Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

Archives: Federal

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NIOSH Will Use Experience in Managing Engineered Nanomaterials to Address Advanced Manufacturing

Posted in Federal, Legal/Regulatory Issues, Occupational Health and Safety Issues, United States
Charles Geraci, PhD, CIH, FAIHA, Associate Director for Nanotechnology and Advanced Materials at the National Institute for Occupational Safety and Health (NIOSH), and Laura Hodson, MSPH, CIH, FAIHA, Coordinator of the NIOSH Nanotechnology Research Center, co-authored an article entitled “From ‘Just in Time’ to ‘Just Next Door’:  21st-century Manufacturing Challenges and Opportunities for Industrial Hygienists.” … Continue Reading

B&C Publishes Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018

Posted in Federal, International, Legal/Regulatory Issues, Occupational Health and Safety Issues, United States
Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) published on January 4, 2018, their “Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018.”  In the Forecast, the lawyers, scientists, and chemical regulatory specialists at B&C and Acta offer comprehensive and highly useful observations on the fast-changing and… Continue Reading

NIOSH Plans to Support Implementation of WHO Guidelines to Protect Workers from Nanomaterials

Posted in Federal, International, Occupational Health and Safety Issues, United States
On December 15, 2017, the National Institute for Occupational Safety and Health (NIOSH) posted a blog item entitled “WHO Guidelines to Protect Workers from Nanomaterials.”  As reported in our December 13, 2017, blog item, the World Health Organization (WHO) recently published WHO Guidelines on Protecting Workers from Potential Risks of Manufactured Nanomaterials.  NIOSH Director John… Continue Reading

FDA Publishes Draft Guidance on Drug Products, Including Biological Products, That Contain Nanomaterials

Posted in Federal, Legal/Regulatory Issues, United States
On December 18, 2017, the Food and Drug Administration (FDA) published a Federal Register notice announcing the availability of a draft guidance for industry entitled “Drug Products, Including Biological Products, That Contain Nanomaterials:  Guidance for Industry.”  According to the notice, FDA developed the guidance to provide industry with its current thinking for the development of… Continue Reading

FDA Will Publish Draft Guidance on Drug Products, Including Biological Products, that Contain Nanomaterials

Posted in Federal, Legal/Regulatory Issues, United States
The Food and Drug Administration (FDA) is scheduled to publish a Federal Register notice announcing the availability of a draft guidance for industry entitled “Drug Products, Including Biological Products, that Contain Nanomaterials.”  According to the pre-publication version of the notice, FDA developed the guidance to provide industry with its current thinking for the development of… Continue Reading

NNI Publishes Supplement to President’s 2018 Budget Request

Posted in Federal, Research, United States
On November 30, 2017, the National Nanotechnology Initiative (NNI) published a supplement to the President’s 2018 budget.  The supplement also serves as NNI’s annual report and summarizes the progress made in achieving NNI’s goals, the research and development (R&D) activities and plans of the participating agencies, and the agency investments in each program component area. … Continue Reading

NSF NSE Will Hold Grantees Conference on Progress in Nanotechnology

Posted in Federal, Research, United States
Nanotechnology   The National Science Foundation (NSF) Nanoscale Science and Engineering (NSE) grantees conference on progress in nanotechnology will be held December 12-13, 2017.  The conference will highlight the research and education activities of ongoing NSE grant projects.  It will include a combination of keynotes, panels, posters, program information sessions, discussions of research trends, and… Continue Reading

EPA Publishes SNUR for MWCNTs (Generic)

Posted in Federal, Legal/Regulatory Issues, Occupational Health and Safety Issues, Research, United States
The U.S. Environmental Protection Agency published on October 19, 2017, a direct final rule promulgating significant new use rules (SNUR) for 29 chemical substances that were the subject of premanufacture notices (PMN).  The 29 chemical substances are subject to consent orders issued by EPA under Section 5(e) of the Toxic Substances Control Act.  The direct… Continue Reading

