[Federal Register: July 21, 2004 (Volume 69, Number 139)]
[Rules and Regulations]
[Page 43525-43533]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21jy04-8]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0141; FRL-7364-1]
Acequinocyl; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for combined residues
of acequinocyl, 2-(acetyloxy)-3-dodecyl-1,4-naphthalenedione, and its
metabolite, 2-dodecyl-3-hydroxy-1,4-naphthoquinone, expressed as
acequinocyl equivalents in or on almond; almond, hulls; apple, wet
pomace; citrus, oil; fat and liver of cattle, goat, horse, and sheep;
fruit, citrus, group 10; fruit, pome, group 11; pistachio; and
strawberry. Arvesta Corporation requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective July 21, 2004. Objections and
requests for hearings must be received on or before September 20, 2004.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
ID number OPP-2004-0141. All documents in the docket are listed in the
EDOCKET index at http://www.epa.gov/edocket/. Although listed in the
index, some information is not publicly available, i.e., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically in EDOCKET or in hard copy at the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall 2, 1801 South Bell St., 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.
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), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
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 Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
A frequently updated electronic version of 40 CFR part 180
is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
II. Background and Statutory Findings
In the Federal Register of February 25, 2004 (69 FR 8645) (FRL-
7344-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP
2F6440 and 3F6596) by Arvesta Corporation, 100 First St., Suite 1700,
San Francisco, CA 94105. That notice included a summary of the
petitions prepared by Arvesta Corporation, the registrant. There were
no comments received in response to the notice of filing.
The petitions requested that 40 CFR part 180 be amended by
establishing tolerances for combined residues of the insecticide
acequinocyl, 3-dodecyl-1,4-dihydro-1,4-dioxo-2-naphthyl acetate, and
its metabolite, 2-dodecyl-3-hydroxy-1,4-naphthoquinone (acequinocyl-
OH), expressed as acequinocyl equivalents, in or on the listed
commodities as follows:
PP 2F6440: Fruit, pome group at 0.4 parts per million (ppm); apple, wet
pomace at1.0 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
The petition, PP 2F6440, was subsequently amended to: Increase the
tolerances for almond and pistachio from 0.01 ppm to 0.02 ppm; increase
the tolerance for almond hulls from 1.5 ppm to 2.0 ppm; to decrease the
tolerance for citrus fruit group from 0.3 ppm to 0.20 ppm; add separate
tolerances for fat and liver of goat, horse and sheep; withdraw the
proposed tolerances for milk, and meat and kidney of cattle; and to
correct the terms for certain commodities as summarized in the Table 1
of this unit.
The almond and pistachio tolerances were increased to account for
the combined limit of quantification (LOQ) of the residue analytical
method for the parent and its metabolite. The LOQ for each one is 0.01
ppm in/on each plant and livestock commodity, with the exception of
citrus oil, where the LOQ for each one is 0.5 ppm. The withdrawal of
the proposed milk, kidney and meat commodities and the addition of
other livestock commodities are based on the results of the submitted
cattle feeding study.
In addition, the chemical name is corrected from 3-dodecyl-1,4-
dihydro-1,4-dioxo-2-naphthyl acetate to 2-(acetyloxy)-3-dodecyl-1,4-
naphthalenedione to be consistent with the nomenclature used in the
Chemical Abstracts Chemical Substance Index, published by the American
Chemical Society.
