Source: http://www.goodwinprocter.com/Publications/Newsletters/Client-Alert/2008/1209_Regulating-Nanoscale-Silver-as-a-Pesticide-Is-EPA-Opening-Pandoras-Box.aspx?article=1
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Document Index: 125463195

Matched Legal Cases: ['§2', '§136', '§2', '§136', '§3', '§136', '§3', '§12', '§136']

Regulating Nanoscale Silver as a Pesticide: Is EPA Opening Pandora’s Box?
Newsletters > Client Alert > December 9, 2008
Clean TechEnvironmentalLife SciencesProducts Liability & Mass Torts
Matthew M. HoffmanPartner
Regulating Nanoscale Silver as a Pesticide: Is EPA Opening Pandora's Box?
As nanoscale materials continue to find their way into a larger range of products, the United States Environmental Protection Agency (“EPA”) appears to be stepping up its efforts to regulate these materials under its existing statutory authorities. Recently, the agency requested public comment on a petition filed by a coalition of consumer and environmental groups demanding that EPA regulate nanoscale silver (or “nanosilver”) as a pesticide under the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”) and halt the sale of consumer products containing nanosilver. The request for comment on the nanosilver petition comes on the heels of other recent regulatory actions by EPA regarding carbon nanotubes. (For more information about these recent actions, see Goodwin Procter’s November 6, 2008 Client Alert titled “EPA Takes First-Ever Regulatory Actions Aimed at Potential Nanomaterial Risks.”)
In light of EPA’s increased focus on the potential environmental, health and safety risks of various nanomaterials, companies that work with these materials should pay close attention to EPA’s actions in this arena. In particular, any companies that are currently manufacturing or marketing products that incorporate nanoscale silver or similar nanomaterials should evaluate whether their business would be affected by EPA regulation in this area and consider whether to submit comments on the nanosilver petition. The regulations that will govern the use of nanomaterials in the United States will likely be written over the next few years, and it is important that the companies that work with these materials have a voice in the process.
The Increasing Use of Nanosilver in Consumer and Commercial Products EPA appears to be renewing its focus on nanosilver in acknowledgment of the ever-increasing number of nanotechnology innovations made part of commercial and consumer products. Over $32 billion in products incorporating nanomaterials were sold in 2007 – more than twice what was sold in 2006. It is predicted that by 2014, at least $2.6 trillion worth of manufactured products – or about 15% of total global manufacturing – will contain nanomaterials, including nanoscale silver, carbon, zinc, silica, titanium dioxide, gold and iron.1th Edition (2006); Lloyd’s of London, Risks: Lloyd’s Emerging Risks Team Report, Nanotechnology Recent Developments, Risks and Opportunities, at 10 (2007).
[2] Project on Emerging Nanotechnologies, Nanotechnology Consumer Products Inventory, Analysis (as of Dec. 2, 2008).
[3] “Nanotech Watchdog Launches First-Ever Legal Challenge To EPA Over Unregulated Nanotech Pesticide Pollution” (May 1, 2008) (ICTA press release announcing filing of petition).
[4] See, e.g., International Center for Technology Assessment, “Nano-silver Product List” (May 16, 2008); Project on Emerging Nanotechnologies, “Nano Silver Inventory” (Sept. 9, 2008).
[5] See Samuel N. Luoma, “Silver Nanotechnologies and the Environment: Old Problems or New Challenges?” (Sept. 9, 2008).
[6] International Council on Nanotechnology, “Environmental Impacts of Nanosilver” (Nov. 18, 2008).
[7] Citizen Petition for Rulemaking to the United States Environmental Protection Agency, Petition Requesting EPA Regulate Nano-Silver Products As Pesticides (May 1, 2008) (“Petition”), at 20-21 (citing NACWA and Tri-Tac letters to EPA).
[8] See, e.g., Rick Weiss, “EPA to Regulate Nanoproducts Sold as Germ-killing,” Washington Post (“Weiss”), at A01 (Nov. 23, 2007); Petition at 21-22 (emphasis added) (citing Phibbs, “EPA to Regulate Nanoscale Silver Used in Washing Machines to Kill Bacteria,” BNA Daily Environment, at A-6 (Nov. 21, 2006)).
