[Federal Register Volume 68, Number 128 (Thursday, July 3, 2003)]
[Notices]
[Pages 39942-39947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-16930]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0229; FRL-7315-4]


Pyridaben; 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-2003-0229, must be 
received on or before August 4, 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: Shaja R. Brothers, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; 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 potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturer (NAICS 311)
    [sbull] Pesticide manufacturer (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 identification (ID) number OPP-2003-0229. 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

[[Page 39943]]

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-2003-0229. 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-2003-0229. 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-2003-0229.
    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-2003-0229. 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

[[Page 39944]]

CD ROM the specific information that is CBI). Information so marked 
will not be disclosed except in accordance with procedures set forth in 
40 CFR part 2.
    In addition to one complete version of the comment that includes 
any information claimed as CBI, a copy of the comment that does not 
contain the information claimed as CBI must be submitted for inclusion 
in the public docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding theelements 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: June 26, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petitions

    The petitioner summary of the pesticide petitions are printed below 
as required by FFDCA section 408(d)(3). The summary of the petitions 
were prepared by the petitioner and represents the view of the 
petitioner. The petition summary announces the availability of a 
description of the analytical methods available to EPA for the 
detection and measurement of the pesticide chemical residues or an 
explanation of why no such method is needed.

Interregional Research Project Number 4 (IR-4)

0E6068, 1E6226, 1E6303, 2E6457, and 2E6460

    EPA has received pesticide petitions (0E6068, 1E6226, 1E6303, 
2E6457, and 2E6460) from IR-4, 681 U.S. Highway 1 South, North 
Brunswick, NJ 08902-3390 proposing, pursuant to section 408(d) of the 
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to 
amend 40 CFR part 180.494 by establishing tolerances for combined 
residues of pyridaben, 2-tert-butyl-5-(4-tert-butylbenzylthio)-4-
chloropyridazin-3(2H)-one in or on the following raw agricultural 
commodities: strawberry at 2.5 parts per million (ppm)(PP 0E6068); hop, 
dried cones at 10.0 ppm (PP 1E6226); tomato at 0.2 ppm (PP 1E6303); 
fruit, stone, group at 2.5 ppm (PP 2E6457), papaya, black sapote, 
canistel, mamey sapote, mango, sapodilla, and star apple at 0.1 ppm (PP 
2E6460). Registration for tomato will be limited to greenhouse grown 
tomato based on the available residue data. The petitioner also 
proposes that established tolerances for nectarine, peach, plum, and 
prune at 2.5 ppm be deleted since they will be superceded by the 
tolerance for fruit, stone, group at 2.5 ppm.
    EPA has determined that the 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 the 
petitions. Additional data may be needed before EPA rules on the 
petitions. This summary has been prepared by the BASF Corporation.

A. Residue Chemistry

    1. Plant metabolism. The nature of the residue in plants is 
adequately understood. The residue of concern is pyridaben per se as 
specified in 40 CFR 180.494.
    2. Analytical method. The proposed analytical method involves 
extraction, partition, clean-up and detection of residues by gas 
chromatography/electron capture detector (gc/ecd).
    3. Magnitude of residues. Field trials were carried out in order to 
determine the magnitude of the residue in the following crops: 
Strawberries, hops, cherries (to satisfy the requirements for a stone 
fruits group), and papaya. Two greenhouse tomato residue trials were 
conducted in Canada. Residue trials were carried out using the maximum 
label rate, the maximum number of applications, and the minimum pre-
harvest interval for each crop or crop group.

