1,3-Dichloropropene Risk Assessment; Notice of Availability, 40342-40345 [05-13378]
Download as PDF
40342
Federal Register / Vol. 70, No. 133 / Wednesday, July 13, 2005 / Notices
regarding the applicability of this action
to a particular entity, consult the person
listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Copies of this
Document and Other Related
Information?
1. Docket. EPA has established an
official public docket for this action
under docket identification (ID) number
OPP–2004–0295. The official public
docket consists of the documents
specifically referenced in this action,
any public comments received, and
other information related to this action.
Although a part of the official docket,
the public docket does not include
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute. The official public
docket is the collection of materials that
is available for public viewing at the
Public Information and Records
Integrity Branch (PIRIB), Rm. 119,
Crystal Mall #2, 1801 S. Bell St.,
Arlington, VA. This docket facility is
open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The docket telephone number
is (703) 305–5805.
2. Electronic access. You may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr/.
An electronic version of the public
docket is available through EPA’s
electronic public docket and comment
system, EPA Dockets. You may use EPA
Dockets at https://www.epa.gov/edocket/
to view public comments, access the
index listing of the contents of the
official public docket, and to access
those documents in the public docket
that are available electronically.
Although not all docket materials may
be available electronically, you may still
access any of the publicly available
docket materials through the docket
facility identified in Unit I.B.1. Once in
the system, select ‘‘search,’’ then key in
the appropriate docket ID number.
II. Background
A. What Action is the Agency Taking?
EPA has reassessed risks associated
with use of the pesticide cyhexatin, and
on June 13, 2005, reached a tolerance
reassessment and risk management
decision. Cyhexatin is used as an
insecticide/acaricide to control mites on
a variety of crops. The last U.S. product
registration was canceled in 1989. There
are currently 41 tolerances for
cyhexatin. However, the manufacturers
have indicated that they are only
supporting the tolerance for orange juice
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for import purposes. Therefore, EPA
will revoke all existing cyhexatin
tolerances and a tolerance with no U.S.
registrations will be established for
orange, juice. The orange juice
tolerance, in effect, replaces the existing
citrus tolerance. This tolerance will be
time-limited pending submission and
review of confirmatory generic data. The
Agency is now issuing a Report on Food
Quality Protection Act (FQPA)
Tolerance Reassessment Progress and
Risk Management Decision for
Cyhexatin, known as a TRED, as well as
all related technical support documents.
EPA must review tolerances and
tolerance exemptions that were in effect
when FQPA was enacted in August
1996, to ensure that these existing
pesticide residue limits for food and
feed commodities meet the safety
standard established by the new law.
Tolerances are considered reassessed
once the safety finding has been made
or a revocation occurs. EPA has
reviewed and made the requisite safety
finding for the orange juice tolerance
only. The 41 existing cyhexatin
tolerances will be proposed for
revocation.
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. Due to its uses,
risks, and other factors, cyhexatin was
reviewed through the modified 4-Phase
public participation process. Through
this process, EPA worked extensively
with stakeholders and the public to
reach the regulatory decisions for
cyhexatin.
The tolerance reassessment program
is being conducted under
Congressionally mandated time frames,
and EPA recognizes the need both to
make timely decisions and to involve
the public. A comment period is not
needed for the cyhexatin TRED because
all issues related to this pesticide were
resolved through consultations with
stakeholders. The Agency therefore is
issuing the cyhexatin TRED without a
comment period. However, the
proposed tolerance revocation for
cyhexatin will include a 30–day public
comment period.
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B. What is the Agency’s Authority for
Taking this 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: June 29, 2005.
Debra Edwards,
Director, Special Review and Reregistration
Division, Office of Pesticide Programs.
[FR Doc. 05–13374 Filed 7–12–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2005–0124; FRL–7721–9]
1,3-Dichloropropene Risk Assessment;
Notice of Availability
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: This notice announces the
availability of EPA’s human health risk
assessment for the soil fumigant 1,3Dichloropropene (1,3-D), which is
commonly referred to as telone, and
opens a public comment period on this
document. Although 1,3-D has
undergone reregistration and a
Reregistration Eligibility Decision was
published for 1,3-D in December 1998,
EPA is concurrently assessing six soil
fumigants to ensure that its risk
assessment approaches are consistent,
and to ensure that risk tradeoffs and
economic outcomes can be adequately
predicted in reaching risk management
decisions for the five other soil
fumigants. EPA has developed a human
health risk assessment for 1,3-D and is
seeking comment through a public
participation process in order to make
available current and accurate
information on this pesticide. Using this
approach, EPA expects to address risks
of concern for the five other soil
fumigants while maintaining key use
benefits.
