Blogs

The European Union (EU) Observatory for Nanomaterials (EUON) is conducting a web satisfaction survey.  EUON provides information on the safety, innovation, research, and uses of nanomaterials on the EU market.  It is intended for stakeholders developing policies in the area, consumers, industry representatives, and non-governmental organizations.  EUON is funded by the European Commission (EC) and hosted and maintained by the European Chemicals Agency (ECHA).  Information from the survey...

On December 7, 2020, the U.S. Environmental Protection Agency (EPA) issued for comment the Proposed Interim Decision (PID) for chlorpyrifos.  85 Fed. Reg. 78849.  EPA announced it is proposing new risk mitigation measures to address potential human and environmental risks identified in EPA’s September 2020 draft risk assessments.  The PID proposes the following measures: Label amendments limiting application to address potential drinking water risks of...

On December 1, 2020, the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) announced the results of an assessment of R-Nano, France’s national reporting scheme for substances in nanoparticle form.  In 2013, France began requiring companies that manufacture, import, and/or distribute a “substance with nanoparticle status” in an amount of at least 100 grams per year to submit an annual report with substance identity, quantity, and use...

The U.S. Environmental Protection Agency (EPA) announced on December 8, 2020, that it received a complete manufacturer request to conduct a risk evaluation of octahydro-tetramethyl-naphthalenyl-ethanone (OTNE), a category of chemical substances consisting of four inseparable individual isomers.  International Flavors and Fragrances, Inc., Privi Organics USA Corporation, and DRT America, Inc. formally requested the risk evaluation through the OTNE Consortium managed by B&C® Consortia...

On November 25, 2020, the U.S. Environmental Protection Agency (EPA) released updates to the interim final list of manufacturers and importers subject to fees for the next 20 chemicals undergoing risk evaluation under Section 6(b) of the Toxic Substances Control Act.  According to EPA, “[t]he updated list includes additional manufacturers not identified on the final list of companies and removes manufacturers that self-identified in error or imported the chemical solely for the...

The U.S. Environmental Protection (EPA) will hold a webinar on December 10, 2020, to educate stakeholders on the risk management process under the Toxic Substances Control Act (TSCA) and the findings in the final risk evaluation for carbon tetrachloride.  The webinar will also provide an opportunity for the public to provide input on considerations EPA should take into account for managing these unreasonable risks.  Registration is open.  Stakeholders who would like to provide oral...

By Lynn L. Bergeson On November 25, 2020, EPA announced the amendment of the Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) regulations by extending the submission deadline for 2020 reports. CDR submissions are now due on January 29, 2021. According to EPA, this is the final extension, and it only applies to 2020 submissions. CDR regulations require manufacturers of certain chemical substances included on the TSCA Chemical Substance Inventory to report data on the...

By Lynn L. Bergeson On November 18, 2020, U.S. Representatives Cheri Bustos (D-IL) and Jim Hagedorn (R-MN) introduced a bipartisan, bicameral legislation that aims to lower greenhouse gas (GHG) emissions and encourage low-carbon fuel production. Titled “The Streamlining Advanced Biofuels Registration Act,” this bill would eliminate existing barriers for biofuels plants to increase production of cellulosic biomass into renewable fuels. Representative Bustos criticized the lack of...

By Lynn L. Bergeson On November 13, 2020, DOE’s EERE announced that the Co-Optimization of Fuels & Engines (Co-Optima) initiative issued a call for white papers. The Co-Optima initiative focuses on the development of new high-performance fuels that, when combined with advanced combustion approaches, can increase energy efficiency and reduce the carbon footprint. The initiative is seeking white papers to leverage National Laboratory resources and overcome technical challenges to...

By Lynn L. Bergeson On November 12, 2020, DOE issued its multi-year Hydrogen Program Plan aimed at providing a strategic framework for its hydrogen research, development, and demonstration (RD&D) efforts. A coordinated departmental effort, the Hydrogen Program focuses on the advancement of affordable production, transport, storage, and use of hydrogen across different economy sectors. Offices involved in this plan include DOE’s EERE, FE, NE, and the Advanced Research Projects...

