  SEQ CHAPTER \h \r 1

	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:		5/14/07

Subject:	Amended. Imidacloprid.  Section 3 Requests for Uses on Peanut,
Proso Millet, Pearl Millet, Oat, Kava, Globe Artichoke, Caneberries,
Wild Raspberry, and Soybeans. Summary of Analytical Chemistry and
Residue Data.  PP# 6E7116, 6E7108, & 6F7049.

DP#s:	332757, 333517, & 334153	Decision #:	370491,371243 & 365863

PC Code:	129099	40 CFR:	180.472

MRID#s:	46785001-02, 46952901, 46927301, & 47035901

From:		W. Cutchin, Acting Branch Senior Scientist

	Alternative Risk Integration Assessment Team (ARIA)

	Risk Integration Minor Use and Emergency Response Branch (RIMUERB)

		Registration Division (RD) (7505P)

Through:	G. Kramer, Ph.D., Senior Chemist

		Registration Action Branch (RAB1)

		Health Effects Division (HED) (7509P)

To:		S. Jackson/D. Rosenblatt, PM Team 05

		RIMUERB/RD (7505P)

Executive Summary

The Interregional Research Project No. 4 (IR-4), on behalf of the
Agricultural Experiment Stations of Texas, Missouri, Georgia, Wisconsin,
and Hawaii, has submitted a petition for the use of imidacloprid on
peanuts; proso and pearl millet; oats; kava; globe artichoke; caneberry,
subgroup13A; and wild raspberry.  IR-4 is not requesting a change in the
existing tolerance for globe artichokes; the request is for the addition
of a soil use to the existing foliar use.  Bayer Corp. has also
submitted a petition for the use of imidacloprid on soybeans.    SEQ
CHAPTER \h \r 1 Imidacloprid
(1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-imidazolidinimine) is an
insecticide registered for uses on a variety of crops for the control of
aphids, cucumber beetles and whiteflies (including sweet potato or
Silverleaf whitefly).  Imidacloprid is a member of the
pyridylmethylamine class of compounds.

In conjunction with these petitions, the following tolerances have been
requested for 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:

Commodity	Proposed Tolerance

(ppm)

Peanut	0.45

Peanut, hay	70

Peanut, meal	0.9

Millet, proso, grain	0.05

Millet, pearl, grain	0.05

Oat, grain	0.05

Kava, roots	0.4

Kava, leaves	4.0

Caneberry, subgroup 13A	2.5

Raspberry, wild	2.5

Soybean, seed	1.6

Soybean, forage	8.0

Soybean, hay	30

Soybean, aspirated grain fractions	240

The petitioners have submitted sample labels for numerous imidacloprid
products.  The uses on peanuts and kava include both an in-furrow spray
on or below seed during or before planting and a foliar use. The peanut
and kava seed use is for a single application at 0.38 pounds active
ingredient per acre (lb ai/A).  The foliar uses on peanut and kava are
for up to 3 applications for a total 0.13 lb ai/A with pre-harvest
intervals (PHI) of 14 days for peanut and 7 days for kava.  The uses on
millet and oats include commercial seed treatment or below seed during
or before planting at 0.25 or 0.09 lb ai/100lb seed, respectively.  The
use on globe artichoke includes both an in-furrow spray on or below seed
during or before planting at and a foliar use, both at 0.5 lb ai/A with
a 7-day PHI.  These use directions are adequate.

The labels for caneberries indicate either a foliar application at 0.3
lb ai/A with a 3-day PHI or a drench application 0.5 lb ai/A with a
7-day PHI.  Since the previous lower tolerance for caneberries was based
using the drench application at the higher rate, the use is supported
may remain on the labels.

There is an existing use of imidacloprid on soybean seeds for protection
from damage caused by seed corn maggot, to reduce feeding damage caused
by soybean aphids and over-wintering bean leaf beetles, and to help
suppress the spread of certain viruses, at 2.0-4.0 fl. oz. per
hundredweight of seed.  The requested foliar use on soybeans is in
addition to the current use on soybean seeds for three applications at
0.047 lb ai/A with a maximum total application of 0.14 lb ai/A.  These
use directions are adequate.

The nature of imidacloprid residues in plants and livestock is
adequately understood.  The residue of concern in plants and livestock
is imidacloprid and its metabolites containing the 6-chloropyridinyl
moiety, all expressed as the parent.

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).  Bayer GC/MS Method 00200 is a
common moiety method that uses oxidation of parent and metabolites to
6-chloronicotinic acid (6-CNA) with demonstrated limit of detection
(LOD) and limit of quantitation (LOQ) at 0.01 and 0.05 ppm,
respectively, in plant commodities.  Previously submitted multiresidue
methods (MRM) recovery data for imidacloprid and the metabolites
5-hydroxy imidacloprid, imidacloprid olefin, des nitro imidacloprid and
6-CNA indicate that these residues were not recoverable by these
methods.

Samples in the submitted peanut crop field trial and processing studies
were for analyzed for combined residues of imidacloprid and its
metabolites containing 6-chloropyridinyl moiety, all expressed as the
parent, using a modification of Bayer GC/MS Method 00200.  The LOD and
LOQ were calculated as 0.03 ppm and 0.076 ppm for nutmeat; 0.01 ppm and
0.033 ppm, for oil; and 0.02 ppm and 0.062 ppm for meal.

For caneberries, total residues of imidacloprid were determined using a
working method based on Bayer Method 00200.  The lower limit of method
validation (LLMV) of the modified method in this study was reported as
0.05 ppm.  LODs were estimated as 0.009 ppm, 0.02 ppm and 0.03 ppm for
raspberry, marionberry and boysenberry, respectively.  Another
analytical method was used in the caneberry trial designated as Study
No. AAFC03-085R.  The method used quantitation by high performance
liquid chromatography with mass spectroscopy detector (HPLC/MS).  The
LLMV in this study was reported as 0.30 ppm.  The LOD and LOQ were
calculated to be 0.068 ppm and 0.203 ppm, respectively.  However, total
residues of imidacloprid were determined to be below the LLMV (<0.30
ppm) and/or calculated LOQ (<0.203 ppm) at all PHIs.  As the method used
could not be validated at the target LOQ (0.05 ppm), the method LLMV was
unacceptably high and the residues reported at each PHI were below the
LLMV, this residue study is considered scientifically unacceptable.
Therefore, the results from this trial should not be used to support the
registration of imidacloprid in/on caneberries.

The total imidacloprid residue was analyzed in soybean field trial and
processing samples by a common moiety method (oxidation to 6-CNA) and
quantitated by liquid chromatography with tandem mass spectroscopy
detection (LC-MS/MS).  The method in these studies, NT-001-P04-01, is
based on an earlier method, 00834.  The LOQ for imidacloprid in soybean
forage, hay, and seed was 0.025 ppm, 0.100 ppm, and 0.05 ppm,
respectively.  The calculated LODs for soybean forage, hay, and seed
were 0.0111 ppm, 0.0382 ppm, and 0.0136 ppm, respectively.  The data
from the soybean processing study support a method LOQ of 0.050 ppm for
each analyte in soybean seed and processed commodities.  The method is
adequate for data collection purposes.

Residues of imidacloprid have previously been shown to be stable in a
variety of raw agricultural commodities (RACs) for up to 2 years.  In
addition, analysis of samples from the 14C-imidacloprid plant metabolism
studies for corn, cotton, apples, and potatoes showed no loss of
imidacloprid and its major metabolites during a period of 2 years of
frozen storage.  The maximum storage interval for field-treated samples
in the peanut studies was approximately 4 years (1489 days for nutmeat,
1506 days for oil, 1662 days for hay, and 1534 days for meal).  Storage
stability testing performed after approximately 4.4 years of frozen
storage (1600 days for both nutmeat and oil, 1609 days for hay, and 1595
days for meal) showed no appreciable degradation.  Caneberries were
stored frozen for up to 87 days.  Concurrent storage stability studies
with marionberries indicated that residues were stable when frozen for
up to 75 days.  The soybean field trial samples analyzed in this study
were held in frozen storage for a maximum of 15 months (450 days) prior
to extraction.  Soybean aspirated grain fractions and the processed
commodities of soybean seed were analyzed within 3.1 months (95 days) of
production.

The expected residue levels in the livestock feed items associated with
the subject petition were used to recalculate the maximum theoretical
dietary burden (MTDB) for livestock  The newly calculated MTDBs are
insufficient raise the existing tolerances on cattle commodities.
Therefore, the proposed uses will not require an increase in livestock
tolerances.

Twelve peanut field trials were conducted using a single in-furrow
applications at a rate of approximately 0.375 lb ai/A at planting
followed by foliar applications made 4 to 6 days apart at a rate of
approximately 0.044 lb ai/A for a total of approximately 0.507 lb ai/A.
In addition to peanuts and hay harvested 13 to 15 days PHI, each
commodity was harvested at 21 and 28 days at the 98-TX17 trial for
decline determination.  The results from the trials show that the
maximum combined residues in nutmeat were 0.40 ppm.  Maximum residues in
14-day and 28-day hay samples were 24 ppm.  Residues declined in nutmeat
to a maximum of 0.14 ppm by 28 days. The submitted studies are adequate
in number and geographic diversity and are supported by adequate storage
stability data and analytical methodology.  However, the residue data as
analyzed by the Tolerance/MRL Harmonization Spreadsheet indicates that
the requested tolerances on peanut nutmeat and hay are not appropriate.
A new Section F requesting imidacloprid tolerances on peanuts at 0.60
ppm and peanut, hay at 35 ppm is required.

No crop-specific data to support the tolerance requests in conjunction
with the requested uses for proso millet, pearl millet, and oats. There
are existing tolerances for residues of imidacloprid on barley, grain;
corn, field, grain; corn, pop, grain; corn, sweet, kernel plus cob with
husks removed; oats, grain; rye, grain; sorghum, grain; and wheat, grain
all at 0.05 ppm.  In addition, there is a tolerance for indirect or
inadvertent combined residues of imidacloprid on grain, cereal, group 15
also at 0.05 ppm.  Since there are identical seed treatment uses with
tolerances for most of the cereal grain crop group and a tolerance for
indirect or inadvertent residues on the cereal grain crop group,
tolerances can be translated to the seed treatment uses on proso millet
and pearl millet.  ARIA recommends for the proposed tolerances on proso
and pearl millet grain at 0.05 ppm.  In addition, residues would be
expected on the other millet RACs as residues are found on other grain
RACs from the same uses.  A revised Section F is required for proso
millet, forage at 2.0 ppm; proso millet, hay at 6.0 ppm; proso millet,
straw at 3.0 ppm; pearl millet, forage at 2.0 ppm; pearl millet, hay at
6.0 ppm; and pearl millet, straw at 3.0 ppm.

As noted above, there are already existing tolerances for the seed
treatment use on oats: oats, grain at 0.05 ppm; oats, forage at 2.0 ppm;
oats, hay at 6.0 ppm; oats, straw at 3.0 ppm as a result of the same
proposed seed treatment use as proposed here. The request for use and
tolerance for imidacloprid on oats is not necessary; the requested
tolerances should be removed from Section F.

