Blogs

The U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced on September 23, 2019, that it plans to begin an evaluation of EPA’s implementation of the 2009 Toxic Substances Control Act (TSCA) premanufacture notice (PMN) consent order with DuPont [Chemours].  According to OIG, its objective is to determine what actions EPA took to verify compliance with the requirements of the consent order to prevent release of the chemical GenX into the Cape Fear...

On October 11, 2019, the U.S. Environmental Protection Agency (EPA) published proposed significant new use rules (SNUR) for 31 chemical substances, including multiwalled carbon nanotubes (generic), that were the subject of premanufacture notices (PMN).  84 Fed. Reg. 54816.  EPA notes that eight of the chemical substances are subject to orders under the Toxic Substances Control Act (TSCA) issued by EPA.  The effective date of the TSCA Section 5(e) order for multiwalled...

On September 23, 2019, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced that it plans to begin fieldwork on EPA’s Safer Choice program.  According to OIG, its objectives are to identify and assess the controls that EPA has in place to verify that the Safer Choice program meets its goals and achieves quality standards through its product qualification, renewal, and required audit process.  OIG states that Safer Choice “is a voluntary labeling...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On October 2, 2019, the Governor of Minnesota, Tim Walz, announced that applications are now open for all 15 seats on the Governor’s Biofuels Council.  Established in September 2019 by Governor Walz, the Governor’s Biofuels Council advises the Governor and cabinet on how best to support Minnesota’s biofuels industry. Council members will include representatives of agriculture, biofuels, and transportation industries and...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On October 2, 2019, the Green Party of Canada commented, via a press release, on its Green Climate Action Plan called “Mission:  Possible.” Aiming to exceed the U.S. Green New Deal, under this plan, the Green Party outlines a 20-step action plan to achieve the goal of zero emissions by 2050.  Part of the strategy outlined emphasizes the idea that heavy-duty industrial machinery will need to rely on biofuels.  Although...

By Lynn L. Bergeson On October 2, 2019, the government of Quebec, Canada, published in its Official Gazette a notice of a draft regulation setting standards for the integration of renewable fuels into gasoline and diesel fuel.  Under the draft regulation, the standards will apply on July 1, 2021, and will then increase. As of July 1, 2025, the integration of a minimum volume of ethanol of 15 percent into gasoline and a minimum volume of biobased diesel fuel of 4 percent into diesel fuel...

By Lynn L. Bergeson On October 3, 2019, the U.S. Food and Drug Administration (FDA) announced that a technical guidance for industry titled “Bioanalytical Methods Templates” is now available.  The technical specifications guidance provides ready-to-use templates for sponsors to submit summaries of bioanalytical methods used in clinical pharmacology studies that require pharmacokinetic concentration evaluation.  The templates provided are applicable to bioanalytical...

By Lynn L. Bergeson On October 4, 2019, U.S. Environmental Protection Agency (EPA) Administrator, Andrew Wheeler, and U.S. Department of Agriculture (USDA) Secretary, Sonny Perdue, announced President Trump’s negotiated agreement on the Renewable Fuel Standard (RFS).  Under the agreement, EPA and USDA will undertake the following actions: In a forthcoming supplemental notice building off the recently proposed 2020 Renewable Volume Standards and the Biomass-Based Diesel Volume for...

On October 7, 2019, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion by Lise Bitsch, Governing Nanotechnologies through Societal Engagement (GoNano), entitled “Strengthening societal engagement with nanotechnologies.”  Bitsch presents several arguments for why actors in the research and innovation world of nanotechnologies and other key enabling technologies should care about societal engagement.  Bitsch also explains what societal engagement is...

On September 30, 2019, the U.S. Environmental Protection Agency (EPA) released an updated Aquatic Life Benchmarks Table for registered pesticides.  The update includes four newly registered pesticides and their degradants as well as new values for more than 30 previously registered pesticides. The benchmarks inform state and local regulators in their interpretation of water quality monitoring data. Waterbodies where benchmarks are exceeded may be prioritized for further investigation.  EPA...

