[Federal Register: July 13, 2005 (Volume 70, Number 133)]
[Rules and Regulations]
[Page 40202-40212]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13jy05-8]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0075; FRL-7714-3]
Spirodiclofen; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
spirodiclofen (3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-
yl 2,2-dimethylbutanoate) in or on grape; grape, raisin; grape, juice;
fruit, citrus, crop group 10; citrus, oil; citrus, juice; fruit, pome,
crop group 11; apple, wet pomace; fruit, stone, crop group 12; nut,
tree, crop group 14; almond, hulls; and pistachio; and for residues of
spirodiclofen and its free enol metabolite (3-(2,4-dichlorophenyl)-4-
hydroxy-1-oxaspiro[4,5]dec-3-en-2-one) in or on cattle, fat; cattle,
meat byproducts; cattle, meat; goat, fat; goat, meat byproducts; goat,
meat; sheep, fat; sheep, meat byproducts; sheep, meat; horse, fat;
horse, meat byproducts; horse, meat; milk; and milk, fat. Bayer
CropScience 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 13, 2005. Objections and
requests for hearings must be received on or before September 12, 2005.
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
identification (ID) number OPP-2005-0075. 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.,
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 Mall2, 1801 S. 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: Rita Kumar, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8291; e-mail address:kumar.rita@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 at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
To access the OPPTS Harmonized Guidelines referenced in this document,
go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/
.
II. Background and Statutory Findings
In the Federal Register of February 18, 2004 (69 FR 7632) (FRL-
7343-2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
2F6469) by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014,
Research Triangle Park, NC 27709. The petition requested that 40 CFR
part 180 be amended by establishing a tolerance for residues of the
insecticide spirodiclofen (3-(2,4-dichlorophenyl)-2-oxo-1-
oxaspiro[4,5]dec-3]-en-4-yl 2,2-dimethylbutanoate), in or on citrus
fruit group at 0.3 parts per million (ppm), citrus pulp, dried, at 0.4
ppm, citrus oil at 20 ppm, pome fruit group at 0.8 ppm, pome fruit
pomace, wet, at 6.0 ppm, stone fruit group at 1.0 ppm, tree nut group
at 0.05 ppm, almond hulls at 20 ppm, pistachios at 0.05 ppm, grape at
2.0 ppm and grape, raisin at 4.0 ppm; and for combined residues of
spirodiclofen (3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3]-en-4-
yl 2,2-dimethylbutanoate), and/or its enol metabolite, 3-(2,4-
dichlorophenyl)-4-hydroxy-1-oxaspiro[4,5]dec-3-en-2-one, in or on
cattle, fat, at 0.01 ppm and cattle, meat by-products, at 0.05 parts
per million (ppm). That notice included a summary of the petition
prepared by Bayer CropScience, the registrant. There were no comments
received in response to the notice of filing.
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
[[Page 40203]]
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 a tolerance for residues of spirodiclofen on
grape at 2.0 ppm; grape, raisin at 4.0 ppm; grape, juice at 2.4 ppm;
citrus, fruit, crop group 10 at 0.50 ppm; citrus, oil at 20 ppm;
citrus, juice at 0.60 ppm; fruit, pome, crop group 11 at 0.80 ppm;
apple, wet pomace at 2.0 ppm; fruit, stone, crop group 12 at 1.0 ppm;
nut, tree, crop group 14 at 0.10 ppm; almond, hulls at 20 ppm;
pistachio at 0.10 ppm; and for combined residues of spirodiclofen and
its free enol metabolite BAJ 2510 in or on cattle, meat and cattle, fat
at 0.02 ppm; cattle, meat byproducts at 0.10 ppm; goat, meat and goat,
fat at 0.02 ppm; goat, meat byproducts at 0.10 ppm; sheep, meat and
sheep, fat at 0.02 ppm; sheep, meat byproducts at 0.10 ppm; horse, meat
and horse, fat at 0.02 ppm; horse, meat byproducts at 0.10 ppm; milk at
0.01 ppm, and milk, fat at 0.03 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.
Spirodiclofen has low acute toxicity via oral, dermal, or
inhalation route. It is not an eye or dermal irritant. However, it is a
potential skin sensitizer. The nature of the toxic effects caused by
spirodiclofen are discussed in Table 1 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.
