Thiamethoxam; Pesticide Tolerances for Emergency Exemptions

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: August 27, 2003 (Volume 68, Number 166)]
[Rules and Regulations]
[Page 51471-51479]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27au03-14]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0254; FRL-7320-2]

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for the
combined residues of thiamethoxam and CGA-322704 on hops at 0.10 parts
per million (ppm); bean, succulent at 0.02 ppm; and bean, dried at 0.02
ppm. This action is in response to EPA's granting of emergency
exemptions under section 18 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) authorizing use of the pesticide on hops,
succulent bean seed and dry bean seed. This regulation establishes
maximum permissible levels for residues of thiamethoxam in these food
commodities. The tolerances will expire and are revoked on December 31,
2006.

DATES: This regulation is effective August 27, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0254,
must be received on or before October 27, 2003.

ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION.

[[Page 51472]]

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9367; e-mail address: Sec-18- Mailbox@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 a Federal
or State Government Agency involved in administration of environmental
quality programs (i.e., United States Departments of Agriculture,
Environment, etc). Potentially affected entities may include, but are
not limited to:
? Federal or State Government Entity (NAICS 9241).
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 Get Copies of This Document and Other Related Information?

1. Docket. EPA has established an official public docket for this
action under docket ID number OPP-2003-0254. The official public docket
consists of the documents specifically referenced in this action, any
public comments received, and other information related to this action.
Although a part of the official docket, the public docket does not
include Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. The official public docket
is the collection of materials that is available for public viewing at
the Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall #2, 1921 Jefferson Davis Hwy., 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.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/. A frequently updated
electronic version of 40 CFR part 180 is available at http://www.access.
gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html,
a beta site currently under development.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.regulations.gov/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.

II. Background and Statutory Findings

EPA, on its own initiative, in accordance with sections 408(e) and
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346(a), is establishing tolerances for the combined residues of
thiamethoxam and CGA-322704 on hops at 0.10 ppm; bean, succulent at
0.02 ppm; and bean, dried at 0.02 ppm. These tolerances will expire and
are revoked on December 31, 2006. EPA will publish a document in the
Federal Register to remove the revoked tolerances from the Code of
Federal Regulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18-related tolerances to set binding precedents for the
application of section 408 of the FFDCA and the new safety standard to
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA
to establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
Section 408(b)(2)(A)(i) of the 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 the 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 the 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. . .
.''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
Agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by the Food Quality Protection Act (FQPA) of 1996. EPA has
established regulations governing such emergency exemptions in 40 CFR
part 166.

III. Emergency Exemption for Thiamethoxam on Hops, Succulent Bean Seed
and Dry Bean Seed and FFDCA Tolerances

The States of Washington and Idaho requested the use of
thiamethoxam on succuelent and dry bean seed to control leaf hoppers.
EPA has authorized under FIFRA section 18 the use of thiamethoxam on
succulent and dry bean seed for control of leaf hoppers in Washington
and Idaho. After having reviewed the submissions, EPA concurs that
emergency conditions exist for these States. The State of Oregon
requested the use of thiamethoxam on hops to control garden symphylans.
EPA has authorized under FIFRA section 18 the use of thiamethoxam on
hops for control of garden symphylans in Oregon. After having reviewed
the submission, EPA concurs that an emergency condition exists for this
State.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of thiamethoxam in or on
hops, succulent bean seed and dry bean seed. In doing so, EPA
considered the safety standard in section 408(b)(2) of the FFDCA, and
EPA decided that the necessary tolerances under section 408(l)(6) of
the FFDCA would be consistent with the safety standard and with FIFRA
section 18. Consistent with the need to move quickly on the emergency
exemption in order to address an urgent non-routine situation and to
ensure that the resulting food is safe and lawful, EPA is issuing

