Document ID: EPA-HQ-OPP-2006-0968-0004
Agency: epa
Document Type: Rule
Title: Imidacloprid; Pesticide Tolerance
Posted Date: 2007-06-20T04:00Z

[Federal Register: June 20, 2007 (Volume 72, Number 118)]
[Rules and Regulations]               
[Page 33907-33913]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20jn07-24]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0968; FRL-8135-5]

 
Imidacloprid; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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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 peanut, peanut hay and 
peanut meal; pearl millet grain, forage, hay and straw; proso millet 
grain, forage, hay and straw; kava roots and leaves; raspberry, wild; 
soybean forage and hay; and aspirated grain fractions. It also amends 
existing tolerances for combined residues of imidacloprid and its 
metabolites containing the 6-chloropyridinyl moiety in or on caneberry 
subgroup 13-A and soybean seed. Bayer CropScience LLC and Interregional 
Research Project No. 4 (IR-4) requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA). This regulation also 
corrects a typographical error in the commodity term for the existing 
tolerance on the herbs subgroup, fresh herbs.

DATES: This regulation is effective June 20, 2007. Objections and 
requests for hearings must be received on or before August 20, 2007, 
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-2006-0968. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 

Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov web site to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in 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: 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 those 
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    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?

    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 EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, 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-2006-0968 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 August 20, 2007.
    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-2006-0968, 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'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 Facility telephone number is (703) 305-5805.

[[Page 33908]]

II. Petition for Tolerance

    In the Federal Register of December 20, 2006 (71 FR 76321) (FRL-
8104-4), 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 
6E7108 and PP 6E7116) 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 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 peanut at 0.45 parts per million (ppm); peanut, 
hay at 70 ppm; peanut, meal at 0.9 ppm; kava, roots at 0.4 ppm; kava, 
leaves at 4.0 ppm; millet, pearl, grain at 0.05 ppm; millet, proso, 
grain at 0.05 ppm; and oat, grain at 0.05 (all requested in PP 6E7116); 
and on caneberry subgroup 13A and raspberry, wild at 2.5 ppm (requested 
in PP 6E7108). That notice included summaries of the petitions prepared 
by IR-4, which are available to the public in the docket, http://www.regulations.gov.
 There were no comments received in response to the 

notice of filing.
    In the Federal Register of July 14, 2006 (71 FR 40099) (FRL-8060-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
6F7049) by Bayer CropScience LLC, 2 T. W. Alexander Drive, Research 
Triangle Park, NC 27709. The petition requested that 40 CFR 180.472 be 
amended by establishing tolerances for combined residues of the 
insecticide imidacloprid, 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine, and its metabolites containing the 6-chloropyridinyl 
moiety, all expressed as imidacloprid, in or on soybean, aspirated 
grain fractions at 240.0 parts per million (ppm); soybean, forage at 
8.0 ppm; soybean, hay at 30.0 ppm; and soybean, seed at 1.6 ppm. That 
notice referenced a summary of the petition prepared by Bayer 
CropScience LLC, 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 petitions, EPA has 
modified the proposed tolerances. The modifications and reasons for 
these changes are explained in Unit V.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.'' These provisions were added to the FFDCA by the Food Quality 
Protection Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for the petitioned-for tolerances 
for combined residues of imidacloprid, 1-[(6-chloro-3-
pyridinyl)methyl]-N-nitro-2- imidazolidinimine, and its metabolites 
containing the 6-chloropyridinyl moiety, all expressed as the parent, 
in or on peanut at 0.45 ppm; peanut, hay at 35 ppm; peanut, meal at 
0.75 ppm; millet, proso, grain at 0.05 ppm; millet, proso, forage at 
2.0 ppm; millet, proso, hay at 6.0 ppm; millet, proso, straw at 3.0 
ppm; millet, pearl, grain at 0.05 ppm; millet, pearl, forage at 2.0 
ppm; millet, pearl, hay at 6.0 ppm; millet, pearl, straw at 3.0 ppm; 
kava, roots at 0.40 ppm; kava, leaves at 4.0 ppm; caneberry, subgroup 
13-A at 2.5 ppm; raspberry, wild at 2.5 ppm; soybean, seed at 3.5 ppm; 
soybean, forage at 8.0 ppm; soybean hay at 35 ppm and aspirated grain 
fractions at 240 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 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 are discussed in the 
final rule published in the Federal Register of June 13, 2003 (68 FR 
35303), (FRL-7310-8); available 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 toxicological level of concern (LOC) is derived 
from the highest dose at which the NOAEL in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the LOAEL of concern are identified is 
sometimes used for risk assessment. Uncertainty/safety factors (UF) are 
used in conjunction with the LOC 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 
risks by comparing aggregate 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 LOC by all 
applicable uncertainty/safety factors. Short-term, intermediate-term, 
and long-term risks are evaluated by comparing aggregate exposure to 
the LOC to ensure that the margin of exposure (MOE) called for by the 
product of all applicable uncertainty/safety factors is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. 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/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.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

