Clothianidin; Pesticide Tolerance, 7886-7894 [05-2984]
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Federal Register / Vol. 70, No. 31 / Wednesday, February 16, 2005 / Rules and Regulations
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,
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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.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
2. Section 180.449 is amended as
follows.
I i. By alphabetically adding the
following commodities to the table in
paragraph (a) to read as follows
I ii. By removing the entries for the
commodities ‘‘Celery’’; ‘‘Lettuce, head’’;
‘‘Pepper’’; and ‘‘Tomato’’; in the table in
paragraph (a).
I iii. The text of paragraph (b) is
removed and reserved.
I
§ 180.449 Avermectin B1 and its delta-8,9isomer; tolerances for residues.
(a)
*
*
*
Parts per
million
Commodity
*
*
*
Avocado ....................................
*
*
*
Food products in food handling
establishments (other than
those already covered by
higher tolerances as a result
of use on growing crops, and
other than those already covered by tolerances on milk,
meat, and meat byproducts)
Goat, meat ................................
Goat, meat byproducts .............
*
*
*
Herbs, crop subgroup 19A (except chives) ...........................
Hog, meat .................................
Hog, meat byproducts ..............
*
*
*
Horse, meat ..............................
Horse, meat byproducts ...........
*
*
*
Mint ...........................................
*
*
*
Plum ..........................................
Plum, prune, dried ....................
*
*
*
Poultry, meat ............................
Poultry, meat byproducts ..........
Sheep, meat .............................
Sheep, meat byproducts ..........
*
*
*
Vegetable, fruiting, crop group
8 ............................................
Vegetable, leafy, except Brassica, crop group 4 .................
*
*
*
*
*
*
0.020
*
*
0.01
0.02
0.02
*
*
*
*
*
*
0.020
*
[FR Doc. 05–2985 Filed 2–15–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[OPP–2004–0406; FRL–7690–2]
1. The authority citation for part 180
continues to read as follows:
Clothianidin; Pesticide Tolerance
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Authority: 21 U.S.C. 321(q), 346a and 371.
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0.10
*
(b) Section 18 emergency exemptions.
[Reserved]
*
*
*
*
*
PART 180—[AMENDED]
I
0.030
0.02
0.02
*
0.02
0.02
*
0.010
*
0.010
0.025
*
0.02
0.02
0.02
0.02
*
Environmental Protection
Agency (EPA).
AGENCY:
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ACTION:
Final rule.
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;
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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
(https://www.epa.gov/edocket/), you may
access this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr/. A
frequently updated electronic version of
40 CFR part 180 is available on E-CFR
Beta Site Two at https://
www.gpoaccess.gov/ecfr/. To access the
OPPTS Harmonized Guidelines
referenced in this document, go directly
to the guidelines at https://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-thiazol5-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
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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
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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, Interspecies and
Intraspecies and any Traditional UF
Special FQPA SF and
LOC for Risk Assessment
Study and Toxicological Effects
Acute dietary
(Females 13–50 years of age)
Developmental NOAEL = 25
mg/kg/day
UF = 1000
Acute RfD = 0.025 mg/kg
FQPA SF = 1
aPAD = acute RfD ÷ FQPA
SF
= 0.025 mg/kg
Developmental rabbit study
Developmental LOAEL = 75 mg/kg/day based
on an increased litter incidence of a missing
lobe of the lung.
Acute dietary
(General population)
NOAEL = 25 mg/kg/day
UF = 1000
Acute RfD = 0.025 mg/kg
FQPA SF = 1
aPAD = acute RfD ÷ FQPA
SF
= 0.025 mg/kg
Special Neurotoxicity/Pharmacology Study in
Mice and Rats
LOAEL = 50 mg/kg based on transient signs
of decreased spontaneous motor activity,
tremors and deep respirations.
Chronic dietary
(All populations)
Offspring NOAEL = 9.8 mg/
kg/day
UF = 1000
Chronic RfD = 0.0098 mg/kg/
day
FQPA SF = 1
cPAD = chronic RfD ÷
FQPA SF
= 0.0098 mg/kg/day
2–Generation 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.
Incidental Oral
(All Durations)
NOAEL = 9.8 mg/kg/day
Residential LOC for MOE
= 1000
2–Generation 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.
Exposure/Scenario
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7889
TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR CLOTHIANIDIN FOR USE IN HUMAN RISK
ASSESSMENT—Continued
Exposure/Scenario
Dose Used in Risk Assessment, Interspecies and
Intraspecies and any Traditional UF
Special FQPA SF and
LOC for Risk Assessment
Study and Toxicological Effects
Dermal
(All Durations)
Oral study NOAEL= 9.8 mg/
kg/day (dermal absorption
rate = 1%)
Residential LOC for MOE
= 1000
2–Generation 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.
