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Chemical Notification Process Under New TSCA (November 2016)

The Frank R. Lautenberg Chemical Safety for the 21st Century Act amends the Toxic Substances Control Act (TSCA) to change the process by which new chemicals are evaluated before they are brought to market. The Environmental Protection Agency (EPA) is enforcing the principle of “affirmative finding”, which maintains that the agency must give special attention to pre-manufacture notices (PMN) to identify and address safety risks.

The affirmative finding determination tends to overestimate the toxicity of chemicals, which may benefit companies to be more thorough in their analyses and documentation of data. Unless a new substance has minimal human health and environmental hazard implications, EPA will likely consider the substance hazardous. Similarly, unless the exposure to this substance is close to none, EPA will likely attribute it as a risk. EPA’s models will generally inflate the level of toxicity and exposure based on the description in the PMN.

Under the new law, EPA must make an affirmative finding of safety on both “known” and “reasonably foreseen” uses of a substance. The agency currently evaluates uses that are “known” to be those included in a PMN, and uses that are “reasonably foreseen” as known uses of similar substances.

TSCA is a living document that is constantly being amended to incorporate new findings and align regulations with modern research.

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