Imidacloprid; Pesticide Tolerances, 46110-46117 [E6-13092]
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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 FFDCA section 408(n)(4).
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.
Dated: August 3, 2006.
Frank Sanders,
Director, Antimicrobials Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—AMENDED
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1021 is amended by
revising paragraph (c) to read as follows:
I
§ 180.1021 Copper; exemption from the
requirement of a tolerance.
*
*
*
*
*
(c) Copper sulfate pentahydrate (CAS
Reg. No. 7758–99–8) is exempt from the
requirement of a tolerance when applied
as a fungicide to growing crops or to raw
agricultural commodities after harvest,
and as a bactericide/fungicide in or on
meat, fat and meat by-products of cattle,
sheep, hogs, goats, horses and poultry,
milk and eggs when applied as a
bactericide/fungicide to animal
premises and bedding.
*
*
*
*
*
[FR Doc. E6–13082 Filed 8–10–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
X. Congressional Review Act
[EPA–HQ–OPP–2005–0542; FRL–8081–8]
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).
Imidacloprid; Pesticide Tolerances
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List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements, copper sulfate
pentahydrate.
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Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for combined residues of
imidacloprid and its metabolites
containing the 6-chloropyridinyl
moiety, all expressed as the parent in or
on caneberry subgroup 13A; coffee,
green bean; seed of: Black mustard,
borage, crambe, field mustard, flax,
Indian mustard, Indian rapeseed,
rapeseed, safflower, and sunflower;
atemoya, biriba, cherimoya, custard
apple, ilama, soursop, and sugar apple;
almond hulls, pistachio and tree nut
group 14; pomegranate; banana; herbs
subgroup 19A dried; and herbs
subgroup 19A fresh. Interregional
Research Project No. 4 (IR–4), requested
these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection
Act of 1996 (FQPA).
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This regulation is effective
August 11, 2006. Objections and
requests for hearings must be received
on or before October 10, 2006, 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–2005–0542. All documents in the
docket are listed in the index for the
docket. 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
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive,
Arlington, VA. The 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.
FOR FURTHER INFORMATION CONTACT:
Barbara Madden, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–6463; e-mail address:
madden.barbara@epa.gov..
SUPPLEMENTARY INFORMATION:
DATES:
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:
• Crop production (NAICS 111), e.g.,
agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS 112),
e.g., cattle ranchers and farmers, dairy
cattle farmers, livestock farmers.
• Food manufacturing (NAICS 311),
e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
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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 Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s pilot e-CFR site at https://
www.gpoaccess.gov/ecfr. To access the
OPPTS Harmonized Guidelines
referenced in this document, go directly
to the guidelines at https://www.epa.gpo/
opptsfrs/home/guidelin.htm.
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C. Can I File an Objection or Hearing
Request?
Under section 408(g) of the FFDCA, as
amended by the FQPA, any person may
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.
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–2005–0542 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 October 10, 2006.
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 your
copies, identified by docket ID number
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EPA–HQ–OPP–2005–0542, by one of
the following methods:
• Federal eRulemaking Portal: https://
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 Building), 2777 S.
Crystal Drive, Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket telephone number is (703) 305–
5805.
II. Background and Statutory Findings
In the Federal Register of March 22,
2006 (71 FR 14524) (FRL–7769–7), 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 3E6543, PP
3E6561, PP 3E6738, PP 3E6760, PP
5E6920, PP 5E6921, PP 5E6922, PP
5E6923) by Interregional Research
Project No. 4 (IR–4), 681 U.S. Highway
No. 1 South, North Brunswick, NJ
08902–3390. The petitions requested
that 40 CFR 180.472 be amended by
establishing tolerances for residues of
the insecticide imidacloprid, 1-[(6chloro-3-pyridinyl)methyl]-N-nitro-2imidazolidinimine, and its metabolites
containing the 6-chloropyridinyl
moiety, all expressed as imidacloprid in
or on the raw agricultural commodities
as follows: Caneberry subgroup 13A at
0.05 parts per million (ppm) (PP
3E6543); coffee at 0.6 ppm (PP 3E6561);
seed of: Black mustard, borage, crambe,
field mustard, flax, Indian mustard,
Indian rapeseed, rapeseed, safflower,
and sunflower at 0.05 ppm (PP 3E6738);
atemoya, biriba, cherimoya, custard
apple, ilama, soursop, and sugar apple
at 0.2 ppm (PP 3E6760); almond hulls
at 2.5 ppm; and pistachio and tree nut
group 14 at 0.01 ppm (PP 5E6920);
pomegranate at 0.7 ppm (PP 5E6921);
banana at 0.6 ppm (PP 5E6922); herbs
subgroup 19A dried at 62.0 ppm and
herbs subgroup 19A fresh at 6.0 ppm
(PP 5E6923).
Tolerances were later amended as
follows: Coffee at 0.80 ppm (PP 3E6561);
atemoya, biriba, cherimoya, custard
apple, ilama, soursop, and sugar apple
at 0.30 ppm (PP 3E6760); almond hulls
at 4.0 ppm; and pistachio and tree nut
group 14 at 0.05 ppm (PP 5E6920);
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pomegranate at 0.90 ppm (PP 5E6921);
banana at 0.50 ppm (PP 5E6922); herb
subgroup, 19A, herbs, dried at 48.0 ppm
and herb subgroup, 19A, herbs, fresh at
8.0 ppm (PP 5E6923).
In addition to establishing tolerances,
EPA is also deleting several established
tolerances from the tables in
§ 180.472(a), (b), and (d) that are no
longer needed as a result of this action.
The tolerance deletions under
§ 180.472(b) are time-limited tolerances
established under section 18 emergency
exemptions that are superceded by the
establishment of general tolerances for
imidacloprid and its metabolites under
§ 180.472(a).
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....’’
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 https://
www.epa.gov/fedrgstr/EPA-PEST/1997/
November/Day-26/p30948.htm.
III. Aggregate Risk Assessment and
Determination of Safety
Consistent with 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,
consistent with section 408(b)(2) of
FFDCA, for tolerances for combined
residues of the insecticide imidacloprid,
1-[(6-chloro-3-pyridinyl)methyl]-Nnitro-2-imidazolidinimine, and its
metabolites containing the 6chloropyridinyl moiety, all expressed as
imidacloprid in or on caneberry
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subgroup 13A at 0.05 parts per million
(ppm); coffee, green bean at 0.80 ppm;
seed of: Black mustard, borage, crambe,
field mustard, flax, Indian mustard,
Indian rapeseed, rapeseed, safflower,
and sunflower at 0.05 ppm; atemoya,
biriba, cherimoya, custard apple, ilama,
soursop, and sugar apple at 0.30 ppm;
almond hulls at 4.0 ppm; pistachio and
tree nut group 14 at 0.05 ppm;
pomegranate at 0.90 ppm; banana at
0.50 ppm; herb subgroup, 19A, herbs,
dried at 48.0 ppm and herb subgroup,
19A, herbs, fresh at 8.0 ppm. EPA’s
assessment of exposures and risks
associated with establishing the
tolerance follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. Specific
information on the studies received and
the nature of the toxic effects caused by
imidacloprid as well as the no-observedadverse-effect-level (NOAEL) and the
lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can
be found at https://www.epa.gov/
fedrgstr/EPA-PEST/2003/June/Day-13/
p14880.htm.
