[Federal Register Volume 68, Number 55 (Friday, March 21, 2003)]
[Notices]
[Pages 13920-13924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-6823]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0049; FRL-7295-5]


Tralkoxydim; 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 ID number OPP-2003-0049, must be 
received on or before April 21, 2003.

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.

[[Page 13921]]


FOR FURTHER INFORMATION CONTACT: Jim Tompkins, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5697; 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:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Pesticide manufacturing (NAICS 311)
    [sbull] Food 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.

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-2003-0049. 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, 
1921 Jefferson Davis Hwy., 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

[[Page 13922]]

system, select ``search,'' and then key in docket ID number OPP-2003-
0049. 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-2003-0049. 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-2003-0049.
    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, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket 
ID number OPP-2003-0049. 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 support 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 record keeping 
requirements.

    Dated: March 13, 2003.
 Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner's 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.

Syngenta Crop Protection, Inc.

PP 6F4631

    EPA has received a pesticide petition (6F4631) from Syngenta Crop 
Protection, Inc., P.O. Box 18300, Greensboro, NC, 27419-8300 proposing, 
pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 
CFR part 180 by establishing a tolerance for residues of tralkoxydim, 
2-Cyclohexen-1-one, 2-[1-(ethoxyimino)propyl]-3-hydroxy-5-(2,4,6-
trimethylphenyl)-(9Cl), in or on the raw agricultural commodity (RAC) 
barley grain, barley hay, wheat grain, and wheat hay at 0.02 parts per 
million (ppm) and barley straw, wheat forage, and wheat straw at 0.05 
ppm. 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 support granting of the petition. 
Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

    1. Plant metabolism. The nature of the residue in barley, wheat, 
rotational crops, and livestock is adequately understood. The residues 
of concern for the tolerance expression are parent per se. Based on the 
results of animal metabolism studies it is unlikely that secondary 
residues would occur in animal commodities from the use of tralkoxydim 
on wheat and barley. Tralkoxydim rapidly metabolizes in plants, and no 
residues of parent are detected at harvest. Extensive metabolism in 
grain, forage and straw occurs, with none of the individual metabolites 
exceeding 3.6% total radioactive residue (TRR).

[[Page 13923]]

    2. Analytical method. An adequate analytical method, gas 
chromatography/mass spectrometry (GC/MS) with selected ion monitoring, 
is available for enforcement purposes.
    3. Magnitude of residues. Magnitude of the residue trials conducted 
on spring wheat, winter wheat, and barley showed no residues above the 
limit of quantification ((LOQ) = 0.02 ppm) on wheat grain, straw, hay, 
or processed commodities at the harvest timing prescribed by the label. 
Residues in forage ranged from <0.02 ppm to 0.03 ppm at 28 days 
posttreatment. Based on the results of animal metabolism studies, it is 
unlikely that significant residues would occur in secondary animal 
commodities from the use of tralkoxydim on wheat and barley. The nature 
of the residue in plants is adequately understood.