Comments, identified by docket
identification (ID) number OPP–2005–
0124, must be received on or before
September 12, 2005.
ADDRESSES: Comments may be
submitted electronically, by mail, or
DATES:
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Federal Register / Vol. 70, No. 133 / Wednesday, July 13, 2005 / Notices
through hand delivery/courier. Follow
the detailed instructions as provided in
Unit I. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT:
Diane Sherman, 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–
0128; fax number: (703) 305–8041; email address: sherman.diane@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. How Can I Get Copies of this
Document and Other Related
Information?
1. Docket. EPA has established an
official public docket for this action
under docket ID number OPP–2005–
0124. The official public docket consists
of the documents specifically referenced
in this action, any public comments
received, and other information related
to this action. Although a part of the
official docket, the public docket does
not include Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
The official public docket is the
collection of materials that is available
for public viewing at the Public
Information and Records Integrity
Branch (PIRIB), Rm. 119, Crystal Mall
#2, 1801 S. Bell St., Arlington, VA. This
docket facility is open from 8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays. The docket
telephone number is (703) 305–5805.
2.Electronic access. You may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr/.
An electronic version of the public
docket is available through EPA’s
electronic public docket and comment
system, EPA Dockets. You may use EPA
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Dockets at https://www.epa.gov/edocket/
to submit or view public comments,
access the index listing of the contents
of the official public docket, and to
access those documents in the public
docket that are available electronically.
Once in the system, select ‘‘search,’’
then key in the appropriate docket ID
number.
Certain types of information will not
be placed in the EPA Dockets.
Information claimed as CBI and other
information whose disclosure is
restricted by statute, which is not
included in the official public docket,
will not be available for public viewing
in EPA’s electronic public docket. EPA’s
policy is that copyrighted material will
not be placed in EPA’s electronic public
docket but will be available only in
printed, paper form in the official public
docket. To the extent feasible, publicly
available docket materials will be made
available in EPA’s electronic public
docket. When a document is selected
from the index list in EPA Dockets, the
system will identify whether the
document is available for viewing in
EPA’s electronic public docket.
Although not all docket materials may
be available electronically, you may still
access any of the publicly available
docket materials through the docket
facility identified in Unit I.B.1. EPA
intends to work towards providing
electronic access to all of the publicly
available docket materials through
EPA’s electronic public docket.
For public commenters, it is
important to note that EPA’s policy is
that public comments, whether
submitted electronically or in paper,
will be made available for public
viewing in EPA’s electronic public
docket as EPA receives them and
without change, unless the comment
contains copyrighted material, CBI, or
other information whose disclosure is
restricted by statute. When EPA
identifies a comment containing
copyrighted material, EPA will provide
a reference to that material in the
version of the comment that is placed in
EPA’s electronic public docket. The
entire printed comment, including the
copyrighted material, will be available
in the public docket.
Public comments submitted on
computer disks that are mailed or
delivered to the docket will be
transferred to EPA’s electronic public
docket. Public comments that are
mailed or delivered to the docket will be
scanned and placed in EPA’s electronic
public docket. Where practical, physical
objects will be photographed, and the
photograph will be placed in EPA’s
electronic public docket along with a
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brief description written by the docket
staff.
C. How and to Whom Do I Submit
Comments?
You may submit comments
electronically, by mail, or through hand
delivery/courier. To ensure proper
receipt by EPA, identify the appropriate
docket ID number in the subject line on
the first page of your comment. Please
ensure that your comments are
submitted within the specified comment
period. Comments received after the
close of the comment period will be
marked ‘‘late.’’ EPA is not required to
consider these late comments. If you
wish to submit CBI or information that
is otherwise protected by statute, please
follow the instructions in Unit I.D. Do
not use EPA Dockets or e-mail to submit
CBI or information protected by statute.
