Mandipropamid Summary of Analytical Chemistry and Residue Data DP Barcode D415807

Page **1** of **7** ITED STA TES ENVIRONMENTAL PROTECTION AGENCY

**UNITED STATES ENVIRONMENTAL PROTECTION AGENCY**

**WASHINGTON, D.C. 20460 OFFICE OF CHEMICAL SAFETY AND**  **POLLUTION PREVENTION MEMORANDUM**  **DATE :**  **31 October 2013 SUBJECT:**  **Mandipropamid.** Petition to Establish Permanent Tolerances (and Section 3

Registration) for Residues Resulting from Use of the Fungicide on Basil, Succulent Beans, Cowpea Forage, Ginseng and Greenhouse Tomatoes; to Update Fruiting Vegetables Group 8 to Group 8 - 10; to Extend the Tolerance in Grapes to S ubgroup 13 - 07F, the Tolerance in Dry Bulb Onions to Subgroup 3 - 07A, and the Tolerance in Green Onions to Subgroup 3 - 07B. **A DD**  **END UM to**  **Summary of Analytical Chemistry and Residue Data.**  **PC Code:** 036602 **DP Barcode:** D415807 **Decision Number:** 4 7274 8 **Registration Number :**  100 - 1254 **Petition:** 2 E 8 126 **Regulatory Action:** Section 3 **Risk Assessment Type:** NA **Case Number**  **:** 7058 **T XR Number:**  NA **CAS Number:** 374726 - 62 - 2 **MRID Numbers**  **:** 48992001 - 04 **40 CFR:** §180. 637 **FROM:** William T. Drew, Chemist

Risk Assessment Branch II (RAB2) Health Effects Division ( HED ) , 7509P **THRU:** Dennis McNeill y , Chem ist

Michael A. Doherty, PhD, Senior Chemist RAB2/HED, 7509P **TO:** Laura Nollen and Barbara Madden, RM Team 5

Risk Integration, Minor Use, Emergency Response Branch (RIMUERB) Registration Division ( RD), 7505PMandipropamid Summary of Analytical Chemistry and Residue Data DP Barcode D415807

Page **2** of **7 Background**  Sy ngenta has contacted RD concerning HED’s most recent risk assessment for mandipropamid ( D414944; D. McNeill y; 27 August 2013) . That document address ed, inter alia, the request s by Interregional Research Project Number 4 (IR - 4) to e xpan d the existing t olerance in grapes to s ubgroup 13 - 07F ( small vine climbing f ruit s except fuzzy

kiwifruit) , the existing t olerance in dry b ulb o nions to s ubgroup 3 - 07A (bulb onions ) , and the existing t olerance in green o nions to s ubgroup 3 - 07B ( green onions ). IR - 4 also request ed that the expand ed tolerances be harmonize d with the corresponding establish ed Codex maximum residue limits (MRL s) . Sy ngenta has subsequently request ed that the US tolerance s in subgroup 13 - 07F , subgroup 3 - 07A and subgroup 3 - 07B remain at the current level s in order to maintain harmonization with the corresponding established Canadian MRL s . W ith this request , Sy ngenta has submitted export information o n grapes and onions from the US Department of Agriculture (USDA), and these data demonstrate that the major export market for US growers of these commodities is Canada. Sy ngenta also states that m aintaining this harmonization with Canada is critical to allow ing US growers to continue to export to other key markets, such as the European Union ( EU) . IR - 4 had requested (and HED had recommended) several crop group expan sions with tolerance revisions that would have harmonized with Codex MRL s , but w ould have result ed in disharmony with Canadian MRL s , as follows: a) The expanded tolerance in subgroup 13 - 07F (represented b y grape) wa s recommended at 2.0 ppm in order to harmonize with the Codex MRL in grapes . This w ould supersede the current US grape tolerance of 1.4 ppm, and w ould no longer be harmonized with the Canadian grape MRL of 1.4 mg/kg. b) The tolerance in s ubgroup 3 - 07A (translated from dry bulb onion) was recommended at 0.1 0 ppm in order to harmonize with the Codex MRL in bulb onions . This would supersede the current US dry bulb onion tolerance of 0.05 ppm, and would no longer be harmonized with the Canadian MRL of 0 .05 mg/kg in various bulb onions . c) Finall y, the tolerance in subgroup 3 - 07B (translated from green onion) was recommended at 7.0 ppm in order to harmonize with the Codex MRLin spring onions. This would supersede the current US green onion tolerance of 4.0 ppm , and would no longer be harmonized with the Canadian MRL of 4 mg/kg in various green onions . HED had recommended for harmonization with Codex MRL s in the residue chemistry summary document of 27 August 2013 ( D409363 ; W . T. Drew), rather than retaining harmonization with the existing Canadian MRL s , due to the FQPA directive to harmonize with Codex . However, in this case it appears that the greatest trade irritant would be created b y not retaining the harmonizing of the US tolerances with the Canadian MRL s . Therefore , HED is revising theMandipropamid Summary of Analytical Chemistry and Residue Data DP Barcode D415807

