As EPA continues its important work to implement the amended Toxic Substances Control Act (TSCA), we wanted to highlight another milestone in that process and what ACC has been doing to help ensure successful implementation.
Earlier this summer, EPA released for comment the first 10 problem formulations for risk evaluation under TSCA and its proposal for systematic review.
The First 10 Problem Formulations
For the first 10 risk evaluations, EPA released the scopes of the risk evaluations, followed by more detailed problem formulations. Those documents are important because they provide more clarity about how the agency plans to undertake the risk evaluations for the first 10 chemicals. They are also important because the problem formulation step will be integrated into future risk evaluation scopes. Together, the scope and problem formulations are the blueprints that describe how EPA will perform each risk evaluation.
The law requires EPA to ensure that each risk evaluation identifies and addresses the circumstances that could present the highest potential for risk. The problem formulations show that EPA is consistently applying this principle.
Below are several recommendations we made to the agency for the first 10 problem formulations and future scoping documents for TSCA risk evaluations. You can also read our comments in full by clicking here.
- Systematic review: EPA’s development of a structured process to identify, evaluate and integrate evidence from both the hazard and exposure assessments developed during the TSCA risk evaluations is appropriate and will provide increased transparency into the TSCA risk evaluation process.
- Conditions of use: EPA should develop a framework for its scoping approach that articulates its process for deciding when conditions of use will be in or out of scope of the risk evaluation. This would help streamline the agency’s future efforts, increase transparency and help industry anticipate EPA’s information needs in the risk evaluations.
- Coordination with other appropriate federal executive departments or agencies: EPA should develop new or update existing memoranda of understanding with other federal agencies, in particular OSHA, to clarify how it will undertake its TSCA Section 9(d) consultation obligations. This coordination is essential to avoid duplicative and unnecessary regulation.
- Tiered approaches to assessment: EPA should apply tiered approaches to hazard and exposure assessments throughout the risk evaluation process. This will enable EPA to meet TSCA’s deadlines, adhere to TSCA’s science standards and enable EPA and the regulated community to apply resources efficiently. For example, a roadmap showing EPA’s approach to tiered exposure assessments and guidance on the same would be useful.
Systematic Review Proposal
Another proposal that was released at the same time as the problem formulations was EPA’s approach to application of systematic review in TSCA risk evaluations. That document is important because it will guide the way the agency identifies and evaluates studies and should provide more transparency about how scientific information will be evaluated by EPA.
We believe the systematic review proposal has many positive attributes and that several areas of guidance are well developed. It focuses on fit-for-purpose evaluations and an iterative evaluation process, which allow for flexibility that is necessary given the wide array of chemical substances that will be reviewed under TSCA.
However, the approach would benefit from additional explicit guidance, particularly related to evidence integration, which will ensure objective, comprehensive, scientifically supported risk evaluations for TSCA chemicals.
You can read our full comments on the proposal for systematic review by clicking here.
ACC will continue to support the efficient and effective implementation of TSCA. Successful implementation of this important bipartisan legislation is essential to ensuring protections for human health and environment while enabling our industry to continue to innovate, create jobs and grow the economy.