Bergeson & Campbell, P.C. (B&C®) is a proud sponsor of the Environmental Law Institute’s (ELI) GreenTech Conference, bringing together leaders from some of the world’s most innovative companies to engage with policymakers, lawmakers, technologists, and non-governmental organizations (NGO) to explore environmental protection in an era of transformative technological change. Dr. Andrey J. Zarur, CEO and President of GreenLight Biosciences, will discuss using targeted...
August 16, 2019
WBC To Host Small Business Awards Ceremony — Applications Open
By Lynn L. Bergeson On September 18, 2019, the D.C. Women’s Business Center (WBC) and the National Community Reinvestment Coalition (NCRC) will host the 2019 Just Ambitious Small Business Awards. The awards honor woman entrepreneurs who have demonstrated achievements, innovation, and vision in support of the District of Columbia’s small business community and economic vitality. WBC and NCRC are now accepting applications for the 2019 awards in the following categories: NCRC Community...
August 16, 2019
FDA Announces Biosimilar User Fee Rates For FY 2020
By Lynn L. Bergeson On August 2, 2019, the U.S. Department of Health and Human Services (HHS)’s Food and Drug Administration (FDA) announced via the Federal Register the rates for biosimilar user fees for FY 2020. The Federal Food, Drug, and Cosmetic Act (FFDCA) authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar...
August 16, 2019
EPA OIG Publishes Report On Its Compliance With The Law
By Lynn L. Bergeson On August 9, 2019, the U.S. Environmental Protection Agency (EPA) published a report on its compliance with the law titled EPA Exceeded the Deregulatory Goals of Executive Order 13771. Executive Order 13771, titled Reducing Regulation and Controlling Regulatory Costs, includes regulatory savings goals for FYs 2017 and 2018, EPA’s deregulatory actions, and its compliance with the Office of Management and Budget’s (OMB) goal-setting requirements. EO 13771 was issued...
By Lynn L. Bergeson On August 12, 2019, the U.S. Department of Energy (DOE) announced its Fiscal Year (FY) 2020 Phase I Release 1 funding opportunity for the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. In its announcement, DOE encourages small businesses with strong research capabilities in science or engineering to apply. DOE’s Funding Opportunity Announcement (FOA) includes participation from its Advanced Scientific Computing...
August 15, 2019
EPA Names Dr. Lynn Dekleva as Associate Deputy Assistant Administrator for New Chemicals
The U.S. Environmental Protection Agency (EPA) has named Dr. Lynn Dekleva as Associate Deputy Assistant Administrator for New Chemicals. Dr. Dekleva joined EPA in October 2018 as a Science Advisor, working to streamline and improve EPA’s processes and timeliness concerning the review of new chemicals under the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Dr. Dekleva is an environmental engineer with degrees in environmental microbiology, medical technology, and biology....
August 14, 2019
Registration Open for NNI Webinar on Respiratory Effects of Engineered Nanomaterials in Relation to Physicochemical Properties
Registration has begun for the National Nanotechnology Initiative’s (NNI) September 10, 2019, webinar on “Respiratory Effects of Engineered Nanomaterials in Relation to Physicochemical Properties.” The speaker will be Dr. Junfeng (Jim) Zhang, Nicholas School of the Environment and Duke Global Health Institute, Duke University, and Dr. William Boyes, U.S. Environmental Protection Agency, will moderate. NNI states that the interaction between engineered nanomaterials...
August 13, 2019
German Chemical Industry Association Publishes Guidance on Safe Recovery and Disposal of Wastes Containing Nanomaterials
On August 1, 2019, the German Chemical Industry Association (VCI) announced the availability of a guidance document on the safe recovery and disposal of wastes containing nanomaterials. According to VCI, wastes containing nanomaterials can be generated in the production or use of nanomaterials. Such wastes can occur in the production of substances, mixtures, or products; in the processing and repair of products; or in the disposal of products at the end of their life...
