### Page 1 of 29 **UNITED STA TES ENVIRONMENTA**  **L PROTECTION A GENCY**  WA SHINGTON, D.C. 20460 **OFFICE OF CHEMICAL SAFETY AND**

**POLLUTION PREVENTION** 

### MEMORANDUM Date: 10 - JU L - 201 4 Subject: **Metaldehyde .**  Section 3 Registration for New Uses on Vegetable, Legume,

E dible P odded [ S ubgroup 6A], Pea and B ean, S ucculent S helled [ S ubgroup 6B], Vegetable, Foliage of Legume, Except Soy bean [ S ubgroup 7A], Clover F orage and H ay , and Ginseng ; and for Amendments to Existing Tolerances for Tomato [ S ubgroup 8 - 10A], and Citrus Fruit [ Group 10 - 10]. Summary of Anal ytical Chemistry

and Residue Data . **PC Code:** 0 53001 **DP Barcode:** D418047 **Decision No.:** 486426 **Registration No. :**  NA **Petition No.:** 3E8223 **Regulatory Action:** Section 3 Registration **Risk Assessment Type:** NA **Case No.:** NA **T XR No.:**  NA **CAS No.:** 108 - 62 - 3 **MRID Nos.:** 

### See MRID table below **40 CFR:** 

### § 180. 523 

### FROM: Austin Doh, Chemist

Risk Assessment Branch (RAB ) V/VII Health Effects Division (HED) (7509P) THROUGH: William H. Donovan, Ph.D., Chemist

Michael S. Metzger, Branch Chief RAB V/VII , HED (7509P) TO: Laura Nollen/Barbara Madden, RM 0 5

Risk Integration, Minor Use, Emergency Response Branch Registration Divisi on (7505P) **Table A. MRID Summary Table For Me** **taldehyde MRID No.**  **Study Type Comments**  49277201 860.15 0 0 edible podded pea and bean field trials 49277201 .der.docx 49277203 860.1500 succulent shelled pea field trials 49277203 .der .docx 49277204 860.150 0 clover field trials 49277204 .der .docx 49277205 860.1500 ginseng field trials 49277205 .der.docx 49299501 860.150 0 succulent shelled bean field trials 49299501. der.docxMetaldehyde Summary of Analytical Chemistry and Residue Data D 418047



### Page 2 of 29 **1.0 Executive Summary**  The Interregional Research Project Number 4 (IR- 4) has submitted a petition for establishing a tolerance for metaldehyde in or on vegetable, legume, edible podded (subgroup 6A) , p ea and bean, succulent shelled (subgroup 6B), vegetable, foliage of legume, except soy bean, (subgroup 7A), clover hay , clover forage, and ginseng ; and for replacing the existing tolerances for tomato with tomato subgroup 8 - 10A , and replacing citrus , fruit group 10 with fruit, citrus, group 10 - 10 . For c lover grown for seed , a regio nal registration (P acific NW) was requested while national registrations are intended for the other requested crops. Adequate residue chemistry data have been provided to support the new use requests for metaldehyde . The nature of the residue in plants is adequatel y understood for the purposes of this petition based on previou sly submitted metabolism studies . Livestock metabolism and feeding studies have been waived. Field trials are of adequate number and geographic representation. Crop field trial data analyses employed validated and sufficientl y sensitive anal ytical methods that determine the residue of concern, and are supported by adequate storage stability data. No processed commodities are associated with the new uses proposed in the current petition. A previously- submitted field rotational crop study indicates that a plant back interval (PBI) of 30 days is appropriate for all rotated crops not listed on the label. **2.0 R** **egulatory R ecommendations**  The residue chemistry

database is adequate for the new use requests for metaldehyde , and there are no residue chemistry

considerations that would preclude establishment of the re commended tolerances . **2.1 Data Deficiencies/Data Needs**  There are no residue chemistry deficiencies identified for this petition. **2.2 Tolerance Considerations**  **2.2.1 Enforcement**  **Analytical Method** EN - CAS TM Method No. ENC - 3/99, Revision 1 (a gas chromatography/mass spectrometry ( GC/MS ) method) is acceptable for tolerance enforcement of metaldehyde residues in plants. For this method, residues in homogenized pl ant matrices are extracted with dichloromethane (DCM) , filtered through sodium sulfate, concentrated with rotary evaporation , then brought back up to volume with DCM before anal ysis with GC/MS . The limit of quantitation (LOQ) for metaldehyde in/on plant commodities is 0.05 ppm. An adequate enforcement method is available to enforce recommended tolerances for the proposed new uses of metaldehyde.Metaldehyde Summary of Analytical Chemistry and Residue Data D 418047



### Page 3 of 29 **2.2.2 Recommended Tolerances**  HED has examined the residue chemistry database for metaldehyde . Pending submission of revised Section s B (see Section 2.3 ) and F (see requirements under Proposed Tolerances) there are no residue chemistry

issues that would preclude the establishment of tolerances for residues of m etaldehyde in/on the requested crops and crop sub groups . The tolerance expression for metaldehyde [40 CFR § 180.523(a)] appropriately read s as follows: Tolerances are established for residues of the molluscicide metaldehyd e , its metabolites and degradates , in or on the commodities listed in the following table . Compliance with the specified tolerance levels is to be determined by measuring only metaldehyde, 2 ,4,6,8 - tetramethyl - 1,3,5,7 - tetrox ocane , in or on the commodity . **Table 2**  **. 2.2**  **a Tolerance Summary f**  **or M**  **etaldehyde , §180.523(a)**  **.** Commodity Proposed Tolerance (ppm) Recommended

Tolerance (ppm) Comments; Correct Commodity

Definition Vegetable, legume, edible podded, subgroup 6A 0.8 0 0.8 0 Pea and bean, succulent shelled, subgroup 6B 0.2 0 0.2 0 Vegetable, foliage of legume, except soybean, subgroup 7A 1.5 0 1.5 0 Tomato subgroup 8 - 10A 0.24 0.24 Fruit, citrus, group 10 - 10 0.26 0.26 Ginseng 0.05 0.05 

### Note to RD: Upon establishment of the recommended subgroup 8 - 10A and group 10 - 10 tolerances, the existing tomato and group 10 tolerance listings should be deleted. Further, 40 CFR § 180.523(c) should read as follows:

“ Tolerances with a regional registration as defined in 180.1(l) are established for residues of the mollusc icide metaldehyde , includin g its metabolites and degradates , in or on the commodities listed below. Comp liance with the tolerance level specified below is to be determined b y measuring only metaldehyd e, 2 ,4,6,8 - tetramethyl - 1,3,5,7 - tetrox ocane , in or on the comm odity . **Table 2**  **. 2.2c**  **Tolerance Summary for M**  **etaldehyde , §180.523(c)**  **.** Commodity Proposed Tolerance (ppm) Recommended

