[Federal Register Volume 68, Number 10 (Wednesday, January 15, 2003)]
[Notices]
[Pages 2027-2032]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-848]



[[Page 2027]]

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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0339; FRL-7285-1]


Fluroxypyr; 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 
fluroxypyr in or on various food commodities.

DATES: Comments, identified by docket ID number OPP-2002-0339, must be 
received on or before February 14, 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.

FOR FURTHER INFORMATION CONTACT: Joanne I. Miller, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6224; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] 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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
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-2002-0339. 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

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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-2002-0339. 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-2002-0339. 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-2002-0339.
    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-2002-0339. 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 recordkeeping 
requirements.

    Dated: December 31, 2002.
Meredith F. Laws,
Acting 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.

Dow AgroSciences

PP 9F6050

    EPA has received a pesticide petition (9F6050) from Dow 
AgroSciences, 9330 Zionsville Road, Indianapolis, IN 46268 proposing, 
pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing 
tolerances for combined residues of fluroxypyr 1-methylheptyl ester [1-
methylheptyl ((4-amino-3,5-dicloro-6-fluoro-2-pyridinyl)oxy)acetate or 
fluroxypyr MHE] and its metabolite fluroxypyr [((4-amino-3,5-dichloro-
6-fluoro-2-pyridinyl)oxy)acetic acid], free and conjugated, all 
expressed as fluroxypyr, in or on the following raw

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agricultural commodities at 0.02 parts per million (ppm) for kernels 
plus cob with husk removed, and 1.0 ppm for forage. Tolerances for 
residues of fluroxypyr MHE in or on field corn are being proposed in 
support of this registration as follows: Grain, 0.02 ppm; forage, 1.0 
ppm; and stover, 0.5 ppm. Tolerances for residues of fluroxypyr MHE in 
or on sorghum as follows: Sorghum grain, 0.02 ppm; sorghum forage, 2.0 
ppm; sorghum stover, 4.0 ppm. Tolerances for residues of fluroxypyr MHE 
in or on grasses as follows: Grass forage, 120 ppm; grass hay, 160 ppm; 
and grass silage, 100 ppm. Based on the above tolerances and an animal 
feeding study, increased tolerances are also proposed for fluroxypyr 
MHE and fluroxypyr, expressed as combined residues of total fluroxypyr, 
in or on the following animal commodities: Milk of cattle, goats, hogs, 
horses and sheep, 0.3 ppm; and kidney of cattle, goats, hogs, horses 
and sheep, 1.5 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. Fluroxypyr is a systemic herbicide that is 
readily translocated and rapidly converts to the acid form following 
absorption. Fluroxypyr moves readily throughout the plant via the 
phloem (nutrient transporting) system and to a lesser extent through 
the xylem (water-transporting). Fluroxypyr is distributed throughout 
the entire plant, including the meristems and other developing plant 
parts.
    2. Analytical method. There is a practical method (GC with MS 
detection) for measuring levels of fluroxypyr MHE in or on food with a 
limit of detection that allows monitoring of food with residues at or 
above the levels set for, the proposed tolerances. Fluroxypyr has been 
tested through the FDAs Multi-residue Methodology, Protocols C, D. and 
E. The results have been published in the FDA Pesticide Analytical 
Manual, Volume I.
    3. Magnitude of residues. The metabolism of fluroxypyr MHE in 
plants and animals (goats and poultry) is adequately understood for the 
purposes of these tolerances. Magnitudes of residue studies were 
conducted for field corn, sweet corn, sorghum and grasses. A process 
products study was not conducted in field corn since residues of 
fluroxypyr MHE were not detected in corn grain at 5X the application 
rate. In addition, processing of sorghum was not conducted since 
residue data for flour are not required at this time because sorghum 
flour is used exclusively in the U.S. as a component for drywall, and 
not as either a human food or a feedstuff. No residues of fluroxypyr 
are expected in root or leafy vegetable crops grown in rotation to 
fluroxypyr-treated field corn, sweet corn, sorghum, and grasses, after 
a 30-day plant-back interval at the maximum allowable label rate of 8 
oz active ingredient/Acre. Field corn, sweet corn, sorghum and grasses 
grown in rotation may contain low levels of fluroxypyr residues; 
however, the tolerance values proposed for these crops will adequately 
assure compliance with the labeled use patterns.

