NAFTA Guidance for Conducting Terrestrial Field Dissipation Studies, 34758-34761 [05-11830]
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34758
Federal Register / Vol. 70, No. 114 / Wednesday, June 15, 2005 / Notices
Immediately following the conclusion
of the Commission Meeting, a press
briefing will be held in Hearing Room
2. Members of the public may view this
briefing in the Commission Meeting
overflow room. This statement is
intended to notify the public that the
press briefings that follow Commission
meetings may now be viewed remotely
at Commission headquarters, but will
not be telecast through the Capitol
Connection service.
[FR Doc. 05–11859 Filed 6–10–05; 4:16 pm]
BILLING CODE 6717–01–P
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–7924–6]
Science Advisory Board Staff Office;
Notification of Upcoming Meeting of
the Science Advisory Board, Homeland
Security Advisory Committee (HSAC)
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: The EPA Science Advisory
Board (SAB) Staff Office announces a
public meeting of the Homeland
Security Advisory Committee (HSAC).
DATES: July 15, 2005. The Committee
will hold a public face-to-face meeting
on July 15, 2005 from 8:30 a.m.to 4 p.m.
(EST).
ADDRESSES: The meeting of the
Committee will be held at the SAB
Conference Center located at the
Woodies Building, 1025 F St. NW.,
Room 3705, Washington, DC, 20004.
FOR FURTHER INFORMATION CONTACT:
Members of the public who wish to
obtain more information regarding this
meeting may contact Dr. Heidi Bethel,
EPA Science Advisory Board Staff
Office (1400F), U.S. Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460;
telephone/voice mail: (202) 343–9975;
Fax (202) 233–0643 or via e-mail at
bethel.heidi@epa.gov.
SUPPLEMENTARY INFORMATION:
Background: The Agency’s overall
mission with respect to homeland
security is the protection of the nation
against the environmental and health
consequences of acts of terrorism. Five
Mission Critical Areas (MCAs) are
described in the U.S. EPA’s 2004
Homeland Security Strategy (https://
www.epa.gov/homelandsecurity/htm/
ohs-sp.htm). EPA’s roles within the
MCAs include protection of critical
infrastructure including water and
wastewater industries; aiding other
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federal agencies in the protection of the
chemical, food, transportation, and
energy sectors; responding and
recovering from any chemical,
biological, radiological, or nuclear
terrorist events; providing
environmental expertise to support
federal law enforcement activities;
improving compliance monitoring and
surveillance of imports in U.S. ports of
entry; and synthesizing and
communicating complex information
related to human health and the
environment. Additionally, EPA is
committed to protecting its own
personnel and infrastructure and
conducting internal evaluations of the
Agency’s homeland security activities to
determine if objectives are achieved.
Because of the cross-disciplinary
nature of homeland security issues,
multiple EPA offices are involved and
their efforts are coordinated by the
Administrator’s Office of Homeland
Security (OHS) (https://www.epa.gov/
homelandsecurity/index.htm).
Homeland security research at EPA is
conducted by the Office of Research and
Development’s National Homeland
Security Research Center (NHSRC)
(https://www.epa.gov/nhsrc/). Research
is conducted by the Agency in the
following three areas: building cleanup
through detection, containment,
decontamination and disposal of
terrorist agents and building materials;
threat and consequence assessment,
which involves the development of
information systems and tools, risk
estimates, and risk communication; and
water infrastructure protection with an
emphasis on water supply, treatment,
and distribution infrastructures.
In response to a request from the
Agency, the SAB has formed a
subcommittee of the Chartered SAB to
provide independent scientific and
technical advice on matters pertaining
to EPA’s mission in protecting against
the environmental and health
consequences of terrorism. Background
on this SAB Committee and its charge
was provided in a Federal Register (FR)
Notice published on July 30, 2003 (68
FR 44761–44762).
Pursuant to the Federal Advisory
Committee Act, Public Law 92–463,
Notice is hereby given that the SAB
HSAC, a subcommittee of the Chartered
SAB, will hold a public face-to-face
meeting. The Committee will receive
briefings from EPA offices regarding the
Agency’s role in homeland security and
the scope of their research and program
activities. EPA’s technical contact is Ms.
