animals experience little or no discomfort in their lives as test subjects, others experience temporary pain to one degree or another, and still others experience extreme pain for prolonged periods of time. The amount of suffering caused during any one project depends upon many factors, including the substance being tested, the type of test being conducted, the number of animals being used, whether anesthetics or pain-killing drugs are used, how the animals are housed, and when and how they are killed at the end of the test.
Toxicology - Predicting the Potential for Harm
The study of the harmful effects of chemical substances on living organisms is called toxicology. It is a complex science, because a substance that is safe for use at one level of exposure can be harmful at just a slightly higher level. All substances-even water-can be harmful at some exposure level. The toxicologist's job is to determine the probability and extent to which a particular substance will be harmful to plants, animals, or humans under various exposure conditions. It is a difficult job, because a substance that is harmful to one species is not always harmful to another.
It is estimated that 80,000 chemicals are currently in use in the United States, with over 2,000 new ones introduced every year. American industry spends billions of dollars every year on toxicology studies in an effort to protect living things from harm by the products made with these chemicals.
Types of Tests
Many different kinds of tests have been developed over the last half century to assess the risk of routine or accidental exposure to various products. Acute toxicity tests provide an assessment of the risk of short-term exposure through normal use, accidental contact with the eyes or skin, and accidental ingestion. Two examples of acute-toxicity tests are the much-publicized LD50 (lethal dose 50 percent) test - which estimates the dose of a substance needed to kill half of a group of rats or other test animals -and the Draize eye irritancy test, which uses rabbits to estimate the ability of a test substance to irritate or damage the eye.
Chronic toxicity tests assess risks of long-term exposure-often at low levels-such as the potential to cause cancer, birth defects, and developmental abnormalities. Tests are also conducted to explore the body's absorption, distribution, metabolism, storage, and excretion of new chemicals and products and to monitor the long-term effect of a chemical on the brain and nervous system. Lifetime animal-feeding studies, such as those conducted over the two-year lifetime of a rat or the 18-month lifetime of a mouse, are examples of chronic-toxicity tests.
While computer data searches and other nonanimal tests can now be used to determine the toxicity of some substances before they reach the animal-testing stage, animal tests are still widely used as a second line of defense against potentially harmful products. Animal tests also always precede human tests in evaluating the safety of human drugs and vaccines. Many state and federal laws depend on specific animal test data to identify and classify potentially hazardous substances released into our air, food, and water supplies.
Trends in Consumer Product Safety Testing
Ironically, consumer interest in "green" products that protect the environment has recently increased the amount of animal testing, as manufacturers attempt to develop new, less toxic products. The push for new products to meet the needs of the developing world, such as affordable toothpaste for people living in poverty, has also resulted in some increases in animal testing.
The number of animals used to test cosmetics and other personal-care products, however, has declined in recent years. The reason is that the ingredients used in cosmetics are generally mild to begin with, many of these ingredients have already been proven safe through years of animal tests and human use, and a wide array of non-animal skin- and eye-irritation tests have recently been developed to determine the effects of short-term exposure to new ingredients. Public pressure has been instrumental in the development of these alternative tests.
Today, it is increasingly likely that some combination of alternative tests will be used at least initially to screen out potentially harmful substances before they reach the animal testing stage. Some of the largest multi-national consumer products manufacturers like Procter & Gamble, Unilever, and L'Oreal have played a key role in the development of alternative tests. These tests are then often used by smaller companies that sell products labeled "cruelty-free" or "not tested on animals" (see the Center's publication on Issues & Answers-Cruelty-Free Labeling, What Does it Mean?).
Laws and Regulations
Federal laws don't always require animal tests, but many do indirectly influence testing procedures through regulations and guidelines. Unfortunately, however, animal test results have become well established as the international standard upon which product safety is evaluated. Because countries differ significantly on the degree to which they are willing to consider alternative test results for products sold within their borders, scientists who want to employ alternative test methods can become frustrated in their efforts to use nontraditional, non-animal safety data.
Alternatives Development
In response to increasing worldwide interest in reducing animal use in product safety testing, a growing number of alternative tests have been developed that replace, reduce, or refine animal tests (see the Center's publication on Alternatives: The Three Rs).
In vitro tests (involving cell and tissue cultures grown "in glass" in the laboratory) are among the alternatives showing the most promise in product testing. They are faster, cheaper, and often more reliable than animal tests. Some completely replace animals. Others reduce their numbers. Still others, called refinements, make tests less painful or stressful for the animals involved.
The Issues of Validation and Acceptance
Many promising alternative test methods have been developed in the field of product testing since the early 1980s. Widespread acceptance of them, however, has been slow. Scientists at the forefront of alternatives development say time is needed to confirm the reliability of the new tests-that is, to determine if they produce the same results in every laboratory every time-and to build consensus among scientists on which tests best suit different purposes. This entire process is referred to as scientific validation.
Safety evaluation standards--set by national and international regulatory agencies--must also be changed. While some companies have spent millions of dollars in the development of alternatives in recent years, the new tests will never be officially or widely accepted until they receive governmental "seals of approval."
