Blogs

By Lynn L. Bergeson  On September 20, 2021, the U.S. Food and Drug Administration (FDA) announced the availability of its revised final guidance for industry on biosimilar development and the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). Titled “Questions and Answers on Biosimilar Development and the BPCI Act,” the revised guidance aims to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable...

The U.S. Environmental Protection Agency (EPA) announced on September 24, 2021, that it is extending the submission deadline for manufacturers (including importers) of 50 chemicals to report data from certain unpublished health and safety studies. The deadline for the reporting rule was originally September 27, 2021, and EPA has extended the deadline until December 1, 2021, for 20 of the 50 chemicals and to January 25, 2022, for 30 of the 50 chemicals. The 50 chemicals...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On September 22, 2021, as part of Pollution Prevention Week, the U.S. Environmental Protection Agency (EPA) recognized 33 Safer Choice Partner of the Year award winners for their achievements in design, manufacture, selection, and use of products with safer chemicals. Michal Freedhoff, Assistant Administrator for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), commented on the winners’ achievements,...

Bergeson & Campbell, P.C. (B&C®) is pleased to offer the recording, slides, and written Question and Answer (Q&A) document from our “PFAS Reporting Rules -- What Every Company Needs to Know” webinar, focusing on the U.S. Environmental Protection Agency’s (EPA) proposed reporting rules for per- and polyfluoroalkyl substances (PFAS), presented by B&C Managing Partner Lynn L. Bergeson and Director of Chemistry Richard E. Engler, Ph.D. Do you wonder if the PFAS...

By Lynn L. Bergeson On September 15, 2021, the Senate Committee on Environment and Public Works held a hearing on several U.S. Environmental Protection Agency (EPA) nominees, including Amanda Howe, nominated for Assistant Administrator for Mission Support, and David Uhlmann, nominated for Assistant Administrator for Enforcement and Compliance Assurance. Amanda Howe has a long history of public service, including such roles as the Chief Operating Officer for the now-Vice President, Kamala...

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., Director of Chemistry with Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®), to discuss the U.S. Environmental Protection Agency’s (EPA) continuing struggle to regulate certain persistent, bioaccumulative, and toxic (PBT)...

On September 15, 2021, the U.S. Environmental Protection Agency (EPA) announced that it is terminating the Temporary Amendment to Pesticide Registration (PR) Notice 98-10, effective September 15, 2022. EPA states that it is providing 12 months’ notice to registrants before the termination takes effect to give registrants time to adjust their contractual commitments. Registrants must ensure that by September 15, 2022, their product is produced using a source of active...

On September 17, 2021, the U.S. Environmental Protection Agency (EPA) published a final rule amending the regulations applicable to phenol, isopropylated phosphate (3:1) (PIP (3:1)) promulgated under the Toxic Substances Control Act (TSCA). 86 Fed. Reg. 51823. Specifically, EPA is extending the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles, and the PIP (3:1) used to make those articles, from March 8, 2021, to March 8, 2022....

The New York State Department of Environmental Conservation (NYS DEC) held a virtual public meeting on September 15, 2021, on its forthcoming regulations to implement the Toxic Chemicals in Children’s Products Law. New York’s Environmental Conservation Law (ECL) Article 37 Title 9 establishes an ingredient disclosure program and prohibits certain chemicals in children’s products. ECL Article 37 instructs NYS DEC to promulgate lists of chemicals of concern and high priority chemicals that...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. As part of a White House roundtable to launch the Sustainable Aviation Fuels (SAF) Grand Challenge to decarbonize the aviation sector by 2050, on September 9, 2021, the U.S. Department of Energy (DOE) announced the availability of $64.7 million in funding for projects focused on the production of cost-effective and low-carbon biofuels. DOE aims to advance technologies to replace petroleum fuels used in heavy-duty forms of...

The Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST) announced on August 9, 2021, publication of a study entitled Characterization of Unintentionally Released Nanometric Particles in Various Workplaces. The study characterizes unintentionally released nanoparticles (URNP) found in six workplaces — an underground mine, a truck repair shop, an underground transportation network, a foundry, a machine shop, and a wax casting shop — on the basis of...

