UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF CHEMICAL SAFETY AND

                                                                                POLLUTION PREVENTION

MEMORANDUM

DATE:  	August 9, 2010

SUBJECT:	Fluazifop-p- Butyl Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for the Section 3 Registration Action to add uses on Banana, Plantains, Citrus, Grapes, Potato and Sugar beet.

PC Code:  122809	DP Barcode:   D379452

Decision No.: 421332	Registration No.: 100-1070

Petition No.: 7F7289	Regulatory Action: Amended Section 3

Risk Assessment Type: Dietary Exposure	Case No.: 2285

TXR No.: NA	CAS No.: 79241-46-6

MRID No.: 	40 CFR:180.411

REVIEWER:	Seyed Tadayon, Chemist

Risk Assessment Branch V

Health Effects Division (7509P)

THROUGH:	Thurston Morton, Chemist

David Soderberg, Chemist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

TO:		Pete Savoia, Risk Assessor

Risk Assessment Branch V

Health Effects Division (7509P)

Executive Summary

Acute and chronic dietary risk assessments for fluazifop-p-butyl were conducted using the Dietary Exposure Evaluation Model DEEM-FCID(, Version 2.03,  which uses food consumption data from the USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  The analysis was performed to support newly proposed Section 3 registrations on banana, plantains, citrus, grapes, potato and sugar beet.

An acute dietary (food and drinking water) exposure assessment was conducted for all established and proposed uses of fluazifop-p-butyl.  Acute anticipated residues for all commodities were derived from tolerance level residues, and a ratio adjustment for additional metabolites of concern.  Estimated and default processing factors along with percent crop treated (100%CT) were also used as available.  Estimated drinking water concentrations (EDWCs) from the Environmental Fate and Effects Division (EFED) were also included.  Surface drinking water concentrations were estimated using the PRZM/EXAMS computer model with the Index Reservoir and Percent Crop Area.  The model predicts that the maximum concentration of total residues of fluazifop-p-butyl in surface water is not likely to exceed 33.4 ppb from the use of an aerial application to banana and plantains.  Dietary risk estimates are provided for the only population subgroup with an acute dietary endpoint, females 13-49 years of age (13% aPAD).  No acute dietary end point attributable to a single dose was identified for general population including infants and children. This assessment concludes that for all supported registered commodities and new uses, the acute food plus water dietary risk estimates are below the Agency’s level of concern (<100 % aPAD).

A refined chronic dietary exposure analyses was also performed in order to determine the chronic exposure and risks that result from the registered uses and proposed uses of fluazifop-p-butyl.  Mean residue level from crop field trials with a ratio adjustment for additional metabolites of concern, percent crop treated estimates, and experimentally determined processing factors were used in these assessments (where available; otherwise default processing factors were used).  A point estimate was used to assess the dietary exposure and risk resulting from fluazifop-p-butyl residues in water. Drinking water was represented by a single point estimate of average fluazifop-p-butyl residues.  The estimated surface water concentration of 6.6 ppb was based on the one in ten year annual mean from the grape application rate.  Dietary risk estimates are provided for the U.S. population (total) and various population subgroups.  This assessment also concludes that for all commodities, the chronic food plus water dietary risk estimates are below the Agency’s level of concern (<100 %cPAD) for the U.S. population (12% cPAD) and all population subgroups.  The most highly exposed population subgroup in the chronic dietary exposure analysis is children 1-2 years of age (40% cPAD).

Fluazifop-p-butyl is classified as a “not likely to be carcinogenic to humans;” therefore, no dietary cancer assessment was performed.

I.	Introduction

	Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the population adjusted dose (PAD).  The PAD is equivalent to point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

	For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site:  “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 6/21/2000, web link:  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf.

	The most recent dietary assessment for fluazifop-p-butyl was conducted by S. Tadayon, D 3562009, 9/16/ 2008.

II.	Residue Information

	Fluazifop-p-butyl is the resolved isomer (R enantiomer) of fluazifop-butyl [(R,S)-2-(4-((5-(trifluoromethyl)-2-pyridinyl)oxy)phenoxy)propanoic acid, butyl ester].  The fluazifop-butyl isomers are List B chemicals.  Fluazifop-butyl (PC code 122805) has been canceled and only fluazifop-p-butyl is being supported for reregistration.

	Fluazifop-p-butyl [(R)-2-(4-((5-(trifluoromethyl)-2-pyridinyl)oxy)phenoxy)propanoic acid, butyl ester] is a selective herbicide registered for use for postemergence control of perennial and annual grass weeds.  Fluazifop-p-butyl is currently registered for food/feed use on asparagus, carrot, coffee, cotton, endive (escarole), garlic, macadamia nut, onion (bulb), pecan, pepper, rhubarb, soybean, stone fruit, sweet potato, dry beans, peanuts, soybeans and yam (DP Barcode: 298939, S. Kinard, 6/22/04 and DP Barcode 3562009, S.Tadayon, 9/16/2008 ).

Fluazifop-p-butyl Use

	Fluazifop-p-butyl products are registered in the U.S. to Syngenta Crop Protection, Inc. Currently, the 0.086, 0.47, 1, 2, and 4 lb/gal emulsifiable concentrate (EC) formulations of fluazifop-p-butyl are registered for use on food/feed crops.  The products are typically applied as postemergence foliar or soil applications using ground or aerial equipment; preplant, at-planting and/or postharvest applications (to the plant) are also registered for some crops.

	The nature of the residue in plants and livestock is not adequately understood; additional plant metabolism studies with a root crop and a leafy vegetable, as well as ruminant and poultry metabolism studies must be submitted.  In a meeting on March 3, 2004, the Metabolism Assessment Review Committee (MARC) recommended that for tolerance expression (both plants and animals), risk assessment of livestock commodities, and drinking water, the residues of concern are parent and fluazifop-acid (free and conjugated). However, the MARC also recommended that for risk assessment, the residues of concern are parent, fluazifop-acid (free and conjugated), 5-trifluoromethyl-2-pyridone, and 2-(4-hydroxyphenoxy) propionic acid (free and conjugated) (DP Barcode: 298939, S. Kinard, 6/22/04).

Residue Data used for Acute and Chronic Assessments

	For acute dietary exposure assessment, tolerance level residues with a ratio adjustment for additional metabolites of concern, 100 % crop treated (CT), and default processing factors were used. For chronic dietary exposure assessment, %CT estimates from BEAD (memo dated May 27, 2010 by A. Grube) and average value from field trials with a ratio adjustment were utilized.  Default processing factor and measured processing factor (potato) were also used in chronic assessment.

	The analytical protocol can not detect the additional residues resulting from all metabolites. To account for all additional metabolites of concern for non-cancer risk identified by the MARC (parent, fluazifop-acid plus 5-trifluoromethyl-2-pyridone, and 2-(4-hydroxyphenoxy) propionic acid), data from the fluazifop carrot (MRID No. 00152494), celery (MRID No. 40693102), and soybean (MRID Nos. 41994701-41994703) metabolism studies were used to derive residue adjustment factors by dividing residues of the pyridone plus the propionic acid by residues of parent and fluazifop-acid.  Adjustment factors ranged from 0.12 xs  to 0.9 xs. These adjustment factors were multiplied by the tolerance level or average field trial residues (parent plus fluazifop acid), to derive estimates of non-measured metabolite residues.  The derived values and tolerance level residues were added together to reflect the total residue of concern (parent and fluazifop acid plus the pyridone plus the propionic acid).  The ratios and estimates used in these assessments are listed in the tables 1 and 2.

Table 1.  Metabolite Ratios

Residue	Carrot roots*	Celery stems	Celery leaves	Soybean

	%TRR	ppm	%TRR	ppm	%TRR	ppm	%TRR	ppm

fluazifop plus fluazifop acid	33.75	0.0885	39.6	0.032	62.7	0.401	28	3.1

5-trifluoromethyl-2-pyridone	1.0	0.003	2.8	0.003	9.6	0.061	–	--

2-(4-hydroxyphenoxy) propionic acid	5.6	0.019	1.1	0.001	0.3	0.002	25.5 2.8

Ratio used in the assessment	0.25X	0.12X	0.16X	0.9X

eg calculation (0.003 + 0.019)/0.0885=0.25X

(0.25X)(Tolerance)+Tolerance=AR

For the purpose of this petition only, the available soybean metabolism study and derived metabolite ratio will support the new uses on banana, plantains, citrus, grapes, potato and sugar beet.  The soybean ratio of 0.9x used for the new uses.  The resulting dietary assessment is very conservative.

Field Trials

Adequate field trial data depicting fluazifop-p-butyl residues following applications made according to the maximum or proposed use patterns have been submitted for various crops. A summary of submitted field trial data are presented below:

Apricot

Apricot translated from peach and 100% CT assumed.   Peach field trial data were used for apricot from MRID 92068039.  There were 4 residue values.  An average fluazifop-p-butyl residue point estimate of 0.015 ppm and an adjustment factor of 1.9 were used for the chronic analysis for all food forms.

Asparagus

BEAD estimates average % crop treated (CT) and maximum % CT of 2.5% and 5% CT for asparagus.  Field trial data were used for asparagus from MRID 92068023. There were 8 residue values for asparagus.  An average fluazifop-p-butyl residue point estimate of 0.57 ppm and an adjustment factor of 1.12 (0.64 ppm) were used for the chronic analysis for all food forms. To account for % crop treated factor 2 was set to 0.025.

