[Federal Register Volume 68, Number 1 (Thursday, January 2, 2003)]
[Notices]
[Pages 103-107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-33107]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0322; FRL-7282-5]


Fosetyl-Al; 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-2002-0322, must be 
received on or before February 3, 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: Sidney Jackson, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; 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 categories and entities may incude, but are not 
limited to:
    [sbull] Crop production (NAICS Industry 111)
    [sbull] Animal production (NAICS 112)

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    [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 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-2002-0322. 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 system, select ``search,'' and then key in docket ID number 
OPP-2002-0322. 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-2002-0322. 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

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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-2002-0322.
    3. By hand delivery or courier. Deliver your comments to: 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-2002-0322. 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. Offer alternative ways to improve the notice or collection 
activity.
    7. Make sure to submit your comments by the deadline in this 
notice.
    8. 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 20, 2002
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 the FFDCA section 408(d)(3). The summary of the petition 
was prepared by Bayer CropScience Company and represents the view of 
the company. The petition summary announces the availability of a 
description of the analytical methods available to EPA for the 
detection and measurement of the pesticide chemical residues, or an 
explanation of why no such method is needed.

PP 2E6366

    EPA has received a pesticide petition (PP 2E6366) from the 
Interregional Research Project Number 4 (IR-4), New Jersey Agricultural 
Experiment Station, Rutgers University, New Brunswick, NJ 08903 
proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), 
to amend 40 CFR 180.415 by establishing a tolerance for residues of the 
fungicide, fosetyl-al (aluminum tris O-ethylphosphonate), in or on the 
raw agricultural commodity onion, green, at 10 parts per million (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 metabolism of fosetyl-al in plants is 
adequately understood. Adequate data on the nature of the residues in 
plants, including identification of major metabolites and degradates of 
fosetyl-al, are available. Radiolabeled studies on the uptake, 
translocation and metabolism in plants show that the chemical proceeds 
through hydrolytic cleavage of the ethyl ester. The major residues are 
fosetyl-al, phosphorus acid, and ethanol. The tolerances are 
established for the parent only, that is fosetyl-al.
    2. Analytical method. Adequate methods are available for 
enforcement purposes. There are two analytical methods acceptable for 
determining residues of fosetyl-al in plants: a gas chromatography 
method is available for enforcement of tolerance in pineapple and is 
listed as Method I in Pesticide Analytical Manual (PAM), Vol. II; a gas 
chromatography/phosphorus specific flame photometric detector (FPD-P) 
method (Rhone-Poulenc Method No. 163) for citrus has undergone a 
successful method tryout on oranges and has been sent to the Food and 
Drug Administration (FDA) for inclusion in PAM as Method II.
    3. Magnitude of residues. Magnitude of residue data on green onions 
were collected form field trials conducted in Texas (Region 6) and 
California (Region 10). Each treated plot received seven foliar 
broadcast applications of the test substance at a rate of approximately 
4.0 pounds active ingredient/acre (lb a.i./acre), for a total of 
approximately 28.0 lb a.i./acre. All applications were made 6 to 8 days 
apart, and marketable green

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onions were collected 2 to 3 days following the final application. 
Residues of fosetyl-al in green onions ranged from 0.39 ppm to 7.75 
ppm.