B. Toxicological Profile

    1. Acute. In general, the acute toxicology studies conducted on 
technical grade pyridaben demonstrate that it has moderate to mild 
toxic effects. It was classified as Toxicity Category III based upon 
the acute oral lethal dose (LD)50 of 1,100 mg/kg in male 
rats and 570 mg/kg in female rats. The dermal LD50 in 
rabbits was greater than or equal to 2,000 mg/kg (Tox. Cat. III) and 
the inhalation lethal concentrations (LC)50 were 0.66 and 
0.64 mg/kg in male and female rats, respectively (Tox Cat. III). The 
eye irritation study (rabbits) produced slight ocular irritation (Tox. 
Cat. III). Pyridaben was not a dermal irritant (Tox. Cat. IV) or 
sensitizer.
    2. Genotoxicity. Genotoxicity studies including Ames testing, in 
vitro cytogenicity (chinese hamster lung cell), in vivo micronucleus 
assay (mouse) and DNA damage/repair (E. coli) showed no genotoxic 
activity associated with pyridaben.
    3. Reproductive and developmental toxicity. In a developmental 
toxicity study, Sprague-Dawley rats (22/group) from Charles River, 
U.K., received Pyridaben (98.0% pure) via gavage at dose levels of 0, 
2.5, 5.7, 13.0, or 30.0 milligram kilogram day (mg/kg/day) from 
gestation day 6 through 15, inclusive. Maternal toxicity, observed at 
13.0 and 30.0 mg/kg/day, consisted of decreased body weight/weight gain 
and food consumption during the dosing period. Based on these effects, 
the maternal toxicity lowest observed adverse effect level (LOAEL) is 
13.0 mg/

[[Page 39945]]

