Product Safety Testing: A Brief Background
In 1933, at least 17 American women were blinded by, and one died of, complications resulting from the use of Lash Lure, a new mascara. At that time, no laws or regulations governed the safety of consumer products. Manufacturers were free to market almost anything.
As a result of this and other tragic incidents related to untested products, the U.S. Congress passed the Federal Food, Drug, and Cosmetic Act of 1938, requiring that food, drugs, and cosmetics be verified as safe for human use before they could be sold. Following this, animals came into widespread use as the mechanism for testing the safety of personal care products in the United States. This was based on the premise that animals are similar enough to people to be used as models for human response.
Today, the federal government still requires manufacturers to establish product safety. Personal care products covered by federal laws include shampoo, deodorant, eye shadow, lipstick, nail polish, hair spray, perfume, toothpaste, shaving cream, sunscreen, and hand lotion. Some of these are regulated as cosmetics; others — including certain sunscreens, fluoride toothpastes, and antiperspirants that claim some medicinal value — are regulated as over-the-counter drugs.
The Ethical Dilemma
The public has become increasingly aware of the potential of some chemicals to harm humans, wildlife, and the environment. Lawmakers have pushed hard for strict product safety standards; unfortunately, these can often come at the expense of lab animals. At the same time, many people have grown concerned about the potential for animal suffering in product testing labs.
The MSPCA believes this dilemma can be resolved through the continued development of alternative test methods that dramatically reduce the number of animals used in labs today. And, perhaps, this may eventually lead to their complete elimination — while providing the public with vital product safety assurances.
The Role of Animals
Because the Animal Welfare Act (AWA) does not require that all laboratory animal use in the U.S. be reported (it exempts mice, rats, and birds), exact numbers are impossible to obtain. It has been estimated that millions of animals per year are used to test the safety of cosmetics, household cleaners, pesticides, industrial chemicals, food additives, packing materials, drugs and vaccines for both people and animals, and even the food eaten by companion animals.
Product safety testing is estimated to make up a smaller percentage of all animal use for scientific purposes compared to its biomedical counterparts, but still amounts to many millions of animals per year worldwide. The most common animals used in testing are mice and rats, but others used include rabbits, guinea pigs, hamsters, birds, cats, dogs, and fish. During a typical product test, a group of animals is exposed to a test substance in various ways: 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, the control, is left unexposed to the test substance. 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, and still others experience extreme pain for prolonged periods of time. The amount of suffering caused during any project depends upon many factors, including the substance being tested, the type of test, the number of animals being used, whether anesthetics or pain-killing drugs are administered, the animals’ housing, and how they are killed at the end of the test, if that is the final outcome.
The efficiency of doing animal testing as opposed to non-animal alternatives has fallen under close scrutiny. Evaluating a single pesticide requires more than 50 experiments and the use of as many as 12,000 animals. Also, according to the Food and Drug Administration, nine out of ten pharmaceuticals that pass the animal testing stage fail to pass clinical studies on humans. In 2016, the Environmental Protection Agency (EPA) released a guide for waiving acute toxicity tests. Additionally, the EPA committed in 2019 to reduce reliance on mammalian animal testing by 30% by 2025 and to end it entirely by 2035. Also, in February 2020, the EPA issued final guidance that reduces unnecessary testing on birds in the pesticide registration review process, which is expected to save 720 test animals annually. And in July 2020, EPA released guidance that reduces unnecessary testing on fish in the pesticide registration process, expected to save 240 test animals annually.
Toxicology: Predicting the Potential for Harm
Toxicology is the study of the harmful effects of chemical substances on living organisms. It is a complex science because something that is safe for use at one level of exposure can be harmful at just a slightly higher level. All ingredients – 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. This complicates matters further because a chemical that is harmful to one species is not always harmful to another. Tens of thousands of chemicals are likely in current use in the United States, with thousands more introduced each year.
Types of Tests
Many kinds of toxicity tests have been developed to assess the risks associated with routine or accidental exposure to various products. Adverse effects from these exposures are known as “clinical endpoints” and can include skin or eye irritation or corrosion, reproductive or developmental toxicity, development of cancers, and impacts on the neurological systems. The species and number of animals used in these tests depend upon the type of toxicity being assessed.