On September 7, 2021, the European Commission (EC) Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) posted a preliminary opinion on “Draft Environmental Quality Standards for Priority Substances under the Water Framework Directive” for silver and its compounds. The Water Framework Directive requires the EC to identify priority substances among those presenting significant risk to or via the aquatic environment and to set environmental quality standards (EQS) for...

Registration has opened for a September 22, 2021, webinar held by the National Nanotechnology Coordination Office (NNCO) on “What We Know about NanoEHS: Measurement and Characterization.” The webinar’s speakers will explore the impact of advances in nanomaterial measurement and characterization on the safe and responsible development of nanotechnology. Vincent Hackley, Research Chemist, National Institute of Standards and Technology (NIST), will moderate. The panel will include:...

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...

On August 31, 2021, the U.S. Environmental Protection Agency (EPA) released the final scope documents for the Toxic Substances Control Act (TSCA) risk evaluations of diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP). 86 Fed. Reg. 48695; 86 Fed. Reg. 48693. In its August 31, 2021, press release, EPA notes that both DIDP and DINP “belong to a family of chemicals called phthalates and are commonly used as plasticizers in the production of plastic and...

WEBINARThursday, September 9, 202111:00 a.m. – 12:00 p.m. (EDT)Register Now Bergeson & Campbell, P.C. (B&C®) is pleased to present a complimentary webinar focused on the U.S. Environmental Protection Agency’s (EPA) proposed per- and polyfluoroalkyl substances (PFAS) regulations on September 9, 2021, 11:00 a.m. – 12:00 p.m. (EDT). B&C Managing Partner Lynn L. Bergeson and Director of Chemistry Richard E. Engler, Ph.D., will discuss three actions recently...

By Lynn L. Bergeson    On August 27, 2021, DOE’s EERE, in partnership with the Clean Energy Smart Manufacturing Institute (CESMII), announced the selections of four new Smart Manufacturing Innovation Centers (SMICs). SMICs offer specialized training and direct industry engagement to help U.S. manufacturers implement smart manufacturing technologies to optimize their use of materials and energy. CESMII, an institute funded by DOE’s Advanced Manufacturing Office, focuses...

The New York State Department of Environmental Conservation (NYSDEC) will hold a virtual public meeting on September 15, 2021, on the toxic chemicals in children’s products law. NYSDEC will present the chemicals under consideration for listing as Chemicals of Concern and High Priority Chemicals and their practical quantification limits. NYSDEC will also re-present select topics from the May 26, 2021, public meeting, as some details have changed in response to feedback received. NYSDEC...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.   On August 26, 2021, DOE’s Office of Energy Efficiency and Renewable Energy (EERE) and the Office of Economic Impact and Diversity (ED) announced the launch of the Inclusive Energy Innovation Prize. The new prize will provide cash prizes of up to $250,000 each -- totaling $2.5 million -- to groups and organizations in support of entrepreneurship and innovation in communities historically underrepresented and...

 The U.S. Environmental Protection Agency (EPA) announced on August 31, 2021, the availability of the latest Toxic Substances Control Act (TSCA) Inventory. EPA states that the biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. EPA plans the next regular update of the Inventory for winter 2022. According to EPA, the Inventory contains 86,607 chemicals of which 41,953 are active in U.S commerce. Other updates to the TSCA...

By Lynn L. Bergeson  On August 18, 2021, DOE’s Biological and Environmental Research (BER) Program issued a request for information (RFI) seeking input on technical and logistical pathways that would enhance BER’s research portfolio in comparison to similar international research efforts. The BER Program is DOE’s coordinating office for research on biological systems, bioenergy, environmental science, and Earth system science. Written comments and information must be...

On August 25, 2021, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced its release of a draft guide detailing the information requirements and process for submitting a Regulatory Status Review (RSR) request. Developers of certain genetically modified organisms may use the RSR process to determine the regulatory status of the organisms. The draft guide is open for public comment for 60 days. APHIS also will host a webinar to...

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:...

