[Federal Register Volume 69, Number 37 (Wednesday, February 25, 2004)]
[Notices]
[Pages 8645-8649]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-3936]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0228; FRL-7344-7]


Acequinocyl; Notice of Filing Pesticide Petitions 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 pesticide 
petitions proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket identification (ID) number OPP-
2003-0228, must be received on or before March 26, 2004.

ADDRESSES: Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Marilyn Mautz, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6785; 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:
     Crop production (NAICS 111)
     Animal production (NAICS 112)
     Food manufacturing (NAICS 311)
     Pesticide manufacturing (NAICS 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket ID number OPP-2003-0228. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA. This 
docket facility is open from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The docket telephone number is (703) 
305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.
    Certain types of information will not be placed in EPA's 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.1. 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

[[Page 8646]]

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-2003-0228. 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-2003-0228. 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-2003-0228.
    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-2003-0228. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

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

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

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

II. What Action is the Agency Taking?

    EPA has received pesticide petitions 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 these petitions contain data or information 
regarding the elements set forth in FFDCA section 408(d)(2); however, 
EPA has not fully evaluated the sufficiency of the submitted data at 
this time or whether the data support granting of these petitions. 
Additional data may be needed before EPA rules on the petitions.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: February 12, 2004.
 Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner's summary of the pesticide petitions is printed 
below as required by FFDCA section 408(d)(3). The summary of the 
petitions was prepared by the petitioner and represents the view of the 
petitioner. The petitions summaries announces the availability of a 
description of the analytical methods available to EPA for the 
detection and measurement of the

[[Page 8647]]

pesticide chemical residues or an explanation of why no such method is 
needed.

Arvesta Corporation

PP 2F6440 and 3F6595

    EPA has received pesticide petitions (2F6440 and 3F6595) from 
Arvesta Corporation, 100 First Street, Suite 1700, San Francisco, CA 
94105 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 the 
combined residues of acequinocyl (3-dodecyl-1,4-dihydro-1,4-dioxo-2-
naphthyl acetate) and its metabolite 2-dodecyl-3-hydroxy-1,4-
naphthoquinone expressed as acequinocyl equivalents in or on the raw 
agricultural commodities as follows:
    PP 2F6440. Fruit, pome group at 0.4 parts per million (ppm); apple, 
wet pomace at 1.0 ppm; fruit, citrus, group at 0.3 ppm; orange, oil at 
30 ppm; almond and pistachio at 0.01 ppm; almond, hulls at 1.5 ppm; 
cattle, meat, and kidney at 0.01 ppm; cattle, liver, and fat at 0.02 
ppm; and milk at 0.01 ppm.
    PP 3F6595. Strawberries at 0.4 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 petition. 
Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

    1. Plant metabolism. The nature of the residues of acequinocyl in 
plants is adequately understood based on three crops: Apples, oranges, 
and eggplant. The major residue in all plant metabolism studies is 
acequinocyl. A minor but significant metabolite is acequinocyl-OH (2-
dodecyl-3-hydroxy-1,4-naphthoquinone). The proposed tolerance 
expression is the parent, acequinocyl and its hydroxy metabolite, 
acequinocyl-OH.
    2. Analytical method. The analytical methods to quantitate residues 
of acequinocyl and acequinocyl-OH in/on fruit crops, almond nutmeats, 
and hulls utilize high pressure liquid chromatography (HPLC) using mass 
spectrometric/molecular size (MS/MS) detection. The analytical method 
to quantitate acequinocyl and acequinocyl-OH in various animal tissues 
and milk utilizes the same principles as in the crop method. After 
cleanup the purified extract is submitted for HPLC analysis using MS/MS 
detection. The target limit of quantitation (LOQ) for all matrices is 
0.01 ppm.
    3. Magnitude of residues. The proposed use of acequinocyl calls for 
a maximum application rate of 2 applications at 0.3 lb active 
ingredient per acre per application, with a 21-day interval between 
applications. The pre-harvest interval is 14 days for pome fruit, 7 
days for citrus, almond, and pistachio and 1-day for strawberries.
    i. Pome fruit. The maximum residues expressed as acequinocyl 
equivalents were 0.23 ppm in apple and 0.05 in pear. The results of the 
apple processing study indicated that acequinocyl residues do not 
concentrate in apple juice but do concentrate in wet apple pomace with 
a concentration factor of 3.5.
    ii. Citrus. The maximum residues expressed as acequinocyl 
equivalents were 0.18 ppm in oranges, 0.08 ppm in grapefruit and 0.11 
ppm in lemons. The results of the orange processing study indicated 
that acequinocyl residues do not concentrate in orange juice or dry 
pulp but do concentrate in the orange oil with a concentration factor 
of 165.
    iii. Almonds. All residues in nutmeat were <0.01 ppm (LOQ). The 
maximum residues expressed as acequinocyl equivalents in hulls was 1.3 
ppm.
    iv. Strawberry. The maximum residues expressed as acequinocyl 
equivalents in/on strawberry fruit were 0.36 ppm.
    The crop field trial data are adequate to support the proposed 
tolerances of 0.4 ppm for pome fruit, 0.3 ppm for citrus, 0.01 ppm for 
almond and pistachio, 1.5 ppm for almond hulls, 1.0 ppm for apple wet 
pomace, 30 ppm for orange oil and 0.4 ppm for strawberry fruit.