In addition to understanding the effects of exposure, toxicity tests also measure different durations of exposure: acute, subchronic, and chronic.
Acute toxicity tests assess the risk of short-term — usually a single or brief — exposure through normal use or accidental contact. Two examples of these 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 and skin irritancy tests, which use rabbits to estimate the ability of a test substance to irritate or damage these organs.
Subchronic toxicity tests are used to determine toxicity from repeated exposure to a chemical over a period of several weeks to several months. These tests usually last less than 10% of the test subjects’ (typically rats) natural life span. Subchronic toxicity tests are used to measure the toxicity in chemicals, food additives, and even common spices such as paprika. Hydroquinone, a chemical commonly used in skin lightening, age spot, and blemish creams, was also tested using these tests. At the end of the exposure period, the animals are typically killed.
Chronic toxicity tests assess risks of long-term exposure — often at low levels for a substantial portion of the test subjects’ life — such as the potential to cause cancer, birth defects, and developmental abnormalities. They may also explore the body’s absorption, distribution, metabolism, storage, and excretion of new chemicals and products, and/or monitor the long-term effect of a chemical on the brain, DNA, 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. Like in subchronic toxicity tests, these animals are typically killed after the test is over.
While data searches and various other non-animal 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 line of defense against potentially harmful products. Animal tests also 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 has increased the amount of animal testing as manufacturers attempt to develop new, less environmentally harmful 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 increased animal testing. Furthermore, the rise of breeding genetically engineered or modified animals, particularly mice, has led to these animals’ routine use in biomedical research and testing.
Overall, however, the number of animals used to test cosmetics and other personal care products has declined in recent years. U.S. government statistics show an 8% drop in the number of animals used in labs since 2014. 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. A Gallup poll found that 67% of Americans were “very concerned” or “somewhat concerned” about animals used in research, and a Pew Research Center poll in 2018 found that 52% of American adults opposed the use of animals in research.
Some of the largest multi-national consumer products manufacturers, such as Procter & Gamble and L’Oréal have developed alternatives, responding to the public’s support of ending animal testing. For example, L’Oréal’s human skin model, EPISKIN, was validated by the European Centre for the Validation of Alternative Methods (ECVAM) in 2007 as an alternative to skin irritation tests performed on animals. Often, these tests are then used by smaller companies that sell products labeled “cruelty-free” or “not tested on animals” (see Cruelty-Free Labeling and Leaping Bunny Program).
Alternatives Development
As 21st-century science moves away from animal testing and toward more efficient and predictive non-animal alternatives, companies can save money, time, and lives by taking advantage of these alternative test methods. While animal research and testing often fails to mimic human pathophysiology—and therefore fails to predict human responses accurately—scientific advancements such as 3-D printing, artificial human tissue, organs-on-chips, and sophisticated computer programs allow researchers and companies to better assess the safety of chemicals, cosmetics, and consumer products. A list of alternative testing methods approved by U.S. federal agencies is published online.
Many scientific experts have noted the superiority of alternative, non-animal test methods. For example, Dr. David Jacobson-Kram, former executive director for pharmacology and toxicology of the FDA, in 2010 stated, “We want to migrate away from animal testing.” Dr. Christopher Austin, Director of NIH’s Chemical Genomics Center, stated in 2008, “Traditional [toxicological] animal testing is expensive, time-consuming, uses a lot of animals and, from a scientific perspective, the results do not necessarily translate to humans.” Additionally, the Harvard Wyss Institute has already engineered organs-on-chips, which contain human cells grown in a state-of-the-art system to mimic the structure and function of human organs, and which provide robust and accurate predictions of drug/toxin effects.
For example, 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. For instance, a Draize rabbit skin corrosion test may cost $1800, whereas a test using an in vitro human tissue model such as EpiDerm costs approximately $850 and more accurately shows the effects of a chemical or product on human skin. Some of these in vitro tests completely replace animals while others reduce their numbers. Additionally, tests that are in silico (computer-based) have also reduced the numbers of animals used. While these methods often eliminate the need for animals in the early stages of research, animals are often needed in later stages of product development. Still other alternatives, called refinements, make tests less painful or stressful for the animals involved.
