Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C., law firm providing biobased and renewable chemical product stakeholders unparalleled experience, judgment, and excellence in bringing innovative products to market.
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By   Lynn L. Bergeson 

On January 12, 2021, EPA and the Occupational Safety and Health Administration (OSHA) announced a memorandum of understanding (MOU) that advances collaboration and communication on EPA’s review of new chemicals under TSCA. EPA states that the MOU provides a framework for coordination and communication between the two agencies on exposure to new chemicals in the workplace and will help achieve the agencies’ shared goal of ensuring workers are protected from potential health and environmental risks. As required by TSCA, EPA and OSHA are collaborating on workplace exposures as part of EPA’s review of new chemicals. The MOU formalizes coordination efforts that EPA and OSHA have already implemented and provides a framework for additional opportunities for collaboration. Highlights of the MOU include:

  • Establishing designated staff and management points of contact from each agency to discuss and resolve workplace exposure issues related to EPA’s review of new chemicals;
     
  • Providing OSHA with regular updates on EPA’s new chemical determinations, including any necessary worker protection identified during EPA’s review; and
     
  • Documenting EPA’s role in identifying and notifying OSHA of the need for formal consultation on EPA’s review of new chemicals.

More information will be available in a forthcoming memorandum that will be posted on our website.

Tags: EPA, OSHA, MOU

 
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By   Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On January 19, 2021, EPA issued a request for comment on petitions submitted in 2020 for a waiver of the RFS obligations that apply to 2019 and 2020. The petitions argue that recent events warrant EPA exercising its general waiver authority on the basis of severe economic harm. In late March 2020, a group of small refineries requested a waiver of the 2019 and 2020 RFS obligations. In April 2020, Governors of several states submitted three petitions for waivers of the nationwide volumes. Under the Clean Air Act (CAA), EPA is granted the discretion to waive the requirements of the RFS program in whole or in part if the EPA Administrator determines, after a notice and comment, that the implementation of the applicable annual volume requirements would severely harm the economy or environment of a state, region, or the United States. Comments on the aforementioned petitions are due on February 18, 2021.


 
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By   Lynn L. Bergeson 

Dan Utech, Incoming Chief of Staff for EPA, announced to EPA on January 21, 2021, that until Michael Regan, Secretary of the North Carolina Department of Environmental Quality, is confirmed as EPA Administrator, Jane Nishida will serve as Acting Administrator. According to Utech, EPA will be guided by science as it moves to achieve these goals and address other threats to public health and the environment.

Utech states that Biden also signed an Executive Order on Advancing Racial Equity and Support for Underserved Communities through the Federal Government. In addition to providing a framework for advancing equity, it revokes Executive Order 13950, “Combating Race and Sex Stereotyping.”

Utech’s announcement includes the following updated list of current and acting leaders, as well as a list of the incoming appointees who onboarded this week.

Current and Acting Leadership

  • Acting Administrator: Jane Nishida
  • Office of the Chief Financial Officer (OCFO): David Bloom
  • Office of Air and Radiation (OAR): Joseph Goffman
  • Office of Water (OW): Radhika Fox
  • Office of Land and Emergency Management (OLEM): Barry Breen
  • Office of Chemical Safety and Pollution Prevention (OCSPP): Michal Ilana Freedhoff (as of January 25, 2021)
  • Office of Research and Development (ORD): Jennifer Orme-Zavaleta
  • Office of General Counsel (OGC): Melissa Hoffer
  • Office of Enforcement and Compliance Assurance (OECA): Larry Starfield
  • Office of International and Tribal Affairs (OITA): Mark Kasman
  • Office of Mission Support (OMS): Donna Vizian
  • Office of Policy (OP): Victoria Arroyo
  • Office of Congressional and Intergovernmental Relations (OCIR): Robin Richardson
  • Office of Public Engagement and Environmental Education (OPEEE): Rosemary Enobakhare
  • Office of Public Affairs (OPA): Lindsay Hamilton
  • Region 1: Deb Szaro
  • Region 2: Walter Mugdan
  • Region 3: Diana Esher
  • Region 4: John Blevins
  • Region 5: Cheryl Newton
  • Region 6: David Gray
  • Region 7: Ed Chu
  • Region 8: Deb Thomas
  • Region 9: Deb Jordan
  • Region 10: Michelle Pirzadeh

