[Federal Register Volume 69, Number 106 (Wednesday, June 2, 2004)]
[Notices]
[Pages 31106-31110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-12020]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0139; FRL-7359-3]


Aminopyralid; 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-2004-0139, must be 
received on or before July 2, 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: Joanne 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: Joanne [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 
agricultual producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 110)
     Animal production (NAICS code 112)
     Food manufacturing (NAICS code 311)
     Pesticide manufacturing (NAICS code 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 ID number OPP-2004-0139. 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 on paper, 
will be made available for public

[[Page 31107]]

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-2004-0139. 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-2004-0139. 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-2004-0139.
    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-2004-0139. 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

[[Page 31108]]

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: May 14, 2004.
Betty Shackleford,
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 Dow AgroScience, LLC 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, LLC

 PP 7F4851

     EPA has received a pesticide petition PP 7F4851 from Dow 
AgroSciences, LLC 9330 Zionsville Road, Indianapolis, IN 46268 
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 
combined residues of aminopyralid (XDE-750: 4-amino-3,6-
dichloropyridine-2-carboxylic acid) and its glucose conjugate, 
expressed as total parent in or on the raw agricultural commodity grass 
forage at 25 parts per million (ppm), grass hay at 65 ppm, wheat forage 
at 2 ppm, wheat hay at 4 ppm, wheat grain at 0.05 ppm, wheat straw at 
0.5 ppm, wheat bran at 0.1 ppm, wheat middlings at 0.02 ppm, wheat 
shorts at 0.05 ppm, wheat flour at 0.01 ppm, wheat germ at 0.02 ppm, 
wheat aspirated grain fractions at 0.5 ppm. Tolerances of the parent, 
aminopyralid (free) are also proposed for milk at 0.02 ppm, cream at 
0.02 ppm, edible animal tissues except kidney at 0.05 ppm and kidney at 
1.0 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 plants (grass and 
wheat) and in animals is adequately understood for the purpose of this 
tolerance. Based on the findings from these metabolism studies, the 
residues of concern in grass and wheat are the combined residues of 
aminopyralid and its glucose conjugates, expressed as the total parent. 
In animal commodities, the residue of concern is only the parent, 
aminopyralid (free).
    2. Analytical method. Adequate analytical methods for enforcement 
purposes are available to monitor residues of aminopyralid in grass and 
wheat commodities, milk, meat and meat by-products. The analytical 
method uses liquid chromatography and positive ion electrospray tandem 
spectrometry (LC/MS/MS) with limits of quantitation (LOQ) of 0.01 ppm. 
The methods had been successfully validated independently by outside 
laboratories. Aminopyralid had also been tested through the Food and 
Drug Administration (FDA), Multi-residue Methodology, Protocols C, D, 
and E.
    3. Magnitude of residues. Geographically representative field 
trials were conducted on grass pasture and wheat according to use 
patterns to support the proposed tolerances in these commodities. In 
addition, wheat processing and cow feeding studies were conducted to 
determine transfer of residues into wheat processed products, milk, 
meat and meat by-products. The proposed tolerances in grass and wheat 
commodities and in milk, meat and meat by-products are adequate to 
cover the highest residues from the maximum label use of aminopyralid 
in grass pasture and wheat.

