Dear Concerned Citizen:

Thank you for contacting us regarding use of laboratory animals in toxicity testing under the High Production Volume (HPV) Chemical Challenge Initiative.

The Challenge Initiative was announced last fall by the Environmental Defense Fund, U.S. Environmental Protection Agency, and Chemical Manufacturers Association. Through this program, producers of about 2,800 widely used industrial chemicals (those produced in quantities exceeding one million pounds annually) will voluntarily agree to make basic toxicity data on their chemicals available to the public over the next six years.

In recent weeks, we have received numerous communications raising concerns similar to yours about the use of animal testing in this Initiative. Many of these have been thoughtful letters that are prompting us to redouble efforts to assure that the Initiative takes every feasible step to minimize the number of test animals used, and to improve their welfare, while producing scientifically useful data.

These efforts are bearing fruit. On October 15, 1999, People for the Ethical Treatment of Animals (PETA) called off its campaign opposing the initiative, after reaching an agreement with the Environmental Protection Agency EDF on specific recommendations for conducting work under the HPV Initiative. Although PETA stated that it still has concerns about the program, it characterized the agreement as a "landmark" that reflects "a high-level recognition of animal protection." EDF also participated in discussions leading to the agreement, which is memorialized in an October 14 letter from the Environmental Protection Agency to all companies participating in the HPV Initiative. In addition to setting forth a number of specific principles that will minimize animal testing in the HPV Initiative, the letter also commits over $5 million in federal funds to development and validation of non-animal alternative test methods and protocols.

Despite this development, we do understand that some advocates of animal rights believe that absolutely no animal testing is morally justified. Though we respect this view, we believe it is not currently possible to avoid animal testing altogether and still answer critical questions about the health and environmental effects of high-volume chemicals. (Please note that testing under the Initiative will involve primarily rats, fish, and invertebrates; none of the testing under the Initiative involves primates, cats, or dogs.) But our society's current inability to achieve zero animal testing is no excuse for failing to reduce animal testing to the greatest extent feasible. Mindful of this - and forcefully reminded by your letter and many others - we are exploring ways to minimize animal use through the following steps. (These and related points are covered in the October 14 letter from the Environmental Protection Agency to HPV participants.)

• Use of Existing Data. First, to the extent that relevant toxicity data already exist, the program is being structured to allow those data to be located, evaluated, and (if valid) to be submitted in lieu of additional testing. EDF strongly supports reliance on existing data, where adequate, both to minimize unnecessary use of test animals, and to reduce overall testing costs and duration. Companies that volunteer to sponsor a particular chemical or category will have many months, and in most instances several years, to review all existing data on a chemical. (Inclusion of a substance on the list of 2,800 chemicals simply means that a chemical is high-volume, not necessarily that it needs any further testing.) Specifically, while the deadline for signing up to sponsor a chemical is December 1, 1999, test plans need not be submitted - and thus evaluation of existing data need not be completed - until the year in which testing is scheduled to start. In the substantial majority of instances, that year will be 2001, 2002, or 2003. This will allow ample time to make sure that relevant data have not been overlooked, and to consider any data identified by animal welfare advocates.
• Testing Groups of Chemicals. Second, the program is expressly allowing for grouping of related chemicals into categories, and for testing of representative members of the category rather than every chemical in the category. While care must be taken to construct scientifically robust categories, this approach will help significantly reduce animal use.
• Use of Non-traditional Methods. Third, under the Challenge Initiative, chemical producers will be providing the information that comprises the "Screening Information Data Set" (SIDS), as defined by the Organisation for Economic Cooperation and Development through an international consensus process. Minimizing animal use has been a key consideration in defining the specific endpoints and protocols in SIDS. For example, SIDS does not include any tests for eye or skin irritation. Similarly, it does not require use of the LD50 test for acute toxicity, but rather allows methods that use many fewer animals. In addition, mathematical estimations and non-animal in vitro methods are already approved for some portions of SIDS.
• Use of Combined Experiments. In mid-February, the U.S. Environmental Protection Agency announced a method for reducing the number of animals used in SIDS testing for a single chemical by up to 70% compared to traditional approaches. Under this strategy, information on several longer-term effects is gained by studying one group of animals, instead of studying a separate group for each separate effect. EDF will strongly encourage chemical manufacturers to use this approach wherever feasible.
• Promotion of Additional Non-animal Methods. EDF recently established a major project in conjunction with Johns Hopkins University's Center for Alternatives to Animal Testing, the University of Pittsburgh, and Carnegie-Mellon University, to assess specific alternative test methods and evaluation techniques, with a goal of getting these methods validated and into practical use as soon as possible. The current initiative offers a unique opportunity to validate, and promote reliance on, a wider array of non-animal tests and other techniques for reducing animal use. (Already, this project has begun to bear fruit: the new EPA strategy described in the prior paragraph was developed for a January 1999 workshop held in connection with this project.) As the Challenge Initiative is implemented, EDF intends to advocate for use of these new approaches wherever feasible.

This last is most important in the long term, of course. Since EDF has been influential in demanding needed tests, it is only right that EDF should also work to develop non-animal testing methods.

In closing, we think it is important to note that although EDF strongly believes it is important to avoid unnecessary animal testing, we disagree with those who argue that animal toxicity data are irrelevant to protecting human health and the environment. Many of the SIDS tests directly assess the effects of chemicals on ecosystems and nonhuman organisms - key data for establishing safeguards that protect the environment on which all species depend. In terms of human health, screening tests on animals are widely recognized as highly relevant in predicting adverse effects on humans. It is true that animal effects are not perfect predictors of human effects; understandably, some chemical companies like to stress the occasional findings of differences between human and animal outcomes. But they are only occasional.

Indeed, every regulatory agency in the world relies on animal data in setting environmental health standards. In general, results of well-conducted studies on animals are highly effective in identifying which chemicals are toxic to humans. By contrast, epidemiological studies (the study of patterns of disease in human populations) typically are not useful except where the risk is very high or involves an unusual "signature" disease - and by definition, epidemiology can only provide information after people have become ill. And of course, intentionally exposing people to suspected toxicants for the purpose of observing whether they get sick is contrary to international law and widely viewed throughout our society (and certainly by EDF) as wholly unacceptable. Moreover, while in vitro studies (studies of cells grown in isolation) are useful (and are allowed for some SIDS endpoints), these techniques have not yet become sophisticated enough to displace the need for animal testing - particularly for more complex outcomes such as toxicity to future generations.

Finally, we want to note that we are convinced that basic information on chemical risks of widely used chemicals is essential. Without it, some risks won't even be recognized; sensible priorities for taking action to reduce risks can't be set; and efforts to adopt safer substitutes can be stymied. We also believe that an important component of the public's right-to-know about chemicals includes having access to basic data on health and environmental effects of widely used chemicals. Unfortunately, separate studies by EDF, EPA, and CMA all found that even preliminary screening data are not available for the substantial majority of widely used industrial chemicals. We believe this situation is not acceptable, and we welcome the participation of industry and government in the Challenge Initiative.

Based on the concerns raised by you and others, we will be placing increased emphasis on assuring that this vital program is implemented in a way that takes advantage of every opportunity to minimize use of animal testing while producing the necessary information.

Very truly yours,
The Environmental Defense Fund