### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, DC 20460

OFFICE OF CHE MICAL SAFETY

AND POLLUTION PREVENTIO N



### MEMORANDUM

DATE: 12/4/2014



### SUBJECT: Deltamethrin. Petition for the Proposed Use of the Insecticide as a Mosquito

Adu lti c id e: Summary of Analytical Chemistry and Residue Data



### PC Code: 097805



### Decision Number: 484277



### P etition Number: 3F821 0



### Risk Assessment Type: NA

TXR Number: NA

MRID Number: 49114112 

### DP Barcode: D 423045



### Registration Number: 432-RLGU



### Regulatory Action: Section 3 Registration



### Case Number: 7414



### CAS Number: 52918-6 3-5

40 

### CFR: § 180.435



### FROM: Douglas Dotson, Ph.D, Chemist 

# J

.**/)~** Risk Assessment Branch II (RAB2)



### THRU :

TO: Health Effects Division (HED), 7509P

William Drew, Chemist

# ~~O _ 

## jl 

## c;:;:::::./--

Michae l Doherty, Ph.D.

, Senior C h emis t

# ~ /(

# ~ RAB2/HED, 7509P

Olga Odiott!Richard Gebken, PM 

### Team 10

InvertebrateN ertebrate Branch II (IVB2)

Registration Division (RD)

, 7505POeltamethrin Summary of Analytical Chem i stry and Residue Data DP Barcode 0423045



### Table of Contents



### 1.0 Executive Summary

............ ......... ............... ...... . ... .. . .. .. .. .. .. .. .. .. ................................. . ........... 4

2.0 Regulatory R ecommendatio ns

. .. . ... ............................... ... . ....... .......................... ....... ............ 4

2.1 Data Deficiencies/Data Needs

....................................................................... ... .. . ... .. ........ 4

2

. 2 Toleran ce Considerations

.......................................... .. ...................................................... 4

2.2 .1 Enforcement Analytical Method/Multi residue Methods

.......................................... 4

2.2

. 2 Recommended Tolerances

.................................................................... .. ... .. .. .. ......... 5

2.2.3 Revisions to Pet i tione d- For Tolerances

.......... ... . .. .................................................... 5

2.2.4 International Harmonization

..................................................................................... 5

2.3 Label Recommendations

.. ................................... .. .. .. .......................... . ... . ... .. .. .. ............... 5

2.4 Submittal of Analyt i ca l Reference Standards (86 0.1650)

............................................... 6

3. 0 Chemical Identity

................ . ... . .................................. . .. .. .. ... ...................... .. .. .. ... .. .. ... . ... ...... 6

3.1 Nomenclature

........ .. .. .. . .. .. .. .. .. ................................ .. .. .. .. .. .. .. .. .. ........................... .. ... .. ...... 7

3.2 Physicochemical Characteristics

.................................................................... .. ................ 8

3.3 Pesticide Use Pattern/Directions for Use (860.1200)

. ................................... ... . .. ............ 8

4.0 Metabolite/Degrada t e R esidue Pr ofile

................................................................................. 9

4. 1 Nature of the Residue and Summary of Env ir onmental Degradation

.......... . .. .... ............ 9

5.0 R esidue Profile

................... . .. ... . .. ............................ .. .. .. .. ...... ........................... .......... ... .. ... 10

5.1 Residue Analytical Methods (860.1340)

........ ...... . ...... .. .. .. .. ........................ . .. .. ............ 10

5 .1.1 Dat a Collection Methods

............................... . ........................................................ 10

5.1.2 Multi-Residue Methods (860.1360)

............................................. . .......... . ............... 11

5.1.3 To l erance Enfo rcement Methods

.......... ........................ .................. .................... .... 11

5.2 Storage Stability (860.1380)

.......................................................................................... 11

5.3 Residue Data

.................................................................................................................. 12

5.3.1 Crop Field T ri als (860 .1 500)

.................................................................................. 12

5.3.2 Field Rotational Crops (860.1900)

............................. :

........................... ............ .... 1 8

5 .3.3 Processed Food and Feed (860.1520)

............. ...... .................................................. 1 8

5.3.4 Meat, Milk, Poultry and Eggs (860.1480)

................................... . ................... ....... 18

5.3

. 5. Food Handling (860. 1 460)

...................... .. .. .. . .. .. ... .................................................. 20

5.3.6 Water, Fish and Irrigated Crops (860.1400)

.. . .. .. ....... .. .......................... ... .. ... .. .. ..... 20

5.4 Food Residue Profi l e

................. .............................................................................. . ...... 20

6.0 Tolerance Derivation

........... . .. .. ............................ .. .. ...... .............................. .. .. ...... ........... 20

References

......................... . ...................................................... ...... ............................... . ... ...... ...... 21

Attachment 1: International Residue Limit Status

....................................................................... 22

Page 2 of25Deltamethrin Summary of Analytical Chemistry and Residue Data DP Barcode D4 23045



### Page 3 of 25 

### 1.0 Executive Summary

Deltamethrin (with CAS registry number 52918

- 63

- 5, and CAS name (1R,3R)

- R

- cyano(3

- phenoxyphenyl)methyl 3

- (2,2

- dibromoethenyl)

- 2,2

- dimethylcyclopropanecarboxylate) is a

broad

- spectrum pyrethroid insecticide that is registered in the US for direct application to a wide

variety of food/feed crops and for use on stored grains . In addition

, deltamethrin is regi stered for

use in food/feed handling establishments (FHEs) , and a tolerance of 0.05 ppm is established for

this use

. The registrant, Bayer Environmental Science , petitioned the Agency to amend 40CFR

§180.435 (a)(2) to include the use of deltamethrin as a w ide

- area mosquito adulticide in the

airspace over agricultural crops and proposed that the 0.05 ppm tolerance apply to the adulticide

use as well

.

T olerances are established for the combined residues of deltamethrin and its major metabolites

,

trans

- del tamethrin and alpha

- R

- deltamethrin

, in/on plant commodities at levels ranging from

0.03 ppm in sweet corn ears (K+CWHR) to 65 ppm in aspirated grain fractions (40 CFR

§180.435[a] [1] ). T olerances have also been established for residues in livestock commodi ties.

Deltamethrin residues of concern (ROC s ) are comprised of the active ingredient (ai), cis

deltamethrin, along with its isomeric metabolites, trans

- deltamethrin and alpha

- R

- deltamethrin.

The nature of deltamethrin residues in plants and animals is adequately understood, based on

tomato, cotton, apple, goat

, and poultry metabolism studies. The three deltamethrin isomers ( cis

,

trans

- , and alpha

- R

- ) are the major [ 14 

### C]

- residues in plant commodities, and in milk, eggs, meat

, and fat. For purposes of b oth tolerance enforcement and risk assessment, HED has concluded

that the ROCs for both plant and livestock commodities include the cis

- , trans

- and alpha

- R

isomers.

Bayer performed mosquito adulticide residue trials in accordance with a protocol that was previously approved by HED’s Chemistry Science Advisory Council (ChemSAC) and submitted

a report of the results (MRID 49114112). Residue results are supported by adequate storage

stability and analytical method data. Residues were below 0.05 ppm in a ll samples of leaf lettuce

treated at both the 1x and 1⁄2x rate. In grass forage, residues ranged up to 0.087 ppm in samples

treated at a 1x rate. In alfalfa forage, residues ranged up to 0.070 ppm in samples treated at a 1x

rate. Residues in alfalfa hay and grass hay are not being considered for tolerance

- setting

purposes for crops because hay is a dried commodity. I n all trials , residues increased with an

increase in number of treatments.

Adequate methods, utilizing gas chromatograph y with electron capture detection (GC/ECD), are

available for enforcing tolerances for residues of deltamethrin in plant commodities

, as described

in Pesticide Analytical Manual ( PAM ) Volume II, Section 180.422. Another GC/ECD method

(Method HRAV

- 22) is av ailable for enforcing tolerances in livestock commodities. Adequate

confirmatory method validation data have been submitted for these methods, along with

adequate independent laboratory validation (ILV) trials.

Codex and Canada have established MRLs fo r residues of deltam ethrin in /on numerous

commodities. An International Residue Limit Status sheet is appended as Attachment 1.

H armonization of MRLs is not an issue for this risk assessment.Deltamethrin Summary of Analytical Chemistry and Residue Data DP Barcode D4 23045



### Page 4 of 25 

### 2.0 Regulatory Recom m endations

HED has examined the residue chemistry database for deltamethrin

. T here are no residue

chemistry issues that would preclud e establishing a tolerance for all crops as a result of the use of

deltamethrin as a mosquito adulticide

. HED does not object to the amending of 40CFR

§180.435 (a)(2) to include the use of deltamethrin as a wide

- area mosquito adulticide

.

HED recommends that the tolerance expression f or deltame thrin, cited under 40CFR

§180.4 3 5[a][ 2 ], be amended to read as follows:

A tolerance of 0

. 05 ppm is established for residues of the insecticide deltam ethrin,

including its metabolites and degradates, in or on all raw agricultural commodities

and processed food or feed from use of deltam ethrin in food or feed handling

establishments where food /fee d and food /feed products are held, processed,

prepared and/or served, or as a wide

- area mosquito adulticide. Compliance with

the tolerance level specified is to be determined by measuring only deltamethrin

[(1 R ,3 R )

- 3

- (2,2

- dibromovinyl)

- 2,2

- dimethylcyclopr opanecarboxylic acid ( S )

- alpha

- cyano

- 3

- phenoxybenzyl ester ], and its major metabolites, trans

deltamethrin [( S )

- alpha

- cyano

- m

- phenoxybenzyl(1R,3S)

- 3

- (2,2

- dibromovinyl)

- 2,2

- dimethylcyclopropanecarboxylate] and alpha

- R

- deltamethrin [( R )

- alpha

cyano

- m

- phenoxybenzyl

- (1 R ,3 R )

- 3

- (2,2

- dibromovinyl)

- 2,2

- dimethylcyclopropanecarboxylate] in or on the commodity.

The use directions in 40CFR §180. 43 5[a][2] (i and ii) should be deleted because use directions

are not necessary or needed in the 40CFR listing fo r deltam ethrin.

2.1 Data Deficiencies/Data Needs

None.

2.2 Tolerance Con sid erations

2.2.1 Enforcement Analytical Method/Multiresidue Methods

Adequate GC/ECD methods are available for enforcing tolerances for residues of deltamethrin in

both plant a nd animal commodities. A GC/ECD method is available in PAM Volume II (Section

180.422) for enforcing tolerances for residues of deltamethrin, along with a modified version of

this method (Method ENC 8/92) for analysis of deltamethrin in plant commodities.

Two other GC/ECD methods are also available for enforcing deltamethrin tolerances in plant

commodities. Method ENC

- 6/92 is for determining residues in grain crops and processed

fractions, while Method HRAV

- 20 is for determining residues in other food/ feed crops.

Adequate confirmatory method validation, radiovalidation

, and ILV data have been submitted

for these GC/ECD methods, and HED has concluded that an Agency validation was not requiredDeltamethrin Summary of Analytical Chemistry and Residue Data DP Barcode D4 23045



### Page 5 of 25 

### for these methods. The reported LOQs for each deltamethrin i somer range from 0.005 to 0.050

ppm, depending on the plant commodity.

Another GC/ECD method (Method HRAV

- 22) is available for enforcing tolerance s i n livestock

commodities. Adequate confirmatory method validation data have been submitted for this

method, along with an adequate ILV trial. The reported LOQ for each deltamethrin isomer is

0.005 ppm in all l ivestock matrices, except fat, which has an LOQ of 0.015 ppm.

Multiresidue methods dat a for cis

- deltamethrin and trans

- deltamethrin wer e previously sent to

the Food and Drug Administration ( FDA )

. Cis

- deltamethrin is completely recovered through

Methods 302 and 303, and partially recovered through Method 304. Trans

- Deltamethrin is

partiall y recovered through Method 303, but not recovered through Method 304.

2.2.2 Recommended Tolerances

As stated above, HED recommends that the tolerance expression and use directions for

deltame thrin, cited under 40CFR §180.4 3 5[a][ 2 ], be amended to read as follows:

A tolerance of 0 .05 ppm is established for residues of the insecticide deltam ethrin,

including its metabolites and degradates, in or on all raw agricultural commodities and

processed food or feed from use of deltam ethrin in food or feed handling establishments

where food

/feed and food /feed products are held, processed, prepared and/or served, or as

a wide

- area mosquito adulticide. Compliance with the tolerance level specified is to be

determined by measuring only deltame thrin [(1 R ,3 R )

- 3

- (2,2

- dibromovinyl)

- 2,2

- dimethylcyclopropanecarboxylic acid ( S )

- alpha

- cyano

- 3

- phenoxybenzyl ester ], and its

major metabolites, trans deltamethrin [( S )

- alpha

- cyano

- m

- phenoxybenzyl(1R,3S)

- 3

- (2,2

- dibromovinyl)

- 2,2

- dimethylcyclopropanecarboxyla te] and alpha

- R

- deltamethrin [( R )

- alpha

- cyano

- m

- phenoxybenzyl

- (1 R ,3 R )

- 3

- (2,2

- dibromovinyl)

- 2,2

- dimethylcyclo

propanecarboxylate] in or on the commodity.

2.2.3 Revisions to Petitioned

- For Tolerances

None

2.2.4 International Harmonization

Codex and Canada have established MRLs for residues of deltam ethrin in /on numerous

commodities. An International Residue Limit Status sheet is appended as Attachment 1.

H armonization of MRLs is not an issue for this risk assessment.

2.3 Label Recommendations

T he label contains the following statement: “Apply at a rate not to exceed 0.0014 pounds of

deltamethrin per acre in any given 24

- hour period.” The adulticide residue trials were performed

at a 3

- day retreatment interval, however. As a result, the regist rant should revise the label toDeltamethrin Summary of Analytical Chemistry and Residue Data DP Barcode D4 23045



### Page 6 of 25 

### state that the maximum single application rate is 0.00134 lb ai/A and the minimum re

- treatment

interval is 3 days.

The label also states: “Do not make more than 25 applications per site per year.” In the residue

trials that were performed, the registrant only made 10 applications. As a result, the registrant

should revise the label to state that no more than 10 appl ications per year may be made at the

maximum application rate of 0.00134 lb ai/A.

The label also states: “Do not exceed 0.036 pounds of AI per acre per year to any site.” This

maximum value of 0.036 lb ai/A is based on 25 applications per year, rather t han 10. As a result,

the registrant should revise the label to state that 0.0134 lb ai/A is the maximum seasonal

application rate.

2.4 Submittal of Analytical Reference Standards ( 860.1650 )

The analytical standard for deltamethrin , with an expiration date of 11/ 1 8 / 201 5 , is currently

available in the EPA’s National Pesti cide Standards Repository (NPSR, electronic

communication from Theresa Cole of the Biological and Economic Analysis Division’s

(BEAD’s) Analytical Chemistry Branch ( ACB) to William Drew (4/ 24 / 2014 ) )

. C is

- deltamethrin

is also currently available ( expiration date of 12/ 7 / 201 5), along with alpha

- R

- deltamethrin

( 3/ 1 / 2018) and trans

- deltamethrin ( 2/ 19 / 2015) . The registrant is required to maintain reasonable

amounts of th e analytical reference standard s for deltamethrin and its individual isomers in the

NPSR

. When necessary, a new reference standard or updated certificate of analysis (COA)

should be sent to the ACB, which is located at Fort Meade, MD. It should be sent t o the

attention of either Theresa Cole or Thuy Nguyen at the address listed below, along with a letter

of transmittal. Please note that the full 9

- digit ZIP Code is required, or the mail will be

returned to the registrant.

USEPA

National Pesticide Standards Repository

Analytical Chemistry Branch/BEAD/OPP

701 Mapes Road

Fort George G. Meade, MD 20755

- 5350

The letter of transmittal should include the assay of the standard, name of the analytical method

used, a statement of principal impurities , purification procedures employed, storage

requirements, and special precautions for safe handling. Replacement of standards may be

required periodically if supplies are exhausted, if the standards expire, or if decomposition

occurs during storage. Safe ty Data Sheets (SDSs) must accompany all analytical standards as

specified in 29CFR§1910.1200 by the Occupational Safety and Health Administration (OSHA).

3.0 Chemical Identity

Deltamethrin is a pyrethroid insecticide that kills insects on contact and through ingestion. It is

used to control apple and pear suckers, plum fruit moths, caterpillars, pea moths, aphids ( onDeltamethrin Summary of Analytical Chemistry and Residue Data DP Barcode D4 23045



### Page 7 of 25 

### apples, plums, and hops), winter moths ( on apples and plums), and codling and tortrix moths ( on

apples). It controls aphids, mealy bug s, scale insects and whitefly on glasshouse cucumbers,

tomatoes, peppers, ornamentals

, and potted plants. Formulations include micro

- emulsions

( MEs ) , emulsifiable concentrates ( ECs ) , wettable powders (WP s ), flowable formulations, and

granules. There are no known incompatibilities with other common insecticides and fungicides.

Deltamethrin is a synthetic insecticide (based structurally on natural pyrethrins) t h at rapidly

paralyzes the insect nervous system, giving a quick knockdown effect. Deltamethrin has a rapid

disabling effect on feeding insects and it is useful for control ling the vectors of “non

- persistent”

viruses, which can be passed on by the vector within a few minutes of starting to feed on the

plant. Death of insects seems to be due to irre versible damage to the nervous system that occurs

when exposure lasts more than a few hours. Deltamethrin poisoning occurs through cuticular

penetration, or oral uptake. The susceptibility of insects is dependent on a variety of factors, and

can vary (as with many insecticides) according to the environmental conditions.

The chemical structure and nomenclature of deltamethrin are presented in Table 3. 1 . The

physicochemical properties of the technical grade of deltamethrin are presented in Table 3. 2

, be low

.

