Biobased Products News and Policy Report
March 19, 2020
EPA Will Amend CDR Rule And Extend 2020 Submission Period
On March 17, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a final rule amending the Chemical Data Reporting (CDR) rule. According to EPA, the amendments are intended to reduce the burden for certain CDR reporters, improve the quality of CDR data collected, and align reporting requirements with the Frank R. Lautenberg Chemical Safety for the 21st Century Act’s (Lautenberg Act) amendments to the Toxic Substances Control Act (TSCA). EPA states that some of the key revisions include:
- Simplifying reporting,
including allowing manufacturers to use certain processing and use data
codes already in use by many chemical manufacturers as part of
international codes developed through the Organization for Economic
Cooperation and Development (OECD);
- Updating requirements for
making confidentiality claims to align with the requirements in amended
- Adding reporting exemptions for
specific types of byproducts manufactured in certain equipment.
Additionally, EPA is extending the reporting period for CDR data submitters from September 30, 2020, to November 30, 2020, to provide additional time for the regulated community to familiarize themselves with the amendments and to allow time for reporters to familiarize themselves with an updated public version of the reporting tool. The reporting period will still begin on June 1, 2020. EPA will host a webinar on Tuesday, March 31, 2020, to discuss the revised reporting requirements, provide an overview of the 2020 CDR submission period, and to give an introduction to the updated e-CDR web reporting tool. EPA has posted pre-publication versions of the final rules amending the CDR rule and extending the reporting period. More information will be available in a forthcoming memorandum that will be posted on our website.
EPA Announces Latest Update To TSCA Inventory
The U.S. Environmental Protection Agency (EPA) announced on March 11, 2020, the availability of the latest Toxic Substances Control Act (TSCA) Inventory. EPA states that this biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. According to EPA, this update adds 81 new chemicals, and the Inventory as a whole now contains 86,405 chemicals, of which 41,484 are active in U.S commerce. Other updates to the TSCA Inventory include:
- Updates to commercial activity
data, or active/inactive status;
- Updated regulatory flags, such
as consent orders and significant new use rules (SNUR); and
- Additional unique identifiers.
EPA notes that the TSCA inventory is a list of all existing chemical substances manufactured, processed, or imported in the United States that do not qualify for an exemption or exclusion under TSCA. More information on the TSCA Inventory is available on EPA’s website.
EPA Announces SNPRM On Strengthening Transparency In Regulatory Science
On March 18, 2020, EPA published its supplemental notice of proposed rulemaking (SNPRM) titled “Strengthening Transparency in Regulatory Science” in the Federal Register. Per last week’s Bergeson & Campbell, P.C. (B&C®) blog post, the supplemental notice proposes the following changes to the 2018 proposed rulemaking:
- A scope that applies to
influential scientific information and significant regulatory decisions;
- A modified approach to the
availability provisions for data and models that would underlie
influential scientific information and significant regulatory decisions as
well as an alternate approach;
- Clarification on the ability of
the EPA Administrator to grant exemptions; and
- Definitions and clarifications
that the proposed rule applies to data and models underlying both pivotal
science and pivotal regulatory science.
EPA is seeking comment on each of the proposed changes by April 17, 2020. In particular, EPA is asking for feedback on whether this approach may improve consistency between this proposed rulemaking and certain provisions of those statutes that refer to standards for data availability. Interested parties may also wish to review B&C’s March 9, 2020, memorandum on the SNPRM.
DOE Cancels Biomass R&D Technical Advisory Committee Meeting
On March 16, 2020, the U.S. Department of Energy (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced the cancellation of the March 24 and March 25, 2020, Biomass Research and Development (R&D) Technical Advisory Committee.
DOE Releases FOA For Plastics Recycling R&D
On March 16, 2020, DOE EERE’s Advanced Manufacturing Office and Bioenergy Technologies Office used a joint funding opportunity announcement (FOA) of up to $25 million for plastics recycling R&D. As part of the Department’s Plastics Innovation Challenge, this FOA has been titled “BOTTLE: Bio-Optimized Technologies to Keep Thermoplastics Out of Landfills and the Environment.” The BOTTLE FOA will support the development of new plastics capable of efficient recyclability and improvement of recycling strategies that can break existing plastics into chemical building blocks that can be used in other products.
Also as part of the Plastics Innovation Challenge, DOE has launched a new BOTTLE Consortium, which will be led by three of DOE’s national laboratories. The Consortium will work with stakeholders in industry and academia to focus on BOTTLE’s core mission. The three national laboratories in the Consortium currently are the National Renewable Energy Laboratory, Oak Ridge National Laboratory, and Los Alamos National Laboratory.
This BOTTLE FOA includes three topic areas:
- Highly recyclable or
- Novel methods for
deconstructing and upcycling existing plastics; and
- BOTTLE Consortium
collaborations to tackle challenges in plastic waste.
Concept papers for the BOTTLE FOA are due on April 22, 2020, and full applications are due on June 18, 2020. Information on how to submit concept papers and applications can be found here.