[9] EPA, Nanotechnology White Paper (EPA 100/B-07/001) (Feb. 2007), at 66.
[10] EPA Office of Pesticide Programs, “Pesticide Registration: Clarification for Ion Generating Equipment” (Sept. 21, 2007).
[12] FIFRA defines “pesticide” as “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest ….” FIFRA §2(u), 7 U.S.C. §136(u). Under the statute, “pest” means “(1) any … fungus, weed, or (2) any other form of terrestrial or aquatic plant or animal life or virus, bacteria, or other micro-organism … which the Administrator declares to be a pest ….” FIFRA §2(t), 7 U.S.C. §136(t). FIFRA requires that manufacturers of pesticides register any such product before selling it for commercial use. FIFRA §3, 7 U.S.C. §136a. The statute makes it is unlawful “to distribute or sell any pesticide that is not registered” in accordance with §3. FIFRA §12(a)(1)(A), 7 U.S.C. §136j.
[13] EPA has explained the concept of “pesticidal intent” as follows: “The regulations implementing FIFRA and the case law make it clear that if a reasonable consumer, considering the product’s label, would use the product as a pesticide, the statute applies. Pesticidal intent is measured objectively; it is not based on the subjective intent of manufacturer, seller or distributor.” In the Matter of: FRM Chem, Inc., a.k.a. Industrial Specialties, Docket No. FIFRA-07-2004-0041 (Feb. 16, 2005), p. 10 (citing N. Jonas & Co., Inc. v. EPA, 666 F. 2d 829, 832 (3rd Cir. 1981)[14] See 73 Fed. Reg. 69644, 69645-69646 (Nov. 19, 2008). The Project on Emerging Nanotechnologies’ (“PEN’s”) inventory of nanotechnology consumer products contained 803 products or product lines, 426 of them manufactured by companies in the United States, as of August 2008. According to PEN, the inventory has grown by nearly 279% (from 212 to 803 products) since it was first released in March 2006. Listed products include paints, sunscreens, sporting goods, cosmetics, vitamins, food and food packaging, computer accessories, children’s pacifiers, and laundry detergent and fabric softeners.2
Nanosilver is currently the most common commercialized nanomaterial.3 As of September 2008, there were over 260 manufacturer-identified nanosilver products on the market – including wound dressings, medical equipment, household appliances and cleaners, clothing, children’s toys and personal care products – and this number is projected to grow every year.4 Most of these products seek to take advantage of silver’s effectiveness in killing a wide range of bacteria, including some of the strains that have proven resistant to modern antibiotics, by incorporating nanosilver particles into plastics and fabrics and onto surfaces.5
The increasingly widespread use of nanosilver in consumer products has raised concern in some quarters. While the toxicity of silver is well understood, nanosilver – like other many other nanoscale materials – may have very different properties from non-nanoscale silver and may pose new or different environmental, health and safety risks.6
EPA’s Mixed Signals on Nanosilver to Date Concerns about the potential environmental and human health effects of nanosilver were first brought to EPA’s attention in early 2006. The National Association of Clean Water Agencies (“NACWA”) and Tri-TAC, a technical advisory group to publicly owned wastewater treatment facilities in California, alerted EPA that certain new household consumer products, such as the Samsung Silver Care washing machine, were designed to release silver ions for disinfectant purposes, and that these ions could be highly toxic to aquatic organisms and may bioaccumulate in some aquatic species. NACWA and Tri-TAC asked EPA to require pesticide registration for such products, including the Samsung washing machine.7
Several months later, in November 2006, a flurry of media reports announced that EPA had decided to regulate consumer products incorporating nanosilver as pesticides under FIFRA if they made pesticide claims.8 A Nanotechnology White Paper issued by EPA in February 2007 appeared to confirm these reports, expressly stating that “[p]esticide products containing nanomaterials will be subject to FIFRA’s review and registration requirements.”9
The EPA, however, did not actually act on NACWA and Tri-TAC’s request until September 2007, and when it did it expressly disavowed any intention to regulate nanotechnology as such. It issued a notice merely stating that machines with ion-generating equipment “will be regulated as pesticides if the machines contain silver or other substances, and if they generate ions of those substances for express pesticidal purposes.”10 But it was careful not to characterize this action as a regulation of nanotechnology:
While recent press articles have referred to the silver ion generating washing machine as a product of nanotechnology, EPA has not yet received any information that suggests that this product uses nanotechnology. EPA will evaluate any applications to register this type of equipment according to the same regulatory standards as any other pesticide. The notice does not represent an action to regulate nanotechnology.11
The ICTA Petition and the Potential for Regulatory Action by EPA EPA now appears to be revisiting the issue of whether nanosilver itself should be specifically regulated under FIFRA in response to a petition filed by the International Center for Technology Assessment (“ICTA”), Friends of the Earth, Greenpeace, Consumers Union and several other advocacy groups (collectively, the “petitioners”). On November 19, 2008, EPA requested public comment on this petition. While this does not necessarily mean that EPA will take any action –much less adopt the petitioners’ proposal – it is a strong signal that the agency is considering further regulation in this area.
