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: Legal/Regulatory Issues

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Final TSCA Reporting and Recordkeeping Rule for Nanoscale Materials Available

Posted in Federal, Legal/Regulatory Issues, United States
On January 12, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish in the Federal Register a Section 8(a) of the Toxic Substances Control Act (TSCA) rule establishing reporting and recordkeeping requirements for certain chemical substances when they are manufactured or processed at the nanoscale.  According to a pre-publication version of the final… Continue Reading

Germany Begins Consultation on Announcement Concerning Manufactured Nanomaterials

Posted in International, Legal/Regulatory Issues, Occupational Health and Safety Issues
The Committee on Hazardous Substances (AGS) of the Federal Institute for Occupational Safety and Health (BAuA) began a public consultation on its update to several technical rules.  AGS seeks comment on Bekanntmachung zu Gefahrstoffen (BekGS) 527, “Hergestellte Nanomaterialien.”  Although BAuA has published an English translation of Announcement 527, “Manufactured Nanomaterials,” BAuA notes that it is… Continue Reading

Bill Presented to President Obama Would Lengthen Time between NNI Strategic Plans, Reviews, and Evaluations

Posted in Federal, Legal/Regulatory Issues, United States
The American Innovation and Competitiveness Act (S. 3084) would amend the 21st Century Nanotechnology Research and Development Act (15 U.S.C. § 7501 et seq.) to change the frequency of National Nanotechnology Initiative (NNI) reports.  The strategic plan would be released every five instead of every three years, and the triennial review would be renamed the… Continue Reading

France Releases 2016 Report on Nanomaterial Reporting Scheme

Posted in International, Legal/Regulatory Issues
In November 2016, the Ministry of the Environment, Energy, and the Sea released its 2016 report, in French, Éléments issus des déclarations des substances à l’état nanoparticulaire.  The report analyzes nanomaterial declarations received in 2016 for reporting year 2015.  Under Decree No. 2012-232, companies that manufacture, import, and/or distribute a “substance with nanoparticle status” in… Continue Reading

Draft REACH Guidance Documents for Nanomaterials Move to Next Consultation Step

Posted in International, Legal/Regulatory Issues
The European Chemicals Agency (ECHA) announced in its December 14, 2016, ECHA Weekly that the following drafts for updated ECHA guidance on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation have moved to the next consultation step and been sent to the Member State Committee for review: Guidance on recommendations for nanomaterials for… Continue Reading

ECHA Announces Signed Agreement for EU Observatory for Nanomaterials

Posted in International, Legal/Regulatory Issues
On December 7, 2016, the European Chemicals Agency (ECHA) announced the signing of a delegation agreement between ECHA and the European Commission (EC) on the European Union Observatory for Nanomaterials (EU-ON).  According to ECHA, the information sources for the EU-ON will include data generated by various pieces of EU legislation regulating the safe use of… Continue Reading

Australian Draft National Standard for the Environmental Risk Management of Industrial Chemicals Addresses Nanomaterials

Posted in International, Legal/Regulatory Issues
On November 24, 2016, the Australian Department of the Environment and Energy began a public consultation on the Draft National Standard for the Environmental Risk Management of Industrial Chemicals and a supporting Draft Explanatory Document.  According to the Department, the primary purpose of the papers is to outline the design and operation of the National… Continue Reading

FDA CDER Identifies Nanotechnology as Area of Interest for Site Visit Training Program for OPQ Staff

Posted in Federal, Legal/Regulatory Issues, United States
The Food and Drug Administration (FDA) published a Federal Register notice on November 16, 2016, announcing the 2017 Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program.  According to the notice, “[a] critical part of the commitment by CDER to make safe and effective high-quality drugs… Continue Reading