No crop-specific data were submitted to support the tolerance requests
in conjunction with the requested use for kava.  Since kava is projected
to be part of the root and tuber vegetable crop group 1 in the near
future and the proposed use is identical to that used for root and tuber
vegetables, ARIA recommends for the proposed imidacloprid tolerances on
kava, leaves at 4.0 ppm and kava, roots at 0.4 ppm.

No new crop-specific data to support the tolerance requests in
conjunction with the requested use on globe artichoke.  A tolerance of
2.5 ppm has already been established for imidacloprid on globe
artichokes as a result of a foliar use.  IR-4 is now requesting a use
either below the seed row before planting, in-furrow during planting, or
by chemigation into the root zone. Comparisons of data on foliar vs.
limited soil-applied imidacloprid or the two treatments combined
indicate that the foliar treatments clearly drive the magnitude of the
resulting residues.  Any slight additional residues from soil treatments
are expected to be covered by existing tolerances established to reflect
foliar application.  Therefore, it is unlikely that the residues of
imidacloprid from the proposed soil treatment use on globe artichoke
will exceed the existing 2.5 ppm tolerance. ARIA recommends for the
proposed imidacloprid use on globe artichoke without a change in the
existing tolerance.

A previous petition for the use of imidacloprid on caneberries as drench
application 0.5 lb ai/A with a 7-day PHI resulted in a conditional
registration and permanent tolerance at 0.05 ppm.  The registration was
conditional until the submission of additional crop field trial data.
Residue data have now been submitted.  A total of ten trials were
conducted in the US and Canada.  Imidacloprid was applied to caneberries
in three foliar-directed broadcast sprays at a rate of 0.10 to 0.11 lb
ai/A/application at 6 to 11-day retreatment intervals (RTIs) for total
application rates of 0.30 to 0.31 lb ai/A.  Crops were harvested 2-4
days after the last application (DALA).  The maximum residues observed
in caneberries were 0.70 ppm in blackberry, 0.96 ppm in raspberry, 1.7
ppm in marionberry and 1.5 ppm in boysenberry.  The residue data as
analyzed by the Tolerance/MRL Harmonization Spreadsheet indicates that
the requested tolerance on caneberries, crop group 13A at 2.5 ppm is
appropriate.

The petitioner has requested a tolerance for wild raspberry.  The wild
raspberry is distributed in tropical northern Queensland in open forests
and the rainforest and is similar to raspberries and other Rubus
species.  U.S. growers are evaluating improved varieties.  ARIA will
extend the residue information to from the caneberry subgroup to wild
raspberries; therefore, a tolerance for the residues of imidacloprid on
wild caneberries at 2.5 ppm is appropriate.

Bayer Corp. submitted a total of 21 crop residue field trials on
soybeans.  The trials were conducted to measure the magnitude of
residues in soybeans resulting from the existing pre-plant seed
treatment followed by three foliar applications of imidacloprid to the
growing soybean plants.  The soybean seeds were treated at a nominal
rate of 0.125 lb ai/100 lb seed prior to planting.  The growing soybean
plants were subsequently treated with three foliar broadcast
applications of imidacloprid at a target rate of 0.047 lb ai/A.  Total
imidacloprid application rates (seed + foliar) ranged from 0.201 to
0.275 lb ai/A.  The highest imidacloprid residue on soybean forage and
hay at 0-day PHI was 8.87 ppm and 24.0 ppm, respectively.  The highest
imidacloprid residue on soybean seed at a 21-day PHI was 2.04 ppm.  The
total imidacloprid residue was found to decline significantly on soybean
forage with time.  In soybean hay, total imidacloprid residue was found
to decline significantly at one trial but remained relatively constant
at the other.  On soybean seed, total imidacloprid residue remained
constant with time.  The residue data as analyzed by the Tolerance/MRL
Harmonization Spreadsheet indicates that the requested tolerance on
soybean, forage is appropriate at 8.0 ppm.  However, the requested
tolerance levels on the other soybean commodities are not appropriate.
A new Section F requesting imidacloprid tolerances on soybean, seed at
3.5 ppm, and soybean, hay at 35 ppm is required.

There are many processed commodities of regulatory interest associated
with these petitions among which are millet flour, oat flour, and rolled
oats.  It has been determined that imidacloprid residues do not
concentrate in grain processed commodities; therefore, no imidacloprid
tolerances are required on millet and oat processed commodities.

The submitted peanut processing study indicates that imidacloprid
residues do not concentrate in peanut oil.  Therefore, a separate
tolerance for imidacloprid residues in peanut oil is not required.  The
average of the two processing studies indicates that imidacloprid
residues will concentrate at 2.5X in peanut meal ((1.9+3.1)/2).
However, this is higher than the theoretical maximum of 2.2X.  The
highest average field trial (HAFT) of 0.32 ppm times the theoretical
maximum of 2.2X yields an expected residue of 0.704 ppm in peanut meal.
Therefore, the requested tolerance for imidacloprid residues in peanut
meal at 0.9 ppm is not appropriate.  ARIA recommends for the
establishment of an imidacloprid tolerance on peanut, meal at 0.75 ppm.
A revised Section F requesting an imidacloprid tolerance on peanut, meal
at 0.75 ppm is required.

The submitted processing study indicates that imidacloprid residues do
not concentrate in soybean meal, hulls, or oil.  Therefore, a separate
tolerance for imidacloprid residues in soybean meal, hulls, or oil is
not required.  The processing study indicates that imidacloprid residues
will concentrate at 160X in aspirated grain fractions.  The HAFT of 1.50
ppm for soybean seed at the proposed application rate and PHI times the
empirical concentration value of 160X yields an expected residue of 240
ppm in aspirated grain fractions. The requested tolerance for
imidacloprid residues in aspirated grain fractions is appropriate.
However, the Agency does not differentiate soybean from other aspirated
grain fractions, therefore a revised Section F for aspirated grain
fractions at 240 ppm is required.

The rotational crop restrictions are adequate.

There are no international harmonization issues with these petitions.

Conclusion/Recommendations

Provided revised labels and Section F are submitted as specified, the
residue chemistry database supports the establishment of the permanent
tolerances for the combined residues of imidacloprid and its metabolites
containing the 6-chloropyridinyl moiety, all expressed as the parent,
in/on the RACs listed below.

Commodity	Recommended Tolerance (ppm)

Peanut	0.60

Peanut, hay	35

Peanut, meal	0.75

Millet, proso, grain	0.05

Millet, proso, forage 	2.0

Millet, proso, hay 	6.0

Millet, proso, straw 	3.0

Millet, pearl, grain	0.05

Millet, pearl, forage	2.0

Millet, pearl, hay	6.0

Millet, pearl, straw	3.0

Oat, grain	none

Kava, roots	0.4

Kava, leaves	4.0

Caneberry, subgroup 13A	2.5

Raspberry, wild	2.5

Soybean, seed	3.5

Soybean, forage	8.0

Soybean, hay	35

Aspirated grain fractions	240

A human-health risk assessment will be prepared as a separate document.

Residue Chemistry Deficiencies

A new Section F requesting imidacloprid tolerances on peanuts at 0.60
ppm and peanut, hay at 35 ppm is required.

The request for use and tolerance for imidacloprid on oats is not
necessary; the request should be removed from Section F.

A revised Section F is required for proso millet, forage at 2.0 ppm;
proso millet, hay at 6.0 ppm; proso millet, straw at 3.0 ppm; pearl
millet, forage at 2.0 ppm; pearl millet, hay at 6.0 ppm; and pearl
millet, straw at 3.0 ppm.

A revised Section F requesting an imidacloprid tolerance on peanut, meal
at 0.75 ppm is required.

A revised Section F requesting imidacloprid tolerances on soybean, seed
at 3.5 ppm, and soybean, hay at 35 ppm is required.

A revised Section F for aspirated grain fractions at 240 ppm is
required.

Background

Imidacloprid is an insecticide registered for uses on a variety of crops
for the control of aphids, cucumber beetles and whiteflies (including
sweet potato or silverleaf whitefly).  Imidacloprid is a member of the
pyridylmethylamine class of compounds.  Its mode of action is the
disruption of the nervous system by acting as an inhibitor at nicotinic
acetylcholine receptors.  Imidacloprid blocks the signals that are
induced by acetylcholine at the post-synaptic membrane, resulting in
normal nerve function impairment.

Tolerances are currently established for the combined residues of
imidacloprid and its metabolites containing the 6-chloropyridinyl
moiety, all expressed as the parent, under 40 CFR §180.472 in/on
various plant and livestock commodities.  Section 18 Emergency Exemption
tolerances with expiration/revocation dates are established in/on plant
commodities under 40 CFR §180.472(b), and indirect or inadvertent
tolerances are established as a result of application of the pesticide
to growing crops and other non-food crops under 40 CFR §180.472(d).

The nomenclature and physicochemical properties of imidacloprid are
presented below in Tables 1 and 2.

Common Name	Imidacloprid

Company experimental name	BAY NTN 33893

IUPAC name
(EZ)-1-(6-chloro-3-pyridylmethyl)-N-nitroimidazolidin-2-ylideneamine

CAS name	1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-imidazolidinimine

CAS #	138261-41-3

End-use products/(EP)	Provado® 1.6F (EPA Reg. No. 264-763)

Provado® Pro (EPA Reg. No. 264-858)

Admire® 2F (EPA Reg. No. 264-758)

Gaucho® 550 SC
(EPA删来潎㘲ⴴ㈸⤷䜍畡档깯㘠〰匠⁃䔨䅐删来
潎㘲ⴴ㈸⤸倍潲慶潤₮〷䝗⠠偅⁁敒⹧丠⹯㈠㐶㠭㌲
ഩ慇捵潨₮㔷匠⁔䔨䅐删来潎㘲ⴴ㔹⤹䜍畡档깯㐠
〸䘠潬慷汢䔨䅐删来潎㘲ⴴ㔹⤷䜍畡档깯㘠〰䘠
潬慷汢䔨䅐删来潎㘲ⴴ㘹⤸

Encore™ (EPA Reg. No. 264-783)

Trimax™ Pro (EPA Reg. No. 264-855)

Table 2.  Physicochemical Properties of the Technical Grade Test
Compound.

Parameter	Value	Reference

Melting point	144oC	The Pesticide Manual

Twelfth Edition (2000)

pH	5 to 11

	Specific gravity	1.54 (@ 23oC)

	Water solubility (g/L at 20oC)	0.61

	Solvent solubility (g/L at 20oC)	Dichloromethane: 55, Isopropanol: 1.2,
Toluene: 0.68, n-hexane: < 0.1

	Vapor pressure (mPa at 20oC)	4 x 10-7

	Octanol/water partition coefficient [Log(KOW)]	0.57 (21oC)

	UV/visible absorption spectrum	Not provided.

860.1200 Directions for Use

Table 3.  Summary of Directions for Use of Imidacloprid.

