Document ID: EPA-HQ-OPP-2008-0887-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-06-05T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                               WASHINGTON, D.C.  20460
                                       
	OFFICE OF
	CHEMICAL SAFETY AND
	POLLUTION PREVENTION

MEMORANDUM

Date:  		15-MAY-2013

SUBJECT:	Propamocarb Hydrochloride (Propamocarb-HCl):  Petition for Tolerances and Use on Lima Beans (Succulent).  Summary of Analytical Chemistry and Residue Data.

PC Code:  119302 (propamocarb-HCl)
         119301 (propamocarb)
DP Barcode:  D359104
Decision No.: 402658
Registration No.: 264-678
Petition No.:  8E7473
Regulatory Action:  Section 3 Registration
Risk Assessment Type:  NA
Case No.:  3124
TXR No.:  NA
CAS No.:  25606-41-1 (propamocarb-HCl)
         24579-73-5 (propamocarb)
MRID No.:  47593301
40 CFR:  §180.499

FROM:	Jennifer R. Tyler, Chemist
		Risk Assessment Branch 1 (RAB1)
		Health Effects Division (HED; 7509P)

THROUGH:	George F. Kramer, Ph.D., Branch Senior Chemist
		RAB1/HED (7509P)

TO:		Barbara Madden, RM Team 5
		Registration Division (RD; 7505P)

This document was originally prepared under contract by Dynamac Corporation (1910 Sedwick Road, Building 100, Suite B; Durham, NC 27713).  The document has been reviewed by the HED and revised to reflect current Office of Pesticide Programs (OPP) policies.

Executive Summary

Propamocarb-HCl is a carbamate fungicide that interferes with fungal synthesis of phospholipids and fatty acids.  Bayer CropScience currently has a single end-use product of propamocarb-HCl that is registered for use on food/feed crops in the United States.  This 6 pounds (lb)/gallon (gal) flowable-concentrate (FlC) formulation (EPA Reg. No. 264-678) is registered for the control of fungal diseases on lettuce, potatoes, fruiting vegetables, and cucurbit vegetables.  It is approved for multiple broadcast foliar applications to the above crops using ground or aerial equipment at 0.45-1.5 lb active ingredient (ai)/acre (A)/application for a maximum of 4.5-6.0 lb ai/A/season. Preharvest intervals (PHIs) range from 0-14 days.  Permanent tolerances have been established for residues of propamocarb-HCl in/on the above crops at levels ranging from 0.06 ppm in/on potatoes to 90 ppm in/on leaf lettuce [40 CFR §180.499 (a)]. 

The Interregional Research Project No. 4 (IR-4) has submitted a petition proposing the use of the above 6 lb/gal FlC formulation of propamocarb-HCl on succulent lima beans grown east of the Rocky Mountains.  The proposed use is for up to four broadcast foliar applications at 1.5 lb ai/A/application, with a minimum 7-day retreatment interval (RTI), for a maximum of 6.0 lb ai/A/season.  The minimum PHI is 12 hours after application (0-day).  Applications can be made using aerial or ground equipment, or by chemigation.  In conjunction with this use, IR-4 is proposing the following permanent tolerance with a geographical restriction for residues of propamocarb-HCl:

            Bean, lima, succulent 	2.0 ppm
            
The nature of propamocarb residues in vegetable crops is adequately understood based on the available potato, cucumber, and spinach metabolism studies.  The residue of concern for both risk assessment and tolerance enforcement is propamocarb per se.

As the proposed use on succulent lima beans does not include any regulated livestock feedstuffs, issues pertaining to livestock metabolism, analytical methods and storage stability data for livestock commodities, and residues in livestock commodities are not relevant to the current petition.

