Blogs

By Lynn L. Bergeson On May 22, 2019, DOE EERE announced Ohio State University’s year one win of the EcoCAR Mobility Challenge.  The EcoCAR competition, a four-year collegiate engineering competition focused on advancing energy technologies in the transportation sector, challenges universities to apply advanced propulsion systems, electrification, and other innovative technologies to transform their vehicles from design concept into reality.  Sponsored by General Motors and...

By Lynn L. Bergeson On May 22, 2019, Senator Ron Wyden (D-OR) introduced a bill (S. 1614) to amend the Clean Air Act (CAA) to modify the definition of “renewable biomass” under the Renewable Fuel Standard (RFS).  The CAA currently prohibits the use of biomass from federal lands in the making of renewable fuels as defined by the RFS.  The bill would allow the use of biomass from certain federal lands needing ecological restoration in the making of renewable fuels.  The...

By Lynn L. Bergeson On May 29, 2019, DOE EERE’s BETO reminded funding applicants of the upcoming deadline for concept paper submissions for a $79 million funding opportunity for bioenergy research and development (R&D): June 3, 2019. In support of DOE’s goal to provide consumers and businesses with a range of domestic energy options that are affordable, reliable, and secure, this funding opportunity announcement focuses on advancing BETO’s objectives. It includes biopower,...

By Lynn L. Bergeson On May 28, 2019, the U.S. Department of Energy (DOE) Office of Energy Efficiency and Renewable Energy’s (EERE) Bioenergy Technologies Office (BETO) announced that, in partnership with its National Laboratories, it is dedicating the months of May and June to the public exploration of renewable biomass feedstocks used for the production of biofuels, bioproducts, and biopower in support of the U.S. bioeconomy. This means that during the months of May and June 2019, BETO...

The Organization for Economic Cooperation and Development (OECD) has posted the following reports in its Series on the Safety of Manufactured Nanomaterials: Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour de Table: The Tour de Table compiles information provided by delegations on the occasion of the 19th meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in February 2019.  It aims to summarize relevant information on activities...

On May 21, 2019, the U.S. Environmental Protection Agency (EPA) announced that “to increase transparency and ensure information is easily accessible,” it has created a new web-based table of the most recent pesticide registration review actions that contains a list of the registration review actions EPA has taken over the current fiscal year, including the chemical name, docket number, and public comment period when applicable. EPA will update the table each time a registration...

On May 29, 2019, the California Department of Pesticide Regulation (DPR) released California Notice 2019-05: Changes to California Notice 2018-06: California-like Conditions for Terrestrial Field Dissipation Studies (Notice 2019-05), which updates the guidance in California Notice 2018-06: California-like Conditions for Terrestrial Field Dissipation Studies (Notice 2018-06).   Notice 2018-06, issued in January of 2018, provided to applicants for California registration...

On May 28, 2019, the California Department of Pesticide Regulation (DPR) posted a new presentation identifying the top ten agricultural pesticide use violations of 2018.  Its announcement states that “DPR suggests reviewing these common violations of pesticide laws and regulations to help ensure … compliance.”  The presentation, “Top 10 Agricultural Pesticide Use Violations of 2018,” is available here.  The violations are listed from the least common (number 10) to...

On May 16, 2019, the Swedish National Platform for Nanosafety (SweNanoSafe) announced the availability of eREACHNano, “a new web tool focused on helping small and medium-sized companies that may lack sufficient in-house expertise on the regulation covering nanomaterials.”  The web tool explains the data requirements for nanoforms according to the guideline documents of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, including:...

Please check out Bergeson & Campbell, P.C.'s (B&C®) new podcast "Inside OCSPP with EPA Assistant Administrator Alexandra Dapolito Dunn" on its All Things Chemical™ webpage.  In this podcast, Lynn L. Bergeson, Managing Partner of B&C, presents a very special guest, the Assistant Administrator for EPA's Office of Chemical Safety and Pollution Prevention (OCSPP):  Alexandra Dapolito Dunn.  As Assistant Administrator Dunn has spent just over...

