All Knowledge & Insights By Date

By Lynn L. Bergeson  On October 1, 2021, EPA announced a series of virtual meetings of the Board of Scientific Counselors (BOSC) Chemical Safety for Sustainability and Health and Environmental Risk Assessment (CSS HERA) Subcommittee to review recent progress and activities of the Chemical Safety Analytics (CSA) and Emerging Materials and Technologies (EMT) research areas. Meetings are open to the public, and EPA is accepting comments until November 3, 2021. Interested parties may also...

On October 1, 2021, the U.S. Environmental Protection Agency (EPA) announced the availability of the Draft FY 2022-2026 EPA Strategic Plan. 86 Fed. Reg. 54448. The draft Strategic Plan communicates EPA’s priorities and provides the roadmap for achieving its mission to protect human health and the environment. The draft Strategic Plan outlines objectives within the following strategic goals: Goal 1: Tackle the Climate Crisis; Goal 2: Take Decisive Action to Advance Environmental...

The Swedish National Platform for Nanosafety (SweNanoSafe) will hold a workshop on November 29, 2021, on “Safe and Sustainable by Design: a prerequisite for achieving a circular economy.” SweNanoSafe states that “Safe and Sustainable by Design (SSbD) is based on the consideration and minimization of uncertainties and risks to human health and the environment from an early stage of the innovation process and throughout the lifecycle of the innovation product.” The concept of SSbD...

In early July 1996, I was returning on a flight from Amman, Jordan, wondering what kind of negotiation we in the Clinton Administration faced in completing the legislative text of what became the Food Quality Protection Act (FQPA). (I had been asked to go to Jordan to visit the Jordanian pesticide regulatory program by a friend who was a senior official at the State Department. The result of my visit may have played a very, very small role in the Middle East peace process -- but that is another...

As reported in our May 7, 2021, blog item, the European Commission (EC) held a targeted stakeholder consultation as part of its review of the Recommendation on the definition of a nanomaterial. The EC held the consultation to update, test, and verify the preliminary findings of its review, gathering further evidence and feedback from a wide range of stakeholders who have a role in application of the harmonized regulatory definition of nanomaterial in the European Union (EU)....

The National Research Center for the Working Environment (NFA) in Denmark will hold a course on October 10, 2019, on the Nano-Risk Governance Portal, a new portal for the risk management of nanomaterials.  NanoSafety Cluster Week will be held October 7-10, 2019, in Copenhagen, Denmark, and will include: October 7, 2019: caLIBRAte Final Conference — Building Confidence on Risk Assessment and Governance of Nanomaterials; October 8-9, 2019: Open Conference:...

On August 18, 2021, the U.S. Environmental Protection Agency (EPA) announced that it will stop the use of the pesticide chlorpyrifos on all food. In the pre-publication of the Federal Register notice released on August 19, 2021, EPA revoked all “tolerances” for chlorpyrifos, which establish an amount of a pesticide that is allowed on food. In addition, EPA states that it will issue a Notice of Intent to Cancel under the Federal Insecticide, Fungicide, and...

On August 17, 2021, Representatives Frank Pallone, Jr. (D-NJ), Chair of the House Energy and Commerce Committee, Diana DeGette (D-CO), Chair of the Subcommittee on Oversight and Investigations, and Paul Tonko (D-NY), Chair of the Subcommittee on Environment and Climate Change, sent a letter to U.S. Environmental Protection Agency (EPA) Administrator Michael Regan to request information regarding “concerning reported irregularities” in EPA’s chemical review program. The Committee’s August...

On August 13, 2021, the U.S. Environmental Protection Agency (EPA) announced that it appointed two new members, Cheryl A. Murphy, Ph.D., Professor, Director of Center for PFAS Research, Michigan State University, and Veronica J. Berrocal, Ph.D., Associate Professor, Department of Statistics, University of California, to serve on the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP). The Chair and one other existing member also were...

