PPDC Discusses Nanotechnology and Pesticides

On April 29, 2010, during the U.S. Environmental Protection Agency’s (EPA) Pesticide Program Dialogue Committee (PPDC) meeting, William Jordan, Senior Policy Advisor, Office of Pesticide Programs (OPP), presented slides regarding nanotechnology and pesticides. Jordan briefly described how OPP is defining nanoscale materials and how the technology is being applied to the field of pesticides. His presentation described OPP’s recent consultation with EPA’s Scientific Advisory Panel (SAP) concerning nanosilver and other nanometal pesticide products, as well as other ongoing regulatory activity and future actions OPP intends to take.

OPP’s working definition of nanomaterial is:

An ingredient that contains particles that have been intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers.

Although nanomaterials occur naturally and can be produced unintentionally, Jordan noted that OPP’s working definition includes the phrase “intentionally produced,” and that those are the ones OPP intends to address.

To obtain more data on hazard and exposure from nanosilver and other nanometal pesticide products, OPP is in the process of preparing a Federal Register notice on nanomaterials and pesticide products. The notice will announce a new interpretation of regulations under Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and propose a new policy in June 2010. The new interpretation will be that the presence of a nanoscale material is reportable under FIFRA Section 6(a)(2). In the same notice, EPA is expected also to memorialize OPP’s view that an active or inert ingredient would be considered “new” if it is a nanoscale material.

Jordan also announced that OPP intends to respond in June 2010 to the International Center for Technology Assessment’s (ICTA) May 2008 petition. In its petition, ICTA urged EPA to regulate nanosilver products as pesticides, and asked EPA to take action on an estimated 600 unregistered nanosilver products marketed in the U.S.

Jordan noted the following activities in other EPA offices:

  • Office of Research and Development (ORD) developing a Draft Case Study on nanosilver (expected in 2010); and
  • Office of Pollution Prevention and Toxics (OPPT) developing the following rules under the Toxic Substances Control Act (TSCA):
  • Significant New Use Rule (SNUR) -- Intended to address nanoforms of existing chemicals;
  • Section 8(a) Rule -- Would obtain existing data on current nanomaterials; and
  • Section 4 Test Rule -- Likely at the end of 2010.

 

SNWG Responds to SAP Report on Nanosilver and Other Nanometal Oxide Pesticide Products

In a February 5, 2010, letter to the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs, the Silver Nanotechnology Working Group (SNWG) provides its reactions to the recent Scientific Advisory Panel (SAP) report on nanosilver and other nanometal oxide pesticide products. In its letter, SNWG highlights a number of the statements and recommendations from the SAP report that it considers “highly relevant for the shaping of EPA policy towards nanosilver materials.” SNWG notes that nanosilver is not a new material; clarity is needed on EPA concept of nano; real-life conditions are essential for realistic risk assessment; EPA policy must allow for sustainable technology development; and SAP frequently confounded general “nano”-related issues and uncertainties with issues specific to nanosilver.

EPA SAP Releases Report on Nanosilver and Other Nanometal Pesticide Products

The U.S. Environmental Protection Agency (EPA) Scientific Advisory Panel (SAP) has released the minutes of its November 3-5, 2009, meeting regarding evaluation of the hazard and exposure associated with nanosilver and other nanometal pesticide products.  In addition to the general observations noted here, more information is available in our February 8, 2010, memorandum. First, the SAP final recommendations address nanosilver almost entirely, and little or no mention is made of “nanometal pesticide products.” Second, the Panel stated that existing models “are not appropriate” for use with silver nanomaterials and “will not accurately predict nanosilver exposure scenarios.” The Panel stated that it “strongly believe[s] that in addition to current data requirements under [the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)], additional assays which compared nanoscale and bulk materials would be most beneficial in addressing” differences in toxicokinetics and toxicodynamics for nanoscale materials. This conclusion alone poses formidable challenges for nanosilver pesticide applicants wishing to obtain registration status under FIFRA. Third, the Panel agreed that pesticide products should be tested on a “case-by-case basis,” EPA should use a meta-analysis on the products to understand better trends in life cycle analyses, and “close attention” should be given to products that claim a non-ionic mode of action as an antimicrobial agent. Fourth, the Panel outlined detailed research needs that EPA should consider. The outline will discourage even the most optimistic potential FIFRA registrant for a nanopesticide as the research needs are extensive and likely costly. The Panel also identified the “most useful short-term information needs,” of which stakeholders should be aware. Finally, the Panel stated that a “critical issue” that “must be clarified is the use of [the] terminology ‘nano’” and that for standardization, “the unique property for nanosilver should be established.”

SNWG Presents Data on Silver and Nanotechnology to the SAP

The Silver Nanotechnology Working Group (SNWG) issued a press release regarding its presentation to the U.S. Environmental Protection Agency’s (EPA) Scientific Advisory Panel (SAP) at its November 3-6, 2009, meeting. EPA asked the SAP “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.” According to EPA, companies with an interest in marketing products that contain nanosilver and/or other nanometals or nanometal oxides as pesticides regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) have approached the Office of Pesticide Programs (OPP) seeking product registration. SNWG’s analysis included the key conclusions that nanosilver is not a new material and that EPA has “safely and successfully” regulated nanosilver products for decades.

EPA Will Webcast SAP Meeting

The U.S. Environmental Protection Agency (EPA) has announced that it will stream its November 3-6, 2009, Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) meeting on the Internet. EPA has asked the SAP “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.” According to EPA, companies with an interest in marketing products that contain nanosilver and/or other nanometals or nanometal oxides as pesticides regulated under FIFRA have approached the Office of Pesticide Programs (OPP) seeking product registration. OPP believes, based on its understanding of the scientific literature, that pesticides containing nanoscale materials may pose different risks to humans and the environment than those of pesticides that do not contain nanomaterials.

EPA Announces SAP Meeting Concerning Nanosilver

The U.S. Environmental Protection Agency (EPA) announced in a September 16, 2009, Federal Register notice that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) will meet November 3-6, 2009, “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.” Nominations of candidates to serve as ad hoc SAP members for this meeting are due September 30, 2009. The meeting will be open to the public. EPA asks that written comments be submitted by October 20, 2009, to allow for distribution to the SAP, and that requests for oral comments be made by October 27, 2009.  EPA also states that written comments and requests to make oral comments may be submitted until the date of the meeting, however.