On May 27, 2025, President Trump signed an Executive Order (EO) on “Restoring Gold Standard Science.” 90 Fed. Reg. 22601. The EO states that the Trump Administration “is committed to restoring a gold standard for science to ensure that federally funded research is transparent, rigorous, and impactful, and that Federal decisions are informed by the most credible, reliable, and impartial scientific evidence available.” The EO restores the scientific integrity policies of the first Trump...
Category: Research and Testing
The 41st SQA Annual Meeting will cover "hot topics" in GCP, GLP, GMP, pharmacovigilance, scientific archiving, computer validation, veterinary medicine, and other QA disciplines. Lara A. Hall, MS, RQAP-GLP, Senior Regulatory Scientist and Quality Assurance Specialist, B&C, and Michelle C. Mims, MS, RQAP-GLP, Regulatory Scientist and Quality Assurance Specialist, B&C, will present "A Sponsor’s Role in Regulatory Testing under EPA GLP" on April 8, 2025.
Bergeson & Campbell, P.C. (B&C®), its global consulting affiliate The Acta Group (Acta®), and consortia management affiliate B&C® Consortia Management, L.L.C. (BCCM) are pleased to share with you our 2025 Forecast. For all the reasons you might imagine, our seasoned team was especially challenged this year in speculating on what to expect in 2025 regarding global industrial, agricultural, and biocidal chemical regulatory and policy initiatives. Given the European Parliamentary...
October 30, 2024
Registration Open for NURA Webinar Series on Addressing Systemic Toxicity with NAMs
The Physicians Committee for Responsible Medicine (PCRM) New Approach Methodologies (NAM) Use for Regulatory Application (NURA) program has announced two upcoming webinars in the DyNAMic Discussions series. This webinar series invites speakers to share candid perspectives on how they have overcome barriers to apply NAMs in their fields and discuss how these examples can be used to promote the use of NAMs in other situations. November 14, 2024, at 10:00 a.m. (EST): Next steps toward the...
August 21, 2024
EPA Authors Describe Categorization Approach to PFAS to Identify Potential Candidates for Testing and Human Health Assessments
On August 18, 2024, Computational Toxicology published an article entitled “Development of chemical categories for per- and polyfluoroalkyl substances (PFAS) and the proof-of-concept approach to the identification of potential candidates for tiered toxicological testing and human health assessment.” Co-authored by members of the U.S. Environmental Protection Agency’s (EPA) Center for Computational Toxicology & Exposure (CCTE) and Office of Chemical Safety and Pollution Prevention...
The U.S. Environmental Protection Agency (EPA) announced on August 7, 2024, that it will hold a webinar on August 28, 2024, on the use of new approach methodologies (NAM). The webinar, “The CATMoS Model for Acute Oral Toxicity and Evaluation of its Potential Use in a Regulatory Context for Pesticide Hazard and Risk Assessment,” is the fifth in a series held in collaboration with PETA Science Consortium International (PSCI), the Institute for In Vitro Sciences (IIVS), and the California...
On July 5, 2024, the U.S. Court of Appeals for the District of Columbia Circuit issued its decision in Vinyl Institute, Inc. v. EPA (No. 22-1089). As reported in our May 31, 2022, blog item, on May 23, 2022, the Vinyl Institute, Inc. (VI) filed suit against the U.S. Environmental Protection Agency (EPA), seeking review of EPA’s March 2022 test order for 1,1,2-trichloroethane (1,1,2-TCA) issued under Section 4(a)(2) of the Toxic Substances Control Act (TSCA). The court states that “EPA’s...
The National Nanotechnology Coordination Office (NNCO), on behalf of the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the Committee on Technology, National Science and Technology Council (NSTC), requested comments on June 13, 2024, on the “National Nanotechnology Initiative Environmental, Health, and Safety Research Strategy: 2024 Update” (2024 Update). 89 Fed. Reg. 50390. NNCO states that federal agencies participating in NSET’s Nanotechnology Environmental and...
