Document ID: EPA-HQ-OPP-2008-0772-0006
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Imidacloprid
Posted Date: 2010-04-28T04:00Z

[Federal Register Volume 75, Number 81 (Wednesday, April 28, 2010)]
[Rules and Regulations]
[Pages 22245-22252]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9761]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0772; FRL-8818-5]

Imidacloprid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of imidacloprid in or on vegetables, bulb, group 3; cereal grains, 
group 15 and cereal grains, forage, fodder and straw, group 16. This 
regulation also deletes tolerances for various commodities and 
tolerances from direct/inadvertent residues on cereal grains, group 15 
and cereal grains, forage, fodder and straw, group 16, as they will be 
superseded by group tolerances. Bayer CropScience requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 28, 2010. Objections and 
requests for hearings must be received on or before June 28, 2010, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2008-0772. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Kable Bo Davis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 306-0415; e-mail address: davis.kable@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide 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 Access Electronic Copies of this Document?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2008-0772 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 as required by 40 CFR part 178 
on or before June 28, 2010.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2008-0772, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW, Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The

[[Page 22246]]

Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of December 3, 2008 (73 FR 73640) (FRL-
8390-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
8F7414, 8F7415) by Bayer CropScience, 2 T.W. Alexander Drive, Research 
Triangle Park, NC 27709. The petitions requested that 40 CFR 180.472 be 
amended by establishing tolerances for combined residues of the 
insecticide imidacloprid, 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine, in or on vegetable, bulb, group 3 at 2.5 parts per 
million (ppm) (PP 8F7414) and cereal, grains, group 15 at 0.05 ppm (PP 
8F7415). That notice referenced a summary of the petitions prepared by 
Bayer CropScience, the registrant, which is available to the public in 
the docket, http://www.regulations.gov. There were no comments received 
in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
determined that the available toxicology, occupational/residential, and 
residue chemistry databases support the establishment of permanent 
tolerances of imidacloprid in or on onion, green, subgroup 3-07B at 2.5 
ppm, onion, dry bulb, subgroup 3-07A at 0.15 ppm and grain, cereal, 
except rice, group 15 at 0.05 ppm. The reasons for these changes are 
explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of 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 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 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. . . 
.''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of 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 and to 
make a determination on aggregate exposure for the petitioned-for 
tolerances for combined residues of imidacloprid in or on onion, green, 
subgroup 3-07B at 2.5 ppm, onion, dry bulb, subgroup 3-07A at 0.15 ppm 
and grain, cereal, except rice, group 15 at 0.05 ppm. EPA's assessment 
of exposures and risks associated with establishing tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the adverse effects caused by imidacloprid as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Imidacloprid: Human-Health Risk 
Assessment,'' pages 43 - 46 in docket ID number EPA-HQ-OPP-2008-0772.
    Imidacloprid has low acute toxicity via the dermal and inhalation 
routes and moderate acute toxicity via the oral route. It is not an eye 
or dermal irritant and is not a dermal sensitizer. The nervous system 
is the primary target organ of imidacloprid. Nervous system effects 
evidenced as changes in clinical signs and functional observation 
battery (FOB) assessments were seen in rat acute and subchronic 
neurotoxicity studies. Also, in the rat developmental neurotoxicity 
study, a decrease in the caudate/putamen width was noted in female 
pups. Retinal atrophy was seen in high-dose females in the rat combined 
chronic toxicity/carcinogenicity study. No nervous system effects were 
noted in the mouse carcinogenicity or the reproduction and 
developmental studies or in the rabbit dermal or rat inhalation 
studies. The dog was less sensitive than rodents to the effects of 
imidacloprid. The rabbit appeared to be very sensitive as there was 
increased mortality in the oral developmental study at the highest dose 
tested. Increased incidence of mineralized particles in the thyroid 
colloid was noted in the rat combined chronic toxicity/carcinogenicity 
study. Body weight decrements were noted in the rat and/or mouse 
chronic and carcinogenicity studies, the rat subchronic neurotoxicity 
study, and the developmental, developmental neurotoxicity and 
reproduction studies. No effects were observed in the rabbit dermal or 
rat inhalation studies. There was no evidence of carcinogenic potential 
in either the rat chronic toxicity/carcinogenicity or mouse 
carcinogenicity studies, and there is no concern for mutagenicity. 
There was no evidence of increased qualitative or quantitative 
susceptibility of rats or rabbits to in utero exposure to imidacloprid 
and no evidence of qualitative or quantitative increased susceptibility 
of rat offspring in the reproduction study. There was evidence of an 
increased qualitative susceptibility in the rat developmental 
neurotoxicity study. At the highest dose tested, maternal effects 
consisted largely of slight decreases in food consumption and body-
weight gain during early lactation, while pup effects included 
decreased body weight, decreased motor activity, and decreased caudate/
putamen width in females.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account 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. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and 
residential exposure to the POD to ensure that the

