Regulatory Developments

TSCA Reform: EPA Web Page on the Frank R. Lautenberg Chemical Safety for the 21st Century Act Includes FAQs Addressing PMNs and CDR Reporting for 2016

June 23, 2016

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:

According to the FAQs, EPA's plans for meeting the deadlines under the Act include:

  • Identifying the initial ten Work Plan chemical risk assessments;
     
  • Establishing a process and criteria for identifying high priority chemicals for risk evaluation; and
     
  • 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#.

As a service to those in the regulated community, Bergeson & Campbell, P.C. (B&C®) has collaborated with Chemical Watch in assembling an impressive faculty of TSCA experts representing the perspectives of industry, environmental organizations, and U.S. Federal and State regulatory authorities to present a series of complimentary webinars titled "'The New TSCA' -- What You Need to Know."

  • Webinar I, "The New TSCA -- Overview and Summary of Major Changes: What to Expect and When to Expect It," held June 13, 2016, provided an overview of the new law and major changes to TSCA. The archived webcast for this webinar is available online. The webinar's format involved a summation of the key provisions in amended TSCA followed by discussion on each of these major provisions amongst a panel of TSCA experts to provide context and additional explanation as time allowed. The panel participants included:
     
    • Lynn L. Bergeson, Managing Partner, B&C;
       
    • Richard A. Denison, Ph.D., Lead Senior Scientist, Environmental Defense Fund;
       
    • Charles M. Auer, Charles Auer & Associates, LLC, former Director of the Office of Pollution Prevention and Toxics (OPPT), EPA; and
       
    • James V. Aidala, Senior Government Affairs Consultant, B&C, former EPA Assistant Administrator for Toxics.

To request webinar materials, please contact .(JavaScript must be enabled to view this email address). Later webinars will provide a deeper dive into how and when TSCA programs will change and adapt to the "New TSCA." Webinar II will be held July 14, 2016. It will cover impacts on new and existing chemicals programs (Sections 4, 5, and 6). More information on Webinar II and a link for registration will be sent at a later date.

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.

B&C plans to continue to provide updates and alerts as matters warrant. We also plan to provide our clients with additional detailed insights and analyses as well as B&C's thoughts and suggestions regarding specific matters. You have our commitment that B&C's team of in-house TSCA experts, working closely with our affiliates, will do the best job we can to keep clients fully and timely advised on important matters. Our TSCAblog™, launched today, TSCAblog.com, is a convenient platform for our professionals to offer timely updates, expert insight, and clear analysis on TSCA implementation matters.

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.

Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm offering clients an unparalleled level of experience and excellence in matters relating to TSCA. Our TSCA practice group includes five former senior EPA scientific and executive staff, seven Ph.D.s, and a robust and highly experienced team of lawyers and non-lawyer professionals extremely well versed in all aspects of TSCA law, regulation, and litigation. More information on TSCA Reform is available on our TSCA Reform News & Information page. Visit our website for Regulatory Memoranda regarding TSCA, Articles on TSCA and TSCA Reform, and TSCA FAQs.

Charles M. Auer, President of Charles Auer & Associates, LLC, and former Director of EPA's Office of Pollution Prevention and Toxics (OPPT), Office of Prevention, Pesticides, and Toxic Substances (OPPTS), is an affiliate of B&C and its consulting affiliates, The Acta Group (Acta®) and The Acta Group EU, Ltd (Acta® EU). Charlie Auer has a distinguished record of public service, and is well known domestically and internationally in the chemical regulatory community. Auer was Director of OPPT from September 2002 to January 2009, where he was responsible for the management and direction of the nation's chemical and pollution prevention programs.


 
BIOBASED AND RENEWABLE PRODUCTS ADVOCACY GROUP
2200 Pennsylvania Avenue, NW, Suite 100W
Washington, D.C. 20037
202-833-6580 | www.braginfo.org
Contact
 
Privacy Policy | Acceptable Use Policy 
©2019 Biobased And Renewable Products Advocacy Group
All Rights Reserved.