Applic. Timing, Type, and Equip.	Formulation

[EPA Reg. No.]	Applic. Rate

(lb ai/A)	Max. No. Applic. per Season	Max. Seasonal Applic. Rate

(lb ai/A)	RTI1

(days)	PHI

(days)	Use Directions and Limitations

Peanuts

Apply as directed or broadcast spray	Provado® 70 [264-823]	0.043	3	0.13
5	14	Use not permitted in CA

Spray band below seed row before planting, in-furrow during planting,
chemigation	Gaucho® 600 SC [264-828]	0.38	1	0.38	NA	15	Spray band below
seed row up to 7 days before planting, Use not permitted in CA

Apply as directed or broadcast spray	Provado® 1.6 Flowable [3125-457]
0.043	3	0.13	5	14	Use not permitted in CA

In-furrow spray on or  below seed during planting, chemigation	Gaucho®
550 SC  [264-827]	0.38	1	0.38	NA	15	Use not permitted in CA

In-furrow spray on or  below seed during planting, chemigation	Admire®
2 Flowable [3125-422]	0.38	1	0.38	NA	15	Use not permitted in CA

Millet

Seed

treatment: commercial or at or immediately before planting 	Gaucho® 480
[7501-155]	0.25/ 	1	0.25/

100 lb seed	NA

Do not graze or feed livestock for 45 days after planting

Seed

treatment: commercial or at or immediately before planting	Gaucho® 600
Flowable [7501-173]	0.25/ 100 lb seed	1	0.25/

100 lb seed	NA

Do not graze or feed livestock for 45 days after planting

Oat

Seed

treatment: commercial or at or immediately before planting	Gaucho® 480
[7501-155]	0.03-0.09 /100 lb seed	1	0.09/100 lb seed	NA

Do not graze or feed livestock for 45 days after planting

Seed

treatment: commercial or at or immediately before planting	Gaucho® 600
Flowable [7501-173]	0.03-0.09

/100 lb seed	1	0.09/100 lb seed	NA

Do not graze or feed livestock for 45 days after planting

Vegetable, root and tuber, crop group 1, (except sugarbeets) plus Kava

Directed or broadcast foliar spray and chemigation	Provado® 70 WG
[264-823]	0.044	1-3	0.044 (radish)

0.13 (all others)	5	7	Not for use on crops grown for seed. Use not
permitted in CA

Spray band below seed row before planting, in-furrow during planting,
chemigation	Gaucho® 600 SC [264-828]	0.25-0.38	1	0.38	NA	21	Spray band
below seed row up to 14 days before planting. Not for use on crops grown
for seed. Use not permitted in CA

Directed or broadcast foliar spray and chemigation	Provado® 1.6
Flowable [3125-457]	0.044	1-3	0.044 (radish)

Encore™

[264-783] 	0.047	3	0.14	7	7	Do not apply through any type of irrigation
system or in enclosed structures.

Apply as directed or broadcast spray.	Trimax™ Pro [264-855]	0.047	3
0.14	7	7	Do not apply through any type of irrigation system or in
enclosed structures.

1 RTI = retreatment interval; PHI = preharvest interval.

Conclusions:  The proposed use directions are all adequate. Since the
previous lower tolerance for caneberries was based using the drench
application at the higher rate, the use is supported may remain on the
labels.

860.1300 Nature of the Residue - Plants and Livestock

Data concerning the metabolism of imidacloprid in apples, potatoes,
tomatoes, eggplant, cottonseed, field corn, tobacco, ruminants, and
poultry have been submitted and reviewed (PP#3F4169/3H5655, DP Num:
185148, 9/20/93; DP Num: 200233, 6/8/94; and DP Num: 217632, 2/29/96; F.
Griffith).  The results of the aforementioned plant and livestock
metabolism studies were presented to the HED Metabolism Assessment
Review Committee (MARC) on 6/22/93 (TXR#: 0050886, F. Griffith,
6/25/93).  The nature of imidacloprid residues in plants and livestock
is adequately understood.  The residue of concern in plants and
livestock is imidacloprid and its metabolites containing the
6-chloropyridinyl moiety, all expressed as the parent, as specified in
40 CFR §180.472.

860.1340 Residue Analytical Methods

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) (DP Num: 187911, 6/18/93; DP Num: 202113, 6/1/94; DP Num:
200233, 6/8/94; DP Num: 213252, 6/8/95; and DP Num: 221591, 12/18/95; F.
Griffith).  The LOD and LOQ for the GC/MS Method 00200 are 0.01 and 0.05
ppm, respectively, in plant commodities.

Bayer GC/MS Method 00200 is a common moiety method that uses a 3:1
methanol/1% sulfuric acid extraction, filtering through Celite/filter
paper, XAD-4 resin column clean-up, oxidation of parent and metabolites
to 6-chloronicotinic acid (6-CNA) by refluxing in a 32% sodium hydroxide
(NaOH) solution combined with a 5% potassium permanganate (KMnO4)
solution, extracted 3 times with methyl t-butyl ether, then
N-methyl-N-(trimethylsilyl) trifluroacetamide (MSFTA) derivatization for
1 hour, and determination by capillary GC/MS selective ion monitoring at
m/z 214, 216, 170, and 140.

Samples in the submitted peanut crop field trial and processing studies
were for analyzed for combined residues of imidacloprid and its
metabolites containing 6-chloropyridinyl moiety, all expressed as the
parent, using a modification of Bayer GC/MS Method 00200.  The LOD and
LOQ were calculated as 0.03 ppm and 0.076 ppm for nutmeat; 0.01 ppm and
0.033 ppm, for oil; and 0.02 ppm and 0.062 ppm for meal.

For caneberries, total residues of imidacloprid (including the
metabolites containing the 6-chloropicolyl moiety) were determined using
working methods based on the gas chromatographic Bayer Method 00200 -
Reformatted (Report Number 102624-R1) with GC/MS.  In IR-4 PR No. 08257,
minor modifications to the reference analytical method did not affect
the validity of the method for the determination of total residues of
imidacloprid in/on caneberries.  The LLMV of the modified method in this
study was reported as 0.05 ppm.  LODs were estimated as 0.009 ppm, 0.02
ppm and 0.03 ppm for raspberry, marionberry and boysenberry,
respectively.  The method is valid for the determination of total
imidacloprid residues in caneberries

Also in the caneberry Study No. AAFC03-085R, the method was modified to
allow quantitation by HPLC/MS.  The LLMV in this study was reported as
0.30 ppm.  The LOD and LOQ were calculated to be 0.068 ppm and 0.203
ppm, respectively.  Concurrent recoveries in raspberry samples ranged
from 60.9% to 86.2% (n=6) when samples were fortified at the LLMV.
Total residues of imidacloprid were determined to be below the LLMV
(<0.30 ppm) and/or calculated LOQ (<0.203 ppm) at all PHIs.  As the
modified method used could not be validated at the target LOQ (0.05
ppm), the method LLMV was unacceptably high and the residues reported at
each PHI were below the LLMV, this residue study is considered
scientifically unacceptable.  Therefore, the results from this study
should not be used to support the registration of imidacloprid in/on
caneberries.

The total imidacloprid residue (imidacloprid + des nitro imidacloprid +
hydroxyl imidacloprid+ olefin imidacloprid + 6-chloronicotinic acid) was
analyzed in soybean samples by a common moiety method (oxidation to
6-chloronicotinic acid) and quantitated by using isotopically-labeled
internal standards and liquid chromatography with tandem mass
spectroscopy detection (LC-MS/MS).  The method in this study,
NT-001-P04-01, is based on an earlier method,

00834.  The LOQ for imidacloprid in soybean forage, hay, and seed was
0.025 ppm, 0.100 ppm, and 0.05 ppm, respectively.  The calculated LOD
for soybean forage, hay, and seed were 0.0111 ppm, 0.0382 ppm, and
0.0136 ppm, respectively.  The data from the soybean processing study
support a method LOQ of 0.050 ppm for each analyte in soybean seed and
processed commodities.  The method is adequate for data collection
purposes.

Conclusions:  These data indicate that the GC/MS method, Bayer Method
00200, and HPLC/MS method, NT-001-P04-01, are adequate for determining
residues of imidacloprid and its metabolites containing the
6-chloropyridinyl moiety, all expressed as the parent, in/on the
commodities associated with the proposed uses.

860.1360 Multiresidue Method (MRM)

Bayer Corporation previously submitted adequate MRM recovery data for
imidacloprid and the metabolites 5-hydroxy imidacloprid, imidacloprid
olefin, des nitro imidacloprid and 6-CNA through Food and Drug
Administration (FDA) Protocols A through E (DP Num: 187911, 6/18/93; DP
Num: 193027, 7/15/93; DP Num: 200233, 6/8/94; and 194206, 6/22/94; F.
Griffith).  Imidacloprid and its metabolites were not recoverable by
these methods.  The results of the MRM testing for imidacloprid were
forwarded to FDA for inclusion in the Pesticide Analytical Method Volume
I (PAM I) (DP Num: 193005, F. Griffith, 7/15/93).

860.1380 Storage Stability

Residues of imidacloprid have been shown to be stable in a variety of
raw agricultural commodities (RACs) for up to 2 years (~728 days) of
storage (PP#5F4480, F. Griffith, 6/8/95).  In addition, analysis of
samples from the 14C-imidacloprid plant metabolism studies for corn,
cotton, apples, and potatoes showed no loss of imidacloprid and its
major metabolites during a period of 2 years of frozen storage
(PP#3F4169, DP Num: 185148, F. Griffith, 9/21/93).

The maximum storage interval for field-treated samples in the peanut
studies was approximately 4 years (1489 days for nutmeat, 1506 days for
oil, 1662 days for hay, and 1534 days for meal).  Storage stability
testing performed after approximately 4.4 years of frozen storage (1600
days for both nutmeat and oil, 1609 days for hay, and 1595 days for
meal) showed no appreciable degradation.  Caneberries were stored frozen
for up to 87 days.  Concurrent storage stability studies with
marionberries indicated that residues were stable when frozen for up to
75 days.  The soybean field trial samples analyzed in this study were
held in frozen storage for a maximum of 15 months (450 days) prior to
extraction.  Soybean aspirated grain fractions and the processed
commodities of soybean seed were analyzed within 3.1 months (95 days) of
production.

Conclusions:  The available storage stability data are adequate to
support the submitted residue field trials and processing studies.

