[Federal Register Volume 67, Number 3 (Friday, January 4, 2002)]
[Notices]
[Pages 592-597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-224]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1059; FRL-6812-2]


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 control number PF-1059, must be 
received on or before February 4, 2002.

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-1059 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Cynthia Giles-Parker, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-7740; 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 under FOR 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'' 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-1059. 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-1059 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.

[[Page 593]]

    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-1059. 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.
    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: December 17, 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.

PP IF06300

    EPA has received a pesticide petition (IF06300) from Aventis 
CropScience, 2 Alexander Drive, Research Trianagle Park, NC 27709 
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 
fenamidone, and its metabolites RPA 412708, RPA 412636, and RPA 410193 
in or on the raw agricultural commodities: Potato, 0.05 parts per 
million (ppm) tomato, 1.0 ppm; tomato paste, 3.5 ppm, tomato puree, 3.5 
ppm, bulb vegetable crop group, 1.5 ppm; cucurbit crop group, 0.1 ppm; 
head lettuce, 15.0 ppm; leaf lettuce, 20.0 ppm; wheat grain, 0.05 ppm, 
wheat straw, 0.5 ppm; wheat forage, 0.5 ppm, and wheat hay, 0.5 ppm. 
Tolerances are also proposed for fenamidone and its metabolite RPA 
410193 on imported wine grapes at 0.5 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. The plant metabolism of fenamidone (RPA 
407213) is adequately understood in four distinct crops (lettuce, 
tomatoes, potatoes, and grapes) to support these tolerances. In all 
cases, the primary residue was the parent fungicide, RPA 407213. The 
only significant metabolite was RPA 410193 (~17 of the total 
radioactive residue (TRR) in grapes, ~9% of the TRR in tomatoes, <1% of 
the TRR in lettuce (mostly in the wrapper leaves), and <1% of the TRR 
in potatoes (haulm or tubers)). RPA 412708 and RPA 412636 were minor 
metabolites reported in the lettuce and potato metabolism studies, and 
may account for part of the unidentified residue reported in the grape 
and tomato metabolism studies.
    2. Analytical method. Although residue levels approaching the 
proposed tolerances are unlikely, independently validated enforcement 
methods are available for determining residues of fenamidone and 
relevant metabolites. Residues are first extracted from the crop matrix 
by blending or shaking with a mixture of acetonitrile and water. After 
filtration, an aliquot of the extract is rotary evaporated to near 
dryness; then diluted with water. Cleanup is accomplished on a HRP 
polymeric solid phase extraction (SPE) cartridge and an amino SPE 
cartridge. Residues are quantified by high performance liquid 
chromotography (HPLC) with tandem mass spectrometric detection (LC/MS/
MS). The method limits of quantification (LOQ) are 0.02 ppm for 
fenamidone, and its metabolites, RPA 412636, RPA 412708, and RPA 410193 
in potato tubers, and processed fractions, tomatoes and processed 
fractions, cucumbers, squash, cantaloupes, head and leaf lettuce, 
onions, spinach, and wheat raw agricultural commodities and processed 
fractions.
    3. Magnitude of residues--i. Cucurbit crops. The magnitude and 
decline of residues of fenamidone were determined on cucumber, 
cantaloupe, and summer squash, the representative commodities for the 
cucurbit vegetable

[[Page 594]]