The European Union (EU) Observatory for Nanomaterials (EUON) invites proposals for upcoming studies aimed at addressing knowledge gaps for nanomaterials within the EU market, such as: Questions related to the health and safety aspects of nanomaterials, including hazard and risk assessment; Specific issues surrounding the uses, associated risks, and benefits of nanomaterials; or Information about markets of nanomaterials. EUON notes that studies are based on desk research and surveys and should...
The U.S. Environmental Protection Agency (EPA) announced on March 25, 2024, that it has issued the fourth Toxic Substances Control Act (TSCA) test order requiring testing on per- and polyfluoroalkyl substances (PFAS) under its National PFAS Testing Strategy. According to EPA, the action requires the 3M Company (3M) and Wacker Chemical Corporation (Wacker) to conduct and submit testing on the physical-chemical properties of 2-(N-Methylperfluoro-1-octanesulfonamido)ethanol (NMeFOSE) (Chemical...
On March 5, 2024, the National Nanotechnology Initiative (NNI) published its supplement to the President’s 2024 budget request. NNI states that the President’s 2024 budget requests an “all-time record” of $2.16 billion for it, with a sustained investment in foundational research that will fuel new discoveries and increase investments in application-driven research and development (R&D) to advance technologies of the future and address national priorities. The President’s 2024...
February 20, 2024
NNI Webinar on Nanometrology for Nanoscale Medical and Pharmaceutical Products Will Be Held March 1, 2024
The National Nanotechnology Coordination Office (NNCO) is organizing a series of National Nanotechnology Initiative (NNI) webinars on nanometrology, metrological challenges, and recent advances in three topical areas: food, agriculture, and environment; nanoscale medical and pharmaceutical products; and electronics. Registration is open for the third webinar in the series, Nanoscale Medical and Pharmaceutical Products, which will be held March 1, 2024, at 12:00 p.m. (EST). The webinar will...
February 5, 2024
EUON Announces New Tender Notices Published by ECHA
The European Union (EU) Observatory for Nanomaterials (EUON) announced on February 5, 2024, that the European Chemicals Agency (ECHA) has published two new ex-ante publicity notices for two service contracts: “Survey on state of the art of carbon-based nanomaterial detection and quantification in environmental and biological matrices”: ECHA expects to launch a call for tender to initiate an EUON systematic survey on the current state of the art for carbon-based nanomaterial detection and...
According to NNI, the roundtable is a critical part of the Nano4EARTH National Nanotechnology Challenge, which aims to leverage recent investments in understanding and controlling matter at the nanoscale to develop technologies and industries that address climate change. Nano4EARTH focuses on facilitating opportunities for members of the nanotechnology community to convene, collaborate, and share resources. Nano4EARTH also strives to provide mechanisms that support technology development and...
The European Union (EU) Observatory for Nanomaterials (EUON) has posted two Nanopinions: “Seeing is believing,” posted on April 11, 2023, by Dr. Chandima Bulumulla, Postdoctoral Fellow at the Janelia Research Campus of the Howard Hughes Medical Institute, and Dr. Abraham G. Beyene, Group Leader at the Janelia Research Campus of the Howard Hughes Medical Institute. The column explains how single-walled carbon nanotubes (SWCNT) can help measure biochemical processes happening inside the brain....
By Lisa R. Burchi, James V. Aidala, and Heather F. Collins, M.S. On May 31, 2023, the U.S. Environmental Protection Agency (EPA) released a final rule exempting a class of plant-incorporated protectants (PIP) created using genetic engineering, from registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and from the food or feed residue tolerance requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA). 88 Fed. Reg. 34756. PIPs are pesticidal...
The White House Office of Science and Technology Policy (OSTP) has extended the comment period for its April 5, 2023, request for information (RFI) seeking public input in updating the National Nanotechnology Initiative (NNI) Environmental, Health, and Safety (EHS) Research Strategy. 88 Fed. Reg. 33174. OSTP is soliciting public input from a wide variety of stakeholders, including individuals, industry, academia, research laboratories, nonprofits, and think tanks. OSTP states that it is...
