
[Federal Register Volume 78, Number 108 (Wednesday, June 5, 2013)]
[Rules and Regulations]
[Pages 33736-33744]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13203]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0204; FRL-9387-9]


Imidacloprid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
imidacloprid in or on fish and fish-shellfish, mollusc requested by the 
Interregional Research Project Number 4 (IR-4) under the Federal Food, 
Drug, and Cosmetic Act (FFDCA). In addition, this regulation 
establishes time-limited tolerances for residues of imidacloprid in or 
on sugarcane, cane and sugarcane, molasses. This action is associated 
with the use of the pesticide on sugarcane under a crisis exemption 
granted by EPA under section 18 of the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA). The time-limited tolerances expire on 
December 31, 2015.

DATES: This regulation is effective June 5, 2013. Objections and 
requests for hearings must be received on or before August 5, 2013, 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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2012-0204, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional

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information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; email address: jackson.sidney@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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2012-0204 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
August 5, 2013. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    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 (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2012-0204, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of May 23, 2012 (77 FR 30481) (FRL-9347-8), 
EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 2E7988) 
by IR-4, IR-4 Headquarters, 500 College Road East, Suite 201W, 
Princeton, NJ 08540. The petition 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, in or on fish at 0.05 parts per million (ppm), and fish-
shellfish, mollusc at 0.05 ppm. That document referenced a summary of 
the petition prepared by the Willapa-Grays Harbor Oyster Growers 
Association, the registrant, which is available in the docket, http://www.regulations.gov.
    There were no comments received in response to the notice of 
filing.

III. Time-Limited Tolerance for Sugarcane

    Also in this action, EPA, on its own initiative, in accordance with 
FFDCA sections 408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 
346a(l)(6), is establishing time-limited tolerances for residues of 
imidacloprid in or on sugarcane, cane at 6.0 ppm and sugarcane, 
molasses at 50 ppm. These time-limited tolerances expire on December 
31, 2015.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under FIFRA 
section 18. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
FIFRA section 18 related time-limited tolerances to set binding 
precedents for the application of FFDCA section 408 and the safety 
standard to other tolerances and exemptions. Section 408(e) of FFDCA 
allows EPA to establish a tolerance or an exemption from the 
requirement of a tolerance on its own initiative, i.e., without having 
received any petition from an outside party. Section 18 of FIFRA 
authorizes EPA to exempt any Federal or State agency from any provision 
of FIFRA, if EPA determines that ``emergency conditions exist which 
require such exemption.'' EPA has established regulations governing 
such emergency exemptions in 40 CFR part 166.
    The Agency is establishing these time-limited tolerances in 
response to a crisis exemption request under FIFRA section 18 on behalf 
of the Louisiana Department of Agriculture and Forestry, for the 
emergency use of imidacloprid on sugarcane to control West Indian cane 
fly (Saccharosydne saccharivora). This was the first emergency 
exemption request for the use of imidacloprid on sugarcane.
    As part of its assessment of the emergency exemption request, EPA 
assessed the potential risks presented by the residues of imidacloprid 
in or on sugarcane, cane and sugarcane, molasses. In doing so, EPA 
considered the safety standard in section 408(b)(2) of the FFDCA, and 
EPA decided that the necessary time-limited tolerances under section 
408(l)(6) of the FFDCA would be consistent with the safety standard. 
Consistent with the need to move quickly on the emergency exemption in 
order to address the urgent non-routine situation and to ensure that 
the resulting food is safe and lawful, EPA is issuing these time-
limited tolerances without notice and opportunity for public comment, 
as provided for in section 408(l)(6). Although, these time-limited 
tolerances expire and are revoked on December 31, 2015, under section 
408(l)(5) of the FFDCA, residues of the pesticide not in excess of the 
amount specified in the tolerance remaining in or on sugarcane, cane 
and sugarcane, molasses after that date will not be