crop group. Nine field trials were conducted on each crop during 1999. 
EXP 10623A, a suspension concentrate end use formulation containing 500 
g fenamidone per liter, was applied as six broadcast applications, each 
at the maximum rate of 0.178 lb ai/acre (200 g ai/A/ha). Applications 
were made approximately 5 days apart. The target pre-harvest interval 
(PHI) was 14 days. Residues of fenamidone RPA 407213 were detected in 
two of nine trials of cucumbers at levels of 0.022 to 0.041 ppm, with 
the metabolite RPA 412708 measured in only one trial at 0.028 ppm. 
Quantifiable residues of fenamidone were measured in eight of nine 
trials of cantaloupes at levels ranging from 0.021 to 0.098 ppm, with 
no quantifiable residues of metabolites detected. Residues of parent 
fenamidone were found in only one of nine summer squash trials at 0.039 
to 0.077 ppm with no quantifiable residues of any metabolites detected.
    ii. Tomato. Seventeen residue trials were conducted in 1999-2000. 
EXP 10623A, a suspension concentrate containing 500 g fenamidone per 
liter, was applied as four broadcast applications of 0.268 lb ai/acre 
(300 g ai/ha) each or six broadcast applications of 0.178 lb ai/acre 
(200 g ai/A) each, for a maximum seasonal use rate of 1.068 lb ai/acre 
(1,200 g ai/ha). Applications were made approximately 5 days apart. The 
target PHI was 14 days. Cherry tomatoes were grown at 4 of the 18 
trials. Trace residues of the fenamidone metabolite RPA 410193 were 
detected in tomatoes from only one trial, on cherry tomatoes, at levels 
of 0.023 to 0.028 ppm. Measurable residues of the parent fungicide, 
fenamidone were found in tomatoes from 15 of the 17 harvestable trials 
at levels ranging from 0.044 to 0.800 ppm. The residues did not seem to 
correlate with the application scenario. The extent of potential 
residue concentration in processed tomato fractions was estimated by 
processing tomatoes after application of fenamidone at 5X the maximum 
seasonal use rate. Fenamidone residues concentrated in tomato puree by 
a factor of about 2.2 and in tomato paste by a factor of about 3.5. 
When corrected to account for the exaggerated application rate, residue 
levels were 0.089 ppm in whole tomato fruit, 0.198 ppm in tomato puree 
and 0.316 ppm in tomato paste.
    iii. Lettuce. In 2000, nine residue trials were conducted with 
fenamidone on leaf lettuce and nine trials were conducted on head 
lettuce. EXP 10623A was applied as four broadcast applications of 0.268 
lb ai/acre (300 g ai/ha) each, for a maximum seasonal use rate of 1.068 
lb ai/acre (1,200 g ai/ha). Applications were made approximately 5 days 
apart. The target PHI was 2 days. Residues of the parent fungicide, 
fenamidone (RPA 407213) were found in/on leaf lettuce from all nine 
trials at levels ranging from 50 of >5,000 mg/kg (males) and >2,028 mg/kg 
(females). The acute dermal toxicity study in rats resulted in a 
LD50 of >2,000 mg/kg for both males and females. The acute 
inhalation study in rats resulted in a LC50 of >5 mg/L for 
males and females. Fenamidone was not irritating in the primary eye 
irritation or primary dermal irritation studies. The dermal 
sensitization study in guinea pigs was negative.
    In an acute neurotoxicity study in rats, fenamidone was not 
neurotoxic at doses up to the limit dose of 2,000 mg/kg. The no 
observed adverse effect level (NOAEL) was 500 mg/kg for males and 125 
mg/kg for females.
    2. Genotoxicty. Mutagenicity studies conducted include: A 
Salmonella typhimurium reverse mutation assay (negative at the limits 
of cytotoxicity and solubility with and without activation), in vitro 
unscheduled DNA synthesis test in rat liver (negative at the limits of 