Table 1.--Subchronic, Chronic, and Other Toxicity Profile for
Spirodiclofen
------------------------------------------------------------------------
Guideline No. Study Type Results
------------------------------------------------------------------------
870.3100 Subchronic oral - For males, NOAEL =
rat 32.1 milligram/
kilogram/day (mg/
kg/day), LOAEL =
166.9 mg/kg/day
based on
increased
incidence and
severity of small
cytoplasmic
vacuolation in
the cortex of
adrenal glands,
decreased
cholesterol (week
5 and 13), and
decreased
triglycerides
(week 5),
For females, NOAEL
= 8.1 mg/kg/day,
LOAEL = 47.1 mg/
kg/day based on
increased
incidence of
small cytoplasmic
vacuolation in
the cortex of
adrenal glands
---------------------------------
870.3100 Subchronic oral - For males, NOAEL =
mouse 15 mg/kg/day,
LOAEL= 164 mg/kg/
day based on an
increased
incidence of
hypertrophic
Leydig cells in
the testes
For females, NOAEL
= 30 mg/kg/day,
LOAEL = 234 mg/kg/
day based on an
increased
incidence of
cytoplasmic
vacuolation of
the adrenal
cortex
---------------------------------
870.3150 Subchronic oral - For males, NOAEL =
dog 7.7 mg/kg/day,
LOAEL = 26.6 mg/
kg/day based on
decreased body
weight gains,
increased liver
and adrenal
weights,
decreased
prostate weights,
and
histopathology
findings in the
adrenal glands,
testes,
epididymis,
thymus, and
prostates
For females, NOAEL
< =8.4 mg/kg/day.
LOAEL = 8.4 mg/kg/
day based on
increased adrenal
gland weight (two
out of four
animals) which
coincided with
histopathology
findings
(cytoplasmic
vacuoles in the
Zona fasciculata
of the adrenal
glands)
---------------------------------
[[Page 40204]]
870.3200 21-Day dermal NOAEL is 1,000 mg/
toxicity - rat kg/day (highest
dose tested
(HDT)); however,
the
histopathology
was not
appropriately
conducted as
required by the
guideline. The
study did not
examine all of
the tissues,
especially the
possible target
organs (i.e.,
uterus, prostate,
etc)
---------------------------------
870.3700 Prenatal Maternal: NOAEL =
developmental - 1,000 mg/kg/day
rat (HDT)
Developmental:
NOAEL = 300 mg/kg/
day, LOAEL =
1,000 mg/kg/day
based on an
increased
incidence of
slight dilatation
of the renal
pelvis
---------------------------------
870.3700 Prenatal Maternal: NOAEL =
developmental - 100 mg/kg/day,
rabbit LOAEL = 300 mg/kg/
day based on body
weight loss and
decreased food
consumption
Developmental:
NOAEL = 1,000 mg/
kg/day (HDT)
---------------------------------
870.3800 Reproduction and Parental/system:
fertility effects For males: NOAEL =
- rat 5.2-6.4 mg/kg/
day, LOAEL = 26.2-
30.2 mg/kg/day
based on
decreased body
weight in F
males; decreased
absolute and
relative liver
weight in F0
males; decreased
cholesterol and
triglycerides in
F1 males; and
increased
severity of
adrenal cortical
vacuolation in F1
males. For
females, NOAEL =
5.5-7.0 mg/kg/
day, LOAEL = 27.6-
34.4 mg/kg/day
based on
decreased
unesterified
fatty acids in F1
females, and
increased
severity of
adrenal cortical
vacuolation in F0
and F1 females
Reproductive:
For males: NOAEL =
26.2-30.2 mg/kg/
day, LOAEL =
134.8- 177.6 mg/
kg/day based on
delayed sexual
maturation;
decreased
testicular
spermatid and
epididymal sperm
counts
(oligospermia);
and atrophy of
the testes,
epididymides,
prostate and
seminal vesicles.
