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Petition for Rulemaking Requesting EPA Regulate Nanoscale Silver Products as Pesticides; Notice of Availability

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Environmental Protection Agency (EPA).




This notice makes available for public review and comment a petition for rulemaking and collateral relief filed by the

International Center for Technology Assessment (ICTA) and others. In general, the petition requests that the Agency classify nanoscale silver as a pesticide, require formal pesticide registration of all products containing nanoscale silver, analyze the potential human health and environmental risks of nanoscale silver, take regulatory actions under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) against existing products that contain nanoscale silver, and take other regulatory actions under FIFRA as appropriate for nanoscale silver products. The Agency has determined that the petition raises issues that potentially affect private and public sector stakeholders. Through this notice, EPA is asking for public comment on the petition.


Comments must be received on or before January 20, 2009.


Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2008-0650, by one of the following methods:

  • Federal eRulemaking Portal: Follow the on-line instructions for submitting comments.
  • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
  • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

Instructions: Direct your comments to docket ID number EPA-HQ-OPP-2008-0650. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through or e-mail. The website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

Docket: All documents in the docket are listed in the docket index available at Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, Start Printed Page 69645is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.

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Nathanael R. Martin, Field and External Affairs Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-6475; fax number: (703) 305-5884; e-mail address:

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I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are a business engaged in the manufacturing of pesticides and other agricultural chemicals. Potentially affected entities may include, but are not limited to:

  • Pesticide and other agricultural chemical manufacturing (NAICS 325320), e.g., businesses engaged in the manufacture of pesticides.
  • Antimicrobial pesticides (NAICS 32561)

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, please contact Betty Shackleford, Associate Director, Antimicrobials Division of the Office of Pesticide Programs at (703) 308-6411 or via email,

B. What Should I Consider as I Prepare My Comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

vi. Provide specific examples to illustrate your concerns and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

II. Summary of the Petition

The following entities are listed as petitioners in the “Petition for Rulemaking Requesting EPA Regulate Nano-Silver Products as Pesticides”:

1. International Center for Technology Assessment (CTA)

2. Center for Food Safety (CFS)

3. Beyond Pesticides

4. Friends of the Earth (FOE)

5. Greenpeace

6. Action Group on Erosion, Technology and Concentration

7. Center for Environmental Health (CEH)

8. Silicon Valley Toxics Coalition (SVTC)

9. Institute for Agriculture and Trade Policy (IATP)

10. Clean Production Action (CPA)

11. Food & Water Watch

12. Loka Institute

13. Center for the Study of Responsive Law (CSRL)

14. Consumers Union

The petitioners note the rapid increase in the number of products containing manufactured or engineered nanoscale materials. They further point out that scientists have identified that nanoscale materials can have fundamentally different properties from the non-nanoscale or bulk forms of the same compounds, and that these unique properties may pose new environmental and human health risks. Additionally, the petitioners review EPA's procedural history with respect to nanotechnology and conclude that the Agency has not provided adequate regulatory oversight for this emerging technology.

Due to the rapid commercialization of nanotechnology, potential environmental and health concerns, and perceived lack of regulatory oversight, the petitioners request that the EPA undertake the following actions:

1. Classify nanoscale silver as a pesticide and require manufacturers to register nanoscale silver products as pesticides pursuant to Federal Insecticide Fungicide and Rodenticide Acts (FIFRA). Furthermore, in reference to nanoscale silver, petitioners request that EPA 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.

2. 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.

3. Assess the potential human health and environmental risks of nanoscale silver pursuant to EPA's statutory obligations under FIFRA, the Food Quality Protection Act (FQPA), the Endangered Species Act (ESA), and the National Environmental Policy Act (NEPA). 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 environment impacts of any Agency actions involving nanoscale silver, including completing a programmatic environmental impact statement.

4. Take immediate statutory and regulatory action to prohibit the sale of nanoscale silver products, classifying Start Printed Page 69646these products as illegal pesticide products with unapproved health benefit claims. In this regard, the petition claims that the nanoscale silver products currently on the market are in clear violation of FIFRA. The petition recommends that EPA pursue enforcement actions against and issue enforcement penalties to those manufacturers and/or distributors currently selling nanoscale silver products.

III. What Action is the Agency Taking?

Through this notice, the Agency is making the petition submitted by ICTA et al. available for review and is asking for public comment on the same. Any public comment received on this petition before the issuance of this notice will be reviewed and listed in the electronic docket. Following the review of the petition and any comments received in response to this notice, EPA will decide how best to respond to the petition. The petition is available on EPA's Electronic Docket at To locate this information on the homepage of EPA's Electronic Docket, select “Quick Search” and type the OPP docket ID number EPA-HQ-OPP-2008-0650. Once the search has located the docket, clicking on “Docket ID” will bring up a list of all documents in the docket related to the petition.

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List of Subjects

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Dated: November 5, 2008.

Debra Edwards,

Director, Office of Pesticide Programs.

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[FR Doc. E8-27204 Filed 11-18-08; 8:45 am]