Organophosphate Cumulative Risk Assessment; Notice of Availability, 43740-43742 [E6-12343]
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43740
Federal Register / Vol. 71, No. 148 / Wednesday, August 2, 2006 / Notices
expected effectiveness of the PBW
eradication program using sterile insect
technology, 100% Bollgard and Bollgard
II cotton, pheromones, and limited
insecticide use. The Agency is
concerned with the potential increased
insect resistance that may be posed by
the use of 100% Bollgard and Bollgard
II cotton (i.e., no structured non-Bt
cotton refuge, very high selection
intensity) and whether the SIT can be
used effectively to manage PBW
resistance should it occur during the 4–
year eradication program. The State of
Arizona, in consultation with USDA
and University experts, devised a plan
that replaces the biological function
served by non-Bt cotton refuges with
artificially raised sterile pink bollworm
moths. The Panel will be asked to
comment on the Agency’s review of the
effectiveness of this plan using field
level systematic monitoring and
mapping data in conjunction with
modeling simulations.
C. FIFRA SAP Documents and Meeting
Minutes
EPA’s position paper, charge/
questions to FIFRA SAP, FIFRA SAP
composition (i.e., members and
consultants for this meeting), and the
meeting agenda will be available by the
end of September 2006. In addition, the
Agency may provide additional
background documents as the materials
become available. You may obtain
electronic copies of these documents,
and certain other related documents that
might be available electronically, from
the regulations.gov website and the
FIFRA SAP homepage at https://
www.epa.gov/scipoly/sap.
The FIFRA SAP will prepare meeting
minutes summarizing its
recommendations to the Agency in
approximately 90 days after the
meeting. The meeting minutes will be
posted on the FIFRA SAP website or
may be obtained by contacting the OPP
Regulatory Public Docket at the address
or telephone number listed under
ADDRESSES.
List of Subjects
wwhite on PROD1PC61 with NOTICES
Environmental protection, Pesticides
and pests.
Dated: July 27, 2006.
Clifford Gabriel,
Director, Office of Science Coordination and
Policy.
[FR Doc. E6–12435 Filed 8–1–06; 8:45 am]
BILLING CODE 6560–50–S
VerDate Aug<31>2005
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Jkt 208001
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2006–0618; FRL–8082–5]
Organophosphate Cumulative Risk
Assessment; Notice of Availability
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: This notice announces the
availability of EPA’s cumulative risk
assessment for the organophosphate
group of pesticides and opens a public
comment period on this document and
other support documents. As required
by the Food Quality Protection Act
(FQPA), a cumulative risk assessment,
which evaluates exposures based on a
common mechanism of toxicity, was
conducted to evaluate the risk from
food, drinking water, residential, and
other non-occupational exposures
resulting from registered uses of
organophosphate pesticides. The
organophosphate group includes over
30 pesticides including acephate,
azinphos-methyl (AZM), bensulide,
chlorethoxyfos, chlorpyrifos,
chlorpyriphos-methyl, diazinon,
dichlorvos (DDVP), dicrotophos,
dimethoate, disulfoton, ethoprop,
fenamiphos, fenthion, fosthiazate,
malathion, methamidophos,
methidathion, methyl-parathion,
mevinphos, naled, omethoate,
oxydemeton-methyl, phorate,
phosalone, phosmet, phostebupirim,
pirimiphos-methyl, profenofos, terbufos,
tetrachlorvinphos, tribufos, and
trichlorfon. Several organophosphate
pesticides, however, were not
incorporated into the cumulative risk
assessment because no dietary, drinking
water, or residential human exposure to
these pesticides is anticipated from any
of the currently registered uses.
DATES: Comments must be received on
or before October 2, 2006.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2006–0618, by
one of the following methods:
• Federal eRulemaking Portal: https://
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 Building), 2777 S.
Crystal Drive, Arlington, VA. Deliveries
are only accepted during the Docket’s
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Sfmt 4703
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 telephone number is (703) 3055805.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPP–2006–
0618. EPA’s policy is that all comments
received will be included in the docket
without change and may be made
available on-line at https://
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 email. The Federal 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 email 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. 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,
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 https://
www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400,
One Potomac Yard (South Building),
2777 S. Crystal Drive, 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 telephone number
is (703) 305-5805.
