[Federal Register: October 29, 2003 (Volume 68, Number 209)]
[Rules and Regulations]
[Page 61624-61634]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29oc03-9]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0327; FRL-7330-4]
Imidacloprid; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for the
combined residues of imidacloprid, (1-[6-chloro-3-pyridinyl) methyl]-N-
nitro-2-imidazolidinimine) and its metabolites containing the 6-
chloropyridinyl moiety, all expressed as parent in or on soybean seed.
This action is in response to EPA's granting of an emergency exemption
under section 18 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) authorizing use of the pesticide as a seed treatment on
soybean seed. This regulation establishes a maximum permissible level
for residues of imidacloprid in this food commodity. The tolerance will
expire and is revoked on December 31, 2006.
DATES: This regulation is effective October 29, 2003. Objections and
requests for hearings, identified by docket (ID) number OPP-2003-0327,
must be received on or before December 29, 2003.
ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-9367; e-mail address: Sec-18-Mailbox@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are a Federal
or State government agency involved in administration of environmental
quality programs (e.g., Departments of Agriculture, Environment).
Potentially affected entities may include, but are not limited to:
[sbull] Federal or State Government Entity (NAICS 9241).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action
[[Page 61625]]
under docket (ID) number OPP-2003-0327. The official public docket
consists of the documents specifically referenced in this action, any
public comments received, and other information related to this action.
Although a part of the official docket, the public docket does not
include Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. The official public docket
is the collection of materials that is available for public viewing at
the Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA. This
docket facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The docket telephone number is (703)
305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/ A frequently updated electronic version of 40 CFR part 180 is available at http://.
http://www.access.gpo.gov/nara/cfr/cfrhtml_00/ Title--40/40cfr180--00.html, a
beta site currently under development.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with sections 408(e) and
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing a tolerance for the combined residues of
imidacloprid, (1-[6-chloro-3-pyridinyl) methyl]-N-nitro-2-
imidazolidinimine) and its metabolites containing the 6-chloropyridinyl
moiety, all expressed as parent in or on soybean seed at 1.0 parts per
million (ppm). This tolerance will expire and is revoked on December
31, 2006. EPA will publish a document in the Federal Register to remove
the revoked tolerance from the Code of Federal Regulations.
Section 408(l)(6) of the 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 section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 of the FFDCA and the new safety standard to
other tolerances and exemptions. Section 408(e) of the 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 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Section 18 of the 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.'' This
provision was not amended by the Food Quality Protection Act of 1996
(FQPA). EPA has established regulations governing such emergency
exemptions in 40 CFR part 166.
III. Emergency Exemption for Imidacloprid on Soybean Seed and FFDCA
Tolerances
The States of Iowa and Wisconsin requested the use of imidacloprid
as a seed treatement on soybean seed to control the bean leaf beetle, a
vector of bean pod mottle virus. Due to abnormal weather pattens, the
incidence of bean pod mottle virus was expected to be highter than
normal in 2003. EPA has authorized under FIFRA section 18 the use of
imidacloprid on soybean seed for control of bean leaf beetle in Iowa
and Wisconsin. After having reviewed the submissions, EPA concurs that
emergency conditions exist for these States.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of imidacloprid in or on
soybean seed. In doing so, EPA considered the safety standard in
section 408(b)(2) of the FFDCA, and EPA decided that the necessary
tolerance under section 408(l)(6) of the FFDCA would be consistent with
the safety standard and with FIFRA section 18. Consistent with the need
to move quickly on the emergency exemption in order to address an
urgent non-routine situation and to ensure that the resulting food is
safe and lawful, EPA is issuing this tolerance without notice and
opportunity for public comment as provided in section 408(l)(6) of the
FFDCA. Although this tolerance will expire and is revoked on December
31, 2006, under section 408(l)(5) of the FFDCA, residues of the
pesticide not in excess of the amounts specified in the tolerance
remaining in or on soybean seed 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
this tolerance at the time of that application. EPA will take action to
revoke this tolerance earlier if any experience with, scientific data
on, or other relevant information on this pesticide indicate that the
residues are not safe.
Because this tolerance is being approved under emergency
conditions, EPA has not made any decisions about whether imidacloprid
meets EPA's registration requirements for use on soybean seed or
whether a permanent tolerance for this use would be appropriate. Under
these circumstances, EPA does not believe that this tolerance serves as
a basis for registration of imidacloprid by a State for special local
needs under FIFRA section 24(c). Nor does this tolerance serve as the
basis for any State other than Iowa and Wisconsin 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.
[[Page 61626]]
IV. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances November 26, 1997 (62 FR 62961) (FRL-
5754-7).