[[Page 43526]]
Table 1.--Tolerance Summary
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Proposed tolerance (in
Commodity ppm) Amended (in ppm) Correct commodity term
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Almond 0.01 0.02
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Almond, hulls 1.5 2.0
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Apple, wet pomace 1.0
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Cattle, fat 0.02
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Cattle, kidney 0.01 Withdrawn
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Cattle, liver 0.02
--------------------------------------
Cattle, meat 0.01 Withdrawn
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Fruit, citrus, group 0.3 0.20 Fruit, citrus, group 10
--------------------------------------
Fruit, pome group 0.4 0.40 Fruit, pome, group 11
--------------------------------------
Goat, fat 0.02
--------------------------------------
Goat, liver 0.02
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Horse, fat 0.02
--------------------------------------
Horse, liver 0.02
--------------------------------------
Milk 0.01 Withdrawn
--------------------------------------
Orange, oil 30 Citrus, oil
--------------------------------------
Pistachio 0.01 0.02
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Sheep, fat 0.02
--------------------------------------
Sheep, liver 0.02
--------------------------------------
Strawberries 0.4 0.40 Strawberry
----------------------------------------------------------------------------------------------------------------
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for tolerances for combined residues of acequinocyl
and its metabolite, acequincyl-OH, on almond, pistachio, and the liver
and fat of cattle, horse, goat, and sheep at 0.02 ppm; almond hulls at
2.0 ppm; wet apple pomace at 1.0 ppm; citrus fruit crop group 10 at
0.20 ppm; citrus oil at 30 ppm; and pome fruit crop group 11 and
strawberry at 0.40 ppm. EPA's assessment of exposures and risks
associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by acequinocyl are
discussed in Table 2 of this unit as well as the no observed adverse
effect level (NOAEL) and the lowest observed adverse effect level
(LOAEL) from the toxicity studies reviewed.
[[Page 43527]]
Table 2.--Subchronic, Chronic, and Other Toxicity
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Guideline No. Study type Results
----------------------------------------------------------------------------------------------------------------
870.3100 90-Day oral toxicity-- NOAEL = Male/Female (M/F); 16/21
rodents; mouse milligrams/kilogram/day (mg/kg/day)
LOAEL = M/F; 81/100 mg/kg/day based on
hepatocyte vacuolation
----------------------------------------
870.3100 90-Day oral toxicity-- NOAEL = M/F; 30.4/32.2 mg/kg/day
rodents; rat LOAEL = M/F; 119.5/129.2 mg/kg/day based
on increased prothrombin times in males
and increased activated partial
thromboplastin times in both sexes
----------------------------------------
870.3150 90-Day oral toxicity-- NOAEL = M/F; 40/40 mg/kg/day
nonrodents LOAEL = M/F; 160/160 mg/kg/day based on
decreased body weight gains and reduced
food efficiencies in males and for female
beagle dogs based on increased platelet
counts
----------------------------------------
870.3200 21/28-Day dermal toxicity Systemic NOAEL = 200 mg/kg/day
Systemic LOAEL = 1,000 mg/kg/day based on
increased clotting factor times
Dermal NOAEL= 1,000 mg/kg/day
Dermal LOAEL not established
----------------------------------------
870.3700 Prenatal developmental-- Maternal NOAEL = 150 mg/kg/day
rodents Maternal LOAEL = 500 mg/kg/day based on
signs of internal hemorrhage and
increased incidence of clinical signs
(pale eyes, piloerection, red vaginal
discharge)
Developmental NOAEL = 500 mg/kg/day
Developmental LOAEL = 750 mg/kg/day based
on increased resorptions
----------------------------------------
870.3700 Prenatal developmental-- Maternal NOAEL = 60 mg/kg/day
nonrodents Maternal LOAEL = 120 mg/kg/day based on
treatment-related clinical signs leading
to premature sacrifice (hematuria,
reduced fecal output, body weight loss,
and reduced food consumption) and gross
necropsy findings (pale lungs and liver,
hemorrhaging uterus, fluid in the cecum,
fur in the stomach, blood stained vaginal
opening, blood-stained urinary bladder
contents/urine, and hair loss)
Developmental NOAEL = 60 mg/kg/day
Developmental LOAEL =120 mg/kg/day based
on increased number of complete
resorptions
----------------------------------------
870.3800 Reproduction and fertility Parental/Systemic NOAEL = M/F; 7.3/134 mg/
effects kg/day
Parental/Systemic LOAEL = Males; 58.9 mg/
kg/day based on increased incidences of
hemorrhagic effects in F1 males.
