Page 1 of 12 **UNITED STA TES ENVIRONMENTA**  **L PROTECTION A GENCY** 

**WA SHINGTON, 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 Li ma Beans (Succulent) . Summary of Analy tical Chemistry

and Residue Data. **PC Code:** 119302 (propamocarb
- HCl)

119301 (propamocarb) **DP Barcode:** D 359104 **Decision No. :**  402658 **Registration No. :**  264
- 678 **Petition No.:** 8E7473 **Regulatory Action:** Section 3 Registration **Risk Assessment Type:** NA **Case No.:** 3124 **T XR 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 s ynthesis of phospholipids and fatty acids. Bayer CropScience currentl y 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.Propamocarb
- HCl Summary of Analytical Chemistry and Residue Data DP#: 359104

Page 2 of 12 P reharvest intervals (PHIs) range from 0
- 14 day s . Permanent tolerances have been established for resi dues 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 peti tion proposing the use of the above 6 lb/gal FlC formulation of propamocarb
- HCl on succulent lima beans grown e ast 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 re treatment interval (RTI ), for a maximum of 6.0 lb ai/A/season . The minimum PHIis 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 follo wing permanent tolerance with a geographical restriction for residues of propamocarb
- HC l :

Bean, lima, succulent
................................ ................... 2.0 ppm The nature of propamocarb residues in vegetable crops is adequatel y 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, anal ytical 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 dete ction (GC/NPD) method (Anal ytical Method No. XAM
- 3 4 ) is available for enforcing propamocarb tolerances on plant commodities
. The limit of quantitation (LOQ) for th e enforcement method is 0.05 ppm. In the current l ima 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 b y solvent partitioning , and elution through a Chem
Elut column. Residues were determined as propamocarb b y 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 cal culated LOQs are 0 .035 and 0.061 ppm for succulent seeds and foliage, respectivel y, and the calculated limits of detection (LODs) are 0.012 and 0.020 ppm. The method was adequately validate d in conjunction with the anal ys is 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 samp les 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 f or foliage. No residue
- decline data were submitted.Propamocarb
- HCl Summary of Analytical Chemistry and Residue Data DP#: 359104

Page 3 of 12 Although eight field trials are typicall y 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] ar e 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 anal yz ed 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 anal ytical reference standard for propamocarb to the EPA National Pes ticide 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 assessm ent 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 de gradates of fenp yroximate not specifically mentioned; (2) clarify that compliance with the specified tolerance levels is to be determined b y 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. Compli ance with the following tolerance levels is to be determined b y measuring onl y propamocarb (propyl N
- [3
- (dimethylamino)prop yl ]carbamate)." **Background** Propamocarb
- HCl is a carbamate fungicide that acts by interfering with fungal s ynthesis of phospholipids and fatty

acids. A 6 lb/gal FlC formulation of propamocarb
- HCl (Previcur ® Flex; EPA Reg. No. 264
- 678) is currentl y registered to Bayer CropScience for the control of diseases such as late blight ( Phytop h thora infes tans ), earl y blight ( Alternaria solani), P hy tophthora fruit rot, and D owny M ildew on field
- grown lettuce, potatoes, fruiting vegetables , and cucurbit vegetables. It is also registered for use on greenhouse
- grown tomatoes, lettuce, cucurbits , and peppers.Propamocarb
- HCl Summary of Analytical Chemistry and Residue Data DP#: 359104

Page 4 of 12 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 e ast of the Rocky Mountains for the control of Downy Mildew ( Phytophthora phaesoli) and Phy thium root rots and seedling diseases ( Phythium spp. ). The chemical structure and nomenclature of propamocarb
- HCl is listed in Tabl e 1, and the physicochemical properties of technical grade propamocarb
- HCl are listed in Table 2. **T able**  **1. Propam**  **ocarb 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 (P revicur® Flex Fungicide; EPA Reg No. 264
- 678) **T able**  **2. Physicochemical Properties of the Technical Grade Propam**  **ocarb -**  **HCl .**  Parameter Value Reference Melting range 45
- 64°C DP# D 267921 , J. Tyler, 2/20/04 pH 4.7 Density 1.083 g/mL Water solubility (20°C) 1 005 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 (2 5 °C) 0.87 mPa Dissociation constant, pKa 9.29 Octanol/water partition coefficient, log P OW (20°C) - 2.6 (pH 4.1 ) UV/visible absorption spectrum Not available **860.1200 Directions for Use** Baye r 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 m ildew and Phy

thium 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. N C H 3 N

H O C H 3 C H 3 O Cl HPropamocarb
- HCl Summary of Analytical Chemistry and Residue Data DP#: 359104

Page 5 of 12 **Table 3. Summary of Directions for Use of Propamocarb**  **- HC**  **l. Applic. Tim** **ing, Type, and Equip.**  **1 Formulation** 

