[Federal Register Volume 66, Number 100 (Wednesday, May 23, 2001)]
[Notices]
[Pages 28479-28482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-12906]



[[Page 28479]]

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ENVIRONMENTAL PROTECTION AGENCY

[PF-1019; FRL-6780-2]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
fora 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 control number PF-1019, must be 
received on or before June 23, 2001.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number PF-1019 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-3194; 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:

 
------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 underFOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number PF-1019. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any information claimed 
as confidential business information (CBI). This official record 
includes the documents that are physically located in the docket, as 
well as the documents that are referenced in those documents. The 
public version of the official record does not include any information 
claimed as CBI. The public version of the official record, which 
includes printed, paper versions of any electronic comments submitted 
during an applicable comment period, is available for inspection in the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number PF-1019 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number PF-1019. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
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 version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person identified 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.

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    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 
control 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 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 9, 2001.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by section 408(d)(3) of the FFDCA. The summary of the 
petition was prepared by the petitioner and represents the view of the 
petitioners. EPA is publishing the petition summary verbatim without 
editing it in any way. 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.

Interregional Reseach Project Number 4 (IR-4)

PP 5E4434 and 0E6219

    EPA has received pesticide petitions (5E4434 and 0E6219) from the 
Interregional Reseach Project Number 4 (IR-4), New Jersey Agricultural 
Experiment Station, Rutgers University, New Brunswick, NJ 08903 
proposing, pursuant to section 408(d) of FFDCA, 21 U.S.C. 346a(d), to 
amend 40 CFR part 180 by establishing tolerances for residues of the 
fungicide, aluminum tris (O-ethylphosphonate) (referred to in this 
document as fosetyl-Al) in or on the raw agricultural commodities as 
follows:
    1. PP 5E4434 proposes the establishment of tolerances for the 
bushberrysubgroup, and lingonberry, salal, and juneberry at 40 parts 
per million (ppm).
    2. PP 0E6221 proposes the establishment of tolerances for turnip 
roots and tops (leaves) at 50 ppm, peas (succulent) at 0.3 ppm, and 
citrus at 5 ppm.
    EPA has determined that these petitions contain 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 these 
petitions. Additional data may be needed before EPA rules on these 
petitions.

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 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 for 
inclusion in PAM as Method II.
    3. Magnitude of residues. Magnitude of residue data are adequate 
for the proposed commodities.

B. Toxicological Profile

    1. Acute toxicity. A complete battery of acute toxicity studies for 
fosetyl-Al technical has been conducted. The lethal doseLD50 
from the acute oral rat is 5.4 grams/kilograms (g/kg) and the 
LD50 from an acute dermal rabbit study is>2 g/kg. The 
LD50 for a rat inhalation study is >1.73 milligrams/liter 
(mg/L). The acute oral rat and primary dermal irritation studies 
indicate category IV toxicity. A guinea pig dermal sensitization study 
shows fosetyl-Al is not a skin sensitizer. The primary eye irritation 
study in rabbits shows fosetyl-Al to be an eye irritant with Category I 
toxicity.
    2. Genotoxicity. Fosetyl-Al is neither mutagenic nor genotoxic. The 
genetic toxicity potential of fosetyl-Al was assessed in several 
assays. Eight mutagenicity tests performed with fosetyl-Al were 
negative. The tests included two Ames assays withS. typhimurium, two 
phase induction assays usingE. coli, two micronucleus studies in mice, 
one DNA repair assay using E. coli and one mutation assay in 
Saccharomyces cerevisiae.
    3. Reproductive and developmental toxicity. Fosetyl-Al is not a 
reproductive toxicant and shows no evidence of estrogenic or androgenic 
related effects.
    i. In a three generation reproduction study, fosetyl-Al was 
administered to rats at dietary levels of 0, 6,000, 12,000 or 24,000 
ppm. No adverse effects on reproductive performance or pup survival 
were observed in any dose group. The lowest observed adverse effect 
level (LOAEL) was established at 12,000 ppm based on effects on animal 
weights and urinary tract changes. The no observed adverse effect level 
(NOAEL) for all effects was 6,000 ppm.
    ii. A developmental study in rats dosed via oral gavage at 500, 
1,000 or 4,000 mg/kg/day showed a developmental NOAEL of 1,000 mg/kg. 
At 4,000 mg/kg, there was maternal toxicity, as evidenced by effects on 
animal weights, maternal deaths, increased resorptions, and delayed 
fetal ossification.
    iii. A rabbit developmental study showed no toxic effects at oral 
doses up to 500 mg/kg. Effects of fosetyl-Al on fetal development were 
observed only in the rat at a dose producing severe maternal toxicity. 
In the absence of maternal toxicity, no adverse effects on fetal 
development were observed, i.e. at