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Federal Register / Vol. 71, No. 148 / Wednesday, August 2, 2006 / Notices
FOR FURTHER INFORMATION CONTACT:
Kelly Sherman, Special Review and
Reregistration Division (7508P), Office
of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001;
telephone number: (703) 305-8401; fax
number: (703) 308-8005; e-mail address:
sherman.kelly@epa.gov; or Kendra
Tyler, Special Review and
Reregistration Division (7508P);
telephone number: (703) 308-0125; email address: tyler.kendra@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 also may 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.
wwhite on PROD1PC61 with NOTICES
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
VerDate Aug<31>2005
16:40 Aug 01, 2006
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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 making available the
completed cumulative risk assessment
for the organophosphate pesticides. The
Agency developed this risk assessment
as part of its ongoing 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 FQPA.
Section 408(b)(2)(D)(v) of the FFDCA
directs the Agency to consider available
information on the cumulative risk from
substances sharing a common
mechanism of toxicity. The Agency
determined in 1999 that the
organophosphate pesticides share a
common mechanism of toxicity,
cholinesterase inhibition. The
organophosphates have been among
EPA’s highest priority pesticides for
review under FQPA.
In developing the organophosphate
cumulative risk assessment and
underlying methodologies, EPA
consulted with the FIFRA Scientific
Advisory Panel numerous times,
seeking expert review, advice, and
recommendations at each major step of
the process. The Agency also met with
several of its advisory committees to
obtain input from a broad spectrum of
stakeholders representing the pesticide
industry, environmental and public
interest groups, growers, academia, and
others, including other federal and state
regulatory agencies. EPA issued the
Preliminary Organophosphate
Cumulative Risk Assessment for public
comment in December 2001, and
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43741
presented the cumulative assessment at
a Technical Briefing for the public in
January 2002. The Agency released the
Revised Organophosphate Cumulative
Risk Assessment for public comment in
June 2002. The Organophosphate
Cumulative Risk Assessment (2006
update) is considered an addendum to
the June 2002 assessment, and includes
improvements and refinements in
assessing the cumulative risks of the
organophosphate pesticides. The
previous versions of the
Organophosphate Cumulative
Assessment may be accessed on the EPA
website at https://www.epa.gov/
pesticides/cumulative.
EPA has concluded that the
cumulative risks associated with the
remaining uses of the organophosphate
pesticides are below the Agency’s level
of concern. While completing
reregistration eligibility and tolerance
reassessment decisions for individual
organophosphates, the Agency also
evaluated the cumulative risk posed by
this group. Although individual risk
assessments were conducted for each of
the organophosphate pesticides, several
were not incorporated into the
cumulative risk assessment because no
dietary, drinking water, or residential
human exposure is anticipated from any
of the currently registered uses of these
pesticides.
The Interim Reregistration Eligibility
Decisions (IREDs) previously issued for
a number of organophosphate pesticides
are now considered final; the tolerance
reassessment and reregistration
eligibility process for these pesticides is
complete. EPA has determined that the
remaining/reassessed tolerances for
these pesticides meet the FFDCA safety
standard and that no further risk
mitigation is necessary as a result of the
organophosphate cumulative risk
assessment.
EPA is providing an opportunity,
through this notice, for interested
parties to provide comments and input
on the Agency’s completed cumulative
risk assessment for the
organophosphates. Such comments and
input could address the Agency’s risk
assessment methodologies and
assumptions as applied to this
cumulative assessment. The Agency
will consider all comments received,
and make changes, if appropriate, to the
organophosphate cumulative risk
assessment.
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
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43742
Federal Register / Vol. 71, No. 148 / Wednesday, August 2, 2006 / Notices
wwhite on PROD1PC61 with NOTICES
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
organophosphate pesticides, 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, EPA is
tailoring its public participation process
to be commensurate with the level of
risk, extent of use, complexity of issues,
and degree of public concern associated
with each pesticide. The
organophosphate pesticides have had
extensive opportunities for public
comment as part of their reregistration
and tolerance reassessment process.
Comments should be limited to issues
raised within the organophosphate
cumulative risk assessment and
associated documents. Failure to
comment on any such issues as part of
this opportunity will not limit a
commenter’s opportunity to participate
in any later notice and comment
processes on this matter. 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 the organophosphate
cumulative risk assessment. Comments
received after the close of the comment
period will be marked ‘‘late.’’ EPA is not
required to consider these late
comments.
section 408(b)(2) of (c)(2) of FFDCA.
This review is to be completed by
August 3, 2006. A tolerance or
exemption meets the requirements of
section 408(b)(2) or (c)(2), respectively,
if ‘‘the Administrator determines the
pesticide chemical residue is safe,’’ i.e.,
‘‘that there is a reasonable certainty that
no harm will result from aggregate
exposure to the pesticide chemical
residue, including all anticipated
dietary exposures and all other
exposures for which there is reliable
information.’’ 21 U.S.C. 346a(b)(2)(A),
and (c)(2)(A). In making this safety
finding, FFDCA requires the
Administrator to consider, among other
factors, ‘‘available information
concerning the cumulative effects of
such residues and other substances that
have a common mechanism of
toxicity...’’ 21 U.S.C. 346a(b)(2)(D)(v),
and (c)(2)(B).