B. Toxicological Profile

     EPA has evaluated the available fosetyl-al toxicity data and 
considered their validity, completeness, and reliability as well as the 
relationship of the results of the studies to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children. The nature of the toxic effects caused by 
fosetyl-al is discussed in the Federal Register of August 18, 2000 (65 
FR 50431) (FRL-6599-4), as well as the no observed adverse effect level 
(NOAEL), and the lowest observed adverse effect level (LOAEL) from the 
toxicity studies reviewed. Please refer to this document should you 
desire detailed toxicological information on fosetyl-al.
    1. Carcinogenicity. Long-term feeding studies were conducted with 
technical grade fosetyl-al in mice and rats and with monosodium 
phosphite, the primary urinary metabolite of fosetyl-al, in rats. These 
studies, in addition to a mechanistic study in rats, are described 
below:
    i. Rat. Fosetyl-al was administered via admixture in the diet to CD 
rats at target levels of 0, 2,000, 8,000, and 30,000/40,000 ppm for 
approximately 2 years. After 2 weeks at 40,000 ppm, this dietary level 
was reduced to 30,000 ppm due to the occurrence of red coloration of 
the urine and a decrease in body weight gain. Although, these findings 
were no longer apparent after week 2, analytical verification of 
dietary levels revealed that the highest dietary level ranged from 
approximately 38,000 to 61,000 ppm during the first 32 weeks of the 
study. Calculi in the urinary bladder were observed for several male 
and female rats at 30,000/40,000 ppm. Microscopic examination revealed 
transitional cell carcinomas and papillomas in the urinary bladders of 
high dose males. In addition, a statistically significant increase in 
adrenal pheochromocytomas (benign and malignant combined) was observed 
in males at 8,000 and 30,000/40,000 ppm. The adrenal slides were 
independently reread by two consulting pathologists who found no 
significant dose-related increases in the incidence of 
pheochromocytomas or hyperplasia.
     The NOAEL for fosetyl-al in the chronic rat study was 8,000 ppm. A 
subsequent mechanistic study in rats conducted with dietary levels of 
8,000, 30,000 and 50,000 ppm demonstrated that the massive doses of 
30,000 and 50,000 ppm fosetyl-al alter calcium/phosphorous homeostasis 
resulting in severe acute renal injury, similar to that observed in the 
chromic rat study, and the formation of calculi in kidneys, ureters, 
and bladder. Under conditions of chronic exposure, these effects could 
lead to the formation of bladder tumors as seen in the chronic rat 
study. At 8,000 ppm, no evidence of renal injury was observed, a result 
consistent with the absence of bladder tumors. Thus, the bladder tumors 
induced by fosetyl-al were the result of acute renal injury followed by 
a chronic toxic reaction rather than a true carcinogenic effect. An 
carcinogenicity study in rats was conducted with monosodium phosphite 
administered via dietary mixture at levels of 2,000, 8,000, and 32,000 
ppm. No evidence of carcinogenicity was observed in this study.
    ii. Mouse. A 2-year feeding/carcinogenicity study was conducted in 
mice fed diets containing fosetyl-al at 0, 2,500, 10,000, or 20,000/
30,000 ppm. The 20,000 ppm dose was increased to 30,000 ppm during week 
19 of the study. The NOAEL for all effects was 20,000/30,000 ppm 
(3,000/4,500 milligrams/kilogram (mg/kg/day)). There were no 
carcinogenic effects observed under the conditions of this study.
    iii. EPA's Carcinogenicity Peer Review Committee (CPRC) concluded 
in their report of June 29, 1993 that the pesticidal use of fosetyl-al 
is unlikely to pose a carcinogenic hazard for humans given that: (a) 
Tumors develop in rats under extreme conditions that are unlikely to be 
achieved other than under laboratory conditions (at a dose in excess of 
the EPA dose limit for carcinogenicity studies); (b) tumors in rats are 
believed to develop only at doses that produce stones; (c) human 
dietary exposure to fosetyl-al is only about one-500,000th of the NOAEL 
for stone formation in the rat (the most sensitive experimental model); 
and (d) the dose of fosetyl-al which can be absorbed dermally by 
applicators is also probably too low to result in stone formation. 
Therefore, a cancer dietary exposure analysis for fosetyl-al is not 
performed.
    2. Animal metabolism. Rat metabolism studies showed that most of 
the radiolabel rapidly appeared in exhaled carbon dioxide. There was 
also some radiolabel excreted in the urine as phosphite, along with a 
smaller amount as the unchanged parent compound. It appears that 
fosetyl-al is essentially completely absorbed after ingestion and 
extensively hydrolyzed to carbon dioxide which is exhaled. The 
phosphite is excreted in the urine without further oxidation to 
phosphate. Aluminum does not appear to be absorbed to a significant 
extent from the gastrointestinal tract.
    3. Metabolite toxicology. There are no metabolites of toxicological 
concern. The tolerances are established for the parent only, that is 
fosetyl-al.
    4. Endocrine disruption. No evidence of estrogenic or androgenic 
effects were noted in any study with fosetyl-al. No adverse effects on 
mating or fertility indices and gestation, live birth, or weaning 
indices were noted in a three-generation rat reproduction study at 
doses well above EPA's limit of 1,000 mg/kg/day. Therefore, Bayer 
CropScience concludes that fosetyl-al does not have any effect on the 
endocrine system.

C. Aggregate Exposure

    1. Dietary exposure. EPA has established the chronic reference dose 
(RfD) for fosetyl-al at 2.5 mg/kg/day. This reference dose (RfD) is 
based on a NOAEL of 250 mg/kg/day from a 2-year feeding study in dogs 
and the use of a 100 fold safety factor to account for interspecies and 
intraspecies differences. No appropriate endpoint attributable to a 
single dose exposure was identified in oral toxicity studies. 
Therefore, an acute RfD was not established and there is no expectation 
of acute risk. Since no dermal or systemic toxicity was seen at the 
limit dose following repeated dermal applications in the 21-day 
toxicity study using rats, no endpoint value was calculated for short- 
and intermediate-term exposure and risk. The Agency has concluded that 
fosetyl-al is unlikely to pose a carcinogenic hazard to humans. 
Therefore, a cancer exposure and risk assessment is not appropriate.
    i. Food. For all currently registered uses of fosetyl-al, chronic 
food exposure for various subgroups of the U.S. population was 
estimated by EPA through the use of the Dietary Exposure Evaluation 
Model (DEEM) software. The DEEM analysis evaluated the individual food 
consumption as reported by respondents in the USDA 1989-1992 nationwide 
continuing surveys of food intake by individuals. As the risk estimate 
was low for even the most highly exposed subpopulation, no anticipated 
residues were used. One hundred percent crop treated and tolerance 
level residues were assumed for all crops. EPA has concluded that 
exposure to fosetyl-al from food utilizes 4.0% of the chronic 
population adjusted dose (cPAD) for the U.S. population, 5% of the cPAD 
for infants, and 8% of the cPAD for children 1-6 years old, the

