[Federal Register Volume 66, Number 69 (Tuesday, April 10, 2001)]
[Rules and Regulations]
[Pages 18554-18561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8805]



[[Page 18554]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301114; FRL-6777-6]
RIN 2070-AB78


Imidacloprid; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for combined residues 
of imidacloprid in or on edible podded beans, succulent shelled beans, 
turnip greens, cilantro, sweet corn, field corn, leaf petiole vegetable 
subgroup, and the citrus fruits group. The Interregional Research 
Project Number 4 (IR-4) and the Bayer Corporation requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act, as amended 
by the Food Quality Protection Act of 1996.

DATES: This regulation is effective April 10, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301114, 
must be received by EPA on or before June 11, 2001.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301114 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW.,Washington, DC 20460; telephone number: (703) 308-3194; and e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                      affected  entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
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 Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically.You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to 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.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301114. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of July 5, 2000 (65 FR 41455) (FRL-6590-6), 
and February 11, 2000 (65 FR 7008) (FRL-6487-9) EPA issued notices 
pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act 
of 1996 (FQPA) (Public Law 104-170) announcing the filing of pesticide 
petitions (PP) for tolerances by IR-4, Technology Centre of New Jersey, 
681 US Highway #1 South, North Brunswick, NJ 08902-3390, and Bayer 
Corporation, 8400 Hawthorn Road, POB 4913, Kansas City, MO 64120-0013. 
These notices included summaries of these petitions prepared by Bayer 
Corporation, the registrant. There were no comments received in 
response to the notices of filing.
    The petitions requested that 40 CFR 180.472 be amended by 
establishing tolerances for combined residues of the insecticide 
imidacloprid, [(1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine) and its metabolites containing the 6-chloropyridinyl 
moiety, in or on the following commodities:
    1. PP 0E6101 proposes the establishment of a tolerance for edible 
podded beans at 1.0 part per million (ppm).
    2. PP 0E6104 proposes the establishment of a tolerance for 
succulent shelled beans at 1.0 ppm.
    3. PP 0E6156 proposes the establishment of a tolerance for turnip 
greens at 3.5 ppm.
    4. PP 9E6041 proposes the establishment of a tolerance for cilantro 
at 3.5 ppm.
    5.PP 0E6106 proposes the establishment of tolerances for sweet corn 
grain at 0.05 ppm, sweet corn forage at 0.10 ppm, and sweet corn stover 
at 0.20 ppm.
    6. PP 6F4682 proposes the establishment of tolerances for field 
corn grain at 0.05 ppm, field corn forage at 0.10 ppm, and field corn 
fodder at 0.20 ppm.
    7. PP 8F4940 proposes the establishment of tolerances for leaf 
petiole vegetable subgroup at 6.0 ppm, citrus fruits group at 0.7 ppm, 
and citrus dried pulp at 5.0 ppm.
    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) defines ``safe'' to

[[Page 18555]]

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) requires EPA to give 
special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for tolerances for combined residues of imidacloprid on 
edible podded beans at 1.0 ppm, succulent shelled beans at 1.0 ppm, 
turnip greens at 3.5 ppm, cilantro at 3.5 ppm, sweet corn grain at 0.05 
ppm, sweet corn forage at 0.10 ppm, sweet corn fodder at 0.20 ppm, 
field corn grain at 0.05 ppm, field corn forage at 0.10 ppm, field corn 
fodder at 0.20 ppm, leaf petiole vegetable subgroup at 6.0 ppm, citrus 
fruits group at 0.7 ppm, and citrus dried pulp at 5.0 ppm. EPA's 
assessment of exposures and risks associated with establishing these 
tolerances follow.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by imidacloprid are 
discussed in Unit II. A. in the Federal Register of March 25, 1998 
(FRL-5776-5).