3.1 Nomenclature

T able 3.1

. Test Compound Nomenclature

Compound Chemical Structure

Common Name Cis

- d eltamethrin

Molecular Formula C 22 H 19 Br 2 NO 3 Molecular Weight 505.24

Company Experimental Name AEF108569

IUPAC Name (S)

- α

- cyano

- 3

- phenoxybenzyl (1R,3R)

- 3

- (2,2

- dibromovinyl)

- 2,2

- dimethylcyclopropanecarboxylate

CAS Name (1R,3R)

- R

- cyano(3

- phenoxyphenyl)methyl 3

- (2,2

- dibromoethenyl)

- 2,2

- dimethylcyclopropanecarboxylate

CAS Number 52918

- 63

- 5

End

- use Products (EPs) AlphaMax ( No current EPA r egistration); AMX ( No current EPA registration )

.Deltamethrin Summary of Analytical Chemistry and Residue Data DP Barcode D4 23045



### Page 8 of 25 

### 3.2 Physic oc hemical Characteristics

T able 3.2

. Physicochemical Properties of Technical Grade Deltamethrin.*

Parameter Value

Melting Point/Range (°C) 100

- 102

pH Not available

Density (g/cm 3 at 25°C) 0.550

Water Solubility (ug/L at 25°C) <0.2

Solvent Solubility (% by w eight at 20oC) Acetone 33

Alcohol 0.6

Isopropanol 0.2

Ethyl acetate 25

n

- Hexane 0.2

Toluene 23

DMF 38

Dioxane 39

Vapor Pressure (mm Hg at 25oC) [mP a at 25°C] 1.5 x 10

- 8 [1.24 x 10

- 5 ]

Dissociation C onstant, pK

a Does not dissociate

. Octanol/ Water Partition C oefficient, K OW ( at 25oC ) 2.7 x 10 5

UV/ V isible A bsorption S pectrum Not available

.

* Reference: MARC Briefing Memorandum; D284320; D. Dotson; 5 November 2002.



### Deltamethrin is a solid under ambient conditions, and it has low volatility. The compound has a

ve r y low solubility in water, and low to high solubility in organic solvents. Its octanol/water

partition coefficient suggests that accumu lation in fatty tissues is possible.

3.3 Pesticide Use Pattern/Directions for Use (860.1200)

Bayer Environmental Science submitted a proposed label for the mosquito adulticide

formulation, BES0668 Insecticide. BES0668 is formulated as a liquid an d contains 2.0% of the

active ingredient. It may be applied by ULV truck mounted fogger and portable backpack or

hand

- carried equipment at a single maximum application rate of 0.00134 lb ai/acre in residential,

industrial, urban, recreational, municipal, agricultural and other areas where adult mosquitoes

and flies are found. BES0668 is also to be applied in indoor/outdoor livestock and poultry

facilities. This product is to be applied by Federal, State, Tribal, or local government officials

responsible for public health or vector control, or by persons certified in the appropriate

category, authorized by the state or tribal lead pesticide regulatory agency to perform adult

mosquito control applications, or by persons under their direct supervision, or as allowed by s tate

regulations for persons treating private property. A summary of the proposed use pattern is

presented in Table 3.3 , below

.Deltamethrin Summary of Analytical Chemistry and Residue Data DP Barcode D4 23045



### Page 9 of 25 

### The label contains the following statement: “Apply at a rate not to exceed 0.0014 pounds of

deltamethrin per acre in any given 24

- hour period.” The adulticide residue trials were performed

at a 3

- day retreatment interval, however. As a result, the registrant should revise the label to

state that the maximum single application rate is 0.00134 lb ai/A and the minimum re

- treatment

interval is 3 days

.

The label also states: “Do not make more than 25 applications per site per year.” In the residue

trials that were performed, the registrant only made 10 applications. As a result, the registrant

should revise the label to state that no more than 10 a pplications per year may be made at the

maximum application rate of 0.00134 lb ai/A

.

The label also states: “Do not exceed 0.036 pounds of AI per acre per year to any site.” This

maximum value of 0.036 lb ai/A is based on 25 applications per year, rathe r than 10. As a result,

the registrant should revise the label to state that 0.0134 lb ai/A is the maximum seasonal

application rate.

Conclusions : The d irections for use on the proposed label should be revised as discussed above

.

4.0 Metabolite/Degrad ate Residue Profile

4.1 Nature of the Residue and Summary of Environmental Degradation

The nature of the residue in plants

, livestock, rats, and rotational crops is adequately understood

based on acceptable plant and animal metabolism studies. In addition, the environmental

degradation is understood based on acceptable environmental fate studies. Details of the various

submitted in support of the metabolism and environmental d egradation of deltamethrin as well as

HED’s conclusions concerning these studies can be found in the Metabolism Assessment Review

Committee Decision Memo (D286801, D. Dotson and N. McCarroll, 1/14/2003) as well as in the Table 3.3. Summary of Directions for Proposed Mosquito Vector Control Use of Deltamethrin

Method of

Application Product and

Formulation

(Reg. No.) Application

Rate

(lb ai/A) Maximum

No.

Applications

per Season Maximum

Seasonal

Application

Rate

(lb ai/A) RT I

(days) Use Directions,

Application Timing,

Type and Limitations

Truck mounted

ULV fogger,

Ground and

Hand Held

Equipment BES0668

Insecticide

Reg. No. 432

-

RLGU

(0.17 lb ai/gal) 0.00134

lb ai/A

over crops 25 0.0 36

lb ai/A in

one year over

crops 3 More frequent

applications may be

made to prevent or

control a threat to

public/animal health

det ermined by a state,

tribal or local health or

vector control agency.Deltamethrin Summary of Analytical Chemistry and Residue Data DP Barcode D4 23045



### Page 10 of 25 

### previous residue chemistry summary document and risk assessment prepared for deltamethrin

(D413135, D. Dotson, 6/17/2014 and D413048, D. Dotson, et al., 10/10/2014, respectively).

HED has determined the plant and livestock ROCs for purposes of tolerance enforcement and

risk assessment ( see Table 4.1.1, below )

.

T able 4.1.1

. Summary of Deltamethrin Metabolites and Degradates to be Included in Risk

Assessment and the Tolerance Expression

Matrix Residues in Risk Assessment Residues in the Tolerance Expression

Plants Primary crops Cis

- , trans

- and alpha

- R

- deltamethrin Cis

- , trans

- and alpha

- R

- deltamethrin

Rotational crops Not Applicable Not applicable

Livestock Ruminants Cis

- , trans

- and alpha

- R

- deltamethrin Cis

- , trans

- and alpha

- R

- deltamethrin

Poultry

Drinking water Cis

- , trans

- and alpha

- R

- deltamethrin Not applicable



### 5.0 Residue Profile

5.1 Residue Analytical Methods (860.1340)

5.1.1 Data Collection Methods

A complete method description and method validation data for the method were included in the

submission. Bayer analyzed the samples for cis

- and trans

- deltamethrin. Although alpha

- R

deltamethrin is a residue of concern for both tolerance enforcement and risk assessment, Bayer

did not report results for the alpha

- R isomer. Bayer stated that residues of the a lpha

- R isomer

were non

- detectable in the samples that were analyzed (electronic communication from J. Brill

(Bayer CropSciences) to D. Dotson, 10/30/2014). Bayer also stated that the alpha

- R isomer is

present in only trace amounts in the technical materia l and would be present in even lower

amounts in the end

- use product. In the field trials that were performed, samples were taken the

day of application. There would be no time for conversion of the cis isomer to the alpha

- R

isomer. In the adulticide tri als, samples were stored for up to 13 months. The cis isomer would

not have converted to the trans isomer because the available storage stability data for

deltamethrin demonstrate that the three individual isomers are stable during frozen storage.

Residu es of the cis and tr a ns isomers were extracted from plant tissues using acetone/n

hexane/dichloromethane (1/1/1, v/v) as the extraction solvent. Extract cleanup was by cation

exchange SPE and analysis was by LC

- MS/MS.

Acceptable method validation recover ies o f cis

- and trans

- deltamethrin were obtained from

samples of alfalfa forage, alfalfa hay, leaf lettuce, grass forage, and grass hay fortified at levels

ranging from 0.01 ppm to 0.86 ppm, as specified in the table below. Mean r ecoveries ranged

from 7 2 to 1 05 %

.

The LOQ for cis

- and trans

- deltamethrin in lettuce and forage (both grass and alfalfa) was 0.01

ppm. The LOQ for both isomers in hay (both grass and alfalfa) was 0.04 ppm. The reportedDeltamethrin Summary of Analytical Chemistry and Residue Data DP Barcode D4 23045



### Page 11 of 25 

### LODs ranged from 0.003 ppm to 0.02 ppm, depending on isomer and matrix.

Conclusions: The data collection method used for analysis of residues of cis

- and trans

deltamethrin in alfalfa forage, alfalfa hay, leaf lettuce, grass forage, and grass hay is adequate

based on acceptable method validation data

.

5.1.2 Multi r esidue Methods (860.1360)

Multiresidue methods data for ci s

- deltamethrin and trans

- deltamethrin have previously been sent

to FDA. Cis

- deltamethrin is completely recovered through Methods 302 and 303, and partially

recove red through Method 304. Trans

- Deltamethrin is partially recovered through Method 303,

but not recovered through Method 304.

5.1.3 Tolerance Enforcement Methods

Adequate GC/ECD methods are available for enforcing tolerances for residues of deltamethrin in

both plant and livestock commodities. A tolerance enforcement method using GC/ECD is

available in PAM Volume II (Section 180.422) for determining residues of deltamethrin, along

with a modified version of this method (Method ENC 8/92) for analysis of deltamethrin in plant

commodities.

Two other GC/ECD methods are also available for enforcing deltamethrin tolerances in plant

commodities. Method ENC

- 6/92 is for determining residues in grain crops and processed

fractions, while Method HRAV

- 20 is for d etermining residues in other food/feed crops.

Adequate confirmatory method validation, radiovalidation and ILV data were submitted for these

GC/ECD methods, and HED concluded that an Agency validation was not required for these

methods. The reported LOQs for each deltamethrin isomer range from 0.005 to 0.050 ppm,

depending on the plant commodity.

Another GC/ECD method ( Method HRAV

- 22) is available for enforcing tolerances in livestock

commodities. Adequate confirmatory method validation data have been submitted for this

method, along with an adequate ILV trial. The reported LOQ for each deltamethrin isomer is

0.005 ppm in all livestock matrices, except fat, which has an LOQ of 0.015 ppm.

5.2 Storage Stability (860.1380)

Bayer did not submit storage stability data for the alfalfa, grass, and lettuce samples taken in the

adulticide residue study. However, data previously submitted by Bayer indicate that residues of

cis

- , trans

- , and α

- R

- deltamethrin are stable under frozen storage conditions for at least 3 years

in/on cottonseed and field corn grain, forage, stover

, starch, flour, and oil. Each analyte was also

stable for at least 2 years in frozen tomato, 1 year in frozen apples and cucumbers, 16 months in

lettuce, tomato puree, and tomato wet pomace

. The samples taken in the adulticide trials were

stored for a maximum of 13 months.

Conclusions : The storage stability data that have been previously submitted for deltamethrin

demonstrate that the chemical is generally very stable under frozen storage conditions. TheDeltamethrin Summary of Analytical Chemistry and Residue Data DP Barcode D4 23045



### Page 12 of 25 

### storage stability data are adequate to support the frozen storage intervals of all samples from the

current adulticide residue trials

.

5.3 Residue Data

5.3.1 Crop Field Trials (860.1500)

Bayer performed residue trials in accordance with a protocol the company submitted to

ChemSAC in 2012. Two trials were performed in EPA Growing Zone 5. One trial was

performed in Lenexa, Kansas, and the other trial was performed in Springfield, Nebraska. As

ChemSAC requested, Bayer ensured the trials were independent by per forming them 200 miles

apart and used application equipment that was consistent with that specified on the label

(ground

- based fogger) . Residues were measured in alfalfa forage, alfalfa hay, leaf lettuce, grass

forage, and grass hay. At each location, tw o plots of each commodity were treated 10 times with

a broadcast foliar ultra low volume (ULV) spray application of an EW (emulsion in water)

formulation of deltamethrin. One plot was treated at a 1⁄2x application rate (0.00067 lb a.i./A for

a total applica tion rate of 0.0067 lb ai/A) and the other at a 1x application rate (0.00134 lb a.i./A

for a total application rate of 0.0134 lb ai/A). Applications were made at a 3

- day re

- treatment

interval (RTI), and samples were collected on the same day as the last a pplication. Duplicate

composite samples were taken after each application at each location (both low and high rate

plots). As there were two separate locations, f our samples were taken for analysis.

Residues were below 0.05 ppm in all samples of leaf lettuce treated at both the 1x and 1⁄2x rate.

In grass forage, residues ranged up to 0.087 ppm in samples treated at a 1x rate. In alfalfa

forage, residues ranged up to 0.070 ppm in samples treated at a 1x rate. Residues in alfalfa hay

and grass hay are n ot being considered for tolerance

- setting purposes because hay is a dried

commodity and not representative of fresh

- market commodities . In all trials, residues increased

with an increase in number of treatments. Table 5.3.1, below, summarizes the results of the

residue trials that were performed.Deltamethrin Summary of Analytical Chemistry and Residue Data DP Barcode D4 23045



### Page 13 of 25 Table 5.3.1. Summary of Total Residues from Alfalfa Forage Field Trials with Deltamethrin

Crop

Matrix Analyte No. of

Appli

cations Applic.

Rate

(lb

ai/acre) PHI

(days) n Residues (ppm)

Min Max LAFT HAFT Mean SD

Alfalfa Forage : Proposed Total Application Rate = 0.0 067 lb ai/A (1⁄2 x)

Alfalfa

Forage Cis and

Trans

Delta

methrin 1 0.00066

-

0.00068 0 4 <0.004 0.011 2 0.005 5 0.0089 0.0073 0.00302

2 0.00067

-

0.00070 0 4 0.0105 0.014 8 0.010 8 0.0131 0.0120 0.0020

3 0.00068 0 4 0.0084 0.0178 0.0131 0.0139 0.0135 0.00423

4 0.00066

-

0.00068 0 4 0.0172 0.0208 0.0173 0.0 200 0.0187 0.0014 4

5 0.00067

-

0.00068 0 4 0.0160 0.0244 0.0202 0.020 6 0.0204 0.00363

6 0.00067

-

0.00069 0 4 0.0113 0.0220 0.013 6 0.0209 0.0172 0.00471

7 0.00066 0 4 0.0237 0.0382 0.0249 0.03 88 0.0313 0.00749

8 0.00066

-

0.00068 0 4 <0.004 0.0294 0.011 5 0.0281 0.0198 0.01142

9 0.00067

-

0.00069 0 4 0.0165 0.054 4 0.0170 0.0434 0.0302 0.0178

10 0.00067

-

0.00068 0 4 0.0144 0.0441 0.016 2 0.0380 0.0271 0.0136

Alfalfa Forage: Proposed Total Application Rate = 0.0134 lb ai/A (1x)

Alfalfa

Forage Cis and

Trans

Delta

methrin 1 0.0013 0 4 <0.004 0.007 5 <0.004 0.00 69 0.0055 0.0018

2 0.0013

-

0.0014 0 4 0.0066 0.0394 0.0075 0.0363 0.0219 0.0168

3 0.0013

-

0.0014 0 4 0.0072 0.0337 0.009 3 0.0294 0.0194 0.0122

4 0.0013 0 4 0.0139 0.0385 0.0147 0.03 60 0.02 54 0.0124

5 0.0013 0 4 0.0143 0.0507 0.0164 0. 0 455 0.0310 0.0174

6 0.0013 0 4 0.0122 0.0525 0.012 4 0.046 3 0.0293 0.0202

7 0.0013 0 4 0.0128 0.03 62 0.014 3 0.03 2 4 0.0228 0.0101

8 0.0013 0 4 0.0205 0.0444 0.02 90 0.0409 0.0349 0.0102

9 0.0013 0 4 0.0315 0.0696 0.039 7 0.0620 0.0508 0.0158

10 0.0013 0 4 0.0040 0.06 9 0 0.0301 0.06 71 0.0343 0.0332

LAFT = Lowest Average Field Trial, HAFT = Highest Average Field Trial, SD = Standard Deviation. For computation of the

LAFT, HAFT, median, mean, and standard deviation, values <LO Q are assumed to be at the LOQ.Deltamethrin Summary of Analytical Chemistry and Residue Data DP Barcode D4 23045



### Page 14 of 25 Table 5.3.1. Summary of Total Residues from Alfalfa Hay Field Trials with Deltamethrin

Crop

Matrix Analyte No. of

Appli

cations Applic.

Rate

(lb

ai/acre) PHI

(days) n Residues (ppm)

Min Max LAFT HAFT Mean SD

Alfalfa Hay : Proposed Total Application Rate = 0.0067 lb ai/A (1⁄2 x)

Alfalfa

Hay Cis and

Trans

Delta

methrin 1 0.00066

-

0.00068 0 4 <0.0 15 0 0.0 50 7 0.0150 0.0 48 0 0.0 316 0.0 193

2 0.00067

-

0.00070 0 4 0.0356 0.0885 0.039 9 0.07 07 0.0555 0.0233

3 0.00068 0 4 0.0340 0.0495 0.036 5 0.0456 0.0413 0.0065

4 0.00066

-

0.00068 0 4 0.05 12 0. 164 0.0 548 0. 1530 0.0564 0.0069

5 0.00067

-

0.00068 0 4 0.0560 0.0 930 0.058 9 0.0 805 0.0603 0.0029

6 0.00067

-

0.00069 0 4 < 0.0 15 0.0 537 0.0 278 0.0 522 0.0 400 0.01 76

7 0.00066 0 4 0.0 331 0.0737 0.03 80 0.0716 0.0613 0 .0125

8 0.00066

-

0.00068 0 4 0.0 350 0.0707 0.0 357 0.0624 0.0480 0.0205

9 0.00067

-

0.00069 0 4 < 0.0 15 0.0709 0.0 15 0.0679 0.0565 0.0140

10 0.00067

-

0.00068 0 4 0.05 29 0.0854 0.0 618 0.0848 0.0681 0.0195

Alfalfa Hay : Proposed Total Application Rate = 0.0134 lb ai/A (1x)

Alfalfa

Hay Cis and

Trans

Delta

methrin 1 0.0013 0 4 < 0.0 15 0 .0 253 0.0150 0.0 213 0.0 182 0.0 049

2 0.0013

-

0.0014 0 4 0.0 354 0.0 8 36 0.0 193 0.0 592 0.0 393 0.0 305

3 0.0013

-

0.0014 0 4 0.0 201 0.0 687 0.0 205 0.0 643 0.0 4 24 0.0 255

4 0.0013 0 4 0.0305 0.0 952 0.0326 0.0935 0.0 631 0.0 352

5 0.0013 0 4 0.0337 0.0878 0.0348 0.0736 0.0515 0.0193

6 0.0013 0 4 0.0186 0.1 64 0.021 7 0.1410 0.0792 0.0680

7 0.0013 0 4 0.0378 0.0930 0.039 1 0.0680 0.0537 0.0263

8 0.0013 0 4 0.0150 0.0832 0.0 352 0.080 5 0.0 579 0.0314

9 0.0013 0 4 0.0333 0.1205 0.0428 0.110 1 0.0765 0.0404

10 0.0013 0 4 0.0178 0.1110 0.0363 0.1110 0.0272 0.0108

LAFT = Lowest Average Field Trial, HAFT = Highest Average Field Trial, SD = Standard Deviation. For computation of the

LAFT, HAFT, median, mean, and standard deviation, values <LOQ are assumed to be at the LOQ.Deltamethrin Summary of Analytical Chemistry and Residue Data DP Barcode D4 23045



### Page 15 of 25 Table 5.3.1. Summary of Total Residues from Lettuce Field Trials with Deltamethrin

Crop

Matrix Analyte No. of

Appli

cations Applic.

