| 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:
- Verify the asserted CBI claims
are correct and consistent; and
- 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 gci@acs.org 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
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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” |