Page **3** of **7** original tolerance recommendations for these three crop subgroups in order to continue the ir harmoniz ation with Canada’s Pest Management Regulatory Agency (PMRA) MRL s, as shown in Table 1 (below). The tolerance recommendations for other commodities remain the same. **TABLE 1 Summary**  **of Revision**  **s to Recomm**  **ended Tolerance**  **s for**  **Mandipropamid .**  **Comm odity as Proposed by**  **Registrant Proposed**  **Tolerance (ppm) Revised** 

**Recommended Tolerance (ppm)**  **Comments; Correct**  **Commodity Definition**  Fruit, small, vine climbing, subgroup 13 - 07F, except fuzzy kiwifruit 2.0 1.4 Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13 - 07F. See footnote 1 below . Onion, bulb, subgroup 3 - 07A 0.1 0.05 See footnote 2 below . Onion, green, subgroup 3 - 07B 7.0 4.0 See footnote 3 below . 1. When the crop subgroup 13 - 07F tolerance is established, the grape tolerance should be remov ed. 2. When the crop subgroup 3 - 07A tolerance is established, the tolerance in dry bulb onio n s shoul d be removed . 3. When the crop subgroup 3 - 07B tolerance is established, the tolerance in green onion s should be removed . **HED Recommendations**  HED recommend s in favor o f establishing tolerance s for residues of mandipropamid as specified in Table 2 (below) . **Data Deficiencies** No additional data are required to support HED’s currentl y recommended tolerances . As noted in the previous residue chemistry evaluation, however , additional data ar e needed to support all of the proposed tolerances associated with the petition. The submitted snap bean data do not support the proposed tolerances in succulent beans and cowpea forage (ChemSAC meeting; 17 July 2013). Additional field trial data on a succulent shelled bean cultivar (such as lima beans) would be necessary

in order to establish a tolerance in succulent beans. Because of the possibility

of detectable residues occurring in dairy cattle commodities (fat, milk and liver) arising from the feeding of treated cowpea forage, the concurrent establishment of mandipropamid tolerances at the limit of quantitation (L OQ) in those commodities would be necessary . However, with no validated anal ytical method for enforcing tolerances in livestock commodities, it i s not possible to establish such tolerances. Therefore, the proposed tolerance in cowpea forage cannot be established until a validated method for determining mandipropamid residues in livestock (cattle) commodities is available. Any such method submitte d would need an independent laboratory validation (ILV) . HED reiterates that i f tolerances for additional livestock feed items other than cowpea forage are proposed , a livestock fee ding study should be submitted.Mandipropamid Summary of Analytical Chemistry and Residue Data DP Barcode D415807

Page **4** of **7 Tolerance Considerations**  HED has examined the residue chemistry database for mandipropamid. There are no issues that would preclude establishing tolerance s for mandipropamid for the commodities listed in Table 2 (below) . **Note to RD:** Concurrent with the establishment of the tolerance in subgroup 13 - 07F, the existing tolerance in grapes sh ould be removed (40CFR §180.637[a]) . Concurrent with the establishment of the tolerance in subgroup 3 - 07A, the existing tolerance in dry bulb onions sh ould be removed (40CFR §180.637[a]) . Concurrent with the establishment of the tolerance in subgroup 3 - 07B, the existing tolerance in green onions sh ould be removed (40CFR §180.637[a]) . **Note to RD:** According to HED’s Interim Guidance on Tolerance Expressions (S. Knizner; 27 May 2009), the tolerance expression for mandipropamid cited in 40CFR §180.6 37 [a] should be revised to state: Tolerances are established for residues of mandipropamid, including its metabolites and degradates, in or on the commodities listed in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only mandipropamid ( 4 - chloro -N - [2 - [3 - methoxy- 4 - (2 - propy nyloxy) phenyl]ethyl] - α - (2 - prop ynyl oxy)benzeneacetamide ) in or on the commodity . **Recommende d Tolerances**  Pending submission of a revised Section F (to propose tolerance levels in accordance with those recommended b y HED , and to correct some of the commodity definitions) , there are no residue chemistry issues that would preclude establishing tolerance s in the requested commodities , except for those in cowpea forage and succulent beans . The recommended tolerances are listed in Table 2. **TABLE 2**  **Tolerance Summary for Ma**  **ndipropamid .**  **Comm odity as Proposed by**  **Registrant Proposed**  **Tolerance (ppm)**  **Recommended**

