Propylene Oxide Risk Assessment, Notice of Availability, and Risk Reduction Options, 68031-68034 [05-22381]
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Federal Register / Vol. 70, No. 216 / Wednesday, November 9, 2005 / Notices
[FR Doc. 05–22295 Filed 11–8–05; 8:45 am]
BILLING CODE 6717–01–C
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2005–0294; FRL–7745–1]
The Association of American Pesticide
Control Officials/State FIFRA Issues
Research and Evaluation Group;
Notice of Public Meeting
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: The Association of American
Pesticide Control Officials (AAPCO)/
State FIFRA Issues Research and
Evaluation Group (SFIREG) will hold a
2–day meeting, beginning on December
5, 2005 and ending December 6, 2005.
This notice announces the location and
times for the meeting and sets forth the
tentative agenda topics.
DATES: The meeting will be held on
Monday, December 5, 2005 through
Tuesday, December 6, 2005 from 8:30
a.m. to 5 p.m. on Monday, December 5
and 8:30 a.m. to 12 p.m. on Tuesday,
December 6, 2005.
ADDRESSES: The meeting will be held at
the Doubletree Hotel, 300 Army Navy
Drive, Crystal City, Arlington, VA.
FOR FURTHER INFORMATION CONTACT:
Georgia A. McDuffie, Field and External
Affairs Division (7506C), Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001; telephone number: (703) 605–
0195; fax number: (703) 308–1850; email address: mcduffie.georgia@epa.gov
or Philip H. Gray, SFIREG Executive
Secretary, P.O. Box 1249, Hardwick, VT
05843–1249; telephone number: (802)
472–6956; fax (802) 472–6957; e-mail
address: aapco@plainfield.bypass.com.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are interested in
SFIREG information exchange with EPA
regarding important issues related to
human health, environmental exposure
to pesticides, and insight into EPA’s
decision-making process. Potentially
affected entities may include, but are
not limited to: Those persons who are
or may be required to conduct testing of
chemical substances under the Federal
Food, Drug and Cosmetic Act (FFDCA),
or the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA).
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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–2005–0294. 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. Tentative Agenda
The tentative agenda of issues to be
discussed at the meeting includes:
1. Update on uses on mosquito
misters.
2. Process for registering bio-decon
products.
3. Antimicrobial Division/CDC
strategy on foot spas.
4. Chlorpyrifos: Close out strategy.
5. Performance measures: Steering
Committee assessment.
6. Endangered Species Program
update.
7. Emergency disaster: Registrations.
8. Multinational pesticide
registrations.
9. Update on X596 Recycling
Standard.
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10. Update on container management
rulemaking.
11. EPA/SFIREG Coordination of
issues with Annual Work Plan.
12. Update on data issues related to
OPPIN.
13. OPP and OECA update.
14. Human Study Rule.
List of Subjects
Environmental protection. Pesticides
and pest.
Dated: November 1, 2005.
William R. Diamond,
Director, Field and External Affairs Division,
Office of Pesticide Program.
[FR Doc. 05–22383 Filed 11–8–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2005–0253; FRL–7740–2]
Propylene Oxide Risk Assessment,
Notice of Availability, and Risk
Reduction Options
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: This notice announces the
availability of EPA’s human health risk
assessment and related documents for
the insecticidal fumigant pesticide
propylene oxide (PPO), 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 PPO
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. This notice opens
phase 3 of the 4–phase process.
DATES: Comments must be received on
or before January 9, 2006.
ADDRESSES: Comments, identified by
docket identification (ID) number OPP–
2005–0253, may be submitted
electronically, by mail, or through hand
delivery/courier. Follow the detailed
instructions as provided in Unit I. of the
SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT:
Susan Bartow, Special Review and
Reregistration Division (7508C), Office
of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001; telephone number: (703) 603–
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Federal Register / Vol. 70, No. 216 / Wednesday, November 9, 2005 / Notices
0065; fax number: (703) 308–8041; email address: bartow.susan@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–
0253. 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, to
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.
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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
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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–2005–0253. 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–
2005–0253. In contrast to EPA’s
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
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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–2005–0253.
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–2005–0253. 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.
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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 releasing for public comment
its human health risk assessment and
related documents for PPO, and
soliciting public comment on risk
management ideas or proposals. PPO is
an insecticidal fumigant used on several
food items such as processed spices,
cocoa (beans and powder), and in-shell
and processed nutmeats (except
peanuts). PPO also has nonfood uses for
bird seeds, cosmetic articles, gums, ores,
packaging, pigments, pharmaceutical
materials, and discarded nut shells prior
to disposal. EPA developed the risk
assessment and risk characterization for
PPO 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).
EPA is providing an opportunity,
through this notice, for interested
parties to provide comments and input
on the Agency’s risk assessment for
PPO. Such comments and input could
address, for example, the availability of
additional data to further refine the risk
assessments, such as worker exposure
data, or could address the Agency’s risk
assessment methodologies and
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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 PPO. Risks of concern
associated with the use of PPO include
cancer dietary risk estimates that are
above the Agency’s level of concern.
