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.

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.


 

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.


 

From June 14 through 18, 2021, the American Chemical Society Green Chemistry Institute (ACS GCI) will host its annual Green Chemistry & Engineering Conference. Fully virtual this year, the conference will include live sessions and poster presentations focused on green and sustainable chemistry and engineering under the 2021 theme of Sustainable Production to Advance the Circular Economy. Registration is now open via this link.


 

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

On January 19, 2021, the U.S. Department of Energy (DOE) released its Plastics Innovation Challenge Draft Roadmap (Draft Roadmap) alongside a Request for Information (RFI) seeking stakeholder input on the draft document. The Plastics Innovation Challenge is a DOE program focused on accelerating innovations in energy-efficient plastic recycling technologies. The aim of the Plastics Innovation Challenge is to make domestic processing of plastic waste energy efficient and economically viable, develop new and improved plastic materials lacking the same end-of-life concerns as incumbent materials, and to reduce plastic waste accumulation. Based on these aims, the Plastics Innovation Challenge has outlined four strategic goals within its scope:

  • Deconstruction: Develop biological and chemical methods for deconstructing plastic wastes into useful chemicals;
     
  • Upcycling: Develop technologies to upcycle waste chemical streams into higher value products;
     
  • Recycle by Design: Design new, renewable plastics and bioplastics that are easily upcycled and can be manufactured domestically at scale; and
     
  • Scale and Deployment: Support an energy and material-efficient domestic plastics supply chain.

The Draft Roadmap, therefore, identifies key research needs and opportunities for DOE-sponsored research and development (R&D). It also identifies challenges and opportunities across thermal, chemical, biological, and physical recycling and upcycling methods, as well as material design strategies for recyclability. According to DOE, the Draft Roadmap additionally:

  • Provides an overview of the plastic waste problem;
     
  • Identifies the initiative’s 2030 vision, mission, strategic goals, and objectives;
     
  • Details challenges and opportunities identified by previous DOE activities;
     
  • Lays out key research directions;
     
  • Delivers an outline of current DOE activities, capabilities and coordination; and
     
  • Describes targets for each research area.

The Draft Roadmap aims to guide DOE efforts to meet the Plastics Innovation Challenge goals. The purpose of DOE’s RFI on the Draft Roadmap, therefore, is to solicit feedback from stakeholders to ensure the road toward the Plastics Innovation Challenge 2030 goals is clear and well positioned. Responses to the RFI are due to DOE by March 1, 2021.


 

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.


 

By Lynn L. Bergeson

On October 15, 2020, the U.S. Department of Energy (DOE) announced the availability of over $27 million in funding for 12 projects supporting research and development (R&D) efforts toward advanced plastics recycling technologies and new recyclable plastics. These efforts are part of DOE’s Plastics Innovation Challenge, which aims to improve existing recycling processes that break plastics down into chemical building blocks that can be used to make new products. The 12 projects selected will address highly recyclable or biodegradable plastics, novel methods for deconstructing and upcycling existing plastics, and collaborations to tackle challenges in plastic waste.


 

By Lynn L. Bergeson

On September 24, 2020, EPA announced the 2020 Safer Choice Partner of the Year award winners. EPA recognized 18 Safer Choice Partner of the Year award winners across ten states and the District of Columbia for achievement in the design, manufacture, selection, and use of products with safer chemicals that further outstanding or innovative source reduction. EPA states that the Safer Choice program helps consumers and purchasers for facilities, such as schools and office buildings, find products that perform and are safer for human health and the environment. According to EPA, the 2020 Partner of the Year award winners represent businesses, including woman-owned and small- and medium-sized; federal and local government; and associations. The following organizations from eight EPA regions are being awarded this year:

  • Apple -- Cupertino, California;
  • BASF Home Care and I&I Cleaning Solutions -- Florham Park, New Jersey;
  • Berkley Green -- Uniontown, Pennsylvania;
  • The Clorox Company -- Oakland, California;
  • Defunkify -- Eugene, Oregon;
  • DuPont Nutrition & Biosciences -- Palo Alto, California;
  • ECOS -- Cypress, California;
  • Grove Collaborative -- San Francisco, California;
  • Hazardous Waste Management Program -- King County, Washington;
  • Household & Commercial Products Association -- Washington, D.C.;
  • Jelmar, LLC -- Skokie, Illinois;
  • Lemi Shine -- Austin, Texas;
  • Naval Supply Systems Command Weapons System Support -- Mechanicsburg, Pennsylvania;
  • PROSOCO -- Lawrence, Kansas;
  • PurposeBuilt Brands -- Gurnee, Illinois;
  • Sea Mar Community Health Centers -- Seattle, Washington;
  • Seventh Generation -- Burlington, Vermont; and
  • Wegmans Food Markets -- Rochester, New York.