Members of the incoming EPA leadership team who onboarded this week:

  • Radha Adhar, Deputy Associate Administrator for Congressional Affairs;
  • Victoria Arroyo, Associate Administrator for Policy;
  • Tomás Elias Carbonell, Deputy Assistant Administrator for Stationary Sources, OAR;
  • Alison Cassady, Deputy Chief of Staff for Policy;
  • Dimple Chaudhary, Deputy General Counsel for Nationwide Resource Protection Programs;
  • Rosemary Enobakhare, Associate Administrator for Public Engagement and Environmental Education;
  • Philip Fine, Principal Deputy Associate Administrator for Policy;
  • Radhika Fox, Principal Deputy Assistant Administrator, OW;
  • Michal Ilana Freedhoff, Principal Deputy Assistant Administrator for Chemical Safety and Pollution Prevention;
  • Joseph Goffman, Principal Deputy Assistant Administrator, OAR;
  • Lindsay Hamilton, Associate Administrator for Public Affairs;
  • Sinceré Harris, White House Liaison;
  • Melissa Hoffer, Principal Deputy General Counsel;
  • Casey Katims, Deputy Associate Administrator for Intergovernmental Affairs; and
  • John Lucey, Special Assistant to the Administrator.
     

 
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By  Lynn L. Bergeson 

On December 21, 2020, the U.S. Environmental Protection Agency (EPA) released a pre-publication notice of proposed updates to the Toxic Substances Control Act (TSCA) Fees Rule. Specifically, the proposed updates to the original 2018 TSCA Fees Rule include:

  • Narrowing the scope of the rule by exempting importers of articles containing a chemical substance, companies that produce a chemical as a byproduct or manufacture or import as an impurity, companies that produce a chemical in de minimis amounts, companies that use chemicals solely for research and development (R&D) purposes, and companies that manufacture a chemical that is produced as a non-isolated intermediate from fees;
     
  • Using cost data gathered over the past two years, instead of estimates, to update the fee calculations;
     
  • Ensuring fees are fairly and appropriately shared across companies by proposing a production-volume based fee allocation and including export-only manufacturers for EPA-initiated risk evaluations;
     
  • Allowing for corrections to be made to the list of manufacturers subject to fees for EPA-initiated risk evaluations after the final list is published, ensuring the accuracy of the list;
     
  • Increasing flexibility for companies by extending the amount of time to form consortia to share in fee payments;
     
  • Ensuring that EPA can fully collect fees and enabling companies to prepare better for paying fees by allowing payments in installments for EPA-initiated and manufacturer-requested risk evaluations; and
     
  • Adding new fee categories associated with new chemicals activities.

EPA will accept public comments on the proposal for 45 days after its publication in the Federal Register. Further details are available here, and a Bergeson & Campbell, P.C. (B&C®) commentary can be accessed here.


 
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By  Lynn L. Bergeson 

EPA has posted a Compliance Advisory entitled “Applicability of the Toxic Substances Control Act to Chemicals made from Petroleum and Renewable Sources Used as Fuels and Fuel Additives and Distillates.” The Compliance Advisory states that EPA is reaffirming that chemical substances used as fuels, fuel additives, and distillates made from either petroleum or renewable sources are subject to TSCA. Anyone who plans to manufacture (including import) a chemical made from petroleum or renewable sources must comply with the statutory and regulatory new chemical requirements under TSCA Section 5. According to the Compliance Advisory, EPA has received stakeholder inquiries “as to whether fuel and fuel additives made from renewable sources (such as renewable naphtha) are subject to the TSCA new chemicals requirements under section 5.” EPA states that it is issuing the Compliance Advisory “to affirm that fuel and fuel additives either made from petroleum or renewable sources are subject to TSCA and have been subject to its requirements since 1976.”