By Lynn L. Bergeson On November 9, 2020, the U.S. Department of Energy’s (DOE) Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs office issued topics for its Fiscal Year (FY) 2021 SBIR/STTR Phase I Release 2 Funding Opportunity Announcement (FOA). Participating in the FOA are the following program offices: Office of Cyber Security, Energy Security, and Emergency Response (CESER); Office of Defense Nuclear Nonproliferation (NNSA); Office...

The January 15, 2021, deadline for payment of the U.S. Environmental Protection Agency’s (EPA) annual maintenance fee for pesticide registrations is approaching.  The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 4(i)(1)(A) requires that everyone who holds an active or suspended pesticide registration granted under FIFRA Sections 3 and 24(c) (special local needs) to pay an annual maintenance fee to keep the registration in effect.  The maintenance fee...

On December 3, 2020, a workshop will be held on “Creating a NanoRisk Governance Council:  Stakeholder evaluation and feedback.”  The workshop is aimed at working with stakeholders to obtain their feedback on the services and on the four scenarios being discussed for the establishment of the proposed NanoRisk Governance Council.  The workshop will comprise a plenary session plus up to four breakout sessions.  Some information about the scenarios will be provided prior...

On November 30, 2020, Bloomberg Law Environment & Energy Report published a Practitioner Insight column entitled “The Toxic Substances Control Act Under Biden:  Impact on Tribal, Fenceline Populations” by Jeffery Morris, former Director of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) and founder of Jeff Morris Solutions LLC.  Morris examines how the Biden Administration could apply the Toxic Substances Control Act’s (TSCA)...

The European Union (EU) Observatory for Nanomaterials (EUON) announced on November 16, 2020, the results of a study on how citizens perceive nanomaterials and their potential risks to human health and the environment.  According to EUON, the study found that general awareness about the nature, characteristics, and properties of nanomaterials is low.  EUON notes that the level of awareness has increased compared to earlier surveys, however, and is expected to continue...

The U.S. Environmental Protection Agency (EPA) announced on November 20, 2020, the availability of a supplemental analysis to the draft risk evaluation of 1,4-dioxane under the Toxic Substances Control Act (TSCA).  85 Fed. Reg. 74341.  EPA states that it developed the supplemental analysis in response to public and peer review comments on the draft risk evaluation.  The supplemental analysis includes eight consumer uses, including surface cleaners, laundry/dishwashing detergents, and...

The U.S. Environmental Protection Agency (EPA) has extended the comment period for the revised draft risk evaluation for C.I. Pigment Violet 29 (PV29).  85 Fed. Reg. 74718.  As reported in our October 29, 2020, blog item, EPA states that after it issued a draft risk evaluation in November 2018, it received additional data on PV29 in response to test orders, as well as additional information voluntarily submitted by the sole U.S. manufacturer.  EPA’s updated analysis, reflected in the...

On November 19, 2020, the European Food Safety Authority (EFSA) published a report entitled “Environmental Risk Assessment (ERA) of the application of nanoscience and nanotechnology in the food and feed chain.”  The authors analyzed existing ERA guidance documents for their adequacy to cover issues that are specific for nanomaterials, but note that none of the guidance has a specific focus on the food and feed chain.  Each nanospecific issue was addressed by briefly reviewing the...

Registration is now open for the National Nanotechnology Initiative’s (NNI) 2021 NNI Strategic Planning Stakeholder Workshop:  Charting the Path Forward, which will be held January 11-13, 2021.  NNI states that over the past 20 years, it has supported nanotechnology discovery, development, and deployment and has nurtured the strong ecosystem that exists today.  Building on this foundation, nanoscience will underpin a wide range of advanced technologies and enable...

On November 16, 2020, the U.S. Environmental Protection Agency (EPA) announced that it will now provide pesticide registrants with electronic Certificates of Registration, commonly known as “Gold Seal” letters.  A Gold Seal letter from EPA certifies that a product to be exported is registered with EPA and meets all necessary registration requirements.  EPA states that this improved process will allow for the electronic Gold Seal letters to be e-mailed to registrants...