Cherry

BEAD estimates average % crop treated (CT) and maximum % CT of 1% and 2.5% CT for cherry.  Field trial data were used for cherry from MRID 92068038. There were 5 residue values for cherry.  An average fluazifop-p-butyl residue point estimate of 0.015 ppm and an adjustment factor of 1.9 (0.029 pm) were used for the chronic analysis for all food forms. To account for % crop treated factor 2 was set to 0.01.

Dry Beans

BEAD estimates average % crop treated (CT) and maximum % CT of 1% and 2.5% CT for dry beans.  Field trial data were used for dry beans from MRID 47285501. There were 24 residue values for dry beans.  An average fluazifop-p-butyl residue point estimate of 5.4 ppm and an adjustment factor of 1.9 (10.26 ppm) were used for the chronic analysis for all food forms. To account for % crop treated factor 2 was set to 0.01.

Endive

Field trial data were used for endive from MRID 92068027.  There were 4 residue values for endive.  An average fluazifop-p-butyl residue point estimate of 0.005 ppm and an adjustment factor of 1.16 were used for the chronic analysis for all food forms.

Macadamia Nut

Field trial data were used for macadamia nut from MRID 92068037.  There were 8 residue values for macadamia nut.  An average fluazifop-p-butyl residue point estimate of 0.05 ppm and an adjustment factor of 1.9 were used for the chronic analysis for all food forms.

Peach

BEAD estimates average % crop treated (CT) and maximum % CT of 2.5 and 10.0% CT for peach.  Field trial data were used for peach from MRID 92068039. There were 4 residue values for peach.  An average fluazifop-p-butyl residue point estimate of 0.015 ppm and an adjustment factor of 1.9 (0.029 ppm) were used for the chronic analysis for all food forms. To account for % crop treated factor 2 was set to 0.025.

Peanut

BEAD estimates average % crop treated (CT) and maximum % CT of 1% and 2.5% CT for peanut.  Field trial data were used for peanut from MRID 47285503. There were 21 residue values for peanut.  An average fluazifop-p-butyl residue point estimate of 0.40 ppm and an adjustment factor of 1.9 (0.76 ppm) were used for the chronic analysis for all food forms. To account for % crop treated factor 2 was set to 0.01.

Peppers

BEAD estimates average % crop treated (CT) and maximum % CT of 1% and 2.5% CT for peppers.  Field trial data were used for pepper from MRID 92068031. There were 4 residue values for pepper.  An average fluazifop-p-butyl residue point estimate of 0.06 ppm and an adjustment factor of 1.12 (0.67 ppm) were used for the chronic analysis for all food forms.  To account for % crop treated factor 2 was set to 0.01.

Plum

Field trial data were used for plum from MRID 92068034.  There were 8 residue values for plum.  An average fluazifop-p-butyl residue point estimate of 0.01 ppm and an adjustment factor of 1.9 (0.19 ppm) were used for the chronic analysis for all food forms. To account for % crop treated factor 2 was set to 0.01.

Rhubarb

Field trial data were used for rhubarb from MRID 92068032.  There were 8 residue values for rhubarb.  An average fluazifop-p-butyl residue point estimate of 0.19 ppm and an adjustment factor of 1.12 were used for the chronic analysis for all food forms.

Citrus

Field trial data were used for citrus from MRID 47874602.  There were 17 residue values for citrus.  An average fluazifop-p-butyl residue point estimate of 0.05 ppm and an adjustment factor of 1.9 were used for the chronic analysis for all food forms.

Carrot

BEAD estimates average % crop treated (CT) and maximum % CT of 10% and 20% CT for carrot.  Field trial data were used for carrot from MRID 92068024. There were 12 residue values for carrot.  An average fluazifop-p-butyl residue point estimate of 0.03 ppm and an adjustment factor of 1.125 (0.038) were used for the chronic analysis for all food forms. To account for % crop treated factor 2 was set to 0.10.

Onion

BEAD estimates average % crop treated (CT) and maximum % CT of 15% and 25% CT for onion.  Field trial data were used for onion from MRID#s 92068028, 92068029. There were 19 residue values for onion.  An average fluazifop-p-butyl residue point estimate of 0.03 and an adjustment factor of 1.125 (0.038) were used for the chronic analysis for all food forms. To account for % crop treated factor 2 was set to 0.15

Garlic

BEAD estimates average % crop treated (CT) and maximum % CT of 5% and 10% CT for onion.  Field trial data were translated from onion from MRID#s 92068028, 92068029. There were 19 residue values for onion.  An average fluazifop-p-butyl residue point estimate of 0.03 and an adjustment factor of 1.125 (0.038) were used for the chronic analysis for all food forms. To account for % crop treated factor 2 was set to 0.05.

Grapes

Field trial data were used for grape from MRID 47874604.  There were 12 residue values for grape.  An average fluazifop-p-butyl residue point estimate of 0.005 ppm and an adjustment factor of 1.9 were used for the chronic analysis for all food forms.

Potato

Field trial data were used for potato from MRID 47920402.  There were 26 residue values for potato.  An average fluazifop-p-butyl residue point estimate of 0.11 ppm and an adjustment factor of 1.25 were used for the chronic analysis for all food forms.

Soybeans

Field trial data were used for soybeans from MRID 92067046.  There were 34 residue values for soybeans.  An average fluazifop-p-butyl residue point estimate of 1.0 ppm and an adjustment factor of 1.9 (1.9) were used for the chronic analysis for all food forms. To account for % crop treated factor 2 was set to 0.025.

Sugar beet

Field trial data were used for sugar beet from MRID 47874603.  There were 24 residue values soybeans.  An average fluazifop-p-butyl residue point estimate of 0.08 ppm and an adjustment factor of 1.9 were used for the chronic analysis for all food forms.

Table 2.  Residue Estimates Used in Dietary Analyses

RAC	Food

Forms	%CT

(Acute)	%CT

(chronic)	Processing

Factors	Tolerance

	Average Residue (Field Trials)	Ratio

Apricot	all except dried	100	100	1	0.05	0.015	0.9 x1

	dried

	6

	Asparagus	all	100	2.5	1	3.0	0.57	0.12x2

Banana (New Use)	all	100	100	1	0.01	0.01	0.9 x1

Beef	all except dried	100	100	1	0.05	0.05	NA

	dried	100

1.92

	Carrot	all	100	10	1	2.0	0.03	0.25x4

1.5 juice

	Cherry	all	100	1.0	1	0.05	0.015	0.9x1

Chicken	all	100	100	1	0.05	0.05	NA

Citrus (New Use)	all	100	100	1	0.05	0.05	0.9x1

Coffee	all	100	100	1	0.10	0.10	0.9x1

Cottonseed	all	100	2.5	1	0.20	0.20	0.9x1

Dry Beans	all	100	1.0	1	50 	5.4	0.9x1

Egg	all	100	100	1	0.05	0.05	NA

Endive	all	100	100	1	6.0	0.05	0.16x3

Grapes (New Use)	all	100	100

0.01	0.005	0.9x1

Goat	all	100	100	1	0.05	0.05	NA

Garlic	all except dried	100	5	1	0.50	0.03	0.25x4

	dried

Horsemeat	all	100	100	1	0.05	0.05	NA

Macadamia Nut	all	100	100	1	0.10	0.05	0.9x

Milk	all	100	100	1	0.05	0.05	NA

Nectarine	all	100	100	1	0.05	0.05	0.9x1

Onion (bulb)	all except dried	100	15	1	0.50	0.03	0.25x4

	dried	100

9

Peach	all except dried	100	2.5	1	0.05	0.015	0.9x1

	dried	100

7

	Pecan	all	100	100	1	0.05	0.05	0.9x1

Peanut	all	100	1	1	1.5	0.38	0.9x1

Peanut oil

0.01

	Peanut butter

1.89

	Pepper (non-bell)	all	100	1	1	1.0	0.6	0.12x2

Plantain (New Use)	all	100	100	1	0.01	0.01	0.9x1

Plum	all except dried and juice	100	100	1	0.05	0.01	0.9x1

	dried	100

5

Prune, juice	100

1.4

	Pork	all	100	100	1	0.05	0.05	NA

Poultry	all	100	100	1	0.05	0.05	NA

Potato (New Use)	all	100	100	1.4 cooked	1	0.11	0.25x4

3.3 chips

	6.4 dried

	Rhubarb	all	100	100	1	0.50	0.19	0.12x2

Sheep	all	100	100	1	0.05	0.05	NA

Soybean	all except oil	100	100	1	2.5 	1.0	0.9x1

Soybean, oil	oil	100	100	0.01	2.0	2.0	0.9x1

Spinach	all	100	100	1	6	0.05	0.16x3

Sugar Beet (New Use)	Root	100	100	1	0.25	0.08	0.9x1

	Top

100	1	1.50	008	0.9x1

	Dried Pulp

100	1	1	0.08	0.9x1

	Molasses

100	1	3.5	0.08	0.9x1

Sweet potato	all	100	10	1	1.0	0.11	0.25x4

Turkey	all	100	100	1	0.05	0.05	NA

Water	all direct and indirect sources	100	100	1	0.0334 (acute)

0.0066 (chronic)

NA

Yam	all	100	100	1	1.0	0.11	0.25x4

1		Soybean metabolism study.

2		Celery metabolism study (stalks).

3		Celery metabolism study (leaves).

4		Carrot metabolism study (roots).

III Drinking Water Data

	The drinking water residues used in the dietary risk assessment were provided by the Environmental Fate and Effects Division (EFED) in the following memorandum: “Revised Drinking Water Assessment for the Section 3 Registration of Fluazifop-p-butyl For Use on bananas, plantains, citrus, grapes, and sugar beets pre-bloom and post-bloom (Wm. J. Shaughnessy, D371093, 05/25/2010) and incorporated directly into this dietary assessment.  Water residues were incorporated in the DEEM-FCID into the food categories “water, direct, all sources” and “water, indirect, all sources.”

