Document ID: EPA-HQ-OPP-2012-0980-0009
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-12-20T05:00Z

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 Subgroup 13-07F, the Tolerance in Dry Bulb Onions to Subgroup 3-07A, and the Tolerance in Green Onions to Subgroup 3-07B.  ADDENDUM to Summary of Analytical Chemistry and Residue Data.  

PC Code:  036602
DP Barcode:  D415807
Decision Number:  472748
Registration Number:  100-1254
Petition:  2E8126
Regulatory Action:  Section 3
Risk Assessment Type:  NA
Case Number:  7058
TXR 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 McNeilly, Chemist
		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), 7505P

Background

Syngenta has contacted RD concerning HED's most recent risk assessment for mandipropamid (D414944; D. McNeilly; 27 August 2013).  That document addressed, inter alia, the requests by Interregional Research Project Number 4 (IR-4) to expand the existing tolerance in grapes to subgroup 13-07F (small vine climbing fruits except fuzzy kiwifruit), the existing tolerance in dry bulb onions to subgroup 3-07A (bulb onions), and the existing tolerance in green onions to subgroup 3-07B (green onions).  IR-4 also requested that the expanded tolerances be harmonized with the corresponding established Codex maximum residue limits (MRLs).  Syngenta has subsequently requested that the US tolerances in subgroup 13-07F, subgroup 3-07A and subgroup 3-07B remain at the current levels in order to maintain harmonization with the corresponding established Canadian MRLs.  With this request, Syngenta has submitted export information on 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.  Syngenta also states that maintaining this harmonization with Canada is critical to allowing 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 expansions with tolerance revisions that would have harmonized with Codex MRLs, but would have resulted in disharmony with Canadian MRLs, as follows:  

      a)  The expanded tolerance in subgroup 13-07F (represented by grape) was recommended at 2.0 ppm in order to harmonize with the Codex MRL in grapes.  This would supersede the current US grape tolerance of 1.4 ppm, and would no longer be harmonized with the Canadian grape MRL of 1.4 mg/kg.  
       
      b)  The tolerance in subgroup 3-07A (translated from dry bulb onion) was recommended at 0.10 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)  Finally, the tolerance in subgroup 3-07B (translated from green onion) was recommended at 7.0 ppm in order to harmonize with the Codex MRL in 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 MRLs in the residue chemistry summary document of 27 August 2013 (D409363; W.T. Drew), rather than retaining harmonization with the existing Canadian MRLs, 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 retaining the harmonizing of the US tolerances with the Canadian MRLs.  Therefore, HED is revising the original tolerance recommendations for these three crop subgroups in order to continue their harmonization with Canada's Pest Management Regulatory Agency (PMRA) MRLs, as shown in Table 1 (below).  The tolerance recommendations for other commodities remain the same.  

TABLE 1	Summary of Revisions to Recommended Tolerances for Mandipropamid.  
                      Commodity 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 removed.  
2. When the crop subgroup 3-07A tolerance is established, the tolerance in dry bulb onions should be removed.  
3. When the crop subgroup 3-07B tolerance is established, the tolerance in green onions should be removed.

HED Recommendations

HED recommends in favor of establishing tolerances for residues of mandipropamid as specified in Table 2 (below).  

Data Deficiencies

No additional data are required to support HED's currently recommended tolerances.  As noted in the previous residue chemistry evaluation, however, additional data are 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 (LOQ) in those commodities would be necessary.  However, with no validated analytical method for enforcing tolerances in livestock commodities, it is 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 submitted would need an independent laboratory validation (ILV).  HED reiterates that if tolerances for additional livestock feed items other than cowpea forage are proposed, a livestock feeding study should be submitted.  

Tolerance Considerations

HED has examined the residue chemistry database for mandipropamid.  There are no issues that would preclude establishing tolerances 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 should be removed (40CFR §180.637[a]).  

Concurrent with the establishment of the tolerance in subgroup 3-07A, the existing tolerance in dry bulb onions should be removed (40CFR §180.637[a]).  

Concurrent with the establishment of the tolerance in subgroup 3-07B, the existing tolerance in green onions should 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 §180.637[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-propynyloxy) phenyl]ethyl]-α-(2-propynyloxy)benzeneacetamide) in or on the commodity.  

Recommended Tolerances

Pending submission of a revised Section F (to propose tolerance levels in accordance with those recommended by HED, and to correct some of the commodity definitions), there are no residue chemistry issues that would preclude establishing tolerances 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 Mandipropamid.  
                      Commodity 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
                                     0.30

Cowpea, 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
                                     0.05

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 significantly above the tolerance (0.34 ppm, for example) would be considered non-violative.  

The submitted snap bean data do not support the proposed tolerance in succulent beans.  A cowpea forage tolerance cannot be established due to the lack of a livestock analytical enforcement method, and a supporting livestock analytical method ILV.  Therefore, HED is not recommending in favor of the proposed tolerances in succulent beans and cowpea forage.  

In the previous residue chemistry summary document for mandipropamid (D409363; W.T. Drew; 27 August 2013), HED had originally 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 harmonized with Codex, rather than harmonization with the PMRA's existing MRLs, 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 MRLs.  Therefore, HED is revising the tolerance recommendations for these three crop subgroups to recommend harmonization with PMRA as described in Tables 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 harmonize with PMRA on the commodity definition, as the submitted snap bean data do not support use on all succulent beans.

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 Codex (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 MRLs, even though this will result in discrepancies between US tolerances and Codex MRLs.  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 MRL of 2.0 mg/kg in grapes.  HED's recommended tolerance of 0.05 ppm in subgroup 3-07A, translated from dry bulb onion data, will be harmonized with PMRA's MRL in various bulb onions, but will not be harmonized with the Codex MRL of 0.1 mg/kg in bulb onions.  HED's recommended tolerance of 4.0 ppm in subgroup 3-07B, translated from green onion data, will be harmonized with PMRA's MRL  in various green onions, but will not be harmonized with the Codex MRL of 7.0 mg/kg in spring onions.  

Label 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, snap"), 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 Registration #100-1254).  The proposed new uses would be on basil, cowpea forage, ginseng, succulent beans, and greenhouse tomatoes.  The proposed use directions 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 Beans (Cowpea Forage)
                    Foliar; any ground or aerial equipment.
                                  0.09 - 0.13
                                       4
                                     0.52
                                       1
RTI of 7-10 days.  

                              Greenhouse Tomatoes
                    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 aerial application, use only on crops where 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 chemigation, use 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 bean 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, snap"), and the listing of all other succulent bean commodities should be deleted.  A cowpea forage tolerance cannot be established due to the lack of a livestock analytical enforcement method, and supporting livestock analytical method ILV. 

No other revisions were made to HED's previous residue chemistry summary document for mandipropamid (D409363; W.T. Drew; 27 August 2013).