June 30, 2017
EPA released scoping documents for the first ten chemical risk evaluations required under the Lautenberg Chemical Safety for the 21st Century Act amendments to the Toxic Substances Control Act (TSCA). Each scope includes the potential hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations EPA expects to consider when evaluating potential risks for these chemicals. Acknowledging that there was insufficient time to provide an opportunity for public comment on the scoping documents, EPA has re-opened the dockets for each of the 10 chemicals so the public can provide additional information/data to inform the Agency’s problem formulation, which is the next step in the risk evaluation process. Information should be submitted to the dockets by September 19, 2017. A prepublication copy of a Federal Register notice indicates EPA will take public comment on the problem formulation for each chemical in December 2017. EPA indicates that it is not planning to evaluate any hazard, exposure, condition of use, or potentially exposed/susceptible subpopulations that are not already included in the scoping documents. Furthermore, in response to public input regarding the problem formulation for each chemical, EPA could drop some conditions of use in the final scope. In general, EPA will consider the following conditions of use for each chemical:
Each scope discusses the existing hazard and risk data EPA has identified for each chemical, such as the Integrated Risk Information System (IRIS) and chemical-specific risk assessments. In addition, each scope includes a link to a bibliography of additional, more recent studies on potential human and ecological hazards, as well as exposure, engineering, and chemical fate literature.
Noteworthy differences in scopes for individual chemicals include unique use categories for asbestos (i.e., known uses and evidence of use in products such as adhesives, sealants, friction products) and consideration of increased health susceptibility for individuals with certain genetic predispositions from exposure to chlorinated solvents (e.g., trichloroethylene, carbon tetrachloride, methylene chloride). Also, EPA indicated that generation of 1,4-dioxane as a by-product during production of other chemicals will be better managed through risk evaluation of the parent chemicals; therefore, its presence as a contaminant in industrial, commercial, and consumer products will be excluded from the risk evaluation.
Please contact us if you have any questions about how the scoping documents may affect your business needs or if you need help determining what additional information you might consider providing to EPA for the upcoming problem formulation. This is the final email in a five-part series on this topic.
Eric M. Dube, M.P.H., Senior Environmental Health Scientist
edube@gradientcorp.com
Lisa A. Bailey, Ph.D., Senior Toxicologist
lbailey@gradientcorp.com
Lorenz R. Rhomberg, Ph.D., ATS, Principal
lrhomberg@gradientcorp.com
Rosemary Mattuck, M.S., Senior Environmental Engineer
rmattuck@gradientcorp.com
About Gradient
Gradient is an environmental and risk sciences consulting firm renowned for our specialties in Toxicology, Epidemiology, Risk Assessment, Product Safety, Contaminant Fate and Transport, Industrial Hygiene, Geographic Information Systems, and Environmental/Forensic Chemistry. We employ sound science to assist national and global clients in resolving their complex problems relating to chemicals in the environment, in the workplace, and in consumer products. www.gradientcorp.com