860.1480 Meat, Milk, Poultry, and Eggs

Ruminants

No ruminant feeding study was submitted with the subject petition.
Permanent tolerances have been previously established for the combined
residues of imidacloprid and its metabolites containing the
6-chloropyridinyl moiety, expressed as the parent, in/on the following
livestock commodities: fat, meat and meat byproducts of cattle, goats,
hogs, horses and sheep at 0.3 ppm, and milk at 0.1 ppm (DP Num: 185148,
F. Griffith, 9/21/93).  From the results of that study, HED estimated
the maximum theoretical dietary burden (MTDB) using proposed and
established imidacloprid tolerances.  Results from the feeding study
indicated that at the 50 ppm feeding level expected residues for milk,
muscle, fat, liver, and kidney would be 0.177 ppm, 0.192 ppm, 0.079 ppm,
0.566 ppm, and 0.384 ppm, respectively.  In a recent memo, HED
calculated that the total dietary burden from the worst case diet
calculated for dairy cattle was approximately 20 ppm and consisted of
60% wheat forage (dietary burden = 18.2 ppm), 20% potato waste (dietary
burden = 1.2 ppm) and 20% wet apple pomace (1.5 ppm).  The total dietary
burden from the worst case diet for beef cattle was approximately 12 ppm
and consisted of 25% wheat forage (dietary burden = 7 ppm), 35% potato
waste (dietary burden = 2.1 ppm) and 40% wet apple pomace (dietary
burden = 3.0 ppm).  Based on these results, the aforementioned
tolerances were established.

The ruminant feed items associated with the subject petition are grain,
forage, hay, and straw of millet and oat, and peanut meal and hay.  ARIA
and HED have recalculated the MTDB for beef and dairy cattle to include
these new uses (personal communication, G. Kramer, 4/3/07).  The
resulting MTDB for beef and dairy cattle are 18.2 and 20.8 ppm,
respectively.

Conclusions:  The newly calculated MTDBs are insufficient raise the
existing tolerances on cattle commodities.  Therefore, the proposed uses
on millet, oats, and peanuts, will not require an increase in livestock
tolerances.

Poultry

The poultry feed items associated with the subject petitions are millet,
grain; peanut, meal; and oat, grain.   SEQ CHAPTER \h \r 1 A poultry
feeding study was previously submitted (DP Num: 185148, F.Griffith,
9/20/93).  In this study 3 groups of 12 laying hens were fed
imidacloprid at levels of 2, 6 and 20 ppm of feed for up to 32
consecutive days.  ARIA and HED have recalculated the MTDB for poultry
to include these new uses (personal communication, G. Kramer, 4/3/07).
The resulting MTDB for poultry is 0.9 ppm.  The actual dose levels in
the poultry feeding study are equivalent to 2.2x, 6.6x, and 20.2x the
MTDB for poultry.  At a 2 ppm feeding level, the maximum total
imidacloprid residues were 0.042 in liver and residues were not
detectable in fat, eggs and muscle (<0.02 ppm).  These values are all
less than the existing meat and egg tolerances (0.02 ppm for eggs and
0.05 ppm for meat, fat and meat byproducts).

Conclusions:  The existing poultry meat and egg tolerances are adequate
to support the proposed new uses of imidacloprid.

Swine

The swine feed items associated with the subject petitions are millet,
grain; peanut, meal; and oat, grain. Based on the bovine feeding study
and the recalculated MTDB for swine, 0.5 ppm (personal communication, G.
Kramer, 4/3/07), residues of imidacloprid in swine from feeding
imidacloprid treated feed items are not above the presently established
hog food items of regulatory interest.

Conclusions:  The existing swine meat tolerances are adequate to support
the proposed new uses of imidacloprid.

Table 4.  Reasonably Balanced Diets for Livestock Dietary Burdens for
Imdacloprid a.

	%  Diet b	Residue (ppm)

Feedstuff	Type	Tolerance(ppm)	% DM	Beef	Dairy	Poultry	Swine	Beef 	Diary
Poultry 	Swine

Peanut, hay	R	35	85	25	20	Nu	Nu	10.3	8.2	--	--

Wheat, forage	R	7	25	25	40	Nu	Nu	7	11.2	--	--

Almond, hulls	R	4.0	90	--	10	Nu	Nu	--	0.44	--	--

Potato, waste	CC	0.9	15	--	--	Nu	Nu	--	--	--	--

Corn, field, grain /other grains/grain milled byproducts) 	CC	0.05	88	35
30	75	85	0.034	0.026	0.038	0.042

Cottonseed, meal	PC	8.0	89	10	10	10	5	0.90	0.90	0.80	0.40

Soybean, meal	PC	0.5	92	--	--	15	10

	0.075	0.05

Totals

100	100	100	100	18.2	20.8	0.9	0.5

a    All data are based on this revision of Table 1 (180.1000 OPPTS Test
Guidelines).  Residue levels for beef and dairy are corrected for
moisture content and are determined by formula: tolerance / %Dry Matter
(DM) x % in diet.  Residue levels for poultry and swine are considered
“as-is” and are determined by formula: tolerance x % in diet.

b   Typical compositions of daily rations for the animals of choice for
Table 1 data  are listed in Attachment 2.

Nu= not usually fed

860.1500 Crop Field Trials

Peanuts

46952901CFT.der.doc

IR-4 has submitted field trial data for imidacloprid on peanuts.  Twelve
field trials were conducted in FL (3 trials; Region 3); TX (4 trials;
Region 6); GA (3 trials; Region 2); and NC (2 trials; Region 2).  At
each trial site, one in-furrow application of Admire® 2F and three
foliar applications of Provado® 1.6F were made.  The in-furrow
application was made at a rate of approximately 0.375 lb ai/A at
planting; the foliar applications were made 4 to 6 days apart at a rate
of approximately 0.044 lb ai/A per application.  The total amount of
imidacloprid applied at each trial was approximately 0.507 lb ai/A.  An
organosilicone surfactant was added to each foliar spray tank mix.  In
addition to peanuts and hay harvested 13 to 15 days after the final
application, each commodity was harvested at 21 and 28 days at the
98-TX17 trial for decline determination.

Sample analysis for combined residues of imidacloprid and metabolites
hydroxyl imidacloprid, desnitro imidacloprid, olefin imidacloprid, and
6-chloronicotinic acid (6-CNA) was conducted by USDA-ARS-SAA, Tifton,
GA.  The procedure used was based on the reference method Bayer Method
No. 00200-Reformatted, dated February 23, 1994, "Method for the
Determination of Total Residues of Imidacloprid in Plant Materials and
Beverages."  Residues of imidacloprid and its metabolites were oxidized
to 6-CNA using potassium permanganate.  The 6-CNA was converted to its
trimethylsilyl ester prior to quantitation by GC/MS.  The LLMV in this
study was 0.05 ppm imidacloprid equivalents.  The LOD and LOQ were
calculated as 0.03 ppm and 0.076 ppm, respectively, for nutmeat.  The
LOD and LOQ for hay were estimated as 0.02 ppm and 0.068 ppm,
respectively.  Method validation recoveries ranged from 63 to 138% (avg.
96 ± 21%) for nutmeat and from 71 to 130% (avg. 103 ± 15%) for hay.
The method is adequate for data collection.  Imidacloprid residues have
been shown to be stable for the duration of storage that occurred during
the conduct of this study.

The results from the trials show that the maximum combined residues in
nutmeat following a total application of approximately 0.507 lb ai/A and
a pre-harvest interval (PHI) of approximately 14 days were 0.40 ppm.
Maximum residues in 14-day and 28-day hay samples were 24 ppm.  Residues
declined in nutmeat to a maximum of 0.14 ppm by 28 days.

Table 5.   Summary of Residue Data from Peanut Field Trials with
Imidacloprid.

Commodity	Total Applic. Rate

 (lb ai/A)	PHI (days)	Residue Levels

 (ppm) 1

	n	Min.	Max.	HAFT2	Median	Mean	Std. Dev.

Nutmeat	0.493-0.518	13-15	25	0.05	0.40	0.32	0.011	0.1356	0.093

21	3	0.16	0.20	0.18	0.16	0.173	0.023

28	2	0.10	0.14	0.12	0.12	0.12	0.028

Hay

13-15	15	0.95	24	22.5	9.7	11.22	7.737

21	1	20	20	20	NA	NA	NA

28	1	24	24	24	NA	NA	NA

1 Residue values expressed as imidacloprid equivalents.

2 HAFT = Highest Average Field Trial.

NA = Not Applicable.

Conclusions: The submitted studies are adequate in number and geographic
diversity and are supported by adequate storage stability data and
analytical methodology.  However, the residue data as analyzed by the
Tolerance/MRL Harmonization Spreadsheet indicates that the requested
tolerances on peanut nutmeat and hay are not appropriate.  A new Section
F requesting imidacloprid tolerances on peanuts at 0.60 ppm and peanut,
hay at 35 ppm is required.

Proso Millet, Pearl Millet, and Oat

IR-4 has submitted no crop specific data to support the tolerance
requests in conjunction with the requested uses for proso millet, pearl
millet, and oats.

There are existing tolerances for residues in terms of 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 on barley,
grain; corn, field, grain; corn, pop, grain; corn, sweet, kernel plus
cob with husks removed; oats, grain; rye, grain; sorghum, grain; and
wheat, grain all at 0.05 ppm.  In addition, there is a tolerance 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 on grain,
cereal, group 15 also at 0.05 ppm.  Since there are identical seed
treatment uses with tolerances for most of the cereal grain crop group
and a tolerance for indirect or inadvertent residues on the cereal grain
crop group, tolerances can be translated to the seed treatment uses on
proso millet and pearl millet.  In addition, residues would be expected
on the other millet RACs as residues are found on other grain RACs from
the same uses: forage at 2.0 ppm, hay at 6.0 ppm, and straw at 3.0 ppm.

There are already existing tolerances for the seed treatment use on
oats: oats, grain at 0.05 ppm; oats, forage at 2.0 ppm; oats, hay at 6.0
ppm; oats, straw at 3.0 ppm as a result of the same proposed seed
treatment use [Federal Register: March 22, 2006 (Volume 71, Number 55)].
 The tolerance was established based on the existing registrations as a
seed treatment on barley; canola; corn, field; corn, sweet; corn, pop;
cotton; mustard seed; sorghum; soybeans; and wheat.  Seed treatment
residue data, which can be translated to oats and rye, are available for
these crops.  As a result of these seed treatment uses, there are
permanent tolerances for the use of imidacloprid on barley grain (0.05
ppm), hay (0.5 ppm), and straw (0.5 ppm); field corn forage (0.10 ppm),
grain (0.05 ppm), and stover (0.20 ppm); sorghum forage (0.10 ppm),
grain (0.05 ppm), straw (0.1 ppm) and stover (0.10 ppm); and wheat grain
(0.05 ppm), straw (0.5 ppm), grain (0.5 ppm), forage (7.0).  Tolerance
for inadvertent residues of imidacloprid on the cereal crop group (0.05
ppm) and forage (2.0 ppm), hay (6.0 ppm), and stover (0.3 ppm) of the
cereal crop group.  As a result of these tolerances, oats and rye were
included in the most recent dietary exposure assessment and human health
risk assessment, so the addition of these uses will not change the
overall risk picture (email, J. Tyler, 1/11/07).

Conclusions: The request for use and tolerance for imidacloprid on oats
is not necessary; the request should be removed from Section F.  ARIA
recommends for the proposed imidacloprid tolerances on proso millet and
pearl millet at 0.05 ppm.  Tolerances are also required on the other
millet RACs.  A revised Section F for proso millet, forage at 2.0 ppm;
proso millet, hay at 6.0 ppm; proso millet, straw at 3.0 ppm; pearl
millet, forage at 2.0 ppm; pearl millet, hay at 6.0 ppm; and pearl
millet, straw at 3.0 ppm.

