Blogs

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on November 15, 2018, announcing the availability of and seeking public comment on the first draft chemical risk evaluation under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg).  The draft risk evaluation for Colour Index (C.I.) Pigment Violet 29 is intended to determine whether C.I. Pigment Violet 29 presents an...

The European Union (EU) released the EU US Roadmap Nanoinformatics 2030 on November 15, 2018.  The Roadmap, developed by scientists from the EU, U.S., and a few other countries, is a compilation of state-of-the-art commentaries from multiple interconnecting scientific fields, combined with issues involving nanomaterial risk assessment and governance.  The Roadmap states that in bringing these issues together into a coherent set of milestones, the authors address three recognized challenges...

The U.S. Senate Committee on Environment and Public Works (EPW) will hold a hearing on the nomination of Alexandra Dapolito Dunn to be the U.S. Environmental Protection Agency (EPA) Assistant Administrator (AA) for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) on Thursday, November 29, 2018, at 10:30 a.m. (EST) in room 406 of the Dirksen Senate Office Building.  The hearing will be webcast and will be available on the EPW Committee website. Ms. Dunn has...

By Lynn L. Bergeson On November 13, 2018, the European Parliament (EP) announced its approval of new targets for renewables and energy efficiency rates to be achieved by 2030.  According to the press release, “by 2030, energy efficiency in the [European Union (EU)] has to have improved by 32.5%, whereas the share of energy from renewables should be at least 32% of the EU’s gross final consumption.”  Highlighting the crucial role of second generation biofuels...

By Lynn L. Bergeson On November 13, 2018, the U.S. Environmental Protection Agency (EPA) announced the submission for review of an information collection request (ICR) on the Renewable Fuel Standard (RFS) Program to the Office of Management and Budget (OMB).  83 Fed. Reg. 56319.  The Federal Register notice states that purpose of this submission is to obtain OMB approval of an ICR that consolidates some existing collections.  By consolidating the existing collections and...

By Lynn L. Bergeson On November 9, 2018, DOE’s Assistant Secretary for Fossil Energy, Steven Winberg, announced the new director of the DOE National Energy Technology Laboratory (NETL): Brian J. Anderson, Ph.D.  Dr. Anderson will serve, as of November 11, 2018, as the new director of NETL.  Dr. Anderson founded and headed the West Virginia University Energy Institute prior to taking the role of NETL director.  Winberg highlighted that Dr. Anderson’s background in...

By Lynn L. Bergeson On November 13, 2018, the U.S. Department of Energy (DOE) announced the topic areas for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) for research and development (R&D) proposals for funding by the Office of Energy Efficiency and Renewable Energy (EERE) in fiscal year (FY) 2019.  The topics include:  advanced manufacturing; bioenergy; buildings; fuel cells; geothermal; solar; vehicles; water; and wind.  They also...

On November 7, 2018, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published the tenth revision of The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation.  The guidance contains relevant information on the different aspects of testing and safety evaluation of cosmetic substances in Europe.  The document states that it is designed to provide guidance to public authorities and to the cosmetic industry to...

On November 7, 2018, the U.S. Environmental Protection Agency (EPA) announced that it was ordering Pool Water Products Inc. to stop selling an improperly registered pesticide, ALL CLEAR 3” Jumbo Chlorinating Tablets.  The announcement states that even though the ALL CLEAR 3” Jumbo Chlorinating Tablets product was registered with EPA, Pool Water Products was selling and distributing an unregistered version of the product made in China that has not been evaluated by EPA. EPA’s...

In September 2018, the U.S. Environmental Protection Agency (EPA) issued a consent agreement with Chevron USA, Inc. (Chevron) related to an alleged violation of the Toxic Substances Control Act (TSCA).  EPA’s issuance of a consent agreement for the alleged TSCA violation is not especially newsworthy.  Neither is the agreed upon penalty for the violation, which could be considered minor based on the penalty provisions allowed under TSCA.  What is newsworthy here is that...

