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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

	OFFICE OF PREVENTION, PESTICIDESs

                                                                                AND TOXIC SUBSTANCES

MEMORANDUM

Date:  		29-MAY-2009

SUBJECT:	Halosulfuron-methyl Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Section 3 Registration Action on Soybeans.

PC Code:  128721	DP Barcode:  359457

Decision No.: 399589	Registration No.: 81880-2

Petition No.: 8F7424	Regulatory Action: Section 3 Registration

Risk Assessment Type: Single Chemical/Aggregate	Case No.: NA

TXR No.: NA	CAS No.: 100784-20-1

MRID No.: NA	40 CFR: 180.479

FROM:	Nancy Dodd, Chemist

Registration Action Branch 3/Health Effects Division (7509P)

THROUGH:	Douglas Dotson, Chemist

Julie Langsdale, Environmental Health Scientist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

and

Paula Deschamp, Branch Chief

Registration Action Branch 3/Health Effects Division (7509P)

TO:		Whang Phang, Toxicologist

		Registration Action Branch 3/Health Effects Division (7509P)

and

		Vickie Walters/James Tompkins (RM Team #25)

		Herbicide Branch/Registration Division (7505P)

Executive Summary

DEEM-FCID™, Version 2.03, which uses food consumption data from the U.S. Department of Agriculture’s (USDA’s) Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  The analyses were performed to support a Section 3 request for use on soybeans.

Acute Dietary (Food and Drinking Water) Exposure Results and Characterization

An acute dietary (food and drinking water) exposure assessment was conducted for the proposed use on soybeans, all established uses, and drinking water.  An unrefined assessment was conducted.  The residue levels used in the assessment for all commodities were the established or recommended tolerance levels.  The assessment was conducted using the assumption that 100% of the crop was treated.  Default (DEEM 7.81) processing factors were used unless processing studies were available.  For some commodities, processing studies showed that residues do not concentrate upon processing (for example, tomato paste and puree).

Estimated concentrations of halosulfuron-methyl in drinking water from use on rice, which reflected the highest use rate, were provided by the Environmental Fate and Effects Division (EFED) and incorporated directly into the acute assessment.  A Tier 1 drinking water assessment for the use on rice was performed using the FQPA Index Reservoir Screening Tool (FIRST) modeling.  The acute estimated drinking water concentration (acute EDWC) of halosulfuron-methyl is not expected to exceed 59.2 ppb (0.0592 ppm).

The acute dietary (food and drinking water) exposure to halosulfuron-methyl is below HED’s level of concern for the general U.S. population and all population subgroups.  For the general U.S. population, an appropriate dose/endpoint attributable to a single dose was not observed in the reviewed oral toxicity studies.  The acute dietary exposure estimate at the 95th percentile is <1% of the aPAD for females 13-49 years old, the only population subgroup of concern.

Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization

A chronic dietary (food and drinking water) exposure assessment was conducted for the proposed use on soybeans, all established uses, and drinking water.  An unrefined assessment was conducted.  The residue levels used in the assessment for all commodities were the established or recommended tolerance levels.  The assessment was conducted using the assumption that 100% of the crop was treated.  Default (DEEM 7.81) processing factors were used unless processing studies were available.  For some commodities, processing studies showed that residues do not concentrate upon processing (for example, tomato paste and puree).

Estimated concentrations of halosulfuron-methyl in drinking water from use on rice, which reflected the highest use rate, were provided by EFED and incorporated directly into the chronic assessment.  A Tier 1 drinking water assessment for the use on rice was performed using FIRST modeling.  The annual mean (chronic) estimated drinking water concentration (chronic EDWC) of halosulfuron-methyl is not expected to exceed 59.2 ppb (0.0592 ppm).

The chronic dietary (food and drinking water) exposure to halosulfuron-methyl is below HED’s level of concern for the general U.S. population and all population subgroups.  The chronic dietary exposure estimates are 1.6% of the cPAD for the general U.S. population and 4.6% of the cPAD for all infants (<1 year old), the most highly exposed population subgroup.

