Spirodiclofen; Pesticide Tolerances, 24428-24434 [2010-10129]
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Federal Register / Vol. 75, No. 86 / Wednesday, May 5, 2010 / Rules and Regulations
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not 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).
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).
VII. Congressional Review Act
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The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report 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.
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Dated: April 20, 2010.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office
of Pesticide Programs.
dimethylethyl)-1H-1,2,4-triazole-1ethanol, in or on the commodity.
*
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[FR Doc. 2010–10406 Filed 5–4–10; 8:45 am]
■
Therefore, 40 CFR chapter I is
amended as follows:
BILLING CODE 6560–50–S
PART 180—[AMENDED]
ENVIRONMENTAL PROTECTION
AGENCY
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.474 is amended by
revising the introductory text of
paragraphs (a)(1), (a)(2), and (c) and
alphabetically add the commodity
‘‘vegetable, fruiting, group 8’’ to the table
in paragraph (a)(1) to read as follows:
■
40 CFR Part 180
[EPA–HQ–OPP–2009–0139; FRL–8820–4]
Spirodiclofen; Pesticide Tolerances
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes
tolerances for residues of spirodiclofen
per se (3-(2,4-dichlorophenyl)-2-oxo-1(a) General. (1) Tolerances are
oxaspiro[4,5]dec-3-en-4-yl 2,2established for residues of the fungicide dimethylbutanoate) in or on multiple
tebuconazole, including its metabolites
commodities which are identified and
and degradates, in or on the
discussed later in this document. Bayer
commodities in the following table.
CropScience requested these tolerances
Compliance with the tolerance levels
under the Federal Food, Drug, and
specified in the following table is to be
Cosmetic Act (FFDCA).
determined by measuring only
DATES: This regulation is effective May
tebuconazole (alpha-[2-(45, 2010. Objections and requests for
chlorophenyl)ethyl]-alpha-(1,1hearings must be received on or before
dimethylethyl)-1H-1,2,4-triazole-1July 6, 2010, and must be filed in
ethanol), in or on the commodity.
accordance with the instructions
provided in 40 CFR part 178 (see also
Commodity
Parts per million
Unit I.C. of the SUPPLEMENTARY
INFORMATION.
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ADDRESSES: EPA has established a
Vegetable, fruiting,
group 8 ..............
1.3 docket for this action under docket
*
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*
*
identification (ID) number EPA–HQ–
OPP–2009–0139. All documents in the
(2) Tolerances are established for
docket are listed in the docket index
residues of the fungicide tebuconazole,
available at https://www.regulations.gov.
including its metabolites and
Although listed in the index, some
degradates, in or on the commodities in information is not publicly available,
the following table. Compliance with
e.g., Confidential Business Information
the tolerance levels specified in the
(CBI) or other information whose
following table is to be determined by
disclosure is restricted by statute.
measuring only the sum of tebuconazole Certain other material, such as
(alpha-[2-(4-chlorophenyl)ethyl]-alphacopyrighted material, is not placed on
(1,1-dimethylethyl)-1H-1,2,4-triazole-1the Internet and will be publicly
ethanol) and its diol metabolite (1-(4available only in hard copy form.
chlorophenyl)-4,4-dimethyl-3-(1H
Publicly available docket materials are
-1,2,4-triazole-1-yl-methyl)-pentane-3,5- available in the electronic docket at
diol), calculated as the stoichiometric
https://www.regulations.gov, or, if only
equivalent of tebuconzole, in or on the
available in hard copy, at the OPP
commodity.
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
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2777 S. Crystal Dr., Arlington, VA. The
(c) Tolerances with Regional
Registrations. Tolerances are established Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
for residues of the fungicide
excluding legal holidays. The Docket
tebuconazole, including its metabolites
Facility telephone number is (703) 305–
and degradates, in or on the
5805.
commodities in the following table.
Compliance with the tolerance levels
FOR FURTHER INFORMATION CONTACT: Rita
specified below is to be determined by
Kumar, Registration Division (7505P),
measuring only tebuconazole, alpha-[2Office of Pesticide Programs,
(4-chlorophenyl)ethyl]-alpha-(1,1Environmental Protection Agency, 1200
§ 180.474 Tebuconazole; tolerances for
residues.
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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 those engaged in the
following activities:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Get Electronic Access to
Other Related Information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
cite at https://www.gpoaccess.gov/ecfr.
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C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2009–0139 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before July 6, 2010. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
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In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit this copy,
identified by docket ID number EPA–
HQ–OPP–2009–0139, by one of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’s normal hours of operation
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Petition for Tolerance
In the Federal Register of June 10,
2009 (74 FR 27538) (FRL–8915–5), 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 8F7500) by Bayer
CropScience, P.O. Box 12014, 2 T.W.
Alexander Dr., Research Triangle Park,
N.C. 27709. The petition requested that
40 CFR 180.608 be amended by
establishing tolerances for residues of
the insecticide spirodiclofen,(3-(2,4dichlorophenyl)-2-oxo-1oxaspiro[4,5]dec-3-en-4-yl 2,2dimethylbutanoate), in or on avocado,
black sapote, canistel, mamey sapote,
mango, papaya, sapodilla, and star
apple at 1.3 parts per million (ppm).
That notice referenced a summary of the
petition prepared by Bayer CropScience,
the registrant, which is available in the
docket, https://www.regulations.gov.
There were no comments received in
response to the notice of filing.
Based upon review of the data
supporting the petition, EPA has revised
the proposed tolerances to 1.0 ppm; and
changed the tolerance expression to
spirodiclofen per se (3-(2,4dichlorophenyl)-2-oxo-1oxaspiro[4,5]dec-3-en-4-yl 2,2dimethylbutanoate). The reason for
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these changes are explained in Unit
IV.D.
III. Aggregate Risk Assessment and
Determination of Safety
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.’’
Consistent with section 408(b)(2)(D)
of FFDCA, and the factors specified in
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 for spirodiclofen
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with spirodiclofen 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 a low acute toxicity
via the oral, dermal, and inhalation
routes. It is not an eye or dermal irritant.