Tolerance (ppm) Comments; Correct Commodity

Definition Clover, forage 0 .5 0. 6 0 Pacific Northwest Clover, hay 0.5 0. 6 0 Pacific NorthwestMetaldehyde Summary of Analytical Chemistry and Residue Data D 418047



### Page 4 of 29 **2.2.3 Revisions to Petitioned**  **- For Tolerances**  HED recommend s tolerance s of 0.6 0 ppm for clover hay and forage because of the determination that only three independent clover trials were conducted instead of the four trials assumed by the petitioner. Use of the OECD tolerance calculation procedures with three residue values each for clover hay

and forage results in suggested tolerances of 0.60 ppm for both commodities. **2.2.4 International Harmonization**  As there are no CODEX or Canadian MRLs established for metaldehyde, no international harmonization issues are expected to arise from establishment of the recommended tolerances (see Appendix B) . **2.3 Label Recommendations**  The proposed labels should contain the following restriction: A 30 - day plant back interval (PBI) is appropriate for rotational crops. Labeled crops may be replanted immediatel y. All other metaldehyde labels should be amended in registration review to contain the aforementioned restriction. **3.0 Introduction**  **3.1 Chemical**  **Identity TABLE 3.1.**  **Nom enclature of Metaldehyde.**  Compound Chemical Structure

Common name Metaldehyde Company experimental names Not applicable IUPAC name r- 2, c - 4, c - 6, c - 8 - tetramethyl - 1,3,5,7 - tetroxocane (or) 2,4,6,8 - tetramethyl - 1,3,5,7 - tetraoxacyclo - octane CAS name 2,4,6,8 - tetramethyl - 1,3,5,7 - tetroxocane CAS # 108 - 62 - 3 (tetramer) and 9002 - 91 - 9 (homopolymer) End -use products/EP 7.5% G (Durham Metaldehyde Granules; EPA Reg No. 5481 - 103); 4% P/T (Deadline MPs Mini - Pe llets; EPA Reg. No. 5481 - 511); and 4% RTU/L (Deadline Force II; EPA Reg. No. 8119 - 6)

O O O O C H 3 C H 3

C H 3 C H 3Metaldehyde Summary of Analytical Chemistry and Residue Data D 418047



### Page 5 of 29 **3.2 Physical/Chemical Characteristics**  P hysiochemical properti es for metaldehyde are shown in Table 3.2. **TABLE 3 .2.**  **Physicochemical Properties of Metaldehyde.**  Parameter Value Reference Melting point/range 246 °C Metaldehyde RED, PC Chapter pH Not applicable due to the low solubility of metaldehyde in water. - Density 1.27 g/cm3

Metaldehyde RED, PC Chapter Water solubility (20°C) 0.222 g/L at 20 °C Solvent solubility (g/L at 20.3 - 22.4°C) 5.21 x 10 - 2 in hexane 0.53 in toluene 1.56 in tetrahydrofuran 1.73 in methanol Vapor pressure 1 mm Hg at 20 °C 6.6 ± 0.3 Pa at 25 °C Dissociation constant (pKa) 3.5 Pa (m3 /mol) (Henry’s Law Constant) Octanol/water partition coefficient, Log (Kow) 1.33 (log P OW = 0.12) at 20 °C 

### 3.3 **Pesticide Use Pattern/ Directions for Use**  **(860.1200) Table 3.3. Summ**  **ary of Directions for Use of Metaldehyde Granular Formulation**  **Application Timing, Type,**  **and Equip. Form** **ulation**

**[EPA Reg. No.]**  **Applicat**

**ion Rate (lb ai/A)**  **Max. No.**

**Application per Season**  **Max.**

**Seasonal Application**  **Rate (lb ai/A)**  **PHI (days) Use Directions and**  **Limitations Vegetable,**  **legum e, edible podded (Subgroup 6A)**  Broadcast (ground & handheld equipment) 71096 - 13 1. 0 3 3 Pre -b loom RTI = 7 days **Pea and Bean, succulent shelled (Subgroup 6B)** Broadcast (ground & handheld equipment) 71096 - 13 1.0 3 3 Pre -bloom RTI = 7 days

**Vegetable, foliage of legum**  **e, except soybean (Subgroup 7A)** Broadcast (ground & handheld equipment) 71096 - 13 1.0 3 3 1 RTI = 7 days **Clover, forage** ***** Broadcast (ground & handheld equipment) 71096 - 13 0.8 2 1.6 30 RTI = 10 days **Clover, hay** *****Metaldehyde Summary of Analytical Chemistry and Residue Data D 418047



### Page 6 of 29 **Table 3.3. Summ ary of Directions for Use of**  **Metaldehyde Granular Formulation Application**  **Timing, Type, and Equip.**  **Form ulation** 

**[EPA Reg. No.]**  **Applicat**

**ion Rate (lb ai/A)**  **Max. No.**

**Application per Season**  **Max.**

**Seasonal Application**  **Rate (lb ai/A)**  **PHI (days) Use Directions and**  **Limitations** Broadcast (ground & handheld equipment) 71096 - 13 0 .8 2 1.6 30 RTI = 10 days **Ginseng** Broadcast (ground & handheld equipment) 71096 - 13 1.0 6 6 21 RTI = 21 days * For use in the following states: Oregon, Idaho, and Washington 

### The use directions are adequate to allow evaluation of the residue data relative to the proposed uses. The proposed maximum application rates , RTI s, and PHI s are supported by the submitted field trial data. Refer to section 2.3 for recommended modifications to the proposed labels. **4.0 Metabol** **ite/Degradate Residue Profile 4.1**  **Nature of the Residue 4.1.1**  **Summary of Plant Metabolism (860.1300)** Residue Chemistry Chapter of the RED; DP No. D311889 , 05 - MAY - 20 0 5 , F. Fort 

### The qualitative nature of metaldehyde residues in plants is understood based on the adequate lettuce and sugar beet metabolism studies (DP Barcode D224844, S. Hummel, 7/02/96). The HED Metabolism Committee concluded that the regulated residue of concern in plants is parent metaldehyde, per se . In the lettuce metabolism study , radioactive residues were taken up and translocated to leaves following a single directed application of [ 14 

### C]metaldehyde to the so il at a rate equivalent to 13.8 lb ai/A (10x). The maximum total radioactive residues (TRR) were 4.43 ppm and 3.78 ppm in the inner and outer lettuce leaves, respectively , with a PHIof 28 days. Up to 95.3% of TRR was identified as the parent metaldehyde. In the sugar beet metabolism study, a single directed application of [ 14 

### C]metaldehyde was made to the soil at a rate equivalent to 13.8 lb ai/A (10x). The TRR were 1.65 - 5.60 ppm in/on sugar beet foliage and 0.30 - 1.13 ppm in/on sugar beet root (PHI= 48days), indicating uptake and translocation to foliage. Metaldehyde was the only radioactive residue identified in the organic fractions of foliage (~33% TRR, 1.84 ppm) and root (~35% TRR, 0.39 ppm). Although no anal ytical anal ys es of the nonextractable residues of foliage (43.2% TRR, 2.42 ppm) and root (43.4% TRR, 0.49 ppm) were conducted, overall the plant metabolism data for metaldehyd e support the HED Metabolism Committee's decision to regulate onl y the parent in the tolerance expression for plant commodities.Metaldehyde Summary of Analytical Chemistry and Residue Data D 418047