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B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the dose at which the NOAEL from
the toxicology study identified as
appropriate for use in risk assessment is
used to estimate the toxicological level
of concern (LOC). However, 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.
The linear default risk methodology
(Q*) is the primary method currently
used by the Agency to quantify nonthreshold hazards such as cancer. The
Q* approach assumes that any amount
of exposure will lead to some degree of
cancer risk, estimates risk in terms of
the probability of occurrence of
additional cancer cases. More
information can be found on the general
principles EPA uses in risk
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characterization at https://www.epa.gov/
pesticides/health/human.htm.
A summary of the toxicological
endpoints for imidacloprid used for
human risk assessment is discussed in
Unit III.B. of the final rule published in
the Federal Register of June 13, 2003
(68 FR 35303) (FRL–7310–8), or at
https://www.epa.gov/fedrgstr/EPA-PEST/
2003/June/Day-13/p14880.htm.
C. 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. Risk assessments were
conducted by EPA to assess 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.
The Dietary Exposure Evaluation
Model - Food Commodity Intake
Database (DEEM-FCIDTM) analysis
evaluated the individual food
consumption 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 following
assumptions were made for the acute
exposure assessments: An unrefined,
acute dietary exposure assessment using
tolerance-level residues and assuming
100 pecent crop treated (PCT) for all
registered and proposed commodities
was conducted for the general U.S.
population and various population
subgroups. Drinking water was
incorporated directly in the dietary
assessment using the acute (peak)
concentration for surface water
generated by the FQPA Index Reservoir
Screening Tool (FIRST) model.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the DEEM-FCIDTM, which
incorporates food consumption data as
reported by respondents in the USDA
1994–1996 and 1998 nationwide CSFII,
and accumulated exposure to the
chemical for each commodity. The
following assumptions were made for
the chronic exposure assessments: A
partially refined, chronic dietary
exposure assessment using tolerancelevel residues for all registered and
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proposed commodities, and PCT
information for some commodities was
conducted for the general U.S.
population and various population
subgroups. Drinking water was
incorporated directly into the dietary
assessment using the chronic (annual
average) concentration for surface water
generated by the FIRST model.
iii. Cancer. An exposure assessment
related to cancer risk is unnecessary.
The Agency has classified imidacloprid
as a ‘‘Group E’’ chemical, no evidence
of carcinogenicity for humans, by all
routes of exposure based upon lack of
evidence of carcinogenicity in rats and
mice.
iv. Anticipated residue and PCT
information. Section 408(b)(2)(F) of
FFDCA states that the Agency may use
data on the actual percent of food
treated for assessing chronic dietary risk
only if 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 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 30%; artichokes
5%; beets 15%; blueberries 10%;
broccoli 35%; brussels sprouts 55%;
cabbage 20%; cantaloupe 30%; carrots
1%; cauliflower 40%; celery 5%;
cherries 5%; collards 10%; corn, field
1%; cotton 5%; cucumber 5%; eggplant
45%; grapefruit 5%; grape 30%;
honeydew 10%; hops 90%; kale 30%;
lemon 1%; lettuce, head 60%; orange
5%; peaches 5%; pear 10%; pepper
25%; potatoes 35%; pumpkin 5%;
spinach 20%; squash 10%; strawberries
10%; sugarbeet 1%; sweet corn 1%;
tangerine 10%; tomato 15%;
watermelon 10%. A default value of 1%
was used for all commodities which
were reported as having 1 PCT.
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EPA uses an average PCT for chronic
dietary risk analysis. The average PCT
figure for each existing use is derived by
combining available Federal, State, and
private market survey data for that use,
averaging by year, averaging across all
years, and rounding up to the nearest
multiple of 5% except for those
situations in which the average PCT is
less than 1. In those cases 1% is used
as the average and 2.5% is used as the
maximum. EPA uses a maximum PCT
for acute dietary risk analysis. The
maximum PCT figure is the single
maximum value reported overall from
available Federal, State, and private
market survey data on the existing use,
across all years, and rounded up to the
nearest multiple of 5%. In most cases,
EPA uses available data from USDA/
National Agricultural Statistics Service
(USDA/NASS), Proprietary Market
Surveys, and the National Center for
Food and Agriculture Policy (NCFAP)
for the most recent 6 years.
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. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www.epa.gov/
oppefed1/models/water/index.htm.
Based on the FIRST and screening
concentration in ground water (SCIGROW) models, the estimated
environmental concentrations (EECs) of
imidacloprid for acute exposures are
estimated to be 36.0 parts per billion
(ppb) for surface water and 2.09 ppb for
ground water. The EECs for chronic
exposures are estimated to be 17.2 ppb
for surface water and 2.09 ppb for
ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model (DEEMFCIDTM, Version 2.03). For acute dietary
risk assessment, the peak water
concentration value of 36.0 ppb was
used to access the contribution to
drinking water. For chronic dietary risk
assessment, the annual average
concentration of 17.2 ppb was used to
access the contribution to drinking
water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
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(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 nondietary 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; readyto-use liquid for directed spot
application to cats and dogs. In
addition, there are numerous registered
products intended for use by
commercial applicators to residential
sites. These include gel baits for
cockroach control; products intended
for commercial ornamental, lawn and
turf pest control; products for ant
control; and products used as
preservatives for wood products,
building materials, textiles and plastics.
As these products are intended for use
by commercial applicators only, they
are not to be addressed in terms of
residential pesticide handlers. The risk
assessment was conducted using the
following residential exposure
assumptions: EPA has determined that
residential handlers are likely to be
exposed to imidacloprid residues via
dermal and inhalation routes during
handling, mixing, loading, and applying
activities. Based on the current use
patterns, EPA expects duration of
exposure to be short-term (1–30 days).
EPA does not expect imidacloprid 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:
• Dermal and inhalation exposure
from using a granular push-type
spreader;
• Dermal exposure from using potted
plant spikes;
• Dermal exposure from using a plant
potting medium;
• Dermal and inhalation exposure
from using a garden hose-end sprayer
(dermal and inhalation exposure from
using a RTU trigger pump spray is
expected to be negligible);
• Dermal and inhalation exposure
from using a water can/bucket for soil
drench applications; and
• 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
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residential uses of imidacloprid. Due to
residential application practices and the
half-lives observed in the turf
transferable residue study, intermediateterm 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:
• Toddler oral hand-to-mouth
exposure from contacting treated turf;
• Toddler incidental oral ingestion of
granules;
• Toddler incidental oral ingestion of
pesticide-treated soil;
• Toddler incidental oral exposure
from contacting treated pet;
• Toddler dermal exposure from
contacting treated turf;
• Toddler dermal exposure from
hugging treated pet/contacting treated
pet;
• Adult dermal exposure from
contacting treated turf;
• Adult golfer dermal exposure from
contacting treated turf;
• Adolescent golfer dermal exposure
from contacting treated turf; and
• Adult dermal exposure from
contacting treated pet;
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of the FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
Unlike other pesticides for which EPA
has followed a cumulative risk approach
based on a common mechanism of
toxicity, EPA has not made a common
mechanism of toxicity finding as to
imidacloprid and any other substances
and imidacloprid does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
not assumed that imidacloprid has a
common mechanism of toxicity with
other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see 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 https://
www.epa.gov/pesticides/cumulative.