cytotoxicity), in vitro chromosome aberrations test in human 
lymphocytes (positive at the limits of cytotoxicity and solubility), 
TK+/- mouse lymphoma assay (positive with activation, negative 
without), in vivo mouse micronucleus test (negative with toxicity at 
2,000 mg/kg), and an in vivo unscheduled DNA synthesis assay in the rat 
(negative at up to 2,000 mg/kg with toxicity at the high dose level). 
Based on the data cited above, fenamidone is not considered to be 
mutagenic.
    3. Reproductive and developmental toxicity. A teratology study was 
conducted with rats administered (orally) fenamidone on gestation days 
6-15 at dose levels of 0, 25, 150, or 1,000 mg/kg/day. High dose dams 
had significantly decreased body weight and food consumption. High dose 
fetal body weights were less than controls and correlated with slightly 
delayed skeletal ossification secondary to maternal toxicity. The NOAEL 
for maternal and developmental toxicity is 150 mg/kg/day. The Lowest 
observed adversed effect level (LOAEL) was 1,000 mg/kg/day. A 
teratology study was conducted with rabbits administered (orally) 
fenamidone on gestation days 6-19 at dose levels of 0, 10, 30, or 100 
mg/kg/day. The maternal NOAEL was 10 mg/kg/day. The developmental NOAEL 
was 100 mg/kg/day. The maternal LOAEL was 30 mg/kg/day, based on 
increased maternal liver weights at 30 and 100 mg/kg/day. Fenamidone 
demonstrates no potential to cause developmental toxicity in mammals.
    A 2-generation definitive reproduction study was conducted with 
rats administered (orally) in the diet fenamidone at dose levels of 0, 
3.9, 63.8, 328.3 mg/kg/day (males) and 0, 5.15, 84.4, 459.6 mg/kg/day 
(females). The NOAEL for maternal and off-spring toxicity was 5.15 mg/
kg/day. The maternal NOAEL was based on decreased body weight and food 
consumption. The pup NOAEL is based on F1 pup body weight decrease. The 
reproductive NOAEL was >328.3 mg/kg/day (males) and >459.6 mg/kg/day 
(females). Fenamidone is not considered a reproductive toxicant at non-
maternally toxic dose levels and shows no evidence of endocrine 
effects.
    4. Subchronic toxicity. In a 13-week range-finding study, 
fenamidone was administered in the diets of male and female rats at 
dose levels of 0, 4.05, 10.41, 68.27, 343.93 mg/kg/day to males and 0, 
4.81, 12, 83.33, 380.68 mg/kg/day to females. The NOAEL is 68.27 mg/kg/
day (males) and 83.33 mg/kg/day (females) and the LOAEL is 343.93 mg/
kg/day for males and 380.63 mg/kg/day for females based on adaptive 
liver changes at 68.27 mg/kg/day and increased liver and thyroid 
weights at the highest dose tested (HDT). In a 13-week subchronic 
feeding study, fenamidone was administered in the diet to mice at dose 
levels of 0, 11.33, 44.5, 220.2, 1,064.3 mg/kg/day to males and 0, 
13.7, 54.1, 273.9, 1,375.2 mg/kg/day to females. The NOAEL is 44.5 mg/
kg/day (males), and 54.1 mg/kg/day (females), and the LOAEL is 220.2 
mg/kg/day (males), and 273.9 mg/kg/day (females) based on 14% increase 
in liver weight at the high dose. In a 28-day subchronic dermal study, 
fenamidone was applied to skin of male and female New Zealand white 
rabbits at doses of 0 or 1,000 mg/kg/day for 6 hours/day, 5 days/week. 
Treatment produced a slight decrease in food consumption (8-10%), and 
body weight (6%) in males only. In a 13-week study, fenamidone was 
administered in the diets of male and female dogs at 0, 10, 100, and 
500 mg/kg/day. Based on clinical symptoms at the high dose, the NOAEL 
is 100 mg/kg/day and the LOAEL is 500 mg/kg/day.
    In a subchronic neurotoxicity study, there was no evidence of 
neurotoxicity when fenamidone technical was administered to rats for 13 
weeks at dosage levels up to 5,000 ppm (395.6-414.2 mg/kg/day), the 
MTD. The

