The U.S. Environmental Protection Agency (EPA) convened a public webinar on July 27, 2021, to engage with stakeholders on the development of a proposed rule under the Toxic Substances Control Act (TSCA) to implement a tiered data collection strategy intended to inform EPA’s prioritization, risk evaluation, and risk management activities for chemical substances or mixtures. According to the July 14, 2021, Federal Register notice announcing the webinar, EPA currently primarily collects exposure-related data through the TSCA Chemical Data Reporting (CDR) process. EPA is exploring a data reporting rule that is tiered to specific stages of the TSCA existing chemicals program: identifying a pool of substances as potential candidates for prioritization; selecting candidate chemicals for and completing the prioritization process; and assessing high-priority substances through a robust risk evaluation that may be followed by risk management actions (depending on the outcome of the risk evaluation). EPA states that feedback from the public webinar and comments received will help inform its development of a proposed rule. According to the Federal Register notice, comments are due Sunday, August 15, 2021. During the webinar, EPA stated that comments are due Monday, August 16, 2021. Written comments may be submitted to Docket EPA-HQ-OPPT-2021-0436.
EPA’s July 14, 2021, Federal Register notice describes the following stages of the existing chemicals prioritization, risk evaluation, and risk management program:
- Identification of Potential Candidates and Selection for Prioritization: As amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), TSCA requires the systematic prioritization of tens of thousands of existing chemicals for risk evaluation. EPA is required to select a certain percentage of candidates for prioritization from chemical substances listed on the 2014 Update of the TSCA Work Plan, giving preference to chemicals with certain hazard characteristics. Aside from the statutory preferences and requirements, EPA has broad discretion to select which other chemical substances to prioritize. EPA states that it is interested in ensuring that exposure-related information collected through CDR provides sufficient basic data to inform the potential candidate selection process. According to EPA, once it identifies a chemical substance as a potential candidate, it needs additional information to inform which potential candidates it should select to enter the prioritization stage.
- Prioritization: EPA formally announces when a chemical substance will begin the nine- to 12-month long prioritization stage and provides a three-month period for the public to submit relevant information on the subject chemicals. EPA states that it needs sufficient information to understand the use and other exposure-related scenarios to inform its decision of whether the chemical should be designated as a high-priority substance and, therefore, enter the risk evaluation process. EPA is considering requiring certain necessary data to be reported by chemical manufacturers (including importers), as well as either notifying or collecting information from processors.
- Risk evaluation: Once EPA designates a chemical as a high-priority substance, it begins to evaluate the risk of the chemical. The purpose of risk evaluation is to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, including an unreasonable risk to a relevant potentially exposed or susceptible subpopulation. EPA must evaluate both hazard and exposure, exclude consideration of costs or other non-risk factors, use scientific information and approaches in a manner that is consistent with the TSCA requirements for the best available science, and ensure decisions are based on the weight of scientific evidence. According to EPA, it needs to ensure that sufficient information is available to inform the risk evaluation, including the development of the scope of the evaluation, and information is needed in a timely manner. For example, the scope is generally published as a draft within three months of a chemical being designated as a high-priority substance, and the scope must be prepared in final no later than six months after the initiation of the risk evaluation process. EPA states that it also needs information to inform exposure and hazard assessments. EPA is considering requiring chemical manufacturers (including importers), processors, and distributors to submit information to EPA to support these risk evaluation activities.
- Risk management: If at the end of the risk evaluation process, EPA determines that a chemical substance presents an unreasonable risk of injury to health or the environment, EPA must immediately start the risk management rulemaking process to address the unreasonable risk. EPA states that it needs to ensure that sufficient information is available to develop risk management plans and actions. For chemicals in the risk management stage, EPA is considering requiring manufacturers (including importers), processors, and distributors to report the same type of information reported during the risk evaluation stage to ensure that EPA has the most up-to-date information to inform risk management actions. For example, if a company reported using a chemical in a particular manner at the beginning of the existing chemical process, but changes occurred in some way during the stages of the existing chemical process, the company would report on those data elements that have changed.
July 27, 2021, Webinar
The slides from EPA’s July 27, 2021, webinar are posted online. EPA seeks to build on CDR to develop a pool of chemicals from which it will identify chemicals for prioritization. EPA also seeks to integrate multiple collection authorities in a systematic and comprehensive manner. EPA states that it believes that tiered data reporting (TDR) will reduce reporting of certain data elements under CDR to focus on exposure-related elements.
EPA plans to issue the TDR rule using its TSCA Section 8 authority. TSCA Section 8(a) allows EPA to require reporting from manufacturers (including importers) and processors. CDR is an example of a Section 8(a) rule. TSCA Section 8(c) requires manufacturers, processors, and distributors to maintain and, upon request, submit to EPA information such as significant adverse health effects, consumer allegations, occupational disease or injury, and complaints of injury to the environment. TSCA Section 8(d) requires manufacturers, processors, and distributors to submit to EPA study information that is known or reasonably ascertainable, including lists of health and safety studies and, upon request, copies of such studies. The studies do not need to be published to be included in the submission.
According to EPA, TDR would supplement quadrennial CDR. EPA envisions the following stages:
- Conditions of Use (COU) Data Set: EPA would select a pool from the 8,000-9,000 CDR chemicals (or potentially other substances that might not be reported to CDR) to identify candidates for further data gathering in a COU stage. For the subset of COU Data Set chemicals, EPA would propose a TSCA Section 8(a) reporting rule that requires a wider set of information and annual reporting. Members of this COU pool would either be taken forward to the Prioritization Data Set stage or returned to the overall CDR pool;
- Prioritization Data Set: EPA would collect additional COU data to determine whether a chemical should be designated as high priority, beginning the nine- to 12-month prioritization process; and
- The Risk Evaluation/Risk Management (RE/RM) Data Set: Once EPA designates a chemical as a high priority, it would require submission of data by manufacturers (including importers) and processors to obtain detailed information on use, production, disposal, and environmental and health effects.
EPA is proposing a tiered approach to gathering data to inform its evaluation of existing chemicals under TSCA Section 6. EPA has a need for information and has the authority to gather that information. EPA is to be commended for developing a framework to obtain data in successive tiers rather than casting an “everything on everything” approach. There is a real limitation on resources, both for industry and for EPA; focusing on a subset of chemicals is a sensible approach. Standardizing this approach will also provide EPA and reporters with a clear path forward.
In the COU phase, EPA will require annual reporting for a CDR-like data set. EPA proposes to return some chemicals to the pool of standard CDR reporters. This is a sensible recognition that if one of the COU Data Set chemicals is not taken forward to the Prioritization Data Set, it is inefficient for reporters and EPA to administer annual reporting outside the standard CDR cycle. EPA should focus on collecting those data that will inform its next decisions.
Stakeholders should review carefully EPA’s proposal and provide supporting and constructive comments, as appropriate. This information will help EPA understand better the effects of the initiative on potential reporters.