1. Electronically. If you submit an
electronic comment as prescribed in this
unit, EPA recommends that you include
your name, mailing address, and an email address or other contact
information in the body of your
comment. Also include this contact
information on the outside of any disk
or CD ROM you submit, and in any
cover letter accompanying the disk or
CD ROM. This ensures that you can be
identified as the submitter of the
comment and allows EPA to contact you
in case EPA cannot read your comment
due to technical difficulties or needs
further information on the substance of
your comment. EPA’s policy is that EPA
will not edit your comment, and any
identifying or contact information
provided in the body of a comment will
be included as part of the comment that
is placed in the official public docket,
and made available in EPA’s electronic
public docket. 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.
i. EPA Dockets. Your use of EPA’s
electronic public docket to submit
comments to EPA electronically is
EPA’s preferred method for receiving
comments. Go directly to EPA Dockets
at https://www.epa.gov/edocket/, and
follow the online instructions for
submitting comments. Once in the
system, select ‘‘search,’’ and then key in
docket ID number OPP–2005–0124. The
system is an ‘‘anonymous access’’
system, which means EPA will not
know your identity, e-mail address, or
other contact information unless you
provide it in the body of your comment.
ii. E-mail. Comments may be sent by
e-mail to opp-docket@epa.gov,
Attention: Docket ID Number OPP–
2005–0124. In contrast to EPA’s
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electronic public docket, EPA’s e-mail
system is not an ‘‘anonymous access’’
system. If you send an e-mail comment
directly to the docket without going
through EPA’s electronic public docket,
EPA’s e-mail system automatically
captures your e-mail address. E-mail
addresses that are automatically
captured by EPA’s e-mail system are
included as part of the comment that is
placed in the official public docket, and
made available in EPA’s electronic
public docket.
iii. Disk or CD ROM. You may submit
comments on a disk or CD ROM that
you mail to the mailing address
identified in Unit I.C.2. These electronic
submissions will be accepted in
WordPerfect or ASCII file format. Avoid
the use of special characters and any
form of encryption.
2. By mail. Send your comments to:
Public Information and Records
Integrity Branch (PIRIB) (7502C), Office
of Pesticide Programs (OPP),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001, Attention: Docket ID
Number OPP–2005–0124.
3. By hand delivery or courier. Deliver
your comments to: Public Information
and Records Integrity Branch (PIRIB),
Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm.
119, Crystal Mall #2, 1801 S. Bell St.,
Arlington, VA, Attention: Docket ID
Number OPP–20005–0124. Such
deliveries are only accepted during the
docket’s normal hours of operation as
identified in Unit I.B.1.
D. How Should I Submit CBI to the
Agency?
Do not submit information that you
consider to be CBI electronically
through EPA’s electronic public docket
or by e-mail. You may claim
information that you submit to EPA as
CBI by marking any part or all of that
information as CBI (if you submit CBI
on disk or CD ROM, 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
CBI). Information so marked will not be
disclosed except in accordance with
procedures set forth in 40 CFR part 2.
In addition to one complete version of
the comment that includes any
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 and EPA’s electronic public
docket. If you submit the copy that does
not contain CBI on disk or CD ROM,
mark the outside of the disk or CD ROM
clearly that it does not contain CBI.
Information not marked as CBI will be
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included in the public docket and EPA’s
electronic public docket without prior
notice. If you have any questions about
CBI or the procedures for claiming CBI,
please consult the person listed under
FOR FURTHER INFORMATION CONTACT.
E. What Should I Consider as I Prepare
My Comments for EPA?
You may find the following
suggestions helpful for preparing your
comments:
1. Explain your views as clearly as
possible.
2. Describe any assumptions that you
used.
3. Provide any technical information
and/or data you used that support your
views.
4. If you estimate potential burden or
costs, explain how you arrived at your
estimate.
5. Provide specific examples to
illustrate your concerns.
6. Offer alternatives.
7. Make sure to submit your
comments by the comment period
deadline identified.
8. To ensure proper receipt by EPA,
identify the appropriate docket ID
number in the subject line on the first
page of your response. It would also be
helpful if you provided the name, date,
and Federal Register citation related to
your comments.
II. Background
A. What Action is the Agency Taking?
EPA is making available the human
health risk assessment for the soil
fumigant 1,3-D, which is commonly
known as telone. The Agency developed
this risk assessment and is seeking
comment through a public participation
process in order to make available
current and accurate information on 1,3D for the soil fumigant assessments.
Other soil fumigants are currently
undergoing the full, six-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
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).
A soil fumigant, 1,3-D is applied to
control parasitic root-knot nematodes
and certain pests and diseases in soil
prior to the planting of a variety of food
and feed crops including vegetable
crops, field crops, fruit and nut crops,
and nursery crops. 1,3-D is also
registered for use on golf courses and
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there are proposed uses for turf farms
and post-plant in established vineyards.
1,3-D is also a restricted use pesticide
and as such can only be applied by
certified applicators or those under the
supervision of a certified applicator.
