[Federal Register Volume 68, Number 209 (Wednesday, October 29, 2003)]
[Rules and Regulations]
[Pages 61624-61634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-26926]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0327; FRL-7330-4]


Imidacloprid; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a time-limited tolerance 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 soybean seed. 
This action is in response to EPA's granting of an emergency exemption 
under section 18 of the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA) authorizing use of the pesticide as a seed treatment on 
soybean seed. This regulation establishes a maximum permissible level 
for residues of imidacloprid in this food commodity. The tolerance will 
expire and is revoked on December 31, 2006.

DATES: This regulation is effective October 29, 2003. Objections and 
requests for hearings, identified by docket (ID) number OPP-2003-0327, 
must be received on or before December 29, 2003.

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

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9367; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are a Federal 
or State government agency involved in administration of environmental 
quality programs (e.g., Departments of Agriculture, Environment). 
Potentially affected entities may include, but are not limited to:
    [sbull] Federal or State Government Entity (NAICS 9241).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action

[[Page 61625]]

under docket (ID) number OPP-2003-0327. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA. This 
docket facility is open from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The docket telephone number is (703) 
305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/ Title--40/40cfr180--00.html, a 
beta site currently under development.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing a tolerance 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 soybean seed at 1.0 parts per 
million (ppm). This tolerance will expire and is revoked on December 
31, 2006. EPA will publish a document in the Federal Register to remove 
the revoked tolerance from the Code of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 of the FFDCA and the new safety standard to 
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA 
to establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Section 18 of the 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 of 1996 
(FQPA). EPA has established regulations governing such emergency 
exemptions in 40 CFR part 166.

III. Emergency Exemption for Imidacloprid on Soybean Seed and FFDCA 
Tolerances

    The States of Iowa and Wisconsin requested the use of imidacloprid 
as a seed treatement on soybean seed to control the bean leaf beetle, a 
vector of bean pod mottle virus. Due to abnormal weather pattens, the 
incidence of bean pod mottle virus was expected to be highter than 
normal in 2003. EPA has authorized under FIFRA section 18 the use of 
imidacloprid on soybean seed for control of bean leaf beetle in Iowa 
and Wisconsin. After having reviewed the submissions, EPA concurs that 
emergency conditions exist for these States.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of imidacloprid in or on 
soybean seed. In doing so, EPA considered the safety standard in 
section 408(b)(2) of the FFDCA, and EPA decided that the necessary 
tolerance under section 408(l)(6) of the FFDCA would be consistent with 
the safety standard and with FIFRA section 18. Consistent with the need 
to move quickly on the emergency exemption in order to address an 
urgent non-routine situation and to ensure that the resulting food is 
safe and lawful, EPA is issuing this tolerance without notice and 
opportunity for public comment as provided in section 408(l)(6) of the 
FFDCA. Although this tolerance will expire and is revoked on December 
31, 2006, under section 408(l)(5) of the FFDCA, residues of the 
pesticide not in excess of the amounts specified in the tolerance 
remaining in or on soybean seed 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 
this tolerance at the time of that application. EPA will take action to 
revoke this tolerance earlier if any experience with, scientific data 
on, or other relevant information on this pesticide indicate that the 
residues are not safe.
    Because this tolerance is being approved under emergency 
conditions, EPA has not made any decisions about whether imidacloprid 
meets EPA's registration requirements for use on soybean seed or 
whether a permanent tolerance for this use would be appropriate. Under 
these circumstances, EPA does not believe that this tolerance serves as 
a basis for registration of imidacloprid by a State for special local 
needs under FIFRA section 24(c). Nor does this tolerance serve as the 
basis for any State other than Iowa and Wisconsin to use this pesticide 
on this crop under section 18 of FIFRA without following all provisions 
of EPA's regulations implementing FIFRA section 18 as identified in 40 
CFR part 166. For additional information regarding the emergency 
exemption for imidacloprid, contact the Agency's Registration Division 
at the address provided under FOR FURTHER INFORMATION CONTACT.