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the 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 (acute RfD or 
chronic RfD) 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 Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10x 
to account for interspecies differences and 10x for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk 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 imidacloprid used for human risk assessment is shown in 
the following Table 1:

     Table 1.--Summary of Toxicological Dose and Endpoints for Imidacloprid 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 was not           FQPA SF = 3X aPAD =      Acute RfD = 0.42 mg/kg
 including infants and children         established) LOAEL =     acute RfD FQPA SF =      bwt/day LOAEL = 42 mg/
                                        42 mg/kg/day UF = 100    0.14 mg/kg/day           kg bwt/day based on
                                        Acute RfD = 0.42 mg/kg/                           decreased motor
                                        day                                               activity in female
                                                                                          rats; additional 3x
                                                                                          FQPA factor for all
                                                                                          population subgroups
                                                                                          to account for
                                                                                          neurotoxicity,
                                                                                          structure-activity
                                                                                          concerns and lack of a
                                                                                          NOAEL.
 
                                                                                         aPAD = RfD /3 = 0.14 mg/
                                                                                          kg bwt/day.
----------------------------------------------------------------------------------------------------------------

[[Page 18556]]

 
Chronic Dietary all populations        NOAEL= 5.7 mg/kg/day UF  FQPA SF = 3X cPAD =      Chronic RfD = 0.057 mg/
                                        = 100 Chronic RfD =      chronic RfD FQPA SF =    kg bwt/day; NOAEL =
                                        0.057 mg/kg/day          0.019 mg/kg/day          5.7 mg/kg bwt/day
                                                                                          based on increased
                                                                                          number of thyroid
                                                                                          lesions at the LOAEL
                                                                                          of 16.9/24.9 mg/kg bwt/
                                                                                          day (males and
                                                                                          females,
                                                                                          respectively);
                                                                                          additional 3x FQPA
                                                                                          factor for all
                                                                                          population subgroups.
----------------------------------------------------------------------------------------------------------------
Short-Intermediate-Long Term Dermal    N/A                      N/A                      Dermal endpoints were
                                                                                          notidentified due to
                                                                                          demonstratedabsence of
                                                                                          toxicity.
 
(Residential)
----------------------------------------------------------------------------------------------------------------
Short-Intermediate-Long Term           N/A                      N/A                      Inhalation endpoints
 Inhalation                                                                               were notidentified due
                                                                                          to demonstratedabsence
                                                                                          of toxicity.
 
(Residential)
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      N/A                      N/A                      No evidence of
                                                                                          carcinogenicity.
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.472) for the combined residues of imidacloprid 
and its metabolites containing the 6-chloropyridinyl moiety, all 
expressed as parent, in or on a variety of raw agricultural 
commodities. Tolerances, which also include time-limited tolerances, 
have also been established in or on a variety of raw agricultural and 
animal commodities at levels ranging from 0.02 ppm in eggs to 15 ppm in 
raisins, waste. Risk assessments were conducted by EPA to assess 
dietary exposures from imidacloprid 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) analysis 
evaluated the individual food consumption as reported by respondents in 
the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII) and accumulated exposure to the chemical for each 
commodity. The following assumption was made for the acute exposure 
assessment: Tolerance level residues for imidacloprid were used, and a 
Tier 1 analysis for 100% crop-treated.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the DEEM analysis evaluated the individual food consumption 
as reported by respondents in the USDA 1989-1992- nationwide CSFII and 
accumulated exposure to the chemical for each commodity. The following 
assumptions were made for the chronic exposure assessment: Tolerance 
level residues for imidacloprid were used, and percent crop-treated 
information for some crops.
    iii. Cancer. Imidacloprid has been classified as a Group E 
chemical, no evidence of carcinogenicity for humans. Therefore, a 
cancer risk assessment was not conducted.
    iv. Anticipated residue and percent crop treated information. 
Section 408(b)(2)(F) 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 
provide for the periodic evaluation of the estimate of percent crop 
treated (PCT) as required by section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency used percent crop treated (PCT) information as follows:
    The Agency used PCT information to conduct a routine chronic 
dietary exposure analysis for imidacloprid based on likely maximum 
percent crop treated as follows: 19% apples, 21% brassica leafy 
vegetables, 15% christophine, 15% crenshaws, 15% melons, 15% 
watermelon, 15% wintermelon, 13% citrus citron, 6% cotton, 30% 
eggplant, 6% grapefruit, 11% grapes, 13% kumquats, 13% lemons, 32% 
lettuce-head varieties, 13% limes, 3% oranges, 30% paprika, 2% pears, 
3% peppers, 13% tangelos, 13% tangerines, and 10% tomatoes. Other 
commodities were assumed to be 100% treated.
    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

