Validation

Validation tests the transferability of the protocol to other laboratories, determines the reliability of the protocol, and further documents its relevance. Validation studies are conducted at several different laboratories using the same protocol. After testing is complete, EPA compares the interlaboratory results to determine whether or not the protocol meets the criteria for reliability and relevance. The results of the validation studies are used to statistically evaluate the validity of the methods/protocol; prepare documents required for peer review of the methods; and develop technical guidance and test guidelines.

EPA's approach to interlaboratory validation studies includes:

• Conducting identical studies using an optimized protocol in 3 or more laboratories.
• Using a small number of coded chemicals (one per relevant mode of action if possible).
• Conducting studies using GLP-like or similar criteria.
• Summarizing and analyzing data and results in the validation report.

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