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unlawful, provided the pesticide is applied in a manner that was lawful 
under FIFRA, and the residues do not exceed a level that was authorized 
by these time-limited tolerances at the time of application. EPA will 
take action to revoke these time-limited tolerances earlier if any 
experience with, scientific data, or other relevant information on this 
pesticide indicates that the residues are not safe.
    Because these time-limited tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether 
imidacloprid meets EPA's registration requirements for use on sugarcane 
or whether permanent tolerances for this use would be appropriate. 
Under this circumstance, EPA does not believe that the time-limited 
tolerances provide a basis for registration of sugarcane by a State for 
special local needs under FIFRA section 24(c). Nor do the time-limited 
tolerances serve as the basis for any State other than Louisiana to use 
this pesticide on this crop under section 18 of FIFRA without following 
all provisions of EPA's regulations implementing FIFRA section 18 as 
identified in 40 CFR part 166. For additional information regarding the 
emergency exemption for imidacloprid, contact the Agency's Registration 
Division at the address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA 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 imidacloprid including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with imidacloprid follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
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.
    The main targets of toxicity following oral administration of 
imidacloprid in mammalian systems were the nervous system and the 
thyroid. The most sensitive species tested was the rat. Evidence of 
neurotoxicity was reported in the rat acute neurotoxicity (ACN) study 
as changes in clinical signs and functional-observation battery (FOB) 
measurements, including decreased motor and locomotor activities, 
tremors, gait abnormalities, increased righting reflex impairments and 
body temperature, decreased number of rears and response to stimuli, 
and decreases in forelimb and hindlimb grip strength. Also, in a rat 
developmental neurotoxicity (DNT) study where imidacloprid was 
administered to pregnant/lactating dams in the diet, there were 
decreases in offspring motor activity measurements and a small but 
statistically significant decrease in the caudate/putamen width in the 
brain of female pups. No neurotoxic effects were reported in any other 
toxicity study including the rat subchronic neurotoxicity study. Long-
term dietary exposure to imidacloprid in chronic toxicity studies 
resulted in an increased incidence of mineralized particles in the 
thyroid colloid in rats, decreased body weights in mice, and no toxic 
effects in dogs. No toxic effects were reported via the dermal route in 
rabbits or via the inhalation route in rats at the highest dose or 
concentration tested. No evidence of increased qualitative or 
quantitative susceptibility was found in either rats or rabbits in 
prenatal developmental toxicity studies or in rats in a two-generation 
reproductive toxicity study. Increased qualitative susceptibility was 
indicated in the rat DNT study, however; the neurotoxic offspring 
effects noted above occurred in the presence of maternal decreased food 
consumption and body weight gain, and a clear maternal no-observed-
adverse-effect level (NOAEL) was established. There was no evidence of 
carcinogenic potential in either the rat chronic toxicity/
carcinogenicity or mouse carcinogenicity studies, and imidacloprid was 
not genotoxic in a variety of assays.
    The toxicology database for imidacloprid does not show any evidence 
of treatment-related effects on the immune system. Results of an 
acceptable immunotoxicity study in rats showed no immunotoxic effects 
at the highest dose level tested.
    Specific information on the studies received and the nature of the 
adverse effects caused by imidacloprid as well as the NOAEL and the 
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies 
can be found at http://www.regulations.gov in document: 
``Imidacloprid--Section 3 Request for use on Oyster Beds in Washington 
(WA), and Section 18 Emergency Exemption Request for use on Sugarcane 
in Louisiana (LA). Human-Health Risk Assessment,'' dated March 7, 2013 
at pp. 41-44 in docket ID number EPA-HQ-OPP-2012-0204-0008.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which the NOAEL and the LOAEL are identified. 
Uncertainty/safety factors are used in conjunction with the POD to 
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of 
exposure (MOE). For non-threshold risks, the Agency assumes that any 
amount of exposure will lead to some degree of risk. Thus, the Agency 
estimates risk in terms of the probability of an occurrence of the 
adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for imidacloprid used for