Rate

(lb

ai/acre) PHI

(days) N Residues (ppm)

Min Max LAFT HAFT Mean SD

Leaf Lettuce : Proposed Total Application Rate = 0.0067 lb ai/A (1⁄2 x)

Lettuce

Leaves Cis and

Trans

Delta

methrin 1 0.00066

-

0.00067 0 4 <0.00 35 0.0 24 1 0.00 35 0.0 234 0.0 139 0.0 114

2 0.00067

-

0.00068 0 4 0.0163 0.0311 0.0208 0.0236 0.0225 0.0069

3 0.00067

-

0.00068 0 4 0.0114 0.0408 0.0128 0.0384 0.0259 0.0150

4 0.00067

-

0.00068 0 4 0.0151 0.0375 0.0165 0.037 2 0.0271 0.0120

5 0.00073

-

0.00066 0 4 0.011 5 0.029 7 0.0 210 0.02 25 0.0169 0.0087

6 0.00067

-

0.00068 0 4 0.0073 0.0303 0.0080 0.0284 0.0185 0.0119

7 0.00067 0 4 0.006 4 0.0327 0.0 065 0.0 290 0.0180 0.0133

8 0.00066

-

0.00067 0 4 0.00 59 0 .0306 0.006 2 0.027 8 0.0172 0.0127

9 0.00067

-

0.00068 0 4 0.004 3 0.0349 0.0045 0.034 9 0.0200 0.0175

10 0.00067

-

0.00068 0 4 0.0065 0.0446 0.0080 0.0425 0.0255 0.0201

Leaf Lettuce : Proposed Total Application Rate = 0.0134 lb ai/A (1x)

Lettuce

Leaves Cis and

Trans

Delta

methrin 1 0.0013 0 4 0.004 8 0.0 150 0.0051 0.0 1 40 0.0 098 0.00 52

2 0.0013 0 4 0.0100 0.0234 0.0101 0.0192 0.0150 0.0063

3 0.0013 0 4 0.0100 0.0116 0.0102 0.0106 0.0107 0.0009

4 0.0013 0 4 0.0116 0.0187 0.0120 0.0168 0.0147 0.0032

5 0.0013 0 4 0.0120 0.0188 0.0122 0.015 3 0.0140 0.0034

6 0.0013 0 4 0.0062 0.0089 0.0065 0.0087 0.0079 0.0014

7 0.0013 0 4 0.006 0 0.0 348 0.0085 0.0 342 0.0 213 0.0 150

8 0.0013 0 4 0.0060 0.0222 0.0061 0.0202 0.0134 0.0083

9 0.0013 0 4 0.0052 0.0412 0.0057 0.0365 0.0214 0.0183

10 0.0013 0 4 0.0057 0.0375 0.0063 0.033 1 0.0200 0.0158

LAFT = Lowest Average Field Trial, HAFT = Highest Average Field Trial, SD = Standard Deviation. For computation of the

LAFT, HAFT, median, mean, and standard deviation, values <LO Q are assumed to be at the LOQ.Deltamethrin Summary of Analytical Chemistry and Residue Data DP Barcode D4 23045



### Page 16 of 25 Table 5.3.1. Summary of Total Residues from Grass Forage Field Trials with Deltamethrin

Crop

Matrix Analyte No. of

Appli

cations Applic.

Rate

(lb

ai/acre) PHI

(days) n Residues (ppm)

Min Max LAFT HAFT Mean SD

Grass Forage: Proposed Total Application Rate = 0.0067 lb ai/A (1⁄2 x)

Grass

Forage Cis and

Trans

Delta

methrin 1 0.00066

-

0.00068 0 4 0.00 53 0.01 88 0.0053 0.0 1 4 9 0.0 103 0.00 64

2 0.00067

-

0.00070 0 4 0.0093 0.0232 0.0117 0.0197 0.0159 0.0058

3 0.00067

-

0.00068 0 4 0.0197 0.0330 0.0216 0.0292 0.0255 0.0055

4 0.00067

-

0.00068 0 4 0.0170 0.0203 0.017 4 0.018 8 0.0183 0.0014

5 0.00066

-

0.00067 0 4 0.0167 0.0190 0.016 9 0.0189 0.0181 0.0012

6 0.00067

-

0.00069 0 4 0.0132 0.0333 0.015 3 0.0297 0.0226 0.0089

7 0.00066 0 4 0.0205 0.0351 0.0223 0.0316 0.0271 0.0062

8 0.00073

-

0.00067 0 4 0.0 282 0 .0338 0.0295 0.0324 0.0310 0.0023

9 0.00066

-

0.00068 0 4 0.0218 0.0308 0.0261 0.0285 0.0274 0.0043

10 0.00067 0 4 0.0251 0.0429 0.0303 0.0339 0.0321 0.0086

Grass Forage: Proposed Total Application Rate = 0.0134 lb ai/A (1x)

Grass

Forage Cis and

Trans

Delta

methrin 1 0.0013 0 4 0.0 0716 0.0 16 6 0.0076 0.0 13 5 0 .0108 0.0043

2 0.0013

-

0.0014 0 4 0.01 13 0.0 1 75 0.0114 0.015 7 0.0137 0.0029

3 0.0013 0 4 0.0 194 0.0278 0.0202 0.025 9 0.0232 0.0037

4 0.0013 0 4 0.0168 0.0250 0.0190 0.0245 0.0220 0.0037

5 0.001 4

-

0.0013 0 4 0.0 174 0.0 284 0.0192 0.025 7 0.0227 0.0046

6 0.0013 0 4 0.0 113 0.0 320 0.0146 0.0248 0.0199 0.0086

7 0.0013 0 4 0.0 215 0.0348 0.0274 0.0342 0.0309 0.0063

8 0.0013 0 4 0.0292 0.0341 0.0305 0.0317 0.0302 0.0038

9 0.0013 0 4 0.0187 0.0 791 0.0222 0.0748 0.0486 0.0308

10 0.0013 0 4 0.0217 0.0870 0.0252 0.0698 0.0470 0.0295

LAFT = Lowest Average Field Trial, HAFT = Highest Average Field Trial, SD = Standard Deviation. For computation of the

LAFT, HAFT, median, mean, and standard deviation, values <LOQ are assumed to be at the LOQ.Deltamethrin Summary of Analytical Chemistry and Residue Data DP Barcode D4 23045



### Page 17 of 25 Table 5.3.1. Summary of Total Residues from Grass Hay Field Trials with Deltamethrin

Crop

Matrix Analyte No. of

Appli

cations Applic.

Rate

(lb

ai/acre) PHI

(days) n Residues (ppm)

Min Max LAFT HAFT Mean SD

Grass Hay: Proposed Total Application Rate = 0.0067 lb ai/A (1⁄2 x)

Grass

Hay Cis and

Trans

Delta

methrin 1 0.00066

-

0.00068 0 4 < 0.0 2 0 0 0.0 92 0 <0.02 0.0 8 67 0.0 535 0.0 389

2 0.00067

-

0.00070 0 4 0.0 289 0 .0772 0.0319 0.077 2 0.0549 0.0262

3 0.00067

-

0.00068 0 4 0.0390 0.0859 0.0411 0.0809 0.0613 0.0235

4 0.00067

-

0.00068 0 4 0.0520 0.0876 0.0521 0.0795 0.0661 0.0171

5 0.00066

-

0.00067 0 4 0.0432 0.1240 0.0461 0.122 0.0842 0.0438

6 0.00067

-

0.00069 0 4 0.0537 0.0974 0.057 3 0.0955 0 .0767 0.0224

7 0.00066 0 4 0.057 2 0.1584 0.0574 0.137 0.0974 0.0491

8 0.00073

-

0.00067 0 4 0.0493 0.1340 0.0501 0.13 3 0.0914 0.0474

9 0.00066

-

0.00068 0 4 0.0513 0.1624 0.05 50 0.162 0.1087 0.0618

10 0.00067 0 4 0.0489 0.1976 0.0491 0.188 0.1188 0.0805

Grass Hay: Proposed Total Application Rate = 0.0134 lb ai/A (1x)

Grass

Hay Cis and

Trans

Delta

methrin 1 0.0013 0 4 0.0 29 5 0.0 52 0 0.029 8 0.042 1 0.0 362 0.0 108

2 0.0013

-

0.0014 0 4 0.0293 0.05 58 0.0324 0.0555 0.0443 0.0137

3 0.0013 0 4 0.0705 0.0823 0.0712 0.0823 0.0 771 0.0065

4 0.0013 0 4 0.0913 0.1280 0.0987 0.12 1 0.1095 0.0153

5 0.0014

-

0.0013 0 4 0.079 0 0.1333 0.0791 0.12 3 0.1011 0.0265

6 0.0013 0 4 0.0703 0.1611 0.0729 0.152 0.1124 0.0460

7 0.0013 0 4 0.0 992 0.1078 0.1036 0.15 4 0.0640 0.0459

8 0.0013 0 4 0.1160 0.1398 0.1277 0.139 0.0753 0.0612

9 0.0013 0 4 0.1150 0. 3770 0.1179 0.354 0.0851 0.0388

10 0.0013 0 4 0.1490 0.3690 0.1495 0.34 7 0.1116 0.0438

LAFT = Lowest Average Field Trial, HAFT = Highest Average Field Trial, SD = Standard Deviation. For computation of the

LAFT, HAFT, median, mean, and standard deviation, values <LO Q are assumed to be at the LOQ.



### Conclusions : The residue data are adequate to demonstrate that the 0.05 ppm FHE tolerance in

effect for FHEs is adequate to cover residues that might arise from mosquito adulticide

applications.

HED considers the lettuce , alfalfa forage, and grass forage data to be adequate to serve as

surrogate s for all other crops. These commodities were originally selected because they are

considered to be worst

- case with respect to residue levels. The y are all leafy crops with highDeltamethrin Summary of Analytical Chemistry and Residue Data DP Barcode D4 23045



### Page 18 of 25 

### surface areas. Residues in lettuce were all below 0.05 ppm, even in samples treated ten times at

a 3

- day re

- treatment interval. Of the 120 samples of lettuce, grass forage, and alfalfa forage,

only ten had residues above 0.05 ppm. Eight of these samples received nine or ten treatments.

Furthermore, HED notes that the field tria ls were conducted by driving the fogging truck through

the agricultural field (i.e., application over the crop with the fog settling on the crop ). Given that

the intended application scenario is a truck

- based fogger driven next to an agricultural field and

that applications will be made under low/no wind conditions, the field trial data likely reflect a

significant overestimate of what actual residues would be on crops.

The maximum residues in the dried commodities (grass and alfalfa hay) are only sligh tly higher

than 0.05 ppm when prorated to the same dry matter as the respective forages.

Residues found in the livestock feed items would not affect the dietary burden (as discussed in

the Meat, Milk, Poultry, and Eggs section of this document , Section 5.3.4 ) . Deltamethrin is

already registered for use on a large number of crops, many of which have tolerances that exceed

0.05 ppm.

5.3.2 Field Rotational Crops (860.1900)

A study investigating f

ield accumulation in r otational c rops has not been conducte d with

deltamethrin

. A field study i s not required because the confined rotational crop study indicated

that residues of deltamethrin do not accumulate in rotational crops

.

5.3.3 Processed Food and Feed (860.1520)

T his guideline topic is not relevant to the proposed use of deltamethrin as a mosquito adulticide

.

5.3.4 Meat, Milk, Poultry and Eggs (860.1480)

The livestock commodity tolerances in effect for deltamethrin were established as a result of a

risk assessment that was perfor med in 2004 (D281203, D. Dotson, et al., 11/12/2004). That risk

assessment included a large number of commodities, including numerous livestock feed items.

As part of the risk assessment, HED calculated a maximum theoretical dietary burden s for beef

catt le, dairy cattle, swine, and poultry. Since that risk assessment was performed, HED has

updated its procedure for calculating dietary burdens. HED now calculates maximum reasonably

balanced dietary burdens, which are more realistic estimates of the resid ues to which livestock

will be exposed. In support of the current risk assessment, HED calculated updated dietary

burdens. In all cases , the dietary burdens decreased from the 2004 values . The dietary burdens

decreased as follows: beef cattle: 14 ppm t o 5 ppm ; dairy cattle: 14 ppm to 10 ppm ; poultry: 1.6

ppm to 0.5 ppm ; and swine: 1.6 ppm to 0.5 ppm. The tolerances for cattle, goat, horse, and

sheep commodities were based primarily on residues in sweet corn forage, which has a tolerance

of 10 ppm. The diet was comprised of sweet corn forage at a level of 45%. The tolerances for

poultry and swine commodities were based primarily on residues in wheat milled byproducts,

which have a tolerance of 1.0 ppm. The poultry and swine diets included wheat milled

byproducts at a level of 50%. Inadvertent residues in any livestock feed items that result from

the adulticide use of deltamethrin will not increase the dietary burdens to levels that exceed theDeltamethrin Summary of Analytical Chemistry and Residue Data DP Barcode D4 23045



### Page 19 of 25 

### levels that were used to determine the original dietary bur dens. The data used in determining the

updated reasonably balanced dietary burdens are provided in Table 5.3.4, below.

Table 5.3.4. Calculation of Dietary Burdens of Deltamethrin Residues to Livestock

Feedstuff Type 1 % Dry

Matter 2 % Diet 2 Tolerance Residue Level

(ppm) Dietary

Contribution

(ppm) 3

Beef Cattle (R = 15%; CC = 80%; PC = 5%)

Aspirated Grain Fractions CC 85 5 65 76.4 3.824

Field Corn Stover R 83 15 5.0 6.02 0.903

Wheat Milled Byproducts CC 88 40 1.0 1.136 0.454

Potato Processed Waste CC 15 30 0.04 0.267 0.080

Canola Meal PC 88 5 0.2 0.227 0.0114

Potato Culls CC 20 5 0.04 0.200 0.01

TOTAL BURDEN

-- -- -- 5.3

Dairy Cattle (R = 45%; CC = 45%; RC = 10%)

Sweet Corn Forage R 48 45 10 20.8 9.36

Wheat Milled Byproducts CC 88 25 1.0 1.136 0.284

Wet Apple Pomace CC 40 10 1.0 2.5 0.25

Carrot Culls CC 12 10 0.2 1.667 0.117

Canola Meal PC 88 10 0.2 0.227 0.0227

TOTAL BURDEN

-- -- -- 10

Swine (CC = 85%; PC = 15%)

Wheat Milled Byproducts CC NA 50 1.0 1.0 0.50

Canola Meal PC NA 15 0.2 0.2 0.03

TOTAL BURDEN

-- -- -- 0.53

Poultry (CC = 75%; PC = 25%)

Wheat Milled Byproducts CC NA 50 1.0 1.0 0.50

Canola Meal PC NA 15 0.2 0.2 0.03

Soybean Seed PC NA 10 0.1 0.1 0.01

TOTAL BURDEN

-- -- -- 0.54

1 R: Roughage; CC: Carbohydrate concentrate; PC: Protein concentrate.

2 Table 1 Feedstuffs (July 2008).

3 Contribution = ([tolerance /% DM] X % diet) for beef and dairy cattle; contribution = ([tolerance] X % diet) for

poultry and swine.



### The most current guidance for ca lculation of dietary burdens permits the use of the HAFT for

nonblended livestock feed items and the median residue value for blended livestock feed items.

Using the HAFT and median residue values in place of the tolerances w ould decrease the current

maxi mum reasonably balanced diets to an even greater extent.

Conclusions : The current livestock commodity tolerances were determined using a method

based on very conservative assumptions that provide overestimates of residues that are likely to

occur in live stock commodities. Inadvertent residues in any livestock feed items that result from

the adulticide use of deltamethrin will not increase the dietary burdens to levels that exceed theDeltamethrin Summary of Analytical Chemistry and Residue Data DP Barcode D4 23045



### Page 20 of 25 

### levels that were used to determine the original dietary burdens. Incre ased tolerances are not

needed.

5.3.5 Food Handling (860.1460)

Although Bayer is proposing that the 0.05 ppm food handling establishment tolerance cover the

mosquito adulticide use, this guideline topic is not relevant to the current petition for any ot her

reason

.

5.3.6 Water, Fish, and Irrigated Crops (860.1400)

In order to be efficacious as a mosquito adulticide, deltamethrin applications will be made with

the use of a ULV fogger that emits particles in a size range that will maximize their ability to

remain suspended in air. As a result, residues are not expected to oc cur in water bodies , fish, and

irrigated crops . For this reason, this guideline topic is not relevant to the current tolerance

petition.

5.4 Food Residue Profile

The adulticide trials that were performed demonstrate that deltamethrin residues are expect ed to

occur at low levels in food commodities, if at all

. HED consider s the submitted data to be

adequate to demonstrate that t he 0.05 ppm FHE tolerance cover s the adulticide use.