B. What is the Agency’s Authority for
Taking this Action?
Section 4(g)(2)(A) of FIFRA, as
amended, requires the Administrator to
make ‘‘a determination as to the
eligibility for reregistration (i) for all
active ingredients subject to
reregistration under this section for
which tolerances or exemptions from
tolerances are required under the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq.), not later than the
last date for tolerance reassessment
established under section 408(q)(1)(C) of
that Act (21 U.S.C. 346a((q)(1)(C))...’’
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
SUMMARY: This notice announces the
availability of EPA’s Tolerance
Reassessment Decision (TRED) for the
pesticide sodium cyanide, and opens a
public comment period on this
document, related risk assessments, and
other support documents. EPA has
reviewed this pesticide sodium cyanide
through a modified, streamlined version
of the public participation process that
the Agency uses to involve the public in
developing pesticide tolerance
reassessment and reregistration
decisions. Through the tolerance
reassessment program, EPA is ensuring
that all pesticides meet current health
and food safety standards.
DATES: Comments must be received on
or before October 2, 2006.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
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16:40 Aug 01, 2006
Jkt 208001
List of Subjects
Environmental protection, Pesticides
and pests.
Dated: July 20, 2006.
Debra Edwards,
Director, Special Review and Reregistration
Division, Office of Pesticide Programs.
[FR Doc. E6–12343 Filed 8–1–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2006–0352; FRL–8080–8]
Sodium Cyanide; Tolerance
Reassessment Decision for Low Risk
Pesticide; Notice of Availability
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
PO 00000
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Fmt 4703
Sfmt 4703
number EPA–HQ–OPP–2006–0352, by
one of the following methods:
• Federal eRulemaking Portal: https://
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 Building), 2777 S.
Crystal Drive, Arlington, VA. Deliveries
are only accepted during the Docket’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 telephone number is (703) 3055805.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPP–2006–
0352. EPA’s policy is that all comments
received will be included in the docket
without change and may be made
available on-line at https://
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 email. The Federal 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 email 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. 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
E:\FR\FM\02AUN1.SGM
02AUN1
Agencies
[Federal Register Volume 71, Number 148 (Wednesday, August 2, 2006)]
[Notices]
[Pages 43740-43742]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-12343]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2006-0618; FRL-8082-5]
Organophosphate Cumulative Risk Assessment; Notice of
Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the availability of EPA's cumulative
risk assessment for the organophosphate group of pesticides and opens a
public comment period on this document and other support documents. As
required by the Food Quality Protection Act (FQPA), a cumulative risk
assessment, which evaluates exposures based on a common mechanism of
toxicity, was conducted to evaluate the risk from food, drinking water,
residential, and other non-occupational exposures resulting from
registered uses of organophosphate pesticides. The organophosphate
group includes over 30 pesticides including acephate, azinphos-methyl
(AZM), bensulide, chlorethoxyfos, chlorpyrifos, chlorpyriphos-methyl,
diazinon, dichlorvos (DDVP), dicrotophos, dimethoate, disulfoton,
ethoprop, fenamiphos, fenthion, fosthiazate, malathion, methamidophos,
methidathion, methyl-parathion, mevinphos, naled, omethoate,
oxydemeton-methyl, phorate, phosalone, phosmet, phostebupirim,
pirimiphos-methyl, profenofos, terbufos, tetrachlorvinphos, tribufos,
and trichlorfon. Several organophosphate pesticides, however, were not
incorporated into the cumulative risk assessment because no dietary,
drinking water, or residential human exposure to these pesticides is
anticipated from any of the currently registered uses.
DATES: Comments must be received on or before October 2, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0618, by one of the following methods:
Federal eRulemaking Portal: https://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
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket'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 telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0618. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
https://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 Federal 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.
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, 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 https://
www.regulations.gov, or, if only available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, 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 telephone number is (703)
305-5805.
[[Page 43741]]
FOR FURTHER INFORMATION CONTACT: Kelly Sherman, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 305-8401; fax
number: (703) 308-8005; e-mail address: sherman.kelly@epa.gov; or
Kendra Tyler, Special Review and Reregistration Division (7508P);
telephone number: (703) 308-0125; e-mail address: tyler.kendra@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 also may 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
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. Background
A. What Action is the Agency Taking?
EPA is making available the completed cumulative risk assessment
for the organophosphate pesticides. The Agency developed this risk
assessment as part of its ongoing 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 FQPA.
