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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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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By Lynn L. Bergeson

From July 23-24, 2019, the Food and Drug Law Institute (FDLI) will be hosting the Introduction to Drug, Biologics, and Biosimilars Law and Regulation conference in Boston, MA. The conference will cover an overview of administrative agencies that impact these industries and how they interact with the U.S. Food and Drug Administration (FDA). It will also include sessions on the development of drug and biological products, FDA’s review and approval of marketing applications, biosimilars and generic drugs, manufacturing issues, and case studies, among other topics.

Tags: FDA, Biobased

 

 
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By Lynn L. Bergeson

On April 26, 2019, the U.S. Court of Appeals for the D.C. Circuit (D.C. Circuit) issued its order on the petition for review of the U.S. Environmental Protection Agency’s (EPA) final rule on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements (82 Fed. Reg. 37520 (Aug. 11, 2017)), which denied the petition for review on all but one claim.  Petitioner Environmental Defense Fund (EDF) challenged five distinct features of the Inventory final rule:  (i) EPA’s exclusion of substantiation questions regarding reverse engineering; (ii) the final rule’s criteria for “maintaining” a confidentiality claim; (iii) EPA’s choice not to incorporate certain regulatory requirements into the final rule; (iv) EPA’s failure to implement the Act’s “unique identifier” requirements in this rulemaking; and (v) the final rule’s exemption of exported chemicals from its notification requirements. 
 
The D.C. Circuit’s order states that only the first claim succeeds past the standard of review required under both the Administrative Procedure Act (APA) and TSCA, however; specifically, EPA acted arbitrarily and capriciously via its “omission of any inquiry into a chemical identity’s susceptibility to reverse engineering [which] effectively excised a statutorily required criterion from the substantiation process.”  Even though EPA included several substantiation questions to address reverse engineering in the proposed rule, EPA did not include any “substantiation questions related to the requirement that a substance’s chemical identity not be susceptible to reverse engineering” and declined altogether to “‘secure answers’ substantiating a company’s ‘assertion’ that its chemical product cannot be reverse engineered.”  The court states that this error was “fatal” and remands this issue back to EPA for EPA to “address its arbitrary elimination of substantiation questions regarding reverse engineering.” For further details, see Bergeson & Campbell, P.C.’s (B&C®) TSCAblog™ article.

Tags: TSCA

 
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By Lynn L. Bergeson

On April 29, 2019, the National Chicken Council submitted a letter to EPA’s Office of Transportation and Air Quality outlining the potentially negative impact of the changes to the biofuels policy on the poultry industry. In his letter to EPA, Mike Brown, President of the National Chicken Council, reported concern with EPA’s proposal on year-round ethanol-15 (E15) use under the Renewable Fuels Standard (RFS) Program. The National Chicken Council believes that EPA has failed to consider the impact of such volume waivers on the boiler industry, and for poultry and livestock feeders generally. Brown assures EPA that a year-round E15 use waiver “will result in a rapid expansion of corn use under the RFS adding the potential for price and supply volatility in the corn market.” Instead of the aforementioned proposed modifications, the National Chicken Council is suggesting that EPA consider a predictable, transparent off-ramp based on the U.S. Department of Agriculture (USDA) stocks-to-use-ratio in the June World Agricultural Supply and Demand Estimates (WASDE) report. Partial waivers would then be structured for the remainder of the year. The structure of the partial waivers is further detailed in the letter.

Tags: E15, RFS, Biofuel

 
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