Cancer Dietary (Food and Drinking Water) Exposure Results and Characterization

The HIARC classified halosulfuron-methyl as “not likely to be a human carcinogen;” therefore, quantification of human cancer risk is not required.

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.  HED is generally concerned when estimated cancer risk exceeds one in one million.  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,” 21-JUN-2000, web link:      HYPERLINK "http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf"  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf  ; or see SOP 99.6 (20-AUG-1999).

The most recent dietary risk assessment for halosulfuron-methyl was conducted by William Cutchin (10/4/04, DP#307445).

II.	Residue Information

Halosulfuron-methyl Use:

The Canyon Group LLC, a joint venture formed by Gowan Company and Nissan Chemical Industries (NCI), is proposing use of halosulfuron-methyl on soybeans.  A tolerance of 0.05 ppm on soybean, seed is proposed.  HED is recommending in favor of this tolerance.

Permanent tolerances are established under §180.479(a)(1) for residues of halosulfuron-methyl and its metabolites determined as 3-chloro-1-methyl-5-sulfamoylpyrazole-4-carboxylic acid, expressed as halosulfuron-methyl equivalents, in/on the meat byproducts of cattle, goat, hog, horse, and sheep at 0.1 ppm.  Tolerances are established under §180.479(a)(2) for residues of halosulfuron-methyl in/on a variety of field, fruit, and vegetable crop commodities, at levels ranging from 0.05 to 2.0 ppm.  A time-limited tolerance for sweet potato, established under §180.479(b), has expired (expiration date 12/31/08).

In meetings on 9/15/93 and 5/20/96, the Metabolism Committee concluded that the residue of concern in target plants, rotational plants, and livestock is halosulfuron-methyl (G. J. Herndon, No DP#s, 9/16/93 and 5/21/96).  [Although HED concluded that the residue of concern in livestock is halosulfuron-methyl, tolerances for residues in livestock commodities are expressed in terms of halosulfuron-methyl and its metabolites determined as 3-chloro-1-methyl-5-sulfamoylpyrazole-4-carboxylic acid, expressed as halosulfuron-methyl equivalents, because the enforcement method for livestock commodities quantifies the parent and metabolites containing the 3-chlorosulfonamide moiety (3-CSA) by converting residues to 3-CSA.]

The residue of concern in water is halosulfuron-methyl.  The parent is mobile and persistent.

Residue Data used for Acute and Chronic Assessments:

These acute and chronic assessments are unrefined assessments using tolerance-level residues and 100% CT for all commodities with proposed and established tolerances.

No changes in the established livestock tolerances are being recommended as a result of the proposed and established uses.

Default (DEEM 7.81) processing factors were used unless processing studies were available.  The processing factors which were used were 1.5x for field corn syrup, 14.3x for dried tomato, and 1.5x for tomato juice.  For some commodities, processing studies showed that residues do not concentrate upon processing (for example, tomato paste and puree).

  Drinking Water Data

The drinking water residues used in the dietary risk assessment were provided by EFED in the following memorandum: “Halosulfuron-methyl Drinking Water Assessment for Additional Food Uses (including Proposed Use on Soybean)” (M. Barrett, DP#358032, 5/27/09) 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.”

The Tier I EDWCs for halosulfuron-methyl are based on a maximum annual application rate of 0.125 lb ai/A for rice.  The two screening models, FIRST and Screening Concentrations in Ground Water (SCI-GROW), were used for estimating EDWCs of halosulfuron-methyl.  Estimates for halosulfuron-methyl in surface water based on the FIRST model for rice are 59.2 ppb for acute and chronic concentrations.  It should be noted that the drinking water estimate based on rice application is an upper bound estimate.  The estimate for halosulfuron-methyl in groundwater based on the SCI-GROW model result is 0.065 ppb.