However, it is a potential skin
sensitizer. Following oral
administration, spirodiclofen is rapidly
absorbed, metabolized, and excreted via
urine and feces. A rat whole body
autoradiography study showed no
accumulation in any specific organs or
tissues following oral administration.
Evidence of developmental toxicity was
not observed in the rabbit
developmental toxicity study. The rat
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developmental toxicity study resulted in
an increased incidence of slight
dilatation of the renal pelvis 1,000
milligrams/kilograms/day (mg/kg/day);
highest dose tested (HDT) at a dose
which did not cause maternal toxicity.
In the 2-generation reproductive toxicity
study, developmental effects were
observed in F1 males (i.e., delayed
sexual maturation, decreased testicular
spermatid and epididymal sperm counts
(oligospermia); and atrophy of the
testes, epididymides, prostate, and
seminal vesicles) and F1 females (i.e.,
increased severity of ovarian luteal cell
vacuolation/degeneration) but at a
higher dose (1,750 ppm) than the
systemic effects seen for parents and
offspring (350 ppm). Spirodiclofen did
not show any evidence of neurotoxicity
in the acute and subchronic
neurotoxicity studies. In a
developmental neurotoxicity study
(DNT), a decrease in retention was
observed in the memory phase of the
water maze for postnatal day (PND) 60
females at all doses. In this DNT study,
the morphometric measurements were
not performed at the low- and middoses; therefore, the registrant
conducted a new study using identical
experimental conditions as the previous
study. The results of the new study
demonstrated no treatment related
maternal or offspring toxicity at the
HDT. Therefore, it can be concluded
that spirodiclofen is unlikely to be a
neurotoxic or developmentally
neurotoxic compound.
Spirodiclofen has been shown to have
adverse effects on several organs of the
endocrine system at relatively low
doses. Testicular effects were observed
in dogs, rats, and mice, manifested as
Leydig cell vacuolation in dogs,
hypertrophy in dogs and mice, and
hyperplasia progressing to adenomas in
rats, following chronic exposure. In
female rats, increased incidence of
uterine nodules and uterine
adenocarcinoma were observed at
terminal sacrifice in the chronic toxicity
study. Cytoplasmic vacuolation in the
adrenal cortex, accompanied by
increased adrenal weight, was
consistently observed in rats, dogs, and
mice of both sexes.
Chronic toxicity and carcinogenicity
studies showed increased incidence of
uterine adenocarcinoma in female rats,
Leydig cell adenoma in male rats, and
liver tumors in mice. EPA classified
spirodiclofen as ‘‘likely to be
carcinogenic to humans’’ by the oral
route based on evidence of testes Leydig
cell adenomas in male rats, uterine
adenomas and/or adenocarcinoma in
female rats, and liver tumors in mice.
Mutagenicity studies conducted with
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the technical spirodiclofen formulation
and its major metabolites did not
demonstrate any mutagenic potential.
EPA has determined that quantification
of human cancer risk using a linear lowdose extrapolation approach is
appropriate.
Specific information on the studies
received and the nature of the adverse
effects caused by spirodiclofen as well
as the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in document
‘‘Human Health Risk Assessment
Associated with the Section 3
Registration Application for Avocado,
Black Sapote, Canistel, Mamey Sapote,
Mango, Papaya, Sapodilla, and Star
Apple,’’ p.10 in docket ID number EPA–
HQ–OPP–2009–0139.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level – generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD) – and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
A summary of the toxicological
endpoints for spirodiclofen used for
human risk assessment can be found at
https://www.regulations.gov in document
‘‘Human Health Risk Assessment
Associated with the Section 3
Registration Application for Avocado,
Black Sapote, Canistel, Mamey Sapote,
Mango, Papaya, Sapodilla, and Star
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Apple,’’ p. 12 in docket ID number EPA–
HQ–OPP–2009–0139.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to spirodiclofen, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing spirodiclofen tolerances in 40
CFR 180.608. EPA assessed dietary
exposures from spirodiclofen in food as
follows:
i. Acute exposure. Quantitative acute
dietary exposure and 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 such effects were identified in the
toxicological studies for spirodiclofen;
therefore, a quantitative acute dietary
exposure assessment is unnecessary.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA 1994–1996 and 1998
Continuing Survey of Food Intake
(CSFII). As to residue levels in food,
EPA assumed the following:
a. Average field trial residues;
b. Experimentally determined
processing factors for apple and grape
processed commodities and for citrus
oil, peeled citrus, and citrus peel (DEEM
(ver 7.81) defaults assumed for the
remaining processed commodities); and
c. Maximum reasonably balanced
livestock diets.
iii. Cancer. EPA determines whether
quantitative cancer exposure and risk
assessments are appropriate for a fooduse pesticide based on the weight of the
evidence from cancer studies and other
relevant data. Cancer risk is quantified
using a linear or non-linear approach. If
sufficient information on the
carcinogenic mode of action is available,
a threshold or non-linear approach is
used and a cancer RfD is calculated
based on an earlier non-cancer key
event. If carcinogenic mode of action
data are not available, or if the mode of
action data determines a mutagenic
mode of action, a default linear cancer
slope factor approach is utilized. Based
on the data summarized in Unit III.A.,
EPA has classified spirodiclofen as
‘‘Likely to be Carcinogenic to Humans’’
and used a linear approach to quantify
cancer risk. Exposure for evaluating
cancer risk was assessed using the same
estimates as discussed in Unit III.C.1.ii.
iv. Anticipated residue and percent
crop treated (PCT) information. Section
408(b)(2)(E) of FFDCA authorizes EPA
to use available data and information on
the anticipated residue levels of
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pesticide residues in food and the actual
levels of pesticide residues that have
been measured in food. If EPA relies on
such information, EPA must require
pursuant to FFDCA section 408(f)(1)
that data be provided 5 years after the
tolerance is established, modified, or
left in effect, demonstrating that the
levels in food are not above the levels
anticipated. For the present action, EPA
will issue such data call-ins as are
required by FFDCA section 408(b)(2)(E)
and authorized under FFDCA section
408(f)(1). Data will be required to be
submitted no later than 5 years from the
date of issuance of these tolerances.