The DEEM and Lifeline model cancer
dietary excess lifetime risk estimates for
the U.S. general population were 1.3 x
10-5 and 1.5 x 10-5, respectively. For
occupational risks, the
short-,
intermediate-, and long-term inhalation
non-cancer and cancer risks from the
use of PPO in commodity sterilization/
fumigation are of concern at the
Agency’s current labeled exposure
concentration of 20 parts per million
(ppm). A summary of these potential
risks of concern as well as specific
questions for which the Agency is
requesting public input, are provided in
a separate document titled Request for
Additional Information and Risk
Management Suggestions for the
Reregistration of Propylene Oxide. 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
PPO, 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 PPO, 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
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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 Unit I. and must
be received by EPA on or before the
closing date. Comments will become
part of the Agency Docket for PPO.
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 enduse 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: September 30, 2005.
Debra Edwards,
Director, Special Review and Reregistration
Division, Office of Pesticide Programs.
[FR Doc. 05–22381 Filed 11–8–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2004–0346; FRL–7739–4]
Ethofumesate Reregistration Eligibility
Decision; Notice of Availability
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: This notice announces the
availability of EPA’s Reregistration
Eligibility Decision (RED) for the
pesticide ethofumesate, and opens a
public comment period on this
document. The Agency’s risk
assessments and other related
documents also are available in the
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ethofumesate docket. Ethofumesate is a
selective herbicide used during
preplant, preemergence and
postemergence for control of broadleaf
and grass weeds. Primary uses are for
sugar beets, turf for sod and golf
courses, and grass for seed. Special local
need uses include uses on spinach and
Swiss chard crops which are grown for
seed. EPA has reviewed ethofumesate
through the 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 January 9, 2006.
ADDRESSES: Comments identified by
docket identification (ID) number OPP–
2004–0348, may be submitted
electronically, by mail, or through hand
delivery/courier. Follow the detailed
instructions as provided in Unit I. of the
SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT:
Nathan Mottl, Special Review and
Reregistration Division (7508C), Office
of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001; telephone number: (703) 305–
0208; fax number: (703) 308–8041; email address: mottl.nathan@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–2004–
0346. 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
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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
thisFederal 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, to
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
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]]>Agencies
[Federal Register Volume 70, Number 216 (Wednesday, November 9, 2005)]
[Notices]
[Pages 68031-68034]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-22381]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2005-0253; FRL-7740-2]
Propylene Oxide Risk Assessment, 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 human health
risk assessment and related documents for the insecticidal fumigant
pesticide propylene oxide (PPO), 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 PPO 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. This notice
opens phase 3 of the 4-phase process.
DATES: Comments must be received on or before January 9, 2006.
ADDRESSES: Comments, identified by docket identification (ID) number
OPP-2005-0253, may be submitted electronically, by mail, or through
hand delivery/courier. Follow the detailed instructions as provided in
Unit I. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: Susan Bartow, Special Review and
Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 603-
[[Page 68032]]
0065; fax number: (703) 308-8041; e-mail address: bartow.susan@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-2005-0253. 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, to 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-2005-0253. 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-2005-0253. In contrast to EPA's
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
[[Page 68033]]
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-2005-0253.
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-2005-0253. 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 releasing for public comment its human health risk
assessment and related documents for PPO, and soliciting public comment
on risk management ideas or proposals. PPO is an insecticidal fumigant
used on several food items such as processed spices, cocoa (beans and
powder), and in-shell and processed nutmeats (except peanuts). PPO also
has nonfood uses for bird seeds, cosmetic articles, gums, ores,
packaging, pigments, pharmaceutical materials, and discarded nut shells
prior to disposal. EPA developed the risk assessment and risk
characterization for PPO 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).
EPA is providing an opportunity, through this notice, for
interested parties to provide comments and input on the Agency's risk
assessment for PPO. Such comments and input could address, for example,
the availability of additional data to further refine the risk
assessments, such as worker exposure data, 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 PPO. Risks of concern associated with
the use of PPO include cancer dietary risk estimates that are above the
Agency's level of concern. The DEEM and Lifeline model cancer dietary
excess lifetime risk estimates for the U.S. general population were 1.3
x 10-\5\ and 1.5 x 10-\5\, respectively. For
occupational risks, the short-, intermediate-, and long-term inhalation
non-cancer and cancer risks from the use of PPO in commodity
sterilization/fumigation are of concern at the Agency's current labeled
exposure concentration of 20 parts per million (ppm). A summary of
these potential risks of concern as well as specific questions for
which the Agency is requesting public input, are provided in a separate
document titled Request for Additional Information and Risk Management
Suggestions for the Reregistration of Propylene Oxide. 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 PPO, 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 PPO, 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
[[Page 68034]]
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 Unit I. and
must be received by EPA on or before the closing date. Comments will
become part of the Agency Docket for PPO. 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: September 30, 2005.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. 05-22381 Filed 11-8-05; 8:45 am]
BILLING CODE 6560-50-S