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human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for imidacloprid for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations)..  LOAEL = 42 mg/kg/day  Acute RfD = 0.14 mg/ Acute neurotoxicity--rat LOAEL =
                                   UFA = 10x...........   kg/day               42 mg/kg/day based upon the
                                   UFH = 10x...........  aPAD = 0.14 mg/kg/    decrease in motor and locomotor
                                   FQPA SF = 3x........   day.                 activities observed in females.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 5.7 mg/kg/day  Chronic RfD = 0.057  Combined chronic toxicity/
                                   UFA = 10x...........   mg/kg/day            carcinogenicity--rat. LOAEL =
                                   UFH = 10x...........  cPAD = 0.057 mg/kg/   16.9 mg/kg/day, based upon
                                   FQPA SF = 1x........   day.                 increased incidence of
                                                                               mineralized particles in thyroid
                                                                               colloid in males.
----------------------------------------------------------------------------------------------------------------
Incidental Oral Short-term (1-30   NOAEL= 10 mg/kg/day   LOC for MOE = 100..  Prenatal developmental toxicity--
 days) Intermediate-term (1 to 6   UFA = 10x...........                        rat. LOAEL = 30 mg/kg/day based
 months).                          UFH = 10x...........                        on decreased maternal body weight
                                   FQPA SF = 1x........                        gain.
----------------------------------------------------------------------------------------------------------------
Incidental Oral Long Term (> 6     NOAEL= 5.7 mg/kg/day  LOC for MOE = 100..  Combined chronic toxicity/
 months).                          UFA= 10x............                        carcinogenicity--rat. LOAEL =
                                   UFH= 10x............                        16.9 mg/kg/day, based upon
                                   FQPA SF =1x.........                        increased incidence of
                                                                               mineralized particles in thyroid
                                                                               colloid in males.
----------------------------------------------------------------------------------------------------------------
Dermal Short-term (1 to 30 days)   Oral study NOAEL =    LOC for MOE = 100..  Prenatal developmental toxicity--
 Intermediate-term (1 to 6          10 mg/kg/day                               rat. LOAEL = 30 mg/kg/day based
 months).                           (dermal absorption                         on decreased maternal body weight
                                    = 7.2%)                                    gain.
                                   NOAEL = 10 mg/kg/day
                                   UFA = 10x...........
                                   UFH = 10x...........
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Dermal Long-term (> 6 months)....  Oral study NOAEL=     LOC for MOE = 100..  Combined chronic toxicity/
                                    5.7 mg/kg/day                              carcinogenicity--rat. LOAEL =
                                    (dermal absorption                         16.9 mg/kg/day, based upon
                                    = 7.2%)                                    increased incidence of
                                   NOAEL= 5.7 mg/kg/day                        mineralized particles in thyroid
                                   UFA = 10x...........                        colloid in males.
                                   UFH = 10x...........
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Inhalation Short- (1-30 days) &    Oral study NOAEL= 10  LOC for MOE = 100..  Prenatal developmental toxicity--
 Intermediate- (1-6 months) terms.  mg/kg/day                                  rat. LOAEL = 30 mg/kg/day based
                                    (inhalation                                on decreased maternal body weight
                                    absorption = 100%)                         gain.
                                   UFA = 10x...........
                                   UFH = 10x...........
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation (> 6 months)  Oral study NOAEL =    LOC for MOE = 100..  Combined chronic toxicity/
                                    5.7 mg/kg/day                              carcinogenicity--rat. LOAEL =
                                   (inhalation                                 16.9 mg/kg/day, based upon
                                    absorption = 100%).                        increased incidence of
                                   UFA = 10x...........                        mineralized particles in thyroid
                                   UFH = 10x...........                        colloid in males.
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------

[[Page 33740]]

 
Cancer (Oral, dermal, inhalation)  Classification: ``Not likely to be carcinogenic to humans'' based on no
                                    evidence of carcinogenic potential in either the rat chronic toxicity/
                                    carcinogenicity or mouse carcinogenicity studies.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

