[Federal Register Volume 69, Number 161 (Friday, August 20, 2004)]
[Notices]
[Pages 51672-51676]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-19032]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0257; FRL-7674-2]


Chlorothalonil; Notice of Filing a Pesticide Petition to 
Establish a Tolerance for a Certain Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket identification (ID) number OPP-
2004-0257, must be received on or before September 20, 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: J. R. Tomerlin, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-0598; e-mail address: [email protected].

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 111)
     Animal production (NAICS 112)
     Food manufacturing (NAICS 311)
     Pesticide manufacturing (NAICS 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.

[[Page 51673]]

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-2004-0257. 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 South 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. 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.
    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 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-2004-0257. 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-2004-0257. 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-2004-0257.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information

[[Page 51674]]

and Records Integrity Branch (PIRIB), Office of Pesticide Programs 
(OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1801 South Bell St., Arlington, VA, Attention: Docket ID 
Number OPP-2004-0257. 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 copies of 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 the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in FFDCA section 408(d)(2); however, 
EPA has not fully evaluated the sufficiency of the submitted data at 
this time or whether the data supports granting of the petition. 
Additional data may be needed before EPA rules on the petition.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.


    Dated: August 12, 2004.
Lois A. Rossi,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by FFDCA section 408(d)(3). The summary of the petition was 
prepared by the petitioner and represents the view of the petitioner. 
The petition summary announces the availability of a description of the 
analytical methods available to EPA for the detection and measurement 
of the pesticide chemical residues or an explanation of why no such 
method is needed.

PP 3E6795

    EPA has received a pesticide petition (PP 3E6795) from the Snowpea 
Commission of Guatemala, Guatemala City, Guatemala, proposing pursuant 
to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 
180.275 by establishing a tolerance for residues of chlorothalonil and 
its metabolite, 4-hydroxy-2,5,6-trichloroisophthalonitrile (SDS-3701) 
in or on the raw agricultural commodity snow peas at 5 parts per 
million (ppm). GB Biosciences\TM\ Corporation of Greensboro, NC serves 
as the agent for the Snowpea Commission of Guatemala. EPA has 
determined that the petition contains data or information regarding the 
elements set forth in section 408(d)(2) of the FFDCA; however, EPA has 
not fully evaluated the sufficiency of the submitted data at this time 
or whether the data supports granting of the petition. Additional data 
may be needed before EPA rules on the petition.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of chlorothalonil as well as 
the nature of the residues in plants is adequately understood for 
purposes of the proposed tolerance. Plant metabolism has been evaluated 
in five diverse crops: Carrots, celery, lettuce, snap beans, and 
tomatoes, which should serve to define the similar metabolism of 
chlorothalonil in a wide range of crops. The qualitative nature of 
residues in plants for chlorothalonil is adequately understood. The 
residue of concern is chlorothalonil and its metabolite, 4-hydroxy-
2,5,6-trichloroisophthalonitrile (SDS-3701). Parent metabolite CGA-
64250 is the major compound found in crops.
    2. Analytical method. An adequate residue analytical method (gas 
chromatography) is available for enforcement purposes. The method is 
listed in the Pesticide Analytical Manual (PAM) Vol. II (PAM II).
     3. Magnitude of residues. Field residue trials have been conducted 
on snap beans at various rates, timing intervals, and applications 
methods to represent the use patterns which would most likely result in 
the highest residues. Due to similarity of snap bean and the proposed 
snow pea use patterns, the field residue trial from snap bean will be 
used to support a snow pea import tolerance.

B. Toxicological Profile

    An assessment of the toxic effects caused by chlorothalonil is 
discussed in Unit III.A. and Unit III.B. in the Federal Register of 
March 12, 2001 (66 FR 14330) (FRL-6759-4).
    1. Animal metabolism. The metabolism of chlorothalonil in the rat 
is adequately understood.
    2. Metabolite toxicology. The residues of concern for tolerance 
setting purposes in or on raw agricultural commodity are the parent 
compound and its metabolite, 4-hydroxy-2,5,6-trichloroisophthalonitrile 
(SDS-3701). The residue of concern in meat and milk is SDS-3701.
    3. Endocrine disruption. Chlorothalonil does not belong to a class 
of chemicals known or suspected of having adverse effects on the 
endocrine system. Developmental toxicity studies in rats and rabbits 
and a reproduction study in rats gave no indication that chlorothalonil 
might have any effects on endocrine function related to development and 
reproduction. The

[[Page 51675]]

subchronic and chronic studies also showed no evidence of a long-term 
effect related to the endocrine system.

