A post from the Environmental Law Institute's "Vibrant Environment" Blog
By Lynn L. Bergeson
The last thing the push for TSCA reform needs is another delay, and Senator Paul's unexpected interest in H.R. 2576 has caused just that. Under typical circumstances, a Member's focused interest in legislation is refreshing, and as today highlights, entirely too infrequent. In this instance, the circuitous road to TSCA reform is anything but typical—the complexity of the legislation has invited an unusual divisiveness that has frustrated passage—and delay is the enemy of the good.
When TSCA reform achieved bipartisan support in 2015, the Miracle on 34th Street quality of it all invited cautious optimism that reform of our ancient chemical management law just may be possible after all. Through 2015 and early 2016, the roller coaster ride the legislation took between the House and Senate was both nerve-wracking and energizing. Members and others "close to the legislation" metered out bits of information, sufficient to telegraph the patient was alive but requiring extreme measure to stay afloat. When the House voted on May 24, 2016, by an overwhelming majority to approve H.R. 2576, there was a palpable buzz in the chemical community and a real sense that this insanely stubborn law was finally going to relent and get its much- needed overhaul.
Seemingly out of nowhere, Senator Paul put a hold on the bill's further consideration. Taking his explanation at face value, wishing to read the legislation is not an unreasonable request. In addition to wanting to read the legislation closely, Senator Paul reportedly is concerned about the enhanced criminalization provisions in the bill that raise fines for TSCA violations and enhance penalties for knowingly putting someone in imminent danger. Both of these changes are consistent with penalties stipulated in other federal environmental laws. Paul’s request to put a hold on TSCA, however, disturbs a fragile balance that is not well-suited to sustain disruption, and plainly breaks the momentum the legislation enjoyed before the Memorial Day recess.
It is imperative that days do not turn into weeks, or worse. We need this law, and we need it yesterday. TSCA has not kept pace with chemical innovation and EPA desperately needs enhanced authorities to manage potential risks from existing chemical substances. The Senate must make this vote a priority when it reconvenes so President Obama can sign it, as we expect he will, and we can start the important work of implementing the law.
On May 24, 2016, the U.S. House of Representatives passed H.R. 2576, the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the long-awaited Toxic Substances Control Act (TSCA) Reform. Senate approval is expected, with the bill being signed into law soon after. The current, and likely final, version of the bill does not contain the sustainable chemistry provision in Section 27 entitled "Development and Evaluation of Test Methods and Sustainable Chemistry" that was in earlier versions of the bill. This provision would have provided funding, research, and support of green chemistry issues through the Office of Science and Technology Policy (OSTP). Renewable chemicals will face the same changes as traditional chemicals, which are covered in detail on Bergeson & Campbell, P.C.'s (B&C®) TSCA Reform News & Information web page.
Chemical Watch is presenting a free webinar on the regulatory changes resulting from TSCA Reform, entitled "'The New TSCA' - What You Need to Know." B&C's Lynn L. Bergeson is participating on the expert panel, along with James V. Aidala, B&C, Charles M. Auer from Charles Auer & Associates LLC, and Richard A. Denison from the Environmental Defense Fund. The webinar will take place on June 13, 2016, at 11:00 a.m. (EDT), 8:00 a.m. (PDT), and 4:00 p.m. (BST)..
As we are poised to witness the reauthorization of the Toxic Substances Control Act (TSCA) -- the first revision of our domestic chemical management law in 40 years -- stakeholders will need immediately to understand what the "new TSCA" means for their industrial operations and strategically adjust their global operations to the new law.
In late 2015, Biobased and Renewable Products Advocacy Group (BRAG®) affiliate Bergeson & Campbell, P.C. (B&C®) convened a summit to examine generally the anticipated changes to TSCA, the process and implementation issues that the U.S. Environmental Protection Agency (EPA) will face once 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. Panelists included former EPA Assistant Administrators Lynn R. Goldman, M.D., M.S., M.P.H., Dean of The George Washington University Milken Institute School of Public Health, and James V. Aidala, B&C Senior Government Affairs Consultant, along with 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, and B&C Managing Partner Lynn L. Bergeson, an internationally-recognized expert on TSCA and its application to industrial, specialty, nanotech, and biobased chemicals.