### Page 7 of 29 **4.1.2 Summary of Livestock Metabolism**  **(860.1300)** Residue Chemistry Chapter of the RED ; DP No. D 311889 , 05 - MAY - 20 0 5 , F. Fort 

### Based upon the rapid degradation of metaldehyde to acetaldehyd e in mammalian systems and the subsequent incorporation of acetaldehyde into the tricarboxyl ic acid cycle, the Agency has concluded that the transfer of metaldehyde residues in livestock commodities is unlikely. Therefore, the requirements for livestock metabolism and f eeding studies have been waived (Grey beard Committee: Metaldehyde, 3/11/97). **4.1.3 Summary of**  **Confined Rotational Crops (860.1**  **850)** D 298113, T. Jimerson, 15 - FEB - 2005 

### On December 9, 2004, the Chemistry Science Advisory

Council (ChemSAC) granted a waiver for OPPTS Guideline 860.1850, Confined Accumulation in Rotational Crops for the chemical metaldehyde, provided that a field accumulation in rotational crop study is cond ucted. The rationale was that because of its chemical structure (a tetramer of acetaldehyde), the primary metabolite would be acetaldehyde, a chemical whose metabolism in plants and animals is well documented. Also, because it is likely that total radioactive residues (TRR) greater than 0.01 ppm would be found in a confined rotational crop study , a field accumulation in rotational crop study was requested , submitted, and reviewed (see Section 5.3.2) . **4 .2**  **Residues of Concern Summary and Rationale** The qualitative nature of metaldehyde residues in plants is understood based on lettuce and sugar beet metabolism studies. The HED Metabolism Committee (7/2/96) concluded that the regulated residue of concern in plants is parent metaldehyde. This conclusion w as confirmed in the Metaldehyde Reregistration Eligibility Decision (RED) document (D327385, M. Lloyd et. al., April 3, 2006). Table 4.2 summarizes the metaldehyde residues of concern for the tolerance expression and for risk assessment in the matrices indicated. **Table 4.2. Summary of Metabolites and Degradates to be included in the Risk Assessment and Tolerance Expression**  Matrix Residues included in Risk Assessment Residues included in Tolerance Expression Plants Primary Crop Metaldehyde Metaldehyde

Rotational Crop Metaldehyde Metaldehyde Livestock Not Applicable Not Applicable Drinking Water Metaldehyde Not ApplicableMetaldehyde Summary of Analytical Chemistry and Residue Data D 418047



### Page 8 of 29 **5.0 Residue Profile**  **5.1 Residue Analytical Methods (860.1340)**  **5.1 .1**  **Data Collection Methods** IR- 4 made use of the existing metaldehyde enforcement method for data collection purposes. The method, entitled “Analy tical Residue Method for the Determination of Metaldehyde in Crops by GC/MS” (EN - CAS TM Method No. ENC - 3/99, Revision 1), has been used for the determination of metaldehyde in a wide variety of crop matrices . The method description, method validation data, and an independent laboratory (ILV) validation of the method were reviewed in support of the metaldehyde RED. For this method, residues in homogenized plant matrices are extracted with dichloromethane (DCM), filtered through sodium sulfate, concentrated with a TurboVap evaporation apparatus , then brought back up to volume with DCM before anal ys is. Samples were anal yz ed b y GC/MS using the m/z 89 and 45 ions for quantitation and confirmation, respectively. Clover hay samples were allowed to soak in water prior to extraction. The limit of quantitation (LOQ) for metaldehyde in/on plant commodities is 0.05 ppm. Metho d validation data for the GC/MS method demonstrated adequate method recoveries from plant commodities (bean, pea, clover, and ginseng ) fortified with metaldehyde at 0.05 - 5 .0 ppm. Recoveries were within the acceptable 70 - 120% range and had standard deviati ons of < 20% . **5.1.2 Multi** **- Residue Methods (860.1360)**  D315914, J. Deluzio, 13 - APR - 2005 

### There are no anal ytical methods listed in PAM, Vol. II for the anal ys is of metaldehyde. The FDA multiresidue methods are not suitable for analysis of metaldehyde. The GC/FID response for metaldehyd e in Level Itesting (Module DG6, 130  C) gave an inadequate response as the relative retention time for metaldehyde was <0.3, and Level II testing could not be performed. In addition, solvent front and matrix interferences precluded quantitation of metaldehyde through Protocol D. **5.1 .3**  **Tolerance Enforcement Methods** EN - CAS TM Method No. ENC - 3/99, Revision 1 is acceptable for tolerance enforcement of metaldehyde residues in plants. For this method, residues in homogeni zed plant matrices (except clover hay) are extracted with dichloromethane (DCM) containing sodium sulfate, filtered, concentrated, and anal yz ed by GC/MS . Clover hay samples were allowed to soak in water prior to extraction. The limit of quantitation (LOQ) for metaldehyde in/on plant commodities is 0.05 ppm. Since this method was used for data collection and adequate validation data were reported, an adequate enforcement method is available to enforce tolerances for the proposed new uses of metaldehyde.Metaldehyde Summary of Analytical Chemistry and Residue Data D 418047



### Page 9 of 29 **5.1 .4**  **Submittal of Analytical Reference Standards (860.**  **1650)** The anal ytical standard for metaldehyde (CAS # 108 - 62 - 3 ) at the EPA National Pesticide Standards Repository will expire on January 31 st 

### , 2016 [personal communication from T. Cole of ACB/BEAD to W. Donovan, 0 7 /1 0/201 4 ]. A fresh reference standard should be provided to the Repo sitory , and then replenished as requested by the Repository . The reference standard should be sent to the Anal ytical Chemistry L ab, which is located at Fort Meade, to the attention of Theresa Cole at the following address: USEPA National Pesticide Standards Repository /Anal ytical Chemistry