The U.S. Environmental Protection Agency (EPA) will soon announce that the Chemical Data Reporting (CDR) submission period has been extended from November 30, 2020, to January 29, 2021.  A Federal Register notice has been signed, and EPA expects to post a pre-publication version of the notice on its website.  To assist chemical manufacturers and processors with submitting CDR data, Bergeson & Campbell, P.C.’s (B&C®) affiliate The Acta Group (Acta®)...

On November 10, 2020, the Senate Committee on Appropriations released 12 fiscal year (FY) 2021 appropriations bills and explanatory statements.  The bill for the Department of the Interior, environment, and related agencies includes funding for the U.S. Environmental Protection Agency (EPA).  The explanatory statement for the bill includes language regarding nanomaterials research at EPA and states: The Committee notes the increased capabilities that the Food and...

On November 6, 2020, the U.S. Environmental Protection Agency (EPA) published a final rule in the Federal Register that makes several changes to “Crop Group 19:  Herbs and Spices Group.”  85 Fed. Reg. 70976.  The original proposed rule, which was published on August 27, 2019 (84 Fed. Reg. 44804), was created in response to a petition developed by the International Crop Grouping Consulting Committee (ICGCC) workgroup that was submitted by the Interregional...

On November 4, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the release of an updated list of pests of significant health importance for public review and comment.  85 Fed. Reg. 70146. EPA, in coordination with the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture (USDA), identifies pests of significant public health importance, and in coordination with the Public Health Service,...

On November 2, 2020, the European Commission (EC) requested a scientific opinion from the Scientific Committee on Consumer Safety (SCCS) on the ultraviolet (UV) filter HAA299 (nano) (chemical name “2-(4-(2-(4-Diethylamino-2 hydroxy-benzoyl)-benzoyl)-piperazine-1-carbonyl)-phenyl)-(4-diethylamino-2-hydroxyphenyl)-methanone”).  According to the EC’s request, the applicant seeks to assess the safety of HAA299 (nano) for use as a UV filter up to a maximum concentration of...

The U.S. Environmental Protection Agency (EPA) announced on November 10, 2020, that the Integrated Risk Information System (IRIS) Program released the ORD Staff Handbook for Developing IRIS Assessments (IRIS Handbook) for public comment.  EPA states that the IRIS Handbook provides operating procedures for developing IRIS assessments, including problem formulation approaches and methods for conducting systematic review, dose response analysis, and developing toxicity values.  The IRIS...

On November 9, 2020, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) published two draft opinions for public comment.  In the preliminary opinion on hydroxyapatite (nano), SCCS considered whether the nanomaterial hydroxyapatite is safe when used in leave-on and rinse-off dermal and oral cosmetic products according to the reported maximum concentrations and specifications, taking into account reasonably foreseeable exposure conditions.  SCCS states that...

The U.S. Environmental Protection Agency (EPA) announced on November 9, 2020, that it is inviting small businesses, governments, and not-for-profits to participate as Small Entity Representatives (SER) to provide advice and recommendations to a Small Business Advocacy Review (SBAR) Panel for the cyclic aliphatic bromide cluster (HBCD).  The Panel will focus on EPA’s development of a proposed rule to address unreasonable risks identified in EPA’s recently completed Toxic Substances Control...

By Lynn L. Bergeson On October 8, 2020, the European Commission (EC), under the European Union (EU) State aid rules, approved the prolongation of tax exemptions for biofuels in Sweden. Having exemptions for liquid biofuels from energy and carbon emissions taxation since 2002, Sweden’s scheme aims to increase biofuels use while reducing the fossil fuels use in transport. With EC’s decision, the tax exemption has now been prolonged by one year from January 1, 2021, until December...