6.0 Tolerance Derivation

The existing established tolerance for delta m ethrin residues of 0 .05 ppm in/on all food

commodities, arising from use of the insecticide in food handling establishments, is also

adequate to cover residues arising from the proposed use in the vicinity of, or the airspace above,

agricultural field cro ps. Residues in samples demonstrate that the tolerance of 0.05 ppm will not

be exceeded as a result of the adulticide use.

HED recommends that the tolerance expression for deltame thrin, cited under 40CFR

§180.4 3 5[a][ 2 ], be amended to read as follows:

A tolerance of 0 .05 ppm is established for residues of the insecticide deltam ethrin,

including its metabolites and degradates, in or on all raw agricultural commodities

and processed food or feed from use of deltam ethrin in food or feed handling

establishme nts where food /feed and food /feed products are held, processed,

prepared and/or served, or as a wide

- area mosquito adulticide. Compliance with

the tolerance level specified is to be determined by measuring only deltamethrin

[(1 R ,3 R )

- 3

- (2,2

- dibromovinyl)

- 2 ,2

- dimethylcyclopropanecarboxylic acid ( S )

- alpha

- cyano

- 3

- phenoxybenzyl ester ], and its major metabolites, trans

deltamethrin [( S )

- alpha

- cyano

- m

- phenoxybenzyl(1R,3S)

- 3

- (2,2

- dibromovinyl)

- 2,2

- dimethylcyclopropanecarboxylate] and alpha

- R

- deltamethrin [( R )

- alp ha

cyano

- m

- phenoxybenzyl

- (1 R ,3 R )

- 3

- (2,2

- dibromovinyl)

- 2,2

- dimethylcyclopropanecarboxylate] in or on the commodity.Deltamethrin Summary of Analytical Chemistry and Residue Data DP Barcode D4 23045



### Page 21 of 25 

### Codex and Canada have established MRLs for residues of deltam ethrin in /on numerous

commodities. An International Residue Limit Status shee t is appended as Attachment 1. As the

proposed tolerance applies to all commodities, the MRL status sheet includes all commodities

with deltamethrin tolerances

. It also includes commodities for which there is no U.S. equivalent.

References

Deltamethrin. Petition to Establish Permanent Tolerances ( Without U.S. S ection 3 Registration)

for Residues Resulting from Use of the Insec ticide on Imported Finfish. Summary of Analytical

Chemistry and Residue Data

, D 413135, W. Dre w

, 6/17/2014

MRID 49 114112. M. Krolski (201 3 ) Magnitude of the Residue in/on Alfalfa, Leaf Lettuce, and

Grass Following Ultra Low Volume (ULV) Spray for Mosquito Control. Study Number:

RADAN008 . Unpublished study prepared by Bayer CropScience

. 78 8 pag es , D423045, D.

Dotson, 12/4/2014

.

PP#s 0F6080 and 1E6232: Tolerance Petition for the Use of Deltamethrin on Various Crops,

Summary of Residue Chemistry and Analytical Methods, D281203, D. Dotson, 11/12/2004

PP#s 0F6080 and 1E6232: Human Health Risk Assessment for the Proposed Section 3 Uses of

Deltamethrin on Various Crops and Residential Scenarios; D262496; D. Dotson; 11/ 15 / 2004

Deltamethrin. Human Health Risk Assessment f or the Proposed Use of Deltamethrin Without

U.S. Registration on Finfish , D413048, D. Dotson, et al., 10/10/2014

MARC Decision Memo; D286801; D. Dotson, N. McCarroll; 14 January 2003.

Tier I Estimated Drinking Water Concentrations of Deltamethrin for the Use in the Human

Health Risk Ass essment: IR

- 4 Tolerance Petition for the Use of Deltamethrin on Flax;

D335136; J. Melendez; 24 April 2007.

Tiers I and II Estimated Drinking Waters Concentrations for Deltamethrin for the New Use as an

Adulticide for the Product BES0668 Insecticide

, (PC Code 097805; DP Barcode D417559) , J.

Melendez, 10/9/2014

Revisions of Feedstuffs in Table 1 of OPPTS Test Guideline 860.1000 and Guidance on

Constructing Maximum Reasonably Balanced Diets (MRBD); ChemSAC; 30 June 2008

.

Attachments

Attachment 1: International Residue Limit Status sheet.Deltamethrin Summary of Analytical Chemistry and Residue Data DP Barcode D4 23045



### Page 22 of 25 

### Attachment 1: Deltamethrin International Residue Limit Status

Summary of US and International Tolerances and Maximum Residue Limits

Residue Definition :

US Canada Mexico 1 

### Codex 2

40 CFR 180.435

Plants/Livestock:

Deltamethrin [(1 R ,3 R )

-

3

- (2,2

- dibromovinyl)

- 2,2

- dimethyl

cyclopropanecarboxylic

acid ( S )

- alpha

- cyano

- 3

- phenoxybenzyl ester],

and its major

metabolites, trans

deltamethrin [( S )

- alpha

cyano

- m

- phenoxybenzyl

(1R,3S)

- 3

- (2,2

- dibromovinyl)

- 2,2

- dimethylcyclopropaneca

rboxylate] and alpha

- R

deltamethrin [( R )

- alpha

cyano

- m

phenoxybenzyl

- (1 R ,3 R )

-

3

- (2,2

- dibromovinyl)

- 2,2

- dimethylcyclo

propanecarboxylate] All commodities (except milk):

cyclopropanecarbo xylic acid, 3

- (2,2

- dibromoethenyl)

- 2,2

- dimethyl

- , (S)

- cyano(3

- phenoxyphenyl)methyl ester,

(1R,3R)

- , including the isomers

cyclopropanecarboxylic acid, 3

- (2,2

- dibromoethenyl)

- 2,2

- dimethyl

- , (S)

- cyano(3

- phenoxyphenyl)methyl ester,

(1R,3S)

- and cyclopropaneca rboxylic

acid, 3

- (2,2

- dibromoethenyl)

- 2,2

- dimethyl

- , (R)

- cyano(3

- phenoxyphenyl)methyl ester, (1R,3R)

-

Milk: cyclopropanecarboxylic acid, 3

- (2,2

- dibromoethenyl)

- 2,2

- dimethyl

- , (S)

- cyano(3

- phenoxyphenyl)methyl

ester, (1R,3R)

- , including the isomers

cyclopro panecarboxylic acid, 3

- (2,2

- dibromoethenyl)

- 2,2

- dimethyl

- , (S)

- cyano(3

- phenoxyphenyl)methyl ester,

(1R,3S)

- and cyclopropanecarboxylic

acid, 3

- (2,2

- dibromoethenyl)

- 2,2

- dimethyl

- , (R)

- cyano(3

- phenoxyphenyl)methyl ester, (1R,3R)

-

(calculated on the fat cont ent) Sum of deltamethrin,

alpha

- R

- and trans

deltamethrin (1R

- [1alpha(R*),3alpha]]

-

3

- (2,2

- dibromoethenyl)

- 2,2

- dimethyl

cyclopropanecarboxyl

ic acid, cyano(3

- phenoxyphenyl)meth

yl ester and [1R

- [1alpha(S*),3beta]]

-

3

- (2,2

- dibromoethenyl)

- 2,2

- dimethyl

cyclopropanecarboxyl

ic acid, cyano(3

- phenoxyphenyl)meth

yl ester)

(fat

- soluble)



### Commodity Tolerance (ppm) /Maximum Residue Limit (mg/kg)

US Canada Mexico 1 

### Codex 2

Almond, hulls 2.5

Apple, wet pomace 1.0

Artichoke, globe 0.5

Barley, bran 5.0

Cattle, fat 0.05 0.05

Cattle meat 0.02 0.02 0.5 (fat) meat (from

mammals other than

marine mammals ) 3

Cattle, meat byproducts 0.05 0.02 0.03 (*) kidney and

liver of cattle

Corn, field, forage 0.7

Corn, field, refined oil 2.5

Corn, field, stover 5.0

Corn, pop, stover 5.0

Corn, sweet, forage 10

Corn, sweet, kernel plus cob

with husks removed 0.03 0.02 (*) sweet corn

(corn on

- the

- cob)

Corn, sweet, stover 15

Cotton, refined oil 0.2Deltamethrin Summary of Analytical Chemistry and Residue Data DP Barcode D4 23045



### Page 2 3 of 25 

### Commodity Tolerance (ppm) /Maximum Residue Limit (mg/kg)

US Canada Mexico 1 

### Codex 2

Cotton, undelinted seed 0.04

Egg 0.02 0.02 0.02 (*)

Fruit, pome, group 11 0.2 0.2 apple

Goat, fat 0.05 0.05

Goat, meat 0.02 0.02 0.5 (fat) meat (from

mammals other than

marine mammals) 3

Goat, meat byproducts 0.05 0.02 0.03 (*) kidney and

liver of goats

Grain, aspirated fractions 65

Grain, cereal, Group 15,

except sweet corn 1.0 2 Po cereal grains

Hog, fat 0.05 0.05

Horse, fat 0.05 0.05

Horse, meat 0.02 0.02 0.5 (fat) meat (from

mammals other than

marine mammals) 3

Horse, meat byproducts 0.05 0.02

Lychee 4 0.2

Milk, fat (reflecting 0.02 ppm

in whole milk) 0.1 0.05 milk 0.05 F milks

Nut, tree, Group 14 0.1 0.02 (*) hazelnuts,

walnuts

Onion, bulb 0.1 0.05

Onion, green 1.5

Poultry, fat 0.05 0.05

Poultry, meat 0.02 0.02 0.1 (fat)

Poultry, meat byproducts 0.02 0.02 0.02 (*)

Radish, tops 4.0 0.01 (*) radish

Rapeseed 0.2 0.2

Rice, hulls 2.5

Rye, bran 5.0

Sheep, fat 0.05 0.05

Sheep, meat 0.02 0.02 0.5 (fat) meat (from

mammals other than

marine mammals) 3

Sheep, meat byproducts 0.05 0.02 0.03 (*) kidney and

liver of sheep

Sorghum, grain, forage 0.5

Sorghum, grain, stover 1.0

Soybean, seed 0.1 0.1

Soybean, hulls 0.2

Starfruit 4 0.2

Sunflower, seed 0.1 0.05 (*)

Tomato 0.2 0.3 0.3 tomato

Tomato, paste 1.0

Tomato, puree 1.0

Vegetable, cucurbit, Group 9 0.2 0.2 fruiting

vegetables, cucurbitsDeltamethrin Summary of Analytical Chemistry and Residue Data DP Barcode D4 23045



### Page 24 of 25 

### Commodity Tolerance (ppm) /Maximum Residue Limit (mg/kg)

US Canada Mexico 1 

### Codex 2

Vegetable, fruiting, Group 8 0.3 0.3 African eggplants,

bell peppers, bush

tomatoes, coconas,

currant tomatoes,

eggplants, garden

huckleberries, goji

berries, groundcherries,

martynias, naranjillas,

nonbell peppers, okras,

pea eggplants, pepinos,

roselles, scarlet

eggplants

, s unberries,

tomatillos, tomatoes,

tree tomatoes 0.3 tomato

Vegetable, root, except sugar

beet, Subgroup 1B 0.2 0.02 carrot

Vegetable, tuberous and corm,

Subgroup 1C 0.04 0.04 potato 0.01 (*) potato

Wheat, bran 5.0 5 PoP wheat bran,

unprocessed

MRLs with NO US Equivalent

Citrus fruits 0.02

Flowerhead brassicas

(includes broccoli: broccoli,

Chinese and cauliflower 0.1

Grapes 0.2

Ho g , meat 0.02 0.5 (fat) meat (from

mammals other than

marine mammals) 3

Ho g , meat byproducts 0.02 0.03 (*) kidney and

liver of pigs

Leafy vegetables 2

Leek 0.2

Legume vegetables 0.2

Mushrooms 0.05 F

Nectarine 0.05

Olives 1 1

Peach 0.05

Plums (including prunes) 0.05

Pulses 1 Po

Spices, fruits and berries 0.03

Spices, roots and rhizomes 0.5

Strawberry 0.2

Tea, green, black (black,

fermented and dried) 5

Wheat flour 0.3 PoP

Wheat wholemeal 2 PoP

Br occoli

, B russels sprouts

, cabbage s, cauliflower s,

Chinese broccoli, Chinese

mustard cabbages, kohlrabi es,

napa Chinese cabbages 3.5Deltamethrin Summary of Analytical Chemistry and Residue Data DP Barcode D4 23045



### Page 25 of 25 

### Commodity Tolerance (ppm) /Maximum Residue Limit (mg/kg)

US Canada Mexico 1 

### Codex 2

Seeds (Borage, cuphea,

echium, flax seed, gold of

pleasure, hare's ear mustard,

milkweed, mustard seed (oil

seed type), oil radish, poppy

seed, rapeseeds (canola),

sesame, sweet rocket 0.2



### Completed: M. Negussie; 10/07/14

1 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.

2 * = absent at the limit of quantitation; Po = postharvest treatment, such as treatment of stored grains. PoP =

processed postharvest treated commodity, such as processing of treated stored wheat. (fat) = to be measured on the

fat portion of the sample. MRLs indicated as proposed have not been finalized by the CCPR and the CAC.

3 MRL accommodates external animal treatment.

4 There are no U.S. registrations for use of deltamethri n on starfruit and lychee.



### (2) A tolerance of 0.05 ppm is established for residues of the insecticide deltamethrin (1R,3R)

- 3

- (2,2

- dibromovinyl)

- 2,2

- dimethylcyclopropanecarboxylic acid (S)

- alpha

- cyano

- 3

- phenoxybenzyl ester and its

major metabolites, trans deltamethrin (S)

- alpha

- cyano

- m

- phenoxybenzyl

- (1R,3R)

- 3

- (2,2

- dibromovinyl)

- 2,2

- dimethylcyclopropanecarboxylate and alpha

- R

- deltamethrin[(R)

- alpha

- cyano

- m

- phenoxybenzyl

- (1R,3R)

- 3

- (2,2

- dibromovinyl)

- 2,2

- dimethylcyclopropanecarboxylate] as follows:

(i) In or on all food/feed items (other than those covered by a higher tolerance as a result of use on

growing crops) in food/feed handling establishments.

### I Deltamethrin!PC Code 097805/Bayer

### ~ropSci~nce

==:- 

# 1 OCSPP 860.1500/0ECD IIA 6.3.1

, 6

. .;,.2

, 

### 6.3

. .;, and lilA 8.3.1, 8.3.2, 8.3.3

Crop Field Trials

- Alfalfa (Forage and Hay), Grass (Forage and Hay)

, Leaf Lettuce (Leaves)



### Primary E valuator 

# ..&

.**J~** Da t e: 12 /4/20 1 4

Douglas Dotson

, Ph.D., Chemist, HED/RAB2

Peer Re v ie wer

# ~~ · Date: 1 2/4/20 1 4

Michael DohertY:Ph:I:.Chemist, HED /RAB2

S T UDY REPORT



### MRID 49114112. M. Krolski (20 13) Magnitude of the Residue inion Alfalfa, Leaf Lett uc e, and

Grass Following Ultra Low Volume (ULV) Spray for Mosquito Control. Study Number:

RADAN008. Unpublished study prepared by Bayer CropScience. 788 pages.

EXECUTIVE SUMMARY



### Bayer Environmental Science submi tted field trial data for deltamethrin on alfalfa, grass, and

leaf lettuce. Bayer performed two trials for each crop. The trials were conducted in the U.S.

during the 2012 growing season in NAFTA Growing Zone 5. One trial was performed in

Springfield, Nebraska and the other trial was performed in Lenexa, Kansas. At each trial

location, 10 broadcast foliar ultra-low vo l ume (UL V) spray applications of deltamethrin EW

(BES0668, Eagle Adulticide) were made. Deltamethrin EW i s an evapora t ion-re tard ed

formulation containing 20 g deltamethrin/L.

Bayer performed the residue trials in accordance with a protocol that was previously approved by

HED's Chemist r y Science Advisory Council (ChemSAC) and submitted a report of the results

(MRID 49114112). As ChemSAC requested, B aye r ensured the trials were independent by

performing them 200 miles apart and used application equipment that was consistent with that

specified on the label. Residues were measured in alfalfa forage, alfalfa hay, l eaf l ettuce, grass

forage, and grass hay. At each location, two plot s of each commodity were treated I 0 times at a

3-day re -treatment interval (RTI). One plot was tr eated at a Ylx application rate (0.00067 lb

a.i./A for a total seasonal app lication rat e of0.0067 lb ai/A) and the other was performed at a 1x

application rate (0.00134lb a.i./A for a total seasona l application rate of0.0134 lb ai / A). In each

trial, two samples were tak en for analysis immediately after each application.

Bayer analyzed the samples for cis- 

### and trans-deltamethrin. Although alpha-R-deltamethrin i s a

residue of concern for both tolerance enforcement a nd risk assessmen t

, Bayer did not report

results for th e alpha-R isomer. Bayer s tat ed that residues of the alpha-R isomer we re nondetectable in the samples that were analyzed. Bayer also stated that the alpha-R isomer is

present in only trace amounts in the technical material and would be present in even lower

amounts in th e end-use product. In the field trials that were performed, samples were taken th e

day of application. There wou ld be no t ime for conversion of the cis 

### isomer to the alpha- 

### R

Isomer.

In all of the tr ials that were performed, residues increased with number of app lication s

. In



## samples of alfalfa forage treated at the Ylx 

## application ra te, residues ranged up to 0.054 ppm (9

applications). The highest of the highest average field trial (HAFT) va lue s was 0.043 ppm. In

DP Barcode 0 423045 / MRID # 49114112 Page I of24Deltamethrin / PC Code 097805 / Ba yer CropScience

OCSPP 860.1500 / 0ECD IIA 6. 3.1

, 6.3.2

, 6.3

. 3 and IliA 8.3.1

, 8.3

. 2

, 8.3.3

Crop Field Trial s

- Alfalfa ( Fora ge and H a y )

, Grass (Forage a nd Hay)

, Leaf Lettuce ( L eaves)



### sa

mples treated at th e lx application rat e, r es idu es ranged up to 0.070 ppm (9 applications). The

hi g hest HAF T valu e was 0.067 ppm. 