**Tolerance (ppm) Comments;**  **Correct Commodity Definition**  Basil, fresh 30 30 Basil, fresh leaves Basil, dried 200 200 Basil, dried leaves Bean, succulent 0.90 None Field trial data on a succulent shelled bean cultivar is needed. Bean, snap None 0.90 The snap bean field trials support the establishment of this tolerance. Ginseng 0.3 0.30Mandipropamid Summary of Analytical Chemistry and Residue Data DP Barcode D415807

Page **5** of **7 TABLE**  **2 Tolerance Summary for**  **Ma ndipropamid**  **. Comm**  **odity as Proposed by Registrant**  **Proposed Tolerance**  **(ppm) Recommended** 

**Tolerance (ppm) Comments;**  **Correct Commodity Definition**  Cow pea, forage 15 None A validated method (with an ILV) is needed for residues in cattle commodities . Vegetable, fruiting, group 8 - 10 1.0 1.0 Fruit, small, vine climbing, subgroup 13 - 07F, except fuzzy kiwifruit 2.0 1.4 Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13 - 07F. Onion, bulb, subgroup 3 - 07A 0.1 0.0 5 Onion, green, subgroup 3 - 07B 7.0 4 .0 **Revisions to Petitioned -**  **For Tolerances**  Instead of the proposed tolerance in ginseng (0.3 ppm), HED recommends establishing the tolerance at 0.30 ppm, in order to avoid the situation where a field sample containing residues significantl y above the tolerance (0.34 ppm, for example) w ould be considered non - violative. The submitted snap bean data do not support the proposed tolerance in succulent bean s . A cowpea forage tolerance cannot be established due to the lack of a livestock anal ytical enforcement method , and a supporting live stock analy tical method ILV . Therefore, HED is not recommending in favor of the proposed tolerances in succulent bean s and cowpea forage . In the previous residue chemistry summary document for mandipropamid ( D409363; W.T. Drew; 27 August 2013) , HED had originall y recommended tolerances in subgroup 13 - 07F (small vine climbing fruits except fuzzy kiwifruit), in subgroup 3 - 07A (bulb onions), and in subgroup 3 - 07B ( green onions) that were harmoniz ed with Codex , rather than harmonization with the PMRA ’s existing MRL s , due to the FQPA directive to harmonize with Codex . However, in this case it appears that the greatest trade irritant would be created by not harmonizing the US tolerances with PMRA’s MRL s. Therefore , HED is revising the tolerance recomm endations for these three crop subgroups to recommend harmoniz ation with PMRA as described in Table s 1 and 2 . **International Harmonization** Neither Codex nor PMRA have established MRLs for mandipropamid in/on fresh basil, dried basil, ginseng, or succulent beans. As such, there is no harmonization issue associated with Codex for these specific proposed new uses in the current action. PMRA and EPA are jointly reviewing the basil, ginseng and snap bean data in the current action, and EPA and PMRA are harmonized for fresh basil, dried basil, and ginseng. PMRA is establishing an MRL in edible podded beans at 0.9 mg/kg , while HED is recommending for a tolerance in snap beans at 0.90 ppm. Although the tolerance/MRL level is harmonized, HED cannot harm onize with PMRA on the commodity

definition, as the submitted snap bean data do not support use on all succulent beans.Mandipropamid Summary of Analytical Chemistry and Residue Data DP Barcode D415807