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D. Safety Factor for Infants and
Children
1. In general. Section 408 of 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 based on reliable data 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 exposure (MOE) analysis
or through using uncertainty (safety)
factors in calculating a dose level that
poses no appreciable risk to humans. In
applying this provision, EPA either
retains the default value of 10X when
reliable data do not support the choice
of a different factor, or, if reliable data
are available, EPA uses a different
additional safety factor (SF) value based
on the use of traditional uncertainty
factors and/or special FQPA safety
factors, as appropriate.
2. Prenatal and postnatal sensitivity.
There is no quantitative or qualitative
evidence of increased susceptibility of
rat and rabbit fetuses to in utero
exposure in developmental studies.
There is no quantitative or qualitative
evidence of increased susceptibility of
rat offspring in the multi-generation
reproduction study. There is evidence of
increased qualitative susceptibility in
the rat developmental neurotoxicity
study, but the concern is low since:
i. The effects in pups are wellcharacterized with a clear NOAEL;
ii. The pup effects occur in the
presence of maternal toxicity with the
same NOAEL for effects in pups and
dams; and,
iii. The doses and endpoints selected
for regulatory purposes are protective of
the pup effects noted at higher doses in
the developmental neurotoxicity study.
Therefore, there are no residual
uncertainties for 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:
The toxicological data base is
complete for FQPA assessment.
The acute dietary food exposure
assessment utilizes existing and
proposed tolerance level residues and
100 PCT information for all
commodities. By using these screening-
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Jkt 208001
level assessments, actual exposures/
risks will not be underestimated.
The chronic dietary food exposure
assessment utilizes existing and
proposed tolerance level residues and
PCT data verified by the Agency for
several existing uses. For all proposed
uses, 100 PCT is assumed. The chronic
assessment is somewhat refined and
based on reliable data and will not
underestimate exposure/risk.
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 postapplication 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.
These assessments of exposure are not
likely to underestimate the resulting
estimates of risk from exposure to
imidacloprid.
E. Aggregate Risks and Determination of
Safety
The Agency currently has two ways to
estimate total aggregate exposure to a
pesticide from food, drinking water, and
residential uses. First, a screening
assessment can be used, in which the
Agency calculates drinking water levels
of comparison (DWLOCs) which are
used as a point of comparison against
estimated drinking water concentrations
(EDWCs). The DWLOC values are not
regulatory standards for drinking water,
but 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. More information on the use of
DWLOCs in dietary aggregate risk
assessments can be found at https://
www.epa.gov/oppfead1/trac/science/
screeningsop.pdf.
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More recently the Agency has used
another approach to estimate aggregate
exposure through food, residential and
drinking water pathways. In this
approach, modeled surface water and
ground water EDWCs are directly
incorporated into the dietary exposure
analysis, along with food. This provides
a more realistic estimate of exposure
because actual body weights and water
consumption from the CSFII are used.
The combined food and water exposures
are then added to estimated exposure
from residential sources to calculate
aggregate risks. The resulting exposure
and risk estimates are still considered to
be high end, due to the assumptions
used in developing drinking water
modeling inputs. The risk assessment
for imidacloprid used in this tolerance
document uses this approach of
incorporating water exposure directly
into the dietary exposure analysis.
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to
imidacloprid will occupy 26% of the
acute population adjusted dose (aPAD)
for the U.S. population, 18% of the
aPAD for females 13 years and older,
54% of the aPAD for all infants 1 year
old, and 67% of the aPAD for children
1–2 years old. EPA does not expect the
aggregate exposure to exceed 100% of
the aPAD.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to imidacloprid from food
and water will utilize 11% of the
chronic population adjusted dose
(cPAD) for the U.S. population, 22% of
the cPAD for all infants 1 year old, and
33% of the cPAD for children 1–2 years
old. Based on the use pattern, chronic
residential exposure to residues of
imidacloprid is not expected. EPA does
not expect the aggregate exposure to
exceed 100% of the cPAD.
3. Short-term risk. Short-term
aggregate exposure takes into account
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Imidacloprid is currently registered
for use that could result in short-term
residential exposure and the Agency has
determined that it is appropriate to
aggregate chronic food and water and
short-term exposures for imidacloprid.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded that food
and residential exposures aggregated
result in worst-case aggregate MOEs of
320 for the general U.S. population and
170 for children 1–2 years old, the subpopulation at greatest exposure. These
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aggregate MOEs do not exceed the
Agency’s LOC for aggregate exposure to
food, water and residential uses.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account residential exposure
plus chronic exposure to food and water
(considered to be a background
exposure level).
Intermediate- 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- or long-term exposures.
5. Aggregate cancer risk for U.S.
population. The Agency has classified
imidacloprid as a ‘‘Group E’’ chemical,
no evidence of carcinogenicity for
humans, by all routes of exposure based
upon lack of evidence of carcinogenicity
in rats and mice. Imidacloprid is not
expected to pose a cancer risk.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, and to infants and children
from aggregate exposure to imidacloprid
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methods are
available for determination of
imidacloprid residues of concern in
plant (Bayer Gas Chromatography/Mass
Spectrometry (GC/MS) Method 00200)
and livestock commodities (Bayer GC/
MS Method 00191). These methods
have undergone successful EPA petition
method validations (PMVs), and the
registrant has fulfilled the remaining
requirements for additional raw data,
method validation, independent
laboratory validation (ILV), and an
acceptable confirmatory method (High
Performance Liquid Chromatography/
Ultraviolet (HPLC/UV) Method 00357).
The validated limit of detection (LOD)
and limit of quantitation (LOQ) for the
GC/MS Method 00200 are 0.01 and 0.05
ppm, respectively, in plant
commodities. 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.
rwilkins on PROD1PC63 with RULES
B. International Residue Limits
There are no established Mexican
maximum residue limits (MRLs) for the
proposed uses. There are established
Codex MRLs for the sum of
imidacloprid and its metabolites
containing the 6-chloropyridinyl
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16:23 Aug 10, 2006
Jkt 208001
moiety, expressed as imidacloprid, in or
on rapeseed at 0.05 ppm and banana at
0.05 ppm. In addition, there is currently
Canadian MRLs for: 1-[(6-chloro-3pyridinyl) methyl]-4,5-dihydro-N-nitro1H-imidazol-2-amine, including
metabolites containing the 6chloropicolyl moiety in or on mustard,
seed at 0.05 ppm, rapeseed (canola) at
0.05 ppm and pecans at 0.05 ppm. The
Codex and Canadian MRLs for rapeseed
(canola) is the same as the U.S.
recommended tolerance for rapeseed,
seed; and the Canadian MRL for pecans
is the same as the U.S. recommended
tolerance. However, the Canadian MRL
for banana is not equivalent to the U.S.
recommended tolerance as the available
crop field trial data supported a higher
tolerance level. Therefore,
harmonization is not possible at this
time.
