[Federal Register: February 16, 2005 (Volume 70, Number 31)]
[Rules and Regulations]
[Page 7886-7894]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16fe05-13]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0406; FRL-7690-2]
Clothianidin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
[[Page 7887]]
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
clothianidin in or on pome fruit. Arvesta Corporation requested this
tolerance 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 February 16, 2005. Objections and
requests for hearings must be received on or before April 18, 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-2004-0406. 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 Mall 2, 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: Daniel Kenny, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-7546; e-mail address:kenny.dan@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
A frequently updated electronic version of 40 CFR part 180
is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
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 December 31, 2003 (68 FR 75504) (FRL-
7334-2), 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
1F6342) by Arvesta Corporation, 100 First St., Suite 1700, San
Francisco, CA 94105. The petition requested that 40 CFR 180.586 be
amended by establishing a tolerance for residues of the insecticide
clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-
nitroguanidine, in or on pome fruit at 1.0 parts per million (ppm).
That notice included a summary of the petition prepared by Arvesta
Corporation, 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 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 clothianidin on
pome fruit at 1.0 ppm. EPA's assessment of exposures and risks
associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by clothianidin as
well as the no observed adverse effect level (NOAEL) and the lowest
observed adverse effect level (LOAEL) from the toxicity studies
reviewed are discussed in the Federal Register of May 30, 2003 (68 FR
32390) (FRL-7306-8).
B. Toxicological Endpoints
The dose at which 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 LOAEL
[[Page 7888]]
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 clothianidin used for
human risk assessment is shown in Table 1 of this unit:
Table 1.--Summary of Toxicological Dose and Endpoints for Clothianidin for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk
Assessment,
Exposure/Scenario Interspecies and Special FQPA SF and LOC Study and Toxicological
Intraspecies and any for Risk Assessment Effects
Traditional UF
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Acute dietary Developmental NOAEL = FQPA SF = 1 Developmental rabbit
(Females 13-50 years of age)......... 25 mg/kg/day aPAD = acute RfD / FQPA study
UF = 1000.............. SF. Developmental LOAEL =
Acute RfD = 0.025 mg/kg = 0.025 mg/kg.......... 75 mg/kg/day based on
an increased litter
incidence of a missing
lobe of the lung.
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Acute dietary NOAEL = 25 mg/kg/day FQPA SF = 1 Special Neurotoxicity/
(General population)................. UF = 1000.............. aPAD = acute RfD / FQPA Pharmacology Study in
Acute RfD = 0.025 mg/kg SF. Mice and Rats
= 0.025 mg/kg.......... LOAEL = 50 mg/kg based
on transient signs of
decreased spontaneous
motor activity,
tremors and deep
respirations.
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Chronic dietary Offspring NOAEL = 9.8 FQPA SF = 1 2-Generation
(All populations).................... mg/kg/day cPAD = chronic RfD / reproduction study
UF = 1000.............. FQPA SF. Offspring LOAEL = 31.2
Chronic RfD = 0.0098 mg/ = 0.0098 mg/kg/day..... mg/kg/day based on
kg/day. decreased mean body
weight gain and
delayed sexual
maturation, decreased
absolute thymus
weights in F1 pups and
an increase in
stillbirths in both
generations.
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Incidental Oral NOAEL = 9.8 mg/kg/day Residential LOC for MOE 2-Generation
(All Durations)...................... = 1000 Reproduction Study
Offspring LOAEL = 31.2
mg/kg/day based on
decreased mean body
weight gain and
delayed sexual
maturation, decreased
absolute thymus
weights in F1 pups and
an increase in
stillbirths in both
generations.
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[[Page 7889]]
Dermal Oral study NOAEL= 9.8 Residential LOC for MOE 2-Generation
(All Durations)...................... mg/kg/day (dermal = 1000 Reproduction Study
absorption rate = 1%) Offspring LOAEL = 31.2
mg/kg/day based on
decreased mean body
weight gain and
delayed sexual
maturation, decreased
absolute thymus
weights in F1 pups and
an increase in
stillbirths in both
generations.
