[Federal Register Volume 75, Number 81 (Wednesday, April 28, 2010)]
[Rules and Regulations]
[Pages 22245-22252]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-9761]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0772; FRL-8818-5]
Imidacloprid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for combined residues
of imidacloprid in or on vegetables, bulb, group 3; cereal grains,
group 15 and cereal grains, forage, fodder and straw, group 16. This
regulation also deletes tolerances for various commodities and
tolerances from direct/inadvertent residues on cereal grains, group 15
and cereal grains, forage, fodder and straw, group 16, as they will be
superseded by group tolerances. Bayer CropScience requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective April 28, 2010. Objections and
requests for hearings must be received on or before June 28, 2010, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0772. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Kable Bo Davis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 306-0415; e-mail address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2008-0772 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or before June 28, 2010.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2008-0772, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW, Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The
[[Page 22246]]
Docket Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of December 3, 2008 (73 FR 73640) (FRL-
8390-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP
8F7414, 8F7415) by Bayer CropScience, 2 T.W. Alexander Drive, Research
Triangle Park, NC 27709. The petitions requested that 40 CFR 180.472 be
amended by establishing tolerances for combined residues of the
insecticide imidacloprid, 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine, in or on vegetable, bulb, group 3 at 2.5 parts per
million (ppm) (PP 8F7414) and cereal, grains, group 15 at 0.05 ppm (PP
8F7415). That notice referenced a summary of the petitions prepared by
Bayer CropScience, the registrant, which is available to the public in
the docket, http://www.regulations.gov. There were no comments received
in response to the notice of filing.
Based upon review of the data supporting the petition, EPA has
determined that the available toxicology, occupational/residential, and
residue chemistry databases support the establishment of permanent
tolerances of imidacloprid in or on onion, green, subgroup 3-07B at 2.5
ppm, onion, dry bulb, subgroup 3-07A at 0.15 ppm and grain, cereal,
except rice, group 15 at 0.05 ppm. The reasons for these changes are
explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
tolerances for combined residues of imidacloprid in or on onion, green,
subgroup 3-07B at 2.5 ppm, onion, dry bulb, subgroup 3-07A at 0.15 ppm
and grain, cereal, except rice, group 15 at 0.05 ppm. EPA's assessment
of exposures and risks associated with establishing tolerances follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by imidacloprid as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Imidacloprid: Human-Health Risk
Assessment,'' pages 43 - 46 in docket ID number EPA-HQ-OPP-2008-0772.
Imidacloprid has low acute toxicity via the dermal and inhalation
routes and moderate acute toxicity via the oral route. It is not an eye
or dermal irritant and is not a dermal sensitizer. The nervous system
is the primary target organ of imidacloprid. Nervous system effects
evidenced as changes in clinical signs and functional observation
battery (FOB) assessments were seen in rat acute and subchronic
neurotoxicity studies. Also, in the rat developmental neurotoxicity
study, a decrease in the caudate/putamen width was noted in female
pups. Retinal atrophy was seen in high-dose females in the rat combined
chronic toxicity/carcinogenicity study. No nervous system effects were
noted in the mouse carcinogenicity or the reproduction and
developmental studies or in the rabbit dermal or rat inhalation
studies. The dog was less sensitive than rodents to the effects of
imidacloprid. The rabbit appeared to be very sensitive as there was
increased mortality in the oral developmental study at the highest dose
tested. Increased incidence of mineralized particles in the thyroid
colloid was noted in the rat combined chronic toxicity/carcinogenicity
study. Body weight decrements were noted in the rat and/or mouse
chronic and carcinogenicity studies, the rat subchronic neurotoxicity
study, and the developmental, developmental neurotoxicity and
reproduction studies. No effects were observed in the rabbit dermal or
rat inhalation studies. There was no evidence of carcinogenic potential
in either the rat chronic toxicity/carcinogenicity or mouse
carcinogenicity studies, and there is no concern for mutagenicity.
There was no evidence of increased qualitative or quantitative
susceptibility of rats or rabbits to in utero exposure to imidacloprid
and no evidence of qualitative or quantitative increased susceptibility
of rat offspring in the reproduction study. There was evidence of an
increased qualitative susceptibility in the rat developmental
neurotoxicity study. At the highest dose tested, maternal effects
consisted largely of slight decreases in food consumption and body-
weight gain during early lactation, while pup effects included
decreased body weight, decreased motor activity, and decreased caudate/
putamen width in females.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the
[[Page 22247]]
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded. This latter value is referred to as the Level of
Concern (LOC).