Consistent with section 408(b)(2)(D) of the 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
imidacloprid and to make a determination on aggregate exposure,
consistent with section 408(b)(2) of the FFDCA, for a time-limited
tolerance for combined residues of imidacloprid in or on soybean seed
at 1.0 ppm. EPA's assessment of the dietary exposures and risks
associated with establishing the tolerance follows.
A. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological endpoint. However, the
lowest dose at which adverse effects of concern are identified (the
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved
in the toxicology study selected. An uncertainty factor (UF) is applied
to reflect uncertainties inherent in the extrapolation from laboratory
animal data to humans and in the variations in sensitivity among
members of the human population as well as other unknowns. An UF of 100
is routinely used, 10X to account for interspecies differences and 10X
for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (aRfD or cRfD) where
the RfD is equal to the NOAEL divided by the appropriate UF (RfD =
NOAEL/UF). Where an additional safety factor is retained due to
concerns unique to the FQPA, this additional factor is applied to the
RfD by dividing the RfD by such additional factor. The acute or chronic
Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to
accommodate this type of FQPA SF.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (LOC). For example, when 100 is the
appropriate UF (10X to account for interspecies differences and 10X for
intraspecies differences) the LOC is 100. To estimate risk, a ratio of
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is
calculated and compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-\6\ or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for imidacloprid used for human risk assessment is shown in
the following Table 1:
Table 1.--Summary of Toxicological Dose and Endpoints for Imidacloprid for Use in Human Risk Assessment
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FQPA SF* and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (all populations NOAEL = not determined FQPA SF = 1 Acute neurotoxicity -
including infants and children) LOAEL = 42 milligrams/ aPAD = acute RfD....... rats
kilogram/day (mg/kg/ FQPA SF = 0.14 mg/kg/ LOAEL = 42 mg/kg/day
day). day. based on decreased
UF = 300............... motor activity in
Acute RfD = 0.14 mg/kg/ female rats
day.
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Chronic dietary (all populations) NOAEL = 5.7 mg/kg/day FQPA SF = 1 Combined chronic toxic/
UF = 100............... cPAD = chronic RfD..... carcinogenicity - rat
Chronic RfD = 0.057 mg/ FQPA SF = 0.057 mg/kg/ LOAEL = 16.9 mg/kg/day,
kg/day. day. based upon increased
incidence of
mineralized particles
in thyroid colloid in
males
----------------------------------------------------------------------------------------------------------------
Short-term oral (1-30 days) Oral study LOC for MOE = 100 Developmental toxicity
NOAEL = 10 mg/kg/day... (residential, includes rat
the FQPA SF) Maternal LOAEL = 30 mg/
kg/day, based upon
decreased body weight
gain and corrected
body weight gain
----------------------------------------------------------------------------------------------------------------
Intermediate-term oral (1-6 months) Oral study LOC for MOE = 100 Subchronic
NOAEL = 9.3 mg/kg/day.. (residential, includes neurotoxicity - rat
the FQPA SF) LOAEL = 63.3 mg/kg/day,
based upon decreased
body weight gain
----------------------------------------------------------------------------------------------------------------
Short-term dermal (1-30 days) Oral study LOC for MOE = 100 Developmental toxicity
NOAEL = 10 mg/kg/day (occupational) rat
(dermal absorption LOC for MOE = 100 Maternal LOAEL = 30 mg/
rate = (7.2%). (residential, includes kg/day, based upon
the FQPA SF). decreased body weight
gain and corrected
body weight gain
----------------------------------------------------------------------------------------------------------------
[[Page 61627]]
Intermediate-term dermal (1-6 months) Oral study LOC for MOE = 100 Subchronic
NOAEL = 9.3 mg/kg/day (occupational) neurotoxicity - rat
(dermal absorption LOC for MOE = 100 LOAEL = 63.3 mg/kg/day,
rate = 7.2%). (residential, includes based upon decreased
the FQPA SF). body weight gain
----------------------------------------------------------------------------------------------------------------
Long-term dermal (6 months) Oral study LOC for MOE = 100 Combined chronic toxic/
NOAEL = 5.7 mg/kg/day (occupational) carcinogenicity - rat
(dermal absorption LOC for MOE = 100 LOAEL = 16.9 mg/kg/day,
rate = 7.2%). (residential, includes based upon increased
the FQPA SF). incidence of
mineralized particles
in thyroid colloid in
males
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1-30 days) Oral study LOC for MOE = 100 Developmental toxicity
NOAEL = 10 mg/kg/day (occupational) rat
(inhalation absorption LOC for MOE = 100 Maternal LOAEL = 30 mg/
rate = 100%). (residential, includes kg/day, based upon
the FQPA SF). decreased body weight
gain and corrected
body weight gain
----------------------------------------------------------------------------------------------------------------
Intermediate-term inhalation (1-6 Oral study LOC for MOE = 100 Subchronic
months) NOAEL = 9.3 mg/kg/day (occupational) neurotoxicity - rat
(inhalation absorption LOC for MOE = 100 LOAEL = 63.3 mg/kg/day,
rate = 100%). (residential, includes based upon decreased
the FQPA SF). body weight gain
----------------------------------------------------------------------------------------------------------------
Long-term inhalation (> 6 months) Oral study LOC for MOE = 100 Combined chronic toxic/
NOAEL = 5.7 mg/kg/day (occupational) carcinogenicity - rat
(inhalation absorption LOC for MOE = 100 LOAEL = 16.9 mg/kg/day,
rate = 100%). (residential, includes based upon increased
the FQPA SF). incidence of
mineralized particles
in thyroid colloid in
males
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) No evidence of Not applicable No evidence of
carcinogenicity for carcinogenicity in
humans rats and mice
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.
