[Federal Register Volume 66, Number 216 (Wednesday, November 7, 2001)]
[Rules and Regulations]
[Pages 56225-56233]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-27601]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301187; FRL-6806-9]
RIN 2070-AB78


Imidacloprid; 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 imidacloprid in or on almond nutmeat, almond 
hulls, and cranberries and modifies the existing time limited 
tolerances for stone fruit and prunes. This action is in response to 
EPA's granting of an emergency exemption under section 18 of the 
Federal Insecticide, Fungicide, and Rodenticide Act authorizing use of 
the pesticide on almonds, stone fruit, and cranberries. This regulation 
establishes maximum permissible levels for residues of imidacloprid in 
these food commodities. The tolerances will expire and are revoked on 
December 31, 2003.

DATES: This regulation is effective November 7, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301187, 
must be received by EPA on or before January 7, 2002.

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 VII. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301187 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Andrew Ertman, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-9367; and e-mail address: 
[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 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-301187. 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, 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

    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. 346a, is establishing a tolerance 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, all expressed as parent, in or on almond nutmeat at 0.05 part 
per million (ppm), almond hulls at 4.0 ppm, cranberries at 0.5 ppm and 
modifying the existing time limited tolerances for stone fruit from 1.0 
ppm to 3.0 ppm and prunes from 3.5 ppm to 10.0 ppm. These tolerances 
will expire and are revoked on December 31, 2003. EPA will publish a 
document in the Federal Register to remove the revoked tolerance from 
the Code of Federal Regulations.
    Section 408(1)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the

[[Page 56226]]

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 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) 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) 
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 the Federal Insecticide, Fungicide, and Rodenticide 
Act (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). EPA has established regulations 
governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Imidacloprid on Stone Fruit and 
Almonds and FFDCA Tolerances

    The glassy-winged sharpshooter (GWSS) poses a significant threat to 
viticulture throughout California. Native to Southeast United States, 
this large leafhopper was inadvertently introduced into Southern 
California about 10 years ago. It went unrecognized for several years 
due to its similarity to the smoke tree sharpshooter, a native insect. 
It is of particular concern to grape growers due to its ability to 
transmit Xylella fastidiosa, the bacterium that causes Pierce's 
Disease. EPA has authorized under FIFRA section 18 the use of 
imidacloprid on stone fruit and almonds for control of the glassy- 
winged sharpshooter in California. After having reviewed the 
submission, EPA concurs that emergency conditions exist for this State.
    EPA has also authorized under FIFRA section 18 the use of 
imidacloprid on cranberries for control of cranberry weevils in 
Massachusetts. After having reviewed the submission, EPA concurs that 
emergency conditions exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of imidacloprid in or on 
stone fruit, almonds and cranberries. In doing so, EPA considered the 
safety standard in FFDCA section 408(b)(2), and EPA decided that the 
necessary tolerances under FFDCA section 408(l)(6) 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 these tolerances without notice and 
opportunity for public comment as provided in section 408(l)(6). 
Although these tolerances will expire and are revoked on December 31, 
2003, under FFDCA section 408(l)(5), residues of the pesticide not in 
excess of the amounts specified in the tolerances remaining in or on 
stone fruit, prunes, almond nutmeat, almond hulls and cranberries 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 imidacloprid 
meets EPA's registration requirements for use on stone fruit, almonds, 
and/or cranberries 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 imidacloprid by a 
State for special local needs under FIFRA section 24(c). Nor do these 
tolerances serve as the basis for any States other than California to 
use this pesticide on stone fruit and almond or Massachusetts on 
cranberries under section 18 of FIFRA without following all provisions 
of EPA's regulations implementing section 18 as identified in 40 CFR 
part 166. For additional information regarding the emergency exemption 
for imidacloprid, 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 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).
    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 
imidacloprid and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for time-limited tolerance for the 
combined residues of imidacloprid in or on almond nutmeat at 0.05 ppm, 
almond hulls at 4.0 ppm, stone fruit at 3.0 ppm, prunes at 10.0 ppm, 
and cranberries at 0.5 ppm. EPA's assessment of the dietary exposures 
and risks associated with establishing the tolerance follows.