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for imidacloprid used for
human risk assessment can be found at http://www.regulations.gov in
document ``Imidacloprid: Human-Health Risk Assessment,'' pages 16 - 17
in docket ID number EPA-HQ-OPP-2008-0772.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to imidacloprid, EPA considered exposure under the petitioned-
for tolerances as well as all existing imidacloprid tolerances in (40
CFR 180.472). EPA assessed dietary exposures from imidacloprid in food
as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
In estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture (USDA)
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels in food, EPA conducted an
unrefined, acute dietary exposure assessment using tolerance-level
residues and assuming 100% crop treated (CT) for all registered and
proposed commodities for the general U.S. population and various
population subgroups.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA conducted a partially
refined, chronic dietary exposure assessment using tolerance-level
residues for all registered and proposed commodities and percent crop
treated (PCT) for some registered commodities.
iii. Cancer. A cancer exposure assessment was not performed because
imidacloprid is not carcinogenic. On November 11, 1993, the Agency
classified imidacloprid as a Group E chemical, ``Evidence of non-
carcinogenicity for humans,'' by all routes of exposure based upon lack
of evidence of carcinogenicity in rats and mice.
iv. Percent crop treated (PCT) information. Section 408(b)(2)(F) of
FFDCA states that the Agency may use data on the actual percent of food
treated for assessing chronic dietary risk only if:
Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency used PCT information as follows:
------------------------------------------------------------------------
Average percent Crop
Commodity Treated Data
------------------------------------------------------------------------
Almonds........................................ <1
Apples......................................... 25
Artichokes..................................... 5
Avocados....................................... <1
Blueberries.................................... 10
Broccoli....................................... 50
Cabbage........................................ 20
Cantaloupe..................................... 40
Cauliflower.................................... 50
Celery......................................... 10
Cherries....................................... 10
Cotton......................................... 10
Cucumbers...................................... 5
Eggplant....................................... 35
Field corn..................................... <2.5
Filberts (hazelnuts)........................... <1
Grapefruit..................................... 10
Grapes......................................... 30
Honeydew....................................... 30
Lemons......................................... 5
Lettuce........................................ 65
Oranges........................................ 10
Peaches........................................ 5
Pears.......................................... 5
Pecans......................................... 10
Peppers........................................ 30
Potatoes....................................... 35
Prunes......................................... <1
Pumpkin........................................ 10
Soybeans....................................... <1
Spinach........................................ 20
Squash......................................... 10
Strawberries................................... 10
Sugar beets.................................... <1
Sweet corn..................................... <1
Tangerines..................................... 5
Tobacco........................................ 20
Tomatoes....................................... 15
Walnuts........................................ <1
Watermelon..................................... 15
------------------------------------------------------------------------
In most cases, EPA uses available data from the United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6 years.
EPA uses an average PCT for chronic dietary risk analysis. The average
PCT figure for each existing use is derived by combining available
public and private market survey data for that use, averaging across
all observations, and rounding to the nearest 5%, except for those
situations in which the average PCT is less than one. In those cases,
1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA
uses a maximum PCT for acute dietary risk analysis. The maximum PCT
figure is the highest observed maximum value reported within the recent
6 years of available public and private market survey data for the
existing use and rounded up to the nearest multiple of 5%.
The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which imidacloprid may be applied in a particular area.
[[Page 22248]]
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for imidacloprid in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of imidacloprid. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of imidacloprid for
acute exposures are estimated to be 36.0 parts per billion (ppb) for
surface water and 2.09 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 36.0 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 17.2 ppb was used to
assess the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Imidacloprid is currently registered for the following uses that
could result in residential exposures: Indoor and outdoor ornamental
plantings, ornamental lawns and turf, pre- and post-construction
termiticide applications, spot-on treatments for dogs and cats, and
crack and crevice treatments. Additionally, it is registered for use on
mattresses for bed bug control. EPA assessed residential exposure using
the assumption that residential pesticide handlers (i.e., persons who
might mix, load and, or apply a pesticide material) could be exposed to
several formulations that contain imidacloprid. The Agency also
assessed post-application exposure for adults and children contacting
surfaces, foliage, or pets that were treated with imidacloprid.