[[Page 107]]

subpopulation at greatest exposure. Based on the results of this 
conservative analysis, exposure to fosetyl-al residues from the 
proposed uses is expected to be minimal. Bayer CropScience concludes 
that dietary exposure to fosetyl-al resulting from the currently 
registered uses and the proposed use of the product will be well below 
the Agency's level of concern.
    ii. Drinking water. The potential for ground water and/or surface 
water contamination by fosetyl-al and its degradates is expected to be 
very low, in most cases, due to the rapid degradation of the compound 
in soil to non-toxic degradates under both aerobic and anaerobic 
conditions. Under aerobic laboratory conditions, the half-life of 
fosetyl-al is between 1 and 1.5 hours in loamy sand, silt loam, and 
clay loam and 20 minutes in sandy loam soil. The degradation proceeds 
through the hydrolysis of the ethyl ester bond, resulting in the 
formation of phosphorous acid and ethanol. The ethanol is further 
degraded into carbon dioxide. Based on the short half-life of fosetyl-
al and the known fate of phosphates under anaerobic conditions, EPA 
determined that an anaerobic soil metabolism study was not necessary. 
An anaerobic aquatic soil metabolism study was conducted. When 
anaerobic conditions were established by flooding soil, the half-life 
was 40 hours with silty clay loam, and 14 hours with sandy loam soil. 
Bayer CropScience expects that potential fosetyl-al residues in 
drinking water are not a significant contribution to aggregate 
exposure.
    2. Non-dietary exposure. Fosetyl-al is currently registered for 
residential use on turf and ornamental plants. Chronic exposure is not 
expected for residential uses. There is also no expectation of acute 
risk. No appropriate endpoint attributable to a single dose exposure 
was identified in oral toxicity studies and consequently, an acute RfD 
cannot be calculated. No endpoint value is calculable for short- and 
intermediate-term exposure and a risk analysis cannot be performed 
since no dermal or systemic toxicity was seen at the limit dose 
following repeated dermal applications in the 21-day toxicity study 
using rats. The Agency has previously concluded that fosetyl-al is 
unlikely to pose a carcinogenic hazard to human. Therefore, a cancer 
exposure and risk assessment is not appropriate. Thus, Bayer 
CropScience concludes that the ornamental and turf uses do not add 
significantly to the aggregate exposure for fosetyl-al.

D. Cumulative Effects

    Effects associated with fosetyl-al are unlikely to be cumulative 
with any other compound. The formation of calculi and bladder tumors in 
rats is the only significant toxicological effect observed with 
fosetyl-al. These effects were observed in rat only at a dose which not 
only exceeds estimated human exposure by several orders of magnitude 
but is in excess of the OPP dose limit for carcinogenicity studies. 
Therefore, an aggregate assessment based on common mechanisms of 
toxicity is not appropriate as exposure to humans will be well below 
the levels producing calculi and bladder tumors in rats. Further, 
considering the rapid elimination of fosetyl-al in the rat metabolism 
study, any effects associated with fosetyl-al are unlikely to be 
cumulative with any other compound. Based on these reasons, only the 
potential risks of fosetyl-al are considered in the exposure 
assessment.

E. Safety Determination

    1. U.S. population. Chronic risk estimates associated with exposure 
to fosetyl-al in food and water are expected to be well below the 
Agency's level of concern. The Tier I chronic exposure analysis 
performed by the Agency for all currently registered food uses shows 
that exposure to fosetyl-al utilizes 4.0% of the cPAD for the U.S. 
population, 5% of the cPAD for infants, and 8% of the cPAD for children 
1-6 years old, the subpopulation at greatest exposure. This analysis 
was conducted assuming 100% crop treated and tolerance level residue 
values for all crops. The contribution of fosetyl-al residues in 
surface water and ground water to chronic aggregate exposure is 
expected to be minimal. Therefore, Bayer CropScience concludes that 
even when considering the potential incremental risk resulting from the 
proposed use on green onion, there is a reasonable certainty that no 
harm will result from aggregate exposure to fosetyl-al residues.
    2. Infants and children. No indication of increased susceptibility 
of rat or rabbit fetuses to in utero and/or postnatal exposure was 
noted in the developmental and reproductive toxicity studies. The 
Agency has previously determined that no additional safety factor to 
protect infants and children is necessary for this product.
     Using the conservative assumptions described in the exposure 
section above, aggregate exposure to fosetyl-al from currently 
registered food uses will utilize up to 8% of the RfD for children 1-6 
years old, the subpopulation at greatest exposure. Even when 
considering the potential incremental dietary risk resulting from the 
proposed use on green onion, the potential for exposure to residues in 
drinking water and from non-dietary, non-occupational exposure, the 
aggregate exposure to fosetyl-al is expected to be well below the level 
of concern. Bayer CropScience concludes that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to fosetyl-al residues.

F. International Tolerances

    There are no Codex Alimentarius Commission (CODEX) maximum residue 
limits established for residues of fosetyl-al in or on green onion.
[FR Doc. 02-33107 Filed 12-31-02; 8:45 am]
BILLING CODE 6560-50-S