Standard fate testing protocols and guidelines (EPA, OECD, ASTM and others) have been used for many years to evaluate chemical fate and degradation. Under the Toxic Substances Control Act (TSCA, amended June 2016), EPA evaluates new chemicals’ potential hazard, exposure and fate and degradation processes. When data is submitted, EPA reviews and assesses the test guidelines and corresponding test data to characterize chemical substances.<br/>Existing test guidelines are not always applicable to all substances and situations that EPA must evaluate under the TSCA. Standard protocols for biodegradation, hydrolysis and photolysis and other studies are well established by OECD and EPA; however, new chemistries may necessitate significant modifications to existing protocols. Many aspects of protocols may be modified, including approaches for quantification and clean-up of residual monomers, characterization and introduction of test material, extraction procedures for test media and vessels, analytical methods for degradation intermediates and products, test duration, test vessel design, volatiles collection and quantification, and other test details. Examples of test protocols that were modified compared to those that adhered closely to standard guidelines, will be used to illustrate modifications that enhance the value of data generated. Study designs may be modified by testing laboratories conducting studies on behalf of new chemical sponsors as each new set of results provides a better understanding of how to conduct these studies. Specific examples of standard test guideline modifications that have been required will be used to provide insights for design of future studies.<br/>

Modifications in chemicals’ degradation testing guidelines for EPA new chemicals’ evaluation under TSCA

254th National Meeting (2017)

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