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Validation

Validation is a process whereby a test method is evaluated to determine whether the information it produces is reliable, reproducible, and relevant to humans. Not only is test method validation a prerequisite for good science, in the case of the Endocrine Disruptor Screening Program (EDSP), it is also legally required. The law mandating the EDSP, the Food Quality Protection Act of 1996, states that only appropriate validated test systems may be used in the program.

The government-sanctioned process in the U.S. for validating new test methods, test methods with new endpoints, and test methods with cross-agency application is through the Interagency Coordinating Committee for the Validation of Alternative Methods (ICCVAM). The ICCVAM Authorization Act of 2000 requires that every federal agency carrying out a program that prescribes or recommends toxicological testing ensure that any new or revised acute or chronic test method, including animal test methods and alternatives, is determined to be valid for its proposed use before requiring, recommending, or encouraging the application of such test method.

The EPA is attempting to circumvent ICCVAM validation of animal-based test methods in the EDSP by conducting in-house reviews that it describes as ICCVAM-like. Perhaps a better description is ICCVAM-lite since the agency is looking to conduct a rushed and superficial procedure in a fraction of the time that a legitimate ICCVAM validation effort would require.

In March of 2000, the Advisory Committee on Alternative Toxicological Methods (ACATM) for the National Toxicology Program recommended unanimously that all test methods being considered in the EDSP should be validated through ICCVAM. Although the EPA does indeed require all non-animal tests to be validated through ICCVAM with very rigorous and thorough standards, it plans to follow a double standard by not requiring ICCVAM validation of animal tests. In November of 2000, the ACATM reiterated its position even more strongly with the following unanimous motion:

    The ACATM expresses grave concern at the bifurcated approach being taken with review of methods for evaluation of endocrine disruption activity, with ICCVAM considering in vitro [non-animal] methods and with the U.S. EPA proposing to review in vivo [animal] methods using an ICCVAM-like approach. The Committee’s primary concern is that both in vitro and in vivo methods be subjected to the same rigorous peer review and validation process to ensure the highest likelihood of acceptance by the regulatory agencies, the scientific community, and the public.

Even the EPAs own Endocrine Disruptor Standardization and Validation Taskforce rejected the EPAs plan to divide the scientific oversight of the proposed test methods between the agencys in-house review (for the animal tests) and ICCVAM (for the non-animal tests). The taskforce rejected the plan because members were concerned there would be a perception of bias in the plan. The panel members were concerned that all types of methods would not receive the same level of review under such a system [and] that certain new methods could appear to be facing more rigorous reviews than others.

In one of its animal welfare factsheets, the EPA states: Scientific validation is an essential step in determining the adequacy of new alternative test methods. Why is rigorous validation so important to the EPA for non-animal tests but so unnecessary for the animal tests?

As the chair of the European Commission for the Validation of Alternative Methods has written about the EDSP: “It has even been said that the validation phase of the new test development and acceptance sequence should be applied flexibly in this situation because of the [time] pressure being applied by the U.S. Congress. 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?”

The EPAs refusal to hold animal tests to the same validity standards as non-animal tests will render the EDSP test results invalid. Not only will animals lives be lostso, too, will any semblance of scientific integrity in the program. The EPA will be without the applicable data needed to prompt regulatory action for the tangible protection of human health and the environment. In other words, after millions of animals have been killed in laboratories, we will be no closer to actually reducing emissions of hazardous chemicals and protecting our environment.

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