Lee Ann Byrd, EPA Office of Homeland
Security (1109A), 1200 Pennsylvania
Ave, NW., Washington, DC 20460;
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telephone/voice mail: (202) 564–0675/
6978; or via e-mail at byrd.lee@epa.gov.
Availability of Meeting Materials: The
meeting agenda and meeting materials
will be posted on the SAB Web site at:
https://www.epa.gov/science1/
agendas.htm prior to the meeting.
Procedures for Providing Public
Comment: It is the policy of the EPA
Science Advisory Board (SAB) Staff
Office to accept written public
comments of any length, and to
accommodate oral public comments
whenever possible. Oral Comments:
Requests to provide oral comments must
be in writing (e-mail, fax or mail) and
received by Dr. Bethel no later than five
business days prior to the meeting in
order to reserve time on the meeting
agenda. For face-to-face meetings,
opportunities for oral comment will
usually be limited to no more than ten
minutes per speaker or organization
(unless otherwise stated). Speakers
should bring at least 35 copies of their
comments and presentation slides for
distribution to the reviewers and public
at the meeting. Written Comments:
Although written comments are
accepted until the date of the meeting
(unless otherwise stated), written
comments should be received in the
SAB Staff Office at least five business
days prior to the meeting date so that
the comments may be made available to
the committee for their consideration.
Comments should be supplied to the
DFO at the address/contact information
noted above in the following formats:
one hard copy with original signature
and one electronic copy via e-mail
(acceptable file format: Adobe Acrobat,
WordPerfect, Word, or Rich Text files
(in IBM–PC/Windows 98/2000/XP
format).
Dated: June 9, 2004.
Vanessa T. Vu,
Director, EPA Science Advisory Board Staff
Office.
[FR Doc. 05–11826 Filed 6–14–05; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2005–0129; FRL–7713–7]
NAFTA Guidance for Conducting
Terrestrial Field Dissipation Studies
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: Under the North American
Free Trade Agreement (NAFTA), EPA
and the Canadian Pest Management
Regulatory Agency (PMRA) have agreed
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Federal Register / Vol. 70, No. 114 / Wednesday, June 15, 2005 / Notices
to harmonize their testing guidelines so
that one set of tests can be used for the
registration of pesticides in Canada and
the United States. The NAFTA
harmonized guidance for terrestrial field
dissipation (TFD) studies are conducted
to demonstrate the transformation,
transport, and fate of pesticides under
representative actual use conditions.
These field studies are needed to
substantiate the physicochemical,
mobility, and biotransformation data
from laboratory studies. Environmental
fate studies have shown that pesticide
dissipation may proceed at different
rates under field conditions and may
result in degradates forming at levels
different from those observed in
laboratory studies. The objective of this
revised guidance document is to help
ensure that TFD studies are conducted
in a manner that will provide risk
assessors and risk managers with more
confidence in the data generated and
with a better understanding of the
assumptions and limitations of the data
and estimated half-lives of the pesticide.
The revised guidance can be found at:
https://www.epa.gov/oppefed1/
ecorisk_ders/
efed_final_draft_tfd_guidance.pdf.
Comments, identified by docket
ID number OPP–2005–0129, must be
received on or before August 1, 2005.
ADDRESSES: 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.
DATES:
FOR FURTHER INFORMATION CONTACT:
Mark Corbin, Environmental Fate and
Effects Division (7507C), Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001; telephone number: 703–605–0033;
fax number: 703–305–6309; e-mail
address: mark.corbin@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS code 111)
• Animal production (NAICS code
112)
• Food manufacturing (NAICS code
311)
• Pesticide manufacturing (NAICS
code 32532)
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This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, 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–2005–0129. 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
athttps://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
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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. 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
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Federal Register / Vol. 70, No. 114 / Wednesday, June 15, 2005 / Notices
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
athttps://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–2005–0129. 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 toopp-docket@epa.gov,
Attention: Docket ID Number OPP–
2005–0129. 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 youre-mail address. E-mail
addresses that are automatically
captured by EPA’se-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
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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–2005–0129.