Halosulfuron-methyl, like most other sulfonylurea herbicides, is extremely mobile with a median Koc of 104 g/mL and Kf (Freundlich partition) values ranging from 0.32 to 3.6 in four test soils.  Its persistence in soil and water appears to be highly variable.  Halosulfuron-methyl has the potential to leach to groundwater, and also presents concerns for transport to surface water by runoff.

The FIRST and SCI-GROW models and their descriptions are available at the EPA internet site:   HY䕐䱒义⁋栢瑴㩰⼯睷⹷灥⹡潧⽶灯数敦洯摯汥⽳慷 整⽲•ᐁ瑨灴⼺眯睷攮慰朮癯漯灰晥摥⼱潭敤獬眯瑡牥 ᔯഠ

IV.	DEEM-FCID™ Program and Consumption Information

Halosulfuron-methyl 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 unrefined assessments, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

V.  Toxicological Information

The risk assessment team confirmed endpoints that were selected previously (DP#331643, M. Clock-Rust, 9/21/2006).

The FQPA Safety Factor was reduced to 1x for all population subgroups (DP#331643, M. Clock-Rust, 9/21/2006).

Halosulfuron-methyl is classified as “not likely to be carcinogenic to humans” based on a lack of evidence of carcinogenicity in male and female mice and rats.  Therefore, halosulfuron-methyl is not expected to pose a cancer risk for humans.

Toxicological endpoints for use in dietary exposure risk assessments are summarized in Table 1 below.

Table 1.  Summary of Toxicological Doses and Endpoints for Halosulfuron-methyl for Use in Dietary Exposure Risk Assessments

Exposure/

Scenario	Point of Departure	Uncertainty/FQPA Safety Factors	RfD, PAD, Level of Concern 	Study and Toxicological Effects

Acute Dietary

(Females 13-49 years of age)	NOAEL= 50 mg/kg/day	UFA= 10x

UFH= 10x

FQPA SF= 1x	Acute RfD = 0.5 mg/kg/day

aPAD =0.5 mg/kg/day	Developmental Toxicity - Rabbit

LOAEL = 150 mg/kg/day based on decreased mean litter size, increased number of resorptions (total and per dam) and increased postimplantation loss. (developmental toxicity)

Acute Dietary (General Population, including Infants and Children)	N/A N/A	N/A	No appropriate dose/endpoint selected.

Chronic Dietary (All Populations)	NOAEL= 10 mg/kg/day	UFA= 10x

UFH= 10x

FQPA SF= 1x 	Chronic RfD = 0.1

mg/kg/day

cPAD = 0.1 mg/kg/day	Chronic Toxicity - Dog

LOAEL = 40 mg/kg/day based on decreased body weight gains in females.

Cancer (oral, dermal, inhalation)	Classification: “not likely to be carcinogenic to humans” by the oral route, based on no evidence of carcinogenicity from studies in rats and mice.

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.  NOAEL = no observed adverse effect level.  LOAEL = lowest observed adverse effect level.  UF = uncertainty factor.  UFA = extrapolation from animal to human (interspecies).  UFH = potential variation in sensitivity among members of the human population (intraspecies).  FQPA SF = FQPA Safety Factor.  PAD = population adjusted dose (a = acute, c = chronic).  RfD = reference dose.  N/A = not applicable.

VI.	Results/Discussion

As stated above, for acute and chronic dietary 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 Table 2 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.  Cancer risk is determined for the general U.S. population only.

Results of Acute Dietary (Food and Drinking Water) Exposure Analysis

The results of the acute (food and drinking water) dietary exposure analysis are reported in Table 2 below.  The acute dietary exposure estimate at the 95th percentile is <1% of the aPAD for females 13-49 years old, the only population subgroup of concern.

