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(FDA) Department of Health and Human Services (HHS) announced via the Federal Register the availability of a draft guidance for industry titled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.” The draft guidance is a revision of the 2015 guidance titled “Quality Considerations in Demonstrating Biosimilarity of a...
May 24, 2019
EERE Announces Grants For SBIR Innovation Projects
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...
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...
May 24, 2019
EPA Announces Section 5 Notices To Be Posted Without EPA Review — Filers Should Be Extra Diligent A
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...
May 23, 2019
Annual Green Chemistry and Engineering Conference/International Conference on Green and Sustainable Chemistry
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...
May 22, 2019
Registration Now Open For “TSCA: Three Years Later”
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: NIOSH congratulates Dr. Charles Geraci, Ph.D., Associate Director for Advanced Manufacturing, on being awarded the Henry F. Smyth, Jr. Award for his outstanding ability to recognize technical or scientific challenges that, when solved, benefit the industrial hygiene...
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...
May 17, 2019
Slides Available from ACS Webinar on Working Safely with Nanomaterials in the Laboratory
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: The panel members discussed the importance of managing products containing nanomaterials by integrating them into an existing lab safety program. They highlighted the...
May 17, 2019
Neste Announces Sustainable Menu For Zero Island
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...
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...
May 17, 2019
BETO Announces New Biobased Adhesive Material
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...
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...