According to the Compliance Advisory, there are about 142 “naphthas” and 178 “distillates” (that compositionally can qualify as naphthas) currently on the TSCA Inventory, and they are considered Unknown, Variable composition, Complex, or Biological (UVCB) substances. Any substance that is not on the TSCA Inventory is a new chemical under TSCA Section 5(a)(1)(A). Prior to manufacture (including import) of a new chemical for commercial use, a premanufacture notice (PMN) must be filed with EPA under TSCA Section 5. The Compliance Advisory includes several questions and answers (Q&A), including:

Can you manufacture or import a chemical substance made from a renewable source if it is not listed on the TSCA Inventory?

No. Anyone who intends to manufacture (including import) a new chemical substance that is subject to TSCA for a non-exempt commercial purpose is required to submit a PMN at least 90 days prior to the manufacture of the chemical. Manufacturers (importers) are in violation of TSCA if they fail to comply or are late in complying with TSCA notice requirements. If you are required to submit a PMN, failure to do so is a violation of TSCA Section 15 and you may be subject to penalties. PMN submissions must include all available data, pursuant to 40 CFR 720.45 and 720.50. TSCA requires EPA to review the notice and make a determination; and, if appropriate, regulate the proposed activity.

EPA’s “compliance advisory” is disappointing. It signals this EPA is disinclined to promote renewable petroleum cuts and essentially (and emphatically) reaffirms what we believe to be EPA’s inflexible and unimaginative stance on “source” being determinative in petroleum cut UVCBs. This position, as we have noted in a variety of regulatory contexts, is a substantial disincentive to commercializing renewable petroleum cuts. EPA’s view is especially problematic when a refinery might wish to use a combination of petroleum and renewable feedstocks to make a single naphtha (or other distillate) cut.

For example, to avail itself of the equivalence determination, a company would have to submit a PMN for the renewable equivalent of a petroleum cut, sign the almost certain resultant consent order (EPA will undoubtedly identify aquatic toxicity concerns and may also identify health concerns), commence manufacture, file a Notice of Commencement of Manufacture or Import (NOC), and then request an equivalency determination. If EPA denies the equivalency determination, any downstream processor or user will have to either segregate the renewable products from the petroleum products so that the downstream entity can maintain records of compliance with the consent order or treat both the renewable and petroleum products as being subject to the order. Neither option is commercially feasible or sustainable.

This sequence of events illustrates why commercial entities are disinclined to avail themselves of renewable sources in the distillate space. EPA’s compliance advisory is an unexpected and, to many, unwanted parting gift from the Trump Administration. The Biden Administration may wish to revisit the wisdom and prudence of this inflexible, antiquated, and inequitable view.


 
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By  Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On December 17, 2020, the U.S. Department of Energy’s (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced the seven winners of Phase II of the Lithium-Ion Battery Recycling Prize. The prize is designed to facilitate innovative solutions to collecting, storing, and transporting discarded lithium-ion batteries for eventual recycling. Its goal is to develop processes that have the potential to capture 90 percent of all discarded or spent lithium-based batteries in the United States and reintroduce key materials into the U.S. supply chain. The seven selected prize teams will focus on building industry partnerships to design, simulate, and prototype a proof-of-concept solution. Each Phase II winner will receive a $357,000 cash prize in addition to $100,000 in non-cash vouchers to use at DOE National Laboratories and approved organizations within the American-Made Challenges Network. The winners will also advance to the third and final phase of the prize that entails a pilot validation.


 
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By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On December 14, 2020, DOE’s Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs Office issued its fiscal year (FY) 2021 Phase I Release 2 Funding Opportunity Announcement (FOA) for the SBIR and STTR Programs. Participating in the FOA are the following DOE program offices:

  • Office of Cyber Security, Energy Security, and Emergency Response;
  • Office of Defense Nuclear Nonproliferation;
  • Office of Electricity;
  • Office of Environmental Management;
  • EERE;
  • Office of Fossil Energy;
  • Office of Fusion Energy Sciences;
  • Office of High Energy Physics; and
  • Office of Nuclear Energy.

The FOA is available for qualified small businesses with strong research capabilities in science or engineering in any of the research areas sought in the announcement. Grant applications for Phase I are due by February 22, 2021.

