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HPV CHEMICAL RE-TESTING
PROPOSED BY VP GORE AND EPA
Comments submitted by Civitas
Plus comments of Alix Fano, author of Lethal Laws
September 7, 1999 deadline
The Environmental Protection Agency will accept comments until September 7 on its proposal to add 4 new animal toxicity tests to the battery of 19 animal tests it currently requires for approving products like weedkillers and insecticides. Your comment expressing opposition is more important than what you write. Feel free to borrow from Civitas submission below.
The email address is opp-docket@epa.gov
DOCKET NUMBER IS A NECESSITY OPP-00610
Submission by Civitas followed by a more detailed one from Alix Fano:
Public Information and Records Integrity Branch August 31, 1999
Information and Resources Division (7502C)
Office of Pesticide Programs, EPA
401 M Street SW
Washington DC 20450
Docket Control Number OPP-00610
Adding four new chemical toxicity tests to the battery already required by EPA is like carrying coals to Newcastle or selling refrigerators to the Eskimos. They simply are not needed.
What is needed is a good dose of common sense and strict scientific evaluation of present test requirements which (1) do not reliably predict human responses, (2) hobble the development of new products, (3) cause a great deal of avoidable animal suffering, and (4) add to the cost the public must pay for the products that are required to go through this antiquated animal-testing process.
Animal testing has been used as an alibi to sanction the use of poisons that contaminate our food, our water and our soil. Three years ago, EPA was given the option of increasing present "safe" exposure levels by a factor of 10. Enacting this option would immediately do more to protect the public from poisons than a century of animal testing. Animal test results can be skewed depending on
(1) the species or strain used, (2) variations in individual animals, and (3) variations in human judgement in interpreting the results..
In 1993, the NIH Revitalization Act charged government agencies, including
EPA, with reducing their reliance upon animal testing. Adding four additional animal tests, some of them redundant, does not comply with this act.
EPA (and other government agencies) have been slow to recognize the value of
human cell culture tests. Corrositex, for assessing effects on human skin, has been available for 15 years according to its manufacturer but has only recently found acceptance by several agencies. There are a number of valid tests for eye toxicity, and the Ames test using salmonella bacteria has been shown to predict human carcinogenicity more accurately than animal testing.
One of the world's most respected cell toxicologists, Dr Bjorn Ekwall of the University of Uppsala, Sweden, stated at an International Scientific Congress, in London in 1991: "….the use of an animal as a representative of the human body and mind for testing purposes is not correct. We have a species gap between the various animals due to differences in bodily functions, making their responses to chemicals differ from one to another."
I would like to know why EPA is taking this big step backward into primitive animal technology when it should be taking advantage of modern cell, molecular, and other technologies based on human rather than other species' characteristics in order to comply with the 1993 NIH Revitalization Act.
Respectfully submitted,
Bina Robinson
A More Detailed Submission
from Alix Fano, author of LETHAL LAWS
As the author of a book that exposes the fraudulence and wastefulness of government animal testing programs, I would like to register my strong opposition to the Environmental Protection Agency's (EPA's) continued reliance on animal testing. More specifically, on July 8, 1999, the EPA issued a proposal that would add four new animal tests to the standard battery of toxicity experiments carried out on every new pesticide. (Currently, every pesticide must be run through a battery of 19 separate animal tests, including eye irritation, chronic inhalation, injection into the stomach, skin penetration, and a variety of long- and short-term feeding studies. These requirements kill thousands of animals, including dogs, for each pesticide tested, and they do NOTHING to protect the public health. These tests are used as alibis to allow the continued production of thousands of toxic chemicals that go on to poison our food, water, and our bodies.
I was shocked and disgusted to learn that the EPA is now looking to add four more animal tests to this screening process, including a 21-day dermal toxicity study, in which rabbits will be slowly poisoned by having >pesticides rubbed into their abraded skin, and a "developmental neurotoxicity" study that alone will kill 1,200 animals per test. The EPA has proposed adding this test despite having heard testimony from
scientists at a recent meeting who maintained that the addition of this test to the standard battery was redundant as there are already several tests included that screen for neurotoxicity. Yet the EPA is dead set on conducting this test for every pesticide.
The fact is that the EPA does not have to add any of these new tests. A 1996 >law allows the EPA to simply set a 10-fold safety factor for all pesticide exposures.
Piling new tests on to the EPA's already massive animal-poisoning battery for pesticides will NOT protect the public. The developmental neurotoxicity test should not be required. The addition of this test is doubly cruel and wasteful because the EPA already requires many other tests of this nature.
The EPA should conduct a full review of the existing 19 animal tests required in the pesticide battery with an eye toward removing as many as possible. Let me remind you that the 1993 NIH Revitalization Act stipulates that "Agencies with regulatory programs should … reduce reliance on animal testing" and should, "periodically review and revise test methods in light of scientific and policy developments."
The EPA must cease poisoning dogs and other animals by force feeding them pesticides. The EPA has admitted in writing that these tests are simply not necessary, yet currently has no plans to stop requiring them.
Instead of calling for massive amounts of new animal testing, the EPA could better assure public safety by adding on a 10-fold safety factor to all pesticides today. Such protection would be immediate, would ensure the safety of children who are more sensitive to pesticides, and would be a sure step toward reducing exposures to pesticides that we already know are dangerous. Environmental organizations have criticized the agency sharply because it is extremely slow to take action on harmful pesticides and
because its policies (based on crude extrapolations from animal toxicity studies) fall far short of ensuring public safety.
The EPA should end its near exclusive reliance on crude and cruel animal tests and redirect its efforts to modern, non-animal tests that already >exist. I sent a list of these tests to Phil Robinson at the EPA last February, including names of their manufacturers and provided addresses and phone numbers. As the federal agency that requires the most chemical toxicity tests on animals, the EPA has an obligation to promote the use of non-animal tests. To date, it has failed miserably to meet this obligation and to consider animal welfare concerns.
I am outraged by the EPA's continued narrow-mindedness and ignorance of scientific and ethical standards and I sincerely hope you will stop these sham animal tests immediately.
Sincerely,
Alix Fano, MA
Author, Lethal Laws: Animal Testing, Human Health & Environmental Policy
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