B. Toxicological Profile

    1. Acute toxicity. Fluroxypyr MHE has low acute toxicity. The rat 
oral LD50 is >5,000 milligrams/kilogram (mg/kg), the rabbit 
dermal LD50 is >2,000 mg/kg, and the rat inhalation 
LC50 is >1.0 mg/L (1,000 mg/cubic meter). In addition, 
fluroxypyr MHE is not a skin sensitizer in guinea pigs, has no dermal 
irritation in rabbits, and shows mild ocular irritation in rabbits. The 
end use formulation of fluroxypyr MHE has a similar low acute toxicity 
profile.
    2. Genotoxicity. Short-term assays for genotoxicity consisting of a 
bacterial reverse mutation assay (Ames test), an in vitro assay for 
cytogenetic damage using the Chinese hamster ovary cells, an in vitro 
chromosomal aberration assay using rat lymphocytes, and an in vivo 
cytogenetic assay in the mouse bone marrow (micronucleus test) have 
been conducted with fluroxypyr MHE. These studies show a lack of 
genotoxicity. In addition, short-term assays for genotoxicity 
consisting of an Ames metabolic activation test, possible induction of 
point mutations at the HGPRT-Locus of Chinese hamster ovary cells, in 
vivo and in vitro chromosomal aberrations in the Chinese hamster ovary 
cells, unscheduled DNA synthesis in human embryonic cells, and an assay 
in mouse lymphoma cells have been conducted with fluroxypyr. These 
studies also show a lack of genotoxicity.
    3. Reproductive and developmental toxicity. Developmental studies 
in rats and rabbits were conducted with both fluroxypyr MHE and 
fluroxypyr. Studies with fluroxypyr MHE showed maternal and fetal no 
observed adverse effect levels (NOAELs) of 300 mg/kg/day (rat) and 500 
mg/kg/day (rabbit). Studies with fluroxypyr showed NOAELs in the rat of 
250 mg/kg/day for maternal effects and 500 mg/kg/day for fetal effects 
and a NOAEL in the rabbit of 250 mg/kg/day for both maternal and fetal 
effects. These studies show that fluroxypyr and fluroxypyr MHE are not 
teratogenic nor will they interfere with in utero development. Two 
multi-generation reproduction studies were conducted with fluroxypyr in 
rats. The first in Wistar rats showed no effect on fertility or 
reproductive performance and had a NOAEL of 500 mg/kg/day (highest dose 
tested). The second study in Sprague-Dawley rats showed a parental 
NOAEL for systemic effects of 100 mg/kg/day in male rats and 500 mg/kg/
day in female rats. The NOAEL for reproductive effects was 750 mg/kg/
day for males and 1,000 mg/kg/day for females (highest dose tested). 
The NOAEL for neonatal effects was 500 mg/kg/day.
    4. Subchronic toxicity. Fluroxypyr MHE showed a NOAEL of 1,000 mg/
kg/day in a 90-day rat dietary study and a 21-day rabbit dermal study. 
Ninety-day feeding studies with fluroxypyr showed NOAELs of 80 mg/kg/
day (Wistar rats), 700 mg/kg/day (Fischer 344 rats), 1,342 mg/kg/day 
(male mice), and 1,748 mg/kg/day (female mice). In a 4-week dietary, 
range finding study with fluroxypyr in dogs, the NOAEL found was >50 
mg/kg/day.
    5. Chronic toxicity. Based on chronic testing with fluroxypyr in 
the mouse, dog, and rat (two studies), a reference dose (RfD) of 0.8 
mg/kg/day is proposed for fluroxypyr and fluroxypyr MHE. The RfD has 
incorporated a 100-fold safety factor to the NOAEL found in the rat 
chronic test. NOAELs found in the chronic dietary studies are as 
follows: 150 mg/kg/day (dog), 300 mg/kg/day (mouse), 80 mg/kg/day 
(Wistar rats), 100 mg/kg/day (male Fischer 344 rats), and 500 mg/kg/day 
(female Fischer 344 rats).
    6. Animal metabolism. Both fluroxypyr and fluroxypyr MHE have been 
evaluated in rat metabolism studies. In summary, these studies show 
that fluroxypyr MHE is rapidly hydrolyzed and the fate of the 
hydrolysis products, fluroxypyr and 1-methylheptanol, are independent 
of whether they were given as the ester or the acid. Fluroxypyr, per 
se, was extensively absorbed and rapidly excreted principally unchanged 
in the urine; 1-methylheptanol also was rapidly absorbed and rapidly 
eliminated. Repeated administration of fluroxypyr MHE was not 
associated with accumulation in tissues. Also, the metabolism and 
pharmacokinetics of 1-methylheptanol are comparable to that of the 
methylheptyl portion of fluroxypyr MHE.
    7. Metabolite toxicology. Administration of fluroxypyr, as the

