Netherlands Delegation Notes Risks Associated with Nanomaterials

The Netherlands delegation submitted a paper entitled “Risks associated with nanomaterials” for discussion during the June 21, 2011, meeting of the Environment Council of the European Union (EU).  The paper states that, under current EU legislation and the precautionary principle, “industry bears primary responsibility for the safety of its products for workers and consumers.” The current legislation is intended, however, “to assess the hazards of chemical substances used in products, such as cosmetics, but is not geared to evaluating the specific hazards related to nanoengineered particles.” According to the delegation, a key problem is the lack of a generally accepted definition of what constitutes a nanomaterial. The paper calls on the European Commission (EC) to take three steps to regulate nanomaterials: (1) reach agreement on a broadly applicable definition of nanomaterials that covers as many materials with nanospecific risks as possible; (2) ensure traceability and enable a fast and adequate response should a specific nanomaterial ever be found to be hazardous; and (3) develop an adequate risk assessment system for nanomaterials and for products with nanoscale features, and, where necessary, of risk control measures. The paper urges the EU to take action, rather than member states, to prevent industry from facing non-harmonized definitions of nanomaterials, different substance databases, additional administrative costs, and possible market restrictions for certain materials or products. The paper notes that, in the absence of such measures, however, member state initiatives “may be necessary to protect health and the environment.”

Correction: "Nanotechnology 101" Will Be Held in Russell Senate Office Building

The Nanotechnology Caucus will hold a lecture entitled “Nanotechnology 101” on June 22, 2011, at 11:00 a.m. (EDT) in Room 253 of the Russell Senate Office Building. Please note that the location has been corrected.

EPA Proposes Policy on Nanoscale Materials in Pesticide Products

The U.S. Enviromental Protection Agency (EPA) published in the June 17, 2011, Federal Register a notice describing several possible approaches for obtaining certain additional information on the composition of pesticide products. EPA focuses particularly on information about what nanoscale materials are present in registered pesticide products, and defines “nanoscale material” as “an active or inert ingredient and any component parts thereof intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers (nm).” Under one approach, EPA would use Section 6(a)(2) of the Federal Insecticide, Fungicide, and rodenticide Act (FIFRA) to obtain information regarding what nanoscale material is present in a registered pesticide product and its potential effects on humans or the environment. Under an alternative approach, EPA would obtain such information using a data call-in (DCI) under FIFRA Section 3(c)(2)(B). According to the notice, EPA believes FIFRA Section 6(a)(2) “is the most efficient and expedient administrative approach to obtaining information about nanoscale materials in pesticides and EPA would prefer to use this approach.” The notice also proposes a “new approach” that EPA will use to determine on a case-by-case basis whether a nanoscale active or inert ingredient is a “new” active or inert ingredient for purposes of FIFRA and the Pesticide Registration Improvement Act, even when an identical, non-nanoscale form of the nanoscale ingredient is already registered. Comments are due July 18, 2011.

Nanotechnology Caucus Will Hold Lecture on June 22

The Nanotechnology Caucus will hold a lecture entitled “Nanotechnology 101” on June 22, 2011, at 11:00 a.m. (EDT) in Room 253 of the Dirksen Senate Building. The agenda includes:

  • Opening Remarks: Vincent Caprio, Executive Director, NanoBusiness Commercialization Association;
  • Senator Ron Wyden (D-OR);
  • Sally Tinkle, Ph.D., Acting Director, National Nanotechnology Coordination Office, Nanoscale Science, Engineering, and Technology Subcommittee, Committee on Technology National Science and Technology Council;
  • Travis Earles, Ph.D. (Invited), Advanced Materials and Nanotechnology Initiatives, Lockheed Martin Corporation (formerly Assistant Director of Nanotechnology, White House Office of Science and Technology Policy);
  • Jim Hussey, CEO, NanoInk;
  • Frank Ignazzitto, Vice President, Government Business, QD Vision, Inc.;
  • Ajay Malshe (Invited), Co-Founder and Chief Technology Officer, NanoMech; and
  • Scott Livingston, Chairman and CEO, Livingston Securities.

To RSVP, please contact Vincent Caprio.

 

White House ETIPC Releases Policy Principles Concerning Regulation and Oversight of Nanotechnology and Nanomaterials

On June 9, 2011, the Office of Science and Technology Policy (OSTP) announced that the White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) has developed a set of principles specific to the regulation and oversight of applications of nanotechnology. The principles are intended to guide the development and implementation of policies, as described in the title “U.S. Decision-making Concerning Regulation and Oversight of Nanotechnology and Nanomaterials” that occur at the agency level. According to OSTP, the principles reinforce the overarching principles for the regulation and oversight of emerging technologies released on March 11, 2011. The principles also reflect recommendations from a report on nanotechnology prepared by the President’s Council of Advisors on Science and Technology and, importantly, reflect the results of a multi-agency, consensus-based process lead by the National Economic Council (NEC), the Office of Management and Budget (OMB), OSTP, and the Office of the U.S. Trade Representative (USTR). OSTP states that the goals of all of these documents “are to achieve consistent approaches across different emerging technologies and to ensure the protection of public health and the environment while avoiding unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers.”

EPA Proposes Policy on Nanoscale Materials in Pesticide Products

The U.S. Environmental Protection Agency (EPA) released on June 9, 2011, a pre-publication copy of a forthcoming Federal Register notice describing several possible approaches for obtaining certain additional information on the composition of pesticide products. EPA focuses particularly on information about what nanoscale materials are present in registered pesticide products, and defines “nanoscale material” as “an active or inert ingredient and any component parts thereof intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers (nm).” Under one approach, EPA would use Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to obtain information regarding what nanoscale material is present in a registered pesticide product and its potential effects on humans or the environment. Under an alternative approach, EPA would obtain such information using a data call-in (DCI) under FIFRA Section 3(c)(2)(B). According to the notice, EPA believes FIFRA Section 6(a)(2) “is the most efficient and expedient administrative approach to obtaining information about nanoscale materials in pesticides and EPA would prefer to use this approach.” The notice also proposes a “new approach” that EPA will use to determine on a case-by-case basis whether a nanoscale active or inert ingredient is a “new” active or inert ingredient for purposes of FIFRA and the Pesticide Registration Improvement Act (PRIA), even when an identical, non-nanoscale form of the nanoscale ingredient is already registered. Comments will be due 30 days after the notice is published in the Federal Register.

OECD Provides Snapshot on Current and Planned Activities on the Safety of Manufactured Nanomaterials

On May 26, 2011, the Organization for Economic Cooperation and Development (OECD) posted a document entitled “Current Developments/Activities on the Safety of Manufactured Nanomaterials,” which provides information on the outcomes and developments of the OECD Working Party on Manufactured Nanomaterials (WPMN) related to the safety of manufactured nanomaterials. OECD states that the document “provides a snapshot of information on current/planned activities related to the safety of manufactured nanomaterials in OECD member countries and other delegations that attended the 8th meeting of OECD’s Working Party on Manufactured Nanomaterials (Paris France, 16-18 March 2011).” The document also includes written reports on current activities from other international organizations such as the International Organization for Standardization (ISO), Food and Agriculture Organization of the United Nations (FAO), and World Health Organization (WHO).