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 May 12, 2021, from 3:30 p.m. to 5:00 p.m. (EDT), the European Commission (EC) Helpdesk will host a webinar on appropriate Intellectual Property (IP) rights for biotechnology inventions.  The 60-minute webinar will provide an overview of:

  • Relevant IP rights;
  • Product development IP context;
  • IP specifics in biotechnology;
  • IP portfolio development; and
  • IP portfolio management.

The webinar is free of charge, but registration is required.  Additional information is available here.


 
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By Lynn L. Bergeson
 
On April 28, 2021, University of York researchers announced the discovery of a new enzyme derived from a fungus called Parascedosporium putredinis NO1, that can act as a catalyst for a biochemical reaction that breaks down forestry and agricultural waste.  The research was done in collaboration with DOE’s Great Lakes Bioenergy Research Center and the University of Wisconsin.  This development, according to the University of York, could play a key part in upscaling renewable fuels and chemicals.  Professor Neil Bruce explained that this discovery is a breakthrough because, currently, there are no industrial biocatalytic processes for breaking down lignin, which is present in lignocellulose.  This enzyme, however, can break through the lignin to begin the degradation process needed to produce biofuels.  Professor Bruce elaborated that the “treatments with this enzyme can increase the digestibility of lignocellulosic biomass, offering the possibility of producing a valuable product from lignin while decreasing processing costs.”


 
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By Lynn L. Bergeson

On April 29, 2021, the U.S. Department of Energy (DOE), in partnership with nine National Laboratories, issued a report titled “Hybrid Energy Systems: Opportunities for Coordinated Research.” The report outlines opportunities for innovation through joint research and development (R&D) on hybrid energy systems.  According to DOE, these opportunities can drive the production of valuable chemicals, fuels, and products that are cost-efficient, increase grid flexibility, and decarbonize the U.S. economy.  The report comes at a crucial point in time as DOE focuses on meeting the Biden Administration’s goal of achieving 100 percent clean energy by 2050.  DOE Hybrids Task Force members and representatives from various DOE offices will use the report as an optimization tool to design more cost-efficient and grid-friendly hybridization technologies.


 
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By Lynn L. Bergeson

On April 28, 2021, DOE issued a $22.5 million request for proposals (RFP) for projects that support recovery, recycling, and reuse of material waste generated by the manufacturing sector.  DOE EERE stated that “[p]rojects funded through this solicitation will develop technologies that reduce embodied energy and carbon emissions associated with the production and consumption of metals, polymers, fibers, and electronic waste, as well as identify training activities that will expand the American manufacturing workforce.”  The projects will be managed by DOE’s Reducing Embodied-Energy and Decreasing Emissions (REMADE) Institute, which is funded by DOE EERE’s Advanced Manufacturing Office.


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

On April 27, 2021, DOE’s Federal Energy Management Program (FEMP) issued a Federal Agency Call (FAC) titled “Assisting Federal Facilities with Energy Conservation Technologies (AFFECT 2021),” soliciting $13 million for new energy projects that will help federal facilities to improve the efficiency of their operations and reduce their carbon footprints.  These efforts come with the hope that DOE will contribute to the Biden Administration’s goal of a 100 percent clean-energy economy and net-zero emissions by 2050.  DOE’s FEMP actions will, according to DOE Office of Energy Efficiency and Renewable Energy’s (EERE) Acting Assistant Secretary, Kelly Speakes-Backman, “… both decarbonize and strengthen the critical energy and water infrastructure at … federal facilities, ensuring continuous operations in times of crisis.”
 
AFFECT 2021 will fund efficient, clean-energy projects that address directly climate change mitigation and adaptation through privately financed performance contracts, including:

  • Energy savings performance contracts (ESPC);
  • ESPC ENABLE – An initiative designed to permit a standardized and streamlined procurement process for small federal energy conservation measures (ECM) projects in six months or less; and
  • Utility energy services contracts (UESC).

The goal is for these performance contracts to leverage the $13 million in AFFECT grants into approximately $260 million or more in project investments.
 
Applications are being accepted for the AFFECT 2021 FAC until July 16, 2021, at 5:00 p.m. (EDT).  Registration is required prior to submission through EERE Exchange. Additional information is available here.