Estimated exposure concentrations (EECs) in ground water were modeled using Tier I SCIGROW (version 2.3, dated July 29, 2003) and surface water EECs were modeled using Tier II PRZM (Pesticide Root Zone Model; vers. 3.12.2, May 12, 2005) and EXAMS (Exposure Analysis Modeling System; Vers. <IP_ADDRESS>).  The results of this analysis are presented in   REF _Ref201544974 \h  \* MERGEFORMAT  Table 3 .  Estimated exposure concentrations represent exposure to fluazifop-acid, with assumptions that fluazifop-acid may be present in the R or S form or as a mixture of the enantiomers.

The results of current assessment are higher than 2008 assessment (DP No. D347521, K. White, 08/04/2008).  For aerial applications the highest surface water EECs reported for peak, 1 in 10 year average, and the 30 year average as estimated by PRZM/EXAMS for all crop use scenarios were 33.4, 6.6 ppb, and 4.4 ppb, respectively.  For ground applications the highest EECs for peak, 1 in 10 year average, and the 30 year average were 32.1 ppb, 5.8 ppb, and 3.1 ppb, respectively.  SCI-GROW estimated the concentration of fluazifop-acid in shallow ground water sources to be 1.56 ppb.  The difference between the 2008 and current assessment results can be attributed to a proposed increase in the maximum number of allowable applications (i.e., 3 vs. 2), and differences in crop use scenarios used in the two assessments.

g/L)

	Acute or Peak	1 in 10 year Average (Noncancer Chronic)	30 year Average (Cancer Chronic)

Aerial Applications 	Surface Water

Bananas & Plantains	33.4	6.2	3.2

Citrus	28.5	5.4	3.7

Grapes	19.8	6.6	4.4

Sugar Beets

	Ground Applications	Surface Water

Bananas & Plantains	32.1	5.8	2.7

Citrus	27.3	5.1	2.8

Grapes	16.6	5.3	3.1

Sugar Beets	10.6	3.9	2.3

All Uses	Ground Water

	1.56	1.56	1.56

IV DEEM-FCID( Program and Consumption Information

	Fluazifop-p-butyl acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID(, Version 2.03), which incorporates consumption data from USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII), 1994-1996 and 1998.  The 1994-96, 98 data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods “as consumed” (e.g., apple pie) are linked to EPA-defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA.  For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events.  Based on analysis of the 1994-96, 98 CSFII consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.

	For chronic dietary exposure assessment, an estimate of the residue level in each food or food-form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate.  The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure.  Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD.  This procedure is performed for each population subgroup.

	For acute exposure assessments, individual one-day food consumption data are used on an individual-by-individual basis.  The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic assessment.  The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis.  In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis.  However, for tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

V.	Toxicological Information

	On May 6, 2004, the Health Effects Division (HED) Hazard Identification Assessment Review Committee (HIARC) reviewed the recommendations of the toxicology reviewer for Fluazifop-butyl and Fluazifop-p-butyl with regard to the acute and chronic Reference Doses (RfDs) and the toxicological endpoint selection for use as appropriate in occupational/residential exposure risk assessments.  The potential for increased susceptibility of infants and children from exposure to Fluazifop-butyl and Fluazifop-p-butyl was also evaluated as required by the Food Quality Protection Act (FQPA) of 1996 (TXR NO.  0052611; memo dated June 15, 2004 by D. Anderson).  The conclusions drawn at this meeting are presented in Table 4 below.

Table 4.  Summary of Toxicological Doses and Endpoints for Fluazifop-p-butyl for Use in Dietary Exposure Assessment

Exposure

Scenario

Dose Used in Risk

Assessment, UF

Hazard and Exposure Based  FQPA Safety Factor

Study and Toxicological Effects

Acute Dietary

(General population including infants and children)

An appropriate endpoint attributable to a single dose was not identified in the available studies including the developmental toxicity studies.

Acute Dietary

(Females 13-49 years of age)

NOAEL = 50 mg/kg/day

UF = 100

Acute RfD = 0.50 mg/kg

FQPA SF = 1X

aPAD = acute RfD

              FQPA SF

 = 0.50  mg/kg/day

Developmental Toxicity in rats.

LOAEL = 200 mg/kg/day based on diaphragmatic hernia.

Chronic Dietary

(All populations)

NOAEL= 0.74  mg/kg/day

UF = 100

Chronic RfD =

0.008 mg/kg/day

FQPA SF = 1X

cPAD = chronic RfD

               FQPA SF

= 0.0074 mg/kg/day

Two-Generation Reproduction in rats.

LOAEL = 5.8 mg/kg/day in males and 7.1 in females based on decreased spleen, testes & epididymal weights in males and uterine & pituitary weights in females.

Cancer

“Not likely to be carcinogenic to humans.”

VI.	Results/Discussion

	As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID( analyses estimate the dietary exposure of the U.S. population and various population subgroups.  The results reported in Tables 5 and 6 are for the general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years.

Results of Acute Dietary Exposure Analysis

	Dietary risk estimates are presented for the only population subgroup with an acute dietary endpoint, females 13-49 years of age (13 % aPAD at 95.0th percentile).  No acute dietary end point attributable to a single dose was identified for general population including infants and children. This assessment concludes that for all supported registered commodities and new uses, the acute food plus water dietary risk estimates are below the Agency’s level of concern (<100 % aPAD).This assessment is considered to be conservative.  The results are listed below in Table 5.

Table 5.  Summary of Acute Dietary (Food + Drinking Water) Exposure and Risk for Fluazifop-p-butyl

Population Subgroup	aPAD (mg/kg/day)	95th Percentile	99th Percentile 99.9th Percentile

Exposure (mg/kg/day)	% aPAD	Exposure (mg/kg/day)	% aPAD	Exposure (mg/kg/day)	% aPAD

Female 13-49 years old	0.5	0.0641	13	0.1515	30	0.3673	74

Results of Chronic Dietary Exposure Analysis

This assessment concludes that for all commodities, the chronic food plus water dietary risk estimates are below the Agency’s level of concern (<100 %cPAD) for the U.S. population (12% cPAD) and all population subgroups.  The most highly exposed population subgroup in the chronic dietary exposure analysis is children 1-2 years of age (40% cPAD). This assessment is still considered to be fairly conservative since mean residue estimates were used.  Results for all populations considered are listed below in Table 6.

Table6.  Summary of Chronic Dietary (Food + Drinking Water) Exposure and Risk for Fluazifop-p-butyl.

Population Subgroup	cPAD (mg/kg/day)	Exposure (mg/kg/day)	% cPAD

General U.S. Population	0.0074	0.0009	12

All Infants (< 1 year old)

0.0015	20

Children 1-2 years old

0.003	40

Children 3-5 years old

0.0022	30

Children 6-12 years old

0.0014	19

Youth 13-19 years old

0.0008	11

Adults 20-49 years old

0.007	8.9

Adults 50+ years old

0.0006	8.7

Females 13-49 years old

0.0006	8.6

VII.	Characterization of Inputs/Outputs

	Anticipated residues for all registered and proposed food commodities were based on field trial data and percent crop treated.  Although field trial data provide more refined exposure estimates than tolerances, the results may still be considered somewhat conservative, since field trials are conducted under maximum use conditions (maximum allowed application rate and number of applications, minimum PHI, etc.).

VIII.	Conclusions

	Acute and chronic dietary exposure analyses (including food and water) were performed in order to determine the exposure and risks resulting from the registered uses and new proposed uses of fluazifop-p-butyl.  Tolerance level values with a ratio adjustment for additional metabolites of concern, default processing factors, and refined point estimates for residues in water were used in these assessments. Percent CT refinements were included for the acute and chronic dietary exposure analysis.  This assessment concludes that for all supported registered commodities and new proposed uses, the acute dietary risk estimates are below the Agency’s level of concern (<100 %aPAD) for  females 13-49 years of age (<13 % aPAD) at the 95th exposure percentile.  Chronic dietary risk estimates are provided for the U.S. population (total) and various population subgroups.  The chronic assessment concludes that for all supported commodities and proposed uses, the chronic dietary risk estimates are below the Agency’s level of concern  (<100 %cPAD) for the U.S. population (12% cPAD) and all population subgroups.  The most highly exposed population subgroup in the chronic dietary exposure analysis is children 1-2 years of age (40% cPAD).

VIII.	List of Attachments

Acute Food plus Water Residue Input file.

Chronic Food plus Water Residue Input file.

Acute Results file.

Chronic Results file.

