On February 18, 2016, Richard E. Engler, Ph.D., Senior Chemist at Bergeson & Campbell, P.C. (B&C®), presented at Cellulosic Fuels: First Commercials and Beyond, a session at the ABLC2016. Dr. Engler's presentation, "TSCA and the Cellulosic Revolution," covered Toxic Substances Control Act (TSCA) nomenclature, chemical Inventory, and model manufacturing process issues for cellulosic products. The presentation discussed the differences in nomenclature between Class I and Class II substances on the TSCA Inventory, and what regulatory responsibilities are triggered by different uses of substances. While cellulose is a naturally occurring substance, it is only automatically included on the Inventory if it is unprocessed or if it is processed using only a few narrowly defined methods that specifically exclude chemical modifications. This definition results in chemical notification requirements that may not be anticipated by companies unfamiliar with TSCA. Dr. Engler fielded several questions from session attendees during the Q&A period. In response to a question regarding whether biobased fuel and chemicals produced in Europe, China, or Brazil would face regulatory requirements similar to TSCA, Dr. Engler confirmed that many substances would be regulated by the European Union's (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, by Decrees Number 7 and Number 591 in China, and by similar but less well-defined programs in Brazil. He also stated that B&C affiliate The Acta Group (Acta®) offers expert guidance for companies doing business in Europe, Asia, and South America. Dr. Engler was also asked if a mixture made of substances, all of which can be found on the TSCA Inventory, would be subject to a new listing on the Inventory. He responded that a mixture of TSCA-listed substances would not be subject to additional reporting requirements, but that many biobased substances are of more variable composition, and would be considered unknown or variable composition, complex reaction products and biological materials (UVCB). He advised companies to get expert help in identifying the correct identity of their products and processes.
There is still no definitive answer as to whether the green/sustainable chemistry provisions in S. 697, the Frank R. Lautenberg Chemical Safety for the 21st Century Act, will survive the U.S. Senate and House of Representatives conference committee process as lawmakers confer and prepare the final compromise legislation of the Toxic Substances Control Act (TSCA) reform bill. Passed by the Senate on December 17, 2015, S.697 includes sustainable chemistry provisions in Section 27 entitled “Development and Evaluation of Test Methods and Sustainable Chemistry.” The TSCA Modernization Act of 2015 (H.R. 2576), which passed the House of Representatives on June 23, 2015, has no sustainable or green chemistry provisions and takes a much narrower view on TSCA reform. The sustainable chemistry section in S. 697 has been substantially amended from the approach outlined in the previous version of S. 697 passed by the Senate Environment and Public Works Committee in June 2015. These sustainable provisions were initially introduced in May 2015 in a green chemistry bill, S. 1446, by Senator Chris Coons (D-DE) and Senator Susan Collins (R-ME). S. 697 does not include all of the provisions from S. 1446, such as a grant program to fund sustainable chemistry partnerships between industry and universities, and a National Academy of Sciences study, but does include funding, research, and support of green chemistry issues. The sustainable chemistry provisions in S. 697 are as follows:
- The Office of Science and Technology Policy (OSTP) is to convene a National Coordinating Entity (Entity) for Sustainable Chemistry made up of various federal entities and chaired by the Director of the National Science Foundation (NSF) and the U.S. Environmental Protection Agency (EPA) Assistant Administrator for the Office of Research and Development (ORD). The Entity has several duties, including:
- Those related to establishing the Sustainable Chemistry Initiative (described in detail in Section 27(d));
- Development of a national strategy for sustainable chemistry;
- Supporting establishment, through financial, technical, and other assistance, of partnerships between academia, non-governmental organizations, and companies to advance research, training, development of curricular materials and courses, etc.;
- Reporting to Congress two years after enactment of S. 697 on the Entity’s efforts and progress; and
- Submitting an implementation plan for sustainable chemistry to Congress three years after enactment.
Inside EPA has reported that Senator Coons is speaking with key members to allow the provisions to stay in through the compromise conferences. Inside EPA also reported that Senator Coons held a January 13, 2016, Capitol Hill briefing to garner support for the provisions, and that speakers at the briefing outlined the following green chemistry goals:
- To change the way chemists are taught to think about chemistry choices, to include an understanding of toxicology and environmental sciences, so that sustainability considerations inform all chemistry decisions;
- To develop novel chemical products and processes that are less hazardous than, and cost and performance competitive with, traditional technologies;
- To develop a deeper understanding of toxicological properties and mechanisms to inform chemistry decisions and design; and
- To recognize the fundamental limitations related to material selection and move to renewable or abundant resources as starting materials.