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Inhalation Oral study Residential LOC for MOE 2-Generation
(All durations)...................... NOAEL = 9.8 mg/kg/day = 1000 Reproduction Study
(inhalation absorption Offspring LOAEL = 31.2
rate = 100%). mg/kg/day based on
decreased mean body
weight gain and
delayed sexual
maturation, decreased
absolute thymus
weights in F1 pups and
an increase in
stillbirths in both
generations.
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Cancer (oral, dermal, inhalation) Classification: Not likely to be carcinogenic to humans
----------------------------------------------------------------------------------------------------------------
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.586) for the residues of clothianidin, in or on
a variety of raw agricultural commodities. Tolerances for clothianidin
are established on canola, field corn, pop corn, sweet corn, and milk.
Since clothianidin is a major metabolite of thiamethoxam, which has
many registered uses and several pending uses, residues of clothianidin
that would theoretically result from the metabolism of thiamethoxam are
included in the analysis. Risk assessments were conducted by EPA to
assess dietary exposures from clothianidin in food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide, if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1-day or
single exposure. In conducting the acute dietary risk assessment EPA
used the Dietary Exposure Evaluation Model software with the Food
Commodity Intake Database (DEEM-FCID\T\), which incorporates food
consumption data as reported by respondents in the United States
Department of Agriculture (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 acute exposure assessments: The acute
analysis is a conservative assessment that was based on tolerance level
residues and the assumption of 100% crop treated (PCT) for established
and proposed clothianidin uses. For the commodities that have both
thiamethoxam tolerances and established or proposed clothianidin
tolerances (i.e., sweet corn, field corn, pop corn, canola, milk, and
pome fruit), the proposed clothianidin tolerances are added to the
residues that could result from use of thiamethoxam. The assumptions
made for the acute exposure assessments for thiamethoxam are discussed
in the Federal Register of January 5, 2005 (70 FR 708) (FRL-7689-7).
The general U.S. population and all population subgroups have exposure
and risk estimates which are below EPA's LOC (i.e., the aPADs are all
below 100%). The most highly exposed population subgroup is infants
less than 1 year old, which utilizes 80% of the aPAD.
ii. Chronic exposure. In conducting the chronic dietary risk
assessment EPA used the DEEM-FCID\TM\, which incorporates food
consumption data as reported by respondents in the USDA 1994-1996 and
1998 Nationwide CSFII, and accumulated exposure to the chemical for
each commodity. The following assumptions were made for the chronic
exposure assessments: The chronic analysis is a relatively conservative
assessment that was based on tolerance level residues and the
assumption of 100% CT for established and proposed clothianidin uses,
with the exception of anticipated residues (AR) for apples and pears.
For the commodities that have both thiamethoxam tolerances and
established or proposed clothianidin tolerances (i.e., sweet corn,
field corn, pop corn, canola, and milk), the proposed clothianidin
tolerances are added to the residues that could result from use of
thiamethoxam. For apples and pears, the highest average field trial
(HAFT) levels from the residue field trials were added to the residues
that could result from use of thiamethoxam. The assumptions made for
the chronic exposure assessments for thiamethoxam are discussed in the
Federal Register of January 5, 2005 (70 FR 708) (FRL-7689-7). The
general U.S. population and all population subgroups have exposure and
risk estimates which are below EPA's LOC (i.e., the cPADs are all below
100%). The most highly exposed population subgroup is children 1 to 2
years of age, which utilizes 15% of the cPAD.
iii. Cancer. EPA has determined that clothianidin is not likely to
be a human carcinogen. As a result, a quantitative cancer dietary
exposure analysis was not performed.
iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide chemicals that have been measured in food. If EPA
relies on such information, EPA must require 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. Following the initial data submission, EPA is authorized
to require similar data on a time frame it deems appropriate. As
required by section 408(b)(2)(E) of FFDCA, EPA will issue a data call-
in for information relating to anticipated residues to be submitted no
later than 5 years from the date of issuance of this tolerance.
[[Page 7890]]
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for clothianidin 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 clothianidin.