Residential exposures are expected to be short-term (i.e., 1 to 30
days) or intermediate-term (1 to 6 months) based upon the pest spectra,
sites of application, methods of application, formulations and the
retreatment intervals. Since the indoor crack and crevice and mattress
scenarios resulted in the highest potential exposures, these
assessments are protective of all residential exposures from
imidacloprid.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found imidacloprid to share a common mechanism of
toxicity with any other substances, and imidacloprid does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
imidacloprid does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA SF. In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
2. Prenatal and postnatal sensitivity. There was no quantitative or
qualitative evidence of increased susceptibility of rat and rabbit
fetuses to in utero exposure in developmental studies. There was no
quantitative or qualitative evidence of increased susceptibility of rat
offspring in the multi-generation reproduction study. There was
evidence of increased qualitative susceptibility in the rat
developmental neurotoxicity study; however, the concern is low for the
following reasons:
i. The effects in pups are well-characterized with a clear NOAEL;
ii. The pup effects occur in the presence of maternal toxicity with
the same NOAEL for effects in both pups and dams; and
iii. The doses and endpoints selected for regulatory purposes are
protective of the pup effects noted at higher doses in the
developmental neurotoxicity study. Therefore, there are no residual
uncertainties for prenatal/postnatal toxicity in this study.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X for all exposure scenarios, except acute
dietary (all populations). That decision is based on the following
findings:
i. The toxicological database for imidacloprid is complete, with
the exception of an immunotoxicity study.
ii. The toxicology database for imidacloprid does not show any
evidence of treatment-related effects on the immune system. The overall
weight of evidence suggests that this chemical does not directly target
the immune system. An immunotoxicity study is required as a part of new
data requirements in 40 CFR part 158 for conventional pesticide
registration; however, the Agency does not believe that conducting a
functional immunotoxicity study will result in a lower POD than that
currently used for overall risk assessment. Therefore, a database
uncertainty factor (UFDB) is not needed to account for lack
of this study.
iii. There is no evidence that imidacloprid results in increased
susceptibility in utero to rats or rabbits in the prenatal
developmental studies or in offspring in the 2-generation reproduction
study.
iv. A developmental neurotoxicity study was performed with
imidacloprid and well-defined NOAELs were achieved in the study.
v. There was evidence of increased qualitative susceptibility in
the rat developmental neurotoxicity study; however, the concern is low
for reasons stated above.
vi. There are no residual uncertainties for prenatal/postnatal
toxicity.
vii. The acute dietary food exposure assessment utilizes existing
and proposed tolerance-level residues and 100% CT information for all
commodities. By using these screening-level assessments, actual
exposures/risks will not be underestimated.
viii. The chronic food exposure assessment utilizes and proposed
tolerance-level residues and %CT data for several existing uses. For
all proposed uses, 100% CT is assumed. The chronic assessment is
somewhat refined and based on reliable data and will not underestimate
exposure/risk.
ix. The dietary drinking water assessment utilizes water
concentration
[[Page 22249]]
values generated by model and associated modeling parameters which are
designed to provide conservative, health-protective, high-end
estimatesof water concentrations which will not likely be exceeded.
x. The residential handler assessment is based upon the residential
standard operating procedures (SOPs) in conjunction with chemical-
specific study data in some cases and Pesticide Handler Exposure
Database (PHED) unit exposures in other cases. The majority of the
residential post-application assessment is based upon chemical-specific
Turf Transfer Residue (TTR) data or other chemical-specific post-
application exposure study data. The chemical-specific study data as
well as the surrogate study data used are reliable and also are not
expected to underestimate risk to adults as well as to children. In a
few cases where chemical-specific data were not available, the SOPs
were used alone. The residential SOPs are based upon reasonable
``worst-case'' assumptions and are not expected to underestimate risk.
These assessments of exposure are not likely to underestimate the
resulting estimates of risk from exposure to imidacloprid.
