Since enactment three and a half years ago, EPA has been hard at work effectively and efficiently implementing the 2016 amendments to the Toxic Substances Control Act (TSCA) as Congress intended. The agency continues to consistently meet key TSCA deadlines and requirements, and today marks another milestone in that process as EPA finalized the designation of 20 chemical substances as high priority for risk evaluations and 20 substances as low priority for risk evaluations.
What are high and low priority chemicals?
The prioritization process for high and low priority substances is central to EPA’s ability to conduct a more systematic evaluation of chemicals in commerce. Designation as a low priority substance means the agency has determined that chemical does not require a risk evaluation at the time, but it can be reconsidered based on new information in the future.
A final high priority designation, on the other hand, initiates a TSCA risk evaluation of the substance. It is important to note that—as EPA has said—designation of a substance as a high priority “does not constitute a finding of risk” and should not be cause for concern.
So, what’s next for the 20 high priority chemicals?
- The final designation of these 20 chemicals as high priority for risk evaluations triggers the TSCA statutory three and a half year deadline by which EPA must complete the risk evaluations. During that time period, stakeholders will have more opportunities to provide the agency with further information and comments. For a more detailed explanation of the TSCA risk evaluation process, we encourage you to visit EPA’s risk evaluation process and timeline page.
- Manufacturers and importers of a high priority substance must share a $1.35 million fee for its risk evaluation. The law’s aggressive timeline for EPA to complete those evaluations impacts the time available for gathering reasonably available hazard, use and exposure information needed to inform a science-based evaluation and, if ordered by EPA, the development of new hazard or exposure potential information needed for the risk evaluation (e.g., through testing).
- It is anticipated that a preliminary list of manufacturers and importers required to pay for the share of a risk evaluation will be released next month. Companies will have at least 60 days from the release of the list to correct errors or omissions on it (e.g., self-identify, identify other manufacturers that may have been missed, or certify that they have ceased manufacturing and do not intend to reenter the market for five years from the date of certification).
- Each time EPA completes a TSCA risk evaluation, it is required by statute to initiate the prioritization of another chemical as a high priority for risk evaluation. Think of the prioritization and risk evaluation processes as working like a conveyor belt meant to ensure the agency designates priority substances and conducts risk evaluations at a pace consistent with EPA’s ability to complete risk evaluations within the 3 and ½ year deadline.
Information and cost sharing
In an effort to share costs and promote efficiency to address the requirements of a TSCA risk evaluation, stakeholders can form consortia to collaborate on the development of comments, generate relevant data/information and meet with EPA to discuss the draft TSCA risk evaluation. The ACC’s Center for Chemical Safety can serve as the scientific, technical and advocacy hub for providing information and building consortia to help those stakeholders navigate the TSCA prioritization and risk evaluation processes.
Looking forward
There is much more EPA has been doing to successfully implement the law, and there is a lot of work left to be done. ACC and its member companies will continue to support and meet the requirements of the law in order to help ensure implementation enhances public, industry, and government confidence in TSCA’s federal chemical regulatory system.
We are confident that once fully implemented, TSCA will represent the premier chemical regulation in the world. Successful implementation of the law, in accordance with the statute and congressional intent, is essential to ensuring protections for human health and the environment, while enabling our industry to continue to innovate, create jobs and grow the economy.