Biobased Products News and Policy Report – Update from Bergeson & Campbell, P.C.

Biobased and Renewable Products Update
May 23, 2019
 

Federal
 

EPA Announces Section 5 Notices To Be Posted Without EPA Review
— Filers Should Be Extra Diligent About Proper CBI Redactions

 
On May 20, 2019, the U.S. Environmental Protection Agency (EPA) announced that on May 30, 2019, it will begin publishing Toxic Substances Control Act (TSCA) Section 5 notices, including premanufacture notices (PMN), microbial commercial activity notices (MCAN), and significant new use notices (SNUN), their attachments, including any health and safety studies, any modifications thereto, and all other associated information in ChemView — in the form they are received by EPA, without review by EPA.  EPA states that it will not be reviewing confidential business information (CBI)-sanitized filings before publishing.  EPA states that this announcement will be the first of several reminders that EPA sends and, in addition, EPA has incorporated a reminder to check accompanying sanitized submissions as part of the Central Data Exchange (CDX) reporting module for TSCA Section 5 notices.
 
EPA’s announcement states the following as guidance for submitters to take heed of before submitting their TSCA Section 5 notices:

  1. Verify the asserted CBI claims are correct and consistent; and
     
  2. Verify the sanitized versions of the form, attachments, and file names are checked for proper and consistent CBI redactions and that watermarks or stamps indicating CBI are removed.  

EPA Announces New Version Of An Interactive Excess Food Opportunities Map
 
On May 21, 2019, EPA announced a new version of a mapping tool designed to assist in the reduction of food waste by displaying facility-specific information about potential generators and recipients of excess food. According to EPA, the Excess Food Opportunities Map serves as an online “matching” service, linking, for example, owners of anaerobic digestion facilities with people looking to dispose of organic waste, including excess food. These anaerobic digestion facilities control organic decomposition in an oxygen-free, sealed tank to produce bioproducts and biosolids for on-site use or sale. This interactive map is part of EPA’s attempt to address the 133 billion pounds of wasted food in the U.S. through the diversion from landfills. It displays locations of potential excess food generators and recipients of excess food in industrial, commercial, and institutional sectors. The interactive and easy-to-use map was initially designed in 2014 by the Office of Research and Development’s (ORD) Regional Sustainability and Environmental Sciences Research Program (RESES). Since then, it was taken over by the Office of Land and Emergency Management (OLEM) and has evolved from a regional tool to a national one. The most recent version 2.0 includes 1.2 million potential excess food generators and identifies about 4,000 recipients.
 
DOE Celebrates EERE’s Better Building Initiative Partners
                                                                                                                     
On May 16, 2019, the U.S. Department of Energy (DOE) released the 2019 Better Buildings Report, announcing the progress made by public- and private-sector organizations that participate in DOE’s Office of Energy Efficiency and Renewable Energy’s (EERE) Better Buildings Initiative. Aimed at improving U.S. energy efficiency, partners in the Better Building Initiative represent 32 of the country’s Fortune 100 companies, 12 of the top 25 U.S. employers, 12 percent of the U.S. manufacturing energy footprint, and 13 percent of total commercial building space. According to the report, together they leverage new energy-saving technologies, collaborate to overcome obstacles, invest in innovative projects, and achieve impressive energy savings. Investing in the commercial, industrial, residential, and public sectors to improve energy, these market leaders’ achievements include:

  • Savings of approximately $4 billion since the program started;
     
  • Savings of more than six billion gallons of water;
     
  • Cost savings of about $5.3 billion over the last seven years; and
     
  • An increase in the creation of new tools and strategies targeting efficiency barriers, among other achievements further outlined in the report.

In addition, 20 of the partners and allies achieved their energy, water, or financing goals this year.  Since the program began, 85 partners have now met their original goals. The full report can be accessed here.
 
