The Humane Society Legislative Fund

Frequently Asked Questions: Animal Testing

Here are the answers to some frequently asked questions about animal testing. Be sure to take action to help end animal testing by contacting EPA Administrator Lisa Jackson here.

Animal Testing of Chemicals

Animal Testing to Identify Endocrine Disrupting Substances

Animal Testing of Pesticides

Animal Testing of Chemicals

What kinds of chemicals are candidates for testing?
It’s estimated that at least 80,000 chemicals are currently in commercial use in the United States, with up to 700 new chemicals being introduced each year. Most are ingredients used in plastics and related polymers, while a smaller proportion are used in cleansers, paints, adhesives, lubricants, industrial solvents and a variety of short-lived by-products or “intermediates.” Some are kept tightly contained in closed systems and never released into the environment, while others may be marketed in high volumes and/or used as ingredients in products to which humans and the environment may be exposed (e.g., cosmetics and household cleaning products, plastic packaging, and gasoline).

How are chemicals regulated in the United States?
The U.S. law that deals most directly with the safety assessment and testing of chemicals is the Toxic Substances Control Act of 1976 (TSCA), which is administered by the Environmental Protection Agency (EPA). TSCA grants the EPA limited powers to assess chemicals before they are sold to consumers (new chemicals) and to review those chemicals already available (existing chemicals).

In addition to its legal powers under TSCA, the EPA has, in partnership with the chemical industry and environmental groups, created the following voluntary programs to gather chemical toxicity information:

• High Production Volume Chemical Challenge Program
• Extended High Production Volume Program
• Voluntary Children’s Chemical Evaluation Program
• Nanoscale Materials Stewardship Program
• Chemical Assessment and Management Program

The agency is also in the process of implementing its Endocrine Disruptor Screening Program, which may lead to extensive new animal testing of chemicals used as ingredients in pesticides, as well as chemicals found in rivers, lakes and drinking water.

Recognizing the limitations of TSCA, Members of Congress have in recent years sought to fundamentally reform the legislation. The bill currently before the Senate is called the Safe Chemicals Act of 2010 (S. 3209), and the House discussion version is called the Toxic Chemicals Safety Act.

How are animals used to test chemicals?
The former Environmental Protection Agency (EPA) High Production Volume (HPV) Chemical Challenge Program, Extended HPV Program and Chemical Assessment and Management Program have prescribed a “screening information data set” consisting of lethal poisoning tests in rodents and fish, as well as 28-day repeated dosing test, gene mutation and reproductive/developmental toxicity tests. Altogether, nearly 800 animals are used to test each chemical. Voluntary Children’s Chemical Evaluation Program information requirements are the same as those above, but often more extensive. Under the Nanoscale Materials Stewardship Program, the EPA has requested submission of “all relevant information that is known or reasonably ascertainable,” including data concerning human health and environmental effects, but has not yet called for specific animal tests to be conducted.

In contrast, the most recent version of the Kid Safe Chemicals Act (110th Congress) proposes to borrow the legal safety standard currently applied to pesticides, which could mean In contrast, the Senate and House bills to amend TSCA currently propose to borrow the legal safety standard currently applied to pesticides, which could mean that each chemical could be subject to dozens of separate toxicity studies (in the worst case consuming and as many as 12,000 animals per chemical). If such an extravagant testing approach were to be applied to the estimated 80,000 industrial chemicals currently in commercial use, the implications in terms of number of animals being poisoned and killed in laboratory toxicity tests would be unprecedented.

Are animals used in testing given pain relief or other protections?
No, pain relief is not normally provided. And to make matters worse, laboratory-bred rodents and fish—the species most commonly used in chemical tests—are not protected under U.S. law governing animal experimentation.

Besides animal welfare, are there other arguments against testing on animals?
Yes, there are a number of points to consider. Most animal tests have never been properly “validated” to demonstrate their relevance to humans, and as a result may under- or over-estimate real-world hazards to people. For example, both rat and rabbit tests failed to predict the birth defect-causing properties PCBs, industrial solvents and many drugs, while cancer tests in rats and mice failed to detect the hazards of asbestos, benzene, cigarette smoke, and many other substances—delaying consumer and worker protection measures by decades in some cases.

Animal tests are also quite time- and resource-intensive and inefficient. To evaluate the cancer-causing potential of a single pesticide chemical in a standard rat and mouse study test takes up to five years, 800 animals, and $4 million, yet for the same price and without any use of animals, as many as 350 chemicals could be tested in less than a week in 200 different cell tests using modern robotics. In order to process the backlog of existing chemicals already in use, as well as new substances, regulators need timely access to reliable and relevant toxicity information, which animal tests cannot provide.