Section 5(g) of the Toxic Substances Control Act (TSCA) requires the U.S. Environmental Protection Agency (EPA) to publish a statement of its findings after its review of TSCA Section 5(a) notices when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment. On August 12, 2019, EPA published a statement of its findings for June 2019. 84 Fed. Reg. 39828. EPA notes that such statements apply...
August 9, 2019
Pace Environmental Law Review Issues Call for Papers
The Pace Environmental Law Review (PELR) will publish a themed issue this winter concerning issues in the development and regulation of nanotechnology and biotechnology. Articles or essays should discuss the intersection between nanotechnology and/or biotechnology and environmental issues. PELR encourages submitters to take an interdisciplinary approach to nanotechnology and/or biotechnology from legal and other perspectives, including technology, science, public health, economics, or...
On August 7, 2019, the League of United Latin American Citizens, Pesticide Action Network North America, Natural Resources Defense Council, and other petitioners (Petitioners) filed a new petition in the Ninth Circuit Court of Appeals seeking judicial review of United States Environmental Protection Agency (EPA) orders denying their request that EPA revoke all tolerances and cancel all registrations for chlorpyrifos. On August 8, 2019, New York, California, Hawaii, Maryland, Vermont,...
The U.S. Environmental Protection Agency (EPA) released on August 9, 2019, the draft risk evaluation for 1-bromopropane (1-BP), the fourth of the first ten chemicals undergoing risk evaluation under the amended Toxic Substances Control Act (TSCA). EPA made the following initial determinations on risk: Unreasonable risks to workers, occupational non-users, and consumers under certain conditions of use. EPA notes that these initial determinations are not its final determinations...
By Lynn L. Bergeson On August 6, 2019, the Utility Workers Union of America (UWUA) announced its partnership with The Power for America Training Trust Fund (P4A) for the launch of a renewable energy specialist apprenticeship program. Certified by the U.S. Department of Labor (DOL), the program aims at assisting individuals with a path to employment for highly demanded jobs in the renewable energy sector. Under this program, individuals will be taught specialized skills in the fields of solar...
August 9, 2019
MDA Announces Grants To Expand Biofuel Access And Production
By Lynn L. Bergeson On August 6, 2019, the Minnesota Department of Agriculture (MDA) announced four grants aiming to expand biofuel access and production to advance the state’s renewable energy efforts. Awarded to four recipients by MDA’s Agricultural Growth, Research and Innovation (AGRI) Program, the grants total more than $500,000. One Bioenergy/Biochemical Pilot Project Grant was awarded, providing funding to advance bioenergy and biochemical production technology to a commercial...
August 9, 2019
Toomey-Feinstein RESTORE Act Would Abolish Ethanol Mandate
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On July 26, 2019, U.S. Senator Pat Toomey (R-PA) announced that he is working with U.S. Senator Dianne Feinstein (D-CA) on the Restore Environmental Sustainability to Our Renewable Energy (RESTORE) Act. In an effort to end what Toomey describes as an “egregious form of corporate welfare that hurts the environment and drives up the cost of everything,” the RESTORE Act would abolish the corn ethanol mandate under the Renewable Fuel...
August 9, 2019
DOE Announces Funding For Innovative Research Technologies For Trucks, Off-Road Vehicles, And The Fu
By Lynn L. Bergeson On July 29, 2019, the U.S. Department of Energy (DOE) announced that $50 million of funding is now available for innovative research of technologies for trucks, off-road vehicles, and gaseous fuels research. Funded through DOE’s Office of Energy Efficiency and Renewable Energy (EERE), “it is important our trucking industry has access to advanced technologies, such as electrification and fuel cells, as a way to move goods efficiently and economically,” stated...
On August 1-2, 2019, the National Nanotechnology Initiative (NNI) held “The Future of the NNI: A Stakeholder Workshop.” The NNI has played a pivotal role in fostering and advancing a dynamic nanotechnology ecosystem in support of the initiative’s four goals: advance world-class research; foster commercialization; develop and sustain research infrastructure; and support the responsible development of nanotechnology. Building on this foundation, experts from the...