A. 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 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 intra species 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).

[[Page 56227]]

 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 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 x10-6 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 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 females 13-50 years of   NOAEL = Not Determined   FQPA SF = 3              Acute Neurotoxicity -
 age                                   LOAEL = 42 mg/kg/day...  aPAD = acute RfD/FQPA     Rats
                                       UF = 100...............   SF = 0.14 mg/kg/day.    LOAEL = 42 mg/kg/day
                                       Acute RfD = 0.42 mg/kg/                            based on decreased
                                        day.                                              motor activity in
                                                                                          female rats.
----------------------------------------------------------------------------------------------------------------
Acute Dietary general population       NOAEL = Not Determined   FQPA SF = 3              Acute Neurotoxicity -
 including infants and children        LOAEL = 42 mg/kg/day...  aPAD = acute RfD/FQPA     Rats
                                       UF = 100...............   SF = 0.14 mg/kg/day.    LOAEL = 42 mg/kg/day
                                       Acute RfD = 0.42 mg/kg/                            based on decreased
                                        day.                                              motor activity in
                                                                                          female rats.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations        NOAEL= 5.7 mg/kg/day     FQPA SF = 3              Combined Chronic
                                       UF = 100...............  cPAD = chronic RfD/FQPA  Toxicity/
                                       Chronic RfD = 0.057 mg/   SF = 0.019 mg/kg/day.    Carcinogenicity - Rats
                                        kg/day.                                          LOAEL = 16.9 (males)
                                                                                          24.9 (females) mg/kg
                                                                                          bwt/day based on
                                                                                          increased number of
                                                                                          thyroid lesions.
----------------------------------------------------------------------------------------------------------------
Short-Term Dermal (1 to 7 days)        N/A                      N/A                      No dermal or systemic
(Residential)........................                                                     toxicity was seen in a
                                                                                          21-day dermal toxicity
                                                                                          study in rabbits
                                                                                          following repeated
                                                                                          dermal applications of
                                                                                          imidacloprid at 1,000
                                                                                          mg/kg bwt/day (Limit-
                                                                                          Dose) for 3 weeks.
                                                                                          Therefore, this risk
                                                                                          assessment is not
                                                                                          required.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Dermal (1 week to    N/A                      N/A                      No dermal or systemic
 several months)                                                                          toxicity was seen in a
(Residential)........................                                                     21-day dermal toxicity
                                                                                          study in rabbits
                                                                                          following repeated
                                                                                          dermal applications of
                                                                                          imidacloprid at 1,000
                                                                                          mg/kg bwt/day (Limit-
                                                                                          Dose) for 3 weeks.
                                                                                          Therefore, this risk
                                                                                          assessment is not
                                                                                          required.
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (several months to    N/A                      N/A                      No dermal or systemic
 lifetime)                                                                                toxicity was seen in a
(Residential)........................                                                     21-day dermal toxicity
                                                                                          study in rabbits
                                                                                          following repeated
                                                                                          dermal applications of
                                                                                          imidacloprid at 1,000
                                                                                          mg/kg bwt/day (Limit-
                                                                                          Dose) for 3 weeks.
                                                                                          Therefore, this risk
                                                                                          assessment is not
                                                                                          required.
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1 to 7 days)    N/A                      N/A                      A short-term inhalation
(Residential)........................                                                     endpoint was not
                                                                                          identified due to the
                                                                                          demonstrated absence
                                                                                          of toxicity.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1 week   N/A                      N/A                      Based on the LC50 of
 to several months)                                                                       >5.33 mg/L (Limit-
(Residential)........................                                                     Dose), imidacloprid is
                                                                                          placed in Toxicity
                                                                                          Category IV.
                                                                                          Additionally, the
                                                                                          vapor pressure for
                                                                                          imidacloprid is
                                                                                          relatively low (6.9 x
                                                                                          10-9 torr). Therefore,
                                                                                          a separate risk
                                                                                          assessment via this
                                                                                          route is not required.
----------------------------------------------------------------------------------------------------------------