Branch/OPP 701 Mapes Road Fort George G. Meade, MD 20755 - 5350 The full 9 digit zip code is mandatory or the mail will be returned. **5.2 Storage Stability (860.1380)**  As detailed in the residue chemistry chapter of the metaldehyde RED, acceptable storage stability studies for metaldehyde have been reported . Thus, metaldehyde is stab le in frozen storage for at least 8 months in citrus oil, 12 months in lettuce, strawberry , broccoli, and oranges, and 23 months in tomatoes. Furthermore, additional storage stability data w ere submitted in support of crop field trial data in 2013 (D41804 7 , W. Donovan). In these studie s metaldehyde was found to be stable for 10.6 months in celery , 18.3 months in corn forage, 6.3 months in corn grain, 9.6 months in corn stover, 15.9 months in grass (forage, hay), 10.5 months in mint leaf, 24.2 months in mint oil, 7.8 months in soy bean seed, 12.4 months in taro leaf and corm, 14.8 months in radish (roots, tops), sorghum (forage, grain, stover) and wheat (forage, hay , grain and straw). In support of the crop field trial data submitted for the proposed new us es of metaldehyde , concurrent storage stability studies were conducted for bean, pea, clover and ginseng . These studies confirm and extend the previous findings of residue stability, with recoveries in the acceptable range of 70 - 120% for the intervals needed to cover the sample storage intervals from the field trial studies, see Table 5.2.2 . **TABLE 5.2.2. Summary of Storage Conditions in**  **Primary Crop, Processing**  **Stu dies**  **, and Rotational Crops**  **.** Crop Matrix Storage Tem perature (°C) Maximum Storage

Duration (days) Interval of Demonstrated

Storage Stability (days) Primary Crops Bean Edible Pod

≤ 0 346 366



### Shelled Succ. 459 442 

### Foliage 355 366 Pea Edible Pod 351 368



### Shelled Succ. 277 279 

### Foliage 371 368Metaldehyde Summary of Analytical Chemistry and Residue Data D 418047



### Page 10 of 29 **TABLE 5.2.2. Summary of Storage Conditions in**  **Primary Crop, Processing**  **Stu dies**  **, and Rotational Crops**  **.** Crop Matrix Storage Tem perature (°C) Maximum Storage

Duration (days) Interval of Demonstrated

Storage Stability (days) Clover Hay 666 670



### Forage 530 552 

### Ginseng Root 412 430 

### Thus, metaldehyde is stable in frozen storage for at least 7.7 months in b ean (pod and foliage), 10.0 months in p ea (pod and foliage), 12.9 months in b ean (succulent shelled), 2.9 months in p ea (succulent shelled), 13.6 months in c lover forage, 18.3 months in c lover hay , and 14.1 months in ginseng. **5.3 Residue Data**  **5.3.1 Crop Field Trials (860.1500)**  49277201.der (Bean and pea, edible podded) 49277203.der (Pea, succulent shelled) 49277204.der (Clover) 49277205.der (Ginseng) 49299501.der (Bean, succulent shelled) 

### The crop field trial data submitted in support of this petition were generated by IR- 4. Bean and Pea (Edible Podded) Field Trials [ Subgroups 6A and 7A] Seven bean trials were conducted in the North American Free Trade Agreement (NAFTA) Growing Zone 1 (NY; 1 trial), 2 (NC; 1 trial), 3 (FL; 1 trial), 5 (OH and WI; 2 trials), 10 (CA; 1 trial), and 11 (WA; 1 trial) ; and three pea trials were conducted in Zones 2 (GA; 1 trial), 10 (CA; 1 trial), and 11 (ID; 1 trial) . Each trial consisted of one untreated plot and one treated plot . At each trial location, the treated plots received three soil broadcast applications of a 4% mini -pelleted (P/T) formulation of metaldehyde (De adline ® 

### M - Ps TM 

### ) at 0.99 - 1.00 lb ai/A/application, with a 6 - to 8 - day retreatment interval (RTI), for a total seasonal rate of 2.99 - 3.01 lb ai/A. Applications were made during cotyledon through vegetative stages of development using soil broadcast applications. No adjuvants were used with these ty pes of applications. Bean and pea were harvested at pre harvest intervals (PHIs) of 30 - 97 days to evaluate edible podded bean, 1 - 22 days to evaluate bean foliage, 39 - 55 days to evaluate edible podded peas and 1 - 3 5 days to evaluate pea foliage. Residue decline was not evaluated. Residues of metaldehyde were found in all but one of the pea trials, and all but three of the bean (podded) trials. A summary of the field trial results is shown in Table 5.3.1.1, below.Metaldehyde Summary of Analytical Chemistry and Residue Data D 418047



### Page 11 of 29 **TABLE 5.3.1.1**  **Summary of Residue Data from Crop Field Trials with**  **Me taldehyde**  **.** Commodity Total Rate ( lb ai/A) PHI

(days) Residue Levels 1 (ppm) n Sample Min. Sample

Max. LAFT 2 HAFT 2 Median Mean Std. Dev. Bean, edible podded 2.988 - 3.012 30 - 97 7 < 0.05 0.432 <0.05 0.347 0.0508 0.159 0.140 Bean, foliage 1 - 22 7 0.0600 0.668 0.0827 0.647 0.172 0.269 0.222 Pea, edible podded 2.997 - 3.000 39 - 55 3 <0.05 0.258 <0.05 0.252 0.0970 0.133 0.105 Pea, foliage 1 - 35 3 <0.05 0.352 <0.05 0.330 0.208 0.196 0.140 1 Except for sample min/max, values reflect per trial averages; n = no. of field trials. For calculation of median, mean, and standard deviation, the L OQ of 0.05 ppm was used fo r any results reported as <LOQ . 2 LAF T = lowest average field trial; HAFT = highest average field trial. 

### The number of bean field trials and their geographical distribution are adequate. The samples were anal yz ed using a suitable method and the sample storage intervals are supported by storage stability data. The edible podded and foliage data set s were anal yz ed using the OECD tolerance calculation procedures to determine a rec ommended tolerance level of 0.8 ppm for edible podded bean, 0.6 ppm for edible podded pea; 1.5 ppm for bean fo liage , and 0. 8 ppm for pea foliage . The higher value for the subgroup was selected for tolerance determination, giving a recommended tolerance of 0.8 ppm for edible podded (subgroup 6A) and 1.5 ppm for foliage matrices (subgroup 7A) (see Appendix C) . Bean (Succulent Shelled) Field Trials [Subgroup 6B] A total of 6 field trials were conducted in the United States during the 2011 growing season in the NAFTA Growing Zone 2 (MD and NC; 3 trials), 5 (MI; 1 trial), 10 (CA; 1 trial) and 11 (ID; 1 trial) . The two Clinton, NC trials were considered independent due to the use of different lima bean varieties (Thorogreen [NC13] and Fordhook 242 [NC14]) and a difference in application timing of approximately

3 weeks. Each trial consisted of one untreated plot and one treated plot . At each trial location, the treated plots received three soil broadcast applications of a 4% mini -pelleted (P/T) formulation of metaldehyde (Deadline ® 

### M - Ps TM 

### ) at 1.00 lb ai/A/application, with a 6 - to 8 - day RTI, for a seasonal rate of 3.00 lb ai/A. Applications were made during cotyl edon through vegetative stages of development using ground equipment. No adjuvants were used with these ty pes of applications. Beans (succulent shelled) were harvested at PHIs of 48 - 83 days. Residue dec line was not evaluated. Residues of metaldehyde were found in 2 bean (succulent shelled) trials. A summary of the field trial results is shown in Table 5.3.1. 2 , below. **TABLE 5.3.1.**  **2 .**  **Summary of Residue Data from Crop Field Trials with**  **Me taldehyde**  **.** Commodity Total Rate ( lb ai/A) PHI

(days) Residue Levels 1 (ppm) n Sample Min. Sample

Max. LAFT 2 HAFT 2 Median Mean Std. Dev. Beans (succulent shelled) 2 .99 - 3.00 48 - 83 6 <0.05 0.152 <0.05 0.139 0.050 0.068 0.035 1 Except for sample min/max, values reflect per trial averages; n = no. of field trials. For calculation of median, mean, andMetaldehyde Summary of Analytical Chemistry and Residue Data D 418047



### Page 12 of 29 standard deviation, the LOQ of 0.05 ppm was used fo r any results reported as <LOQ. 2 LAF T = lowest average field trial; HAFT = highest average field trial. 

