Document ID: EPA-HQ-OPP-2007-0338-0008
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-04-02T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF                  

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES        

February 29, 2008

MEMORANDUM

SUBJECT:	Flonicamid: Amendment to D347805 Human Health Risk Assessment
for Proposed Uses on Root Vegetables (Except Sugarbeet; Subgroup 1B),
Tuberous and Corm Vegetables (Subgroup 1C), Leafy Brassica Green
Vegetables (Subgroup 5B), Turnip Greens, Hops and Okra. PC Code: 128016,
Petition No: 6E7081, DP Barcode: D332317.

Section 3 Registration Action

Single Chemical Aggregate

FROM:	Sheila Piper, Risk Assessor

Alternative Risk Integration Assessment Team (ARIA)

Registration Branch (7505P)

			and

Amelia Acierto, Residue Chemist 

Registration Action Branch 3 (RAB3)

Health Effects Division (7509P)

THROUGH:	Paula Deschamp, Chief

Registration Action Branch 3 (RAB3)

Health Effects Division (7509P)

TO:		Ann Sibold, PM Team #10

Insecticide Branch

	and

Sidney Jackson, IR-4

Registration Division (7505P)

This memorandum amends the Flonicamide Human Health Risk Assessment
(D347805, S. Piper, 12/21/07 to include recommendation for a tolerance
(16 ppm) for flonicamide residues on radish, tops.  The previous
assessment concluded that a tolerance for radish tops was not needed for
the proposed flonicamid use on subgroup 1B (root vegetable, except sugar
beet).  With the exception of this error all the information contained
in the 12/21/07 risk assessment document remains unchanged.

The amended tolerance recommendation is based on the following: 
Sufficient residue data are available to support the tolerance for the
combined residues of flonicamid, TFNA, TFNA-AM and TFNG in/on radish
tops of 16 ppm.  In addition, a chronic dietary exposure assessment was
conducted including the recommended tolerance level on radish top and it
was concluded that the exposure to flonicamid is below HED’s level of
concern for the general U.S. population and all population subgroups (DP
#343466, A. M. Acierto, 11/8/07). 

Recommendations

Provided a revised Section F is submitted, there are no residue
chemistry issues that would preclude granting a registration for the
requested uses of flonicamid on root vegetables (except sugar beets),
tuberous and corm vegetables, leafy Brassica greens, turnip greens,
hops, and okra, or establishment of tolerances for flonicamid residues
as follows:

Tolerances to be established under 40 CFR 180.613(a)(1):

Brassica, leafy greens, subgroup 5B ……………….16 ppm

Hop, dried cones…………………………………....7.0 ppm

Okra	 ………………………………….…………0.40 ppm

Turnip, greens ………………………………………16 ppm

Radish, tops	16 ppm

Vegetable, root, except sugar beet, subgroup 1B	..0.60 ppm

Vegetable, tuberous and corm, subgroup 1C	…..   . 0.20 ppm

Tolerances to be revised under 40 CFR 180.613(a)(2):

Cattle, fat	0.03 ppm

Cattle, meat	0.08 ppm

Egg	0.04 ppm

Goat, fat	0.03 ppm

Goat, meat	0.08 ppm

Horse, fat	0.03 ppm

Horse, meat	0.08 ppm

Milk	0.03 ppm

Poultry, fat	0.03 ppm

Poultry, meat	0.03 ppm

Poultry, meat byproducts	0.03 ppm

Sheep, fat	0.03 ppm

Sheep, meat	0.08 ppm

Revised Tolerance Summary Table

A summary of the recommended tolerances for the combined residues of the
insecticide flonicamid and its metabolites TFNA, TFNA-AM, and TFNG in/on
the commodities is presented in Table 11.1 below.  

Table 11.1. 	Tolerance Summary for Flonicamid

Commodity or Subgroup	Proposed Tolerance (ppm)	Established Tolerance
(ppm)	Recommended Tolerance (ppm)	Comments; Correct Commodity Definition

Tolerances for combined residues of flonicamid and its metabolites TFNA,
TFNA-AM, and TFNG

[40 CFR 180.613(a)(1)]:

Brassica, leafy greens, subgroup 5B	16	--	16

	Hop, dried cones	7.0	--	7.0

	Mustard greens	--	11	16	Residues in/on mustard greens will be covered
by the tolerance for leafy Brassica green, subgroup 5B.

Okra	0.4	--	0.40

	Potato

0.20	None	Residues in/on potato will be covered by the tolerance for
tuberous and corm vegetables, subgroup 1C.

Radish, tops	16	--	16

	Turnip, greens	16	--	16

	Vegetable, root, except sugar beet, subgroup 1B	0.45	--	0.60
Recommended tolerance based on crop field trial data

Vegetable, tuberous and corm, subgroup 1C	0.2	--	0.20

	Tolerances for combined residues of flonicamid and its metabolites
TFNA-AM and TFNA in/on livestock commodities [40 CFR 180.613(a)(2)]:

Cattle, fat	--	0.02	0.03	Increased tolerances are needed to reflect
combined limits of quantitation for all regulated residues.

Cattle, meat	--	0.05	0.08

	Egg	--	0.03	0.04	An increased tolerance is needed to account for all
regulated residues.

Goat, fat	--	0.02	0.03	Increased tolerances are needed to reflect
combined limits of quantitation for all regulated residues.

Goat, meat	--	0.05	0.08

	Horse, fat	--	0.02	0.03	Increased tolerances are needed to reflect
combined limits of quantitation for all regulated residues.

Horse, meat	--	0.05	0.08

	Milk	--	0.02	0.03	Increased tolerances are needed to reflect combined
limits of quantitation for all regulated residues.

Poultry, fat	--	0.02	0.03

	Poultry, meat	--	0.02	0.03

	Poultry, meat byproducts	--	0.02	0.03

	Sheep, fat	--	0.02	0.03

	Sheep, meat	--	0.05	0.08

	

References

HED/ARIA Flonicamid: Human Health Risk Assessment (D347805, S Piper,
12/21/07)

HED Amendment to Residue Chemistry Summary Document (D330980, A Acierto,
2/21/08)

HED Flonicamid Risk Assessment (D289592, J. Arthur, 5/25/2005)

HED Residue Chemistry Summary Document (D343466, A. Acierto, 11/08/2007)

HED Dietary Exposure & Risk Assessment (D332316, A. Acierto, 11/16/2007)

EFED Estimated Environmental Concentrations (D330894, D331070, and
D331027, L.              Shanaman, 10/29/2007)

HED/ARIA Occupational Exposure Memo (D345362, M. Dow, 10/16/2007)

Page   PAGE  4  of   NUMPAGES  4