[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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