EERE Announces Grants For SBIR Innovation Projects
 
On May 20, 2019, U.S. Energy Secretary, Rick Perry, announced that DOE’s EERE will be awarding up to $46 million in grants to small businesses funded through DOE’s Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs for Phase I research and development (R&D). DOE will award 231 grants to 202 small businesses in 39 states and the District of Columbia (DC). Phase I grants provide small businesses with the opportunity to research technical feasibility of innovative technologies that advance DOE’s EERE’s mission. Successful Phase I grantees will then be eligible to apply for Phase II awards in 2020. Phase II allows small businesses to develop prototypes/processes to validate their research for up to two years.  Nine EERE technology offices will fund 109 awards under 12 topics — one for each office (Advanced Manufacturing Office (AMO), Bioenergy Technologies Office, Building Technologies Office, Fuel Cell Technologies Office (FCTO), Geothermal Technologies Office (GTO), Solar Energy Technologies Office (SETO), Vehicle Technologies Office, Water Power Technologies Office and the Wind Energy Technologies Office), as well as three joint office topics (AMO with FCTO, AMO with GTO, and AMO with SETO).
 
HHS Announces Availability Of Draft Guidance On Therapeutic Protein Biosimilars
 
On May 22, 2019, the U.S. Food and Drug Administration’s (FDA) Department of Health and Human Services (HHS) announced via the Federal Register the availability of a draft guidance for industry titled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.” The draft guidance is a revision of the 2015 guidance titled “Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product.” It provides recommendations on the design and evaluation of comparative analytical studies that intend to demonstrate that a proposed therapeutic protein product is biosimilar to a reference product licensed under the Public Health Service Act (PHS Act). Additionally, the draft guidance makes recommendations to sponsors on the scientific and technical information for the chemistry, manufacturing, and controls (CMC) portion of a marketing application. Comments on the draft guidance are due on or prior to July 22, 2019.

 
State
 

CEC Awards Funding For Clean Energy Projects
 
On May 15, 2019, the California Energy Commission (CEC) approved approximately $11 million for clean energy demonstration projects that include biofuels, renewable gas, and microgrids. Funded by CEC’s Alternative and Renewable Fuels and Vehicle Technology Program, in support of clean transportation innovation, $2 million from the total funds have been approved for technology and investment solutions in hopes of demonstrating cost-effective and more sustainable processes for creating biomethane for waste hauling trucks. Funding was also awarded in support of renewable gas production using wood waste from trees killed by beetle infestation and drought, as well as in support of the natural gas sector. Microgrids at schools and residential areas in the City of Lancaster are also being supported by a $5 million grant.  The project’s distributed energy resources will be integrated and managed by a virtual power plant that optimizes cost savings, grid resilience, and revenue generation. Further details can be found in CEC’s business meeting agenda.
 

Events
 

Registration Now Open For “TSCA: Three Years Later”
 
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.
 
ACS And EPA To Host Green Chemistry Challenge Awards
 

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 [email protected] 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).

Annual Green Chemistry And Engineering Conference/International Conference On Green And Sustainable Chemistry
 
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.
 

Other News
 

Interesting Engineering, “Reversible Plastic Developed That Can Be Repeatedly Recycled
 
Politico, “De Blasio Praises Biofuels, Promises More Recycling at First Iowa Stop
 
RFA, “New Study: Renewable Fuel Standard Saves Consumers 22 Cents on Every Gallon of Gas
 
Saigon Online, “Ministry Proposes Environmental Protection Tax Cut for Biofuel
 
UPI, “Japan’s Renewables-powered Olympics Could Spur Global Race for Clean Energy
 
Reuters, “Britain’s Genus Signs Deal to Bring Gene-edited Pigs to China
 
Ethanol Producer Magazine, “EU Repeals Anti-dumping Duties on US Ethanol
 
The Daily Caller, “Liz Warren Pushes Bill Imposing Green New Deal Climate Goals on the US Military
 
Reuters, “Brazil Seeks China’s OK for Genetically Modified Sugarcane
 
Fast Company, “These ‘Biosolar Panels’ Suck CO2 from the Air to Grow Edible Algae
 
Standard Digital, “Defining Moment as Kenyans Await Cabinet’s GMO Verdict