By Lynn L. Bergeson On October 31, 2018, the Canadian National Energy Board released its 2018 report on energy supply and demand projections to 2040: “Canada’s Energy Future 2018: An Energy Market Assessment.” Based on a set of assumptions about technology, energy, climate, human behaviors, and the structure of the economy, the assessment identifies five key findings as follows: Canada’s energy demand growth is slowing, while the sources to meet these demands are becoming...

By Lynn L. Bergeson On November 6, 2018, Neste, a BRAG member, announced its partnership with Clariant to develop new sustainable material solutions. While Clariant concentrates on specialty chemicals, Neste consists of one of the leading companies providing renewable diesel and drop-in chemical solutions. In the announcement, Neste outlined the phases of the partnership, as follows:   Phase 1: The companies will start to replace fossil-fuel based ethylene and propylene with monomers from...

By Lynn L. Bergeson On November 5, 2018, the U.S. Food and Drug Administration (FDA) announced that a proposed collection of information on the Biosimilars User Fee Program was submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. FDA’s Biosimilars User Fee Program was established under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which amended the Public Health Service Act...

By Kathleen M. Roberts Is your company engaged in Class 2 chemistries that are similar to existing Class 2 chemicals but are derived from an innovative bio-source? We are looking for pioneering companies working on new biobased Class 2 chemicals to assist in advancing an important project with the U.S. Environmental Protection Agency (EPA).   ISSUE:  While EPA sustainability goals would seemingly include adoption of improved biobased technologies, EPA’s policies under the...

On November 5, 2018, the European Commission’s (EC) Joint Research Center (JRC) announced the availability of the NANoREG Toolbox, an inventory of publicly available tools for the safety assessment of nanomaterials.  As reported in our October 5, 2017, blog item, JRC first published the inventory as a Microsoft Excel®-based dataset.  JRC scientists have now published an article, “An inventory of ready-to-use and publicly available tools for the safety assessment of nanomaterials,”...

On November 1, 2018, Bergeson & Campbell, P.C. (B&C®) launched a podcast called All Things Chemical™ that will engage listeners in intelligent, insightful conversation about everything related to industrial, pesticidal, and specialty chemicals and the law and business issues surrounding chemicals.  B&C’s talented team of lawyers, scientists, and consultants will keep listeners abreast of the changing world of both domestic and international chemical regulation and...

On October 26, 2018, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) published its final opinion on colloidal silver (nano).  According to the final opinion, the EC received 63 notifications of cosmetic products containing colloidal silver in nano form.  The final opinion states that, according to the applicants, the ingredient is used in nano uncoated form both in leave-on and rinse-off oral cosmetics products, including toothpastes and skin care products, with a...

On October 30, 2018, the National Institute for Occupational Safety and Health (NIOSH) held a webinar on its revised draft document entitled Current Intelligence Bulletin:  Health Effects of Occupational Exposure to Silver Nanomaterials.  The meeting agenda and slide presentation are available in the docket, as well as a list of meeting attendees.  As reported in our September 19, 2018, blog item, the revised draft Current Intelligence Bulletin (CIB) provides an updated scientific...

On October 17, 2018, the Trump Administration published its Unified Agenda of Regulatory and Deregulatory Actions (Regulatory Agenda).  There are many interesting entries, some of which are flagged here. Not surprisingly, the U.S. Environmental Protection Agency (EPA) listed implementing Toxic Substances Control Act (TSCA) amendments to enhance public health and chemical safety as one of its top priorities.  According to EPA, the amendments to TSCA that were enacted in June 2016...

On October 31, 2018, the U.S. Environmental Protection Agency (EPA) announced that it is extending the registration of dicamba for two years for “over-the-top” use (application to growing plants) to control weeds in fields for cotton and soybean plants genetically engineered to resist dicamba.  EPA states that the registration for these dicamba products will expire on December 20, 2020, unless EPA decides to further extend it.  EPA states that the label changes described below...

By Lynn L. Bergeson On October 30, 2018, the U.S. Food and Drug Administration (FDA) published a statement by FDA Commissioner Scott Gottlieb, M.D., and FDA Deputy Commissioner Anna Abram regarding FDA’s new action plan to advance plant and animal biotechnology innovation.  Aimed at ensuring the safety of plant and animal biotechnology products and avoiding unnecessary barriers to future innovation, the Action Plan focuses on three key priorities: Advancing public health by promoting...