[[Page 61626]]

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances November 26, 1997 (62 FR 62961) (FRL-
5754-7).
    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action. EPA has sufficient data to assess the hazards of 
imidacloprid and to make a determination on aggregate exposure, 
consistent with section 408(b)(2) of the FFDCA, for a time-limited 
tolerance for combined residues of imidacloprid in or on soybean seed 
at 1.0 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 intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (aRfD or cRfD) where 
the RfD is equal to the NOAEL divided by the appropriate UF (RfD = 
NOAEL/UF). Where an additional safety factor is retained due to 
concerns unique to the FQPA, this additional factor is applied to the 
RfD by dividing the RfD by such additional factor. The acute or chronic 
Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to 
accommodate this type of FQPA SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the level of concern (LOC). For example, when 100 is the 
appropriate UF (10X to account for interspecies differences and 10X for 
intraspecies differences) the LOC is 100. To estimate risk, a ratio of 
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is 
calculated and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-\6\ or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for 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 (all populations         NOAEL = not determined   FQPA SF = 1              Acute neurotoxicity -
 including infants and children)       LOAEL = 42 milligrams/   aPAD = acute RfD.......   rats
                                        kilogram/day (mg/kg/    FQPA SF = 0.14 mg/kg/    LOAEL = 42 mg/kg/day
                                        day).                    day.                     based on decreased
                                       UF = 300...............                            motor activity in
                                       Acute RfD = 0.14 mg/kg/                            female rats
                                        day.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL = 5.7 mg/kg/day    FQPA SF = 1              Combined chronic toxic/
                                       UF = 100...............  cPAD = chronic RfD.....   carcinogenicity - rat
                                       Chronic RfD = 0.057 mg/  FQPA SF = 0.057 mg/kg/   LOAEL = 16.9 mg/kg/day,
                                        kg/day.                  day.                     based upon increased
                                                                                          incidence of
                                                                                          mineralized particles
                                                                                          in thyroid colloid in
                                                                                          males
----------------------------------------------------------------------------------------------------------------
Short-term oral (1-30 days)            Oral study               LOC for MOE = 100        Developmental toxicity
                                       NOAEL = 10 mg/kg/day...   (residential, includes    rat
                                                                 the FQPA SF)            Maternal LOAEL = 30 mg/
                                                                                          kg/day, based upon
                                                                                          decreased body weight
                                                                                          gain and corrected
                                                                                          body weight gain
----------------------------------------------------------------------------------------------------------------
Intermediate-term oral (1-6 months)    Oral study               LOC for MOE = 100        Subchronic
                                       NOAEL = 9.3 mg/kg/day..   (residential, includes   neurotoxicity - rat
                                                                 the FQPA SF)            LOAEL = 63.3 mg/kg/day,
                                                                                          based upon decreased
                                                                                          body weight gain
----------------------------------------------------------------------------------------------------------------
Short-term dermal (1-30 days)          Oral study               LOC for MOE = 100        Developmental toxicity
                                       NOAEL = 10 mg/kg/day      (occupational)            rat
                                        (dermal absorption      LOC for MOE = 100        Maternal LOAEL = 30 mg/
                                        rate = (7.2%).           (residential, includes   kg/day, based upon
                                                                 the FQPA SF).            decreased body weight
                                                                                          gain and corrected
                                                                                          body weight gain
----------------------------------------------------------------------------------------------------------------

[[Page 61627]]

 
Intermediate-term dermal (1-6 months)  Oral study               LOC for MOE = 100        Subchronic
                                       NOAEL = 9.3 mg/kg/day     (occupational)           neurotoxicity - rat
                                        (dermal absorption      LOC for MOE = 100        LOAEL = 63.3 mg/kg/day,
                                        rate = 7.2%).            (residential, includes   based upon decreased
                                                                 the FQPA SF).            body weight gain
----------------------------------------------------------------------------------------------------------------
Long-term dermal (6 months)            Oral study               LOC for MOE = 100        Combined chronic toxic/
                                       NOAEL = 5.7 mg/kg/day     (occupational)           carcinogenicity - rat
                                        (dermal absorption      LOC for MOE = 100        LOAEL = 16.9 mg/kg/day,
                                        rate = 7.2%).            (residential, includes   based upon increased
                                                                 the FQPA SF).            incidence of
                                                                                          mineralized particles
                                                                                          in thyroid colloid in
                                                                                          males
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1-30 days)      Oral study               LOC for MOE = 100        Developmental toxicity
                                       NOAEL = 10 mg/kg/day      (occupational)            rat
                                        (inhalation absorption  LOC for MOE = 100        Maternal LOAEL = 30 mg/
                                        rate = 100%).            (residential, includes   kg/day, based upon
                                                                 the FQPA SF).            decreased body weight
                                                                                          gain and corrected
                                                                                          body weight gain
----------------------------------------------------------------------------------------------------------------
Intermediate-term inhalation (1-6      Oral study               LOC for MOE = 100        Subchronic
 months)                               NOAEL = 9.3 mg/kg/day     (occupational)           neurotoxicity - rat
                                        (inhalation absorption  LOC for MOE = 100        LOAEL = 63.3 mg/kg/day,
                                        rate = 100%).            (residential, includes   based upon decreased
                                                                 the FQPA SF).            body weight gain
----------------------------------------------------------------------------------------------------------------
Long-term inhalation (> 6 months)      Oral study               LOC for MOE = 100        Combined chronic toxic/
                                       NOAEL = 5.7 mg/kg/day     (occupational)           carcinogenicity - rat
                                        (inhalation absorption  LOC for MOE = 100        LOAEL = 16.9 mg/kg/day,
                                        rate = 100%).            (residential, includes   based upon increased
                                                                 the FQPA SF).            incidence of
                                                                                          mineralized particles
                                                                                          in thyroid colloid in
                                                                                          males
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      No evidence of           Not applicable           No evidence of
                                        carcinogenicity for                               carcinogenicity in
                                        humans                                            rats and mice
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.

