March 20, 2020

DOE Releases FOA For Plastics Recycling R&D

By Lynn L. Bergeson On March 16, 2020, DOE EERE’s Advanced Manufacturing Office and Bioenergy Technologies Office used a joint funding opportunity announcement (FOA) of up to $25 million for plastics recycling R&D. As part of the Department’s Plastics Innovation Challenge, this FOA has been titled “BOTTLE: Bio-Optimized Technologies to Keep Thermoplastics Out of Landfills and the Environment.” The BOTTLE FOA will support the development of new plastics capable of...
March 20, 2020

EPA Will Amend CDR Rule And Extend 2020 Submission Period

By Lynn L. Bergeson On March 17, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a final rule amending the Chemical Data Reporting (CDR) rule. According to EPA, the amendments are intended to reduce the burden for certain CDR reporters, improve the quality of CDR data collected, and align reporting requirements with the Frank R. Lautenberg Chemical Safety for the 21st Century Act’s (Lautenberg Act) amendments to the Toxic Substances Control Act (TSCA)....
March 13, 2020

EPA Publishes Final Rule Establishing CBI Claims Review For TSCA Inventory

By Lynn L. Bergeson On March 6, 2020, EPA announced via the Federal Register its final rule on requirements for regulated entities to substantiate certain confidential business information (CBI) made under TSCA. The substantiation requirements describe the applicable procedures and provide instructions for regulated entities, providing the review criteria and related procedures that EPA will use to complete the reviews within the five-year time frame set in TSCA. The final rule will be effective...
March 13, 2020

DOE Announces Funds Available For Workforce Development At Universities

By Lynn L. Bergeson On March 6, 2020, the U.S. Department of Energy (DOE) announced that up to $20 million in funding is available for workforce development at universities in emerging energy fields. Aiming to prepare the next generation of scientists and engineers, DOE’s investment will fund a land grant university to pursue interdisciplinary research through the support of expansions of existing joint graduate education programs with DOE National Laboratories. This effort will be led by...
March 13, 2020

EPA Announces SNPRM On Strengthening Transparency In Regulatory Science

By Lynn L. Bergeson On March 3, 2020, EPA announced that a supplemental notice of the proposed rulemaking (SNPRM) titled “Strengthening Transparency in Regulatory Science” will be published in the Federal Register in the near future. While the notice would only modify EPA internal procedures, industry stakeholders are asked to comment on the proposed rule during a 30-day period after the date of publication in the Federal Register. The supplemental notice proposes the following...
March 13, 2020

EPA Adds Two Microorganisms To List Of Microoganisms Eligible For Exemption From Certain TSCA Report

By Lynn L. Bergeson On March 10, 2020, EPA announced that it issued a final rule to add two strains of microorganisms to the list of microorganisms eligible for an exemption from certain reporting requirements under the Toxic Substances Control Act (TSCA). EPA states that manufacturers of new intergeneric Trichoderma reesei (strain QM6a) and Bacillus amyloliquefaciens (subspecies amyloliquefaciens) may now be eligible to undergo a streamlined review process under TSCA’s new chemicals...
March 13, 2020

EPA Announces Grant Opportunity Supporting Innovative Solutions For Reducing Pollution, Including In

By Lynn L. Bergeson On March 5, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is seeking grant applications through the Source Reduction Assistance Grant Program from states, federally recognized tribes, universities, local governments, and other groups to support innovative solutions for source reduction or pollution prevention (P2) through research, education, training, or certain other methods. EPA notes that as it highlights chemical safety during the month of March,...
March 11, 2020

EPA Announces Latest Update to TSCA Inventory

The U.S. Environmental Protection Agency (EPA) announced on March 11, 2020, the availability of the latest Toxic Substances Control Act (TSCA) Inventory.  EPA states that this biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data.  According to EPA, this update adds 81 new chemicals, and the Inventory as a whole now contains 86,405 chemicals of which 41,484 are active in U.S commerce.  Other updates to the TSCA...
March 6, 2020