More information on S. 697 and how it compares with the previous version of the bill as well as with H.R. 2576 are available in Bergeson & Campbell, P.C.’s (B&C®) memorandum TSCA Reform: Detailed Summary of Key Changes in Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697) as Compared with S. 697 Passed by Senate EPW in June. Please also see B&C’s 2016 Forecast memorandum Predictions and Outlook for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) 2016 for further analysis and discussion of likely legislative next steps regarding TSCA reform.
REGISTER TO ATTEND THE "TSCA REFORM PANEL SUMMIT," OR TO VIEW THE LIVE WEBCAST, AT THE ELI WEBSITE.
George Washington University (GWU) Milken Institute School of Public Health, GWU Law School, Environmental Law Institute, Arnold & Porter LLP, and Bergeson & Campbell, P.C. Present: TSCA Reform Panel Summit: What's Happening Now, and What's Next?
Thursday, November 19, 2015, 12:00 – 1:30 p.m. (EST)
George Washington University Milken Institute School of Public Health Main Auditorium, 950 New Hampshire Avenue, N.W. Washington, D.C. 20052. A light lunch will be served, beginning at 11:30 a.m.
With prospects for the Senate and House versions of TSCA reform legislation the subject of considerable speculation and conjecture, join us this Thursday, November 19, 2015, for a wide-ranging panel discussion titled “TSCA Reform: What’s Happening Now, and What’s Next” featuring the inside view from two former EPA Assistant Administrators, George Washington University Milken Institute School of Public Health Dean Lynn R. Goldman, M.D., M.S., M.P.H. and Bergeson & Campbell, P.C. Senior Government Affairs Consultant James V. Aidala; and Arnold & Porter LLP partner Lawrence E. Culleen, whose former EPA roles include Chief of the New Chemicals Branch, managing the premanufacture notice program under TSCA.
No subject will be off-limits as these EPA alumni discuss the legislative prospects of the competing bills, the process and administrative issues that will face EPA the day after a revised law is passed, and the equally interesting prospect of what the industrial chemical community will face if this once-in-a-generation chance at TSCA reform is lost. The 75-minute panel discussion will be moderated by Lynn L. Bergeson, with a 15-minute question and answer period for audience members in the room and viewing the webcast at the conclusion. Register to attend the "TSCA Reform Panel Summit," or to view the LIVE Webcast, at the ELI website. ELI membership is not required.
TSCA Reform Summit Information Flyer
Wondering where we are now and what may happen to the Toxic Substances Control Act (TSCA) reform when Congress is back in session? "TSCA Reform: The Current State of Play," featuring Lynn L. Bergeson and hosted by Compliance & Risks, will bring you up to date on the very latest developments in the Congress and key regulatory developments and initiatives should TSCA reform fail to materialize. If Congress is unable to enact new TSCA measures, many question whether the law will be revised before the Presidential elections in 2016, which means TSCA reform would not occur until 2017 or later. This would put renewed pressure on the U.S. Environmental Protection Agency (EPA) to deploy its current authority in new and even more innovative ways. Free registration is available online.
Competing proposals are working their way through the House and Senate to amend the Toxic Substances Control Act (TSCA), the nation's primary law for managing chemicals in commerce, including biobased and renewable chemicals. In an article published in the July 23, 2015, Bloomberg BNA Daily Environment Report, former senior U.S. Environmental Protection Agency (EPA) officials Charles Auer and James V. Aidala, and attorney Lynn L. Bergeson, Of Counsel to the Biobased and Renewable Products Advocacy Group (BRAG®), discuss making the bill clearer and how Congressional direction can be provided on what EPA is to do with certain new provisions to implement them in the first years of any amended TSCA. "TSCA Reform Legislation and Its Workability: Thoughts on Steps to Help Ensure Successful Implementation at the Outset and Over Time," is available on BRAG affiliate Bergeson & Campbell, P.C.'s (B&C®) website.