[[Page 18557]]

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 imidacloprid 
may be applied in a particular area.
    2. Dietary exposure from drinking water. Imidacloprid is 
persistent, water soluble, and fairly mobile. Thus, residues of 
imidacloprid may be transported to both surface and ground waters. As a 
condition of registration, the Agency is requiring the submission of 
the results of two prospective ground water monitoring studies. Results 
from these studies are not yet available. However, estimates of 
imidacloprid's residue concentration in surface and ground waters has 
been provided by EPA water models.
    The Agency lacks sufficient monitoring exposure data to complete a 
comprehensive dietary exposure analysis and risk assessment for 
imidacloprid 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 imidacloprid.
    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 
Screening Concentration in Ground Water (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 water shed 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 %RfD or %PAD. Instead drinking 
water levels of comparison (DWLOCs) are calculated and used as a point 
of comparison against the model estimates of a pesticide's 
concentration in water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food, and from residential uses. Since 
DWLOCs address total aggregate exposure to imidacloprid they are 
further discussed in the aggregate risk sections below.
    Based on the GENEEC and SCI-GROW models the EECs of imidacloprid 
for acute exposures are estimated to be 17.4 parts per billion (ppb) 
for surface water and 1.4 ppb for ground water. The EECs for chronic 
exposures are estimated to be 15.8 ppb for surface water and 1.4 ppb 
for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Imidacloprid is currently registered for use on the following 
residential non-dietary sites: Turf, home garden and pet uses. Dermal 
and inhalation short- and intermediate-term risk assessments were not 
conducted for imidacloprid as dermal and inhalation exposure endpoints 
were not identified due to the demonstrated absence of toxicity. Short- 
and intermediate term oral exposures are not expected for adult 
population subgroups. A short-term aggregate risk assessment is 
required for hand-to-mouth (oral) exposure for children. The risk 
assessment was conducted using the following residential exposure 
assumptions: (oral exposure) hand to mouth exposure for children from 
home garden, turf, and pet uses.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) 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 imidacloprid 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, 
imidacloprid 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 imidacloprid 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).

D. Safety Factor for Infants and Children

    1. In general. FFDCA section 408 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 safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a margin of exposure 
(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. In assessing the potential 
for additional sensitivity of infants and children to residues of 
imidacloprid, EPA considered data from developmental toxicity studies 
in the rat and rabbit and a 2-generation reproduction study in the rat 
(Federal Register September 18, 1998, Unit II. A.). The developmental 
toxicity data demonstrated no increased

[[Page 18558]]

sensitivity of rats or rabbits to in utero exposure to imidacloprid. In 
addition, the multi-generation reproductive toxicity study did not 
identify any increased sensitivity of rats to in utero or postnatal 
exposure.
    3. Conclusion. Based on the clinical signs of neurological toxicity 
in the acute toxicity studies and the requirement for a developmental 
neurotoxicity study, EPA concluded that a FQPA safety factor of 3x is 
appropriate for this risk assessment. The safety factor of 10x was 
reduced to 3x because there was no qualitative or quantitative evidence 
of increased susceptibility of fetuses or offspring exposed to 
imidacloprid in the prenatal developmental toxicity studies in rats and 
rabbits, or in the 2-generation reproduction toxicity study in rats.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against 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 + residential exposure). This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2L/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 groundwater are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP 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, OPP will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
imidacloprid will occupy 23% of the aPAD for the U.S. population, 18% 
of the aPAD for females 13 years and older, 35% of the aPAD for all 
infants < 1 year old and 46% of the aPAD for children 1-6 years old. In 
addition, there is potential for acute dietary exposure to imidacloprid 
in drinking water. After calculating DWLOCs and comparing them to the 
EECs for surface and ground water, EPA does not expect the aggregate 
exposure to exceed 100% of the aPAD, as shown in the following Table 2:

                     Table 2.--Aggregate Risk Assessment for Acute Exposure to Imidacloprid
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population (48 states)                             0.14           23         17.4          1.4         3900
----------------------------------------------------------------------------------------------------------------
All infants (<1 yr)                                     0.14           35         17.4          1.4          900
----------------------------------------------------------------------------------------------------------------
Children (1-6 yrs old)                                  0.14           46         17.4          1.4          760
----------------------------------------------------------------------------------------------------------------
Females (13-50 yrs old)                                 0.14           18         17.4          1.4         3600
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
imidacloprid from food will utilize 24% of the cPAD for the U.S. 
population, 38% of the cPAD for all infants <1 years old and 51% of the 
cPAD for children 1-6 years old]. Based the use pattern, chronic 
residential exposure to residues of imidacloprid is not expected. In 
addition, there is potential for chronic dietary exposure to 
imidacloprid in drinking water. After calculating DWLOCs and comparing 
them to the EECs for surface and ground water, EPA does not expect the 
aggregate exposure to exceed 100% of the cPAD, as shown in the 
following Table 3:

              Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Imidacloprid
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD (mg/kg/    % cPAD     Water EEC    Water EEC     Chronic
                                                     day)        (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population (48 states)                            0.019           24         15.8          1.4          490
----------------------------------------------------------------------------------------------------------------
All infants (<1 yr)                                    0.019           38         15.8          1.4          120
----------------------------------------------------------------------------------------------------------------
Children (1-6 yrs old)                                 0.019           51         15.8          1.4           92
----------------------------------------------------------------------------------------------------------------
Females (13-50 yrs old)                                0.019           18         15.8          1.4          450
----------------------------------------------------------------------------------------------------------------


[[Page 18559]]

    3. Short-term risk. Dermal and inhalation exposure endpoints were 
not identified due to the absence of toxicity. As a result, dermal and 
inhalation short term risk assessments are not required for 
imidacloprid. Subsequently, short term oral exposures are not expected 
for adult population subgroups. However, EPA has identified potential 
short-term oral exposures to children for these uses.
    Short-term aggregate exposure takes into account residential 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level).
    Imidacloprid is currently registered for use that could result in 
short-term residential exposure and the Agency has determined that it 
is appropriate to aggregate chronic food and water and short-term oral 
exposures for children.
    Using the exposure assumption described in this unit for short-term 
exposure, EPA has concluded that food and residential exposures 
aggregated result an aggregate MOE of 350 for children 1-6 years old 
(hand to mouth). This aggregate MOE does not exceed the Agency's level 
of concern for aggregate exposure to food and residential uses. In 
addition, short-term DWLOCs were calculated and compared to the EECs 
for chronic exposure of imidacloprid in ground and surface water. After 
calculating DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expect short-term aggregate exposure to 
exceed the Agency's level of concern, as shown in the following Table 
4:

                   Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Imidacloprid
----------------------------------------------------------------------------------------------------------------
                                                  Aggregate    Aggregate
                                                MOE  (Food +    Level of     Surface       Ground     Short-Term
              Population Subgroup                               Concern     Water EEC    Water EEC   DWLOC (ppb)
                                                Residential)     (LOC)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Children 1-6 yrs old                                     350          300         17.4          1.4          200
----------------------------------------------------------------------------------------------------------------

    4. Aggregate cancer risk for U.S. population. Imidacloprid has been 
classified as a Group E chemical, no evidence of carcinogenicity for 
humans. Accordingly, EPA does not consider imidacloprid to pose a 
cancer risk.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to imidacloprid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods are available for determination of the 
regulated imidacloprid residues in plant commodities (Bayer GC/MS 
Method 00200 and Bayer HPLC-UV Confirmatory Method 00357). EPA 
concludes that these methods are suitable for enforcement purposes on 
the subject commodities.