An adequate gas chromatography/nitrogen-phosphorus detection (GC/NPD) method (Analytical Method No. XAM-34) is available for enforcing propamocarb tolerances on plant commodities.  The limit of quantitation (LOQ) for the enforcement method is 0.05 ppm.  In the current lima bean field trials, residues of propamocarb were determined using a GC/mass spectrometry (MS) method that is derived from the tolerance enforcement method.  For this method, residues were extracted with acidic methanol, cleaned up by solvent partitioning, and elution through a Chem-Elut column.  Residues were determined as propamocarb by GC/mass-selective detection (MSD) using external standards.  The lowest level of method validation (LLMV) was 0.05 ppm for lima bean seeds and 0.1 ppm for foliage.  The statistically calculated LOQs are 0.035 and 0.061 ppm for succulent seeds and foliage, respectively, and the calculated limits of detection (LODs) are 0.012 and 0.020 ppm.  The method was adequately validated in conjunction with the analysis of field trial samples.

The results of the field trials are adequate.  The results of the field trials are adequate.  Following 4 or 5 broadcast foliar applications totaling 5.84-7.42 lb ai/A, residues of propamocarb were 0.21-0.65 ppm in/on 8 samples of succulent seeds and 29.88-126.88 ppm in/on 8 samples of foliage harvested at 0 DAT.  In the NC field trial in which propamocarb-HCl was applied as 8 applications totaling 11.83 lb ai/A, residues of propamocarb were 0.971 and 1.01 ppm in/on succulent seeds and 38.69 and 36.04 ppm in/on foliage.  Following 4 or 5 foliar applications of propamocarb-HCl, average residues of propamocarb were 0.39 ppm in/on succulent seeds and 66.1 ppm in/on foliage.  Overall, the highest-average field trial (HAFT) residues of propamocarb were 0.99 ppm for seeds and 120.6 ppm for foliage.  No residue-decline data were submitted.

Although eight field trials are typically required to support a use on lima beans, only five field trials [1 trial in North America Free Trade Agreement (NAFTA) Growing Zone 5 and 4 trials in Zone 2] are required to support a use on lima beans restricted to east of the Rocky Mountains.  Therefore, the geographic representation of the four acceptable trials is adequate.

The residue data for lima beans were analyzed using the Organization for Economic Co-operation and Development (OECD) tolerance calculation procedures.  The recommended tolerance for residues of propamocarb is 2.0 ppm in/on beans, lima, succulent. 

Although residue data on foliage were provided in the lima bean field trials, HED notes that lima bean foliage is not a regulated livestock feedstuff.  Therefore, a tolerance and residue data for lima bean foliage are not required.

Adequate confined and field rotational crop studies are available, and the data from these studies support the rotational crop restrictions currently specified on the proposed label.

Regulatory Recommendations and Residue Chemistry Deficiencies

Pending the submission of an analytical reference standard for propamocarb to the EPA National Pesticide Standards Repository, there are no residue chemistry deficiencies that would preclude the establishment an unconditional registration and a permanent tolerance of 2.0 ppm with a geographical restriction for residues of propamocarb in/on beans, lima, succulent.  A human-health risk assessment for propamocarb is forthcoming.

Note to RD:  HED recommends the following revision to the tolerance expression to (1) clarify that, as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of fenpyroximate not specifically mentioned; (2) clarify that compliance with the specified tolerance levels is to be determined by measuring only the specific compounds mentioned in the tolerance expression; and (3) to harmonize with the codex maximum residue limit (MRL) expression:

     "Tolerances are established for residues of propamocarb, including its metabolites and degradates, in or on the commodities listed below resulting from the application of the hydrochloride salt of propamocarb.  Compliance with the following tolerance levels is to be determined by measuring only propamocarb (propyl N-[3-(dimethylamino)propyl]carbamate)."

Background

Propamocarb-HCl is a carbamate fungicide that acts by interfering with fungal synthesis of phospholipids and fatty acids.  A 6 lb/gal FlC formulation of propamocarb-HCl (Previcur (R) Flex; EPA Reg. No. 264-678) is currently registered to Bayer CropScience for the control of diseases such as late blight (Phytophthora infestans), early blight (Alternaria solani), Phytophthora fruit rot, and Downy Mildew on field-grown lettuce, potatoes, fruiting vegetables, and cucurbit vegetables.  It is also registered for use on greenhouse-grown tomatoes, lettuce, cucurbits, and peppers.