[[Page 22247]]

margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded. This latter value is referred to as the Level of 
Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for imidacloprid used for 
human risk assessment can be found at http://www.regulations.gov in 
document ``Imidacloprid: Human-Health Risk Assessment,'' pages 16 - 17 
in docket ID number EPA-HQ-OPP-2008-0772.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to imidacloprid, EPA considered exposure under the petitioned-
for tolerances as well as all existing imidacloprid tolerances in (40 
CFR 180.472). EPA assessed dietary exposures from imidacloprid in food 
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and 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.
    In estimating acute dietary exposure, EPA used food consumption 
information from the United States Department of Agriculture (USDA) 
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII). As to residue levels in food, EPA conducted an 
unrefined, acute dietary exposure assessment using tolerance-level 
residues and assuming 100% crop treated (CT) for all registered and 
proposed commodities for the general U.S. population and various 
population subgroups.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA conducted a partially 
refined, chronic dietary exposure assessment using tolerance-level 
residues for all registered and proposed commodities and percent crop 
treated (PCT) for some registered commodities.
    iii. Cancer. A cancer exposure assessment was not performed because 
imidacloprid is not carcinogenic. On November 11, 1993, the Agency 
classified imidacloprid as a Group E chemical, ``Evidence of non-
carcinogenicity for humans,'' by all routes of exposure based upon lack 
of evidence of carcinogenicity in rats and mice.
    iv. Percent crop treated (PCT) information. Section 408(b)(2)(F) of 
FFDCA states that the Agency may use data on the actual percent of food 
treated for assessing chronic dietary risk only if:
     Condition a: 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 the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: 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 FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency used PCT information as follows:

------------------------------------------------------------------------
                                                   Average percent Crop
                   Commodity                           Treated Data
------------------------------------------------------------------------
Almonds........................................                       <1
Apples.........................................                       25
Artichokes.....................................                        5
Avocados.......................................                       <1
Blueberries....................................                       10
Broccoli.......................................                       50
Cabbage........................................                       20
Cantaloupe.....................................                       40
Cauliflower....................................                       50
Celery.........................................                       10
Cherries.......................................                       10
Cotton.........................................                       10
Cucumbers......................................                        5
Eggplant.......................................                       35
Field corn.....................................                     <2.5
Filberts (hazelnuts)...........................                       <1
Grapefruit.....................................                       10
Grapes.........................................                       30
Honeydew.......................................                       30
Lemons.........................................                        5
Lettuce........................................                       65
Oranges........................................                       10
Peaches........................................                        5
Pears..........................................                        5
Pecans.........................................                       10
Peppers........................................                       30
Potatoes.......................................                       35
Prunes.........................................                       <1
Pumpkin........................................                       10
Soybeans.......................................                       <1
Spinach........................................                       20
Squash.........................................                       10
Strawberries...................................                       10
Sugar beets....................................                       <1
Sweet corn.....................................                       <1
Tangerines.....................................                        5
Tobacco........................................                       20
Tomatoes.......................................                       15
Walnuts........................................                       <1
Watermelon.....................................                       15
------------------------------------------------------------------------

    In most cases, EPA uses available data from the United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the National Pesticide Use 
Database for the chemical/crop combination for the most recent 6 years. 
EPA uses an average PCT for chronic dietary risk analysis. The average 
PCT figure for each existing use is derived by combining available 
public and private market survey data for that use, averaging across 
all observations, and rounding to the nearest 5%, except for those 
situations in which the average PCT is less than one. In those cases, 
1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA 
uses a maximum PCT for acute dietary risk analysis. The maximum PCT 
figure is the highest observed maximum value reported within the recent 
6 years of available public and private market survey data for the 
existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, 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 reliable information on the regional consumption of 
food to which imidacloprid may be applied in a particular area.