End-use product formulations
containing 1,3-D may be applied
through drip irrigation or by injection
below the soil surface either in rows or
broadcast across an area.
1,3-D was deemed eligible for
reregistration in December 1998. The
volatility of 1,3-D in the environment
and results of metabolism studies in
plants assure that there is no reasonable
expectation of finite residues to be
incurred in/on any raw agricultural
commodities when end-use product
formulations containing 1,3-D are
applied according to label directions.
Therefore, this fumigant does not
require food tolerances. EPA does not
expect any need for additional risk
mitigation for 1,3-D but has developed
this risk assessment to ensure that risk
tradeoffs and economic outcomes can be
adequately predicted in reaching risk
management decisions for the five
othersoil fumigants.
EPA is providing an opportunity,
through this notice, for interested
parties to provide comments and input
on the Agency’s human health risk
assessment for 1,3-D. Such comments
and input could address, for example,
the availability of additional data to
further refine the risk assessment or
information about specific use practices
for crops that are produced using 1,3-D.
When providing information to the
Agency you might consider providing
pictures or video footage to help clarify
your comment. The following
information would be helpful to EPA in
characterizing regional and crop
differences in use practices and possible
effects on potential:
• Crop.
• Fumigant use.
• Average acres grown per enterprise.
• Maximum acres fumigated per day.
• Percent of the acres grown that are
fumigated.
• Typical application rate (pound
active ingredient/acre (lb a.i./acre)).
• Minimum application rate used (lb
a.i./acre) (for high pest pressure
situations).
• Time of year that soil is fumigated.
• Fumigation cycle (every crop cycle,
1 time/year, 1 time/2 years).
• Target pests (by category or specific
pests).
• Method of application (e.g.,
chemigation, soil injection, specific
equipment used).
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• Methods or actions taken to reduce
emissions (polyethylene tarps or soil
cap).
• Could high-density polyethylene
(HDPE) or high barrier tarps be used on
this crop?
• Time between treatment and next
production activity (e.g., time until
planting).
• Typical crops following the
fumigated crop (only if they benefit
from the fumigation).
• Regulatory restrictions in your area
on this fumigant or an alternative
fumigant (such as weather restrictions).
• Soil restrictions on this fumigant or
an alternative fumigant.
• Any restrictions or concerns about
minimum soil temperature, hilly terrain,
etc.
• Best available alternative (another
fumigant or strategy such as leaving
land fallow, etc.).
• Could the use of different fumigants
be alternated (e.g., metam sodium
followed by 1,3-D)? Specify how.
• Yield or quality impacts that are
likely to result from moving to best
available alternative (i.e., change in
commodity price or grade).
• Would moving to the next best
alternative impact key market windows?
How?
• Cost per acre of active ingredient.
• Cost per acre of other fumigation
inputs (e.g., tarps and equipment).
• Is there a crop budget available for
your area and crop?
• Do you know of any other contacts
or other sources of information for this
crop that could provide information on
acreage, prices, pests, etc.?
• Are there non-chemical alternatives
that can be used in place of fumigants?
Describe use.
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
1,3-D, 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 of May 14, 2004 (69 FR 26819)
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(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. Although 1,3-D has
undergone reregistration, the Agency
plans to follow a similar public
participation process for the human
health risk assessment for 1,3-D to
ensure that human health risk
assessment approaches are consistent,
and that risk management decisions for
the five other soil fumigants consider
the relative risks and benefits of each
chemical. Using this approach, EPA
expects to address risks of concern for
the five other fumigants while
maintaining key use benefits. If, at the
conclusion of the soil fumigant
assessment and risk management
process, EPA determines that it is
appropriate to modify its 1998 risk
mitigation decision for 1,3-D
considering the relative risks and
benefits of the others, EPA may relax
certain measures or add new ones.
Comments should be limited to issues
raised within the risk assessment.
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 Unit I. of the
SUPPLEMENTARY INFORMATION, and must
be received by EPA on or before the
closing date. Comments will become
part of the Agency Docket for 1,3-D.
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.’’
1,3-D was deemed eligible for
reregistration in December 1998. EPA
has developed a human health risk
assessment for 1,3-D in order to make
available current and accurate
information on this pesticide which will
be discussed as EPA assesses risks and
develops risk management decisions,
including reregistration decisions, for
five other soil fumigants.
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40345
List of Subjects
Environmental protection, Pesticides
and pests.
Dated:June 29, 2005.
Debra Edwards,
Director, Special Review and Reregistration
Division, Office of Pesticide Programs.