By Lynn L. Bergeson In October 2018, DOE’s Bioenergy Technologies Office (BETO) published a report called “Cell-Free Synthetic Biology and Biocatalysis:  Prototyping and Conversion Platforms.”  The report consists of a summary from discussions held on a listening day by BETO in Denver, Colorado, in 2017.  The public meeting was intended to discuss research and development opportunities related to cell-free synthetic biology and biocatalysis, and how these...

By Lynn L. Bergeson On October 30, 2018, the U.S. Department of Energy (DOE) announced the topics for 2019 funding opportunities.  Amongst the program offices that are participating in this solicitation, is the Office of Energy Efficiency and Renewable Energy, who will be hosting an informational webinar on November 6, 2018, at 2:00 p.m. (EST) as an opportunity to ask the DOE Program Managers any questions about DOE funding opportunities.  The 90-minute webinar requires registration...

By Lynn L. Bergeson On October 30, 2018, Earthjustice and the Clean Air Task Force submitted to the U.S. Environmental Protection Agency (EPA) a petition “to amend its ‘aggregate compliance’ approach to the definition of biomass under the Renewable Fuel Standard (RFS) … to prevent the conversion of native grasslands.”  The petition was filed on behalf of 11 organizations, including the National Wildlife Federation and the Sierra Club, and urges EPA’s...

The European Commission (EC) Joint Research Center (JRC) posted a report on the October 5-6, 2017, “NanoReg2 Regulatory Preparedness for Innovation in Nanotechnology Workshop.”  Regulatory preparedness was defined at the workshop as the regulators’ timely awareness of innovations and the regulators’ actions to check whether present legislation covers all safety aspects of each innovation, including initiating revision of the legislation as appropriate.  Achieving...

The European Commission (EC) Joint Research Center (JRC) announced publication of a paper introducing a new standardized testing procedure for nanomaterial environmental toxicity, “Introducing a new standardized nanomaterial environmental toxicity screening testing procedure, ISO/TS 20787:  aquatic toxicity assessment of manufactured nanomaterials in saltwater lakes using Artemia sp. nauplii.”  The abstract states that the testing procedure is intended to generate more reliable and...

In August 2018, Safe Work Australia (SWA) issued a national guide on classifying hazardous chemicals.  SWA intends the guidance for manufacturers and importers of substances, mixtures, and articles who have a duty under the Work Health and Safety (WHS) Act and Regulations to classify them.  SWA suggests that the guidance may also be useful for suppliers, persons undertaking business and undertakings, workers, and other persons involved with hazardous chemicals.  The guidance...

The Office of Information and Regulatory Affairs (OIRA) published a request for information (RFI) on October 9, 2018, seeking comment on how the federal government, under the auspices of the Regulatory Cooperation Council (RCC), may reduce or eliminate unnecessary regulatory differences between the U.S. and Canada.  According to the RFI, this information may inform agencies’ development of regulatory reform proposals to modify or repeal existing agency requirements to increase efficiency...

B&C is launching a podcast November 1, 2018.  It’s called All Things Chemical™ and it will engage listeners in intelligent, insightful conversation about everything related to industrial, pesticidal, and specialty chemicals and the law and business issues surrounding chemicals. B&C’s talented team of lawyers, scientists, and consultants will keep listeners abreast of the changing world of both domestic and international chemical regulation and provide analysis of the many...

By Lynn L. Bergeson In the beginning of October 2018, researchers from the University of California – Berkeley published a paper in Nature Nanotechnology that explains how a new bacterium can produce fuels through artificial photosynthesis upon being fed gold. The formerly undiscovered bacterium, Moorella thermoacetica, allows for the development of photosynthetic biohybrid systems (PBS), linking inorganic light with preassembled biosynthetic pathways. The addition of gold nanoclusters,...

