Blogs

The European Chemicals Agency (ECHA) has posted the German Federal Institute for Occupational Safety and Health’s (BAuA) substance evaluation conclusion document for multi-walled carbon nanotubes (MWCNT), synthetic graphite in tubular shape and tangled.  The conclusion provides a summary of how the information on the substance can be used for the purposes of regulatory risk management. Concern(s) Subject to Evaluation MWCNTs were originally selected for substance evaluation to...

The Environmental Law Institute (ELI) recently released Environment 2021:  What Comes Next?, a report that looks at the Trump Administration’s impact on environmental law and policy and what lies ahead.  ELI states that the report is “a response to growing demand for analysis of how deregulatory initiatives by the Trump Administration will affect environmental protection, governance, and the rule of law with a focus on what might happen in a second Trump administration or a...

On August 31, 2020, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Nanosilver in healthcare — does the silver bullet exist?” by Dr. Dorota Napierska, Chemicals Policy and Projects Officer, Health Care Without Harm Europe (HCWH Europe).  Napierska examines how beneficial the properties of nanosilver are in clinical settings and the risks involved.  Napierska notes that a key point in assessing the toxicity of nanosilver is to adopt...

The U.S. Environmental Protection Agency (EPA) announced on April 29, 2020, that is seeking applications from states, federally-recognized tribes, Native American organizations, and non-governmental organizations (NGO) to provide technical support for the National Tribal Toxics Council (NTTC).  The NTTC works collaboratively with EPA to represent tribal interests in the development and implementation of chemical risk assessment, risk management, and pollution prevention...

The U.S. Environmental Protection Agency (EPA) announced on August 27, 2020, that it submitted an information collection request (ICR), “Chemical-Specific Rules under the Toxic Substances Control Act Section 8(a); Certain Nanoscale Materials” to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA).  85 Fed. Reg. 52995.  The ICR covers reporting and recordkeeping requirements for persons who manufacture or...

On August 26, 2020, the U.S. Environmental Protection Agency (EPA) released an interim final list of businesses subject to fees for the 20 chemicals designated as high priority for risk evaluation under the Toxic Substances Control Act (TSCA).  EPA notes that the interim list is an updated version of the preliminary list released in January 2020.  According to EPA, making the interim final list available now gives businesses and other stakeholders an opportunity to review the list for...

On August 24, 2020, the U.S. Environmental Protection Agency (EPA) announced the issuance of a Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 18 emergency exemption to the state of Texas permitting it to allow American Airlines and Total Orthopedics Sports & Spine to use a new product that is believed to inactivate coronaviruses like the SARS-CoV-2 virus on surfaces for up to seven days.  EPA states that after carefully reviewing the available data and...

The U.S. National Nanotechnology Initiative (NNI) and European Commission (EC) have organized the ninth annual meeting of the environmental, health, and safety effects of nanomaterials (nanoEHS) Communities of Research (COR) as a virtual workshop on September 16-17, 2020.  According to NNI, as the nanoEHS research ecosystem continues to evolve, the workshop will identify future needs and opportunities.  Conversations will further address how the lessons learned from...

On August 20, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is seeking to add chitosan to the list of active ingredients allowed for in minimum risk pesticides exempted from pesticide registration requirements under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b).  A minimum risk product must meet six specific conditions to be exempted from pesticide registration.  One of those conditions is that the active ingredient in the minimum...

Jeff Morris, former Director of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT), wrote a column published on August 18, 2020, by Chemical Watch.  In the column, “Expert Focus:  Community-based exposures and susceptibilities -- a social justice challenge for TSCA implementation,” Morris discusses how risk evaluations conducted under the Toxic Substances Control Act (TSCA) provide an opportunity to address community exposures and...

The European Union’s (EU) Horizon 2020 project GRACIOUS has launched its stakeholder engagement platform and started an open consultation on the GRACIOUS Framework.  The GRACIOUS project invites stakeholders from industry, regulators, policy makers, consultants, non-governmental organizations (NGO), and academia to use the platform to provide their opinions on the progress within the project, including whether the structure of the GRACIOUS Framework is “clear and...

The U.S. Environmental Protection Agency (EPA) announced on August 17, 2020, that it is accepting nominations for the 2021 Green Chemistry Challenge Awards.  EPA intends these awards to recognize innovation by American businesses and researchers that redesign chemical products and processes to reduce or eliminate the use and manufacture of hazardous substances.  The 2021 Green Chemistry Challenge Awards nomination package is now available, and nominations are due December 4, 2020.  EPA...

The European Union (EU)-funded projects NanoHarmony and NANOMET-Organization for Economic Cooperation and Development (OECD) have jointly organized a September 16, 2020, webinar on “The Pathway to Test Guidelines:  from science to standards for nanomaterials.”  Participants will learn how OECD develops Test Guidelines, using case studies from the Test Guidelines that are supported through the projects for expansion into nanomaterials.  The webinar will explain how novel...