Results of Chronic Dietary (Food and Drinking Water) Exposure Analysis

The results of the chronic dietary (food and drinking water) exposure analysis are reported in Table 2 below.  The chronic dietary (food and drinking water) exposure to halosulfuron-methyl is below HED’s level of concern for the general U.S. population and all population subgroups.  The chronic dietary exposure estimates are 1.6% of the cPAD for the general U.S. population and 4.6% of the cPAD for all infants (<1 year old), the most highly exposed population subgroup.

Table 2.  Summary of Dietary (Food and Drinking Water) Exposure and Risk for Halosulfuron-methyl

Population Subgroup	Acute Dietary

(95th Percentile)	Chronic Dietary	Cancer

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

(mg/kg/day)	% cPAD*	Dietary Exposure

(mg/kg/day)	Risk

General U.S. Population	N/A	N/A	0.001584	1.6	N/A	N/A

All Infants (< 1 year old)

	0.004592	4.6

Children 1-2 years old

	0.002498	2.5

Children 3-5 years old

	0.002405	2.4

Children 6-12 years old

	0.001689	1.7

Youth 13-19 years old

	0.001239	1.2

Adults 20-49 years old

	0.001446	1.4

Adults 50+ years old

	0.001488	1.5

Females 13-49 years old	0.003305	<1	0.001436	1.4

VII.	Characterization of Inputs/Outputs

An unrefined assessment was conducted.  The residue levels used in the assessment for all commodities were the established or recommended tolerance levels.  The assessment was conducted using the assumption that 100% of the crop was treated.  Default (DEEM 7.81) processing factors were used unless processing studies were available.  For some commodities, processing studies showed that residues do not concentrate upon processing (for example, tomato paste and puree).

The assessment could be refined with percent crop treated estimates, anticipated residues, or monitoring data.  Since risk estimates are well below HED’s level of concern, a more highly refined analysis is not needed at this time.

Conclusions

Acute and chronic dietary exposure assessments were conducted for the proposed use on soybeans.  The analyses were unrefined assessments, using the proposed or established tolerances for all commodities and using the assumption of 100% crop treated.

For both the acute and chronic assessments, the general U.S. population and all population subgroups have risk estimates which are below HED’s level of concern.

IX.		List of Attachments

Attachment 1:  Acute and Chronic Food plus Water Residue Input File

Attachment 2:  Acute Results File

Attachment 3:  Chronic Results File

cc:  N. Dodd, W. Phang

Attachment 1:  Acute and Chronic Food plus Water Residue Input File

Filename: C:\Documents and Settings\NDODD\My Documents\Deemfcidndodd\Halosulfuron-methyl\Halosulfuron-methyl.R98

Chemical: halosulfuron-methyl

RfD(Chronic): .1 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): .5 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day