Tags: DOE, EERE, FOA, SBIR, STTR

 
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By  Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

DOE’s EERE announced an FOA of up to $35 million for bioenergy feedstock technologies and algae R&D. This FOA supports the White House’s priority to advance the domestic bioeconomy and DOE’s Bioenergy Technologies Office’s (BTO) goal to improve the performance and lower the cost and risk of technologies that can be used to produce biofuels, biopower, and bioproducts. Topic areas include the characterization of municipal solid waste (MSW) to enable production of conversion-ready feedstocks and algae productivity exceeding expectations (APEX). The application process requires a concept paper and a full application. While concept papers must be submitted to DOE by February 1, 2021, the full applications are due on April 5, 2021.


 
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By  Lynn L. Bergeson 

EPA announced on January 5, 2021, that it is reopening the reporting period under the TSCA Inventory notification active-inactive rule where companies identified chemicals that were manufactured, imported, or processed in the United States during the ten-year time period ending on June 21, 2016. As reported in our June 26, 2017, memorandum, “EPA Issues Final TSCA Framework Rules,” the final TSCA Inventory notification (active-inactive) rule established a retrospective electronic notification of chemical substances on the TSCA Inventory that were manufactured (including imported) for nonexempt commercial purposes during the ten-year time period ending on June 21, 2016, with provision to also allow notification by processors. From August 11, 2017, through October 5, 2018, chemical manufacturers and processors provided information on which chemicals were manufactured, imported, or processed in the United States over the past ten years. The reporting period included an opportunity for submitters to assert claims to retain specific chemical identities as confidential business information (CBI). In May 2020, EPA posted an interim list of chemicals expected to lose their CBI status and move to the public portion of the TSCA Inventory. In its January 5, 2021, announcement, EPA states that it has since become aware of “submitter confusion and issues regarding CBI claims” during the initial reporting period. EPA is allowing companies to submit, amend, or withdraw filings under the TSCA Inventory notification (active-inactive) rule to maintain existing CBI claims for specific chemical identity. The reporting period will reopen 30 days after publication in the Federal Register and run for 60 days after that date.


 
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By  Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On January 6, 2021, EPA issued in final its rule titled “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information.” The rule establishes how EPA will consider the availability of dose-response data underlying pivotal science used in its significant regulatory actions and influential scientific information. Under this rule, EPA will give greater consideration to studies where underlying dose-response data are available with sufficient independent validation. The rule also requires EPA to identify and make publicly available the science that serves as a basis for its regulatory decisions and actions at the draft stage to the extent practicable. Peer review required for pivotal science and criteria for the EPA Administrator to exempt certain studies from the rulemaking requirements are also part of the final rule. The rule became effective on January 6, 2021.


 
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By  Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On December 19, 2020, the Government of Canada’s Department of the Environment published a proposed rule titled Clean Fuel Regulations. The proposed rule addresses Canada’s concerns in achieving its net-zero emissions by 2050 under the Paris Agreement. In an effort to reduce the largest sources of greenhouse gases (GHG), the Clean Fuel Regulations would require liquid fossil fuel primary suppliers to reduce the carbon intensity (CI) of the liquid fossil fuels they produce in and import into Canada from 2016 CI levels by 2.4 g of CO2/megajoule (MJ) in 2022, increasing to 12 g of CO2/MJ in 2030. The proposed rule would also establish a credit market whereby the annual CI reduction requirement could be met via three main categories of credit-creating actions:

  • Actions that reduce the CI of the fossil fuel throughout its life cycle;
  • Supplying low-carbon fuels; and
  • Specified end-use fuel switching in transportation.

The Clean Fuels Regulations would also retain the minimum volumetric requirements of at least five percent low CI fuel content in gasoline and two percent low CI fuel content in diesel fuel and light fuel oil that are currently set out in the federal Renewable Fuels Regulation (RFR). The RFR would be repealed, and parties that are not primary fossil fuel suppliers would be able to participate in the credit market as voluntary credit creators by completing certain actions. Further details are available here.


