Product Safety Testing: A Brief Background
In 1933, more than a dozen American women were blinded and one woman died of complications from Lash Lure, a new kind of mascara. At that time, no laws or regulations governed the safety of consumer products. Manufacturers were free to market almost anything.
Following this and other 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. Consequently, the widespread use of animals came into practice, as they were used to test 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 sunscreen, fluoride toothpaste, and antiperspirants — 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, this can often come at the cost of animal suffering. At the same time, many people have grown concerned about the potential for animal suffering in product testing labs. The MSPCA advocates for the continued development of alternative test methods that reduce the number of animals used in labs today.
The Role of Animals
Because the Animal Welfare Act (AWA) does not require that all laboratory animal use in the U.S. be reported, exempting mice, rats, and birds, exact numbers are impossible to obtain. Product safety testing is estimated to make up a smaller percentage of all animals used for scientific purposes compared to their use in biomedical research, but still amounts to many millions of animals per year worldwide 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 food eaten by companion animals.
The most common animals used in testing are mice and rats; 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.
The experiences of animals used in product testing vary widely; some have little discomfort throughout their lives, others experience brief pain, and others experience extreme pain for prolonged periods. 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 if and how they are killed at the end of the test.
The efficiency of animal testing, as opposed to non-animal alternatives, has been scrutinized. Evaluating a single pesticide requires more than 50 experiments and 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. In 2019, the EPA reiterated its focus on ending the use of mammals, both in their own studies and in funding requirements. Additionally, in February 2020, the EPA issued final guidance to reduce unnecessary testing on birds in the pesticide registration process. And, in July 2020, it released guidance to minimize unnecessary testing on fish in the pesticide registration process, which is 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 (plants, animals, humans). These effects are determined by assessing the probability and extent to which a particular substance will be harmful. Notably, a chemical that is toxic to one species is not always dangerous to another.
Types of Tests
Many toxicity tests have been developed to assess the risks of routine or accidental exposure to various products. Determinative adverse effects from these exposures are known as “clinical endpoints,” such as skin or eye irritation or corrosion, reproductive or developmental toxicity, development of cancers, and impacts on the neurological system.
There are three categories of exposure length toxicity tests: acute, subchronic, and chronic. Acute toxicity tests assess the risk of short-term exposure through regular use or accidental contact. Examples include the 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 several weeks to several months. These tests usually last less than 10% of the test subjects’ (typically rats) natural life span. Some commonly tested substances are food additives, chemicals used in skin lightening, and blemish creams. At the end of the exposure period, animals are typically killed.
Chronic toxicity tests assess risks of long-term exposure — often at low levels for a substantial portion of the test subject’s life — such as the potential to cause cancer, congenital disabilities, and developmental abnormalities. They may also explore the body’s absorption, distribution, metabolism, storage, and excretion of new chemicals and products and monitor long-term effects 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, animals are typically killed after the test is over.
Trends in Consumer Product Safety Testing
Overall, the number of animals used to test cosmetics and other personal care products has declined in recent years. Today, it is likely that some combination of alternative tests will be used for any given product to screen for 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 using 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 for 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.” (Learn about Cruelty-Free Labeling and the 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 using 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, said 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 human organs’ structure and function, providing 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. In contrast, 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, in silico (computer-based) tests have also reduced the number of animals used. While these methods often eliminate the need for animals in the early stages of research, animals are frequently needed in later stages of product development. Other alternatives, called refinements, make tests less painful or stressful for the animals involved.
Laws and Regulations
Governmental reports, strategic plans, and regulations have propelled the replacement of animal testing with non-animal methods for products where animals are not required. 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. In 2019, the U.S. Environmental Protection Agency (EPA) announced that it was working particularly hard toward ending the use of mammals in science and testing, both in their own studies and in funding requirements. 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 testing in 2018 and, in 2023, made significant updates to the law. New York, the third-highest recipient state for NIH funding, and New Jersey also passed similar laws in 2008 and 2007, respectively, and Virginia bans cosmetics testing on animals. Additionally, laws in twelve states prohibit the sale of cosmetics newly tested on animals: California, Hawaii, Illinois, Louisiana, Maine, Maryland, Nevada, New Jersey, New York, Oregon, Virginia, and Washington.
Massachusetts is currently considering 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 this bill.
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 1993, the National Institutes of Health Revitalization Act was passed, which requires the government to develop validation and acceptance programs for non-animal testing methods. The passage was primarily 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 was 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 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 a global 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), determines if a new chemical will likely 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 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/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 federal agencies and subagencies participate 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. The agency regulates various products, including animal and human food and drugs, medical devices, cosmetics, color additives, electronic products, and animal organs and tissues for human transplantation. Except for color additives, the FDA has no authority to require cosmetics testing for safety. However, by regulation, the FDA requires any cosmetic product or ingredient not substantiated for safety to bear a prominent label stating that the product’s safety has not been determined, prompting many companies to voluntarily test their cosmetics.
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 new chemicals that might be added to everyday consumer products. Animals used for food crop and household pesticide tests (e.g., bug spray, rat poison, etc.) 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 products like 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.” Rabbits have been used in these sensitivity and irritation tests for decades. 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 to reduce 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.