 
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By Lynn L. Bergeson

Under Canada’s New Substances Fees Regulations, fees must be provided with each New Substance Notification (NSN) package submitted under the New Substance Notification Regulations (Chemicals and Polymers). The amount of the fee is dependent on the annual sales in Canada for the notifier, the specific Schedule being submitted, and other services being requested (e.g., confidential search on the Domestic Substances List (DSL) or Non-Domestic Substances List (NDSL) or masked name application). As of April 1, 2019, Environment and Climate Change Canada (ECCC) modifies NSN fees annually based on the country’s Consumer Price Index (CPI). Based on a decrease in Canada’s CPI over the past 12 months, fees for NSN submissions will decrease by 0.2% starting April 1, 2021. ECCC has posted a revised fees table, effective April 1, 2021, to March 31, 2022.


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

National Renewable Energy Laboratory (NREL) researchers are leading analyses of recycling, repairing, and reusing solar photovoltaic (PV) installations in support of NREL’s mission to incentivize a circular economy for energy materials.  According to NREL, the increase in the installation of PV systems is leading to environmental and supply chain concerns because the technology relies on imports and mining of raw materials to meet domestic demands.  NREL predicts that, by 2030, decommissioned PV modules could total a million tons of waste in the United States or one percent of the world’s e-waste.  Concerned by these facts, NREL researchers have been leading ongoing analyses of the end-of-life management of PV modules in the current market.  Taylor Curtis, an NREL sustainability analyst, highlights that “[r]epair, reuse, or recovery of this equipment would reduce negative environmental impacts, reduce resource constraints, and stimulate U.S. economic growth.”
 
According to NREL research, if best practices are applied and regulatory barriers removed in the future, the U.S. industry for recovered PV materials could total $60 million by 2030 or $2 billion by 2050, from modules alone.  A summary of NREL’s recommended best practices for retiring PV systems is detailed in this report, and a detailed analysis of current federal and state regulatory barriers to PV module recycling and recovery is available in NREL’s March 2021 report titled “Solar Photovoltaic Module Recycling: A Survey of U.S. Policies and Initiatives.”


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

On March 25, 2021, researchers from the University of Maryland Department (UMD) of Materials Science and Engineering (MSE) published, in Nature Sustainability, a study titled “A strong, biodegradable and recyclable lignocellulosic bioplastic.”  The study outlines UMD MSE’s new in situ lignin regeneration strategy that synthesizes a high-performance bioplastic from lignocellulosic resources such as wood.  According to the published article, renewable and biodegradable materials derived from biomass often exhibit mechanical performance and wet stability that are insufficient for practical applications.  Given these circumstances, the newly developed method for bioplastic production improves efficiency and reduces environmental impacts because it involves only green and recyclable chemicals.  The study can be accessed here, detailing the process in which porous matrices of natural wood are deconstructed to form the lignocellulosic bioplastic.


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

On April 5, 2021, U.S. Senators Amy Klobuchar (D-MN) and Joni Ernst (R-IA), introduced a $500 million bill on biofuels infrastructure.  The bill, titled the Renewable Fuel Infrastructure Investment and Market Expansion Act, would create a grant program to aid fuel retailers in streamlining sales of fuels with higher ethanol blends.  These infrastructure grants would be available for five years.  Senator Klobuchar highlighted that "[d]iversifying our fuel supply and introducing higher blends of biofuels in the market are great steps forward as we work to promote clean energy technologies and invest in transportation infrastructure.”  She also stated that this legislation would highly benefit the economy and the environment by making cleaner fuels more accessible.


 
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SAVE THE DATE
NEW TSCA AT FIVE
Virtual Conference
June 30, 2021
 
This June marks the fifth anniversary of the enactment of the game-changing Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) that amended the Toxic Substances Control Act (TSCA). With a new Administration and the relentless pace of regulatory developments related to Lautenberg implementation, there are many issues to consider and problems to solve.

The Environmental Law Institute (ELI), the George Washington University Milken Institute School of Public Health, and Bergeson & Campbell, P.C. (B&C®) are pleased to announce the fifth annual conference providing updates and insights regarding the current state of TSCA implementation, ongoing and emerging issues, and related developments. Topics will include how EPA is implementing Section 6 risk evaluation provisions, changes in new chemical review, existing chemical risk management provisions, and TSCA’s role in achieving environmental justice, among other topics.

As with our previous TSCA anniversary events, a stellar faculty of speakers from government, non-governmental organizations, industry, and academia will convene to inform, analyze, discuss, and debate the most pressing issues related to TSCA with regulatory practitioners and other stakeholder attendees.

Detailed program and registration information to come. SAVE THE DATE!


