Document ID: EPA-HQ-OPP-2017-0224-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2018-07-23T04:00Z

MEMORANDUM

DATE:	July 5, 2018

SUBJECT:	Flonicamid. Revised Human Health Risk Assessment for the Petition for the Establishment of Permanent Tolerances for Clover, Crop Group Conversions to Brassica, Head and Stem Vegetable, Group 5-16; Brassica, Leafy Greens, Subgroup 4-16B, Leaf Petiole Vegetable, Subgroup 22B; Leafy Greens, Subgroup 4-16A, Except Spinach; Celtuce; Florence Fennel; and Kohlrabi; Expansion of Cottonseed Tolerances to Cottonseed Subgroup 20C Tolerance, and Revised Use Directions for Citrus.  
 
PC Code:  128016
DP Barcodes:  D447674
Decision No.: 526902
Registration No.:  71512-9, 71512-10, 71512-7
Petition No.:  7E8556
Regulatory Action:  Section 3 registration, Revised Label 
Risk Assessment Type:  not applicable
Case No.:  NA
TXR No.:  not applicable
CAS No.:  158062-67-0
MRID No:  see below
40 CFR:  §180.613

FROM:	William D. Wassell, Chemist    
Risk Assessment Branch III (RAB3) 
Health Effects Division (7509P)

THROUGH:	Thomas Moriarty, Branch Chief 
RAB3/HED (7509P)

TO:		Sidney Jackson/Carmen Rodia, RM 05
		Minor Use and Emergency Response Branch 
            Registration Division (7505P) 
            

The Registration Division (RD) has requested that HED harmonize to the extent possible the U.S tolerances for residues of flonicamid [N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide] and its metabolites TFNA (4-trifluoromethylnicotinic acid), TFNA-AM (4-trifluoromethylnicotinamide), and TFNG, N-(4-trifluoromethylnicotinoyl)glycine, with the Codex maximum residue limits (MRLs) for residues of flonicamid.

In the most recent flonicamid risk assessment (Memo, 05/09/2018, W.D. Wassell, D439902), HED harmonized certain flonicamid tolerances but (i) did not harmonize for all commodities of Brassica, leafy greens, subgroup 4-16B, where a U.S. tolerance level of 16 ppm was recommended for residues of flonicamid and its metabolites; and, (ii) did not harmonize for leaf lettuce.  

With respect to harmonization of commodities of Brassica, leafy greens, subgroup 4-16B, HED notes that Codex has a MRL for residues of flonicamid in/on radish tops at 20 ppm.  Radish tops is a member of subgroup 4-16B.  HED examined tolerances and Codex MRLs of the other commodities of subgroup 4-16B and notes that for all other commodities of subgroup 4-16B, the Codex MRLs are lower than the U.S. tolerance (MRLs at 15 ppm verses the U.S. tolerance at 16 ppm).  Consequently, only harmonization with radish tops was considered.  HED notes:  The tolerance expression for the U.S. tolerances is flonicamid and its metabolites TFNA, TFNA-AM and TFNG while the tolerance expression for Codex only includes flonicamid.  

HED concludes that the tolerance for residues of flonicamid and its metabolites at 20 ppm in/on radish tops is adequate.  Therefore, the tolerance for residues of flonicamid and its metabolites at 16 ppm should be set on Brassica, leafy greens, subgroup 4-16B, except radish tops and a tolerance for flonicamid and its metabolites in/on radish tops should be set at 20 ppm.

With respect to leaf lettuce, a commodity of leafy greens, subgroup 4-16A, the US tolerance is 4 ppm whereas the Codex MRL is 8 ppm.  It is HED's understanding that the petitioner, Interregional Research Project 4 (IR-4) has indicated that it is IR-4's preference that US tolerance for leaf lettuce not be harmonized with Codex MRL.  The Canadian MRL for leaf lettuce is also 4 ppm and IR-4 indicated that harmonization of the US tolerance for leaf lettuce with Codex MRL would result in a trade irritant with Canada, which is considered the more important trade partner of the US respect to leaf lettuce.  Therefore, HED is not proposing to harmonize US tolerance for leaf lettuce with the Codex MRL for leaf lettuce.

HED also notes that the dietary exposure and risk estimates identified in the most recent flonicamid risk assessment is not altered by modifying the tolerance level for radish, tops from 16 ppm to 20 ppm.  Therefore, all risk estimates and risk conclusions identified in the most recent risk assessment, (Memo, 05/09/2018, W.D. Wassell, D439902) remain unchanged.