B. Toxicological Profile

    1. Acute toxicity. EPA has established an acute reference dose 
(RfD) for tralkoxydim of 0.3 milligrams/kilogram/day (mg/kg/day). This 
RfD is based on the no observed adversed effect level (NOAEL) of 30 mg/
kg/day established in the rat developmental study and using an 
uncertainty factor (UF) of 100 based on 10X for inter-species 
extrapolation and 10X for intra-species variation.
    2. Genotoxicity. Tralkoxydim was negative for mutagenic/genotoxic 
effects in a gene mutation Ames Assay in bacteria, a forward gene 
mutation in mouse lymphoma cells in culture, chromosome damage/in vitro 
assay in human lymphocyte cells, deoxyribonucleic acid (DNA) damage 
repair in vivo assay in rat hepatocytes, and chromosome damage in vivo 
mouse micronuclei.
    3. Reproductive and developmental toxicity. The developmental and 
reproductive toxicity data do not indicate increased susceptibility of 
rats or rabbits to in utero and/or postnatal exposure to tralkoxydim. A 
3-generation rat reproduction study indicated a parental systemic NOAEL 
of 200 ppm, 20 mg/kg/day and a systemic lowest observed averse effect 
level (LOAEL) of 1,000 ppm, 100 mg/kg/day based on reduced body weights 
and body weight gains in females. No reproductive toxicity was 
observed. A rat developmental study with a maternal NOAEL of 30 mg/kg/
day and with a maternal LOAEL of 200 mg/kg/day based on maternal 
mortality, reduced body weights, and reduced food consumption and a 
developmental NOAEL of 30 mg/kg/day and a developmental LOAEL of 200 
mg/kg/day based on reduced ossification of the centrum and hemicentrum, 
centrum bipartite, misshapen centra and fused centra. A rabbit 
developmental study with a maternal NOAEL of 20 mg/kg/day and a 
maternal LOAEL of 100 mg/kg/day based on reduced food consumption and a 
developmental NOAEL of 20 mg/kg/day and a developmental LOAEL of 100 
mg/kg/day based on abortions and increases in late resorptions.
    4. Subchronic toxicity.Tralkoxydim is of low subchronic toxicity in 
21-day dermal testing.
    5. Chronic toxicity. EPA has established the RfD for tralkoxydim at 
0.005 mg/kg/day. This RfD is based on NOAEL of 0.5 mg/kg/day in the 
chronic toxicity study in dogs with a 100-fold UF to account for 
interspecies extrapolation (10x) and intraspecies variability (10x). 
The Health Effects Division (HED) Cancer Assessment Review Committee 
(CARC) has classified tralkoxydim in accordance with the Agency's 
Proposed Guidelines for Carcinogen Risk Assessment (April 10, 1996), 
``likely to being human carcinogen.'' This classification is based on 
the following factors:
    [sbull] Occurrence of benign Leydig cell tumors at all dose levels 
with the incidences at the high dose exceeding the concurrent and 
historical control range.
    [sbull] Lack of an acceptable carcinogenicity study in a second 
species as required by OPPTS Harmonized Guidelines.
    [sbull] The relevance of the testicular tumors to human exposure 
can not be discounted.
    6. Animal metabolism. Based on the results of animal metabolism 
studies it is unlikely that significant residues would occur in 
secondary animal commodities from the use of tralkoxydim on wheat and 
barley.
    7. Metabolite toxicology. The nature of the residue in barley, 
wheat, rotational crops, and livestock is adequately understood. The 
residues of concern for the tolerance expression are parent per se.
    8. Endocrine disruption. There has been no evidence of endocrine 
disruption concerns with resulting from tralkoxydim use on wheat and 
barley.

C. Aggregate Exposure

    1. Dietary exposure. The proposed tolerances in or on RACs: Barley 
grain, barley hay, wheat grain, and wheat hay at 0.02 ppm, and barley 
straw, wheat forage, and wheat straw at 0.05 ppm are the first to be 
established for tralkoxydim. There is no reasonable expectation of 
residues of tralkoxydim occurring in meat, milk, poultry, or eggs from 
its use on wheat and barley. Risk assessments were conducted by EPA to 
assess dietary exposures from tralkoxydim as follows:
    i. Acute exposure and risk. Acute dietary risk assessments are 
performed for a food-use pesticide if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a 1-day or single exposure. An acute dietary risk assessment was 
conducted for tralkoxydim based on the NOAEL of 30 milligram/kilogram/
day (mg/kg/day) from the rat developmental study. The acute dietary 
analysis using the dietary exposure evaluation model (DEEM) computer 
program estimates that the distribution of single-day exposures 
utilizes 0.02% of acute RfD.
    ii. Chronic exposure and risk. The RfD for tralkoxydim is 0.005 mg/
kg/day. This value is based on the systemic NOAEL of 0.5 mg/kg/day in 
the dog chronic feeding study with a 100-fold safety factor to account 
for interspecies extrapolation (10x) and intraspecies variability 
(10x).
    iii. Food. A DEEM chronic exposure analysis was conducted using 
tolerance levels for wheat and barley and assuming that 100% of the 
crop is treated to estimate dietary exposure for the general population 
and 22 subgroups. The chronic analysis showed that exposures from the 
tolerance level residues in or on wheat, and barley for children 1 to 6 
years old (the subgroup with the highest exposure) would be 1.4% of the 
RfD. The exposure for the general U.S. population would be less than 1% 
of the RfD.
    A lifetime dietary carcinogenicity exposure analysis was conducted 
for tralkoxydim using the proposed tolerances along with the assumption 
of 100% of the crop treated and a Q* of 1.68 x 10-2 (mg/kg/
day)-1. A lifetime risk exposure analysis was also conducted 
using the DEEM computer analysis. The estimated cancer risk (5 x 
10-7) is less than the level that the Agency usually 
considers for negligible cancer risk estimates.
    iv. Drinking water. Drinking water estimated concentrations (DWECs) 
for surface water (parent tralkoxydim) were calculated by EPA's 
pesticide root zone model (PRIZM) computer models to be an average of 
9.1 parts per billion (ppb). the DWECs for ground water based on the 
computer model screening concentration in ground water (SCI-GROW2) were 
calculated to be an average of .016 ppb.
    2. Non-dietary exposure. There are no non-food uses of tralkoxydim 
currently registered under the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), as amended. No non-dietary