For females:
NOAEL = 27.6-34.4
mg/kg/day, LOAEL
= 139.2-192.7 mg/
kg/day based on
increased
severity of
ovarian luteal
cell vacuolation/
degeneration
Offspring:
NOAEL = 5.2-6.4
(M)/5.5-7.0 (F)
mg/kg/day, LOAEL
= 26.2-30.2 (M)/
27.6-34.4(F) mg/
kg/day based on
decreased body
weight and weight
gain in F1 male
and female pups
---------------------------------
870.4100 Chronic toxicity - NOAEL = 1.38 (M)/
dog 1.52(F) mg/kg/
day, LOAEL =
4.33(M)/4.74 (F)
mg/kg/day based
on increased
relative adrenal
weights in both
sexes, increased
relative testis
weight in males
and
histopathology
findings in the
adrenal gland of
both sexes
---------------------------------
[[Page 40205]]
870.4200 Carcinogenicity - NOAEL = 4.1(M)/
mouse 5.1(F) mg/kg/day,
LOAEL = 610 (M)
mg/kg/day based
on increased
absolute and
relative liver
and adrenal
weights,
decreased
absolute and
relative kidney
weight, enlarged
adrenal gland,
discolored
testis, adrenal
gland
vacuolization,
interstitial cell
degeneration of
the testes. For
females, LOAEL =
722 mg/kg/day
based on
increased
absolute and
relative adrenal
weight, decreased
absolute and
relative kidney
weight, increased
incidences of
adrenal gland
pigmentation, and
adrenal
vacuolization.
Hepatocellular
adenoma and
carcinoma
---------------------------------
870.4300 Chronic toxicity - For males: NOAEL =
rat 14.7 mg/kg/day,
LOAEL = 110.1 mg/
kg/day based on
decreased body
weights,
decreased body
weight gain,
increased APh
levels, decreased
cholesterol and
triglyceride
levels, increased
vacuolated
jejunum
enterocytes, and
increased
incidences of
Leydig cell
hyperplasia
For females: NOAEL
= 19.9 mg/kg/day,
LOAEL = 152.9 mg/
kg/day based on
decreased body
weights,
decreased body
weight gain,
increased APh
levels, increased
TSH, uterus
nodules, and
increased
vacuolated
jejunum
enterocytes
testes Leydig cell
adenoma in males,
uterine adenoma
and/or
adenocarcinoma in
females
---------------------------------
870.5100 Gene mutation - There was no
Salmonella evidence of
typhimurium increased
revertant
colonies above
control in 5
Salmonella
strains (TA1535,
TA1537, TA1538,
TA100, TA98)
S9
at concentrations
up to 5,000 [mu]g/
plate
---------------------------------
870.5300 In vitro mammalian Negative, tested
gell gene in Chinese
mutation Hamster lung
fibroblast V79
cells at
concentrations up
to 300 [mu]g/mL -
S9 and +S9.
Cytotoxicity was
observed at >=15
[mu]g/mL -S9 and
80 [mu]g/mL +S9
---------------------------------
870.5375 In vitro mammalian Negative, tested
chromosome in Chinese
aberration hamster lung
(V79) cells at
concentrations 5-
80 [mu]g/mL or
0.75-12 [mu]g/mL
S9 or 10-160
[mu]g/mL +S9
---------------------------------
870.5395 In vivo mouse bone Negative, tested
morrow at a dose 800 mg/
micronucleus kg (MTD).
