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Government-Required Animal Testing: Overview

Government regulations in most countries require some animal-based toxicity testing as a condition for the importation or sale of pesticides, industrial chemicals, drugs and vaccines, genetically manipulated foods, and some consumer products. Depending on the substance in question, its likely toxicity, and the degree of anticipatedhuman or environmental exposure, as many as 50 separate animal-poisoning studies may be required.

Animal Numbers and Suffering

Statistics published by government authorities and research-oversight bodies in North America and Europe reveal that the vast majority of the cruelest and most painful animal experiments are conducted to satisfy government-mandated testing requirements. In these tests,animals such as birds, dogs, fish, guinea pigs, mice, rabbits, rats, and even monkeys are forced to swallow or inhale massive doses of a test substance—which can cause severe abdominal pain, paralysis, swelling and ulceration of the skin and/or eyes, convulsions and seizures, and bleeding from the nose, mouth, and genitals—before they are poisoned to death or killed by the experimenter.

In 2000,regulatory testing accounted for 81 percent of Canadian experiments known to “cause pain near, at, or above the pain tolerance threshold of unanesthetized, conscious animals”. Although at least one research-oversight body acknowledges that such invasive procedures are “highly questionable or unacceptable, irrespective of the significance of the anticipated results,” these tests are stillpermitted—even required—by government regulators around the world. In fact, lethal-poisoning (“acute”) studies accounted for one-third of all toxicity tests carried out in U.K. labs in 2002. Other common tests involve dosing an animal daily with a test chemical for one month (“subacute”), three months (“subchronic”), or for most of the animal’s life (“chronic”) to determine what kind of harmful healtheffects result. Comparable U.S. statistics are not currently available because the species most commonly used in toxicity testing (birds, mice, and rats) are specifically exempt from even the minimal protections of the federal Animal Welfare Act, so experimenters are not even required to report the number and species of animals used.

Scientific Validity

In addition to the horrendous cruelty,there is another problem with animal testing: No animal test in use today has ever been properly scientifically validated according to internationally agreed-upon criteria, a fact that calls into question the reliability, accuracy, and relevance of animal-test results as predictors of possible human-health or environmental hazards. The following examples illustrate this unreliability:

• Oneinternational study examined the results of rat and mouse “lethal dose” tests for 50 chemicals and found that these tests were able to predict toxicity in humans with, at best, only 65 percent accuracy.
• During the Draize eye- and skin-irritation test, rabbits are immobilized in full-body restraints while a substance is dripped or smeared into their eyes or onto their shaved skin. One studyfound that the Draize test “grossly over predicted the effects that could be seen in the human eye,” and another concluded that the test “does not reflect the eye irritation hazard for man.” The human four-hour patch skin test has proved to provide chemical skin-irritation data that are “inherently superior to that given by a surrogate model, such as the rabbit.”
• With respect to thestandard rat test for toxicity to the developing nervous system, the U.S. Environmental Protection Agency’s (EPA) Scientific Advisory Panel concluded that the tests “must be further refined to develop more sensitive endpoints which are relevant to significant outcomes in humans.”
So despite a longstanding bias on the part of toxicologists and regulators who claim that animal tests are intrinsically...
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