On Behalf of the Experiment Station of Delaware, IR-4 has submitted a petition (PP#8E7347) proposing a new use for this formulation of propamocarb-HCl on lima beans grown east of the Rocky Mountains for the control of Downy Mildew (Phytophthora phaesoli) and Phythium root rots and seedling diseases (Phythium spp.).  The chemical structure and nomenclature of propamocarb-HCl is listed in Table 1, and the physicochemical properties of technical grade propamocarb-HCl are listed in Table 2. 

Table 1.  Propamocarb Nomenclature.
Compound

Common name
Propamocarb HCl
Company experimental name
AE B066752
IUPAC name
Propyl 3-(dimethylamino) propylcarbamate hydrochloride
CAS name
Propyl 3-[(dimethylamino) propyl]carbamate monohydrochloride
CAS registry number
25606-41-1 (propamocarb-HCl)
24579-73-5 (propamocarb)
End-use product (EP)
6.0 lb/gal FlC (Previcur(R) Flex Fungicide; EPA Reg No. 264-678)

Table 2.  Physicochemical Properties of the Technical Grade Propamocarb-HCl.
Parameter
Value
Reference
Melting range
45-64°C
DP# D267921, J. Tyler, 2/20/04
pH
4.7

Density
1.083 g/mL

Water solubility (20°C)
1005 g/L

Solvent solubility (mg/L 20°C to 25°C)
Dichloromethane > 4.3 x 10[5]
Hexane <100 
Toluene <100
Methanol >7 x 10[5]
Ethyl Acetate 2.3 x 10[4]

Vapor pressure (25°C)
0.87 mPa 

Dissociation constant, pKa
9.29

Octanol/water partition coefficient, log POW (20°C)
-2.6 (pH 4.1)

UV/visible absorption spectrum
Not available

860.1200 Directions for Use

Bayer CropScience currently has a 6 lb/gal FlC formulation of propamocarb-HCl (EPA Reg. No. 264-678) registered for control of fungal diseases on lettuce, potatoes, fruiting vegetables, and cucurbit vegetables.  IR-4 has proposed the use of this formulation for the control of downy mildew and Phythium root rots and seedling diseases on lima beans grown east of the Rocky Mountains.  An example label containing use directions for lima beans was provided, and is summarized below in Table 3.
Table 3.  Summary of Directions for Use of Propamocarb-HCl.
                      Applic. Timing, Type, and Equip.[1]
                                  Formulation
                                [EPA Reg. No.]
                                 Applic. Rate
                                   (lb ai/A)
                          Max. No. Applic. per Season
                          Max. Seasonal Applic. Rate
                                   (lb ai/A)
                                      PHI
                                    (days)
                       Use Directions and Limitations[2]
             Lima beans (For Use East of the Rocky Mountains Only)
Broadcast foliar  applications under favorable disease conditions; ground or aerial equipment
                                6.0 lb/gal FlC
                                   [264-678]
                                      1.5
                                       4
                                      6.0
                                     0[3]
A minimum 7-day RTI is specified.
Apply in a minimum volume of 5 and 15 gal/A using aerial and ground equipment, respectively.
[1]	Applications can also be made by irrigation: transplant watering, dip irrigation or sprinklers.
[2]	The label lists the following rotational crop restrictions:  Do not rotate to root and leafy vegetables for 30 days, and do not rotate to winter wheat or other non-labeled crops for 120 days.
[3]	Do not harvest lima beans within 12 hours of application.  The restricted-entry interval (REI) is also 12 hours.

HED Conclusions.  The submitted use directions are sufficient to allow for evaluation of the submitted residue data relative to the proposed use patterns.  The available field trial data support the proposed use directions for succulent lima beans.

860.1300 Nature of the Residue - Plants

DP# D264293, J. Rowell, 5/3/00

The nature of propamocarb residues in vegetable crops is adequately understood based on the available potato, cucumber, and spinach metabolism studies.  The residue of concern for both risk assessment and tolerance enforcement is propamocarb per se.
 
860.1300 Nature of the Residue - Livestock

DP# D264293, J. Rowell, 5/3/00
DP# D266084, J. Rowell, 5/15/00
DP#D267921, J. Tyler, 3/10/05

The nature of the residues in ruminants is adequately understood based on the acceptable cattle metabolism study, and HED has determined that the residues of concern in ruminants for purposes of risk assessment include parent propamocarb and the metabolites 2-hydroxy propamocarb and propamocarb glucuronide.  No poultry metabolism data are available.  As the proposed use on lima beans does not include any regulated livestock feedstuffs, consideration of residues in livestock is not required for the current petition.