What are some practical alternatives to using animals to test chemicals?
More than two-dozen non-animal or animal-reduction methods and testing strategies have been endorsed as scientifically “validated” by the European Centre for the Validation of Alternative Methods and its counterparts worldwide. Additionally, movement away from rigid “check-the-box” lists of animal tests in favor of flexible testing strategies could have a dramatic impact on reducing animal use.

What is the Humane Society Legislative Fund doing to spare animals from chemical testing?
Our scientists and policy experts are working with the Environmental Protection Agency and its counterparts worldwide to shorten the time between the development of alternative testing methods and their real-world application to replace or reduce animal use in chemical testing. We are also actively engaged in political discussions surrounding Toxic Substances Control Act of 1976 reform to ensure that any new federal legislation reflects sound animal welfare considerations. However, this approach is just the first step toward our ultimate goal of ending animal testing forever. To this end, we have built unprecedented partnerships with scientists from universities, private companies and government agencies worldwide to support and push for a totally new—"21st century"—approach to safety testing that combines ultra-fast cell tests and sophisticated computer models to deliver results in hours instead of months or even years for some animal tests.

How can I help?
Take action to urge your federal legislators to strengthen measures to reduce and replace animal testing in S. 3209, the Safe Chemicals Act of 2010.

Animal Testing to Identify Endocrine Disrupting Substances

What does “endocrine disruption” mean?
Endocrine disruption refers to harmful effects on reproduction, development, or overall health resulting from chemical interactions with the body’s hormone system.

What kinds of substances have been identified as potential endocrine disruptors?
A range of man-made and naturally occurring substances have been flagged as potential endocrine disrupters, including artificial hormones, pesticides, chemicals used in the plastics industry and in consumer products, industrial by-products and pollutants, and even some nutrients found in plants.

What is the United States doing to address endocrine disruption concerns?
In 1996 the U.S. Congress passed the Food Quality Protection Act, which directed the Environmental Protection Agency (EPA) to develop a program to screen all pesticides, and possibly other chemicals, to identify those which “may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect as [the EPA] may designate.”

How has the EPA responded to its Congressional mandate?
On the advice of an advisory committee, the EPA has developed an ambitious testing program that goes well beyond its Congressional mandate to screen for estrogen-like effects in humans. More than 15 new screens and tests have been, or are being, developed to detect interactions with androgen and thyroid hormone systems in addition to estrogen, including tests on bird, fish, amphibian and invertebrate species that can consume as many as 2,600 animals per chemical . These deviations from the Food Quality Protection Act mandate have the potential to increase animal testing demands by up to five-fold.

The EPA’s Endocrine Disruptor Screening Program consists of two main steps:

• Tier 1 screening—a “battery” of six animal tests and five non-animal tests meant to identify substances that interact with the body’s hormone systems; and
• Tier 2 testing—five in-depth, long-term animal tests (e.g. breeding studies to assess toxicity to reproduction in two generations of offspring) intended to thoroughly characterize toxic effects and the exposure levels at which they occur for substances identified as “endocrine active” in Tier 1.

Late in 2009, the EPA published the first in a series of test orders calling on companies to perform the entire Tier 1 battery (600 animals and $1 million) for 67 pesticides and industrial chemicals.

Are animals used in testing given pain relief or other protections?
No, pain relief is not normally provided. And to make matters worse, laboratory-bred rodents, fish, and other species slated for use under the Endocrine Disruptor Screening Program are not protected under U.S. law governing animal experimentation.

Besides animal welfare, what are some arguments against the EPA’s current approach to the Endocrine Disruptor Screening Program?
The EPA Congressional mandate was to focus on pesticides, which are among the most heavily animal-tested products in existence—with often dozens of tests having been carried out for every substance used or sold in the United States. In most cases, this includes a 2-generation reproductive toxicity study , which is substantially equivalent to the Endocrine Disruptor Screening Program (EDSP) Tier 2 “definitive” test for endocrine disruption (see “How has the EPA responded to its Congressional mandate?”). Yet by its actions, the EPA seems intent on disregarding existing, relevant test results in favor of a new round of “check-the-box” animal testing. This new testing is unlikely to have change how human or environmental exposure levels are regulated. In the worst case, 2,600 animal 2-generation studies could end up being repeated under the EDSP—with limited public health benefit.

How else could the EPA be implementing the Endocrine Disruptor Screening Program?
The EPA could acknowledge the vast amount of safety testing information already available for most pesticides and determine additional testing needs in a thoughtful, case-by-case manner. One approach for doing so is an existing EPA program called “registration review,” under which pesticide safety information is examined on an ongoing basis to ensure that all registered products continue to meet the legal statutory standard of “no unreasonable adverse effects.” If periodic registration reviews identify the need for additional safety test data, EPA could call on companies to produce data from individual Endocrine Disruptor Screening Program Tier 1 screens (see “How has the EPA responded to its Congressional mandate?”) or other scientifically relevant information as appropriate. This could include data from a series of ultra-rapid cellular tests being developed under EPA’s own ToxCast™ research program.

