On Friday, the United States Government Accountability Office issued its Report to the Chairman (Barbara Boxer) of the Committee on Environment and Public Works, US Senate, GAO-10-549:

Nanotechnology: Nanomaterials Are Widely used in Commerce, but EPA Faces Challenges in Regulating Risk.

Highlights from the report follow.  The report confirms speculation that EPA intends to issue certain new rules pertaining to select nanomaterials by the end of 2010.

Background

"EPA has taken a mulitpronged approach to understanding and regulating the risks of nanomaterials, including conducting further research and implementing a voluntary data collection program. Furthermore, under its existing statutory framework, EPA has regulated some nanomaterials but not others. Although the EPA is planning to issue additional regulations later this year, these changes have not yet gone into effect and products may be entering into the market without EPA review of all available information on their potential risk. Moreover, EPA 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 statutes include volume based regulatory thresholds that may be too high for effectively regulating the production and disposal of nanomaterials."

TSCA

"In the fall of 2009, EPA announced it would reconsider the policy described in its January 2008 document, TSCA Inventory Status of Nanoscale Substances — General Approach, and subsequently announced it planned to develop a SNUR to regulate nanoscale versions of conventional scaled chemicals that are already on the TSCA inventory as a significant new use of that chemical. The agency intends to propose this rule in December 2010."

"TSCA also gives EPA authority to issue rules requiring companies to submit certain information about chemicals. EPA plans to issue one such rule for nanomaterials that would require manufacturers to provide information on production volume, methods of manufacture and processing, and exposure and release, as well as available health and safety studies. Evaluation of this information will provide EPA with an opportunity to consider appropriate action under TSCA to reduce unreasonable risks to human health or the environment, according to EPA. This rule may also help them collect information on nanomaterials not covered by the SNUR discussed above. EPA intends to propose this rule in December 2010."

"EPA officials told us they intend to propose a rule in December 2010 that would require companies to generate test data on the health effects of 15 to 20 different nanomaterials, including carbon nanotubes, nanoclays, and nano aluminum, and also on nanomaterials used in aerosol-applied products. This information will help EPA correlate the properties of these materials with specific health effects, manage or minimize risk and exposure, and help EPA determine the need for additional testing of these materials, according to EPA. EPA officials told us they will be working with the National Institute for Safety and Health Administration, and the Consumer Product Safety Commission on this effort."

FIFRA

"EPA officials told us that if a company replaces a conventionally sized active ingredient in a pesticide with a nanoscale version of that ingredient, it is mandatory for the company to amend its registration. Officials also noted, however, that the agency’s position on this point needs to be made explicit to the regulated community and such a clarification could be made in EPA guidance. According to stakeholders, manufacturers of nanopesticides are required to obtain an amended registration in such a circumstance even without new EPA guidance explicitly requiring it since the registration requirement is based not only on questions of chemical identity, but also on claims made about the pesticide; its composition; and its chemistry, toxicology, and other information."

GAO’s Recommendations

"We recommend that the Administrator of EPA, take the following three actions:

  • Complete its plan to issue a Significant New Use rule for nanomaterials.
  • Modify 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.

In addition, the Administrator of EPA should make greater use of the agency’s authorities to gather information under existing environmental statutes. Specifically, EPA 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.

Finally, the Administrator of EPA 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."

EPA’s May 4, 2010 Response to GAO

Finally, attached as an exhibit to the report was a written response from EPA in which the agency largely agreed with all of GAO’s recommendations. Regarding GAO’s Clean Water Act recommendation, EPA stated that its Office of Research and Development is currently developing methods to detect nanomaterials in water and predict levels of concern. Once able to detect and measure nanomaterials in water, EPA will then consider whether reporting requirements should be amended.

We will continue to monitor these issues and provide timely updates to our readers.