B. Toxicological Profile

    1. Acute toxicity. Acequinocyl technical has low acute, dermal and 
inhalation toxicity in laboratory animals. The oral lethal dose 
(LD)50 (male and female) in the rat and mouse was 
5,000 milligrams/kilogram (mg/kg). The dermal 
LD50 (male and female) was 2,000 mg/kg. The 
inhalation lethal concentration (LC)50 was reported as 
0.84 milligram/Liter (mg/L). In the eye and dermal 
irritation studies, acequinocyl technical was not an eye or skin 
irritant to rabbits and was not a skin sensitizer in guinea pigs.
    2. Genotoxicity. Acequinocyl was found to be negative in the Ames 
reverse mutation, mouse lymphoma, Chinese hamster lung (CHL) chromosome 
aberration and mouse micronucleus assays.
    3. Reproductive and developmental toxicity--i. Rat teratology. 
Acequinocyl technical was administered by oral gavage to pregnant 
Sprague Dawley rats at dose levels of 0, 50, 150, 500, or 750 mg/kg/
day. Common signs in the descendants included vaginal discharge, 
pallor, pale eyes, hypoactivity, piloerection, slow or irregular 
breathing, intra-uterine hemorrhage, and blood stained stomach and/or 
intestinal contents. Maternal no observed effect level (NOEL) = 150 mg/
kg/day based on these signs. Developmental NOEL = 500 mg/kg/day based 
on increase in certain skeletal variants that may be attributed to the 
observed maternal toxicity.
    ii. Rabbit teratology. Groups of New Zealand white rabbits received 
acequinocyl technical by gavage at doses of 0, 30, 60, or 120 mg/kg/
day. Maternal NOEL = 60 mg/kg/day based on reduction in maternal body 
weight and 5 females were sacrificed at 120 mg/kg/day. Fetal NOEL = 60 
mg/kg/day due to skeletal variations in the thoraco-lumbar ribs.
    iii. Rat reproduction study. Acequinocyl technical was fed to 2-
generations of male and female Sprague Dawley rats at dietary 
concentrations of 0, 100, 800, or 1,500 ppm (0, 7.3, 59, or 111 mg/kg/
day for males and 0, 8.7, 69, or 134 mg/kg/day for females). Systemic 
and pup NOEL = 100 ppm (7.3 and 8.7 mg/kg/day).
    iv. Systemic. Hemorrhage and swollen body parts were seen at 800 
and 1,500 ppm in F1 males. At 800 and 1,500 ppm, treatment-related 
clinical signs, hemorrhagic effects, subcutaneous bleeding on body 
parts and/or cranium and/or brain were seen in the F1 pups. At 800 and 
1,500 ppm toxicity seen in F2 pups included subcutaneous bleeding on 
body parts and/or cranium and/or brain at weaning.
    4. Subchronic toxicity--i. Rat feeding study. Fischer rats received 
acequinocyl technical at dietary concentrations of 0, 100, 400, 1,600, 
or 3,200 ppm (0, 7.57, 30.4, 120, 253 mg/kg/day for males and 0, 8.27, 
32.2, 129, 286 mg/kg/day for females respectively) for 13 consecutive 
weeks. Treatment-related yellow brown urine in all animals of both 
sexes at 400 ppm suggested the presence of the metabolite of the test 
material. Macroscopic examination on the surviving animals revealed no 
treatment-related abnormalities. At 3,200 and 1,600 ppm, macroscopic 
and microscopic examination of the mortalities revealed hemorrhaging of 
muscle and other organs. NOEL = 400 ppm (30.4 mg/kg/day for males and 
32.2 mg/kg/day for females).
    ii. Mouse feeding study. Groups of CD-1 (ICR) BR mice received 
acequinocyl technical by oral route at concentrations of 0, 100, 500, 
1,000, or

