How does “substantial risk” under TSCA §8(e) differ from other types of risks addressed by TSCA?
A.1. “Substantial risk” is defined in Part V of the 2003 TSCA §8(e) Reporting Guidance as a risk of considerable concern because of (a) the seriousness of the effect, and (b) the fact or probability of its occurrence. Unlike “unreasonable risk” under TSCA, economic or social benefits of use or costs of restricting use are not considered when determining whether there is reasonable support for a conclusion of “substantial risk” for purposes of §8(e). Q.2. If a company obtains new human exposure-related information on a chemical it manufactures, such as blood or urine monitoring data on a chemical known to have serious toxic effects, is it reportable under TSCA §8(e)? A.2. Yes. If the new information on a chemical known to have serious toxic effects indicates a level of exposure previously unknown to the Administrator, it should be reported. Information that corroborates known exposure levels, such as those within the range of chemical blood levels and other biological monitoring data re