By Lynn L. Bergeson The European Commission (EC) announced on October 16, 2018, the launch of a new web-based tool called BioWatch. Developed by BIOWAYS, a project funded by the European Union (EU), this new tool expands BIOWAYS’ efforts in raising awareness of biobased products and their social, economic, and environmental benefits. BioWatch consists of “an interactive online platform that provides projects in the bioeconomy sector with a free service to position themselves...

By Lynn L. Bergeson On October 16, 2018, the Office of Information and Regulatory Affairs released the Trump Administration’s Fall 2018 Unified Agenda of Regulatory and Deregulatory Actions (Agenda). The Agenda aims to report on actions that administrative agencies, such as EPA, plan to put forward in the near- and long-terms. As its name implies, the Agenda includes both regulatory and deregulatory actions and attempts to justify any burden associated with these actions. According to...

On October 19, 2018, the U.S. Environmental Protection Agency (EPA) posted the Final Work Plan (FWP) for the nanosilver registration review process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  The FWP explains what the Office of Pesticide Programs (OPP) “knows about nanosilver generally, highlighting anticipated data and assessment needs for each unique nanosilver chemistry, identifying the types of information that would be especially useful to the...

On October 19, 2018, the U.S. Environmental Protection Agency (EPA) posted the Final Work Plan (FWP) for the nanosilver registration review process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The FWP explains what the Office of Pesticide Programs (OPP) “knows about nanosilver generally, highlighting anticipated data and assessment needs for each unique nanosilver chemistry, identifying the types of information that would be especially useful to the Agency...

On October 10, 2018, EPA’s Office of Pesticide Programs (OPP) announced that it will be holding a public meeting of the Pesticide Program Dialogue Committee (PPDC) on October 31, 2018, from 8:30 a.m. to 5:00 p.m., and that on November 1, 2018, from 8:30 a.m. to 12:00 p.m., it will be hosting an informational seminar on biotechnology-pesticide issues for stakeholders.  83 Fed. Reg. 50921.  The PPDC meeting and informational seminar will be held at 1 Potomac Yard South, 2777...

The National Nanotechnology Initiative (NNI) has published key takeaways and a transcript for the September 19, 2018, webinar, “Technology Pathways Toward Commercializing Nanotechnology.”  The webinar focused on quality control in the manufacturing process and built on NNI’s November 2017 Technology Pathways workshop.  Webinar panelists Katherine Barton, Laboratory and Production Manager at Nano-C, and Doug Singer, Executive Vice President in Charge of Manufacturing,...

On October 17, 2018, the U.S. Environmental Protection Agency (EPA) issued its final fees rule under the Toxic Substances Control Act (TSCA) in the Federal Register.  83 Fed. Reg. 52694.  The final rule largely tracks the proposed rule.  EPA is establishing fees applicable to any person required to submit information to EPA; or a notice, including an exemption or other information, to be reviewed by EPA; or who manufactures (including imports) a chemical substance that is the subject of...

By Lynn L. Bergeson On October 15, 2018, the American Chemical Society (ACS) held the 2018 Green Chemistry Challenge Awards Ceremony at the National Education Association in Washington, D.C. This year, five awards were given to academics, scientists, and business innovators across the biobased industry sector. Promoting environmental and economic benefits of developments in green chemistry, the ACS Green Chemistry Institute hosts this event on an annual basis. Of particular interest in this...

By Lynn L. Bergeson On October 12, 2018, the EC announced new requirements for labeling fuel. As of the aforementioned date, European Union (EU) Member States must use set fuel labels on newly produced vehicles, at vehicle dealerships, and at gas stations that dispense hydrogen, diesel, compressed natural gas, liquefied petroleum gas, petrol, and liquefied natural gas. Given the growing variety of fuels on the market, the EC’s new requirements address the greater need for...

By Lynn L. Bergeson On October 11, 2018, the European Commission (EC) released a statement announcing its new action plan for a sustainable bioeconomy in Europe. The new action plan, originally announced by President Juncker and First Vice-President Timmermans in their letter of intent, aims to “improve and scale up the sustainable use of renewable sources to address global and local challenges such as climate change and sustainable development.” In his remarks, EC Vice-President for...