On August 17, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) published a report entitled Lack of Planning Risks EPA’s Ability to Meet Toxic Substances Control Act Deadlines.  OIG conducted the audit to determine whether EPA met the deadlines already imposed by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) in 2016, which amended the Toxic Substances Control Act (TSCA), and has the staff, resources, and...

The U.S. Environmental Protection Agency (EPA) is extending the nomination and public comment periods for the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) to receive additional nominees and input on prospective candidates for membership.  EPA states that it will use public comments to assist it in selecting multiple members of SACC over the next year.  EPA anticipates appointing approximately 15 members to SACC by March 2021.  EPA notes that current...

The European Commission’s (EC) Joint Research Center (JRC) and the Directorate-General for Research and Innovation (RTD) will jointly organize a virtual “Workshop on Safe and Sustainable Smart Nanomaterials” on September 9-10, 2020.  The workshop is focused on smart (responsive, multi-functional) nanomaterials, as such or embedded in products, that are developed for application in industrial sectors such as agriculture, food, packaging, and cosmetics.  The program is...

The NanoExplore project, which is supported by the European Union’s (EU) LIFE program, aims at an integrated approach for exposure and health effects monitoring of engineered and incidental nanomaterials in occupational settings.  The project is currently in its pilot phase.  According to NanoExplore, the pilot study will take place following a two-step procedure over two field campaigns separated by a six- or nine-month interval.  Each field campaign will last for four...

On August 12, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of the final risk evaluation for 1-bromopropane (1-BP).  85 Fed. Reg. 48687.  After evaluating 25 conditions of use, EPA determined that 16 present an unreasonable risk to workers, occupational non-users (ONU), consumers, and bystanders.  For those conditions of use for which EPA has found an unreasonable risk, EPA states that it must take regulatory action to address that...

On July 31, 2020, the plaintiffs and EPA filed a joint case management statement in the U.S. District Court for the Northern District of California case seeking a rulemaking under Section 6 of the Toxic Substances Control Act (TSCA) to prohibit the addition of fluoridation chemicals to drinking water supplies.  Food & Water Watch, Inc. v. EPA, Case No. 3:17-cv-02162-EMC.  As reported in our June 12 and June 22, 2020, blog items, the court held a bench trial that...

The U.S. Food and Drug Administration (FDA) published a report entitled Nanotechnology — Over a Decade of Progress and Innovation that highlights FDA’s advancements in the field of nanotechnology since it released its last report in 2007.  The report also reviews FDA’s role in advancing the public health through its regulation of products within its jurisdiction that involve the application of nanotechnology.  According to the report, FDA “will rely on a combination...

The Australian Industrial Chemicals Introduction Scheme (AICIS) took effect on July 1, 2020.  Under AICIS, companies that import or manufacture (including introduce) industrial chemicals, or products that release industrial chemicals, into Australia for commercial purposes should first check whether the industrial chemical is listed on the Inventory.  If the chemical is on the Inventory and the introduction meets the terms of Inventory listing, the introduction is automatically...

Bergeson & Campbell, P.C.’s (B&C®) Karin F. Baron, MSPH, and Richard E. Engler, Ph.D., will present “Evaluating New Chemicals and Disconnects in Hazard Communication” during this year’s virtual PSX Conference from September 15 to 17, 2020.  Ms. Baron is a Senior Regulatory Consultant with B&C and has more than 15 years of experience developing, implementing, and managing complex chemical regulatory compliance matters for industrial...

By Lynn L. Bergeson  ACS has also recently announced a call for symposia topics for its 25th GC&E conference mentioned in the article above. The theme of the conference is “Sustainable Production to Advance the Circular Economy,” which directly links to the United Nations (U.N.) Sustainable Development Goal 12: Responsible Consumption and Production. The proposal submission deadline is October 9, 2020, and notifications of acceptance will be announced by November 20, 2020.

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. The American Chemical Society (ACS) has announced its 2021 call for nominations for the ACS Sustainable Chemistry and Engineering (SC&E) Lectureship Awards. The awards will recognize the contributions of early career investigators from around the world who are doing exceptional research impacting sustainability, green chemistry, or green engineering. One award recipient will be chosen from three regions: the Americas, Europe/Middle...

By Lynn L. Bergeson  On July 14, 2020, DOE EERE announced that it will fund approximately $53 million to 49 new SBIR and STTR R&D projects. The selected projects will receive Phase II Release 2 grants for principal R&D efforts based on the technical feasibility demonstrated in Phase I projects. Phase II awards range up to $1,500,000 for two years. Further information about the awardees can be found here.