Registration Open for NNI Workshop on Open Technology Development Pathways

Posted in Federal, Research, United States
As reported in our August 30, 2017, blog item, the “Technology Development Pathways:  Case Studies from the [National Nanotechnology Initiative (NNI)]” workshop will be held November 1, 2017.  According to NNI, the workshop will showcase application areas where nanotechnology has had commercial impact.  Keynote presentations will highlight the pathways companies have taken to get from… Continue Reading

EPA Promulgates Final SNUR for Bimodal Mixture Consisting of MWCNTs and Other Classes of CNTs

Posted in Federal, Legal/Regulatory Issues, Occupational Health and Safety Issues, United States
On October 3, 2017, the U.S. Environmental Protection Agency (EPA) promulgated a final significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical substance identified generically as bimodal mixture consisting of multi-walled carbon nanotubes (MWCNT) and other classes of carbon nanotubes (CNT), which was the subject of… Continue Reading

EPA Issues Direct Final SNURs for Carbon Nanotube (Generic) and Nanocarbon (Generic)

Posted in Federal, Legal/Regulatory Issues, Occupational Health and Safety Issues, United States
The U.S. Environmental Protection Agency (EPA) promulgated on September 21, 2017, significant new use rules (SNUR) for 37 chemical substances that were the subject of premanufacture notices (PMN).  Six of the chemical substances, including carbon nanotube (generic) and nanocarbon (generic), are subject to consent orders issued by EPA under Section 4 of the Toxic Substances… Continue Reading

NIOSH Engineering Controls Program Protects Workers from Emerging Hazards

Posted in Federal, Legal/Regulatory Issues, Occupational Health and Safety Issues, United States
On September 6, 2017, the National Institute for Occupational Safety and Health (NIOSH) published a Program Performance One-Pager entitled NIOSH Engineering Controls Program.  The Program’s activities include providing engineering control recommendations to protect workers from emerging hazards in nanotechnology and advanced materials used in additive manufacturing/three-dimensional (3D) printing.  The Program is currently working to: Complete… Continue Reading

Technology Development Pathways Workshop Will Highlight NNI Case Studies

Posted in Federal, Research, United States
The “Technology Development Pathways:  Case Studies from the [National Nanotechnology Initiative (NNI)]” workshop will be held November 1, 2017.  According to NNI, the workshop will showcase application areas where nanotechnology has had commercial impact.  Keynote presentations will highlight the pathways companies have taken to get from research to commercialization.  Panel discussions will focus on specific… Continue Reading

NIOSH Draft Research Agenda for Manufacturing Addresses Nanomaterials

Posted in Federal, Occupational Health and Safety Issues, Research, United States
On August 23, 2017, the National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice requesting comment on its draft National Occupational Research Agenda (NORA) for Manufacturing for public comment.  The NORA Manufacturing Sector Council wrote the Agenda, which “identifies the most important occupational safety and health research needs for the next… Continue Reading

NIOSH Report Highlighting Second Decade of Research Agenda Includes Nano Developments

Posted in Federal, Occupational Health and Safety Issues, United States
On August 10, 2017, the National Institute for Occupational Safety and Health (NIOSH) published a report entitled National Occupational Research Agenda:  Second Decade in Review | 2006-2016.  The report outlines the progress and impact made in addressing occupational safety and health research needs over the second decade of the National Occupational Research Agenda (NORA).  The… Continue Reading

EPA Publishes Final Guidance as Final TSCA Section 8(a) Rule Takes Effect

Posted in Federal, Legal/Regulatory Issues, United States
On August 14, 2017, as the final Toxic Substances Control Act (TSCA) Section 8(a) information gathering rule on nanomaterials took effect, the U.S. Environmental Protection Agency (EPA) published “working guidance” intended to assist stakeholders in complying with the rule.  The working guidance notes that it “will not provide answers to all of the potential questions… Continue Reading