Percent Crop Treated Memo from BEAD

Attachment: Acute Food plus Water Residue Input File

Filename: C:\Documents and Settings\stadayon\My Documents\Work in Progress\122809a.R98

Chemical: Fluazifop p butyl

RfD(Chronic): 0 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): 0 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day

Date created/last modified: 07-27-2010/13:23:34/8          Program ver. 2.03

------------------------------------------------------------------------ --------

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

-------- ---- -------------------------------  ----------  ------ ------  -------

12000120 12   Apricot                            0.095000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

12000121 12   Apricot-babyfood                   0.095000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

12000130 12   Apricot, dried                     0.095000   6.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

12000140 12   Apricot, juice                     0.095000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

12000141 12   Apricot, juice-babyfood            0.095000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

95000190 O    Asparagus                          3.360000   1.000  0.010  Ratio

          Full comment: Ratio from celery metabolism

95000230 O    Banana                             0.019000   1.000  1.000

95000231 O    Banana-babyfood                    0.019000   1.000  1.000

95000240 O    Banana, dried                      0.019000   1.000  1.000

95000241 O    Banana, dried-babyfood             0.019000   1.000  1.000

06030300 6C   Bean, black, seed                 95.000000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

06030320 6C   Bean, broad, seed                 95.000000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

06030340 6C   Bean, cowpea, seed                95.000000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

06030350 6C   Bean,  great northern, seed       95.000000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

06030360 6C   Bean, kidney, seed                95.000000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

06030380 6C   Bean, lima, seed                  95.000000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

06030390 6C   Bean, mung, seed                  95.000000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

06030400 6C   Bean, navy, seed                  95.000000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

06030410 6C   Bean, pink, seed                  95.000000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

06030420 6C   Bean, pinto, seed                 95.000000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

21000440 M    Beef, meat                         0.050000   1.000  1.000

21000441 M    Beef, meat-babyfood                0.050000   1.000  1.000

21000450 M    Beef, meat, dried                  0.050000   1.920  1.000

21000460 M    Beef, meat byproducts              0.050000   1.000  1.000

21000461 M    Beef, meat byproducts-babyfood     0.050000   1.000  1.000

21000470 M    Beef, fat                          0.050000   1.000  1.000

21000471 M    Beef,fat-babyfood                  0.050000   1.000  1.000

21000480 M    Beef, kidney                       0.050000   1.000  1.000

21000490 M    Beef, liver                        0.050000   1.000  1.000

21000491 M    Beef, liver-babyfood               0.050000   1.000  1.000

01010500 1AB  Beet, garden, roots                0.475000   1.000  1.000

01010501 1AB  Beet, garden, roots-babyfood       0.475000   1.000  1.000

02000510 2    Beet, garden, tops                 2.850000   1.000  1.000

01010520 1A   Beet, sugar                        0.475000   1.000  1.000

01010521 1A   Beet, sugar-babyfood               0.475000   1.000  1.000

01010530 1A   Beet, sugar, molasses              6.650000   1.000  1.000

01010531 1A   Beet, sugar, molasses-babyfood     6.650000   1.000  1.000

01010780 1AB  Carrot                             2.500000   1.000  0.100  Ratio

          Full comment: Ratio from carrot metabolism

01010781 1AB  Carrot-babyfood                    2.500000   1.000  0.100  Ratio

          Full comment: Ratio from carrot metabolism

01010790 1AB  Carrot, juice                      2.500000   1.000  0.100  Ratio

          Full comment: Ratio from carrot metabolism

12000900 12   Cherry                             0.095000   1.000  1.000

12000901 12   Cherry-babyfood                    0.095000   1.000  1.000

12000910 12   Cherry, juice                      0.095000   1.500  1.000

12000911 12   Cherry, juice-babyfood             0.095000   1.500  1.000

40000930 P    Chicken, meat                      0.050000   1.000  1.000

40000931 P    Chicken, meat-babyfood             0.050000   1.000  1.000

40000940 P    Chicken, liver                     0.050000   1.000  1.000

40000950 P    Chicken, meat byproducts           0.050000   1.000  1.000

40000951 P    Chicken, meat byproducts-babyfoo   0.050000   1.000  1.000

40000960 P    Chicken, fat                       0.050000   1.000  1.000

40000961 P    Chicken, fat-babyfood              0.050000   1.000  1.000

40000970 P    Chicken, skin                      0.050000   1.000  1.000

40000971 P    Chicken, skin-babyfood             0.050000   1.000  1.000

06030980 6C   Chickpea, seed                    95.000000   1.000  1.000

06030981 6C   Chickpea, seed-babyfood           95.000000   1.000  1.000

06030990 6C   Chickpea, flour                   95.000000   1.000  1.000

10001060 10   Citrus citron                      0.100000   1.000  1.000

10001070 10   Citrus hybrids                     0.100000   1.000  1.000

10001080 10   Citrus, oil                        0.100000   1.000  1.000

95001150 O    Coffee, roasted bean               0.190000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

95001160 O    Coffee, instant                    0.190000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

95001280 O    Cottonseed, oil                    0.380000   1.000  0.025  Ratio

          Full comment: Ratio from soybean metabolism

95001281 O    Cottonseed, oil-babyfood           0.380000   1.000  0.025  Ratio

          Full comment: Ratio from soybean metabolism

70001450 P    Egg, whole                         0.050000   1.000  1.000

70001451 P    Egg, whole-babyfood                0.050000   1.000  1.000

70001460 P    Egg, white                         0.050000   1.000  1.000

70001461 P    Egg, white (solids)-babyfood       0.050000   1.000  1.000

70001470 P    Egg, yolk                          0.050000   1.000  1.000

70001471 P    Egg, yolk-babyfood                 0.050000   1.000  1.000

04011500 4A   Endive                             6.960000   1.000  1.000

03001640 3    Garlic                             0.625000   1.000  1.000

03001650 3    Garlic, dried                      0.625000   9.000  1.000

03001651 3    Garlic, dried-babyfood             0.625000   9.000  1.000

23001690 M    Goat, meat                         0.050000   1.000  1.000

23001700 M    Goat, meat byproducts              0.050000   1.000  1.000

23001710 M    Goat, fat                          0.050000   1.000  1.000

23001720 M    Goat, kidney                       0.050000   1.000  1.000

23001730 M    Goat, liver                        0.050000   1.000  1.000

13021740 13B  Gooseberry                         0.019000   1.000  1.000

95001750 O    Grape                              0.019000   1.000  1.000

95001760 O    Grape, juice                       0.019000   1.000  1.000

95001761 O    Grape, juice-babyfood              0.019000   1.000  1.000

95001770 O    Grape, leaves                      0.019000   1.000  1.000

95001780 O    Grape, raisin                      0.019000   1.000  1.000

95001790 O    Grape, wine and sherry             0.019000   1.000  1.000

10001800 10   Grapefruit                         0.100000   1.000  1.000

10001810 10   Grapefruit, juice                  0.100000   1.000  1.000

06031820 6C   Guar, seed                        95.000000   1.000  1.000

06031821 6C   Guar, seed-babyfood               95.000000   1.000  1.000

10001970 10   Kumquat                            0.100000   1.000  1.000

10001990 10   Lemon                              0.100000   1.000  1.000

10002000 10   Lemon, juice                       0.100000   1.000  1.000

10002001 10   Lemon, juice-babyfood              0.100000   1.000  1.000

10002010 10   Lemon, peel                        0.100000   1.000  1.000

06032030 6C   Lentil, seed                      95.000000   1.000  1.000

10002060 10   Lime                               0.100000   1.000  1.000

10002070 10   Lime, juice                        0.100000   1.000  1.000

10002071 10   Lime, juice-babyfood               0.100000   1.000  1.000

14002130 14   Macadamia nut                      0.190000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

27002220 D    Milk, fat                          0.050000   1.000  1.000

27002221 D    Milk, fat - baby food/infant for   0.050000   1.000  1.000

27012230 D    Milk, nonfat solids                0.050000   1.000  1.000

27012231 D    Milk, nonfat solids-baby food/in   0.050000   1.000  1.000

27022240 D    Milk, water                        0.050000   1.000  1.000

27022241 D    Milk, water-babyfood/infant form   0.050000   1.000  1.000

27032251 D    Milk, sugar (lactose)-baby food/   0.050000   1.000  1.000

12002300 12   Nectarine                          0.095000   1.000  1.000

03002370 3    Onion, dry bulb                    0.625000   1.000  0.150  Ratio

          Full comment: Ratio from carrot metabolism

03002371 3    Onion, dry bulb-babyfood           0.625000   1.000  0.150  Ratio

          Full comment: Ratio from carrot metabolism

03002380 3    Onion, dry bulb, dried             0.625000   9.000  0.150  Ratio

          Full comment: Ratio from carrot metabolism

03002381 3    Onion, dry bulb, dried-babyfood    0.625000   9.000  0.150  Ratio

          Full comment: Ratio from carrot metabolism

10002400 10   Orange                             0.100000   1.000  1.000

10002410 10   Orange, juice                      0.100000   1.000  1.000

10002411 10   Orange, juice-babyfood             0.100000   1.000  1.000

10002420 10   Orange, peel                       0.100000   1.000  1.000

12002600 12   Peach                              0.095000   1.000  0.010  Ratio

          Full comment: Ratio from soybean metabolism

12002601 12   Peach-babyfood                     0.095000   1.000  0.010  Ratio

          Full comment: Ratio from soybean metabolism

12002610 12   Peach, dried                       0.095000   7.000  0.010  Ratio

          Full comment: Ratio from soybean metabolism

12002611 12   Peach, dried-babyfood              0.095000   7.000  0.010  Ratio

          Full comment: Ratio from soybean metabolism

12002620 12   Peach, juice                       0.095000   1.000  0.010  Ratio

          Full comment: Ratio from soybean metabolism

12002621 12   Peach, juice-babyfood              0.095000   1.000  0.010  Ratio

          Full comment: Ratio from soybean metabolism

95002630 O    Peanut                             2.850000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

95002640 O    Peanut, butter                     2.850000   1.890  1.000  Ratio

          Full comment: Ratio from soybean metabolism

95002650 O    Peanut, oil                        2.850000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

14002690 14   Pecan                              0.095000   1.000  1.000

08002720 8    Pepper, nonbell                    1.120000   1.000  1.000  Ratio

          Full comment: Ratio from celery metabolism

08002721 8    Pepper, nonbell-babyfood           1.120000   1.000  1.000  Ratio

          Full comment: Ratio from celery metabolism

08002730 8    Pepper, nonbell, dried             1.120000   1.000  1.000  Ratio

          Full comment: Ratio from celery metabolism

12002850 12   Plum                               0.095000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