Average field trial residues were
assumed for chronic and cancer
analysis.
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:
• Condition A: 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 the pesticide residue.
• Condition B: The exposure estimate
does not underestimate exposure for any
significant subpopulation group.
• Condition C: 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 FFDCA section 408(b)(2)(F),
EPA may require registrants to submit
data on PCT.
The Agency estimated the PCT for
existing uses as follows: Hop (92%),
pome fruit (15%), stone fruit (10%),
grape (7%), and citrus (14%).
In most cases, EPA uses available data
from United States Department of
Agriculture/National Agricultural
Statistics Service (USDA/NASS),
proprietary market surveys, and the
National Pesticide Use Database for the
chemical/crop combination for the most
recent 6–7 years. EPA uses an average
PCT for chronic dietary risk analysis.
The average PCT figure for each existing
use is derived by combining available
public and private market survey data
for that use, averaging across all
observations, and rounding to the
nearest 5%, except for those situations
in which the average PCT is less than
one. In those cases, 1% is used as the
average PCT and 2.5% is used as the
maximum PCT. EPA uses a maximum
PCT for acute dietary risk analysis. The
maximum PCT figure is the highest
observed maximum value reported
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within the recent 6 years of available
public and private market survey data
for the existing use and rounded up to
the nearest multiple of 5%.
The Agency believes that the three
conditions discussed in Unit III.C.1.iv.
have been met. With respect to
Condition A, PCT estimates are derived
from Federal and private market survey
data, which are reliable and have a valid
basis. The Agency is reasonably certain
that the percentage of the food treated
is not likely to be an underestimation.
As to Conditions B and C, 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 reliable 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 used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for spirodiclofen in drinking water.
These simulation models take into
account data on the physical, chemical,
and fate/transport characteristics of
spirodiclofen. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www.epa.gov/
oppefed1/models/water/index.htm.
Based on the PRZM/EXAMS and
Screening Concentration in Ground
Water (SCI-GROW) models, the
estimated drinking water concentrations
(EDWCs) of spirodiclofen for chronic
exposures for non-cancer assessments
are estimated to be 4.99 ppb for surface
water and 0.44 ppb for ground water.
The EDWCs of spirodiclofen for chronic
exposures for cancer assessments are
estimated to be 1.67 ppb for surface
water and 0.44 ppb for ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model.
For chronic dietary risk assessment,
the water concentration of value 4.99
ppb was used to assess the contribution
to drinking water.
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For cancer dietary risk assessment,
the water concentration of value 1.67
ppb was used to assess the contribution
to drinking water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, 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 any
specific use patterns 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.’’
EPA has not found spirodiclofen to
share a common mechanism of toxicity
with 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
assumed that spirodiclofen does not
have 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 EPA’s website at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) 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. This additional margin of
safety is commonly referred to as the
FQPA Safety Factor (SF). In applying
this provision, EPA either retains the
default value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
The spirodiclofen toxicity database is
adequate to evaluate the potential
increased susceptibility of infants and
children. In 2004, the Agency
determined that there is no evidence
(qualitative or quantitative) of increased
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susceptibility in the rabbit
developmental toxicity study or in the
rat reproduction toxicity study
following in utero and/or pre-/post-natal
exposure of spirodiclofen. However,
evidence for quantitative susceptibility
was observed in a rat developmental
toxicity study where an increased
incidence of slight dilatation of the
renal pelvis was observed at a dose
(1,000 mg/kg/day; the limit dose) which
did not cause any maternal toxicity.
Two rat developmental neurotoxicity
(DNT) studies were submitted to EPA
following the assessment in 2004. The
first study demonstrated increased
susceptibility in the offspring based on
the observed decreased retention in the
memory phase of the water maze for
postnatal day 60 females at all doses
(LOAEL 6.5 mg/kg/day) and changes in
brain morphometric parameters at the
HDT (135.9 mg/kg/day; caudate
putamen, parietal cortex, hippocampal
gyrus, and dentate gyrus); there was no
maternal toxicity at doses up to and
including 135.9 mg/kg/day HDT. EPA
requested information concerning the
brain morphometric parameters in the
low and mid doses with the petitioner
indicating that the brain tissues were
not appropriately preserved and
analysis was therefore not possible. As
a result, a second rat DNT study was
submitted which also indicated
increased susceptibility in offspring
based on decreased pre-weaning body
weight and body weight gain in males
and females and decreased postweaning body weights in males (LOAEL
= 119.2 mg/kg/day; NOAEL = 28.6 mg/
kg/day). Neurotoxicity was not observed
in offspring in the second DNT study,
and there was no maternal toxicity
observed at doses up to and including
119.2 mg/kg/day.
EPA determined that the degree of
concern is low for the quantitative
susceptibility seen in the developmental
toxicity study in rats. The increased
incidence of slight renal pelvic dilation
was observed at the limit-dose only
without statistical significance and dose
response. Renal pelvic dilation was
considered to be a developmental delay
and not a severe effect for
developmental toxicity. The low
background incidences in this study
may be idiosyncratic to the strain of rats
tested (Wistar), since renal pelvis
dilations are commonly seen at higher
incidences in other strains (SpragueDawley or Fisher) of rats. In addition,
doses selected for risk assessment of
spirodiclofen are much lower than the
dose that caused these developmental
delays. The two DNT studies suggest
increased susceptibility of offspring due
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to exposure to spirodiclofen. However,
there is no concern for the increased
susceptibility seen in the first DNT
study because the results were not
reproduced in the second DNT study
conducted using the identical doses and
experimental conditions. The concern
for increased susceptibility in the
second DNT study is low because there
is a well established NOAEL, marginal
toxicity (slight changes in body
weights), and all developmental/
functional parameters were comparable
to controls. In addition, doses selected
for risk assessment of spirodiclofen are
much lower than the dose that caused
these marginal changes in the body
weights of offspring in the second DNT
study. There was no evidence of
increased susceptibility in the
developmental toxicity study in rabbits
or the 2-generation reproduction study
in rats.