Date created/last modified: 05-06-2009/16:37:18/8          Program ver. 2.03

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

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

14000030 14   Almond                             0.050000   1.000  1.000  8F4937

14000031 14   Almond-babyfood                    0.050000   1.000  1.000

14000040 14   Almond, oil                        0.050000   1.000  1.000  8F4937

14000041 14   Almond, oil-babyfood               0.050000   1.000  1.000

95000190 O    Asparagus                          0.800000   1.000  1.000  1F6229

09020210 9B   Balsam pear                        0.500000   1.000  1.000

06030300 6C   Bean, black, seed                  0.050000   1.000  1.000

06030320 6C   Bean, broad, seed                  0.050000   1.000  1.000

06030340 6C   Bean, cowpea, seed                 0.050000   1.000  1.000

06030350 6C   Bean,  great northern, seed        0.050000   1.000  1.000

06030360 6C   Bean, kidney, seed                 0.050000   1.000  1.000

06030380 6C   Bean, lima, seed                   0.050000   1.000  1.000

06030390 6C   Bean, mung, seed                   0.050000   1.000  1.000

06030400 6C   Bean, navy, seed                   0.050000   1.000  1.000

06030410 6C   Bean, pink, seed                   0.050000   1.000  1.000

06030420 6C   Bean, pinto, seed                  0.050000   1.000  1.000

06010430 6A   Bean, snap, succulent              0.050000   1.000  1.000

06010431 6A   Bean, snap, succulent-babyfood     0.050000   1.000  1.000

21000460 M    Beef, meat byproducts              0.100000   1.000  1.000  3F4193

21000461 M    Beef, meat byproducts-babyfood     0.100000   1.000  1.000

21000480 M    Beef, kidney                       0.100000   1.000  1.000  3F4193

21000490 M    Beef, liver                        0.100000   1.000  1.000  3F4193

21000491 M    Beef, liver-babyfood               0.100000   1.000  1.000

14000590 14   Brazil nut                         0.050000   1.000  1.000  8F4937

14000680 14   Butternut                          0.050000   1.000  1.000

09010750 9A   Cantaloupe                         0.100000   1.000  1.000  0E6206

09010800 9A   Casaba                             0.100000   1.000  1.000  0E6206

14000810 14   Cashew                             0.050000   1.000  1.000  8F4937

09020880 9B   Chayote, fruit                     0.500000   1.000  1.000

14000920 14   Chestnut                           0.050000   1.000  1.000  8F4937

06030980 6C   Chickpea, seed                     0.050000   1.000  1.000

06030981 6C   Chickpea, seed-babyfood            0.050000   1.000  1.000

06030990 6C   Chickpea, flour                    0.050000   1.000  1.000

09021020 9B   Chinese waxgourd                   0.500000   1.000  1.000

15001200 15   Corn, field, flour                 0.050000   1.000  1.000  6F4661

15001201 15   Corn, field, flour-babyfood        0.050000   1.000  1.000

15001210 15   Corn, field, meal                  0.050000   1.000  1.000  6F4661

15001211 15   Corn, field, meal-babyfood         0.050000   1.000  1.000

15001220 15   Corn, field, bran                  0.050000   1.000  1.000  6F4661

15001230 15   Corn, field, starch                0.050000   1.000  1.000  6F4661

15001231 15   Corn, field, starch-babyfood       0.050000   1.000  1.000

15001240 15   Corn, field, syrup                 0.050000   1.500  1.000  6F4661

15001241 15   Corn, field, syrup-babyfood        0.050000   1.500  1.000

15001250 15   Corn, field, oil                   0.050000   1.000  1.000  6F4661

15001251 15   Corn, field, oil-babyfood          0.050000   1.000  1.000

15001260 15   Corn, pop                          0.050000   1.000  1.000  6F4661

15001270 15   Corn, sweet                        0.050000   1.000  1.000  6F4661

15001271 15   Corn, sweet-babyfood               0.050000   1.000  1.000

95001280 O    Cottonseed, oil                    0.050000   1.000  1.000  8F4937

95001281 O    Cottonseed, oil-babyfood           0.050000   1.000  1.000

09021350 9B   Cucumber                           0.500000   1.000  1.000  0E6085

08001480 8    Eggplant                           0.050000   1.000  1.000

14001550 14   Filbert                            0.050000   1.000  1.000  8F4937

14001560 14   Filbert, oil                       0.050000   1.000  1.000

23001700 M    Goat, meat byproducts              0.100000   1.000  1.000

23001720 M    Goat, kidney                       0.100000   1.000  1.000

