

[Federal Register: August 11, 2006 (Volume 71, Number 155)]
[Rules and Regulations]               
[Page 46110-46117]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11au06-12]                         

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0542; FRL-8081-8]

 
Imidacloprid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for combined residues 
of imidacloprid and its metabolites containing the 6-chloropyridinyl 
moiety, all expressed as the parent in or on caneberry subgroup 13A; 
coffee, green bean; seed of: Black mustard, borage, crambe, field 
mustard, flax, Indian mustard, Indian rapeseed, rapeseed, safflower, 
and sunflower; atemoya, biriba, cherimoya, custard apple, ilama, 
soursop, and sugar apple; almond hulls, pistachio and tree nut group 
14; pomegranate; banana; herbs subgroup 19A dried; and herbs subgroup 
19A fresh. Interregional Research Project No. 4 (IR-4), requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as 
amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective August 11, 2006. Objections and 
requests for hearings must be received on or before October 10, 2006, 
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-2005-0542. All documents in the 
docket are listed in the index for the docket. 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 Building), 2777 S. Crystal Drive, 
Arlington, VA. The 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.

FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6463; e-mail address: madden.barbara@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:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.

[[Page 46111]]

    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 Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 

frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
 To access the OPPTS Harmonized Guidelines 

referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm
.


C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. 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-2005-0542 in the 
subject line on the first page of your submission. All requests must be 
in writing, and must be mailed or delivered to the Hearing Clerk on or 
before October 10, 2006.
    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 your copies, identified by docket ID 
number EPA-HQ-OPP-2005-0542, 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 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket'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 
Docket telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of March 22, 2006 (71 FR 14524) (FRL-7769-
7), 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 
3E6543, PP 3E6561, PP 3E6738, PP 3E6760, PP 5E6920, PP 5E6921, PP 
5E6922, PP 5E6923) by Interregional Research Project No. 4 (IR-4), 681 
U.S. Highway No. 1 South, North Brunswick, NJ 08902-3390. The petitions 
requested that 40 CFR 180.472 be amended by establishing tolerances for 
residues of the insecticide imidacloprid, 1-[(6-chloro-3-
pyridinyl)methyl]-N-nitro-2-imidazolidinimine, and its metabolites 
containing the 6-chloropyridinyl moiety, all expressed as imidacloprid 
in or on the raw agricultural commodities as follows: Caneberry 
subgroup 13A at 0.05 parts per million (ppm) (PP 3E6543); coffee at 0.6 
ppm (PP 3E6561); seed of: Black mustard, borage, crambe, field mustard, 
flax, Indian mustard, Indian rapeseed, rapeseed, safflower, and 
sunflower at 0.05 ppm (PP 3E6738); atemoya, biriba, cherimoya, custard 
apple, ilama, soursop, and sugar apple at 0.2 ppm (PP 3E6760); almond 
hulls at 2.5 ppm; and pistachio and tree nut group 14 at 0.01 ppm (PP 
5E6920); pomegranate at 0.7 ppm (PP 5E6921); banana at 0.6 ppm (PP 
5E6922); herbs subgroup 19A dried at 62.0 ppm and herbs subgroup 19A 
fresh at 6.0 ppm (PP 5E6923).
    Tolerances were later amended as follows: Coffee at 0.80 ppm (PP 
3E6561); atemoya, biriba, cherimoya, custard apple, ilama, soursop, and 
sugar apple at 0.30 ppm (PP 3E6760); almond hulls at 4.0 ppm; and 
pistachio and tree nut group 14 at 0.05 ppm (PP 5E6920); pomegranate at 
0.90 ppm (PP 5E6921); banana at 0.50 ppm (PP 5E6922); herb subgroup, 
19A, herbs, dried at 48.0 ppm and herb subgroup, 19A, herbs, fresh at 
8.0 ppm (PP 5E6923).
    In addition to establishing tolerances, EPA is also deleting 
several established tolerances from the tables in Sec.  180.472(a), 
(b), and (d) that are no longer needed as a result of this action. The 
tolerance deletions under Sec.  180.472(b) are time-limited tolerances 
established under section 18 emergency exemptions that are superceded 
by the establishment of general tolerances for imidacloprid and its 
metabolites under Sec.  180.472(a).
    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....''
    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 http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.