[[Page 51473]]

these tolerances without notice and opportunity for public comment as
provided in section 408(l)(6) of the FFDCA. Although these tolerances
will expire and are revoked on December 31, 2006, under section
408(l)(5) of the FFDCA, residues of the pesticide not in excess of the
amounts specified in the tolerances remaining in or on hops, succulent
beans and dry beans after that date will not be unlawful, provided the
pesticide is applied in a manner that was lawful under FIFRA, and the
residues do not exceed a level that was authorized by these tolerances
at the time of that application. EPA will take action to revoke these
tolerances earlier if any experience with, scientific data on, or other
relevant information on this pesticide indicate that the residues are
not safe.
Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether thiamethoxam
meets EPA's registration requirements for use on hops, succulent bean
seed and dry bean seed or whether permanent tolerances for these uses
would be appropriate. Under these circumstances, EPA does not believe
that these tolerances serve as a basis for registration of thiamethoxam
by a State for special local needs under FIFRA section 24(c). Nor do
these tolerances serve as the basis for any State other than Washington
and Idaho (succulent and dry bean seed) and Oregon (hops) to use this
pesticide on these crops under section 18 of FIFRA without following
all provisions of EPA's regulations implementing FIFRA section 18 as
identified in 40 CFR part 166. For additional information regarding the
emergency exemption for thiamethoxam, contact the Agency's Registration
Division at the address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

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 the FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances November 26, 1997 (62 FR 62961) (FRL-
5754-7).
Consistent with section 408(b)(2)(D) of the 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
thiamethoxam and to make a determination on aggregate exposure,
consistent with section 408(b)(2) of the FFDCA, for time-limited
tolerances for the combined residues of thiamethoxam and CGA-322704 on
hops at 0.10 ppm; bean, succulent at 0.02 ppm; and bean, dried at 0.02
ppm. EPA's assessment of the dietary exposures and risks associated
with establishing the tolerance follows.

A. Toxicological Endpoints

The dose at which no observed adverse effect levels are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological endpoint.
However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (aRfD or cRfD) where
the RfD is equal to the NOAEL divided by the appropriate UF (RfD =
NOAEL/UF). Where an additional safety factor is retained due to
concerns unique to the FQPA, 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 FQPA SF.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (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 is expressed as 1 x 10-6 or one in a million).
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 (MOE_cancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for thiamethoxam used for human risk assessment is shown in
the following Table 1:

Table 1.--Summary of Toxicological Dose and Endpoints for Thiamethoxam for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF* and level of
Exposure scenario Dose used in risk concern for risk Study and toxicological
assessment, UF assessment effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (general population NOAEL = 100 mg/kg/day FQPA SF = 10 Acute mammalian
including infants and children) UF = 100............... aPAD = acute RfD....... neurotoxicity study in
Acute RfD = 1 mg/kg/day FQPA SF = 0.1 mg/kg/day the rat
LOAEL = 500 mg/kg/day
based on treatment-
related
neurobehavioral
effects observed in
the FOB and LMA
testing (drooped
palpebral closure,
decreased rectal
temperature and
locomotor activity,
increased forelimb
grip strength).
----------------------------------------------------------------------------------------------------------------

[[Page 51474]]