[[Page 56228]]

 
Long-Term Inhalation (several months   N/A                      N/A                      Based on the LC50 of
 to lifetime)                                                                             >5.33 mg/L (Limit-
(Residential)........................                                                     Dose), imidacloprid is
                                                                                          placed in Toxicity
                                                                                          Category IV.
                                                                                          Additionally, the
                                                                                          vapor pressure for
                                                                                          imidacloprid is
                                                                                          relatively low (6.9 x
                                                                                          10-9 torr). Therefore,
                                                                                          a separate risk
                                                                                          assessment via this
                                                                                          route is not required.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      N/A                      N/A                      Imidacloprid has been
                                                                                          classified by the
                                                                                          Agency as a Group E
                                                                                          chemical, no evidence
                                                                                          of carcinogenicity for
                                                                                          humans, thus, a cancer
                                                                                          risk assessment is not
                                                                                          required.
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances, some time-
limited, are currently established (40 CFR 180.472) for the combined 
residues of the insecticide imidacloprid and its metabolites containing 
the 6-chloropyridinyl moiety, all expressed as parent, 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 one day 
or single exposure. The Dietary Exposure Evaluation Model 
(DEEMTM) 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 assumptions were made 
for the acute exposure assessments: 100% crop treated and tolerance 
level residues.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the DEEMTM 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 
assessments: Tolerance level residues and some percent crop treated 
data used of selected commodities.
    iii. Cancer. Imidacloprid has been classified by the Agency as a 
Group E chemical, no evidence of carcinogenicity for humans, thus, a 
cancer risk assessment is not required.
    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 tolerance level residues and some percent crop 
treated data on selected commodities. 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 imidacloprid 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 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

[[Page 56229]]

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 Concentrations in Ground Water (SCI-GROW), which predicts 
pesticide concentrations in groundwater. 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 %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 estimated environmental 
concentrations (EECs) of imidacloprid for acute exposures are estimated 
to be 4.1 parts per billion (ppb) for surface water and 1.1 ppb for 
ground water. The EECs for chronic exposures are estimated to be 0.1 
ppb for surface water and 1.1 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: Ornamentals (e.g., flowering and foliage 
plants, ground covers, turf, and lawns), tobacco, golf courses, 
walkways, recreational areas, household or domestic dwellings (indoor/
outdoor), and cats/dogs. The risk assessment was conducted using the 
following exposure assumptions: Short- and intermediate-term oral 
exposure are not expected for adult population subgroups. However, 
since imidacloprid is registered for use on turf, home gardens and 
pets, the Agency has identified potential short-term oral exposures to 
children for these uses. Thus, a residential short-term risk assessment 
via the oral route is required.
    The DWLOC for short-term exposure to imidacloprid was calculated 
relative to the aPAD which was utilized for estimating risk for short-
term oral exposure to imidacloprid. To calculate the DWLOC for short-
term exposure relative to an acute toxicity endpoint, the sum of 
average dietary food exposure and the oral exposure from imidacloprid 
home garden, turf, and pet uses was subtracted from the aPAD to obtain 
the maximum allowable short-term exposure to imidacloprid in drinking 
water (Chronic food exposure = 0.011 mg/kg/day. Oral exposure from home 
garden and turf uses = 0.0059 mg/kg bwt/day, oral exposure from pet 
uses = 0.10 mg/kg bwt/day). DWLOCs were then calculated using default 
body weights and drinking water consumption figures, and then compared 
to the chronic water number.
    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).