[[Page 22248]]

    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for imidacloprid in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of imidacloprid. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of imidacloprid for 
acute exposures are estimated to be 36.0 parts per billion (ppb) for 
surface water and 2.09 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 36.0 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 17.2 ppb was used to 
assess the contribution to drinking 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 the following uses that 
could result in residential exposures: Indoor and outdoor ornamental 
plantings, ornamental lawns and turf, pre- and post-construction 
termiticide applications, spot-on treatments for dogs and cats, and 
crack and crevice treatments. Additionally, it is registered for use on 
mattresses for bed bug control. EPA assessed residential exposure using 
the assumption that residential pesticide handlers (i.e., persons who 
might mix, load and, or apply a pesticide material) could be exposed to 
several formulations that contain imidacloprid. The Agency also 
assessed post-application exposure for adults and children contacting 
surfaces, foliage, or pets that were treated with imidacloprid. 
Residential exposures are expected to be short-term (i.e., 1 to 30 
days) or intermediate-term (1 to 6 months) based upon the pest spectra, 
sites of application, methods of application, formulations and the 
retreatment intervals. Since the indoor crack and crevice and mattress 
scenarios resulted in the highest potential exposures, these 
assessments are protective of all residential exposures from 
imidacloprid.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of 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 has not found imidacloprid to share a common mechanism of 
toxicity with any other substances, and imidacloprid does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
imidacloprid does not have 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 EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) 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 database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA SF. In 
applying this provision, EPA either retains the default value of 10X, 
or uses a different additional safety factor when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There was no quantitative or 
qualitative evidence of increased susceptibility of rat and rabbit 
fetuses to in utero exposure in developmental studies. There was no 
quantitative or qualitative evidence of increased susceptibility of rat 
offspring in the multi-generation reproduction study. There was 
evidence of increased qualitative susceptibility in the rat 
developmental neurotoxicity study; however, the concern is low for the 
following reasons:
    i. The effects in pups are well-characterized with a clear NOAEL;
    ii. The pup effects occur in the presence of maternal toxicity with 
the same NOAEL for effects in both pups and dams; and
    iii. 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. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X for all exposure scenarios, except acute 
dietary (all populations). That decision is based on the following 
findings:
    i. The toxicological database for imidacloprid is complete, with 
the exception of an immunotoxicity study.
    ii. The toxicology database for imidacloprid does not show any 
evidence of treatment-related effects on the immune system. The overall 
weight of evidence suggests that this chemical does not directly target 
the immune system. An immunotoxicity study is required as a part of new 
data requirements in 40 CFR part 158 for conventional pesticide 
registration; however, the Agency does not believe that conducting a 
functional immunotoxicity study will result in a lower POD than that 
currently used for overall risk assessment. Therefore, a database 
uncertainty factor (UFDB) is not needed to account for lack 
of this study.
    iii. There is no evidence that imidacloprid results in increased 
susceptibility in utero to rats or rabbits in the prenatal 
developmental studies or in offspring in the 2-generation reproduction 
study.
    iv. A developmental neurotoxicity study was performed with 
imidacloprid and well-defined NOAELs were achieved in the study.
    v. There was evidence of increased qualitative susceptibility in 
the rat developmental neurotoxicity study; however, the concern is low 
for reasons stated above.
    vi. There are no residual uncertainties for prenatal/postnatal 
toxicity.
    vii. The acute dietary food exposure assessment utilizes existing 
and proposed tolerance-level residues and 100% CT information for all 
commodities. By using these screening-level assessments, actual 
exposures/risks will not be underestimated.
    viii. The chronic food exposure assessment utilizes and proposed 
tolerance-level residues and %CT data for several existing uses. For 
all proposed uses, 100% CT is assumed. The chronic assessment is 
somewhat refined and based on reliable data and will not underestimate 
exposure/risk.
    ix. The dietary drinking water assessment utilizes water 
concentration