April 27, 2023
EUON Extends Deadline for Study Proposals
As reported in our March 16, 2023, blog item, on March 14, 2023, the European Union (EU) Observatory for Nanomaterials (EUON) issued a call for study proposals. EUON is looking for studies on: Questions related to the health and safety aspects of nanomaterials, including hazard and risk assessment, exposure to nanomaterials, or worker safety and protection; Specific issues surrounding the uses of nanomaterials; or Information about markets for nanomaterials (e.g., the market for...
April 24, 2023
GAO Science and Tech Spotlight Describes Benefits of Synthetic Biology and Challenges Ahead
By Lynn L. Bergeson and Carla N. Hutton The U.S. Government Accountability Office (GAO) published a “Science & Tech Spotlight” on synthetic biology on April 17, 2023. GAO defines synthetic biology as “a multidisciplinary field of biotechnology that involves engineering the genetic material of organisms -- such as viruses, bacteria, yeast, plants, or animals -- to have new characteristics.” According to GAO, scientists are currently exploring the use of...
April 12, 2023
USDA Researchers Develop Natural, Washable, Antimicrobial Cleaning Wipes Using Nanocomposite Raw Cotton Fiber
The U.S. Department of Agriculture (USDA) announced on April 11, 2023, that its Agricultural Research Service (ARS) recently developed sustainable, machine-washable antimicrobial wipes that can be used at least 30 times for cleaning hard and nonporous surfaces. According to USDA, ARS researchers developed the antimicrobial wipes “by using raw cotton fiber that naturally produced silver nanoparticles inside the fiber in the presence of a silver precursor.” USDA states that the...
The National Nanotechnology Initiative (NNI) will hold a public meeting May 31-June 1, 2023, to discuss the revision of the 2011 National Nanotechnology Initiative Environmental, Health, and Safety Research Strategy (EHS Research Strategy). NNI encourages individuals, non-governmental organizations (NGO), academic and research institutions, and the private sector interested in the responsible development of nanotechnology to attend and contribute to creating an updated EHS Research Strategy....
March 21, 2023
EUON Posts Nanopinions on Graphene Electronic Tattoos and How to Monitor the Crystal Defect Structure in Nanomaterials
The European Union (EU) Observatory for Nanomaterials (EUON) has posted two Nanopinions: “Graphene Electronic Tattoos,” posted on February 20, 2023, by Dr. Dmitry Kireev. “Graphene Electronic Tattoos (GETs) are a type of skin-wearable electronic device that can be used for personalized healthcare by transmitting the bio-electrical activity of the human body in the measurable electrical signal. […] The GETs are optically transparent, lightweight, and flexible, making them adhere and...
March 16, 2023
EUON Issues Call for Study Proposals
The European Union (EU) Observatory for Nanomaterials (EUON) has issued a call for study proposals. EUON is looking for studies on: Questions related to the health and safety aspects of nanomaterials, including hazard and risk assessment, exposure to nanomaterials, or worker safety and protection; Specific issues surrounding the uses of nanomaterials; or Information about markets for nanomaterials (e.g., the market for specific materials such as graphene or specific market sectors)....
March 10, 2023
OECD Webinar on TG No. 125: Nanomaterial Particle Size and Size Distribution of Nanomaterials Available for Replay
The Organization for Economic Cooperation and Development (OECD) held a webinar on February 7, 2023, to present the methods described in Test Guideline (TG) No. 125 to determine the size and size distributions of nanomaterial particles and fibers spanning from one nanometer (nm) to 1,000 nm. It also presented the use and limitations of this TG, as well as of the validation exercise that was done to support its development. OECD organized the webinar to increase awareness of the newly adopted...
March 7, 2023
Registration Opens for NNI Webinar on “What’s Next in NanoEHS: The Young Professional’s Perspective”
The National Nanotechnology Initiative (NNI) will hold a webinar on “What’s Next in NanoEHS: The Young Professional’s Perspective” on March 28, 2023. NNI’s 2023 nano environmental, health, and safety (nanoEHS) webinar series will focus on the questions, challenges, and breakthroughs needed to continue advancing the responsible development of nanotechnology. According to the National Nanotechnology Coordination Office’s (NNCO) announcement, the 2023 theme complements the NNI’s...
