On August 2, 2016, Lynn L. Bergeson, Managing Partner of B&C, presented the webinar "New TSCA's Impact on Biotechnology," with the National Academies of Sciences, Engineering, and Medicine (NAS). This webinar, available for free on the NAS website, includes an overview of TSCA updates resulting from the passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Ms. Bergeson focused specifically on how these updates could impact the regulation of biotechnology, especially under Sections 3, 4, 5, and 26. Changes include: how EPA defines "conditions of use" and "potentially exposed or susceptible subpopulations," and applies them to intergeneric microorganisms; an expansion of EPA's authority to compel testing; and a requirement for EPA to provide an affirmative determination when reviewing Section 5 notifications.
On July 15, 2016, Environmental Leader published "What Does the Loss of 'Green Chemistry' Provision from Amended TSCA Mean for Biochemicals?," featuring comments by Lynn L. Bergeson, Managing Partner of Biobased and Renewable Products Advocacy Group (BRAG®) affiliate Bergeson & Campbell, P.C. (B&C®). Ms. Bergeson expanded on a previous blog post titled "Inside EPA Reports On Loss Of Green Chemistry Provision From TSCA Reform," stating:
"While regrettable, the absence of the green chemistry provisions in the amended Toxic Substances Control Act (TSCA) is a setback, not a deal breaker," Bergeson told Environmental Leader. "The green chemistry provisions in Section 24 of H.R. 2576 were taken from Senator Chris Coons' (D-DE) Sustainable Chemistry Research and Development Act. Section 24 was eliminated reportedly because its inclusion would have been subject to review by the House Science, Space, and Technology Committee, a different House Committee from the House Energy and Commerce Committee that had primary jurisdiction over TSCA reform, potentially complicating and delaying an already complicated and time-sensitive Congressional review process. The decision to forego this review and eliminate the green chemistry provisions is disappointing, but a failed TSCA reform effort would have been more so."
Bergeson notes that the provision's absence in the updated chemical safety law eliminates -- for now -- the development of and funding for a green chemistry strategy at the federal level. Senator Coons is expected to introduce a similar bill next year.
Senators Coons, Susan Collins (R-ME), and Ed Markey (D-MA) have asked the U.S. Government Accountability Office (GAO) for a technology review of sustainable chemistry. "The report, expected to be complete in the spring of 2017, can help illuminate the options available to the federal government to promote green chemistry whether by instigating new legislation or by serving as a resource which existing legal authorities can use to support this field that is so vital to economic competitiveness and/or use to diminish the less positive impacts of chemistry throughout our economy," Bergeson stated.
On July 1, 2016, Inside EPA published "Committee Jurisdiction Issues Blocked Green Chemistry From TSCA Reform," an article discussing the passage of the Toxic Substances Control Act (TSCA) law and the lack of language from previous versions boosting federal support of green chemistry. The majority of the bill was reviewed by the House Energy and Commerce Committee, but the green chemistry provision would have needed to be reviewed by the House Science, Space, and Technology Committee, further complicating the fragile House and Senate negotiations. Inside EPA's source stated: "Nobody wanted to step on anybody's toes. [...] Pretty much everything else [was] in [Energy and Commerce's] jurisdiction or was sufficiently small enough [to not raise concerns.] There were a lot of concessions on all sides." The green chemistry provision was originally added to the Senate version of the TSCA Reform, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697), by Senator Chris Coons (D-DE), and was primarily focused on funding the research and development of green chemistry.
The green chemistry provision of S. 697 called for a study of how to best incentivize sustainable chemistry research and development, as well as support "economic, legal and other appropriate social science research to identify barriers to commercialization and methods to advance commercialization of sustainable chemistry." The bill also created a working group to coordinate federal sustainable chemistry activities that would be lead by EPA's research chief and the National Science Foundation (NSF) director, as well as an advisory council to coordinate with the working group. Although green chemistry language in S. 697 did not remain in the final version of the bill, there are still supporters in Congress who are prepared to work to get the programs outlined in S. 697 into law.
On June 22, 2016, President Obama signed H.R. 2576, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) during a signing ceremony. Lautenberg represents years of negotiation and is a towering achievement to enhance the U.S. Environmental Protection Agency's (EPA) authority to review industrial and consumer chemicals and provide the public with confidence that chemical products do not pose unreasonable risks.
Of particular interest to biobased chemical manufacturers and users, Lautenberg requires that EPA maintain the use of Class 2 nomenclature and the Soap and Detergent Association Nomenclature System. In addition, if a manufacturer or processor demonstrates that a "substance appears multiple times on the [Inventory] under different [Chemical Abstracts Service] numbers, [EPA] may recognize the multiple listings as a single chemical substance." While it is not yet clear how the nomenclature provisions of Lautenberg will affect the ability of novel biobased chemicals to be incorporated into supply chains without triggering new chemical notification, it does raise the profile of Class 2 nomenclature and may enable additional high-level discussions related to source-based nomenclature and the barriers that such nomenclature present to new chemicals.
On June 7, 2016, the U.S. Senate unanimously approved the Frank R. Lautenberg Chemical Safety for the 21st Century Act (H.R. 2576), after Senator Rand Paul (R-KY) dropped the hold placed on the bill. The U.S. House of Representatives passed the bill on May 24, 2016, with a 403-12 roll call vote. Toxic Substances Control Act (TSCA) Reform is now only waiting for President Obama's signature, which is expected soon, based on the White House's endorsement of the bill in May. Bergeson & Campbell, P.C. (B&C®) has collaborated with Chemical Watch to assemble TSCA experts to present a series of complimentary webinars titled "'The New TSCA' -- What You Need To Know." The speakers will include:
- 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), U.S. Environmental Protection Agency (EPA); and
- James V. Aidala, Senior Government Affairs Consultant, B&C, former EPA Assistant Administrator for Toxics.
The first webinar of the series, "Overview and Summary of Major Changes: What to Expect and When to Expect it," is taking place on June 13, 2016, at 8:00 a.m. PDT /11:00 a.m. EDT /4:00 p.m. BST.
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.