Please check out Bergeson & Campbell, P.C.'s (B&C®) new podcast "Inside OCSPP with EPA Assistant Administrator Alexandra Dapolito Dunn" on its All Things Chemical™ webpage.  In this podcast, Lynn L. Bergeson, Managing Partner of B&C, presents a very special guest, the Assistant Administrator for EPA's Office of Chemical Safety and Pollution Prevention (OCSPP):  Alexandra Dapolito Dunn.  As Assistant Administrator Dunn has spent just over five...

I am so pleased to present a very special guest this week, the Assistant Administrator for EPA's Office of Chemical Safety and Pollution Prevention (OCSPP):  Alexandra Dunn.  Alex’s professional training could not be more perfect.  Alex is a lawyer and has practiced in both the private and non-profit sectors.  Alex has taught environmental law at several law schools and, while Dean of Environmental Law Programs at the Elisabeth Haub School of Law at Pace University, focused...

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...

By Lynn L. Bergeson 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...

By Lynn L. Bergeson 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...

By Lynn L. Bergeson 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...

By Lynn L. Bergeson 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...

By Lynn L. Bergeson 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...

By Lynn L. Bergeson 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...

By Lynn L. Bergeson 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,...

On June 11-13, 2019, the American Chemical Society (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...

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 the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (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...

Register Today 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), U.S. Environmental Protection Agency (EPA), and Lynn R. Goldman, Michael and Lori Milken Dean and...

Registration is now available for the National Nanotechnology Initiative’s (NNI) June 11, 2019, webinar on “Practical Applications of 15 Years of NanoEHS Research:  Measurements of Potential Ecotoxicological Risk.”  The speaker will be Dr. Elijah Petersen, National Institute of Standards and Technology (NIST), and Dr. Treye Thomas, U.S. Consumer Product Safety Commission (CPSC) and NNI Coordinator for Environmental, Health, and Safety (EHS) Research, will moderate.  The webinar will...

On May 8, 2019, the California Environmental Protection Agency (CalEPA) announced that the California Department of Pesticide Regulation (DPR) will be initiating cancellation proceedings of chlorpyrifos.  In its press release, CalEPA states that the decision to commence cancellation proceedings “follows mounting evidence, including recent findings by the state’s independent Scientific Review Panel on Toxic Air Contaminants, that the pesticide causes serious health...

On May 17, 2019, the National Institute for Occupational Safety and Health (NIOSH) announced that its presentations at the May 20-22, 2019, American Industrial Hygiene Conference & Expo (AIHce EXP) include: PDC 601: How to Assess and Manage Nanomaterial RisksPresenters:  Laura Hodson, Adrienne EastlakeType:  Professional Development Course, May 19, 2019; 119 — An Evaluation of Engineered Nanomaterial Safety Data Sheets Post [Globally Harmonized System of...

On May 9, 2019, the U.S. Environmental Protection Agency (EPA) announced that it would soon be making available a signed action signed on May 6, 2019, that identifies chemical substances for inactive designation according to the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements rule.  The pre-publication version of the notice is available here.  Specifically, EPA states that the signed action is a companion to the first version of the TSCA...

The American Chemical Society (ACS) has posted the slides from its May 16, 2019, webinar on working safely with nanomaterials in the laboratory.  Chuck Geraci, Associate Director for Emerging Technologies at the National Institute for Occupational Safety and Health (NIOSH), moderated a panel including: Ken Kretchman, Director of Environmental Health Safety, North Carolina State University; Craig Merlic, Professor of Chemistry, University of California, Los Angeles (UCLA); and...

By Lynn L. Bergeson On May 15, 2019, Neste, a Biobased and Renewable Products Advocacy Group (BRAG®) member, announced the introduction of a sustainable menu to be served on Zero Island. A Neste initiative to find sustainable solutions for building a fossil-free future for an island, Zero Island is located in the Swedish archipelago. The newly developed menu, also known as the Zero Menu, has been developed with renowned chef Jonas Svensson, taking into consideration not only what is served...

By Lynn L. Bergeson On May 15, 2019, DOE EERE’s BETO announced the deadline for concept paper submissions for a $79 million funding opportunity for bioenergy research and development (R&D): June 3, 2019. This funding opportunity includes biopower, biofuels, and bioproducts, aiming to reduce the price of drop-in biofuels, lower the cost of biopower, and enable high-value products from waste or biomass resources. The opportunity includes ten topic areas: Cultivation Intensification...