By Lynn L. Bergeson  On July 13, 2020, DOE’s Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs Office (SBIR/STTR Programs Office) issued topics for its FY 2021 SBIR/STTS Phase I Release 1 Funding Opportunity Announcement (FOA). The topics are available online. DOE participating program offices include the Office of Science’s (SC) Office of Advanced Scientific Computing Research (ASCR), Office of Basic Energy Sciences (BES), Office...

By Lynn L. Bergeson  On July 10, 2020, DOE EERE announced that it has selected eight projects totaling more than $5 million to conduct R&D needed to accelerate the U.S. biomanufacturing sector. These projects are a part of the Agile BioFoundry (ABF) consortium and will leverage National Laboratory capabilities to address challenges in biomanufacturing. Each of these ABF selected projects has been invited to collaborate with National Laboratory research facilities to conduct their...

By Lynn L. Bergeson  On July 24, 2020, the U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) announced its solicitation for comments and feedback on recommendations to update the List of Bioengineered Foods as it pertains to the National Bioengineered Food Disclosure Standard. Comments are due by August 24, 2020.

By Lynn L. Bergeson  On August 4, 2020, the U.S. Food and Drug Administration (FDA) Department of Health and Human Services (DHHS) announced the rates for biosimilar user fees for fiscal year (FY) 2021. The fees assessed are used by FDA for certain activities in connection with biosimilar biological product development, review of applications for approval of biosimilar biological products, and approval of product applications. The established fees will apply from October 1, 2020, through...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On July 20, 2020, DOE announced that approximately $64 Million in funding for 18 projects to advance the H2@Scale vision. H2@Scale is a concept that explores the potential for wide-scale hydrogen production and utilization in the United States to enable resiliency of the power generation and transmission sectors while aligning diverse domestic industries, competitiveness, and job creation. Funded through DOE’s Office of Energy Efficiency...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On July 23, 2020, the National Defense Authorization Act (NDAA) was passed by the U.S. Senate; it includes the bipartisan Sustainable Chemistry Research and Development Act of 2019, led by U.S. Senators Chris Coons (D-DE) and co-sponsored by Senators Susan Collins (R-ME), Amy Klobuchar (D-MN), and Shelley Moore Capito (R-WV). Introduced to the Senate in December 2019, the Sustainable Chemistry Research and Development Act of 2019 establishes an...

By Lynn L. Bergeson  On August 4, 2020, U.S. Senators Joni Ernst (R-IA) and Chuck Grassley (R-IA) voted against Mark Menezes, who is nominated to become Deputy Secretary of Energy. In a statement, both Senators said that “[g]iven the uncertainty with the ‘gap year’ small refinery waivers, the wasted time and resources to score the waivers again, the lack of transparency in the entire process, and most importantly, the toll this has taken on Iowa’s farmers and biofuel...

This week's All Things Chemical™ Podcast will be of interest to readers of the TSCAblog™. A brief description of the episode written by Lynn L. Bergeson is below. This week I sat down with Richard E. Engler, Ph.D., B&C’s Director of Chemistry, and all-around TSCA savant. Rich is an organic chemist and a 17-year veteran with the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics, where Rich managed the Green Chemistry Program and reviewed some...

On August 5, 2020, the U.S. Environmental Protection Agency (EPA) issued a Stop Sale, Use or Removal Order (SSURO) against EcoShield LLC (EcoShield) for selling a clip-on badge product called the Eco AirDoctor Portable that claims to sanitize the air of pathogens.  EPA states that the product was being sold and distributed in violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) because it is an unregistered pesticide making false disinfectant claims. ...

As reported in our May 29, 2020, blog item, on May 28, 2020, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) issued a report entitled EPA Toxic Substances Control Act Consent Orders Need Better Coordination.  OIG conducted the evaluation to determine what actions EPA took to verify compliance with the requirements of a 2009 Toxic Substances Control Act (TSCA) Premanufacture Notice Consent Order.  OIG’s recommendations included that EPA implement a process...

On August 3, 2020, the U.S. Environmental Protection Agency (EPA) announced $3,980,782 in funding to five academic research teams to develop New Approach Methods (NAM) for evaluating chemical toxicokinetics.  According to EPA, compared to traditional animal testing, NAMs allow researchers better to predict potential hazards for risk assessment purposes without the use of traditional methods that rely on animal testing.  EPA is providing a grant of up to $800,000 to each...

As reported in our March 23, 2020, memorandum, on March 18, 2020, a coalition of non-governmental organizations (NGO) filed suit in the U.S. District Court for the District of Columbia against the U.S. Environmental Protection Agency (EPA), claiming that EPA fails to disclose information about new chemical substances under the Toxic Substances Control Act (TSCA).  Environmental Defense Fund v. Wheeler, No. 1:20-cv-762.  On July 27, 2020, the parties submitted a joint case...