12002851 12   Plum-babyfood                      0.095000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

12002860 12   Plum, prune, fresh                 0.095000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

12002861 12   Plum, prune, fresh-babyfood        0.095000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

12002870 12   Plum, prune, dried                 0.095000   5.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

12002871 12   Plum, prune, dried-babyfood        0.095000   5.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

12002880 12   Plum, prune, juice                 0.095000   1.400  1.000  Ratio

          Full comment: Ratio from soybean metabolism

12002881 12   Plum, prune, juice-babyfood        0.095000   1.400  1.000  Ratio

          Full comment: Ratio from soybean metabolism

25002900 M    Pork, meat                         0.050000   1.000  1.000

25002901 M    Pork, meat-babyfood                0.050000   1.000  1.000

25002910 M    Pork, skin                         0.050000   1.000  1.000

25002920 M    Pork, meat byproducts              0.050000   1.000  1.000

25002921 M    Pork, meat byproducts-babyfood     0.050000   1.000  1.000

25002930 M    Pork, fat                          0.050000   1.000  1.000

25002931 M    Pork, fat-babyfood                 0.050000   1.000  1.000

25002940 M    Pork, kidney                       0.050000   1.000  1.000

25002950 M    Pork, liver                        0.050000   1.000  1.000

01032960 1C   Potato, chips                      1.250000   3.300  1.000

01032970 1C   Potato, dry (granules/ flakes)     1.250000   6.400  1.000

01032971 1C   Potato, dry (granules/ flakes)-b   1.250000   6.400  1.000

01032980 1C   Potato, flour                      1.250000   6.400  1.000

01032981 1C   Potato, flour-babyfood             1.250000   6.400  1.000

01032990 1C   Potato, tuber, w/peel              1.250000   1.400  1.000

01032991 1C   Potato, tuber, w/peel-babyfood     1.250000   1.400  1.000

01033000 1C   Potato, tuber, w/o peel            1.250000   1.400  1.000

01033001 1C   Potato, tuber, w/o peel-babyfood   1.250000   1.400  1.000

60003010 P    Poultry, other, meat               0.050000   1.000  1.000

60003020 P    Poultry, other, liver              0.050000   1.000  1.000

60003030 P    Poultry, other, meat byproducts    0.050000   1.000  1.000

60003040 P    Poultry, other, fat                0.050000   1.000  1.000

60003050 P    Poultry, other, skin               0.050000   1.000  1.000

10003070 10   Pummelo                            0.050000   1.000  1.000

04023220 4B   Rhubarb                            0.560000   1.000  1.000  Ratio

          Full comment: Ratio from celery metabolism

26003390 M    Sheep, meat                        0.050000   1.000  1.000

26003391 M    Sheep, meat-babyfood               0.050000   1.000  1.000

26003400 M    Sheep, meat byproducts             0.050000   1.000  1.000

26003410 M    Sheep, fat                         0.050000   1.000  1.000

26003411 M    Sheep, fat-babyfood                0.050000   1.000  1.000

26003420 M    Sheep, kidney                      0.050000   1.000  1.000

26003430 M    Sheep, liver                       0.050000   1.000  1.000

06003470 6    Soybean, seed                      4.750000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

06003480 6    Soybean, flour                     4.750000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

06003481 6    Soybean, flour-babyfood            4.750000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

06003490 6    Soybean, soy milk                  4.750000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

06003491 6    Soybean, soy milk-babyfood or in   4.750000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

06003500 6    Soybean, oil                       4.750000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

06003501 6    Soybean, oil-babyfood              4.750000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

04013550 4A   Spinach                            6.960000   1.000  1.000  Ratio

          Full comment: Ratio from celery metabolism

04013551 4A   Spinach-babyfood                   6.960000   1.000  1.000  Ratio

          Full comment: Ratio from celery metabolism

01033660 1CD  Sweet potato                       1.250000   1.000  1.000  Ratio

          Full comment: Ratio from carrot metabolism

01033661 1CD  Sweet potato-babyfood              1.250000   1.000  1.000  Ratio

          Full comment: Ratio from carrot metabolism

10003690 10   Tangerine                          0.050000   1.000  1.000

10003700 10   Tangerine, juice                   0.050000   1.000  1.000

50003820 P    Turkey, meat                       0.050000   1.000  1.000

50003821 P    Turkey, meat-babyfood              0.050000   1.000  1.000

50003830 P    Turkey, liver                      0.050000   1.000  1.000

50003831 P    Turkey, liver-babyfood             0.050000   1.000  1.000

50003840 P    Turkey, meat byproducts            0.050000   1.000  1.000

50003841 P    Turkey, meat byproducts-babyfood   0.050000   1.000  1.000

50003850 P    Turkey, fat                        0.050000   1.000  1.000

50003851 P    Turkey, fat-babyfood               0.050000   1.000  1.000

50003860 P    Turkey, skin                       0.050000   1.000  1.000

50003861 P    Turkey, skin-babyfood              0.050000   1.000  1.000

86010000 O    Water, direct, all sources         0.033400   1.000  1.000

86020000 O    Water, indirect, all sources       0.033400   1.000  1.000

01034060 1CD  Yam, true                          1.250000   1.000  1.000

01034070 1CD  Yam bean                           1.250000   1.000  1.000

Attachment: Chronic Food plus Water Residue Input File

Filename: C:\Documents and Settings\stadayon\My Documents\Work in Progress\122809c 2010 .R98

Chemical: Fluazifop p butyl

RfD(Chronic): 0 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): 0 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day

Date created/last modified: 07-28-2010/07:57:28/8          Program ver. 2.03

------------------------------------------------------------------------ --------

Note: No residue distributions have been assigned to Commodities/FoodForms below

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

-------- ---- -------------------------------  ----------  ------ ------  -------