As reported in our February 1, 2019, blog item, the American Conference of Governmental Industrial Hygienists (ACGIH®) Threshold Limit Values for Chemical Substances (TLV®-CS) Committee included carbon nanotubes on its 2019 list of chemical substances and other issues under study. Being placed on the under study list indicated that the TLV®-CS Committee had selected carbon nanotubes for development of a threshold limit value (TLV®). On July 30, 2019,...
On August 2, 2019, the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) announced that it has decided to reduce the Food Quality Protection Act (FQPA) safety factor for infants and children for pyrethroids from its current value of 3X to a new value of 1X. This decision is based on a July 1, 2019, OPP report entitled “USEPA Office of Pesticide Programs’ Re-evaluation of the FQPA Safety Factor for Pyrethroids: Updated Literature and CAPHRA Program Data...
The U.S. Environmental Protection Agency (EPA) announced on August 1, 2019, that it is making additional information about new chemical notices available on its website. The new web page, “Statistics for the New Chemicals Review Program under TSCA,” allows users to view and search monthly updates for any active Premanufacture Notice (PMN), Significant New Use Notice (SNUN), and Microbial Commercial Activity Notice (MCAN) of interest by case number. Users can also download a...
August 2, 2019
Nordic Council of Ministers Publishes Report on Applicability of GHS Classification Criteria to Nanomaterials
In May 2019, the Nordic Council of Ministers published a working paper entitled The applicability of the GHS classification criteria to nanomaterials. The goal of the project was to review the applicability of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) to manufactured nanomaterials, taking into account the progress of international scientific work. The report notes that the Organization for Economic Cooperation and Development (OECD) Working...
The U.S. Environmental Protection Agency (EPA) announced on August 1, 2019, that it is making additional information about new chemical notices available on its website. The new web page, “Statistics for the New Chemicals Review Program under TSCA,” allows users to view and search monthly updates for any active Premanufacture Notice (PMN), Significant New Use Notice (SNUN) and Microbial Commercial Activity Notice (MCAN) of interest by case number. Users can also download a...
August 2, 2019
EPA Holds Public Hearing On RVO Proposed Rule Under RFS
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On July 31, 2019, EPA held a public hearing in Ypsilanti, MI, to obtain stakeholders’ input on its proposed rule to set Renewable Fuel Standard (RFS) 2020 renewable volume obligations (RVO) and 2021 biomass-based diesel volume. Among the various stakeholders providing oral statements to EPA were representatives from Growth Energy, the National Corn Growers Association (NCGA), the Renewable Fuels Association (RFA), Hero BX, and the National...
August 2, 2019
DOE Announces Winners Of AIM Onshore Competition
By Lynn L. Bergeson On July 29, 2019, the U.S. Department of Energy (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced the winners of the American Inventions Made Onshore (AIM Onshore) Prize Competition. Opened in 2018, this competition was an initiative aimed at closing the gap between American innovators who develop new energy technologies and manufacturers who produce them. Selected among four finalists, two winners were awarded for their innovative proposals. In first...
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On July 25, 2019, Bergeson & Campbell, P.C. (B&C®) hosted a webinar titled “New TSCA at 3: Key Implementation Issues” led by B&C’s Managing Partner, Lynn L. Bergeson. Webinar speakers included the U.S. Environmental Protection Agency’s (EPA) Assistant Administrator, Alexandra Dapolito Dunn, and B&C’s Director of Chemistry and former EPA staff, Richard E. Engler, Ph.D. Assistant Administrator...