By Lynn L. Bergeson The government of Manitoba, Canada, is currently working to amend three regulations under the Biofuels Act. The amendments will update Manitoba’s clean fuel standards by increasing the ethanol and renewable fuel content in gasoline. The proposed amendments include: “Ethanol General Regulation is amended to:   Include the latest fuel standards for ethanol blended gasoline;   Remove the quarterly reporting requirements of obligated entities; and...

After reading the article below by Jeffery Morris, former Director of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT), we were inspired to post it. We appreciate having the opportunity to share his analysis with our audience. TSCA as a Gap-Filling Statute: Potentially Exposed and Susceptible Subpopulations By Jeffery Morris, PhD In its response to public comments on the scope documents for its next twenty chemical risk evaluations conducted...

By Lynn L. Bergeson On October 19, 2020, the U.S. Energy Information Administration (EIA) announced that, in 2019, renewable energy consumption levels in the United States increased for the fourth year in a row, reaching a record 11 percent of total energy consumption. Wood and waste energy, wood pellets, and biomass waste from landfills accounted for approximately 24 percent of U.S. renewable energy use. According to EIA, industrial, commercial, and electric power facilities use wood and...

By Lynn L. Bergeson On October 15, 2020, the U.S. Department of Energy (DOE) announced the availability of over $27 million in funding for 12 projects supporting research and development (R&D) efforts toward advanced plastics recycling technologies and new recyclable plastics. These efforts are part of DOE’s Plastics Innovation Challenge, which aims to improve existing recycling processes that break plastics down into chemical building blocks that can be used to make new products....

By Lynn L. Bergeson On October 8, 2020, Secretary of Agriculture, Sonny Perdue, announced that the U.S. Department of Agriculture (USDA) has made $22 million available in grants to increase sales of ethanol and biodiesel. The funds are coming out of the $100 million in grants available through the Higher Blends Infrastructure Incentive Program (HBIIP) and have been disbursed to 14 states. USDA predicts that the investments will increase ethanol demand by approximately 150 million gallons...

By Lynn L. Bergeson On October 30, 2020, the U.S. Food and Drug Administration (FDA) announced that it will host a virtual public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2023 through 2027. Under BsUFA, FDA collects user fees to support its process for the review of biosimilar and biological products and the current legislative authority is set to expire in September 2022. At the aforementioned time, new legislation will be required for FDA to...

By Lynn L. Bergeson On October 20, 2020, Senator Jeff Merkley (D-OR) and Representative Mike Levin (D-CA) introduced in the U.S. Senate and the U.S. House of Representatives the Zero-Emission Vehicles At of 2020 (the Act). The Act would amend Part A of Title II of the Clean Air Act (CAA) to create a federal national zero-emission vehicle (ZEV) standard and address climate change by ending U.S. sales of new gasoline-powered vehicles in 2035. Senator Merkley and Representative Levin’s...

The U.S. Environmental Protection Agency (EPA) announced on November 3, 2020, that it will hold webinars to consult with environmental justice communities on risk management for methylene chloride and 1-bromopropane (1-BP).  EPA states that the webinars are open to the public and will focus on the environmental justice impacts of EPA’s development of proposed rules to address the unreasonable risks identified in the final Toxic Substances Control Act (TSCA) risk evaluations for these...

We are pleased to announce that the American Bar Association (ABA) Section of Environment, Energy, and Resources published an article written by Lynn L. Bergeson and Eve C. Gartner entitled “The essentials of TSCA practice” in the November/December 2020 issue of Trends.  According to the authors, legal practitioners should be aware of the commercial, legal, and reputational implications of the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for...

On November 2, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the proposed rule to add chitosan (Poly-D-Glucosamine) to its list of active ingredients eligible for EPA’s minimum risk pesticide exemption under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b).  85 Fed. Reg. 69307. The proposed rule is in response to a petition submitted to EPA on October 10, 2018, requesting...

On October 30, 2020, the U.S. Environmental Protection Agency (EPA) issued a final rule on the Agricultural Worker Protection Standard (WPS) regulation that revises the requirements on the pesticide application exclusion zone (AEZ), defined as an “area surrounding the point(s) of pesticide discharge from the application equipment that must generally be free of all persons during pesticide applications.”  According to EPA, the targeted changes improve the enforceability and...