Parental/Systemic LOAEL was not
established for females
Reproductive NOAEL = M/F; 124/136 mg/kg/
day
Reproductive LOAEL = was not established
Offspring NOAEL = M/F; 7.3/8.7 mg/kg/day
Offspring LOAEL = M/F; 58.9/69.2 mg/kg/day
based on hemorrhagic effects, swollen
body parts, protruding eyes, clinical
signs, delay in pupil development, and
increased mortality post weaning
----------------------------------------
870.4100 Chronic toxicity--dogs NOAEL = M/F; 80/80 mg/kg/day
LOAEL = M/F; 320/320 mg/kg/day based on
premature sacrifice (inappetence, body
weight loss)
----------------------------------------
870.4300 Combined chronic/ NOAEL = M/F; 2.25/46.20 mg/kg/day
carcinogenicity--rats LOAEL = M/F; 9.02/93.56 mg/kg/day based on
enlarged eyeballs in male and female rats
(coagulopathy)
No evidence of carcinogenicity
----------------------------------------
870.4300 Combined chronic/ NOAEL = M/F; 2.7/3.5 mg/kg/day
carcinogenicity--mouse LOAEL = M/F; 7.0/8.7 mg/kg/day based on
clinical chemistry and microscopic
nonneoplastic lesions (brown pigmented
cells and perivascular inflammatory cells
in liver)
No evidence of carcinogenicity
----------------------------------------
870.5100 Gene mutation There was no evidence of induced mutant
colonies over background
----------------------------------------
870.5300 Gene mutation There was no clear evidence of
biologically significant induction of
mutant colonies over background
----------------------------------------
870.5375 Chromosome aberration There was no evidence of chromosome
aberrations induced over background
----------------------------------------
870.5395 Mammalian erythrocyte There was no statistically significant
micronucleus test in mice increase in the frequency of
micronucleated polychromatic erythrocytes
in mouse bone marrow at any dose or
harvest time
----------------------------------------
[[Page 43528]]
870.7485 Metabolism and Acequinocyl exhibits marginal absorption,
pharmacokinetics relatively rapid and complete excretion
primarily via the bile and feces, and
undergoes nearly complete metabolism to
hydrolysis products and a glucuronide
conjugate. There was no evidence for
selective tissue accumulation or
sequestration of acequinocyl or its
metabolites in rats
----------------------------------------
870.7600 Dermal penetration Percent of dose absorbed decreased with
exposure concentration indicating that
saturation of absorption at/or about the
high dose. Absorption at 168 hours was
12.23%, 19.75%, and 14.77% for the 0.1,
0.01, and 0.001 mg/centimeter squared
(cm\2\ dose groups, respectively
----------------------------------------------------------------------------------------------------------------
B. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
Three other types of safety or uncertainty factors may be used:
``Traditional uncertainty factors;'' the ``special FQPA safety
factor;'' and the ``default FQPA safety factor.'' By the term
``traditional uncertainty factor,'' EPA is referring to those
additional uncertainty factors used prior to FQPA passage to account
for database deficiencies. These traditional uncertainty factors have
been incorporated by the FQPA into the additional safety factor for the
protection of infants and children. The term ``special FQPA safety
factor'' refers to those safety factors that are deemed necessary for
the protection of infants and children primarily as a result of the
FQPA. The ``default FQPA safety factor'' is the additional 10X safety
factor that is mandated by the statute unless it is decided that there
are reliable data to choose a different additional factor (potentially
a traditional uncertainty factor or a special FQPA safety factor).
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by an UF of
100 to account for interspecies and intraspecies differences and any
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF).
Where a special FQPA safety factor or the default FQPA safety factor is
used, this additional factor is applied to the RfD by dividing the RfD
by such additional factor. The acute or chronic Population Adjusted
Dose (aPAD or cPAD) is a modification of the RfD to accommodate this
type of safety factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk). An example of how such a probability risk is expressed
would be to describe the risk as one in one hundred thousand (1 X
10-\5\), one in a million (1 X 10-\6\), or 1 in
10 million (1 X 10-\7\). Under certain specific
circumstances, MOE calculations will be used for the carcinogenic risk
assessment. In this non-linear approach, a ``point of departure'' is
identified below which carcinogenic effects are not expected. The point
of departure is typically a NOAEL based on an endpoint related to
cancer effects though it may be a different value derived from the dose
response curve. To estimate risk, a ratio of the point of departure to
exposure (MOEcancer = point of departure/exposures) is
calculated.