[[Page 2030]]

acid or methylheptyl ester, in a variety of toxicological studies has 
produced similar effects. The principal response to sufficiently high 
dosages, whether administered over the short-term or, in some cases, 
over a lifetime, was nephrosis. Fluroxypyr is an organic acid that is 
actively excreted into the urine by the kidney. Thus, the target organ 
and dose response relationship for fluroxypyr toxicity is entirely 
consistent with the data on the toxicokinetics of fluroxypyr. 
Metabolism studies have shown that fluroxypyr MHE is rapidly and 
completely hydrolyzed to fluroxypyr acid and methylheptanol.
    8. Endocrine disruption. There is no evidence to suggest that 
fluroxypyr and fluroxypyr MHE have an effect on any endocrine system.

C. Aggregate Exposure

    1. Dietary exposure--Acute dietary exposure and risk. A Tier I 
acute dietary exposure and risk assessment was conducted. Potential 
dietary exposure and risk was estimated using DEEMTM 
software (Dietary Exposure Evaluation Model, Version 7.075, Novigen 
Sciences, Inc., Washington, DC). A deterministic analysis was conducted 
by combining the distribution of single-day food consumption events 
with residues assumed at tolerance levels for each commodity to obtain 
a distribution of exposure. In this report, acute dietary risk was 
assessed at the 95th percentile of exposure.
    i. Food. Very conservative assumptions were made in this dietary 
risk assessment. The dietary exposure assessment was based on all 
commodities with tolerances for fluroxypyr established at 40 CFR 
180.535 together with proposed tolerances for field corn, sweet corn, 
grain sorghum, and forage grass and hay, including revised tolerances 
for milk and meat. It was assumed that fluroxypyr residues were present 
at tolerance or proposed tolerance levels and that 100% of the crops 
were treated. The USDA food consumption data from 1989-92 were used by 
DEEM in estimating acute dietary exposure. Acute dietary risk was 
assessed using an acute RfD of 1.25 mg/kg/day, based on a maternal 
NOAEL of 125 mg/kg/day from a rat developmental toxicity study and an 
uncertainty factor of 100 (10X for interspecies extrapolation and 10X 
for intraspecies variation). There was no indication of increased 
susceptibility in young animals to prenatal or postnatal exposure to 
fluroxypyr in the toxicology studies. Therefore, an FQPA additional 
safety factor for infants and children was not included in this 
assessment. Acute dietary exposure at the 95th percentile for females 
13 to 50 years old is estimated at 0.004939 mg/kg/day, which occupies 
0.4% of the acute RfD. Pregnant females are estimated to have acute 
dietary exposure of 0.006582 mg/kg/day at the 95th percentile, which 
occupies 0.53% of the acute RfD. Adverse effects are not expected for 
exposures occupying 100% or less of the RfD. Therefore, acute dietary 
exposure and risk are well within acceptable levels.
    A chronic dietary assessment estimated that dietary exposure would 
occupy only 0.4% of the RfD for the overall U.S. population and 1.3% of 
the RfD for children 1 to 6 years of age, the population subgroup 
estimated to be most highly exposed.
    ii. Drinking water--Acute drinking water exposure and risk. There 
are no established Maximum Contaminant Levels for residues of 
fluroxypyr in drinking water and health advisory levels for fluroxypyr 
in drinking water have not been established.
    Potential drinking water concentrations of fluroxypyr were 
estimated in ground water and surface water using the Screening 
Concentration in Ground Water (SCI-GROW) and the Generic Expected 
Environmental Concentration (GENEEC) models, respectively. Both GENEEC 