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 concentration in ground water (SCI-GROW) model
is used to predict pesticide concentrations in shallow ground water.
For a screening-level assessment for surface water EPA will use FIRST
(a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model). The FIRST
model is a subset of the PRZM/EXAMS model that uses a specific high-end
runoff scenario for pesticides. Both FIRST and PRZM/EXAMS incorporate
an index reservoir environment, and both models include a percent crop
area factor as an adjustment to account for the maximum percent crop
coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a screen for sorting out pesticides for which it is
unlikely that drinking water concentrations would exceed human health
LOC.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs), which are the model estimates of a
pesticide's concentration in water. EECs derived from these models are
used to quantify drinking water exposure and risk as a %RfD or %PAD.
Instead drinking water levels of comparison (DWLOCs) are calculated and
used as a point of comparison against the model estimates of a
pesticide's concentration in water. DWLOCs are theoretical upper limits
on a pesticide's concentration in drinking water in light of total
aggregate exposure to a pesticide in food, and from residential uses.
Since DWLOCs address total aggregate exposure to clothianidin they are
further discussed in the aggregate risk sections in Unit III.E.
Based on the FIRST and SCI-GROW models, the EECs of clothianidin
for acute exposures are estimated to be 7.29 parts per billion (ppb)
for surface water and 5.84 ppb for ground water. The EECs for chronic
exposures are estimated to be 1.35 ppb for surface water and 5.84 ppb
for ground water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Clothianidin is
currently registered for use on the following residential non-dietary
sites: Turfgrasses. The risk assessment was conducted using the
following residential exposure assumptions: Due to the use patterns on
turfgrasses, a number of residential or recreational post-application
exposures are possible. In a residential setting, a ``homeowner'' may
be exposed during application of the material to his or her lawn.
Further, the ``homeowner'' may also experience post-application dermal
exposure. Toddlers may be exposed via ``hand-to-mouth'' oral exposures
and/or dermal exposures. ``Aggregated'' exposures are presented for
toddlers (i.e., hand-to-mouth turf plus hand-to-mouth soil plus dermal
post-application). EPA considers hand-to-mouth ingestion of granules to
be episodic in nature, that is, a ``one-time'' event. Therefore the
exposure from ingestion of granules is not combined with believed
multiple exposures from ``mouthing'' of turf or soil or from post-
application dermal exposure. The estimated exposures and risks are
presented below in Table 2 of this unit:
Table 2.--Summary of Residential Post-Application Exposures and Risks to
Clothianidin
------------------------------------------------------------------------
Exposure
(Dose)/mg
Activity a.i./kg bw/ MOE
day
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Toddler oral hand to mouth from contacting 0.0059 1,700
treated turf
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Toddler incidental oral ingestion of treated 0.00002 490,000
soil
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Adult dermal post-application turf contact 0.00108 9,100
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Adult combined dermal exposure = application + 0.000026 + 8,900
post-application 0.00108
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Toddler dermal post-application turf contact 0.00155 6,300
-------------------------------------------------------------
Toddler combined oral (except granules) and 0.00747 1,300
dermal exposures (treated turf + treated soil
+ dermal)
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Adult golfer post-application turf contact 0.000075 130,000
-------------------------------------------------------------
Child golfer post-application turf contact 0.000128 77,000
------------------------------------------------------------------------
A MOE of 1,000 is adequate to protect adults and children from
residential non-dietary post-application exposures to clothianidin. The
estimated MOE's are based upon conservative assumptions and are greater
than 1,000. Therefore, the estimated risks from residential non-dietary
post-application exposures do not exceed EPA's LOC.
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 does not have, at this time, available data to determine
whether clothianidin has a common mechanism of toxicity with other
substances. Unlike
[[Page 7891]]
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 clothianidin and any other
substances and clothianidin 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 clothianidin 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 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. No quantitative or
qualitative susceptibility was observed in either of the developmental
rat or rabbit studies. Quantitative susceptibility was observed in both
the reproduction and developmental neurotoxicity studies; however, the
degree of concern for these studies is low because the observed effects
are well characterized and there are clear NOAELs/LOAELs in each case.