A 3X FQPA SF was retained in the form of a UFL (uncertainty factor
due to extrapolation from a LOAEL in the absence of a NOAEL) for the
acute dietary (all populations) exposure scenario only, since a NOAEL
was not observed in the relevant study for that exposure scenario
(acute neurotoxicity study in rats). A 3X uncertainty factor was judged
to be adequate (as opposed to a 10X) for the following reasons:
1. The LOAEL (42 mg/kg) is comparable to the LOAELs seen in adults
in the developmental rat study (30 mg/kg/day) and the 2-generation
reproduction study [47/52 milligrams/kilograms/day (mg/kg/day) (male/
female)] and in the offspring in the DNT study (55 mg/kg/day);
2. The extrapolated NOAEL of 14 mg/kg (42/3 = 14) is comparable to
the NOAEL of 20 mg/kg/day established in the offspring in the DNT; and,
3. The neurotoxic effects in this study showed a good dose response
which resulted in minimal effects on motor activity and locomotor
activity at the LOAEL.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No adverse effect resulting from a single-oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
imidacloprid is not expected to pose an acute risk. Using the exposure
assumptions discussed in this unit for acute exposure, the acute
dietary exposure from food and water to imidacloprid will occupy 70% of
the aPAD for (children 1 to 2 years old) the population group receiving
the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
imidacloprid from food and water will utilize 32% of the cPAD for
(children 1 to 2 years old) the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
imidacloprid is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Imidacloprid is currently registered for crack and crevice uses and
bed bug uses that could result in short-term residential exposure and
the Agency has determined that it is appropriate to aggregate chronic
exposure through food and water with short-term residential exposures
to imidacloprid. Using the exposure assumptions described in Unit
III.C.3. for short-term exposures, EPA has concluded the combined
short-term food, water, and residential exposures aggregated result in
aggregate MOEs of 430 for adults and 170 for children. Toddlers'
residential short-term aggregate exposure includes dermal and
inhalation exposure from the crack and crevice uses, dermal exposure
from the bed-bug uses, and incidental oral exposure from hand-to-mouth
contact with treated surfaces. Adult short-term aggregate exposure
includes dermal and inhalation exposure from indoor crack and crevice
uses, and dermal exposure from the bed-bug uses. These exposures were
higher than those calculated for all other residential uses of
imidacloprid. Therefore, the crack and crevice and bed bug treatment
exposure estimates were aggregated with the chronic dietary to provide
a worst-case estimate of short-term aggregate risk for the U.S.
population and children 1 to 2 years old. The combined short-term
residential MOEs for these scenarios were 580 for adults and 240 for
children.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
Imidacloprid is currently registered for crack and crevice uses and
bed bug uses that could result in intermediate-term residential
exposure and the Agency has determined that it is appropriate to
aggregate chronic exposure through food and water with intermediate-
term residential exposures to imidacloprid.
Using the exposure assumptions described in Unit III.C.3. for
short-term exposures, EPA has concluded the combined short-term food,
water, and residential exposures aggregated result in aggregate MOEs of
400 for adults and 150 for children. Toddlers' residential
intermediate-term aggregate exposure includes dermal and inhalation
exposure from the crack and crevice uses, dermal exposure from the bed-
bug uses, and incidental oral exposure from hand-to-mouth contact with
treated surfaces. Adult intermediate-term aggregate exposure includes
dermal and inhalation exposure from indoor crack and crevice uses, and
dermal exposure from the bed-bug uses. These exposures were higher than
those calculated for all other residential uses of imidacloprid.
Therefore, the crack and crevice and bed bug treatment exposure
estimates were aggregated with the chronic dietary exposure to provide
a worst-case estimate of intermediate-term aggregate risk for the U.S.
population and children 1 to 2 years old. The combined intermediate-
term residential MOEs for these scenarios were 540 for adults and 260
for children.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in mice and rats at doses that were judged
to be adequate to assess the carcinogenic potential, imidacloprid was
classified as ``not likely to be carcinogenic to humans,'' and is not
expected to pose a cancer risk to humans. Therefore, a
[[Page 22250]]
quantitative cancer risk assessment is not needed.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to imidacloprid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodologies, Bayer Gas Chromatography/Mass
Spectrometry (GC/MS) Method 00200 and Bayer GC/MS Method 00191, is
available to enforce the tolerance expression. The methods may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; e-mail address: [email protected].