860.1340 Residue Analytical Methods

An adequate GC/NPD method (Analytical Method No. XAM-34) is available for enforcing tolerances on plant commodities.  This method has undergone successful independent laboratory validation (ILV) and petition method validation (PMV) trails (DP# D268955, J. Rowell, 10/3/2000).  The method has been sent to the Food and Drug Administration (FDA) and is currently listed in the Pesticide Analytical Method (PAM) Vol. II for determining residues of propamocarb hydrochloride in plant commodities.  The LOQ for this method is 0.05 ppm.

In the current field trials, propamocarb residues in/on lima bean seeds and foliage were determined using a GC/MSD method that was derived from the above tolerance enforcement method.  For this method, residues were extracted with acidified methanol, filtered, and then concentrated to remove the methanol.  Residues in the resulting aqueous fraction were then acidified and partitioned sequentially against dichloromethane and diisopropyl ether, discarding the organic fractions.  The remaining aqueous fraction was then concentrated to remove any organic solvents and alkalinized by the addition of 10N NaOH.  Residues were then purified using a Chem-Elut column, and analyzed by GC/MSD using external standards.  Residues were determined as propamocarb using the m/z 188 ion for detection and quantitation.  The LLMV was 0.05 ppm for lima bean seeds and 0.1 ppm for foliage.  The statistically calculated LOQs are respectively 0.035 and 0.061 ppm for succulent seeds and foliage, and the calculated LODs are 0.012 and 0.020 ppm.

The method was adequately validated prior to and in conjunction with the analysis of field trial samples.  Although recoveries were high from seeds and foliage samples fortified at their respective LLMVs (126-152%), acceptable recoveries were obtained at fortification levels approximating the residues found in the treated samples.  Apparent residues of propamocarb were <LLMV in/on all control samples of lima beans and all but one control sample of foliage.  The control sample of foliage from the NC trial had apparent residues of propamocarb at 0.41 ppm.

HED Conclusions.  An adequate GC/NPD method is available for enforcing the proposed tolerances, and the field trial data were collected using an adequate GC/MSD method.

860.1360 Multiresidue Methods

DP# D266084, J. Rowell, 5/15/2000

Adequate multiresidue method testing data are available for propamocarb and these data have been forwarded to FDA for evaluation.  Parent compound was not recovered by any of the FDA multiresidue methods.

860.1380 Storage Stability

Adequate data are available indicating that propamocarb is stable at -20[∘]C for at least 785 days (~26 months) in potatoes, cabbage, and tomatoes  (DP# 267921, J. Tyler, 2/20/2004).  Samples of succulent beans and foliage from the current lima bean field trials were stored at <-20°C for up to 16.1 and 17.9 months, respectively, prior to analysis (Table 4). 

Table 4.  Summary of Storage Conditions.  
Matrix 
                           Storage Temperature (°C)
                      Actual Storage Duration (months)[1]
            Interval of Demonstrated Storage Stability (months)[2]
Lima Beans
                                    <-20
                                   3.3-16.1
                                      26
Lima Bean Foliage
                                       
                                    5-17.9
                                       
1 	Interval from harvest to analysis.
[2] 	The storage stability data was based on previously submitted study (DP# 267921, J. Tyler 2/20/2004). 

HED Conclusions.  The available storage stability data adequately support the storage conditions and durations for samples from the lima bean field trials.

860.1480 Meat, Milk, Poultry, and Eggs

As there are no livestock feed items associated with lima beans, residues in livestock commodities are not relevant to the current petition.

860.1500 Crop Field Trials

47593301.der.doc

IR-4 has submitted field trial data supporting the proposed use of propamocarb-HCl (FlC) on succulent lima beans grown east of the Rocky Mountains.  The results from these field trials are discussed below and the residue data are summarized in Table 5.