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, the use on sugarcane under the FIFRA section 18 
emergency exemption authorized by EPA, 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.
    Such effects were identified for imidacloprid. In estimating acute 
dietary exposure, EPA used food consumption information from the United 
States Department of Agriculture (USDA) 2003-2008 National Health and 
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). 
As to residue levels in food, EPA conducted an unrefined, acute dietary 
exposure assessment using tolerance-level residues and assumed 100 
percent crop treated (PCT) for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the 2003-2008 
NHANES/WWEIA. As to residue levels in food, EPA conducted a partially 
refined chronic dietary exposure assessment using tolerance-level 
residues for all commodities and PCT information for some registered 
commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that imadicloprid does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Percent crop treated (PCT) information. Section 408(b)(2)(F) of 
FFDCA states that the Agency may use data on the actual percent of food 
treated for assessing chronic dietary risk only if:
     Condition A: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition B: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition C: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency estimated the PCT for existing uses as follows: For the 
chronic assessment, the following average weighted PCT information was 
used: Almonds 1%; apples: 30%; artichokes: 5%; avocados: 1%; beans, 
green: 5%; blueberries: 10%; broccoli: 55%; cabbage: 25%; caneberries: 
10%; cantaloupe: 40%; carrots: 1%; cauliflower: 50%; celery: 10%; 
cherries: 15%; corn (seed treatment): 2.5%; cotton: 5%; cotton: 5%; 
cucumbers: 5%; dry beans/peas: 1%; eggplant: 60%; filberts (hazelnuts): 
2.5%; grapefruit: 25%; grapes: 30%; honeydew: 30%; lemons: 5%; lettuce: 
65%; onions: 1%; oranges: 20%; peaches: 5%; peanuts: 1%; pears: 5%; 
peas, green: 2.5%; pecans: 15%; peppers: 15%; pistachios: 1%; potatoes: 
35%; prunes: 1%; pumpkin: 10%; sorghum: 15%; soybeans: 5%; spinach: 
20%; squash: 15%; strawberries: 10%; sugar beets: 2.5%; sweet corn: 1%; 
tangerines: 10%; tobacco: 25%; tomatoes: 25%; walnuts: 5%; watermelon: 
20%; wheat: 10%.
    In most cases, EPA uses available data from the United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the National Pesticide Use 
Database for the chemical/crop combination for the most recent 6-7 
years. EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available public and private market survey data for that use, averaging 
across all observations, and rounding to the nearest 5%, except for 
those situations in which the average PCT is less than one. In those 
cases, 1% is used as the average PCT and 2.5% is used as the maximum 
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The 
maximum PCT figure is the highest observed maximum value reported 
within the recent 6 years of available public and private market survey 
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit 
IV.C.1.iv. have been met. With respect to Condition A, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions B and C, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which imidacloprid may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary

[[Page 33741]]

exposure analysis and risk assessment for imidacloprid in drinking 
water. These simulation models take into account data on the physical, 
chemical, and fate/transport characteristics of imidacloprid. Further 
information regarding EPA drinking water models used in pesticide 
exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST), and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of imidacloprid for 
acute exposures are estimated to be 36.0 parts per billion (ppb) for 
surface water and 2.09 ppb for ground water.
    For chronic exposures, assessments 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). The proposed use of 
imidacloprid on oyster beds is professionally applied and not expected 
to result in residential handler exposure, but can result in 
residential post-application exposures via potential contact with 
residues in the oyster bed water or sediment during recreational 
swimming, or in the case of subsistence fishermen or local Native 
American tribes, collecting oysters. There are no residential uses 
associated with the proposed Section 18 Emergency Exemption use on 
sugarcane. Imidacloprid is currently registered for the following uses 
that could result in residential exposures: Residential lawns and 
gardens, indoor uses for bed bugs and crack-and-crevice treatments, pet 
uses in spot-on treatments and collars, and pre- and post-construction 
termiticide and wood preservative uses. EPA assessed residential 
exposure using the assumption that residential pesticide handlers 
(i.e., persons who might mix, load and, or apply a pesticide material) 
could be exposed to several formulations that contain imidacloprid as 
well as the pest spectra, sites of application, methods of application, 
formulations and the retreatment intervals.
    For the registered imidacloprid residential uses, in general, 
short-term dermal, inhalation, and incidental oral post-application 
exposures are expected. Intermediate- and long-term dermal, incidental 
oral and inhalation exposures are expected from the pet collar use, as 
it presents the potential for prolonged exposure via a continuous 
source and frequent contact (i.e., playing with pets). Short-term 
dermal and inhalation handler exposures are expected. The Agency also 
assessed potential for post-application exposure for adults and 
children as a result of both the proposed use on oyster beds and from 
existing residential uses. Based on the proposed oyster bed use 
pattern, only short-term post-application dermal, incidental oral, and 
inhalation exposures to imidacloprid residues in affected water and 
sediment are expected. The exposure assessment used equations and 
inputs that are generally derived from SWIMODEL 3.0, developed by EPA 
as a screening tool to conduct exposure assessments of pesticides found 
in swimming pools and spas and EPA's Risk Assessment Guidance for 
Superfund--Part E, Supplemental Guidance for Dermal Risk Assessment 
(``RAGS-E'').
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/science/residential-exposure-sop.html.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found imidacloprid to share a common mechanism of 
toxicity with any other substances, and imidacloprid does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
imidacloprid does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. No evidence of increased 
quantitative or qualitative susceptibility was found in rats and 
rabbits in the prenatal developmental toxicity studies or in rats in 
the two-generation reproductive toxicity study, where developmental 
effects were observed at the same or higher doses than those causing 
maternal effects. Increased qualitative susceptibility was found in the 
rat DNT study, but the concern is low based on the following 
observations:
    i. The pup effects (body-weight deficits, decreased motor activity, 
and small decrease in female caudate/putamen width) which occurred only 
in the presence of maternal toxicity (decreased body weight gain and 
food consumption) are well-characterized with a clear maternal NOAEL 
that is protective of both maternal and pup effects.
    ii. The doses selected for regulatory purposes are lower and thus 
protective of the pup effects noted in the DNT study, which occurred at 
higher doses of imidacloprid.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X for all exposure scenarios, except for the 
acute dietary assessment. For the acute dietary assessment, EPA has 
determined that reliable data show the safety of infants and children 
would be adequately protected if the FQPA SF were reduced to 3X. Those 
decisions are based on the following findings:
    i. The toxicity database for imidacloprid contains all the required 
studies, although the acute neurotoxicity study, which was selected for 
determining the acute dietary endpoint, lacks a NOAEL. An FQPA SF of 3X 
is retained for the acute dietary