In its objections to a separate imidacloprid tolerance action, NRDC
claims that EPA erred by regulating on the basis of a LOAEL for acute
and chronic toxicity. As can be seen from the above table, NRDC is
mistaken with regard to use of a LOAEL for estimating the RfD for
chronic risk. The acute toxicity endpoint was based upon a LOAEL of 42
mg/kg/day from an acute neurotoxicity study in rats. This value was
adjusted with a safety factor of 3X to approximate the value of a
NOAEL. EPA has high confidence that this value of 3X is sufficient for
several reasons. The effect seen at the LOAEL in the acute
neurotoxicity study (decreased motor activity), occurred only in one
sex of the rat (females), was characterized as minimal, and may have
been a result of the use of the gavage dosing in the study. The
decreased motor activity was not replicated following repeated dietary
administration (non-gavage) at lower and higher doses (10, 70 or 200
mg/kg/day) in the subchronic neurotoxicity study in the same species
(rats). Further, using a safety factor of 3X produces a regulatory
endpoint lower than the acute effect levels in other standard studies
for determining an acute endpoint, developmental toxicity studies in
two species, and in another study that is on occasion used for such a
purpose, the developmental neurotoxicity study in rats. Also in these
objections, NRDC claims that EPA failed to calculate residential risks
for some scenarios, based on low toxicity (no endpoints were chosen).
On October 8, 2002, the Health Effects Division (HED), Hazard
Identification Assessment Review Committee (HIARC) reviewed the hazard
data base for imidacloprid and established additional endpoints.
Endpoints were chosen for each of the following exposure scenarios:
Acute dietary, chronic dietary, short-term oral, intermediate-term
oral, short-term dermal, intermediate-term dermal, long-term dermal,
short-term inhalation, intermediate-term inhalation, and long-term
inhalation. In the current risk assessment (Unit II.E. of this
document), EPA calculated short-term residential risks (oral, dermal,
and inhalation) for both adults and children for a wide-range of
representative scenarios, including applications to lawns, ornamental
plantings, indoor and outdoor potted plants, and dogs and cats. Based
on current residential use patterns for imidacloprid, EPA expects the
duration of exposure to be short-term (1-30 days), and would not result
in intermediate-term or long-term exposure. EPA also conducted human
health aggregate risk assessments for the following exposure scenarios:
Acute aggregate (food + drinking water), short-term aggregate exposure
(food + drinking water + residential), and chronic aggregate exposure
(food + drinking water).
B. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.472) for the combined residues of imidacloprid,
in or on a variety of raw agricultural commodities. Meat, milk,
poultry, and egg tolerances have also been established for the combined
residues of imidacloprid. In conducting dietary exposure assessments,
EPA used the Dietary Exposure Evaluation Model software with the Food
Commodity Intake Database (DEEM\TM\-FCID) which
[[Page 61628]]
incorporates food consumption data as reported by respondents in the
U.S. Department of Agriculture (USDA) 1994-1996 and 1998 nationwide
Continuing Surveys of Food Intake by Individuals (CSFII) and
accumulated exposure to the chemical for each commodity. The 1994-96
and 1998 data are based on the reported consumption of more than 20,000
individuals over two non-consecutive survey days. Consumption data are
averaged for the entire U.S. population and within population subgroups
for chronic exposure assessment, but are retained as individual
consumption events for acute exposure assessment. Risk assessments were
conducted by EPA to assess dietary exposures from imidacloprid in food
as follows:
i. Acute exposure. Acute dietary 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. DEEM\TM\ analysis evaluated the individual food
consumption as reported by respondents in the USDA 1994-1996/1998
nationwide CSFII and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the acute exposure
assessments: A Tier 1, deterministic acute dietary exposure assessment
was conducted using tolerance-level residues, 100 PCT information for
registered and proposed commodities; and modified DEEM\TM\ (vision
7.76) processing factors for some commodities based on guideline
processing studies. EPA estimated exposure based on the 95\th\
percentile value from this deterministic exposure assessment.
