The Biobased and Renewable Products Advocacy Group (BRAG) helps members develop and bring to market their innovative biobased and renewable chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.
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Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health are pleased to present the one day conference “TSCA: Three Years Later” on June 24, 2019. Panelists Alexandra Dunn, Assistant Administrator, Office of Chemical Safety and Pollution Prevention (OCSPP), EPA, and Lynn R. Goldman, Michael and Lori Milken Dean and Professor, Environmental and Occupational Health, Milken Institute School of Public Health, George Washington University, will dive into a host of topics, including the current impacts of TSCA on science policies, challenges faced by industry, and the impacts of TSCA on regulatory policies, especially those concerning ensuring compliance and enforcement. This conference (in-person and webinar) is free and open to the public, but registration is required by June 21, 2019, at the ELI website.

Tags: ELI, B&C, GWU, TSCA

 
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By Lynn L. Bergeson

On June 10, 2019, at 5:00 p.m., the American Chemical Society (ACS) will hold the 2019 Green Chemistry Challenge Awards ceremony in Washington, D.C.  Sponsored by EPA’s OCSPP, in partnership with the ACS Green Chemistry Institute® and members of the chemical community, these prestigious annual awards recognize chemical technologies that incorporate the principles of green chemistry into chemical design, manufacture, and use.  If you are interested in attending this event, please RSVP to .(JavaScript must be enabled to view this email address) for more information.
 
EPA usually presents one Green Chemistry Challenge Award in each award category. For the 2019 competition, there are five award categories:
  • Focus Area 1: Greener Synthetic Pathways;
     
  • Focus Area 2: Greener Reaction Conditions;
     
  • Focus Area 3: The Design of Greener Chemicals;
     
  • Small Business* (for a technology in any of the three focus areas developed by a small business); and
     
  • Academic (for a technology in any of the three focus areas developed by an academic researcher).

 
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On June 11-13, 2019, the ACS Green Chemistry Institute® will host the 23rd Annual Green Chemistry and Engineering Conference and the 9th International Conference on Green and Sustainable Chemistry.  The Conference will be held right outside of Washington D.C. in Reston, Virginia, and will focus on the theme of “Closing the Loop” in the chemical life cycle.  With over three days of programming, the Conference offers more than 40 technical sessions in seven concurrent tracks and multiple opportunities to network with hundreds of attendees from around the world.  This year’s featured keynote speakers are:

  • Udit Batra, Ph.D., Chief Executive Officer, MilliporeSigma;
     
  • Lee Cronin, Ph.D., Regis Professor of Chemistry, University of Glasgow; and
     
  • Dana Kralisch, Ph.D., Professor of Pharmaceutical Technology and Biopharmacy, Institute of Pharmacy, Faculty of Biological Sciences, Friedrich Schiller University of Jena, and Chief Technical Officer, JeNACell GmbH.
Richard E. Engler, Ph.D., Director of Chemistry for B&C and The Acta Group (Acta®), will be presenting Regulatory Barriers to a Circular Economy on June 13, 2019, and Ligia Duarte Botelho, M.A., a Regulatory Associate with B&C and Acta and Manager with B&C® Consortia Management, L.L.C. (BCCM), will be presenting Role of Regulations in Circular Economy: Challenge of New Chemical Bias on June 13, 2019.
 
Reduced rates for advanced registration are available until May 31, 2019.  Registration is available online.

 

 
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By Lynn L. Bergeson

On May 13, 2019, the U.S. Food and Drug Administration (FDA) issued in final guidance designed to assist sponsors in demonstrating that a proposed biological product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement. This would mean that an abbreviated licensure pathway would be created, where biological products shown to be biosimilar to or interchangeable with an FDA-licensed biological reference product may be submitted without intervention. The guidance focuses on therapeutic protein products, providing an overview of scientific considerations in showing interchangeability of a proposed therapeutic protein product with a reference product. It pertains to a series of guidance documents FDA is developing to implement the Biologics Price Competition and Innovation Act of 2009. This final guidance provides sponsors with more certainty on the development of these proposed interchangeable products. Its scope includes scientific considerations of:

  • The data and information needed to support a demonstration of interchangeability;
     
  • The design and analysis of a switching study or studies to support a demonstration of interchangeability;
     
  • The comparator product in a switching study or studies; and
     
  • The development of presentations, container closure systems, and delivery device constituent parts for proposed interchangeable products.