[[Page 22249]]

values generated by model and associated modeling parameters which are 
designed to provide conservative, health-protective, high-end 
estimatesof water concentrations which will not likely be exceeded.
    x. The residential handler assessment is based upon the residential 
standard operating procedures (SOPs) in conjunction with chemical-
specific study data in some cases and Pesticide Handler Exposure 
Database (PHED) unit exposures in other cases. The majority of the 
residential post-application assessment is based upon chemical-specific 
Turf Transfer Residue (TTR) 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. 
These assessments of exposure are not likely to underestimate the 
resulting estimates of risk from exposure to imidacloprid.
    A 3X FQPA SF was retained in the form of a UFL (uncertainty factor 
due to extrapolation from a LOAEL in the absence of a NOAEL) for the 
acute dietary (all populations) exposure scenario only, since a NOAEL 
was not observed in the relevant study for that exposure scenario 
(acute neurotoxicity study in rats). A 3X uncertainty factor was judged 
to be adequate (as opposed to a 10X) for the following reasons:
    1. The LOAEL (42 mg/kg) is comparable to the LOAELs seen in adults 
in the developmental rat study (30 mg/kg/day) and the 2-generation 
reproduction study [47/52 milligrams/kilograms/day (mg/kg/day) (male/
female)] and in the offspring in the DNT study (55 mg/kg/day);
    2. The extrapolated NOAEL of 14 mg/kg (42/3 = 14) is comparable to 
the NOAEL of 20 mg/kg/day established in the offspring in the DNT; and,
    3. The neurotoxic effects in this study showed a good dose response 
which resulted in minimal effects on motor activity and locomotor 
activity at the LOAEL.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the POD to ensure that the MOE called for 
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. No adverse effect resulting from a single-oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
imidacloprid is not expected to pose an acute risk. Using the exposure 
assumptions discussed in this unit for acute exposure, the acute 
dietary exposure from food and water to imidacloprid will occupy 70% of 
the aPAD for (children 1 to 2 years old) the population group receiving 
the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
imidacloprid from food and water will utilize 32% of the cPAD for 
(children 1 to 2 years old) the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
imidacloprid is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Imidacloprid is currently registered for crack and crevice uses and 
bed bug uses that could result in short-term residential exposure and 
the Agency has determined that it is appropriate to aggregate chronic 
exposure through food and water with short-term residential exposures 
to imidacloprid. Using the exposure assumptions described in Unit 
III.C.3. for short-term exposures, EPA has concluded the combined 
short-term food, water, and residential exposures aggregated result in 
aggregate MOEs of 430 for adults and 170 for children. Toddlers' 
residential short-term aggregate exposure includes dermal and 
inhalation exposure from the crack and crevice uses, dermal exposure 
from the bed-bug uses, and incidental oral exposure from hand-to-mouth 
contact with treated surfaces. Adult short-term aggregate exposure 
includes dermal and inhalation exposure from indoor crack and crevice 
uses, and dermal exposure from the bed-bug uses. These exposures were 
higher than those calculated for all other residential uses of 
imidacloprid. Therefore, the crack and crevice and bed bug treatment 
exposure estimates were aggregated with the chronic dietary to provide 
a worst-case estimate of short-term aggregate risk for the U.S. 
population and children 1 to 2 years old. The combined short-term 
residential MOEs for these scenarios were 580 for adults and 240 for 
children.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Imidacloprid is currently registered for crack and crevice uses and 
bed bug uses that could result in intermediate-term residential 
exposure and the Agency has determined that it is appropriate to 
aggregate chronic exposure through food and water with intermediate-
term residential exposures to imidacloprid.
    Using the exposure assumptions described in Unit III.C.3. for 
short-term exposures, EPA has concluded the combined short-term food, 
water, and residential exposures aggregated result in aggregate MOEs of 
400 for adults and 150 for children. Toddlers' residential 
intermediate-term aggregate exposure includes dermal and inhalation 
exposure from the crack and crevice uses, dermal exposure from the bed-
bug uses, and incidental oral exposure from hand-to-mouth contact with 
treated surfaces. Adult intermediate-term aggregate exposure includes 
dermal and inhalation exposure from indoor crack and crevice uses, and 
dermal exposure from the bed-bug uses. These exposures were higher than 
those calculated for all other residential uses of imidacloprid. 
Therefore, the crack and crevice and bed bug treatment exposure 
estimates were aggregated with the chronic dietary exposure to provide 
a worst-case estimate of intermediate-term aggregate risk for the U.S. 
population and children 1 to 2 years old. The combined intermediate-
term residential MOEs for these scenarios were 540 for adults and 260 
for children.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in mice and rats at doses that were judged 
to be adequate to assess the carcinogenic potential, imidacloprid was 
classified as ``not likely to be carcinogenic to humans,'' and is not 
expected to pose a cancer risk to humans. Therefore, a

[[Page 22250]]

quantitative cancer risk assessment is not needed.
    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, or to infants and children from aggregate 
exposure to imidacloprid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies, Bayer Gas Chromatography/Mass 
Spectrometry (GC/MS) Method 00200 and Bayer GC/MS Method 00191, is 
available to enforce the tolerance expression. The methods 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: residuemethods@epa.gov.