[[Page 596]]

NOAEL for the study was 1,000 ppm (equivalent to 74.2-83.4 mg/kg/day).
    5. Chronic toxicity. A 1-year oral study was conducted with dogs 
administered fenamidone at dose levels of 0, 10, 100, and 1,000 mg/kg/
day in capsules. The NOAEL is 100 mg/kg/day for both sexes, based on 
significantly increased liver weights and biliary hyperplasia in the 
high dose. The LOAEL is 1,000 mg/kg/day.
    A 2-year combined chronic toxicity/carcinogenicity study was 
conducted with fenamidone administered in the diet to rats at doses of 
0, 2.83, 7.07, 47.68, 260.13 mg/kg/day (males) and 0, 3.63, 9.24, 
60.93, 335.10 mg/kg/day (females). The NOAEL for systemic toxicity is 
2.83 mg/kg/day (males) and 3.36 mg/kg/day (females). The LOAEL is 7.07 
mg/kg/day (males) 9.24 mg/kg/day (females). No statistically 
significant linear dose response was observed for any tumor incidence.
    A 104-week combined carcinogenicity study in mice was conducted 
with mice administered fenamidone in the diet at dose levels of 0, 9.5, 
47.5, 525.5, 1,100.2 mg/kg/day (males) and 0, 12.6, 63.8, 690.5, 
1,393.2 mg/kg/day (females). The NOAEL was 9.5 mg/kg/day (males) and 
12.6 mg/kg/day (females). The LOAEL for carcinogenicity was 47.5 mg/kg/
day (males) and 63.8 mg/kg/day (females). The NOAEL is based on non-
neoplastic liver changes and decreased body weight gain at the top two 
dose levels. Fenamidone demonstrates no potential for carcinogenic 
effects in mammals.
    6. Animal metabolism. Metabolism studies conducted with goat and 
hen demonstrate that fenamidone is rapidly metabolized and excreted. 
Residue levels in edible animal tissues (meat, milk and eggs) are 
negligible and do accumulate in those tissues. The metabolic pathway 
proceeds via cleavage of the amino-phenyl group and the thiomethyl 
group with further metabolism by hydroxylation. There is also evidence 
to that glucuronide and sulfate conjugates are formed.
    A single low dose (3 mg/kg), a single high dose (300 mg/kg) and a 
low dose (3 mg/kg) administered for 15 consecutive days were fed to 
rats. Fenamidone was relatively well absorbed at a nominal dose of 3 
mg/kg in both sexes and intensively metabolized by phase I (oxidation, 
reduction and hydrolysis) and phase II (conjugation) reactions. The 
elimination of radiolabeled fenamidone was relatively rapid with the 
majority of the administered dose being excreted via the biliary route 
(for the low dose experiments). The comparison of the levels of 
radioactivity recovered in bile kinetic and ADME studies suggested that 
a part of the radioactivity excreted via the bile could be reabsorbed 
and subsequently re-excreted via the urine. High levels of 
radioactivity measured in blood samples from the tissue kinetics also 
supported this hypothesis. At the high dose level fenamidone was not 
very well absorbed: Some 50-60% of the radioactivity was present as 
parent compound in the feces. Radioactivity was widely distributed in 
the tissues with predominance in the thyroids, blood, liver, kidneys, 
fat and pancreas. Fenamidone is therefore expected to be rapidly and 
extensively metabolized and excreted in mammals.
    7. Metabolite toxicology. The major dietary metabolites of 
fenamidone, RPA 412708, RPA 410193 and RPA 412636 were evaluated for 
mammalian toxicity in an acute oral toxicity study, a 90-day repeated 
dose study and in genotoxicity tests. The metabolites are considered to 
be of comparable toxicity to the parent fenamidone.
    8. Endocrine disruption. Chronic, lifespan, and multi-generational 
bioassays in mammals and acute and subchronic studies on aquatic 
organisms and wildlife did not reveal endocrine effects. Any endocrine 
related effects would have been detected in this definitive array of 
required tests. The probability of any such effect due to agricultural 
uses of fenamidone is negligible.