3. Conclusion. EPA has determined
that reliable data show the safety of
infants and children would be
adequately protected if the FQPA SF
were reduced to 1X. That decision is
based on the following findings:
i. The toxicity database for
spirodiclofen is complete except for an
immunotoxicity study which is required
as a part of new data requirements in
the 40 CFR part 158. However, the
Agency does not believe that conducting
a functional immunotoxicity study will
result in a lower POD than that
currently used for overall risk
assessment. The toxicology database for
spirodiclofen does not show any
evidence of treatment-related effects on
the immune system. The overall weight
of evidence suggests that this chemical
does not target the immune system.
Therefore, a database uncertainty factor
(UFDB) is not needed to account for the
lack of this study.
ii. Based on the results of acute,
subchronic and developmental
neurotoxicity studies in rats (see Units
III.A. and III.D.2.), EPA has concluded
that there is no indication that
spirodiclofen is a neurotoxic chemical.
iii. There is no evidence (qualitative
or quantitative) of increased
susceptibility in the rabbit
developmental toxicity study or in the
rat reproduction toxicity study
following in utero and/or pre-/post-natal
exposure of spirodiclofen. However,
evidence for quantitative susceptibility
was observed in a rat developmental
toxicity study and the second DNT
study. See Unit III.D.2. for a detailed
discussion of why EPA determined that
the degree of concern is low for the
quantitative susceptibility seen in this
studies.
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iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed using reliable PCT
information and anticipated residue
values calculated from residue field trial
results. EPA made conservative
(protective) assumptions in the ground
and surface water modeling used to
assess exposure to spirodiclofen in
drinking water. Residential exposures
are not expected. These assessments
will not underestimate the exposure and
risks posed by spirodiclofen.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. An acute aggregate risk
assessment takes into account acute
exposure estimates from dietary
consumption of food and drinking
water. No adverse effect resulting from
a single oral exposure was identified
and no acute dietary endpoint was
selected. Therefore, spirodiclofen is not
expected to pose an acute risk.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to spirodiclofen
from food and water will utilize 3.3% of
the cPAD for all infants < 1 year old the
population group receiving the greatest
exposure. There are no residential uses
for spirodiclofen.
3. Short-term and intermediate-term
risk. Short-term and intermediate-term
aggregate exposure take into account
short-term and intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Spirodiclofen is not registered for any
uses that would result in residential
exposure. Therefore the short-term/
intermediate-term aggregate risk is the
sum of the risk from exposure to
spirodiclofen through food and water
and will not be greater than the chronic
aggregate risk.
4. Aggregate cancer risk for U.S.
population. Using the exposure
assumptions described in Unit III.C.1.iii.
for cancer, EPA has concluded that
exposure to spirodiclofen to cancer from
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food and water will result in a life-time
cancer risk of 3 x 10-6. EPA generally
considers cancer risks in the range of
10-6 or less to be negligible. The
precision which can be assumed for
cancer risk estimates is best described
by rounding to the nearest integral order
of magnitude on the log scale; for
example, risks falling between 3 x 10-7
and 3 x 10-6 are expressed as risks in the
range of 10-6. Considering the precision
with which cancer hazard can be
estimated, the conservativeness of lowdose linear extrapolation, and the
rounding procedure described above in
this Unit, cancer risk should generally
not be assumed to exceed the
benchmark level of concern of the range
of 10-6 until the calculated risk exceeds
approximately 3 x 10-6. This is
particularly the case where some
conservatism is maintained in the
exposure assessment. For the reasons
explained below in this Unit, EPA
concludes that there are significant
conservatisms in the spirodiclofen
exposure assessment. First, residue
values are based on average field trial
levels and not monitoring data.
Monitoring data tends to be significantly
lower than field trial data and the
spirodiclofen monitoring data confirms
this (all less than the limit of detection
(LOD); LOD = 0.001-0.05 ppm; 2.5-23x
lower than the residue used in the
cancer assessment). Second, based on a
critical commodity analysis conducted
in DEEM-FCID, the major contributors
to the cancer risk were hops (40% of the
total exposure), water (19% of the total
exposure), and orange juice (16% of the
total exposure) and conservative residue
estimates were used for these three
commodities as follows:
i. Hops. Dietary exposure from hops is
the result of beer consumption. DEEMFCID assumes that 100% of the residue
in hops are transferred to beer during
the brewing process (no residue remain
in/on the spent hops). Since
spirodiclofen has low water solubility,
this is a conservative assumption;
ii. Drinking water. The water residue
estimate assumed 87% of the basin is
cropped with 100% of the crops treated.
Spirodiclofen is proposed/registered for
application to orchard crops (pome
fruit, citrus fruit, stone fruit, tree nuts,
grape, and tropical fruits) which are
unlikely to occupy 87% of a water
basin. In addition, it is unlikely that
spirodiclofen will capture the entire
market within a water basin.
iii. Orange juice. Pending the
submission of a new orange processing
study, default grapefruit (2.1x), lemon
(2.0x), lime (2.0x), orange (1.8x), and
tangerine (2.3x) juice processing factors
were assumed. In all likelihood this
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exaggerates exposure estimates given
that grape and apple processing studies
with spirodiclofen resulted in a
reduction in residues in juice.
5. 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, or to infants and children
from aggregate exposure to spirodiclofen
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(a liquid chromatography (LC)/mass
spectrometry (MS)/(MS) method) 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; email address: residuemethods@epa.gov.
B. International Residue Limits
There are no Codex, Canadian, or
Mexican maximum residue limits
(MRLs) in/on these crops.
C. Response to Comments
There were no comments received in
response to the notice of filing of the
pesticide petition 8F7500.