### The number of bean field trials and their geographical distribution are adequate. The samples were anal yz ed using a suitable method and the sample storage intervals are supported by storage stability data. The succulent shell ed bean data were anal yz ed using the OECD tolerance calculation procedures to determine the recommended tolerance level of 0.2 0 ppm (see Appendix C). Pea (Succulent Shelled) Field Trials [Subgroup 6B] A total of 7 field trials on pea were conducted in the United States during the 20 10 growing season in NAFTA Growing Zones 1 (NY; 1 trial), 5 (MI, OH, and WI; 3 trials), 10 (CA; 1 trial), 11 (ID; 1 trial) and 12 (OR; 1 trial) . Each trial consisted of one untreated plot and one treated plot . At each trial location, the treated plots received three soil broadcast applications of a 4% mini -pelleted (P/T) formulation of metaldehyde (Deadline ® 

### M - Ps TM 

### ) at 1.00 - 1.08 ai/A/application, with a 6 - to 8 - day retreatment interval (RTI), for a total seasonal rate of 3.00 - 3.25 lb ai/A . Applications were made during newly emerged through vegetative stages of development using ground equipment. No adjuvants were used with these ty pes of application. Pea (succulent shelled) was harvested at preharvest intervals (PHIs) of 21 - 125 days. Residue decline was not evaluated. Residues of metaldehyde were found in 4 pea trials. A summary of the field trial results is shown in Table 5.3.1. 3 , below. **TABLE 5.3.1.**  **3 .**  **Summary of Residue Data from Crop Field Trials**  **with Metaldehyde.** Commodity Total Rate

lb a. i ./A PHI

(days) Residue Levels 1 (ppm) n Sample Min. Sample

Max. LAFT 2 HAFT 2 Median Mean Std. Dev. Pea (succulent shelled) 2.997 - 3.246 21 - 125 7 <0.05 0.140 <0.05 0.13 0 0.08 3 0.08 0 0.031 1 Except for sample min/max, values reflect per trial averages; n = no. of field trials. For calculation of median, mean, and standard deviation, the LOQ of 0.05 ppm was used fo r any results reported as <LOQ. 2 LAF T = lowest average field trial; HAFT = highest average field trial. 

### The number of pea field trials and their geographical distribution are adequate. The samples were anal yz ed using a suitable method and the sample storage intervals are supported by storage stability data. The succulent shelled pea data were anal yz ed using the OECD tolerance calculation procedures to determine the recommended tolerance level of 0.2 0 ppm . As both studies conducted on succulent shelled legumes (bean and pea) resulted in suggested tolerance s of 0 .2 ppm, the recommended tolerance for subgroup 6B is 0.2 0 ppm (see Appendix C). Clover Field Trials A total of 3 field trials on clover were conducted in the United States during the 2009 growingMetaldehyde Summary of Analytical Chemistry and Residue Data D 418047



### Page 13 of 29 season in NAFTA Growing Zones 11 (WA , 1 trial) and 12 ( OR , 2 trial s ). The submitted study report indicated that three trials were conducted in OR (OR14, OR15, and OR16). However, consideration of the trial conditions showed that trials designated OR15 and OR16 are not independent ; instead they are replicate treatments at one trial site. The soil ty pes and clover varieties were identical in OR15 and OR16 and the only difference noted was a one week separation in application dates . Trial OR14 was considered independent from OR15 and OR16 due to the different soil characteristics as compared to those in the other plots. Each trial consisted of one untreated plot and one treated plot . At each trial location, the treated plots received two broadcast soil applications of a 4% mini -pellete d (P/T) bait of metaldehyde (Deadline ® 

### M - Ps TM 

### ) at 0. 80 - 0.84 lb ai/A/application, with a 10 - to 12 - day RTI , for a total seasonal rate of 1. 60 - 1.66 lb ai/A. Applications were made during vegetative to blooming stages of development. No adjuvants were used with these ty pes of application. Clover forage was harvested at PHI s of 23 - 29 days. Clover hay was harvested at PHI s of 29 - 51 days and was allowed to dry

for 5 - 8 days prior to collection. Residue decline was not evaluated. Residues of metaldehyde were found in all 3 clover trials. A summary of the field trial results is shown in Table 5.3.1. 4 , below. **TABLE 5.3.1.**  **4 .**  **Summary of Residue Data from Crop Field Trials with Metaldehyde.**  Commodity Total Rate

lb a.i./A PHI

(days) Residue Levels 1 (ppm) n Sample Min. Sample

Max. LAFT 2 HAFT 2 Median Mean Std. Dev. Clover (hay) 1.598 - 1.661 23 - 29 3 <0.05 0.275 0.053 0.235 0.165 0.151 0.110 Clover (forage) 1.598 - 1.661 29 - 51 3 <0.05 0.255 <0.05 0.241 0.050 0.114 0.092 1 Except for sample min/max, values reflect per trial averages; n = no. of field trials. For calculation of median, mean, and standard deviation, the LOQ of 0.05 ppm was used fo r any results reported as <LOQ. 2 LAF T = lowest average field trial; HAFT = highest average field trial. 

