By Kathleen M. Roberts
Is your company engaged in Class 2 chemistries that are similar to existing Class 2 chemicals but are derived from an innovative bio-source? We are looking for pioneering companies working on new biobased Class 2 chemicals to assist in advancing an important project with the U.S. Environmental Protection Agency (EPA).
ISSUE: While EPA sustainability goals would seemingly include adoption of improved biobased technologies, EPA’s policies under the Toxic Substances Control Act (TSCA) mean that many novel, sustainable technologies are considered “new chemicals” requiring EPA to conduct new chemical assessments. If these new chemicals are converted to other substances by downstream customers, those substances are likely also new, requiring additional new chemical submissions and assessments. Each new chemical submission and assessment represents a cost and a commercial delay and each is a barrier to adoption of what may be a promising sustainable technology. These reviews can and do result in EPA applying risk management conditions on the production and distribution in commerce of the novel, renewable chemicals -- restrictions that may not apply to older chemistries even though they may be functionally identical in performance, hazard, and risk. Ironically, the new chemical may offer a more benign environmental footprint but nonetheless be subject to stricter controls.
POTENTIAL SOLUTION: To address these issues, the Biobased and Renewable Products Advocacy Group (BRAG®) has submitted to EPA, in partnership with the Biotechnology Innovation Organization (BIO), a BRAG member, a White Paper proposing a TSCA Inventory representation and equivalency determinations for renewable and sustainable biobased chemicals. EPA’s initial response to the White Paper has been positive and staff has indicated a willingness to conduct equivalency determinations if submitted.
REQUEST: BRAG is now seeking companies interested in participating in a pilot project to prepare and submit such requests. Specifically, we are looking for companies that manufacture or plan to manufacture a Class 2 chemical substance that is functionally equivalent to another Class 2 chemical, but due to existing naming conventions, the two chemicals are not listed as equivalent. If your company fits this description and you wish to support an effort to alleviate commercial burden for yourself and others in the future, please consider working with BRAG on this important project so we present impactful equivalency cases to EPA.
BRAG and Bergeson & Campbell, P.C. (B&C®) are committed to this project. As such, we will evaluate all candidate chemicals submitted, select what we believe is a good test case for the project, and prepare as a courtesy the necessary submission paperwork and equivalency arguments, in conjunction with the nominating company.
By Lynn L. Bergeson
On October 17, 2018, the U.S. Environmental Protection Agency (EPA) issued its final fees rule under the Toxic Substances Control Act (TSCA) in the Federal Register
. 83 Fed. Reg. 52694. The final rule largely tracks the proposed rule. EPA is establishing fees applicable to any person required to submit information to EPA; or a notice, including an exemption or other information, to be reviewed by EPA; or who manufactures (including imports) a chemical substance that is the subject of a risk evaluation. This final rulemaking describes the final TSCA fees and fee categories for fiscal years 2019
, and 2021
, and explains the methodology by which the final TSCA fees were determined. It identifies some factors and considerations for determining fees for subsequent fiscal years; and includes amendments to existing fee regulations governing the review of premanufacture notices, exemption applications and notices, and significant new use notices. As required in TSCA, EPA is also establishing standards for determining which persons qualify as “small business concerns” and thus would be subject to lower fee payments. Small businesses will be eligible to receive a substantial discount of approximately 80 percent on their fees. EPA has been hosting a series of webinars focusing on making TSCA submissions and paying fees under the final rule. The first webinar was held on October 10, 2018, and the second was held on October 24, 2018.
The third webinar will be held on November 7, 2018, from 1:00 p.m. to 2:30 p.m. (EST)
. The final rule became effective on October 18, 2018. For an overview of the rule, see Bergeson & Campbell, P.C.’s regulatory developments update
By Lynn L. Bergeson
On October 16, 2018, the Office of Information and Regulatory Affairs released the Trump Administration’s Fall 2018 Unified Agenda of Regulatory and Deregulatory Actions (Agenda). The Agenda aims to report on actions that administrative agencies, such as EPA, plan to put forward in the near- and long-terms. As its name implies, the Agenda includes both regulatory and deregulatory actions and attempts to justify any burden associated with these actions. According to its announcement, it should reflect four broad regulatory reform priorities: advancing regulatory reform, public notice of regulatory development, transparency, and consistent practice across the Federal Government.