The U.S. Environmental Protection Agency (EPA) announced on August 6, 2021, that it will provide $9,272,545 in funding to seven institutions for research to estimate better children’s chemical exposures from soil and dust ingestion. According to EPA, the research will focus on improving estimates of children’s ingestion rates of chemicals such as lead, mercury, polychlorinated biphenyls (PCBs), and asbestos. EPA states that “[a]ccurate, comprehensive measurements of soil and dust...

The European Food Safety Authority (EFSA) has updated its “Guidance on risk assessment of nanomaterials to be applied in the food and feed chain: human and animal health.” The updated guidance, published on August 3, 2021, covers the application areas within EFSA’s remit, including novel foods, food contact materials, food and feed additives, and pesticides. The guidance takes into account relevant scientific studies on physico‐chemical properties, exposure assessment and hazard...

 On February 16, 2021, the National Academies of Sciences, Engineering, and Medicine (National Academies) announced the availability of a report entitled The Use of Systematic Review in EPA’s Toxic Substances Control Act Risk Evaluations.  The U.S. Environmental Protection Agency (EPA) requested that the National Academies convene a committee to review EPA’s 2018 guidance document on Application of Systematic Review in TSCA Risk Evaluations and associated...

On June 15, 2021, the U.S. Environmental Protection Agency (EPA) appointed nine new members to serve on the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC). Additionally, EPA appointed a new Chair and reappointed seven existing members. In EPA’s July 13, 2021, announcement, EPA notes that members of the TSCA SACC serve staggered terms of appointment, generally of three years. They possess expertise in scientific and technical fields relevant to chemical risk...

On July 12, 2021, the U.S. Environmental Protection Agency (EPA) announced in the Federal Register a notice of availability of a petition filed on April 8, 2021, by the Center for Biological Diversity (CBD) requesting that EPA cancel Elanco US Inc.’s (formerly Bayer Healthcare LLC) Product, PNR1427, more commonly known as Seresto (Petition). 86 Fed. Reg. 36546. The Petition also requests that EPA suspend the registration pending the requested cancellation. Seresto has been registered...

The European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) have received a draft assessment of glyphosate carried out by four European Union (EU) member states and have begun to consider the findings. According to ECHA’s June 15, 2021, press release, the national authorities of France, Hungary, the Netherlands, and Sweden -- known as the Assessment Group of Glyphosate (AGG) -- examined all the evidence submitted by the companies that are seeking renewed approval to...

On May 21, 2021, Law 360 quoted Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), regarding some of the first moves of the Biden Administration.  President Joe Biden picked Michal Freedhoff, who helped draft the amendments and worked for the Democrats on the Senate Environment and Public Works Committee during the Trump administration, to lead the agency's Office of Chemical Safety and Pollution Prevention. Freedhoff is already in place at...

Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) are pleased to announce that Amy L. Babcock, MPH, DABT®, ERT, MRSB has joined our firms as Senior Scientist. Ms. Babcock has 15-plus years of experience leading qualitative and quantitative human health risk assessments in industry and agency roles, most recently as Supervisory Toxicologist and Branch Chief of the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP), Office...

The U.S. Environmental Protection Agency (EPA) announced on May 7, 2021, that it is partnering with the People for the Ethical Treatment of Animals (PETA) Science Consortium International, Unilever, and Syngenta on a three-part virtual workshop series on “Using In Silico and In Vitro Approaches for Next Generation Risk Assessment of Potential Respiratory Toxicants.”  EPA states that this webinar series supports its commitment “to collaborate with partners and stakeholders to reduce,...

The Society of Toxicology (SOT) in conjunction with the U.S. Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) have partnered to provide a colloquia series on Emerging Toxicological Science:  Challenges in Food and Ingredient Safety.  The colloquia will present scientific information that is high-quality, cutting-edge, future-oriented toxicological science and is intended to provide a well-grounded foundation to inform the work of FDA...

The European Union (EU) Observatory for Nanomaterials (EUON) announced on March 19, 2021, that it is looking for topic suggestions that could be addressed in its upcoming studies.  According to EUON, up to three studies are conducted annually to address knowledge gaps on nanomaterials that are of interest to the general public and the research community.  EUON states that it seeks studies that address: Questions relating to the health and safety of nanomaterials, including...

