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...