Germany Publishes Action Plan Nanotechnology 2020

Posted in EU Member State, International, Legal/Regulatory Issues, Research
The Federal Ministry of Education and Research (BMBF) recently published an English version of its Action Plan Nanotechnology 2020.  Based on the success of the Action Plan Nanotechnology over the previous ten years, the federal government will continue the Action Plan Nanotechnology for the next five years.  Action Plan Nanotechnology 2020 is geared towards the… Continue Reading

OECD Publishes a Number of New Reports in Series on the Safety of Manufactured Nanomaterials, Including Nanosilver Case Study and Gold Nanoparticle Occupational Exposure Assessment in Pilot Scale Facility

Posted in Legal/Regulatory Issues, Occupational Health and Safety Issues, OECD
In November 2016, the Organization for Economic Cooperation and Development (OECD) published the following new reports in its Series on the Safety of Manufactured Nanomaterials: Toxicokinetics of Manufactured Nanomaterials: Report from the OECD Expert Meeting:  As part of its Program on the Safety of Manufactured Nanomaterials, OECD initiated a series of expert meetings to discuss… Continue Reading

NNCO Announces 2016 NNI Strategic Plan

Posted in Federal, Legal/Regulatory Issues, Research, United States
On November 1, 2016, the National Nanotechnology Coordination Office (NNCO) announced the release of the 2016 National Nanotechnology Initiative Strategic Plan.  The 21st Century Nanotechnology Research and Development Act of 2003 requires National Nanotechnology Initiative (NNI) agencies to develop an updated Strategic Plan every three years.  The 2016 Strategic Plan represents a consensus among the… Continue Reading

ECHA Committee Adopts First Opinion Approving Nano Biocide

Posted in EU Member State, Legal/Regulatory Issues
On October 13, 2016, the European Chemicals Agency (ECHA) announced that the Biocidal Products Committee adopted three opinions supporting the approval of active substances for use in biocidal products, including its first opinion on a nanomaterial.  The Committee supports the use of pyrogenic, synthetic amorphous silicon dioxide, nano, surface treated for insecticides, acaricides, and products… Continue Reading

EPA Proposes SNUR for Functionalized Carbon Nanotubes (Generic)

Posted in Federal, Legal/Regulatory Issues, Occupational Health and Safety Issues, United States
On October 27, 2016, the U.S. Environmental Protection Agency (EPA) proposed significant new use rules (SNUR) for three chemical substances that were the subject of premanufacture notices (PMN), including functionalized carbon nanotubes (generic).  According to the notice, the PMN states that the substance will be used as a thin film for electronic device applications.  Based… Continue Reading

ECHA Board of Appeal Annuls Four Decisions Requesting Substance Identity Information on a Nano Structured Substance

Posted in EU Member State, International, Legal/Regulatory Issues
In cases A-008-2015, A-009-2015, A-010-2015, and A-011-2015, the European Chemicals Agency (ECHA) Board of Appeal examined appeals against compliance check decisions made by ECHA requesting further substance identity information from four registrants of a “nano structured” substance.  As reported in our July 29, 2015, blog item, ECHA adopted the contested decisions on December 17, 2014,… Continue Reading

EPA Submits Final TSCA Rule on Nanomaterials to OMB for Review

Posted in Federal, Legal/Regulatory Issues, United States
On October 7, 2016, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget (OMB) a final rule that would require reporting and recordkeeping information on certain chemical substances when they are manufactured or processed as nanoscale materials.  EPA issued a proposed rule, under Section 8(a) of the Toxic Substances Control… Continue Reading

Germany Publishes Review of the Joint Research Strategy of the Higher Federal Authorities

Posted in EU Member State, International, Legal/Regulatory Issues, Research
Germany Publishes Review of the Joint Research Strategy of the Higher Federal Authorities   On September 19, 2016, the Federal Institute for Occupational Safety and Health (BAuA) published a report entitled Review of the joint research strategy of the higher federal authorities — Nanomaterials and other advanced materials:  Application safety and environmental compatibility.  The report… Continue Reading