By Lynn L. Bergeson On October 11, 2018, President Trump issued a Presidential Determination that the development and purchase of equipment and materials needed for alane fuel cells are essential to the national defense.  Alane fuel cells are, essentially, comprised of aluminum hydride and are possible alternatives to hydrogen fuel cells.  According to manufacturers, the only byproducts are water and aluminum, the latter of which can be recycled.   Issuing the determination under...

By Lynn L. Bergeson On October 15, 2018, U.S. Representatives Ruben Gallego (D-AZ) and Danny Davis (D-IL) submitted a letter to the U.S. Environmental Protection Agency (EPA) expressing concern over President Trump’s issuance of waivers to the Renewable Fuel Standard (RFS). Particularly worried about EPA’s recent actions to waive RFS blending requirements, the letter, signed by 19 members of Congress, urges EPA “to halt the issuance of additional RFS waivers and to reallocate...

The U.S. Environmental Protection Agency (EPA) issued on October 16, 2018, a proposed rule that would establish significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that are the subject of premanufacture notices (PMN).  83 Fed. Reg. 52179.  The proposed rule is significant.  Unlike other recent SNURs (i.e., those enacted since entry into force of amended TSCA), the 13 chemical substances are not also subject to consent...

As part of Amazon’s commitment to responsible sourcing, Amazon has posted its chemicals policy, which includes its first Restricted Substance List (RSL). Amazon states that it defines chemicals of concern as those chemicals that: (1) meet the criteria for classification as a carcinogen, mutagen, reproductive, or other systemic toxicant; or (2) are persistent, bioaccumulative, and toxic. Amazon “strategically prioritize[s] which chemicals of concern to focus on based on product type, customer...

The Nanotechnology Industries Association (NIA) announced on October 5, 2018, that the NanoReg2 project, of which NIA is a partner, has published a comprehensive review of European Union (EU) legislation addressing chemical substances and the potential for grouping and read across in nanomaterials.  The article, “Insights into possibilities for grouping and read-across for nanomaterials in EU chemicals legislation,” considers both the overarching regulation of chemical substances under the...

The Environment Council of the Council of the European Union (EU) met on October 9, 2018.  According to the outcome of the Council meeting, the items debated under any other business included the “Berlin Declaration” on nanomaterials, submitted by the German delegation and supported by the French and Luxembourg delegations.  The Berlin Declaration summarizes the conclusions and recommendations of the 12th International Nano-Authorities Dialogue of Germany, Liechtenstein,...

On October 3, 2018, the European Agency for Safety and Health at Work (EU-OSHA) published an info sheet on “Manufactured nanomaterials in the workplace.”  According to the info sheet, “[t]he requirements for managing nanomaterials in the workplace are the same as those for managing other hazardous chemicals, including the provision of information and training for workers, carrying out risk assessments and taking action to ensure a safe workplace.”  The prerequisites for...

By Lynn L. Bergeson In September 2018, researchers Harmen Willemse, from The Netherlands Standardization Institute (NEN), and Dr. Maarten van der Zee, from the Wageningen Food & Biobased Research Center, published a White Paper on “Communicating the bio-based content of products in the EU and the US.” Analyzing how bio-based content information is exchanged between businesses, consumers, and government, the paper aims to address the significant challenges associated with the...

By Lynn L. Bergeson On October 9, 2018, during a rally in Council Bluffs, Iowa, U.S. President Donald Trump announced that he will order the U.S. Environmental Protection Agency (EPA) to expand its sales of corn ethanol. This action, which farmers across the U.S. have been waiting for, will allow for year-round sales of 15 percent biofuels (E15) ethanol blends. Currently, E15 sales are restricted during the summer months in certain states, limiting the expansion...

By Lynn L. Bergeson On October 9, 2018, the U.S. Department of Energy (DOE) announced a memorandum of understanding (MOU) with the U.S. Army on a collaborative project designed to develop hydrogen and fuel cell technologies for civilian and military use. The MOU was signed by the U.S. Department of Army’s Tank & Automotive Research Development and Engineering Command (TARDEC) and the DOE’s Fuel Cell Technologies Office (FCTO). It aims to facilitate the research and...