August 2, 2019
Zero Waste Act Introduced By U.S. Representative Omar
By Lynn L. Bergeson On July 25, 2019, U.S. Representative Ilhan Omar (D-MN) introduced the Zero Waste Act, which intends to create a federal grant program to invest in solutions that address waste. The bill, if passed, will go towards recycling infrastructure or the creation of partnerships with local businesses focused on waste reduction. Representative Omar believes the bill will not only create jobs, but also reduce greenhouse gas (GHG) emissions, grow domestic manufacturing, clean waterways,...
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on May 15, 2019, announcing the availability of a signed action identifying chemical substances for inactive designation according to the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements rule. 84 Fed. Reg. 21772. The signed action, dated May 6, 2019, initiated a 90-day period after which substances identified as inactive will be designated as inactive. Inactive...
On July 29, 2019, the U.S. Environmental Protection Agency (EPA) published in the Federal Register its proposed rule intended to reduce exposures to certain chemicals that are persistent, bioaccumulative, and toxic (PBT). 84 Fed. Reg. 36728. EPA identified five chemicals pursuant to Section 6(h) of the Toxic Substances Control Act (TSCA): decabromodiphenyl ether (DecaBDE); phenol, isopropylated phosphate (3:1) (PIP (3:1)), also known as tris(4-isopropylphenyl) phosphate;...
On July 3, 2019, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) published its final opinion on the solubility of synthetic amorphous silica (SAS). The EC asked whether SCCS considers that SAS materials are soluble (100 milligram per liter (mg/L) or higher) or degradable/non-persistent in biological systems in light of the nanomaterial definition of the Cosmetics Regulation. Having considered the data provided in this dossier and that available in published...
On July 12, 2019, the U.S. Environmental Protection Agency (EPA) announced in a Decision Memorandum that it has registered new uses and restored previously registered uses for sulfoxaflor. EPA has approved the use of sulfoxaflor on alfalfa, corn, cacao, grains (millet, oats), pineapple, sorghum, teff, teosinte, tree plantations, and restored the uses on citrus cotton, cucurbits (squash, cucumbers, watermelons, some gourds), soybeans, and strawberries. EPA states that...
July 26, 2019
Brazil Approves Measures To Clarify Agrochemical Classification In Accordance With GHS
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On July 23, 2019, the Agencia Nacional de Vigilancia Sanitaria (ANVISA -- National Sanitation Surveillance Agency) in Brazil approved measures that clarify the toxicological classification of agrochemicals. Under the approved rules, the evaluation criteria of agrochemicals’ toxicity categories are established and label requirements are updated to include clearer warnings and pictograms. The changes established by ANVISA were based on the...
July 26, 2019
U.K. Announces Open Consultation Call For Evidence To Develop Standards For Compostable, And Biobase
By Lynn L. Bergeson On July 22, 2019, the United Kingdom (U.K.) Department for Business, Energy and Industrial Strategy and Department for Environment, Food and Rural Affairs announced an open consultation for the development of standards for biodegradable, compostable, and biobased plastics. The consultation welcomes views from any interested parties to identify gaps and provide expert advice on: The overall sustainability of biobased and biodegradable plastic products in comparison with other...
By Lynn L. Bergeson On July 23, 2019, DOE announced its recognition of Gundersen Health System (Gundersen), a Better Buildings Alliance (BBA) partner, for its portfolio-wide energy efficiency advances at its Sparta Clinic in Sparta, Wisconsin. Gundersen, as part of its Envision Sustainability Program, continues to pursue energy efficiency through low-energy design standards and renewable energy combined. According to DOE, since 2008, Gundersen has saved over $11 million dollars through energy...
July 26, 2019
DOE EERE Continues To Support Small Businesses
By Lynn L. Bergeson On July 22, 2019, the U.S. Department of Energy (DOE) Office of Energy Efficiency and Renewable Energy (EERE) highlighted small businesses funding under the Small Business Innovation Research (SBIR) program. Having received $43.6 million in funding from DOE thus far, small businesses continue to grow as DOE announces Phase II awards. Last week, DOE announced Phase II Release grants that demonstrate commercial feasibility for innovations during the second phase of small...
