Posted on July 9, 2010 by David Wagner

U.S. General Accounting Office Provides Recommendations to USEPA on the Regulation of Nanomaterials

This post was written by David Wagner.

Underscoring the U.S. Environmental Protection Agency (USEPA) intent to issue rules regulating nanomaterials this year, the U.S. Government Accountability Office (GAO) raised some concerns and offered remedies in its report issued late last month titled, “Nanotechnology: Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk”.

In the report, GAO (an investigative arm of the U.S. Congress) stated its concerns that products with nanomaterials may be entering the market without USEPA review of all available information on their potential risk. Moreover, USEPA faces challenges in effectively regulating nanomaterials that may be released in air, water, and waste because it lacks the technology to monitor and characterize these materials or the relevant statutes include volume-based regulatory thresholds that may be too high to effectively regulate the production and disposal of nanomaterials.

Before offering recommendations, the GAO report discussed the growing world market for products that contain nanomaterials, which is expected to reach $2.6 trillion by 2015. The report identified a variety of products that currently incorporate nanomaterials already available in commerce across the following eight sectors: automotive; defense and aerospace; electronics and computers; energy and environment; food and agriculture; housing and construction; medical and pharmaceutical; and personal care, cosmetics, and other consumer products. Within each of these sectors, GAO also identified a wide variety of other uses that are currently under development and are expected to be available in the future. According to GAO, the extent to which nanomaterials present a risk to human health and the environment “depends on a combination of the toxicity of specific nanomaterials and the route and level of exposure to these materials.”

GAO’s report includes several recommendations to USEPA and indicated that these recommendations are already “in process” at the Agency:

  • Complete its plan to issue a Significant New Use rule for nanomaterials.
  • Modify Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) pesticide registration guidelines to require applicants to identify nanomaterial ingredients in pesticides.
  • Complete its plan to clarify that nanoscale ingredients in already registered pesticides, as well as in those products for which registration is being sought, are to be reported to EPA and that EPA will consider nanoscale ingredients to be new.
  • Should consider revising the Inventory Update under TSCA so that it will capture information on the production and use of nanomaterials and so that the agency will receive periodic updates on this material."
  • Make greater use of the Agency’s authorities to gather information under existing environmental statutes. Specifically, USEPA should:
    • complete its plan to use data gathering and testing authorities under TSCA to gather information on nanomaterials, including production volumes, methods of manufacture and processing, exposure and release, as well as available health and safety studies; and
    • use information-gathering provisions of the Clean Water Act to collect information about potential discharges containing nanomaterials.
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Posted on August 21, 2009 by David Wagner

Recent EPA Notice Indicates Intent to Develop a Data Collection Rule for Nanoscale Materials

This post was written by David Wagner.

On August 4, EPA published a report discussing its intent to develop a data collection rule for nanoscale materials under Toxic Substances Control Act’s (TSCA) Section 8(a). Section 8(a) requires certain manufacturers, importers, or processors of a chemical substance to maintain records and submit reports of production and exposure information. 

The report, prepared by the TSCA Interagency Testing Committee (ITC), stated EPA’s intent to develop a proposed TSCA Section 8(a) rule to obtain information on the production, uses, and exposures of existing nanoscale materials. The ITC was established to make recommendations to the EPA Administrator regarding chemical substances and mixtures to which EPA should give priority consideration for testing under Section 4 of TSCA, which gives EPA the authority to require chemical manufacturers and processors to test chemical substances and mixtures. 

The report identified the need for additional data for the following nanoscale materials: fullerenes; carbon black; titanium oxide nanowires; titanium oxide nanoparticles; zinc oxide; nanosilver; single–walled carbon nanotubes; multi–walled carbon nanotubes; carbon nanofibers; nanoceramic particles; and nanoclays. The report added that “EPA has indicated that it will ensure that the chemicals where there is ITC interest as described in this [report] are either included in [the proposed Section 8(a) rule] or are otherwise new chemical substances subject to premanufacture notification (PMN) reporting under TSCA.  EPA also intends to develop a proposed TSCA Section 4 rule to develop needed environmental, health, and safety data.” 

Comments on the notice are due by September 3, 2009.
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Posted on February 13, 2008 by David Wagner

EPA Unified Agenda: EPA May Issue Significant New Use Rule for Nanoscale Materials in February 2008

In case you missed the explanation in previous articles, nanotechnology is the understanding and control of matter at dimensions of roughly 1 to 100 nanometers, where unique phenomena enable novel applications. A nanometer is about one ten-thousandth the diameter of a human hair. Materials made using nanotechnology, also known as nanoscale materials, may have organizations and properties different than the same chemical substances displayed at a larger scale. And don’t think these are “space” age products – many are being developed to replace everyday items. More than 700 nanoproducts are currently available on the U.S. market. Nanotechnology materials currently in the marketplace include:

  • Burn and wound dressings
  • Water filtration devices
  • Industrial catalysts
  • A dental-bonding agent
  • Step assists on vans
  • Coatings that allow for easier-cleaning glass
  • Bumpers and catalytic converters on cars
  • Protective and glare-reducing coatings for eyeglasses
  • Sunscreens and cosmetics
  • Longer-lasting tennis balls
  • Light-weight, stronger tennis racquets
  • Stain-free clothing and mattresses
  • Ink

The U.S. Environmental Protection Agency’s unified regulatory agenda, published in December, includes a notice on the Nanoscale Materials Stewardship Program (NMSP), which is a voluntary program that EPA established to assemble existing data and information from manufacturers and processors of certain nanoscale materials. The notice states that, under the Toxic Substances Control Act (TSCA), EPA has the authority to require the development of data necessary for risk assessment when statutory findings concerning (1) production volume and exposure/entry into the environment or (2) potential hazard, can be made, and to prevent and eliminate unreasonable risk of injury to human health and the environment.  EPA added that “[i]f information from the NMSP or other information indicates potential new uses of existing chemicals that may result in new exposures or to fill information gaps, EPA may issue a significant new use rule or section 8 reporting rule under TSCA.”

This follows EPA’s July 2007 announcement of the availability of an NMSP concept paper, a proposed information collection request and a paper that describes determining the TSCA inventory status of nanoscale materials. According to the unified regulatory agenda notice, EPA intends to publish in February 2008 a final NMSP notice, including final versions of any documents. 

For more information about Reed Smith's nanotechnology team, please visit their Nanotechnology Team Page.

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