[[Page 13924]]

exposures are expected for the general population.

D. Cumulative Effects

    EPA does not have, at this time, available data to determine 
whether tralkoxydim has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Tralkoxydim is structurally a cyclohexanedione. Unlike 
other pesticides for which EPA has followed a cumulative risk approach 
based on a common mechanism of toxicity, tralkoxydim does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of these tolerances action, therefore, EPA has not assumed 
that tralkoxydim has a common mechanism of toxicity with other 
substances.

E. Safety Determination

    1. U.S. population--i. Acute risk. The acute dietary analysis based 
on the NOAEL of 30 mg/kg/day from the rat developmental study using the 
DEEM computer program estimates that the distribution of single-day 
exposures utilizes 0.02% of acute RfD. The drinking water level of 
comparisons (DWLOCs) for acute exposure to tralkoxydim in drinking 
water calculated for females 13 + years old was 9,000 ppb. The 
estimated average concentration in surface water for tralkoxydim is 9 
ppb. EPA's acute DWLOC is well above the estimated exposures for 
tralkoxydim in water for the subgroup of concern. For ground water, the 
estimated environmental concentrations (EEC's) using the SCI-GROW model 
were all less than 1 ppb.
    ii. Chronic risk. A DEEM chronic exposure analysis showed that 
exposure from tolerance level residues in or on wheat, and barley for 
children 1 to 6 years old (the subgroup with the highest exposure) 
would be 1.4% of the RfD. The exposure for the general U.S. population 
would be less than 1% of the RfD. The DWLOCs for chronic exposure to 
tralkoxydim in drinking water calculated for U.S. population was 150 
ppb and for children (1 to 6 years old) the DWLOC was 50 ppb. The 
estimated average concentration in surface water for tralkoxydim is 9 
ppb. EPA's chronic DWLOC is above the estimated exposures for 
tralkoxydim in water for the U.S. population and the subgroup of 
concern. Conservative model estimates SCI-GROW of the concentrations of 
tralkoxydim in ground water indicate that exposure will be minimal.
    iii. Cancer risk. A DWLOC for cancer was calculated as 1 ppb. The 
estimated concentration in surface water and ground water for 
tralkoxydim for chronic exposure are 0.9 ppb, 2.8 ppb, (the 56-day 
concentration)/3, and 0.1 ppb, respectively. The model exposure 
estimates are less than the cancer DWLOC. EPA concludes that there is a 
reasonable certainty that no harm will result from aggregate exposure 
to tralkoxydim residues.
    2. Infants and children. The Agency concluded that an extra safety 
factor to protect infants and children is not needed based on the 
following considerations: The toxicology data base is complete for the 
assessment of special sensitivity of infants and children. The 
developmental and reproductive toxicity data do not indicate increased 
susceptibility of rats or rabbits to in utero and/or postnatal 
exposure. The NOAEL used in deriving the RfD is based on changes in 
liver function and morphology in male adult dogs (not developmental or 
neurotoxic effects) after chronic exposure and thus are not relevant 
for enhanced sensitivity to infants and children. Unrefined dietary 
exposure estimates (assuming all commodities contain tolerance level 
residues) overestimate dietary exposure. Model data used for ground 
water and surface water source drinking water exposure assessments 
result in estimates considered to be upper-bound concentrations. There 
are no registered uses for tralkoxydim that could result in residential 
exposures. EPA concludes that there is a reasonable certainty that no 
harm will result to children from aggregate exposure to tralkoxydim 
residues.

F. International Tolerances

    There are no codex Alimentarius Commission (Codex) or Mexican 
maximum residue levels for tralkoxydim at this time.
[FR Doc. 03-6823 Filed 3-20-03; 8:45 am]
BILLING CODE 6560-50-S