V. Conclusion
Therefore, the tolerances are
established for combined residues of the
insecticide imidacloprid, 1-[(6-chloro-3pyridinyl)methyl]-N-nitro-2imidazolidinimine, and its metabolites
containing the 6-chloropyridinyl
moiety, all expressed as imidacloprid in
or on caneberry subgroup 13A at 0.05
ppm; coffee, green bean at 0.80 ppm;
seed of: Black mustard, borage, crambe,
field mustard, flax, Indian mustard,
Indian rapeseed, rapeseed, safflower,
and sunflower at 0.05 ppm; atemoya,
biriba, cherimoya, custard apple, ilama,
soursop, and sugar apple at 0.30 ppm;
almond hulls at 4.0 ppm; pistachio at
0.05 ppm; tree nut group 14 at 0.05
ppm; pomegranate at 0.90 ppm; banana
at 0.50 ppm; herb subgroup, 19A, herbs,
dried at 48.0 ppm and herb subgroup,
19A herbs, fresh at 8.0 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 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
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Fmt 4700
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46115
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 petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. 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
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
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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.
VII. 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: August 1, 2006.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
rwilkins on PROD1PC63 with RULES
I
Authority: 21 U.S.C. 321(q), 346a and 371
2. Section 180.472 is revised to read
as follows:
I
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§ 180.472 Imidacloprid; tolerances for
residues.
Commodity
(a) General. Tolerances are
established permitting the combined
residues of the insecticide imidacloprid
(1-[6-chloro-3-pyridinyl) methyl]-Nnitro-2-imidazolidinimine) and its
metabolites containing the 6chloropyridinyl moiety, all expressed as
1-[(6-chloro-3-pyridinyl)methyl]-Nnitro-2-imidazolidinimine, in or on the
following food commodities:
Commodity
Parts Per Million
Acerola ............................
Almond, hulls ..................
Apple ...............................
Apple, wet pomace .........
Atemoya ..........................
Artichoke, globe ..............
Avocado ..........................
Banana ...........................
Barley, grain ...................
Barley, hay ......................
Barley, straw ...................
Beet, sugar, roots ...........
Beet, sugar, tops ............
Beet, sugar, molasses ....
Biriba ...............................
Blueberry ........................
Borage, seed ..................
Caneberry, subgroup
13A ..............................
Canistel ...........................
Canola, seed ..................
Cattle, fat ........................
Cattle, meat byproducts
Cattle, meat ....................
Cherimoya ......................
Citrus, dried pulp ............
Coffee, green bean .........
Corn, field, forage ...........
Corn, field, grain .............
Corn, field, stover ...........
Corn, pop, grain ..............
Corn, pop, stover ............
Corn, sweet, forage ........
Corn, sweet, kernel plus
cob with husks removed .........................
Corn, sweet, stover ........
Cotton, gin byproducts ...
Cotton, undelinted seed
Cotton, meal ...................
Crambe, seed .................
Cranberry ........................
Currant ............................
Custard apple .................
Egg .................................
Elderberry .......................
Feijoa ..............................
Flax, seed .......................
Fruit, citrus, group 10 .....
Fruit, pome, group 11 .....
Fruit, stone, group 12 .....
Goat, fat ..........................
Goat, meat byproducts ...
Goat, meat ......................
Gooseberry .....................
Grape, juice ....................
Grape, pomace (wet or
dried) ...........................
Grape, raisin ...................
Grape, raisin, waste .......
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1.0
4.0
0.5
3.0
0.30
2.5
1.0
0.50
0.05
0.5
0.5
0.05
0.5
0.3
0.30
3.5
0.05
0.05
1.0
0.05
0.3
0.3
0.3
0.3
5.0
0.80
0.10
0.05
0.20
0.05
0.20
0.10
0.05
0.20
4.0
6.0
8.0
0.05
0.05
3.5
0.30
0.02
3.5
1.0
0.05
0.7
0.6
3.0
0.3
0.3
0.3
3.5
1.5
5.0
1.5
15.0
Grape ..............................
Guava .............................
Herbs subgroup 19A,
dried herbs ..................
Herbs subgroup 19B,
fresh herbs ..................
Hog, fat ...........................
Hog, meat byproducts ....
Hog, meat .......................
Hop, dried cone ..............
Horse, fat ........................
Horse, meat byproducts
Horse, meat ....................
Huckleberry .....................
Ilama ...............................
Jaboticaba ......................
Juneberry ........................
Leaf petioles subgroup
4B ................................
Leafy greens subgroup
4A ................................
Lettuce, head and leaf ....
Lingonberry .....................
Longan ............................
Lychee ............................
Mango .............................
Milk .................................
Mustard, black, seed ......
Mustard, field, seed ........
Mustard, Indian, seed .....
Mustard, rapeseed, seed
Mustard, seed .................
Nut, tree, group 14 .........
Oats, forage ....................
Oats, grain ......................
Oats, hay ........................
Oats, straw .....................
Okra ................................
Passionfruit .....................
Papaya ............................
Pecans ............................
Persimmon ......................
Pistachio .........................
Pomegranate ..................
Potato, chip .....................
Potato, waste ..................
Poultry, fat ......................
Poultry, meat byproducts
Poultry, meat ..................
Pulasan ...........................
Rambutan .......................
Rapeseed, seed .............
Rye, forage .....................
Rye, grain .......................
Rye, hay .........................
Rye, straw .......................
Safflower, seed ...............
Salal ................................
Sapodilla .........................
Sapote, black ..................
Sapote, mamey ..............
Sheep, fat .......................
Sheep, meat byproducts
Sheep, meat ...................
Sorghum, forage .............
Sorghum, grain ...............
Sorgum, stover ...............
Soursop ..........................
Soybean, meal ................
Soybean, seed ................
Spanish lime ...................
Star apple .......................
Starfruit ...........................
Strawberry ......................
E:\FR\FM\11AUR1.SGM
11AUR1
Parts Per Million
1.0
1.0
48.0
8.0
0.3
0.3
0.3
6.0
0.3
0.3
0.3
3.5
0.30
1.0
3.5
6.0
3.5
3.5
3.5
3.0
3.0
1.0
0.1
0.05
0.05
0.05
0.05
0.05
0.05
2.0
0.05
6.0
3.0
1.0
1.0
1.0
0.05
3.0
0.05
0.90
0.4
0.9
0.05
0.05
0.05
3.0
3.0
0.05
2.0
0.05
6.0
3.0
0.05
3.5
1.0
1.0
1.0
0.3
0.3
0.3
0.10
0.05
0.10
0.30
4.0
1.0
3.0
1.0
1.0
0.50
Federal Register / Vol. 71, No. 155 / Friday, August 11, 2006 / Rules and Regulations
Commodity
Parts Per Million
Sugar apple ....................