[[Page 8648]]

1,500 ppm (0, 16, 81, 151, 295 mg/kg/day for males and 0, 21, 100, 231, 
342 mg/kg/day for females respectively) for 13 weeks. At 100 ppm, there 
were hepatic histopathological lesions and an increase in relative 
liver weight. A clear NOEL for both sexes was not determined.
    iii. Dog feeding study. Acequinocyl technical was administered via 
gelatin capsule to male and female Beagle dogs at dose levels of 0, 40, 
160, 640, or 1,000 mg/kg/day once a day 7 days a week for 13 weeks. At 
40, 160, and 640 mg/kg/day colored feces was observed in both sexes. At 
160 and 640 mg/kg/day, treatment-related decrease in body weight gain 
in males and an increase platelet count for females was observed. 
Macroscopic and microscopic examinations on the surviving animals 
revealed no treatment-related abnormalities. A clear NOEL was not 
determined.
    iv. A 28-day dermal toxicity. Groups of Sprague Dawley rats 
received daily dermal applications of acequinocyl technical at doses of 
0, 40, 200, or 1,000 mg/kg/day for 6 hours/day for 28 days followed by 
a 14-day treatment free period only in the high dose group. There were 
no macroscopic findings. Red staining occurred on the back of the 
animals and was only seen in the morning after dosing. There was no 
evidence of systemic toxicity. NOEL = 1,000 mg/kg/day.
    5. Chronic toxicity--i. Dog feeding study. Beagle dogs were dosed 
by capsule at 0, 5, 20, 80, or 320 mg/kg/day for 1-year with 
acequinocyl technical. Minor disturbances in platelet counts were 
observed in both sexes at 80 and 320 mg/kg/day. There were no 
treatment-related macroscopic histopathological findings. Colored feces 
and/or abnormally stained sawdust were observed for all treatment 
groups. Varying degrees of discoloration of the urine was observed for 
animals receiving 20 mg/kg/day or more. The discoloration was 
considered to be attributable to a colored metabolite of the test 
substance. NOEL = 20 mg/kg/day.
    ii. Rat feeding/oncogenicity study. Groups of F344 rats received 
acequinocyl technical at dietary levels of 0, 50, 200, 800, or 1,600 
ppm (0, 2.25, 9.02, 36.4, 74.0 mg/kg/day for males and 0, 2.92, 11.6, 
46.3, 93.6 mg/kg/day for females respectively) for 2 years. NOEL = 200 
ppm (9.02 and 11.6 mg/kg/day for males and females respectively). 
Corneal abnormalities and hypertrophy of the eye were observed in 800 
ppm and 1,600 ppm males and 1,600 ppm females respectively. At 800 ppm 
and 1,600 ppm, prothrombin time (PT) was observed to be longer in males 
and shorter in females and activated partial thromboplastin time (APTT) 
longer in females. Reddish brown urine was observed in both males and 
females respectively. There was no incidence of tumors.
    iii. Mouse oncogenicity study. Acequinocyl technical was 
administered in the diet of Crl:CD-1(ICR)BR mice at 0, 20, 50, 150, or 
500 ppm for 80 weeks. NOEL = 20 ppm (lowest dose tested (LDT) equal to 
2.7 and 3.5 mg/kg/day in males and females respectively), based on 
brown pigmented cells. At 50 and 500 ppm in both sexes, there was an 
increase incidence of fatty hepatocytes. Other associated findings were 
increased liver weight, slight increase in pale livers, or pale areas 
within livers. Glomerular amyloidosis was statistically increased in 
the 150 and 500 ppm males. Yellow brown urine was consistently found in 
both sexes at high dose. There was no increase in the incidence of 
tumors.
    6. Animal metabolism. Sprague Dawley rats were dosed orally with 
acequinocyl labeled 14C-phenyl or 14C-dodecyl. Both labels were used in 
the single low dose (10 mg/kg) study. The high dose (500 mg/kg) and 14-
day repeat dose studies (10 mg/kg/day) were conducted with 14C-phenyl 
acequinocyl only. Excretion was rapid, with most of the dose in the 
feces. Less than 15% of the radioactivity was found in the urine. 
Absorption was about 25-42% based on the bile duct cannulation studies, 
which found 20-33% of the administered dose in bile, plus 5-9% in urine 
plus cage wash. Acequinocyl was not detected in urine and was only a 
minor component (1-2%) in the feces. The major fecal metabolite (12-
36%) was the 2-hydroxy-3-dodecyl-1,4-naphthalenedione (acequinocyl-OH 
or designated R1). Subsequent oxidation of the dodecyl chain yielded 
butanoic and hexanoic acids, the only measurable identified urinary 
metabolites. 2-(1,2-dioxotetradecyl)-benzoic acid comprised 19-40% of 
the radioactivity in the feces. There were no remarkable differences in 
metabolite disposition due to gender and no effect of pre-dosing for 2 
weeks. The large dose slowed transit time and reduced absorption.
    7. Metabolite toxicology. The toxicity of acequinocyl-OH is 
concurrently evaluated during toxicity testing because this metabolite 
is both a plant and animal metabolite and is formed in the course of 
toxicity tests and is considered not of toxicological concern.
    8. Endocrine disruption. A standard battery of toxicity tests have 
been conducted on acequinocyl. No effects were seen to indicate that 
acequinocyl has an effect on the endocrine system.