The European Chemicals Agency (ECHA) issued a press release on October 8, 2019, reminding companies that by January 1, 2020, companies must provide more information on nanomaterials on the European Union (EU) market under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  The new information requirements concern companies that manufacture or import nanoforms of substances that are subject to registration under REACH.  As...

On September 17, 2019, the European Food Safety Authority (EFSA) opened a consultation period on two pilot assessments of the risks posed to humans by residues of multiple pesticides in food.  EFSA is seeking comments from interested parties on the assessments.  The first assessment considers the chronic effects of multiple pesticides on the thyroid system.  The second looks at acute effects on the nervous system. EFSA produced the assessments in collaboration with the...

We are pleased to announce that the Fall 2019 issue of The SciTech Lawyer, published by the American Bar Association’s (ABA) Section of Science and Technology Law, includes an article co-authored by Lynn L. Bergeson and Carla N. Hutton, “Nanotechnology and Regulatory Certainty Closer Now Than Ever.”  Nanoscale technologies and their resultant innovations have long captured the imaginations of scientists and inventors, the scrutiny of regulators, and the apprehension of...

By Lynn L. Bergeson The U.S. Food and Drug Administration (FDA), on September 30, 2019, announced the availability of a draft guidance for industry (GFI) #171 titled “Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Manufactured from Active Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media.” The draft GFI describes how EPA intends to evaluate requests for waiving the requirement for performing in vivo...

By Lynn L. Bergeson On September 30, 2019, DOE’s Smart Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs Office announced the opening of applications for Cohort of Innovators through October 31, 2019. Three DOE National Laboratories are accepting such applications: (1) Argonne National Laboratory (ANL) Chain Reaction Innovation; (2) Oak Ridge National Laboratory (ORNL) Innovation Crossroads; and (3) Lawrence Berkeley National Laboratory (LBL)...

By Lynn L. Bergeson On September 30, 2019, DOE announced that the Lawrence Livermore National Laboratory (LLNL) will host an informational webinar about the High Performance Computing for Energy Innovation (HPC4EI) Program. In honor of National Manufacturing Day, the webinar is scheduled for October 4, 2019, at 12:00 p.m. (EDT). The HPC4EI Program pairs national laboratory scientists with partners in industry to apply high-performance computing technology and improve energy utilization in the...

By Lynn L. Bergeson On October 1, 2019, the U.S. Department of Energy (DOE) announced that 35 projects have been selected to receive funding for bioenergy research and development (R&D). Totaling $73 million in funding provided by DOE’s Office of Energy Efficiency and Renewable Energy (EERE), the selected projects aim to: Reduce the price of drop-in biofuels; Lower the cost of biopower; and Enable high-value products from biomass or waste resources. According to DOE, the United States...

According to an item in the September 2019 issue of NIOSH eNews, the National Institute for Occupational Safety and Health (NIOSH) is working with RTI International to distribute a survey to companies that manufacture, distribute, fabricate, formulate, use, or provide services related to engineered nanomaterials.  The item states that the goal of the survey is to assess the impact of NIOSH’s contribution to guidelines and risk mitigation practices for the safe handling of...

On September 30, 2019, the U.S. Environmental Protection Agency (EPA) announced the availability of the meeting minutes and final report for the June 18-21, 2019, meeting of the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) on the draft risk evaluation for Pigment Violet 29 (PV29).  SACC’s report addresses the scientific issues being considered by EPA regarding the peer review for the draft risk evaluation.  As reported in our...

On October 2, 2019, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of, and soliciting public comment on, the draft document entitled “Antimicrobial Performance Evaluation Program (APEP) A (Draft) Risk Based Strategy to Ensure the Effectiveness of Hospital-Level Disinfectants” (draft Strategy).  EPA states that “The draft Strategy provides a framework to ensure that registered hospital-level disinfectants...

