[Federal Register Volume 68, Number 166 (Wednesday, August 27, 2003)]
[Rules and Regulations]
[Pages 51471-51479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-21783]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0254; FRL-7320-2]


Thiamethoxam; Pesticide Tolerances for Emergency Exemptions

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- [email protected].

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:
    [sbull] 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/cfrhtm_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.epa.gov/edocket/ 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 (MOEcancer = 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: 
[email protected].

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 [email protected], 
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: [email protected]. 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 (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.

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.

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), 346(a) and 371.

0
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