Kava

IR-4 has submitted no crop specific data to support the tolerance
requests in conjunction with the requested use for kava.  Kava is
projected to be part of the root and tuber vegetable crop group 1 in the
near future (email, B. Schnieder, 7/25/06).  Since the proposed use is
identical to that used for root and tuber vegetables, ARIA can translate
the existing data to kava.

Conclusions: ARIA recommends for the proposed imidacloprid tolerances on
kava, leaves at 4.0 ppm and kava, roots at 0.4 ppm.

Globe Artichoke

IR-4 has submitted no new crop specific data to support the tolerance
requests in conjunction with the requested use on globe artichoke.  A
tolerance of 2.5 ppm has already been established for imidacloprid on
globe artichokes as a result of a foliar use.  IR-4 is now requesting a
use either below the seed row before planting, in-furrow during
planting, or by chemigation into the root zone.  ChemSAC determined that
tolerances reflecting foliar applications of imidacloprid should easily
cover the much lower and typically nondetectable residues resulting from
soil application.  Metabolites resulting from soil and foliar treatments
have previously been determined to be similar.  Also, existing foliar
treatment field trial data and the tolerances are based on a common
moiety method.  Comparisons of IR-4 data on foliar vs. limited
soil-applied imidacloprid or the two treatments combined indicate that
the foliar treatments clearly drive the magnitude of the resulting
residues.  ChemSAC concluded that additional field trial data reflecting
soil applications of imidacloprid are not required to support this
proposed amended registration on perennial food crops (orchard, berry,
and vine crops) as the residues resulting from foliar treatments are
expected to greatly outweigh those resulting from soil treatments.  Any
slight additional residues from soil treatments are expected to be
covered by existing tolerances established to reflect foliar application
(ChemSAC, 7/23/03).  Therefore, it is unlikely that the residues of
imidacloprid from the proposed soil treatment use on globe artichoke
will exceed the existing 2.5 ppm tolerance.

Conclusions: ARIA recommends for the proposed imidacloprid use on globe
artichoke without a change in the existing tolerance.

Caneberries

46927301.der.doc

A previous petition for the use of imidacloprid on caneberries resulted
in a conditional registration and permanent tolerance at 0.05 ppm.  The
registration was conditional until the submission of additional crop
field trial data on either blackberry or raspberry from Region 1 (1
trial), Region 5 (1 trial) and Region 10 (1 trial) (PP#3E6543, DP Num:
322834, J. Tyler, 6/14/06).

Residue data have now been submitted by Agriculture and Agri-Food Canada
(AAFC) and Interregional Research Project No. 4 (IR-4) for imidacloprid
(1-[(6-chloro-3-pyridyl)methyl]-4,5-dihydro-N-nitro-1H-
imidazol-2-amine) in/on raspberries and blackberries (including
marionberry and boysenberry) to support the establishment of a maximum
residue limit (MRL)/tolerance in/on Crop Subgroup 13A (caneberry).  A
total of ten trials were conducted in the US and Canada in the 2003 and
2005 growing seasons, encompassing NAFTA growing regions 2 (2 trials; NJ
and NC), 5 (1 trial; ON), 5A (1 trial; MI), 5B (1 trial; QC), 10 (2
trials; CA) and 12 (3 trials; WA and OR).  Imidacloprid, formulated as a
flowable suspension, was applied to caneberries in three foliar-directed
broadcast sprays at a rate of 111 to 123 g ai/ha/ application (0.10 to
0.11 lb ai/A/application) at 6 to 11-day retreatment intervals (RTIs)
for total application rates of 333 to 347 g ai/ha (0.30 to 0.31 lb
ai/A).  A control plot was maintained at each test site, and crops were
harvested 2-4 days after the last application (DALA).  At one trial site
(Trial ID# 510; Study No. AAFC03-085R), additional samples were
harvested at 0, 7 and 11 DALA.

For both studies, total residues of imidacloprid (including the
metabolites containing the 6-chloropicolyl moiety) were determined using
working methods based on the gas chromatographic Bayer Method 00200 -
Reformatted (Report Number 102624-R1) with mass selective detection
(GC/MSD).  Bayer Method 00200 has been previously deemed acceptable as a
data gathering method in a variety of plant matrices.

In Study No. AAFC03-085R, the method was modified to allow quantitation
by HPLC/MS.  The lowest limit of method validation (LLMV) in this study
was reported as 0.30 ppm.  The LOD and LOQ were calculated to be 0.068
ppm and 0.203 ppm, respectively.  Concurrent recoveries in raspberry
samples ranged from 60.9% to 86.2% (n=6) when samples were fortified at
the LLMV.  Total residues of imidacloprid were determined to be below
the LLMV (<0.30 ppm) and/or calculated LOQ (<0.203 ppm) at all PHIs.  As
the modified method used in Study No. AAFC03-085R could not be validated
at the target LOQ (0.05 ppm), the method LLMV was unacceptably high and
the residues reported at each PHI were below the LLMV, this residue
study is considered scientifically unacceptable.  Therefore, the results
from this study should not be used to support the registration of
imidacloprid in/on caneberries.

In IR-4 PR No. 08257, minor modifications to the reference analytical
method did not affect the validity of the method for the determination
of total residues of imidacloprid in/on caneberries.  The LLMV of the
modified method in this study was reported as 0.05 ppm.  LODs were
estimated as 0.009 ppm, 0.02 ppm and 0.03 ppm for raspberry, marionberry
and boysenberry, respectively.  Concurrent recoveries in raspberries
ranged from 93% to 95% (n=2) when samples were fortified at the LLMV,
indicating that the method is valid for the determination of total
imidacloprid residues in caneberries.

Caneberries from IR-4 PR No. 08257 were stored frozen for up to 87 days.
 Concurrent storage stability studies with marionberries fortified with
an equimolar mixture of imidacloprid and its four metabolites indicated
that residues were stable when frozen for up to 75 days.  In addition,
the freezer storage stability of total imidacloprid residues (including
the metabolites containing the 6-chloropicolyl moiety) has been
previously demonstrated in a variety of crops (apples, potatoes, wheat,
sugar beets, sunflower seeds, tomatoes and cotton seed) for up to 25
months (MRID: 43197203), which adequately covers the storage intervals
within the current study.  Therefore, there are no concerns with the
stability of residues over time in this study.

In the submitted IR-4 field trials, the maximum residues observed in
caneberries treated with imidacloprid at 336-347 g ai/ha (0.30-0.31 lb
ai/A) and harvested at PHIs of 2-4 days were 0.70 ppm in blackberry,
0.96 ppm in raspberry, 1.7 ppm in marionberry and 1.5 ppm in
boysenberry.  As study No. AAFC03-085R was deemed scientifically
unacceptable, the residue decline behavior of imidacloprid in/on
caneberries could not be assessed.

The submitted residue trials from IR-4 PR No. 08257 fulfill the residue
trial requirements established in DIR98-02 (Section 9) and OPPTS
860.1500 for registration in/on caneberries.

Table 6.  Summary of Residue Data from Caneberry Field Trials with
Imidacloprid

Commodity	Total Applic. Rate

g ai/ha

(lb ai/A)	PHI (days)	Residue Levels

 (ppm)

	n	Min.	Max.	HAFT*	Median	Mean	Std. Dev.

Total Imidacloprid

blackberry

marionberry

boysenberry	336-347

(0.30-0.31)	2-4	10	0.32	1.7	1.6	0.70	0.93	0.53

raspberry	339-347

(0.30-0.31)	2-4	8	0.41	0.96	0.96	0.54	0.61	0.22

* HAFT = Highest Average Field Trial.

Conclusions:  The submitted studies are adequate in number and
geographic diversity and are supported by adequate storage stability
data and analytical methodology.  Some of the submitted sample labels
indicate an application rate higher than that used in these residue
field trials.  Since the previous lower tolerance for caneberries was
based using the drench application at the higher rate, the use is
supported may remain on the labels.  The residue data as analyzed by the
Tolerance/MRL Harmonization Spreadsheet indicates that the requested
tolerance on caneberries, crop group 13A at 2.5 ppm is not appropriate.
The commodities blackberry, marionberry, and boysenberry are considered
cultivars of blackberries while raspberries are separate.  The
Tolerance/MRL Harmonization Spreadsheet indicates appropriate tolerance
levels of 3.5 ppm and 1.3 ppm for blackberries and raspberries,
respectively.  However, since the data bases are small for blackberries
and raspberries, the fruits are essentially the same size and texture,
and in the interest of harmonizing with Canada, ARIA will consider the
entire database for caneberries together.  The Tolerance/MRL
Harmonization Spreadsheet indicates the appropriate tolerance level for
the entire database of caneberry residues should be 2.5 ppm.  Therefore,
ARIA recommends for the proposed tolerance for caneberry, crop group 13A
at 2.5 ppm.

The petitioner has requested a tolerance for wild raspberry.  The crop
definition for caneberry, crop group 13A includes Rubus strigosus and
Rubus idaeus which are the American red and black raspberry,
respectively.  The wild raspberry is distributed in tropical northern
Queensland in open forests and the rainforest.  This fruit has clusters
of juicy, pink to bright red lobes which form the berry, some 1 to 3 cm
in diameter.  It is similar to raspberries and other Rubus species.
They grow on a bramble thicket with regularly spaced sharp barbs on the
stems.  Flavor is a sharp berry-raspberry, stronger than exotic
raspberries.  U.S. growers are evaluating improved varieties (email, B.
Schnieder, 5/2/07).  ARIA will extend the residue information to from
the caneberry subgroup to wild raspberries; therefore, a tolerance for
the residues of imidacloprid on wild caneberries at 2.5 ppm is
appropriate.

Soybeans

46785002cft.der.doc

Bayer Corp. submitted a total of 21 crop residue field trials.  The
trials were conducted to measure the magnitude of imidacloprid
(1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-imidazolidinimine) residues
in soybeans resulting from pre-plant seed treatment followed by three
foliar applications of TRIMAX 4F to the growing soybean plants.  The
soybean seeds were treated with TRIMAX 4F at a nominal rate of 0.125 lb
ai/100 lb seed prior to planting.  Resulting imidacloprid application
rates determined from seeding densities at each trial ranged from 0.064
lb ai/A to 0.153 lb ai/A.  The growing soybean plants were subsequently
treated with three foliar broadcast applications of TRIMAX 4F at a
target rate of 0.047 lb ai/A/application (0.053 kg ai/ha/application)
for a total seasonal application rate of 0.141 lb ai/A (0.159 kg ai/ha)
in spray volumes ranging from 5 to 20 GPA (47-187 L/ha).  The total
seasonal foliar application rate ranged from 0.138 to 0.147 lb ai/A
(0.155 to 0.164 kg ai/ha).  For treated plot A (TRTDA) in all trials,
the first application was made to soybeans at Biologische Bundesanstalt,
Bundessortenamt and CHemical scale (BBCH) of 13 to 66 (trifoliate leaf
on the 3rd node unfolded to about 60% of flowers open).  For treated
plot B (TRTDB) in all trials, the first application to soybeans was made
at BBCH 75 to 91 (50% of pods reached final length to about 10% of
leaves discolored or fallen).  The interval between applications was 5
to 20 days.  Total imidacloprid application rates (seed + foliar) ranged
from 0.201 to 0.275 lb ai/A (0.226 to 0.308 kg ai/ha).