On October 1, 2019, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the that fees under the Pesticide Registration Improvement Extension Act of 2018 (PRIA 4) were increased by five percent for pesticide applications received on or after October 1, 2019.  The five percent increase is on fee amounts established by Public Law 116-8, which became effective on March 8, 2019.  The revised fees will remain in effect...

On September 25, 2019, the U.S. Environmental Protection Agency (EPA) submitted a proposed significant new use rule (SNUR) on long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS) chemical substances to the Office of Management and Budget (OMB) for review.  The item on the rulemaking in EPA’s Spring 2019 Regulatory Agenda states that in 2015, EPA proposed amending the SNURs under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for LCPFAC...

On September 24, 2019, the U.S. Environmental Protection Agency (EPA) announced the availability of the premises treatment final test guideline, under Series 810, Product Performance Test Guidelines.  The guideline, 810.3500 Premise Treatment, provides recommendations on how to conduct efficacy testing against invertebrate pests in premises, such as cockroaches, ticks, mosquitoes, flies and wasps in connection with registration of pesticide products for use against public health...

On November 12, 2019, the European Chemicals Agency (ECHA) will hold a webinar on the amended information requirements for nanoforms under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  As reported in our December 4, 2018, blog item, the European Commission (EC) announced on December 3, 2018, that it adopted amendments to several REACH Annexes to clarify the information requirements for nanomaterials.  The amended...

By Lynn L. Bergeson The U.S. Green Building Council Massachusetts (USGBC) recently published its 2019 Report titled Zero Energy Buildings in Massachusetts: Saving Money from the Start. The report assesses zero energy (ZE) upfront building costs, model performance, and life-cycle costs in Massachusetts (MA). Local MA leaders have been working to curb greenhouse gas (GHG) emissions and reduce energy use in the built environment. This work has been done by retrofitting existing buildings and...

By Lynn L. Bergeson On September 24, 2019, DOE EERE’s Assistant Secretary, Daniel R. Simmons, announced the winners of the first round of the American-Made Solar Prize. The prize consists of a $3 million competition to revitalize U.S. solar manufacturing. Each prize winner received $500,000 for use at DOE National Laboratories. In addition to the aforementioned announcements, DOE also declared two initiatives led by EERE’s Solar Energy Technologies Office (SETO): the National...

By Lynn L. Bergeson On September 25, 2019, EPA’s Office of Pollution Prevention and Toxics (OPPT) recognized fourteen Safer Choice Partner of the Year award winners for their outstanding achievements in the design, manufacture, selection, and use of products with safer chemicals for use in households and facilities nationwide. Representing businesses, including woman-owned, small- and medium-sized, local government, and associations, winners from across 12 states and the District of...

By Lynn L. Bergeson September 25, 2019, DOE EERE announced via the Federal Register a request for information (RFI) on the identification of wells of opportunity for critical geothermal field research applications. DOE’s RFI is directed to the geothermal community, seeking information about underutilized wells in known geothermal resource areas in the United States. Its aim is to obtain feedback on industry willingness to partner with DOE’s Geothermal Technologies Office (GTO) to...

By Lynn L. Bergeson On September 25, 2019, DOE EERE announced that its Better Buildings, Better Plants partners have saved more than 1.3 quadrillion British thermal units (BTUs) and $6.7 billion in energy costs. With more than 220 partners, DOE accepted 22 new companies this year, which include more than 3,200 facilities and represent approximately 12 percent of the U.S. manufacturing energy footprint. Designed to work with partners who have set ambitious energy, water, and/or waste reduction...

By Lynn L. Bergeson On September 18, 2019, the U.S. Department of Energy (DOE) and the National Oceanic and Atmospheric Administration (NOAA) announced a $3 million prize competition to power ocean observing platforms with marine renewable energy. To generate innovation, the Powering the Blue Economy Ocean Observing Prize will offer a series of contests to demonstrate marine renewable energy use for observing platforms. DOE hopes that this prize will help spur technological innovation through a...