Helsinki Announces Energy Challenge

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On February 26, 2020, the city of Helsinki announced the opening of applications for the Helsinki Energy Challenge (HEC), which aims to address challenges associated with urban heating produced with coal. According to its press release, Helsinki is one of the leading cities in the transition toward a sustainable future. Its aim is to achieve carbon neutrality by 2035. Currently, however, Helsinki needs solutions to meet its heat demand. Given...
March 6, 2020

IEDA Opens Applications For Renewable Chemicals Production Tax Credit

By Lynn L. Bergeson The Iowa Economic Development Authority (IEDA) is offering the first Renewable Chemicals Production (RCP) Tax Credit in the United States. What does this mean? It means that the program provides an opportunity for industry stakeholders to advance Iowa’s economy through a focus on biomass as a feedstock for the production of renewable chemicals. As an attempt to incentivize the production of 30 high-value chemicals derived from biomass feedstocks, IEDA developed the RCP...
March 6, 2020

FDA Requests Comments On Its Licensed Biological Products Database

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On March 5, 2020, FDA opened a public docket for comments on its enhancement of the Purple Book, which is otherwise known as FDA’s “Database of FDA-Licensed Biological Products.” As reported in B&C’s biobased products blog on February 28, 2020, FDA is working to expand the Purple Book by transitioning from its current table list format to a searchable online database for all approved biosimilar products and their...
March 6, 2020

USDA Requests Comments On Updates To Technical Guidelines For GHG Quantification And Carbon Sequestr

By Lynn L. Bergeson On March 4, 2020, USDA announced that it is now accepting comments on its technical guidelines and science-based methods to quantify greenhouse gas (GHG) sources and sinks from the agriculture and forest sectors at the entity-scale. USDA intends to update the technical guidelines based on newly available data and methodologies within the next three years. Interested parties must submit comments on or prior to April 20, 2020.
March 6, 2020

Guidance On Biological Product Transition Issued By FDA

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On March 4, 2020, FDA announced that it has issued in final a guidance for industry titled “The ‘Deemed to be a License’ Provision of the BPCI Act: Questions and Answers,” which addresses FDA’s “transition” provision of the BPCI Act. Established in 2009, the Biologics Price Competition and Innovation Act (BPCI Act) deemed applications for an approved biological product under Section 505 of the Federal...
March 6, 2020

FDA Announces Educational Initiative To Inform Consumers Of GE Foods

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On March 4, 2020, the U.S. Food and Drug Administration (FDA), in collaboration with EPA and the U.S. Department of Agriculture (USDA), launched a new initiative called “Feed Your Mind” to help consumers better understand genetically engineered (GE) foods. Consisting of science-based information, the initiative’s features include a wide range of resources designed to teach consumers, health care professionals, and students...
March 6, 2020

DOE Announces Biomass R&D Technical Advisory Committee Meeting

By Lynn L. Bergeson On March 2, 2020, the U.S. Department of Energy (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced open meetings of the Biomass Research and Development (R&D) Technical Advisory Committee. Occurring on March 24, 2020, from 8:00 a.m. to 5:00 p.m. (EDT) and March 25, 2020, from 1:00 p.m. to 4:30 p.m. (EDT), both meetings will take place in Arlington, VA. The purpose of the meetings is to develop advice and guidance that promotes R&D leading to the...
March 6, 2020

USPTO Announces Nominations Opportunity For NMTI

By Lynn L. Bergeson On February 25, 2020, the U.S. Patent and Trademark Office (USPTO) announced that nominations are now open for the 2020 National Medal of Technology and Innovation (NMTI) to recognize those who have worked to advance U.S. competitiveness and quality of life and who have strengthened the workforce through technological innovations. The award is presented annually by the President of the United States to leading technological honorees. Applications will be accepted until April...
March 4, 2020