kg/day and the maternal toxicity no observed adverse effect level 
(NOAEL) is 4.7 mg/kg/day (82% of 5.7 mg/kg/day based on concentration 
analysis). The developmental toxicity NOAEL is 13.0 mg/kg/day based on 
observed decreased fetal body weight and increased incomplete 
ossification in selected bones at 30.0 mg/kg/day LOAEL.
    New Zealand white rabbits (19 or 20/group) were orally dosed with 
0, 1.5, 5, or 15 mg/kg/day pyridaben from day 6 through 19 of 
gestation. Maternal toxicity was evidenced by a dose-dependent decrease 
in body weight gain and food consumption at all dose levels. There was 
also increased incidences of abortions and clinical signs (few feces) 
in the 15 mg/kg/day group. There was no evidence that the chemical had 
a developmental effect at any of the tested levels. The maternal NOAEL 
was <1.5 mg/kg/day and the Maternal LOAEL was 1.5 mg/kg/day based on 
decreases in body weight gain and food consumption at all dose levels. 
No developmental toxicity was observed at any dose level. Therefore, 
the NOAEL for developmental toxicity is greater than or equal to 15 mg/
kg/day.
    In a standard two-generation reproduction study, CD rats were 
administered pyridaben in the diet at doses of 0, 10, 28 or 80 ppm. The 
Parental/Systemic NOAEL is 28 ppm (2.20 and 2.41 mg/kg/day for males 
and females, respectively). The parental/systemic LOAEL is 80 ppm (6.31 
and 7.82 mg/kg/day for males and females, respectively) based on 
decreased body weights, body weight gains and food efficiency. There 
was no effect on reproductive parameters on the dose levels tested. The 
reproductive NOAEL is >=80 ppm in males and females. The reproductive 
LOAEL is >80 ppm in males and females.
    4. Subchronic toxicity. In a 21-day dermal study, rats received 
repeated topical applications of pyridaben (98% pure) to about 10% of 
the body surface area at dosages of 30, 100, 300 and 1,000 mg/kg for 21 
days. The treatment produced body weight decreases in the 300 mg/kg/day 
females and in the 1,000 mg/kg/day males and females. The NOAEL was 100 
mg/kg/day and the LOAEL was 300 mg/kg/day based on decreased body 
weight gain in females. The toxicology endpoints from this study were 
selected by the Agency for short- and intermediate-term dermal risk 
assessments.
    5. Chronic toxicity. In a 12-month chronic feeding study in dogs 
pyridaben was administered in capsules at dosages of 0, 1.0, 4.0, 16.0 
or 32.0 mg/kg/day. All animals survived until the end of the study and 
there were no treatment-related changes in hematology, clinical 
chemistry, or urinalysis parameters. The NOAEL was determined to be 
<1.0 mg/kg/day and the LOAEL was <=1.0 mg/kg/day based on increased 
incidences of clinical signs (thinness, dehydration, diarrhea, emesis, 
soft stool, ptyalism, and relaxed nictitans) in treatment groups of 
both sexes and decreased body weight gain in females at 1.0 mg/kg/day.
    In a follow-up study, Pyridaben was administered in capsules to 
beagle dogs at dosages of 0 and 0.5 mg/kg/day for 1 year. The NOAEL was 
determined to be <0.5 mg/kg/day for males and females and the LOAEL was 
<=0.5 mg/kg/day for males and females based on an increased incidence 
of clinical signs in both treated sexes and decreased weight gain in 
the treated females.
    Pyridaben was administered in the diet to CD-1 mice at dosages of 
0, 2.5, 8.0, 25 or 80 ppm for 78 weeks. There was no evidence of a 
carcinogenic effect of the chemical. The NOAEL was determined to be 25 
ppm (2.78 mg/kg/day) for males and females and a LOAEL of 80 ppm (8.88 
and 9.74 mg/kg/day for males and females, respectively). The LOAEL was 
determined to be 80 ppm for males and females based on decreased body 
weight gain, decreased food efficiency and changes in organ weights and 
histopathology (males).
    Pyridaben was administered in the diet to groups of Wistar rats for 
104 weeks at doses of 0, 4, 10, 28 or 80 ppm to assess carcinogenicity. 
Additional groups (35 animals/sex/dose) received doses of 0, 4, 10, 28 
or 120 ppm for 104 weeks (with an interim sacrifice at 53 weeks) to 
assess chronic toxicity. There was no treatment-related neoplastic or 
non-neoplastic pathology in either phase of the study. The NOAEL was 
determined to be 28 ppm in males (1.13 mg/kg/day) and 28 ppm (1.46 mg/
kg/day) in females. The LOAEL was determined to be 120 ppm (5.00 mg/kg/
day) in males and 120 ppm (6.52 mg/kg/day) in females based on 
decreased body weight gain in males and females and decreased ALT 
levels in males in the chronic toxicity phase. There was no evidence of 
a carcinogenic effect of this chemical.
    6. Animal metabolism. In an acceptable rat metabolism study by the 
oral route, pyridaben was mainly eliminated in the feces where 80-97% 
of the administered dose was excreted regardless of the dose or site of 
label (pyridazinone or benzyl ring). Nearly 20% of the excreted residue 
in the feces was unmetabolized parent compound and there was some 
evidence of glucoronide conjugate(s) in the bile. The plasma levels 
following a single low oral dose (3 mg/kg) peaked at 23 hours while 
peak levels at the high dose (30 mg/kg) were at approximately 24 hours 
post-dose due, at least in part, to enterhepatic circulation (nearly 
22-30% of an administered radioactive dose is excreted in bile within a 
period of 24 hours). Residual radioactivity was at or near background 
levels for most tissues by 72 to 168 hours. Generally, there seemed to 
be increased distribution to fat over time and, compared to other 
tissues, fat seemed to have relatively more residual radioactivity. 
Several metabolites, totaling up to 20-30, were resolved in urine and 
feces and some were structurally identified.
    7. Metabolite toxicology. The nature of the residue in animals is 
adequately understood. The residue of concern is pyridaben and its 
metabolites PB-7, 2-tert-butyl-5-[4-(1-carboxy-1-
methylethyl)benzylthio]-4-chloropyridazin-3(2H)-one and PB-9, 2-tert-
butyl-4-chloro-5-[4-(1,1-dimethyl-2-hydroxyethyl) benzylthio]-
chloropyridazin-3(2H)-one as specified in 40 CFR 180.494.
    8. Endocrine disruption. The most common toxicity endpoint across 
the various studies and test species was decreased body weight/
decreased body weight gain followed by decreased feed consumption and/
or feed efficiency. These effects were observed in the 13-week feeding 
study in mice, in a 13-week rat study, in two 13-week dog studies, in a 
21-day rat dermal study, in a 28-day inhalation toxicity study in rats, 
in two 1-year feeding studies in dogs, in a 78-week feeding/
carcinogenicity study in mice, in a developmental toxicity study in 
rats, in two developmental studies in rabbits, and in a 2-year feeding 
carcinogenicity study in rats. The LOAELs were always based on 
decreases in body weight gain/body weight decreases or decreases in 
food consumption. Other effects were sporadic and involved changes in 
certain clinical chemistry values or increases or decreases in organ 
weights. Thus, there is no indication that effects on the endocrine 
system were responsible for any of the observed effects.