95000190 O    Asparagus                          0.640000   1.000  0.025  Ratio

          Full comment: Ratio from celery metabolism

95001150 O    Coffee, roasted bean               0.190000   1.000  1.900  Ratio

          Full comment: Ratio from soybean metabolism

95001160 O    Coffee, instant                    0.190000   1.000  1.900  Ratio

          Full comment: Ratio from soybean metabolism

95001280 O    Cottonseed, oil                    0.380000   1.000  0.025  Ratio

          Full comment: Ratio from soybean metabolism

95001281 O    Cottonseed, oil-babyfood           0.380000   1.000  0.025  Ratio

          Full comment: Ratio from soybean metabolism

95001750 O    Grape                              0.005000   1.000  1.900

95001760 O    Grape, juice                       0.005000   1.000  1.900

95001761 O    Grape, juice-babyfood              0.005000   1.000  1.900

95001770 O    Grape, leaves                      0.005000   1.000  1.900

95001780 O    Grape, raisin                      0.005000   1.000  1.900

95001790 O    Grape, wine and sherry             0.005000   1.000  1.900

95002630 O    Peanut                             0.760000   1.000  0.010  Ratio

          Full comment: Ratio from soybean metabolism

95002640 O    Peanut, butter                     0.760000   1.890  0.010  Ratio

          Full comment: Ratio from soybean metabolism

95002650 O    Peanut, oil                        0.760000   0.010  0.010  Ratio

          Full comment: Ratio from soybean metabolism

86010000 O    Water, direct, all sources         0.006600   1.000  1.000

86020000 O    Water, indirect, all sources       0.006600   1.000  1.000

21000440 M    Beef, meat                         0.050000   1.000  1.000

21000441 M    Beef, meat-babyfood                0.050000   1.000  1.000

21000450 M    Beef, meat, dried                  0.050000   1.920  1.000

21000460 M    Beef, meat byproducts              0.050000   1.000  1.000

21000461 M    Beef, meat byproducts-babyfood     0.050000   1.000  1.000

21000470 M    Beef, fat                          0.050000   1.000  1.000

21000471 M    Beef,fat-babyfood                  0.050000   1.000  1.000

21000480 M    Beef, kidney                       0.050000   1.000  1.000

21000490 M    Beef, liver                        0.050000   1.000  1.000

21000491 M    Beef, liver-babyfood               0.050000   1.000  1.000

23001690 M    Goat, meat                         0.050000   1.000  1.000

23001700 M    Goat, meat byproducts              0.050000   1.000  1.000

23001710 M    Goat, fat                          0.050000   1.000  1.000

23001720 M    Goat, kidney                       0.050000   1.000  1.000

23001730 M    Goat, liver                        0.050000   1.000  1.000

25002900 M    Pork, meat                         0.050000   1.000  1.000

25002901 M    Pork, meat-babyfood                0.050000   1.000  1.000

25002910 M    Pork, skin                         0.050000   1.000  1.000

25002920 M    Pork, meat byproducts              0.050000   1.000  1.000

25002921 M    Pork, meat byproducts-babyfood     0.050000   1.000  1.000

25002930 M    Pork, fat                          0.050000   1.000  1.000

25002931 M    Pork, fat-babyfood                 0.050000   1.000  1.000

25002940 M    Pork, kidney                       0.050000   1.000  1.000

25002950 M    Pork, liver                        0.050000   1.000  1.000

26003390 M    Sheep, meat                        0.050000   1.000  1.000

26003391 M    Sheep, meat-babyfood               0.050000   1.000  1.000

26003400 M    Sheep, meat byproducts             0.050000   1.000  1.000

26003410 M    Sheep, fat                         0.050000   1.000  1.000

26003411 M    Sheep, fat-babyfood                0.050000   1.000  1.000

26003420 M    Sheep, kidney                      0.050000   1.000  1.000

26003430 M    Sheep, liver                       0.050000   1.000  1.000

40000930 P    Chicken, meat                      0.050000   1.000  1.000

40000931 P    Chicken, meat-babyfood             0.050000   1.000  1.000

40000940 P    Chicken, liver                     0.050000   1.000  1.000

40000950 P    Chicken, meat byproducts           0.050000   1.000  1.000

40000951 P    Chicken, meat byproducts-babyfoo   0.050000   1.000  1.000

40000960 P    Chicken, fat                       0.050000   1.000  1.000

40000961 P    Chicken, fat-babyfood              0.050000   1.000  1.000

40000970 P    Chicken, skin                      0.050000   1.000  1.000

40000971 P    Chicken, skin-babyfood             0.050000   1.000  1.000

70001450 P    Egg, whole                         0.050000   1.000  1.000

70001451 P    Egg, whole-babyfood                0.050000   1.000  1.000

70001460 P    Egg, white                         0.050000   1.000  1.000

70001461 P    Egg, white (solids)-babyfood       0.050000   1.000  1.000

70001470 P    Egg, yolk                          0.050000   1.000  1.000

70001471 P    Egg, yolk-babyfood                 0.050000   1.000  1.000

60003010 P    Poultry, other, meat               0.050000   1.000  1.000

60003020 P    Poultry, other, liver              0.050000   1.000  1.000

60003030 P    Poultry, other, meat byproducts    0.050000   1.000  1.000

60003040 P    Poultry, other, fat                0.050000   1.000  1.000

60003050 P    Poultry, other, skin               0.050000   1.000  1.000

50003820 P    Turkey, meat                       0.050000   1.000  1.000

50003821 P    Turkey, meat-babyfood              0.050000   1.000  1.000

50003830 P    Turkey, liver                      0.050000   1.000  1.000

50003831 P    Turkey, liver-babyfood             0.050000   1.000  1.000

50003840 P    Turkey, meat byproducts            0.050000   1.000  1.000

50003841 P    Turkey, meat byproducts-babyfood   0.050000   1.000  1.000

50003850 P    Turkey, fat                        0.050000   1.000  1.000

50003851 P    Turkey, fat-babyfood               0.050000   1.000  1.000

50003860 P    Turkey, skin                       0.050000   1.000  1.000

50003861 P    Turkey, skin-babyfood              0.050000   1.000  1.000

27002220 D    Milk, fat                          0.050000   1.000  1.000

27002221 D    Milk, fat - baby food/infant for   0.050000   1.000  1.000

27012230 D    Milk, nonfat solids                0.050000   1.000  1.000

27012231 D    Milk, nonfat solids-baby food/in   0.050000   1.000  1.000

27022240 D    Milk, water                        0.050000   1.000  1.000

27022241 D    Milk, water-babyfood/infant form   0.050000   1.000  1.000

27032251 D    Milk, sugar (lactose)-baby food/   0.050000   1.000  1.000

01010500 1AB  Beet, garden, roots                0.080000   1.000  1.900

01010501 1AB  Beet, garden, roots-babyfood       0.080000   1.000  1.900

01010520 1A   Beet, sugar                        0.080000   1.000  1.900

01010521 1A   Beet, sugar-babyfood               0.080000   1.000  1.900

01010530 1A   Beet, sugar, molasses              0.080000   1.000  1.900

01010531 1A   Beet, sugar, molasses-babyfood     0.080000   1.000  1.900

01010780 1AB  Carrot                             0.038000   1.000  0.100  Ratio

          Full comment: Ratio from carrot metabolism

01010781 1AB  Carrot-babyfood                    0.038000   1.000  0.100  Ratio

          Full comment: Ratio from carrot metabolism

01010790 1AB  Carrot, juice                      0.038000   1.500  0.100  Ratio

          Full comment: Ratio from carrot metabolism

01032960 1C   Potato, chips                      0.110000   3.300  1.250

01032970 1C   Potato, dry (granules/ flakes)     0.110000   6.400  1.250

01032971 1C   Potato, dry (granules/ flakes)-b   0.110000   6.400  1.250

01032980 1C   Potato, flour                      0.110000   6.400  1.250

01032981 1C   Potato, flour-babyfood             0.110000   6.400  1.250

01032990 1C   Potato, tuber, w/peel              0.110000   1.400  1.250

01032991 1C   Potato, tuber, w/peel-babyfood     0.110000   1.400  1.250

01033000 1C   Potato, tuber, w/o peel

01033001 1C   Potato, tuber, w/o peel-babyfood   0.110000   1.400  1.250

01033660 1CD  Sweet potato                       0.110000   1.000  1.250  Ratio

          Full comment: Ratio from carrot metabolism

01033661 1CD  Sweet potato-babyfood              0.110000   1.000  1.250  Ratio

          Full comment: Ratio from carrot metabolism

01034060 1CD  Yam, true                          0.110000   1.000  1.250

01034070 1CD  Yam bean                           0.110000   1.000  1.250

02000510 2    Beet, garden, tops                 1.300000   1.000  1.900

03001640 3    Garlic                             0.038000   1.000  0.050

03001650 3    Garlic, dried                      0.038000   9.000  0.050

03001651 3    Garlic, dried-babyfood             0.038000   9.000  0.050

03002370 3    Onion, dry bulb                    0.038000   1.000  0.150  Ratio

          Full comment: Ratio from carrot metabolism

03002371 3    Onion, dry bulb-babyfood           0.038000   1.000  0.150  Ratio

          Full comment: Ratio from carrot metabolism

03002380 3    Onion, dry bulb, dried             0.038000   9.000  0.150  Ratio

          Full comment: Ratio from carrot metabolism

03002381 3    Onion, dry bulb, dried-babyfood    0.038000   9.000  0.150  Ratio

          Full comment: Ratio from carrot metabolism

04011500 4A   Endive                             0.050000   1.000  1.160

04023220 4B   Rhubarb                            0.190000   1.000  1.120  Ratio

          Full comment: Ratio from celery metabolism

04013550 4A   Spinach                            0.050000   1.000  1.160  Ratio

          Full comment: Ratio from celery metabolism

04013551 4A   Spinach-babyfood                   0.050000   1.000  1.160  Ratio

          Full comment: Ratio from celery metabolism

06030300 6C   Bean, black, seed                 10.260000   1.000  0.010  Ratio

          Full comment: Ratio from soybean metabolism

06030320 6C   Bean, broad, seed                 10.260000   1.000  0.010  Ratio

          Full comment: Ratio from soybean metabolism

06030340 6C   Bean, cowpea, seed                10.260000   1.000  0.010  Ratio

          Full comment: Ratio from soybean metabolism

06030350 6C   Bean,  great northern, seed       10.260000   1.000  0.010  Ratio

          Full comment: Ratio from soybean metabolism

06030360 6C   Bean, kidney, seed                10.260000   1.000  0.010  Ratio

          Full comment: Ratio from soybean metabolism

06030380 6C   Bean, lima, seed                  10.260000   1.000  0.010  Ratio

          Full comment: Ratio from soybean metabolism

06030390 6C   Bean, mung, seed                  10.260000   1.000  0.010  Ratio

          Full comment: Ratio from soybean metabolism

06030400 6C   Bean, navy, seed                  10.260000   1.000  0.010  Ratio

          Full comment: Ratio from soybean metabolism

06030410 6C   Bean, pink, seed                  10.260000   1.000  0.010  Ratio

          Full comment: Ratio from soybean metabolism