In its objections to a separate imidacloprid tolerance action, NRDC
asserts that EPA erred by relying on the exposure value for the 95\th\
percentile of the population in estimating exposure. NRDC claims that
this approach leaves 5% of the population unprotected. These comments
by NRDC represent a misunderstanding of EPA's exposure assessments.
Although EPA estimated exposure using the 95\th\ percentile, EPA most
definitely was not, however, acting in a manner designed to protect
only 95% of the population. To the contrary, EPA's exposure estimates
were designed to reasonably capture the full range of exposures in each
population subgroup. As explained in its science policy paper on this
subject, EPA, in estimating exposure for population subgroups,
generally considers various population percentiles of exposure between
95 and 99.99, depending on the extent of overestimation in the residue
data used in the assessment. In each exposure assessment EPA is
attempting to reasonably estimate the full range of exposures in a
subgroup. Accordingly, as EPA noted in its policy paper, just as when
EPA uses the 95\th\ percentile with non-probabilistic exposure
assessments EPA is not suggesting that EPA is leaving 5% of the
population unprotected, EPA is not by choosing the 99.9\th\ percentile
for probabilistic exposure assessments concluding that only 99.9% of
the population deserves protection. Rather, it is EPA's view that, with
probabilistic assessments, the use of the 99.9\th\ percentile generally
produces a reasonable high-end exposure such that if that exposure does
not exceed the safe level, EPA can conclude there is a reasonable
certainty of no harm to the general population and all significant
population groups. (Office of Pesticide Programs, EPA, Choosing a
Percentile of Acute Dietary Exposure as a Threshold of Regulatory
Concern 31 (March 22, 2000)). Importantly, EPA generally uses a
population percentile of 95 when EPA relies on worst-case residue
values - i.e., all crops covered by the tolerance contain residues at
the tolerance value. Even at the 95\th\ percentile of estimated
exposure, actual exposure, when based on this assumption tends to be
significantly overstated. For example, EPA has found that when it uses
realistic residue information (e.g., data from monitoring of the food
supply), that exposure estimates are generally substantially lower even
at the 99.99\th\ percentile.
As noted above, EPA did use the worst-case assumption that all food
covered by imidacloprid tolerances would bear residues at the tolerance
level. Hence, EPA believes its exposure estimate is unlikely to
understate exposure; rather, in all likelihood, the estimate probably
substantially overstates exposure.
ii. Chronic exposure. The following assumptions were made for the
chronic exposure assessments: The chronic dietary exposure assessment
was performed using published and proposed tolerance levels, DEEM\TM\
default processing factors, and percent crop treated (PCT) information
on some commodities.
iii. Cancer. A quantitative cancer aggregate risk assessment was
not performed because imidacloprid is not carcinogenic.
iv. Anticipated residue and PCT information. Section 408(b)(2)(F)
of the FFDCA states that the Agency may use data on the actual percent
of food treated for assessing chronic dietary risk only if the Agency
can make the following findings: Condition 1, that the data used are
reliable and provide a valid basis to show what percentage of the food
derived from such crop is likely to contain such pesticide residue;
Condition 2, that the exposure estimate does not underestimate exposure
for any significant subpopulation group; and Condition 3, if data are
available on pesticide use and food consumption in a particular area,
the exposure estimate does not understate exposure for the population
in such area. In addition, the Agency must provide for periodic
evaluation of any estimates used. To provide for the periodic
evaluation of the estimate of PCT as required by section 408(b)(2)(F)
of the FFDCA, EPA may require registrants to submit data on PCT.
The Agency used PCT information as follows: For the acute
assessment, 100 PCT was assumed for all registered and proposed
commodities. For the chronic assessment, average weighted PCT
information was used for the following commodities: Apple 34%; Brussels
sprouts 56%; broccoli 35%; cabbage 14%; cantaloupe 31%; cauliflower
52%; collards 10%; corn, field 1%; cotton 3%; cucumber 2%; eggplant
36%; grapefruit 3%; grape 32%; mustard greens 16%; honeydew 26%; kale
30%; lemon 1%; lettuce, head 49%; lime 5%; orange 1%; pear 16%; pepper
62%; pumpkin 7%; spinach 15%; squash 7%; sugarbeet 1%; tangerine 9%;
tomato 9%; watermelon 6%; wheat 1%. A default value of 1% was used for
all commodities which were reported as having >1% CT.