B. International Residue Limits

    There are no established Mexican maximum residue limits (MRLs) for 
the proposed new uses. There are established Codex MRLs for the sum of 
imidacloprid and its metabolites containing the 6-chloropyridinyl 
moiety expressed as imidacloprid, in or on cereal grain at 0.05 ppm, 
leeks at 0.05 ppm, and bulb onions at 0.1 ppm. There are also 
established Canadian MRLs for 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-
1H-imidazol-2-amine, including metabolites containing the 6-
chloropicolyl moiety in or on sweet corn at 0.05 ppm and field corn at 
0.05 ppm. With the exception of onions, there is no harmonization issue 
for these petitions. The Codex MRLs for leeks (0.05 ppm) and bulb 
onions (0.1 ppm) can not be harmonized as the U.S. use pattern 
necessitates higher tolerances (0.15 ppm for onion, dry bulb, subgroup 
3-07A; and 2.5 ppm for onion, green, subgroup 3-07B).

C. Response to Comments

    There were no comments submitted in response to the Notice of 
Filing published in the Federal Register on December 3, 2008.

D. Revisions to Petitioned-For Tolerances

    Due to residues on dry bulb onions and green onions varying by 
greater than 5X, the establishment of a crop group tolerance for crop 
group 3 was not appropriate. The Agency determined that the available 
toxicology, occupational/residential, and residue chemistry databases 
support the establishment of permanent tolerances of imidacloprid in or 
on onion, green, subgroup 3-07B at 2.5 ppm and onion, dry bulb, 
subgroup 3-07A at 0.15 ppm.
    No new field trial data were submitted in support of the proposed 
tolerance for cereal grains, however there are existing tolerances of 
combined residues of imidacloprid in or on barley, grain; corn, field, 
grain; corn, pop, grain; corn, sweet, kernel plus cob with husks 
removed; millet, pearl, grain; millet, proso, grain; oats, grain, 
grain; rye, grain; sorghum, grain; and wheat, grain at 0.05 ppm. There 
are no existing field trial data on rice, another member of the cereal 
grains crop group. In the absence of rice data, the available 
toxicology, occupational/residential, and residue chemistry databases 
support the establishment of permanent tolerances of imidacloprid in or 
on grain, cereal, except rice, group 15 at 0.05 ppm. In connection with 
the imidacloprid petition for cereal grain group tolerance, EPA has 
reviewed the available cereal grain data on forage, fodder, and straw 
of cereal grains. Individual imidacloprid tolerances now exist for many 
forage, fodder, and straw cereal grain commodities. EPA has determined 
that sufficient data are available to establish the following group 
tolerances associated with the cereal grain group tolerance: Grain, 
cereal, forage, fodder and straw, group 16, forage at 7.0 ppm; grain, 
cereal, forage, fodder and straw, group 16, hay at 6.0 ppm; grain, 
cereal, forage, fodder and straw, group 16, stover at 0.3 ppm and 
grain, cereal, forage, fodder and straw, group 16, straw at 3.0 ppm. 
The Crop Group 16 tolerances are being limited like the Crop Group 15 
tolerance to exclude rice.
    The following established tolerances are being deleted because they 
are superseded by inclusion in groups 15 and 16: Barley, grain at 0.05 
ppm; barley, hay at 0.5 ppm; barley, straw at 0.5 ppm; corn, field, 
forage at 0.10 ppm; corn, field, grain at 0.05 ppm; corn, field, stover 
at 0.20 ppm; corn, pop, grain at 0.05 ppm; corn, pop, stover at 0.20 
ppm; corn, sweet, forage at 0.10 ppm; corn, sweet, kernel plus cob with 
husks removed at 0.05 ppm; corn, sweet, stover at 0.20 ppm; millet, 
pearl, forage at 2.0 ppm; millet, pearl, grain at 0.05 ppm; millet, 
pearl, hay at 6.0 ppm; millet, pearl, straw at 3,0 ppm; millet, proso, 
forage at 2.0 ppm; millet, proso, grain at 0.05 ppm; millet, proso, hay 
at 6.0 ppm; millet, proso, straw at 3.0 ppm; oat, forage at 2.0 ppm; 
oat, grain at 0.05 ppm; oat, hay at 6.0 ppm; oat, straw at 3.0 ppm; 
rye, forage at 2.0 ppm; rye, grain at 0.05 ppm; rye, hay at 6.0 ppm; 
rye, straw at 3.0 ppm; sorghum, forage at 0.10 ppm; sorghum, grain, 
grain at 0.05 ppm; sorghum, grain, stover at 0.10 ppm; wheat, forage at 
7.0 ppm; wheat, grain at 0.05 ppm; wheat, hay at 0.5 ppm and wheat, 
straw at 0.5 ppm.
    Additionally, the following tolerances from indirect or inadvertent 
residues are also being deleted: Corn, sweet, kernel plus cob with 
husks removed at 0.05 ppm; grain, cereal, forage, fodder and straw, 
group 16, forage at 2.0 ppm; grain, cereal, forage, fodder and straw, 
group 16, hay at 6.0 ppm; grain, cereal, forage, fodder and straw, 
group 16, stover at 0.3 ppm; grain, cereal, forage, fodder and straw, 
group 16, straw at 3.0 ppm and grain, cereal, group 15 at 0.05 ppm. The 
following tolerance from indirect or inadvertent residues is being 
added: Rice, grain at 0.05 ppm.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
imidacloprid, 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine, in or on onion, dry bulb, subgroup 3-07A at 0.15 
ppm; onion, green, subgroup 3-07B at 2.5 ppm; grain, cereal, except 
rice, group 15 at 0.05 ppm; grain, cereal, forage, fodder and straw, 
except rice, group 16, forage at 7.0 ppm; grain, cereal, forage, fodder 
and straw, except rice, group 16, hay at 6.0 ppm; grain, cereal, 
forage, fodder and straw, except rice, group 16, stover at 0.3 ppm and 
grain, cereal, forage, fodder and straw, except rice, group 16, straw 
at 3.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). 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., 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).

