Nanotechnology Lawyer & Attorney : Porter Wright Morris & Arthur : Nanotechnology Law Report - Germanium nanobead image provided by UT-Battelle, which manages Oak Ridge National Laboratory for the Department of Energy

As a follow-up to and outgrowth of the June 2005 OECD Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides, and Biotechnology, the OECD Working Party on Manufactured Nanomaterials (WPMN) was established in September 2006, with the mission of helping "member countries efficently address the safety challenges of nanomaterial".

Presented at the WPMN's March 2011 meeting, "Current Developments/Activities on the Safety of Manufactured Nanomaterials" ". . .is intended to provide delegations and other stakeholders with a "snapshot" of information on activities related to manufactured nanomaterials, as well as other activities . . . at the national and international level".

The "snapshot" consists of two sections; section I, "Recent and Planned National Activities in Chemical Regulatory Area on Health and Environmental Safety Aspects of Manufactured Nanomaterials" and section II, "Current Activities in Other Organisations Related to Nanotechnologies/Nanomaterials". Section I is the larger of the two sections, focusing on the written reports that members of the OECD submitted to the WPMN. From the length and depth of these reports, it is easy to gauge which nations are actively involved in nanomaterials research, development and can be judged to have a fairly well developed nanoindustrial segment to their national economies. Australia, for example, submitted a five and a half page report discussing what the government and regulatory agencies have done and plan to do in the future to insure that facilities manufacturing nanomaterials reduce the levels of worker exposure, possible impact on the environment, etc, while Belgium's report, in contrast, consisted of four paragraphs.

Section II is far shorter, totaling four pages, focused on the activities of the International Organisation for Standardisation Technical Committee-Nanotechnologies (ISO/TC 229), the World Health Organisation (WHO) and the Food and Agriculture Organisation of the UN (FAO).

The value of the "snapshot" is that it provides stakeholders, both in the respective nations and internationally, with useful information regarding various nations support of their nanoindustries and how current and future regulation affecting workers, the environment and the general public's exposure to nanomaterials might impact on established and emerging nanoindustries.

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The NanoSafety Consortium for Carbon just submitted a proposed toxicity testing agreement to EPA under Section 4 of the Toxic Substances Control Act covering a range of nanoscale materials including multi-walled carbon nanotubes, double-walled carbon nanotubes, single-walled carbon nanotubes, and graphene. 

Key elements for the curious:

• The chemical substances to be tested may include representative (i) purified multi-walled carbon nanotubes ranging from 4 to 600 nanometers in diameter and less than 30 micrometers in length; (ii) purified double-walled carbon nanotubes ranging from 1.5 to 4 nanometers in diameter and less than 5 micrometers in length; (iii) purified single-walled carbon nanotubes ranging from .7 to 2 nanometers in diameter and less than 30 micrometers in length; and (iv) purified graphene nanoplatelets in flake/sheet form ranging from .5 nanometers to 100 nanometers thick. All test materials will be purified by the National Institute of Standards and Technology to be at least 99 percent pure. Final test materials will be approved by the EPA and will be selected to adequately represent the constituency of the final signatories to the testing agreement.

• The characteristic for which testing will be conducted is subchronic inhalation toxicity in rodents, or such other toxicity testing as may be approved by EPA to achieve the intent and purpose of the testing agreement. As appropriate, consideration will be given to using in vivo instillation rather than inhalation test methods. Test data will be developed under standards based on TSCA test guidelines in 40 CFR parts 796, 797, and 798, Organization for Economic Cooperation and Development (OECD) test guidelines, or other suitable test methodologies.  Specifically, the signatories will conduct a 90 day inhalation toxicity study in rats with a post exposure observation period of up to 3 months, including broncholaveolar lavage fluid analysis (OPPTS 870.3465 or OECD 413), or such other testing as may be approved by the EPA to achieve the intent and purpose of the testing agreement. Testing guidelines will be modified to account for nanoscale properties of the materials being tested. Such modifications are subject to EPA approval and will be incorporated into the below-referenced study plan.

If EPA decides to pursue the proposed testing agreement, it will initiate a six-month negotiation and comment period which will open to the public pursuant to 40 C.F.R. § 790.28.

Stay tuned.

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The Working Party on Manufactured Nanomaterials (“WPMN”) of the Organisation for Economic Co-operation and Development (“OECD”) has revised its nanomaterial testing guidance document, first published in 2009 to support nanotechnology safety in the industry.

The guidance manual was conceived primarily to assist sponsors of the OECD Sponsorship Programme for the Testing of Manufactured Nanomaterials, who conduct testing in support of the WPMN's exploratory testing program. The manual addresses includes general and common issues in nanomaterials safety as well as specific consideration on sample preparation and dosimetry for the safety testing of manufactured nanomaterials. Specific consideration includes  i) physic-chemical properties; ii) ecotoxicity studies; iii) degradation, transformation and accumulation; and iv) health effects.

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Nanotechnology Law Report -- Spring 2009

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On June 2, 2008 the Organization  for Economic Co-operation and Development (OECD) released the first stage in its effort to study the impacts of certain nanoparticles.   In 2006, the OECD formed its Working Party on Manufactured Nanomaterials to implement the "Project on Safety Testing of a Representative Set of Manufactured Nanomaterials."  The Project was divided into two parts: 1) develop a priority list of nanomaterials currently, or soon to be, in commerce, for health impact study, and 2) develop a program for the testing and understanding of those nanomaterials.  The June 2 report is the culmination of the first step--the creation of list of nanomaterials to be studied.

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