The Sustainable Nanotechnology Organization (SNO) and the Nanotechnology, Occupational and Environmental Health (NanOEH) Committee have partnered to present the 9th NANO Conference.  This conference combines the interests of SNO and NanOEH by offering a virtual program containing sessions that are of interest to both groups. SNO is a permanent non-profit corporation that provides the infrastructure to carry out its mission of research, education, and responsibility related to both...

On October 30, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Enforcement and Compliance Assurance (OECA) announced that it issued a Compliance Advisory on ultraviolet (UV) lights claiming to kill or be effective against viruses and bacteria.  EPA states that the Advisory was issued to provide an explanation to the UV light industry that UV lights are regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) as pesticide devices...

On October 28, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of its progress report in meeting its performance measures and goals for pesticide reregistration during fiscal year (FY) 2018 (2018 Report).  85 Fed. Reg. 68327.  Section 4(l) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires EPA to publish information about EPA’s annual achievements in this area.  The...

The U.S. Environmental Protection Agency (EPA) announced on October 29, 2020, that it is releasing a revised draft risk evaluation for C.I. Pigment Violet 29 (PV29) for public comment and peer review under the Toxic Substances Control Act (TSCA).  EPA states that after it issued a draft risk evaluation in November 2018, it received additional data on PV29 in response to test orders, as well as additional information voluntarily submitted by the sole U.S. manufacturer.  According to EPA,...

According to the Toxics Use Reduction Institute’s (TURI) website, the Toxics Use Reduction Act (TURA) Program in Massachusetts has received a petition to list carbon nanotubes (both single-walled and multi-walled) and carbon nanofibers.  The TURA Science Advisory Board (SAB) is beginning the process of reviewing these substances and seeks additional information from stakeholders.  SAB’s primary role is to consider petitions to add or delete chemicals from the TURA list and...

On October 26, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is soliciting public comment on the interim guidance on registering products that claim to have “residual” or “long-lasting” effectiveness against viruses.  This announcement follows up on EPA’s October 14, 2020, announcement that it would begin expediting its review of products with residual efficacy intended for use against SARS-CoV-2, the coronavirus that causes...

On October 14, 2020, a coalition of North Carolina non-governmental organizations (NGO) petitioned the U.S. Environmental Protection Agency (EPA) for a Toxic Substances Control Act (TSCA) Section 4 test rule for 54 per- and polyfluoroalkyl substances (PFAS) manufactured by The Chemours Company (Chemours) at its chemical production facility in Fayetteville, North Carolina.  The petition, filed under TSCA Section 21, seeks issuance of a rule or order under TSCA Section 4 compelling...

On October 27, 2020, the U.S. National Nanotechnology Initiative published the National Nanotechnology Initiative Supplement to the President’s 2021 Budget (Supplement), which serves as the annual report for NNI, called for under the provisions of the 21st Century Nanotechnology Research and Development Act.  According to the Supplement, the President’s 2021 budget requests more than $1.7 billion for NNI, with an increased investment in the foundational research intended to lead to...

The U.S. National Nanotechnology Initiative (NNI) will hold a virtual stakeholder workshop January 11-13, 2021.  NNI states that over the past 20 years, it has supported nanotechnology discovery, development, and deployment and has nurtured the strong ecosystem that exists today.  Building on this foundation, nanoscience will underpin a wide range of advanced technologies and enable solutions to challenges into the future.  As NNI enters its third decade, conversations...

The U.S. National Nanotechnology Initiative (NNI) will hold a webinar on November 4, 2020, on “Implantable Nanosensors:  A Forward-Looking View on Technical and Non-Technical Challenges.”  According to NNI, implantable nanosensors could revolutionize healthcare and improve real-time health monitoring.  NNI states that while there have been significant advances in developing implantable sensors for monitoring and responding to tissue growth, infection, and inflammation...