TABLE 5.  Summary of Residue Data from Lima Bean Field Trials with Propamocarb-HCl (FlC).
Commodity
                              Total Applic. Rate
                                   (lb ai/A)
                                  PHI (days)
                      Propamocarb Residue Levels (ppm)[1]

                                       
                                       
                                       n
                                     Min.
                                     Max.
                                    LAFT[3]
                                    HAFT[3]
                                    Median
                                     Mean
                                   Std. Dev.
Succulent seeds
                                  5.84-11.83
                                       0
                                       5
                                     0.21
                                     1.01
                                     0.21
                                     0.99
                                     0.36
                                     0.51
                                     0.29
Foliage
                                       
                                       
                                       5
                                     29.8
                                     126.8
                                     34.1
                                     120.6
                                     41.4
                                     60.4
                                     35.0
[1]	The validated LLMV was 0.05 ppm for beans and 0.1 ppm for foliage.
[2]	LAFT = lowest-average field trial.
[3]	HAFT = highest-average field trial.

IR-4 submitted field trial data for propamocarb on lima beans from 5 trials conducted in North American Free Trade Agreement (NAFTA) Growing Zones 2 (4 trials) and 5 (1 trials) during the 2005 and 2006 growing seasons.  In each trial, a 6 lb/gal FlC formulation of propamocarb-HCl was applied as repeated broadcast foliar applications during bean pod set and development at rates of 1.44-1.55 lb ai/A/application and RTIs of 6-8 days.  A total of four applications were made in three of the trials, for a total rate of 5.84-6.05 lb ai/A (1X), and a fifth application was required at one site to allow the crop to mature, for a total rate of 7.42 lb ai/A.  At one site (NC trial), seed development failed to occur during the initial four foliar applications; therefore, four additional applications were made until mature seeds were available, for a total rate of 11.83 lb ai/A (2X).  All applications in each trial were made using ground equipment in volumes of 30-78 gallons/A (GPA), and no adjuvants were used for any applications.

Duplicate control and treated samples of succulent seeds and foliage were collected from each trial on the day of the final application [0 DAT], and samples were stored at <=-20°C for up to 17.9 months prior to analysis.  Adequate storage stability data are available to support the duration and conditions of sample storage.

Residues of propamocarb in/on lima bean seeds and foliage were determined using an adequate GC/MSD method.  For this method, residues were extracted with acidic methanol, filtered, and concentrated.  Residues in the resulting aqueous fraction were then cleaned up by solvent partitioning and elution through a Chem-Elut column.  Residues were determined as propamocarb by GC/MSD using external standards.  The LLMV was 0.05 ppm for lima bean seeds and 0.1 ppm for foliage.  The statistically calculated LOQs are 0.035 and 0.061 ppm for succulent seeds and foliage, respectively, and the calculated LODs are 0.012 and 0.020 ppm, respectively.

Following 4 or 5 broadcast foliar applications totaling 5.84-7.42 lb ai/A, residues of propamocarb were 0.21-0.65 ppm in/on 8 samples of succulent seeds and 29.88-126.88 ppm in/on 8 samples of foliage harvested at 0 DAT.  In the NC field trial in which propamocarb-HCl was applied as 8 applications totaling 11.83 lb ai/A, residues of propamocarb were 0.971 and 1.01 ppm in/on succulent seeds and 38.69 and 36.04 ppm in/on foliage.  Following 4 or 5 foliar applications of propamocarb-HCl, average residues of propamocarb were 0.39 ppm in/on succulent seeds and 66.1 ppm in/on foliage.  Overall, the HAFT residues were 0.99 ppm for seeds and 120.6 ppm for foliage.  No residue-decline data were submitted.

HED Conclusions:  The results of the field trials are adequate to support the proposed use on lima beans.  Although eight field trials are typically required to support a use on lima beans, only five field trials (1 trial in Zone 5 and 4 trials in Zone 2) are required to support a use on lima beans restricted to east of the Rocky Mountains.  Therefore, the geographic representation of the four acceptable trials is adequate (see Table 6).