**[EPA Reg. No.] Applic.** 

**Rate (lb ai/A)**  **Ma x.**  **No.**

**Applic. per Season**  **Ma x.**  **Seasonal**

**Applic. Rate (lb ai/A)**  **PHI**

**(days) Use Directions and** 

**Lim itations**  **2 Lim**  **a 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 grou

n d 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 th e Residue**  **- Plants**  DP# D 264293, J. Rowell, 5/3/00 The nature of propamocarb residues in vegetable crops is adequatel y 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# D 264293, J. Rowell, 5/3/00 DP# D 266084, 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 ri sk assessment include parent propamocarb and the metabolites 2
- hydrox y 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 (Anal ytical Method No. XAM
- 3 4 ) 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, 10/3/20 00). The method has been sent to the Food and Drug Administration (FDA) and is currentl y listed in the Pesticide Anal ytical Method ( PAM ) Vol. II for determining residues of propamocarb hydrochloride in plant commodities . The L OQ 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 enforcementPropamocarb
- HCl Summary of Analytical Chemistry and Residue Data DP#: 359104

Page 6 of 12 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 anal yz ed b y 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 fo r foliage. The statisticall y calculated LOQ s are respectivel y 0.035 and 0.061 ppm for succulent seeds and foliage, and the calculated LOD s are 0.012 and 0.020 ppm. The method was adequately validated prior to and in conjunction with the an aly sis 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 res idues of propamocarb were <LLMV in/on all control sample s 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 meth od 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# D 26 6084 , J. Rowell, 5/15/2000 Adequate multiresidue m ethod t esting 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 st abl e at - 20 ∘ C for at least 785 day s (~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 , respectivel y, prior to anal ys is (Table 4). **T able**  **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 adequate ly support the storage conditions and durations for samples from the lima bean field trials.Propamocarb
- HCl Summary of Analytical Chemistry and Residue Data DP#: 359104

Page 7 of 12 **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 Propam**  **ocarb -**  **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 2 005 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 day s. A total o f 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 fail ed 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 volume s 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 propamo carb b y GC/MSD using external standards. The LLMV was 0.05 ppm for lima bean seeds and 0.1 ppm for foliage. The statisticall y calculated LOQs are 0.035 and 0.061 ppm for succulent seeds and foliage, respectivel y, and the calculated LODs are 0.012 and 0.0 20 ppm, respectivel y.Propamocarb
- HCl Summary of Analytical Chemistry and Residue Data DP#: 359104

Page 8 of 12 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. Inthe 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
- HC l, 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, onl y 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 **Lim a 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 registrati on (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 anal yz ed 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 (prop yl 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.Propamocarb
- HCl Summary of Analytical Chemistry and Residue Data DP#: 359104

Page 9 of 12 **860.1650 Submittal of Analytical Reference Standards** An anal ytical standard for propamocarb is not currently available in the EPA National Pesticide Standards Repository

(pe rsonal communication with T. Cole, ACB, 9/5/12 ). An anal ytical reference standard of propamocarb should be supplied and replenished as requested by the Repository . The reference standard should be sent to the Analy tical Chemistry

L ab, 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# D 267921, J. Rowell , 5 / 15 /200 0 A dequate confined and field rotational crop studies are available . Based on the confine d rotational crop study, HED has concluded that the residues of the concern f or purposes of risk assessment are parent propamocarb and the metabolites 2
- hydrox y 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 lab els specify

PBIs of 30 day s for root and leafy vegetables and 120 day s 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 b y I R
- 4 for the current petition is listed in Table 6, along with the HED’s recommended tolerance. As the proposed use is geographicall y restricted, the tolerance on lima bean should be established under 40 CFR §180.499(c). D ata from the field trials are ade quate to support the establishment of a permanent tolerance. The residue data for lima beans were anal yz ed using the OECD tolerance calculation procedures (see Appendix II). The recommended tolerance for residues of propamocarb is 2.0 ppm for beans, lim a, 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 MRL s for propamocarb on lima beans. An International Residue Limit Status Sheet is attached in Appendix I
.Propamocarb
- HCl Summary of Analytical Chemistry and Residue Data DP#: 359104

Page 10 of 12 **Table 7 .**  **Tolerance Summary for Propam ocarb.**  Commodity Proposed Tolerance (ppm) Recommended

Tolerance (ppm) Comments;

Correct Commodity Definition **40 CFR §180.499(c)** 1 Bean, lima, s ucculent 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 To matoes. 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 Fr uiting 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

c c: 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 Ap ril 2008Propamocarb
- HCl Summary of Analytical Chemistry and Residue Data DP#: 359104

Page 11 of 12 **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 mo nohydrochloride also known as propamocarb hydrochloride propyl [3
- (dimethylamino)propyl]carbama te 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 In cludes only commodities of interest for this action. Tolerance values should be the HED recommendations and not those prop osed 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 treat ed 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.Propamocarb
- HCl Summary of Analytical Chemistry and Residue Data DP#: 359104

Page 12 of 12 **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]