EPA Releases TSCA 2.0 Framework and Rules to Mark Law’s Refresh Last Year
The bipartisan law actually grants EPA more power to regulate more hazardous chemicals, with important upgrades that EPA is beginning to implement.
On June 22, 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act made major and long overdue amendments to the Toxic Substances Control Act (TSCA), which is the primary chemicals management law in the U.S. The TSCA refresh (“new TSCA” or “TSCA 2.0”) received wide bipartisan support from Republicans and Democrats in both the U.S. House of Representatives and the Senate. The new law makes a number of important and necessary improvements such as: mandatory requirement for EPA to evaluate existing chemicals with clear and enforceable deadlines; new risk-based safety standard (similar to Risk Based Corrective Action used in cleanups); increased public transparency for chemical information; and consistent source of funding for EPA to carry out the responsibilities under the new law.
One year later, on June 22, 2017, EPA announced a number of implementation activities to meet its first-year statutory responsibilities. EPA’s pre-publication Federal Register notices of the final framework actions under TSCA as revised (TSCA 2.0) were also released. The final rules include a prioritization process rule, which establishes EPA’s process and criteria for identifying High-Priority chemicals for risk evaluation and Low-Priority chemicals that do not warrant a risk evaluation. They also include a risk evaluation process rule, which establishes EPA’s process for evaluating High-Priority chemicals to determine whether or not they present an unreasonable risk to health or the environment. The rules also include the TSCA Inventory active-inactive rule, which requires industry to report chemicals manufactured, imported, or processed in the U.S. over the past ten years.
More information about these three final framework rules can be found at the links below:
- Procedures for Chemical Risk Evaluation
- Procedures for Prioritization of Chemicals for Risk Evaluation
- TSCA Inventory Notification (Active-Inactive) Requirements
EPA's final rule incorporates the following key definitions, all but one of which (the last one) are given in the law:
High-Priority Substance: a chemical substance that EPA determines, without consideration of costs or other non-risk factors, may present an unreasonable risk of injury to health or the environment because of a potential hazard and a potential route of exposure under the conditions of use, including an unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant by EPA.
Low-Priority Substance: a chemical substance that EPA concludes, based on information sufficient to establish, without consideration of costs or other non-risk factors, does not meet the standard for a High-Priority Substance.
Conditions of Use: are the circumstances, as determined by the EPA Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.
Potentially Exposed or Susceptible Subpopulation: a group of individuals within the general population identified by the EPA Administrator who, due to either greater susceptibility or greater exposure, may be at greater risk than the general population of adverse health effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women, workers, or the elderly.
Reasonably Available Information: is information that EPA possesses or can reasonably generate, obtain, and synthesize for use, considering the deadlines specified in TSCA Section 6(b) for prioritization and risk evaluation. Reasonably available information includes information in EPA’s possession that is confidential business information. In some instances, information that can be obtained through testing is “reasonably available.”
EPA also released scoping documents of the risk evaluations and supplemental resources on the first ten chemicals under the amended TSCA 2.0, as well as a companion guidance document to assist interested persons in developing and submitting draft risk evaluations. Links to the scoping documents for each of these ten chemicals are below:
- 1, 4-Dioxane
- Methylene Chloride
- N-Methylpyrolidone (NMP)
- Pigment Violet 29
- Carbon Tetrachloride
- Cyclic Aliphatic Bromide Cluster (HBCD)
- Tetrachloroethylene (perchloroethylene)
The final rule will be effective 60 days after its publication in the Federal Register. EPA intends to defend the severability of the rule, so that in the event that any individual provision or part of the rule is invalidated, the agency will not consider the entire rule invalid and any individual provisions should continue to operate as if it will be left in place.
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