23001730 M    Goat, liver                        0.100000   1.000  1.000

06031820 6C   Guar, seed                         0.050000   1.000  1.000

06031821 6C   Guar, seed-babyfood                0.050000   1.000  1.000

14001850 14   Hickory nut                        0.050000   1.000  1.000

09011870 9A   Honeydew melon                     0.100000   1.000  1.000  0E6206

14002130 14   Macadamia nut                      0.050000   1.000  1.000  8F4937

08002340 8    Okra                               0.050000   1.000  1.000

14002690 14   Pecan                              0.050000   1.000  1.000  8F4937

08002700 8    Pepper, bell                       0.050000   1.000  1.000

08002701 8    Pepper, bell-babyfood              0.050000   1.000  1.000

08002710 8    Pepper, bell, dried                0.050000   1.000  1.000

08002711 8    Pepper, bell, dried-babyfood       0.050000   1.000  1.000

08002720 8    Pepper, nonbell                    0.050000   1.000  1.000

08002721 8    Pepper, nonbell-babyfood           0.050000   1.000  1.000

08002730 8    Pepper, nonbell, dried             0.050000   1.000  1.000

14002820 14   Pistachio                          0.050000   1.000  1.000  8F4937

25002920 M    Pork, meat byproducts              0.100000   1.000  1.000  3F4193

25002921 M    Pork, meat byproducts-babyfood     0.100000   1.000  1.000

25002940 M    Pork, kidney                       0.100000   1.000  1.000  3F4193

25002950 M    Pork, liver                        0.100000   1.000  1.000  3F4193

09023080 9B   Pumpkin                            0.500000   1.000  1.000  0E6085

09023090 9B   Pumpkin, seed                      0.500000   1.000  1.000

15003230 15   Rice, white                        0.050000   1.000  1.000  8F4937

15003231 15   Rice, white-babyfood               0.050000   1.000  1.000

15003240 15   Rice, brown                        0.050000   1.000  1.000  8F4937

15003241 15   Rice, brown-babyfood               0.050000   1.000  1.000

15003250 15   Rice, flour                        0.050000   1.000  1.000  8F4937

15003251 15   Rice, flour-babyfood               0.050000   1.000  1.000

15003260 15   Rice, bran                         0.050000   1.000  1.000  8F4937

15003261 15   Rice, bran-babyfood                0.050000   1.000  1.000

26003400 M    Sheep, meat byproducts             0.100000   1.000  1.000  3F4193

26003420 M    Sheep, kidney                      0.100000   1.000  1.000

26003430 M    Sheep, liver                       0.100000   1.000  1.000

15003440 15   Sorghum, grain                     0.050000   1.000  1.000

15003450 15   Sorghum, syrup                     0.050000   1.000  1.000

06003470 6    Soybean, seed                      0.050000   1.000  1.000  8F7424

06003480 6    Soybean, flour                     0.050000   1.000  1.000

06003481 6    Soybean, flour-babyfood            0.050000   1.000  1.000

06003490 6    Soybean, soy milk                  0.050000   1.000  1.000

06003491 6    Soybean, soy milk-babyfood or in   0.050000   1.000  1.000

06003500 6    Soybean, oil                       0.050000   1.000  1.000  8F7424

06003501 6    Soybean, oil-babyfood              0.050000   1.000  1.000

09023560 9B   Squash, summer                     0.500000   1.000  1.000  0E6085

09023561 9B   Squash, summer-babyfood            0.500000   1.000  1.000

09023570 9B   Squash, winter                     0.500000   1.000  1.000  0E6085

09023571 9B   Squash, winter-babyfood            0.500000   1.000  1.000

95003620 O    Sugarcane, sugar                   0.050000   1.000  1.000  6F4661

95003621 O    Sugarcane, sugar-babyfood          0.050000   1.000  1.000

95003630 O    Sugarcane, molasses                0.050000   1.000  1.000  6F4661

95003631 O    Sugarcane, molasses-babyfood       0.050000   1.000  1.000

08003740 8    Tomatillo                          0.050000   1.000  1.000  0F6169

08003750 8    Tomato                             0.050000   1.000  1.000  0F6169

08003751 8    Tomato-babyfood                    0.050000   1.000  1.000

08003760 8    Tomato, paste                      0.050000   1.000  1.000  0F6169

08003761 8    Tomato, paste-babyfood             0.050000   1.000  1.000

08003770 8    Tomato, puree                      0.050000   1.000  1.000  0F6169

08003771 8    Tomato, puree-babyfood             0.050000   1.000  1.000

08003780 8    Tomato, dried                      0.050000  14.300  1.000  0F6169

08003781 8    Tomato, dried-babyfood             0.050000  14.300  1.000