The European Food Safety Authority (EFSA) announced on March 15, 2021, that it has begun a public consultation on a draft updated Guidance on the assessment of exposure of operators, workers, residents, and bystanders in risk assessment for plant protection products (PPP).  According to EFSA, the Guidance is designed to assist risk assessors and applicants when quantifying potential non-dietary, systemic exposures as part of the regulatory risk assessment for PPPs.  The Guidance is based on...

On March 5, 2021, the U.S. Environmental Protection Agency (EPA) announced that “in support of the Biden-Harris Administration’s commitment to making evidence-based decisions to protect human health, U.S. Environmental Protection Agency (EPA) is taking an important step by proposing the cancellation of the registration of pentachlorophenol.” Pentachlorophenol, a well-recognized wood preservative in use for decades, is registered under the Federal Insecticide, Fungicide, and Rodenticide Act...

On March 5, 2021, the U.S. Environmental Protection Agency (EPA) announced that “[i‌]n support of the Biden-Harris Administration’s commitment to making evidence-based decisions to protect human health, U.S. Environmental Protection Agency (EPA) is taking an important step by proposing the cancellation of the registration of pentachlorophenol.” Pentachlorophenol, a well-recognized wood preservative in use for decades, is registered under the Federal Insecticide, Fungicide, and...

The Verband der Mineralfarbenindustrie e. V. (VdMi), which represents German manufacturers of inorganic, organic, and metallic pigments, fillers, carbon black, ceramic and glass colors, food colorants, artists’ and school paints, masterbatches, and products for applied photocatalysis, has published a “Comparative Compilation of relevant nano definitions in different regulations and their corresponding consequences.”  The compilation notes that pigments and fillers often fall under the...

On February 19, 2021, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “eREACHNano helps you to register nanoforms under REACH” by Dorte Rasmussen, Ph.D., who has been working on the exposure and risk assessment of chemicals at DHI A/S for almost 25 years.  Rasmussen describes eREACHNano, a tool developed to explain Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation requirements for nanoforms. ...

The Organization for Economic Cooperation and Development (OECD) has published the latest edition of the Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour de Table.  The Tour de Table compiles information provided by delegations on the occasion of the 20th meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in September 2020.  Below are highlights from the Tour de Table: Canada: Canada is developing a nanomaterial...

On February 1, 2021, the U.S. District Court for the District of Montana granted the U.S. Environmental Protection Agency’s (EPA) January 31, 2021, unopposed motion to vacate and remand its January 6, 2021, final rule on “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information” (86 Fed. Reg. 469).  EDF v. EPA, No. 4:21-cv-03-BMM.  On January 11, 2021, the Environmental Defense Fund (EDF), Montana...

Chemical Watch’s “Global Outlook 2021: Risk assessment and management under TSCA – what should we expect?” includes a conversation between Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®) and Terry Hyland, North America Managing Editor, Chemical Watch, regarding what to expect from the Biden Administration and the U.S. Environmental Protection Agency (EPA) in 2021. Excerpts from the article are below. New challenges also lie ahead for the EPA,...

On January 11, 2021, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) posted a final opinion entitled Scientific Advice on the Safety of Nanomaterials in Cosmetics.  The EC requested that SCCS determine the nanomaterials, as published in the 2019 catalogue of nanomaterials, for which specific concerns can be identified and justified to establish a priority list of nanomaterials for risk assessment (Article 16(4) Reg. 1223/2009).  The final opinion...

The Organization for Economic Cooperation and Development (OECD) published a report entitled Moving Towards a Safe(r) Innovation Approach (SIA) for More Sustainable Nanomaterials and Nano-enabled Products.  According to the Executive Summary, the report “presents common working descriptions to ensure a common understanding of concepts such as: Safe(r) Innovation Approach and its elements, Safe(r)-by-Design and Regulatory Preparedness.”  The report compiles existing risk...