Laws and Regulations
While federal laws don’t always require animal tests, many indirectly influence testing procedures through regulations and guidelines. To date, many reports, strategic plans, and actual laws have propelled the replacement of animal testing with non-animal methods.
In 2016, for example, the Frank R. Lautenberg Chemical Safety of the 21st Century Act passed with widespread bipartisan support, revising the Toxic Substances Control Act to, among other changes, direct the U.S. Environmental Protection Agency (EPA) to reduce and replace the use of vertebrate animals in the testing of chemical substances or mixtures. And in September of 2019, EPA announced that it would reduce mammal study requests and funding by 30 percent by 2025, and end reliance on tests using mammals entirely by 2035. In 2018, EPA released the Interim Science Policy: Use of Alternative Approaches for Skin Sensitization as a Replacement for Laboratory Animal Testing, which allows pesticide and industrial chemical manufacturers to choose one of two different defined approaches to determine skin sensitization utilizing non-animal methods. The defined approaches were found to have comparable or superior performance to the traditional animal test.
Additionally, the NIH 2016-2020 research strategic plan states:
“To improve the efficiency, relevance, and accuracy of preclinical research, NIH will catalyze powerful innovations, including molecule cross-coupling methods that will open a vast new frontier of “chemical space” and human 3D organoid technologies that will be better than animal models.”
And also:
“Petri dish and animal models often fail to provide good ways to mimic disease or predict how drugs will work in humans, resulting in much wasted time and money while patients wait for therapies. To address that challenge, NIH, DARPA, and FDA are collaborating to develop 3D platforms engineered to support living human tissues and cells, called tissue chips or organs-on-chips. An integrated body-on-a-chip is the ultimate goal.”
California, currently the leading recipient state for NIH funding, adopted legislation to reduce animal use in testing and also provided important updates to the law in 2023. New York, the third-highest recipient state for NIH funding, and New Jersey also passed similar laws in 2008 and 2007, respectively. Eleven states have also passed laws to prohibit the sale of cosmetics tested with new animal testing: California, Hawaii, Illinois, Louisiana, Maine, Maryland, Nevada, New Jersey, New York, Oregon, and Virginia.
Massachusetts is currently considering S. 1424/H. 850: An Act promoting humane cosmetics and other household products by limiting the use of animal testing, which requires the use of non-animal test methods when available. Learn more about these bills.
Globally, in 2010 the European Union adopted Directive 2010/63/EU, which updates and replaces the 1986 Directive 86/609/EEC regarding the protection of animals used for scientific purposes. Directive 2010/63/EU states that, wherever possible, a scientifically satisfactory non-animal method should be used. The overall aim of the Directive is “to strengthen legislation, and improve the welfare of those animals still needed to be used, as well as to firmly anchor the principle of the Three Rs, to Replace, Reduce and Refine the use of animals, in EU legislation.”
The ICCVAM Act
In the U.S., a 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 was largely the work of a powerful coalition of animal advocates (including the MSPCA) and several academic and industry groups.
As a result of this mandate, the Interagency Coordinating Committee for the Validation of Alternative Methods (ICCVAM) was formed the following year. In 2000, the ICCVAM Authorization Act passed, making it a permanent committee under the NIH. ICCVAM is charged with establishing criteria for scientific validation and regulatory acceptance of new tests, including alternative methods that can reduce or eliminate the use of animals in safety testing. ICCVAM then encourages the government agencies involved in regulating toxicity testing to accept the new testing methods. ICCVAM also works to reduce the use of animals in toxicological testing by sharing information among agencies to reduce duplicative tests.
ICCVAM members include federal agencies involved in animal testing, such as the Food and Drug Administration, the Environmental Protection Agency, the Consumer Product Safety Commission, and the Occupational Safety and Health Administration. These agencies work closely with other international agencies, such as the European Center for the Validation of Alternative Methods (ECVAM), to coordinate validation efforts on an international level. In recent years, the collaboration between ICCVAM and ECVAM has been strengthened. Sometimes a member of ICCVAM sits on ECVAM (and vice versa); the groups have also collaborated on ongoing peer reviews of alternative test methods and have jointly conducted several studies and workshops. The two groups also formed an International Cooperation on Alternative Test Methods (ICATM) with the Japanese Center for Validation of Alternative Methods (JaCVAM) and Health Canada to work towards coordinating scientific validation on non-animal toxicity test methods.