BRAG is relentlessly tracking developments regarding the ongoing TSCA reform efforts and analyzing how these developments will impact our members' operations, influence their selection of chemicals as raw material feedstocks, and affect their ability to continue to produce and/or use certain "high priority" chemicals most affected by TSCA reform. Stay tuned for complete coverage of what these changes mean to your business, and how you can use them to maximum competitive advantage.
On February 19, 2016, Kathleen M. Roberts, Executive Director of BRAG, presented "Achieving Critical Policy Changes through Consortia" at the 2016 Advanced Bioeconomy Leadership Conference (ABLC2016). Ms. Roberts presented as part of The Bioeconomy R&D Consortia Summit and discussed the work being done by BRAG to level the regulatory playing field for biobased chemicals. BRAG has successfully petitioned the U.S. Environmental Protection Agency (EPA) to make Chemical Data Reporting (CDR) partial reporting exemptions that are already granted to petroleum products available to biodiesel products as well. BRAG is also currently working to resolve the limitations of the Soap and Detergent Association (SDA) nomenclature system for Toxic Substances Control Act (TSCA) Inventory purposes. SDA nomenclature allows for chemical identification by alkyl range rather than source, but is limited to 35 predetermined sources. BRAG petitioned EPA on October 7, 2015, to implement, via rulemaking, a process that would broaden the sources on the SDA nomenclature list. BRAG sought to include such sources as algae and non-traditional plant materials. The petition was denied because, according to EPA, the Agency lacks the authority to initiate rulemaking under TSCA Section 8(b). EPA also claimed that BRAG did not justify the need for regulatory relief, given that the petition lacked a specific example of products experiencing this issue. While BRAG respectfully disagrees with EPA's reasoning, the denial allowed EPA to express its concurrence with BRAG's view that the SDA nomenclature is limited to the predetermined sources, and expressed a willingness to discuss approaches to address the limitation, either through changes to nomenclature guidance, or through rulemaking to establish an exemption under TSCA Section 5(h)(4). If companies wish to ensure that the SDA nomenclature list expands, they should consider joining BRAG and assist with future engagement with EPA.
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
On September 30, 2015, the U.S. Environmental Protection Agency (EPA) held a workshop on genetically engineered (GE) algae to give stakeholders an opportunity to hear about EPA's plans for improving its risk assessments of GE algae under the Toxic Substances Control Act (TSCA). Dr. Jeff Morris, Deputy Director of Programs for the Office of Pollution Prevention and Toxics (OPPT), welcomed participants and laid out the scope of the meeting: to assist EPA in understanding the questions it needs to ask and answer when it receives a Microbial Commercial Activity Notice (MCAN) for GE algae. Dr. Morris discussed how this workshop will contribute to EPA's broader effort to update the Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms document that relates to other GE microorganisms, as well as the update to the federal Coordinated Framework on the Regulation of Products of Biotechnology. While updating the framework will assist EPA in handling risk assessments for GE algae, regulation will continue to be risk-based and determined on a case-by-case basis.
Members of EPA's biotech review team discussed aspects of MCAN review and pointed out particular areas where EPA seeks input, in particular:
- Taxonomy of algae;
- Propensity to transfer genetic material to other species;
- Ability to produce toxins or allergenic effects;
- How the growth rate and forms (unicellular or filamentous) might relate to exposure;
- Survivability of GE algae in the wild; and
- Propensity to out-compete wild populations of algae, and organismal control mechanisms.
The panel, as well as stakeholders, commented on how algae are different than traditional industrial microbes in some significant ways:
- The organisms are not as well studied, largely because, unlike bacteria and fungi, they have only recently been used for industrial production.
- Inactivation methods are quite different because of the protective cell walls that algae have, that most microbes lack.
Dr. Morris also made it clear that this meeting is just the beginning of the conversation. EPA continues to seek input from stakeholders on algae, in particular, and other GE organisms as part of EPA's effort to update the regulatory framework for GE organisms. Draft Charge questions are available on the workshop website, speaker presentations can be accessed through the meeting agenda webpage, and the deadline for written comments is October 31, 2015. More information on EPA's development and use of biotechnology is available in B&C's memorandum EPA Posts Information on Biotechnology Algae Project.
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.
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.