D. Revisions to Petitioned-For
Tolerances
EPA has revised the proposed
tolerance levels and tolerance
expression of spirodiclofen in/on the
following commodities: Avocado from
1.3 ppm to 1.0 ppm; black sapote from
1.3 ppm to 1.0 ppm; canistel from 1.3
ppm to 1.0 ppm; mamey sapote from 1.3
ppm to 1.0 ppm; mango from 1.3 ppm
to 1.0 ppm; papaya from 1.3 ppm to 1.0
ppm; sapodilla from 1.3 ppm to 1.0
ppm; and star apple from 1.3 ppm to 1.0
ppm. Based on review of the residue
chemistry data submitted in support of
this petition, EPA concluded that 1.0
ppm tolerance for residues of
spirodiclofen per se in/on these crops is
appropriate.
V. Conclusion
Therefore, tolerances are established
for residues of spirodiclofen per se, (3(2,4-dichlorophenyl)-2-oxo-1oxaspiro[4,5]dec-3-en-4-yl 2,2dimethylbutanoate), in or on avocado,
black sapote, canistel, mamey sapote,
mango, papaya, sapodilla, and star
apple at 1.0 ppm.
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24433
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
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 final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
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., 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).
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.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
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Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104–4).
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).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report 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: April 20, 2010.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
■
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.608, alphabetically add the
following commodities to the table in
paragraph (a)(1) to read as follows:
■
§ 180.608
residues.
Spirodiclofen; tolerances for
(a) General. (1) * * *
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Commodity
*
*
*
Avocado ....................
Black sapote .............
Canistel .....................
*
*
*
Mamey sapote ..........
Mango .......................
*
*
*
Papaya ......................
*
*
*
Sapodilla ...................
Star apple ..................
VerDate Mar<15>2010
Parts per million
*
*
*
*
*
*
*
*
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
14:33 May 04, 2010
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*
*
*
*
*
[FR Doc. 2010–10129 Filed 5–4–10; 8:45 am]
BILLING CODE 6560–50–S
GENERAL SERVICES
ADMINISTRATION
41 CFR Parts 300–3, 301–10, 301–51,
301–52, 301–70, 301–75, Appendix C to
Chapter 301, 302–6, and 302–9
[FTR Amendment 2010–02; FTR Case 2010–
302; Docket Number 2010–0010, sequence
1]
RIN 3090–AJ02
Federal Travel Regulation (FTR);
Transportation in Conjunction With
Official Travel and Relocation
AGENCY: Office of Governmentwide
Policy, General Services Administration
(GSA).
ACTION: Final rule.
SUMMARY: This final rule amends the
Federal Travel Regulation (FTR), by
adding new terms and definitions for
‘‘Official travel’’ and ‘‘Transit system’’;
clarifies reimbursement for
transportation at an official station
while en route to and/or from an
authorized temporary duty (TDY)
location; clarifies reimbursement for
transportation expenses within the
surrounding area of a TDY location and
provisions for payment under the FTR;
and clarifies when the Government
contractor-issued travel charge card
must be used while on official travel.
Clarification of this rule is addressed in
the supplementary information below.
DATES: Effective date: This final rule is
effective June 4, 2010. Applicability
date: This final rule is applicable to
travel performed on and after June 4,
2010.
The
Regulatory Secretariat (MVCB), Room
4041, GS Building, Washington, DC
20405, (202) 501–4755, for information
pertaining to status or publication
schedules. For clarification of content,
contact Rick Miller, Office of
Governmentwide Policy, at (202) 501–
3822 or e-mail at rodney.miller@gsa.gov.
Please cite FTR Amendment 2010–02,
FTR case 2010–302.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
A. Background
Title 5, United States Code § 5707 (5
U.S.C. 5707), authorizes the
Administrator of General Services to
prescribe necessary regulations to
implement laws regarding Federal
employees who are traveling while in
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the performance of official business
away from their official stations.
Similarly, 5 U.S.C. 5738 mandates that
the Administrator of General Services
prescribe regulations relating to official
relocation. The overall implementing
authority is the Federal Travel
Regulation (FTR), codified in Title 41
Code of Federal Regulations, Chapters
300–304 (41 CFR chapters 300–304).
Expenses incurred at an employee’s
official station not in conjunction with
TDY and/or relocation do not fall under
the authority of the FTR. Therefore, this
final rule adds terms and definitions for
‘‘Official travel’’ and ‘‘Transit system’’
and also removes references to ‘‘local
travel,’’ ‘‘local transit system,’’ ‘‘local
transportation,’’ ‘‘local transportation
system,’’ ‘‘local telephone calls,’’ and
‘‘local metropolitan transportation
fares,’’ for reimbursement that is not in
conjunction with TDY and/or
relocation. Federal employees should
adhere to their agency’s policies for
reimbursement of expenses incurred for
transportation within the vicinity of
their official stations when expenses do
not pertain to TDY or relocation. This
final rule clarifies that the Government
contractor-issued travel charge card will
only be used for the purposes of official
travel-related expenses and not for
personal use while on an official travel
authorization.
B. Executive Order 12866
This is not a significant regulatory
action and, therefore, was not subject to
review under Section 6(b) of Executive
Order 12866, Regulatory Planning and
Review, dated September 30, 1993. This
final rule is not a major rule under 5
U.S.C. 804.
C. Regulatory Flexibility Act
This final rule will not have a
significant economic impact on a
substantial number of small entities
within the meaning of the Regulatory
Flexibility Act, 5 U.S.C. 601, et seq.,
because the revisions are not considered
substantive. This final rule is also
exempt from the Regulatory Flexibility
Act per 5 U.S.C. 553(a)(2) because it
applies to agency management.