### In samples of alfalfa hay treated at th e 'l-2 x application rate

,

re si dues ranged up to 0.16 ppm (4 application s). Th e highest HAFT value was 0.15 ppm. In

samples treated at th e l x ap plication rate

, r es idu es r a n ged up to 0.16 ppm (6 a pplications). The

highest H AFT valu e wa s 0.14 ppm. 

### In samples of grass forage treated at th e Y2x application rate

,

re si dues ranged up to 0.043 ppm (1 0 application s). The highest HAFT value was 0.034 ppm. In

sam ples treated at th e 1 x ap plication rate

, residues ran ge d up to 0.08 7 ppm (1 

### 0 applications).

The hi ghes t HAFT va l ue was 0.075 ppm. 

### In samples of grass hay treated at the Y2 x application

r ate

, r esidues ran ged up to 0.20 ppm ( 1 0 applications). The highest H AFT value was 0.19 ppm.

In s amples trea ted at the 1 x application rat e

, residues ranged up to 0.38 ppm (9 applications).

T h e highest HAFT va lu e was 0.36 ppm. In samp l es ofleaflettuce treated at the Y2x application

rate, residues ran ge d up to 0.045 ppm (10 applications). The highest HAFT value was 0.043

ppm. In samples treated at the lx application rate

, residues ran ge d up to 0.041 ppm (9

applications). The hi g h est HAFT value was 0

. 0 3 7 ppm. The residue dat a are s upported by

adequate method va lid a ti o n and storage stability data.



### STUDY/WAIVERACCEPTABILITYIDEFICIENCIES/CLARIFICATIONS

Under the condition s and parameters used in th e st udy

, the alfalfa

, grass a nd leaf lettuce field

t rial residue data are classified as scientifically accep tabl e. The acceptability of this study for

regulatory p u rposes i s addressed in the US EPA Residue Chemistry Summary Document,

D423045 (D. Dot so n

, 1 2/4/2 0 14).



### COMPLIANCE

Sig n ed and dated Good Labo r atory Practi ce (GLP)

, Quality Assurance

, and D ata Confidentiality

state ments were provided. No deviations from r egu l atory requir ements were r e ported which

would have an impa ct on the v alidity of t he st udy.



### A. BACKGROUND INFORMATION

Deltamethrin (w ith CAS registry numb e r 52918-63-5

, and CAS name (1R

, 3 R ) -R-c y ano (3-

ph e noxyphen y l )m eth y l 3-(2

, 2- dibromoethen y l )-2

, 2- dimeth ylcyclo pr o pan ecarboxyla te ) i s a

broad-spectrum pyrethroid insecticide that is r eg i ste red in the US for direct appl ication to a wide

variety of food / feed crops and for use on stored grai n s

. In addition, delt a m et hrin is registered for

use in food/f ee d handlin g establishments (FHEs), and a tolerance of 0.0 5 ppm is established for

this use. The registrant

, Bayer Environm ental Science, petitioned the Agency to amend 40 CFR

§ 180.435(a)(2) to includ e the use of deltamethrin as a wide

- area mo s quito adulticide in th e

airspace over agricultural c rop s and propo se d that the 0.05 ppm toleranc e apply to the adulticide

use as we ll.

Tolerances are establis h ed for the combined residues of deltamethrin and it s major metab o lit es

(trans -deltam ethrin and a/pha -R-deltamethrin ) inion plant commodities at l evels ranging from

0.03 ppm in sweet com ears (K+C WHR ) to 65 ppm in aspirated grain fractio ns ( 40 CFR

DP B arcode 04 23045/MR.ID # 49114112 Pa ge 2 of24Deltamethrin /PC Code 097805 / Bayer CropScience

OCSPP 860.1500/OECD IIA 6.3.1, 6.3.2, 6.3.3 and IIIA 8.3.1, 8.3.2, 8.3.3

Crop Field Trials

– Alfalfa (Forage and Hay), Grass ( Forage and Hay), Leaf Lettuce (Leaves)

_____________________________________________________________________________________________ DP Barcode D4 2304 5/MRID #49114112 Page 3 of 24 

### §180.435[a] [1] ). T olerances have also been established for residues in livestock commodities.

Deltamethrin residues of concern (ROC s ) are comprised of the active ingredient (ai), cis

deltamethrin, along with its isomeric metabolites, trans

- deltamethrin and alpha

- R

- deltamethrin.

The chemical structure and nomenc lature of deltam ethrin are listed in Table A.1, and the

physicochemical properties of deltam ethrin are presented in Table A.2

, below

.

Table A .1. Test Compound Nomenclature

Compound Chemical Structure

Common Name Cis

- d eltamethrin

Molecular Formula C 22 H 19 Br 2 NO 3 Molecular Weight 505.24

Company Experimental Name AEF108569

IUPAC Name (S)

- α

- cyano

- 3

- phenoxybenzyl (1R,3R)

- 3

- (2,2

- dibromovinyl)

- 2,2

- dimethylcyclopropanecarboxylate

CAS Name (1R,3R)

- R

- cyano(3

- phenoxyphenyl)methyl 3

- (2,2

- dibromoethenyl)

- 2,2

- dimethylcyclopropanecarboxylate

CAS Number 52918

- 63

- 5

End

- use Products (EPs) AlphaMax (No current EPA r egistration); AMX (No current EPA registration)

.



### 3.2 Physicochemical Characteristics

Table A .2. Physicochemical Properties of Technical Grade Deltamethrin.*

Parameter Value

Melting Point/Range (°C) 100

- 102

pH Not available

Density (g/cm 3 at 25°C) 0.550

Water Solubility (ug/L at 25°C) <0.2

Solvent Solubility (% by w eight at 20oC) Acetone 33

Alcohol 0.6

Isopropanol 0.2

Ethyl acetate 25

n

- Hexane 0.2

Toluene 23

DMF 38

Dioxane 39

Vapor Pressure (mm Hg at 25oC) [mPa at 25°C] 1.5 x 10

- 8 [1.24 x 10

- 5 ]

Dissociation C onstant, pK

a Does not dissociate

. Octanol/ Water Partition C oefficient, K OW ( at 25oC ) 2.7 x 10 5

UV/ V isible A bsorption S pectrum Not available

.

* Reference: MARC Briefing Memorandum; D284320; D. Dotson; 5 November 2002.Deltamethrin /PC Code 097805 / Bayer CropScience

OCSPP 860.1500/OECD IIA 6.3.1, 6.3.2, 6.3.3 and IIIA 8.3.1, 8.3.2, 8.3.3

Crop Field Trials

– Alfalfa (Forage and Hay), Grass ( Forage and Hay), Leaf Lettuce (Leaves)

_____________________________________________________________________________________________ DP Barcode D4 2304 5/MRID #49114112 Page 4 of 24 

### Deltamethrin is a solid under ambient conditions, and it has low volatility. The compound has a

ve r y low solubility in water, and low to high solubility in organic solvents. Its octanol/water

partition coefficient suggests that accumulation in fatty tissues is possible.

B. EXPERIMENTAL DESIGN

B.1. Study Site Information

Bayer performed residue trials in accordance with a protocol the company submitted to

ChemSAC in 2012. Two trials were performed in EPA Growing Zone 5. One trial was

performed in Lenexa, Kansas, and the other trial was performed in Springfield, Nebraska. As

ChemSAC requested, Bayer ensured the trials were independent by performing them 200 miles

apart and used application equipment that was consistent with that specified on the label (i.e.,

truck

- based fogger) . Residues were measured in alfalfa forage, alfalfa hay, leaf lettuc e, grass

forage, and grass hay. At each location, two plots of each commodity were treated 10 times with

a broadcast foliar ULV spray application of an EW (emulsion in water) formulation of

deltamethrin. All applications were made using ground

- based fogg ing equipment that produced

droplets less than 20 microns in diameter. Adjuvants were not used in any of the trials.

One plot was treated at a 1⁄2x application rate (0.00067 lb a.i./A for a total seasonal application

rate of 0.0067 lb ai/A) and the other w as treated at a 1x application rate (0.00134 lb a.i./A for a

total seasonal application rate of 0.0134 lb ai/A). Applications were made directly in the field at

a 3

- day re

- treatment interval (RTI), and samples were collected on the same day as the last

ap plication. Duplicate composite samples were taken after each application at each location

(both low and high rate plots). As there were two separate locations, four samples were taken for

analysis. The study use pattern is presented in Table B.1. 1

, belo w

.

TABLE B.1.1 Study Use Pattern.

Trial ( City, State;

Year [Crop] ) EP 1 Application Information Adjuvants

Method; Timing Volume

( GP A) 2 Total Rate

(lb ai/A)

Lenexa

, KS ; 201 2

[A lfalfa ] BES0668 Broadcast foliar, ULV mister,

1 st app: BBCH 55

- 63, 3

- day RTI 0.053 0.0075 None

Lenexa, KS; 201 2

[G rass ] BES0668 Broadcast foliar, ULV mister,

1 st app: BBCH 25

- 63, 3

- day RTI 0.053 0.0075 None

Lenexa

, KS ; 201 2

[ Lettuce ] BES0668 Broadcast foliar, ULV mister,

1 st app: BBCH 13

- 16, 3

- day RTI 0.053 0.0075 None

Springfield, NE; 201 2

[ A lfalfa ] BES0668 Broadcast foliar, ULV mister,

1 st app: BBCH 55

- 63, 3

- day RTI 0.053 0.015 None

Springfield, NE; 2012

[ G rass ] BES0668 Broadcast foliar, ULV mister,

1 st app: BBCH 25

- 63, 3

- day RTI 0.053 0.015 None

Springfield, NE; 2012

[L ettuce ] BES0668 Broadcast foliar, ULV mister,

1 st app: BBCH 13

- 16, 3

- day RTI 0.053 0.015 None

1. EP = End

- use Product; 0. 1 7 lb ai/gal BES0668 Insecticide

2 . GPA = Gallons Per Acre.Deltamethrin /PC Code 097805 / Bayer CropScience

OCSPP 860.1500/OECD IIA 6.3.1, 6.3.2, 6.3.3 and IIIA 8.3.1, 8.3.2, 8.3.3

Crop Field Trials

– Alfalfa (Forage and Hay), Grass ( Forage and Hay), Leaf Lettuce (Leaves)

_____________________________________________________________________________________________ DP Barcode D4 2304 5/MRID #49114112 Page 5 of 24 

### B.2. Sample Handling and Preparation

At each sampling interval, duplicate composite samples (two separate runs through the plot) of

alfalfa raw agricultural commodities of forage and hay were harvested from the treated plots.

Similarly, duplicate composite samples (two separate runs through the plot ) of leaf lettuce

leaves, and the grass RACs of forage and hay were harvested from the treated plots. Single

composite samples of alfalfa forage, alfalfa hay, leaf lettuce leaves, grass forage, and grass hay

were harvested from one of the plots prior to t he first application to provide control matrices.

Each composite sample of alfalfa forage, alfalfa hay, leaf lettuce leaves, grass forage, and grass

hay contained a minimum of 0.50 kg of sample collected from at least 12 individual plants (or

areas of the plot). Composite samples were placed into labeled (study number and sample

number) containers for shipment. All samples were frozen within 4 hours of collection and

remained frozen until receipt at Bayer Research

B.3. Analytical Methodology

Bayer analyzed the samples for cis

- and trans

- deltamethrin. Although alpha

- R

- deltamethrin is a

residue of concern for both tolerance enforcement and risk assessment, Bayer did not report

results for the alpha

- R isomer. Bayer stated that residues of the a lpha

- R isomer were non

detectable in the samples that were analyzed (electronic communication from J. Brill (Bayer

CropSciences) to D. Dotson, 10/30/2014). Bayer also stated that the alpha

- R isomer is present in

only trace amounts in the technical materia l and would be present in even lower amounts in the

end

- use product. In the field trials that were performed, samples were taken the day of

application. There would be no time for conversion of the cis isomer to the alpha

- R isomer.

A complete method description and method validation data for the method were included in the

submission. Residues of deltamethrin ( cis and trans isomers) were extracted from homogenous

10 g samples of alfalfa forage, lettuce leaves, and grass forage using acetone/n

- hexane/

dichloromethane (1/1/1, v/v) as the extraction solvent. After evaporation of the organic phase to

dryness, the dry residue was taken up with toluene. An aliquot of the toluene extract was

concentrated to dryness and dissolved in dichloromethane/acetone (3/1, v/v), followed by solid

phase extraction (SPE) clean

- up with Varian MEGA BE SCX

- 2 GM cartridges. The extracts

were again concentrated to dryness and dissolved in a solution of internal standard (IS) and

aqueous acetonitrile/10 mM ammonium acetate (9 /1, v/v) before analysis by LC

- MS/MS.

Homogenous 5 gram samples of alfalfa hay and grass hay were soaked in water over night prior

to extraction. Residues of cis

- deltamethrin and trans

- deltamethrin were extracted using

acetone/n

- hexane/dichloromethane (1 /1/1,v/v) as the extraction solvent. Samples were sonicated

and shaken twice, then filtered before an internal standard solution was added. After evaporation

of the organic phase to dryness, the dry residue was taken up with toluene. An aliquot of the

t oluene extract was concentrated to dryness and dissolved in dichloromethane/acetone (3/1, v/v),

followed by SPE clean

- up with Varian MEGA BE SCX

- 2 GM cartridges. The extracts were

again concentrated to dryness and dissolved in aqueous acetonitrile/10 mM a mmonium acetateDeltamethrin /PC Code 097805 / Bayer CropScience

OCSPP 860.1500/OECD IIA 6.3.1, 6.3.2, 6.3.3 and IIIA 8.3.1, 8.3.2, 8.3.3

Crop Field Trials

– Alfalfa (Forage and Hay), Grass ( Forage and Hay), Leaf Lettuce (Leaves)

_____________________________________________________________________________________________ DP Barcode D4 2304 5/MRID #49114112 Page 6 of 24 

### (9/1, v/v) before analysis by LC

- MS/MS. HPLC separation was performed with an Ascentis

Express C18, 2.7 μm, 150 mm x 3 mm HPLC column.

Quantitation of each analyte was based on the daughter ion transitions of the analyte and the

respectiv e internal standard analog. The response of the LC

- MS/MS system to each analyte and

its internal standard was measured in samples and in standards, and a relative re s ponse was

calculated (calculated as the ratio of the analyte and the stable isotopically labeled internal

standard responses). The relative response of the analyte in each sample was compared to the

relative response of the analyte in the standards.

The relative responses of cis

- deltamethrin and trans

- deltamethrin in solvent were measured ov er

the ranges of 0.0025 ppm to 0.20 ppm in alfalfa forage, leaf lettuce, and grass forage

, and 0.005

ppm to 0.40 ppm in alfalfa hay and grass hay. The correlation coefficients were calculated using

linear regression analysis with 1/x weighting. The total deltamethrin residue is the sum of the

individual measured residue of cis

- deltamethrin and trans

- deltamethrin (in parent equivalents).

The method for determining cis

- deltamethrin and trans

- deltamethrin residues in/on alfalfa

forage, alfalfa hay, leaf let tuce, grass forage, and grass hay were validated by measuring the

recovery of these analytes from control matrices fortified at their respective LOQs. Additional

recoveries at higher fortification levels validated the method for the highest residues obser ved in

individual matrices. Concurrent recoveries of cis

- deltamethrin and trans

- deltamethrin from

alfalfa forage, alfalfa hay, leaf lettuce, grass forage, and grass hay were measured with each set

of samples to verify method performance.

C. RESULTS AND DISCUSSION

Acceptable method validation recoveries o f cis

- and trans

- deltamethrin were obtained from

samples of alfalfa forage, alfalfa hay, leaf lettuce, grass forage, and grass hay fortified at levels

ranging from 0.01 ppm to 0.86 ppm, as specified in Table C.1, below. Mean r ecoveries ranged

from 7 2 to 1 05 %

.

The LOQ for cis

- and trans

- deltamethrin in lettuce and forage (both grass and alfalfa) was 0.01

ppm. The LOQ for both isomers in hay (both grass and alfalfa) was 0.04 ppm. The reported

LODs rang ed from 0.003 ppm to 0.02 ppm, depending on isomer and matrix.

The analytical method was determined to be adequate for use in data collection for this study

, based on method validation and concurrent recovery results

. In all of the trials that were

performed, residues increased with number of applications. Results of the individual trials a re as

follows.

Alfalfa F orage : In samples treated at the 1⁄2x application rate, residues ranged up to 0.054 ppm (9

applications). The highest HAFT value was 0.043 ppm. In samples treated at the 1x application

rate, residues ranged up to 0.070 ppm (9 applications). The highest HAFT valu e was 0.067 ppm.Deltamethrin /PC Code 097805 / Bayer CropScience

OCSPP 860.1500/OECD IIA 6.3.1, 6.3.2, 6.3.3 and IIIA 8.3.1, 8.3.2, 8.3.3

Crop Field Trials

– Alfalfa (Forage and Hay), Grass ( Forage and Hay), Leaf Lettuce (Leaves)

_____________________________________________________________________________________________ DP Barcode D4 2304 5/MRID #49114112 Page 7 of 24 

### Alfalfa Hay : In samples treated at the 1⁄2x application rate, residues ranged up to 0. 16 ppm ( 4

applications). The highest HAFT value was 0. 15 ppm. In samples treated at the 1x application

rate, residues ranged up to 0. 16 ppm ( 6 appl ications). The highest HAFT value was 0. 14 ppm.

Grass F orage : In samples treated at the 1⁄2x application rate, residues ranged up to 0.043 ppm (10

applications). The highest HAFT value was 0.034 ppm. In samples treated at the 1x application

rate, residu es ranged up to 0.087 ppm (10 applications). The highest HAFT value was 0.075

ppm.

Grass Hay : In samples treated at the 1⁄2x application rate, residues ranged up to 0. 20 ppm (10

applications). The highest HAFT value was 0.1 9 ppm. In samples treated at the 1x application

rate, residues ranged up to 0.38 ppm (9 applications). The highest HAFT value was 0. 36 ppm.

Leaf L ettuce : In samples treated at the 1⁄2x application rate, residues ranged up to 0.045 ppm (10

applications). The highest HAFT value was 0.043 ppm. In samples treated at the 1x application

rate, residues ranged up to 0.041 ppm (9 applications). The highest HAFT value was 0.037 ppm.