Sunflower, seed ..............
Tomato, paste .................
Tomato, pomace (wet or
dried) ...........................
Tomato, puree ................
Vegetable, brassica
leafy, group 5 ..............
Vegetable, cucurbit,
group 9 ........................
Vegetable, fruiting, group
8 ..................................
Vegetable, leaves of root
and tuber, group 2 ......
Vegetable, legume, except soybean, group 6
Vegetable, root and
tuber, group 1, except
sugar beet ...................
Watercress ......................
Watercress, upland .........
Wax jambu ......................
Wheat, forage .................
Wheat, grain ...................
Wheat, hay .....................
Wheat, straw ...................
0.30
0.05
6.0
4.O
3.0
1.0
4.0
4.0
0.40
3.5
3.5
1.0
7.0
0.05
0.5
0.5
rwilkins on PROD1PC63 with RULES
Parts Per Million
Forage, fodder, and
straw of Grain, cereal
crop group (forage) .....
Forage, fodder, and
straw of Grain, cereal
crop group (hay) .........
Forage, fodder, and
straw of Grain, cereal
crop group (stover) .....
Forage, fodder, and
straw of Grain, cereal
crop group (straw) .......
Grain, cereal, group 15 ..
Sweet corn, kernel plus
cob with husks removed .........................
Vegetable, foliage of legume, group 7 ...............
Vegetable, legume, crop
group 6 ........................
2.0
6.0
0.3
3.0
0.05
0.05
2.5
0.3
[FR Doc. E6–13092 Filed 8–10–06; 8:45 am]
BILLING CODE 6560–50–S
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40 CFR Part 180
16:23 Aug 10, 2006
Jkt 208001
DC 20460–0001; telephone number:
(703) 305–6463; e-mail address:
madden.barbara@epa.gov.
SUPPLEMENTARY INFORMATION:
[EPA–HQ–OPP–2006–0366; FRL–8081–7]
I. General Information
Bifenthrin; Pesticide Tolerance
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:
• Crop production (NAICS 111), e.g.,
agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS 112),
e.g., cattle ranchers and farmers, dairy
cattle farmers, livestock farmers.
• Food manufacturing (NAICS 311),
e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
This listing is not intended to be
exhaustive, but rather 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.
Environmental Protection
Agency (EPA).
0.5 ACTION: Final rule.
3.5
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
Tolerances are established for indirect
or inadvertent combined residues of the
insecticide imidacloprid (1-[(6-chloro-3pyridinyl)methyl]-N-nitro-2imidazolidinimine) and its metabolites
containing the 6-chloropyridinyl
moiety, all expressed as 1-[(6-chloro-3pyridinyl)methyl]-N-nitro-2imidazolidinimine, 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
ENVIRONMENTAL PROTECTION
AGENCY
46117
AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of bifenthrin in
or on Vegetable, tuberous and corm,
subgroup 1C; Brassica, leafy greens,
subgroup 5B; turnip, greens; Pea and
bean, dried shelled, except soybean,
subgroup 6C; coriander, leaves;
coriander, dried leaves; coriander, seed
and okra. Interregional Research Project
Number 4 (IR-4) requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection
Act of 1996 (FQPA). EPA is also
deleting an existing time-limited
bifenthrin tolerance that is no longer
needed as a result of this action.
DATES: This regulation is effective
August 11, 2006. Objections and
requests for hearings must be received
on or before October 10, 2006, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0366. All documents in the
docket are listed in the index for the
docket. 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
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive,
Arlington, VA. The 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.
FOR FURTHER INFORMATION CONTACT:
Barbara Madden, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
PO 00000
Frm 00045
Fmt 4700
Sfmt 4700
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s pilot e–CFR site at https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of the FFDCA, as
amended by the FQPA, any person may
file an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
E:\FR\FM\11AUR1.SGM
11AUR1
Agencies
[Federal Register Volume 71, Number 155 (Friday, August 11, 2006)]
[Rules and Regulations]
[Pages 46110-46117]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-13092]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0542; FRL-8081-8]
Imidacloprid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for combined residues
of imidacloprid and its metabolites containing the 6-chloropyridinyl
moiety, all expressed as the parent in or on caneberry subgroup 13A;
coffee, green bean; seed of: Black mustard, borage, crambe, field
mustard, flax, Indian mustard, Indian rapeseed, rapeseed, safflower,
and sunflower; atemoya, biriba, cherimoya, custard apple, ilama,
soursop, and sugar apple; almond hulls, pistachio and tree nut group
14; pomegranate; banana; herbs subgroup 19A dried; and herbs subgroup
19A fresh. Interregional Research Project No. 4 (IR-4), requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective August 11, 2006. Objections and
requests for hearings must be received on or before October 10, 2006,
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-2005-0542. All documents in the
docket are listed in the index for the docket. 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 https://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The 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.
FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-6463; e-mail address: madden.barbara@epa.gov..
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
[[Page 46111]]
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 Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at https://
www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized Guidelines
referenced in this document, go directly to the guidelines at https://
www.epa.gpo/opptsfrs/home/guidelin.htm.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may 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. 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-2005-0542 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 October 10, 2006.
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 your copies, identified by docket ID
number EPA-HQ-OPP-2005-0542, by one of the following methods:
Federal eRulemaking Portal: https://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
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of March 22, 2006 (71 FR 14524) (FRL-7769-
7), 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
3E6543, PP 3E6561, PP 3E6738, PP 3E6760, PP 5E6920, PP 5E6921, PP
5E6922, PP 5E6923) by Interregional Research Project No. 4 (IR-4), 681
U.S. Highway No. 1 South, North Brunswick, NJ 08902-3390. The petitions
requested that 40 CFR 180.472 be amended by establishing tolerances for
residues of the insecticide imidacloprid, 1-[(6-chloro-3-
pyridinyl)methyl]-N-nitro-2-imidazolidinimine, and its metabolites
containing the 6-chloropyridinyl moiety, all expressed as imidacloprid
in or on the raw agricultural commodities as follows: Caneberry
subgroup 13A at 0.05 parts per million (ppm) (PP 3E6543); coffee at 0.6
ppm (PP 3E6561); seed of: Black mustard, borage, crambe, field mustard,
flax, Indian mustard, Indian rapeseed, rapeseed, safflower, and
sunflower at 0.05 ppm (PP 3E6738); atemoya, biriba, cherimoya, custard
apple, ilama, soursop, and sugar apple at 0.2 ppm (PP 3E6760); almond
hulls at 2.5 ppm; and pistachio and tree nut group 14 at 0.01 ppm (PP
5E6920); pomegranate at 0.7 ppm (PP 5E6921); banana at 0.6 ppm (PP
5E6922); herbs subgroup 19A dried at 62.0 ppm and herbs subgroup 19A
fresh at 6.0 ppm (PP 5E6923).