    In its objections to a separate imidacloprid tolerance action, NRDC 
claims that EPA erred by regulating on the basis of a LOAEL for acute 
and chronic toxicity. As can be seen from the above table, NRDC is 
mistaken with regard to use of a LOAEL for estimating the RfD for 
chronic risk. The acute toxicity endpoint was based upon a LOAEL of 42 
mg/kg/day from an acute neurotoxicity study in rats. This value was 
adjusted with a safety factor of 3X to approximate the value of a 
NOAEL. EPA has high confidence that this value of 3X is sufficient for 
several reasons. The effect seen at the LOAEL in the acute 
neurotoxicity study (decreased motor activity), occurred only in one 
sex of the rat (females), was characterized as minimal, and may have 
been a result of the use of the gavage dosing in the study. The 
decreased motor activity was not replicated following repeated dietary 
administration (non-gavage) at lower and higher doses (10, 70 or 200 
mg/kg/day) in the subchronic neurotoxicity study in the same species 
(rats). Further, using a safety factor of 3X produces a regulatory 
endpoint lower than the acute effect levels in other standard studies 
for determining an acute endpoint, developmental toxicity studies in 
two species, and in another study that is on occasion used for such a 
purpose, the developmental neurotoxicity study in rats. Also in these 
objections, NRDC claims that EPA failed to calculate residential risks 
for some scenarios, based on low toxicity (no endpoints were chosen). 
On October 8, 2002, the Health Effects Division (HED), Hazard 
Identification Assessment Review Committee (HIARC) reviewed the hazard 
data base for imidacloprid and established additional endpoints. 
Endpoints were chosen for each of the following exposure scenarios: 
Acute dietary, chronic dietary, short-term oral, intermediate-term 
oral, short-term dermal, intermediate-term dermal, long-term dermal, 
short-term inhalation, intermediate-term inhalation, and long-term 
inhalation. In the current risk assessment (Unit II.E. of this 
document), EPA calculated short-term residential risks (oral, dermal, 
and inhalation) for both adults and children for a wide-range of 
representative scenarios, including applications to lawns, ornamental 
plantings, indoor and outdoor potted plants, and dogs and cats. Based 
on current residential use patterns for imidacloprid, EPA expects the 
duration of exposure to be short-term (1-30 days), and would not result 
in intermediate-term or long-term exposure. EPA also conducted human 
health aggregate risk assessments for the following exposure scenarios: 
Acute aggregate (food + drinking water), short-term aggregate exposure 
(food + drinking water + residential), and chronic aggregate exposure 
(food + drinking water).

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.472) for the combined residues of imidacloprid, 
in or on a variety of raw agricultural commodities. Meat, milk, 
poultry, and egg tolerances have also been established for the combined 
residues of imidacloprid. In conducting dietary exposure assessments, 
EPA used the Dietary Exposure Evaluation Model software with the Food 
Commodity Intake Database (DEEM\TM\-FCID) which