Inhalation
(All durations)
Oral study
NOAEL = 9.8 mg/kg/day (inhalation absorption rate =
100%)
Residential LOC for MOE
= 1000
2–Generation 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.
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 fooduse 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 (DEEMFCIDT), 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
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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-FCIDTM, 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
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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.
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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
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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 nonoccupational, 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 nondietary 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-tomouth soil plus dermal postapplication). EPA considers hand-tomouth 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 postapplication 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
PO 00000
Exposure
(Dose)/mg
a.i./kg bw/
day
Activity
MOE
Toddler oral
hand to
mouth from
contacting
treated turf
0.0059
1,700
Toddler incidental oral
ingestion of
treated soil
0.00002
490,000
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TABLE 2.—SUMMARY OF RESIDENTIAL
POST-APPLICATION EXPOSURES AND
RISKS TO CLOTHIANIDIN—Continued
Activity
Adult dermal
post-application turf
contact
Exposure
(Dose)/mg
a.i./kg bw/
day
MOE
0.00108
9,100
0.000026 +
0.00108
8,900
Toddler dermal postapplication
turf contact
0.00155
6,300
Toddler combined oral
(except
granules)
and dermal
exposures
(treated turf
+ treated
soil + dermal)
0.00747
1,300
Adult golfer
post-application turf
contact
0.000075
130,000
Child golfer
post-application turf
contact
0.000128
77,000
Adult combined dermal exposure = application +
post-application
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
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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 https://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
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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 2generation 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
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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:
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TABLE 3.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO CLOTHIANIDIN
aPAD(mg/
kg)
Population/Subgroup
Surface
Water EEC/
(ppb)
%/aPAD/
(Food)
Ground
Water EEC/
(ppb)
Acute
DWLOC
(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
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:
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
TABLE 4.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO CLOTHIANIDIN
cPAD/mg/
kg/day
Population/Subgroup
Surface
Water EEC/
(ppb)
%/cPAD
(Food)
Ground
Water EEC/
(ppb)
Chronic
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/
MOE/(Food
+ Residential)
Aggregate/
LOC
Surface
Water EEC/
(ppb)
Ground/
Water EEC/
(ppb)
Short-Term
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
Population/Subgroup
4. Intermediate-term risk.
Intermediate-term aggregate exposure
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takes into account residential exposure
plus chronic exposure to food and water
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(considered to be a background
exposure level).
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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 intermediateterm 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
7893
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
IntermediateTerm
DWLOC
(ppb)
Aggregate/
MOE/(Food
+ Residential)
Aggregate/
LOC
Surface
Water EEC/
(ppb)
Ground/
Water EEC/
(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
Population/Subgroup
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; email 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-(2chloro-1,3-thiazol-5-ylmethyl)-3-methyl2-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
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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
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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 14th 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
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location of the PIRIB described in
ADDRESSES. You may also send an
electronic copy of your request via email 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
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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
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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.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.586 is amended by
alphabetically adding the commodity
‘‘Pome fruit’’ to the table in paragraph (a)
to read as follows:
I
§ 180.586 Clothianidin; tolerances for
residues.
(a) * * *
Commodity
Parts per million
*
*
*
*
Pome fruit .......................
*
*
*
*
*
*
[FR Doc. 05–2984 Filed 2–15–05; 8:45 am]
BILLING CODE 6560–50–S
E:\FR\FM\16FER1.SGM
16FER1
1.0
]]>Agencies
[Federal Register Volume 70, Number 31 (Wednesday, February 16, 2005)]
[Rules and Regulations]
[Pages 7886-7894]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2984]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 (https://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180
is available on E-CFR Beta Site Two at https://www.gpoaccess.gov/ecfr/.
To access the OPPTS Harmonized Guidelines referenced in this document,
go directly to the guidelines at https://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
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------
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.
----------------------------------------------------------------
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.
----------------------------------------------------------------
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.
----------------------------------------------------------------
[[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.
----------------------------------------------------------------
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.
----------------------------------------------------------------
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
------------------------------------------------------------------------
Toddler oral hand to mouth from contacting 0.0059 1,700
treated turf
-------------------------------------------------------------
Toddler incidental oral ingestion of treated 0.00002 490,000
soil
-------------------------------------------------------------
Adult dermal post-application turf contact 0.00108 9,100
-------------------------------------------------------------
Adult combined dermal exposure = application + 0.000026 + 8,900
post-application 0.00108
-------------------------------------------------------------
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)
-------------------------------------------------------------
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
https://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