C. Aggregate Exposure

    1. Dietary exposure. Assessments were conducted to evaluate the 
potential risk due to chronic and acute dietary exposure of the U.S. 
population to residues of pyridaben (BAS 300 I). Commodities (crops and 
animal products) specified in 40 CFR 180.494 and all new/updated crop 
tolerances were included in the dietary assessment (citrus, pome fruit, 
stone fruit, grapes,

[[Page 39946]]

cranberries, tree nuts, pistachio, papaya and similar fruit, 
strawberries, hops, green house tomatoes, and secondary residues in 
animal products meat, meat byproducts, fat - from cattle, goat, hog, 
horse, sheep).
    i. Food. Specific inputs and default values were considered in the 
pyridaben dietary assessment. Anticipated residue values from the raw 
agricultural commodities and the residue tolerances utilized in the 
assessment were multiplied by a factor of 2.3 to include all 
organosoluble residues of pyridaben. Tolerance values were assumed for 
pistachios, tree nuts, and secondary residues in meat, meat byproducts, 
fat, and milk. The 2.3 multiplication factor was not used for these 
animal commodities since the residues of concern (pyridaben and its 
metabolites), as specified in 40 CFR 180.494 are well understood in 
animals. Default processing factors were used for all commodities 
except for those specified in Table 1 below. In addition, percent crop 
treated (% CT) values of 23, 5.8, and 11.4% were utilized for pome 
fruit, grapes, and citrus, respectively. These percent crop treated 
values were based on the 2000 to 2002 pyridaben peak sales year and 
peak acreage year. All other crops were considered to have 100% crop 
treated.

   Table 1.--Process Factors Used in the Pyridaben Dietary Assessment
------------------------------------------------------------------------
                                                               Process
             Commodity                       Process            Factor
------------------------------------------------------------------------
Citrus                               washed                         0.48
                                     juice.................        0.096
------------------------------------------------------------------------
Apples/Pears                         washed                         0.68
                                     juice.................         0.09
------------------------------------------------------------------------
Grapes                               juice                          0.04
                                     dried.................         0.94
------------------------------------------------------------------------
* Default processing factors were used for all other commodities.

    ii. Drinking water. There are no established maximum contaminant 
levels or health advisory levels for residues of pyridaben (BAS 300 I) 
or its metabolites in drinking water. The PRZM/EXAMS and SciGrow models 
were used to estimate the maximum concentrations in surface and ground 
water, respectively. Pyridaben is immobile and thus unlikely to leach 
to groundwater. Results of environmental modeling indicate an estimated 
0.215 ppm (acute) and 0.020 ppm (chronic) of pyridaben in surface 
water.
    2. Non-dietary exposure. Pyridaben (BAS 300 I) is a plant 
protection product used to control insects. This product is not 
considered for residential use and therefore the aggregate exposure is 
a result of pyridaben residues in food and water.

D. Cumulative Effects

    The cumulative exposure to substances with common mechanism of 
toxicity must be considered. Currently at this time there is not 
available data to determine whether pyridaben 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, pyridaben does not appear to form a toxic metabolite produced 
by other substances. As a result, for the purposes of this tolerance 
action, it is assumed that pyridaben does not have a common mechanism 
of toxicity with other substances.