July 25, 2019
Notification Requirements for Methylene Chloride Paint Removers Will Take Effect August 26
In the March 27, 2019, Federal Register, the U.S. Environmental Protection Agency (EPA) issued its final regulatory rulemaking that prohibits the manufacture (including import), processing, and distribution of methylene chloride for consumer paint and coating removal. 84 Fed. Reg. 11420. See Bergeson & Campbell, P.C.’s memorandum, “EPA Bans Consumer Sales of Methylene Chloride Paint Removers, Seeks Comment on Program for Commercial...
July 24, 2019
WEBINAR — New TSCA At 3: Key Implementation Issues, Thursday, July 25, 2019, 1:00 p.m. – 2:00 p.m. (EDT)
Bergeson & Campbell, P.C. (B&C®) is pleased to present the complimentary webinar “New TSCA at 3: Key Implementation Issues.” The webinar will drill down on key implementation challenges facing industry and the U.S. Environmental Protection Agency (EPA) three years into navigating the legal, regulatory, and science policy issues arising under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). Alexandra Dapolito Dunn, Assistant Administrator,...
The House Science, Space, and Technology Subcommittee on Research and Technology will hold a hearing on “Benign by Design: Innovations in Sustainable Chemistry” on July 25, 2019. Witnesses will include: Dr. Tim Persons, Chief Scientist and Managing Director, Science, Technology Assessment, and Analytics, U.S. Government Accountability Office (GAO); Dr. John Warner, President and Chief Technology Officer, Warner Babcock Institute for Green Chemistry; Dr. Julie...
July 24, 2019
NIOSH Report on Occupational Exposure Banding Process for Chemical Management Addresses Nanofibers and Nanoparticles
The National Institute for Occupational Safety and Health (NIOSH) announced on July 10, 2019, the availability of a new Technical Report, The NIOSH Occupational Exposure Banding Process for Chemical Risk Management. NIOSH describes occupational exposure banding as “a voluntary process that assigns each chemical to a category based on its toxicity and any negative health outcomes associated with exposure to that chemical.” The Technical Report “provides a process...
The European Chemicals Agency (ECHA) announced on July 3, 2019, that several new features and improvements are now publicly available in its chemicals database, including new information in substance Infocards. ECHA has updated the substance Infocards with a new nanomaterial form section that shows whether the substance is placed on the European Economic Area (EEA) market in nanoform and provides links to the European Union (EU) Observatory for Nanomaterials (EUON). As...
On July 18, 2019, the U.S. Environmental Protection Agency (EPA) issued a pre-publication version of a Federal Register notice announcing a final order denying the Pesticide Action Network North America’s (PANNA) and the Natural Resources Defense Council’s (NRDC) 2007 Petition requesting that EPA revoke all tolerances and cancel all registrations for chlorpyrifos (Order). This Order constitutes final Agency action denying all of the Petitioners’ objections to EPA’s...
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on June 28, 2019, announcing that the EPA Safer Choice Program is accepting submissions for its 2019 Safer Choice Partner of the Year Awards. 84 Fed. Reg. 31066. The Safer Choice Program partners with businesses and others to help consumers and commercial buyers identify products with safer chemical ingredients, “without sacrificing quality or performance.” Toward this end, according to EPA, the Safer...
By Lynn L. Bergeson On July 8, 2019, the National Corn Growers Association (NCGA) announced the winners of the Consider Corn Challenge II, a challenge intended to highlight the range of biobased materials that can be produced with field corn feedstock. The three winners included: ExoPolymer, Inc. for a plan to create a new profile of customizable, polysaccharide-based hydrocolloids that are domestically produced by microbial fermentation using corn sugar as a feedstock. These new hydrocolloids...
