Over the past year, EPA has been working to implement new chemical regulations under the amended TSCA rule. This month, the Agency held two public meetings to update the stakeholders on the progress of implementing these changes as well as the approaches they are taking on certain parts of the new rule.
The first of the two meetings was held on December 6, 2017 at the Ronald Reagan Building and International Trade Center in downtown Washington, D.C. EPA provided updates on the progress they have made in implementing the 2016 TSCA amendments. The Agency has developed a draft Points to Consider When Preparing TSCA New Chemical Notifications document. This document is meant to assist submitters in preparing Premanufacture Notices, Significant New Use Notices, or exemption notices. The EPA often faces delayed reviews due to a lack of detail in PMN submissions. With this document, the Agency intends to reduce follow-up with submitters by making sure they are including correct and substantial information.
EPA will be publishing a final draft, with an opportunity to provide public comment. Comments will be due on or before January 20, 2018. The Agency addressed questions from the audience at the December 6 meeting regarding this guidance document. One commenter wanted to see a full history of the development of the document, and EPA announced that they would be publishing both an original red-lined copy as well as the final draft. Another commenter asked about the process for submissions from downstream users. One potential solution is having downstream users submit a support document for information that they don’t want to give to their suppliers – EPA is considering this approach.
The Agency also had a brief discussion of the Decision Guidelines Manual. This document will summarize how the EPA reviews new chemical submissions and makes final decisions, as well as providing an overview of the risk assessment and rick management processes. This document will help chemical manufacturers understand the potential regulatory action that may arise from an EPA determination. EPA has published an outline of the document that they seek comment on – specifically, they are looking for comments on whether additional sections should be added to the final document.
Finally, a representative of the Risk Assessment Division of the EPA touched on the Agency’s Sustainable Futures program. This program provides computer-based models and training to help companies develop safer chemicals more quickly and cost-effectively. Companies that participate in this program become eligible for an expedited EPA premanufacture review.
SGIA will continue to monitor the implementation of this regulation. Sign up to recieve the most up-to-date regulatory and legislatvie information about specialty imaging.