B. International Residue Limits
There are no established Mexican maximum residue limits (MRLs) for
the proposed new uses. There are established Codex MRLs for the sum of
imidacloprid and its metabolites containing the 6-chloropyridinyl
moiety expressed as imidacloprid, in or on cereal grain at 0.05 ppm,
leeks at 0.05 ppm, and bulb onions at 0.1 ppm. There are also
established Canadian MRLs for 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-
1H-imidazol-2-amine, including metabolites containing the 6-
chloropicolyl moiety in or on sweet corn at 0.05 ppm and field corn at
0.05 ppm. With the exception of onions, there is no harmonization issue
for these petitions. The Codex MRLs for leeks (0.05 ppm) and bulb
onions (0.1 ppm) can not be harmonized as the U.S. use pattern
necessitates higher tolerances (0.15 ppm for onion, dry bulb, subgroup
3-07A; and 2.5 ppm for onion, green, subgroup 3-07B).
C. Response to Comments
There were no comments submitted in response to the Notice of
Filing published in the Federal Register on December 3, 2008.
D. Revisions to Petitioned-For Tolerances
Due to residues on dry bulb onions and green onions varying by
greater than 5X, the establishment of a crop group tolerance for crop
group 3 was not appropriate. The Agency determined that the available
toxicology, occupational/residential, and residue chemistry databases
support the establishment of permanent tolerances of imidacloprid in or
on onion, green, subgroup 3-07B at 2.5 ppm and onion, dry bulb,
subgroup 3-07A at 0.15 ppm.
No new field trial data were submitted in support of the proposed
tolerance for cereal grains, however there are existing tolerances of
combined residues of imidacloprid in or on barley, grain; corn, field,
grain; corn, pop, grain; corn, sweet, kernel plus cob with husks
removed; millet, pearl, grain; millet, proso, grain; oats, grain,
grain; rye, grain; sorghum, grain; and wheat, grain at 0.05 ppm. There
are no existing field trial data on rice, another member of the cereal
grains crop group. In the absence of rice data, the available
toxicology, occupational/residential, and residue chemistry databases
support the establishment of permanent tolerances of imidacloprid in or
on grain, cereal, except rice, group 15 at 0.05 ppm. In connection with
the imidacloprid petition for cereal grain group tolerance, EPA has
reviewed the available cereal grain data on forage, fodder, and straw
of cereal grains. Individual imidacloprid tolerances now exist for many
forage, fodder, and straw cereal grain commodities. EPA has determined
that sufficient data are available to establish the following group
tolerances associated with the cereal grain group tolerance: Grain,
cereal, forage, fodder and straw, group 16, forage at 7.0 ppm; grain,
cereal, forage, fodder and straw, group 16, hay at 6.0 ppm; grain,
cereal, forage, fodder and straw, group 16, stover at 0.3 ppm and
grain, cereal, forage, fodder and straw, group 16, straw at 3.0 ppm.
The Crop Group 16 tolerances are being limited like the Crop Group 15
tolerance to exclude rice.
The following established tolerances are being deleted because they
are superseded by inclusion in groups 15 and 16: Barley, grain at 0.05
ppm; barley, hay at 0.5 ppm; barley, straw at 0.5 ppm; corn, field,
forage at 0.10 ppm; corn, field, grain at 0.05 ppm; corn, field, stover
at 0.20 ppm; corn, pop, grain at 0.05 ppm; corn, pop, stover at 0.20
ppm; corn, sweet, forage at 0.10 ppm; corn, sweet, kernel plus cob with
husks removed at 0.05 ppm; corn, sweet, stover at 0.20 ppm; millet,
pearl, forage at 2.0 ppm; millet, pearl, grain at 0.05 ppm; millet,
pearl, hay at 6.0 ppm; millet, pearl, straw at 3,0 ppm; millet, proso,
forage at 2.0 ppm; millet, proso, grain at 0.05 ppm; millet, proso, hay
at 6.0 ppm; millet, proso, straw at 3.0 ppm; oat, forage at 2.0 ppm;
oat, grain at 0.05 ppm; oat, hay at 6.0 ppm; oat, straw at 3.0 ppm;
rye, forage at 2.0 ppm; rye, grain at 0.05 ppm; rye, hay at 6.0 ppm;
rye, straw at 3.0 ppm; sorghum, forage at 0.10 ppm; sorghum, grain,
grain at 0.05 ppm; sorghum, grain, stover at 0.10 ppm; wheat, forage at
7.0 ppm; wheat, grain at 0.05 ppm; wheat, hay at 0.5 ppm and wheat,
straw at 0.5 ppm.