The Agency believes that the three conditions listed above have
been met. With respect to Condition 1, PCT estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. EPA uses a weighted average PCT for chronic dietary
exposure estimates. This weighted average PCT figure is derived by
averaging State-level data for a period of up to 10 years, and
weighting for the more robust and recent data. A weighted average of
the PCT reasonably represents a person's dietary exposure over a
lifetime, and is unlikely to underestimate exposure to an individual
because of the fact that pesticide use patterns (both regionally and
nationally) tend to change continuously over time, such that an
individual is unlikely to be exposed to more than the average PCT over
a lifetime. For acute dietary exposure estimates, EPA uses an estimated
maximum PCT. The exposure estimates resulting from this approach
reasonably represent the highest levels to which an individual could be
exposed, and are unlikely to
[[Page 61629]]
underestimate an individual's acute dietary exposure. The Agency is
reasonably certain that the percentage of the food treated is not
likely to be an underestimation. As to Conditions 2 and 3, regional
consumption information and consumption information for significant
subpopulations is taken into account through EPA's computer-based model
for evaluating the exposure of significant subpopulations including
several regional groups. Use of this consumption information in EPA's
risk assessment process ensures that EPA's exposure estimate does not
understate exposure for any significant subpopulation group and allows
the Agency to be reasonably certain that no regional population is
exposed to residue levels higher than those estimated by the Agency.
Other than the data available through national food consumption
surveys, EPA does not have available information on the regional
consumption of food to which imidacloprid may be applied in a
particular area.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for imidacloprid in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of imidacloprid.
The Agency uses the First Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS)
to produce estimates of pesticide concentrations in an index reservoir.
The SCI-GROW model is used to predict pesticide concentrations in
shallow ground water. For a screening-level assessment for surface
water EPA will generally use FIRST (a Tier 1 model) before using PRZM/
EXAMS (a Tier 2 model). The FIRST model is a subset of the PRZM/EXAMS
model that uses a specific high-end runoff scenario for pesticides.
While both FIRST and PRZM/EXAMS incorporate an index reservoir
environment, the PRZM/EXAMS model includes a percent crop area factor
as an adjustment to account for the maximum percent crop coverage
within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a percent reference dose (%RfD) or
percent population adjusted dose (%PAD). Instead drinking water levels
of comparison (DWLOCs) are calculated and used as a point of comparison
against the model estimates of a pesticide's concentration in water.
DWLOCs are theoretical upper limits on a pesticide's concentration in
drinking water in light of total aggregate exposure to a pesticide in
food, and from residential uses. Since DWLOCs address total aggregate
exposure to imidacloprid, they are further discussed in the aggregate
risk sections below.
Analysis of monitoring data for degradates (ground water only)
shows that imidacloprid parent is the dominant residue with
imidacloprid urea the most likely degradate. Based on the available
information, modeling of total residue results in only modest increases
over the exposure estimates with parent alone. Based on the FIRST and
SCI-GROW models the estimated environmental concentrations (EECs) of
imidacloprid (total residue) for acute exposures are estimated to be
36.04 parts per billion (ppb) for surface water and 2.09 ppb for ground
water. The EECs for imidacloprid (parent only) for acute exposures are
estimated to be 35.89 ppb for surface water and 1.43 ppb for ground
water. The EECs for imidacloprid (total residue) for chronic exposures
are estimated to be 17.24 ppb for surface water and 2.09 ppb for ground
water. The EECs for imidacloprid (parent only) for chronic exposures
are estimated to be 16.52 ppb for surface water and 1.43 ppb for ground
water.
The New York State Department of Environmental Conservation,
Division of Solid and Hazardous Materials has submitted extensive water
monitoring information from Nassau and Suffolk Counties of New York.
Nassau and Suffolk counties have ground water that is exceptionally
vulnerable to pesticide contamination and have a long history of a
number of pesticides being banned from use in these counties over the
years. In general, the kinds of concentrations of imidacloprid (parent
only) found in the monitoring/observation and private drinking water
wells are in the range expected in highly vulnerable ground water.
Imidacloprid has been detected in approximately 20 (including some
clusters of wells in the same immediate area) out of about 2,000 public
and private water supply and monitoring wells. Imidacloprid was
detected in 24 of the approximately 3,500 well samples analyzed for
imidacloprid in Nassau and Suffolk Counties. Although detection of
imidacloprid in about 20 of 2,000 wells in an area with highly
vulnerable ground water does not demonstrate particularly widespread
ground water contamination, 3 of 2,000 wells in this highly vulnerable
ground water have at least one detection greater than the SCI-GROW for
imidacloprid (parent only) at 1.43 ppb. The three samples that exceed
the SCI-GROW ECs are reported at 2.06 ppb, 5.98 ppb, and 6.69 ppb.