In addition, the endpoint of concern is the one that is being used for
short-, intermediate- and long-term dietary and non-dietary exposure
risk assessments. There are no residual uncertainties. Therefore, there
are no to low concerns with regard to prenatal and/or postnatal
toxicity.
3. Conclusion. The toxicology database for clothianidin is not
complete for FQPA purposes. A complete complement of acceptable
developmental, reproduction, developmental neurotoxicity, mammalian
neurotoxicity and special neurotoxicity studies are available; however,
due to evidence of decreased absolute and adjusted organ weights of the
thymus and spleen in multiple studies in the clothianidin data base,
and since juvenile rats in the 2-generation reproduction study appear
to be more susceptible to these effects, EPA has determined that
testing should be conducted to assess immune system function in adults
and in young animals following developmental exposures (i.e., a
developmental immunitoxicity study).
In the absence of the developmental immunotoxicity study, EPA
determined that there is insufficient data to justify selection of an
additional safety factor for the protection of infants and children
lower than the default value of 10X for both single and repeated dose
exposure scenarios. Therefore, an additional FQPA safety factor of 10X,
in the form of a data base uncertainty factor (UFDB), will be applied
to both single and repeated dose exposure scenarios (i.e., acute and
chronic RfDs, short- and intermediate-term incidental oral exposures,
and short-, intermediate-, and long-term dermal and inhalation exposure
resulting from residential uses of clothianidin) to account for the
lack of the developmental immunotoxicity study with clothianidin.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against EECs. DWLOC values are
not regulatory standards for drinking water. DWLOCs are theoretical
upper limits on a pesticide's concentration in drinking water in light
of total aggregate exposure to a pesticide in food and residential
uses. In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water (e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure)). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the EPA's Office of Water are used to calculate
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and
1L/10 kg (child). Default body weights and drinking water consumption
values vary on an individual basis. This variation will be taken into
account in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, EPA will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
clothianidin will occupy 18% of the aPAD for the U.S. population, 12%
of the aPAD for females 13 years and older, 80% of the aPAD for infants
less than one year old, and 60% of the aPAD for children 1 to 2 years
old. In addition, there is potential for acute dietary exposure to
clothianidin in drinking water. After calculating DWLOCs and comparing
them to the EECs for surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the aPAD, as shown in Table 3 of
this unit:
[[Page 7892]]
Table 3.--Aggregate Risk Assessment for Acute Exposure to Clothianidin
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population/Subgroup aPAD(mg/kg) %/aPAD/ Water EEC/ Water EEC/ Acute DWLOC
(Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. Population 0.025 18 7.29 5.84 710
--------------------------------------------------------------
All infants (less than one year old) 0.025 80 7.29 5.84 48
--------------------------------------------------------------
Children 1-2 years old 0.025 60 7.29 5.84 92
--------------------------------------------------------------
Females 13-49 years old 0.025 12 7.29 5.84 640
--------------------------------------------------------------
Adults 50+ years old 0.025 14 7.29 5.84 1,500
----------------------------------------------------------------------------------------------------------------
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
clothianidin from food will utilize 6% of the cPAD for the U.S.
population, 13% of the cPAD for infants less than one year old, and 15%
of the cPAD for children 1-2 years old. There are also registered uses
on turfgrasses for clothianidin that may result in chronic residential
exposure. Combined residential exposure estimates range from an MOE of
1,300 for combined oral and dermal exposure to toddlers (treated turf +
treated soil + dermal) to 8,900 for dermal exposure to adults
(application + post-application) adults. In addition, there is
potential for chronic dietary exposure to clothianidin in drinking
water. After calculating DWLOCs and comparing them to the EECs for
surface and ground water, EPA does not expect the aggregate exposure to
exceed 100% of the cPAD, as shown in Table 4 of this unit:
Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Clothianidin
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population/Subgroup cPAD/mg/kg/ %/cPAD Water EEC/ Water EEC/ Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.0098 6 1.35 5.84 320
--------------------------------------------------------------
All infants (less than one year old) 0.0098 13 1.35 5.84 85
--------------------------------------------------------------
Children 1-2 years old 0.0098 15 1.35 5.84 83
--------------------------------------------------------------
Females 13-49 years old 0.0098 5 1.35 5.84 280
--------------------------------------------------------------
Adults 50+ years old 0.0098 5 1.35 5.84 330
----------------------------------------------------------------------------------------------------------------
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).
