
                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C.  20460
                                                                      OFFICE OF
                                                            CHEMICAL SAFETY AND
--------------------------------------------------------------------------------

                                                           POLLUTION PREVENTION

MEMORANDUM


	Date:	4 June 2015

	SUBJECT:  	Fluensulfone  -  Human Health Risk Impact of the Revised Tolerance Recommendation for Tomato Paste.
 
PC Code:  050410
DP Barcode:  D427631
Decision No.: 505068
Registration No.:  66222-243
Petition No.:  5F8365
Regulatory Action:  Section 3
Risk Assessment Type:  Single Chemical Aggregate
Case No.:  None
TXR No.:  NA
CAS No.:  318290-98-1
MRID No.:  49556801
40 CFR:  180.680

	FROM:	Michael A. Doherty, Ph.D., Senior Chemist
		Risk Assessment Branch II (RAB II)
		Health Effects Division (HED; 7509P)

	THROUGH:	Christina Swartz, Chief
		RAB II 
		HED (7509P)

	TO:	Rita Kumar/Mark Suarez/Meredith Laws
		Invertebrate and Vertebrate Branch 3
		Registration Division (7505P)

The new nematicide fluensulfone was recently evaluated under a global joint review project, with Canada and Australia, for use on cucurbit and fruiting vegetables (crop groups 9 and 8-10, respectively). In the human health risk assessment (D403767, 18 June 2014; D422674, 4 September 2014), HED concluded that a tolerance for residues of fluensulfone in/on both crop groups was supported at 0.5 ppm, and tolerances were established in September 2014 (40 CFR 180.680). Based on the information available to the Agency at that time, separate tolerances for residues in processed tomato products were not established. 

Recently, the Agency received a new tomato processing study which demonstrates concentration of BSA to a degree that warrants a separate tolerance for residues in tomato paste, at 1.0 ppm (see D427654, M. Doherty, 4 June 2015). 

HED Conclusions

In food commodities, dietary risk assessments for fluensulfone are based on residues of the parent compound only. Since residues of fluensulfone did not show concentration in any processed tomato commodities, a new risk assessment is not necessary to support a new tolerance for residues in tomato paste. Typically, HED is concerned when risk estimates exceed 100% of a population-adjusted dose. In the previous assessment (D403767, 18 June 2014), aggregate risk estimates were less than 10% of population-adjusted doses for all population groups for both acute and chronic exposure. 

There are no risk issues that would preclude establishing a permanent tolerance for residues of fluensulfone in/on tomato, paste at 1.0 ppm.