Clinical signs
and cytotoxicity
were seen at 800
mg/kg
---------------------------------
870.6200 Acute NOAEL = 2,000 mg/
neurotoxicity - kg/day, no
rat neurotoxicity
observed
---------------------------------
870.6200 Subchronic NOAEL = 70.3(M)/
neurotoxicity - 87.3(F) mg/kg/
rat day. LOAEL =
1088.8(M)/
1306.5(F) mg/kg/
day based on
decreased body
weights, food
consumption, and
increased urine
staining in both
sexes and
decreased motor
and locomotor
activity (week 4)
in females only
---------------------------------
[[Page 40206]]
870.6300 Developmental Maternal NOAEL =
neurotoxicity 135.9/273.8 mg/kg/
day
LOAEL = Not
established
Offspring NOAEL =
Not established
LOAEL = 6.5/14.0
mg/kg/day based
on effects in
memory phase of
the water maze
test in PND 60
females
The study
classification is
reserved for the
guideline
requirement
pending receipt
of additional
morphometric
measurements for
the low and mid
dose groups
------------------------------------------------------------------------
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 one in ten
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 spirodiclofen used for
human risk assessment is shown in Table 2 of this unit:
Table 2.--Summary of Toxicological Dose and Endpoints for Spirodiclofen for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Special FQPA SF* and
Exposure Scenario Dose Used in Risk Level of Concern for Study and Toxicological
Assessment, UF Risk Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary Acute RfD = Not An effect of concern attributable to a single
established dose was not identified
--------------------------------------
Chronic dietary (all populations) LOAEL = 6.5 mg/kg/day FQPA SF = 1X Developmental
UF = 1,000............. cPAD = Chronic RfD/FQPA Neurotoxicity Study -
Chronic RfD = 0.0065 mg/ SF = 0.0065 mg/kg/day. Rat
kg/day. LOAEL of 6.5 mg/kg/day
based on decreased
retention (memory) in
females on day 60 in
the water maze at all
doses
--------------------------------------
Cancer (Oral, dermal, inhalation) Classification: ``Likely to be Carcinogenic to Humans'' with Q1* (mg/kg/
day)-1 = 1.49 x 10-2
----------------------------------------------------------------------------------------------------------------
[[Page 40207]]
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have not
been established for (40 CFR 180.000) for the residues of
spirodiclofen, in or on a variety of raw agricultural commodities. Risk
assessments were conducted by EPA to assess dietary exposures from
spirodiclofen in food as follows:
i. Acute exposure. Acute quantitative 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 1-day or single exposure. No appropriate single-dose endpoint was
available for the acute oral exposure of the general population,
including infants and children. Therefore, an acute quantitative
dietary assessment was not performed.
ii. Chronic exposure. In conducting the chronic and cancer dietary
risk assessment EPA used the Lifeline (version 2.0) and Dietary
Exposure Evaluation Model software with the Food Commodity Intake
Database (DEEM-FCID\TM\), both of 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:
The chronic and cancer analyses were refined through the use of average
field trial residues, experimentally determined processing factors, and
projected average percent crop treated estimates. These averages were
based on the typical average of all insecticides used to control all
pests on the specific crop.
The projected average percent crop treated estimates were provided
for apple, peach, grape, orange, and grapefruit. These averages were
based on the typical average of all insecticides used to control all
pests on the specific crop. The Agency determined that it is
appropriate to translate the projected percent crop treated estimates
for peach, apple, and grapefruit to the remaining crops in the stone
fruit, pome fruit, and citrus crop groups, respectively.
Since the analysis made use of average residues derived from crop
field trial studies (maximum application rate and minimum preharvest
interval (PHI)), incorporated maximum theoretical processing factors
for juice, and surface drinking water estimates which assumed 87% of
the basin cropped and 100% of the cropped area treated at the maximum
rate (citrus, pecan, apple, peach, and grape), the Agency concluded
that the exposure estimates are unlikely to underestimate actual
exposure.
iii. Cancer. The Agency has classified spirodiclofen as ``likely to
be carcinogenic to humans.'' Quantification of cancer risk used a
Q1*(mg/kg/day)-1 of 1.49 x 10-2 in
human equivalents based on male rat testes Leydig cell adenoma.
As indicated above, the chronic and cancer analyses incorporated
average field trial residues; processing factors from the apple, grape,
plum, and orange processing studies (DEEM-FCID\TM\ (ver. 7.76) default
processing factors assumed for juice commodities); projected average
percent crop treated estimates; and the SCI-GROW and/or PRZM-EXAMS
drinking water estimates.
DEEM-FCID\TM\ resulted in similar chronic and cancer risk estimates
(all included drinking water), but due to differing drinking water
assumptions, the result was a higher risk estimate using DEEM-FCID\TM\.
Based on a critical commodity analysis conducted in DEEM-FCID\TM\, the
major contributors to the cancer risk were water (34% of the total
exposure), orange (20% of the total exposure) and apple (16% of the
total exposure).