The U.S. Environmental Protection Agency (EPA) is now accepting nominations for the 2022 Green Chemistry Challenge Awards from companies or institutions that have developed a new green chemistry process or product that helps protect human health and the environment. EPA states that in support of the Biden-Harris Administration’s commitment to tackle the climate crisis, it is adding a new award category to recognize technology that reduces or eliminates greenhouse gas emissions....

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Environmental Protection Agency (EPA) is now accepting nominations for the 2022 Green Chemistry Challenge Awards from companies or institutions that have developed a new green chemistry process or product that helps protect human health and the environment. EPA states that in support of the Biden-Harris Administration’s commitment to tackle the climate crisis, it is adding a new award category to recognize technology that reduces or...

According to Australia, after the first year of operation of the Australian Industrial Chemicals Introduction Scheme (AICIS), the regulated industry and staff within the Office of Chemical Safety have identified “minor operational issues” that require amendments to the details set out in the Ministerial Rules. Australia is proposing targeted amendments to the Industrial Chemicals (General Rules) 2019 and the Industrial Chemicals (Consequential Amendments and Transitional...

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 23, 2021, the U.S. Environmental Protection Agency (EPA) announced the availability of and solicited public comment on guidance on two petition processes applicable to the Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) regulations. 86 Fed. Reg. 47102. The guidance covers petitions for full exemption of byproduct substances that are recycled or otherwise used within site-limited, physically enclosed systems and petitions for partial exemption of chemicals for which...

ASTM recently announced that it published a standard, E3275, that seeks to familiarize laboratory scientists with background information and technical content necessary to image and identify engineered nanomaterials in cellular and noncellular samples. According to ASTM, the standard is specific to the use of the darkfield microscopy/hyperspectral imaging analysis technique. ASTM states that in this technique, the resulting sample analysis allows for direct visualization and...

On August 25, 2021, the U.S. Environmental Protection Agency (EPA) announced that it issued a penalty against Seychelle Environmental Technologies, Inc. (Seychelle), based in Aliso Viejo, California, for violations of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The violations, which EPA states that Seychelle has since corrected, involved the sale of unregistered antimicrobial products and the manufacture of products in an unregistered establishment. According to EPA, in 2017...

On August 17, 2021, the U.S. Environmental Protection Agency (EPA) announced that it is now accepting official Foreign Purchaser Acknowledgement Statements (FPAS) and FPAS annual summaries through the Central Data Exchange Pesticide Submission Portal (CDX PSP). EPA states this improved process allows for pesticide exporters to submit an FPAS electronically rather than physically mailing them, providing a key flexibility during the COVID-19 public health emergency. According...

On August 18, 2021, the U.S. Environmental Protection Agency (EPA) issued several significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for chemical substances that were the subject of premanufacture notices (PMN), including the chemical substance identified generically as multiwalled carbon nanotubes (PMN P-18-182). 86 Fed. Reg. 46133. The SNUR requires persons who intend to manufacture (defined by statute to include import) or process multiwalled carbon nanotubes...

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...

The U.S. Environmental Protection Agency (EPA) met with the Environmental Defense Fund (EDF) on August 5, 2021, to clarify concepts from the July 27, 2021, tiered data reporting (TDR) webinar. EPA’s meeting summary states that EDF representatives requested clarification on the following issues discussed during the webinar: Whether EPA intends to scale back the Chemical Data Reporting (CDR) requirements with respect to the amount of information collected per chemical or to the number...

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 European Food Safety Authority (EFSA) published a Scientific Opinion entitled “Safety assessment of the substance silver nanoparticles for use in food contact materials.” The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the additive silver nanoparticles intended to be used in plastics. All the silver particles were in the size range of 1-100 nanometers (nm), with about 15 nm mean diameter and 99% by number of particles below 20 nm. The...

By Lynn L. Bergeson   On August 9, 2021, the U.S. Department of Energy (DOE) issued its Fiscal Year (FY) 2022 Phase I Release 1 Funding Opportunity Announcement (FOA) for the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. DOE encourages applications from qualified small businesses with strong research capabilities in science, engineering, or any research area sought in the announcement.   To become eligible to submit a Phase I...