and SCI-GROW are Tier I screening level models that use conservative 
assumptions. SCI-GROW estimates pesticide concentrations in shallow, 
highly vulnerable ground water. GENEEC simulates a 1 hectare by 2 
meters deep edge of the field farm pond that receives pesticide runoff 
from a treated 10 hectare field. The estimated concentration of 
fluroxypyr in ground water according to SCI-GROW is 0.16 [mu]g/L. The 
estimated peak concentration of fluroxypyr in surface water using 
GENEEC is 20.88 [mu]g/L.
    To calculate the Drinking Water Levels of Concern (DWLOC) for acute 
exposure relative to an acute toxicity endpoint, the acute dietary 
exposure (from the DEEM analysis) was subtracted from the acute RfD to 
obtain the acceptable upper limit of fluroxypyr in drinking water for 
acute exposure. DWLOCs were then calculated using default values for 
adult female body weight (60 kg) and water consumption (2 L/day).
    The upper-bound estimated fluroxypyr concentration in ground water 
(0.16 [mu]g/L) and surface water (20.88 [mu]g/L) are substantially 
below the acute DWLOCs of 37,352 [mu]g/L and 37,303 for females 13 to 
50 years old and pregnant females, respectively. Aggregated acute 
fluroxypyr exposure for pregnant females and females 13 to 50 years old 
resulting from dietary exposure and upper-bound drinking water exposure 
is well within acceptable limits of exposure and risk.
    The chronic DWLOC for both the overall U.S. population and children 
1 to 6 years of age was over 3,000-fold greater than residue levels in 
surface water or ground water estimated by conservative screening-level 
models. Therefore, chronic exposure and risk is expected to be well 
within acceptable levels.
    2. Non-dietary exposure. The proposed use of fluroxypyr on 
residential turf presents the potential for non-occupational, non-
dietary (or residential) exposure. Transferable foliar residue data 
from a fluroxypyr study on turf was used instead of default residue 
values.
    Post-application dermal exposure for adults and toddlers was 
estimated for the day of application (day 0) since the exposure 
potential is greatest at this time. Transferable residue of fluroxypyr 
from turf was found to range from 0.03 to 0.74% (used as a high end 
stimate) of the fluroxypyr applied and to dissipate with a half-life 
ranging from 1.4 to 2.5 days.
    Homeowners may be exposed to fluroxypyr during application to turf 
and also may have dermal exposure due to post-application activity on 
the treated turf.
    Homeowner exposure during the application of fluroxypyr to turf 
includes both dermal and inhalation exposure. Surrogate dermal and 
inhalation exposure data from Pesticide Handlers Exposure Database 
(PHED V1.1) was used in estimating applicator exposure. The PHED 
surrogate data used to estimate exposure assumes residential applicator 
attire to include short pants, short-sleeve shirt, and no gloves. The 
applicator exposure estimate was based on a broadcast application using 
a garden hose end sprayer. Applicator dermal and inhalation exposure 
was estimated to be 0.0986 mg/kg/day and 0.00003 mg/kg/day, 
respectively.
    Adult post-application dermal exposure from treated turf on the day 
of application was estimated to be 0.0172 mg/kg/day. The combined 
dermal exposure from application along with post-application activity 
is 0.1158 mg/kg/day (0.0986 mg/kg/day + 0.0172 mg/kg/day). Oral post-
application exposure is not expected for adults and was not included in 
this assessment. The Margin of Exposure (MOE) for dermal exposure is 
8,635 and for inhalation exposure 2,666,667. These MOEs are 
substantially greater than 100, indicating that risk