Ms. Bergeson will participate in TSCA Reform: The Current State of Play, a webinar hosted by Compliance & Risks on September 24, 2015, at 11:00 a.m. (EDT). This webinar will bring registrants up to date on the very latest developments in Congress, and key regulatory developments and initiatives should TSCA reform fail to materialize.
Unfortunately, the Senate will not be taking up the TSCA reform issue until after the August recess. Supporters of TSCA reform remain optimistic, but the delay is not welcome news. More information on TSCA reform is available on the TSCA Reform News and Information website, published by B&C, a one-stop source for news, commentary, and useful links. Bookmark it!
The full presentation is available upon request.
The July 20, 2015, Federal Register includes a notice for direct final action to amend the electronic reporting regulations for Section 5 under the Toxic Substances Control Act (TSCA). The U.S. Environmental Protection Agency (EPA) action goes into effect on January 19, 2016, unless adverse comments are received by August 19, 2015. The rule requires the use of new electronic premanufacture notice (e-PMN) software that is reportedly easier to use. The rule also adds the requirement that "bona fide intents to manufacture" submissions be made electronically, and changes the procedure for notifying EPA of any new manufacturing site of a chemical substance for which an exemption was granted by EPA. This action is intended to further streamline and reduce the administrative costs and burdens of TSCA Section 5 notifications for both industry and EPA.
On June 2 and 3, 2015, the House Committee on Energy and Commerce held a markup hearing for the TSCA Modernization Act of 2015 (H.R. 2576) after years of progress on Toxic Substances Control Act (TSCA) Reform. The bill was praised for its bipartisan support as well as the removal of burdensome testing that has hindered the implementation of TSCA. The modernized TSCA will change how EPA regulates existing chemicals, with EPA first deciding if a chemical poses an unreasonable risk under its conditions of use, and then deciding how to manage the risk. A technical amendment was added to the Act and the Committee passed the amended bill. Committee Chair Fred Upton (R-MI) expects the bill to be on the House floor by the end of June 2015. Bergeson & Campbell, P.C. has published a memorandum on the hearing and a memorandum providing a detailed analysis of the slightly revised version of the bill on its website.
Part 3 of Biofuels Digest's "Thought Leadership" series highlighting some of the ways the Toxic Substances Control Act (TSCA) applies to biobased products was published May 18, 2015. Summaries of the first two "TSCA and the Bioeconomy" articles, written by Biobased and Renewable Products Advocacy Group (BRAG®) Senior Policy Advisor and former head of the U.S. Environmental Protection Agency's (EPA) Green Chemistry program, Richard E. Engler, Ph.D., were summarized in the May 7, 2015, BRAG report.
"The Toxic Substances Control Act and the Bioeconomy: Part 3, Call to Action," presents options for reforming TSCA and the related implementing regulations to put novel, biobased chemistry on an even footing with incumbent products and processes that were grandfathered under the original TSCA Inventory. Among the suggestions and options offered is the expansion of the Soap and Detergent Association (SDA) nomenclature system to cover more sources related to biobased products:
Opening the 40-year-old list of organisms eligible to use SDA nomenclature would go a long way towards enabling novel triglyceride sources to enter commerce without triggering new chemical substance notifications throughout the supply chain. Right now, EPA has no mechanism for adding sources without conducting a full rulemaking. A mechanism that enables EPA to add sources to the SDA list as part of the premanufacture notice (PMN) review of a new source would maintain EPA's ability to ensure new sources do not present unreasonable risk to human health and the environment, as well as lower the barrier to market adoption of these new sources.
The article closes with a call for the regulated community, both producers and their customers to:
[E]ngage with EPA to seek broad solutions, as a group, rather than individual companies seeking individual solutions. These solutions may require rulemaking and a collective approach could bring the issue to a high enough priority to justify the effort and expense for EPA to undertake rulemaking.
On May 8, 2015, the U.S. Environmental Protection Agency (EPA) issued a direct final rule for 25 chemical substances that were the subject of premanufacture notices (PMN), including several biobased chemical substances. The rulemaking under Section 5, known as a significant new use rule or SNUR, requires persons who intend to manufacture (including import) or process any of these 25 chemical substances for an activity that is designated in the SNUR as a significant new use to notify EPA at least 90 days before commencing that activity. The required notification provides EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. The rule will be effective July 7, 2015.
Bergeson & Campbell, P.C. (B&C®) has posted an analysis of the restrictions and testing included in the SNURs for the biobased chemicals.