Single composite samples of soybean forage, hay, and seed were collected
from the control plot of each trial.  Samples of soybean forage were
collected from TRTDA at 0-day pre-harvest interval (PHI).  Soybean hay
was cut from TRTDA at 0-day PHI and allowed to dry to commercial
standards and collected.  Samples of soybean seed were collected from
TRTDB at PHIs of 19 to 32 days.  In addition, at two field trials
samples of soybean forage and hay were collected from the TRTDA plot at
PHIs of 0, 1, 3, 7 and 10 days after the last application, and samples
of soybean seed were collected from the TRTDB plot at PHIs of 7, 14, 21,
28, and 34 days (± 1 day) to monitor residue decline.

The total imidacloprid residue (imidacloprid + des nitro imidacloprid +
hydroxyl imidacloprid+ olefin imidacloprid + 6-chloronicotinic acid) was
analyzed in soybean samples by a common moiety method (oxidation to
6-chloronicotinic acid) and quantitated by using isotopically-labeled
internal standards and liquid chromatography with tandem mass
spectroscopy detection (LC-MS/MS).  The method in this study,
NT-001-P04-01 (Gould, T. J., Beedle, E. C., Brungardt and Timberlake,
2005.  “An Analytical Method for the Determination of Residues of
Imidacloprid in Soybean Matrices Using HPLC-MS/MS”) is based on an
earlier method, 00834 (Schoening, R. 2003.  “Analytical Method 00834
for the Determination of Residues of Imidacloprid and Total Residue of
Imidacloprid in/on Cereals, Olive and Cacao Including Processing
Products of Olive and Cacao by HPLC-MS/MS.”).  Recovery of
imidacloprid, its three metabolites (des nitro imidacloprid, hydroxy
imidacloprid, and olefin imidacloprid), the common moiety
6-chloronicotinic acid (6-CNA), and a mixture of imidacloprid/des nitro
imidacloprid from soybean forage fortified at 0.025 ppm (each analyte)
ranged from 60% to 95%.  Recovery of imidacloprid, its three
metabolites, the common moiety 6-CNA, and a mixture of imidacloprid/des
nitro imidacloprid from soybean hay fortified at 0.010 ppm (each
analyte) ranged from 57% to 99%.  Recovery of imidacloprid, its three
metabolites, the common moiety 6-CNA, and a mixture of imidacloprid/des
nitro imidacloprid from soybean seed fortified at 0.050 ppm (each
analyte) ranged from 58% to 93%.  The LOQ for imidacloprid in soybean
forage, hay, and seed was 0.025 ppm, 0.100 ppm, and 0.05 ppm,
respectively.  The calculated LOD for soybean forage, hay, and seed were
0.0111 ppm, 0.0382 ppm, and 0.0136 ppm, respectively.  The method is
adequate for data collection purposes.

The highest imidacloprid residue on soybean forage and hay at 0-day PHI
was 8.87 ppm and 24.0 ppm, respectively.  The highest imidacloprid
residue on soybean seed at a 21-day PHI was 2.04 ppm.  The total
imidacloprid residue was found to decline significantly on soybean
forage with time.  In soybean hay, total imidacloprid residue was found
to decline significantly at

one trial but remained relatively constant at the other.  On soybean
seed, total imidacloprid

residue remained constant with time.

Table 7.  Summary of Residue Data from Soybean Crop Field Trials with
Imidacloprid.

Commodity	Total Applic. Rate

 (lb ai/A)	PHI (days)	Residue Levels

 (ppm)

	n	Min.	Max.	HAFT*	Median	Mean	Std. Dev.

Soybean Forage 	0.125 lb ai/100 lb seed &

0.138-0.147	0	42	1.12	8.87	6.50	3.23	3.24	1.351

1	4	0.79	1.79	1.74	1.52	1.41	0.449

3	4	0.90	1.50	1.46	1.18	1.19	0.312

7	4	0.62	1.10	1.00	0.84	0.85	0.202

10	4	0.61	0.90	0.88	0.82	0.79	0.128

Soybean Hay

0	42	3.50	23.98	22.37	10.20	11.70	5.567

1	4	3.01	4.41	4.36	3.82	3.82	0.663

3	4	3.40	5.05	4.57	4.37	4.30	0.719

7	4	1.66	3.98	3.61	2.62	2.72	1.079

10	4	1.89	3.01	2.92	2.50	2.48	0.527

Soybean Seed

7-8	4	0.04	0.04	0.04	0.04	0.04	0.003

14	4	0.02	0.04	0.04	0.03	0.03	0.009

19-25	42	0.02	2.04	1.50	0.34	0.42	0.441

27-28	4	0.03	0.04	0.04	0.03	0.03	0.004

34	4	0.03	0.04	0.04	0.04	0.04	0.005

* HAFT = Highest Average Field Trial.

Conclusions:  The submitted studies are adequate in number and
geographic diversity and are supported by adequate storage stability
data and analytical methodology.  The residue data as analyzed by the
Tolerance/MRL Harmonization Spreadsheet indicates that the requested
tolerance on soybean, forage is appropriate at 8.0 ppm.  However, the
requested tolerance levels on the other soybean commodities are not
appropriate.  A new Section F requesting imidacloprid tolerances on
soybean, seed at 3.5 ppm, and soybean, hay at 35 ppm is required.

860.1520 Processed Food and Feed

Peanut Oil and Meal

46952901PFF.der.doc

The Interregional Research Project No. 4 (IR-4) has submitted processed
food and feed data for imidacloprid on peanuts.  Peanuts were treated by
one in-furrow application of Admire® 2F and three foliar applications
of Provado® 1.6F.  The in-furrow application was made at a rate of
approximately 0.375 lb ai/A at planting; the foliar applications were
made 4 to 6 days apart at a rate of approximately 0.044 lb ai/A per
application.  The total amount of imidacloprid applied was approximately
0.507 lb ai/A.  An organosilicone surfactant was added to each foliar
spray tank mix.  Peanuts for processing into peanut meal and oil were
harvested at 14 and 22 days (the peanuts were shelled at the processing
facility).

Sample analysis for combined residues of imidacloprid and metabolites
hydroxyl imidacloprid, desnitro imidacloprid, olefin imidacloprid, and
6-chloronicotinic acid (6-CNA) was conducted by USDA-ARS-SAA, Tifton,
GA.  The procedure used was based on the reference method Bayer Method
No. 00200-Reformatted, dated February 23, 1994, "Method for the
Determination of Total Residues of Imidacloprid in Plant Materials and
Beverages."  Residues of imidacloprid and its metabolites were oxidized
to 6-CNA using potassium permanganate.  The 6-CNA was converted to its
trimethylsilyl ester prior to quantitation by GC/MS.  The LLMV in this
study was 0.05 ppm imidacloprid equivalents.  The LOD and LOQ were
calculated as 0.03 ppm and 0.076 ppm for nutmeat; 0.01 ppm and 0.033
ppm, respectively, for oil; and 0.02 ppm and 0.062 ppm for meal.  Method
validation recoveries ranged from 63 to 138% (avg. 96 ± 21%) for
nutmeat; from 77 to 129%, (avg. 85 ± 7%) for oil; and 63 to 114% (avg.
91 ± 18%) for meal.  The method is adequate for data collection.
Imidacloprid residues have been shown to be stable for the duration of
storage that occurred during the conduct of this study.

Residues in peanut nutmeat ranged from 0.25-0.40 ppm (avg. 0.32 ppm) for
14-day samples and 0.16 ppm for the 22-day sample.  No residues above
the LLMV were observed in oil samples derived from peanuts collected at
14 and 22 days.  Meal samples derived from peanuts collected at 14 and
22 days yielded residues of 0.62 ppm and 0.49 ppm, respectively.  The
calculated concentration factors were 1.9X for the 14-day samples and
3.1X for the 22-day samples.  The average of the two concentration
factors, 2.5X, was higher than the theoretical maximum in peanut meal
2.2X.

FIGURE 1.	Processing Flowchart for Peanuts.

Table 8.  Residue Data from Peanuts Processing Study with Imidacloprid.

RAC	Processed Commodity	Total Rate

(lb ai/A)

	PHI

(days)	Residues (ppm)	Processing Factor

Peanut	Nutmeat	0.508	14	0.25-0.40 (avg. 0.32)	NA

	22	0.16	NA

	Oil

14	<LLMV	0

	22	<LLMV	0

	Meal

14	0.62	1.9

	22	0.49	3.1

Conclusions: The submitted processing study indicates that imidacloprid
residues do not concentrate in peanut oil.  Therefore, a separate
tolerance for imidacloprid residues in peanut oil is not required.  The
average of the two processing studies indicates that imidacloprid
residues will concentrate at 2.5X in peanut meal ((1.9+3.1)/2).
However, this is higher than the theoretical maximum of 2.2X.  The
highest average field trial (HAFT) of 0.32 ppm times the theoretical
maximum of 2.2X yields an expected residue of 0.704 ppm in peanut meal.
Therefore, the requested tolerance for imidacloprid residues in peanut
meal at 0.9 ppm is not appropriate.  ARIA recommends for the
establishment of an imidacloprid tolerance on peanut, meal at 0.75 ppm.
A revised Section F requesting an imidacloprid tolerance on peanut, meal
at 0.75 ppm is required.

Millet Flour and Oat Flour and Rolled Oats

There are processed commodities of regulatory interest associated with
the request uses: millet flour, oat flour, and rolled oats.  It has been
determined that imidacloprid residues do not concentrate in grain
processed commodities (  SEQ CHAPTER \h \r 1 PP# 4F4337 & 4H5700; DP
Num: 212683, 2112688, and 21292; MRID#s: 435344-01 and -02, 435612-01
thru -04, -07, and -08; CBTS#s:15192, 15193,and 15222; F.
Griffith,5/15/95).

Conclusions:  No imidacloprid tolerances are required on millet and oat
processed commodities.

Soybean

46785001PFF.DER.doc

as Trimax™ (EPA Reg. No. 264-855) was applied to soybeans at 0.705 lb
ai/A, and harvested 20 days after final treatment. The soybean seeds
were processed into commodities of soybean meal, hulls, refined oil,
flour, and aspirated grain fractions.