[[Page 61628]]

incorporates food consumption data as reported by respondents in the 
U.S. Department of Agriculture (USDA) 1994-1996 and 1998 nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII) and 
accumulated exposure to the chemical for each commodity. The 1994-96 
and 1998 data are based on the reported consumption of more than 20,000 
individuals over two non-consecutive survey days. Consumption data are 
averaged for the entire U.S. population and within population subgroups 
for chronic exposure assessment, but are retained as individual 
consumption events for acute exposure assessment. 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. DEEM\TM\ analysis evaluated the individual food 
consumption as reported by respondents in the USDA 1994-1996/1998 
nationwide CSFII and accumulated exposure to the chemical for each 
commodity. The following assumptions were made for the acute exposure 
assessments: A Tier 1, deterministic acute dietary exposure assessment 
was conducted using tolerance-level residues, 100 PCT information for 
registered and proposed commodities; and modified DEEM\TM\ (vision 
7.76) processing factors for some commodities based on guideline 
processing studies. EPA estimated exposure based on the 95\th\ 
percentile value from this deterministic exposure assessment.
    In its objections to a separate imidacloprid tolerance action, NRDC 
asserts that EPA erred by relying on the exposure value for the 95\th\ 
percentile of the population in estimating exposure. NRDC claims that 
this approach leaves 5% of the population unprotected. These comments 
by NRDC represent a misunderstanding of EPA's exposure assessments. 
Although EPA estimated exposure using the 95\th\ percentile, EPA most 
definitely was not, however, acting in a manner designed to protect 
only 95% of the population. To the contrary, EPA's exposure estimates 
were designed to reasonably capture the full range of exposures in each 
population subgroup. As explained in its science policy paper on this 
subject, EPA, in estimating exposure for population subgroups, 
generally considers various population percentiles of exposure between 
95 and 99.99, depending on the extent of overestimation in the residue 
data used in the assessment. In each exposure assessment EPA is 
attempting to reasonably estimate the full range of exposures in a 
subgroup. Accordingly, as EPA noted in its policy paper, just as when 
EPA uses the 95\th\ percentile with non-probabilistic exposure 
assessments EPA is not suggesting that EPA is leaving 5% of the 
population unprotected, EPA is not by choosing the 99.9\th\ percentile 
for probabilistic exposure assessments concluding that only 99.9% of 
the population deserves protection. Rather, it is EPA's view that, with 
probabilistic assessments, the use of the 99.9\th\ percentile generally 
produces a reasonable high-end exposure such that if that exposure does 
not exceed the safe level, EPA can conclude there is a reasonable 
certainty of no harm to the general population and all significant 
population groups. (Office of Pesticide Programs, EPA, Choosing a 
Percentile of Acute Dietary Exposure as a Threshold of Regulatory 
Concern 31 (March 22, 2000)). Importantly, EPA generally uses a 
population percentile of 95 when EPA relies on worst-case residue 
values - i.e., all crops covered by the tolerance contain residues at 
the tolerance value. Even at the 95\th\ percentile of estimated 
exposure, actual exposure, when based on this assumption tends to be 
significantly overstated. For example, EPA has found that when it uses 
realistic residue information (e.g., data from monitoring of the food 
supply), that exposure estimates are generally substantially lower even 
at the 99.99\th\ percentile.
    As noted above, EPA did use the worst-case assumption that all food 
covered by imidacloprid tolerances would bear residues at the tolerance 
level. Hence, EPA believes its exposure estimate is unlikely to 
understate exposure; rather, in all likelihood, the estimate probably 
substantially overstates exposure.
    ii. Chronic exposure. The following assumptions were made for the 
chronic exposure assessments: The chronic dietary exposure assessment 
was performed using published and proposed tolerance levels, DEEM\TM\ 
default processing factors, and percent crop treated (PCT) information 
on some commodities.
    iii. Cancer. A quantitative cancer aggregate risk assessment was 
not performed because imidacloprid is not carcinogenic.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(F) 
of the FFDCA states that the Agency may use data on the actual percent 
of food treated for assessing chronic dietary risk only if the Agency 
can make the following findings: Condition 1, that the data used are 
reliable and provide a valid basis to show what percentage of the food 
derived from such crop is likely to contain such pesticide residue; 
Condition 2, that the exposure estimate does not underestimate exposure 
for any significant subpopulation group; and Condition 3, if data are 
available on pesticide use and food consumption in a particular area, 
the exposure estimate does not understate exposure for the population 
in such area. In addition, the Agency must provide for periodic 
evaluation of any estimates used. To provide for the periodic 
evaluation of the estimate of PCT as required by section 408(b)(2)(F) 
of the FFDCA, EPA may require registrants to submit data on PCT.
    The Agency used PCT information as follows: For the acute 
assessment, 100 PCT was assumed for all registered and proposed 
commodities. For the chronic assessment, average weighted PCT 
information was used for the following commodities: Apple 34%; Brussels 
sprouts 56%; broccoli 35%; cabbage 14%; cantaloupe 31%; cauliflower 
52%; collards 10%; corn, field 1%; cotton 3%; cucumber 2%; eggplant 
36%; grapefruit 3%; grape 32%; mustard greens 16%; honeydew 26%; kale 
30%; lemon 1%; lettuce, head 49%; lime 5%; orange 1%; pear 16%; pepper 
62%; pumpkin 7%; spinach 15%; squash 7%; sugarbeet 1%; tangerine 9%; 
tomato 9%; watermelon 6%; wheat 1%. A default value of 1% was used for 
all commodities which were reported as having >1% CT.
    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