 
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By Lynn L. Bergeson

On May 14, 2019, the U.S. Department of Energy (DOE) Office of Energy Efficiency and Renewable Energy’s (EERE) Bioenergy Technologies Office (BETO) announced that scientists at the Oak Ridge National Laboratory (ORNL) have developed a new, plant-derived, stretchy material that outperforms the adhesiveness of the natural chemical that gives mussels the ability to stick to rocks and ships. Composed of lignin and epoxy, the biobased material has the ability to self-heal and elongate up to 2,000 percent. Researchers at ORNL developed a method to extract a specific form of lignin, which results in a molecular structure that is very sticky and elastic. The new biobased lignin shows promise of industrial use, including hydrogels, glues, and coatings.


 
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By Lynn L. Bergeson

On May 15, 2019, DOE EERE’s BETO announced the deadline for concept paper submissions for a $79 million funding opportunity for bioenergy research and development (R&D): June 3, 2019. This funding opportunity includes biopower, biofuels, and bioproducts, aiming to reduce the price of drop-in biofuels, lower the cost of biopower, and enable high-value products from waste or biomass resources. The opportunity includes ten topic areas:

  • Cultivation Intensification Processes for Algae
     
  • Biomass Component Variability and Feedstock Conversion Interface
     
  • Efficient Wood Heaters
     
  • Systems Research of Hydrocarbon Biofuel Technologies
     
  • Optimization of Biomass-Derived Jet Fuel Blends
     
  • Renewable Energy from Urban and Suburban Wastes
     
  • Advanced Bioprocessing and Agile BioFoundry
     
  • Plastics in the Circular Carbon Economy
     
  • Rethinking Anaerobic Digestion
     
  • Reducing Water, Energy, and Emissions in Bioenergy

For further details, see the EERE Exchange website.

Tags: DOE, Biofuel, EERE

 
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By Lynn L. Bergeson

On May 15, 2019, Neste, a Biobased and Renewable Products Advocacy Group (BRAG®) member, announced the introduction of a sustainable menu to be served on Zero Island. A Neste initiative to find sustainable solutions for building a fossil-free future for an island, Zero Island is located in the Swedish archipelago. The newly developed menu, also known as the Zero Menu, has been developed with renowned chef Jonas Svensson, taking into consideration not only what is served on the plate, but also how it is produced and transported. The goal of the Zero Menu is to minimize waste, making it easier for people to make sustainable choices. Food production is responsible for a large percentage of all greenhouse gas (GHG) emissions due to livestock, transportation, packaging, storing, processing, and energy used to cook the food. Hence, the need for sustainable food options as the population grows. The Zero Menu was created to address these needs. It is designed to cause minimal amounts of fossil emissions from the field to the table. All ingredients on the menu are sustainably and locally produced, transported with lower fossil fuel emissions, and cooked with the minimum amount of energy without food waste.

Tags: Neste

 

 
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By Lynn L. Bergeson

On May 7, 2019, Energy Secretary Rick Perry announced a U.S. Department of Energy (DOE) funding opportunity of up to $89 million in support of innovative, advanced manufacturing research and development (R&D) projects. The opportunity aims to tackle key DOE priorities, which include domestic manufacturing for energy storage. Perry stated that “[e]mbracing new technologies that drive innovation in American manufacturing is the key to creating real-world progress that significantly improves energy efficiency in manufacturing. . . . By focusing on energy-related advanced manufacturing technologies, we are building a new era of manufacturing that will stimulate the economy, create jobs and build American energy independence.” DOE’s funding opportunity announcement (FOA) is requesting proposals in three key areas that will drive innovation catalysis around manufacturing and reduce industrial process energy intensity:

  • Topic 1: Innovations for the Manufacture of Advanced Materials
     
  • Topic 2: Lower Thermal Budget Processes for Industrial Efficiency & Productivity 
     
  • Topic 3: Connected, Flexible and Efficient Manufacturing Facilities and Energy Systems 
The initiative will be led by DOE’s Advanced Manufacturing Office (AMO), which anticipates making up to 55 awards for up to three years. The funding application and submission requirements can be accessed here. Concept papers are due on June 20, 2019.
Tags: DOE