Additionally, the following tolerances from indirect or inadvertent
residues are also being deleted: Corn, sweet, kernel plus cob with
husks removed at 0.05 ppm; grain, cereal, forage, fodder and straw,
group 16, forage at 2.0 ppm; grain, cereal, forage, fodder and straw,
group 16, hay at 6.0 ppm; grain, cereal, forage, fodder and straw,
group 16, stover at 0.3 ppm; grain, cereal, forage, fodder and straw,
group 16, straw at 3.0 ppm and grain, cereal, group 15 at 0.05 ppm. The
following tolerance from indirect or inadvertent residues is being
added: Rice, grain at 0.05 ppm.
V. Conclusion
Therefore, tolerances are established for combined residues of
imidacloprid, 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine, in or on onion, dry bulb, subgroup 3-07A at 0.15
ppm; onion, green, subgroup 3-07B at 2.5 ppm; grain, cereal, except
rice, group 15 at 0.05 ppm; grain, cereal, forage, fodder and straw,
except rice, group 16, forage at 7.0 ppm; grain, cereal, forage, fodder
and straw, except rice, group 16, hay at 6.0 ppm; grain, cereal,
forage, fodder and straw, except rice, group 16, stover at 0.3 ppm and
grain, cereal, forage, fodder and straw, except rice, group 16, straw
at 3.0 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
[[Page 22251]]
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 15, 2010.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.472 is revised to read as follows:
Sec. 180.472 Imidacloprid; tolerances for residues.
(a) General. Tolerances are established for residues of the
insecticide imidacloprid, including its metabolites and degradates, in
or on the commodities in the table below. Compliance with the tolerance
levels specified below is to be determined by measuring only the sum of
imidacloprid (1-[6-chloro-3-pyridinyl) methyl]-N-nitro-2-
imidazolidinimine) and its metabolites containing the 6-chloropyridinyl
moiety, calculated as the stoichiometric equivalent of imidacloprid, in
or on the following commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Acerola.............................................. 1.0
Almond, hulls........................................ 4.0
Apple................................................ 0.5
Apple, wet pomace.................................... 3.0
Artichoke, globe..................................... 2.5
Aspirated grain fractions............................ 240
Atemoya.............................................. 0.30
Avocado.............................................. 1.0
Banana............................................... 0.50
Beet, sugar, molasses................................ 0.30
Beet, sugar, roots................................... 0.05
Beet, sugar, tops.................................... 0.50
Biriba............................................... 0.30
Blueberry............................................ 3.5
Borage, seed......................................... 0.05
Caneberry, subgroup 13-A............................. 2.5
Canistel............................................. 1.0
Canola, seed......................................... 0.05
Cattle, fat.......................................... 0.30
Cattle, meat......................................... 0.30
Cattle, meat byproducts.............................. 0.30
Cherimoya............................................ 0.30
Citrus, dried pulp................................... 5.0
Coffee, bean, green.................................. 0.80
Cotton, gin byproducts............................... 4.0
Cotton, meal......................................... 8.0
Cotton, undelinted seed.............................. 6.0
Crambe, seed......................................... 0.05
Cranberry............................................ 0.05
Currant.............................................. 3.5
Custard apple........................................ 0.30
Egg.................................................. 0.02
Elderberry........................................... 3.5
Feijoa............................................... 1.0
Flax, seed........................................... 0.05
Fruit, citrus, group 10.............................. 0.70
Fruit, pome, group 11................................ 0.6
Fruit, stone, group 12............................... 3.0
Goat, fat............................................ 0.30
Goat, meat........................................... 0.30
Goat, meat byproducts................................ 0.30
Gooseberry........................................... 3.5
Grain, cereal, forage, fodder and straw, group 16, 7.0
forage, except rice.................................
Grain, cereal, forage, fodder and straw, group 16, 6.0
hay, except rice....................................
Grain, cereal, forage, fodder and straw, group 16, 0.30
stover, except rice.................................
Grain, cereal, forage, fodder and straw, group 16, 3.0
straw, except rice..................................