C. Aggregate Exposure

    1. Dietary exposure. Acute and chronic risk assessments were 
conducted to assess dietary exposures from acequinocyl in food using 
dietary exposure evaluation model (DEEM) and the following input 
parameters: Tolerance level residues (including a residue value of 0.3 
ppm for citrus dry pulp); consumption data from the United States 
Department of Agriculture (USDA) 1994-1998 Continuing Survey of Food 
Intakes by Individuals (CSFII); 100% crop treated for all commodities; 
default processing factors for all commodities; acute toxicological 
endpoint of 30.4 mg/kg body weight (bwt) no observed adverse effect 
level (NOAEL); 0.304 mg/kg bwt acute reference dose (RfD) from the 90-
day rat subchronic study; chronic toxicological endpoint of 2.7 mg/kg 
bwt NOAEL; 0.027 mg/kg bwt (chronic RfD) from the chronic mouse study.
    i. Food. Acute dietary food exposure estimates to acequinocyl were 
less than 100% of acute RfD for the total U.S. population at 2.21%, 
females 13-50 years at 1.43%, all infants (<1 year) at 4.81%, children 
1 to 6 years at 6.33%. The most highly exposed population was children 
1 to 3 years at 8.18%. The chronic dietary food exposure estimates to 
acequinocyl are less than 100% of chronic RfD for the total U.S. 
population at 5.6%, females 13-50 years at 3.0%, all infants (<1 year) 
at 12.4%. The most highly exposed population was children 1 to 6 years 
at 21.2%.
    ii. Drinking water. The available environmental fate data indicate 
that acequinocyl does not persist in the environment nor does it have 
the ability to leach into ground water resources. Acequinocyl degrades 
rapidly in the environment. Aqueous photolysis T1/2: 14 minutes, soil 
photolysis T1/2: 2 days, aerobic soil metabolism (4 soils) T1/2: <3 
days, aerobic aquatic metabolism T1/2: 0.39 day in water and sediment, 
hydrolysis T1/2: pH4 = 74 days, pH7 = 2.2 days, pH9 = 1.3 hours. 
Acequinocyl shows low soil mobility. Based on First Index Reservoir 
Screening Tool (FIRST) and screening concentration in ground water 
(SCI-GROW) models, for acute exposures, the drinking water estimated 
concentration (DWEC) of acequinocyl is estimated to be 1.561 parts per 
billion (ppb) for surface water and 0.006 ppb for ground water. The 
acute DWEC of 1.561 ppb is the peak day FIRST concentration. The DWEC 
for chronic exposures is estimated to be 0.024 ppb for surface water 
and 0.006 ppb for ground water. The chronic DWEC of