B. Toxicological Profile

    1. Acute toxicity. Aminopyralid has low acute toxicity. The rat 
oral lethal dose (LD)50 is >5,000 milligrams/kilogram (mg/
kg) and the rat inhalation LC50 is >5.5 milligrams per liter 
(mg/L). In addition, aminopyralid is not a dermal sensitizer in guinea 
pigs, has no dermal irritation in rabbits, and shows ocular irritation 
in rabbits.
    2. Genotoxicty. 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 vitro 
cytogenetic assay in the mouse bone marrow (micronucleus test) have 
been conducted with aminopyralid. Taken together, these studies show a 
lack of genotoxicity.
    3. Reproductive and developmental toxicity. Developmental studies 
in rats and rabbits were conducted with aminopyralid. Studies with 
aminopyralid showed maternal no observed effect levels (NOELs) of 1,000 
milligrams/kilogram/day (mg/kg/day) (rat) and 250 mg/kg/day (rabbit) 
and fetal NOELs of 1,000 mg/kg/day (rat) and 500 mg/kg/day (rabbit). 
These studies show that aminopyralid is not teratogenic nor will it 
interfere with in utero development. A multi-generation reproduction 
study conducted with aminopyralid in Sprague-Dawley rats showed a NOEL 
for reproductive effects of 1,000 mg/kg/day for males and 1,000 females 
(highest dose tested). The NOEL for neonatal effects was also 1,000 mg/
kg/day.
    4. Subchronic toxicity. Aminopyralid showed a NOEL of 100 mg/kg/day 
in a 28-day rat dermal study. 90-day feeding studies with aminopyralid 
showed NOELs of 100 mg/kg/day in Fischer 344 rats, 257 mg/kg/day in 
Beagle dogs, and 1,000 mg/kg/day in CD-1 mice.
    5. Chronic toxicity. Based on chronic testing with aminopyralid in 
the mouse, dog, and rat, a reference dose (RfD) of 0.5 mg/kg/day is 
proposed. The RfD has incorporated a 100-fold safety factor to the NOEL 
found in the rat chronic test. NOELs found in the chronic dietary 
studies are as follows: 96 mg/kg/day (male and female dogs), 250 mg/kg/
day in female mice and 1,000 mg/kg/day in male mice, and 50 mg/kg/day 
in male Fischer 344 rats and 500 mg/kg/day in female Fischer 344 rats.
    6. Animal metabolism. Aminopyralid has been evaluated in a rat 
metabolism study. In summary, this study shows that aminopyralid is 
efficiently cleared through the urine and feces with an average of 74-
93% of the administered radioactivity excreted during the first 24-
hours post-dose administration. Aminopyralid is rapidly absorbed and 
urinary and fecal elimination totaled 41-59 and 33-43% of the 
administered dose, respectively. Analysis of excreted material indicate 
no evidence of metabolism. Repeated administration of aminopyralid was 
not associated with accumulation in tissues.
    7. Metabolite toxicology. No mammalian metabolites of aminopyralid

[[Page 31109]]

have been identified in the rat metabolism study. Nature of residue 
studies in wheat and grass (three species) revealed the presence of 
unchanged parent aminopyralid and glucose conjugates of aminopyralid.
    8. Endocrine disruption. There is no evidence to suggest that 
aminopyralid has an effect on any endocrine system.

C. Aggregate Exposure

    1. Dietary exposure--i. Food. In conducting the potential dietary 
exposure and risk assessments, Dow AgroSciences used the Dietary 
Exposure Evaluation Model (DEEM), Version 7.87, Exponent) software that 
evaluated the individual food consumption as reported by respondents in 
the United States Department of Agriculture 1994-1998 nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). The dietary 
exposure assessment was performed using a conservative approach (Tier 
I) wherein the estimated theoretical maximum residue contribution 
(TMRC) was based on the assumptions that 100% of the crops were treated 
with aminopyralid and the residues were present at the proposed 
tolerance levels.
     The chronic population adjusted dose (cPAD) used was 0.50 mg/kg/
day based on a NOEL of 50 mg/kg/day from a 2-year combined chronic 
feeding/carcinogenicity rat study and an uncertainty factor of 100 (10 
for intraspecies variation x 10 for interspecies variation). No 
additional FQPA safety factor is required. For the U.S. general 
population, the theoretical maximum residue contribution (TMRC) was 
estimated to be 0.000237 milligrams/kilogram (mg/kg/day) that utilized 
less than 0.1% of the chronic population adjusted dose (cPAD). The 
population subgroup with the highest potential exposure is children 1-2 
years old with a TMRC of 0.000933 mg/kg/day that represents only 0.2% 
of the cPAD. The percent of the cPAD is significantly below the 
acceptable 100%, therefore, demonstrates no chronic dietary concern.
     No appropriate toxicological endpoint attributable to a single 
exposure was identified in the available toxicological studies on 
aminopyralid. Thus, the risk from acute exposure is considered 
negligible and no acute risk assessment was performed.
    ii. Drinking water. No monitoring exposure data are available to 
complete a comprehensive dietary exposure analysis and risk assessment 
for aminopyralid in drinking water.
     Guidance from EPA has indicated that Tier 1 screening level 
models, such as generic expected environmental concentration (GENEEC) 
and screening concentration in ground water (SCI-GROW), maybe used to 
estimate upper-bound pesticide residues in surface water and ground 
water when assessing potential exposure through drinking water. 
Estimated environmental concentrations (EEC) of pesticide in surface 
water or ground water are then compared to a drinking water level of 
comparison (DWLOC). DWLOC is not a regulatory standard for drinking 
water but a theoretical upper limit on a pesticide's concentration in 
drinking water in light of total aggregate exposure to a pesticide in 
food and from residential uses. DWLOC determines how much of the 
acceptable exposure PAD is available for exposure through drinking 
water. In calculating DWLOC, default values for body weights and water 
consumption were used: 2 Liter/70 kilogram (2L/70 kg) adult male, 2L/60 
kg adult female and 1L/10 kg child.
     The concentration of aminopyralid in surface water using GENEEC is 
4.4 [mu]g/L. For ground water, the estimated concentration by SCI-GROW 
is 1.6 [mu]g/L. As shown below the EECs in surface water and ground 
water are substantially below the DWLOC. Therefore, exposure to 
aminopyralid in drinking water would not result in unacceptable levels 
of aggregate human health risk.
    2. Non-dietary exposure. Aminopyralid is not currently registered 
for use on any sites that would result in residential exposure. 
Therefore, considerations of aggregate exposure to aminopyralid will 
not include non-dietary or residential exposures.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         cPAD/milligrams/                                                 EEC [mu]g/Liter ([mu]g/L)
                  Population Group                    kilogram body weight/   Dietary Exposurea        DWLOCb      -------------------------------------
                                                       day (mg/kg bwt/day)                                            Surface water       Ground water
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population (total)                                                 0.50           0.000237              17492                4.4                1.6
----------------------------------------------------
All infants (<1 year old)                                               0.50           0.000270               4997                4.4                1.6
----------------------------------------------------
Children (1-2 years old)                                                0.50           0.000933               4991                4.4                1.6
----------------------------------------------------
Females (13-49 years old)                                               0.50           0.000145              14996                4.4                1.6
--------------------------------------------------------------------------------------------------------------------------------------------------------
a From DEEM Analysis.
b DWLOC = (cPAD - Dietary Exposure) x Body weight, kg/Drinking water consumption, L x 1,000.