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data on
the actual percent of food treated for assessing chronic dietary risk
only if the Agency can make the following findings: Condition 1, that
the data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit
data on PCT.
The Agency used PCT information as follows:
A routine chronic dietary exposure analysis for spirodiclofen was
based on projected PCT for the following crops: Grapefruit - 20%;
oranges except temple - 10%; grapes - 4%; peaches - 12%; apples - 13%.
These are typical averages of all insecticides used to control all
pests on the specific crop, taken from the Agricultural Chemical Usage
2003 Fruit Summary report published by United States Department of
Agriculture National Agriculture Statistics Service (USDA/NASS). The
projected percent crop treated estimates for peach, apple, and
grapefruit were applied to the remaining crops in the stone fruit, pome
fruit, and citrus crop groups, respectively.
The Agency believes that the three conditions previously discussed
have been met. With respect to Condition 1, EPA finds that the PCT
information described in Unit. C for spirodiclofen is reliable and has
a valid basis. These are average usage figures of all insecticides used
on the crops in question. EPA has not taken into account whether the
insecticide use was directed against the pest that spirodiclofen
controls but instead has averaged each insecticide's total usage. Thus,
these averages are likely to overstate spirodiclofen use because many
insecticides are effective against several pests and total usage of
these pesticides will be significantly higher than an insecticide, such
as spirodiclofen, which is used primarily against a single pest. For
acute risk assessment, the highest percentages of the insecticide used
on the specific crop without naming a specific pest, taken from USDA/
NASS Agricultiral Chemical Usage 2003 Fruit Summary was used. This
indicates the maximum use of an insecticide. Spirodiclofen use could be
much lower than this because its use is targeted at a single pest and
there exist other equally efficacious pesticides, that treat mites
only, that are priced competitively with spirodiclofen. As to
Conditions 2 and 3, regional consumption information and consumption
information for significant subpopulations is taken into account
through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which spirodiclofen
may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure
[[Page 40208]]
analysis and risk assessment for spirodiclofen 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 spirodiclofen.
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 Concentrations in Groundwater (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.
Based on the PRZM/EXAMS and SCI-GROW models, the EECs of
spirodiclofen (total residue including its three metabolites:
Spirodiclofen-enol, spirodiclofen-ketohydroxy, and spirodiclofen-
dihydroxy) for acute exposures are estimated to be 22.86 parts per
billion (ppb) for surface water and 0.44 ppb for ground water. The EECs
for chronic (non-cancer) exposures are estimated to be 4.99 ppb for
surface water and 0.44 ppb for ground water. The EECs for chronic
(cancer) exposures are estimated to be 1.67 ppb for surface water and
0.44 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). Spirodiclofen 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 spirodiclofen and any
other substances and spirodiclofen 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 spirodiclofen 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/.
D. Safety Factor for Infants and Children
1. In general. Section 408 of the 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 data base 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 following in utero and/or prenatal/postnatal
exposure in the developmental toxicity studies in rabbits and 2-
generation reproduction studies in rats.
In the DNT study, toxicity in the offspring (effects in the memory
phase of the water maze test at post natal day 60 in females) was
observed in the absence of maternal toxicity, indicating increased
susceptibility.
3. Conclusion. The 10X FQPA Safety Factor was retained for the use
of LOAEL in a critical study in calculating the reference dose for
chronic risk.
E. Aggregate Risks and Determination of Safety
1. Acute risk. There is no risk from acute dietary exposure, as an
appropriate single-dose endpoint was not identified for the acute oral
exposure of the general population, including infants and children.