 
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By  Lynn L. Bergeson

On April 1, 2021, the U.S. Environmental Protection Agency (EPA) issued its final modifications of certain compliance dates under the Renewable Fuel Standard (RFS) program. The final rule extends the RFS compliance deadline for the 2019 and 2020 compliance years and its associated deadlines for submission of attest engagement reports for the 2019 and 2020 compliance years for small refineries. The new 2019 compliance year and attest engagement report deadlines are now November 30, 2021, and June 1, 2022, respectively. The new 2020 compliance year and attest engagement report deadlines are now January 31, 2022, and June 1, 2022, respectively. EPA has also extended the deadline for submission of attest engagement reports for the 2021 compliance year for obligated parties to September 1, 2022. The final rule became effective on March 20, 2021.

Tags: EPA, RFS, Biofuel

 
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By Lynn L. Bergeson

EPA announced on March 29, 2021, that it is evaluating its policies, guidance, templates, and regulations under the Toxic Substances Control Act (TSCA) new chemicals program to ensure they “adhere to statutory requirements,” the Biden-Harris Administration’s executive orders, and other directives. EPA identified several instances where its approach for making determinations and managing risks associated with new chemicals can, according to EPA, more closely align with TSCA’s requirements to ensure protections for human health and the environment, including the use of significant new use rules (SNUR) and assumptions related to worker exposures. EPA states that it will stop issuing determinations of “not likely to present an unreasonable risk” based on the existence of proposed SNURs. According to EPA, “[r]ather than excluding reasonably foreseen conditions of use from EPA’s review of a new substance by means of a SNUR, Congress anticipated that EPA would review all conditions of use when making determinations on new chemicals and, where appropriate, issue orders to address potential risks.” Going forward, when EPA concludes that one or more uses may present an unreasonable risk, or when EPA believes that it lacks the information needed to make a safety finding, EPA will issue an order to address those potential risks.

EPA states that as has been the “long-standing practice,” it intends to continue issuing SNURs following TSCA Section 5(e) and 5(f) orders for new chemicals to ensure the requirements imposed on the submitter via an order apply to any person who manufactures or processes the chemical in the future. EPA notes that this ensures that other manufacturers of the same new chemical substance are held to the same conditions as the submitter subject to the TSCA Section 5(e) or 5(f) order.

EPA states that it now intends to ensure necessary protections for workers identified in its review of new chemicals through regulatory means. According to the announcement, where EPA identifies a potential unreasonable risk to workers that could be addressed with appropriate personal protective equipment (PPE) and hazard communication, EPA will no longer assume that workers are protected adequately under the Occupational Safety and Health Administration’s (OSHA) worker protection standards and updated safety data sheets (SDS). Instead, EPA will identify the absence of worker safeguards as “reasonably foreseen” conditions of use and mandate necessary protections through a TSCA Section 5(e) order, as appropriate.

Bergeson & Campbell, P.C. Commentary

The first policy change -- that the Office of Pollution Prevention and Toxics (OPPT) will no longer employ the “non-order SNUR” construction to regulate new chemicals without an order -- was somewhat predictable. This construction, since its inception, has led to questions about whether this interpretation meets the requirements under TSCA Section 5. In our view, EPA issuing a SNUR to prohibit conditions of use that EPA identifies as potentially leading to an unreasonable risk was an appropriate and expeditious means to achieve the protective end (the TSCA regulation) without the inefficiency and delays associated with the development of a consent order. EPA would only use this option when EPA concluded the intended conditions of use were not likely to present an unreasonable risk. It is not clear why a SNUR is viewed as being less protective than an order, when an order applies only to the premanufacture notice (PMN) submitter and a SNUR applies to all actors in the supply chain. EPA is required to promulgate a SNUR that conforms to an order absent a reason otherwise. The claim that undertaking a condition of use that is defined in a SNUR as a significant new use “requires only notification to EPA” misrepresents the rigor of the significant new use notice (SNUN) process. A SNUN functions just like a PMN, with a similar level of effort required on the submitter’s and EPA’s parts and nearly identical determination outcomes (a consent order, modification of the existing SNUR, or revocation of the existing SNUR if warranted), so saying that a SNUN is “just a notification to EPA” is the equivalent of stating that a PMN is “just a notification to EPA.” Detractors might also claim that orders include testing, but that presumes that testing is required for EPA to make an informed decision. If EPA can, as it routinely does, make a decision based on conservative assumptions with analogs, models, and information provided by the submitter, EPA can similarly make an informed decision about what measures are necessary to achieve its protective goal without new test data. In Bergeson & Campbell, P.C.’s (B&C®) view, this policy change will add marginal, if any, protective benefit at a significant increase in effort by both EPA and the submitter.