The Organization for Economic Cooperation and Development (OECD) has posted a report entitled Ability of biopersistent/biodurable manufactured nanomaterials (MNs) to induce lysosomal membrane permeabilization (LMP) as a prediction of their long-term toxic effects.  The report describes “the expanding knowledge on the implications and biological significance of lysosomal and autophagy dysfunction and the subsequent assembly and activation of inflammasome NLRP3 induced by biodurable...

In 2016, the Organization for Economic Cooperation and Development’s (OECD) Working Party on Manufactured Nanomaterials (WPMN) included the Advancing Adverse Outcome Pathway (AOP) Development for Nanomaterial Risk Assessment and Categorization (NanoAOP) project in its program of work.  The objective of the project is to contribute to the future development and application of AOPs for manufactured nanomaterial regulatory decision making by following the principles established by the OECD...

The Toxic Substances Control Act (TSCA) authorizes the U.S. Environmental Protection Agency (EPA) to collect fees from chemical manufacturers (including importers) to defray a portion of the costs associated with TSCA implementation efforts. The TSCA fees rule requires payment for eight categories of fee-triggering events under TSCA, including EPA-initiated risk evaluations under TSCA Section 6. The EPA must prepare a preliminary list of manufacturers subject to fee obligations for EPA-initiated...

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...

Under Toxic Substances Control Act (TSCA) Section 26(b), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), the U.S. Environmental Protection Agency (EPA) is authorized to collect fees from chemical manufacturers (defined to include importers under TSCA) to defray a portion of the EPA costs associated with TSCA implementation efforts. The TSCA Fees Rule, which became effective on October 18, 2018, requires payment of fees for eight categories 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...

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...

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...

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...

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 6, 2020, the California Developmental and Reproductive Toxicant Identification Committee (DARTIC) announced it will be meeting on December 11, 2020, to discuss the possible developmental and reproductive toxicity (DART) of 22 chemical substances and chemical groups, including glyphosate and its salts, and three neonicotinoid pesticides (acetamiprid, clothianidin, and imidacloprid).  DARTIC is composed of scientists who advise California’s Office of Environmental Health...

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...

The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) began a public consultation on October 5, 2020, on a preliminary opinion entitled Scientific Advice on the Safety of Nanomaterials in Cosmetics.  The EC requested that SCCS determine the nanomaterials, as published in the 2019 catalogue of nanomaterials, for which specific concerns can be identified and justified to establish a priority list of nanomaterials for risk assessment (Article 16(4)...

The U.S. Food and Drug Administration (FDA) Nanotechnology Task Force is celebrating NanoDay on October 9, 2020, by hosting a virtual research symposium to showcase more than a decade of progress and innovation in nanotechnology at FDA.  The agenda lists the following presentations: A Decade of Progress and Innovation in Nanotechnology at U.S. FDA; Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology; Regulatory Science Research in...

According to the Summer 2020 edition of the National Nanotechnology Coordination Office (NNCO) Quarterly Newsletter, the 2020-2021 National Nanotechnology Initiative (NNI) nanomaterial environmental, health, and safety (nanoEHS) webinars will begin in November 2020.  According to the Newsletter, the Nanotechnology Environmental and Health Implications (NEHI) Working Group is planning nanoEHS webinars to present progress in the following areas:  nanomaterial...

The U.S. Environmental Protection Agency (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) will be reorganizing at the end of September 2020. OCSPP currently consists of the Office of Pollution Prevention and Toxics (OPPT), the Office of Pesticide Programs (OPP), and the Office of Science Coordination and Policy (OSCP). According to reporting in Bloomberg Environmental, EPA is reorganizing within OPPT and OPP, as well as reorganizing at the OCSPP level. EPA has recently...

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 Chinese Ministry of Ecology and Environment (MEE), formerly the Ministry of Environmental Protection (MEP), issued the “Measures on the Environmental Management of New Chemical Substances” (MEE Order No. 12) on April 29, 2020, which will replace the current MEP Order No. 7 on January 1, 2021. To implement MEE Order No. 12, the MEE released the “Guidance for Environmental Management Registration of New Chemical Substances (Draft for Consultation)” (Draft Guidance) on August 17,...