Tolerances were later amended as follows: Coffee at 0.80 ppm (PP
3E6561); atemoya, biriba, cherimoya, custard apple, ilama, soursop, and
sugar apple at 0.30 ppm (PP 3E6760); almond hulls at 4.0 ppm; and
pistachio and tree nut group 14 at 0.05 ppm (PP 5E6920); pomegranate at
0.90 ppm (PP 5E6921); banana at 0.50 ppm (PP 5E6922); herb subgroup,
19A, herbs, dried at 48.0 ppm and herb subgroup, 19A, herbs, fresh at
8.0 ppm (PP 5E6923).
In addition to establishing tolerances, EPA is also deleting
several established tolerances from the tables in Sec. 180.472(a),
(b), and (d) that are no longer needed as a result of this action. The
tolerance deletions under Sec. 180.472(b) are time-limited tolerances
established under section 18 emergency exemptions that are superceded
by the establishment of general tolerances for imidacloprid and its
metabolites under Sec. 180.472(a).
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....''
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 https://www.epa.gov/
fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
III. Aggregate Risk Assessment and Determination of Safety
Consistent with 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, consistent with section
408(b)(2) of FFDCA, for tolerances for combined residues of the
insecticide imidacloprid, 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine, and its metabolites containing the 6-chloropyridinyl
moiety, all expressed as imidacloprid in or on caneberry
[[Page 46112]]
subgroup 13A at 0.05 parts per million (ppm); coffee, green bean at
0.80 ppm; seed of: Black mustard, borage, crambe, field mustard, flax,
Indian mustard, Indian rapeseed, rapeseed, safflower, and sunflower at
0.05 ppm; atemoya, biriba, cherimoya, custard apple, ilama, soursop,
and sugar apple at 0.30 ppm; almond hulls at 4.0 ppm; pistachio and
tree nut group 14 at 0.05 ppm; pomegranate at 0.90 ppm; banana at 0.50
ppm; herb subgroup, 19A, herbs, dried at 48.0 ppm and herb subgroup,
19A, herbs, fresh at 8.0 ppm. EPA's assessment of exposures and risks
associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the toxic 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 https://
www.epa.gov/fedrgstr/EPA-PEST/2003/June/Day-13/p14880.htm.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the dose at which the NOAEL from the toxicology study
identified as appropriate for use in risk assessment is used to
estimate the toxicological level of concern (LOC). However, 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.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at https://www.epa.gov/pesticides/health/human.htm.
A summary of the toxicological endpoints for imidacloprid used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of June 13, 2003 (68 FR 35303) (FRL-
7310-8), or at https://www.epa.gov/fedrgstr/EPA-PEST/2003/June/Day-13/
p14880.htm.
C. 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. Risk assessments were conducted by EPA to
assess 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.
The Dietary Exposure Evaluation Model - Food Commodity Intake
Database (DEEM-FCID\TM\) analysis evaluated the individual food
consumption 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 following assumptions were made for
the acute exposure assessments: An unrefined, acute dietary exposure
assessment using tolerance-level residues and assuming 100 pecent crop
treated (PCT) for all registered and proposed commodities was conducted
for the general U.S. population and various population subgroups.
Drinking water was incorporated directly in the dietary assessment
using the acute (peak) concentration for surface water generated by the
FQPA Index Reservoir Screening Tool (FIRST) model.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the DEEM-FCID\TM\, which incorporates food
consumption data as reported by respondents in the USDA 1994-1996 and
1998 nationwide CSFII, and accumulated exposure to the chemical for
each commodity. The following assumptions were made for the chronic
exposure assessments: A partially refined, chronic dietary exposure
assessment using tolerance-level residues for all registered and
proposed commodities, and PCT information for some commodities was
conducted for the general U.S. population and various population
subgroups. Drinking water was incorporated directly into the dietary
assessment using the chronic (annual average) concentration for surface
water generated by the FIRST model.
iii. Cancer. An exposure assessment related to cancer risk is
unnecessary. The Agency has classified imidacloprid as a ``Group E''
chemical, no evidence of carcinogenicity for humans, by all routes of
exposure based upon lack of evidence of carcinogenicity in rats and
mice.
iv. Anticipated residue and PCT information. Section 408(b)(2)(F)
of FFDCA states that the Agency may use data on the actual percent of
food treated for assessing chronic dietary risk only if 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 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 30%;
artichokes 5%; beets 15%; blueberries 10%; broccoli 35%; brussels
sprouts 55%; cabbage 20%; cantaloupe 30%; carrots 1%; cauliflower 40%;
celery 5%; cherries 5%; collards 10%; corn, field 1%; cotton 5%;
cucumber 5%; eggplant 45%; grapefruit 5%; grape 30%; honeydew 10%; hops
90%; kale 30%; lemon 1%; lettuce, head 60%; orange 5%; peaches 5%; pear
10%; pepper 25%; potatoes 35%; pumpkin 5%; spinach 20%; squash 10%;
strawberries 10%; sugarbeet 1%; sweet corn 1%; tangerine 10%; tomato
15%; watermelon 10%. A default value of 1% was used for all commodities
which were reported as having 1 PCT.
[[Page 46113]]
EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available Federal, State, and private market survey data for that use,
averaging by year, averaging across all years, and rounding up to the
nearest multiple of 5% except for those situations in which the average
PCT is less than 1. In those cases 1% is used as the average and 2.5%
is used as the maximum. EPA uses a maximum PCT for acute dietary risk
analysis. The maximum PCT figure is the single maximum value reported
overall from available Federal, State, and private market survey data
on the existing use, across all years, and rounded up to the nearest
multiple of 5%. In most cases, EPA uses available data from USDA/
National Agricultural Statistics Service (USDA/NASS), Proprietary
Market Surveys, and the National Center for Food and Agriculture Policy
(NCFAP) for the most recent 6 years.
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. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/models/water/index.htm.
Based on the FIRST and screening concentration in ground water
(SCI-GROW) models, the estimated environmental concentrations (EECs) of
imidacloprid for acute exposures are estimated to be 36.0 parts per
billion (ppb) for surface water and 2.09 ppb for ground water. The EECs
for chronic exposures are estimated to be 17.2 ppb for surface water
and 2.09 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model (DEEM-FCID\TM\, Version 2.03).