Clothianidin is currently registered for use that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for clothianidin.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures
aggregated result in aggregate MOEs of 5,900 for the general U.S.
population; 1,100 for children 1-2 years old; and 6,200 for females 13
to 49 years old. These aggregate MOEs do not exceed the Agency's LOC
for aggregate exposure to food and residential uses. In addition,
short-term DWLOCs were calculated and compared to the EECs for chronic
exposure of clothianidin in ground and surface water. After calculating
DWLOCs and comparing them to the EECs for surface and ground water, EPA
does not expect short-term aggregate exposure to exceed the Agency's
LOC, as shown in Table 5 of this unit:
Table 5.--Aggregate Risk Assessment for Short-Term Exposure to Clothianidin
----------------------------------------------------------------------------------------------------------------
Aggregate/ Surface Ground/
Population/Subgroup MOE/(Food + Aggregate/ Water EEC/ Water EEC/ Short-Term
Residential) LOC (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. Population 5,900 1,000 1.35 5.84 280
--------------------------------------------------------------
Children 1-2 years old 1,100 1,000 1.35 5.84 8.7
--------------------------------------------------------------
Females 13-49 years old 6,200 1,000 1.35 5.84 250
----------------------------------------------------------------------------------------------------------------
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).
[[Page 7893]]
Clothianidin is currently registered for use(s) that could result
in intermediate-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic food and water and
intermediate-term exposures for clothianidin.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that food and
residential exposures aggregated result in aggregate MOEs of 5,900 for
the general U.S. population: 1,100 for children 1-2 years old; and
6,200 for females 13 to 49 years old. These aggregate MOEs do not
exceed the Agency's LOC for aggregate exposure to food and residential
uses. In addition, intermediate-term DWLOCs were calculated and
compared to the EECs for chronic exposure of clothianidin in ground
water and surface water. After calculating DWLOCs and comparing them to
the EECs for surface water and ground water, EPA does not expect
intermediate-term aggregate exposure to exceed the Agency's LOC, as
shown in Table 6 of this unit:
Table 6.--Aggregate Risk Assessment for Intermediate-Term Exposure to Clothianidin
----------------------------------------------------------------------------------------------------------------
Aggregate/ Surface Ground/ Intermediate-
Population/Subgroup MOE/(Food + Aggregate/ Water EEC/ Water EEC/ Term DWLOC
Residential) LOC (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. Population 5,900 1000 1.35 5.84 280
------------------------------------------------------------
Children 1-2 years old 1,100 1,000 1.35 5.84 8.7
------------------------------------------------------------
Females 13-49 years old 6,200 1,000 1.35 5.84 250
----------------------------------------------------------------------------------------------------------------
5. Aggregate cancer risk for U.S. population. Clothianidin has been
classified as a ``not likely human carcinogen.'' Therefore, it is not
expected to pose a cancer risk.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to clothianidin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (liquid chromatography/mass
spectroscopy/mass spectroscopy LC/MS/MS analysis) 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
No Codex, Canadian, or Mexican maximum residue levels (MRLs) have
been established for residues of clothianidin.
V. Conclusion
Therefore, the tolerance is established for residues of
clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-
nitroguanidine, in or on pome fruit at 1.0 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-2004-0406 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 April 18,
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-2004-0406, 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
[[Page 7894]]
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
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: February 7, 2005.
Losi Rossi,
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. Section 180.586 is amended by alphabetically adding the commodity
``Pome fruit'' to the table in paragraph (a) to read as follows:
Sec. 180.586 Clothianidin; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Pome fruit.......................................... 1.0
------------------------------------------------------------------------
* * * * *
[FR Doc. 05-2984 Filed 2-15-05; 8:45 am]
BILLING CODE 6560-50-S