7 July 2017
EPA Issues Status Update on Implementation of Chemical Reform Legislation
The Environmental Protection Agency has issued a status report on its implementation of the landmark chemical reform legislation that was enacted into law last year. EPA Administrator Scott Pruitt indicated on 22 June that his agency has met its first-year statutory responsibilities under the law, including issuing three new rules, providing a guidance document for external parties, and releasing the scoping documents for the first ten risk evaluations that will be conducted. Pruitt noted that these activities “demonstrate this Administration’s commitment to providing regulatory certainty to American businesses, while protecting human health and the environment.” Pruitt believes the new process for evaluating existing chemicals “will increase public confidence in chemical safety without stifling innovation.”
Actions taking by the EPA over this past year include the following.
- A rule has been finalised to establish the EPA’s process and criteria for identifying high priority chemicals for risk evaluation as well as low priority chemicals for which risk evaluation is not needed. In response to public comments, this final rule affirms the EPA’s commitment to following the best available science, engaging stakeholders in the prioritisation process, and recognising the value of designating chemicals as low priority when appropriate.
- A rule has been finalised to establish the EPA’s process for evaluating high priority chemicals to determine whether or not they present an unreasonable risk to health or the environment. In response to public comments, this final rule clearly defines important scientific terms to ensure transparency and confidence in the risk evaluation process while retaining flexibility to allow for new scientific approaches to be incorporated as they are developed. Additionally, the final rule clarifies the EPA’s authority to determine what uses of a chemical are appropriate for risk evaluation, ensuring that the agency’s resources are focused on those uses that may pose the greatest risk.
- A rule has been finalised to require industry reporting of chemicals manufactured or processed in the United States over the past ten years. This reporting will be used to identify which chemical substances on the TSCA inventory are active in U.S. commerce and will help inform the chemicals the EPA prioritises for risk evaluation. In response to public comments, the agency streamlined the reporting requirements for manufacturers and processors in the final rule to help reduce the overall regulatory burden.
- Scope documents have been released for the initial ten chemicals for risk evaluation under the amended law. These documents identify what uses of the chemicals will be evaluated and how the evaluation will be conducted.
The EPA also released on 22 June guidance for external parties interested in submitting draft risk evaluations to the agency for consideration. The agency indicates that its guidance avoids being prescriptive as to the EPA’s approaches; consequently, the guidance that the agency would provide to external parties will likely evolve over time and new relevant guidance documents will be developed as necessary. The EPA’s goal is to ensure that external parties have flexibility to use the best available science by adapting and keeping current with changing science. The guidance may be refined, updated or superseded in the future to capture the latest changes to the risk evaluation process resulting from agency experience, advances in science, and future guidance that may be developed or updated.
The EPA expects external party draft risk evaluations to be of the same high quality as those developed by the agency. To that end, the guidance discusses the science standards, data quality considerations, and steps of the risk evaluation process that external parties should follow when developing draft TSCA risk evaluations. The EPA believes that having these key factors in the risk evaluation process laid out in the guidance will foster predictability by transparently communicating the EPA’s expectations.
The American Chemistry Council welcomed the release of this important guidance, describing it as a “critical companion” to the accompanying risk evaluation rule. The industry association commended the EPA for developing the guidance and the risk evaluation rule on the same schedule and for releasing them at the same time, thereby ensuring that the processes for risk evaluations, whether undertaken by the agency or other stakeholders, are consistent and apply the same standards for their conduct, for data quality and integrity, and for scientific conclusions.
On the other hand, the California-based consumer watchdog group Center for Environmental Health is expressing serious concern at how the EPA intends to regulate dangerous chemicals. In a 23 June press release, this association described the EPA’s efforts to implement the various provisions of the chemical reform legislation as favouring the chemical corporations over the health of Americans. The association is also calling for an ethics investigation to examine EPA Deputy Assistant Administrator Nancy Beck’s alleged ties to the chemical sector.