D. Paperwork Reduction Act
The Paperwork Reduction Act does
not apply because the changes to the
FTR do not impose recordkeeping or
information collection requirements, or
the collection of information from
offerors, contractors, or members of the
public that require the approval of the
Office of Management and Budget under
44 U.S.C. 3501, et seq.
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Agencies
[Federal Register Volume 75, Number 86 (Wednesday, May 5, 2010)]
[Rules and Regulations]
[Pages 24428-24434]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-10129]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0139; FRL-8820-4]
Spirodiclofen; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances 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 multiple commodities which
are identified and discussed later in this document. Bayer CropScience
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective May 5, 2010. Objections and
requests for hearings must be received on or before July 6, 2010, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION.
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0139. All documents in the
docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., 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 in the electronic
docket at https://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Rita Kumar, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200
[[Page 24429]]
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 those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Get Electronic Access to Other Related Information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR cite at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2009-0139 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
July 6, 2010. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2009-0139, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of June 10, 2009 (74 FR 27538) (FRL-8915-
5), 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
8F7500) by Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Dr.,
Research Triangle Park, N.C. 27709. The petition requested that 40 CFR
180.608 be amended by establishing tolerances 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 avocado,
black sapote, canistel, mamey sapote, mango, papaya, sapodilla, and
star apple at 1.3 parts per million (ppm). That notice referenced a
summary of the petition prepared by Bayer CropScience, the registrant,
which is available in the docket, https://www.regulations.gov. There
were no comments received in response to the notice of filing.
Based upon review of the data supporting the petition, EPA has
revised the proposed tolerances to 1.0 ppm; and changed the tolerance
expression to spirodiclofen per se (3-(2,4-dichlorophenyl)-2-oxo-1-
oxaspiro[4,5]dec-3-en-4-yl 2,2-dimethylbutanoate). The reason for these
changes are explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
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.''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in 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 for spirodiclofen including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with spirodiclofen
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 a low acute toxicity via the oral, dermal, and
inhalation routes. It is not an eye or dermal irritant. However, it is
a potential skin sensitizer. Following oral administration,
spirodiclofen is rapidly absorbed, metabolized, and excreted via urine
and feces. A rat whole body autoradiography study showed no
accumulation in any specific organs or tissues following oral
administration. Evidence of developmental toxicity was not observed in
the rabbit developmental toxicity study. The rat
[[Page 24430]]
developmental toxicity study resulted in an increased incidence of
slight dilatation of the renal pelvis 1,000 milligrams/kilograms/day
(mg/kg/day); highest dose tested (HDT) at a dose which did not cause
maternal toxicity. In the 2-generation reproductive toxicity study,
developmental effects were observed in F1 males (i.e., delayed sexual
maturation, decreased testicular spermatid and epididymal sperm counts
(oligospermia); and atrophy of the testes, epididymides, prostate, and
seminal vesicles) and F1 females (i.e., increased severity of ovarian
luteal cell vacuolation/degeneration) but at a higher dose (1,750 ppm)
than the systemic effects seen for parents and offspring (350 ppm).
Spirodiclofen did not show any evidence of neurotoxicity in the acute
and subchronic neurotoxicity studies. In a developmental neurotoxicity
study (DNT), a decrease in retention was observed in the memory phase
of the water maze for postnatal day (PND) 60 females at all doses. In
this DNT study, the morphometric measurements were not performed at the
low- and mid-doses; therefore, the registrant conducted a new study
using identical experimental conditions as the previous study. The
results of the new study demonstrated no treatment related maternal or
offspring toxicity at the HDT. Therefore, it can be concluded that
spirodiclofen is unlikely to be a neurotoxic or developmentally
neurotoxic compound.
Spirodiclofen has been shown to have adverse effects on several
organs of the endocrine system at relatively low doses. Testicular
effects were observed in dogs, rats, and mice, manifested as Leydig
cell vacuolation in dogs, hypertrophy in dogs and mice, and hyperplasia
progressing to adenomas in rats, following chronic exposure. In female
rats, increased incidence of uterine nodules and uterine adenocarcinoma
were observed at terminal sacrifice in the chronic toxicity study.
Cytoplasmic vacuolation in the adrenal cortex, accompanied by increased
adrenal weight, was consistently observed in rats, dogs, and mice of
both sexes.
Chronic toxicity and carcinogenicity studies showed increased
incidence of uterine adenocarcinoma in female rats, Leydig cell adenoma
in male rats, and liver tumors in mice. EPA classified spirodiclofen as
``likely to be carcinogenic to humans'' by the oral route based on
evidence of testes Leydig cell adenomas in male rats, uterine adenomas
and/or adenocarcinoma in female rats, and liver tumors in mice.
Mutagenicity studies conducted with the technical spirodiclofen
formulation and its major metabolites did not demonstrate any mutagenic
potential. EPA has determined that quantification of human cancer risk
using a linear low-dose extrapolation approach is appropriate.
Specific information on the studies received and the nature of the
adverse effects caused by spirodiclofen as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document ``Human Health Risk Assessment
Associated with the Section 3 Registration Application for Avocado,
Black Sapote, Canistel, Mamey Sapote, Mango, Papaya, Sapodilla, and
Star Apple,'' p.10 in docket ID number EPA-HQ-OPP-2009-0139.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level - generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD) - and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for spirodiclofen used for
human risk assessment can be found at https://www.regulations.gov in
document ``Human Health Risk Assessment Associated with the Section 3
Registration Application for Avocado, Black Sapote, Canistel, Mamey
Sapote, Mango, Papaya, Sapodilla, and Star Apple,'' p. 12 in docket ID
number EPA-HQ-OPP-2009-0139.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to spirodiclofen, EPA considered exposure under the
petitioned-for tolerances as well as all existing spirodiclofen
tolerances in 40 CFR 180.608. EPA assessed dietary exposures from
spirodiclofen in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and 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 such effects were identified in the toxicological studies for
spirodiclofen; therefore, a quantitative acute dietary exposure
assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 Continuing Survey of Food Intake (CSFII). As to residue levels
in food, EPA assumed the following:
a. Average field trial residues;
b. Experimentally determined processing factors for apple and grape
processed commodities and for citrus oil, peeled citrus, and citrus
peel (DEEM (ver 7.81) defaults assumed for the remaining processed
commodities); and
c. Maximum reasonably balanced livestock diets.
iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Cancer risk is quantified using a linear or non-linear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or non-linear approach is used and a cancer RfD is
calculated based on an earlier non-cancer key event. If carcinogenic
mode of action data are not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized. Based on the data summarized in Unit
III.A., EPA has classified spirodiclofen as ``Likely to be Carcinogenic
to Humans'' and used a linear approach to quantify cancer risk.