Madison Le Will Be Director of EPA’s Chemical Control Division

Effective March 15, 2020, Madison Le will join the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) as Director of the Chemical Control Division (CCD).  Ms. Le will replace Acting Director Lynn Vendinello.  Ms. Le is currently Director of the Fuels Compliance Policy Center within the Office of Air and Radiation.  In that capacity, Ms. Le manages the implementation of EPA’s national fuels programs, including the Renewable Fuel...
March 2, 2020

New Guidance Portal Provides Public Access to EPA Guidance Documents

On February 28, 2020, the U.S. Environmental Protection Agency (EPA) announced that, in support of President Trump’s (R) Executive Order to promote transparency, EPA launched a new guidance portal that provides public access to its guidance documents.  According to EPA, the new searchable database will make it easier for the regulated community to find and follow agency guidance.  On October 9, 2019, President Trump issued Executive Order 13891, Promoting the Rule...
February 28, 2020

Finnish Scientists Develop Bioplastic With Capacity To Block UV Radiation

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On February 19, 2020, the University of Oulu, Finland, announced that scientists from its Research Unit of Sustainable Chemistry have developed a new synthetic bioplastic that provides protection from ultraviolet (UV) radiation. In addition to its UV-light blocking capacity, the transparent bioplastic made from a biomass-based copolymer with bisfuran structure, the new bioplastic also has airtightness capabilities three to four times higher than...
February 28, 2020

ASTM International Biotechnology Task Group Seeking Members

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. The international standards organization, ASTM International, is seeking additional task group members to further develop the current terminology standard in industrial biotechnology (E3072-19). ASTM International develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services. Its sub-committee, E62.91 for Terminology in Industrial Biotechnology, is responsible for suggesting new...
February 28, 2020

DOE ORNL Develops Method For Observing Biomaterials’ Nanostructure

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On February 25, 2020, DOE’s Oak Ridge National Laboratory (ORNL) announced that its scientists have developed a novel technique to closely observe the nanostructure of biomaterials without damaging the sample. Using a nonintrusive soft mechanical nanoablation (sMNA) technique can confirm structural features in starch, which is an important carbohydrate in the production of biofuels. ORNL’s chief scientist for systems biology and...
February 28, 2020

DOE EERE To Host Public Workshops On ESGC Across The Country

By Lynn L. Bergeson On February 21, 2020, U.S. Department of Energy’s (DOE) Office of Energy Efficiency and Renewable Energy (EERE), announced that it will hold a series of workshops to receive input on the approaches and activities for its new initiative, the Energy Storage Grand Challenge (ESGC). Launched in January 2020 by DOE Secretary Dan Brouillette, ESGC was created to accelerate the development, commercialization, and utilization of next-generation energy storage technologies. With...
February 28, 2020

FDA Upgrades Its Database Of Licensed Biological Products

By Lynn L. Bergeson On February 24, 2020, FDA Commissioner Stephen M. Hahn, M.D., announced that FDA is upgrading its Purple Book, which is otherwise known as its “Database of FDA-Licensed Biological Products.” According to Dr. Hahn, FDA is working to expand the Purple Book by transitioning from its current list format to a searchable online database for all approved biosimilar products and their reference products. An upgrade planned to be released in multiple phases, the full...
February 28, 2020

FDA Issues Final Rule Amending The Definition Of “Biological Product”

By Lynn L. Bergeson On February 21, 2020, the U.S. Food and Drug Administration (FDA) issued a final rule to amend its regulation that defines “biological product.” The new definition incorporates changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and the Further Consolidated Appropriations Act, 2020 (FCA Act). Under the final rule, the statutory term “protein” is interpreted to mean any alpha amino acid polymer with a specific, defined...
February 21, 2020

UMass Amherst Unveils A Renewable Device Capable Of Generating Energy

By Lynn L. Bergeson On February 17, 2020, researchers from the University of Massachusetts Amherst (UMass Amherst) announced that one of its laboratories has developed a device using a natural protein to create electricity from moisture in the air. Electrical engineer Jun Yao and microbiologist Derek Lovley have created what they call “Air-Gen,” which consists of an air-powered generator with electrically conductive protein nanowires produced by the microbe Geobacter. The Air-gen...
February 21, 2020

