Nanoscale Carbon Toxicity Testing Proposal Submitted to EPA

 

 

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.

 

EPA Releases Draft Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray

The EPA recently released a draft of its "Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray" which you can download here.  The document is 323 pages long and has 6 chapters: (i) Introduction; (ii) Introduction to Silver and Nanoscale Silver; (iii) Life-Cycle Stages; (iv) Fate and Transport in Environmental Media; (v) Exposure, Uptake, and Dose; and (vi) Characterization of Effects.

In two chapters most pertinent to our readers, the document discusses the possible EHS ramifications of the manufacturing and use of nanoscale silver disinfectants over a wide-range of issues.  Regarding Life-Cycle Stages, the document covers five primary product stages: feedstocks; manufacturing; distribution and storage; use; and disposal.  Similarly, regarding fate and transport in the environment, the document discusses air, terrestrial, and aquatic systems and factors that effect transport and fate in each media.

Overall , the document appears to mirror the approach used in EPA's prior draft case study on nanoscale titanium dioxide used in drinking water systems and in sunscreens which was published in 2009. 

Written comments on the draft are due to EPA by September 27, 2010.

 

New Edition of Nanotechnology Law Report

New Edition of Nanotechnology Law Report

Inside you will find:

  • EPA Considering New Approach to Nanoscale Materials Under TSCA
  • EPA May Issue Mandatory Data Collection Rule for Nanoscale Materials Under TSCA
  • EPA Takes Aim at Antimicrobial Products Under FIFRA
  • EPA Unveils New Principles for Chemical Management Reform
  • EPA Report on the Use of Nanoscale TiO2 in Water and Sunscreens
  • EPA Withdraws Carbon Nanotube SNURs
  • Press Release: New Contributing Editor for InterNano
  • Virginia CLE presentation: “Insurance, Nanotechnology, and Risk”
  • Nanoparticles and Deaths in the People’s Republic
  • Sweating the Small Stuff
  • Soil Association Cites China Deaths in Renewed Call for Moratorium on Nanotechnology Commercialization
  • Nanotechnology Legislation in the 111th Congress
  • Mapping Nano
  • Flight of the Nanobees

 

EPA Report on the Use of Nanoscale TiO2 in Water and Sunscreens

Last Friday, EPA's Office of Research and Development announced in the Federal Register a 45 day comment period for its new draft case study on the use of nanoscale TiO2 in water and sunscreens:

"Nanomaterial Case Studies: Nanoscale Titanium Dioxide in Water Treatment and in Topical Sunscreen"

FR 74,146 at 38188 (July 31, 2009).  The report focuses on two specific applications of nanoscale titanium dioxide (nano-TiO2): (i) as an agent for removing arsenic from drinking water, and (ii) as an active ingredient in topical sunscreen. The draft report is divided into five chapters:

  1. Introduction
  2. Life Cycle Stages
  3. Fate and Transport
  4. Exposure - Dose Characterization
  5. Characterization of Effects

The report is formidable in length, scope, and detail.  For those looking for some quick highlights, the report provides a great series of summaries of the existing TiO2 environmental, health, and safety literature.  For example:

  • Table 4-4 presents an overview of approximately 25 existing TiO2 skin absorption/penetration studies dating back to 1997;
  • Table 5-3 provides a summary of nano-TiO2 ecological effects; and
  • Tables 5-4 through 5-6 provide a summary of health effects of nano-TiO2 particles in mammalian animal models via dermal, oral, and respiratory exposure routes.

EPA notes that the "document is not intended to serve as a basis for risk management decision in the near term on these specific uses of nano-TiO2."  Rather, its focus is on developing necessary data for "future assessment efforts." Specifically, the "document is a starting point to determine what is known and what needs to be known about selected nanomaterials as part of a process to identify and prioritize research to inform future assessments of the potential ecological and health implications of these materials."