Page **6** of **7** Both the current tolerance in crop group 8 (1.0 ppm) and the proposed tolerance in crop group 8 - 10 (1.0 ppm) are harmonized with the Co dex (bell and non - bell peppers) and PMRA’s (tomatoes, okras and peppers) MRLs. For the other crop group expansions, EPA is harmonizing with PMRA’s MRL s, even though this will result in discrepancies between US tolerances and Codex MRL s. HED ’s recommended tolerance of 1.4 ppm in subgroup 13 - 07F, translated from grape data, will be harmonized with PMRA’s MRL in grapes, but will not be harmonized with the Codex MRLof 2.0 mg/kg in grapes. H ED’s recommended tolerance of 0.05 ppm in subgroup 3 - 07A, translated from dry bulb onion data, will be harmonized with PMRA’s MRLin various bulb onions, but will not be harmonized with the Codex MRL o f 0.1 mg/kg in bulb onions. HED’s recommended tolerance of 4.0 ppm in subgroup 3 - 07B, translated from green onion data, wi ll be harmonized with PMRA’s MRL in various green onions, but will not be harmonized with the Codex MRLof 7.0 mg/kg in spring onions. **L abel Recommendations**  Because the submitted snap bean data do not support the proposed use on all succulent beans, the label section containing directions for the requested use on succulent beans ( “ Bean, succulent”) should instead refer only

to snap beans (“Bean, sn ap ”) , and the listing of all other succulent bean commodities should be deleted from the proposed label . The requested use on greenhouse tomatoes listed in the proposed label is supported by the submitted greenhouse trial data. **Pesticide Use Pattern** IR - 4 has requested that new Section 3 uses of the fungicide mandipropamid be added to the label for Revus 2 .08SC (EPA Reg istration # 100 - 1254 ). The proposed new uses would be on basil, cowpea forage, ginseng, succulent beans, and greenhouse tomatoes . The proposed use direc tions are summarized in Table 3 (below) . **TABLE 3**  **Summary of Proposed**  **Directions for Use of Mandipropamid**  **. Application Type;**  **Equipment 1**  **Use**

**Rate (lb ai/A)**  **Max. Uses**

**Per Season Max. Seasonal** 

**Use Rate (lb ai/A)**  **PHI 2** 

**(Days) Use Directions,**  **Application Timing,**

**and Limitations 3**  **Basil** Foliar; any ground or aerial equipment . 0.09 -

0.13 4 0.52 1 RTI **4** of 7 - 10 days. **Ginseng** Foliar; any ground or aerial equipment. 0.09 -

0.13 4 0.52 2 RTI of 7 - 10 days.

**Succulent B eans**  **(Cowpea Forage)** Foliar; any ground or aerial equipment. 0.09 -

0.13 4 0.52 1 RTI of 7 - 10 days.Mandipropamid Summary of Analytical Chemistry and Residue Data DP Barcode D415807

Page **7** of **7 TABLE**  **3 Summary of**  **Proposed Directions for Use of**  **Mandipropamid .**  **Application Type; Equipment**  **1 Use** 

**Rate (lb ai/A)**  **Max. Uses**

**Per Season Max. Seasonal** 

**Use Rate (lb ai/A)**  **PHI 2** 

**(Days) Use Directions,**  **Application Timing,**

**and Limitations 3**  **G reenhouse**  **T om**  **atoes** Foliar; any ground or aerial equipment. 0.09 -

0.13 4 0.52 1 RTI of 7 - 10 days. May be applied via chemigation . 1. For ground application, apply in a minimum of 10 gallons of water per acre (GPA) , unless specified otherwise on the label. Do not apply through any ultra - low volume (ULV) spray system. For a erial application, u se only on crops w here aerial applications are indicated. Apply in a minimum of 5 GPA, unless specified otherwise on this label. Do not apply through any ULV spray system. For c hemigation, u se only on crops where chemigation is specified on the label. Apply no more than 2 sequential applications unless otherwise stated in the crop - specific section. Do not use in transplant production. 2. PHI = Pre - Harvest Interval. 3. Begin applications prior to disease development. Use the shorter interval and/or higher rates under high pressure, or when conditions are conducive to disease. The addition of a spreading/penetrating type adjuvant such as a non ionic based surfactant (NIS) or crop oil concentrate (COC) or blend is recommended. 4. RTI = Re - Treatment Interval. Conclusions : The use directions are adequate to allow for evaluation of the residue data. However, as the submitted snap b ean data do not support the proposed use on succulent beans, the label section containing directions for use on succulent beans ( “ Bean, succulent”) should instead refer to snap beans (“Bean, sn ap ”) , and the listing of all other succulent bean commodities s hould be deleted . A cowpea forage tolerance cannot be established due to the lack of a livestock analy

tical enforcement method, and supporting livestock analy tical method ILV. No other revisions we re made to HED’s previous residue chemistry summary document for mandipropamid ( D409363; W.T. Drew; 27 August 2013) .