C. Aggregate Exposure

    1. Dietary exposure. Fenamidone is a fungicide with proposed uses 
on the food crops tomato, potato, head lettuce, leaf lettuce, the bulb 
vegetable crop group, and the cucurbit crop group. Although 
quantifiable residues are highly unlikely, wheat tolerances are also 
proposed to cover any conceivable plant back residues. An import 
tolerance for wine grapes is also proposed to cover imported wine. 
There are no residential uses proposed for fenamidone. Therefore the 
aggregate exposure would consist of any potential exposures to 
fenamidone residues from the above food crops from drinking water, and 
from imported wine. The chronic reference dose (RfD) of 0.03 mg/kg bwt/
day is based on a NOAEL of 3 mg/kg bwt/day from a 2-year rat chronic 
study. There are no acute effects of concern for fenamidone and an 
acute analysis was not conducted.
    i. Food. Chronic dietary exposure estimates resulting from the 
proposed and registered uses of fenamidone as listed above are well 
within acceptable limits for all sectors of the population. Potential 
dietary exposures from food were estimated using the chronic module of 
the DEEMTM software system, Version 7.62 (Novigen Sciences, 
Inc.), and the 1994-96 Department of Agriculture (USDA) consumption 
data. Anticipated residue values were calculated from the appropriate 
field trial studies conducted for fenamidone and its metabolites and 
submitted as part of the fenamidone petition. Processing factors were 
derived for tomato paste and puree and potato flakes and chips. For 
this chronic assessment, percent crop treated (PCT) values were 
estimated for the compound at market maturity. The PCT value for wine 
grapes is 20%. This assumes that all wine imported into the country 
(USDA FATUS tables) is made from grapes treated with fenamidone. This 
over estimates the risk significantly since fenamidone will only be 
registered on wine grapes in Western European countries. The wheat 
residue is included at 100% crop treated even though the actual plant 
back of a wheat crop behind vegetable crops (mostly potato) is 
estimated at 15%. Using these conservative assumptions, the most highly 
exposed population was children 1-6 utilizing 1.0% (0.000302 mg/kg/bwt/
day) of the chronic RfD. The U.S. population utilized 0.8% (0.000236 
mg/kg/bwt/day) of the RfD. Actual exposures are likely to be much less 
in real world situations because of the many conservative assumptions 
incorporated in this analysis.
    ii. Drinking water. EPA's Standard Operating Procedure (SOP) for 
Drinking Water Exposure and Risk Assessments was used to perform the 
drinking water assessment. This SOP uses a variety of tools to conduct 
drinking water assessments, including water models such as SCI-GROW, 
FIRST, PRZMS/EXAMS, and monitoring data. If monitoring data are not 
available, then the models are used to predict potential residues in 
surface and ground water and the highest levels are assumed to be the 
drinking water residue. In the case of fenamidone, monitoring data do 
not exist, therefore SCI-GROW and FIRST were used to estimate a water 
residue. The calculated drinking water levels of comparison (DWLOC) for 
chronic exposure for all adults and children exceed the drinking water 
estimated concentration (DWEC) from the models. The chronic DWLOC for 
adults is 1,042 ppb. The chronic DWLOC for children/toddlers is 297 
ppb. The DWEC for the worst case chronic scenario is 20 ppb. The 
drinking water levels of comparison are based on conservative dietary 
(food) exposures and are expected to be much higher in real world 
situations.
    2. Non-dietary exposure. Fenamidone products are not labeled for 
residential

[[Page 597]]

uses (food or non-food), thereby eliminating the potential for 
residential exposure or non-occupational exposure.

D. Cumulative Effects

    Section 408(b)(2)(D)(v) requires that, when considering whether to 
establish, modify, or revoke a tolerance, the Agency consider 
``available information'' concerning the cumulative effects of a 
particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity. There is no available data to determine 
whether fenamidone has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
fenamidone does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance petition, 
therefore, it has not been assumed that fenamidone has a common 
mechanism of toxicity with other substances.

E. Safety Determination

    1. U.S. population. Using the assumptions and data described above, 
based on the completeness, and reliability of the toxicity data, it is 
concluded that chronic dietary exposure to the proposed uses of 
fenamidone will utilize at most 0.8% of the chronic reference dose for 
the U.S. population. The actual exposure is likely to be much less as 
more realistic data, and models are developed. EPA generally has no 
concern for exposures below 100% of the RfD because the RfD represents 
the level at or below which daily aggregate exposure over a lifetime 
will not pose appreciable risk to human health. Drinking water levels 
of comparison based on the dietary and aggregate exposures are greater 
than highly conservative estimated levels, and would be expected to be 
well below the 100% level of the RfD, if they occur at all. Therefore, 
there is a reasonable certainty that no harm will occur to the U.S. 
population from aggregate exposure (food and drinking water) to 
residues of fenamidone.
    2. Infants and children. The relevant toxicity studies as discussed 
in the toxicology section above show no extra sensitivity of infants 
and children to fenamidone, therefore, the food quality protection act 
(FQPA) safety factor can be removed. Using the assumptions and data 
described in the exposure section above, the percent of the chronic RfD 
that will be used for exposure to residues of fenamidone in food for 
children 1-6 (the most highly exposed subgroup) is 1.0% (0.000302 mg/
kg/bwt/day). Infants utilize 0.2% (0.000056 mg/kg/bwt/day) of the 
chronic RfD. There are no non-dietary concerns for infants and 
children. As in the adult situation, drinking water levels in 
comparison are higher than the worst case drinking water estimated 
concentrations, and are expected to use well below 100% of the 
reference dose, if they occur at all. Therefore, there is a reasonable 
certainty that no harm will occur to infants and children from 
aggregate exposure to residues of fenamidone.

F. International Tolerances

    To date, no Codex, Canadian or Mexican tolerances exist for 
fenamidone.
[FR Doc. 02-224 Filed 1-3-02; 8:45 am]
BILLING CODE 6560-50-S