[[Page 61629]]

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 the physical 
characteristics of imidacloprid.
    The Agency uses the First Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) 
to produce estimates of pesticide concentrations in an index reservoir. 
The SCI-GROW model is used to predict pesticide concentrations in 
shallow ground water. For a screening-level assessment for surface 
water EPA will generally use FIRST (a Tier 1 model) before using PRZM/
EXAMS (a Tier 2 model). The FIRST model is a subset of the PRZM/EXAMS 
model that uses a specific high-end runoff scenario for pesticides. 
While both FIRST and PRZM/EXAMS incorporate an index reservoir 
environment, the PRZM/EXAMS model includes a percent crop area factor 
as an adjustment to account for the maximum percent crop coverage 
within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a percent reference dose (%RfD) or 
percent population adjusted dose (%PAD). Instead drinking water levels 
of comparison (DWLOCs) are calculated and used as a point of comparison 
against the model estimates of a pesticide's concentration in water. 
DWLOCs are theoretical upper limits on a pesticide's concentration in 
drinking water in light of total aggregate exposure to a pesticide in 
food, and from residential uses. Since DWLOCs address total aggregate 
exposure to imidacloprid, they are further discussed in the aggregate 
risk sections below.
    Analysis of monitoring data for degradates (ground water only) 
shows that imidacloprid parent is the dominant residue with 
imidacloprid urea the most likely degradate. Based on the available 
information, modeling of total residue results in only modest increases 
over the exposure estimates with parent alone. Based on the FIRST and 
SCI-GROW models the estimated environmental concentrations (EECs) of 
imidacloprid (total residue) for acute exposures are estimated to be 
36.04 parts per billion (ppb) for surface water and 2.09 ppb for ground 
water. The EECs for imidacloprid (parent only) for acute exposures are 
estimated to be 35.89 ppb for surface water and 1.43 ppb for ground 
water. The EECs for imidacloprid (total residue) for chronic exposures 
are estimated to be 17.24 ppb for surface water and 2.09 ppb for ground 
water. The EECs for imidacloprid (parent only) for chronic exposures 
are estimated to be 16.52 ppb for surface water and 1.43 ppb for ground 
water.
    The New York State Department of Environmental Conservation, 
Division of Solid and Hazardous Materials has submitted extensive water 
monitoring information from Nassau and Suffolk Counties of New York. 
Nassau and Suffolk counties have ground water that is exceptionally 
vulnerable to pesticide contamination and have a long history of a 
number of pesticides being banned from use in these counties over the 
years. In general, the kinds of concentrations of imidacloprid (parent 
only) found in the monitoring/observation and private drinking water 
wells are in the range expected in highly vulnerable ground water. 
Imidacloprid has been detected in approximately 20 (including some 
clusters of wells in the same immediate area) out of about 2,000 public 
and private water supply and monitoring wells. Imidacloprid was 
detected in 24 of the approximately 3,500 well samples analyzed for 
imidacloprid in Nassau and Suffolk Counties. Although detection of 
imidacloprid in about 20 of 2,000 wells in an area with highly 
vulnerable ground water does not demonstrate particularly widespread 
ground water contamination, 3 of 2,000 wells in this highly vulnerable 
ground water have at least one detection greater than the SCI-GROW for 
imidacloprid (parent only) at 1.43 ppb. The three samples that exceed 
the SCI-GROW ECs are reported at 2.06 ppb, 5.98 ppb, and 6.69 ppb. 
Since the surface water model screening levels are greater than the 
ground water model screening levels and the detection levels reported 
from the water monitoring from Nassau and Suffolk Counties, New York, 
the Agency will use the surface water ECs for imidacloprid total 
residue as a worse case estimate for drinking water in the aggregate 
risk assessment.
    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: Granular products for application to 
lawns and ornamental plants; ready-to-use spray for application to 
flowers, shrubs and house plants; plant spikes for application to 
indoor and outdoor residential potted plants; ready-to-use potting 
medium for indoor and outdoor plant containers; liquid concentrate for 
application to lawns, trees, shrubs and flowers; ready-to-use liquid 
for directed spot application to cats and dogs. In addition, there are 
numerous registered products intended for use by commercial applicators 
to residential sites. These include gel baits for cockroach control; 
products intended for commercial ornamental, lawn and turf pest 
control; products for ant control; and products used as preservatives 
for wood products, building materials, textiles and plastics.
    As these products are intended for use by commercial applicators 
only, they are not addressed in terms of residential pesticide 
handlers. The risk assessment was conducted using the following 
residential exposure assumptions: EPA has determined that residential 
handlers

