Environmental Defense Fund, Washington, District of Columbia, USA.
Department of Environmental and Occupational Health Sciences, University of Washington School of Public Health, Seattle, Washington, USA.
Environ Health Perspect. 2022 Feb;130(2):25003. doi: 10.1289/EHP9649. Epub 2022 Feb 23.
In 2016, Congress enacted the Frank R. Lautenberg Chemical Safety for the 21st Century Act ("the Lautenberg Act"), which made major revisions to the main U.S. chemical safety law, the 1976 Toxic Substances Control Act (TSCA). Among other reforms, the Lautenberg Act mandates that the U.S. Environmental Protection Agency (U.S. EPA) conduct comprehensive risk evaluations of chemicals in commerce. The U.S. EPA recently finalized the first set of such chemical risk evaluations.
We examine the first 10 TSCA risk evaluations in relation to risk science recommendations from the National Academies to determine consistency with these recommendations and to identify opportunities to improve future TSCA risk evaluations by further implementing these key approaches and methods.
Our review of the first set of TSCA risk evaluations identified substantial deviations from best practices in risk assessment, including overly narrow problem formulations and scopes; insufficient characterization of uncertainty in the evidence; inadequate consideration of population variability; lack of consideration of background exposures, combined exposures, and cumulative risk; divergent approaches to dose-response assessment for carcinogens and noncarcinogens; and a flawed approach to systematic review. We believe these deviations result in underestimation of population exposures and health risks. We are hopeful that the agency can use these insights and have provided suggestions to produce chemical risk evaluations aligned with the intent and requirements of the Lautenberg Act and the best available science to better protect health and the environment-including the health of those most vulnerable to chemical exposures. https://doi.org/10.1289/EHP9649.
2016 年，美国国会颁布了《21 世纪弗兰克·R·劳滕伯格化学安全法》（简称“劳滕伯格法案”），对美国主要的化学安全法——1976 年《有毒物质控制法》（TSCA）进行了重大修订。除其他改革外，劳滕伯格法案要求美国环保署（EPA）对商业用化学品进行全面的风险评估。美国环保署最近完成了首批此类化学品风险评估。
我们根据国家科学院（National Academies）提出的风险科学建议，对前 10 项 TSCA 风险评估进行了考察，以确定与这些建议的一致性，并确定通过进一步实施这些关键方法和手段，改进未来 TSCA 风险评估的机会。
我们对首批 TSCA 风险评估的审查发现，在风险评估方面存在严重偏离最佳实践的情况，包括问题制定和范围过于狭窄；证据不确定性的特征描述不足；对人群变异性的考虑不足；没有考虑背景暴露、联合暴露和累积风险；对致癌物和非致癌物的剂量-反应评估方法存在分歧；以及系统审查方法存在缺陷。我们认为这些偏差导致对人群暴露和健康风险的低估。我们希望该机构能够利用这些见解，并提出建议，制定符合劳滕伯格法案的意图和要求以及最佳可用科学的化学品风险评估，以更好地保护健康和环境——包括那些最易受到化学品暴露影响的人群的健康。https://doi.org/10.1289/EHP9649.