Since the surface water model screening levels are greater than the
ground water model screening levels and the detection levels reported
from the water monitoring from Nassau and Suffolk Counties, New York,
the Agency will use the surface water ECs for imidacloprid total
residue as a worse case estimate for drinking water in the aggregate
risk assessment.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Imidacloprid is currently registered for use on the following
residential non-dietary sites: Granular products for application to
lawns and ornamental plants; ready-to-use spray for application to
flowers, shrubs and house plants; plant spikes for application to
indoor and outdoor residential potted plants; ready-to-use potting
medium for indoor and outdoor plant containers; liquid concentrate for
application to lawns, trees, shrubs and flowers; ready-to-use liquid
for directed spot application to cats and dogs. In addition, there are
numerous registered products intended for use by commercial applicators
to residential sites. These include gel baits for cockroach control;
products intended for commercial ornamental, lawn and turf pest
control; products for ant control; and products used as preservatives
for wood products, building materials, textiles and plastics.
As these products are intended for use by commercial applicators
only, they are not addressed in terms of residential pesticide
handlers. The risk assessment was conducted using the following
residential exposure assumptions: EPA has determined that residential
handlers
[[Page 61630]]
are likely to be exposed to imidacloprid residues via dermal and
inhalation routes during handling, mixing, loading, and applying
activities. Based on the current use patterns, EPA expects duration of
exposure to be short-term (1-30 days). EPA does not expect imidacloprid
to result in exposure durations that would result in intermediate-term
or long-term exposure.
The scenarios likely to result in adult dermal and/or inhalation
residential handler exposures are as follows:
[sbull] Dermal and inhalation exposure from using a granular push-
type spreader.
[sbull] Dermal exposure from using potted plant spikes.
[sbull] Dermal exposure from using a plant potting medium.
[sbull] Dermal and inhalation exposure from using a garden hose-end
sprayer (dermal and inhalation exposure from using a RTU trigger pump
spray is expected to be negligible).
[sbull] Dermal and inhalation exposure from using a water can/
bucket for soil drench applications.
[sbull] Dermal exposure from using pet spot-on.
EPA has also determined that there is potential for short-term (1
to 30 days), post-application exposure to adults and children/toddlers
from the many residential uses of imidacloprid. Due to residential
application practices and the half-lives observed in the turf
transferable residue study, intermediate-term and long-term post-
application exposures are not expected. The scenarios likely to result
in dermal (adult and child/toddler) and incidental non-dietary (child/
toddler) short-term post-application exposures are as follows:
[sbull] Toddler oral hand-to-mouth exposure from contacting treated
turf.
[sbull] Toddler incidental oral ingestion of granules.
[sbull] Toddler incidental oral ingestion of pesticide-treated
soil.
[sbull] Toddler incidental oral exposure from contacting treated
pet.
[sbull] Toddler dermal exposure from contacting treated turf.
[sbull] Toddler dermal exposure from hugging treated pet/contacting
treated pet.
[sbull] Adult dermal exposure from contacting treated turf.
[sbull] Adult golfer dermal exposure from contacting treated turf.
[sbull] Adolescent golfer dermal exposure from contacting treated
turf.
[sbull] Adult dermal exposure from contacting treated pet
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether imidacloprid has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
imidacloprid does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that imidacloprid has a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the policy
statements released by EPA's Office of Pesticide Programs concerning
common mechanism determinations and procedures for cumulating effects
from substances found to have a common mechanism on EPA's website at
http://www.epa.gov/pesticides/cumulative/.
C. Safety Factor for Infants and Children
1. In general. Section 408 of the FFDCA provides that EPA shall
apply an additional tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of explosure
(MOE) analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. There is no quantitative or
qualitative evidence of increased susceptibility of rat and rabbit
fetuses to in utero exposure in developmental studies. There is no
quantitative or qualitative evidence of increased susceptibility of rat
offspring in the multi-generation reproduction study. There is evidence
of increased qualitative susceptibility in the rat developmental
neurotoxicity study, but the concern is low since:
[sbull] The effects in pups are well-characterized with a clear
NOAEL.
[sbull] The pup effects occur in the presence of maternal toxicity
with the same NOAEL for effects in pups and dams.
[sbull] The doses and endpoints selected for regulatory purposes
are protective of the pup effects noted at higher doses in the
developmental neurotoxicity study.
Therefore, there are no residual uncertainties for prenatal/
postnatal toxicity in this study.
3. Conclusion. There is a complete toxicity data base for
imidacloprid and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. EPA determined
that the 10X SF to protect infants and children should be reduced to 1X
for the following reasons:
[sbull] The toxicological data base is complete for FQPA
assessment.
[sbull] The acute dietary food exposure assessment utilizes
existing and proposed tolerance level residues and 100 PCT information
for all commodities. By using these screening-level assessments, actual
exposures/risks will not be underestimated.