[[Page 8649]]

0.024 ppb is the annual average FIRST concentration. To determine 
drinking water exposure, drinking water levels of comparison (DWLOCs) 
were calculated and used as a point of comparison against the model 
estimates of the pesticide concentration in drinking water. For 
acequinocyl, the acute and chronic DWLOC values were greater than the 
estimated concentration DWEC in surface water and ground water for each 
population group. Therefore, exposures to acequinocyl in drinking water 
do not pose a significant human health risk.
    2. Non-dietary exposure. There are no residential uses for 
acequinocyl.

D. Cumulative Effects

    There is no information available to indicate that toxic effects 
produced by acequinocyl are cumulative with those of any other 
compound.

E. Safety Determination

    1. U.S. population. The acute dietary food exposure to acequinocyl 
was estimated at 2.21% of acute RfD for the total U.S. population. The 
calculated DWLOCs ranged from 2,791 to 10,405 ppb for all the 
population subgroups. The surface water and ground water DWECs for 
acequinocyl were estimated to be 1.561 ppb and 0.006 ppb, respectively. 
Since the acute DWECs are less than the DWLOCs for all population 
subgroups, the acute aggregate risk estimates are below the level of 
concern. The chronic dietary food exposure to acequinocyl was estimated 
at 5.6% of chronic RfD for total U.S. population. The calculated DWLOCs 
ranged from 213 to 892 ppb for all the population subgroups. The 
surface water and ground water DWECs for acequinocyl were estimated to 
be 0.024 ppb and 0.006 ppb, respectively. Since the chronic DWECs are 
less than the DWLOCs for all population subgroups, the chronic 
aggregate risk estimates are below the level of concern.
    2. Infants and children. The acute dietary food exposure to 
acequinocyl was estimated at 4.81% of acute RfD for all infants (<1 
year), 6.33% of acute RfD for children 1 to 6 and 8.18% of acute RfD 
for children 1 to 2 (most highly exposed). The calculated DWLOCs ranged 
from 2,791 to 10,405 ppb for all the population subgroups. The surface 
water and ground water DWECs for acequinocyl were estimated to be 1.561 
ppb and 0.006 ppb, respectively. Since the acute DWECs are less than 
the DWLOCs for all population subgroups including infants, the acute 
aggregate risk estimates are below the level of concern. The chronic 
dietary food exposure to acequinocyl was estimated at 12.4% of chronic 
RfD for all infants (<1 year), and 21.2% of chronic RfD for children 1 
to 6 (most highly exposed). The calculated DWLOCs ranged from 213 to 
892 ppb for all the population subgroups. The surface water and ground 
water DWECs for acequinocyl were estimated to be 0.024 ppb and 0.006 
ppb, respectively. Since the chronic DWECs are less than the DWLOCs for 
all population subgroups including infants, the chronic aggregate risk 
estimates are below the level of concern.

F. International Tolerances

    To date, no Codex, Canadian or Mexican tolerances exists for 
acequinocyl.
[FR Doc. 04-3936 Filed 2-24-04; 8:45 am]
BILLING CODE 6560-50-S