[Federal Register Volume 69, Number 127 (Friday, July 2, 2004)]
[Notices]
[Pages 40476-40479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-15179]



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Part II





Environmental Protection Agency





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Thiram; Availability of Revised Risk Assessments; Notice

  Federal Register / Vol. 69, No. 127 / Friday, July 2, 2004 / 
Notices  

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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0183; FRL-7366-7]


Thiram; Availability of Revised Risk Assessments

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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SUMMARY:  This notice announces the availability of documents that were 
developed as part of EPA's process for making pesticide reregistration 
eligibility decisions and tolerance reassessments consistent with the 
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food 
Quality Protection Act of 1996 (FQPA). These documents are the human 
health and environmental risk assessments and related documents for 
thiram. This notice also starts a 60-day public comment period during 
which the public is encouraged to submit comments on EPA's preliminary 
assessment of benefits of thiram and risk management ideas or proposals 
for thiram. This action is in response to a joint initiative between 
EPA and the U.S. Department of Agriculture (USDA) to increase 
transparency in the tolerance reassessment process for all pesticides. 
Comments are to be limited to issues directly associated with thiram 
and its benefits raised by the risk assessments, potential risk 
reduction options, or other documents placed in the docket. By allowing 
access and opportunity for comment on the risk assessments and 
potential risk reduction options, EPA is seeking to strengthen 
stakeholder involvement and help ensure that our decisions under FQPA 
are transparent and based on the best available information.

DATES:  Comments, identified by docket ID number OPP-2004-0183, must be 
received on or before August 31, 2004.

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:  Craig Doty, Special Review and 
Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-0122; fax 
number: (703) 308-8041; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

 A. Does this Action Apply to Me?

    This action is directed to the public in general but may be of 
interest to a wide range of stakeholders, including environmental, 
human health, and agricultural advocates; the agrochemical industry; 
pesticide users; and members of the public interested in pesticide use 
on food. This list 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. If you have any questions regarding the applicability 
of this action to you or a particular entity, consult the person listed 
under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2004-0183. 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,'' 
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

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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-2004-0183. 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 [email protected], 
Attention: Docket ID number OPP-2004-0183. 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-2004-0183.
    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-2003-0183. 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

    EPA has revised the preliminary assessments of the risks of thiram 
and identified areas of concern that may require risk mitigation 
measures. The Agency's dietary, worker, and ecological risk estimates 
for thiram indicate risks of concern. The Agency's dietary risk 
estimate indicates acute risk of concern for the general U.S. 
population and all population subgroups as a result of foliar 
treatments of apples, peaches, and strawberries. EPA's potential risk 
mitigation measures for foliar treatments may focus on the apple and 
strawberry uses because thiram's main foliar uses are on these crops.
    For ecological effects, Agency estimates of exposure resulting from 
thiram's foliar usage and turf applications on sod farms, golf courses, 
parks, and athletic fields, indicate acute risk to freshwater fish and 
invertebrates, estuarine/marine fish and invertebrates, reproductive 
risk to birds, and indirect effects to mammals. These risk estimates 
also apply to endangered species. Agency estimates of exposure strongly 
suggest that thiram-treated seed may pose a risk of causing 
reproductive impairments to wild bird species. EPA received additional 
information submitted during the Phase 3 comment period pertaining to 
thiram's use on seed and impact to avian species, but has not completed 
the review of the data. This additional data may be used to further 
refine the risk estimates to birds from thiram-treated seed.
    Further, worker risks of concern include some loading scenarios for 
aerial granular application, some handheld equipment use, and a few 
commercial and on-farm seed treatment scenarios.