[sbull] The chronic dietary food exposure assessment utilizes
existing and proposed tolerance level residues and PCT data verified by
the Agency for several existing uses. For all proposed uses, 100 PCT is
assumed. The chronic assessment is somewhat refined and based on
reliable data and will not underestimate exposure/risk.
The dietary drinking water assessment utilizes water concentration
values generated by model and associated modeling parameters which are
designed to provide conservative, health protective, high-end estimates
of water concentrations which will not likely be exceeded.
The residential handler assessment is based upon the residential
standard operating procedures (SOPs) in conjunction with chemical-
specific study data in some cases and the Pesticide Handlers Exposure
Database (PHED) unit exposures in other cases. The majority of the
residential post-application assessment is based upon chemical-specific
turf transferrable residue data or other chemical-specific post-
application exposure study data. The chemical-specific study data as
well as the surrogate study data used are reliable and also are not
expected to underestimate risk to adults as well as to children. In a
few cases where chemical-specific data were not available, the SOPs
were used alone. The residential SOPs are based upon reasonable worst-
case assumptions and are not expected to underestimate risk.
[[Page 61631]]
These assessments of exposure are not likely to underestimate the
resulting estimates of risk from exposure to imidacloprid.
In its objections to a separate imidacloprid tolerance action, NRDC
argues that in light of the outstanding data requirement for
prospective ground water monitoring studies, EPA should have retained a
10X FQPA factor for imidacloprid. EPA disagrees. Two small-scale
prospective ground water monitoring studies were originally requested
by the Agency in 1994. This request predates the development of the
Tier 1 ground water screening model in 1997 and the FQPA. The field
phase of these prospective ground water monitoring studies commenced in
1996. Results from these studies have now been received and the levels
of imidacloprid observed (0.1 ppb) are below the screening
concentration of 2.09 ppb calculated on the basis of the SCI-GROW, the
Tier 1 ground water screening model. In any event, as noted above,
since higher values are predicted for imidacloprid residues in surface
water, these higher values were used in conducting the risk assessment.
D. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + chronic non-dietary, non-occupational exposure).
This allowable exposure through drinking water is used to calculate a
DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by EPA's Office of Water are used to calculate DWLOCs: 2
liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to imidacloprid in drinking water (when considered along with
other sources of exposure for which EPA has reliable data) would not
result in unacceptable levels of aggregate human health risk at this
time. Because EPA considers the aggregate risk resulting from multiple
exposure pathways associated with a pesticide's uses, levels of
comparison in drinking water may vary as those uses change. If new uses
are added in the future, EPA will reassess the potential impacts of
imidacloprid on drinking water as a part of the aggregate risk
assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
imidacloprid will occupy 25% of the aPAD for the U.S. population, 17%
of the aPAD for females 13 to 49 years, 54% of the aPAD for infants < 1
year old and 64% of the aPAD for children 1-2 years. In addition,
despite the potential for acute dietary exposure to imidacloprid in
drinking water, after calculating DWLOCs and comparing them to
conservative model estimated environmental concentrations of
imidacloprid in surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the aPAD, as shown in the
following Table 2:
Table 2.--Aggregate Risk Assessment for Acute Exposure to Imidacloprid
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ %aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.14 25 36.04 2.09 3,700
----------------------------------------------------------------------------------------------------------------
Females (13-49 years) 0.14 17 36.04 2.09 3,500
----------------------------------------------------------------------------------------------------------------
Infants (< 1 year) 0.14 54 36.04 2.09 650
----------------------------------------------------------------------------------------------------------------
Children (1-2 years) 0.14 64 36.04 2.09 510
----------------------------------------------------------------------------------------------------------------
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
imidacloprid from food will utilize 11% of the cPAD for the U.S.
population, 26% of the cPAD for infants < 1 year, and 35% of the cPAD
for children 1-2 years. Based on the use pattern, chronic residential
exposure to residues of imidacloprid is not expected. In addition,
there is potential for chronic dietary exposure to imidacloprid in
drinking water. After calculating DWLOCs and comparing them to the EECs
for surface water and ground water, EPA does not expect the aggregate
exposure to exceed 100% of the cPAD, as shown in following Table 3:
Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Imidacloprid
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ %cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.057 11 17.24 2.09 1,800
----------------------------------------------------------------------------------------------------------------
[[Page 61632]]
Infants (< 1 year) 0.057 26 17.24 2.09 420
----------------------------------------------------------------------------------------------------------------
Children (1-2 years) 0.057 35 17.24 2.09 370
----------------------------------------------------------------------------------------------------------------
Females (13-49 years) 0.057 8.3 17.24 20.9 1,600
----------------------------------------------------------------------------------------------------------------
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Short-term aggregate risk assessments are needed for adults as
there is potential for both dermal and inhalation handler exposure, and
dermal post-application exposure from the residential uses of
imidacloprid on turf and pets. In addition, short-term aggregate risk
assessments are needed for children/toddlers because there is a
potential for oral and dermal, post-application exposure resulting from
the residential uses of imidacloprid on turf and pets. The pet-
treatment scenario resulted in the lowest combined MOE for adults (MOE
= 400; handler and post-application) and children (MOE = 260; post-
application). The turf-treatment resulted in much lower exposures for
both adults (MOE = 15,000; handler and post-application) and children
(MOE = 1,500; post-application). Therefore, the pet-treatment exposure
estimates were aggregated with the chronic dietary (food) to provide a
worst-case estimate of short-term aggregate risk for the U.S.