[FR Doc. 05–13378 Filed 7–12–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2005–0151; FRL–7724–9]
Simazine Risk Assessments and Risk
Reduction Options; Notice of
Availability
Environmental Protection
Agency (EPA).
AGENCY:
ACTION:
Notice.
SUMMARY: This notice announces the
availability of EPA’s human health and
environmental fate and effects risk
assessments and related documents for
the chlorinated triazine pesticide
simazine, 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 an Interim Reregistration
Eligibility Decision (IRED) for simazine
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.
Comments, identified by docket
identification (ID) number OPP–2005–
0151, must be received on or before
September 12, 2005.
DATES:
Comments may be
submitted electronically, by mail, or
through hand delivery/courier. Follow
the detailed instructions as provided in
Unit I. of the SUPPLEMENTARY
INFORMATION.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Diane Sherman, 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–
0128 fax number: (703) 305–8041; email address: sherman.diane@epa.gov.
SUPPLEMENTARY INFORMATION:
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Agencies
[Federal Register Volume 70, Number 133 (Wednesday, July 13, 2005)]
[Notices]
[Pages 40342-40345]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-13378]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2005-0124; FRL-7721-9]
1,3-Dichloropropene Risk Assessment; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the availability of EPA's human health
risk assessment for the soil fumigant 1,3-Dichloropropene (1,3-D),
which is commonly referred to as telone, and opens a public comment
period on this document. Although 1,3-D has undergone reregistration
and a Reregistration Eligibility Decision was published for 1,3-D in
December 1998, EPA is concurrently assessing six soil fumigants to
ensure that its risk assessment approaches are consistent, and to
ensure that risk tradeoffs and economic outcomes can be adequately
predicted in reaching risk management decisions for the five other soil
fumigants. EPA has developed a human health risk assessment for 1,3-D
and is seeking comment through a public participation process in order
to make available current and accurate information on this pesticide.
Using this approach, EPA expects to address risks of concern for the
five other soil fumigants while maintaining key use benefits.
DATES: Comments, identified by docket identification (ID) number OPP-
2005-0124, must be received on or before September 12, 2005.
ADDRESSES: Comments may be submitted electronically, by mail, or
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through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: Diane Sherman, Special Review and
Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-0128; fax
number: (703) 305-8041; e-mail address: sherman.diane@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. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket ID number OPP-2005-0124. The official public docket
consists of the documents specifically referenced in this action, any
public comments received, and other information related to this action.
Although a part of the official docket, the public docket does not
include Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. The official public docket
is the collection of materials that is available for public viewing at
the Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The docket telephone number is (703) 305-
5805.
2.Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://www.epa.gov/fedrgstr/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at https://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Once in the system, select ``search,''
then key in the appropriate docket ID number.
Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B.1. EPA intends to work
towards providing electronic access to all of the publicly available
docket materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
C. How and to Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. Do not use EPA Dockets or e-mail to submit CBI or information
protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. 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.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at https://www.epa.gov/
edocket/, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID number
OPP-2005-0124. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment.
ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov,
Attention: Docket ID Number OPP-2005-0124. In contrast to EPA's
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electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
2. By mail. Send your comments to: Public Information and Records
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2005-0124.
3. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID
Number OPP-20005-0124. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.
D. How Should I Submit CBI to the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
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 CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includes
any 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 and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person listed under FOR FURTHER INFORMATION CONTACT.
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide any technical information and/or data you used that
support your views.
4. If you estimate potential burden or costs, explain how you
arrived at your estimate.
5. Provide specific examples to illustrate your concerns.
6. Offer alternatives.
7. Make sure to submit your comments by the comment period deadline
identified.
8. To ensure proper receipt by EPA, identify the appropriate docket
ID number in the subject line on the first page of your response. It
would also be helpful if you provided the name, date, and Federal
Register citation related to your comments.
II. Background
A. What Action is the Agency Taking?
EPA is making available the human health risk assessment for the
soil fumigant 1,3-D, which is commonly known as telone. The Agency
developed this risk assessment and is seeking comment through a public
participation process in order to make available current and accurate
information on 1,3-D for the soil fumigant assessments. Other soil
fumigants are currently undergoing the full, six-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 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).