The analytical residue method of analysis for determining imidacloprid
residue employs a common moiety method which oxidizes the residues of
concern (imidacloprid + des nitro imidacloprid + hydroxyl imidacloprid +
olefin imidacloprid + 6-chloronicotinic acid (6-CNA)) in soybean samples
to 6-CNA and quantitates the 6-CNA by using isotopically-labeled
internal standards and liquid chromatography with tandem mass
spectroscopy/mass spectroscopy detection (LC-MS/MS).  The 6-CNA residues
are reported in parent equivalents.  The analytical method for this
study was previously designated as NT-001-P04-01 and was used with minor
modifications.  The recoveries from the appropriate controls fortified
at the various levels (0.10 ppm, 0.20, ppm, 2.00 ppm, 30 ppm, and 150
ppm) of each of the analytes demonstrated acceptable method performance
(recovery ranges all within 60% to 94%) during sample analyses. These
data support a method LOQ of 0.050 ppm for each analyte in soybean seed
and processed commodities.  The method is adequate for data collection.

Adequate storage stability data have been previously submitted.
Residues of imidacloprid have been shown to be stable in a variety of
raw agricultural commodities (RACs) for up to 2 years (~728 days) of
storage.  Soybean seed in this study was frozen a maximum of 10.6 months
(322 days) prior to extraction.  Soybean aspirated grain fractions and
the processed commodities of soybean seed were analyzed within 3.1
months (95 days) of production.  All samples were analyzed within 30
days (1 to 8 days) of extraction.

No concentration (<1X) of total imidacloprid residue was seen in the
commodities of soybean meal (0.86X), hulls (0.72X), refined oil
(<0.02X), or defatted flour (0.80X).  Concentration of the total
imidacloprid residue was seen in soybean aspirated grain fractions
(160X).  These concentration factors did not conform with the
theoretical concentration factors.

FIGURE 2.  Process Flowchart for Soybean

Table 9.  Residue Data from Soybean Processing Study with Imidacloprid.

RAC	Processed Commodity	Total Rate

(lb a.i./A)

(kg a.i./ha)	PHI

(days)	Residues (ppm)	Processing Factor

Soybean Seed	NA	0.705

(0.791)

	20	0.4228 	NA

	Soybean AGF*

	67.5881 	159.9

	Soybean Flour

	0.3381 	0.80

	Soybean Hulls

	0.3052 	0.72

	Soybean Meal

	0.3647 	0.86

	Soybean Oil

	<LOD 	NA

		* AGF= aspirated grain fractions

Conclusions: The submitted processing study indicates that imidacloprid
residues do not concentrate in soybean meal, hulls, or oil.  Therefore,
a separate tolerance for imidacloprid residues in soybean meal, hulls,
or oil is not required.  The processing study indicates that
imidacloprid residues will concentrate at 160X in aspirated grain
fractions.  The HAFT of 1.50 ppm for soybean seed at the proposed
application rate and PHI times the empirical concentration value of 160X
yields an expected residue of 240 ppm in aspirated grain fractions. The
requested tolerance for imidacloprid residues in aspirated grain
fractions is appropriate.  However, the Agency does not differentiate
soybean from other aspirated grain fractions, therefore a revised
Section F for aspirated grain fractions at 240 ppm is required.

860.1850 and 860.1900 Confined/Field Accumulation in Rotational Crops

No new studies were submitted with these petitions.  The nature of the
imidacloprid residue in rotational crops has been adequately
characterized and identified.  The identified residue in rotational
crops is nearly identical to that identified in the primary crops, and
the regulable residues in rotated crops are imidacloprid and its
metabolites containing the 6-chloropyridinyl moiety.  According to the
proposed use labels, treated areas may be replanted with any crop
specified on the labels or with any crop for which a tolerance exists
for imidacloprid.  However, a 12-month plant-back interval should be
observed for crops not listed on the labels and for those crops for
which no tolerances for imidacloprid have been established.  Also, cover
crops for soil building or erosion control may be planted any time, but
do not graze or harvest for food or feed

(PP# 6F4682 & 0E6106; DP Num: 224074 & 263729; MRID: 43939401, 43939402,
& 45051401; Y. Donovan; 7/12/00).

The following rotational crop restrictions are currently on the proposed
labels:

Table 10.  Rotational Crop Instructions

Commodity	Plantback Interval (PBI)

All crops on this label plus the following crops not on this label:
barley, canola, corn (field, pop & sweet), rapeseed, sorghum, soybean
and wheat.	Immediate Plantback

Cereals (including buckwheat, corn, millet, oats, popcorn, rice, rye,
and triticale); Legume (including soybeans, beans and peas); Safflower
30-day

Onion and bulb vegetables	10-month

All Other Crops	12-month

Conclusions:  The rotational crop restrictions are adequate.

860.1550 Proposed Tolerances

A summary of the recommended tolerances and the correct commodity
definitions for the proposed uses are listed in Table 11.  The
appropriate tolerance levels were calculated using the methodology
formulated by the NAFTA MRL/Tolerance Harmonization Workgroup for
calculating statistically based pesticide tolerances for plant
commodities based on field trial residue data (see Attachment 3).

Provided revised Sections B and F are submitted as specified, the
residue chemistry database supports the establishment of the permanent
tolerances for the combined residues of imidacloprid and its metabolites
containing the 6-chloropyridinyl moiety, all expressed as the parent,
in/on the RACs listed in Table 11.

Table 11.  Tolerance Summary for Imidacloprid.

Commodity	Proposed Tolerance (ppm)	Recommended Tolerance (ppm)	Comments

(correct commodity definition)

Peanut	0.45	0.60

	Peanut, hay	70	35

	Peanut, meal	0.9	0.75

	Millet, proso, grain	0.05	0.05

	Millet, proso, forage

2.0

	Millet, proso, hay

6.0

	Millet, proso, straw

3.0

	Millet, pearl, grain	0.05	0.05

	Millet, pearl, forage

2.0

	Millet, pearl, hay

6.0

	Millet, pearl, straw

3.0

	Oat, grain	0.05	none

	Kava, roots	0.4	0.4

	Kava, leaves	4.0	4.0

	Caneberry, subgroup 13A	2.5	2.5

	Raspberry, wild	2.5	2.5

	Soybean, seed	1.6	3.5

	Soybean, forage	8.0	8.0

	Soybean, hay	30	35

	Aspirated grain fractions	240	240	Change from soybean, aspirated grain
fractions

The International Residue Limit Status (IRLS) Sheet is attached as
Attachment 2.  There are no established Canadian or Mexican MRLs for the
proposed uses.  There is an established Codex MRLs for the sum of
imidacloprid and its metabolites containing the 6-chloropyridinyl
moiety, expressed as imidacloprid, in/on cereal grain at 0.05 ppm.
Therefore, there is no harmonization issue for these petitions.

Attachment 1:  International Residue Status Sheet

Attachment 2.  Inputs for calculating statistically based pesticide
tolerances.Attachment 1:  IRLS Sheet.

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:

1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-imidazolidinimine	Common
Name:

Imidacloprid	x Proposed tolerance

 Reevaluated tolerance

 Other	Date: 1/24/06

Codex Status (Maximum Residue Limits)	U. S. Tolerances

 No Codex proposal step 6 or above

No Codex proposal step 6 or above for the crops requested	Petition
Number:  6E7108

Residue definition (step 8/CXL):  Sum of imidacloprid and its
metabolites containing the 6-chloropyridinyl moiety, expressed as
imidacloprid.	Reviewer/Branch: W. Cutchin/ARIA

	Residue definition:  combined residues of imidacloprid and its
metabolites containing the 6-chloropyridinyl moiety, all expressed as
the parent.

Crop (s)	MRL (mg/kg)	Crop(s) 	Tolerance (ppm)

Peanut, meal	0.75

Cereal grains	0.05	Millet, proso, grain	0.05

Millet, proso, forage 	2.0

Millet, proso, hay 	6.0

Millet, proso, straw 	3.0

Millet, pearl, grain	0.05

Millet, pearl, forage	2.0

Millet, pearl, hay	6.0

Millet, pearl, straw	3.0

Kava, roots	0.4

Kava, leaves	4.0

Caneberry, subgroup 13A	2.5

Limits for Canada	Limits for Mexico

No Limits

√ No Limits for the crops requested	No Limits

√ No Limits for the crops requested

Residue:  1-[(6-chloro-3-pyridinyl)
methyl]-4,5-dihydro-N-nitro-1H-imidazol-2-amine, including metabolites
containing the 6-chloropicolyl moiety.	Residue definition:
imidacloprid

Crop(s)	MRL (mg/kg)	Crop(s)	MRL (mg/kg)

	Notes/Special Instructions:  S.Funk, 01/24/2007.

Attachment 2.  Inputs for calculating statistically based pesticide
tolerances.

Peanut Nutmeat:

EPA

Imidaclo

Peanut

14-15day

Residues

0.050

0.050

0.050

0.050

0.050

0.050

0.150

0.170

0.400

0.310

0.250

0.080

0.110

0.100

0.100

0.050

0.050

0.130

0.150

0.230

0.190

0.120

0.100

0.140

0.260

Peanut Hay:

Ë

Ñ

â

ô

/

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¡

Ë

à

á

â

ô

õ

昀Ĵ咊

7

kd

7

7

7

kdÌ

7

7

7

\

愀Ĥ

H*

耀

耀윆

@

㐀ۖĀ̊&☃昀Ĵ

愀Ĥ

愀Ĥ

愀Ĥ

愀Ĥ

愀Ĥ

W

X

g

l

p

…

†

‰

Š

”

•

˜

™

ª

«

¹

º

Ä

È

É

Í

Î

Ô

Ø

Ù

Ý

ß

ì

-

)

*

/

6

E

W

m

p

†

‰

Š

Š

‹

Œ

•

˜

Ÿ

¢

¨

ª

«

«

¬

®

±

·

¹

Á

Ä

É

Í

Î

Î

Ï

Ð

Ñ

Ô

Ù

Ý

ᘀ

㓿ۖĀ̊d搃昀Ĵ

㓿ۖĀ̊d搃昀Ĵ

愀Ĥ

愀Ĥ

$

$

¼

kd

9.500

4.100

4.000

1.100

21.000

24.000

11.000

12.000

9.700

12.000

23.000

Caneberries: Blackberry

Caneberries: Raspberry

EPA

Imidaclo

rasp

2-4day

0.590

0.590

0.960

0.950

0.480

0.440

0.490

0.410

Caneberries: Blackberry & Raspberry

EPA

Imidaclo

caneber

2-4day

Residues

0.38

0.69

0.7

0.59

0.96

0.48

0.49

1.7

1.5

0.32

0.58

0.54

0.59

0.95

0.44

0.41

1.5

1.4

Soybeans:

EPA

Imidaclo

soy seed

21day

Residues

0.054

0.047

0.165

0.354

0.712

0.323

0.024

0.169

0.148

0.203

0.455

0.517

0.645

0.944

0.558

0.734

0.025

1.600

0.569

0.039

0.069

0.093

0.249

0.411

0.635

0.429

0.03

0.194

0.066

0.183

0.402

0.45

0.614

2.04

0.652

0.734

0.029

1.39

0.665

0.065

0.034

0.096

Imidacloprid	Summary of Analytical Chemistry and Residue Data		DP#:
332757, 333517, & 334153

