Rotenone Risk Assessments; Notice of Availability, and Risk
Reduction Options
[Federal Register: February 10, 2006 (Volume 71, Number 28)]
[Notices]
[Page 7041-7043]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10fe06-69]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-EPA-HQ-2005-0494; FRL-7762-6]
Rotenone Risk Assessments; Notice of Availability, and Risk
Reduction Options
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the availability of EPA's risk
assessments, and related documents for the pesticide rotenone, and
opens a public comment period on these documents. The public is
encouraged to suggest risk management ideas or proposals to address the
risks identified. EPA is developing a Reregistration Eligibility
Decision (RED), for roteneone through a modified, 4-Phase public
participation process that the Agency uses to involve the public in
developing pesticide reregistration and tolerance reassessment
decisions. Through these programs, EPA is ensuring that all pesticides
meet current health and safety standards.
DATES: Comments must be received on or before April 11, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number OPP-EPA-HQ-2005-0494, by one of the following methods:
http://www.regulations.gov/ 
. Follow the on-line
instructions for submitting comments.
E-mail: opp-docket@epa.gov.
Mail: Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
Hand delivery: Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St.,
Arlington, VA, Attention: Docket ID number OPP-EPA-HQ-2005-0494. The
docket facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the docket
facility is (703) 305-5805. Such deliveries are only accepted during
the Docket's normal hours of operation, and special arrangements should
be made for deliveries of boxed information.
Instructions. Direct your comments to docket ID number OPP-EPA-HQ-
2005-0494. EPA's policy is that all comments received will be included
in the public 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 captured automatically and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA
[[Page 7042]]
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. For
additional information about EPA's public docket, visit the EPA Docket
Center homepage at http://www.epa.gov/epahome/docket.htm.
Docket. All documents in the docket are listed in the
regulation.gov index. Although listed in the index, some information is
not publicly available, i.e., CBI or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket materials are available either electronically at
http://www.regulations.gov/ or in hard copy at the Public
Information and Records Integrity Branch (PIRIB) (7502C), Office of
Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119,
Crystal Mall #2, 1801 S. Bell St., Arlington, VA. The docket facility is
open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the docket facility is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Katie Hall, Special Review and
Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-0166; fax
number: (703) 308-8041; e-mail address: hall.katie@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others may also be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
http://www.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 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. Background
A. What Action is the Agency Taking?
EPA is releasing for public comment its human health and
environmental fate and effects risk assessments and related documents
for rotenone. Rotenone is a botanical insecticide, acaracide, and
piscicide obtained from extracts of roots, seeds, and leaves of various
plants that are members of the pea or bean family (Leguminosae),
including jewel vine (Derris spp.). EPA developed the risk assessments
and risk characterization for rotenone through a modified version of
its public process for making pesticide reregistration eligibility and
tolerance reassessment decisions. Through these programs, EPA is
ensuring that pesticides meet current standards under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (FQPA).
Rotenone is used as a insecticide, acaracide, and piscicide in many
different use sites. It is used as an insecticide/acaracide for home
and garden use, as an insecticide/acaracide for agricultural crops, and
as a an insecticide on domesticated animals by veterinarians and
private citizens. Rotenone also has an important use as a piscicide in
fisheries and in lakes and streams to eradicate unwanted species.
EPA is providing an opportunity, through this notice, for
interested parties to provide comments and input on the Agency's risk
assessments for rotenone. Such comments and input could address, for
example, the availability of additional data to further refine the risk
assessments, such as worker exposure information, or could address the
Agency's risk assessment methodologies and assumptions as applied to
this specific pesticide.
Through this notice, EPA also is providing an opportunity for
interested parties to provide risk management proposals or otherwise
comment on risk management for rotenone. Risks of concern associated
with the use of rotenone are: Risk to private citizens when rotenone is
used in and around the home, garden, and on pets; post-application risk
to adults, youth and children when rotenone is used around the home,
garden, and on pets; risk to swimmers when rotenone is used in lakes,
ponds, and streams; risk to occupational handlers when rotenone is used
in agriculture, around residential homes, and when used as a piscicide
in lakes, ponds and streams. In targeting these risks of concern, the
Agency solicits information on effective and practical risk reduction
measures.
EPA seeks to achieve environmental justice, the fair treatment and
meaningful involvement of all people, regardless of race, color,
national origin, or income, in the development, implementation, and
enforcement of environmental laws, regulations, and policies. To help
address potential environmental justice issues, the Agency seeks
information on any groups or segments of the population who, as a
result of their location, cultural practices, or other factors, may
have atypical, unusually high exposure to
[[Page 7043]]
rotenone, compared to the general population.
EPA is applying the principles of public participation to all
pesticides undergoing reregistration and tolerance reassessment. The
Agency's Pesticide Tolerance Reassessment and Reregistration; Public
Participation Process, published in the Federal Register on May 14,
2004 (69 FR 26819) (FRL-7357-9), explains that in conducting these
programs, the Agency is tailoring its public participation process to
be commensurate with the level of risk, extent of use, complexity of
the issues, and degree of public concern associated with each
pesticide. For rotenone, a modified, 4-Phase process with one comment
period and ample opportunity for public consultation seems appropriate
in view of its limited use and small number of users. However, if as a
result of comments received during this comment period EPA finds that
additional issues warranting further discussion are raised, the Agency
may lengthen the process and include a second comment period, as needed.
All comments should be submitted using the methods in ADDRESSES,
and must be received by EPA on or before the closing date. Comments
will become part of the Agency Docket for rotenone. Comments received
after the close of the comment period will be marked ``late.'' EPA is
not required to consider these late comments.
B. What is the Agency's Authority for Taking this Action?
Section 4(g)(2) of FIFRA as amended directs that, after submission
of all data concerning a pesticide active ingredient, ``the
Administrator shall determine whether pesticides containing such active
ingredient are eligible for reregistration,'' before calling in
product-specific data on individual end-use products and either
reregistering products or taking other ``appropriate regulatory action.''
Section 408(q) of the FFDCA, 21 U.S.C. 346a(q), requires EPA to
review tolerances and exemptions for pesticide residues in effect as of
August 2, 1996, to determine whether the tolerance or exemption meets
the requirements of section 408(b)(2) or (c)(2) of FFDCA. This review
is to be completed by August 3, 2006.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: February 3, 2006.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E6-1902 Filed 2-9-06; 8:45 am]
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