### The number of clover field trials and their geographical distribution are adequate for the requested regional registration limited to the P acific N orthwest. The samples were anal yz e d using a suitable method and the sample storage intervals are supported b y storage stability data. The clover forage and hay data were analyzed separatel y using the OECD tolerance calculation procedures . For both matrices, the recommended tolerance was determined to be 0. 6 0 ppm (see Appendix C). Ginseng Field Trials A total of 4 crop field trials on ginseng were conducted in the United States during the 20 11 growing season in NAFTA Growing Zone 5 (WI ; 4 trials). Because the field trial sites were sep arated b y ~16 - 27 miles and had different soil types (loam, silt loam, loamy sand, and sandy loam) , they

are considered independent trials. Each trial consisted of one untreated plot and one treated plot . At each trial location, the treated plots received six foliar broadcast applications of a 4% mini -pelleted (P/T) formulation of metaldehyde (Deadline ® 

### M - Ps TM 

### ) at 1.0 lb ai/A/application, with a 20 - to 22 - day RTI, for a total seasonal rate of 6.0 lb ai/A . Applications were made during vegetative through fruiting stages ofMetaldehyde Summary of Analytical Chemistry and Residue Data D 418047



### Page 14 of 29 development using ground equipment. No adjuvants were used with these ty pes of application. Ginseng was harvested at PHI s of 21 - 22 days and was allowed to dry (drying period not reported). S amples were collected at PHIs of 7, 1 4, 21, and 28 days from one trial to assess residue decline. No detectable residue levels were found in any ginseng sample; thus, no residue decline pattern was discernible. Residues of metaldehyde were not found in any of the trials above the LOQ of 0. 05 ppm . A summary of the field trial results is shown in Table 5.3.1. 5 , below. **TABLE 5.3.1**  **. 5**  **. Summary of Residue Data from** **Crop Field Trials with Metaldehyde.** Commodity Total Rate

lb a. i ./A PHI

(days) Residue Levels 1 (ppm) n Sample Min. Sample

Max. LAFT 2 HAFT 2 Median Mean Std. Dev. Ginseng (root) 6.0 21 - 22 4 <0.05 < 0. 05 <0.05 <0.05 0.05 0.05 N/A 1 Except for sample min/max, values reflect per trial averages; n = no. of field trials. For calculation of median, mean, and standard deviation, the LOQ of 0.05 ppm was used fo r any results reported as <LOQ. 2 LAF T = lowest average field trial; HAFT = highest average field trial. 

### The number of ginseng field trials and their geographical distribution are adequate. The samples were anal yz ed using a suitable method and the sample storage intervals are supported by storage stability data. No detectable residue levels were found in any ginseng sample; thu s, the recommended tolerance level of 0.05 ppm was based on the anal ytical method LOQ . Tomato [Subgroup 8 - 10A] and Citrus [Group 10 - 10] proposal Tolerances are established for metaldehyde on tomato at 0.24 ppm and on Fruit, citrus, group 10 at 0.26 ppm. On December 8, 2010, the Federal Register published a final rule with revisions to the fruiting vegetables crop group and the citrus fruit crop group. HED concludes that it is appropriate to translate the established tolerance levels for tomato and citrus , fruit, group 10 to tomato subgroup 8 - 10A and citrus, fruit, group 10 - 10 , respectively; and then to remove the tolerance listings for tomato and group 10. 

### 5.3.2 **Field Rotational Crops (860.1900**  **)** D408745, W. Donovan, 12 - JUL - 2013 4 7623004 .der 

### Lonza , In c. submitted a limited field rotational crop study with metaldehyd e on radish , germ sorghum, and winter wheat . Two field trials were conducted in the Unites States, encompassing Regions 5 (1 trial in Michigan) and Region 10 (1 trial in California) during the 2005 - 2006 growing season. At each test site, three application s of metaldehyde w ere made to bare ground at a nominal target application rate of 1.0 lb ai/A/application and a 14 - day RTI , for a total of 3.0 lb ai/A/season . Radish plant s were planted at nominal plant back intervals (PBI) of 30, 120 and 365 days. Sorghum plant s were planted at nominal PBIs of 30 and 365 days , while wheat plant s were planted at a nominal 120 - day PBI . Plants were harvested at maturity and anal yz ed using the anal ytical method EN - CASTM No. ENC - 3/99, Revision 1. The following plant matrices were anal yz ed for residues of metaldehyde: radish

– tops and roots; sorghum

– forage, grain, andMetaldehyde Summary of Analytical Chemistry and Residue Data D 418047



### Page 15 of 29 stover; and wheat

– forage, grain, hay , and straw. Leafy vegetables were not included in the study because of the availability of magnitude of the residue field trial data in/on broccoli, cabbage, mustard greens, and leaf lettuce reflecting primary crop uses. Conclusions: The maximum frozen storage interval for any sample was 14 months. Concurrent storage stability

data demonstrated stability in all matrices tested for at least 15 months. Residues of metaldehyde were not detected above the LOQ (0.05 ppm) in any of the samples anal yz ed at any

PBI. Based on use of the appropriate application rate, adequate crop diversity in the tested crops, and the results showing that metaldehyde residues are not taken up by rotational crops, HED concludes that 30 - day PBI s are appropriate for rotational crops. This rotational crop PBI specification should be included on all metaldehyde labels concerning agricultural crop uses. Labeled crops may

be replanted immediately . **5 .3.3**  **Processed Food and Feed (860.1520) 5.3.4**  **Meat, Milk, Poultry and Eggs (860.1480)**  Not applicable as the Agency approved a waiver for livestock feeding studies (Grey beard Committee: Metaldehyde, 3/11/97) . **5.4 Food Residue Profile**  Adequate residue chemistry data have been provided for metaldehyde. Field trials are of adequate number and geographic representation. Data analyses employed validated anal ytical methods and are supported by appropriate storage stability data. The Agency

waived livestock metabolism and feeding studies; thus, all uses of metaldehyde are classified under 40 CFR §180.6 (a) (3), no reasonable expectati on of finite residues with respect to residues in livestock commodities. No processed commodities are associated with the new uses proposed in the current petition. Limited rotational crop field trial studies have demonstrate d that residues are not expe cted in crops planted 30 - days after metaldehyde is applied to soil; therefore, 30 - day plant back intervals (PBIs) are appropriate for crops in rotation to primary crops . **6.0 Tolerance Derivation**  The recommended tolerances for metaldehyde were derived b y 1) use of the OECD MRL calculation procedures for crops with measurable residue levels, 2) use of the LOQ for crops where residues in the field trials were not measurable (ginseng) , and 3) direct translation where appropriate (subgroup 8 - 10A and group 10 - 10) . List of Appendices A. Number of Crop Field Trials and Geographical Distributions. B. International Residue Limits Table. C. Tolerance Calculations .Metaldehyde Summary of Analytical Chemistry and Residue Data D 418047



### Page 16 of 29 **Appendix A TABLE**  **A .1.**  **1 .**  **Trial Numbers and Geographical Locations** . NAFTA Gro wing Zones Bean Pea

Submitted Requested 1 Submitted Requested2

Canada U.S. Canada U.S. 1 1 -- 1/1 -- -- -- 1A -- -- -- -- -- -- 2 1 -- 1/1 1 -- -- 3 1 -- 1/1 -- -- -- 4 -- -- -- -- -- -- 5 2 -- 3/2 -- -- -- 5A -- -- -- -- -- -- 5B -- -- -- -- -- -- 6 -- -- -- -- -- -- 7 -- -- -- -- -- -- 7A -- -- -- -- -- -- 8 -- -- -- -- -- -- 9 -- -- -- -- -- -- 10 1 -- 1/0 1 -- -- 11 1 -- 1/1 1 -- -- 12 -- -- -- -- -- -- 13 -- -- -- -- -- -- 14 -- -- -- -- -- -- 15 -- -- -- -- -- -- 16 -- -- -- -- -- -- 17 -- -- -- -- -- -- 18 -- -- -- -- -- -- 19 -- -- -- -- -- -- 20 -- -- -- -- -- -- 21 -- -- -- -- -- -- Total 7 -- 8/6 3 -- 3 1 As per OCSPP 860.1500, Tables 1, 3, and 5. The second number reflects a 25% reduction in the number of trials allowed for the crop as a representative commodity in support of a crop group/subgroup tolerance or when application results in no quantifiable residues. 2 Geographic representation is not specified for crops requiring ≤3 trials.Metaldehyde Summary of Analytical Chemistry and Residue Data D 418047