A summary of the toxicological endpoints for acequinocyl used for
human risk assessment is shown in Table 3 of this unit:
Table 3.--Summary of Toxicological Dose and Endpoints for Acequinocyl for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose used in risk
assessment, Special FQPA SF and
Exposure scenario interspecies and level of concern for Study and toxicological
intraspecies and any risk assessment effects
iraditional UF
----------------------------------------------------------------------------------------------------------------
Acute dietary Not applicable None An endpoint of concern
attributable to a
single dose was not
identified. An aRfD
was not established
--------------------------------------
[[Page 43529]]
Chronic dietary NOAEL = 2.7 FQPA SF = 1X 18-month
(all populations).................... UF = 100X.............. \1\ cPAD = 0.027....... carcinogenicity study
cRfD = 0.027........... in mice;
LOAEL = 7.0 mg/kg/day
based on clinical
chemistry and
microscopic
nonneoplastic lesions
(brown pigmented cells
and perivascular
inflammatory cells in
liver)
----------------------------------------------------------------------------------------------------------------
NOTE: UF = uncertainty factor; FQPA SF = special FQPA safety factor; NOAEL = no observed adverse effect level;
LOAEL = lowest observed adverse effect level; PAD = population adjusted dose (c = chronic) RfD = reference
dose.
\1\ cPAD = cRfD/FQPA SF.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. There are no
tolerances established for residues of acequinocyl. Risk assessments
were conducted by EPA to assess dietary exposures from acequinocyl in
food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a one-day
or single exposure.
An acute exposure assessment is unnecessary because no such effect
was seen in the submitted studies.
ii. Chronic exposure. In conducting the chronic dietary risk
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates
food consumption data as reported by respondents in the USDA 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII), and accumulated exposure to the chemical for each commodity.
The following assumptions were made for the chronic exposure
assessments: Tolerance-level residues, DEEM\TM\ ver. 7.76 default
processing factors, and 100 percent crop treated (%CT) data were used
in the chronic dietary assessment.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for acequinocyl in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of acequinocyl.
The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS) to produce estimates of pesticide concentrations in an index
reservoir. The Screening Ground Water (SCI-GROW) model is used to
predict pesticide concentrations in shallow ground water. For a
screening-level assessment for surface water EPA will use FIRST (a tier
1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a
subset of the PRZM/EXAMS model that uses a specific high-end runoff
scenario for pesticides. Both FIRST and PRZM/EXAMS incorporate an index
reservoir environment, and both models include a percent crop area
factor as an adjustment to account for the maximum percent crop
coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a screen for sorting out pesticides for which it is
unlikely that drinking water concentrations would exceed human health
levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs), which are the model estimates of a
pesticide's concentration in water. EECs derived from these models are
used to quantify drinking water exposure and risk as a %RfD or %PAD.
Instead, drinking water levels of comparison (DWLOCs) are calculated
and used as a point of comparison against the model estimates of a
pesticide's concentration in water. DWLOCs are theoretical upper limits
on a pesticide's concentration in drinking water in light of total
aggregate exposure to a pesticide in food and from residential uses.
Since DWLOCs address total aggregate exposure to acequinocyl they are
further discussed on the aggregate risk in Unit III.E.
Based on the PRZM/EXAMS and SCI-GROW models, the EECs of
acequinocyl for chronic exposures are estimated to be 0.24 parts per
billion (ppb) for surface water and 0.003 ppb for ground water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Acequinocyl is not registered for use on any sites that would
result in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to acequinocyl and any other
substances and acequinocyl does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that acequinocyl has a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA's OPP concerning
common mechanism determinations and procedures for cumulating effects
from substances found to have a common mechanism on EPA's web site at
http://www.epa.gov/pesticides/cumulative/.
[[Page 43530]]
D. Safety Factor for Infants and Children
1.In general. Section 408 of FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. There is no evidence of
increased susceptibility of rat or rabbit fetuses to in utero exposure
to acequinocyl. And, there is no qualitative and/or quantitative
evidence of increased susceptibility to acequinocyl following pre/
postnatal exposure in a 2-generation reproduction study in rats. There
is no concern for developmental neurotoxicity resulting from exposure
to acequinocyl; a DNT study is not required.
There is an apparent qualitative increase in susceptibility in the
rat and rabbit developmental studies as indicated by increases in
resorptions that occurred at the same or higher dose that caused
maternal toxicity, but the concern is low since:
The fetal effects were noted in the presence of maternal
toxicity.