 
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By Lynn L. Bergeson

On April 30, 2019, 15 U.S. Senators signed and submitted a letter to the U.S. Environmental Protection Agency (EPA) Administrator, Andrew Wheeler, urging him to protect U.S. consumers and account for the ethanol blend wall when setting annual target volumes under the Renewable Fuel Standards (RFS) requirements. According to the letter, a decrease in consumer demand for gasoline has occurred since the RFS Program was passed into law. Instead of the original 170 billion gallons projected, now, the U.S. Energy Information Administration (EIA) projects a gasoline demand for 2020 to be closer to 142 billion gallons and to decrease to 137 billion gallons by 2022. Therefore, in the letter, the Senators request that EPA acknowledge the “market reality when resetting the statutory targets such that the contribution of conventional biofuel is set below an implied 10 percent level for 2020.” They also emphasize that, should EPA fail to reset the volume below the blend wall, EPA would be violating the Congressional intent set forth under RFS, harming both consumers and refiners

Tags: RFS, Biofuel, EPA

 
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By Lynn L. Bergeson

From March 4-8, 2019, DOE’s Bioenergy Technologies Office (BETO) hosted the 2019 Project Peer Review in Denver, CO. According to BETO, this was one of the largest Peer Review events in BETO history, with almost 600 attendees present. The purpose of the event was for bioenergy researchers to present results from early-stage R&D projects across BETO’s technology areas. These presentations, as of May 2, 2019, have been made available online for public access, and include presentations from government, national labs, academia, and industry sectors.

Tags: DOE, BETO

 
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By Lynn L. Bergeson

On May 8, 2019, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service’s (APHIS) Biotechnology Regulatory Services (BRS) announced the pilot launch of its new online permitting system: APHIS eFile. Launching on July 23, 2019, APHIS will be inviting, at the end of May, those who have been issued a BRS permit or notification in the past two years to apply for the pilot program. The plan is for BRS to transition fully to APHIS eFile in November 2019 to allow applicants who join the pilot to learn the system. The pilot will be a way for APHIS BRS to test the new system in a real-world environment. Replacing the ePermits system, APHIS eFile, is expected to reduce regulatory burdens and offer intuitive, user-friendly digital experiences. Applicants who do not participate in the pilot should continue to apply for BRS permits using the old system until APHIS eFile’s full release.

Tags: USDA

 
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By Lynn L. Bergeson

On May 2, 2019, DOE’s Office of Energy Efficiency and Renewable Energy (EERE) announced funding of approximately $11 million for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Phase II research projects. Small businesses that demonstrated technical feasibility for innovations during Phase I were required to compete for Phase II funding. Eleven projects have been awarded the funds, which will be used to build prototypes or processes development. The selections were made by EERE’s four technology offices: AMO, BETO, Building Technologies Office (BTO), and Fuel Cell Technologies Office (FCTO).

Tags: DOE, Research

 
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By Lynn L. Bergeson

On May 3, 2019, DOE announced over $79 million in funding for bioenergy R&D, which includes biofuels, bioproducts, and biopower. Under Secretary of Energy, Mark W. Menezes, stated that the FOA will contribute to ensure the nation’s competitive advantage in the bioeconomy and offer more energy choices. The FOA’s objectives are to reduce the price of drop-in biofuels, lower the cost of biopower, and enable high-value products from waste or biomass resources. The FOA includes ten topic areas:

  • Cultivation Intensification Processes for Algae
     
  • Biomass Component Variability and Feedstock Conversion Interface
     
  • Efficient Wood Heaters
     
  • Systems Research of Hydrocarbon Biofuel Technologies
     
  • Optimization of Biomass-Derived Jet Fuel Blends
     
  • Renewable Energy from Urban and Suburban Wastes
     
  • Advanced Bioprocessing and Agile BioFoundry
     
  • Plastics in the Circular Carbon Economy
     
  • Rethinking Anaerobic Digestion
     
  • Reducing Water, Energy, and Emissions in Bioenergy
For further details, the full FOA can be found on the EERE Exchange website.
Tags: DOE, Biofuel

 
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