On July 30, 2020, the U.S. Environmental Protection Agency (EPA) announced it approved amended labels for 13 products based on laboratory testing that shows the products are effective against SARS-CoV-2, the virus that causes COVID-19. These products, and two previously announced products (see our July 7, 2020, blog), are the only products for which EPA has reviewed laboratory testing data and approved label claims specifically against SARS-CoV-2.  In January 2020, at the...

As reported in our February 5, 2020, blog item, the American Conference of Governmental Industrial Hygienists (ACGIH®) Threshold Limit Values for Chemical Substances (TLV®-CS) Committee included carbon nanotubes on its 2020 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®).  ACGIH® has now released...

On July 27, 2020, the U.S. Environmental Protection Agency (EPA) promulgated a final significant use rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate chemical substances.  85 Fed. Reg. 45109.  The final SNUR requires persons to notify EPA at least 90 days before commencing the manufacture (including import) or processing of these chemical substances for the significant new uses described in the notice.  The required significant new use notification...

The Organization for Economic Cooperation and Development (OECD) recently published two guidance documents in its series on testing and assessment: Guidance Document on Aquatic and Sediment Toxicological Testing of Nanomaterials (No. 317): The guidance document addresses practical aspects of carrying out valid tests with manufactured nanomaterials, as well as modifications or additions to OECD Test Guideline procedures intended to improve incrementally the accuracy, intra-laboratory...

The National Academies of Sciences, Engineering, and Medicine (NASEM) are now assembling an ad hoc committee to identify emerging scientific and technological advances from across a broad range of disciplines that the U.S. Environmental Protection Agency’s (EPA) Office of Research and Development (ORD) should consider in its research planning to support EPA’s mission for protecting human health and the environment.  In addition, according to NASEM, the committee will...

This week's All Things Chemical™ Podcast will be of interest to readers of the TSCAblog™. A brief description of the episode written by Lynn L. Bergeson is below. This week I sat down with Congressman John M. Shimkus, a Member of the United States House of Representatives for the 15th District of Illinois.  As listeners of the podcast know well, Congressman Shimkus is a senior Member of the House Energy and Commerce Committee.  In this capacity, Congressman Shimkus has...

On July 23, 2020, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Material manufacturing from nano-scaled particles:  moving forward using plants” by Dr. Blaise Tardy, Research Fellow, Bio-Based Colloids and Materials Research Group — Aalto University in Finland.  Dr. Tardy notes that bio-based nanomaterials such as nanocellulose “have shown great promise in forming high performance materials, with the potential to replace...

The U.S. Environmental Protection Agency (EPA) is accepting public comments on the experts under consideration for membership on the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC).  Biographies of the candidates are available in Docket ID EPA-HQ-OPPT-2020-0135.  Comments are due August 21, 2020.  EPA states that it will use public comments to assist it in selecting multiple members of SACC over the next year.  EPA expects to appoint approximately 15...

The July 2020 issue of the National Institute of Environmental Health Sciences (NIEHS) Environmental Factor includes an item on a new database that facilitates nanomaterial research.  According to the article, NIEHS grantees constructed PubVINAS, “a large database of structure, chemical property, and activity information on 705 nanomaterials, covering 11 material types.”  The article states that the extensive data on each material “allows scientists...

Chemical manufacturers and processors have just over four months to submit Chemical Data Reporting (CDR) data by the November 30, 2020, close of the reporting period. To assist companies in that process, Bergeson & Campbell, P.C. (B&C®) affiliate The Acta Group (Acta®) developed CDR Cross-Check™, an ingenious and cost-efficient tool to identify whether a company’s chemicals are subject to CDR reporting and if so, at what reporting threshold. CDR Cross-Check will identify:...

On July 16, 2020, a coalition of non-governmental organizations (NGO) filed a petition in the U.S. Court of Appeals for the Ninth Circuit, challenging the U.S. Environmental Protection Agency’s (EPA) final risk evaluation for methylene chloride.  The NGOs seek review of EPA’s determination “that the chemical methylene chloride does not present an unreasonable risk of injury to health or the environment under certain conditions of use” and its decision not to consider “certain uses...

On July 7, 2020, the U.S. Environmental Protection Agency (EPA) announced the release of new guidance (Guidance) for registrants of products on or eligible for inclusion on List N, EPA’s list of disinfectant products that EPA has concluded meet EPA’s criteria for use against SARS-CoV-2, the virus that causes COVID-19.  This new guidance provides expedited procedures for those registrants that wish to add electrostatic application methods to their disinfectant product...

On June 30, 2020, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released a report on its audit to determine whether the Safer Choice program effectively meets its goals and whether the program achieves quality standards through its product qualification, renewal, and required audit processes.  OIG states that EPA’s Safer Choice program does not have formal goals included in the fiscal year (FY) 2018-2022 EPA Strategic Plan, and the program has not reported...