There are no residual uncertainties for pre- and/or
postnatal toxicity since the database is complete.
Effects that could be indicative of neurotoxicity were shown in two
studies, the 2-generation reproduction study and the subchronic rat
oral toxicity study. In the 2-generation reproduction study,
significant reduction in startle response in F2 pups was observed in
high-dose groups (58.9/69.2 mg/kg/day and 111.2/133.5 mg/kg/day). In
the subchronic rat oral toxicity study, neurotoxicity signs such as
decreased motor activity, piloerection, and hunched posture were noted
at the high dose 252.7/286.0 mg/kg/day.The concern is low since:
EPA considered these effects as secondary as they were
observed at very high doses.
Other functional development tests (such as pupillary
reflex test at 21 days post partum, an open field exploration test at
35-48 days post partum and a water-maze test with a learning phase and
a memory phase at 35-48 days post partum) that were performed on pups
did not show significant differences as compared to control values even
at the highest dosage level.
Acequinocyl is a known Vitamin K antagonist; neurotoxic
compounds of similar structure were not identified.
3. Conclusion. There is a complete toxicity database for
acequinocyl and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures.
In evaluating whether to retain the 10X SF to protect infants and
children or to select a different safety factor, EPA considered the
following factors:
i. There are no special concerns regarding pre- or postnatal
toxicity exposure.
ii. The exposure databases (food and drinking water) are complete
and/or employ conservative assumptions.
iii. There is no residential exposure.
iv. The risk assessments cover or approximate all the metabolites
and degradates of concern.
v. The assessments do not underestimate the potential risk for
infants and children.
vi. The toxicity database is complete.
Therefore, it is concluded that 1X is adequate to protect infants
and children.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against EECs. DWLOC values are
not regulatory standards for drinking water. DWLOCs are theoretical
upper limits on a pesticide's concentration in drinking water in light
of total aggregate exposure to a pesticide in food and residential
uses. In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water [e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure)]. This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the EPA's Office of Water are used to calculate
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and
1L/10 kg (child). Default body weights and drinking water consumption
values vary on an individual basis. This variation will be taken into
account in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, OPP will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. Acequinocyl is not expected to pose an acute risk
because no acute effects were observed in the submitted studies.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
acequinocyl from food will utilize 4.2% of the cPAD for the U.S.
population, 14% of the cPAD for all infants less than 1 year old, and
23 % of the cPAD for children 1-2 years old. There are no residential
uses for acequinocyl that result in chronic residential exposure to
acequinocyl. In addition, there is potential for chronic dietary
exposure to acequinocyl in drinking water. After calculating DWLOCs and
comparing them to the EECs for surface and ground water, EPA does not
expect the aggregate exposure to exceed 100% of the cPAD, as shown in
Table 4 of this unit:
[[Page 43531]]
Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Acequinocyl
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population subgroup cPAD mg/kg/ %cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.027 4.2 0.24 0.003 910
------------------------------------------------
All infants < =1year old 0.027 14 0.24 0.003 230
------------------------------------------------
Children 1-2 years old 0.027 23 0.24 0.003 210
------------------------------------------------
Children 3-5 years old 0.027 15 0.24 0.003 230
------------------------------------------------
Children 6- 12 years old 0.027 6.5 0.24 0.003 250
------------------------------------------------
Youth 13-19 years old 0.027 3.2 0.24 0.003 780
------------------------------------------------
Adults 20-49 years old 0.027 2.1 0.24 0.003 920
------------------------------------------------
Females 13-19 years old 0.027 2.3 0.24 0.003 790
------------------------------------------------
Adults 50+ yeas old 0.027 2.4 0.24 0.003 920
----------------------------------------------------------------------------------------------------------------
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background-exposure level).
Acequinocyl is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Acequinocyl is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.