By Lynn L. Bergeson On May 14, 2019, the U.S. Department of Energy (DOE) Office of Energy Efficiency and Renewable Energy’s (EERE) Bioenergy Technologies Office (BETO) announced that scientists at the Oak Ridge National Laboratory (ORNL) have developed a new, plant-derived, stretchy material that outperforms the adhesiveness of the natural chemical that gives mussels the ability to stick to rocks and ships. Composed of lignin and epoxy, the biobased material has the ability to self-heal...

By Lynn L. Bergeson On May 13, 2019, the U.S. Food and Drug Administration (FDA) issued in final guidance designed to assist sponsors in demonstrating that a proposed biological product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement. This would mean that an abbreviated licensure pathway would be created, where biological products shown to be biosimilar to or interchangeable with an FDA-licensed biological reference product may be...

On May 16, 2019, the U.S. Environmental Protection Agency (EPA) announced that it was seeking comment on its Draft Revised Method for National Level Endangered Species Risk Assessment Process for Biological Evaluations of Pesticides (Draft Revised Method).  84 Fed. Reg. 22120.  It also announced that it would host a public meeting on June 10, 2019, in which it will present the Draft Revised Method and provide an additional opportunity for the public to provide...

On May 16, 2019, the U.S. Environmental Protection Agency (EPA) announced that it has updated its Statistics for the New Chemicals Review Program under TSCA web page, which is under EPA’s Reviewing New Chemicals under the Toxic Substances Control Act (TSCA) section, to make it easier to find and understand how many chemicals are in each stage of the new chemicals review process.  The revised web page now includes a flow chart showing the number of new chemicals cases...

On May 15, 2019, the U.S. Environmental Protection Agency (EPA) announced that it is extending the comment period for the Draft Guidance for Plant Regulator Label Claim, Including Plant Biostimulants that was made available on March 27, 2019.  94 Fed. Reg. 21773.  The original comment date was May 28, 2019; comments are now due by July 28, 2019, in Docket No. EPA-HQ-OPP-2018-0258.  Several trade groups and a number of individual companies had requested an...

On May 9, 2019, the U.S. Environmental Protection Agency (EPA) announced it will hold the first meeting of the Science Advisory Committee on Chemicals (SACC) under the Toxic Substances Control Act (TSCA), for Pigment Violet 29 (PV29), the first chemical of the initial ten chemicals undergoing review, on June 18-21, 2019, from 9:00 a.m. to 5:30 p.m. (EDT) at the Holiday Inn Rosslyn at Key Bridge, Rosslyn Ballroom, 1900 North Fort Myer Drive, Arlington, Virginia.  84 Fed....

The European Commission’s (EC) Joint Research Center (JRC) announced on May 10, 2019, publication of an article entitled “Measuring particle size distribution of nanoparticle enabled medicinal products, the joint view of EUNCL and NCI-NCL.  A step by step approach combining orthogonal measurements with increasing complexity” in the April 10, 2019, issue of the Journal of Controlled Release.  JRC, in close collaboration with researchers from the French Commissariat...

The U.S. Environmental Protection Agency (EPA) released on March 20, 2019, a list of 20 chemicals that EPA has suggested as candidates for high priority designation under the Toxic Substances Control Act (TSCA), as reported in our March 22, 2019, memorandum "EPA Releases List of 40 Chemicals Undergoing Prioritization for Risk Evaluation."  Should those chemicals go forward as high priority, they will be subject to risk evaluation under TSCA Section 6.  Industry stakeholder...

By Lynn L. Bergeson From July 23-24, 2019, the Food and Drug Law Institute (FDLI) will be hosting the Introduction to Drug, Biologics, and Biosimilars Law and Regulation conference in Boston, MA. The conference will cover an overview of administrative agencies that impact these industries and how they interact with the U.S. Food and Drug Administration (FDA). It will also include sessions on the development of drug and biological products, FDA’s review and approval of marketing...

By Lynn L. Bergeson On May 3, 2019, DOE announced over $79 million in funding for bioenergy R&D, which includes biofuels, bioproducts, and biopower. Under Secretary of Energy, Mark W. Menezes, stated that the FOA will contribute to ensure the nation’s competitive advantage in the bioeconomy and offer more energy choices. The FOA’s objectives are to reduce the price of drop-in biofuels, lower the cost of biopower, and enable high-value products from waste or biomass resources. The...