[[Page 33909]]

(68 FR 35303), (FRL-7310-8); available 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. 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 assumed all foods for which there are tolerances 
were treated and contain tolerance-level residues.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996, 
and 1998 Nationwide CSFII. As to residues in food, EPA assumed 
tolerance-level residues for all registered and proposed commodities. 
EPA relied on percent crop treated (PCT) information for some 
registered commodities but assumed 100 PCT for all proposed new uses.
    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:
    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 
such pesticide residue;
    b. The exposure estimate does not underestimate exposure for any 
significant subpopulation group; and
    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 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 dietary 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: Apples (30%), artichokes (5%), garden beets (15%), 
blueberry (10%), broccoli (35%), brussels sprouts (55%), cabbage (20%), 
cantaloupe (30%), carrots (< 1%), cauliflower (40%), celery (5%), 
cherries (5%), collards (10%), corn, field and sweet (< 1%), cotton 
(5%), cucumbers (5%), eggplant (45%), grapefruit (5%), grapes (30%), 
honeydew (10%), hops (90%), kale (30%), lemons (< 1%), lettuce (60%), 
oranges (5%), peaches (5%), pears (10%), peppers (25%), potatoes (35%), 
pumpkin (5%), spinach (20%), squash (10%), sugar beets (< 1%), 
tangerines (10%), tomatoes (15%), and watermelon (10%). A default value 
of 1% was used for all commodities which were reported as having < 1 
PCT.
    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 five percent except for those situations in which 
the average PCT is less than one. 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 five percent. In most cases, EPA 
uses available data from United States Department of Agriculture/
National Agricultural Statistics Service (USDA/NASS), Proprietary 
Market Surveys, and the National Center for Food and Agriculture Policy 
(NCFAP) for the most recent six years.
    The Agency believes that the three conditions listed above have 
been met. With respect to Condition 1, PCT estimates are derived from 
Federal and private market survey data, which are reliable and have a 
valid basis. The Agency is reasonably certain that the percentage of 
the food treated is not likely to be an underestimation. As to 
Conditions 2 and 3, regional consumption information and consumption 
information for significant subpopulations is taken into account 
through EPA's computer-based model for evaluating the exposure of 
significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which imidacloprid 
may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring 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 environmental 
fate 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 Screening Tool Reservoir (FIRST) and 
Screening Concentration in groundwater (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. 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 residential 
non-dietary

[[Page 33910]]

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 (RTU) potting medium for indoor and outdoor 
plant containers; liquid concentrate for application to lawns, trees, 
shrubs and flowers; and 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 handler.
     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 use to 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 compared to exposures using a garden 
hose-end sprayer and is, therefore, not assessed separately).
     Dermal and inhalation exposure from using a water can/bucket for 
soil drench applications.
     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 of 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 oral 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 
pet.
      Toddler incidental oral exposure from contacting treated 
pet.
      Toddler dermal exposure from hugging treated pet/
contacting treated pet.
      Toddler dermal exposure from contacting treated turf.
      Adult dermal exposure from contacting treated turf.
      Adult golfer dermal exposure from contacting treated 
turf.
      Adolescent golfer dermal exposure from contacting treated 
turf.
      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 EPA's website at http://www.epa.gov/pesticides/cumulative
.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional (10X) 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. This additional margin of 
safety is commonly referred to as the FQPA safety factor. 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 FQPA 
safety factor value based on the use of traditional uncertainty/safety 
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 2-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 pre-natal/post-natal toxicity in this study
    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings:
    i. The toxicity database for imidacloprid is complete.
    ii. Although there is evidence of qualitative susceptibility in the 
developmental neurotoxicity study in the rat, the concern is low and 
there are no residual uncertainties for pre-natal/post-natal toxicity, 
as discussed in Unit III.
    iii. There is no evidence that imidacloprid results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the two-generation 
reproduction study.
    iv. There are no residual uncertainties identified in the exposure 
databases. 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 assumptions, actual 
exposures/