08003790 8    Tomato, juice                      0.050000   1.500  1.000  0F6169

14003910 14   Walnut                             0.050000   1.000  1.000  8F4937

86010000 O    Water, direct, all sources         0.059200   1.000  1.000

86020000 O    Water, indirect, all sources       0.059200   1.000  1.000

09013990 9A   Watermelon                         0.100000   1.000  1.000

09014000 9A   Watermelon, juice                  0.100000   1.000  1.000

15004050 15   Wild rice                          0.050000   1.000  1.000  8F4937

Attachment 2:  Acute Results File

U.S. Environmental Protection Agency                                  Ver. 2.02

DEEM-FCID ACUTE Analysis for HALOSULFURON-METHYL                 (1994-98 data)

Residue file: Halosulfuron-methyl.R98             Adjustment factor #2 NOT used.

Analysis Date: 05-06-2009/16:39:53    Residue file dated: 05-06-2009/16:37:18/8

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:

                    0.003305     0.66    0.005319     1.06    0.008504     1.70

Attachment 3:  Chronic Results File

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for HALOSULFURON-METHYL              (1994-98 data)

Residue file name: C:\Documents and Settings\NDODD\My Documents\Deemfcidndodd\Halosulfuron-methyl\Halosulfuron-methyl.R98

                                                 Adjustment factor #2 NOT used.

Analysis Date 05-06-2009/16:38:06     Residue file dated: 05-06-2009/16:37:18/8

Reference dose (RfD, Chronic) = .1 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)                     0.001584                 1.6%

U.S. Population (spring season)             0.001578                 1.6%

U.S. Population (summer season)             0.001745                 1.7%

U.S. Population (autumn season)             0.001514                 1.5%

U.S. Population (winter season)             0.001496                 1.5%

Northeast region                            0.001466                 1.5%

Midwest region                              0.001598                 1.6%

Southern region                             0.001509                 1.5%

Western region                              0.001796                 1.8%

Hispanics                                   0.001792                 1.8%

Non-hispanic whites                         0.001546                 1.5%

Non-hispanic blacks                         0.001489                 1.5%

Non-hisp/non-white/non-black                0.001995                 2.0%

All infants (< 1 year)                      0.004592                 4.6%

Nursing infants                             0.001824                 1.8%

Non-nursing infants                         0.005642                 5.6%

Children 1-6  yrs                           0.002391                 2.4%

Children 7-12 yrs                           0.001609                 1.6%

Females 13-19 (not preg or nursing)         0.001172                 1.2%

Females 20+ (not preg or nursing)           0.001514                 1.5%

Females 13-50 yrs                           0.001501                 1.5%

Females 13+ (preg/not nursing)              0.001495                 1.5%

Females 13+ (nursing)                       0.002025                 2.0%

Males 13-19 yrs                             0.001298                 1.3%

Males 20+ yrs                               0.001398                 1.4%

Seniors 55+                                 0.001489                 1.5%

Children 1-2 yrs                            0.002498                 2.5%

Children 3-5 yrs                            0.002405                 2.4%

Children 6-12 yrs                           0.001689                 1.7%

=

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Youth 13-19 yrs                             0.001239                 1.2%

Adults 20-49 yrs                            0.001446                 1.4%

Adults 50+ yrs                              0.001488                 1.5%

Females 13-49 yrs                           0.001436                 1.4%

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

Halosulfuron-methyl	Dietary Exposure and Risk Assessment	DP Number: 359457

PC Code: 128721

________________________________________________________________________ ______________

Page   PAGE  1  of   NUMPAGES  14


[Federal Register Volume 83, Number 232 (Monday, December 3, 2018)]
[Rules and Regulations]
[Pages 62251-62253]
[FR Doc No: 2018-26147]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2018-1062]
RIN 1625-AA08