Table 6.  Trial Numbers and Geographical Locations.
NAFTA Growing Zones
                                  Lima Beans

                                   Submitted
                                   Requested
2
                                       4
                                       4
5
                                       1
                                       1
10
                                      --
                                       2
11
                                      --
                                       1
Total
                                       5
                                   8 (5)[1]
[1]	The total number of trials required was determined by multiplying the total number of trials needed for a national registration (8) for lima beans by the % of the crop grown east of the Rocky Mountains (58%), and rounding up to the nearest whole number.

The residue data for lima beans were analyzed using the OECD tolerance calculation procedures (see Appendix II).  Data from the NC field trial, in which propamocarb-HCl was applied as 8 applications totaling 11.83 lb ai/A (2X), was also included as the per-application rate was 1X; thus, the additional applications occurred >28 days prior to harvest.  The recommended tolerance is as follows:

Tolerances are established for residues of propamocarb, including its metabolites and degradates, in or on the commodities listed below resulting from the application of the hydrochloride salt of propamocarb.  Compliance with the following tolerance levels is to be determined by measuring only propamocarb (propyl N-[3-(dimethylamino)propyl]carbamate).

	Bean, lima, succulent							2.0 ppm

Although residue data on foliage were provided in the lima bean field trials, HED notes that lima bean foliage is not a regulated livestock feedstuff.  Therefore, a tolerance and residue data on lima bean foliage is not required.

860.1520 Processed Food and Feed

As there are no regulated processed commodities associated with lima beans, data requirements for processed food and feed are not relevant to this tolerance petition.

860.1650 Submittal of Analytical Reference Standards

An analytical standard for propamocarb is not currently available in the EPA National Pesticide Standards Repository (personal communication with T. Cole, ACB, 9/5/12).  An analytical reference standard of propamocarb should be supplied and replenished as requested by the Repository.  The reference standard should be sent to the Analytical Chemistry Lab, which is located at Fort Meade, to the attention of Theresa Cole at the following address:

	USEPA
	National Pesticide Standards Repository/Analytical Chemistry Branch/OPP
	701 Mapes Road
	Fort George G. Meade, MD  20755-5350

(Note that the mail will be returned if the extended zip code is not used.)

860.1850/1900 Confined and Field Accumulation in Rotational Crops

DP# D264293, J. Rowell, 5/3/2000
DP# D267921, J. Rowell, 5/15/2000

Adequate confined and field rotational crop studies are available.  Based on the confined rotational crop study, HED has concluded that the residues of the concern for purposes of risk assessment are parent propamocarb and the metabolites 2-hydroxy propamocarb and oxazolidine.  The available field rotational crop trials, which were conducted using a total rate of 6.0 lb ai/A (1x rate), indicated that tolerances are not required for rotational crops provided that the labels specify PBIs of 30 days for root and leafy vegetables and 120 days PBI for winter wheat and all other crops.  As these are the rotational crop restrictions currently on the label for the 6 lb/gal FlC formulation, no additional rotational crop data are required for purposes of this petition.

860.1550 Proposed Tolerances

For purposes of the tolerance expression, HED has determined that the residue of concern is propamocarb per se for plant and livestock commodities (DP# 264293, J. Rowell, 5/3/00).  Permanent tolerances have been established for residues of propamocarb in/on a variety of vegetables, at levels ranging from 0.06 ppm in/on potatoes to 90 ppm in/on leaf lettuce [40 CFR §180.499 (a)].  The tolerance being proposed by IR-4 for the current petition is listed in Table 6, along with the HED's recommended tolerance.  As the proposed use is geographically restricted, the tolerance on lima bean should be established under 40 CFR §180.499(c).

Data from the field trials are adequate to support the establishment of a permanent tolerance.  
The residue data for lima beans were analyzed using the OECD tolerance calculation procedures (see Appendix II).  The recommended tolerance for residues of propamocarb is 2.0 ppm for beans, lima, succulent.  Although residue data were also submitted for foliage, the foliage of lima beans is not a regulated livestock feedstuff; therefore, tolerances will not be established on lima bean foliage.