[[Page 33911]]

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. Conservative ground and surface water modeling estimates were 
used to estimate both acute and chronic exposures to residues of 
imidacloprid in drinking water. 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 transferable residue data or other 
chemical-specific post-application exposure study data. The chemical-
specific study data and surrogate study data used are reliable and are 
not expected to underestimate risk to adults or 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 will not underestimate the exposure and risks posed by 
imidacloprid.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable uncertainty/
safety factors. For linear cancer risks, EPA calculates the probability 
of additional cancer cases given aggregate exposure. Short-term, 
intermediate-term, and long-term risks are evaluated by comparing 
aggregate exposure to the LOC to ensure that the MOE called for by the 
product of all applicable uncertainty/safety factors is not exceeded.
    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 70% of the aPAD for the population group 
(children, 1 to 2 years old) receiving the greatest exposure. 
Therefore, 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 38% of the cPAD for the 
population group (children, 1 to 2 years old) receiving the greatest 
exposure. Based on the residential use patterns, chronic residential 
exposure to residues of imidacloprid is not expected. Therefore, 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, water, and residential 
exposures aggregated result in aggregate MOEs of 310 for the general 
U.S. population and 170 for children, 1 to 2 years old, the population 
with the highest estimated aggregate short-term exposure to 
imidacloprid. These aggregate MOEs are based on the pet-treatment 
scenario, the use scenario resulting in the highest estimated 
residential exposures for adults and children. Post-application 
exposures from pet treatment and turf treatment were not combined in 
the short-term aggregate assessment, because of the low probability of 
these exposures co-occurring.
    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-term and long-term aggregate risk assessments were not 
performed because, based on the current use patterns for imidacloprid, 
the Agency does not expect exposures of intermediate- or long-term 
durations to occur.
    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, or 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 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 Canadian or Mexican Maxium Residue Levels 
(MRLs) for the proposed uses. There is an established Codex MRL for the 
sum of imidacloprid and its metabolites containing the 6-
chloropyridinyl moiety, expressed as imidacloprid, in/on cereal grain 
at 0.05 ppm, which is consistent with U.S. tolerances on cereal grains.

V. Conclusion

    Based upon review of the data supporting the petitions, EPA has 
modified the proposed tolerances as follows: 1. Added tolerances for 
millet, proso, forage at 2.0 ppm; millet, proso, hay at 6.0 ppm; 
millet, proso, straw at 3.0 ppm; millet, pearl, forage at 2.0 ppm; 
millet, pearl, hay at 6.0 ppm; and millet, pearl, straw at 3.0 ppm (all 
in PP 6E7116); 2. Revised tolerances for peanut, hay at 35 ppm and 
peanut, meal at 0.75 ppm (PP 6E7116); soybean, hay at 35 ppm and 
soybean, seed at 3.5 ppm (PP 6F7049); and 3. Changed the commodity term 
``soybean, aspirated grain fractions'' (PP 6F7049) to ``aspirated grain 
fractions'', the recommended commodity term in the Office of Pesticide 
Program's Food and Feed Commodity Vocabulary. The proposed tolerance on 
oat grain (PP 6E7116) is not needed, since a tolerance of 0.05 ppm for 
oat, grain already exists. EPA determined that tolerances for millet 
forage, hay and straw are needed based on residue data for similar 
grain crops showing residues in these commodities. EPA determined that 
the proposed tolerances for peanut hay/meal and soybean hay/seed were 
inappropriate and should be revised based on analyses of the residue 
field trial data using the Agency's Tolerance Spreadsheet in accordance 
with the Agency's Guidance for Setting Pesticide Tolerances Based on 
Field Trial Data Standard Operating Procedure (SOP).