06030420 6C   Bean, pinto, seed                 10.260000   1.000  0.010  Ratio

          Full comment: Ratio from soybean metabolism

06030980 6C   Chickpea, seed                    10.260000   1.000  0.010

06030981 6C   Chickpea, seed-babyfood           10.260000   1.000  0.010

06030990 6C   Chickpea, flour                   10.260000   1.000  0.010

06031820 6C   Guar, seed                        10.260000   1.000  0.010

06031821 6C   Guar, seed-babyfood               10.260000   1.000  0.010

06032030 6C   Lentil, seed                      10.260000   1.000  0.010

06003470 6    Soybean, seed                      1.900000   1.000  0.025  Ratio

          Full comment: Ratio from soybean metabolism

06003480 6    Soybean, flour                     1.900000   1.000  0.025  Ratio

          Full comment: Ratio from soybean metabolism

06003481 6    Soybean, flour-babyfood            1.900000   1.000  0.025  Ratio

          Full comment: Ratio from soybean metabolism

06003490 6    Soybean, soy milk                  1.900000   1.000  0.025  Ratio

          Full comment: Ratio from soybean metabolism

06003491 6    Soybean, soy milk-babyfood or in   1.900000   1.000  0.025  Ratio

          Full comment: Ratio from soybean metabolism

06003500 6    Soybean, oil                       1.900000   0.010  0.025  Ratio

          Full comment: Ratio from soybean metabolism

06003501 6    Soybean, oil-babyfood              1.900000   0.010  0.025  Ratio

          Full comment: Ratio from soybean metabolism

08002720 8    Pepper, nonbell                    0.670000   1.000  0.010  Ratio

          Full comment: Ratio from celery metabolism

08002721 8    Pepper, nonbell-babyfood           0.670000   1.000  0.010  Ratio

          Full comment: Ratio from celery metabolism

08002730 8    Pepper, nonbell, dried             0.670000   1.000  0.010  Ratio

          Full comment: Ratio from celery metabolism

10001060 10   Citrus citron                      0.005000   1.000  1.900

10001070 10   Citrus hybrids                     0.005000   1.000  1.900

10001080 10   Citrus, oil                        0.005000   1.000  1.900

10001800 10   Grapefruit                         0.005000   1.000  1.900

10001810 10   Grapefruit, juice                  0.005000   1.000  1.900

10001970 10   Kumquat                            0.005000   1.000  1.900

10001990 10   Lemon                              0.005000   1.000  1.900

10002000 10   Lemon, juice                       0.005000   1.000  1.900

10002001 10   Lemon, juice-babyfood              0.005000   1.000  1.900

10002010 10   Lemon, peel                        0.005000   1.000  1.900

10002060 10   Lime                               0.005000   1.000  1.900

10002070 10   Lime, juice                        0.005000   1.000  1.900

10002071 10   Lime, juice-babyfood               0.005000   1.000  1.900

10002400 10   Orange                             0.005000   1.000  1.900

10002410 10   Orange, juice                      0.005000   1.000  1.900

10002411 10   Orange, juice-babyfood             0.005000   1.000  1.900

10002420 10   Orange, peel                       0.005000   1.000  1.900

10003070 10   Pummelo                            0.005000   1.000  1.900

10003690 10   Tangerine                          0.005000   1.000  1.900

10003700 10   Tangerine, juice                   0.005000   1.000  1.900

12000120 12   Apricot                            0.015000   1.000  1.900  Ratio

          Full comment: Ratio from soybean metabolism

12000121 12   Apricot-babyfood                   0.015000   1.000  1.900  Ratio

          Full comment: Ratio from soybean metabolism

12000130 12   Apricot, dried                     0.015000   6.000  1.900  Ratio

          Full comment: Ratio from soybean metabolism

12000140 12   Apricot, juice                     0.015000   1.000  1.900  Ratio

          Full comment: Ratio from soybean metabolism

12000141 12   Apricot, juice-babyfood            0.015000   1.000  1.900  Ratio

          Full comment: Ratio from soybean metabolism

12000900 12   Cherry                             0.029000   1.000  0.010

12000901 12   Cherry-babyfood                    0.029000   1.000  0.010

12000910 12   Cherry, juice                      0.029000   1.500  0.010

12000911 12   Cherry, juice-babyfood             0.029000   1.500  0.010

12002300 12   Nectarine                          0.015000   1.000  1.900

12002600 12   Peach                              0.029000   1.000  0.025  Ratio

          Full comment: Ratio from soybean metabolism

12002601 12   Peach-babyfood                     0.029000   1.000  0.025  Ratio

          Full comment: Ratio from soybean metabolism

12002610 12   Peach, dried                       0.029000   7.000  0.025  Ratio

          Full comment: Ratio from soybean metabolism

12002611 12   Peach, dried-babyfood              0.029000   7.000  0.025  Ratio

          Full comment: Ratio from soybean metabolism

12002620 12   Peach, juice                       0.029000   1.000  0.025  Ratio

          Full comment: Ratio from soybean metabolism

12002621 12   Peach, juice-babyfood              0.029000   1.000  0.025  Ratio

          Full comment: Ratio from soybean metabolism

12002850 12   Plum                               0.019000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

12002851 12   Plum-babyfood                      0.019000   1.000  1.000  Ratio

          Full comment: Ratio from soybean metabolism

12002860 12   Plum, prune, fresh                 0.019000   1.000  0.010  Ratio

          Full comment: Ratio from soybean metabolism

12002861 12   Plum, prune, fresh-babyfood        0.019000   1.000  0.010  Ratio

          Full comment: Ratio from soybean metabolism

12002870 12   Plum, prune, dried                 0.019000   5.000  0.010  Ratio

          Full comment: Ratio from soybean metabolism

12002871 12   Plum, prune, dried-babyfood        0.019000   5.000  0.010  Ratio

          Full comment: Ratio from soybean metabolism

12002880 12   Plum, prune, juice                 0.019000   1.400  0.010  Ratio

          Full comment: Ratio from soybean metabolism

12002881 12   Plum, prune, juice-babyfood        0.019000   1.400  0.010  Ratio

          Full comment: Ratio from soybean metabolism

14002130 14   Macadamia nut                      0.050000   1.000  1.900  Ratio

          Full comment: Ratio from soybean metabolism

14002690 14   Pecan                              0.050000   1.000  1.900

Attachment:  Acute Food plus Water Results File

U.S. Environmental Protection Agency                                  Ver. 2.02

DEEM-FCID ACUTE Analysis for FLUAZIFOP P BUTYL                   (1994-98 data)

Residue file: 122809a.R98                         Adjustment factor #2 NOT used.

Analysis Date: 07-27-2010/14:01:47    Residue file dated: 07-27-2010/13:23:34/8

Daily totals for food and foodform consumption used.

Run Comment: ""

======================================================================== =======

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th Percentile

                   Exposure   % aRfD    Exposure   % aRfD    Exposure   % aRfD

                  ---------- --------  ---------- --------  ---------- --------

Females 13-49 yrs:

                    0.064111    12.82    0.151503    30.30    0.367295    73.46

Attachment:  Chronic Food plus Water Results File

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for FLUAZIFOP P BUTYL                (1994-98 data)

Residue file name: C:\Documents and Settings\stadayon\My Documents\Work in Progress\122809c 2010 .R98

Adjustment factor #2 used.

Analysis Date 07-28-2010/07:59:35     Residue file dated: 07-28-2010/07:57:28/8

Reference dose (RfD, Chronic) = .0074 mg/kg bw/day

======================================================================== =======

                    Total exposure by population subgroup

------------------------------------------------------------------------ -------

                                                    Total Exposure

                                         -----------------------------------

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

--------------------------------------   -------------       ---------------

U.S. Population (total)                     0.000904                12.2%

U.S. Population (spring season)             0.000903                12.2%

U.S. Population (summer season)             0.000885                12.0%

U.S. Population (autumn season)             0.000925                12.5%

U.S. Population (winter season)             0.000902                12.2%

Northeast region                            0.000874                11.8%

Midwest region                              0.000963                13.0%

Southern region                             0.000853                11.5%

Western region                              0.000949                12.8%

Hispanics                                   0.001045                14.1%

Non-hispanic whites                         0.000887                12.0%

Non-hispanic blacks                         0.000856                11.6%

Non-hisp/non-white/non-black                0.000980                13.2%

All infants (< 1 year)                      0.001482                20.0%

Nursing infants                             0.000521                 7.0%

Non-nursing infants                         0.001846                25.0%

Children 1-6 yrs                           0.002423                 32.7%

Children 7-12 yrs                           0.001322                17.9%

Females 13-19 (not preg or nursing)         0.000685                 9.3%

Females 20+ (not preg or nursing)           0.000624                 8.4%

Females 13-50 yrs                           0.000708                 9.6%

Females 13+ (preg/not nursing)              0.000785                10.6%

Females 13+ (nursing)                       0.000879                11.9%

Males 13-19 yrs                             0.000883                11.9%

Males 20+ yrs                               0.000680                 9.2%

Seniors 55+                                 0.000644                 8.7%

Children 1-2 yrs                            0.002988                40.4%

Children 3-5 yrs                            0.002231                30.1%

Children 6-12 yrs                           0.001406                19.0%

Youth 13-19 yrs                             0.000787                10.6%

Adults 20-49 yrs                            0.000659                 8.9%

Adults 50+ yrs                              0.000643                 8.7%

Females 13-49 yrs                           0.000639                 8.6%

------------------------------------------------------------------------ -------

------------------------------------------------------------------------ -----

Attachment Percent Crop Treated Memo from BEAD

Fluazifop-p-butyl	Dietary Exposure Assessment	DP Bar code: D379452

PC Code: 122809

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Page   PAGE  1  of   NUMPAGES  27