Included in the Agenda are the Administration’s estimated timelines for the rulemakings on year-round sales of 15 percent ethanol (E15) sales and the Renewable Fuel Standard (RFS) resetting renewable volume obligations (RVO). It is expected that EPA will release a proposed rule on permitting E15 sales year-round in February 2019, with a final rulemaking expected in May 2019. While the final rulemaking on RFS Biomass-Based Diesel (BBD) volume is expected to be announced in November 2018, the rulemaking on the RFS modification of applicable volumes is predicted to be announced in 2019. According to the Agenda, the proposed rule will be announced in January 2019 and the final rule should follow in December 2019.
By Lynn L. Bergeson
On September 27, 2018, the U.S. Environmental Protection Agency (EPA) announced the user fees final rule for the administration of the Toxic Substances Control Act (TSCA), the fourth and remaining framework rule to be issued in final under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg).
This final rule, that amends 40 C.F.R. Parts 700, 720, 723, 725, 790, and 791, “describes the final TSCA fees and fee categories for fiscal years 2019, 2020, and 2021”; “explains the methodology by which the final TSCA fees were determined”; “identifies some factors and considerations for determining fees for subsequent fiscal years”; and “includes amendments to existing fee regulations governing the review of premanufacture notices, exemption applications and notices, and significant new use notices.” The final rule has not been published yet in the Federal Register so an effective date is not yet available; a pre-publication version is available here.
Specifically, EPA is establishing fees applicable to any person required to submit information to EPA under TSCA Section 4; or a notice, including an exemption or other information, to be reviewed by EPA under TSCA Section 5; or who manufactures (including imports) a chemical substance that is the subject of a risk evaluation under TSCA Section 6(b). EPA is also establishing standards for determining which persons qualify as "small business concerns" and thus would be subject to lower fee payments.
In the press release announcing the rule, EPA Acting Administrator Andrew Wheeler states that this rule will “provide resources needed to support the valuable work EPA does to review chemicals for safety, manage risk as required, and make chemical information available as appropriate.” During fiscal years 2019-2021, EPA states it will “work to track costs and will use that information to adjust future fees, if appropriate.”
EPA also announced that it will be hosting a series of webinars focusing on making TSCA submissions and paying fees under the final rule. The first webinar was held on October 10, 2018. Two other webinars are scheduled for October 24, 2018, from 1:00 p.m. - 2:30 p.m. (EDT); and November 7, 2018, from 1:00 p.m. - 2:30 p.m. (EST).
More information on TSCA implementation is available on our website under key phrase Lautenberg Implementation. More information on the TSCA user fees final rule is available in Bergeson & Campbell, P.C.’s (B&C®) detailed memorandum, “EPA Issues Final TSCA Fees Rule.”
Borrowing from William Shakespeare … WHAT’S IN A NAME? That which we call a biobased chemical. By any other name would stand as sustainable. And yet, it is the mere name of the biobased chemical that hinders its ability to go to market!
Did you know that the Toxic Substances Control Act (TSCA) is interpreted and applied in ways that often cause new biobased chemicals and their derivatives to be subject to stringent premarket review by EPA? This review often results in the application of restrictions that are not applicable to older chemical substances already in commerce. This lack of consistency results in regulatory and commercial challenges for new biobased chemical products that hamper commercialization pathways and invite considerable delays to market entry. This oddity of the current EPA naming system results in newer biobased technologies that offer the same, if not greater, benefits than existing chemicals now being commercialized. Any company or organization intending to market biobased products -- whether they come from plants, algae, or industrial waste -- should be aware of this situation and join the effort to create a more sensible regulatory approach.
As a company focused on creating chemistry for a sustainable future, we invite your organization to join BRAG as a member in 2019. BRAG is a group of international and well respected member organizations and companies engaged in the development of biobased or renewable chemical products. BRAG members recognize the importance of advocacy, education, and communication.
