June 21, 2008
Q&A About Animal Testing of Chemicals
Q: What kinds of chemicals are candidates for animal testing?
A: An estimated 100,000 chemicals are marketed globally, with hundreds more new chemicals being introduced each year. Most are plastics and related polymers, while a smaller proportion include 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 human beings and the environment may be exposed (e.g., cosmetics and household cleaning products, plastic packaging, and gasoline).
Q: How are chemicals regulated in different parts of the world?
A: Most developed countries have enacted laws governing the testing and marketing of chemicals. Examples include the Canadian Environmental Protection Act, the European Union Registration, Evaluation and Authorisation of Chemicals (REACH) regulation, and the United States Toxic Substances Control Act. These laws and regulations differ greatly from one another, which has prompted the creation of various multinational initiatives aimed at promoting increased common ground among national programs, avoiding duplication, and sharing resources.
Q: What animal tests are carried out on chemicals?
A: The internationally agreed-upon “screening information data set” for chemicals consists of lethal poisoning tests in rodents and fish, as well as 28-day repeated dosing tests, genetic toxicity and reproductive/developmental toxicity tests. Together, these tests use nearly 800 animals for a single chemical. The EU REACH regulation requires these same tests for all chemicals produced in volumes of 10 or more tonnes per year, plus a host of longer-term and even more animal-intensive tests for birth defects, reproductive toxicity, cancer and toxicity to wildlife species for the highest-volume chemicals.
In the United States, two federal bills introduced in April 2010 have proposed to replicate the legal safety standard currently applied in the pesticide sector, which government authorities have interpreted as calling for up to 40 separate animal studies—in total consuming as many as 12,000 animals per chemical. If such an extravagant testing approach were to be required for the estimated 80,000 industrial chemicals currently in commercial use, the implications in terms of the number of animals being poisoned and killed in laboratory toxicity tests would be unprecedented.
Q: Are animals used in testing given pain relief or other protections?
A: No, pain relief is not normally provided. Additionally, in some countries (e.g. the United States) laboratory-bred rats and mice and non-mammalian species are not listed or protected under the national law that establishes standards for animals used in experiments. The situation is even more grim in developing countries that do not have any legislation governing the care and use of animals in laboratories.
Q: Besides animal welfare, are there other arguments against testing on animals?
A: Yes, there are a number of points to consider. Firstly, 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 of 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 large backlog of existing chemicals already in use, as well as new substances, regulators need quick access to reliable and relevant toxicity information, which animal tests cannot provide.
Q: What are some practical alternatives to animal testing?
A: 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, moving away from rigid “tick box” lists of animal tests in favor of flexible testing strategies that allow unnecessary tests to be avoided could have a dramatic impact on reducing animal use.
Q: What is HSI doing to spare animals from chemical testing?
A: Often there can be an unnecessary delay of many months or even years from the time an alternative test method is developed to when it can actually be used in the lab to start replacing animals. HSI scientists and policy experts are working with chemical regulators worldwide to reduce this time delay so that animal use in chemical testing can be reduced and replaced more quickly. In 2009, our efforts helped spare the lives of more than 4 million animals by pressing the European Chemicals Agency to clarify an ambiguity in the REACH regulation that could have seen 6,000 chemicals subject to redundant animal testing. We are also actively engaged in political discussions surrounding revision of the US Toxic Substances Control Act to ensure that any new legislation reflects sound animal welfare principles. 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.
Q: How can I help?
A: You can use our online alert to contact US Environmental Protection Agency administrator Lisa Jackson and ask her to bring her agency’s chemical regulations into the 21st century.