Document ID: EPA-HQ-OPP-2007-0337-0013
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-09-24T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF           

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:  7/9/2008

SUBJECT:  Cyfluthrin and beta-Cyfluthrin:  Second Addendum to D331951,
Cyfluthrin/Beta-cyfluthrin – Human Health Risk Assessment For New Uses
on Grasses, Alfalfa, and Sugar Beet Seed and Revised Tolerances on
Cereal Grain Commodities; and D339413, Cyfluthrin and beta-Cyfluthrin, 
Summary of Analytical Chemistry and Residue Data.

  

 

PC Codes:  128831:  Cyfluthrin

                   118831:  beta-Cyfluthrin	DP Barcode:  D354195

Decision No.:  377622	Registration No.:  264-745 

Petition Nos.:  7F7200	Regulatory Action:  Section 3 

Risk Assess Type:  None	Case No.:  None 

TXR No.:  None	CAS No.:  68359-37-5

MRID No.:   None 	40 CFR:  180.436

		              							

	          	

FROM:  	Douglas Dotson, Ph.D., Chemist

		Registration Action Branch 2

	Health Effects Division (7509P)  SEQ CHAPTER \h \r 1 		

		

THROUGH:	Richard Loranger, Ph.D., Senior Scientist

		Registration Action Branch 2

Health Effects Division (7509P)  SEQ CHAPTER \h \r 1 	

		

TO:		George LaRocca, RM 13

		Insecticide Branch

		Registration Division (7505P)

The purpose of this memorandum is to inform the Registration Division
that HED recommends in favor of the revision of established or
recommended tolerances for cyfluthrin and beta-cyfluthrin on several
cereal grain commodities.  These commodities are as follows:  barley
bran, oat bran, rye bran, wheat shorts, aspirated grain fractions, field
corn milled byproducts, and teosinte grain.  HED completed a human
health risk assessment for cyfluthrin and beta-cyfluthrin (Memo,
D331951, C. Swartz, et al., 10/23/2007).  In support of this risk
assessment, HED also prepared a residue chemistry summary document
(Memo, D339413, D. Dotson, 10/15/2007).  In both of these documents, HED
recommended in favor of the establishment or revision of tolerances for
cereal grain commodities.  At the time, HED should have recommended in
favor of the revision of the established tolerances for the following
processed commodities:  barley bran, oat bran, rye bran, wheat shorts,
and field corn milled byproducts.  In addition, the commodity teosinte,
grain, was inadvertently left off of the list of commodities for which
HED was recommending tolerances.  HED later prepared a memo and
recommended in favor of a tolerance of 0.15 ppm for teosinte grain
(Memo, D349871, D. Dotson, 2/27/2008).  However, the recommended
tolerance for teosinte grain should have been 0.05 ppm.

A tolerance of 6.5 ppm is currently in effect for wheat, bran.  HED’s
risk assessment of 10/23/2007 (C. Swartz, et al., D331951) recommended
that the wheat bran tolerance be reduced from 6.5 ppm to 0.5 ppm.  This
change was recommended because of the cancellation of the tolerance for
stored cereal grains.  The tolerance for wheat grain is being reduced
from 4.0 ppm to 0.15 ppm.  The wheat field trial data were used to set
the recommended tolerances for the grain of barley, oats, and rye.  The
wheat bran processing factor can also be translated to the bran of
barley, oats, and rye.  As a result, the appropriate recommended
tolerance for barley bran, oat bran, and rye bran is the same as that
for wheat bran, 0.5 ppm.

The tolerance of 11.0 ppm that is currently in effect for wheat, shorts
is also based on the stored grains use.  As the stored grains tolerance
is being revoked, the tolerance for wheat, shorts should be based on the
wheat grain HAFT for the preharvest use (0.17 ppm) and the processing
factor for wheat shorts (2.7x).  As a result, the tolerance for wheat,
shorts should be reduced to 0.5 ppm.

A tolerance of 600 ppm is currently in effect for grain, aspirated
fractions.  As the stored grains tolerance is being revoked, the
tolerance for aspirated fractions needs to be reduced.  HED’s residue
chemistry summary document of 7/15/2005 (Memo, D321638, Y. Donovan)
recommended that the tolerance be reduced from 600 ppm to 150 ppm once
the stored grain uses have been revoked.  HED continues to recommend in
favor of this change. 

HED’s residue chemistry summary document of 7/15/2005 (Y. Donovan,
D321638) stated that the existing 7.0 ppm tolerance for field corn
byproducts should be deleted once the stored grain uses have been
revoked.  The reason the tolerance was no longer needed is because
quantifiable residues in this commodity would not be expected after the
stored grain tolerance was cancelled. As the Agency is proceeding with
the cancellation of the stored grains use, the tolerance for corn,
field, milled byproducts should be cancelled.

As stated above, HED has recommended in favor of a tolerance of 0.15 ppm
for teosinte grain (Memo, D349871, D. Dotson, 2/27/2008).  This
tolerance was based on the field trial data for wheat grain.  It has
come to the attention of HED that field corn is a better surrogate for
teosinte. The recommended tolerance for field corn grain is 0.05 ppm. 
As a result, the recommended tolerance for teosinte, grain should be
0.05 ppm as well.

 

The tolerance revisions that are recommended above do not increase the
exposure and risk estimates that were reported in the previous risk
assessment for cyfluthrin (Memo, D331951, C. Swartz, et al.,
10/23/2007).  The recommended tolerance changes result in decreases or
(in one case) cancellation of tolerances.

Table 1 provides the proposed and recommended tolerances associated with
tolerance petition 7F7200.  This list is the same as the list provided
in the previous amendment to the residue chemistry summary document
except that it includes the recommended changes discussed above. 

