On May 26, 2023, the U.S. Environmental Protection Agency (EPA) proposed amendments to the regulations governing new chemicals under the Toxic Substances Control Act (TSCA). The purpose of these amendments is to align the regulations with the amendments made to the TSCA in 2016 and improve the efficiency of EPA’s review process for new chemicals.
The existing regulations for new chemicals under the TSCA needed to be updated to match the amendments made in 2016. There was a need to enhance the efficiency of the EPA’s review process for new chemicals and reduce the need for redoing risk assessments.
The proposed amendments to the regulations aim to address the identified problems. Changes include requiring EPA approval of low volume exemptions (LVE) and low release and exposure exemptions (LoREX) before manufacturing begins, excluding per- and polyfluoroalkyl substances (PFAS) from these exemptions, and declaring certain persistent, bioaccumulative, and toxic (PBT) chemical substances ineligible for exemptions based on EPA’s 1999 PBT policy. Procedural regulations are also being amended to align them with the amended TSCA Section 5, specifying EPA’s required determinations on each notice before manufacturing or processing can commence.
The proposed amendments are expected to improve the efficiency and effectiveness of the EPA’s review process for new chemicals. By improving the initial information submitted in new chemical notices, the need for redoing risk assessments can be reduced, shortening the overall review time. The amendments also address issues related to low volume and low release and exposure exemptions, PFAS, and PBT chemical substances.
The ComplianceXL team is your trusted partner when it comes to navigating regulatory updates and ensuring compliance. Staying compliant with the proposed TSCA amendments is more important than ever. It is our team’s responsibility to stay on top of regulatory changes, including proposed amendments to TSCA regulations that will align them with EPA’s review process and enhance the process. Our tailored solutions assist organizations in understanding the impact, evaluating current practices, and implementing necessary measures. Talk to one of our TSCA Compliance specialists today.
FAQs
Q: What are the proposed changes to the regulations for low volume exemptions and low release and exposure exemptions?
A: The proposed changes require EPA approval of exemption notices before manufacturing begins, make PFAS ineligible for these exemptions, and declare certain PBT chemical substances ineligible based on EPA’s 1999 PBT policy.
Q: How will the proposed amendments improve the EPA’s review process for new chemicals?
A: The proposed amendments aim to reduce the need for redoing risk assessments by improving the initial information submitted in new chemical notices. This improvement will help shorten the review time.
Q: What are the expected benefits of these proposed amendments?
A: The proposed amendments are expected to enhance the efficiency and effectiveness of the EPA’s review process for new chemicals. They will streamline the assessment of new chemical substances, reducing the time required for reviews and improving the overall process.