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–2005–0129. 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.
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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?
The Terrestrial Field Dissipation
study has been a basic requirement for
registrants of new and existing
pesticides since 1982. While laboratory
environmental fate studies are designed
to address one dissipation process at a
time, terrestrial field dissipation studies
address pesticide loss as a combined
result of chemical and biological
processes (e.g., hydrolysis, photolysis,
microbial transformation) and physical
migration (e.g., volatilization, leaching,
plant uptake). Data from these studies
can reduce potential overestimation of
exposure and risk and can confirm
assumptions of low levels of toxic
degradates. Results can be used to
propose scenario-specific effective risk
mitigation.
In general, the terrestrial field
dissipation study results should allow
the risk assessor to:
• Compare predicted routes of
dissipation identified in the laboratory
with those measured in the field.
• Characterize the rates of
dissipation of the parent compound and
formation and decline of the major and/
or toxicologically significant
transformation products under field
conditions.
• Characterize the rates and relative
importance of the different transport
processes, including leaching, runoff,
and volatilization.
• Establish the distribution of the
parent compound and the major
transformation products in the soil
profile.
• Characterize the persistence of the
parent compound and major
transformation products in soil,
including retention and residue
carryover in the soil to the following
crop season.
• Characterize the effect(s) of
different typical pesticide formulation
categories, where applicable.
EPA and PMRA have developed
harmonized guidance for conducting
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Federal Register / Vol. 70, No. 114 / Wednesday, June 15, 2005 / Notices
terrestrial field dissipation studies so
that one set of tests can be used for
registration of a pesticide in Canada, the
United States, and Mexico. In
developing this guidance document,
EPA and PMRA conducted an extensive
outreach and review program, soliciting
input from stakeholders and the
technical community through several
forums: three symposia, one Scientific
Advisory Panel (SAP) meeting, and one
workshop. Working closely with its
stakeholders, PMRA and EPA developed
a conceptual model for designing
terrestrial studies that will evaluate the
overall dissipation of a pesticide in the
field. The conceptual model, which is
specific for each pesticide, is based on
the chemical’s physicochemical
properties, laboratory environmental
fate studies, formulation type and
intended use pattern. At this time, the
Agency is soliciting input from the
public on the draft harmonized
guidance and conceptual model, which
can be found at the following address:
https://www.epa.gov/oppefed1/
ecorisk_ders/
efed_final_draft_tfd_guidance.pdf.
B. What is the Agency’s Authority for
Taking this Action?
This action is being taken under the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA).
List of Subjects
Environmental protection, Terrestrial
field dissipation, Harmonized guidance.
Dated: May 9, 2005.
Steven Bradbury,
Director, Environmental Fate and Effects
Division, Office of Pesticide Programs.
[FR Doc. 05–11830 Filed 6–14–05 8:45 am]
BILLING CODE 6560–50–S
FEDERAL COMMUNICATIONS
COMMISSION
Notice of Public Information
Collection(s) Being Reviewed by the
Federal Communications Commission,
Comments Requested
June 2, 2005.
SUMMARY: The Federal Communications
Commission, as part of its continuing
effort to reduce paperwork burden
invites the general public and other
Federal agencies to take this
opportunity to comment on the
following information collection(s), as
required by the Paperwork Reduction
Act (PRA) of 1995, Public Law 104–13.
An agency may not conduct or sponsor
a collection of information unless it
displays a currently valid control
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17:57 Jun 14, 2005
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number. No person shall be subject to
any penalty for failing to comply with
a collection of information subject to the
Paperwork Reduction Act that does not
display a valid control number.
Comments are requested concerning (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
Commission, including whether the
information shall have practical utility;
(b) the accuracy of the Commission’s
burden estimate; (c) ways to enhance
the quality, utility, and clarity of the
information collected; and (d) ways to
minimize the burden of the collection of
information on the respondents,
including the use of automated
collection techniques or other forms of
information technology.
DATES: Written Paperwork Reduction
Act (PRA) comments should be
submitted on or before August 15, 2005.