July 19, 2019
House Renewable Energy & Energy Efficiency Caucus Co-Hosts Annual Renewable Energy Policy Forum
By Lynn L. Bergeson On July 12, 2019, the House Renewable Energy & Energy Efficiency Caucus and the Environmental and Energy Study Institute co-hosted the 22nd Annual Congressional Renewable Energy and Energy Efficiency EXPO and Policy Forum. The forum brought together government agencies, businesses, and trade associations to showcase renewable energy technologies and discus sustainable public policy options. Ruth McCormick, Director, Federal and State Affairs, Business Council for...
By Lynn L. Bergeson On July 10, 2019, the U.S. Department of Energy (DOE) announced that researchers at Pacific Northwest National Laboratory (PNNL) have developed a model that predicts commercial biocrude outcomes from algae hydrothermal liquefaction (HTL) significantly more accurately than previous analyses. “Techno-economic uncertainty quantification of algal-derived biocrude via hydrothermal liquefaction,” funded by DOE’s Energy Efficiency and Renewable Energy’s...
July 19, 2019
Bipartisan Patent Bill Introduced To House And Senate That Would Protect Biotechnology Innovation
By Lynn L. Bergeson On July 10, 2019, Senators Chris Coons (D-DE) and Tom Cotton (R-AR) and Representatives Steve Stivers (R-OH) and Bill Foster (D-IL) reintroduced the STRONGER (Support Technology & Research for Our Nation’s Growth and Economic Resilience) Patents Act of 2019. This legislation, an improvement on legislation introduced last year under the same name, would reform the inter partes post-grant review process, ensure all fees paid to the Patent and Trademark Office (PTO)...
Earlier this month, David Fischer joined the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) as a Deputy Assistant Administrator. Prior to joining EPA, Mr. Fischer was most recently a partner of legal and regulatory affairs at IBEX Partners LLC, a public affairs firm. Before his partnership at IBEX, Mr. Fischer held several senior positions at the American Chemistry Council in its Office of General Counsel and Chemical Products and...
July 17, 2019
EFSA Publishes Scientific Opinion on Proposed Amendment to EU Specifications for Titanium Dioxide (E 171)
On July 12, 2019, the European Food Safety Authority (EFSA) published in the EFSA Journal its “Scientific opinion on the proposed amendment of the EU specifications for titanium dioxide (E 171) with respect to the inclusion of additional parameters related to its particle size distribution.” The opinion addresses the assessment of data provided by interested business operators in support of an amendment of the European Union (EU) specifications for titanium dioxide (E 171)...
July 15, 2019
EPA, Intervenors File Supplemental Briefs in Case Challenging EPA’s Prioritization and Risk Evaluation Rules
On June 28, 2019, the U.S. Environmental Protection Agency (EPA) filed its response to the non-governmental organizations’ (NGO) supplemental brief in a case challenging EPA’s prioritization and risk evaluation rules. Safer Chemicals, Healthy Families v. EPA, No. 17-72260. According to EPA, petitioners “have plausibly alleged standing to challenge only the definitional interpretation of ‘conditions of use’ and the two provisions still subject to EPA’s motion for voluntary...
The Institute of Technology Assessment of the Austrian Academy of Sciences has published a NanoTrust Dossier entitled “Nano-registries: Country-specific Solutions for Nano-regulation.” While the European Union (EU) has declined to create an EU-wide nano-registry, several EU Member States have adopted their own nano-registries. Belgium and France created stand-alone nano-registries, but Norway and Sweden added a “tick box” for nano to their product registries. Denmark established...
July 12, 2019
Canadian Government Launches Plastics Challenge For The Development Of Biobased Foam Insulation
By Lynn L. Bergeson On June 27, 2019, the Government of Canada’s Natural Resources Canada (NRCan) opened the application process for a grant to develop next generation biobased foam insulation products. Called the Plastics Challenge, this funding opportunity seeks solutions that result in foam insulation products (either spray foam or rigid foam board) that: Are predominantly derived from Canadian forest residue; Have similar insulation values (within 20 percent) as currently...