The ICCVAM Act
One promising development in the effort to replace, reduce, and refine traditional animal research came with the 1993 passage of the National Institutes of Health (NIH) Revitalization Act, which required the government to develop an alternatives validation and acceptance program. Passage of this act was largely the work of a powerful coalition made up of animal advocates, including the MSPCA, and several academic and industry groups.
As a result, in 1994 the Interagency Coordinating Committee for the Validation of Alternative Methods (ICCVAM) was formed. The NIH Revitalization Act calls upon ICCVAM to establish criteria for scientific validation and regulatory acceptance of new tests, including alternative methods that can reduce or eliminate the use of animals in acute or chronic safety testing, and to encourage the acceptance of these new testing methods by the government agencies involved in regulating toxicity testing.
Members of ICCVAM include 15 federal agencies involved in animal testing such as the Food and Drug Administration, the Environ-mental Protection Agency, the Consumer Product Safety Com-mission, and the Occupational Safety and Health Administration. It is intended that these agencies will work closely with other international agencies, including the European Center for the Validation of Alternative Methods (ECVAM), to coordinate validation efforts on an international level.
In 2000, passage of the ICCVAM Authorization Act established ICCVAM as a permanent standing committee under the NIH. In the past few years, ICCVAM has recommended two alternative tests for regulatory agency acceptance. One, called the Local Lymph Node Assay (LLNA), is used to determine if a new chemical is likely to cause allergic skin reactions in workers and consumers handling any one of a wide variety of substances from fragrances to pesticides and industrial chemicals. The LLNA is both a reduction and a refinement. It tests mice instead of guinea pigs, uses far fewer animals, and results in much less pain and distress. Another test is a replacement. It replaces rabbits with a synthetic skin test called Corrositex, which can be used to assess how damaging a chemical is to the skin. Other alternative tests are in the ICCVAM pipeline.
What You Can Do
The Center for Laboratory Animal Welfare urges concerned consumers to learn more about alternatives to animal use in product testing and to communicate with their elected officials and industry representatives about the need to develop more alternative tests, validate those that already exist, and encourage federal and state regulatory agencies to accept them.
Consumers can also urge their legislators to support inclusion of rats, mice, and birds under the provisions of the Animal Welfare Act so that progress in reducing the use of these species can be tracked.
For More Information
The Animal Research Controversy, by Andrew N. Rowan and Franklin M. Loew (210 pages), 1995 (Center for Animals and Public Policy, Tufts University School of Veterinary Medicine, 200 Westboro Road, N. Grafton, MA 01536)
In the Name of Science: Issues in Responsible Animal Experimentation, by F. Barbara Orlans (297 pages), 1993 (Oxford University Press, New York, NY
Animal Testing and Consumer Products, by Heidi J. Welsh (167 pages), 1990 (Investor Responsibility Research Center, 1350 Connecticut Avenue, NW, Suite 700, Washington, DC 20036)
Alternatives to Animal Use in Research, Testing, and Education (441 pages), 1986 (U.S. Congress, Office of Technology Assessment, Washington, DC: U.S. Government Printing Office, OTA-BA-273)
Federal Agencies Regulating Testing
Fifteen federal agencies play a role in animal testing for regulatory purposes. Similar agencies exist in other countries. Four of the most significant in the United States are:
The Food and Drug Administration (FDA) requires that drugs, vaccines, and medical devices be both "safe" and "effective" and that labeling claims be substantiated. The FDA has no authority to require testing of cosmetics for safety, except for their color additives. But, by regulation, the FDA has stated that any cosmetic product or ingredient that has not been substantiated for safety must bear a prominent label stating that the safety of the product has not been determined.
A wide variety of products are regulated by the FDA, including animal and human food, animal and human drugs, medical devices, cosmetics, color additives, electronic products, and animal organs and tissues intended for transplantation into humans.
The Environmental Protection Agency (EPA) administers many laws designed to protect our environment, including the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), the Clean Air Act, and the Clean Water Act. FIFRA is designed to protect human health and the environment from the adverse effects of pesticides. TSCA regulates the use of any new chemicals that might be added to everyday consumer products.
The Consumer Product Safety Commission (CPSC) is charged with preventing injuries from consumer products. The CPSC enforces safety labeling regulations for such products as household cleaners, laundry detergents, fabric softeners, office products, and toys under the Federal Hazardous Substances Act (FHSA). This law requires that a manufacturer determine if a product should be labeled "harmful or fatal if swallowed" or "is a skin or eye irritant."
The CPSC also administers the Flammable Fabrics Act, which authorizes regulation of all flammable materials, including upholstery, pajamas, and other wearing apparel. Industry laboratories conduct animal testing to determine the toxicity of substances applied to fabric in order to reduce or eliminate flammability.
The Occupational Safety and Health Administration (OSHA) governs worker health and safety and ensures that workers are protected from harmful levels of chemicals in the workplace. Currently, most of the information for OSHA's health and safety guidelines comes from research on animals.