Imidacloprid	Summary of Analytical Chemistry and Residue Data		DP#:
332757, 333517, & 334153

 PAGE   6

 PAGE   7


[Federal Register: December 1, 2009 (Volume 229, Number 74)]
[Notices]
[Page 62844]
[DOCID:fr01de09-131]

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

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request; Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Form F-X, OMB Control No. 3235-0379, SEC File No. 270-336.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Form F-X (17 CFR 239.42) is used to appoint an agent for service of
process by Canadian issuers registering securities on Forms F-7, F-8,
F-9 or F-10 under the Securities Act of 1933 (15 U.S.C. 77a et seq.),
or filing periodic reports on Form 40-F under the Exchange Act of 1934
(15 U.S.C. 78a et seq.). The information collected must be filed with
the Commission and is publicly available. We estimate that it takes
approximately 2 hours per response to prepare Form F-X and that the
information is filed by approximately 161 respondents for a total
annual reporting burden of 322 hours (2 hours per response x 161
responses).
    Written comments are invited on: (a) Whether this proposed
collection of information is necessary for the performance of the
functions of the agency, including whether the information will have
practical utility; (b) the accuracy of the agency's estimate of the
burden imposed by the collection of information; (c) ways to enhance
the quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comment to Charles Boucher, Director/
CIO, Securities and Exchange Commission, C/O Shirley Martinson, 6432
General Green Way, Alexandria, Virginia 22312; or send an e-mail to:
<EMAIL_ADDRESS>
    Dated: November 24, 2009.
Elizabeth M. Murphy,
Secretary.
[FR Doc. E9-28686 Filed 11-30-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)]
[Notices]
[Pages 11878-11901]
[FR Doc No: 2016-04882]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2016-0002-N-6]

Agency Request for Emergency Processing of Collection of
Information by the Office of Management and Budget

AGENCY: Federal Railroad Administration (FRA), United States Department
of Transportation (US DOT).

ACTION: Notice.

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

SUMMARY: Consistent with the Paperwork Reduction Act of 1995 and its
implementing regulations, this document provides notice that FRA is
submitting the following Information Collection Request (ICR) to the
Office of Management and Budget (OMB) to collect information on
Positive Train Control (PTC) implementation on an annual form and a
quarterly form. FRA requests emergency processing and OMB authorization
to collect the information on the annual form identified below five
business days after publication of this Notice for a period of 180
days. FRA requests regular processing and OMB authorization to collect
the information on the quarterly form identified below 90 days after
publication of this Notice for a period of three years.

FOR FURTHER INFORMATION CONTACT: A copy of this individual ICR, with
any public applicable supporting documentation, may be obtained by
telephoning FRA's Office of Safety Information Collection Clearance
Officer, Robert Brogan (tel.<PHONE_NUMBER>), or FRA's Office of
Administration Information Collection Clearance Officer, Kimberly Toone
(tel.<PHONE_NUMBER>); these numbers are not toll-free; or by
contacting Mr. Brogan via facsimile at<PHONE_NUMBER> or Ms. Toone via
facsimile at<PHONE_NUMBER>, or via email by contacting Mr. Brogan at
<EMAIL_ADDRESS>or by contacting Ms. Toone at<EMAIL_ADDRESS>
Comments or questions about any aspect of this ICR pertaining to the
Quarterly PTC Progress Report Form should be directed to Mr. Brogan or
Ms. Toone, while comments or questions about any aspect of this ICR
pertaining to the Annual PTC Progress Report Form should be directed to
OMB's Office of Information and Regulatory Affairs, Attn: FRA OMB Desk
Officer.

SUPPLEMENTARY INFORMATION: Under 49 U.S.C. 20157, as amended by the
Positive Train Control Enforcement and Implementation Act of 2015
(PTCEI Act) and the Fixing America's Surface Transportation (FAST) Act,
each railroad required to implement a positive train control (PTC)
system must provide information to FRA on its implementation progress.
Under the PTCEI Act, each railroad subject to 49 U.S.C. 20157(a) must
submit an annual progress report to FRA by March 31, 2016, and annually
thereafter, until PTC implementation is complete. 49 U.S.C.
20157(c)(1). The amended statute specifically requires each railroad to
provide certain information in the annual reports regarding its
progress toward implementing PTC, and authorizes FRA to request that
railroads provide additional information in the annual progress
reports. See id. The annual progress report will report all progress
for the previous calendar year.
    In addition, 49 U.S.C. 20157(c)(2) requires FRA to conduct
compliance reviews, at least annually, to ensure that each railroad is
complying with its revised PTC implementation plan (PTCIP). The amended
statute requires railroads to provide information to FRA that FRA
determines is necessary to adequately conduct such compliance reviews.
See 49 U.S.C. 20157(c)(2).
    To effectively monitor compliance with PTC system implementation,
FRA is proposing to require each subject railroad and entity to submit
quarterly reports on its implementation progress, in addition to the
annual progress reports, under the PTCEI Act and FRA's statutory and
regulatory investigative authorities. See 49 U.S.C. 20157(c)(2); see
also 49 U.S.C. 20107, 20902; 49 CFR 236.1009(h). Specifically, FRA is
proposing that, in addition to the annual report due each March 31
under 49 U.S.C. 20157(c)(1), railroads must provide quarterly progress
reports covering the preceding three-month period and submit the forms
to FRA on the dates in the following table until full PTC system
implementation is completed:

------------------------------------------------------------------------
                                                         Due dates for
                                   Coverage  period    quarterly reports
------------------------------------------------------------------------
Q1..............................  January 1-March 31  June 30, 2016, and
                                                       each April 30
                                                       thereafter.
Q2..............................  April 1-June 30...  July 31.
Q3..............................  July 1-September    October 31.
                                   30.
Q4..............................  October 1-December  January 31.
                                   31.
------------------------------------------------------------------------

    FRA is delaying submission of the first quarterly form to allow
time for the normal 60-days of notice and public comment directed to
the agency and the additional 30 days of public comment directed to OMB
while the submission undergoes OMB review as required under the
Paperwork Reduction Act of 1995 and its concomitant regulations. Since
the annual report is statutorily required by March 31, 2016, FRA is
seeking Emergency Processing for the annual form.
    Annual and quarterly reporting will enable FRA to effectively track
and report railroad progress and compliance, and to perform its roles
in enforcement and industry oversight. The proposed quarterly progress
report form is formatted similar to the ``PTCIP template'' (FRA F
6180.164, OMB No. 2130-0553) and will be used to track railroads'
progress on, and compliance with, the core quantitative implementation
elements and goals, some of which are included in the railroads'
revised PTCIPs. The quarterly frequency will allow FRA to identify
potential trends so that it can manage its technical assistance and
monitor compliance accordingly. The annual report is required by law,
but FRA is providing guidance on what type of information must be
provided to ensure consistency of the information industry provides to
FRA and its usefulness to FRA for assessing progress and compliance.
    FRA is proposing that each railroad must submit its quarterly
progress reports and annual progress reports using Form FRA F 6180.165
and Form FRA F 6180.166, respectively.
    FRA is proposing to let the less detailed monthly reporting that it
currently requires (approved under

OMB No. 2130-0553) expire in June 2016 when railroads would be required
to begin providing the quarterly progress reports.
    As provided under 5 CFR 1320.13, FRA is requesting emergency
processing for the new annual progress report collection of information
under the Paperwork Reduction Act of 1995 and its implementing
regulations. See, e.g., 44 U.S.C. 3507; 5 CFR 1320.13. FRA cannot
reasonably comply with normal clearance procedures since they would be
reasonably likely to disrupt the collection of information. Each
railroad is required to submit its annual PTC progress report by March
31, 2016, under 49 U.S.C. 20157(c)(1). Therefore, FRA cannot wait the
typical 60-day period for public comment. Therefore, FRA is requesting
OMB approval as soon as possible (i.e., 5 business days after
publication of this Notice) for this collection of information.
    FRA is not requesting Emergency Processing for the quarterly PTC
progress reports because the first quarterly reports will be due by
June 30, 2016. The Paperwork Reduction Act of 1995, Public Law 104-13,
sec. 2, 109 Stat. 163 (1995) (codified as revised at 44 U.S.C. 3501-
3520), and its implementing regulations, 5 CFR part 1320, require
Federal agencies to provide 60-days' notice to the public for comment
on information collection activities before seeking approval for
reinstatement or renewal by OMB. 44 U.S.C. 35069(c)(2)(A); 5 CFR
1320.8(d)(1), 1320.10(e)(1), 1320.12(a). Here, FRA is seeking public
comment on its proposed quarterly reporting form to gather the
information FRA needs to conduct the compliance reviews the PTCEI Act
requires and is requesting a minimum OMB review and approval period of
30 days after the 60-day comment period expires. Comments on any aspect
of the Quarterly PTC Progress Report may be sent to the following:
Federal Railroad Administration, 1200 New Jersey Ave. SE., Washington,
DC 20590, Attention: Mr. Robert Brogan or Ms. Kim Toone; or via email
at the following<EMAIL_ADDRESS><EMAIL_ADDRESS>Copies of
both proposed forms are published as attachments to this notice.
    The associated collection of information is summarized below.
    Title: Quarterly Positive Train Control (PTC) Progress Report Form
and Annual Positive Train Control (PTC) Progress Report Form.
    Reporting Burden:

----------------------------------------------------------------------------------------------------------------
                                                                                Average time
                                     Respondent universe        Total annual       per response    Total annual
                                                                 responses            (hours)      burden hours
----------------------------------------------------------------------------------------------------------------
Quarterly PTC Progress Report:
    Form FRA F 6180.165...........  41 Railroads.........  164 Reports/Forms....           1.573             258
Annual PTC Progress Report:
    Form FRA F 6180.166...........  41 Railroads.........  41 Reports/Forms.....           38.41           1,575
----------------------------------------------------------------------------------------------------------------

    Form Number(s): FRA F 6180.165; FRA F 6180.166.
    Respondent Universe: 41 Railroads.
    Frequency of Submission: On occasion.
    Total Estimated Responses for New Quarterly and Annual PTC Progress
Report Forms: 205.
    Total Estimated Responses for Entire Information Collection:
147,776.
    Total Estimated Annual Burden for New PTC Quarterly and Annual
Progress Report Forms: 1,833 hours.
    Total Estimated Burden for Entire Information Collection:
3,122,817.
    Status: Emergency Review (Annual PTC Progress Report Form) and
Regular Review (Quarterly PTC Progress Report Form).
    Pursuant to 44 U.S.C. 3507(a) and 5 CFR 320.5(b), 1320.8(b)(3)(vi),
FRA informs all interested parties that it may not conduct or sponsor,
and a respondent is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.

    Authority:  44 U.S.C. 3501-3520.

    Issued in Washington, DC, on March 1, 2016.
Corey Hill,
Acting Executive Director.
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[FR Doc. 2016-04882 Filed 3-4-16; 8:45 am]
BILLING CODE 4910-06-C