On September 25, 2019, the U.S. Environmental Protection Agency (EPA) recognized 14 Safer Choice Partner of the Year award winners for outstanding achievement in 2018 for the design, manufacture, selection, and use of products with safer chemicals for use in households and facilities nationwide.  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...

The U.S. Environmental Protection Agency (EPA) announced on September 20, 2019, that it will extend the public comment period for 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...

The U.S. Environmental Protection Agency (EPA) announced on September 19, 2019, that it posted the first public Toxic Substances Control Act (TSCA) Inventory to include unique identifier (UID) information.  EPA states that the UID is a numerical identifier assigned to a chemical substance when EPA approves a confidential business information (CBI) claim for specific chemical identity.  When EPA approves such a claim, it assigns a UID to that chemical identity; applies the UID...

On September 19, 2019, the European Union (EU) Observatory for Nanomaterials (EUON) announced the results of a study it commissioned to examine “next generation” nanomaterials and determine whether the current terminology used in the EU chemicals regulations, as well as the implementation of the current legal requirements for identifying nanomaterials, are likely to pose technical challenges.  The objectives of the study were to: Collect existing definitions of generations of...

The National Nanotechnology Initiative will hold a webinar on October 8, 2019, on “Evaluating Worker and Consumer Exposure to Engineered Nanomaterials.”  The webinar, part of NNI’s 2019 series on the environmental, health, and safety effects of nanomaterials (nanoEHS), will examine the tools, techniques, and successes in assessing and managing potential effects of engineered nanomaterials (ENM) in the workplace and consumer environments.  According to NNI, the presentations...

The Environmental Defense Fund (EDF) published a September 16, 2019, blog item entitled “EPA’s latest move to deflect criticism of its TSCA risk evaluations: Muzzle its science advisors.”  EDF notes that it has opposed a number of recent decisions made by the U.S. Environmental Protection Agency (EPA) “that aim to limit the risks it finds when evaluating the safety of chemicals under the Toxic Substances Control Act (TSCA),” including: Excluding from its analysis known human...

The U.S. Environmental Protection Agency (EPA) announced on September 18, 2019, that it is now accepting nominations for the 2020 Green Chemistry Challenge Awards for companies or institutions that have developed a new process or product that helps protect public health and the environment.  EPA defines green chemistry as the design of chemical products and processes that reduce both the generation and use of chemicals that are hazardous to the environment and people’s...

By Lynn L. Bergeson On September 3, 2019, the Chinese Ministry of Ecology and Environment (MEE) and National Health Commission (NHC) jointly issued a final Technical Framework Guideline for Environmental Risk Assessment of Chemical Substances (Trial). This Trial Guideline provides a basic framework, including evaluation steps, technical requirements, and report preparation, for the environmental risk assessment of a single chemical substance under standard production and uses. The Trial...

By Lynn L. Bergeson This month, the American Cleaning Institute (ACI), a Biobased and Renewable Products Advocacy Group (BRAG®) member, published its 2019 Sustainability Report titled The Future Is Clean. In its 2019 report, ACI outlines its sustainability goals, which include increased transparency, the reduction of GHG emissions, and the move toward a circular global economy. As part of its activities to achieve such goals, ACI has worked on filling knowledge gaps, harnessing power in the...

By Lynn L. Bergeson Recently, the North Dakota Corn Utilization Council (NDCUC) announced the implementation of its new program, the North Dakota Unleaded88 Expansion Program, in partnership with the North Dakota Ethanol Council (NDEC). The goal of the program is to partner with fuel retailers to provide drivers with Unleaded 88, which consists of a higher octane fuel containing 15 percent ethanol blend with 85 percent gasoline. Through June 30, 2020, NDCUC will grant funds to fuel retailers for...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On September 17, 2019, U.S. Senator Lisa Murkowski (R-AK) chaired a hearing to discuss the use and sourcing of minerals needed for clean energy technologies. Highlighting the fact that renewable technologies such as batteries and wind turbines are built from minerals, Senator Murkowski stated that “[t]he United States is capable of being a leader in the development of the minerals needed for clean energy technologies.” As Chairman...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On September 16, 2019, Governor of Virginia, Ralph S. Northam (D), signed Executive Order Forty-Three, establishing statewide objectives for clean energy production expansion. The target goals outlined in the Executive Order include a 30 percent increase of electricity powered by renewable energy resources by 2030, and achieving 100 percent of energy by carbon-neutral resources by 2050. Directing the Department of Mines, Minerals and Energy...