EPA Pollution Prevention Program Requests Applications

By Lynn L. Bergeson The EPA Pollution Prevention (P2) Grant Program has announced the availability of funds to provide technical assistance (e.g., information, training, tools) to businesses to encourage the development and implementation of source reduction practices. EPA states that source reduction practices can help businesses save money by reducing resource use, expenditures, waste, and liability costs, while at the same time reducing their environmental footprint and helping to protect...
February 21, 2020

EPA Issues Review Plan For CBI Claims Under TSCA

By Lynn L. Bergeson On February 19, 2020, the U.S. Environmental Protection Agency (EPA) released its review plan for certain confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA). Aiming to provide clarity for affected stakeholders and efficiently fulfill CBI requirements under TSCA, EPA will review CBI claims made for chemical substance identity for chemicals on the “active” portion of the TSCA Inventory. The final rule is a follow-on to the...
February 14, 2020

EC To Host Webinar On Fast Pyrolysis Oil Biobased Products

By Lynn L. Bergeson The European Commission (EC) will host a webinar on biobased products developed from fast pyrolysis oil, where four companies will present their work. A technology that can convert a wide range of biomass into clean and uniform bio-oil that is easy to transport and store, fast pyrolysis has mostly focused, thus far, on the use of pyrolysis oil for energy purposes. According to EC, the Horizon 2020 project called Bio4Products, however, has recently developed a technology to...
February 14, 2020

Wyoming Governor Requests Funding For The Establishment Of A New Energy Program

By Lynn L. Bergeson On February 10, 2020, the Governor of Wyoming, Mark Gordon, delivered his 2020 State of the State Address, which included a request to lawmakers of a $25 million investment to establish the Energy Commercialization Program. The program is designed to provide a coordinated approach to support research on technologies that advance zero or net-negative carbon uses for coal and other fossil fuels. Gordon stated: “Wyoming will always advocate for our industries, whether it...
February 14, 2020

TSCA Stakeholders Beware: Enforcement Is On The Rise

By Lynn L. Bergeson Federal enforcement of chemical product laws is alive and well, despite a broadly held misconception to the contrary. We have seen over the past 18 months or so an uptick in federal enforcement under the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Bergeson & Campbell, P.C. (B&C®) writes to alert stakeholders of this fact. B&C believes that this trend will continue in 2020. Check out its memorandum on...
February 14, 2020

Democrats Propose Legislation To Phase Out Single-Use Plastic Products

By Lynn L. Bergeson On February 11, 2020, U.S. Senator Tom Udall (D-NM), U.S. Representative Alan Lowenthal (D-CA), U.S. Senator Jeff Merkley (D-OR), and U.S. Representative Katherine Clark (D-MA) introduced a bill that would phase out unnecessary single-use plastic products: Break Free From Plastic Pollution Act of 2020. The legislation would also hold corporations accountable for wasteful products, reform the broken waste and recycling collection system, and reduce wasteful packaging....
February 7, 2020

NBB Submits Comments To USDA On HBIIP

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On January 30, 2020, the National Biodiesel Board (NBB) submitted comments to USDA in response to its request for information (RFI) on the Higher Blends Infrastructure Incentive Program (HBIIP). A new USDA Rural Development project, HBIIP is designed to expand the availability of domestic ethanol and biodiesel by incentivizing the expansion of sales of renewable fuels. USDA’s RFI solicited information on options for fuel ethanol and...
February 7, 2020

FDA/FTC To Host Public Workshop On Biosimilars’ Competitive Market

By Lynn L. Bergeson On March 9, 2020, the U.S. Food and Drug Administration (FDA), in collaboration with the Federal Trade Commission (FTC), will host a public workshop titled “FDA/FTC Workshop on a Competitive Marketplace for Biosimilars.” The focus of the workshop will be on FDA and FTC’s collaborative efforts to support appropriate adoption of biosimilars, deter anticompetitive behaviors in the biologic marketplace, and discourage false or misleading statements about...
February 7, 2020

