Document ID: EPA-HQ-OPP-2008-0650-0001
Agency: epa
Document Type: Notice
Title: Petition for Rulemaking Requesting EPA Regulate Nanoscale Silver Products as Pesticides; Notice of Availability
Posted Date: 2008-11-19T05:00Z

[Federal Register: November 19, 2008 (Volume 73, Number 224)]
[Notices]               
[Page 69644-69646]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19no08-83]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0650; FRL-8386-4]

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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: 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.

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

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2008-0650, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
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 
http://www.regulations.gov, 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 regulations.gov or e-
mail. The regulations.gov 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 regulations.gov, 
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 http://www.regulations.gov. 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,

[[Page 69645]]

is 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 http://www.regulations.gov, 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.

FOR FURTHER INFORMATION CONTACT: 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: martin.nathanael@epa.gov.

SUPPLEMENTARY INFORMATION:

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, shackleford.betty@epa.gov

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

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov 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

[[Page 69646]]

these 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 
http://www.regulations.gov. 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.

List of Subjects

    Environmental protection, pesticides and pests, nanotechnology.

    Dated: November 5, 2008.
Debra Edwards,
Director, Office of Pesticide Programs.
[FR Doc. E8-27204 Filed 11-18-08; 8:45 am]

BILLING CODE 6560-50-S