There are currently no established Codex, Canadian, or Mexican MRLs for propamocarb on lima beans.  An International Residue Limit Status Sheet is attached in Appendix I.
Table 7.  Tolerance Summary for Propamocarb.
Commodity
                           Proposed Tolerance (ppm)
                          Recommended Tolerance (ppm)
Comments;
 Correct Commodity Definition
                            40 CFR §180.499(c) [1]
Bean, lima, succulent
                                      2.0
                                      2.0

[1]	As the proposed tolerance is geographically restricted to regions east of the Rocky Mountains, the tolerance should be listed under 40 CFR §180.499(c).

References

DP Number:	D264293
Subject:	Propamocarb HCl.  Results of the Health Effects Division (HED) Metabolism Assessment Review Committee (MARC) Meeting of 4/6/00. 
From:		J. Rowell
To:		G. Kramer
Dated:		5/3/2000
MRID(s):	None

DP Number:	D266084
Subject:	PP# 6F4707.  Propamocarb Hydrochloride in/on Potatoes and Livestock Commodities.  Review of Amendment Submitted in Response to HED's Memo of 10/17/96. 
From:		J. Rowell
To:		W. Waller/T. Ellwanger
Dated:		5/15/2000
MRID(s):	44653701, 44653702, 44653703, 44653704, 44653705, 44704201, 44743701, 44847301, and 44847302

DP Number:	D268955
Subject:	 PP# 6F04707.  Propamocarb Hydrochloride in or on Potatoes and Tomatoes.  Results of Petition Method Validation (PMV) Request.  
From:		J. Rowell
To:		M. Waller/T. Ellwanger
Dated:		10/03/2000
MRID(s):	44653707

DP Number:	D267921
Subject:	Propamocarb Hydrochloride.  Section 3 Request for use on Fruiting Vegetables, Cucurbit Vegetables, and Lettuce.
From:		J. Tyler
To:		L. Jones/M. Waller
Dated:		2/20/2004
MRID(s):	450908-01; 450908-03 thru -09; 457060-01 thru -07; 457482-01 thru 02

Attachments
 
Appendix I - International Residue Limit Status sheet
Appendix II-Tolerance Assessment Calculations

cc: J. Tyler, G. Kramer
RDI: RAB1 Chemists (9/12/12); G. Kramer (9/12/12)
J. Tyler: S-10943: Potomac Yard 1 (PY1): (703) 305-5564: 7509P: RAB1

Template Version April 2008
Appendix I.	International Residue Limit Status Sheet

               Propamocarb (119302; Date of Request: 08/29/2012)
Summary of US and International Tolerances and Maximum Residue Limits 
Residue Definition:
US
Canada
Mexico[2]
Codex[3]
40 CFR §180.499:
propyl[3-(dimethylamino)propyl]carbamate monohydrochloride also known as propamocarb hydrochloride
propyl [3-(dimethylamino)propyl]carbamate
hydrochloride

Propamocarb
Commodity[1]
Tolerance (ppm)/Maximum Residue Limit (mg/kg)

                                      US
                                    Canada
                                   Mexico[2]
                                   Codex[3]
Lima, bean, succulent
                                      2.0

                                       

                                       

                                       

                                       

                                       

                                       

                                       

Completed: M Negussie; 09/04/2012
[1] Includes only commodities of interest for this action.  Tolerance values should be the HED recommendations and not those proposed by the applicant.
2 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.
3 * = 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.

Appendix II.	Tolerance Assessment Calculations.

                               Residues (mg/kg)
                                       n
                                     0.21
                                       1
                                     0.35
                                       1
                                     0.36
                                       1
                                     0.64
                                       1
                                     0.99
                                       1

                                   Compound
                                     Crop
                               Region / Country
                                      GAP
 
 
Total number of data (n)
                                       5
Percentage of censored data
                                      0%
Number of non-censored data
                                       5
Lowest residue
                                     0.210
Highest residue
                                     0.990
Median residue
                                     0.360
Mean
                                     0.510
Standard deviation (SD)
                                     0.310
Correction factor for censoring (CF)
                                     1.000
 
                                       
Proposed MRL estimate
 
 
                                       
- Highest residue
                                     0.990
- Mean + 4 SD
                                     1.752
- CF x 3 Mean
                                     1.530
Unrounded MRL
                                     1.752
 
                                       
Rounded MRL
                                       2
 
                                       
 High uncertainty of MRL estimate.
[Small dataset]