EPA SAP Releases Report on Nanosilver and Other Nanometal Pesticide Products

Posted on February 9, 2010 by Lynn L. Bergeson

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.”

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SNWG Presents Data on Silver and Nanotechnology to the SAP

Posted on December 11, 2009 by Lynn L. Bergeson

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.

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EPA Will Webcast SAP Meeting

Posted on November 2, 2009 by Lynn L. Bergeson

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.

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EPA Announces SAP Meeting Concerning Nanosilver

Posted on September 17, 2009 by Lynn L. Bergeson

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.

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NGOs Call for Obama Administration to Establish Moratorium on Pesticidal Nanotechnology

Posted on January 15, 2009 by Lynn L. Bergeson

According to a draft January 7, 2009, document, non-governmental organizations (NGO) such as Beyond Pesticides and the Pesticide Action Network for North America recommend that the Obama Administration take a number of immediate actions within its first 100 days, including establishing a moratorium on pesticidal nanotechnology. The NGOs call for the suspension of the registration of nanoproducts with pesticidal properties, and the removal of untested products from the market.  The NGOs urge the Obama Administration to direct the U.S. Environmental Protection Agency (EPA) to develop a clear testing protocol that identifies the full range of potential adverse health and environmental effects of nanoproducts with pesticidal properties. The NGOs cite the 60-day comment period on the International Center for Technology Assessment (ICTA) petition as an acknowledgment by EPA of “the critical need for in-depth review of products utilizing nanotechnology pesticides.” ICTA petitioned EPA in May 2008 to regulate nanoscale silver products as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

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EPA to Seek Public Comment on ICTA Petition on Nanoscale Silver Products

Posted on September 11, 2008 by Lynn L. Bergeson

Recent press reports have indicated, and an attorney with the International Center for Technology Assessment (ICTA) has confirmed, that the U.S. Environmental Protection Agency (EPA) contacted ICTA last week and informed the organization that it (EPA) intends to seek public comment on the nanoscale silver petition filed by ICTA and 13 other consumer, health, and environmental groups on May 1, 2008. The petition demanded, inter alia, that EPA regulate as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act consumer products containing nanoscale silver. The petitioners requested that EPA respond to the petition “within a reasonable time.”

According to the ICTA attorney, EPA is preparing a Federal Register notice that will invite public comments on the ICTA Petition. It is not yet known how long the comment period will be or when the notice will be published in the Federal Register. The EPA Office of Pesticide Programs’ recently posted webpage on nanotechnology does not make any mention of the impending notice.
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OPP Posts Page on Nanotechology and Pesticides

Posted on July 31, 2008 by Lynn L. Bergeson
On July 22, 2008, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) posted a web page entitled “Pesticide Issues in the Works:  Nanotechnology, the Science of Small.” The web page states: “[The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)] and EPA’s implementing regulations provide an effective framework for regulating pesticide products that are a product of nanotechnology or that contain nanoscale materials.” According to the page, “EPA is currently examining potential hazard, exposure, policy, regulatory, and international issues that may be associated with pesticides that are a product of nanotechnology or that contain nanoscale materials.” While EPA has met with several companies “to discuss requirements for some specific nanoscale materials being considered for use as pesticides,” EPA has not yet received a formal registration application. EPA “strongly recommends” that companies contact the pesticide registration Ombudsmen “to arrange a pre-application conference as early as possible in the development of any pesticide that would be a product of nanotechnology or that would contain nanoscale material.”
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ICTA-Led Coalition Petitions for FIFRA Regulation of Nanoscale Silver Products

Posted on May 7, 2008 by Lynn L. Bergeson
On May 1, 2008, the International Center for Technology Assessment (ICTA), together with 13 other consumer, health, and environmental groups, filed a petition with the U.S. Environmental Protection Agency (EPA) demanding that EPA regulate as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and that it take additional actions under FIFRA and other environmental statutes concerning, consumer products containing nanoscale silver. ICTA also released an inventory of the nano silver-containing consumer products referenced in the petition.

The petition contends that nano silver is “the most commonly used nanomaterial in consumer products and the fastest growing sector of nanomaterial commercialization,” and that most companies “market their nano-silver products [by] putting emphasis on the nano-silver ingredient, touting its antimicrobial and antibacterial qualities . . . .” The petition states that “research has mounted to indicate that nano-silver materials pose serious risks to human health and the environment.” In support of the petition, the ICTA-led coalition pointed to, inter alia, EPA Region 9’s recent FIFRA enforcement settlement with a California company, IOGEAR, that had been making antimicrobial claims for the nano silver coating on computer accessories it was marketing.

The petition requests that EPA take the following actions:

  • Clarify that nano silver and products containing it are pesticides requiring registration under FIFRA;
  • Classify nanomaterial pesticides such as nano silver as new pesticides [i.e., new active ingredients] that require new registrations, with nano-specific toxicity testing and risk assessment;
  • Assess the potential human health and environmental risks of nano silver under FIFRA, the Food Quality Protection Act, the Endangered Species Act, and the National Environmental Policy Act;
  • Take immediate action, including the issuance of Stop Sale, Use, or Removal Orders, to halt the sale of nano silver products with unapproved antimicrobial claims;
  • Fully apply all FIFRA regulations in the event EPA registers any nano silver products; and
  • Utilize its FIFRA authority to further review the potential human health and environmental impacts of nano silver, including undertaking either a classification review or a Special Review, amending the FIFRA regulations to require as part of a registration application the submission of nanomaterial and/or nano silver-specific data, undertaking a registration review of existing bulk silver registrations, regulating nano silver pesticide devices, and establishing a tolerance for nano silver under the Federal Food, Drug, and Cosmetic Act.

The coalition requests that EPA respond to the petition “within a reasonable time.”
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