[[Page 22251]]

    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not 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).
    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).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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: April 15, 2010.
G. Jeffrey Herndon,
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), 346a and 371.

0
2. Section 180.472 is revised to read as follows:

Sec.  180.472  Imidacloprid; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide imidacloprid, including its metabolites and degradates, in 
or on the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only the sum of 
imidacloprid (1-[6-chloro-3-pyridinyl) methyl]-N-nitro-2-
imidazolidinimine) and its metabolites containing the 6-chloropyridinyl 
moiety, calculated as the stoichiometric equivalent of imidacloprid, in 
or on the following commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Acerola..............................................                1.0
Almond, hulls........................................                4.0
Apple................................................                0.5
Apple, wet pomace....................................                3.0
Artichoke, globe.....................................                2.5
Aspirated grain fractions............................                240
Atemoya..............................................               0.30
Avocado..............................................                1.0
Banana...............................................               0.50
Beet, sugar, molasses................................               0.30
Beet, sugar, roots...................................               0.05
Beet, sugar, tops....................................               0.50
Biriba...............................................               0.30
Blueberry............................................                3.5
Borage, seed.........................................               0.05
Caneberry, subgroup 13-A.............................                2.5
Canistel.............................................                1.0
Canola, seed.........................................               0.05
Cattle, fat..........................................               0.30
Cattle, meat.........................................               0.30
Cattle, meat byproducts..............................               0.30
Cherimoya............................................               0.30
Citrus, dried pulp...................................                5.0
Coffee, bean, green..................................               0.80
Cotton, gin byproducts...............................                4.0
Cotton, meal.........................................                8.0
Cotton, undelinted seed..............................                6.0
Crambe, seed.........................................               0.05
Cranberry............................................               0.05
Currant..............................................                3.5
Custard apple........................................               0.30
Egg..................................................               0.02
Elderberry...........................................                3.5
Feijoa...............................................                1.0
Flax, seed...........................................               0.05
Fruit, citrus, group 10..............................               0.70
Fruit, pome, group 11................................                0.6
Fruit, stone, group 12...............................                3.0
Goat, fat............................................               0.30
Goat, meat...........................................               0.30
Goat, meat byproducts................................               0.30
Gooseberry...........................................                3.5
Grain, cereal, forage, fodder and straw, group 16,                   7.0
 forage, except rice.................................
Grain, cereal, forage, fodder and straw, group 16,                   6.0
 hay, except rice....................................
Grain, cereal, forage, fodder and straw, group 16,                  0.30
 stover, except rice.................................
Grain, cereal, forage, fodder and straw, group 16,                   3.0
 straw, except rice..................................
Grain, cereal, group 15, except rice.................               0.05
Grape................................................                1.0
Grape, juice.........................................                1.5
Grape, raisin........................................                1.5
Guava................................................                1.0
Herbs subgroup 19A, dried herbs......................                 48
Herbs subgroup 19-A, fresh herbs.....................                8.0
Hog, fat.............................................               0.30
Hog, meat............................................               0.30
Hog, meat byproducts.................................               0.30
Hop, dried cones.....................................                6.0
Horse, fat...........................................               0.30
Horse, meat..........................................               0.30
Horse, meat byproducts...............................               0.30
Huckleberry..........................................                3.5
Ilama................................................               0.30
Jaboticaba...........................................                1.0
Juneberry............................................                3.5
Kava, leaves.........................................                4.0
Kava, roots..........................................               0.40
Leaf petioles subgroup 4B............................                6.0
Leafy greens subgroup 4A.............................                3.5
Lettuce, head........................................                3.5
Lettuce, leaf........................................                3.5
Lingonberry..........................................                3.5
Longan...............................................                3.0
Lychee...............................................                3.0
Mango................................................                1.0
Milk.................................................               0.10
Mustard, black, seed.................................               0.05
Mustard, field, seed.................................               0.05
Mustard, Indian, seed................................               0.05
Mustard, rapeseed, seed..............................               0.05
Mustard, seed........................................               0.05
Nut, tree, group 14..................................               0.05
Okra.................................................                1.0
Onion, dry bulbs, subgroup 3-07A.....................               0.15
Onion, green, subgroup 3-07B.........................                2.5
Papaya...............................................                1.0
Passionfruit.........................................                1.0
Peanut...............................................               0.45
Peanut, hay..........................................                 35