[[Page 33742]]

endpoint in the form of a database uncertainty factor (UF) for lack of 
a NOAEL. EPA has determined that an FQPA safety factor of 3X is 
adequate to protect infants and children because the effect (decreased 
motor and locomotor activity), which occurred at the LOAEL is minimal 
and not statistically different from the control group. Furthermore, 
the LOAEL of 42 mg/kg/day is comparable to the LOAEL of 55 mg/kg/day 
for offspring effects (which includes decreased motor activity) in the 
rat DNT study, and the extrapolated NOAEL from the acute neurotoxicity 
study of 14 mg/kg/day (42/3 = 14) is comparable to and more protective 
than the NOAEL of 20 mg/kg/day established in the DNT for offspring 
effects.
    ii. There was evidence of neurotoxicity in the rat neurotoxicity 
studies. Evidence of neurotoxicity was reported in the rat acute 
neurotoxicity study as discussed above in Unit IV.A. Also, in a rat DNT 
study where imidacloprid was administered to pregnant/lactating dams in 
the diet, there were decreases in offspring motor activity measurements 
and a small but statistically significant decrease in the caudate/
putamen width in the brain of female pups. Well-defined NOAELs were 
achieved in the study, therefore the concern is low. No adverse 
neurotoxic effects were reported in any other toxicity study including 
the rat subchronic neurotoxicity study.
    iii. Although the prenatal developmental studies in rats and 
rabbits and the 2-generation reproduction study in rats did not show 
evidence that imidacloprid results in increased susceptibility in utero 
or in offspring, respectively, the rat DNT study showed evidence of 
increased qualitative susceptibility in pups. For the reasons discussed 
in Unit IV.D.2, however, the concern for this susceptibility is low. 
Therefore, there are no residual uncertainties for prenatal/postnatal 
toxicity in this study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The acute dietary food exposure assessment utilizes 
tolerance-level residues and 100 PCT information for all commodities. 
The chronic food exposure assessment utilizes tolerance-level residues 
for all commodities and PCT data for some existing uses and 100 PCT for 
all proposed uses. EPA made conservative (protective) assumptions in 
the dietary drinking water assessment utilizing water concentration 
values generated by models and associated modeling parameters, which 
are designed to provide conservative, health-protective, high-end 
estimates of water concentrations which will not likely be exceeded. 
EPA used similarly conservative assumptions to assess post-application 
exposure of children as well as incidental oral exposure of toddlers. 
These assessments will not underestimate the exposure and risks posed 
by imidacloprid.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    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 74% of the aPAD for children 1-2 years old, 
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic dietary exposure, EPA has concluded that chronic 
exposure to imidacloprid from food and water will utilize 28% of the 
cPAD for children 1-2 years old the population group receiving the 
greatest exposure. The chronic aggregate risk assessment takes into 
account average exposure estimates from dietary consumption of 
imidacloprid (food and drinking water) and long-term residential uses. 
High-end estimates of residential exposure are used, and average values 
are used for food and drinking water exposures. Based on the proposed 
and existing use patterns, there is potential for long-term residential 
exposure from the pet-collar use, as it presents the potential for 
prolonged exposure via a continuous source and frequent contact (i.e., 
playing with pets). Using the exposure assumptions described in this 
unit for long-term exposures, EPA has concluded the combined average 
food and water and long-term residential exposures result in aggregate 
MOEs of 760 for adults and 230 for children 1-2 years old, the 
population subgroup receiving the greatest exposure. Because EPA's 
level of concern for imidacloprid is a MOE of 100 or below, these MOEs 
are not of concern.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Imidacloprid 
is currently registered for uses that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to imidacloprid.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in an aggregate MOE of 240 for adults 
from the combined dermal post-application exposures from contacting 
treated lawns and gardens which resulted in the highest short-term 
exposure and an aggregate MOE of 120 for children from the combined 
dermal and hand-to-mouth exposure from contacting treated wood surfaces 
which resulted in the highest short-term exposure. Because EPA's level 
of concern for imidacloprid is a MOE of 100 or below, these MOEs are 
not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Although there is potential for intermediate-term residential 
exposure from the registered pet collar use, an intermediate-term 
aggregate assessment was not conducted. The short- and intermediate-
term toxicological endpoints are the same; therefore, the exposures 
assessed in the short-term aggregate (adults--combined dermal post-
application exposures from contacting treated lawns and gardens; and 
children--combined dermal and hand-to-mouth from contacting treated 
wood surfaces) are protective of those for intermediate-term duration 
exposures.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, imidacloprid is not expected to pose a cancer risk to humans. 
Therefore, a quantitative cancer risk assessment is not needed.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to imidacloprid residues.

