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Challenges to Safety Testing on Animals

Manufacturers of cosmetics have the option of using non-animal methods to produce safety data. Yet the use of animals in cosmetics testing has become controversial. Animal testing for cosmetic safety has been banned in the European Union, as well as in several other countries. Many other countries, including the U.S., Canada, Australia, Brazil and even China are working to end animal testing, at least for cosmetics.

One of the reasons why European countries have moved more quickly than the U.S. in banning product testing on animals is that they have issued laws, or directives, that companies are required to follow. While the U.S. Food and Drug Administration (FDA) asserts that it is a strong advocate of methodologies for the refinement, reduction and replacement of animal tests, the agency continues to accept the results of animal tests to substantiate safety, and gives companies control over the decision as to whether or not to use animals. Thus, companies have no incentive to change their practices. An FDA statement reads:

Animal testing by manufacturers seeking to market new products may be used to establish product safety. In some cases, after considering available alternatives, companies may determine that animal testing is necessary to assure the safety of a product or ingredient.

This language gives tacit approval to the continued use of animals for safety testing, despite its purported support for the development and use of non-animal methods.

A few states have taken the initiative in addressing animal testing and encourage the use of non-animal alternatives. California became the first state to enact legislation prohibiting the use of animal testing for which there has been a non-animal alternative testing method validated by the Interagency Coordinating Committee on the Validation of Alternative Methods. Arizona and New York have adopted similar laws. None of these laws applies to any animal testing conducted for approval of pharmaceuticals, just personal care products and cosmetics.

On the regulatory front, the Environmental Protection Agency (EPA) no longer supports use of the LD-50 test. And the FDA does not use the LD-50 test any longer, although it continues to accept LD-50 test data from manufacturers.

Setting a New Legal Standard for Reliance on Safety Testing

When animal testing was the standard accepted practice, manufacturers used it as evidence in lawsuits to prove that they had exercised due diligence and had appropriate data to support the safety of their products. In these litigious times, many companies continue to rely on animal testing as a legal safety net, even though it is not required by law. Fortunately, this too is changing.

Manufacturers have claimed that animal testing of personal care and pharmaceutical products proves their safety in humans in case of a lawsuit. However, court rulings have significantly weakened their ability to use this argument.

A landmark case involving the reliance on scientific evidence, Daubert v. Merrell Dow Pharmaceuticals, Inc. (1993), set a standard for review of that evidence that requires a greater degree of scientific accountability in presenting such data.

This standard, or test, identified four factors that can be considered in determining the admissibility of scientific evidence: 1) whether the theory or technique can be and has been tested; 2) whether it has been subjected to peer review and publication; 3) whether the technique has a high known or potential rate of error or whether there are standards controlling the technique’s operation; and 4) whether it enjoys “general acceptance.”

Since the Daubert test has been applied to animal research, admissibility of the evidence of animal testing has declined. In the case, Soldo v. Sandoz Pharmaceutical Corporation (2003), the court specifically found that “animal studies do not present a scientifically reliable basis for the causation opinion of plaintiff’s experts.” The court held that plaintiff’s experts’ failure to take into account critical differences between animal data and human experience–including but not limited to extrapolation in dosing–rendered their methodology scientifically invalid and unreliable.

Not all state courts apply the Daubert test to the admissibility of scientific evidence, but a vast majority of jurisdictions do. Once the courts articulate the unreliability of extrapolating the results of animal testing data to humans, this legal justification for relying on animal data falls apart.