III. Aggregate Risk Assessment and Determination of Safety

    Consistent with 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, consistent with section 
408(b)(2) of FFDCA, for tolerances for combined residues of the 
insecticide imidacloprid, 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine, and its metabolites containing the 6-chloropyridinyl 
moiety, all expressed as imidacloprid in or on caneberry

[[Page 46112]]

subgroup 13A at 0.05 parts per million (ppm); coffee, green bean at 
0.80 ppm; seed of: Black mustard, borage, crambe, field mustard, flax, 
Indian mustard, Indian rapeseed, rapeseed, safflower, and sunflower at 
0.05 ppm; atemoya, biriba, cherimoya, custard apple, ilama, soursop, 
and sugar apple at 0.30 ppm; almond hulls at 4.0 ppm; pistachio and 
tree nut group 14 at 0.05 ppm; pomegranate at 0.90 ppm; banana at 0.50 
ppm; herb subgroup, 19A, herbs, dried at 48.0 ppm and herb subgroup, 
19A, herbs, fresh at 8.0 ppm. EPA's assessment of exposures and risks 
associated with establishing the tolerance 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 toxic 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.epa.gov/fedrgstr/EPA-PEST/2003/June/Day-13/p14880.htm
.


B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which the NOAEL from the toxicology study 
identified as appropriate for use in risk assessment is used to 
estimate the toxicological level of concern (LOC). However, the 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.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of additional cancer cases. More information 
can be found on the general principles EPA uses in risk 
characterization at http://www.epa.gov/pesticides/health/human.htm.

    A summary of the toxicological endpoints for imidacloprid used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of June 13, 2003 (68 FR 35303) (FRL-
7310-8), or at http://www.epa.gov/fedrgstr/EPA-PEST/2003/June/Day-13/p14880.htm
.


C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.472) for the combined residues of imidacloprid, 
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. Risk assessments were conducted by EPA to 
assess 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.
    The Dietary Exposure Evaluation Model - Food Commodity Intake 
Database (DEEM-FCID\TM\) analysis evaluated the individual food 
consumption 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 following assumptions were made for 
the acute exposure assessments: An unrefined, acute dietary exposure 
assessment using tolerance-level residues and assuming 100 pecent crop 
treated (PCT) for all registered and proposed commodities was conducted 
for the general U.S. population and various population subgroups. 
Drinking water was incorporated directly in the dietary assessment 
using the acute (peak) concentration for surface water generated by the 
FQPA Index Reservoir Screening Tool (FIRST) model.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the DEEM-FCID\TM\, which incorporates food 
consumption data as reported by respondents in the USDA 1994-1996 and 
1998 nationwide CSFII, and accumulated exposure to the chemical for 
each commodity. The following assumptions were made for the chronic 
exposure assessments: A partially refined, chronic dietary exposure 
assessment using tolerance-level residues for all registered and 
proposed commodities, and PCT information for some commodities was 
conducted for the general U.S. population and various population 
subgroups. Drinking water was incorporated directly into the dietary 
assessment using the chronic (annual average) concentration for surface 
water generated by the FIRST model.
    iii. Cancer. An exposure assessment related to cancer risk is 
unnecessary. The Agency has classified imidacloprid as a ``Group E'' 
chemical, no evidence of carcinogenicity for humans, by all routes of 
exposure based upon lack of evidence of carcinogenicity in rats and 
mice.
    iv. Anticipated residue and 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 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 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 30%; 
artichokes 5%; beets 15%; blueberries 10%; broccoli 35%; brussels 
sprouts 55%; cabbage 20%; cantaloupe 30%; carrots 1%; cauliflower 40%; 
celery 5%; cherries 5%; collards 10%; corn, field 1%; cotton 5%; 
cucumber 5%; eggplant 45%; grapefruit 5%; grape 30%; honeydew 10%; hops 
90%; kale 30%; lemon 1%; lettuce, head 60%; orange 5%; peaches 5%; pear 
10%; pepper 25%; potatoes 35%; pumpkin 5%; spinach 20%; squash 10%; 
strawberries 10%; sugarbeet 1%; sweet corn 1%; tangerine 10%; tomato 
15%; watermelon 10%. A default value of 1% was used for all commodities 
which were reported as having 1 PCT.

[[Page 46113]]

    EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available Federal, State, and private market survey data for that use, 
averaging by year, averaging across all years, and rounding up to the 
nearest multiple of 5% except for those situations in which the average 
PCT is less than 1. In those cases 1% is used as the average and 2.5% 
is used as the maximum. EPA uses a maximum PCT for acute dietary risk 
analysis. The maximum PCT figure is the single maximum value reported 
overall from available Federal, State, and private market survey data 
on the existing use, across all years, and rounded up to the nearest 
multiple of 5%. In most cases, EPA uses available data from USDA/
National Agricultural Statistics Service (USDA/NASS), Proprietary 
Market Surveys, and the National Center for Food and Agriculture Policy 
(NCFAP) for the most recent 6 years.
    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. 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 and screening concentration in ground water 
(SCI-GROW) models, the estimated environmental concentrations (EECs) 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. The EECs 
for chronic exposures are estimated to be 17.2 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 (DEEM-FCID\TM\, Version 2.03). 
For acute dietary risk assessment, the peak water concentration value 
of 36.0 ppb was used to access the contribution to drinking water. For 
chronic dietary risk assessment, the annual average concentration of 
17.2 ppb was used to access 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 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 to be addressed in terms of residential pesticide 
handlers. The risk assessment was conducted using the following 
residential exposure assumptions: EPA has determined that residential 
handlers 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:
     Dermal and inhalation exposure from using a granular push-
type spreader;
     Dermal exposure from using potted plant spikes;
     Dermal exposure from using a plant potting medium;
     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);
     Dermal and inhalation exposure from using a water can/
bucket for soil drench applications; and
     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:
     Toddler oral hand-to-mouth exposure from contacting 
treated turf;
     Toddler incidental oral ingestion of granules;
     Toddler incidental oral ingestion of pesticide-treated 
soil;
     Toddler incidental oral exposure from contacting treated 
pet;
     Toddler dermal exposure from contacting treated turf;
     Toddler dermal exposure from hugging treated pet/
contacting treated pet;
     Adult dermal exposure from contacting treated turf;
     Adult golfer dermal exposure from contacting treated turf;
     Adolescent golfer dermal exposure from contacting treated 
turf; and
     Adult dermal exposure from contacting treated pet;
    4. Cumulative effects from 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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to imidacloprid and 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 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
.


[[Page 46114]]

D. Safety Factor for Infants and Children

    1. In general. Section 408 of 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 based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
margin of exposure (MOE) analysis or through using uncertainty (safety) 
factors in calculating a dose level that poses no appreciable risk to 
humans. In applying this provision, EPA either retains the default 
value of 10X when reliable data do not support the choice of a 
different factor, or, if reliable data are available, EPA uses a 
different additional safety factor (SF) value based on the use of 
traditional uncertainty factors and/or special FQPA safety factors, as 
appropriate.
    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:
    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 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. 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:
    The toxicological data base is complete for FQPA assessment.
    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.
    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. These 
assessments of exposure are not likely to underestimate the resulting 
estimates of risk from exposure to imidacloprid.

E. Aggregate Risks and Determination of Safety

    The Agency currently has two ways to estimate total aggregate 
exposure to a pesticide from food, drinking water, and residential 
uses. First, a screening assessment can be used, in which the Agency 
calculates drinking water levels of comparison (DWLOCs) which are used 
as a point of comparison against estimated drinking water 
concentrations (EDWCs). The DWLOC values are not regulatory standards 
for drinking water, but 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. More information on the use 
of DWLOCs in dietary aggregate risk assessments can be found at http://www.epa.gov/oppfead1/trac/science/screeningsop.pdf
.

    More recently the Agency has used another approach to estimate 
aggregate exposure through food, residential and drinking water 
pathways. In this approach, modeled surface water and ground water 
EDWCs are directly incorporated into the dietary exposure analysis, 
along with food. This provides a more realistic estimate of exposure 
because actual body weights and water consumption from the CSFII are 
used. The combined food and water exposures are then added to estimated 
exposure from residential sources to calculate aggregate risks. The 
resulting exposure and risk estimates are still considered to be high 
end, due to the assumptions used in developing drinking water modeling 
inputs. The risk assessment for imidacloprid used in this tolerance 
document uses this approach of incorporating water exposure directly 
into the dietary exposure analysis.
    1. 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 26% of the acute population adjusted dose 
(aPAD) for the U.S. population, 18% of the aPAD for females 13 years 
and older, 54% of the aPAD for all infants 1 year old, and 67% of the 
aPAD for children 1-2 years old. EPA does not expect the aggregate 
exposure to exceed 100% of the aPAD.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
imidacloprid from food and water will utilize 11% of the chronic 
population adjusted dose (cPAD) for the U.S. population, 22% of the 
cPAD for all infants 1 year old, and 33% of the cPAD for children 1-2 
years old. Based on the use pattern, chronic residential exposure to 
residues of imidacloprid is not expected. EPA does not expect the 
aggregate exposure to exceed 100% of the cPAD.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Imidacloprid is currently registered for use that could result in 
short-term residential exposure and the Agency has determined that it 
is appropriate to aggregate chronic food and water and short-term 
exposures for imidacloprid.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in worst-case aggregate MOEs of 320 for the general 
U.S. population and 170 for children 1-2 years old, the sub-population 
at greatest exposure. These

[[Page 46115]]

aggregate MOEs do not exceed the Agency's LOC for aggregate exposure to 
food, water and residential uses.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Intermediate- 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- or 
long-term exposures.
    5. Aggregate cancer risk for U.S. population. The Agency has 
classified imidacloprid as a ``Group E'' chemical, no evidence of 
carcinogenicity for humans, by all routes of exposure based upon lack 
of evidence of carcinogenicity in rats and mice. Imidacloprid is not 
expected to pose a cancer risk.
    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.