EPA’s decision that it no longer views use of PPE as reasonably foreseeable is an unwelcome and unprincipled development. B&C, on behalf of the TSCA New Chemicals Coalition (NCC), provided, at OPPT’s request, a robust data set that demonstrated that proper PPE is rarely not used in an industrial/commercial setting. A database of 40 years of OSHA violations contained very few glove, goggle, and general dermal protection violations -- all obvious violations to any inspector. The marginal number of OSHA violations supports the NCC’s view that standard PPE use is both reasonably foreseeable and highly likely and demonstrably so. Today’s unexplained reversal is difficult to reconcile with these facts. If EPA proceeds to issue orders for every PMN that may present a risk if workers do not take routine protective measures, then EPA will be required to regulate nearly every PMN in which EPA identifies a hazard other than “low hazard” for health and ecotoxicity, as was EPA’s practice when the Lautenberg amendments were passed in 2016. As we have stated previously, that would mean that EPA will be implementing TSCA as a hazard-based law, instead of the clear risk-based law that it is.


 
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By  Lynn L. Bergeson

EPA announced on March 23, 2021, that it is now accepting nominations for the 2021 Safer Choice Partner of the Year Awards. According to a Federal Register notice published on March 24, 2021, the awards will recognize the leadership contributions of Safer Choice partners and stakeholders who, over the past year, have shown achievement in the design, manufacture, selection, and use of products with safer chemicals that further outstanding or innovative source reduction. EPA “especially encourages” award applications that show how the applicant’s work in the design, manufacture, selection, and use of those products promotes environmental justice, bolsters resilience to the impacts of climate change, results in cleaner air or water, or improves drinking water quality. All Safer Choice stakeholders and program participants in good standing are eligible for recognition. Interested parties should submit to EPA information about their accomplishments and contributions during 2020. Submissions are due May 31, 2021. EPA will recognize award winners at a ceremony in fall 2021.

Safer Choice is an EPA Pollution Prevention (P2) program, which includes practices that reduce, eliminate, or prevent pollution at its source, such as using safer ingredients in products. The Safer Choice program certifies products containing ingredients that have met its “specific and rigorous” human health and environmental toxicological criteria. EPA notes that the Safer Choice program allows companies to use its label “on certified products that contain safer ingredients and perform, as determined by expert evaluation.” EPA states that the Safer Choice program certification “represents a high level of achievement in formulating products that are safer for people and the environment.”


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

On March 31, 2021, the U.S. Department of Energy (DOE) Office of Energy Efficiency & Renewable Energy (EERE) announced a new request for proposals (RFP) and $4 million in selections for projects aimed at accelerating the adoption of Smart Manufacturing practices. In support of the Biden Administration’s efforts to encourage innovation and reduce the carbon footprint of the manufacturing sector, the new $2 million RFP will expand DOE’s Clean Energy Smart Manufacturing Innovation Institute’s (CESMII) Smart Manufacturing Innovation Centers (SMIC). SMICs consist of a network of individuals and organizations from industry, government, and academia who allow manufacturers of all sizes to benefit from the network’s assets and competencies and to create test beds. CESMII has also selected 14 new research and development (R&D) projects that will apply Smart Manufacturing solutions to real-world manufacturing process and operation challenges to improve performance, quality, and efficiency of energy productivity.


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

DOE EERE announced on March 22, 2021, awards totaling $27.5 million for 16 water infrastructure and treatment projects. Spanning 13 states, each project will focus on bringing new water and wastewater-treatment technologies from the applied R&D stage into the market. According to DOE, increasing numbers of utilities responsible for clean water have shifted from strict wastewater treatment models to a broader model of water-resource management. This new model involves collecting and treating wastewater to produce water suitable for industry and agriculture along with drinkable water for households and energy recovery. Wastewater treated by these utilities serves as a potential source of thermal, chemical and hydraulic energy. With the right technology, therefore, it is possible to convert wastewater into renewable power, chemicals, fertilizers, and reusable water.

The 16 selected projects aim to provide sustainable water sources and affordable treatment options to industry, municipalities, agriculture, utilities, and the oil and gas sector by tackling several objectives, including:

  • Developing widely applicable treatment processes to produce renewable power, extract chemicals and fertilizers, and reuse water locally, while simultaneously minimizing energy consumption and waste generation;
  • Evaluating flexible grid service for opportunities to generate biopower from wastewater;
  • Deploying artificial intelligence, machine learning, and predictive process controls to improve resilience and efficiency;
  • Addressing environmental justice and social inequities produced by lack of access to clean water among rural and Native communities; and
  • Improving wastewater-treatment options for agriculture and livestock.

A complete list of the 16 projects is available here.


 
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