By Lynn L. Bergeson On September 17, 2019, the U.S. Department of Energy’s (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced the selection of the Pacific Ocean Energy Trust (POET) as Network Director for the U.S. Testing Expertise and Access for Marine Energy Research Team (TEAMER) Program. TEAMER is a three-year program that supports testing and research for marine energy technologies. It provides access to test facilities and technical expertise to assist technology...

By Lynn L. Bergeson On September 10, 2019, the U.S. Office of Science and Technology Policy (OSTP) announced in the Federal Register a request for information (RFI) on the U.S. bioeconomy. Calling for input from all interested parties on the U.S. bioeconomy, OSTP’s RFI aims to inform notable gaps, vulnerabilities, and areas to promote and protect in the bioeconomy that may benefit from federal government attention. Input from the public is welcome, including those with capital investments,...

The European Union (EU) Observatory for Nanomaterials (EUON) has created a Nanopinion section, where it invites views from different contributors ranging from policy-makers and authorities to industry and civil society on their work and priorities related to nanomaterials on the EU market.  The first item, posted on September 16, 2019, is “EUON:  past, present and future,” written by Bjorn Hansen, Executive Director of the European Chemicals Agency (ECHA).  As reported in our...

The September 10, 2019, issue of the U.S. Environmental Protection Agency’s (EPA) Science Matters newsletter includes an article entitled “Keeping up with 3D Printing:  EPA Researchers Build on New Plastic Emissions Study.”  According to the article, EPA scientists, through an agreement with the Consumer Products Safety Commission (CPSC), are investigating whether increased use of 3D printers can lead to unintended adverse impacts to human health.  EPA states that...

On September 3, 2019, Earthjustice filed with the U.S. Environmental Protection Agency (EPA) a notice of intent to sue EPA under Section 20(a)(2) of the Toxic Substances Control Act (TSCA) for “EPA’s repeated and ongoing failures to comply with TSCA’s nondiscretionary mandates to disclose to the public information about new chemical substances reviewed by EPA.”  According to Earthjustice, EPA “routinely fails to disclose” certain information regarding the submission and review of...

The Product Stewardship Society (PSS) Board of Directors inducted Lynn L. Bergeson as President during its annual board meeting preceding the Product Stewardship conference being held in Columbus, Ohio, September 10-12, 2019. Ms. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®), will serve as President through 2021. Ms. Bergeson has served on the PSS Board of Directors since 2015. PSS is an affiliate of the American Industrial Hygiene Association (AIHA®), launched...

By Lynn L. Bergeson On September 10, 2019, the House Small Business Subcommittee on Rural Development, Agriculture, Trade, and Entrepreneurship held a hearing on the clean energy economy. In a notice, the Subcommittee stated that there are growing opportunities for small companies, including farmers, to respond to energy challenges through new and innovative solutions. The clean energy economy covers many industries that are dominated by small businesses, including construction, agriculture, and...

By Lynn L. Bergeson On September 9, 2019, the House of Representatives returned to work after a six-week August recess and passed a package of energy-related bills. By a roll call vote of 295 to 114, the House approved a bill (H.R. 1768) that would extend the Diesel Emissions Reduction Act through 2024. The vote would keep alive an EPA program that takes older diesel-powered equipment off the market. House lawmakers also approved: H.R. 1420 to improve energy efficiency in federal buildings; H.R....