[[Page 61630]]

are likely to be exposed to imidacloprid residues via dermal and 
inhalation routes during handling, mixing, loading, and applying 
activities. Based on the current use patterns, EPA expects duration of 
exposure to be short-term (1-30 days). EPA does not expect imidacloprid 
to result in exposure durations that would result in intermediate-term 
or long-term exposure.
    The scenarios likely to result in adult dermal and/or inhalation 
residential handler exposures are as follows:
    [sbull] Dermal and inhalation exposure from using a granular push-
type spreader.
    [sbull] Dermal exposure from using potted plant spikes.
    [sbull] Dermal exposure from using a plant potting medium.
    [sbull] Dermal and inhalation exposure from using a garden hose-end 
sprayer (dermal and inhalation exposure from using a RTU trigger pump 
spray is expected to be negligible).
    [sbull] Dermal and inhalation exposure from using a water can/
bucket for soil drench applications.
    [sbull] Dermal exposure from using pet spot-on.
    EPA has also determined that there is potential for short-term (1 
to 30 days), post-application exposure to adults and children/toddlers 
from the many residential uses of imidacloprid. Due to residential 
application practices and the half-lives observed in the turf 
transferable residue study, intermediate-term and long-term post-
application exposures are not expected. The scenarios likely to result 
in dermal (adult and child/toddler) and incidental non-dietary (child/
toddler) short-term post-application exposures are as follows:
    [sbull] Toddler oral hand-to-mouth exposure from contacting treated 
turf.
    [sbull] Toddler incidental oral ingestion of granules.
    [sbull] Toddler incidental oral ingestion of pesticide-treated 
soil.
    [sbull] Toddler incidental oral exposure from contacting treated 
pet.
    [sbull] Toddler dermal exposure from contacting treated turf.
    [sbull] Toddler dermal exposure from hugging treated pet/contacting 
treated pet.
    [sbull] Adult dermal exposure from contacting treated turf.
    [sbull] Adult golfer dermal exposure from contacting treated turf.
    [sbull] Adolescent golfer dermal exposure from contacting treated 
turf.
    [sbull] Adult dermal exposure from contacting treated pet
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether 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 policy 
statements released by EPA's Office of Pesticide Programs concerning 
common mechanism determinations and procedures for cumulating effects 
from substances found to have a common mechanism on EPA's website at 
http://www.epa.gov/pesticides/cumulative/.

C. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional tenfold margin of safety for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of 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 explosure 
(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. There is no quantitative or 
qualitative evidence of increased susceptibility of rat and rabbit 
fetuses to in utero exposure in developmental studies. There is no 
quantitative or qualitative evidence of increased susceptibility of rat 
offspring in the multi-generation reproduction study. There is evidence 
of increased qualitative susceptibility in the rat developmental 
neurotoxicity study, but the concern is low since:
    [sbull] The effects in pups are well-characterized with a clear 
NOAEL.
    [sbull] The pup effects occur in the presence of maternal toxicity 
with the same NOAEL for effects in pups and dams.
    [sbull] The doses and endpoints selected for regulatory purposes 
are protective of the pup effects noted at higher doses in the 
developmental neurotoxicity study.
    Therefore, there are no residual uncertainties for prenatal/
postnatal toxicity in this study.
    3. Conclusion. There is a complete toxicity data base for 
imidacloprid and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. EPA determined 
that the 10X SF to protect infants and children should be reduced to 1X 
for the following reasons:
    [sbull] The toxicological data base is complete for FQPA 
assessment.
    [sbull] The acute dietary food exposure assessment utilizes 
existing and proposed tolerance level residues and 100 PCT information 
for all commodities. By using these screening-level assessments, actual 
exposures/risks will not be underestimated.
    [sbull] The chronic dietary food exposure assessment utilizes 
existing and proposed tolerance level residues and PCT data verified by 
the Agency for several existing uses. For all proposed uses, 100 PCT is 
assumed. The chronic assessment is somewhat refined and based on 
reliable data and will not underestimate exposure/risk.
    The dietary drinking water assessment utilizes water concentration 
values generated by model and associated modeling parameters which are 
designed to provide conservative, health protective, high-end estimates 
of water concentrations which will not likely be exceeded.
    The residential handler assessment is based upon the residential 
standard operating procedures (SOPs) in conjunction with chemical-
specific study data in some cases and the Pesticide Handlers Exposure 
Database (PHED) unit exposures in other cases. The majority of the 
residential post-application assessment is based upon chemical-specific 
turf transferrable residue data or other chemical-specific post-
application exposure study data. The chemical-specific study data as 
well as the surrogate study data used are reliable and also are not 
expected to underestimate risk to adults as well as to children. In a 
few cases where chemical-specific data were not available, the SOPs 
were used alone. The residential SOPs are based upon reasonable worst-
case assumptions and are not expected to underestimate risk.