More information is available on EPA’s website.


 

By Lynn L. Bergeson

On September 21, 2020, the U.S. Department of Agriculture (USDA) Rural Business-Cooperative Service announced that it is soliciting applications for funds available under the Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program (the Program) to provide guaranteed loans to fund the construction, development, and retrofitting of commercial-scale biorefineries and of biobased product manufacturing facilities. Biorefineries applying must use eligible technology, and biobased product manufacturing facilities must use technologically new commercial-scale processing and manufacturing equipment to convert renewable chemicals and other biobased outputs of biorefineries into end-user products on a commercial scale.

USDA will accept applications during two separate cycles, which have application closing dates of 4:30 p.m. (EDT) October 1, 2020, and 4:30 p.m. (EDT) April 1, 2021. Applications and forms can be obtained from:

  • USDA, Rural Business-Cooperative Service, Program Processing Division, Attention: Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program, 1400 Independence Avenue SW, Room 5801-S, Washington, DC 20250-3225.

Of particular interest to USDA are applications that support recommendations made in the Rural Prosperity Task Force report to help improve life in rural America. Applicants are encouraged by USDA to provide measurable results in rural communities’ assistance to build sustainable and robust economies through: strategic investments in infrastructure, partnerships, and innovation. Key strategies outlined by USDA include:

  • Achieving e-connectivity for rural America;
  • Developing the rural economy;
  • Harnessing technological innovation;
  • Improving quality of life; and
  • Supporting a rural workforce.

 

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

On August 17, 2020, DOE’s Reducing EMbodied-Energy and Decreasing Emissions (REMADE) Manufacturing Institute announced the availability of approximately $35 million in support of research and development (R&D) that will enable U.S. manufacturers to increase the recovery, recycling, reuse, and remanufacturing of plastics, metals, electronic waste, and fibers. This funding opportunity announcement (FOA) is part of DOE’s Plastics Innovation Challenge, a comprehensive program to accelerate innovations in energy-efficient plastics recycling technologies by supporting high-impact R&D for plastics.

DOE issued a request for proposal (RFP) under this FOA for projects in two areas: transformational R&D and traditional R&D. The full RFP can be accessed here. Letters of intent and project abstracts are due September 14, 2020.

The Deputy Secretary of Energy, Mark W. Menezes, commented on the FOA, stating: “The Trump Administration is committed to advancing innovative reuse and remanufacturing technologies, including advanced plastic recycling technologies, and the development of new plastics that are recyclable by design. Through the Plastics Innovation Challenge, and in partnership with REMADE, DOE is proud to take part in the development of new technologies that strengthen the U.S. manufacturing ecosystem.”


 

By Lynn L. Bergeson 

On June 30, 2020, EPA’s Office of Inspector General (OIG) released a report on its audit to determine whether the Safer Choice program effectively meets its goals and whether the program achieves quality standards through its product qualification, renewal, and required audit processes. OIG states that EPA’s Safer Choice program does not have formal goals included in the FY 2018-2022 EPA Strategic Plan, and the program has not reported results for FYs 2018-2019. The program does have internal, non-outcome-oriented goals, however, which it is generally achieving. The Safer Choice program’s goal is to add 200 Safer Choice products to the program and 25 chemicals to the Safer Chemical Ingredients List each year. According to OIG, in FY 2019, EPA added 265 products and 24 chemicals. OIG states that by not including formal goals for the Safer Choice program in EPA reports while continuing to receive Congressional funding and support, EPA limits not only accountability to Congress and the public, but also the extent that the program can use performance management information to make policy, budget, and management decisions. OIG notes that the Safer Choice program has general controls in place for the required Safer Choice audit process, and EPA reviews audit summaries and corrective actions provided by third-party profilers (TPP). EPA does not routinely review all supporting documentation, however, relying on TPPs to review and retain these documents. Additionally, the Safer Choice program does not have procedures in place to conduct any formal performance reviews of TPPs or oversight reviews of TPP partner audits. According to OIG, without periodic audit oversight, including full reviews of supporting documents and formal performance reviews of TPPs, EPA risks approving products that do not comply with the Safer Choice Standard. OIG recommends that the Assistant Administrator for Chemical Safety and Pollution Prevention develop and publish adequate Safer Choice program goals and performance measures, establish and implement procedures for formal audit oversight of TPPs, amend its memorandums of understanding with TPPs to require performance reviews conducted by EPA, and collect and document TPP audit supporting information.


 
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