ACC Welcomes Release of TSCA Prioritization Candidates
We are quickly approaching the third anniversary of the 2016 amendments to the Toxic Substances Control Act (TSCA), which was signed into law on June 22 of that year after passing Congress with overwhelming bipartisan support.
To date, EPA has consistently met the law’s key deadlines and requirements and demonstrated the agency’s commitment to effective and efficient implementation of TSCA. Today marks another important milestone for that implementation with the announcement of the next set of potential candidate chemicals for prioritization.
If this is the first time you’re hearing about prioritization, don’t worry. It’s a new feature of the updated law, and we are here to provide you with the important information you need to know!
Prioritization is an important part of the updated TSCA because it is the first step in EPA’s process to evaluate the safety of existing chemicals. The prioritization rule requires the agency to use a risk based screening process to designate chemicals as either high priority, which will undergo further risk evaluations, or as low priority, which the agency determines do not warrant further evaluation. However, the law does provide EPA the authority to require further evaluation of a chemical substance at any time.
As the agency initiates prioritization of potential candidate chemicals, it is required to take at least 50 percent of all high priority designations from the 2014 TSCA Work Plan, with preference given to those chemicals that are:
- Highly persistent and bioaccumulative;
- Know human carcinogens; or
- Have high acute or chronic toxicity.
Beyond those requirements, EPA has the authority to decide which chemicals it will nominate for prioritization. You can find more details about the entire process on EPA’s website.
Below are some of the most important points to keep in mind when considering the prioritization process:
- It is important to note that—as EPA has said—designation as a high priority candidate “does not constitute a finding of risk” and should not be cause for concern.
A high-priority designation simply means the agency has nominated the chemical substance for further risk evaluation.
EPA’s Prioritization Rule: “Through the process of prioritization, EPA is ultimately making a judgment as to whether or not a particular chemical substance warrants further assessment.”
Prioritization designations must be based on best available science and weight of the scientific evidence as required by Section 26 of the law.
- There will be multiple opportunities for stakeholders to provide relevant information and comments to the agency about potential candidates or proposed chemicals for prioritization including:
A 90 day period at the beginning of the prioritization process, which provides the opportunity for any stakeholder to provide relevant information (e.g., potential hazard, use and exposure information) about a chemical which EPA identifies as a potential candidate as either low or high priority for risk evaluation.
A second 90 day period during which stakeholders can provide comments to EPA on the proposed designation of a chemical as a high or low priority for risk evaluation.
- Once EPA initiates the prioritization process on a chemical, EPA must make its final designations as high or low priority in no less than 9 months and no more than 12 months.
- Once EPA announces its final designation of a chemical as a high priority for risk evaluation, a three and a half year deadline for completing the risk evaluation begins. During that time, stakeholders will have more opportunities to provide the agency with further information and comments.
- A final designation of a chemical as a low priority for risk evaluations is treated as final agency action, which can be challenged.
Once a chemical receives a final designation as a high priority, it will undergo a TSCA risk evaluation, which EPA must complete within three and a half years of the final high priority designation. Manufacturers and importers of a final, designated high priority substance must share a $1.3 million fee for the risk evaluation. The law’s aggressive timeline for EPA to complete the risk evaluation 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 information needed for the risk evaluation (e.g., through testing).
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 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.
Stay tuned to our blog for more updates as TSCA implementation continues!
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