C. 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. Developmental toxicity studies. In a developmental toxicity 
study with Sprague-Dawley rats, groups of pregnant animals (25/group) 
received oral administration of imidacloprid (94.2%) at 0, 10, 30, or 
100 mg/kg bwt/day during gestation days 6 through 16. Maternal toxicity 
was manifested as decreased body weight gain at all dose levels and 
reduced food consumption at 100 mg/kg bwt/day. No treatment-related 
effects were seen in any of the reproductive parameters (i.e., 
Caesarean section evaluation). At 100 mg/kg bwt/day, developmental 
toxicity manifested as wavy ribs (fetus =7/149 in treated vs. 2/158 in 
controls and litters, 4/25 vs. 1/25). For maternal toxicity, the LOAEL 
was 10 mg/kg bwt/day (LDT) based on decreased body weight gain; a NOAEL 
was not established. For developmental toxicity, the NOAEL was 30 mg/kg 
bwt/day and the LOAEL was 100 mg/kg bwt/day based on increased wavy 
ribs.
    In a developmental toxicity study with Chinchilla rabbits, groups 
of 16 pregnant does were given oral doses of imidacloprid (94.2%) at 0, 
8, 24 or 72 mg/kg bwt/day during gestation days 6 through 18. For 
maternal toxicity, the NOAEL was 24 mg/kg bwt/day and the LOAEL was 72 
mg/kg bwt/day based on mortality, decreased body weight gain, increased 
resorptions, and increased abortions. For developmental toxicity, the 
NOAEL was 24 mg/kg bwt/day and the LOAEL was 72 mg/kg bwt/day based

[[Page 56230]]

on decreased fetal body weight, increased resorptions, and increased 
skeletal abnormalities.
    3. Reproductive toxicity study. In a 2-generation reproductive 
toxicity study, imidacloprid (95.3%) was administered to Wistar/Han 
rats at dietary levels of 0, 100, 250, or 700 ppm (0, 7.3, 18.3, or 
52.0 mg/kg bwt/day for males and 0, 8.0, 20.5, or 57.4 mg/kg bwt/day 
for females). For parental/systemic/reproductive toxicity, the NOAEL 
was 250 ppm (18.3 mg/kg bwt/day) and the LOAEL was 750 ppm (52 mg/kg 
bwt/day), based on decreases in body weight in both sexes in both 
generations. Based on these factors, the Agency determined that the 
review be revised to indicate the parental/systemic/reproductive NOAEL 
and LOAEL to be 250 and 700 ppm, respectively, based upon the body 
weight decrements observed in both sexes in both generations.
    4. Prenatal and postnatal sensitivity. The developmental toxicity 
data demonstrated no increased sensitivity of rats or rabbits to in 
utero exposure to imidacloprid. In addition, the multi-generation 
reproductive toxicity study data did not identify any increased 
sensitivity of rats to in utero or postnatal exposure. Parental NOAELs 
were lower or equivalent to developmental or offspring NOAELs.
    5. Conclusion. There is a need for a developmental neurotoxicity 
study for assessment of potential alterations of functional 
development. However, the Agency has determined that this data gap does 
not preclude the establishment/continuance of tolerances. The 10X 
safety factor to account for enhanced sensitivity of infants and 
children (as required by FQPA) was reduced to 3x and the factor applies 
to all population subgroups.

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 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 imidacloprid 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 
imidacloprid 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 
imidacloprid will occupy 24% of the aPAD for the U.S. population, 18% 
of the aPAD for females 13 years and older, 47% of the aPAD for non-
nursing infants less than 1 year old and 47% of the aPAD for children 
1-6 years old. In addition, despite the potential for acute dietary 
exposure to imidacloprid in drinking water, after calculating DWLOCs 
and comparing them to conservative model estimated environmental 
concentrations of imidacloprid in 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                                         0.14          24%          4.1          1.1        3,900
----------------------------------------------------------------------------------------------------------------
Children 1-6                                            0.14          47%          4.1          1.1          740
----------------------------------------------------------------------------------------------------------------

    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 26% of the cPAD for the U.S. 
population, 68% of the cPAD for non-nursing infants and 58% of the cPAD 
for children 1-6 years old. Based on the use pattern, chronic 
residential exposure to residues of imidacloprid is not expected. In 
addition, despite the potential for chronic dietary exposure to 
imidacloprid in drinking water, after calculating DWLOCs and comparing 
them to conservative model estimated environmental concentrations of 
imidacloprid in surface and ground water, EPA does not expect the 
aggregate exposure to exceed 100% of the cPAD, as shown in the 
following Table 3:

[[Page 56231]]



              Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Imidacloprid
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 cPAD  (mg/     % cPAD     Water EEC    Water EEC     Chronic
                                                   kg/day)       (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                        0.019           26          0.1          1.1          490
----------------------------------------------------------------------------------------------------------------
Non-nursing Infants                                    0.019           68          0.1          1.1           60
----------------------------------------------------------------------------------------------------------------
Children 1-6 years old                                 0.019           58          0.1          1.1           90
----------------------------------------------------------------------------------------------------------------

    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).
    Imidacloprid is currently registered for uses that could result in 
short-term residential exposure and the Agency has determined that it 
is appropriate to aggregate chronic food and water and short-term 
exposures for imidacloprid.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in aggregate MOEs of 350 for children 1-6 years old 
(the population sub-group of concern. These aggregate MOEs do 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 
water 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     Level of     Surface       Ground     Short-Term
              Population Subgroup                MOE (Food +    Concern     Water EEC    Water EEC   DWLOC (ppb)
                                                Residential)     (LOC)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Children 1-6 years old                                   350          300          0.1          1.1          200
----------------------------------------------------------------------------------------------------------------

    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).
    Though residential exposure could occur with the use of 
imidacloprid, no toxicological effects have been identified for 
intermediate-term toxicity. 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. Imidacloprid has been 
classified by the Agency as a Group E chemical, no evidence of 
carcinogenicity for humans, thus, a cancer risk assessment is not 
required.
    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 imidacloprid residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (example - gas chromatography) is 
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 for 
imidacloprid on stone fruit, almonds or cranberries.

VI. Conclusion

    Therefore, the tolerance is 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, all expressed as parent, in or on almond nutmeat at 0.05 ppm, 
almond hulls at 4.0 ppm, cranberries at 0.5 ppm, and the exisiting time 
limited tolerance for stone fruit is modified from 1.0 ppm to 3.0 ppm 
and for prunes is modified from 3.5 ppm to 10.0 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 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-301187 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 January 
7, 2002.
    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

[[Page 56232]]

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 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 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.2. Mail your 
copies, identified by the docket control number OPP-301187, 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).

VIII. Regulatory Assessment Requirements

    This final rule establishes time-limited tolerances under FFDCA 
section 408. The Office of Management and Budget (OMB) has exempted 
these types of actions from review under Executive Order 12866, 
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). 
Because this rule has been exempted from review under Executive Order 
12866 due to its lack of significance, this rule is not subject to 
Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any prior consultation as specified by Executive Order 
13084, entitled Consultation and Coordination with Indian Tribal 
Governments (63 FR 27655, May 19, 1998); special considerations as 
required by Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994); or require 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 FFDCA 
section 408, 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 FFDCA section 408(n)(4). For these same reasons, the Agency has 
determined that this rule does not have

[[Page 56233]]

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. 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 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: October 15, 2001.

Peter Caulkins,
Acting 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 the entries for 
``cranberries,'' ``stone fruit, crop group 12,'' and ``prunes'' and 
adding commodities to the table in paragraph (b) to read as follows:


Sec. 180.472  Imidacloprid; tolerances for residues.

* * * * *
    (b)*  *  *  

------------------------------------------------------------------------
                                                    Parts    Expiration/
                    Commodity                        per     Revocation
                                                   million      Date
------------------------------------------------------------------------
Almond, hulls....................................      4.0      12/31/03
Almond, nutmeat..................................     0.05      12/31/03
                  *        *        *        *        *
Cranberries......................................      0.5      12/31/03
                  *        *        *        *        *
Prunes...........................................     10.0      12/31/03
Stone fruit......................................      3.0      12/31/03
                  *        *        *        *        *
------------------------------------------------------------------------

* * * * *

[FR Doc. 01-27601 Filed 11-6-01; 8:45 am]
BILLING CODE 6560-50-S