5. Aggregate cancer risk for U.S. population. Acequinocyl is
classified as not likely to be carcinogenic to humans and thus is not
expected to pose a cancer risk.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to acequinocyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Method validation data support the following two plant methods and
a livestock method: A high-performance liquid chromatography (HPLC)/
mass spectrometry (MS)/MS method (Morse Laboratories Method
Meth-133, revision 3) for determining residues of
acequinocyl and acequinocyl-OH in/on fruit commodities; an HPLC/MS/MS
method (Morse Laboratories Method Meth-135) for determining
residues of acequinocyl and acequinocyl-OH in/on almonds hulls and nut
meats; and an HPLC/MS/MS method (Morse Laboratories Method
Meth-139, Revision 2) for determining residues of
acequinocyl and acequinocyl-OH in fat, milk, meat, and meat-by-
products.
Methods Meth-135 and Meth-133, Revision
3 have each undergone successful independent laboratory
validation (ILV) trials. An ILV is not required for Method
Meth-139, Revision2 because the aforementioned ILV's
should be sufficient to cover this method based on the similarity of
all three methods.
Based on the available method validation data, these methods are
adequate for collecting residue data in/on livestock commodities, milk,
pome and citrus fruit commodities, strawberries, and tree nuts.
Additional confirmatory methods for plants and livestock and
specificity testing of the analytical enforcement methods for plants
and livestock are required as conditions of registration. The validated
LOQ for both acequinocyl and acequinocyl-OH is 0.01 ppm in/on each
plant and livestock commodity, with the exception of citrus oil. The
LOQ for each analyte in citrus oil is 0.5 ppm.
The methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no established or proposed Codex, Canadian, or Mexican
maximum residue limits (MRLs) for acequinocyl.
C. Conditions
The following information must be submitted as conditions for
product registration related to these tolerances: the registrant will
be required to submit additional confirmatory enforcement analytical
methods and specificity testing for plants and livestock; a confined
rotational crop study; and a new livestock storage stability study.
V. Conclusion
Therefore, the tolerances are established for combined residues of
acequinocyl and its metabolite 2-dodecyl-3-hydroxy-1,4-naphthoquinone
expressed as acequinocyl equivalents, in or on almond, pistachio, and
fat and liver of cattle, goat, horse and sheep at 0.02 ppm; on almond
hulls at 2.0 ppm; wet apple pomace at 1.0 ppm; fruit, citrus, group 10
at 0.2 ppm; citrus oil at 30 ppm; and fruit, pome, group 11 and
strawberry at 0.40 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. Although the procedures in those regulations require
some modification to reflect the amendments made to FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of FFDCA provides essentially the same process for persons to
``object'' to a regulation for an exemption from the requirement of a
tolerance issued by EPA under new
[[Page 43532]]
section 408(d) of FFDCA, as was provided in the old sections 408 and
409 of FFDCA. However, the period for filing objections is now 60 days,
rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2004-0141in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk on or before September 20,
2004.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14\th\ Street NW,
Washington, DC. The Office of the Hearing Clerk is open from 8 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Office of the Hearing Clerk is (202) 5646255-.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to PIRIB for its inclusion in
the official record that is described in ADDRESSES. Mail your copies,
identified by docket ID number OPP-2004-0141, to: Public Information
and Records Integrity Branch, Information Resources and Services
Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of PIRIB
described in ADDRESSES. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that
[[Page 43533]]
have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 1, 2004.
James Jones,
Director, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.599 is added to subpart C to read as follows:
Sec. 180.599 Acequinocyl; tolerances for residues.
(a) General. Tolerances for combined residues of the insecticide
acequinocyl, 2-(acetyloxy)-3-dodecyl-1,4-naphthalenedione, and its
metabolite, 2-dodecyl-3-hydroxy-1,4-naphthoquinone, expressed as
acequinocyl equivalents in or on the following commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Almond..................................................... 0.02
Almond, hulls.............................................. 2.0
Apple, wet pomace.......................................... 1.0
Cattle, fat................................................ 0.02
Cattle, liver.............................................. 0.02
Citrus, oil................................................ 30
Fruit, citrus, group 10.................................... 0.20
Fruit, pome, group 11...................................... 0.40
Goat, fat.................................................. 0.02
Goat, liver................................................ 0.02
Horse, fat................................................. 0.02
Horse, liver............................................... 0.02
Pistachio.................................................. 0.02
Sheep, fat................................................. 0.02
Sheep, liver............................................... 0.02
Strawberry................................................. 0.40
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 04-16213 Filed 7-20-04; 8:45 am]
BILLING CODE 6560-50-S