T able C .1

. Recovery Results from Method Validation of Alfalfa, Lettuce, and Grass U sing the Data

Collection Analytical Method.

Matrix Spiking

Level

(ppm) No. of

Samples Recoveries Obtained (%) Mean

Recovery

(%) Standard

Deviation

(%)

Alfalfa Forage

Cis

- deltamethrin 0.01 16 103, 125, 107, 112, 111, 101, 103, 74, 76, 74, 74,

78, 83, 103, 97, 98 95 16

0.07 3 84, 80, 73 79 5.4

Trans

deltamethrin 0.01 16 80, 83, 99, 115, 101, 91, 106, 104, 90, 90, 92, 122,

86, 91, 84, 84 95 12

0.07 3 90, 86, 82 86 4.2

Alfalfa Hay

Cis

- deltamethrin 0.04 15 77, 89, 91, 96, 86, 97, 85, 87, 85, 85, 110, 79, 89,

107, 91 90 9.0

0.5 2 70, 83 76 N/A

Trans

deltamethrin 0.04 15 87, 78, 93, 107, 78, 86, 97, 111, 86, 97, 71, 75, 95,

83, 90 89 11

0.5 2 73, 91 82 N/A

Leaf Lettuce

Cis

- deltamethrin 0.01 15 95, 83, 92, 94, 102, 85, 87, 94, 101, 86, 90, 87, 89,

83, 91 91 5.8

0.046 6 90, 92, 55, 83, 87, 89, 83, 91 82 14

Trans

deltamethrin 0.01 16 110, 85, 90, 82, 75, 83, 90, 93, 111, 96, 98, 96, 96,

84, 84, 78 91 10

0.046 6 97, 99, 63, 107, 105, 102 95 16

Grass Forage

Cis

- deltamethrin 0.01 16 88, 76, 93, 97, 91, 82, 105, 83, 82, 95, 97, 78, 74,

70, 74, 69 85 11

0.86 3 73, 72, 71 72 1.2

Trans

deltamethrin 0.01 16 82, 83, 82, 101, 105, 87, 106, 85, 86, 80, 101, 76,

98, 75, 63, 77 87 12

0.86 3 85, 81, 78 81 3.7Deltamethrin /PC Code 097805 / Bayer CropScience

OCSPP 860.1500/OECD IIA 6.3.1, 6.3.2, 6.3.3 and IIIA 8.3.1, 8.3.2, 8.3.3

Crop Field Trials

– Alfalfa (Forage and Hay), Grass ( Forage and Hay), Leaf Lettuce (Leaves)

_____________________________________________________________________________________________ DP Barcode D4 2304 5/MRID #49114112 Page 8 of 24 

### T able C .1

. Recovery Results from Method Validation of Alfalfa, Lettuce, and Grass U sing the Data

Collection Analytical Method.

Matrix Spiking

Level

(ppm) No. of

Samples Recoveries Obtained (%) Mean

Recovery

(%) Standard

Deviation

(%)

Grass Hay

Cis

- deltamethrin 0.04 15 75, 97, 97, 106, 85, 88, 95, 75, 80, 80, 80, 81, 81,

74, 79 85 9.6

0.5 3 91, 97, 127 105 19

Trans

deltamethrin 0.04 17 70, 116, 102, 109, 84, 94, 96, 81, 80, 91, 82, 81, 94,

80, 116, 75, 112 92 15

0.5 3 87, 96, 123 102 19

TABLE C.2 Summary of Storage Conditions.

Matrix Storage Temperature

(°C) Actual Storage Duration *

(Days ) Interval of Demonstrated Storage

Stability (Days )

Alfalfa forage

- 2 to

- 3 0 60 61

Grass forage 43

Leaf lettuce 31

* Durat i on from sampling to extraction. Most s amples were analyzed the day of

, or the day after, extraction. A few

of the grass samples were analyzed 6 day s after extraction.



### The individual residue values in samples taken after each of the 10 applications are provided in

the tables below. The low est average field trial (LAFT) and the HAFT are also provided.Deltamethrin /PC Code 097805 / Bayer CropScience

OCSPP 860.1500/OECD IIA 6.3.1, 6.3.2, 6.3.3 and IIIA 8.3.1, 8.3.2, 8.3.3

Crop Field Trials

– Alfalfa (Forage and Hay), Grass ( Forage and Hay), Leaf Lettuce (Leaves)

_____________________________________________________________________________________________ DP Barcode D4 2304 5/MRID #49114112 Page 9 of 24 

### Table C.3 . Residue Data from Alfalfa Field Trials with Deltamethrin

Crop

Matrix Analyte No. of

Appli

cations Applic.

Rate

(lb

ai/acre) PHI

(days) n * Residues (ppm)

Cis Trans Total

Deltamethrin Average LAFT HAFT

Alfalfa Forage: Proposed Total Application Rate = 0.0067 lb ai/A (1⁄2 x)

Alfalfa

Forage Cis and

Trans

Delta

methrin 1 0.00066

-

0.00068 0 4 0.00925 <LOD 0.0112 0.00887 0.0 089

0.00455 <LOD 0.00654

<LOD <LOD <0.004 0.0055 0.0055 0.00506 <LOD 0.00705

2 0.00067

-

0.00070 0 4 0.00924 <LOD 0.0112 0.0108 0.0108

0.00852 <LOD 0.0105

0.0129 <LOD 0.0148 0.0131 0.0131 0.00931 <LOD 0.0113

3 0. 00068 0 4 0.00975 <LOD 0.0117 0.0139 0.0139 0.0140 <LOD 0.0160

0.00637 <LOD 0.0084 0.0131 0.0131 0.0158 <LOD 0.0178

4 0.00066

-

0.00068 0 4 0.0171 <LOD 0.0191 0.0200 0.0200

0.0188 <LOD 0.0208

0.0152 <LOD 0.0171 0.0173 0.0173 0.0156 <LOD 0.0175

5 0. 00067

-

0.00068 0 4 0.0171 <LOD 0.0191 0.0206 0.0206

0.0200 <LOD 0.0220

0.0224 <LOD 0.0244 0.0202 0.0202 0.0140 <LOD 0.0160

6 0. 00067

-

0.00069 0 4 0.0138 <LOD 0.0158 0.0136 0.0136

0.00927 <LOD 0.0113

0.0200 <LOD 0.0220 0.0209 0.0209 0.0178 <LOD 0.0198

7 0.00066 0 4 0.0353 <LOD 0.0373 0.0388 0.0388 0.062 <LOD 0.0382

0.0217 <LOD 0.0261 0.0249 0.0249 0.0217 <LOD 0.0237

8 0.00066

-

0.00068 0 4 0.0274 <LOD 0.0294 0.0281 0.0281

0.0248 <LOD 0.0268

0.0169 <LOD 0.0189 0.0115 0.0115 <LOD <LOD <LOD

9 0. 00067

-

0.00069 0 4 0.0304 <LOD 0.0324 0.0434 0.0434

0.0496 <LOD 0.0544

0.0154 <LOD 0.0174 0.0170 0.0170 0.0145 <LOD 0.0165

10 0 .00067

-

0.00068 0 4 0.0299 <LOD 0.0319 0.0380 0.0380

0.0421 <LOD 0.0441

0.0124 <LOD 0.0144 0.0162 0.0162 0.0159 <LOD 0.0179Deltamethrin /PC Code 097805 / Bayer CropScience

OCSPP 860.1500/OECD IIA 6.3.1, 6.3.2, 6.3.3 and IIIA 8.3.1, 8.3.2, 8.3.3

Crop Field Trials

– Alfalfa (Forage and Hay), Grass ( Forage and Hay), Leaf Lettuce (Leaves)

_____________________________________________________________________________________________ DP Barcode D4 2304 5/MRID #49114112 Page 10 of 24 

### Table C.3 . Residue Data from Alfalfa Field Trials with Deltamethrin

Crop

Matrix Analyte No. of

Appli

cations Applic.

Rate

(lb

ai/acre) PHI

(days) n * Residues (ppm)

Cis Trans Total

Deltamethrin Average LAFT HAFT

Alfalfa Forage: Proposed Total Application Rate = 0.0 134 lb ai/A ( 1 x)

Alfalfa

Forage Cis and

Trans

Delta

methrin 1 0.0013 0 4 0.00555 <LOD 0.00754 0.00693 0.00693 0.00433 <LOD 0.00631

<LOD <LOD <0.004 <0.004 <0.004 <LOD <LOD <0.004

2 0. 0013

-

0.0014 0 4 0.00651 <LOD 0.00851 0.00752 0.00752

0.00455 <LOD 0.00653

0.0312 <LOD 0.0332 0.0363 0.0363 0.0374 <LOD 0.0394

3 0. 0013

-

0.0014 0 4 0.00935 <LOD 0.0113 0.00925 0.00925

0.00520 <LOD 0.00719

0.0317 <LOD 0.0337 0.0294 0.0294 0.0231 <LOD 0.0251

4 0. 0013 0 4 0.0136 <LOD 0.0156 0.0147 0.0147 0.0119 <LOD 0.0138

0.0314 <LOD 0.0334 0.0360 0.0360 0.0365 <LOD 0.0385

5 0. 0013 0 4 0.0165 <LOD 0.0185 0.0164 0.0164 0.0123 <LOD 0.0143

0.0487 <LOD 0.0507 0.0455 0.0455 0.0383 <LOD 0.0403

6 0. 0013 0 4 0.0105 <LOD 0.0125 0.0124 0.0124 0.0102 <LOD 0.0122

0.0505 <LOD 0.0525 0.0463 0.0463 0.0380 <LOD 0.0400

7 0.0013 0 4 0.0137 <LOD 0.0157 0.0143 0.0143 0.0108 <LOD 0.0128

0.0265 <LOD 0.0285 0.0324 0.0324 0.0320 <LOD 0.0362

8 0.0013 0 4 0.0354 <LOD 0.0374 0.0409 0.0409 0.0386 0.00582 0.0444

0.0185 <LOD 0.0205 0.0290 0.0290 0.0312 0.00619 0.0374

9 0. 0013 0 4 0.0676 <LOD 0.0696 0.0620 0.0620 0.0523 <LOD 0.0543

0.0304 0.00932 0.0478 0.0397 0.0397 0.0496 0.0608 0.0315

10 0 .0013 0 4 0.0630 0.00607 0.0690 0.0671 0.0671 0.0590 0.00618 0.0652

0.0299 0.00 0.0298 0.0301 0.0301 0.0421 <LOD 0.0303Deltamethrin /PC Code 097805 / Bayer CropScience

OCSPP 860.1500/OECD IIA 6.3.1, 6.3.2, 6.3.3 and IIIA 8.3.1, 8.3.2, 8.3.3

Crop Field Trials

– Alfalfa (Forage and Hay), Grass ( Forage and Hay), Leaf Lettuce (Leaves)

_____________________________________________________________________________________________ DP Barcode D4 2304 5/MRID #49114112 Page 11 of 24 

### Tabl e C. 3. Residue Data from Alfalfa Field Trials with Deltamethrin

Crop

Matrix Analyte No. of

Appli

cations Applic.

Rate

(lb

ai/acre) PHI

(days) n * Residues (ppm)

Cis Trans Total

Deltamethrin Average LAFT HAFT

Alfalfa Hay : Proposed Total Application Rate = 0.0067 lb ai/A (1⁄2 x)

Alfalfa

Hay Cis and

Trans

Delta

methrin 1 0.00066

-

0.00068 0 4 0.0380 <LOD 0.0453 0.0480 0.0480

0.0434 <LOD 0.0507

<LOD <LOD <0.015 <0.015 0.015 <LOD <LOD <0.015

2 0.00067

-

0.00070 0 4 0.0281 <LOD 0.0354 0.0399 0.0399

0.0370 <LOD 0.0443

0.0812 <LOD 0.0885 0.0707 0.0707 0.0457 <LOD 0.0529

3 0. 00068 0 4 0.0265 <LOD 0.0338 0.0365 0.0365 0.0318 <LOD 0.0391

0.0422 <LOD 0.0495 0.0456 0.0456 0.0345 <LOD 0.0417

4 0. 00066

-

0.00068 0 4 0.0511 <LOD 0.0583 0.0548 0.0548

0.0439 <LOD 0.0512

0.148 <LOD 0.164 0.153 0.153 0.128 <LOD 0.141

5 0. 00067

-

0.00068 0 4 0.0485 <LOD 0.0558 0.0589 0.0589

0.0546 <LOD 0.0619

0.0754 0.0176 0.0930 0.0805 0.0805 0.0556 <LOD 0.0680

6 0. 00067

-

0.00069 0 4 0.0464 <LOD 0.0537 0.0522 0.0522

0.0434 <LOD 0.0507

<LOD <LOD <0.015 0.0278 0.0278 0.0284 <LOD 0.0405

7 0.00066 0 4 0.0621 <LOD 0.0694 0.0716 0.0716 0.0665 <LOD 0.0737

0.0258 <LOD 0.0331 0.0380 0.0380 0.0355 <LOD 0.0428

8 0.00066

-

0.00068 0 4 0.0468 <LOD 0.0540 0.0624 0.0624

0.0635 <LOD 0.0707

0.0277 <LOD 0.0350 0.0357 0.0357 0.0290 <LOD 0.0363

9 0. 00067

-

0.00069 0 4 0.0575 <LOD 0.0648 0.0679 0.0679

0.0636 <LOD 0.0709

<LOD <LOD <0.015 0.015 0.015 <LOD <LOD <0.015

10 0 .00067

-

0.00068 0 4 0.0781 <LOD 0.0854 0.0848 0.0848

0.0769 <LOD 0.0842

0.0457 <LOD 0.0529 0.0618 0.0618 0.0634 <LOD 0.0707Deltamethrin /PC Code 097805 / Bayer CropScience

OCSPP 860.1500/OECD IIA 6.3.1, 6.3.2, 6.3.3 and IIIA 8.3.1, 8.3.2, 8.3.3

Crop Field Trials

– Alfalfa (Forage and Hay), Grass ( Forage and Hay), Leaf Lettuce (Leaves)

_____________________________________________________________________________________________ DP Barcode D4 2304 5/MRID #49114112 Page 12 of 24 

### Table C .3. Residue Data from Alfalfa Field Trials with Deltamethrin

Crop

Matrix Analyte No. of

Appli

cations Applic.

Rate

(lb

ai/acre) PHI

(days) n * Residues (ppm)

Cis Trans Total

Deltamethrin Average LAFT HAFT

Alfalfa Hay : Proposed Total Application Rate = 0.0 134 lb ai/A ( 1 x)

Alfalfa

Hay Cis and

Trans

Delta

methrin 1 0.0013 0 4 0.0180 <LOD 0.0253 0.0213 0.0213 0.00991 <LOD 0.0172

<LOD <LOD 0.015 0.015 0.015 <LOD <LOD 0.015

2 0. 0013

-

0.0014 0 4 0.0118 <LOD 0.0190 0.0193 0.0193

0.0122 <LOD 0.0195

0.0275 <LOD 0.0348 0.0592 0.0592 0.0763 <LOD 0.0836

3 0.0013

-

0.0014 0 4 0.0128 <LOD 0.0201 0.0205 0.0205

0.0136 <LOD 0.0209

0.0614 <LOD 0.0687 0.0643 0.0643 0.0526 <LOD 0.0599

4 0. 0013 0 4 0.0230 <LOD 0.0303 0.0326 0.0326 0.0276 <LOD 0.0349

0.0880 <LOD 0.0952 0.0935 0.0935 0.0845 <LOD 0.0918

5 0.0013 0 4 0.0288 <LOD 0.0361 0.0348 0.0348 0.0262 <LOD 0.0335

0.0806 <LOD 0.0878 0.0736 0.0736 0.0520 <LOD 0.0593

6 0. 0013 0 4 0.0176 <LOD 0.0249 0.0217 0.0217 0.0111 <LOD 0.0184

0.110 <LOD 0.118 0.141 0.141 0.148 <LOD 0.164

7 0.0013 0 4 0.0332 <LOD 0.0405 0.0391 0.0391 0.0303 <LOD 0.0376

0.0358 <LOD 0.0430 0.0680 0.0680 0.0754 0.0176 0.0930

8 0.0013 0 4 0.0759 <LOD 0.0832 0.0805 0.0805 0.0704 <LOD 0.0777

0.0520 0.0169 0.0689 0.0352 0.0352 <LOD <LOD <0.015

9 0. 0013 0 4 0.113 <LOD 0.121 0.1101 0.1101 0.0919 <LOD 0.0992

0.0451 <LOD 0.0524 0.0428 0.0428 0.0258 <LOD 0.0331

10 0 .0013 0 4 0.104 <LOD 0.111 0.111 0.111 0.103 <LOD 0.110

0.0302 <LOD 0.0375 0.0363 0.0363 0.0277 <LOD 0.0350Deltamethrin /PC Code 097805 / Bayer CropScience

OCSPP 860.1500/OECD IIA 6.3.1, 6.3.2, 6.3.3 and IIIA 8.3.1, 8.3.2, 8.3.3

Crop Field Trials

– Alfalfa (Forage and Hay), Grass ( Forage and Hay), Leaf Lettuce (Leaves)

_____________________________________________________________________________________________ DP Barcode D4 2304 5/MRID #49114112 Page 13 of 24 

### Table C .3. Residue Data from Leaf Lettuce Field Trials with Deltamethrin

Crop

Matrix Analyte No. of

Appli

cations Applic.

