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...
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...
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,...
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,...
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,...
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...
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....
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...
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...