[Federal Register: November 24, 2004 (Volume 69, Number 226)]
[Notices]
[Page 68352-68355]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24no04-75]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0078; FRL-7688-5]
Certain Ethylenebisdithiocarbamates (EBDCs) and Ethylene Thiourea
(ETU); Risk Assessments and Preliminary Risk Reduction Options (Phase 3
of 4-Phase Process); Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the availability of EPA's risk
assessments, preliminary risk reduction options, and related documents
for the ethylenbisdithiocarbamates (EBDCs) pesticides mancozeb, maneb,
metiram, plus a common degradate, ethylene thiourea (ETU), and opens a
public comment period on these documents. The public also is encouraged
to suggest risk management ideas or proposals to address the risks
identified. EPA is developing a Reregistration Eligibility Decision
(RED) for mancozeb, maneb, metiram, which will include a common
degradate, ETU through a modified, 4-Phase public participation process
that the Agency uses to involve the public in developing pesticide
reregistration and tolerance reassessment decisions. Through these
programs, EPA is ensuring that all pesticides meet current health and
safety standards.
DATES: Comments, identified by docket identification (ID) number OPP-
2004-0078, must be received on or before February 22, 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: Anthony Britten (Mancozeb), telephone
number: (703) 308-8179; fax number: (703) 308-8005; e-mail address:
britten.anthony@epa.gov and Tawanda Spears (Maneb & Metiram), telephone
number: (703) 308-8050; fax number: (703) 308-8005; e-mail address:
spears.tawanda@epa.gov. Special Review and Reregistration Division
(7508C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
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-2004-0078. 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 http://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 http://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,''
[[Page 68353]]
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 http://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-2004-0078. 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-2004-0078. 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
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-2004-0078.
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-2004-0078. 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.
[[Page 68354]]
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 and
environmental fate and effects risk assessments, preliminary risk
reduction options, and related documents for the EBDCs: Mancozeb,
maneb, metiram, plus a common degradate, ETU and encouraging the public
to suggest risk management ideas or proposals. EPA developed the risk
assessments and preliminary risk reduction options for the EBDCs:
Mancozeb, maneb, metiram, plus a common degradate, ETU 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).
The EBDCs are used on a variety of sites such as: Agricultural
crops (vegetables, fruits and nuts); turf (including golf courses and
sod farms); and ornamentals (such as cut flowers). The EBDCs are broad
spectrum contact fungicides used to prevent a variety of fungal
diseases. Each of these chemicals also share a common degradate, ETU.
The majority of the risk concerns are associated with the degradate
ETU, which EPA has classified as a probable human carcinogen. EPA
aggregated (added) to ETU several routes of exposure (food, drinking
water, and residential/recreational) to determine if there are combined
risks of concern for individual uses that currently fit in the ``risk
cup.''
All elements of the Agency's risk assessments for the EBDCs are
open for public comment. We are, however, particularly seeking public
comment on data refinement or mitigation proposals for risk estimates
of concern identified in the Agency's risk assessments and in a stand-
alone document titled ``Preliminary Risk Reduction Options for the
EBDCs (Phase 3 of 4-Phase Process),'' available in the docket. The
document addresses, for example, data that may help refine risk
estimates for residential exposure to turf transplanted from sod farms,
depending on how close to harvest sod farms apply EBDCs to turf, and
how the harvested turf is installed by landscape professionals.
Similarly, information on how EBDCs are used on athletic fields may
refine estimated risks of concern. Mitigation proposals for both these
use patterns will be helpful if new information does not refine risk
estimates.
EPA also welcomes data to refine risk estimates for certain use
patterns that impact aggregate risks, even though the individual use
pattern is not of concern. Examples of useful information include: how
homeowners use EBDCs in gardens (particularly relative to harvesting
sweet corn); use practices for EBDCs on golf courses; and percent crop
treated refinements for certain key crops. For some scenarios, such as
occupational uses of wettable powders, new data are unlikely to
significantly refine risks and mitigation proposals are needed. For
occupational uses where cancer risks fall between 1 x 10\-\4
and 1 x 10\-\6, EPA will need to consider any comments
submitted on risks and benefits of the use. Information on the
prevalence of late blight for potatoes, and EBDC use to control it,
would help EPA evaluate issues relevant to a petition for nationwide
reduction of the pre-harvest interval (PHI). For ecological risks, EPA
would welcome specific information such as: Timing and location of EBDC
applications relative to avian and mammalian reproduction cycles and
habitats; potential impacts to endangered species in light of EPA's
screening level assessment; and data refinement or mitigation proposals
for effects on aquatic species.
EPA is providing an opportunity, through this notice, for
interested parties to provide comments and input on the Agency's risk
assessments for mancozeb, maneb, metiram, plus a common degradate, ETU.
Such comments and input could address, for example, the availability of
additional data to further refine the risk assessments, or could
address the Agency's risk assessment methodologies and assumptions as
applied to this specific pesticide.
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 a typical, unusually high exposure to mancozeb, maneb, metiram,
plus a common degradate, ETU, compared to the general population.
EPA also is releasing for public comment its preliminary risk
reduction options for mancozeb, maneb, metiram, plus a common
degradate, ETU, and is providing an opportunity for interested parties
to provide risk management proposals or otherwise comment on risk
management.
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 mancozeb, maneb, metiram, plus a common degradate, ETU,
a modified, 4-Phase process with 1 comment period and ample opportunity
for public consultation seems appropriate in view of its limited risk
concerns. However, if as a result of comments received during this
comment period EPA finds that additional issues warranting further
discussion are raised, the Agency may lengthen the process and include
a second comment period, as needed.
All comments should be submitted using the methods in 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
mancozeb, maneb, metiram, plus a common degradate, ETU. Comments
received after the close of the comment period will be marked ``late.''
EPA is not
[[Page 68355]]
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: November 16, 2004.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. 04-26132 Filed 11-23-04; 8:45 am]
BILLING CODE 6560-50-S