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 much smaller percentage of all animal use for scientific purposes compared to its biomedical counterparts. This still amounts to many millions of animals per year, worldwide. Tens of millions more are used in education and in basic biomedical research, including the development of new drugs and vaccines.
About 95-98% of the animals used in testing are mice, rats, and other rodents such as guinea pigs and hamsters; in addition, rabbits, dogs, cats, nonhuman primates, birds, fish, and amphibians are also used. During a 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. According to the Humane Society of the United States (link below), evaluating a single pesticide requires more than 50 experiments and the use of as many as 12,000 animals. They also note that, 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 (see link below). Since then, the EPA has continued to work to reduce the number of test requirements by allowing more waivers, some reliance on previous tests, and for some toxicity studies’ data to be combined to meet requirements.
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.
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. American industry spends billions of dollars annually on toxicology studies in an effort to protect living beings from harm. Toxicology tests conducted on animals are also time-consuming: according to the Humane Society International (see link below), evaluating a single pesticide chemical by testing on rodents can take as long as five years.
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, or impacts on the neurological systems, to name a few. 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, and from 2016 to 2017 alone, there was a 3.5% drop in animal testing. This reduction may have occurred because of the following reasons: many ingredients have already been proven safe through years of animal tests and human use, companies are now more apt to share test results, and a wide array of non-animal skin and eye irritation tests (including synthetic skin and eye models) have been developed to determine the effects of short-term exposure to new ingredients. Public pressure has played a major role in the development of these alternatives.
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).
Laws and Regulations
While federal laws don’t always require animal tests, many indirectly influence testing procedures through regulations and guidelines. For example, the Food and Drug Administration (FDA) requires that drugs, vaccines, and medical devices be both “safe” and “effective” and that labeling claims be substantiated.
Unfortunately, animal test results are now well established as the international standard for assessing product safety. Because countries differ widely on the degree to which they will consider alternative test results for products sold within their borders, this can result in frustration and red tape for multinational companies interested in alternative test methods, as their efforts to use non-traditional, non-animal safety data can thus become stymied. For example, in China, laws require that cosmetics are tested on animals before they can be approved, which has created an obstacle for many “cruelty-free” companies looking to expand into the Chinese market.
In the U.S., some progress is being made at the state level. California, Hawaii, Maine, Maryland, New Jersey, New York, and Virginia have all passed legislation restricting the use of animal-tested cosmetics. Other states, including Nevada and Illinois have taken steps toward banning cosmetic testing on animals and have banned the sale and importation of animal-tested products. Massachusetts has considered similar bills. They require that if an appropriate non-animal test has been validated by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), it must be used in lieu of animal-based testing.
In response to increasing 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 Lab Animal 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: for example, 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.
The Issues of Validation and Acceptance
Many promising alternative test methods have been developed for product testing since the early 1980s. Widespread acceptance of them, however, has been slow. Scientists say time is needed to confirm the reliability of 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.
Once scientists are convinced that a new alternative does provide sound safety information for a product, such as hair color, the government agency responsible for assuring hair color safety must be persuaded to accept the new test as a valid alternative to the existing whole animal test. To date, national and international regulatory agencies have been very slow to respond. Until alternatives are officially accepted by these agencies, further progress toward eliminating animal use in all product safety testing will remain slow.
The European Union (EU) has taken the lead in seeking alternatives to using animals in product safety testing for personal care products. In 2004, the EU implemented a directive banning the testing of finished cosmetic products and their component ingredients on animals. In 2009, it was expanded to include a ban on marketing cosmetics in which the final product, or any of its ingredients, have been tested on animals. In 2013, the EU enacted a full ban on the import, sale, and marketing of any cosmetics that were tested on animals and continues to actively work towards animal-free testing alternatives. Many hope this will encourage the development of alternatives that can be validated and approved for use in the U.S. and other countries.
Because of this, it is essential for both consumers and manufacturers to put pressure on governments to validate alternatives already in use or in development.
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 have 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 2008, at the request of Congress, ICCVAM released a five-year plan identifying areas of high priority for non-animal tests, and in 2013, another five-year plan was drafted. Again, in 2018, ICCVAM released a “strategic roadmap” to accelerate the use of alternative cosmetic 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. Despite ICCVAM’s commitment to developing alternative testing methods and strategies moving forward, many of ICCVAM’s recommended methods still have yet to achieve regulatory use in testing facilities. However, ICCVAM scientists continue to work through the ICATM to develop new tests to reduce and refine animal use and have seen success over time.
Federal Agencies Regulating Testing
Fifteen federal agencies and sub-agencies play a role in animal testing for regulatory purposes though ICCVAM; similar agencies exist in other countries. Four of the most significant in the U.S. 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. Yet, devastatingly, in 2017, the Trump Administration worked to roll back regulations in the EPA actively weakening the TSCA.
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.