Rate

(lb

ai/acre) PHI

(days) n * Residues (ppm)

Cis Trans Total

Deltamethrin Average LAFT HAFT

Leaf Lettuce : Proposed Total Application Rate = 0.0067 lb ai/A (1⁄2 x)

Lettuce

Leaves Cis and

Trans

Delta

methrin 1 0.00066

-

0.00068 0 4 0.0210 <LOD 0.0227 0.0234 0.0234

0.0224 <LOD 0.0241

<LOD <LOD 0.0035 0.0035 0.0035 <LOD <LOD 0.0035

2 0. 00067

-

0.00070 0 4 0.0143 <LOD 0.0160 0.0236 0.0236

0.0294 <LOD 0.0311

0.0224 <LOD 0.0241 0.0208 0.0208 0.0158 <LOD 0.0175

3 0. 00068 0 4 0.0342 <LOD 0.0360 0.0384 0.0384 0.0391 <LOD 0.0408

0.00942 <LOD 0.0111 0.0128 0.0128 0.0128 <LOD 0.0145

4 0. 00066

-

0.00068 0 4 0.0358 <LOD 0.0375 0.0372 0.0372

0.0351 <LOD 0.0368

0.0164 <LOD 0.0181 0.0165 0.0165 0.0131 <LOD 0.0148

5 0. 00067

-

0.00068 0 4 0.0279 <LOD 0.0297 0.0210 0.0210

0.0105 <LOD 0.0122

0.00978 <LOD 0.0115 0.0225 0.0225 0.0113 <LOD 0.0130

6 0. 00067

-

0.00069 0 4 0.0286 <LOD 0.0303 0.0284 0.0284

0.0248 <LOD 0.0265

0.00533 <LOD 0.00704 0.00797 0.00797 0.00718 <LOD 0.00889

7 0.00066 0 4 0.0310 <LOD 0.0327 0.0290 0.0290 0.0235 <LOD 0.0252

0.00486 <LOD 0.00658 0.00648 0.00648 0.00466 <LOD 0.00638

8 0.00066

-

0.00068 0 4 0.0289 <LOD 0.0306 0.0278 0.0278

0.0232 <LOD 0.0249

0.00386 <LOD 0.00588 0.0062 0.0062 0.00481 <LOD 0.00653

9 0. 00067

-

0.00069 0 4 0.0330 <LOD 0.0348 0.0349 0.0349

0.0332 <LOD 0.0349

0.00298 <LOD 0.00470 0.0045 0.0450 0.00259 <LOD 0.00430

10 0 .00067

-

0.00068 0 4 0.0387 <LOD 0.0404 0.0425 0.0425

0.0429 <LOD 0.0446

0.00449 <LOD 0.00620 0.0080 0.00795 0.00798 <LOD 0.00970Deltamethrin /PC Code 097805 / Bayer CropScience

OCSPP 860.1500/OECD IIA 6.3.1, 6.3.2, 6.3.3 and IIIA 8.3.1, 8.3.2, 8.3.3

Crop Field Trials

– Alfalfa (Forage and Hay), Grass ( Forage and Hay), Leaf Lettuce (Leaves)

_____________________________________________________________________________________________ DP Barcode D4 2304 5/MRID #49114112 Page 14 of 24 

### Table C. 3. Residue Data from Leaf Lettuce Field Trials with Deltamethrin

Crop

Matrix Analyte No. of

Appli

cations Applic.

Rate

(lb

ai/acre) PHI

(days) n * Residues (ppm)

Cis Trans Total

Deltamethrin Average LAFT HAFT

Leaf Lettuce : Proposed Total Application Rate = 0.0 134 lb ai/A ( 1 x)

Lettuce

Leaves Cis and

Trans

Delta

methrin 1 0.0013 0 4 0.0112 <LOD 0.0129 0.0140 0.0140 0.0133 <LOD 0.0150

0.00284 <LOD 0.00456 0.00507 0.00507 0.00385 <LOD 0.00557

2 0. 0013

-

0.0014 0 4 0.00880 <LOD 0.0105 0.0101 0.0101

0.00800 <LOD 0.00972

0.0133 <LOD 0.0150 0.0192 0.0192 0.0217 <LOD 0.0234

3 0. 0013

-

0.0014 0 4 0.00989 <LOD 0.0116 0.0106 0.0106

0.00796 <LOD 0.00968

0.00798 <LOD 0.00970 0.0102 0.0102 0.00891 <LOD 0.0106

4 0. 0013 0 4 0.00958 <LOD 0.0113 0.0120 0.0120 0.0109 <LOD 0.0126

0.0131 <LOD 0.0148 0.0168 0.0168 0.0170 <LOD 0.0187

5 0. 0013 0 4 0.0106 <LOD 0.0123 0.0122 0.0122 0.0103 <LOD 0.0120

0.0171 <LOD 0.0188 0.0153 0.0153 0.00995 <LOD 0.0117

6 0. 0013 0 4 0.00528 <LOD 0.00700 0.00645 0.00645 0.00419 <LOD 0.00590

0.00716 <LOD 0.00888 0.00872 0.00872 0.00684 <LOD 0.00855

7 0.0013 0 4 0.00429 <LOD 0.00601 0.00851 0.00851 0.00930 <LOD 0.0110

0.0317 <LOD 0.0335 0.0342 0.0342 0.0331 <LOD 0.0348

8 0.0013 0 4 0.0205 <LOD 0.0222 0.0202 0.0202 0.0164 <LOD 0.0181

0.00403 <LOD 0.00575 0.00614 0.00614 0.00481 <LOD 0.00652

9 0. 0013 0 4 0.0395 <LOD 0.0412 0.0365 0.0365 0.0301 <LOD 0.0318

0.00324 <LOD 0.00496 0.00566 0.00566 0.00464 <LOD 0.00635

10 0 .0013 0 4 0.0357 <LOD 0.0375 0.0331 0.0331 0.0269 <LOD 0.0286

0.00374 <LOD 0.00545 0.00632 0.00632 0.00547 <LOD 0.00719Deltamethrin /PC Code 097805 / Bayer CropScience

OCSPP 860.1500/OECD IIA 6.3.1, 6.3.2, 6.3.3 and IIIA 8.3.1, 8.3.2, 8.3.3

Crop Field Trials

– Alfalfa (Forage and Hay), Grass ( Forage and Hay), Leaf Lettuce (Leaves)

_____________________________________________________________________________________________ DP Barcode D4 2304 5/MRID #49114112 Page 15 of 24 

### Table C .3. Residue Data from Grass Field Trials with Deltamethrin

Crop

Matrix Analyte No. of

Appli

cations Applic.

Rate

(lb

ai/acre) PHI

(days) n * Residues (ppm)

Cis Trans Total

Deltamethrin Average LAFT HAFT

Grass Forage: Proposed Total Application Rate = 0.0067 lb ai/A (1⁄2 x)

Grass

Forage Cis and

Trans

Delta

methrin 1 0.00066

-

0.00068 0 4 0.00910 <LOD 0.0109 0.0149 0.0149

0.0170 <LOD 0.0188

0.00360 <LOD 0.00538 0.00525 0.00525 0.00334 <LOD 0.00512

2 0. 00067

-

0.00070 0 4 0.0214 <LOD 0.0232 0.0197 0.0197

0.0144 <LOD 0.0162

0.00726 <LOD 0.00904 0.0117 0.0117 0.0125 <LOD 0.0143

3 0. 00068 0 4 0.0236 <LOD 0.0254 0.0292 0.0292 0.0289 0.00404 0.0330

0.0218 <LOD 0.0236 0.0216 0.0216 0.0177 <LOD 0.0195

4 0. 00066

-

0.00068 0 4 0.0185 <LOD 0.0203 0.0188 0.0188

0.0154 <LOD 0.0172

0.0161 <LOD 0.0179 0.0174 0.0174 0.0150 <LOD 0.0168

5 0. 00067

-

0.00068 0 4 0.0172 <LOD 0.0190 0.0189 0.0189

0.0170 <LOD 0.0188

0.0154 <LOD 0.0172 0.0169 0.0169 0.0147 <LOD 0.0165

6 0. 00067

-

0.00069 0 4 0.0112 <LOD 0.0130 0.0153 0.0153

0.0157 <LOD 0.0175

0.0278 0.00542 0.0333 0.0297 0.0297 0.0215 0.00461 0.0261

7 0.00066 0 4 0.0185 <LOD 0.0202 0.0223 0.0223 0.0225 <LOD 0.0243

0.0221 0.00599 0.0281 0.0316 0.0316 0.0289 0.00625 0.0351

8 0.00066

-

0.00068 0 4 0.0241 0.00411 0.0282 0.0295 0.0295

0.0262 0.00464 0.0308

0.0281 0.00572 0.00338 0.0324 0.0324 0.0238 0.00729 0.00310

9 0. 00067

-

0.00069 0 4 0.0290 <LOD 0.0308 0.0285 0.0285

0.0243 <LOD 0.0261

0.0163 0.00546 0.0218 0.0261 0.0261 0.0244 0.00600 0.0304

10 0.00067

-

0.00068 0 4 0.0376 0.00526 0.0429 0.0339 0.0339

0.0231 <LOD 0.0249

0.0187 0.00664 0.0254 0.0303 0.0303 0.0277 0.00754 0.0352Deltamethrin /PC Code 097805 / Bayer CropScience

OCSPP 860.1500/OECD IIA 6.3.1, 6.3.2, 6.3.3 and IIIA 8.3.1, 8.3.2, 8.3.3

Crop Field Trials

– Alfalfa (Forage and Hay), Grass ( Forage and Hay), Leaf Lettuce (Leaves)

_____________________________________________________________________________________________ DP Barcode D4 2304 5/MRID #49114112 Page 16 of 24 

### Table C .3. Residue Data from Grass Field Trials with Deltamethrin

Crop

Matrix Analyte No. of

Appli

cations Applic.

Rate

(lb

ai/acre) PHI

(days) n * Residues (ppm)

Cis Trans Total

Deltamethrin Average LAFT HAFT

Grass Forage: Proposed Total Application Rate = 0.0 134 lb ai/A ( 1 x)

Grass

Forage Cis and

Trans

Delta

methrin 1 0.0013 0 4 0.0148 <LOD 0.0166 0.0135 0.0135 0.00861 <LOD 0.0104

0.00622 <LOD 0.00800 0.00758 0.00758 0.00538 <LOD 0.00716

2 0. 0013

-

0.0014 0 4 0.0157 <LOD 0.0175 0.0157 0.0157

0.0120 <LOD 0.0138

0.00971 <LOD 0.0115 0.0114 0.0114 0.00949 <LOD 0.0113

3 0. 0013

-

0.0014 0 4 0.0260 <LOD 0.0278 0.0259 0.0259

0.0221 <LOD 0.0239

0.0176 <LOD 0.0194 0.0202 0.0202 0.0192 <LOD 0.0210

4 0. 0013 0 4 0.0150 <LOD 0.0168 0.0190 0.0190 0.0195 <LOD 0.0212

0.0233 <LOD 0.0250 0.0245 0.0245 0.0222 <LOD 0.0240

5 0. 0013 0 4 0.0192 <LOD 0.0210 0.0192 0.0192 0.0157 <LOD 0.0174

0.0266 <LOD 0.0284 0.0257 0.0257 0.0211 <LOD 0.0229

6 0. 0013 0 4 0.00955 <LOD 0.0113 0.0146 0.0146 0.0161 <LOD 0.0179

0.0158 <LOD 0.0176 0.0248 0.0248 0.0267 0.00529 0.0320

7 0.0013 0 4 0.0317 <LOD 0.0335 0.0342 0.0342 0.0331 <LOD 0.0348

0.0275 0.00576 0.0332 0.0274 0.0274 0.0177 0.00377 0.0215

8 0.0013 0 4 0.0323 <LOD 0.0341 0.0317 0.0317 0.0275 <LOD 0.0292

0.0249 0.00429 0.0292 0.0305 0.0305 0.0267 0.00505 0.0317

9 0. 0013 0 4 0.0773 <LOD 0.0791 0.0748 0.0748 0.0687 <LOD 0.0704

0.0202 0.00554 0.0257 0.0222 0.0222 0.0151 0.00359 0.0187

10 0 .0013 0 4 0.0852 <LOD 0.0870 0.0698 0.0698 0.0483 0.0424 0.0525

0.0173 0.00437 0.0217 0.0252 0.0252 0.0211 0.00755 0.0287Deltamethrin /PC Code 097805 / Bayer CropScience

OCSPP 860.1500/OECD IIA 6.3.1, 6.3.2, 6.3.3 and IIIA 8.3.1, 8.3.2, 8.3.3

Crop Field Trials

– Alfalfa (Forage and Hay), Grass ( Forage and Hay), Leaf Lettuce (Leaves)

_____________________________________________________________________________________________ DP Barcode D4 2304 5/MRID #49114112 Page 17 of 24 

### Table C .3. Residue Data from Grass Field Trials with Deltamethrin

Crop

Matrix Analyte No. of

Appli

cations Applic.

Rate

(lb

ai/acre) PHI

(days) n * Residues (ppm)

Cis Trans Total

Deltamethrin Average LAFT HAFT

Grass Hay : Proposed Total Application Rate = 0.0067 lb ai/A (1⁄2 x)

Grass

Hay Cis and

Trans

Delta

methrin 1 0.00066

-

0.00068 0 4 0.0823 <LOD 0.0920 0.0867 0.0867

0.0717 <LOD 0.0814

<LOD <LOD <0.02 0.02 0.02 <LOD <LOD <0.02

2 0. 00067

-

0.00070 0 4 0.0675 <LOD 0.0772 0.0772 0.0772

0.0674 <LOD 0.0771

0.0189 <LOD 0.0285 0.0319 0.0319 0.0256 <LOD 0.0352

3 0.00068 0 4 0.0662 <LOD 0.0759 0.0809 0.0809 0.0763 <LOD 0.0859

0.0338 <LOD 0.0435 0.0411 0.0411 0.0290 <LOD 0.0387

4 0. 00066

-

0.00068 0 4 0.0617 <LOD 0.0713 0.0795 0.0795

0.0779 <LOD 0.0876

0.0429 <LOD 0.0525 0.0521 0.0521 0.0420 <LOD 0.0516

5 0.00067

-

0.00068 0 4 0.110 <LOD 0.120 0.122 0.122

0.114 <LOD 0.124

0.0332 <LOD 0.0429 0.0461 0.0461 0.0395 <LOD 0.0492

6 0. 00067

-

0.00069 0 4 0.0877 <LOD 0.0974 0.0955 0.0955

0.0839 <LOD 0.0936

0.0437 <LOD 0.0534 0.0573 0.0573 0.0514 <LOD 0.0611

7 0.00066 0 4 0.139 0.0194 0.158 0.137 0.137 0.106 <LOD 0.116

0.0478 <LOD 0.0575 0.0574 0.0574 0.0475 <LOD 0.0572

8 0.00066

-

0.00068 0 4 0.114 0.0200 0.134 0.133 0.133

0.109 0.0219 0.131

0.0415 <LOD 0.0512 0.0501 0.0501 0.0393 <LOD 0.0490

9 0. 00067

-

0.00069 0 4 0.140 0.0224 0.162 0.162 0.162

0.141 0.0209 0.162

0.0413 <LOD 0.0510 0.0550 0.0550 0.0492 <LOD 0.0589

10 0.00067

-

0.00068 0 4 0.155 0.0236 0.178 0.188 0.188

0.171 0.0266 0.197

0.0396 <LOD 0.0493 0.0491 0.0491 0.0392 <LOD 0.0489Deltamethrin /PC Code 097805 / Bayer CropScience

OCSPP 860.1500/OECD IIA 6.3.1, 6.3.2, 6.3.3 and IIIA 8.3.1, 8.3.2, 8.3.3

Crop Field Trials

– Alfalfa (Forage and Hay), Grass ( Forage and Hay), Leaf Lettuce (Leaves)

_____________________________________________________________________________________________ DP Barcode D4 2304 5/MRID #49114112 Page 18 of 24 

### Table C .3. Residue Data from Grass Field Trials with Deltamethrin

Crop

Matrix Analyte No. of

Appli

cations Applic.

Rate

(lb

ai/acre) PHI

(days) n * Residues (ppm)

Cis Trans Total

Deltamethrin Average LAFT HAFT

Grass Hay : Proposed Total Application Rate = 0.0 134 lb ai/A ( 1 x)

Grass

Hay Cis and

Trans

Delta

methrin 1 0.0013 0 4 0.0225 <LOD 0.0322 0.0421 0.0421 0.0423 <LOD 0.0520

0.0203 <LOD 0.0300 0.0298 0.0298 0.0198 <LOD 0.0295

2 0. 0013

-

0.0014 0 4 0.0461 <LOD 0.0558 0.0555 0.0555

0.0456 <LOD 0.0552

0.0193 <LOD 0.0290 0.0324 0.0324 0.0261 <LOD 0.0358

3 0. 0013

-

0.0014 0 4 0.0625 <LOD 0.0722 0.0712 0.0712

0.0605 <LOD 0.0702

0.0726 <LOD 0.0823 0.0823 0.0823 0.0726 <LOD 0.0823

4 0. 0013 0 4 0.118 <LOD 0.128 0.121 0.121 0.103 <LOD 0.113

0.0581 0.0332 0.0913 0.0987 0.0987 0.0775 0.0283 0.106

5 0. 0013 0 4 0.0696 <LOD 0.0792 0.0791 0.0791 0.0693 <LOD 0.0790

0.0754 0.0366 0.112 0.123 0.123 0.0821 0.0514 0.133

6 0. 0013 0 4 0.0603 <LOD 0.0700 0.0729 0.0729 0.0661 <LOD 0.0758

0.0792 0.0819 0.161 0.152 0.152 0.0788 0.0633 0.142

7 0.0013 0 4 0.156 <LOD 0.166 0.154 0.154 0.131 <LOD 0.141

0.0601 0.0478 0.108 0.104 0.104 0.0553 0.0439 0.0992

8 0.0013 0 4 0.130 <LOD 0.140 0.140 0.140 0.130 <LOD 0.140

0.0654 0.0744 0.140 0.128 0.128 0.0666 0.0489 0.116

9 0. 0013 0 4 0.322 <LOD 0.332 0.355 0.355 0.349 0.0275 0.377

0.0556 0.0593 0.115 0.118 0.118 0.0415 0.0794 0.121

10 0 .0013 0 4 0.275 0.0494 0.324 0.347 0.347 0.331 0.0375 0.369

0.0415 0.108 0.150 0.150 0.150 0.0502 0.0993 0.150Deltamethrin /PC Code 097805 / Bayer CropScience

OCSPP 860.1500/OECD IIA 6.3.1, 6.3.2, 6.3.3 and IIIA 8.3.1, 8.3.2, 8.3.3

Crop Field Trials

– Alfalfa (Forage and Hay), Grass ( Forage and Hay), Leaf Lettuce (Leaves)

_____________________________________________________________________________________________ DP Barcode D4 2304 5/MRID #49114112 Page 19 of 24 

### Table 5.3.1. Summary of Total Residues from Alfalfa Forage Field Trials with Deltamethrin

Crop

Matrix Analyte No. of

Appli

cations Applic.