If you anticipate that you will be
submitting comments, but find it
difficult to do so within the period of
time allowed by this notice, you should
advise the contact listed below as soon
as possible.
ADDRESSES: Direct all Paperwork
Reduction Act (PRA) comments to
Judith B. Herman, Federal
Communications Commission, Room 1–
C804, 445 12th Street, SW., Washington,
DC 20554 or via the Internet to JudithB.Herman@fcc.gov.
FOR FURTHER INFORMATION CONTACT: For
additional information or copies of the
information collection(s), contact Judith
B. Herman at 202–418–0214 or via the
Internet at Judith-B.Herman@fcc.gov.
SUPPLEMENTARY INFORMATION:
OMB Control No.: 3060–0813.
Title: Enhanced 911 Emergency
Calling Services.
Form No.: N/A.
Type of Review: Extension of a
currently approved collection.
Respondents: Business or other forprofit and state, local or tribal
government.
Number of Respondents: 47,031.
Estimated Time Per Response: 1–5
hours.
Frequency of Response: On occasion
and annual reporting requirements and
third party disclosure requirements.
Total Annual Burden: 198,200 hours.
Total Annual Cost: N/A.
Privacy Act Impact Assessment: N/A.
Needs and Uses: The notification
requirement on Public Safety Answering
Points (PSAPs) will be used by the
carriers to verify that wireless E911 calls
are referred to PSAPs who have the
technical capability to use the data to
the caller’s benefit. TTY and dispatch
notification requirements will be used
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34761
to avoid customer confusion as to the
capabilities of their handsets in reaching
help in emergency situations, thus
minimizing the possibility of critical
delays in response time. The annual
TTY reports will be used to monitor the
progress of TTY technology and thus
capability. Consultations on the specific
meaning assigned to pseudo-Automatic
Location Identification (ANI) are
appropriate to ensure that all parties are
working with the same information.
Coordination between carriers and state
and local entities to determine the
appropriate PSAPs to receive and
respond to E911 calls is necessary
because of the difficulty in assigning
PSAPs based on the location of the
wireless caller. The deployment
schedule that must be submitted by
carriers seeking a waiver of Phase I or
Phase II deployment schedule will be
used by the Commission to guarantee
that the rules are enforced in timely
manner as possible within technological
constraints.
Federal Communications Commission.
Marlene H. Dortch,
Secretary.
[FR Doc. 05–11538 Filed 6–14–05; 8:45 am]
BILLING CODE 6712–01–P
FEDERAL COMMUNICATIONS
COMMISSION
Notice of Public Information
Collection(s) Being Reviewed by the
Federal Communications Commission
for Extension Under Delegated
Authority
May 26, 2005.
SUMMARY: The Federal Communications
Commission, as part of its continuing
effort to reduce paperwork burden
invites the general public and other
Federal agencies to take this
opportunity to comment on the
following information collection(s), as
required by the Paperwork Reduction
Act of 1995, Public Law 104–13. An
agency may not conduct or sponsor a
collection of information unless it
displays a currently valid control
number. No person shall be subject to
any penalty for failing to comply with
a collection of information subject to the
Paperwork Reduction Act (PRA) that
does not display a valid control number.
Comments are requested concerning (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
Commission, including whether the
information shall have practical utility;
(b) the accuracy of the Commission’s
burden estimate; (c) ways to enhance
E:\FR\FM\15JNN1.SGM
15JNN1
Agencies
[Federal Register Volume 70, Number 114 (Wednesday, June 15, 2005)]
[Notices]
[Pages 34758-34761]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-11830]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2005-0129; FRL-7713-7]
NAFTA Guidance for Conducting Terrestrial Field Dissipation
Studies
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Under the North American Free Trade Agreement (NAFTA), EPA
and the Canadian Pest Management Regulatory Agency (PMRA) have agreed
[[Page 34759]]
to harmonize their testing guidelines so that one set of tests can be
used for the registration of pesticides in Canada and the United
States. The NAFTA harmonized guidance for terrestrial field dissipation
(TFD) studies are conducted to demonstrate the transformation,
transport, and fate of pesticides under representative actual use
conditions. These field studies are needed to substantiate the
physicochemical, mobility, and biotransformation data from laboratory
studies. Environmental fate studies have shown that pesticide
dissipation may proceed at different rates under field conditions and
may result in degradates forming at levels different from those
observed in laboratory studies. The objective of this revised guidance
document is to help ensure that TFD studies are conducted in a manner
that will provide risk assessors and risk managers with more confidence
in the data generated and with a better understanding of the
assumptions and limitations of the data and estimated half-lives of the
pesticide. The revised guidance can be found at: https://www.epa.gov/
oppefed1/ecorisk_ders/efed_final_draft_tfd_guidance.pdf.