Chronic dietary (all populations) NOAEL = 0.6 mg/kg/day FQPA SF = 10 2-Generation
UF = 100............... cPAD = chronic RfD..... reproduction study
Chronic RfD = 0.006 mg/ FQPA SF = 0.0006 mg/kg/ LOAEL = 1.8 mg/kg/day
kg/day. day. based on increased
incidence and severity
of tubular atrophy in
testes of F1
generation males.
----------------------------------------------------------------------------------------------------------------
Oral nondietary (all durations) NOAEL = 0.6 mg/kg/day LOC for MOE = 1,000 2-Generation
(Residential).......... reproduction study
LOAEL = 1.8 mg/kg/day
based on increased
incidence and severity
of tubular atrophy in
testes of F1
generation males.
----------------------------------------------------------------------------------------------------------------
Dermal (all durations) Oral study LOC for MOE = 1,000 2-Generation
(Residential)........................ NOAEL = 0.6 mg/kg/day (Residential).......... reproduction study
(dermal absorption LOC for MOE = 100...... LOAEL = 1.8 mg/kg/day
rate = 5%). (Occupational)......... based on increased
incidence and severity
of tubular atrophy in
testes of F1
generation males.
----------------------------------------------------------------------------------------------------------------
Inhalation (all durations) Oral study LOC for MOE = 1,000 2-Generation
(Residential)........................ NOAEL= 0.6 mg/kg/day (Residential).......... reproduction study
(inhalation absorption LOC for MOE = 100...... LOAEL = 1.8 mg/kg/day
rate = 100%). (Occupational)......... based on increased
incidence and severity
of tubular atrophy in
testes of F1
generation males.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Likely carcinogen for humans based on increased incidence of
hepatocellular adenomas and carcinomas in male and female mice.
Quantification of risk based on most potent unit risk: male mouse liver
adenoma and/or carcinoma combined tumor rate. The upper bound estimate
of unit risk, Q1* milligrams/kilogram/day (mg/kg/day)-1 is 3.77 x 10-2
in human equivalents.
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.

B. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances have been
established for the combined residues of thiamethoxam, in or on a
variety of raw agricultural commodities (RAC). The following RAC's have
established tolerances: Barley, canola, cotton, sorghum, wheat,
tuberous and corm vegetables crop subgroup, fruiting vegetables, crop
group, tomato paste, cucurbit vegetables crop group, pome fruits crop
group, milk and the meat and meat by products of cattle, goats, horses,
and sheep. Risk assessments were conducted by EPA to assess dietary
exposures from thiamethoxam 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. The Dietary Exposure Evaluation Model (DEEM\TM\)
analysis evaluated the individual food consumption as reported by
respondents in the United States Department of Agriculture (USDA) 1994-
1996 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:
Tolerence level residues and 100% crop treated.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the DEEM\TM\ analysis evaluated the individual food
consumption as reported by respondents in the USDA 1994-1996 nationwide
CSFII and accumulated exposure to the chemical for each commodity. The
chronic exposure estimates are based on Tier 3 analyses that
incorporate anticipated residues and percent crop treated (PCT) for
most commodities.
iii. Cancer. Cancer dietary exposure has been estimated using the
DEEM-FCID version 1.3. The cancer exposure estimates are based on Tier
3 analyses that incorporate anticipated residues and PCT for most
commodities.
iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of the 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 the 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.
Section 408(b)(2)(F) of the FFDCA states that the Agency may use
data on the actual percent of food treated for assessing chronic
dietary risk only if the Agency can make the following findings:
Condition 1, that the data used are reliable and provide a valid basis
to show what percentage of the food derived from such crop is likely to
contain such pesticide residue; condition 2, that the exposure estimate
does not underestimate exposure for any significant subpopulation
group; and condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To

[[Page 51475]]