[[Page 61631]]

These assessments of exposure are not likely to underestimate the 
resulting estimates of risk from exposure to imidacloprid.
    In its objections to a separate imidacloprid tolerance action, NRDC 
argues that in light of the outstanding data requirement for 
prospective ground water monitoring studies, EPA should have retained a 
10X FQPA factor for imidacloprid. EPA disagrees. Two small-scale 
prospective ground water monitoring studies were originally requested 
by the Agency in 1994. This request predates the development of the 
Tier 1 ground water screening model in 1997 and the FQPA. The field 
phase of these prospective ground water monitoring studies commenced in 
1996. Results from these studies have now been received and the levels 
of imidacloprid observed (0.1 ppb) are below the screening 
concentration of 2.09 ppb calculated on the basis of the SCI-GROW, the 
Tier 1 ground water screening model. In any event, as noted above, 
since higher values are predicted for imidacloprid residues in surface 
water, these higher values were used in conducting the risk assessment.

D. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + chronic non-dietary, non-occupational exposure). 
This allowable exposure through drinking water is used to calculate a 
DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by EPA's Office of Water are used to calculate DWLOCs: 2 
liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to imidacloprid in drinking water (when considered along with 
other sources of exposure for which EPA has reliable data) would not 
result in unacceptable levels of aggregate human health risk at this 
time. Because EPA considers the aggregate risk resulting from multiple 
exposure pathways associated with a pesticide's uses, levels of 
comparison in drinking water may vary as those uses change. If new uses 
are added in the future, EPA will reassess the potential impacts of 
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 25% of the aPAD for the U.S. population, 17% 
of the aPAD for females 13 to 49 years, 54% of the aPAD for infants < 1 
year old and 64% of the aPAD for children 1-2 years. 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           25        36.04         2.09        3,700
----------------------------------------------------------------------------------------------------------------
Females (13-49 years)                                   0.14           17        36.04         2.09        3,500
----------------------------------------------------------------------------------------------------------------
Infants (< 1 year)                                      0.14           54        36.04         2.09          650
----------------------------------------------------------------------------------------------------------------
Children (1-2 years)                                    0.14           64        36.04         2.09          510
----------------------------------------------------------------------------------------------------------------

    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 11% of the cPAD for the U.S. 
population, 26% of the cPAD for infants < 1 year, and 35% of the cPAD 
for children 1-2 years. Based on 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 water and ground water, EPA does not expect the aggregate 
exposure to exceed 100% of the cPAD, as shown in 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                                        0.057           11        17.24         2.09        1,800
----------------------------------------------------------------------------------------------------------------

[[Page 61632]]

 
Infants (< 1 year)                                     0.057           26        17.24         2.09          420
----------------------------------------------------------------------------------------------------------------
Children (1-2 years)                                   0.057           35        17.24         2.09          370
----------------------------------------------------------------------------------------------------------------
Females (13-49 years)                                  0.057          8.3        17.24         20.9        1,600
----------------------------------------------------------------------------------------------------------------