By Lynn L. Bergeson On May 2, 2019, DOE’s Office of Energy Efficiency and Renewable Energy (EERE) announced funding of approximately $11 million for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Phase II research projects. Small businesses that demonstrated technical feasibility for innovations during Phase I were required to compete for Phase II funding. Eleven projects have been awarded the funds, which will be used to build prototypes or...

By Lynn L. Bergeson On May 8, 2019, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service’s (APHIS) Biotechnology Regulatory Services (BRS) announced the pilot launch of its new online permitting system: APHIS eFile. Launching on July 23, 2019, APHIS will be inviting, at the end of May, those who have been issued a BRS permit or notification in the past two years to apply for the pilot program. The plan is for BRS to transition fully to APHIS eFile in...

By Lynn L. Bergeson From March 4-8, 2019, DOE’s Bioenergy Technologies Office (BETO) hosted the 2019 Project Peer Review in Denver, CO. According to BETO, this was one of the largest Peer Review events in BETO history, with almost 600 attendees present. The purpose of the event was for bioenergy researchers to present results from early-stage R&D projects across BETO’s technology areas. These presentations, as of May 2, 2019, have been made available online for public access, and...

By Lynn L. Bergeson On April 30, 2019, 15 U.S. Senators signed and submitted a letter to the U.S. Environmental Protection Agency (EPA) Administrator, Andrew Wheeler, urging him to protect U.S. consumers and account for the ethanol blend wall when setting annual target volumes under the Renewable Fuel Standards (RFS) requirements. According to the letter, a decrease in consumer demand for gasoline has occurred since the RFS Program was passed into law. Instead of the original 170 billion gallons...

By Lynn L. Bergeson On May 7, 2019, Energy Secretary Rick Perry announced a U.S. Department of Energy (DOE) funding opportunity of up to $89 million in support of innovative, advanced manufacturing research and development (R&D) projects. The opportunity aims to tackle key DOE priorities, which include domestic manufacturing for energy storage. Perry stated that “[e]mbracing new technologies that drive innovation in American manufacturing is the key to creating real-world progress that...

The Nanotechnology Industries Association (NIA), a “cross-sectoral, responsible voice for nanotechnology value chains and the global commercial eco-system,” hosts frequent webinars and then posts the webinars on its YouTube channel.  On May 7, 2019, NIA held a webinar on “Nano in Action:  Nanosafety.”  Participants heard about the latest research and support tools intended to advance the development of safe materials from speakers involved in human and environmental safety research...

On May 6, 2019, the U.S. Environmental Protection Agency (EPA) announced it was releasing its Proposed Interim Registration Review Decision (PID) for glyphosate acid and its various salt forms.  84 Fed. Reg. 19782.  In the PID, EPA states that it “did not identify any human health risks from exposure to any use of glyphosate” but did identify “potential risk to mammals and birds” within the application area or areas near the application area and “potential...

On April 29, 2019, the German Federal Institute for Risk Assessment (BfR) announced InnoMat.Life, a joint research project to establish criteria for an efficient assessment of the human health and environmental risks of novel (nano) materials.  The Federal Ministry of Education and Research is providing 2.22 million euro to fund the project, which will be coordinated by BfR and includes ten partners from public authorities, academia, and industry.  BfR states that until now, nanosafety...

On May 3, 2019, the U.S. Environmental Protection Agency (EPA) announced it was seeking comments on the experts who are candidates to serve as ad hoc panelists for the review of EPA’s Draft Product Performance Test Guidelines OCSPP 810.3300:  Treatments Topically Applied to Pets to Control Certain Invertebrate Ectoparasitic Pests.  The candidate list is available on EPA’s Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel...

The Organization for Economic Cooperation and Development’s (OECD) April 2019 issue of its Chemical Safety and Biosafety Progress Report includes an update on OECD’s work to determine the safety of manufactured nanomaterials.  The Report notes that the applicability of OECD Test Guidelines for nanomaterials continues to be a major concern of the work of the Working Party on Manufactured Nanomaterials (WPMN).  WPMN agreed to work on three new projects related to testing...