IV. 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). The validated limit of detection (LOD) and limit of 
quantitation (LOQ) for the GC/MS Method 00200 are 0.01 and 0.05 ppm, 
respectively, in plant commodities. 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: residuemethods@epa.gov.

B. International Residue Limits

    There are no established Mexican maximum residue limits (MRLs) for 
the proposed 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 rapeseed at 0.05 ppm and 
banana at 0.05 ppm. In addition, there is currently Canadian MRLs for: 
1-[(6-chloro-3-pyridinyl) methyl]-4,5-dihydro-N-nitro-1H-imidazol-2-
amine, including metabolites containing the 6-chloropicolyl moiety in 
or on mustard, seed at 0.05 ppm, rapeseed (canola) at 0.05 ppm and 
pecans at 0.05 ppm. The Codex and Canadian MRLs for rapeseed (canola) 
is the same as the U.S. recommended tolerance for rapeseed, seed; and 
the Canadian MRL for pecans is the same as the U.S. recommended 
tolerance. However, the Canadian MRL for banana is not equivalent to 
the U.S. recommended tolerance as the available crop field trial data 
supported a higher tolerance level. Therefore, harmonization is not 
possible at this time.

V. Conclusion

    Therefore, the tolerances are established for combined residues of 
the insecticide imidacloprid, 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-
2- imidazolidinimine, and its metabolites containing the 6-
chloropyridinyl moiety, all expressed as imidacloprid in or on 
caneberry subgroup 13A at 0.05 ppm; coffee, green bean at 0.80 ppm; 
seed of: Black mustard, borage, crambe, field mustard, flax, Indian 
mustard, Indian rapeseed, rapeseed, safflower, and sunflower at 0.05 
ppm; atemoya, biriba, cherimoya, custard apple, ilama, soursop, and 
sugar apple at 0.30 ppm; almond hulls at 4.0 ppm; pistachio at 0.05 
ppm; tree nut group 14 at 0.05 ppm; pomegranate at 0.90 ppm; banana at 
0.50 ppm; herb subgroup, 19A, herbs, dried at 48.0 ppm and herb 
subgroup, 19A herbs, fresh at 8.0 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 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 
petition under section 408(d) of FFDCA, such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of 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

[[Page 46116]]

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.

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: August 1, 2006.
Lois Rossi,
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 permitting the combined 
residues of the insecticide imidacloprid (1-[6-chloro-3-pyridinyl) 
methyl]-N-nitro-2-imidazolidinimine) and its metabolites containing the 
6-chloropyridinyl moiety, all expressed as 1-[(6-chloro-3-
pyridinyl)methyl]-N-nitro-2-imidazolidinimine, in or on the following 
food commodities:

------------------------------------------------------------------------
                      Commodity                        Parts Per Million
------------------------------------------------------------------------
Acerola..............................................                1.0
Almond, hulls........................................                4.0
Apple................................................                0.5
Apple, wet pomace....................................                3.0
Atemoya..............................................               0.30
Artichoke, globe.....................................                2.5
Avocado..............................................                1.0
Banana...............................................               0.50
Barley, grain........................................               0.05
Barley, hay..........................................                0.5
Barley, straw........................................                0.5
Beet, sugar, roots...................................               0.05
Beet, sugar, tops....................................                0.5
Beet, sugar, molasses................................                0.3
Biriba...............................................               0.30
Blueberry............................................                3.5
Borage, seed.........................................               0.05
Caneberry, subgroup 13A..............................               0.05
Canistel.............................................                1.0
Canola, seed.........................................               0.05
Cattle, fat..........................................                0.3
Cattle, meat byproducts..............................                0.3
Cattle, meat.........................................                0.3
Cherimoya............................................                0.3
Citrus, dried pulp...................................                5.0
Coffee, green bean...................................               0.80
Corn, field, forage..................................               0.10
Corn, field, grain...................................               0.05
Corn, field, stover..................................               0.20
Corn, pop, grain.....................................               0.05
Corn, pop, stover....................................               0.20
Corn, sweet, forage..................................               0.10
Corn, sweet, kernel plus cob with husks removed......               0.05
Corn, sweet, stover..................................               0.20
Cotton, gin byproducts...............................                4.0
Cotton, undelinted seed..............................                6.0
Cotton, meal.........................................                8.0
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..............................                0.7
Fruit, pome, group 11................................                0.6
Fruit, stone, group 12...............................                3.0
Goat, fat............................................                0.3
Goat, meat byproducts................................                0.3
Goat, meat...........................................                0.3
Gooseberry...........................................                3.5
Grape, juice.........................................                1.5
Grape, pomace (wet or dried).........................                5.0
Grape, raisin........................................                1.5
Grape, raisin, waste.................................               15.0
Grape................................................                1.0
Guava................................................                1.0
Herbs subgroup 19A, dried herbs......................               48.0
Herbs subgroup 19B, fresh herbs......................                8.0
Hog, fat.............................................                0.3
Hog, meat byproducts.................................                0.3
Hog, meat............................................                0.3
Hop, dried cone......................................                6.0
Horse, fat...........................................                0.3
Horse, meat byproducts...............................                0.3
Horse, meat..........................................                0.3
Huckleberry..........................................                3.5
Ilama................................................               0.30
Jaboticaba...........................................                1.0
Juneberry............................................                3.5
Leaf petioles subgroup 4B............................                6.0
Leafy greens subgroup 4A.............................                3.5
Lettuce, head and leaf...............................                3.5
Lingonberry..........................................                3.5
Longan...............................................                3.0
Lychee...............................................                3.0
Mango................................................                1.0
Milk.................................................                0.1
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
Oats, forage.........................................                2.0
Oats, grain..........................................               0.05
Oats, hay............................................                6.0
Oats, straw..........................................                3.0
Okra.................................................                1.0
Passionfruit.........................................                1.0
Papaya...............................................                1.0
Pecans...............................................               0.05
Persimmon............................................                3.0
Pistachio............................................               0.05
Pomegranate..........................................               0.90
Potato, chip.........................................                0.4
Potato, waste........................................                0.9
Poultry, fat.........................................               0.05
Poultry, meat byproducts.............................               0.05
Poultry, meat........................................               0.05
Pulasan..............................................                3.0
Rambutan.............................................                3.0
Rapeseed, seed.......................................               0.05
Rye, forage..........................................                2.0
Rye, grain...........................................               0.05
Rye, hay.............................................                6.0
Rye, straw...........................................                3.0
Safflower, seed......................................               0.05
Salal................................................                3.5
Sapodilla............................................                1.0
Sapote, black........................................                1.0
Sapote, mamey........................................                1.0
Sheep, fat...........................................                0.3
Sheep, meat byproducts...............................                0.3
Sheep, meat..........................................                0.3
Sorghum, forage......................................               0.10
Sorghum, grain.......................................               0.05
Sorgum, stover.......................................               0.10
Soursop..............................................               0.30
Soybean, meal........................................                4.0
Soybean, seed........................................                1.0
Spanish lime.........................................                3.0
Star apple...........................................                1.0
Starfruit............................................                1.0
Strawberry...........................................               0.50

[[Page 46117]]


Sugar apple..........................................               0.30
Sunflower, seed......................................               0.05
Tomato, paste........................................                6.0
Tomato, pomace (wet or dried)........................                4.O
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, except soybean, group 6...........                4.0
Vegetable, root and tuber, group 1, except sugar beet               0.40
Watercress...........................................                3.5
Watercress, upland...................................                3.5
Wax jambu............................................                1.0
Wheat, forage........................................                7.0
Wheat, grain.........................................               0.05
Wheat, hay...........................................                0.5
Wheat, straw.........................................                0.5
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established 
for indirect or inadvertent combined residues of the insecticide 
imidacloprid (1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine) and its metabolites containing the 6-chloropyridinyl 
moiety, all expressed as 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine, 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
------------------------------------------------------------------------
Forage, fodder, and straw of Grain, cereal crop group                2.0
 (forage)............................................
Forage, fodder, and straw of Grain, cereal crop group                6.0
 (hay)...............................................
Forage, fodder, and straw of Grain, cereal crop group                0.3
 (stover)............................................
Forage, fodder, and straw of Grain, cereal crop group                3.0
 (straw).............................................
Grain, cereal, group 15..............................               0.05
Sweet corn, kernel plus cob with husks removed.......               0.05
Vegetable, foliage of legume, group 7................                2.5
Vegetable, legume, crop group 6......................                0.3
------------------------------------------------------------------------

[FR Doc. E6-13092 Filed 8-10-06; 8:45 am]

BILLING CODE 6560-50-S