Exposure for evaluating cancer risk was assessed using the same
estimates as discussed in Unit III.C.1.ii.
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of
[[Page 24431]]
pesticide residues in food and the actual levels of pesticide residues
that have been measured in food. If EPA relies on such information, EPA
must require pursuant to FFDCA section 408(f)(1) that data be provided
5 years after the tolerance is established, modified, or left in
effect, demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances. Average
field trial residues were assumed for chronic and cancer analysis.
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:
Condition A: 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 the pesticide residue.
Condition B: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition C: 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 FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency estimated the PCT for existing uses as follows: Hop
(92%), pome fruit (15%), stone fruit (10%), grape (7%), and citrus
(14%).
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition A, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions B and C, 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 reliable 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 used screening
level water exposure models in the dietary exposure analysis and risk
assessment for spirodiclofen in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of spirodiclofen. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/models/water/index.htm.
Based on the PRZM/EXAMS and Screening Concentration in Ground Water
(SCI-GROW) models, the estimated drinking water concentrations (EDWCs)
of spirodiclofen for chronic exposures for non-cancer assessments are
estimated to be 4.99 ppb for surface water and 0.44 ppb for ground
water. The EDWCs of spirodiclofen for chronic exposures for cancer
assessments are estimated to be 1.67 ppb for surface water and 0.44 ppb
for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model.
For chronic dietary risk assessment, the water concentration of
value 4.99 ppb was used to assess the contribution to drinking water.
For cancer dietary risk assessment, the water concentration of
value 1.67 ppb was used to assess the contribution to drinking 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 any specific use patterns 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.''
EPA has not found spirodiclofen to share a common mechanism of
toxicity with 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 assumed that
spirodiclofen does not have 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 EPA's website at https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) 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. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. The spirodiclofen toxicity
database is adequate to evaluate the potential increased susceptibility
of infants and children. In 2004, the Agency determined that there is
no evidence (qualitative or quantitative) of increased
[[Page 24432]]
susceptibility in the rabbit developmental toxicity study or in the rat
reproduction toxicity study following in utero and/or pre-/post-natal
exposure of spirodiclofen. However, evidence for quantitative
susceptibility was observed in a rat developmental toxicity study where
an increased incidence of slight dilatation of the renal pelvis was
observed at a dose (1,000 mg/kg/day; the limit dose) which did not
cause any maternal toxicity. Two rat developmental neurotoxicity (DNT)
studies were submitted to EPA following the assessment in 2004. The
first study demonstrated increased susceptibility in the offspring
based on the observed decreased retention in the memory phase of the
water maze for postnatal day 60 females at all doses (LOAEL 6.5 mg/kg/
day) and changes in brain morphometric parameters at the HDT (135.9 mg/
kg/day; caudate putamen, parietal cortex, hippocampal gyrus, and
dentate gyrus); there was no maternal toxicity at doses up to and
including 135.9 mg/kg/day HDT. EPA requested information concerning the
brain morphometric parameters in the low and mid doses with the
petitioner indicating that the brain tissues were not appropriately
preserved and analysis was therefore not possible. As a result, a
second rat DNT study was submitted which also indicated increased
susceptibility in offspring based on decreased pre-weaning body weight
and body weight gain in males and females and decreased post-weaning
body weights in males (LOAEL = 119.2 mg/kg/day; NOAEL = 28.6 mg/kg/
day). Neurotoxicity was not observed in offspring in the second DNT
study, and there was no maternal toxicity observed at doses up to and
including 119.2 mg/kg/day.
EPA determined that the degree of concern is low for the
quantitative susceptibility seen in the developmental toxicity study in
rats. The increased incidence of slight renal pelvic dilation was
observed at the limit-dose only without statistical significance and
dose response. Renal pelvic dilation was considered to be a
developmental delay and not a severe effect for developmental toxicity.
The low background incidences in this study may be idiosyncratic to the
strain of rats tested (Wistar), since renal pelvis dilations are
commonly seen at higher incidences in other strains (Sprague-Dawley or
Fisher) of rats. In addition, doses selected for risk assessment of
spirodiclofen are much lower than the dose that caused these
developmental delays. The two DNT studies suggest increased
susceptibility of offspring due to exposure to spirodiclofen. However,
there is no concern for the increased susceptibility seen in the first
DNT study because the results were not reproduced in the second DNT
study conducted using the identical doses and experimental conditions.
The concern for increased susceptibility in the second DNT study is low
because there is a well established NOAEL, marginal toxicity (slight
changes in body weights), and all developmental/functional parameters
were comparable to controls. In addition, doses selected for risk
assessment of spirodiclofen are much lower than the dose that caused
these marginal changes in the body weights of offspring in the second
DNT study. There was no evidence of increased susceptibility in the
developmental toxicity study in rabbits or the 2-generation
reproduction study in rats.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for spirodiclofen is complete except for
an immunotoxicity study which is required as a part of new data
requirements in the 40 CFR part 158. However, the Agency does not
believe that conducting a functional immunotoxicity study will result
in a lower POD than that currently used for overall risk assessment.
The toxicology database for spirodiclofen does not show any evidence of
treatment-related effects on the immune system. The overall weight of
evidence suggests that this chemical does not target the immune system.