Grain, cereal, group 15, except rice................. 0.05
Grape................................................ 1.0
Grape, juice......................................... 1.5
Grape, raisin........................................ 1.5
Guava................................................ 1.0
Herbs subgroup 19A, dried herbs...................... 48
Herbs subgroup 19-A, fresh herbs..................... 8.0
Hog, fat............................................. 0.30
Hog, meat............................................ 0.30
Hog, meat byproducts................................. 0.30
Hop, dried cones..................................... 6.0
Horse, fat........................................... 0.30
Horse, meat.......................................... 0.30
Horse, meat byproducts............................... 0.30
Huckleberry.......................................... 3.5
Ilama................................................ 0.30
Jaboticaba........................................... 1.0
Juneberry............................................ 3.5
Kava, leaves......................................... 4.0
Kava, roots.......................................... 0.40
Leaf petioles subgroup 4B............................ 6.0
Leafy greens subgroup 4A............................. 3.5
Lettuce, head........................................ 3.5
Lettuce, leaf........................................ 3.5
Lingonberry.......................................... 3.5
Longan............................................... 3.0
Lychee............................................... 3.0
Mango................................................ 1.0
Milk................................................. 0.10
Mustard, black, seed................................. 0.05
Mustard, field, seed................................. 0.05
Mustard, Indian, seed................................ 0.05
Mustard, rapeseed, seed.............................. 0.05
Mustard, seed........................................ 0.05
Nut, tree, group 14.................................. 0.05
Okra................................................. 1.0
Onion, dry bulbs, subgroup 3-07A..................... 0.15
Onion, green, subgroup 3-07B......................... 2.5
Papaya............................................... 1.0
Passionfruit......................................... 1.0
Peanut............................................... 0.45
Peanut, hay.......................................... 35
[[Page 22252]]
Peanut, meal......................................... 0.75
Pecan................................................ 0.05
Persimmon............................................ 3.0
Pistachio............................................ 0.05
Pomegranate.......................................... 0.90
Potato, chip......................................... 0.40
Potato, processed potato waste....................... 0.90
Poultry, fat......................................... 0.05
Poultry, meat........................................ 0.05
Poultry, meat byproducts............................. 0.05
Pulasan.............................................. 3.0
Rambutan............................................. 3.0
Rapeseed, seed....................................... 0.05
Raspberry, wild...................................... 2.5
Safflower, seed...................................... 0.05
Salal................................................ 3.5
Sapodilla............................................ 1.0
Sapote, black........................................ 1.0
Sapote, mamey........................................ 1.0
Sheep, fat........................................... 0.30
Sheep, meat.......................................... 0.30
Sheep, meat byproducts............................... 0.30
Soursop.............................................. 0.30
Soybean, forage...................................... 8.0
Soybean, hay......................................... 35
Soybean, meal........................................ 4.0
Soybean, seed........................................ 3.5
Spanish lime......................................... 3.0
Star apple........................................... 1.0
Starfruit............................................ 1.0
Strawberry........................................... 0.50
Sugar apple.......................................... 0.30
Sunflower, seed...................................... 0.05
Tomato, paste........................................ 6.0
Tomato, puree........................................ 3.0
Vegetable, brassica leafy, group 5................... 3.5
Vegetable, cucurbit, group 9......................... 0.5
Vegetable, fruiting, group 8......................... 1.0
Vegetable, leaves of root and tuber, group 2......... 4.0
Vegetable, legume, group 6, except soybean........... 4.0
Vegetable, root and tuber, group 1, except sugar beet 0.40
Watercress........................................... 3.5
Watercress, upland................................... 3.5
Wax jambu............................................ 1.0
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. Tolerances are established
for indirect or inadvertent residues of the insecticide imidacloprid,
including its metabolites and degradates, in or on the commodities in
the table below. Compliance with the tolerance levels specified below
is to be determined by measuring only the sum of imidacloprid (1-[6-
chloro-3-pyridinyl) methyl]-N-nitro-2-imidazolidinimine) and its
metabolites containing the 6-chloropyridinyl moiety, calculated as the
stoichiometric equivalent of imidacloprid, in or on the following
commodities, when present therein as a result of the application of the
pesticide to growing crops listed in this section and other non-food
crops as follows:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Rice, grain.......................................... 0.05
Vegetable, foliage of legume, group 7................ 2.5
Vegetable, legume, group 6........................... 0.3
------------------------------------------------------------------------
[FR Doc. 2010-9761 Filed 4-27-10; 8:45 am]
BILLING CODE 6560-50-S