February 6, 2023
NNI Publishes Supplement to the President’s 2023 Budget Request
On February 3, 2023, the National Nanotechnology Initiative (NNI) announced that it published a supplement to President Biden’s 2023 budget request. NNI notes that the supplement serves as its annual report, called for under the provisions of the 21st Century Nanotechnology Research and Development Act, and also addresses the requirement for Department of Defense (DOD) reporting on its nanotechnology investments. The NNI budget represents the sum of the nanotechnology-related...
February 1, 2023
ECHA Provides Updated Guidance on Testing Nanomaterials
The European Chemicals Agency (ECHA) announced in its February 1, 2023, ECHA Weekly that it has released an updated appendix for nanomaterials that provides guidance on how to obtain data under the new information requirements for nanoforms. According to ECHA, this includes information on how to perform environmental testing and advice on preparation methods and testing strategies for physico-chemical testing of nanoforms. ECHA notes that the Partner Expert Group (PEG) members...
On January 17, 2023, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “EU 2025: Enjoying the Benefits of Nanotechnology and NMS” by Dr. Anastasios Papadiamantis and Dr. Antreas Afantitis, both of NovaMechanics Ltd. The authors report the findings of a study commissioned by EUON on the EU market for nanomaterials, including substances, uses, volumes, and key operators. The authors state that the EU (including the European Economic Area (EEA)...
January 23, 2023
OECD Will Hold Webinar on Test Guideline No. 125: Nanomaterial Particle Size and Size Distribution of Nanomaterials
The Organization for Economic Cooperation and Development (OECD) will hold a webinar on February 7, 2023, on Test Guideline (TG) No. 125: Nanomaterial Particle Size and Size Distribution of Nanomaterials. OECD states that it will present the methods described in TG No. 125 to determine the size and size distributions of nanomaterial particles and fibers spanning from one nanometer (nm) to 1,000 nm. During the webinar, attendees will be able to learn the use and limitation of the...
On November 25, 2022, the Swedish National Platform for Nanosafety (SweNanoSafe) and the Swedish University of Agricultural Sciences (SLU) held the Fifth Annual Research Network Workshop. According to SweNanoSafe’s December 20, 2022, announcement, the online workshop was chaired by Geert Cornelis and attracted some 40 participants. SweNanoSafe has posted an overview of the workshop contents that includes a summary of the key outcomes. According to the report, the breakout...
January 9, 2023
Registration Begins for NNI Webinar on EHS Implications of Metal Nanoparticles in Aquatic Environments
On February 1, 2023, the National Nanotechnology Initiative (NNI) will hold a webinar on the environmental, health, and safety (EHS) implications of metal nanoparticles in aquatic environments. According to NNI, the focus will be on copper and copper oxide, nickel, and silver nanoparticles. Each expert panelist will provide an overview on the current state of knowledge for a particular metal nanoparticle. The panelists will discuss methods used for identifying, measuring, and assessing the...
December 23, 2022
OECD Accepting Comment on Draft Study Report on Applicability of the key event based TG 442D for in vitro skin sensitisation testing of nano-materials
The Organization for Economic Cooperation and Development has published a draft Study Report on Applicability of the key event based TG 442D for in vitro skin sensitisation testing of nano-materials. The study summary and conclusions include the following questions and answers (Q&A): Is the Test Guideline (TG) technically applicable? Yes, OECD TG 442D (KeratinoSensTM test method) is from a technical point of view applicable for the testing of manufactured nanomaterials. The draft...
December 15, 2022
EUON Announces Results of Desk Study on (Bio)degradation, Persistence, and SbD of Nanomaterials
The European Union (EU) Observatory for Nanomaterials (EUON) announced on December 12, 2022, the results of a desk study entitled Study on (bio)degradation, persistence and safe by design of nanomaterials. The study aimed at providing information on the state of the art, the existing gaps, and the research needs for the (bio)degradation and persistence of nanomaterials and their relevant organic coatings. Another objective was to examine the current state of the art for safe by design (SbD)...