BRAG is helping its members understand and comply with the application of TSCA to their products and operations, educating regulatory officials on biobased chemical production and the application of TSCA to these products, and developing strong and compelling advocacy platforms to ensure the robust commercialization and growth of biobased and renewable chemical feedstocks. No other biobased chemical industry consortium focuses on TSCA in this way or on biobased chemical commercialization and associated regulatory inequities. Because BRAG is managed by B&C® Consortia Management, L.L.C. (BCCM), a group that has regulatory compliance advisors, legal counsel, and science policy experts available for consultation and strategy development, we have the legal, technical, and management capacity to identify, develop, and implement successfully strategic plans to modify current EPA approaches or policies.
BRAG is expanding its membership to include more companies that have already been or may be adversely impacted by EPA’s current policies. As the leader in TSCA compliance issues, BRAG provides strength in numbers, which allows for more efficient engagement with EPA on these critical issues for less cost.
By Lynn L. Bergeson
On September 11, 2018, Bloomberg Environment Insights
published a three-part article series, written by Bergeson & Campbell, P.C. (B&C®
), on the impact of the new Toxic Substances Control Act (TSCA) Section 5 and its implementation. Despite the U.S. Environmental Protection Agency’s (EPA) overall timely and balanced efforts in the implementation of TSCA, EPA’s approach to TSCA Section 5 implementation has proved itself less successful. With emphasis on how EPA’s approach to Section 5 has impeded the commercialization of sustainable chemical technologies, this three-part series delves into the various challenges presented by TSCA on the biobased and biotechnology markets. The obstacles discussed in the articles, ironically, often extend the market presence of less sustainable chemicals rather than allowing for the expansion of more sustainable technologies. The three articles can be accessed here: Part 1
, Part 2
, and Part 3
On June 18, 2018, Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®), presented “New TSCA and Green Chemistry Innovation” at the American Chemical Society’s (ACS) Green Chemistry & Engineering Conference in Portland, Oregon. This presentation covered specific changes to the Toxic Substances Control Act (TSCA) and the impact of those changes for new chemicals, including innovative “green” chemicals. In line with the conference theme, “product innovation using greener chemistries,” Dr. Engler outlined key steps to take when preparing to submit a new chemical for review, including the following items that a robust Premanufacture Notice (PMN) should include:
- Detailed descriptions of all potential releases and exposures throughout the supply chain, including container and equipment cleaning activities
- Identities of analogs that have measured data
- All data on physical-chemical properties
By Lynn L. Bergeson
On June 18, 2018, Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®), will present “New TSCA and Green Chemistry Innovation” at the 22nd Annual Green Chemistry & Engineering Conference (GC&E), hosted by the American Chemical Society’s (ACS) Green Chemistry Institute®. GC&E will highlight product innovation using greener chemistries and provide an opportunity for a diverse group of academic, industrial, and government stakeholders to network and learn about the newest ideas in sustainable approaches to chemistry, chemicals, processes, and products. The conference will be held in Portland, Oregon, from June 18 - 20, 2018, and online registration is now open. B&C is a proud sponsor.
By Lauren M. Graham, Ph.D.
Industrial Biotechnology recently published a special issue to highlight the advances and challenges in algae-based products and applications. The article, written by B&C® Consortia Management, L.L.C. (BCCM) affiliate Bergeson & Campbell, P.C. (B&C®) Managing Partner, Lynn L. Bergeson; B&C Senior Chemist, Richard E. Engler, Ph.D.; and BCCM Manager, Lauren M. Graham, Ph.D., examines the complex regulatory domain and discusses the significance and implications of the Toxic Substances Control Act (TSCA) for industrialized microorganisms, such as algae. The article titled “TSCA Affects on Algae, Other Novel Biosources, and Bioprocesses” provides an overview of the fundamentals of TSCA, the U.S. Environmental Protection Agency’s (EPA) review of new substances, the impact that chemical identity has on EPA’s regulation of new substances, and available reporting exemptions. In the article, the authors highlight the need for chemical product innovators “to understand how TSCA, significantly amended in 2016, applies to biomass starting material, including industrial microorganisms (such as algae); intermediates; and commercial products, and build TSCA compliance into business timelines and budgets.” While the products of industrial microbes have the potential to reduce toxicity, greenhouse gas (GHG) emissions, and dependence on non-renewable resources, companies must comply with TSCA and the Federal Food, Drug, and Cosmetic Act (FFDCA) to ensure that such products successfully enter the market.