For acute dietary risk assessment, the peak water concentration value
of 36.0 ppb was used to access the contribution to drinking water. For
chronic dietary risk assessment, the annual average concentration of
17.2 ppb was used to access 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 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 to be addressed in terms of residential pesticide
handlers. The risk assessment was conducted using the following
residential exposure assumptions: EPA has determined that residential
handlers are likely to be exposed to imidacloprid residues via dermal
and inhalation routes during handling, mixing, loading, and applying
activities. Based on the current use patterns, EPA expects duration of
exposure to be short-term (1-30 days). EPA does not expect imidacloprid
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:
Dermal and inhalation exposure from using a granular push-
type spreader;
Dermal exposure from using potted plant spikes;
Dermal exposure from using a plant potting medium;
Dermal and inhalation exposure from using a garden hose-
end sprayer (dermal and inhalation exposure from using a RTU trigger
pump spray is expected to be negligible);
Dermal and inhalation exposure from using a water can/
bucket for soil drench applications; and
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:
Toddler oral hand-to-mouth exposure from contacting
treated turf;
Toddler incidental oral ingestion of granules;
Toddler incidental oral ingestion of pesticide-treated
soil;
Toddler incidental oral exposure from contacting treated
pet;
Toddler dermal exposure from contacting treated turf;
Toddler dermal exposure from hugging treated pet/
contacting treated pet;
Adult dermal exposure from contacting treated turf;
Adult golfer dermal exposure from contacting treated turf;
Adolescent golfer dermal exposure from contacting treated
turf; and
Adult dermal exposure from contacting treated pet;
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to imidacloprid and any other
substances and imidacloprid does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that imidacloprid has
a common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see 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 https://www.epa.gov/pesticides/
cumulative.
[[Page 46114]]
D. Safety Factor for Infants and Children
1. In general. Section 408 of 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 based on reliable data 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 exposure (MOE) analysis or through using uncertainty (safety)
factors in calculating a dose level that poses no appreciable risk to
humans. In applying this provision, EPA either retains the default
value of 10X when reliable data do not support the choice of a
different factor, or, if reliable data are available, EPA uses a
different additional safety factor (SF) value based on the use of
traditional uncertainty factors and/or special FQPA safety factors, as
appropriate.
2. Prenatal and postnatal sensitivity. There is no quantitative or
qualitative evidence of increased susceptibility of rat and rabbit
fetuses to in utero exposure in developmental studies. There is no
quantitative or qualitative evidence of increased susceptibility of rat
offspring in the multi-generation reproduction study. There is evidence
of increased qualitative susceptibility in the rat developmental
neurotoxicity study, but the concern is low since:
i. The effects in pups are well-characterized with a clear NOAEL;
ii. The pup effects occur in the presence of maternal toxicity with
the same NOAEL for effects in pups and dams; and,
iii. The doses and endpoints selected for regulatory purposes are
protective of the pup effects noted at higher doses in the
developmental neurotoxicity study. Therefore, there are no residual
uncertainties for 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:
The toxicological data base is complete for FQPA assessment.
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.
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. These
assessments of exposure are not likely to underestimate the resulting
estimates of risk from exposure to imidacloprid.
E. Aggregate Risks and Determination of Safety
The Agency currently has two ways to estimate total aggregate
exposure to a pesticide from food, drinking water, and residential
uses. First, a screening assessment can be used, in which the Agency
calculates drinking water levels of comparison (DWLOCs) which are used
as a point of comparison against estimated drinking water
concentrations (EDWCs). The DWLOC values are not regulatory standards
for drinking water, but 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. More information on the use
of DWLOCs in dietary aggregate risk assessments can be found at https://
www.epa.gov/oppfead1/trac/science/screeningsop.pdf.
More recently the Agency has used another approach to estimate
aggregate exposure through food, residential and drinking water
pathways. In this approach, modeled surface water and ground water
EDWCs are directly incorporated into the dietary exposure analysis,
along with food. This provides a more realistic estimate of exposure
because actual body weights and water consumption from the CSFII are
used. The combined food and water exposures are then added to estimated
exposure from residential sources to calculate aggregate risks. The
resulting exposure and risk estimates are still considered to be high
end, due to the assumptions used in developing drinking water modeling
inputs. The risk assessment for imidacloprid used in this tolerance
document uses this approach of incorporating water exposure directly
into the dietary exposure analysis.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to imidacloprid will occupy 26% of the acute population adjusted dose
(aPAD) for the U.S. population, 18% of the aPAD for females 13 years
and older, 54% of the aPAD for all infants 1 year old, and 67% of the
aPAD for children 1-2 years old. EPA does not expect the aggregate
exposure to exceed 100% of the aPAD.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
imidacloprid from food and water will utilize 11% of the chronic
population adjusted dose (cPAD) for the U.S. population, 22% of the
cPAD for all infants 1 year old, and 33% of the cPAD for children 1-2
years old. Based on the use pattern, chronic residential exposure to
residues of imidacloprid is not expected. EPA does not expect the
aggregate exposure to exceed 100% of the cPAD.
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Imidacloprid is currently registered for use that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for imidacloprid.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures
aggregated result in worst-case aggregate MOEs of 320 for the general
U.S. population and 170 for children 1-2 years old, the sub-population
at greatest exposure. These
[[Page 46115]]
aggregate MOEs do not exceed the Agency's LOC for aggregate exposure to
food, water and residential uses.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Intermediate- 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- or
long-term exposures.
5. Aggregate cancer risk for U.S. population. The Agency has
classified imidacloprid as a ``Group E'' chemical, no evidence of
carcinogenicity for humans, by all routes of exposure based upon lack
of evidence of carcinogenicity in rats and mice. Imidacloprid is not
expected to pose a cancer risk.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to imidacloprid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methods are available for determination of
imidacloprid residues of concern in plant (Bayer Gas Chromatography/
Mass Spectrometry (GC/MS) Method 00200) and livestock commodities
(Bayer GC/MS Method 00191). These methods have undergone successful EPA
petition method validations (PMVs), and the registrant has fulfilled
the remaining requirements for additional raw data, method validation,
independent laboratory validation (ILV), and an acceptable confirmatory
method (High Performance Liquid Chromatography/Ultraviolet (HPLC/UV)
Method 00357). The validated limit of detection (LOD) and limit of
quantitation (LOQ) for the GC/MS Method 00200 are 0.01 and 0.05 ppm,
respectively, in plant commodities. 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 established Mexican maximum residue limits (MRLs) for
the proposed 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 rapeseed at 0.05 ppm and
banana at 0.05 ppm. In addition, there is currently Canadian MRLs for:
1-[(6-chloro-3-pyridinyl) methyl]-4,5-dihydro-N-nitro-1H-imidazol-2-
amine, including metabolites containing the 6-chloropicolyl moiety in
or on mustard, seed at 0.05 ppm, rapeseed (canola) at 0.05 ppm and
pecans at 0.05 ppm. The Codex and Canadian MRLs for rapeseed (canola)
is the same as the U.S. recommended tolerance for rapeseed, seed; and
the Canadian MRL for pecans is the same as the U.S. recommended
tolerance. However, the Canadian MRL for banana is not equivalent to
the U.S. recommended tolerance as the available crop field trial data
supported a higher tolerance level. Therefore, harmonization is not
possible at this time.
V. Conclusion
Therefore, the tolerances are established for combined residues of
the insecticide imidacloprid, 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-
2- imidazolidinimine, and its metabolites containing the 6-
chloropyridinyl moiety, all expressed as imidacloprid in or on
caneberry subgroup 13A at 0.05 ppm; coffee, green bean at 0.80 ppm;
seed of: Black mustard, borage, crambe, field mustard, flax, Indian
mustard, Indian rapeseed, rapeseed, safflower, and sunflower at 0.05
ppm; atemoya, biriba, cherimoya, custard apple, ilama, soursop, and
sugar apple at 0.30 ppm; almond hulls at 4.0 ppm; pistachio at 0.05
ppm; tree nut group 14 at 0.05 ppm; pomegranate at 0.90 ppm; banana at
0.50 ppm; herb subgroup, 19A, herbs, dried at 48.0 ppm and herb
subgroup, 19A herbs, fresh at 8.0 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 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
petition under section 408(d) of FFDCA, such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. 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 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
[[Page 46116]]
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.