 
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By  Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

The Scientific Research Honor Society (Sigma Xi) is accepting nominations until January 31, 2021, for awards that recognize achievements in science or engineering research and communication. Nominations are being accepted for the following awards:

  • Gold Key Award – Presented to an individual who has made contributions to their profession and fostered critical innovations to enhance the health of the research enterprise, cultivate research integrity, and/or promote the public understanding of science.
  • William Procter Prize – Presented to a scientist who has made an outstanding contribution to scientific research and demonstrated an ability to communicate this research to scientists in other disciplines. The award includes a $5,000 honorarium and a $5,000 grant to a young colleague of the recipient’s choice.
  • John P. McGovern Award – Presented to an individual who has made an outstanding contribution to science and society. It includes a $5,000 honorarium, and the individual presents his or her work at Sigma Xi’s annual meeting.
  • Walston Chubb Innovation Award – Designed to honor and promote creativity among scientists and engineers, this award provides a $4,000 honorarium and an invitation to present at Sigma Xi’s annual meeting.
  • Young Investigator Award – Includes a certificate of recognition and a $5,000 honorarium to a young scientist who has made an outstanding contribution to scientific research.
  • Evan Ferguson Award – Presented annually since 2008, this award comes with a plaque of recognition and a lifetime subscription to American Scientist.
  • Bugliarello Prize – Honors an essay, review of research, or analytical article published in American Scientist.
  • Monie Ferst Award – Presented to individuals who promote research through teaching and supervising research students.
  • Honorary Membership – Presented to noted science advocate, top science journalists, and friends of research who have made important contributions to science but are not eligible for Sigma Xi membership.

Details of eligibility and instructions for how to nominate an individual can be found here.


 
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By  Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

Researchers at Swansea University’s Energy Safety Research Institute have developed a new method that produces spheres that have strong capacity for carbon capture and work at a large scale. Described as “[a] fast, green and one-step method for producing porous carbon spheres, which are a vital component for carbon capture technology and for new ways of storing renewable energy,” the method was developed by a research team that adapted an existing method known as chemical vapor deposition (CVD). This adapted method involves the use of heat to apply a coating to a material using pyromellitic acid as both carbon and oxygen source. Research scientists involved in the development of this new method report that the new approach brings certain advantages over existing methods of producing carbon spheres, including:

  • It is alkali-free;
  • It does not need a catalyst to trigger the shaping of the spheres;
  • It uses cheap and safe feedstock that is readily available on the market;
  • There is no need for solvents to purify the material; and
  • It is a rapid and safe procedure.

 
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By Lynn L. Bergeson

On November 9, 2020, the U.S. Department of Energy’s (DOE) Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs office issued topics for its Fiscal Year (FY) 2021 SBIR/STTR Phase I Release 2 Funding Opportunity Announcement (FOA). Participating in the FOA are the following program offices:

  • Office of Cyber Security, Energy Security, and Emergency Response (CESER);
  • Office of Defense Nuclear Nonproliferation (NNSA);
  • Office of Electricity (OE);
  • Office of Environmental Management (EM);
  • Office of Energy Efficiency and Renewable Energy (EERE);
  • Office of Fossil Energy (FE);
  • Office of Fusion Energy Sciences (FES);
  • Office of High Energy Physics (HEP); and
  • Office of Nuclear Energy (NE).

DOE will host a webinar on December 18, 2020, to discuss the FOA and application process and changes to the DOE SBIR and STTR programs.

Additional important dates include:

  • FOA Issued: December 14, 2020;
  • Letter of Intent (LOI) Due Date: January 4 , 2021;
  • Non-responsive LOI Feedback Provided: January 25, 2021;
  • Application Due Date: February 22, 2021;
  • Award Notification Date: May 17, 2021 (subject to change); and
  • Start of Grant Budget Period: June 28, 2021 (subject to change).
Tags: DOE, SBIR, STTR, FOA, Funding

 
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By Lynn L. Bergeson

On November 12, 2020, DOE issued its multi-year Hydrogen Program Plan aimed at providing a strategic framework for its hydrogen research, development, and demonstration (RD&D) efforts. A coordinated departmental effort, the Hydrogen Program focuses on the advancement of affordable production, transport, storage, and use of hydrogen across different economy sectors. Offices involved in this plan include DOE’s EERE, FE, NE, and the Advanced Research Projects Agency-Energy.

Tags: DOE, Hydrogen, EERE

 
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