How can reportable information under TSCA §8(e) be distinguished from routine tests, such as LD50s and range-finding tests?
A.23. The June 3, 2003, Republication of the TSCA Section 8(e) Reporting Guidance discusses the types of effects that should be reported when unknown to the EPA Administrator. Although many routine tests are based on a knowledge of toxicity associated with a chemical, previously unknown effects can occur during such tests and may be reportable if the information meets the criteria described in Part V. of the 2003 Reporting Guidance. The most serious human health effects include any pattern of effects or evidence that reasonably supports the conclusion that the chemical substance or mixture can produce cancer, mutation, birth defects or toxic effects resulting in death, or serious or prolonged incapacitation, including the loss of a normal bodily function resulting in relatively serious impairment of normal activities. For these effects, exposure is presumed. For other human health effects, the level of exposure or potential exposure should be used to determine TSCA §8(e) reportability.