DOE EERE Looks To Fill Vacant Positions

By Lynn L. Bergeson On February 4, 2020, the U.S. Department of Energy (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced that it is searching for professionals to fill vacant general engineer and physical scientist positions. Resumes can be submitted directly to EERE’s hiring staff with information on the position of interest and EERE office (Solar, Geothermal, Vehicles, and Buildings, among others). Should EERE be interested in a particular resume, DOE’s Human...
February 7, 2020

USDA Requests Comments On Its Draft Instructions On Testing Methods For BE Foods

By Lynn L. Bergeson On February 3, 2020, the U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) published a notice requesting comments and feedback on its draft instructions on testing methods under the National Bioengineered Food Disclosure Standard (Standard). According to the Standard, which became effective in 2019, with a mandatory compliance date of January 1, 2022, foods that do not contain bioengineered (BE) material do not require label disclosure. USDA’s...
February 7, 2020

EPA Issues Final Rule On RFS Program Standards For 2020 And Biomass-Based Diesel Volume For 2021

By Lynn L. Bergeson On February 6, 2020, EPA issued its final rule setting 2020 renewable fuel percentage standards under its Renewable Fuel Standard (RFS) Program. The final rule established the annual percentage standards for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel that apply to gasoline and diesel transportation fuel produced or imported in 2020. The volume requirements set are below the statutory volume targets. In addition to the 2020 annual...
February 3, 2020

EPA Pollution Prevention Grant Program Requests Applications

The U.S. Environmental Protection Agency (EPA) Pollution Prevention (P2) Grant Program has announced the availability of funds to provide technical assistance (e.g., information, training, tools) to businesses to encourage the development and implementation of source reduction practices.  EPA states that source reduction practices can help businesses save money by reducing resource use, expenditures, waste, and liability costs, while at the same time reducing their environmental...
January 31, 2020

Biofuel Supply Chain Stakeholders Create Strategy For Liquid Fuels

By Lynn L. Bergeson On January 22, 2020, three trade associations announced the launch of a strategy to tackle the transition into 100 percent biofuels for heating oil in English and Irish homes. A United Kingdom (UK) based trade association, the Oil Firing Technical Association (OFTEC) has partnered with the Tank Storage Association (TSA) and the UK and Ireland Fuel Distributors Association (UKIFDA) to launch a future vision for liquid fuels, titled “Supply Chain Strategy for Liquid...
January 31, 2020

B&C Publishes Memorandum On The Sustainable Chemistry R&D Act Of 2019

By Lynn L. Bergeson On January 28, 2020, Bergeson & Campbell, P.C. (B&C®) published a memorandum on the regulatory developments of the Sustainable Chemistry R&D Act of 2019 (Act), which was passed by the U.S. House of Representatives late last year. The memorandum not only provides an overview of the proposed legislation, its implementation, and limitations, but also highlights the important milestones that could be achieved if the bill passes. The proposed bill seeks to broaden...
January 31, 2020

House Democrats Announce New Framework To Achieve Climate Resiliency

By Lynn L. Bergeson On January 29, 2020, Congressman Paul D. Tonko (D-NY) and other House Democrats unveiled a five-year, $760 billion investment framework to repair and upgrade the U.S. infrastructure to create jobs while reducing carbon pollution, improving safety, and supporting economic activity. Called the “Moving Forward Framework for the People,” the plan includes measures to increase climate resiliency and put the United States on a path toward zero carbon pollution from...
January 31, 2020

USDA Proposes Revisions To FSA Regulations

By Lynn L. Bergeson On January 27, 2020, the U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) announced that it is accepting comments on its proposed revisions to regulations implemented under the Federal Seed Act (FSA). The proposed rule includes revisions to seed labeling, testing, and certification requirements, including new eligibility standards and the recognition of current breeding techniques. Revised FSA regulations would add certain seed species to the...
January 31, 2020

