Home > Nanotechnology Columns > Bergeson & Campbell, P.C. > Industry Offers EPA First Nanomaterial Proposed Testing Agreement
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Lynn L. Bergeson Managing Director Bergeson & Campbell, P.C. |
Abstract:
On April 6, 2011, the NanoSafety Consortium submitted to the U.S. Environmental Protection Agency (EPA) a proposed testing agreement under Section 4 of the Toxic Substances Control Act (TSCA). The Consortium consists of a group of single-, double-, and multi-walled carbon nanotube manufacturers, including: Angstron Materials LLC, Applied Sciences, Inc., Cheap Tubes, Inc., Continental Carbon Nanotechnologies, Inc., Nano-C, Inc., NanoLab, Nanoshel, LLC, Pyrograf Products, SouthWest NanoTechnologies, Inc., and XG Sciences, Inc.
April 15th, 2011
Industry Offers EPA First Nanomaterial Proposed Testing Agreement
On April 6, 2011, the NanoSafety Consortium submitted to the U.S. Environmental Protection Agency (EPA) a proposed testing agreement under Section 4 of the Toxic Substances Control Act (TSCA). The Consortium consists of a group of single-, double-, and multi-walled carbon nanotube manufacturers, including: Angstron Materials LLC, Applied Sciences, Inc., Cheap Tubes, Inc., Continental Carbon Nanotechnologies, Inc., Nano-C, Inc., NanoLab, Nanoshel, LLC, Pyrograf Products, SouthWest NanoTechnologies, Inc., and XG Sciences, Inc.
Under the proposed testing agreement, the substances to be tested may include multi-walled carbon nanotubes, double-walled carbon nanotubes, single-walled carbon nanotubes, and graphene nanoplatelets (defined by EPA as thin flakes or sheets of a form of carbon graphene). Key elements in the proposal are: 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; the characteristic for which testing will be conducted is subchronic inhalation toxicity in rodents, or other toxicity testing as may be approved by EPA to achieve the intent and purpose of the testing agreement; and test data will be developed under standards based on TSCA test and Organization for Economic Cooperation and Development (OECD) guidelines, or other suitable test methodologies. Testing guidelines will be modified to account for nanoscale properties of the materials being tested.
Under applicable TSCA rules, the next step is for EPA to consider whether it wishes to accept the proposed testing agreement; it must publish a Federal Register notice and initiate a public process to negotiate the terms of the proposed testing agreement. During this process, entities that have identified themselves as persons who have asked to participate in or monitor the negotiations (interested parties) will be invited to comment on the appropriateness and suitability of all aspects of the proposed testing agreement. Under the controlling rules, EPA will enter into a consent agreement under which the contemplated testing will occur only if there is a consensus among EPA, affected manufacturers, and all interested parties.
The proposed testing agreement is significant for several reasons. First, it is the first such agreement proffered by nanoscale material manufacturers pursuant to TSCA Section 4. The proposal reflects a solid, good faith attempt to provide EPA with information efficiently and quickly, certainly more quickly than a mandatory TSCA Section 4 test rule would allow.
Second, it reflects a promising shared view among at least certain carbon nanotube manufacturers that producing such data as a consortium is a viable and sensible way to proceed.
Third, if EPA enters into a testing agreement, it reflects a willingness on EPA's part to consider alternative testing arrangements to satisfy TSCA data requirements to which each carbon nanotube manufacturer is subject under TSCA by virtue of their TSCA Section 5 notifications. This would set a favorable precedent for future testing initiatives that will enable EPA to obtain needed testing information on nanoscale materials more quickly and efficiently.
It is, of course, unclear how the diverse community of nano stakeholders who are expected to identify themselves as "interested" for purposes of any forthcoming negotiation will react to the testing proposal. The best result would be that all such parties come to the negotiating table with good intentions and a genuine commitment to produce a solid testing agreement that yields meaningful data.
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