Therefore, a database uncertainty factor (UFDB) is not needed to
account for the lack of this study.
ii. Based on the results of acute, subchronic and developmental
neurotoxicity studies in rats (see Units III.A. and III.D.2.), EPA has
concluded that there is no indication that spirodiclofen is a
neurotoxic chemical.
iii. There is no evidence (qualitative or quantitative) of
increased susceptibility in the rabbit developmental toxicity study or
in the rat reproduction toxicity study following in utero and/or pre-/
post-natal exposure of spirodiclofen. However, evidence for
quantitative susceptibility was observed in a rat developmental
toxicity study and the second DNT study. See Unit III.D.2. for a
detailed discussion of why EPA determined that the degree of concern is
low for the quantitative susceptibility seen in this studies.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed using
reliable PCT information and anticipated residue values calculated from
residue field trial results. EPA made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to spirodiclofen in drinking water. Residential exposures are
not expected. These assessments will not underestimate the exposure and
risks posed by spirodiclofen.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
spirodiclofen is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
spirodiclofen from food and water will utilize 3.3% of the cPAD for all
infants < 1 year old the population group receiving the greatest
exposure. There are no residential uses for spirodiclofen.
3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure take into account short-term and
intermediate-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Spirodiclofen is not registered for any uses that would result in
residential exposure. Therefore the short-term/intermediate-term
aggregate risk is the sum of the risk from exposure to spirodiclofen
through food and water and will not be greater than the chronic
aggregate risk.
4. Aggregate cancer risk for U.S. population. Using the exposure
assumptions described in Unit III.C.1.iii. for cancer, EPA has
concluded that exposure to spirodiclofen to cancer from
[[Page 24433]]
food and water will result in a life-time cancer risk of 3 x
10-6. EPA generally considers cancer risks in the range of
10-6 or less to be negligible. The precision which can be
assumed for cancer risk estimates is best described by rounding to the
nearest integral order of magnitude on the log scale; for example,
risks falling between 3 x 10-7 and 3 x 10-6 are
expressed as risks in the range of 10-6. Considering the
precision with which cancer hazard can be estimated, the
conservativeness of low-dose linear extrapolation, and the rounding
procedure described above in this Unit, cancer risk should generally
not be assumed to exceed the benchmark level of concern of the range of
10-6 until the calculated risk exceeds approximately 3 x
10-6. This is particularly the case where some conservatism
is maintained in the exposure assessment. For the reasons explained
below in this Unit, EPA concludes that there are significant
conservatisms in the spirodiclofen exposure assessment. First, residue
values are based on average field trial levels and not monitoring data.
Monitoring data tends to be significantly lower than field trial data
and the spirodiclofen monitoring data confirms this (all less than the
limit of detection (LOD); LOD = 0.001-0.05 ppm; 2.5-23x lower than the
residue used in the cancer assessment). Second, based on a critical
commodity analysis conducted in DEEM-FCID, the major contributors to
the cancer risk were hops (40% of the total exposure), water (19% of
the total exposure), and orange juice (16% of the total exposure) and
conservative residue estimates were used for these three commodities as
follows:
i. Hops. Dietary exposure from hops is the result of beer
consumption. DEEM-FCID assumes that 100% of the residue in hops are
transferred to beer during the brewing process (no residue remain in/on
the spent hops). Since spirodiclofen has low water solubility, this is
a conservative assumption;
ii. Drinking water. The water residue estimate assumed 87% of the
basin is cropped with 100% of the crops treated. Spirodiclofen is
proposed/registered for application to orchard crops (pome fruit,
citrus fruit, stone fruit, tree nuts, grape, and tropical fruits) which
are unlikely to occupy 87% of a water basin. In addition, it is
unlikely that spirodiclofen will capture the entire market within a
water basin.
iii. Orange juice. Pending the submission of a new orange
processing study, default grapefruit (2.1x), lemon (2.0x), lime (2.0x),
orange (1.8x), and tangerine (2.3x) juice processing factors were
assumed. In all likelihood this exaggerates exposure estimates given
that grape and apple processing studies with spirodiclofen resulted in
a reduction in residues in juice.
5. 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, or to infants and children from aggregate
exposure to spirodiclofen residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (a liquid chromatography (LC)/mass
spectrometry (MS)/(MS) method) 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, Canadian, or Mexican maximum residue limits
(MRLs) in/on these crops.
C. Response to Comments
There were no comments received in response to the notice of filing
of the pesticide petition 8F7500.
D. Revisions to Petitioned-For Tolerances
EPA has revised the proposed tolerance levels and tolerance
expression of spirodiclofen in/on the following commodities: Avocado
from 1.3 ppm to 1.0 ppm; black sapote from 1.3 ppm to 1.0 ppm; canistel
from 1.3 ppm to 1.0 ppm; mamey sapote from 1.3 ppm to 1.0 ppm; mango
from 1.3 ppm to 1.0 ppm; papaya from 1.3 ppm to 1.0 ppm; sapodilla from
1.3 ppm to 1.0 ppm; and star apple from 1.3 ppm to 1.0 ppm. Based on
review of the residue chemistry data submitted in support of this
petition, EPA concluded that 1.0 ppm tolerance for residues of
spirodiclofen per se in/on these crops is appropriate.
V. Conclusion
Therefore, 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 avocado, black sapote, canistel, mamey
sapote, mango, papaya, sapodilla, and star apple at 1.0 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances 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 final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). 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., 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).
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.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the
[[Page 24434]]
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).
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).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report 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: April 20, 2010.
G. Jeffrey Herndon,
Acting Director, Registration Division, 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. In Sec. 180.608, alphabetically add the following commodities to
the table in paragraph (a)(1) to read as follows:
Sec. 180.608 Spirodiclofen; tolerances for residues.
(a) General. (1) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Avocado................................... 1.0
Black sapote.............................. 1.0
Canistel.................................. 1.0
* * * * *
Mamey sapote.............................. 1.0
Mango..................................... 1.0
* * * * *
Papaya.................................... 1.0
* * * * *
Sapodilla................................. 1.0
Star apple................................ 1.0
------------------------------------------------------------------------
* * * * *
[FR Doc. 2010-10129 Filed 5-4-10; 8:45 am]
BILLING CODE 6560-50-S