2. Chronic risk. To assess aggregate chronic risk, drinking water
estimates were incorporated directly into the dietary analysis, rather
than using back-calculated drinking water levels of comparison
(DWLOCs). To better evaluate aggregate risk associated with exposure
through food and drinking water, EPA is no longer comparing Estimated
Drinking Water Concentration (EDWCs) generated by water quality models
with Drinking Water Levels of Comparison (DWLOC). Instead, EPA is now
directly incorporating the actual water quality model output
concentrations into the risk assessment. This method of incorporating
water concentrations into our aggregate assessments relies on actual
CSFII-reported drinking water consumptions and more appropriately
reflects the full distribution of drinking water concentrations. Using
the exposure assumptions described in this unit for chronic exposure,
the Lifeline\TM\ chronic risk estimates (including drinking water) were
less than the Agency's level of concern at < =6.1% chronic population-
adjusted dose (cPAD); children 1-2 years old were the most highly
exposed population. The DEEM-FCID\TM\ chronic risk estimates (including
drinking water) were also less than the Agency's level of concern at
< =8.0% cPAD; all infants (< 1 year old) were the most highly exposed
population. EPA does not expect the aggregate exposure to exceed 100%
of the cPAD, as shown in Table 3 of this unit:
[[Page 40209]]
Table 3.-- Aggregate Risk Assessment (including water) for Chronic (Non-Cancer) Exposure to Spirodiclofen
----------------------------------------------------------------------------------------------------------------
Chronic Exposure (mg/kg/ %cPAD
day) -----------------------
Population Subgroup cPAD (mg/--------------------------
kg/day) DEEM- DEEM- Lifeline\TM\
FCID\TM\ Lifeline\TM\ FCID\TM\
----------------------------------------------------------------------------------------------------------------
General U.S. population 0.000177 0.000092 3.7 1.4
----------------------------------------------------- ------------ < 1 year
----------------------------------------------------- ------------
----------------------------------------------------- ------------
----------------------------------------------------- ------------
----------------------------------------------------- ---------------------------
----------------------------------------------------- ---------------------------
----------------------------------------------------- ---------------------------
----------------------------------------------------- ---------------------------
----------------------------------------------------------------------------------------------------------------
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).
Spirodiclofen 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).
Spirodiclofen 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. Under the reasonable
certainty of no harm standard, in FFDCA section 408(b)(2)(A)(ii),
cancer risks must be no greater than negligible. EPA has consistently
interpreted negligible cancer risks to be risks within the range of an
increased cancer risk of 1 in 1 million. Risks as high as 3 in 1
million have been considered to be within this risk range. To assess
aggregate cancer risk, drinking water estimates were incorporated
directly into the dietary analysis, as explained above in section 2 for
chronic risk. Lifeline and DEEM are capable of combining exposure from
food and drinking water sources for an estimate of aggregate risk from
all dietary sources. Cancer aggregate risk was calculated for the U.S.
population only. The Lifeline\TM\ cancer risk estimates with drinking
water estimates included was 1.36 in 1 million. Using DEEM-FCID\TM\,
the cancer risk estimate with drinking water was 1.59 in 1 million.
DEEM-FCID\TM\ resulted in in a higher cancer risk estimate due to
differing drinking water assumptions. Lifeline permits incorporation of
the entire PRZM-EXAMS distribution when conducting a cancer analysis
while DEEM-FCID\TM\ permits only a point estimate. The estimated cancer
risk of 1.59 in 1 million is within the negligible risk range. The
Agency also notes that the cancer risk estimates were generated using
average residues derived from crop field trial studies (maximum
application rate and minimum preharvest interval), incorporated maximum
theoretical processing factors for juice, and incorporated surface
drinking water estimates which assumed 87% of the basin was cropped and
100% of the cropped area was treated at the maximum rate. EPA concludes
that the estimated cancer risk within the range of a risk of 1 in 1
million and therefore is negligible. A summary of aggregate cancer risk
is given in Table 4 of this unit:
Table 4.--Cancer Aggregate Risk (including drinking water) for Spirodiclofen
----------------------------------------------------------------------------------------------------------------
Cancer Exposure (mg/kg/ Cancer Risk
day) -------------------------------
Population Subgroup Q1* --------------------------
DEEM- DEEM-FCID\TM\ Lifeline\TM\
FCID\TM\ Lifeline\TM\
----------------------------------------------------------------------------------------------------------------
General U.S. population\1\ 0.0149 0.000177 0.000092 1.59 x 10-6 1.36 x 10-6
----------------------------------------------------------------------------------------------------------------
\1\ differences between DEEM-FCID\TM\ and Lifeline\TM\ cancer risk estimates due to differences in the water
estimates permitted in each program; DEEM-FCID\TM\ permits only a single point drinking water estimate when
conducting a cancer analysis; Lifeline\TM\ permits incorporation of the entire PRZM-EXAMS distribution and
incorporation of the SCI-GROW point estimate
[[Page 40210]]
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 spirodiclofen residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (HPLC/MS-MS) is available to
enforce the tolerance expression. The method 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 Codex or Mexican maximum residue limits (MRLs) in/on
the requested crops.