    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).
    Short-term aggregate risk assessments are needed for adults as 
there is potential for both dermal and inhalation handler exposure, and 
dermal post-application exposure from the residential uses of 
imidacloprid on turf and pets. In addition, short-term aggregate risk 
assessments are needed for children/toddlers because there is a 
potential for oral and dermal, post-application exposure resulting from 
the residential uses of imidacloprid on turf and pets. The pet-
treatment scenario resulted in the lowest combined MOE for adults (MOE 
= 400; handler and post-application) and children (MOE = 260; post-
application). The turf-treatment resulted in much lower exposures for 
both adults (MOE = 15,000; handler and post-application) and children 
(MOE = 1,500; post-application). Therefore, the pet-treatment exposure 
estimates were aggregated with the chronic dietary (food) to provide a 
worst-case estimate of short-term aggregate risk for the U.S. 
population and children 1-2 years old (the child population subgroup 
with the highest estimated chronic dietary food exposure). 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 320 for the U.S. population, and 170 for children 
1-2 years. 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 
water 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
----------------------------------------------------------------------------------------------------------------
                                                                                                      Short-term
                                            Aggregate    Aggregate Level     Surface       Ground    DWLOC (ppb)
           Population Subgroup             MOE (Food +   of Concern (LOC)   Water EEC    Water EEC       U.S.
                                          Residential)                        (ppb)        (ppb)      population
----------------------------------------------------------------------------------------------------------------
U.S. population                                    320                100        17.24         2.09        2,400
----------------------------------------------------------------------------------------------------------------
Children (1-2 years old)                           170                100        17.24         2.09          410
----------------------------------------------------------------------------------------------------------------

    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).
    Intermediate-term and long-term aggregate risk assessments were not 
performed because, based on the current use patterns, the Agency does 
not expect exposure durations that would result in intermediate-term or 
long-term exposures.
    5. Aggregate cancer risk for U.S. population. There is no evidence 
of carcinogenicity to humans based on carcinogenicity studies in male 
and female rats and mice. The Agency concludes that pesticidal uses of 
imidacloprid are not likely to pose a cancer risk to humans.
    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 methods are available for determination of 
imidacloprid residues of concern in plant (Bayer Gas Chromatography/
Mass Spectrometry (GC/MS) Method 00200) and livestock commodities 
(Bayer GC/MS Method 00191). These methods have undergone successful EPA 
petition method validations (PMVs), and the registrant has fulfilled 
the remaining requirements for additional raw data, method validation, 
independent laboratory validation (ILV), and an acceptable confirmatory 
method (high performance liquid chromatography/ultraviolet (HPLC/UV) 
Method 00357).
    Adequate enforcement methodology (example--gas chromotography) is 
available to enforce the tolerance expression. The method may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; e-mail address: [email protected].

B. International Residue Limits

    There are no CODEX, Canadian, or Mexican Maximum Residue Limits 
(MRLs) for imidacloprid on soybean seed.

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 soybean seed at 1.0 ppm.

VII. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may

[[Page 61633]]

file an objection to any aspect of this regulation and may also request 
a hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. Although the procedures in those regulations require 
some modification to reflect the amendments made to the FFDCA by the 
FQPA, EPA will continue to use those procedures, with appropriate 
adjustments, until the necessary modifications can be made. The new 
section 408(g) of the FFDCA provides essentially the same process for 
persons to ``object'' to a regulation for an exemption from the 
requirement of a tolerance issued by EPA under new section 408(d) of 
the FFDCA, as was provided in the old sections 408 and 409 of the 
FFDCA. However, the period for filing objections is now 60 days, rather 
than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2003-0327 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 December 
29, 2003.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3.  Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.1. Mail your 
copies, identified by the docket ID number OPP-2003-0327, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VIII. Statutory and Executive Order Reviews

    This final rule establishes a time-limited tolerance under section 
408 of the FFDCA. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a FIFRA 
section 18 exemption under section 408 of the FFDCA, such as the 
tolerance in

[[Page 61634]]

this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers, and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency 
has determined that this rule does not have any ``tribal implications'' 
as described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

IX. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: October 17, 2003.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.472 is amended by adding the following commodity to the 
table in paragraph (b) to read as follows:


Sec.  180.472  Imidacloprid; tolerances for residues.

    (a) * * *
    (b) * * *

----------------------------------------------------------------------------------------------------------------
                      Commodity                             Parts per million        Expiration/revocation date
----------------------------------------------------------------------------------------------------------------
                                                    * * * * *
Soybean, seed.......................................                       1.0 ppm                      12/31/06
                                                    * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. 03-26926 Filed 10-28-03; 8:45 am]
BILLING CODE 6560-50-S