Table 1.  Tolerance Summary for Cyfluthrin and beta-Cyfluthrin

Commodity	Established Tolerance

(ppm)	Proposed Tolerance

(ppm)	Recommended Tolerance

(ppm)	Comments, Correct Commodity Definition

Grass, forage, fodder and hay, group 17, forage	6.0 1	13.0	12	Adequate
grass field trial data are available.

Grass, forage, fodder and hay, group 17, hay	8.0 1	40.0	50

	Alfalfa, forage	-	5.0	5.0	Adequate alfalfa field trial data are
available.

Alfalfa, hay	10.0	15.0	13

	Beet, sugar, roots	-	0.09	0.10	Adequate field trial data are available

Beet, sugar, dried pulp	-	11	1.0	Maximum expected residues are 0.59 ppm
based on HAFT residues of 0.049 ppm and a 12x processing factor for
dried pulp.

Grain, cereal; Crop Group 15 (except Rice)	4.0	4.0	0.15	Wheat, grain;
barley, grain; buckwheat, grain; millet, grain; oat, grain; and rye,
grain.

4.0	0.05	Corn, field, grain; corn, pop, grain; and teosinte, grain.

4.0	0.05	Corn, sweet, kernel plus cob with husks removed

4.0	3.5	Sorghum, grain, grain

Grain, aspirated fractions	600	-	150	Stored grain uses have been
revoked.

Wheat, bran	6.5	-	0.5	Stored grain uses have been revoked. A tolerance
of 0.15 ppm is being recommended for wheat grain.

Wheat, shorts	11.0	-	0.5	Stored grain uses have been revoked. A
tolerance of 0.15 ppm is being recommended for wheat grain.

Barley, bran, oat bran, and rye bran	5.0	-	0.5	Stored grain uses have
been revoked. A tolerance of 0.15 ppm is being recommended for wheat
grain.

Corn, field, refined oil	30.0	-	-	The field corn, grain tolerance will
cover residues in corn oil

Corn, field, milled byproducts	7.0	-	-	Stored grain uses have been
revoked.

Tolerance no longer needed.

Rice, bran	6.0	-	-	Stored grain uses have been revoked

Rice, hulls	18.0	-	-	Stored grain uses have been revoked

Grain, cereal, forage, fodder and straw, Crop Group 16 (except Rice)	-2
7.0	25	Grain, cereal, forage, fodder, and hay, group 16, forage, except
Rice

Grain, cereal, forage, fodder and straw, Crop Group 16 (except Rice)	- 3
7.0	30	Grain, cereal, forage, fodder, and hay, group 16, stover, except
Rice

Grain, cereal, forage, fodder and straw, Crop Group 16 (except Rice)	- 4
7.0	7.0	Grain, cereal, forage, fodder, and hay, group 16, straw, except
Rice

Grain, cereal, forage, fodder and straw, Crop Group 16 (except Rice)	- 5
7.0	6.0	Grain, cereal, forage, fodder, and hay, group 16, hay, except
Rice

Wheat, forage	5.0	-	-	Crop group tolerance is being established for
Forage of Grain, Cereal, except Rice (Crop Group 16)

Corn, field, forage	3.0	-	-

	Corn, sweet, forage	15	-	-

	Sorghum, grain, forage	2.0	-	-

	Corn, field, stover	6.0	-	-	Crop group tolerance is being established
for Stover of Grain, Cereal, except Rice (Crop Group 16)

Corn, pop, stover	6.0	-	-

	Corn, sweet, stover	30.0	-	-

	Sorghum, grain, stover	5.0	-	-

	Wheat, hay	6.0	-	-	Crop group tolerance is being established for Hay of
Grain, Cereal, except Rice (Crop Group 16)

Wheat, straw	6.0	-	-	Crop group tolerance is being established for Straw
of Grain, Cereal, except Rice (Crop Group 16)

Cattle, fat	10	NA	2.0	Based on the recalculated MDBs for beef cattle
(20.9 ppm), dairy cattle (27.1 ppm) and swine (3.21 ppm) and the residue
data from the available cattle feeding study, tolerances for livestock
commodities can be substantially reduced.

Cattle, meat	0.4	NA	0.10

	Cattle, meat byproducts	0.4	NA	0.10

	Goat, fat	10	NA	2.0

	Goat, meat	0.4	NA	0.05

	Goat, meat byproducts	0.4	NA	0.05

	Hog, fat	10	NA	0.5

	Hog, meat	0.4	NA	0.01

	Hog, meat byproducts	0.4	NA	0.01

	Horse, fat	10	NA	2.0

	Horse, meat	0.4	NA	0.05

	Horse, meat byproducts	0.4	NA	0.05

	Milk	1.0	NA	0.2

	Milk, fat	30	NA	5.0

	Sheep, fat	10	NA	2.0

	Sheep, meat	0.4	NA	0.05

	Sheep, meat byproducts	0.4	NA	0.05

	

NA = not applicable

1 Regionally restricted tolerances for grass grown in CA, OR, ID and WA.

2 Forage tolerances are established for wheat (5.0 ppm), field corn (3.0
ppm), sweet corn (15 ppm), and sorghum (2.0 ppm)

3 Stover tolerances are established for field corn (6.0 ppm), popcorn
(6.0 ppm), sweet corn (30 ppm), and sorghum (5.0 ppm)

4 A straw tolerance is established for wheat (6.0 ppm)

5 A hay tolerance is established for wheat (6.0 ppm)

.

 

Cyfluthrin and beta-Cyfluthrin		Barcode:  D354195

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