Since its inception, ICCVAM has recommended a handful of 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. 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. Examples of replacements for animal testing include Corrositex, which replaced rabbits with a synthetic skin test that is used to assess how damaging a chemical is to the skin, and the Bovine Corneal Opacity and Permeability (BCOP) and the Isolated Chicken Eye (ICE) Corrositex tests, which utilize tissues obtained from slaughterhouses to replace the use of live animals.
In addition, ICCVAM has recommended replacements or refinements in the fields of acute systemic toxicity, biologics testing, developmental toxicity, endocrine disruptors, eye corrosion/irritation, genetic toxicity, pyrogenicity, skin corrosion, skin irritation, and skin sensitization.
ICCVAM has been criticized for not making enough progress since its inception. Some suggest the Committee’s process for reviewing alternatives is cumbersome and slow, with not enough focus on replacement (rather than refinement and reduction), and insufficient resources have been provided to advance more alternative methods. In 2018, ICCVAM released a “strategic roadmap” to accelerate the use of alternative cosmetics testing. While there have been some revisions to the original 2008 plan that reflect progress in science and technology, ICCVAM’s central goals have generally remained the same: ICCVAM hopes to advance the use of alternatives in the U.S., foster acceptance and appropriate use of alternative test methods, and develop partnerships and strengthen interactions with stakeholders.
Federal Agencies Regulating Testing
Several different federal agencies and subagencies play a role in animal testing for regulatory purposes through ICCVAM. Four of the most significant are the Food and Drug Administration, the Environmental Protection Agency, the Consumer Product Safety Commission, and the Occupational Safety and Health Administration.
The Food and Drug Administration (FDA) requires that drugs, vaccines, and medical devices be both “safe” and “effective” and that labeling claims be substantiated. A wide variety of products are regulated by the FDA, including animal and human food and drugs, medical devices, cosmetics, color additives, electronic products, and animal organs and tissues intended for transplantation into humans. The FDA has no authority to require testing of cosmetics for safety, except for their color additives. However, by regulation, the FDA has stated that any cosmetic product or ingredient not substantiated for safety must bear a prominent label stating the safety of the product has not been determined. Clearly, this is not a label most manufacturers would willingly place on their products.
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. Animals used for food crop pesticide tests — and even household pesticide (bug spray, rat poison, etc) tests — are often subjected to lethal dose tests, in which they must be exposed to or forced to swallow massive quantities of chemicals. In 2016, President Obama signed a revised TSCA that discourages testing conducted on vertebrate animals and requires the EPA to keep a database of validated alternative testing methods, taking a step forward in the U.S. movement to eliminate animal testing.
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.” For decades, rabbits have been most used in these sensitivity and irritation tests. Unlike humans and some other animals, rabbits do not have tear ducts, which means they cannot “cry out” chemicals applied directly to their eyes and are forced to suffer longer.
The CPSC also administers the Flammable Fabrics Act, which authorizes regulation of all flammable materials, including upholstery, pajamas, and other 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. An estimated 190,000 illnesses and 50,000 deaths occur among U.S. workers exposed to chemicals, and OSHA hopes to replace these chemicals with safer alternatives. Currently, most of the information for OSHA’s health and safety guidelines comes from research on animals.
What You Can Do
- Be in the know. Public pressure has been the primary force behind all the improvements in the laws and regulations protecting animals in laboratories. Join groups that promote laboratory animal welfare such as the MSPCA’s Animal Action Team.
- Communicate with 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 express concern for the need to speed the validation process by contacting the Office of Liaison, Policy and Review, National Toxicology Program.
- Be an educated and conscientious consumer. Purchase products made by companies doing the most to develop and promote alternatives to animals in testing their products’ safety. When making investments, consider companies that don’t test on animals, support animal-based research, or that have committed to minimizing the number of animals used to test their products.
- Please see Cruelty-Free Labeling and the Leaping Bunny Program for more information!
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