NIEHS Using Survey to Update 2012-2017 Strategic Plan

Posted in Federal, Occupational Health and Safety Issues, United States
Dr. Linda S. Birnbaum, Director, National Institute of Environmental Health Sciences (NIEHS), wrote an editorial in Environmental Health Perspectives on “Updating the NIEHS Strategic Plan.”  According to Birnbaum, NIEHS is developing a plan to guide its next five years and seeks broad input.  NIEHS has created an online survey, “Trends & Insights: Next Steps for… Continue Reading

USDA Awards $4.6 Million in Nanotechnology Research Grants

Posted in Federal, Research, United States
On July 20, 2017, the United States Department of Agriculture (USDA) National Institute of Food and Agriculture (NIFA) announced 13 grants worth $4.6 million for research on the next generation of agricultural technologies and systems to meet the growing demand for food, fuel, and fiber.  NIFA states that funded projects support nanotechnology-based solutions that improve… Continue Reading

NIOSH Submits Proposed Survey to OMB, Will Accept Comments for 30 Days

Posted in Federal, Legal/Regulatory Issues, Occupational Health and Safety Issues, United States
On July 17, 2017, the National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice announcing it submitted a proposed information collection to the Office of Management and Budget for review and approval.  The proposed project is “Survey of Engineered Nanomaterial Occupational Safety and Health Practices.”  As reported in our February 14,… Continue Reading

NIOSH Publishes Chapter on Analysis of Carbon Nanotubes and Nanofibers on Filters by Transmission Electron Microscopy

Posted in Federal, Occupational Health and Safety Issues, United States
The National Institute for Occupational Safety and Health (NIOSH) has published a chapter in the fifth edition of the NIOSH Manual of Analytical Methods (NMAM) entitled “Analysis of Carbon Nanotubes and Nanofibers on Mixed Cellulose Ester Filters by Transmission Electron Microscopy.”  The draft chapter provides standardized approaches for the analysis of carbon nanoparticles.  The chapter… Continue Reading

EPA Regulatory Agenda Item Revised to Remove, Then Add Back TBD Effective Date

Posted in Federal, Legal/Regulatory Issues, United States
Since July 20, 2017, when the Trump Administration published its Unified Agenda of Regulatory and Deregulatory Actions, the entry for the U.S. Environmental Protection Agency’s (EPA) item (RIN 2070-AJ54) concerning the Toxic Substances Control Act (TSCA) Section 8(a) reporting rule for nanoscale materials has been revised at least twice.  As reported in our July 20,… Continue Reading

NanoEHS Webinar Will Address How NNCI Nodes Support Environmental Research

Posted in Federal, Research, United States
The National Nanotechnology Initiative (NNI) will hold a webinar on July 27, 2017, entitled “The National Nanotechnology Coordinated Infrastructure (NNCI) Nodes and Environmental Research: Examples from the Field.”  The National Science Foundation (NSF) supports NNCI, which includes 16 user facility sites, their affiliated partners, and a coordinating office.  NNCI sites provide researchers, academics, small and… Continue Reading

EPA’s Regulatory Agenda Includes TSCA Section 8(a) Nanomaterials Rule with TBD Effective Date

Posted in Federal, Legal/Regulatory Issues, United States
On July 20, 2017, the Trump Administration published its Unified Agenda of Regulatory and Deregulatory Actions.  The Agenda includes a U.S. Environmental Protection Agency (EPA) item (RIN 2070-AJ54) concerning the Toxic Substances Control Act (TSCA) Section 8(a) reporting rule for nanoscale materials.  According to the Agenda item, the final rule effective date is “To Be… Continue Reading

Appellate Court Vacates Conditional Nanosilver Registration

Posted in Federal, Legal/Regulatory Issues, United States
On May 30, 2017, the U.S. Court of Appeals for the Ninth Circuit responded to two petitions for review of the U.S. Environmental Protection Agency’s (EPA) conditional registration of a nanosilver pesticide product and vacated the conditional registration.  NRDC v. EPA, No. 15-72308.  The Natural Resources Defense Council (NRDC) as well as the Center for… Continue Reading