December 8, 2022
EUON Announces New Study Assessing the Potential Impact of Graphene on Health and the Environment
The European Union (EU) Observatory for Nanomaterials (EUON) announced on December 7, 2022, publication of a June 2022 report by the European Chemicals Agency (ECHA) entitled Assessment of the potential impact of graphene, graphene oxide and other 2D materials on health, and the environment. Commissioned by EUON, the report provides a systematic review and critical assessment of the health and environmental effects of graphene, graphene oxide, and other two-dimensional (2D)...
December 5, 2022
NNI Reports Its Impact on the U.S. Economy
The National Nanotechnology Initiative (NNI) posted a blog item entitled “Impact of the NNI on the U.S. economy: at least $42 billion in one year!” on November 28, 2022. According to NNI, participating government agencies and departments have invested more than $38 billion over the past 20 years in nanoscale research and development (R&D), establishing the United States “as the leader in the field.” In 2014, the Executive Office of the President’s National Science and Technology...
By Lynn L. Bergeson and Carla N. Hutton On November 30, 2022, the U.S. Department of Agriculture’s (USDA) Agricultural Research Service (ARS) announced that its scientists have determined that plants could be used to produce nanobodies that quickly block emerging pathogens in human medicine and agriculture. The nanobodies are small antibody proteins naturally produced in specific animals like camels, alpacas, and llamas. ARS researchers evaluated nanobodies to prevent and...
December 1, 2022
ORD Publishes Six Strategic Research Action Plans for FYs 2023-2026, Including for Chemical Safety f
By Lynn L. Bergeson and Carla N. Hutton Research in the U.S. Environmental Protection Agency’s (EPA) Office of Research and Development (ORD) is organized around six highly integrated and transdisciplinary national research programs that are closely aligned with EPA’s strategic goals and cross-EPA strategies. Each program is guided by a Strategic Research Action Plan (StRAP) developed by EPA with input from its many internal and external partners and stakeholders. In October...
On November 30, 2022, the U.S. Department of Agriculture’s (USDA) Agricultural Research Service (ARS) announced that its scientists have determined that plants could be used to produce nanobodies that quickly block emerging pathogens in human medicine and agriculture. The nanobodies are small antibody proteins naturally produced in specific animals like camels, alpacas, and llamas. ARS researchers evaluated nanobodies to prevent and treat citrus greening disease in citrus trees. The scientists...
November 7, 2022
EUON Study Predicts Growth in European Nanomaterial Market
The European Union (EU) Observatory for Nanomaterials (EUON) announced on November 7, 2022, that it published a study on the EU market for nanomaterials, including substances, uses, volumes, and key producers, traders, and users. The study also covers the European Economic Area (EEA) countries and Switzerland. EUON states that according to the study, which was carried out in 2021 as a combination of literature research, surveys, and interviews, the European nanomaterial market is...
October 28, 2022
NanoHarmony and NANOMET Publish Status Report on Development or Revisions to OECD Test Guidelines and Guidance Documents Applicable to Nanomaterials
NanoHarmony and NANOMET have published a status report summarizing the current status of projects aiming to develop or adapt Organization for Economic Cooperation and Development (OECD) Test Guidelines (TG) and Guidance Documents (GD) for nanomaterials, as well as the outlook for each project as of July 2022. The status report is intended to be a living document that will be updated regularly. A large part of the status report comprises activities in European Union (EU) projects like...
The U.S. Environmental Protection Agency (EPA) will hold a webinar on November 1, 2022, on a new research funding opportunity, “Developing and Demonstrating Nanosensor Technology to Detect, Monitor, and Degrade Pollutants.” EPA states that environmental pollutants such as pesticides, insecticides, dyes, phenols, endocrine disrupters, polycyclic aromatic hydrocarbons, per- and poly-fluoroalkyl substances (PFAS), heavy metals, and nitrogen compounds can have adverse effects on human health...
October 16, 2022
White House OSTP and NNCO Mark National Nanotechnology Day 2022
On October 7, 2022, the White House Office of Science and Technology Policy (OSTP) and the National Nanotechnology Coordination Office (NNCO) made key announcements intended to advance the Biden Administration’s efforts “to leverage the promise of science and technology to benefit all Americans.” They also complement the Administration’s ongoing Creating Helpful Incentives to Produce Semiconductors (CHIPS) and Science Act implementation efforts “that will ensure the United...