population and children 1-2 years old (the child population subgroup
with the highest estimated chronic dietary food exposure). Using the
exposure assumptions described in this unit for short-term exposures,
EPA has concluded that food and residential exposures aggregated result
in aggregate MOEs of 320 for the U.S. population, and 170 for children
1-2 years. These aggregate MOEs do not exceed the Agency's level of
concern for aggregate exposure to food and residential uses. In
addition, short-term DWLOCs were calculated and compared to the EECs
for chronic exposure of imidacloprid in ground water and surface water.
After calculating DWLOCs and comparing them to the EECs for surface
water and ground water, EPA does not expect short-term aggregate
exposure to exceed the Agency's level of concern, as shown in the
following Table 4:
Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Imidacloprid
----------------------------------------------------------------------------------------------------------------
Short-term
Aggregate Aggregate Level Surface Ground DWLOC (ppb)
Population Subgroup MOE (Food + of Concern (LOC) Water EEC Water EEC U.S.
Residential) (ppb) (ppb) population
----------------------------------------------------------------------------------------------------------------
U.S. population 320 100 17.24 2.09 2,400
----------------------------------------------------------------------------------------------------------------
Children (1-2 years old) 170 100 17.24 2.09 410
----------------------------------------------------------------------------------------------------------------
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account non-dietary, non-occupational exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
Intermediate-term and long-term aggregate risk assessments were not
performed because, based on the current use patterns, the Agency does
not expect exposure durations that would result in intermediate-term or
long-term exposures.
5. Aggregate cancer risk for U.S. population. There is no evidence
of carcinogenicity to humans based on carcinogenicity studies in male
and female rats and mice. The Agency concludes that pesticidal uses of
imidacloprid are not likely to pose a cancer risk to humans.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to imidacloprid residues.
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).
Adequate enforcement methodology (example--gas chromotography) is
available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov.
B. International Residue Limits
There are no CODEX, Canadian, or Mexican Maximum Residue Limits
(MRLs) for imidacloprid on soybean seed.
VI. Conclusion
Therefore, the tolerance is established for the combined residues
of imidacloprid, (1-[6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine) and its metabolites containing the 6-chloropyridinyl
moiety, all expressed as parent, in or on soybean seed at 1.0 ppm.
VII. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may
[[Page 61633]]
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. Although the procedures in those regulations require
some modification to reflect the amendments made to the FFDCA by the
FQPA, EPA will continue to use those procedures, with appropriate
adjustments, until the necessary modifications can be made. The new
section 408(g) of the FFDCA provides essentially the same process for
persons to ``object'' to a regulation for an exemption from the
requirement of a tolerance issued by EPA under new section 408(d) of
the FFDCA, as was provided in the old sections 408 and 409 of the
FFDCA. However, the period for filing objections is now 60 days, rather
than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2003-0327 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before December
29, 2003.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Office of the Hearing Clerk is
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.1. Mail your
copies, identified by the docket ID number OPP-2003-0327, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in Unit I.B.1. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VIII. Statutory and Executive Order Reviews
This final rule establishes a time-limited tolerance under section
408 of the FFDCA. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). Because this rule has been exempted from review under Executive
Order 12866 due to its lack of significance, this rule is not subject
to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a FIFRA
section 18 exemption under section 408 of the FFDCA, such as the
tolerance in
[[Page 61634]]
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers, and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this rule does not have any ``tribal implications''
as described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
IX. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: October 17, 2003.
Peter Caulkins,
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), 346(a) and 371.
0
2. Section 180.472 is amended by adding the following commodity to the
table in paragraph (b) to read as follows:
Sec. 180.472 Imidacloprid; tolerances for residues.
(a) * * *
(b) * * *
----------------------------------------------------------------------------------------------------------------
Commodity Parts per million Expiration/revocation date
----------------------------------------------------------------------------------------------------------------
* * * * *
Soybean, seed....................................... 1.0 ppm 12/31/06
* * * * *
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[FR Doc. 03-26926 Filed 10-28-03; 8:45 am]
BILLING CODE 6560-50-S