[Federal Register Volume 78, Number 108 (Wednesday, June 5, 2013)]
[Rules and Regulations]
[Pages 33736-33744]
[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

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:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
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

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

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
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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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.
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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........
----------------------------------------------------------------------------------------------------------------

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.
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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

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

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.

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:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
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

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]
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[Federal Register: December 29, 2008 (Volume 73, Number 249)]
[Notices]
[Page 79495-79496]
[DOCID:fr29de08-76]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0652]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Notice of Participation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on reporting requirements for
filing a notice of participation with FDA.

DATES: Submit written or electronic comments on the collection of
information by February 27, 2009.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Notice of Participation--21 CFR 12.45 (OMB Control Number 0910-0191)--
Extension

    Section 12.45 (21 CFR 12.45) issued under section 701 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371), sets forth the
format and procedures for any interested person to file a petition to
participate in a formal evidentiary hearing, either personally or
through a representative. Section 12.45 requires that any person filing
a notice of participation, state their specific interest in the
proceedings, including the specific issues of fact about which the
person desires to be heard. This section also requires that the notice
include a statement that the person will present testimony at the
hearing and will comply with specific requirements in 21 CFR 12.85, or,
in the case of a hearing before a Public Board of Inquiry, concerning
disclosure of data and information by participants (21 CFR 13.25). In
accordance with Sec.  12.45(e) the presiding officer may omit a
participant's appearance.
    The presiding officer and other participants will use the collected
information in a hearing to identify specific interests to be
presented. This preliminary information serves to expedite the pre-
hearing conference and commits participation.
    The respondents are individuals or households, State or local
governments, not-for-profit institutions and businesses, or other for-
profit groups and institutions.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           No. of         Annual Frequency per      Total Annual        Hours per
                   21 CFR Section                       Respondents             Response             Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
12.45                                                                8                        1                  8                  3                 24
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The burden estimates for this collection of information are based
on agency records and experience over the past 3 years.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

    Dated: December 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30839 Filed 12-24-08; 8:45 am]

BILLING CODE 4160-01-S