Section 408(b)(2)(D)(v) of the FFDCA directs the Agency to consider
available information on the cumulative risk from substances sharing a
common mechanism of toxicity. The Agency determined in 1999 that the
organophosphate pesticides share a common mechanism of toxicity,
cholinesterase inhibition. The organophosphates have been among EPA's
highest priority pesticides for review under FQPA.
In developing the organophosphate cumulative risk assessment and
underlying methodologies, EPA consulted with the FIFRA Scientific
Advisory Panel numerous times, seeking expert review, advice, and
recommendations at each major step of the process. The Agency also met
with several of its advisory committees to obtain input from a broad
spectrum of stakeholders representing the pesticide industry,
environmental and public interest groups, growers, academia, and
others, including other federal and state regulatory agencies. EPA
issued the Preliminary Organophosphate Cumulative Risk Assessment for
public comment in December 2001, and presented the cumulative
assessment at a Technical Briefing for the public in January 2002. The
Agency released the Revised Organophosphate Cumulative Risk Assessment
for public comment in June 2002. The Organophosphate Cumulative Risk
Assessment (2006 update) is considered an addendum to the June 2002
assessment, and includes improvements and refinements in assessing the
cumulative risks of the organophosphate pesticides. The previous
versions of the Organophosphate Cumulative Assessment may be accessed
on the EPA website at https://www.epa.gov/pesticides/cumulative.
EPA has concluded that the cumulative risks associated with the
remaining uses of the organophosphate pesticides are below the Agency's
level of concern. While completing reregistration eligibility and
tolerance reassessment decisions for individual organophosphates, the
Agency also evaluated the cumulative risk posed by this group. Although
individual risk assessments were conducted for each of the
organophosphate pesticides, several were not incorporated into the
cumulative risk assessment because no dietary, drinking water, or
residential human exposure is anticipated from any of the currently
registered uses of these pesticides.
The Interim Reregistration Eligibility Decisions (IREDs) previously
issued for a number of organophosphate pesticides are now considered
final; the tolerance reassessment and reregistration eligibility
process for these pesticides is complete. EPA has determined that the
remaining/reassessed tolerances for these pesticides meet the FFDCA
safety standard and that no further risk mitigation is necessary as a
result of the organophosphate cumulative risk assessment.
EPA is providing an opportunity, through this notice, for
interested parties to provide comments and input on the Agency's
completed cumulative risk assessment for the organophosphates. Such
comments and input could address the Agency's risk assessment
methodologies and assumptions as applied to this cumulative assessment.
The Agency will consider all comments received, and make changes, if
appropriate, to the organophosphate cumulative risk assessment.
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
[[Page 43742]]
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 organophosphate
pesticides, 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, EPA is tailoring its public participation process to be
commensurate with the level of risk, extent of use, complexity of
issues, and degree of public concern associated with each pesticide.
The organophosphate pesticides have had extensive opportunities for
public comment as part of their reregistration and tolerance
reassessment process.
Comments should be limited to issues raised within the
organophosphate cumulative risk assessment and associated documents.
Failure to comment on any such issues as part of this opportunity will
not limit a commenter's opportunity to participate in any later notice
and comment processes on this matter. 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 the organophosphate cumulative risk assessment. 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)(A) of FIFRA, as amended, requires the Administrator
to make ``a determination as to the eligibility for reregistration (i)
for all active ingredients subject to reregistration under this section
for which tolerances or exemptions from tolerances are required under
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), not
later than the last date for tolerance reassessment established under
section 408(q)(1)(C) of that Act (21 U.S.C. 346a((q)(1)(C))...''
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) of (c)(2) of FFDCA. This review
is to be completed by August 3, 2006. A tolerance or exemption meets
the requirements of section 408(b)(2) or (c)(2), respectively, if ``the
Administrator determines the pesticide chemical residue is safe,''
i.e., ``that there is a reasonable certainty that no harm will result
from aggregate exposure to the pesticide chemical residue, including
all anticipated dietary exposures and all other exposures for which
there is reliable information.'' 21 U.S.C. 346a(b)(2)(A), and
(c)(2)(A). In making this safety finding, FFDCA requires the
Administrator to consider, among other factors, ``available information
concerning the cumulative effects of such residues and other substances
that have a common mechanism of toxicity...'' 21 U.S.C.
346a(b)(2)(D)(v), and (c)(2)(B).
List of Subjects
Environmental protection, Pesticides and pests.
Dated: July 20, 2006.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E6-12343 Filed 8-1-06; 8:45 am]
BILLING CODE 6560-50-S