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    EPA has compiled information on thiram's uses and usages, which 
will be used in conjunction with comments received during the Phase 3 
public comment period to perform a benefits analysis. EPA's preliminary 
findings show several other useful protectant fungicides are available 
for foliar use based on a review of the USDA Crop Profiles for 
California, Oregon, and Washington apples, and California and Florida 
strawberries, and communications with several state crop specialists on 
the relative importance of thiram in these states.
    Thiram's importance for uses on non-residential turf on sod farms 
and golf courses appears to be relatively low. Thiram's use on golf 
courses may be less than 0.1% of total golf course acres treated. 
Thiram's use on sod farms appears to be negligible and may be less than 
1% of acres treated.
    Thiram's importance for use on seed seems relatively high. Up to 
631,000 pounds of thiram (active ingredient) per year are used to treat 
about 1.3 billion pounds of seed. About 24 million acres are planted 
with thiram-treated seed. The five crops reflecting the distribution of 
the acres planted with seed treated with thiram in order of total acres 
planted are: Cotton, wheat, barley, oats, and sugar beets. These five 
crops comprise a total of greater than 98% of all acres planted with 
thiram-treated seed.
    EPA has identified some possible preliminary risk reduction options 
for thiram. The Agency is awaiting additional data on thiram that could 
be used to refine the acute dietary risk assessment; however, based on 
the current assessment, eliminating the uses on both strawberries and 
apples would bring the dietary risk below the Agency's level of 
concern. This option would also reduce the worker and ecological risks 
posed by the foliar usage of thiram.
    To address the ecological risks posed by thiram's usage on turf, an 
option would be to limit the use of thiram to golf course tees and 
greens. In relation to addressing these risk concerns, the technical 
registrant has submitted a voluntary letter of cancellation that 
eliminates the uses of thiram for turf applications to parks, athletic 
fields, and commercial landscapes; and all homeowner and retail uses as 
for animal repellency on residential lawns or turf, turf being grown 
for sale or other commercial use such as sod.
    To address the risk concerns for workers, an option would be to add 
additional levels of personal protection (e.g., the use of a 
respirator) or to eliminate certain application methods (e.g., high 
pressure handwand), or use sites (e.g., on-farm seed treatment). In 
relation to addressing these risk concerns, the technical registrant 
has submitted a voluntary letter of cancellation that eliminates the 
on-farm seed treatment of peanuts.
    EPA is investigating additional risk reduction options to mitigate 
ecological risks of concern posed by the seed treatment uses of thiram. 
Commenters are encouraged to discuss the feasibility of restricting the 
broadcasting of treated seed and means to ensure that spillage from 
drilled seeding applications is removed from the field or buried, as 
has been required by the European Union. Alternatively, restrictions 
could be placed on which types of seed are treated, the areas of the 
country where thiram-treated seed could be planted, and/or the time of 
year it is planted. The Agency encourages stakeholders to submit risk 
management proposals.
    EPA has identified the areas of risk posed by thiram as it is 
currently labeled and seeks stakeholder input on how thiram use and 
usages can be modified to reduce these risks. EPA encourages 
stakeholder input on the following items to assist in developing a risk 
mitigation plan:
    1. Describe how you use thiram during your production cycles. What 
production changes would you make if thiram were not available 
including alternative fungicides? What specific pests are being 
targeted?
    2. How effective are the alternatives to thiram? What are the 
differences in costs associated with the use of thiram alternatives? 
What impact, if any, do you observe to quality or yield?
    3. What is the maximum application rate that you use and how often 
do you use it?
    4. How important is thiram for the foliar, turf, and seed treatment 
uses?
    5. How can the Agency reduce ecological risks posed by thiram-
treated seed?
    6. How can the Agency reduce occupational risks posed by thiram 
(e.g., sewing bags of commercially treated seed or applying thiram with 
high pressure handwand)?

III. What Action is the Agency Taking?

    EPA is providing an opportunity, through this notice, for 
interested parties to provide written comments and input to the Agency 
on the risk assessments and preliminary risk reduction options for 
thiram. These documents have been developed as part of the public 
participation process that EPA and USDA are using to involve the public 
in the reassessment of pesticide tolerances under FQPA, and the 
reregistration of individual pesticides under FIFRA. A goal of the 
public participation process has been to find a more effective way for 
the public to participate at critical junctures in the Agency's 
development of pesticide risk assessments and risk management 
decisions. EPA and USDA began implementing this pilot process in August 
1998, to increase transparency and opportunities for stakeholder 
consultation. The documents being released to the public through this 
notice provide information on the revisions that were made to the 
thiram preliminary risk assessments, which were released to the public 
on January 26, 2004 (69 FR 3581) (FRL-7341-2), through notices in the 
Federal Register. The Agency's human health and environmental risk 
assessments and other related documents for thiram are available in the 
individual pesticide docket. As additional comments, reviews, and risk 
assessment modifications become available, these will also be docketed 
for thiram.
    In addition, this notice starts a 60-day public participation 
period during which the public is encouraged to submit risk management 
proposals or other comments on risk management for thiram. The Agency 
is providing an opportunity, through this notice, for interested 
parties to provide written comments on risk management proposals or 
ideas for thiram. Such comments and proposals could address ideas about 
how to manage dietary, occupational, or ecological risks on specific 
thiram use sites or crops across the United States or in a particular 
geographic region of the country. To address dietary risk, for example, 
commenters may choose to discuss the feasibility of modifications in 
use, and usages of thiram or suggest alternative measures to reduce 
residues contributing to dietary exposure. For occupational risks, 
commenters may suggest personal protective equipment or technologies to 
reduce exposure to workers and pesticide handlers. For ecological 
risks, commenters may suggest ways to reduce environmental exposure, 
e.g., exposure.
    All comments should be submitted by August 31, 2004, using the 
methods in Unit I. of the SUPPLEMENTARY INFORMATION. Comments will 
become part of the Agency record for thiram.

List of Subjects

    Environmental protection, Thiram, Pesticides, Tolerance 
reassessment.



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    Dated: June 29, 2004.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
[FR Doc. 04-15179 Filed 7-1-04; 8:45 am]
BILLING CODE 6560-50-S