C. Aggregate Exposure

     1. Dietary exposure. Tier II/III acute, chronic, and cancer 
dietary exposure evaluations were made using the Dietary Exposure 
Evaluation Model (DEEM\TM\), version 7.87 from Exponent. These exposure 
assessments included all registered uses and a proposed use on imported 
snow peas. Empirically derived processing studies for cabbage (0.20X), 
carrots (0.005X), cherries (0.05X), coffee (0.10X), cucumber/cold 
canned (0.20X), cucumber/hot canned (0.04X), plums (0.33X), squash 
(0.001X), tomato juice (0.25X) and tomato paste, puree, and catsup 
(0.02X) were used in these assessments. All other processing factors 
used were the DEEM\TM\ defaults. All consumption data was taken from 
the United States Department of Agriculture's (USDA's) Continuing 
Survey of Food Intake by Individuals (CSFII) with the 1994-1996 
consumption database and the Supplemental CSFII Children's Survey 
(1998) consumption database.
    i. Food. For the purposes of assessing potential dietary exposure, 
Syngenta has estimated aggregate exposure from all crops for which 
tolerances are established or proposed. These assessments utilized 
residue data from monitoring data (Pesticide Data Program (PDP), Food 
and Drug Administration (FDA), and FoodContam) and field trial data 
where available; otherwise currently established tolerances were used. 
Field trial residue data for snap beans were used as a surrogate for 
similarly treated (i.e., application rate and pre-harvest interval) 
imported snow peas. Current tolerances were used as conservative 
estimates for secondary residues of chlorothalonil in meat and milk 
commodities. Percent of crop treated values were conservatively set at 
100% for all commodities.
    ii. Drinking water. Another potential source of exposure of the 
general population to residues of chlorothalonil are residues in 
drinking water. Estimated Drinking Water Concentrations (EDWCs) of 
chlorothalonil in surface and groundwater were typically less than 1 
parts per billion (ppb). However, the Environmental Fate and Effects 
Division (EFED) used an EDWC value of 16 ppb for drinking water 
assessment, which was derived from metabolite concentration that was 
measured in groundwater at a combined concentration of 16 ppb in 
Suffolk County, Long Island, NY in 1981.
    The Acute Drinking Water Level of Comparison (DWLOC) was calculated 
based on an acute reference dose (aRfD) of 0.583 mg/kg/day for the 
subpopulation of children (1-2 years) and a dietary exposure value of 
0.134878 mg/kg-bw/day. For the acute assessment, the acute DWLOC for 
the children (1-2 years) subpopulation was of 4,481 ppb, which is 
considerably higher than the acute EDWC of 16 ppb.
    The Chronic Drinking Water Level of Comparison (DWLOC) was 
calculated based on a chronic reference dose (cRfD) of 0.02 mg/kg/day 
and a dietary exposure value of 0.003984 mg/kg-bw/day. The children 1-2 
years old subpopulation had the lowest chronic DWLOC of 160 ppb. Thus, 
the chronic DWLOC of 160 ppb is considerably higher than the chronic 
EDWC of 16 ppb.
    Cancer risk from chlorothalonil drinking water exposures (upper 
bound 8 x 10-\9\) was considered negligible since the EDWC 
of chlorothalonil in surface and groundwater were typically less than 
1.0 ppb.
     2. Non-dietary exposure. Based upon the residential use patterns, 
there is a potential for exposure to chlorothalonil residues for adult 
homeowners making applications to residential areas (ornamental and 
vegetable gardens) and also for both youth and adults engaged in post-
application activities in these areas. The short- and intermediate-term 
exposure risk estimates are derived from the same daily (short-/
intermediate-term) exposures, since the endpoints are the same for both 
scenarios. The exposure risks were all determined to be acceptable 
(margin of exposure (MOE) > 100) for each scenario assessed. The 
maximum potential non-dietary exposure was for an adult transplanting 
ornamentals, yielding an average daily dose (ADD) of 1.09 mg/kg-bw/day 
and a resulting MOE of 551, and a cancer risk of 9.79 x 
10-\8\. Therefore, cancer exposure risks to chlorothalonil 
from non-dietary exposures were determined to be negligible.
    3. Acute exposure. The acute dietary risk assessment was performed 
for all population subgroups with an aRfD of 0.583 mg/kg-bw/day based 
upon an acute lowest observable adverse effect level (LOAEL) of 175 mg/
kg-bw/day from a subchronic dietary rat study and an uncertainty factor 
of 300X (100X plus additional 3X for the absence of a no observable 
adverse effect level (NOAEL)). For the purpose of the aggregate risk 
assessment, the exposure value was expressed in terms of MOE, which was 
calculated by dividing the LOAEL by the exposure. In addition, exposure 
was expressed as a percent of the acute reference dose (%aRfD). Acute 
exposure for the most sensitive subpopulation (children 1-2 years old) 
was 23.1% of the acute RfD of 0.583 mg/kg-bw/day, with a MOE of 1,297. 
Since the benchmark MOE for this assessment was 300 and since EPA 
generally has no concern for exposures above the benchmark MOE, 
Syngenta believes that there is a reasonable certainty that no harm 
will result from the acute dietary (food) exposures arising from the 
current and proposed uses for chlorothalonil.
    4. Chronic exposure. The cRfD for chlorothalonil is 0.02 mg/kg-bw/
day and is based on a chronic rat study with a NOAEL of 2.0 mg/kg-bw/
day and an uncertainty factor of 100X. No additional FQPA safety factor 
was applied. The chlorothalonil Tier II/III chronic dietary exposure 
assessment was based upon monitoring data and residue field trial 
results. For the purpose of the aggregate risk assessment, the exposure 
values were expressed in terms of MOE, which was calculated by dividing 
the NOAEL by the exposure for each population subgroup. In addition, 
exposure was expressed as a percent of the chronic reference dose 
(%cRfD). Chronic exposure to the most sensitive subpopulation (children 
1-2 years old) was 19.9% of the cRfD of 0.02 mg/kg-bw/day, with an MOE 
of 502. Since the benchmark MOE for this assessment was 100 and since 
EPA generally has no concern for exposures resulting in an MOE above 
the benchmark MOE, Syngenta believes that there is a reasonable 
certainty that no harm will result from the chronic dietary (food) 
exposures arising from the current and proposed uses for 
chlorothalonil.
    5. Cancer exposure. A cancer dietary risk assessment was performed 
for all population subgroups, with a carcinogenic potency factor (Q*) 
of 0.0077 (mg/kg-bw/day)-\1\, based upon female rat renal 
tumor rates. Cancer exposure to chlorothalonil results in a risk of 
5.67 x 10-\7\, or approximately 0.6 in one million, which is 
within the safe level of concern set by the EPA of 1.00 x 
10-\6\.