D. Cumulative Effects

     At this time, no data are available to determine whether 
aminopyralid has a common mechanism of toxicity with other substances. 
Unlike other pesticides for which EPA has followed a cumulative risk 
approach based on a common mechanism of toxicity, aminopyralid does not 
appear to produce a common toxic metabolite generated by other 
substances. For purposes of this tolerance action, therefore, it is 
assumed that aminopyralid does not have a mechanism of toxicity common 
with other substances.

E. Safety Determination

    1. U.S. population. Using the above conservative exposure 
assumptions, aggregate exposure to aminopyralid from the proposed 
tolerances in wheat and animal commodities will utilize less than 0.1% 
of the cPAD for the general U.S. population. The population subgroup 
with the highest exposure of 0.2% of the cPAD is children 1-2 years 
old. Generally, EPA has no concern for exposures below 100% of the cPAD 
because the cPAD represents the level at or below which daily aggregate 
dietary exposures over a lifetime will not pose appreciable risks to 
human health. No endpoint of concern was identified to quantitate 
acute-dietary risk to the general population, therefore, acute risk 
exposure is considered to be negligible. Additionally, the potential 
contribution of aminopyralid residues in drinking water to aggregate 
exposure is expected to be minimal. Calculated DWLOCs for assessing 
aggregate dietary risk ranged from 4991 [mu]g/L children 1-2 years old 
to 1,7492 [mu]g/L; U.S. population which are more than 4,000-10,000 
greater than the potential environmental water concentration. 
Therefore, based on these risk assessments, Dow AgroSciences concludes, 
that there is reasonable

[[Page 31110]]

certainty that no harm will result to the U.S. population from 
aggregate exposure to aminopyralid residues.
    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 aminopyralid relative to prenatal 
and postnatal effects for children is complete. Overall, aminopyralid 
had no effect on reproduction or embryo-fetal development at any dosage 
tested. No quantitative or qualitative susceptibility was seen 
following prenatal and postnatal exposures. In a 2-generation 
reproductive toxicity study in rats, no effects on reproductive 
performance or neonatal development were observed. Dow AgroSciences 
concluded that there is no indication of increased sensitivity of 
infants and children relative to adults and that no additional Food 
Quality Protection Act (FQPA) safety factor is required. Using the 
above conservative assumptions, aggregate exposure to aminopyralid will 
utilize only 0.1% of the cPAD for all infants <1 year old, 0.2% of the 
cPAD for children 1-2 years old and 0.1% of the cPAD for children 6-12 
years old. Even when considering the potential exposure to drinking 
water, the aggregate exposure is not expected to exceed 100% of the 
cPAD. Therefore, based on the completeness and reliability of the 
toxicity data and the conservative exposure assessment, Dow 
AgroSciences concludes, with reasonable certainty that no harm will 
result to infants and children from the aggregate exposure to 
aminopyralid residues.

F. International Tolerances

     No Codex maximum residue levels are established for residues of 
aminopyralid on any food or feed crop. Therefore, no compatibility 
problems exist for the proposed tolerances.

[FR Doc. 04-12020 Filed 6-1-04; 8:45 am]
BILLING CODE 6560-50-S