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BRAG Biobased Products Blog: January 10, 2020

U.S. President Releases Message On Biotechnology Month

On January 1, 2020, U.S. President Donald Trump released a statement recognizing the beginning of National Biotechnology Month and the country’s “enormous potential” of biotechnology to improve lives in the United States and around the globe. Highlighting the benefits of biotechnology in different sectors, President Trump states that for every one job in biotechnology, nearly two other jobs are created in various sectors in the rural United States. In his statement, the President assures Americans that his policies to encourage innovation and drive job growth will continue:

As we mark the start of National Biotechnology Month and a new decade of American ingenuity, we recognize the importance of American leadership in maintaining science- and risk-based review and regulation of biotechnology products, promoting and safeguarding critical biotechnology infrastructure and data, and preparing the next generation of biotechnology scientists, engineers, and innovators. Together, we can ensure this booming, innovative industry continues to foster economic growth and American innovation.

USDA, FDA, And EPA Announce Unified Website On Biotechnology

On January 9, 2020, also in recognition of National Biotechnology Month, the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency (EPA) announced the launch of a unified website for biotechnology regulation. Streamlining information about the three agencies in charge of overseeing agriculture biotechnology products, this website comes, in part, to fulfill President Trump’s Executive Order (EO) on Modernizing the Regulatory Framework for Agricultural Biotechnology Products. The unified website also describes the federal review process for certain biotechnology products and allows users to submit questions to USDA, FDA, and/or EPA. Aiming to improve customer service to innovators and developers, the three agencies also wish to assure Americans about the safe use of biotechnology innovations. According to USDA Secretary of Agriculture, Sonny Purdue, all Americans deserve transparency and science-based regulations that foster innovation, conserve resources, and protect public health. BRAG will supplement this notice with more information next week.

DOE Energy Storage Challenge Sets Goals For U.S. To Reach By 2030

On January 8, 2020, the U.S. Department of Energy (DOE) announced the launch of its Energy Storage Grand Challenge (the Grand Challenge). A comprehensive program to accelerate the development, commercialization, and utilization of next-generation energy storage technologies, the Grand Challenge builds on the $158 million Advanced Energy Storage Initiative announced in President Trump’s Fiscal Year (FY) 2020 budget request. U.S. Secretary of Energy Dan Brouillette states that the Grand Challenge will address the creation and sustainability of U.S. global leadership in energy storage utilization and exports, with a secure and independent manufacturing supply chain. Through a series of research and development (R&D) funding opportunities, prizes, partnerships, and other programs, the Grand Challenge aims to achieve the following goals by 2030:

  • Technology Development -- through the establishment of a comprehensive R&D portfolio;

  • Technology Transfer -- through the acceleration of the technology pipeline from research to private-sector adoption;

  • Policy and Valuation -- through the development of best models, data, and analysis to inform effective value propositions and use cases for storage technologies;

  • Manufacturing and Supply Chain -- through design of new technologies that will strengthen U.S. manufacturing, recyclability, and independence from foreign sources; and

  • Workforce -- through training the next generation of American workers to meet 21st century electric grid and energy storage value chain needs.

As its first step in the Grand Challenge, DOE plans on releasing requests for information (RFI) on the key questions and issues the challenge seeks to address in the near future. Also in the coming weeks, DOE intends to host a series of workshops with key stakeholders to share information about various storage technologies, barriers to their deployment, and overcoming these barriers to bring technologies to market.

Comments On Updated Version Of “Working Approach” Document For New Chemicals Review Due February 18, 2020

On January 2, 2020, EPA published a Federal Register notice announcing the availability of the updated “Working Approach” document for a 45-day comment period. As reported in the Bergeson & Campbell, P.C. (B&C®) December 20, 2019, blog item, EPA released an updated version of the “Working Approach” document that builds upon EPA’s November 2017 “New Chemicals Decision-Making Framework: Working Approach to Making Determinations under Section 5 of TSCA.” Comments are due on or prior to February 18, 2020. The updated document explains its approach for making one of the five affirmative determinations on new chemical notices under the Toxic Substances Control Act (TSCA):

  • The chemical or significant new use presents an unreasonable risk of injury to health or the environment;

  • Available information is insufficient to allow EPA to make a reasoned evaluation of the health and environmental effects associated with the chemical or significant new use;

  • In the absence of sufficient information, the chemical or significant new use may present an unreasonable risk of injury to health or the environment;

  • The chemical is or will be produced in substantial quantities and either enters or may enter the environment in substantial quantities or there is or may be significant or substantial exposure to the chemical; or

  • The chemical or significant new use is not likely to present an unreasonable risk of injury to health or the environment.

EPA notes that the updated document reflects feedback from a 2017 public meeting and comment period and EPA’s additional experience implementing the 2016 amendments to TSCA Section 5, and includes:

  • Additional clarification and detail throughout;

  • General guiding principles and concepts for making determinations;

  • Decision-making logic and key questions that EPA must address; and

  • Example applications of the Working Approach to reach each of the affirmative determinations under TSCA Section 5(a)(3).

EPA has posted a document summarizing public comments received on the 2017 document and its responses. More information is available in B&C’s December 20, 2019, memorandum, “EPA Releases Updated Version of ‘Working Approach’ Document for New Chemicals Review.”

ACS GC&E Call For Abstracts

On January 6, 2020, the American Chemical Society’s (ACS) Green Chemistry Institute opened its call for abstracts for the 24th Annual Green Chemistry & Engineering Conference (GC&E). This year, the conference will be held in Seattle, WA, from June 16 to June 18, 2020. Conference sessions will include a wide variety of topics, including biobased and renewable chemicals innovation, innovation in analytical chemistry applications, and making organic chemistry more sustainable. The full list of sessions can be accessed here. Parties interested in submitting an abstract can do so here prior to February 17, 2018.

Non-Profit Partners With Ukraine Ministry Of Education For Alternative Energy Competition

In late December 2019, CRDF Global, an independent non-profit focused on the global scientific community and alternatives to weapons research, announced a partnership with the Ministry of Education and Science of Ukraine (MES) in launching the 2020 U.S.-Ukraine Alternative Energy Research Competition. Currently accepting proposals from joint teams of U.S. and Ukrainian researchers, the competition will focus on the advancement of alternative energy sources. Intended to work toward a future of affordable solutions to address the rapid increase of the global population and, consequently, energy consumption increase, the competition is accepting proposals that directly apply to photovoltaic or biofuel technology. These include proposals on engineering, nanotechnology, biochemistry, microbiology, and plant study research. Awards of up to $72,000 will be provided for 12 months. Proposals are due no later than February 28, 2020.

©2020 Bergeson & Campbell, P.C.

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About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy process allows her to develop client-focused strategies whether...

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