[[Page 2031]]

from these potential exposures is well within an acceptable level.
    Consistent with the scenario described above for the general adult 
population, female adult homeowners may experience exposure to 
fluroxypyr during application to turf as well as from post-application 
exposure. Female applicator dermal and inhalation exposure was 
estimated to be 0.115 mg/kg/day and 0.00004 mg/kg/day, respectively. 
Additionally, female adults may also experience post-application dermal 
exposure from treated turf on the day of application. Post-application 
dermal exposure for females was estimated to be 0.0201 mg/kg/day. Since 
dermal absorption is assumed to be 100% and since both dermal and 
inhalation exposure are being evaluated against the same toxicity 
endpoint, total potential exposure from fluroxypyr use on turf can be 
estimated by simply adding the dermal and inhalation exposure. The 
combined exposure is 0.13514 mg/kg/day (0.115 mg/kg/day + 0.00004 mg/
kg/day + 0.0201 mg/kg/day). Using a NOAEL of 125 mg/kg/day, the MOE is 
calculated to be 925 (125 mg/kg/day / 0.13514 mg/kg/day). The MOE for 
female adults as a result of potential dermal and inhalation exposure 
from residential use of fluroxypyr on turf is well above 100, 
indicating that risk is within acceptable levels.
    Golfers may have dermal exposure to fluroxypyr due to post-
application activity on the treated turf. Dermal exposure for adult 
golfers was estimated on the day of treatment (day 0) to provide a 
high-end estimate of exposure. Exposure was estimated based on a 
transfer coefficient of 500 cm2/hr (1) and an 
exposure time of 4 hours. Exposure was estimated to be 0.001186 mg/kg/
day. A MOE of 843,170 was calculated based on an assumption of 100% 
dermal absorption and a NOAEL of 1,000 mg/kg/day. Given a MOE of three 
orders of magnitude greater than 100, risk is well within acceptable 
levels.
    Potential exposure for female golfers was estimated to be 0.001383 
mg/kg/day. A MOE of 90,383 was calculated based on an assumption of 
100% dermal absorption and a NOAEL of 125 mg/kg/day. The MOE is 
substantially greater than 100, indicating that risk is well within 
acceptable levels.
    Toddlers may have exposure due to post-application activity on 
treated turf. When a pesticide in liquid formulation is applied to 
turfgrass, toddlers may experience post-application exposure through 
dermal exposure and also through oral exposure due to hand-to-mouth 
transfer of pesticide residue, ingestion of treated turfgrass and 
incidental ingestion of soil from treated areas.
    Toddler post-application dermal exposure from treated turf on the 
day of application was estimated to be 0.0288 mg/kg/day. Oral exposure 
due to hand-to-mouth transfer of residues was estimated to be 0.0011 
mg/kg/day. Oral exposure due to ingestion of treated grass was 
estimated to be 0.0019 mg/kg/day. Combined oral exposure from hand-to-
mouth transfer of residues and ingestion of treated grass is 0.0030 mg/
kg/day (0.0011 mg/kg/day + 0.0019 mg/kg/day). The MOE for dermal 
exposure is 34,722 and oral exposure is 26,667, both of them well above 
100, indicating that risk is well within acceptable levels.
    Use of fluroxypyr on turf results in potential short-term 
residential exposure for adults and children. Potential short-term 
dietary and residential exposures were combined into aggregate MOE 
values. Potential exposure through drinking water was not included in 
the aggregate MOEs, but was evaluated in aggregate through use of a 
DWLOC calculated for short-term exposure. The aggregate MOEs for adults 
and toddlers ranged from 906 to 29,335, but all were well above 100, 
indicating an adequate margin of safety. Additionally, the short-term 
DWLOCs for toddlers and adults were over 3,000-fold greater than 
potential fluroxypyr residues in drinking water predicted by 
conservative screening level models. Therefore, aggregate short-term 
exposure and risk for children and adults is expected to be well within 
acceptable levels.