[Federal Register: December 28, 2007 (Volume 72, Number 248)]
[Notices]
[Page 73930-73932]
[DOCID:fr28de07-190]

-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57020; File No. SR-FINRA-2007-012]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of Proposed Rule Change and Amendment
No. 1 thereto to Amend Trade Reporting Rules to Require Related Market
Center Indicator on Certain Non-Tape Reports Submitted to FINRA

December 20, 2007.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 12, 2007, the Financial Industry Regulatory Authority,
Inc. (``FINRA'') (f/k/a National Association of Securities Dealers,
Inc. (``NASD'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been substantially prepared by
FINRA.\3\ On December 18, 2007, FINRA filed Amendment No. 1 to the
proposed rule change. The Commission is publishing this notice to
solicit comments on the proposed rule change as modified by Amendment
No. 1 from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ On July 26, 2007, the Commission approved a proposed rule
change filed by NASD to amend NASD's Certificate of Incorporation to
reflect its name change to the Financial Industry Regulatory
Authority, Inc., or FINRA, in connection with the consolidation of
the member firm regulatory functions of NASD and NYSE Regulation,
Inc. See Securities Exchange Act Release No. 56146 (July 26, 2007),
72 FR 42190 (August 1, 2007).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to amend its trade reporting rules to require
that on any non-tape report (a non-tape, non-clearing report or a
clearing-only report) submitted to a FINRA Facility (i.e., the
Alternative Display Facility (``ADF''), a Trade Reporting Facility
(``TRF'') \4\ or the OTC Reporting Facility (``ORF'')) associated with
a previously executed trade that was not reported to that same

FINRA Facility, members identify the facility or market where the
associated trade was reported. The text of the proposed rule change is
available at FINRA, the Commission's Public Reference Room, and http://www.finra.org
.

---------------------------------------------------------------------------

    \4\ Effective July 30, 2007, FINRA was formed through the
consolidation of NASD and the member regulatory functions of NYSE
Regulation, Inc. Accordingly, the TRFs are now doing business as the
FINRA TRFs (i.e., the FINRA/Nasdaq TRF, the FINRA/NSX TRF and the
FINRA/NYSE TRF). The formal name change of each TRF is pending and
once completed, FINRA will file a separate proposed rule change to
reflect those changes in the Manual.
---------------------------------------------------------------------------

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, FINRA included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. FINRA has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose

Background

    Certain transactions can be trade reported in related tape (i.e.,
the transaction is reported to the tape for publication) and non-tape
(i.e., the transaction is not reported to the tape for publication but
is reported for clearing or regulatory purposes) reports. Non-tape
reports can be (1) ``non-tape, non-clearing,'' i.e. the transaction is
not reported to the tape and is submitted to FINRA for regulatory--and
not clearing--purposes, or (2) ``clearing-only,'' i.e., the transaction
is not reported to the tape and is submitted to FINRA for clearing (and
perhaps also regulatory) purposes.
    A riskless principal transaction \5\ can be submitted to FINRA as a
single trade report properly marked as riskless principal, or as two
separate reports: (1) A tape report to reflect the initial leg of the
transaction and (2) a non-tape report to reflect the offsetting,
``riskless'' leg of the transaction. For example, where the initial leg
of a riskless principal transaction is executed on and reported through
an exchange (often referred to as the ``street leg'' or ``street
side''), a tape report is not submitted to FINRA to reflect the initial
leg; however, members are permitted, but not required, to submit a non-
tape report to FINRA for the offsetting, ``riskless'' leg of the
transaction. Similarly, agency transactions where one member acts as
agent on behalf of another member, which transactions are the
functional equivalent of riskless principal transactions, can also be
reported in related tape and non-tape reports. Thus, for example,
similar to the riskless principal reporting structure, where Member A,
as agent for Member B, executes a trade on an exchange (and that trade
is reported to the tape through the exchange), Member A may submit a
non-tape report to FINRA to reflect the offsetting portion of the
agency trade between Member A and Member B.\6\ Currently, a non-tape
report provides no specific information pertaining to a related tape
report and as such, it is difficult for FINRA to determine where the
associated trade was reported, especially if that trade was reported to
an exchange or another FINRA Facility.
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    \5\ For purposes of over-the-counter trade reporting
requirements applicable to equity securities, a ``riskless
principal'' transaction is a transaction in which a member, after
having received an order to buy (sell) a security, purchases (sells)
the security as principal (the initial leg) and satisfies the
original order by selling (buying) as principal at the same price
(the offsetting, ``riskless'' leg).
    \6\ See FINRA Regulatory Notice 07-38 (August 2007).
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Proposed Amendments to NASD Rules 6130, 6130A, 6130C and 6130E

    FINRA is proposing to amend NASD Rules 6130 (relating to the NASD/
Nasdaq TRF and ORF), 6130A (relating to the ADF), 6130C (relating to
the NASD/NSX TRF) and 6130E (relating to the NASD/NYSE TRF) to require
that on any non-tape report (either a non-tape, non-clearing report or
a clearing-only report) submitted to a FINRA Facility associated with a
previously executed trade that was not reported to that same FINRA
Facility, members must identify the facility or market where the
associated trade was reported. The proposed rule change also requires
that members retain and produce to FINRA, upon request, documentation
relating to the associated trade (e.g., a confirmation from the
exchange identifying the ``street side'' of a riskless principal
transaction).
    For example, pursuant to the proposed rule change, if the initial
leg of a riskless principal (or agency) transaction is executed on and
reported through the Nasdaq Exchange, a member submitting a non-tape
report for the offsetting leg of the transaction to the NASD/Nasdaq TRF
would be required to use a special indicator on that report to
designate that the initial leg was reported through the Nasdaq
Exchange. By way of further example, if the initial leg is executed
otherwise than on an exchange and reported to the NASD/NYSE TRF, a
member submitting a non-tape report for the offsetting leg to the NASD/
Nasdaq TRF would be required to use a special indicator on that report
to designate that the initial leg was reported to the NASD/NYSE TRF.
Finally, if the initial leg is executed on and reported through a
foreign exchange,\7\ a member submitting a non-tape report for the
offsetting leg to the ORF would be required to use a special indicator
on that report to designate that the initial leg was reported through a
foreign exchange.
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    \7\ This leg would not be reported to FINRA pursuant to NASD
Rule 6620(g).
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    In addition, FINRA is proposing to clarify and consolidate into a
single paragraph in NASD Rules 6130, 6130A, 6130C and 6130E the rules
relating to the submission of non-tape reports associated with
previously executed trades. Pursuant to current Rules 6130(i),
6130A(d), 6130C(h) and 6130E(h), members are prohibited from submitting
to a FINRA Facility any non-tape report, including but not limited to
reports of step-outs and reversals, associated with a previously
executed trade that was not reported to that FINRA Facility, except
where such report reflects the offsetting, ``riskless'' portion of a
riskless principal transaction.\8\ This exception also applies to
agency transactions where a FINRA member is acting as agent on behalf
of another FINRA member.\9\ The requirement proposed herein, i.e., that
a member identify on a non-tape report the market or facility where an
associated trade was reported, would apply where a transaction falls
within this exception for riskless principal or agency transactions and
the related tape and non-tape reports are submitted to different FINRA
Facilities or the non-tape report is associated with a trade that was
reported to the tape through an exchange. Thus, for ease of reference,
FINRA is proposing to include the proposed requirement that members
identify the facility or market where the associated trade was reported
in the same paragraph with the prohibition on the submission of certain
non-tape reports to FINRA in current NASD Rules 6130(i), 6130A(d),
6130C(h) and 6130E(h) and to clarify that the proposed requirement
applies where a non-tape report is permitted pursuant to current Rules
6130(i), 6130A(d), 6130C(h) and 6130E(h).
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    \8\ See Securities Exchange Act Release No. 55962 (June 26,
2007), 72 FR 36536 (July 3, 2007) (notice of filing and immediate
effectiveness of SR-NASD-2007-040). SR-NASD-2007-040 became
operative on November 5, 2007. See also FINRA Regulatory Notice 07-
38 (August 2007).
    \9\ See FINRA Regulatory Notice 07-38 (August 2007).

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    FINRA believes that the proposed rule change will promote a more
complete and accurate audit trail. Additionally, the proposed rule
change will help ensure that members are not using non-tape reports to
circumvent FINRA or Commission rules (e.g., trade-through rules).
    FINRA will announce the operative date of the proposed rule change
on its Web site. In recognition of the technological and systems
changes that the proposed rule change will require, the operative date
will be at least 90 days following Commission approval.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of section 15A(b)(6) of the Act,\10\ which requires, among
other things, that FINRA rules be designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. FINRA believes that the proposed rule change will
promote a more complete and accurate audit trail.
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    \10\ 15 U.S.C. 78o-3(b)(6).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the FINRA consents, the Commission will:
    (A) By order approve such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-FINRA-2007-012 on the subject line.

Paper comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-FINRA-2007-012. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of FINRA. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-FINRA-2007-012 and should be
submitted on or before January 18, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-25206 Filed 12-27-07; 8:45 am]

BILLING CODE 8011-01-P