### Page 17 of 29 **TABLE A**  **.1. 2**  **. Trial Numbers and Geographical Locations**  . NAFTA Growing Regions Bean (succulent shelled) Submitted Requested 1 Canada U.S. 1 -- -- -- 1A -- -- 2 3 -- 4/3 3 -- -- -- 4 -- -- -- 5 1 -- 1/1 5A -- -- -- 5B -- -- -- 6 -- -- -- 7 -- -- -- 7A -- -- -- 8 -- -- -- 9 -- -- -- 10 1 -- 2/1 11 1 -- 1/1 12 -- -- -- 13 -- -- -- 14 -- -- -- 15 -- -- -- 16 -- -- -- 17 -- -- -- 18 -- -- -- 19 -- -- -- 20 -- -- -- 21 -- -- -- Total 6 8/6 1 As per Table 5 of 860.1500 for bean, lima, green ; the second number reflects a 25% reduction in the number of field trials allowed for the crop as a representative commodity in support of a crop group/subgroup tolerance or when application results in no quantifiable residues.Metaldehyde Summary of Analytical Chemistry and Residue Data D 418047



### Page 18 of 29 **TABLE A**  **.1.3. Trial Num** **bers and Geographical Locations** . NAFTA Growing Regions Pea (Succulent Shelled) Submitted Requested 1 Canada U.S. 1 1 -- 1/1 2 1A -- -- 2 -- -- 1/1 2 3 -- -- -- 4 -- -- -- 5 3 -- 4/3 5A -- -- -- 5B -- -- -- 6 -- -- -- 7 -- -- -- 7A -- -- -- 8 -- -- -- 9 -- -- -- 10 1 -- -- 11 1 -- 2/1 12 1 -- 1/1 13 -- -- -- 14 -- -- -- 15 -- -- -- 16 -- -- -- 17 -- -- -- 18 -- -- -- 19 -- -- -- 20 -- -- -- 21 -- -- -- Total 7 8/6 1 As per Table 5 of 860.1500 for pea, garden, succulent ; the second number reflects a 25% reduction in the number of field trials allowed for the crop as a representative commodity in support of a crop group/subgroup tolerance or when application result s in no quantifiable residues. 2 Either region is acceptable.Metaldehyde Summary of Analytical Chemistry and Residue Data D 418047



### Page 19 of 29 **TABLE A**  **.1. 4**  **. Trial Numbers and Geographical Locations**  . NAFTA Growing Regions Clover Submitted Requeste d Canada U.S. 1 -- -- 1/1 1A -- -- 2 -- -- 1/1 3 -- -- -- 4 -- -- 1/1 5 -- -- 3/2 5A -- -- -- 5B -- -- -- 6 -- -- 1/1 7 -- -- 1/1 7A -- -- -- 8 -- -- 1/1 9 -- -- 1/0 10 -- -- 1/1 1 11 1 -- 1/1 1 12 2 2

-- -- 13 -- -- -- 14 -- -- -- 15 -- -- -- 16 -- -- -- 17 -- -- -- 18 -- -- -- 19 -- -- -- 20 -- -- -- 21 -- -- -- Total 3 3 12/9 1 Either region is acceptable. 2 HED has concluded that two trials (OR 15 and OR 16) conducted in Aurora, OR (Zone 12) should constitute a single trial with replicate samples for the purpose of 860.1500 data requirements, while trial OR14 is independent . 3 This study is to support a regional regi stration in the Pacific Northwest on clover grown for seed.Metaldehyde Summary of Analytical Chemistry and Residue Data D 418047



### Page 20 of 29 **TABLE A**  **.1. 5**  **. Trial Numbers and Geographical Locations**  . NAFTA Growing Regions Ginseng Submitted Requested 1 Canada U.S. 1 -- -- -- 1A -- -- 2 -- -- -- 3 -- -- -- 4 -- -- -- 5 4 -- -- 5A -- -- -- 5B -- -- -- 6 -- -- -- 7 -- -- -- 7A -- -- -- 8 -- -- -- 9 -- -- -- 10 -- -- -- 11 -- -- -- 12 -- -- -- 13 -- -- -- 14 -- -- -- 15 -- -- -- 16 -- -- -- 17 -- -- -- 18 -- -- -- 19 -- -- -- 20 -- -- -- 21 -- -- -- Total 4 3 or 2 1 As per OPPTS 860.1500, Table 1 for ginseng; trial locations are not specified for crops requiring ≤3 field trials. According to “Food and Feed Crops of the United States” (G.M. Markle, J.J. Baron, and B.A. Schneider. Second Edition, Meister Publishing Co. 1998), ginseng is grown in Zones 1, 2, 4, and 5 with Zone 5 being the major cultivated region .Metaldehyde Summary of Analytical Chemistry and Residue Data D 418047



### Page 21 of 29 **Appendix B**  **. International Residue Limits Table**  **Appendix B. International Residue Limits**  **Table** Table B1. Summary of US and International Tolerances and Maximum Residue Limits for Metaldehyde (053001) Residue Definition : US Canada Mexico 2 

### Codex 40 CFR 180.523 : Plant: Metaldehyde 

### None None Commodity 1 

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

### US Canada Mexico 2 

### Codex Vegetable, legume, edible podded, subgroup 6A 0.80 Pea and bean, succulent shelled, subgroup 6B 0.20 Vegetable, foliage of legume, except soy bean, subgroup 7A 1.50 Tomato subgroup 8 - 10A 0.24 Fruit, citrus, group 10 - 10 0.26 Clover, forage 0.60 Clover, hay 0.60 Ginseng 0.05

Com pleted: M. Negussie; 06/18/14 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.