Draft 2016 NNI Strategic Plan Available for Public Comment

Posted in Federal, Legal/Regulatory Issues, United States
On September 13, 2016, the National Nanotechnology Initiative (NNI) announced in the Federal Register the availability of the draft 2016 NNI Strategic Plan for public comment.  The NNI Strategic Plan represents a consensus among NNI agencies on the high-level goals and priorities of the NNI, and on specific objectives to be pursued over at least… Continue Reading

National Academies Publishes Prepublication Version of Triennial Review of the NNI

Posted in Federal, Legal/Regulatory Issues, United States
In early September 2016, the National Academies published a prepublication version of the Triennial Review of the National Nanotechnology Initiative.  The National Nanotechnology Coordination Office (NNCO) asked the National Research Council (NRC) to conduct a triennial review of the National Nanotechnology Initiative (NNI).  In particular, the NRC was asked to assess:  (1) mechanisms to advance… Continue Reading

EC Requests Scientific Opinion on Styrene/Acrylates Copolymer (Nano) and Sodium Styrene/Acrylates Copolymer (Nano)

Posted in International, Legal/Regulatory Issues
The European Commission (EC) requested a scientific opinion from the Scientific Committee on Consumer Safety (SCCS) on styrene/acrylates copolymer and sodium styrene/acrylates copolymer in nano forms.  Under the Cosmetics Regulation, any cosmetic product containing a nanomaterial must be notified to the EC six months prior to being placed on the market.  If the EC has… Continue Reading

Global Summit on Regulatory Science Will Focus on Nanotechnology Standards and Applications

Posted in Federal, International, Legal/Regulatory Issues, United States
The 2016 Global Summit on Regulatory Science (GSRS) will be held September 7-9, 2016, in Bethesda, Maryland.  Each GSRS meeting focuses on an area of regulatory science that would benefit from discussions aimed at identifying future research directions, and this GSRS meeting will focus on nanotechnology standards and applications, building on an October 11, 2015,… Continue Reading

EC Requests Scientific Opinion on Colloidal Silver (Nano)

Posted in International, Legal/Regulatory Issues
The European Commission (EC) has requested a scientific opinion from the Scientific Committee on Consumer Safety (SCCS) on colloidal silver (nano). Under the Cosmetics Regulation, any cosmetic product containing a nanomaterial must be notified to the EC six months prior to being placed on the market.  If the EC has concerns about the safety of… Continue Reading

U.S. Army ERDC Conducting Survey to Inform Risk Management Tool for Developing Nano-Enabled Products and Nanomaterials

Posted in Federal, Legal/Regulatory Issues, United States
The U.S. Army Engineer Research and Development Center (ERDC) is developing a web-enabled information and screening tool intended to help small businesses integrating or developing nanoscale materials address uncertainty related to regulatory compliance and environment, health, and occupational safety (EHOS) risks.  To that end, ERDC is conducting a brief survey to identify resources, regulations, and… Continue Reading

CEN Committee Seeks Responses to Survey on Disposal Practices for Manufactured Nano-Objects in Waste

Posted in International, Legal/Regulatory Issues
Under European Commission (EC) funding, the European Committee for Standardization Technical Committee (CEN/TC) 352 — Nanotechnologies is developing guidelines relating to the safe waste management and disposal of deliberately manufactured nano-objects. The TC seeks responses from companies manufacturing or processing manufactured nano-objects by September 5, 2016, to an online questionnaire relating to current disposal practices… Continue Reading

Canada Begins Consultation on Proposed Prioritization Approach for Nanoscale Forms of DSL Substances

Posted in International, Legal/Regulatory Issues
On July 27, 2016, Environment and Climate Change Canada (ECCC) and Health Canada (HC) began a consultation on a proposed prioritization approach for nanoscale forms of substances on the Domestic Substances List (DSL).  Canada will use the proposed approach to:  (1) establish a list of existing nanomaterials in Canada for prioritization; (2) identify how the… Continue Reading