DOE To Collaborate With IMSA

By Lynn L. Bergeson On January 24, 2020, as part of its sustainable transportation efforts, DOE announced a collaborative project with the International Motor Sports Association (IMSA) to encourage the development of advanced fuels and efficient technologies in motorsports. Focused on vehicles at the racetrack, the collaboration was formalized by a Memorandum of Understanding (MOU) that names the combined effort the Green Racing Program (GRP). GRP aims to emphasize the importance of promoting...
January 31, 2020

DOE Releases FOA For Its H2@Scale Initiative

By Lynn L. Bergeson Also on January 23, 2020, DOE announced that up to $64 million will be available in funding to advance innovations that will build new markets for the H2@Scale initiative. H2@Scale is an initiative focused on exploring the potential for wide-scale hydrogen production and utilization in the United States to enable resilience and sustainability of the power generation and transmission sectors. The initiative’s goal is to align diverse multibillion-dollar domestic...
January 31, 2020

DOE Announces More Than $96 Million In Funding For Bioenergy R&D

By Lynn L. Bergeson On January 23, 2020, the U.S. Department of Energy (DOE) announced the availability of more than $96 million in funding for bioenergy research and development (R&D) in support of the U.S. bioeconomy. DOE’s funding efforts also align with its own goal to provide secure, affordable, and reliable domestic energy options for consumers and business. This funding opportunity announcement (FOA) aims to advance DOE’s Bioenergy and Technology Office’s (BETO)...
January 24, 2020

B&C Launches TSCA Tutor Online And On-Demand Training Courses

By Lynn L. Bergeson Bergeson & Campbell, P.C. (B&C®) has launched the complete suite of TSCA TutorTM regulatory training courses online and on-demand at www.TSCAtutor.com. Professionals seeking expert, efficient, essential training can preview and enroll in on-demand classes to complete at their own pace and timing. In addition to the newly released online e-learning courses, B&C’s TSCA TutorTM training platform offers live in-person training at a company’s site and...
January 24, 2020

Penn State Offering IMPACT Seed Grants To Support Biotechnology R&D

By Lynn L. Bergeson Pennsylvania State University’s (Penn State) Huck Institutes of the Life Sciences’ Center of Excellence in Industrial Biotechnology (CoEIB) is now offering a new round of IMPACT Seed Grants to support interdisciplinary research, curricular development, or educational activities in the broad area of industrial biotechnology. These areas include but are not limited to: biopharmaceutical manufacturing, food biotechnology, and production of biobased chemicals....
January 24, 2020

EU Funds Project To Develop Biobased Ropes For Aquaculture

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On January 17, 2020, the European Union (EU) announced a new innovative project called BIOGEARS that will be funded under the European Maritime and Fisheries Fund (EMFF). The project focuses on the development of biobased gear solutions for the creation of an eco-friendly offshore aquaculture sector using a multitrophic approach and new biobased value chains. With the aim to address the gap of biobased ropes for offshore aquaculture, which is...
January 24, 2020

DOE Announces Funding Opportunity For Advanced Vehicle Technologies Research

By Lynn L. Bergeson  On January 23, 2020, DOE announced that up to $133 million will be available for new and innovative advanced vehicle technologies research designed to increase affordable, efficient, and secure transportation energy. This Fiscal Year (FY) 2020 opportunity will be funded by DOE’s Office of Energy Efficiency and Renewable Energy (EERE) and supports priorities in: (1) advanced engine and fuel technologies; (2) lightweight materials; (3) new energy efficient mobility...
January 24, 2020

DOE Announces Launch Of The 2020 Tibbetts Awards Program

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On January 21, 2020, the U.S. Department of Energy’s (DOE) Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) Programs Office announced the launch of the U.S. Small Business Administration’s (SBA) Tibbetts Awards. The Tibbetts Awards recognize companies, organizations, and individuals exemplifying the best of the best in the SBIR and STTR programs. Named after the founder of the SBIR program, Roland...