[[Page 33912]]

    Therefore, tolerances are established for combined residues of 
imidacloprid, 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine, and its metabolites containing the 6-chloropyridinyl 
moiety, all expressed as imidacloprid, in or on peanut at 0.45 ppm; 
peanut, hay at 35 ppm; peanut, meal at 0.75 ppm; millet, proso, grain 
at 0.05 ppm; millet, proso, forage at 2.0 ppm; millet, proso, hay at 
6.0 ppm; millet, proso, straw at 3.0 ppm; millet, pearl, grain at 0.05 
ppm; millet, pearl, forage at 2.0 ppm; millet, pearl, hay at 6.0 ppm; 
millet, pearl, straw at 3.0 ppm; kava, roots at 0.40 ppm; kava, leaves 
at 4.0 ppm; caneberry, subgroup 13-A at 2.5 ppm; raspberry, wild at 2.5 
ppm; soybean, seed at 3.5 ppm; soybean, forage at 8.0 ppm; soybean hay 
at 35 ppm and aspirated grain fractions at 240 ppm.
    In the Federal Register of August 11, 2006 (71 FR 46110) (FRL-8081-
8), EPA established a tolerance for residues of imidacloprid and its 
metabolites containing the 6-chloropyridinyl moiety, all expressed as 
the parent, in or on the commodity ``Herbs subgroup 19B, fresh herbs''. 
The correct commodity term is ``Herbs subgroup 19-A, fresh herbs''. 
Therefore, the tolerance for this commodity is revised to read ``Herbs 
subgroup 19-A, fresh herbs'' at 8.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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, 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) 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).
    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.
    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 6, 
2000) do not apply to this rule. In addition, This 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: June 11, 2007.
Donald R. Stubbs,
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, the table in paragraph (a) is amended by 
alphabetically adding commodities; by revising the entries for 
``Caneberry, subgroup 13A'' and ``Soybean'' seed, and revising the 
entry ``Herbs, subgroup 19B, fresh herbs'', to read ``Herbs, subgroup 
19-A, fresh herbs''.
    The amendments read as follows:

Sec.  180.472  Imidacloprid; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Aspirated grain fractions                                            240
------------------------------------------------------------------------
                                * * * * *
Caneberry, subgroup 13-A                                             2.5
------------------------------------------------------------------------
                                * * * * *
Herbs subgroup 19-A, fresh herbs                                     8.0
------------------------------------------------------------------------
                                * * * * *
Kava, leaves                                                         4.0
------------------------------------------------------------------------

[[Page 33913]]

Kava, roots                                                         0.40
------------------------------------------------------------------------
                                * * * * *
Millet, pearl, forage                                                2.0
------------------------------------------------------------------------
Millet, pearl, grain                                                0.05
------------------------------------------------------------------------
Millet, pearl, hay                                                   6.0
------------------------------------------------------------------------
Millet, pearl, straw                                                 3.0
------------------------------------------------------------------------
Millet, proso, forage                                                2.0
------------------------------------------------------------------------
Millet, proso, grain                                                0.05
------------------------------------------------------------------------
Millet, proso, hay                                                   6.0
------------------------------------------------------------------------
Millet, proso, straw                                                 3.0
------------------------------------------------------------------------
                                * * * * *
Peanut                                                              0.45
------------------------------------------------------------------------
Peanut, hay                                                           35
------------------------------------------------------------------------
Peanut, meal                                                        0.75
------------------------------------------------------------------------
                                * * * * *
Raspberry, wild                                                      2.5
------------------------------------------------------------------------
                                * * * * *
Soybean, forage                                                      8.0
------------------------------------------------------------------------
Soybean, hay                                                          35
------------------------------------------------------------------------
                                * * * * *
Soybean, seed                                                        3.5
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-11792 Filed 6-19-07; 8:45 am]

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