C. Conditions
The following confirmatory data are needed:
Toxicology. In the developmental neurotoxicity study, additional
morphometric analyses of the caudate putamen, parietal cortex,
hippocampal gyrus, and dentate gyrus at the mid and low doses are
requested for both sexes.
Residue chemistry. Apple (juice) and grape (juice) processing
studies which monitor for residue of spirodiclofen, BAJ2510, 3-OH-enol,
and 4-OH-enol. Default factors were used for the risk assessment, and
these studies are needed to refine the risk.
V. Conclusion
Therefore, the tolerance is established for residues of
spirodiclofen (3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-
yl 2,2-dimethylbutanoate) on grape at 2.0 ppm; grape, raisin at 4.0
ppm; grape, juice at 2.4 ppm; citrus, fruit, crop group 10 at 0.50 ppm;
citrus, oil at 20 ppm; citrus, juice at 0.60 ppm; fruit, pome, crop
group 11 at 0.80 ppm; apple, wet pomace at 2.0 ppm; fruit, stone, crop
group 12 at 1.0 ppm; nut, tree, crop group 14 at 0.10 ppm; almond,
hulls at 20 ppm; pistachio at 0.10 ppm; and for combined residues of
spirodiclofen and its free enol metabolite BAJ 2510 in or on cattle,
meat and cattle, fat at 0.02 ppm; cattle, meat byproducts at 0.10 ppm;
goat, meat and goat, fat at 0.02 ppm; goat, meat byproducts at 0.10
ppm; sheep, meat and sheep, fat at 0.02 ppm; sheep, meat byproducts at
0.10 ppm; horse, meat and horse, fat at 0.02 ppm; horse, meat
byproducts at 0.10 ppm; milk at 0.01 ppm, and milk, fat at 0.03 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 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-2005-0075 in 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
12, 2005.
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\ St., NW.,
Washington, DC 20005. 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) 564-6255.
2. 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 the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number OPP-2005-0075, 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 the
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
[[Page 40211]]
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 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: June 30, 2005.
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 180.608 is added to read as follows:
Sec. 180.608 Spirodiclofen; tolerances for residues.
(a) General. (1) Tolerances are established for residues of
spirodiclofen per se (3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-
3-en-4-yl 2,2-dimethylbutanoate) in or on the following plant
commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Almond, hulls............................................... 20.0
Apple, wet pomace........................................... 2.0
Citrus, juice............................................... 0.60
Citrus, oil................................................. 20.0
Fruit, citrus, crop group 10................................ 0.50
Fruit, pome, crop group 11.................................. 0.80
Fruit, stone, crop group 12................................. 1.0
Grape....................................................... 2.0
Grape, juice................................................ 2.4
Grape, raisin............................................... 4.0
Nut, tree, crop group 14.................................... 0.10
Pistachio................................................... 0.10
------------------------------------------------------------------------
(2) Tolerances are established for residues of spirodiclofen (3-
(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-
dimethylbutanoate) and its free enol metabolite BAJ 2510 (3-(2,4-
dichlorophenyl)-4-hydroxy-1-oxaspiro[4,5]dec-3-en-2-one) in or on the
following livestock commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cattle, fat................................................. 0.02
Cattle, meat byproducts..................................... 0.10
Cattle, meat................................................ 0.02
Goat, fat................................................... 0.02
Goat, meat byproducts....................................... 0.1
Goat, meat.................................................. 0.02
Horse, fat.................................................. 0.02
Horse, meat byproducts...................................... 0.1
Horse, meat................................................. 0.02
Milk........................................................ 0.01
Milk, fat................................................... 0.03
Sheep, fat.................................................. 0.02
Sheep. meat byproducts...................................... 0.1
Sheep. meat................................................. 0.02
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
[[Page 40212]]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 05-13774 Filed 7-12-05; 8:45 am]
BILLING CODE 6560-50-S