B. International Residue Limits

    There are no established Codex, Canadian, or Mexican maximum 
residue limits for imidacloprid in/on succulent shelled beans, turnip 
greens, celery, citrus, and cilantro; thus, international harmonization 
is not an issue.

C. Conditions

    Edible podded beans and succulent shelled beans have been made 
conditional for a period of three years to allow time to submit data on 
shelled dried beans to complete the crop group for bean tolerances.

V. Conclusion

    Therefore, these tolerances are established for the combined 
residues of imidacloprid, (1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine) and its metabolites containing the 6-chloropyridinyl 
moiety, in or on edible podded beans at 1.0 ppm, succulent shelled 
beans at 1.0 ppm, turnip greens at 3.5 ppm, cilantro at 3.5 ppm, sweet 
corn grain at 0.05 ppm, sweet corn forage at 0.10 ppm, sweet corn 
fodder at 0.20 ppm, field corn grain at 0.05 ppm, field corn forage at 
0.10 ppm, field corn fodder at 0.20 ppm, leaf petiole vegetable 
subgroup at 6.0 ppm, citrus fruits group at 0.7 ppm, and citrus dried 
pulp at 5.0 ppm.

VI. 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 of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409. 
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 control number OPP-301114 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 June 11, 
2001.
    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 (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of

[[Page 18560]]

the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The telephone number for the Office of the 
Hearing Clerk is (202) 260-4865.
    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.
    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.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket control number OPP-301114, 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. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. 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).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Submission to Congress and the Comptroller General

    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

[[Page 18561]]

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 record 
keeping requirements.


    Dated: March 28, 2001.

James Jones,

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 180.472 is amended by revising ``corn, field, fodder,'' 
``corn, field, forage,'' and ``corn, field, grain'' and alphabetically 
adding the remaining commodities to the table in paragraph (a) to read 
as follows:


Sec. 180.472  Imidacloprid; tolerances for residues.

    (a) *  *  *

----------------------------------------------------------------------------------------------------------------
                                                                                          Expiration/Revocation
                        Commodity                                Parts per million                 Date
----------------------------------------------------------------------------------------------------------------
*                  *                  *                  *                  *                  *
                                                        *
Beans, edible, podded....................................                           1.0                     None
Beans, succulent, shelled................................                           1.0                     None
*                  *                  *                  *                  *                  *
                                                        *
Cilantro.................................................                           3.5                     None
Citrus, dried pulp.......................................                           5.0                     None
Citrus, fruits, group....................................                           0.7                     None
Corn, field, fodder......................................                          0.20                     None
Corn, field, forage......................................                          0.10                     None
Corn, field, grain.......................................                          0.05                     None
Corn, sweet, forage......................................                          0.10                     None
Corn, sweet, (K+CWHR)....................................                          0.05                     None
Corn, sweet, stover......................................                          0.20                     None
*                  *                  *                  *                  *                  *
                                                        *
Greens, turnip...........................................                           3.5                     None
*                  *                  *                  *                  *                  *
                                                        *
Vegetable, leaf petiole, subgroup........................                           6.0                     None
*                  *                  *                  *                  *                  *
                                                        *
----------------------------------------------------------------------------------------------------------------

* * * * *

[FR Doc. 01-8805 Filed 4-9-01; 8:45 am]
BILLING CODE 6560-50-S