### Page 22 of 29

**Appendix C. Results of**  **OECD Tolerance Calculations Metaldehyde**  **Bean (Succulent Shelled)**

**USA 1**  **lb ai/A, 3 aps**  **Total number of data (n)** 6 **Percentage of censored data** 67 % **Number of non -**  **censored data** 2 **Lowest residue** 0.050 **Highest residue** 0.139 **Median residue** 0.050 **Mean** 0.068 **Standard deviation (SD)** 0.035 **Correction factor for censoring (CF)** 0.556 **Proposed MRL estimate**

**- Highest residue**  0 .1 39

**- Mean + 4 SD**  0.210

**- CF x 3 Mean**  0.113 **Unrounded MRL** 0.210 **Rounded MRL 0.**  **2** High uncertainty of MRL estimate. [High level of censoring] **Residues (mg/kg) n**  0.139 1 0.069 1 0.050 4Metaldehyde Summary of Analytical Chemistry and Residue Data D 418047



### Page 23 of 29 **Metaldehyde Bean (Pods with Seed)** 

**USA 1.0**  **lb ai/A, 3 aps**  **Total number of data (n)** 7 **Percentage of censored data** 43 % **Number of non**  **- censored data**  4 **Lowest residue** 0.050 **Highest residue** 0.347 **Median residue** 0. 051 **Mean** 0. 159 **Standard deviation (SD)** 0. 140 **Correction factor for censoring (CF)** 0. 714 **Proposed MRL estimate**

**- Highest residue**  0.347

**- Mean + 4 SD**  0.718

**- CF x 3 Mean**  0.340 **Unrounded MRL** 0.718 **Rounded MRL 0.8**  High uncertainty of MRL estimate. [ Small dataset ] **Residues (mg/kg) n**  0.05 3 0.347 1 0.33 1 0.2325 1 0.05075 1Metaldehyde Summary of Analytical Chemistry and Residue Data D 418047



### Page 24 of 29 **Metaldehyde Bean (Foliage)**  **USA 1**  **.0 lb ai/A, 3 aps**  **Total number of data (n)** 7 **Percentage of censored data** 0 % **Number of non -**  **censored data** 7 **Lowest residue** 0.0 8 0 **Highest residue** 0. 647 **Median residue** 0. 172 **Mean** 0. 268 **Standard deviation (SD)** 0. 222 **Correction factor for censoring (CF)** 1.000 **Proposed MRL estimate**

**- Highest residue**  0. 647

**- Mean + 4 SD**  1.155

**- CF x 3 Mean**  0. 805 **Unrounded MRL** 1.155 **Rounded MRL 1**  **.5** High uncertainty of MRL estimate. [ Small dataset ] **Residues (mg/kg) n**  0.080 1 0.088 1 0.172 1 0.502 1 0.264 1 0.127 1 0.647 1Metaldehyde Summary of Analytical Chemistry and Residue Data D 418047



### Page 25 of 29 **Metaldehyde Pea (Succulent Shelled)** 

**USA 1**  **.0 lb ai/A, 3 aps**  **Total number of data (n)** 7 **Percentage of censored data** 43 % **Number of non -**  **censored data** 4 **Lowest residue** 0. 050 **Highest residue** 0.130 **Median residue** 0. 082 **Mean** 0 . 080 **Standard deviation (SD)** 0. 031 **Correction factor for censoring (CF)** 0 . 714 **Proposed MRL estimate**

**- Highest residue**  0.130

**- Mean + 4 SD**  0.206

**- CF x 3 Mean**  0.171 **Unrounded MRL** 0.206 **Rounded MRL 0.2**  High uncertainty of MRL estimate. [Small dataset] **Residues (mg/kg) n**  0.05 3 0.1295 1 0.08245 1 0.0947 1 0.1035 1Metaldehyde Summary of Analytical Chemistry and Residue Data D 418047



### Page 26 of 29 **Metaldehyde Pea (Pods with Seed)** 

**USA 1**  **.0 lb ai/A,**  **3 aps Total number of data (n)**  3 **Percentage of censored data** 33% **Number of non -**  **censored data** 2 **Lowest residue** 0.050 **Highest residue** 0. 252 **Median residue** 0.09 7 **Mean** 0.1 33 **Standard deviation (SD)** 0. 105 **Correction factor for censoring (CF)** 0.7 78 **Proposed MRL estimate**

**- Highest residue**  0. 252

**- Mean + 4**  **SD** 0. 555

**- CF x 3 Mean**  0.3 10 **Unrounded MRL** 0. 555 **Rounded MRL 0.6**  High uncertainty of MRL estimate. [Small dataset] **Residues (mg/kg) n**  < 0.05 1 0.09 7 1 0. 2515 1Metaldehyde Summary of Analytical Chemistry and Residue Data D 418047



### Page 27 of 29 **Metaldehyde Pea (Foliage)**  **USA 1**  **.0 lb ai/A,**  **3 aps Total**  **number of data (n)** 3 **Percentage of censored data** 33 % **Number of non -**  **censored data** 2 **Lowest residue** 0.0 50 **Highest residue** 0. 330 **Median residue** 0. 208 **Mean** 0. 196 **Standard deviation (SD)** 0. 140 **Correction factor for censoring (CF)** 0. 778 **Proposed MRL estimate** 

**- Highest residue**  0. 330

**- Mean + 4 SD**  0. 758

**- CF x 3 Mean**  0. 457 **Unrounded MRL** 0. 758 **Rounded MRL 0.**  **8** High uncertainty of MRL estimate. [Small dataset and high level of censoring] **Residues (mg/kg) n**  0.05 0 1 0. 330 1 0.208 1Metaldehyde Summary of Analytical Chemistry and Residue Data D 418047



### Page 28 of 29 **Metaldehyde Clover (Forage)**  **Pacific NW -**  **USA 0.8**  **lb ai/A, 2 aps**  **Total number of data (n)** 3 **Percentage of censored data** 0 % **Number of non -**  **censored data** 3 **Lowest residue** 0.05 3 **Highest residue** 0. 235 **Median residue** 0. 1 65 **Mean** 0. 1 51 **Standard deviation (SD)** 0.0 92 **Correction factor for censoring (CF)** 1.000 **Proposed MRL estimate**

**- Highest residue**  0. 235

**- Mean + 4 SD**  0. 519

**- CF x 3 Mean**  0. 453 **Unrounded MRL** 0. 519 **Rounded MRL 0.**  **6** High uncertainty of MRL estimate. [ Small dataset and High level of censoring] **Residues (mg/kg) n**  0.16 5 1 0.053 1 0.235 1Metaldehyde Summary of Analytical Chemistry and Residue Data D 418047



### Page 29 of 29 **Metaldehyde Clover (Hay)**  **USA 0.8**  **lb ai/A, 2 aps**  **Total number of data (n)** 3 **Percentage of censored data** 67 % **Number of non**  **- censored data**  1 **Lowest residue** 0.050 **Highest residue** 0.2 41 **Median residue** 0.050 **Mean** 0. 114 **Standard deviation (SD)** 0. 110 **Correction factor for censoring (CF)** 0.5 56 **Proposed MRL estimate**

**- Highest residue**  0.2 41

**- Mean + 4 SD**  0. 553

**- CF x 3 Mean**  0.1 89 **Unrounded MRL** 0. 553 **Rounded MRL 0.**  **6** High uncertainty of MRL estimate. [High level of censoring] **Residues (mg/kg) n**  0.05 0 2 0. 241 1