provide for the periodic evaluation of the estimate of PCT as required
by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to
submit data on PCT.
The Agency used PCT information as follows: Potatos, 19%; fruiting
vegetables, 15%; cucumbers, 5%; melons, 13%; casabas, 44%; crenshaws,
44%; squash, 44%; pumpkins, 44%; apples, 5%; crabapples, 53%; pears,
9%; quinces, 53%; loquat, 53%; barley, 0.1%; sorghum, 9%; wheat, 2%;
canola, 55%; cotton, 20%.
The Agency believes that the three conditions listed above have
been met. With respect to condition 1, PCT estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. EPA uses a weighted average PCT for chronic dietary
exposure estimates. This weighted average PCT figure is derived by
averaging State-level data for a period of up to 10 years, and
weighting for the more robust and recent data. A weighted average of
the PCT reasonably represents a person's dietary exposure over a
lifetime, and is unlikely to underestimate exposure to an individual
because of the fact that pesticide use patterns (both regionally and
nationally) tend to change continuously over time, such that an
individual is unlikely to be exposed to more than the average PCT over
a lifetime. For acute dietary exposure estimates, EPA uses an estimated
maximum PCT. The exposure estimates resulting from this approach
reasonably represent the highest levels to which an individual could be
exposed, and are unlikely to underestimate an individual's acute
dietary exposure. The Agency is reasonably certain that the percentage
of the food treated is not likely to be an underestimation. As to
conditions 2 and 3, regional consumption information and consumption
information for significant subpopulations is taken into account
through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which thiamethoxam
may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for thiamethoxam 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 thiamethoxam.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
(SCI-GROW), which predicts pesticide concentrations in ground water. In
general, EPA will use GENEEC (a Tier 1 model) before using PRZM/EXAMS
(a Tier 2 model) for a screening-level assessment for surface water.
The GENEEC model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. GENEEC incorporates a
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir
environment in place of the previous pond scenario. The PRZM/EXAMS
model includes 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 coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a percent reference dose (%RfD) or
percent population adjusted dose (%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 thiamethoxam, they are further discussed in the aggregate
risk sections below.
Based on the PRZM/EXAMS and SCI-GROW models, the EECs of
thiamethoxam for acute exposures are estimated to be 7.1 parts per
billion (ppb) for surface water and 1.94 ppb for ground water. The EECs
for chronic exposures are estimated to be 0.43 (non-cancer) and 0.13
ppb (cancer) for surface water and 1.94 ppb for ground water (cancer
and non-cancer).
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). Thiamethoxam is not
registered for use on any sites that would result in residential
exposure.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the 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 thiamethoxam has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
thiamethoxam 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 thiamethoxam 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 final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

C. Safety Factor for Infants and Children

1. In general. Section 408 of the FFDCA provides that EPA shall
apply an additional tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of

[[Page 51476]]

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.
2. Prenatal and postnatal sensitivity. The developmental toxicity
studies indicated no quantitative or qualitative evidence of increased
susceptibility of rat or rabbit fetus to in utero exposure based on the
fact that the developmental NOAELs are either higher than or equal to
the maternal NOAELs. However, the reproductive studies indicate effects
in male rats in the form of increased incidence and severity of
testicular tubular atrophy. These data are considered to be evidence of
increased quantitative susceptibility for male pups when compared to
the parents.
3. Conclusions. Based on:
i. Effects on endocrine organs observed across species.
ii. The significant decrease in alanine amino transferase levels in
the companion animal studies and in the dog studies.
iii. The mode of action of this chemical in insects (interferes
with the nicotinic acetyl choline receptors of the insect's nervous
system) thus a developmental neurotoxicity study is required.
iv. The transient clinical signs of neurotoxicity in several
studies across species.
v. The suggestive evidence of increased quantitative susceptibility
in the rat reproduction study, the Agency is retaining the FQPA factor
which is l0X.

D. 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 the model estimates of
a pesticide's concentration in water (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 + chronic non-dietary, non-occupational 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 EPA 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 thiamethoxam 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
thiamethoxam on 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
thiamethoxam will occupy 3% of the aPAD for the U.S. population; 2% of
the aPAD for females 13 years and older; 7% of the aPAD for all infants
<1 year old; and 9% of the aPAD for children 1-2 years old. In
addition, despite the potential for acute dietary exposure to
thiamethoxam in drinking water, after calculating DWLOCs and comparing
them to conservative EECs of thiamethoxam in surface water and ground
water, EPA does not expect the aggregate exposure to exceed 100% of the
aPAD, as shown in the following Table 2:

Table 2.--Aggregate Risk Assessment for Acute Exposure to Thiamethoxam
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population subgroup aPAD (mg/ % aPAD water EEC water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. population 0.1 3 7.1 1.94 3,400
----------------------------------------------------------------------------------------------------------------
All Infants (<1 year old) 0.1 7 7.1 1.94 930
----------------------------------------------------------------------------------------------------------------
Children (1-2 years old) 0.1 9 7.1 1.94 910
----------------------------------------------------------------------------------------------------------------
Children (3-5 years old) 0.1 6 7.1 1.94 940
----------------------------------------------------------------------------------------------------------------
Children (6-12 years old) 0.1 4 7.1 1.94 960
----------------------------------------------------------------------------------------------------------------
Youth (13-19 years old) 0.1 2 7.1 1.94 3,400
----------------------------------------------------------------------------------------------------------------
Adults (20-49 years old) 0.1 2 7.1 1.94 3,400
----------------------------------------------------------------------------------------------------------------
Adults (50+ years old) 0.1 2 7.1 1.94 3,400
----------------------------------------------------------------------------------------------------------------
Females (13-49 years old) 0.1 2 7.1 1.94 3,000
----------------------------------------------------------------------------------------------------------------

2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
thiamethoxam from food will utilize 4% of the cPAD for the U.S.
population, 8% of the cPAD for all

[[Page 51477]]

infants <1 year old and 12% of the cPAD for children 1-2 years old.
There are no residential uses for thiamethoxam that result in chronic
residential exposure to thiamethoxam. In addition, despite the
potential for chronic dietary exposure to thiamethoxam in drinking
water, after calculating DWLOCs and comparing them to conservative
model estimated environmental concentrations of thiamethoxam in surface
water and ground water, EPA does not expect the aggregate exposure to
exceed 100% of the cPAD, as shown in the following Table 3:

Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Thiamethoxam
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population subgroup cPAD mg/kg/ % cPAD water EEC water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. population 0.0006 4 0.43 1.94 20
----------------------------------------------------------------------------------------------------------------
All infants (<1 year old) 0.0006 8 0.43 1.94 5.6
----------------------------------------------------------------------------------------------------------------
Children (1-2 years old) 0.0006 12 0.43 1.94 5.3
----------------------------------------------------------------------------------------------------------------
Children (3-5 years old) 0.0006 10 0.43 1.94 5.4
----------------------------------------------------------------------------------------------------------------
Children (6-12 years old) 0.0006 6 0.43 1.94 5.6
----------------------------------------------------------------------------------------------------------------
Youth (13-19 years old) 0.0006 4 0.43 1.94 20
----------------------------------------------------------------------------------------------------------------
Adults (20-49 years old) 0.0006 3 0.43 1.94 20
----------------------------------------------------------------------------------------------------------------
Adults (50+ years old) 0.0006 3 0.43 1.94 20
----------------------------------------------------------------------------------------------------------------
Females (13-49 years old) 0.0006 3 0.43 1.94 17
----------------------------------------------------------------------------------------------------------------

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). Thiamethoxam is not
registered for use on any sites that would result in residential
exposure. Therefore, the aggregate risk is the sum of the risk from
food and water, which were previously addressed.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account non-dietary, non-occupational exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Thiamethoxam is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which were previously addressed.
5. Aggregate cancer risk for U.S. population. At the present time,
there are no uses of thiamethoxam that will result in non-dietary, non-
occupational (i.e., residential) exposures. Therefore, aggregate cancer
risk estimates for thiamethoxam address only the food and drinking
water pathways of exposure. EECs for thiamethoxam for comparison to the
DWLOCs are 1.94 [mu]g/L for cancer scenarios. The Agency does not have
aggregate risk concerns when the estimated residues in water are less
than the DWLOCs.
For cancer risk, which is estimated for the total U.S. population
only, the DWLOC is 2.15 [mu]g/L and assumes a negligible risk level of
3 x 10-6 rather than 1 x 10-6. For risk
management purposes, EPA considers a cancer risk to be greater than
negligible when it exceeds the range of 1 in 1 million, however the
Agency has generally treated cancer risks up to 3 in 1 million as
within the range of 1 in 1 million. The DWLOC value indicates that
aggregate exposure to thiamethoxam is not likely to exceed the Agency's
level of concern as shown in the following Table 4:

Table 4.--Aggregate Risk Assessment for Chronic (Cancer) Exposure to Thiamethoxam
----------------------------------------------------------------------------------------------------------------
Maximum Maximum
acceptable Food water Surface Ground Cancer
Population subgroup exposure exposure exposure water EEC water EEC DWLOC
(mg/kg/ (mg/kg/day) (mg/kg/ (ppb) (ppb) (ppb)3
day)1 day)2
----------------------------------------------------------------------------------------------------------------
General U.S. population 0.0000795 0.000018 0.000062 0.13 1.94 2.15
----------------------------------------------------------------------------------------------------------------
1 Maximum acceptable exposure = 3 x 10-6 / 0.0377 (mg/kg/day)-1 = 7.95 x 10-5 mg/kg/day.
2 Maximum water exposure = maximum acceptable exposure - food exposure.
3 DWLOC = maximum water exposure (mg/kg/day) 1,000 [mu]g/mg H body weight (70 kg general population) / water
consumption (2 L/day). Value has been rounded to three significant figures.

EPA recognizes that the active ingredient clothianidin is identical
to the thiamethoxam metabolite-of-concern CGA-322704; however,
clothianidin has not been classified as a carcinogen and therefore, it
has been removed from the cancer assessment.
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 thiamethoxam residues.

V. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology High Performance Liquid
Chromatography using Ultra Violet or Mass Spectrometry (HPLC/UV or MS)
is

[[Page 51478]]

available to enforce the tolerance expression. The method may be
requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address:
furlow.calvin@epa.gov.

B. International Residue Limits

There are no CODEX, Canadian, or Mexican maximum residue limits
that impact this action.

C. Conditions

The thiamethoxam label currently contains the following rotational
crop restriction: Immediate rotation to any crop on the label or to
cucurbit vegetables, fruiting vegetables, cotton, sorghum, corn, wheat,
barley, canola, tuberous and corm vegetables, and tobacco. For all
other crops, a 120-day plant back interval must be observed. That
restriction is adequate to cover the requested section 18 use as a seed
treatment for succulent and dried beans. Hops is not rotated and,
therefore, does not raise any potential rotational crop issues.

VI. Conclusion

Therefore, the tolerances are established for the combined residues
of thiamethoxam and CGA-322704 on hops at 0.10 ppm; bean, succulent at
0.02 ppm; and bean, dried at 0.02 ppm.

VII. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the 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
the FFDCA by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the 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 the FFDCA, as was provided in the old sections 408 and 409 of the
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-2003-0254 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 October
27, 2003.
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 (1900C),
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 Rm.104, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA. 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
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3.Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.1. Mail your
copies, identified by the docket ID number OPP-2003-0254, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in Unit I.B.1. 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).

VIII. Statutory and Executive Order Reviews

This final rule establishes time-limited tolerances under section
408 of

[[Page 51479]]

the FFDCA. The Office of Management and Budget 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 FIFRA section 18 exemption under section
408 of the FFDCA, such as the [tolerances]
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 the
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 (59 FR 22951, 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.

IX. 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: August 14, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.

? Therefore, 40 CFR chapter I is amended as follows:

PART 180--AMENDED

? 1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346(a) and 371.

? 2. Section 180.565 is amended by adding text to paragraph (b) to read
as follows:

Sec. 180.565 Thiamethoxam; tolerances for residues.

* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for the combined residues of the insecticide thiamethoxam
[3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-
oxadiazin-4-imine]
and its metabolite CGA-322704 in connection with use
of the pesticide under section 18 emergency exemptions granted by EPA.
These tolerances will expire and are revoked on the dates specified in
the following table:

------------------------------------------------------------------------
Parts
Commodity per Expiration/
million revocation date
------------------------------------------------------------------------
Bean, dried................................. 0.02 12/31/06
Bean, succulent............................. 0.02 12/31/06
Hops........................................ 0.10 12/31/06
------------------------------------------------------------------------

* * * * *

[FR Doc. 03-21783 Filed 8-26-03; 8:45 am]
BILLING CODE 6560-50-S

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