EPA Releases Final Rule On Procedures For Review Of CBI Claims For The Identity Of Chemicals On The TSCA Inventory
On March 6, 2020, EPA published its final rule on procedures for review of confidential business information (CBI) claims made under TSCA. 85 Fed. Reg. 13062. The final rule includes the requirements for regulated entities to substantiate certain CBI claims made under TSCA to protect the specific chemical identities of chemical substances on the confidential portion of the TSCA Inventory, and EPA’s plan for reviewing certain CBI claims for specific chemical identities. EPA sets out the review criteria and related procedures that it will use to complete the reviews within the five-year time frame set in TSCA. The substantiation requirements describe the applicable procedures and provide instructions for regulated entities. The final rule is effective on May 5, 2020. For more information, please read the full B&C memorandum.
The Product Stewardship Society Is Accepting Board Nominations
The Product Stewardship Society is now accepting nominations for officials from member companies to serve on its Board of Directors. The Board establishes the organization’s strategic direction and goals, and monitors progress toward reaching those goals. Nominees must be members in good standing; self-nominations are allowed.
“Our Board members are leaders in a diverse range of business sectors. We are looking for leaders who have a passion for the Society and who wish to work with like-minded professionals to grow the profession and make a difference,” stated Lynn Bergeson, President of the Product Stewardship Society.
Deadline for the nominations is April 15, 2020. More information is available in the full press release.
Adapting And Evolving: B&C, Acta, and BCCM Services Available Worldwide Without Interruption
Bergeson & Campbell, P.C. (B&C®), The Acta Group (Acta®), and B&C® Consortia Management, L.L.C. (BCCM) extend our best wishes and heartfelt hope that all our clients, friends, and their families are safe and well. We write to assure you that as we all adapt and evolve to accommodate the new normal, we are functioning as usual. You may not know this, but we have operated for more than two decades with full remote-work capability for all professionals worldwide. Institutionally, our business model from the start was designed to provide the flexibility needed to attract the best professionals in the business and retain their services regardless of their locations. While the current global developments are challenging, delivering outstanding and attentive “service as usual” to our clients is not.
Our attorneys, scientists, and regulatory and business consultants are available and working at full-service levels without interruption or delay. Regulatory activity is unabated, and innovators in the industrial and agricultural chemical community will play a substantial and possibly game-changing role in the worldwide campaign to confront, contain, and mitigate collateral effects of COVID-19. No family of firms is better suited to provide nimble, savvy, and effective global regulatory strategy for product approvals, product defense, and associated business issues than B&C, Acta, and BCCM.
Current priorities for chemical companies include those detailed in recent firm memoranda:
- EPA Plans to Provide Additional Clarification on
Self-Identifying as a Manufacturer or Importer of a High-Priority Chemical
- The Essential Value of Forming TSCA Consortia to
Address High-Priority Risk Evaluations
- FIFRA Stakeholders: How to Respond to an Enforcement
Action or Inquiry
- EPA Releases Final Rule on Procedures for Review of
CBI Claims for the Identity of Chemicals on the TSCA Inventory
Visit our website, https://www.lawbc.com/regulatory-developments, for a library of all B&C regulatory memoranda.
Clients and interested stakeholders receive commentary and analysis of regulatory developments via our newsletters and blogs. Make sure you subscribe to all that pertain to your business by visiting our website, www.lawbc.com, and following links at the bottom.
The “All Things Chemical™” podcast continues to broadcast as usual, with new episodes on current hot topics every other Thursday. Visit https://www.lawbc.com/podcasts to listen, or search “All Things Chemical” on your favorite podcast platform.
When travel is restricted, online webinar and training resources allow regulatory professionals to stay current and proactive. B&C’s TSCA Tutor™ online, on-demand regulatory training platform offers expert, efficient, essential training that can be completed at each learner’s own pace and timing. Visit www.TSCAtutor.com to view preview segments of all 12 courses and to enroll. More information is available at https://www.lawbc.com/knowledge-resources/training/tsca-courses/.
Upcoming webinars include:
- Law, Climate Change, and Agriculture: Legal Tools in the Arsenal, April 22, 2020, 12:00 pm (EDT), via webinar
Register for the International Bar Association (IBA) webinar “Law, Climate Change, and Agriculture: Legal Tools in the Arsenal,” covering the role of innovative agriculture practices in combating climate change and highlighting the legal, policy, and institutional changes that will encourage innovation. Lynn L. Bergeson, Managing Partner, B&C, is Vice Chair of the Agricultural Law Section of IBA.
- Navigating the Jurisdictional Tightrope between Biopesticides, Biostimulants, and Related Emerging Technologies, April 29, 2020, 12:00 pm (EDT), via webinar
Register for the American Bar Association (ABA) webinar “Navigating the Jurisdictional Tightrope Between Biopesticides, Biostimulants, and Related Emerging Technologies” with B&C professionals deconstructing the jurisdictional boundaries distinguishing pesticides, biopesticides, plant regulators, biostimulants, and related technologies. The webinar will focus on draft EPA guidance intended to clarify the lines between and among those products that are subject to FIFRA registration as plant regulators and those biostimulant products not subject to FIFRA registration. The webinar also will focus on new and evolving chemistry and technology issues that may blur some jurisdictional lines or potentially move products from one category to another. Lynn L. Bergeson, Managing Partner, B&C; Lisa R. Burchi, Of Counsel, B&C; and Sheryl Lindros Dolan, Senior Regulatory Consultant, B&C, will present.
We hope our business services are helpful as clients navigate a new normal.
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