[Federal Register: February 25, 2004 (Volume 69, Number 37)]
[Notices]
[Page 8645-8649]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25fe04-60]
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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: mautz.marilyn@epa.gov.
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 opp-docket@epa.gov,
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