[[Page 33743]]

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods are available for determination of 
imidacloprid residues of concern in plant Bayer gas chromatography/mass 
spectrometry (GC/MS) Method 00200 and livestock commodities (Bayer GC/
MS Method 00191). These methods have undergone successful EPA petition 
method validations (PMVs), and the registrant has fulfilled the 
remaining requirements for additional raw data, method validation, 
independent laboratory validation (ILV), and an acceptable confirmatory 
method high-performance liquid chromatography/ultraviolet (HPLC/UV) 
Method 00357.
    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; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    There are currently no established Codex, MRLs for imidacloprid on 
fish; fish-shellfish, mollusc; or sugarcane.

VI. Conclusion

    Therefore, tolerances are established for residues of imidacloprid 
(1-[6-chloro-3-pyridinyl)methyl]-N-nitro-2-imidazolidinimine) and its 
metabolites containing the 6-chloropyridinyl moiety, in or on fish at 
0.05 ppm, and fish-shellfish, mollusc at 0.05 ppm.
    In addition, this regulation establishes time-limited tolerances 
for residues of imidacloprid in or on sugarcane, cane at 6.0 ppm and 
sugarcane, molasses at 50 ppm.

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), 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 FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    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) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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: May 23, 2013.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.

    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 amended by adding alphabetically the following 
commodities to the table in paragraph (a) and adding paragraph (b) to 
read as follows:


Sec.  180.472  Imidacloprid; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Fish........................................................        0.05
Fish-shellfish, mollusc.....................................        0.05
 
                                * * * * *
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the insecticide imidacloprid, including its 
metabolites and degradates in connection with use of the pesticide 
under a Section 18 emergency exemption granted by EPA. Compliance with 
the tolerance levels

[[Page 33744]]

specified below is to be determined by measuring only the sum of 
imidacloprid (1-[6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine) and its metabolites containing the 6-chloropyridinyl 
moiety, calculated as the stoichiometric equivalent of imidacloprid. 
These tolerances will expire and are revoked on the dates specified in 
the following table:

----------------------------------------------------------------------------------------------------------------
                     Commodity                             Parts per million         Expiration/revocation date
----------------------------------------------------------------------------------------------------------------
Sugarcane, cane....................................                            6.0                      12/31/15
Sugarcane, molasses................................                           50                        12/31/15
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-13203 Filed 6-4-13; 8:45 am]
BILLING CODE 6560-50-P