DATES: Comments, identified by docket ID number OPP-2005-0129, must be
received on or before August 1, 2005.
ADDRESSES: 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.
FOR FURTHER INFORMATION CONTACT: Mark Corbin, Environmental Fate and
Effects Division (7507C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: 703-605-0033; fax number: 703-305-6309; e-mail
address: mark.corbin@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111)
Animal production (NAICS code 112)
Food manufacturing (NAICS code 311)
Pesticide manufacturing (NAICS code 32532)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, 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-2005-0129. 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 athttps://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. 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
[[Page 34760]]
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 athttps://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-2005-0129. 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 toopp-docket@epa.gov,
Attention: Docket ID Number OPP-2005-0129. 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 youre-mail address. E-mail addresses that
are automatically captured by EPA'se-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-2005-0129.
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-2005-0129. 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?
The Terrestrial Field Dissipation study has been a basic
requirement for registrants of new and existing pesticides since 1982.
While laboratory environmental fate studies are designed to address one
dissipation process at a time, terrestrial field dissipation studies
address pesticide loss as a combined result of chemical and biological
processes (e.g., hydrolysis, photolysis, microbial transformation) and
physical migration (e.g., volatilization, leaching, plant uptake). Data
from these studies can reduce potential overestimation of exposure and
risk and can confirm assumptions of low levels of toxic degradates.
Results can be used to propose scenario-specific effective risk
mitigation.
In general, the terrestrial field dissipation study results should
allow the risk assessor to:
Compare predicted routes of dissipation identified in the
laboratory with those measured in the field.
Characterize the rates of dissipation of the parent
compound and formation and decline of the major and/or toxicologically
significant transformation products under field conditions.
Characterize the rates and relative importance of the
different transport processes, including leaching, runoff, and
volatilization.
Establish the distribution of the parent compound and the
major transformation products in the soil profile.
Characterize the persistence of the parent compound and
major transformation products in soil, including retention and residue
carryover in the soil to the following crop season.
Characterize the effect(s) of different typical pesticide
formulation categories, where applicable.
EPA and PMRA have developed harmonized guidance for conducting
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terrestrial field dissipation studies so that one set of tests can be
used for registration of a pesticide in Canada, the United States, and
Mexico. In developing this guidance document, EPA and PMRA conducted an
extensive outreach and review program, soliciting input from
stakeholders and the technical community through several forums: three
symposia, one Scientific Advisory Panel (SAP) meeting, and one
workshop. Working closely with its stakeholders, PMRA and EPA developed
a conceptual model for designing terrestrial studies that will evaluate
the overall dissipation of a pesticide in the field. The conceptual
model, which is specific for each pesticide, is based on the chemical's
physicochemical properties, laboratory environmental fate studies,
formulation type and intended use pattern. At this time, the Agency is
soliciting input from the public on the draft harmonized guidance and
conceptual model, which can be found at the following address: https://
www.epa.gov/oppefed1/ecorisk_ders/efed_final_draft_tfd_
guidance.pdf.
B. What is the Agency's Authority for Taking this Action?
This action is being taken under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA).
List of Subjects
Environmental protection, Terrestrial field dissipation, Harmonized
guidance.
Dated: May 9, 2005.
Steven Bradbury,
Director, Environmental Fate and Effects Division, Office of Pesticide
Programs.
[FR Doc. 05-11830 Filed 6-14-05 8:45 am]
BILLING CODE 6560-50-S