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
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.
Almost all of us grew up eating meat, wearing leather, and going to circuses and zoos. We never considered the impact of these actions on the animals involved. For whatever reason, you are now asking the question: Why should animals have rights? Read more.