The U.S. Environmental Protection Agency (EPA) announced on August 10, 2021, that it added 36 chemicals to the Safer Chemical Ingredients List (SCIL). EPA states that the SCIL “is a living list of chemicals, by functional-use class, that EPA’s Safer Choice program has evaluated and determined meet Safer Choice criteria.” Listed chemicals “are among the safest for their functional use.” According to EPA, the SCIL is a “critical resource” that can be used by many different...

The International Organization for Standardization (ISO) recently published two standards for nanomaterials. ISO/TS 21633:2021, “Label-free impedance technology to assess the toxicity of nanomaterials in vitro,” describes a methodology of a label-free and real-time detection for non-invasive monitoring of cell-based assays to assess toxicity of nanomaterials to eukaryotic and prokaryotic cells. ISO/TS 23034:2021, “Nanotechnologies — Method to estimate cellular uptake of carbon...

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 U.S. Environmental Protection Agency (EPA) announced on July 27, 2021, that it will provide $3.8 million in funding to create two EPA Science to Achieve Results (STAR) Centers for Early Lifestage Vulnerabilities to Environmental Stressors. The centers will focus on early lifestage exposures to chemicals and non-chemical environmental stressors and how these exposures may impact early childhood developmental health. EPA states that scientific research suggests that exposures to...

According to a memorandum posted in Docket ID EPA-HQ-OPPT-2021-0436, the U.S. Environmental Protection Agency (EPA) will not extend the comment period stemming from the July 27, 2021, public webinar on the development of a proposed rule under the Toxic Substances Control Act (TSCA) to implement a tiered data collection strategy intended to inform EPA’s prioritization, risk evaluation, and risk management activities for chemical substances or mixtures. As reported in our July 29,...

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...

By Lynn L. Bergeson Join the Product Stewardship Society (PSS) and a panel of experts for a unique webinar on how your role as a product steward can make an impact. You will learn strategies you can use to support your organization during business disruptions. “The Critical Role of Product Stewardship in Business Continuity” includes a facilitated panel discussion with real-world examples provided of product stewardship management in the aftermath of disruptive events like the...

As reported in our January 4, 2021, blog item, the American Conference of Governmental Industrial Hygienists (ACGIH®) Threshold Limit Values for Chemical Substances (TLV®-CS) Committee included carbon nanotubes on its 2021 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 its two-tier under...

The U.S. Environmental Protection Agency (EPA) announced on July 29, 2021, the availability of the preliminary Toxics Release Inventory (TRI) data on chemical releases, chemical waste management, and pollution prevention activities that took place during 2020 at almost 21,000 federal and industrial facilities in the United States. EPA notes that the preliminary data include the first-ever reporting on per- and polyfluoroalkyl substances (PFAS) added to the TRI by the 2020 National...

On July 15, 2021, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “The ECHA Nanomaterials Expert Group (NMEG)” by Frank Le Curieux, Scientific Area Leader for Genotoxicity at the European Chemicals Agency (ECHA). Le Curieux provides a brief summary of the creation of NMEG and its history. NMEG’s current mandate is to provide informal and non-binding scientific and technical advice on questions related to nanomaterials or nanoforms of substances...

The January 29, 2021, issue of the U.S. Food and Drug Administration’s (FDA) NCTR Research Highlights includes an item highlighting the National Center for Toxicological Research’s (NCTR) nanotechnology-related activities in 2020.  The activities include: Nanotechnology Standards:  Two work items developed by the NCTR Nanotechnology Core Facility (Nanocore) staff became standards in February 2019 and January 2020 (Standard Practice for Performing...

As reported in our May 7, 2021, blog item, the European Commission (EC) recently held a targeted stakeholder consultation to update, test, and verify the preliminary findings of its review of the 2011 Recommendation on the definition of a nanomaterial. According to a July 23, 2021, news item posted by the French Agency for Food, Environmental and Occupational Health and Safety (ANSES), in its response to the consultation, ANSES maintained that the changes proposed by the EC...