On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Later that day, the U.S. Environmental Protection Agency (EPA) announced the creation of a web page on the new law, landmark legislation that significantly amends many of the provisions of the Toxic Substances Control Act (TSCA). EPA's web page includes links for users to access:
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The text of the Frank R. Lautenberg Chemical Safety for the 21st Century Act(the Act);
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Administrator McCarthy's blog item -- TSCA Reform: A Bipartisan Milestone to Protect Our Health from Dangerous Chemicals.
According to the FAQs, EPA's plans for meeting the deadlines under the Act include:
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Identifying the initial ten Work Plan chemical risk assessments;
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Establishing a process and criteria for identifying high priority chemicals for risk evaluation; and
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Issuing a procedural rule that establishes EPA's process for evaluating risks from high-priority chemicals.
According to the FAQs, the most immediate effects will be on the new chemicals review process. The answer to the relevant FAQ, Are there any areas immediately affected by changes in the new law?, states (emphasis added):
EPA is now required to make an affirmative determination on a new chemical or significant new use of an existing chemical before manufacturing can commence. For companies that submitted premanufacture notices (PMNs) prior to enactment and which are currently undergoing review, the new law effectively resets the 90-day review period. The agency will make every effort to complete its review and make a determination within the remaining time under the original deadline. EPA will be making additional information available on new chemical reviews in the very near future.
Brief commentary on this FAQ: We found EPA's answer to be both interesting and puzzling, and expect to have more to say in the next few days. By our reading, EPA's answer makes clear that it has determined that EPA will apply the new law to new chemical notifications submitted prior to June 22, 2016, that have not reached day 90. As you may recall in our memorandum on this question, at pages 13-14,TSCA Reform: An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA, we had observed that, in our view, EPA has discretion to proceed in this way or to continue to apply the old TSCA provisions to such cases for some time period into the future. While we are pleased to see the question resolved, we would have preferred the second, more flexible option, as this seemed to allow for a smoother and less-rushed transition.
EPA also states that the new law affects chemical data reporting (CDR) for 2016. This reporting is currently underway. According to the FAQs, these changes from the new law are related to confidential business information (CBI) submitted under TSCA. For the 2016 CDR submitters, EPA states that it changed the wording of the CBI certification statement to be consistent with the requirements in the new law. EPA states that it is updating the guidance, instructions, and other information documents to be consistent with the new certification language.
In the coming weeks, EPA plans to provide information on opportunities for stakeholders to learn more about the changes in the new law, and how and when specific stakeholder engagement will begin to take place. Opportunities for input may include briefings, webinars, public meetings, and comment periods; you can sign up for updates on EPA's stakeholder engagement efforts online. EPA will hold a webinar on Thursday, June 30, 2016, from 2:00 p.m. to 3:00 p.m. (EDT) to provide an overview of the Act. EPA states that this initial webinar will be informational only to help inform those unfamiliar with the new law. The login for the webinar will be available online; participants must sign in as guests. Audio will be available by calling 1-866-299-3188 and entering code 2025648098#.
Commentary
We are elated this landmark revision to TSCA is now the law of the land and join in congratulating all who contributed to this accomplishment. As long-time followers of TSCA arcana and its many ups and more frequent downs, we are still pinching ourselves at the realization of a new TSCA, particularly one so deftly drafted, carefully balanced, and appropriately strengthened to remedy most of old TSCA's ills.
We were pleased to see how promptly EPA got off the mark on informing the public about the new law, its initial thoughts, and the plans for future engagement. We encourage all interested stakeholders to follow these developments closely.
An important example that we are actively engaged in thinking through at present concerns what clients should expect and plan for, and how they might best respond to protect their interests, when they are holders of in-play or suspended PMNs previously submitted to the Agency under the old version of TSCA.