When it was passed into law, the FQPA did not specify the number of chemicals that the EPA was required to test. Many believe that the language of the law was only aimed at pesticides and the relatively few industrial chemicals for which there is any public exposure. But instead of focusing on this limited group of chemicals, the EPA has instead decided that nearly every single chemical manufactured or imported into the U.S. will be subject to testing. This means that somewhere between 5,000 and 87,000 chemicals will be tested on animals. A University of Manchester scientist has estimated that for every 1,000 chemicals tested, between 600,000 and 1.2 million animals will be killed.
Further criticism of the EPA’s testing program comes from a recent review conducted by the agency’s independent scientific advisory committee. In its final report, the committee raised many serious concerns about the program, including: recommending against expanding the number of chemicals to be tested, expressing concern that the agency has inadequate plans for interpreting data from the huge number of required studies, and criticizing the agency for the exorbitantly high number of animals who will be killed under current guidelines. The committee stated, "We are concerned about the large number of animals that will be used. … The agency has an obligation to conserve all resources in developing new testing protocols and the use of animals in such tests poses both ethical and practical problems." In fact, one of the main conclusions reached by the committee was to strongly recommend that EPA officials "minimize the number of animals needed for testing." To date, the EPA has failed to respond to even this simple recommendation.
The chair of the EPA’s endocrine advisory committee, Dr. Ernest McConnell, has been even more outspoken about the testing program in statements made to the media. In describing the overall opinion of the scientists on the EPA advisory committee during their review of the program, he stated, "[T]here was an undercurrent through the whole discussion that the EPA program was ahead of the science." Another recent article quoted Dr. McConnell as saying, "This may not be the best use of our nation’s resources," and, "[T]his is probably a classic example where process has gotten ahead of science."
Greatly adding to the astronomical number of animals who will be killed is the EPA’s reluctance to incorporate a scientifically recommended non-animal screen as a first stage in the testing. At the outset of the program, the EPA’s Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC) recommended to the EPA that a tiered approach incorporating a rapid non-animal test method, known as "high throughput screening" (HTPS) be adopted. Congress gave the EPA $4 million to develop and implement the HTPS, but the agency spent only $70,000 and six months’ time before deciding against this approach, and it is now set to begin testing without the initial non-animal screen. As a result, millions of animals could be killed to test chemicals that would have been eliminated early on in the program using the humane and scientifically recommended HTPS.
To make matters worse, the EPA is looking to bypass normal "validation" procedures for the animal tests that it has proposed. Validation is a process in which test data are reviewed in order to confirm that a test method is reliable, reproducible, and relevant to humans. Animal tests are rarely, if ever, formally validated, but in the case of endocrine disruptor testing, the law mandating the program (the FQPA) states that only "appropriately validated" test methods can be used. Incredibly, EPA officials have argued that the ability to extrapolate the results of endocrine disruptor tests between animals and humans should be taken for granted! As a result, instead of spending the time and money to develop the methods as required, the EPA is looking to perform only quick and sloppy validation studies for several animal tests and to complete the process in a fraction of the time that legitimate validation efforts take. This superficial and rushed process contrasts sharply with the EPA’s validation requirements for non-animal tests, which are always held to extremely high standards and subjected to years of scrutiny by regulators. This creates a bias against non-animal tests and compromises the reliability of the resulting data. As the chair of the European Commission for the Validation of Alternative Methods has written: "It has even been said that the validation phase of the new test development and acceptance sequence should be applied flexibly in this situation. … Validation is concerned with the reliability and relevance of methods for particular purposes. How can there possibly be flexibility about whether or not methods are reliable and relevant and about what they should be used for? What would be the value of the data such tests would provide, and with what confidence could they be applied in making decisions?"
Lastly, the tests will cause great animal suffering due to the painful nature of the experiments. Dr. Robert Combes, scientific director of the Fund for the Replacement of Animals in Medical Experiments, writes in a recent editorial that "there are several tests that require large animal group sizes and stressful procedures. In view of the weak activity of endocrine disruptors in general, it will be necessary to use excessive doses, without paying due regard to normal routes of exposure and likely levels normally encountered during environmental exposure." The animals will be subjected to extremely high doses that will, in themselves, overwhelm the animals' normal biological processes.
|
