Document ID: EPA-HQ-OPP-2005-0195-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-12-05T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF           

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date: 11/2/07

Subject:	 Ethalfluralin:  Recommended Tolerances for Residues in
Rapeseed, Crambe and Mustard Seed.  Petition No. 2E6466.

DP No.: D346279	Submission No.: 617383

PC Code: 113101	MRID Nos.: n/a

40 CFR 180.416

	

From:		Christina Swartz, Chemist

		Registration Action Branch 2

		Health Effects Division (7509P)

Through:		Douglas Dotson, Chemist

		Registration Action Branch 2

		Health Effects Division (7509P)

To:		Susan Stanton, Risk Manager

		Risk Integration, Minor Use, and Emergency Response Branch

		Registration Division (7505P)

In a review dated 9/4/07, the ARIA team summarized the residue data and
proposed tolerances for residues of ethalfluralin in potato and dill
commodities.  In addition, the status of the residue chemistry database
with respect to the nature of the residue, storage stability data,
analytical methods, etc. was summarized, and concluded to be adequate. 
In a related petition, PP#2E6466, the IR-4 has proposed to allow use of
ethalfluralin on rapeseed (including canola), crambe and mustard seed;
concomitant tolerances of 0.05 ppm for the above commodities have been
proposed.  The tolerance petition indicates ethalfluralin will be
applied in the Sonalan® HFP and Sonalan® 10G formulations to rapeseed,
canola, crambe and mustard seed, at a maximum single and seasonal
application rate of 1.15 lb ai/A.  There is an existing use on canola
with a similar application rate, and with an established tolerance of
0.05 ppm supported by adequate residue data.  In conjunction with the
newly proposed tolerances a Notice of Filing was issued [Federal
Register, Notice of Filing dated 8/31/05, (Volume 70, Number 168)].

In the current petition, the IR-4 stated that the existing residue data
for canola are adequate to support the proposed tolerances, and no
additional residue data are needed.  The ARIA team of RD has already
reviewed the proposed tolerances and concluded they are appropriate, and
supported by adequate residue data.  The estimated dietary exposure
associated with the proposed tolerances was summarized in a memorandum
dated 7/29/02 (J. Redden, DP Barcode No. D283742).  However, the
relevant tolerances were not established/revoked because an aggregate
risk assessment conducted in accordance with the FQPA had not been
completed.

The aggregate risk assessment has now been completed, and aggregate
risks are not of concern.  Therefore, HED recommended in favor of the
proposed tolerances in potato and dill commodities [Risk Assessment, C.
Swartz, DP Barcode Nos. D323068 and D323069, 11/2/07; Dietary Exposure
Assessment, C. Swartz, DP Barcode No. D336469, 11/2/07].  Since the
tolerances proposed under PP#2E6466 have already been included in
HED’s risk assessment, and are supported by adequate residue data and
analytical methods, HED therefore recommends the following tolerances be
established:

Tolerance Summary for Ethalfluralin – Petition # 2E6466

Commodity	Proposed Tolerance (ppm)	Recommended Tolerance (ppm)	Commodity
definition

Rapeseed (including canola)	0.05	0.05	Rapeseed, seed

Crambe	0.05	0.05	Crambe

Mustard seed	0.05	0.05	Mustard, seed

The petitioner (IR-4) also proposed that the existing tolerance on
canola, seed be revoked.  HED concurs with the proposed tolerance
revocation.

HED notes that no CODEX, Canadian or Mexican MRLs (maximum residue
limits) have been established for residues of ethalfluralin for the
commodities rapeseed, seed, crambe and mustard, seed.

Ethalfluralin	Summary of Analytical Chemistry and Residue Data	DP Num:
346279 

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