Rate

(lb

ai/acre) PHI

(days) n Residues (ppm)

Min Max LAFT HAFT Mean SD

Alfalfa Forage: Proposed Total Application Rate = 0.0067 lb ai/A (1⁄2 x)

Alfalfa

Forage Cis and

Trans

Delta

methrin 1 0.00066

-

0.00068 0 4 <0.004 0.011 2 0.005 5 0.0089 0.0073 0.00302

2 0.00067

-

0.00070 0 4 0.0105 0.014 8 0.010 8 0.0131 0.0120 0.0020

3 0.00068 0 4 0.0084 0.0178 0.0131 0.0139 0.0135 0.00423

4 0.00066

-

0.00068 0 4 0.0172 0.0208 0.0173 0.0 200 0.0187 0.0014 4

5 0.00067

-

0.00068 0 4 0.0160 0.0244 0.0202 0.020 6 0.0204 0.00363

6 0.00067

-

0.00069 0 4 0.0113 0.0220 0.013 6 0.0209 0.0172 0.00471

7 0.00066 0 4 0.0237 0.0382 0.0249 0.03 88 0.0313 0.00749

8 0.00066

-

0.00068 0 4 <0.004 0.0294 0.011 5 0.0281 0.0198 0.01142

9 0.00067

-

0.00069 0 4 0.0165 0.054 4 0.0170 0.0434 0.0302 0.0178

10 0.00067

-

0.00068 0 4 0.0144 0.0441 0.016 2 0.0380 0.0271 0.0136

Alfalfa Forage: Proposed Total Application Rate = 0.0134 lb ai/A (1x)

Alfalfa

Forage Cis and

Trans

Delta

methrin 1 0.0013 0 4 <0.004 0.007 5 <0.004 0.0069 0.0055 0.0018

2 0.0013

-

0.0014 0 4 0.0066 0.0394 0.0075 0.0363 0.0219 0.0168

3 0.0013

-

0.0014 0 4 0.0072 0.0337 0.0093 0.0294 0.0194 0.0122

4 0.0013 0 4 0.0139 0.0385 0.0147 0.03 60 0.0254 0.0124

5 0.0013 0 4 0.0143 0.0507 0.0164 0.0455 0.0310 0.0174

6 0.0013 0 4 0.0122 0.0525 0.012 4 0.046 3 0.0293 0.0202

7 0.0013 0 4 0.0128 0.03 62 0.014 3 0.032 4 0.0228 0.0101

8 0.0013 0 4 0.0205 0.0444 0.02 90 0.0409 0.0349 0.0102

9 0.0013 0 4 0.0315 0.0696 0.039 7 0.0620 0.0508 0.0158

10 0.0013 0 4 0.0040 0.0690 0.0301 0.0671 0.0343 0.0332

LAFT = Lowest Average Field Trial, HAFT = Highest Average Field Trial, SD = Standard Deviation. For computation of the

LAFT, HAFT, median, mean, and standard deviation, values <LO Q are assumed to be at the LOQ.Deltamethrin /PC Code 097805 / Bayer CropScience

OCSPP 860.1500/OECD IIA 6.3.1, 6.3.2, 6.3.3 and IIIA 8.3.1, 8.3.2, 8.3.3

Crop Field Trials

– Alfalfa (Forage and Hay), Grass ( Forage and Hay), Leaf Lettuce (Leaves)

_____________________________________________________________________________________________ DP Barcode D4 2304 5/MRID #49114112 Page 20 of 24 

### Table 5.3.1. Summary of Total Residues from Alfalfa Hay Field Trials with Deltamethrin

Crop

Matrix Analyte No. of

Appli

cations Applic.

Rate

(lb

ai/acre) PHI

(days) n Residues (ppm)

Min Max LAFT HAFT Mean SD

Alfalfa Hay: Proposed Total Application Rate = 0.0067 lb ai/A (1⁄2 x)

Alfalfa

Hay Cis and

Trans

Delta

methrin 1 0.00066

-

0.00068 0 4 <0.0150 0.050 7 0.0150 0.0480 0.0316 0.0193

2 0.00067

-

0.00070 0 4 0.0356 0.0885 0.039 9 0.0707 0.0555 0.0233

3 0.00068 0 4 0.0340 0.0495 0.036 5 0.0456 0.0413 0.0065

4 0.00066

-

0.00068 0 4 0.0512 0.164 0.0548 0.1530 0.0564 0.0069

5 0.00067

-

0.00068 0 4 0.0560 0.0930 0.058 9 0.0805 0.0603 0.0029

6 0.00067

-

0.00069 0 4 < 0.0 15 0.0 537 0.0 278 0.0 522 0.0 400 0.01 76

7 0.00066 0 4 0.0331 0.0737 0.03 80 0.0716 0.0613 0.0125

8 0.00066

-

0.00068 0 4 0.0350 0.0707 0.0357 0.0624 0.0480 0.0205

9 0.00067

-

0.00069 0 4 < 0.0 15 0.0709 0.0 15 0.0679 0.0565 0.0140

10 0.00067

-

0.00068 0 4 0.0529 0.0854 0.0618 0.0848 0.0681 0.0195

Alfalfa Hay: Proposed Total Application Rate = 0.0134 lb ai/A (1x)

Alfalfa

Hay Cis and

Trans

Delta

methrin 1 0.0013 0 4 <0.015 0.0253 0.0150 0.0 213 0.0 182 0.0 049

2 0.0013

-

0.0014 0 4 0.0 354 0.0 836 0.0 193 0.0592 0.0393 0.0305

3 0.0013

-

0.0014 0 4 0.0 201 0.0 687 0.0 205 0.0 643 0.0424 0.0255

4 0.0013 0 4 0.0305 0.0952 0.0326 0.0935 0.0631 0.0352

5 0.0013 0 4 0.0337 0.0878 0.0348 0.0736 0.0515 0.0193

6 0.0013 0 4 0.0186 0.1 64 0.021 7 0.1410 0.0792 0.0680

7 0.0013 0 4 0.0378 0.0930 0.039 1 0.0680 0.0537 0.0263

8 0.0013 0 4 0.0150 0.0832 0.0 352 0.080 5 0.0 579 0.0314

9 0.0013 0 4 0.0333 0.1205 0.0428 0.110 1 0.0765 0.0404

10 0.0013 0 4 0.0178 0.1110 0.0363 0.1110 0.0272 0.0108

LAFT = Lowest Average Field Trial, HAFT = Highest Average Field Trial, SD = Standard Deviation. For computation of the

LAFT, HAFT, median, mean, and standard deviation, values <LOQ are assumed to be at the LOQ.Deltamethrin /PC Code 097805 / Bayer CropScience

OCSPP 860.1500/OECD IIA 6.3.1, 6.3.2, 6.3.3 and IIIA 8.3.1, 8.3.2, 8.3.3

Crop Field Trials

– Alfalfa (Forage and Hay), Grass ( Forage and Hay), Leaf Lettuce (Leaves)

_____________________________________________________________________________________________ DP Barcode D4 2304 5/MRID #49114112 Page 21 of 24 

### Table 5.3.1. Summary of Total Residues from Lettuce Field Trials with Deltamethrin

Crop

Matrix Analyte No. of

Appli

cations Applic.

Rate

(lb

ai/acre) PHI

(days) N Residues (ppm)

Min Max LAFT HAFT Mean SD

Leaf Lettuce: Proposed Total Application Rate = 0.0067 lb ai/A (1⁄2 x)

Lettuce

Leaves Cis and

Trans

Delta

methrin 1 0.00066

-

0.00067 0 4 <0.00 35 0.024 1 0.00 35 0.0234 0.0139 0.0114

2 0.00067

-

0.00068 0 4 0.0163 0.0311 0.0208 0.0236 0.0225 0.0069

3 0.00067

-

0.00068 0 4 0.0114 0.0408 0.0128 0.0384 0.0259 0.0150

4 0.00067

-

0.00068 0 4 0.0151 0.0375 0.0165 0.037 2 0.0271 0.0120

5 0.00073

-

0.00066 0 4 0.011 5 0.029 7 0.0 210 0.02 25 0.0169 0.0087

6 0.00067

-

0.00068 0 4 0.0073 0.0303 0.0080 0.0284 0.0185 0.0119

7 0.00067 0 4 0.0064 0.0327 0.0 065 0.0 290 0.0180 0.0133

8 0.00066

-

0.00067 0 4 0.0059 0 .0306 0.006 2 0.027 8 0.0172 0.0127

9 0.00067

-

0.00068 0 4 0.0043 0.0349 0.0045 0.034 9 0.0200 0.0175

10 0.00067

-

0.00068 0 4 0.0065 0.0446 0.0080 0.0425 0.0255 0.0201

Leaf Lettuce: Proposed Total Application Rate = 0.0134 lb ai/A (1x)

Lettuce

Leaves Cis and

Trans

Delta

methrin 1 0.0013 0 4 0.0048 0.0 150 0.0051 0.01 40 0.0098 0.0052

2 0.0013 0 4 0.0100 0.0234 0.0101 0.0192 0.0150 0.0063

3 0.0013 0 4 0.0100 0.0116 0.0102 0.0106 0.0107 0.0009

4 0.0013 0 4 0.0116 0.0187 0.0120 0.0168 0.0147 0.0032

5 0.0013 0 4 0.0120 0.0188 0.0122 0.015 3 0.0140 0.0034

6 0.0013 0 4 0.0062 0.0089 0.0065 0.0087 0.0079 0.0014

7 0.0013 0 4 0.006 0 0.0 348 0.0085 0.0 342 0.0 213 0.0150

8 0.0013 0 4 0.0060 0.0222 0.0061 0.0202 0.0134 0.0083

9 0.0013 0 4 0.0052 0.0412 0.0057 0.0365 0.0214 0.0183

10 0.0013 0 4 0.0057 0.0375 0.0063 0.033 1 0.0200 0.0158

LAFT = Lowest Average Field Trial, HAFT = Highest Average Field Trial, SD = Standard Deviation. For computation of the

LAFT, HAFT, median, mean, and standard deviation, values <LO Q are assumed to be at the LOQ.Deltamethrin /PC Code 097805 / Bayer CropScience

OCSPP 860.1500/OECD IIA 6.3.1, 6.3.2, 6.3.3 and IIIA 8.3.1, 8.3.2, 8.3.3

Crop Field Trials

– Alfalfa (Forage and Hay), Grass ( Forage and Hay), Leaf Lettuce (Leaves)

_____________________________________________________________________________________________ DP Barcode D4 2304 5/MRID #49114112 Page 22 of 24 

### Table 5.3.1. Summary of Total Residues from Grass Forage Field Trials with Deltamethrin

Crop

Matrix Analyte No. of

Appli

cations Applic.

Rate

(lb

ai/acre) PHI

(days) n Residues (ppm)

Min Max LAFT HAFT Mean SD

Grass Forage: Proposed Total Application Rate = 0.0067 lb ai/A (1⁄2 x)

Grass

Forage Cis and

Trans

Delta

methrin 1 0.00066

-

0.00068 0 4 0.0053 0.01 88 0.0053 0.014 9 0.0103 0.0064

2 0.00067

-

0.00070 0 4 0.0093 0.0232 0.0117 0.0197 0.0159 0.0058

3 0.00067

-

0.00068 0 4 0.0197 0.0330 0.0216 0.0292 0.0255 0.0055

4 0.00067

-

0.00068 0 4 0.0170 0.0203 0.017 4 0.018 8 0.0183 0.0014

5 0.00066

-

0.00067 0 4 0.0167 0.0190 0.016 9 0.0189 0.0181 0.0012

6 0.00067

-

0.00069 0 4 0.0132 0.0333 0.015 3 0.0297 0.0226 0.0089

7 0.00066 0 4 0.0205 0.0351 0.0223 0.0316 0.0271 0.0062

8 0.00073

-

0.00067 0 4 0.0282 0.0338 0.0295 0.0324 0.0310 0.0023

9 0.00066

-

0.00068 0 4 0.0218 0.0308 0.0261 0.0285 0.0274 0.0043

10 0.00067 0 4 0.0251 0.0429 0.0303 0.0339 0.0321 0.0086

Grass Forage: Proposed Total Application Rate = 0.0134 lb ai/A (1x)

Grass

Forage Cis and

Trans

Delta

methrin 1 0.0013 0 4 0.00716 0.0166 0.0076 0.0135 0.0108 0.0043

2 0.0013

-

0.0014 0 4 0.0113 0.01 75 0.0114 0.0157 0.0137 0.0029

3 0.0013 0 4 0.0194 0.0278 0.0202 0.025 9 0.0232 0.0037

4 0.0013 0 4 0.0168 0.0250 0.0190 0.0245 0.0220 0.0037

5 0.0014

-

0.0013 0 4 0.0174 0.0284 0.0192 0.025 7 0.0227 0.0046

6 0.0013 0 4 0.0113 0.0320 0.0146 0.0248 0.0199 0.0086

7 0.0013 0 4 0.0215 0.0348 0.0274 0.0342 0.0309 0.0063

8 0.0013 0 4 0.0292 0.0341 0.0305 0.0317 0.0302 0.0038

9 0.0013 0 4 0.0187 0.0791 0.0222 0.0748 0.0486 0.0308

10 0.0013 0 4 0.0217 0.0870 0.0252 0.0698 0.0470 0.0295

LAFT = Lowest Average Field Trial, HAFT = Highest Average Field Trial, SD = Standard Deviation. For computation of the

LAFT, HAFT, median, mean, and standard deviation, values <LOQ are assumed to be at the LOQ.Deltamethrin /PC Code 097805 / Bayer CropScience

OCSPP 860.1500/OECD IIA 6.3.1, 6.3.2, 6.3.3 and IIIA 8.3.1, 8.3.2, 8.3.3

Crop Field Trials

– Alfalfa (Forage and Hay), Grass ( Forage and Hay), Leaf Lettuce (Leaves)

_____________________________________________________________________________________________ DP Barcode D4 2304 5/MRID #49114112 Page 23 of 24 

### Table 5.3.1. Summary of Total Residues from Grass Hay Field Trials with Deltamethrin

Crop

Matrix Analyte No. of

Appli

cations Applic.

Rate

(lb

ai/acre) PHI

(days) n Residues (ppm)

Min Max LAFT HAFT Mean SD

Grass Hay: Proposed Total Application Rate = 0.0067 lb ai/A (1⁄2 x)

Grass

Hay Cis and

Trans

Delta

methrin 1 0.00066

-

0.00068 0 4 <0.0200 0.092 0 <0.02 0.0867 0.0535 0.0389

2 0.00067

-

0.00070 0 4 0.0289 0 .0772 0.0319 0.0772 0.0549 0.0262

3 0.00067

-

0.00068 0 4 0.0390 0.0859 0.0411 0.0809 0.0613 0.0235

4 0.00067

-

0.00068 0 4 0.0520 0.0876 0.0521 0.0795 0.0661 0.0171

5 0.00066

-

0.00067 0 4 0.0432 0.1240 0.0461 0.122 0.0842 0.0438

6 0.00067

-

0.00069 0 4 0.0537 0.0974 0.057 3 0.0955 0.0767 0.0224

7 0.00066 0 4 0.0572 0.1584 0.0574 0.137 0.0974 0.0491

8 0.00073

-

0.00067 0 4 0.0493 0.1340 0.0501 0.13 3 0.0914 0.0474

9 0.00066

-

0.00068 0 4 0.0513 0.1624 0.05 50 0.162 0.1087 0.0618

10 0.00067 0 4 0.0489 0.1976 0.0491 0.188 0.1188 0.0805

Grass Hay: Proposed Total Application Rate = 0.0134 lb ai/A (1x)

Grass

Hay Cis and

Trans

Delta

methrin 1 0.0013 0 4 0.0295 0.052 0 0.029 8 0.0421 0.0362 0.0108

2 0.0013

-

0.0014 0 4 0.0293 0.05 58 0.0324 0.0555 0.0443 0.0137

3 0.0013 0 4 0.0705 0.0823 0.0712 0.0823 0.0771 0.0065

4 0.0013 0 4 0.0913 0.1280 0.0987 0.12 1 0.1095 0.0153

5 0.0014

-

0.0013 0 4 0.0790 0.1333 0.0791 0.12 3 0.1011 0.0265

6 0.0013 0 4 0.0703 0.1611 0.0729 0.152 0.1124 0.0460

7 0.0013 0 4 0.0992 0.1078 0.1036 0.15 4 0.0640 0.0459

8 0.0013 0 4 0.1160 0.1398 0.1277 0.139 0.0753 0.0612

9 0.0013 0 4 0.1150 0.3770 0.1179 0.354 0.0851 0.0388

10 0.0013 0 4 0.1490 0.3690 0.1495 0.34 7 0.1116 0.0438

LAFT = Lowest Average Field Trial, HAFT = Highest Average Field Trial, SD = Standard Deviation. For computation of the

LAFT, HAFT, median, mean, and standard deviation, values <LO Q are assumed to be at the LOQ.



### D. CONCLUSION

The data that Bayer Environmental Science submitted are adequate to assess the residues of

deltamethrin that occurred in trials performed on alfalfa forage, alfalfa hay, leaf lettuce, grass

forage, and grass hay when deltamethrin was applied ten times at a pplication rates of 0.00067

and 0.0013 lb ai/A. Bayer demonstrated that the analytical method is adequate for quantifying

residues of deltamethrin on the tested commodities. Storage stability data that have beenDeltamethrin /PC Code 097805 / Bayer CropScience

OCSPP 860.1500/OECD IIA 6.3.1, 6.3.2, 6.3.3 and IIIA 8.3.1, 8.3.2, 8.3.3

Crop Field Trials

– Alfalfa (Forage and Hay), Grass ( Forage and Hay), Leaf Lettuce (Leaves)

_____________________________________________________________________________________________ DP Barcode D4 2304 5/MRID #49114112 Page 24 of 24 

### submitted for deltamethrin in support of p revious tolerance petitions are adequate to demonstrate

that residues were stable in the samples taken in the mosquito adulticide trials.

E. REFERENCES

None

.

F. DOCUMENT TRACKING

Petition Number: 3 F 8 210

DP Number : D 4 23045

PC Code: 097805