VII. 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: August 1, 2006.
Lois Rossi,
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 permitting the combined
residues of the insecticide imidacloprid (1-[6-chloro-3-pyridinyl)
methyl]-N-nitro-2-imidazolidinimine) and its metabolites containing the
6-chloropyridinyl moiety, all expressed as 1-[(6-chloro-3-
pyridinyl)methyl]-N-nitro-2-imidazolidinimine, in or on the following
food commodities:
------------------------------------------------------------------------
Commodity Parts Per Million
------------------------------------------------------------------------
Acerola.............................................. 1.0
Almond, hulls........................................ 4.0
Apple................................................ 0.5
Apple, wet pomace.................................... 3.0
Atemoya.............................................. 0.30
Artichoke, globe..................................... 2.5
Avocado.............................................. 1.0
Banana............................................... 0.50
Barley, grain........................................ 0.05
Barley, hay.......................................... 0.5
Barley, straw........................................ 0.5
Beet, sugar, roots................................... 0.05
Beet, sugar, tops.................................... 0.5
Beet, sugar, molasses................................ 0.3
Biriba............................................... 0.30
Blueberry............................................ 3.5
Borage, seed......................................... 0.05
Caneberry, subgroup 13A.............................. 0.05
Canistel............................................. 1.0
Canola, seed......................................... 0.05
Cattle, fat.......................................... 0.3
Cattle, meat byproducts.............................. 0.3
Cattle, meat......................................... 0.3
Cherimoya............................................ 0.3
Citrus, dried pulp................................... 5.0
Coffee, green bean................................... 0.80
Corn, field, forage.................................. 0.10
Corn, field, grain................................... 0.05
Corn, field, stover.................................. 0.20
Corn, pop, grain..................................... 0.05
Corn, pop, stover.................................... 0.20
Corn, sweet, forage.................................. 0.10
Corn, sweet, kernel plus cob with husks removed...... 0.05
Corn, sweet, stover.................................. 0.20
Cotton, gin byproducts............................... 4.0
Cotton, undelinted seed.............................. 6.0
Cotton, meal......................................... 8.0
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.............................. 0.7
Fruit, pome, group 11................................ 0.6
Fruit, stone, group 12............................... 3.0
Goat, fat............................................ 0.3
Goat, meat byproducts................................ 0.3
Goat, meat........................................... 0.3
Gooseberry........................................... 3.5
Grape, juice......................................... 1.5
Grape, pomace (wet or dried)......................... 5.0
Grape, raisin........................................ 1.5
Grape, raisin, waste................................. 15.0
Grape................................................ 1.0
Guava................................................ 1.0
Herbs subgroup 19A, dried herbs...................... 48.0
Herbs subgroup 19B, fresh herbs...................... 8.0
Hog, fat............................................. 0.3
Hog, meat byproducts................................. 0.3
Hog, meat............................................ 0.3
Hop, dried cone...................................... 6.0
Horse, fat........................................... 0.3
Horse, meat byproducts............................... 0.3
Horse, meat.......................................... 0.3
Huckleberry.......................................... 3.5
Ilama................................................ 0.30
Jaboticaba........................................... 1.0
Juneberry............................................ 3.5
Leaf petioles subgroup 4B............................ 6.0
Leafy greens subgroup 4A............................. 3.5
Lettuce, head and leaf............................... 3.5
Lingonberry.......................................... 3.5
Longan............................................... 3.0
Lychee............................................... 3.0
Mango................................................ 1.0
Milk................................................. 0.1
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
Oats, forage......................................... 2.0
Oats, grain.......................................... 0.05
Oats, hay............................................ 6.0
Oats, straw.......................................... 3.0
Okra................................................. 1.0
Passionfruit......................................... 1.0
Papaya............................................... 1.0
Pecans............................................... 0.05
Persimmon............................................ 3.0
Pistachio............................................ 0.05
Pomegranate.......................................... 0.90
Potato, chip......................................... 0.4
Potato, waste........................................ 0.9
Poultry, fat......................................... 0.05
Poultry, meat byproducts............................. 0.05
Poultry, meat........................................ 0.05
Pulasan.............................................. 3.0
Rambutan............................................. 3.0
Rapeseed, seed....................................... 0.05
Rye, forage.......................................... 2.0
Rye, grain........................................... 0.05
Rye, hay............................................. 6.0
Rye, straw........................................... 3.0
Safflower, seed...................................... 0.05
Salal................................................ 3.5
Sapodilla............................................ 1.0
Sapote, black........................................ 1.0
Sapote, mamey........................................ 1.0
Sheep, fat........................................... 0.3
Sheep, meat byproducts............................... 0.3
Sheep, meat.......................................... 0.3
Sorghum, forage...................................... 0.10
Sorghum, grain....................................... 0.05
Sorgum, stover....................................... 0.10
Soursop.............................................. 0.30
Soybean, meal........................................ 4.0
Soybean, seed........................................ 1.0
Spanish lime......................................... 3.0
Star apple........................................... 1.0
Starfruit............................................ 1.0
Strawberry........................................... 0.50
[[Page 46117]]
Sugar apple.......................................... 0.30
Sunflower, seed...................................... 0.05
Tomato, paste........................................ 6.0
Tomato, pomace (wet or dried)........................ 4.O
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, except soybean, group 6........... 4.0
Vegetable, root and tuber, group 1, except sugar beet 0.40
Watercress........................................... 3.5
Watercress, upland................................... 3.5
Wax jambu............................................ 1.0
Wheat, forage........................................ 7.0
Wheat, grain......................................... 0.05
Wheat, hay........................................... 0.5
Wheat, straw......................................... 0.5
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. Tolerances are established
for indirect or inadvertent combined residues of the insecticide
imidacloprid (1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine) and its metabolites containing the 6-chloropyridinyl
moiety, all expressed as 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine, 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
------------------------------------------------------------------------
Forage, fodder, and straw of Grain, cereal crop group 2.0
(forage)............................................
Forage, fodder, and straw of Grain, cereal crop group 6.0
(hay)...............................................
Forage, fodder, and straw of Grain, cereal crop group 0.3
(stover)............................................
Forage, fodder, and straw of Grain, cereal crop group 3.0
(straw).............................................
Grain, cereal, group 15.............................. 0.05
Sweet corn, kernel plus cob with husks removed....... 0.05
Vegetable, foliage of legume, group 7................ 2.5
Vegetable, legume, crop group 6...................... 0.3
------------------------------------------------------------------------
[FR Doc. E6-13092 Filed 8-10-06; 8:45 am]
BILLING CODE 6560-50-S