D. Cumulative Effects

    Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.'' EPA does not have, at this 
time, available data to determine whether chlorothalonil has a

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common mechanism of toxicity with other substances or how to include 
this pesticide in a cumulative risk assessment. For the purposes of 
this tolerance action, EPA has not assumed that chlorothalonil has a 
common mechanism of toxicity with other substances.

E. Safety Determination

    1. U.S. population. The acute and chronic aggregate exposure 
estimates are well below the aRfD of 0.583 mg/kg-bw/day and cRfD of 
0.020 mg/kg-bw/day for all population subgroups. Aggregate cancer 
exposure estimates for the U.S. population were approximately 67% of 
the one-in-a-million exposure limit. Based on this information, 
Syngenta Crop Protection concludes, that there is reasonable certainty 
that no harm will result from acute, chronic, or cancer exposure to 
chlorothalonil.
    2. Infants and children. Since the acute chronic aggregate exposure 
assessments for infants and children are well below the aRfD and cRfD 
of 0.583 mg/kg-bw/day and 0.02 mg/kg-bw/day respectively, there is 
reasonable certainty that no harm will result to infants and children 
from aggregate exposure to chlorothalonil residues.

F. International Tolerances

    There is currently no maximum residue level (MRL) set for 
chlorothalonil on snow peas by the Codex Alimentarius Commission.

[FR Doc. 04-19032 Filed 8-19-04; 8:45 am]
BILLING CODE 6560-50-S