What is the Humane Society Legislative Fund doing to spare animals from Endocrine Disruptor Screening Program testing?
Our scientists and lobbyists are working to promote Endocrine Disruptor Screening Program implementation in a rational manner that builds upon existing test results, rather than disregarding them. However, this approach is just the first step toward our ultimate goal of ending animal testing forever. To this end, we have built unprecedented partnerships with scientists from universities, private companies and government agencies worldwide to support and push for a totally new—“21st century”—approach to safety testing that combines ultra-fast cell tests and sophisticated computer models to deliver results in hours instead of months or even years for some animal tests.

Animal Testing of Pesticides

What types of products are considered pesticides?
The Environmental Protection Agency (EPA) defines a pesticide as any substance or mixture of substances used to repel, control, prevent or destroy living organisms regarded as “pests.” Examples include weed-killers (herbicides), bug sprays and flea collars (insecticides), rat poison (rodenticides), bird poison (avicides), fumigants (nematocides), “germ-killing” soaps and cleaning products (antimicrobials), and even natural biochemicals (e.g., pheromones) and genetically engineered toxins (e.g., BT corn).

How are animals used to test pesticides?
EPA regulations require that all pesticide products and their raw ingredients be individually tested for safety and list more than two-dozen animal tests that companies may be required conduct. Examples include skin and eye irritation tests, behavioral studies in chemically-poisoned animals and their offspring, and even the widely condemned “lethal dose” tests, in which animals are forced to swallow or inhale massive amounts of a test substance to determine the dose that causes death. Tests are conducted using mice, rats, rabbits, birds, fish—even dogs—and certain types of tests use hundreds or thousands of animals at a time. In total, as many as 12,000 animals may be killed during safety testing for just one pesticide chemical.

Are animals used in testing given pain relief or other protections?
No, pain relief is not normally provided. And to make matters worse, laboratory-bred rodents and fish—the species most commonly used in pesticide tests—are not protected under U.S. law governing animal experimentation.

Besides animal welfare, are there other arguments against testing on animals?
Yes, there are a number of points to consider. First, most animal tests have never been properly “validated” to demonstrate their relevance to humans, and as a result may under- or over-estimate real-world hazards to people. For example, both rat and rabbit tests failed to predict the birth defect -causing properties PCBs, industrial solvents and many drugs, while cancer tests in rats and mice failed to detect the hazards of asbestos, benzene, cigarette smoke, and many other substances—delaying consumer and worker protection measures by decades in some cases.

Animal tests are also quite time- and resource-intensive and inefficient. For example, to evaluate the cancer-causing potential of a single pesticide chemical in a standard rat and mouse study test takes up to five years, 800 animals, and $4 million. For the same price and without any use of animals, as many as 350 chemicals could be tested in less than a week in 200 different cell tests using modern robotics.

What are some practical alternatives to using animals to test pesticides?
More than two dozen animal replacement, reduction and refinement methods and testing strategies have been endorsed as scientifically validated by the European Centre for the Validation of Alternative Methods and its counterparts worldwide.

Additionally, animal use in pesticide testing could be reduced dramatically simply through the elimination of redundant EPA testing requirements—for example, by no longer requiring birth defect studies using both rats and rabbits or requiring the repetition of certain tests by as many as three different exposure routes (force-feeding, forced inhalation, and application to the animals’ skin). Movement away from rigid “check-the-box” lists of animal tests in favor of flexible testing strategies would also have a positive impact.

What is the Humane Society Legislative Fund doing to spare animals from pesticide testing?
Our scientists and policy experts are working with the Environmental Protection Agency and its counterparts worldwide to shorten the time between the development of alternative testing methods and their real-world application to replace or reduce animal use in pesticide testing. However, this approach is just the first step toward our ultimate goal of ending animal testing forever. To this end, we have built unprecedented partnerships with scientists from universities, private companies and government agencies worldwide to support and push for a totally new—“21st century”—approach to testing that combines ultra-fast cell tests and sophisticated computer models to deliver results in hours instead of months or even years for some animal tests.

How can I help?
Consumers should be conscious of the food choices they make. Pesticide exposure can be reduced by purchasing organic produce and avoiding meat, dairy and other animal products, which are often contaminated with pesticide and other unappetizing residues. There are also a many alternatives to pesticides for safe and effective lawn and garden care. Also, remember that any product that claims to “kill germs” is regarded as a pesticide, and is subject to substantially more animal testing than equivalent soaps and cleaning products that simply don’t advertise their antibacterial properties. For assistance in identifying cruelty-free soaps and cleaning products, visit How to Be a More Compassionate Consumer.