E. Safety Determination

    1. Acute. Exposure estimates for the pyridaben acute dietary 
assessment were well under 100% of the aPAD at the 99.9th percentile. 
The overall general population and the most sensitive subpopulation 
(females 13-49 years) utilized <11% and 14.5% of the acute population 
adjusted dose (aPAD), respectively. Results from a Tier I dietary 
assessment of pyridaben residues in cranberries indicates the percent 
aPAD for children 1-6 years old and females 13-49 years old were <3%. 
Therefore considering all current and pending commodities, including 
cranberries, the percent chronic reference dose (%cRfD) and percent 
chronic population dose (%cPAD) will be below 20% for all population 
subgroups. Further refinements including additional percent crop 
treated, processing factors, cooking factors, actual residue values for 
the remaining commodities (where default values and tolerance levels 
were used for this assessment) would further reduce the exposure 
estimates.

Table 2. Acute Dietary Exposure Assessment for for Pyridaben (BAS 300 I)
------------------------------------------------------------------------
                                 Exposure Estimate
      Population Subgroups         (mg/kg b. w. /     %aRfD      %aPAD
                                        day)
------------------------------------------------------------------------
Birth to 1 year                            0.04488       8.98       8.98
------------------------------------------------------------------------
1-2 years                                   0.0509      10.18      10.18
------------------------------------------------------------------------
3-5 years                                  0.04339       8.68       8.68
------------------------------------------------------------------------
1-6 years                                  0.03382       6.76       6.76
------------------------------------------------------------------------
6-12 years                                  0.0300       6.00       6.00
------------------------------------------------------------------------
13-19 years                                0.01327       2.65       2.65
------------------------------------------------------------------------
Females 13-49 years                        0.01885      14.50      14.50
------------------------------------------------------------------------
Males 20-49 years                          0.01101       2.20       2.20
------------------------------------------------------------------------
Adults 50+ years                           0.01591       3.18       3.18
------------------------------------------------------------------------


[[Page 39947]]

    2. Chronic. The estimated chronic dietary exposure for all current 
and pending commodities (except cranberries) ranged from 15.6 to 77.3% 
for the cRfD and cPAD for all subpopulations. Results from a Tier I 
dietary assessment of pyridaben residues in cranberries indicates the 
percent cPAD for children 1-6 years old and females of childbearing 
years (13-49 years old) were 7.1% and 12.9%, respectively. Therefore 
considering all current and pending commodities, including cranberries, 
the %cRfD and %cPAD will be below 100% for all population subgroups. 
Further refinements including additional percent crop treated, 
processing factors, cooking factors, actual residue values for the 
remaining commodities (that used default values and tolerance levels) 
would further reduce the exposure estimates.

                     Table 3.--Chronic Dietary Exposure Assessment for pyridaben (BAS 300 I)
----------------------------------------------------------------------------------------------------------------
                                                                          Exposure
                        Population Subgroups                           Estimate(mg/kg      %cRfD        %Cpad
                                                                         b.w./day)
----------------------------------------------------------------------------------------------------------------
Birth to 1 year                                                                0.00371         74.2         74.2
----------------------------------------------------------------------------------------------------------------
12 years                                                                      0.003867        77.34        77.34
----------------------------------------------------------------------------------------------------------------
35 years                                                                      0.002752        55.04        55.04
----------------------------------------------------------------------------------------------------------------
16 years                                                                        0.0031           62           62
----------------------------------------------------------------------------------------------------------------
6-12 years                                                                    0.002541        50.82        50.82
----------------------------------------------------------------------------------------------------------------
13-19 years                                                                  0.0009618       19.236       19.236
----------------------------------------------------------------------------------------------------------------

    The aggregate exposure (food and drinking water) of pyridaben will 
not exceed the U.S. EPA's level of concern (100% of RfD). Overall, we 
can conclude with reasonable certainty that no harm will occur from 
either acute or chronic aggregate exposure of pyridaben residues as a 
result of use on citrus, pome fruit, stone fruit, grapes, cranberries, 
tree nuts, pistachio, papaya (and similar fruit), strawberries, hops, 
and green house tomatoes.

F. International Tolerances

    Maximum residue levels (MRLs) have been established for pyridaben 
in Canada. No MRLs have been established by the Codex Alimentarius 
Commission.
[FR Doc. 03-16930 Filed 7-2-03; 8:45 am]
BILLING CODE 6560-50-S