The petitioners have requested a very stringent set of new regulations. According to EPA, they request that the agency:
Classify nanoscale silver as a pesticide and require manufacturers to register nanoscale silver products as pesticides pursuant to FIFRA.12 Clarify that pesticidal intent and public health claims can be both implicit and explicit, and that manufacturers cannot avoid pesticide classification (and registration under FIFRA) simply by stripping their products of labeling that makes express pesticide claims.13 Determine that nanoscale pesticides, such as nanoscale silver pesticides, are new pesticidal substances that require new pesticide registration under FIFRA, with accompanying toxicity testing and risk assessment specific to nanoscale materials. Assess the potential human health and environmental risks of nanoscale silver pursuant to FIFRA, the Food Quality Protection Act, the Endangered Species Act and the National Environmental Policy Act. The petitioners recommend that EPA analyze existing scientific studies on the environmental health and safety of nanoscale silver; assess the potential impacts of nanoscale silver on children and infants; ensure the protection of threatened and endangered species in connection with any EPA actions involving nanoscale silver; and assess the environmental impacts of any Agency actions involving nanoscale silver, including completing a programmatic environmental impact statement. Take immediate statutory and regulatory action to prohibit the sale of nanoscale silver products, classifying these products as illegal pesticide products with unapproved health benefit claims. EPA notes that “[i]n this regard, the petition claims that the nanoscale silver products currently on the market are in clear violation of FIFRA,” and “recommends that EPA pursue enforcement actions against and issue enforcement penalties to those manufacturers and/or distributors currently selling nanoscale silver products.”14
Concluding that “the petition raises issues that potentially affect private and public sector stakeholders,” EPA announced that it will receive comments until January 20, 2008 and “decide how best to respond to the petition” after the completion of this 60-day comment period. Practical Consequences Whether EPA will actually issue regulations specific to nanosilver (or other nanoscale materials) under FIFRA or its other statutory authorities remains to be seen. As the history in this area shows, the agency has sometimes given contradictory or confusing signals about its intentions in this area. Nonetheless, the fact that EPA has now formally requested comment on a regulatory proposal – coupled with the increasing prevalence of nanosilver in many consumer products – is a good indication that some type of increased regulation may be forthcoming. Companies that manufacture or market products that incorporate nanosilver – or other nanoscale materials – should consider taking advantage of this opportunity to educate EPA about their products and work with the agency on the scope of any appropriate regulatory action.
th Edition (2006); Lloyd’s of London, Risks: Lloyd’s Emerging Risks Team Report, Nanotechnology Recent Developments, Risks and Opportunities, at 10 (2007).
[13] EPA has explained the concept of “pesticidal intent” as follows: “The regulations implementing FIFRA and the case law make it clear that if a reasonable consumer, considering the product’s label, would use the product as a pesticide, the statute applies. Pesticidal intent is measured objectively; it is not based on the subjective intent of manufacturer, seller or distributor.” In the Matter of: FRM Chem, Inc., a.k.a. Industrial Specialties, Docket No. FIFRA-07-2004-0041 (Feb. 16, 2005), p. 10 (citing N. Jonas & Co., Inc. v. EPA, 666 F. 2d 829, 832 (3rd Cir. 1981)[14] See 73 Fed. Reg. 69644, 69645-69646 (Nov. 19, 2008).