D. Cumulative Effects

    The potential for cumulative effects of fluroxypyr MHE and 
fluroxypyr and other substances that have a common mechanism of 
toxicity is also considered. There is no reliable information to 
indicate that toxic effects produced by fluroxypyr MHE and fluroxypyr 
would be cumulative with those of any other pesticide chemical. Thus, 
it is appropriate to consider only the potential risks of fluroxypyr 
MHE and fluroxypyr in an aggregate exposure assessment.

E. Safety Determination

    1. U.S. population. Acute dietary exposure for pregnant females to 
residues of fluroxypyr from current and proposed uses was estimated to 
occupy 0.53% of the acute RfD, indicating very little risk. 
Additionally, the acute DWLOC was calculated to be over 1,700 fold 
greater than potential fluroxypyr residue in drinking water predicted 
by conservative screening level models.
    Potential dietary and residential exposures were combined into an 
aggregate MOE value. Those MOEs range from 906 to 29,335. The aggregate 
MOEs are well above 100, indicating risk is well within acceptable 
levels. Additionally, the DWLOCs were over 11,000-fold greater than 
potential fluroxypyr residue in drinking water. Chronic dietary 
exposure to residues of fluroxypyr from current and proposed uses was 
estimated to occupy 0.4% of the RfD. The DWLOC was calculated to be 
over 11,000 fold greater than potential fluroxypyr residue in drinking 
water.
    It is concluded that there is a reasonable certainty that no harm 
will result to the general U.S. population, pregnant females or 
developing young from acute aggregate, short-term or chronic aggregate 
exposures to fluroxypyr residues from current and proposed uses.
    2. Infants and children. FFDCA section 408 provides that EPA may 
apply an additional safety factor for infants and children in the case 
of threshold effects to account for prenatal and postnatal toxicity and 
the completeness of the data base. Based on the current toxicological 
data requirements, the data base for fluroxypyr MHE relative to 
prenatal and postnatal effects for children is complete. There were no 
indications of neurotoxicity and developmental toxicity was not 
observed in the absence of maternal toxicity. It is concluded that 
there is no indication of increased sensitivity of infants and children 
relative to adults and that an additional FQPA safety factor is not 
required.
    The acute and short-term exposures were assessed for pregnant 
females to evaluate the risk for developmental toxicity and it was 
concluded that there was reasonable certainty of no harm from aggregate 
acute or short-term exposures resulting from current and proposed uses 
of fluroxypyr.
    Toddlers may experience short-term dermal and oral exposure to 
fluroxypyr as a result of post-application activities on treated 
residential turf. Additionally, there is the potential for exposure to 
fluroxypyr through residue in food and drinking water. Tier I 
assessments were conducted to develop very conservative estimates of 
potential exposure through residential, dietary and drinking water 
pathways.
    Potential dietary and residential exposures were combined into an 
aggregate MOE value. The aggregate MOE was 5,120, well above 100, 
indicating risk is well within acceptable

[[Page 2032]]

levels. Additionally, the DWLOC was over 3,000-fold greater than 
potential fluroxypyr residue in drinking water.
    Chronic dietary exposure to residues of fluroxypyr from current and 
proposed uses was estimated to occupy 1.3% of the RfD for children 1 to 
6 years old, the population subgroup predicted to be most highly 
exposed. Additionally, the DWLOC was calculated to be over 3,000 fold 
greater than potential fluroxypyr residue in drinking water predicted 
by conservative screening level models.
    Thus, based on the completeness and reliability of the toxicity 
data and the conservative exposure assessment, it is concluded that 
there is a reasonable certainty that no harm will result to infants and 
children from acute dietary, short-term and chronic aggregate exposures 
to fluroxypyr residues from current and proposed uses.

F. International Tolerances

    There are no Codex maximum residue levels established for residues 
of fluroxypyr MHE and fluroxypyr on any food or feed crop.

[FR Doc. 03-848 Filed 1-14-03; 8:45 am]
BILLING CODE 6560-50-S