• Nanosilver, Nanomaterials EHS Research in the Regulatory Spotlight Again
  • October 30, 2009 | Author: Michael T. Novak
  • Law Firm: Keller and Heckman LLP - Washington Office
  • Nanotechnology will take center stage before the Environmental Protection Agency (EPA) in the coming weeks. In early November, a Scientific Advisory Panel (SAP) will meet to evaluate nanosilver and other nanometal pesticides. Later that month, EPA will hold a meeting on the latest nanotech research sponsored by a host of federal agencies. Both meetings are sure to draw considerable attention from industry, as companies are eager for greater clarity on the regulatory status of nanomaterials.

    Scientific Advisory Panel to Meet on Nano-pesticides

    The SAP, established under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), will meet in Arlington, Virginia on November 3-6 to "consider and review a set of scientific issues related to the assessment of hazard and exposure associated with nanosilver and other nanometal pesticide products." 74 Fed. Reg. 47,575 (September 16, 2009), . As the primary scientific peer review mechanism for EPA's Office of Prevention, Pesticides and Toxic Substances, the SAP provides scientific information, guidance, and recommendations on pesticide issues, especially the effect of regulatory actions on health and the environment.

    EPA intends to use the November meeting to gather guidance and recommendations from the SAP on several issues. First, the Agency is seeking information on how size and other properties affect the behavior of nanoparticles in pesticides compared to conventionally-sized particles in pesticides. Second, EPA wants information on the types of data that would demonstrate that pesticides containing nanomaterials pose no unreasonable risk of harm. This is a key question, as registration of a pesticide under FIFRA requires submission of data showing that the product will not have unreasonable adverse effects on the environment. Specifically, EPA is concerned about the potential leaching of free nanosilver and nanometals or nanometal oxides. Finally, EPA is seeking recommendations from the SAP on whether traditional methods of risk assessment will be effective in the context of nano-pesticides. For example, EPA predicts that lower limits of detection will be needed in order to measure exposure to nanoparticles.

    As nano-pesticides are currently in somewhat of a regulatory holding pattern at EPA pending further progress on these issues, the meeting is likely to attract substantial industry attention in the hope that EPA will clarify the Agency's position on nano-pesticides and identify the types of data necessary to obtain registration under FIFRA for such products. In the weeks before the meeting, interested companies should monitor the SAP's website for background documents and other information: http://www.epa.gov/scipoly/sap. Minutes from the meeting will be posted on the site about three months after the meeting.

    EPA Spearheads Nanotech Research

    In an effort to better understand "how manufactured nanomaterials may harm human health and the environment," EPA recently announced that it will pursue a new research strategy on nanotechnology. The Agency seeks to generate data on the use of nanotechnology and products containing nanomaterials in order to identify potential hazards and minimize risks. The research will focus on several manufactured nanomaterials, including silver.

    EPA's new strategy will likely build on existing research sponsored by the Agency. Industry and other members of the public will have a chance to learn more about research currently being conducted at the Interagency Nanotechnology Implications Grantees Workshop being held in Las Vegas, Nevada on November 9-10. The workshop will feature the latest research on nanotechnology sponsored by EPA, National Science Foundation, National Institutes of Health, National Institute of Environmental Health Sciences, National Institute for Occupational Safety and Health, and Department of Energy. The meeting could be a prime opportunity to understand the most recent findings on nanotechnology and gather insight on how the new information will impact EPA's regulation of nanomaterials.

    State, Federal, and Foreign Agencies Focus on Nano

    EPA is not the only agency focusing on nanomaterials. Nanotechnology is getting attention from state agencies, as well as foreign bodies. For more information, please see the following articles: Nanomaterials and REACH: "No Data, No Market" Rule to Apply to Nanomaterials; EPA Issues Significant New Use Rules (SNURs) for Certain Carbon Nanotubes; California's Data Call-ins on Nanomaterials Raise Legal Issues.