A soil fumigant, 1,3-D is applied to control parasitic root-knot
nematodes and certain pests and diseases in soil prior to the planting
of a variety of food and feed crops including vegetable crops, field
crops, fruit and nut crops, and nursery crops. 1,3-D is also registered
for use on golf courses and there are proposed uses for turf farms and
post-plant in established vineyards. 1,3-D is also a restricted use
pesticide and as such can only be applied by certified applicators or
those under the supervision of a certified applicator. End-use product
formulations containing 1,3-D may be applied through drip irrigation or
by injection below the soil surface either in rows or broadcast across
an area.
1,3-D was deemed eligible for reregistration in December 1998. The
volatility of 1,3-D in the environment and results of metabolism
studies in plants assure that there is no reasonable expectation of
finite residues to be incurred in/on any raw agricultural commodities
when end-use product formulations containing 1,3-D are applied
according to label directions. Therefore, this fumigant does not
require food tolerances. EPA does not expect any need for additional
risk mitigation for 1,3-D but has developed this risk assessment to
ensure that risk tradeoffs and economic outcomes can be adequately
predicted in reaching risk management decisions for the five othersoil
fumigants.
EPA is providing an opportunity, through this notice, for
interested parties to provide comments and input on the Agency's human
health risk assessment for 1,3-D. Such comments and input could
address, for example, the availability of additional data to further
refine the risk assessment or information about specific use practices
for crops that are produced using 1,3-D. When providing information to
the Agency you might consider providing pictures or video footage to
help clarify your comment. The following information would be helpful
to EPA in characterizing regional and crop differences in use practices
and possible effects on potential:
Crop.
Fumigant use.
Average acres grown per enterprise.
Maximum acres fumigated per day.
Percent of the acres grown that are fumigated.
Typical application rate (pound active ingredient/acre (lb
a.i./acre)).
Minimum application rate used (lb a.i./acre) (for high
pest pressure situations).
Time of year that soil is fumigated.
Fumigation cycle (every crop cycle, 1 time/year, 1 time/2
years).
Target pests (by category or specific pests).
Method of application (e.g., chemigation, soil injection,
specific equipment used).
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Methods or actions taken to reduce emissions (polyethylene
tarps or soil cap).
Could high-density polyethylene (HDPE) or high barrier
tarps be used on this crop?
Time between treatment and next production activity (e.g.,
time until planting).
Typical crops following the fumigated crop (only if they
benefit from the fumigation).
Regulatory restrictions in your area on this fumigant or
an alternative fumigant (such as weather restrictions).
Soil restrictions on this fumigant or an alternative
fumigant.
Any restrictions or concerns about minimum soil
temperature, hilly terrain, etc.
Best available alternative (another fumigant or strategy
such as leaving land fallow, etc.).
Could the use of different fumigants be alternated (e.g.,
metam sodium followed by 1,3-D)? Specify how.
Yield or quality impacts that are likely to result from
moving to best available alternative (i.e., change in commodity price
or grade).
Would moving to the next best alternative impact key
market windows? How?
Cost per acre of active ingredient.
Cost per acre of other fumigation inputs (e.g., tarps and
equipment).
Is there a crop budget available for your area and crop?
Do you know of any other contacts or other sources of
information for this crop that could provide information on acreage,
prices, pests, etc.?
Are there non-chemical alternatives that can be used in
place of fumigants? Describe use.
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 1,3-D, 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 of 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.
Although 1,3-D has undergone reregistration, the Agency plans to follow
a similar public participation process for the human health risk
assessment for 1,3-D to ensure that human health risk assessment
approaches are consistent, and that risk management decisions for the
five other soil fumigants consider the relative risks and benefits of
each chemical. Using this approach, EPA expects to address risks of
concern for the five other fumigants while maintaining key use
benefits. If, at the conclusion of the soil fumigant assessment and
risk management process, EPA determines that it is appropriate to
modify its 1998 risk mitigation decision for 1,3-D considering the
relative risks and benefits of the others, EPA may relax certain
measures or add new ones.
Comments should be limited to issues raised within the risk
assessment. 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 Unit I. of the SUPPLEMENTARY
INFORMATION, and must be received by EPA on or before the closing date.
Comments will become part of the Agency Docket for 1,3-D. 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.''
1,3-D was deemed eligible for reregistration in December 1998. EPA
has developed a human health risk assessment for 1,3-D in order to make
available current and accurate information on this pesticide which will
be discussed as EPA assesses risks and develops risk management
decisions, including reregistration decisions, for five other soil
fumigants.
List of Subjects
Environmental protection, Pesticides and pests.
Dated:June 29, 2005.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. 05-13378 Filed 7-12-05; 8:45 am]
BILLING CODE 6560-50-S