[[Page 22252]]

 
Peanut, meal.........................................               0.75
Pecan................................................               0.05
Persimmon............................................                3.0
Pistachio............................................               0.05
Pomegranate..........................................               0.90
Potato, chip.........................................               0.40
Potato, processed potato waste.......................               0.90
Poultry, fat.........................................               0.05
Poultry, meat........................................               0.05
Poultry, meat byproducts.............................               0.05
Pulasan..............................................                3.0
Rambutan.............................................                3.0
Rapeseed, seed.......................................               0.05
Raspberry, wild......................................                2.5
Safflower, seed......................................               0.05
Salal................................................                3.5
Sapodilla............................................                1.0
Sapote, black........................................                1.0
Sapote, mamey........................................                1.0
Sheep, fat...........................................               0.30
Sheep, meat..........................................               0.30
Sheep, meat byproducts...............................               0.30
Soursop..............................................               0.30
Soybean, forage......................................                8.0
Soybean, hay.........................................                 35
Soybean, meal........................................                4.0
Soybean, seed........................................                3.5
Spanish lime.........................................                3.0
Star apple...........................................                1.0
Starfruit............................................                1.0
Strawberry...........................................               0.50
Sugar apple..........................................               0.30
Sunflower, seed......................................               0.05
Tomato, paste........................................                6.0
Tomato, puree........................................                3.0
Vegetable, brassica leafy, group 5...................                3.5
Vegetable, cucurbit, group 9.........................                0.5
Vegetable, fruiting, group 8.........................                1.0
Vegetable, leaves of root and tuber, group 2.........                4.0
Vegetable, legume, group 6, except soybean...........                4.0
Vegetable, root and tuber, group 1, except sugar beet               0.40
Watercress...........................................                3.5
Watercress, upland...................................                3.5
Wax jambu............................................                1.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established 
for indirect or inadvertent residues of the insecticide imidacloprid, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified below 
is to be determined by measuring only the sum of imidacloprid (1-[6-
chloro-3-pyridinyl) methyl]-N-nitro-2-imidazolidinimine) and its 
metabolites containing the 6-chloropyridinyl moiety, calculated as the 
stoichiometric equivalent of imidacloprid, in or on the following 
commodities, when present therein as a result of the application of the 
pesticide to growing crops listed in this section and other non-food 
crops as follows:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Rice, grain..........................................               0.05
Vegetable, foliage of legume, group 7................                2.5
Vegetable, legume, group 6...........................                0.3
------------------------------------------------------------------------

[FR Doc. 2010-9761 Filed 4-27-10; 8:45 am]
BILLING CODE 6560-50-S