September 30, 2022
OECD Accepting Comment on Draft Study Report on Applicability of the Key Event Based TG 442D for In Vitro Skin Sensitisation Testing of Nanomaterials
.The Organization for Economic Cooperation and Development (OECD) has published for comment a draft study report entitled “Applicability of the key event based TG 442D for in vitro skin sensitisation testing of nanomaterials.” Switzerland conducted experimental work with selected nanomaterials using OECD Test Guideline (TG) 442D (KeratinoSensTM) and made a basic in vitro to in vivo correlation to outline the potential relevance of the results for prediction of skin sensitisation of...
September 14, 2022
EUON Publishes Nanopinion on the Transportation of Nanoparticles across the Blood-Brain Barrier
On September 13, 2022, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Can the Brain’s Gatekeeper Fight a Nano-Attack?” by Dr. Eugenia (Éva) Valsami-Jones, Professor of Environmental Nanoscience at the University of Birmingham, who co-authored an article entitled “Biotransformation modulates the penetration of metallic nanomaterials across an artificial blood–brain barrier model.” The researchers set out to explore systematically how...
The Organization for Economic Cooperation and Development (OECD) Series on the Safety of Manufactured Nanomaterials is to provide up-to-date information on the OECD activities related to human health and environmental safety. In September 2022, OECD has published two new reports. Advanced Materials: Working Description (No. 104) aims to illustrate the content of the advanced materials playing field and the purpose of the Working Party on Manufactured Nanomaterials’ (WPMN) engagement...
By Lynn L. Bergeson and Carla N. Hutton On August 25, 2022, the U.S. Environmental Protection Agency (EPA) announced that registration was open for the 2022 Conference on the State of the Science on Development and Use of New Approach Methods (NAM) for Chemical Safety Testing. EPA notes that there will be limited availability in person at EPA headquarters in Washington, DC, on October 12-13, 2022, and a virtual option will also be available. Conference topics include: Variability and...
August 16, 2022
NASEM Recommends That EPA Conduct Ecological Risk Assessment of UV Filters Found in Sunscreen, Including Titanium Oxide and Zinc Oxide
The National Academies of Sciences, Engineering, and Medicine (NASEM) released on August 9, 2022, a report entitled Review of Fate, Exposure, and Effects of Sunscreens in Aquatic Environments and Implications for Sunscreen Usage and Human Health. NASEM was tasked by Congress and funded by the U.S. Environmental Protection Agency (EPA) to undertake a consensus study of the potential risk of ultraviolet (UV) filters on already threatened aquatic environments and the potential...
August 4, 2022
DaNa Publishes Research Spotlight on Three-Stage Model for the Formation of Micro- and Nanoplastic Particles
The German Federal Ministry of Education and Research (BMBF) project (DaNa4.0) is addressing the question of whether new advanced materials, including nanomaterials, can be harmful to humans and the environment and how humans and the environment come into contact with these materials. DaNa has published an August 2022 research spotlight on a “Three-stage model for the formation of micro- and nanoplastic particles.” The paper, “Degradation of low-density polyethylene to nanoplastic...
The Scientific Committee on Consumer Safety (SCCS) announced on June 22, 2022, that the European Commission (EC) asked that it reassess the safety of titanium dioxide with a focus on genotoxicity and exposure via the inhalation and oral route (lip care, lipstick, toothpaste, loose powder, hair spray) “since the currently available scientific evidence supports an overall lack of dermal absorption” of titanium dioxide particles. The request notes that titanium dioxide is authorized...
The 4th Joint Symposium on Nanotechnology, organized by the German Federal Institute for Risk Assessment (BfR) and the Fraunhofer Network Nanotechnology (FNT), was held May 30-31, 2022. The conference included presentations on topics such as the use of nanotechnology in textiles and packaging, its application in agriculture, the introduction of nanomaterials into the body, and future-oriented assessment approaches. The following presentations from the conference have been posted online....