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1,000 mg/kg/day in rats or at 500 mg/kg/day in rabbits.
    4. Subchronic toxicity. In subchronic studies, no significant 
toxicity was observed even at doses exceeding the limit of 1,000 mg/kg/
day.
    i. A 21-day dermal study in rabbits showed mild to moderate skin 
irritation and a NOAEL of 1.5 g/kg/day.
    ii. A 90-day feeding study in rats showed a NOAEL of>5,000 ppm; the 
LOAEL was 25,000 ppm with extramedullary hematopoiesis in the spleen.
    iii. A 90-day dog feeding study showed a NOAEL of 10,000 ppm and a 
LOAEL at 50,000 ppm, at which the test animals had a lower serum 
potassium level than untreated animal.
    5. Chronic toxicity. Chronic toxicity studies have been conducted 
in dogs and rats.
    i. Dog. Fosetyl-Al was fed to dogs for 2 years at concentrations of 
0, 10,000, 20,000, and 40,000 ppm. The NOAEL was 10,000 ppm, equivalent 
to 250 mg/kg/day. The LOAEL was 20,000 ppm based on a slight 
degenerative effect on the testes. These testicular changes, as well as 
a few scattered clinical changes, were seen in the high dose dogs. No 
effects were observed in the urinary tract.
    ii. Rat. Fosetyl-Al was administered via a mixture 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. Based on these levels, respective doses were 
100, 400 and 2,000/1,500 mg/kg/day. 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. No significant differences in body weight or food 
consumption were noted at 2,000 or 8,000 ppm. No biologically 
significant differences were observed in ophthalmoscopy, hematology, 
clinical chemistry, or urinalysis for treated and control animals. 
Calculi in the urinary bladder were observed for several male and 
female rats in the high dose group. Non-neoplastic findings consisted 
of epithelial hyperplasia and inflammation in the urinary bladders of 
males at 30,000/40,000 ppm. Increased incidences of hydronephrosis, 
inflammation, and epithelial hyperplasia in the kidney were also 
observed in males from the high dose group. Females from the same group 
exhibited increased incidences of epithelial hyperplasia in the urinary 
bladder and hydronephrosis in the kidney. The NOAEL in the chronic rat 
study was 8,000 ppm (400 mg/kg/day). The lowest NOAEL for chronic 
effects of fosetyl-Al is 10,000 ppm (250 mg/kg/day) based on the dog 
study. This NOAEL is based on minor changes at 20,000 ppm. In the rat, 
calculi in the urinary bladder and related histopathological changes in 
the bladder and kidneys of males and females were observed at 30,000/
40,000 ppm.
    6. 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, and a mechanistic study in rats, are described below:
    i. Rat. In addition to the chronic studies previously noted, 
calculi in the urinary bladder were also 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. 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; 
however, 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 mg/kg/day). There were no carcinogenic effects observed 
under the conditions of this study.
    iii. The Office of Pesticide Programs', Health Effects Division, 
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: 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); tumors in rats are believed to 
develop only at doses that produce stones; 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 the dose of 
fosetyl-Al which can be absorbed dermally by applicators is also 
probably too low to result in stone formation. EPA has therefore chosen 
to use the Reference Dose (RfD) to quantify dietary risk to humans.
    7. 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 trac.
    8. Metabolite toxicology. There are no metabolites of toxicological 
concern. The tolerances are established for the parent only, that is 
fosetyl-Al.
    9. 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, Aventis 
Crop Science concludes that fosetyl-Al does not have any effect on the 
endocrine system.

C. Aggregate Exposure

    1. Dietary exposure. EPA has established the chronic RfD for 
fosetyl-

[[Page 28482]]

Al at 2.5 mg/kg/day. This 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 1989-1991 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. Based on the results of this 
conservative analysis, exposure to fosetyl-Al residues from the 
proposed uses is expected to be minimal. Aventis Crop Science concludes 
that dietary exposure to fosetyl-Al resulting from the currently 
registered and the proposed uses of the product will be well below the 
Agency's level of concern.
    ii. Drinking water. There is no established maximum contaminant 
level or health advisory level for fosetyl-Al. 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. Aventis Crop Science 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, Aventis Crop 
Science 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 EPA 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 DEEM chronic exposure analysis 
previously performed by the Agency for all currently registered food 
uses shows that exposure to fosetyl-Al utilizes 3.1% of the cPAD for 
the U.S. population, 2.7% of the cPAD for females (13-50 years), 6.3% 
of the cPAD for children 1-6 years old, and 4.2% of the cPAD for non-
Hispanic (other than black or white). This analysis was conducted 
assuming 100% crop treated and tolerance level residue values for all 
crops. The contribution of fosetyl-Al residues in surface and ground 
water to chronic aggregate exposure is expected to be minimal. 
Therefore, Aventis Crop Science concludes that even when considering 
the potential incremental risk resulting from the proposed uses, 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, aggregate exposure to fosetyl-Al from currently registered 
food uses will utilize up to 6.3% of the RfD for infants and children. 
Even when considering the potential incremental dietary risk resulting 
from the proposed uses, 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 100% of 
the RfD. Aventis Crop Science 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 presently no Codex Alimentarius Commission maximum 
residue levels established for residues of fosetyl-Al.
[FR Doc. 01-12906 Filed 5-22-01; 8:45 am]
BILLING CODE 6560-50-S