Safety Zone; Mississippi Canyon Block 20, South of New Orleans,
LA, Gulf of Mexico

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary moving safety zone
around the research vessel OCEAN INTERVENTION II operating in the
Mississippi Canyon Block 20 in the Gulf of Mexico. The safety zone
encompasses all navigable waters within a 500-yard radius of the
vessel. The safety zone is needed to protect persons, vessels, and the
marine environment from hazards associated with the vessel's limited
maneuverability while it deploys underwater equipment and conducts
research activity. Persons and vessels are prohibited from entering or
remaining in this zone unless specifically authorized by the Captain of
the Port Sector New Orleans or a designated representative.

DATES: This rule is effective without actual notice from December 3,
2018 through 8 p.m. on December 4, 2018. For the purposes of
enforcement, actual notice will be used from 6 a.m. on December 2, 2018
through December 3, 2018.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2018-1062 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions about this rule,
call or email Lieutenant Commander Benjamin Morgan, Sector New Orleans,
U.S. Coast Guard; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Sector New Orleans
DHS Department of Homeland Security
FR Federal Register
MM Mile marker
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that
good cause exists for not publishing a notice of proposed rulemaking
(NPRM) with respect to this rule because it is impracticable. We must
establish this safety zone by December 2, 2018 and lack sufficient time
to provide a reasonable comment period and then consider those comments
before issuing the rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be contrary to the public interest because immediate
action is necessary to respond to potential hazards associated with
sub-surface research operations.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port Sector New Orleans (COTP) has determined
that a temporary moving safety zone is necessary to provide for the
safety of persons, vessels, and the marine environment during sub-
surface research operations in the vicinity of the Mississippi Canyon
Block 20. Potential hazards include the risk of injury or pollution if
normal vessel traffic were to interfere with the vessel's movement or
deployed equipment. The survey activities are scheduled to take place
from 6 a.m. on December 2, 2018 through 8 p.m. on December 4, 2018, in
the navigable waters of the Mississippi Canyon Block 20, South of New
Orleans, LA, in the Gulf of Mexico. This rule is needed to protect
persons, vessels, and the marine environment from hazards associated
with the vessel's limited maneuverability while it deploys underwater
equipment and conducts research activity.

IV. Discussion of the Rule

    This rule establishes a temporary moving safety zone from 6 a.m. on
December 2, 2018 through 8 p.m. on December 4, 2018. The safety zone
will cover all navigable waters within 500 yards of the vessel OCEAN
INTERVENTION II and equipment being used by personnel to conduct sub-
surface research in Mississippi Canyon Block 20, South of New Orleans,
LA, in the Gulf of Mexico. The duration of the zone is intended to
protect persons, vessels, and the marine environment on these navigable
waters while research is being conducted. No vessel or person will be
permitted to enter or remain the safety zone without obtaining
permission from the COTP or a designated representative. Vessels
requiring entry into this safety zone must request permission from the
COTP or a designated representative. They may be contacted on VHF-FM
Channel 16 or 67 or by telephone at<PHONE_NUMBER>. Persons and vessels
permitted to enter this safety zone must transit at their slowest safe
speed and comply with all lawful directions issued by the COTP or the
designated representative. The COTP or a designated representative will
inform the public of the enforcement times and date for this safety
zone through Broadcast Notices to Mariners (BNMs), Local Notices to
Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs), as
appropriate.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory

alternatives and, if regulation is necessary, to select regulatory
approaches that maximize net benefits. Executive Order 13771 directs
agencies to control regulatory costs through a budgeting process. This
rule has not been designated a ``significant regulatory action,'' under
Executive Order 12866. Accordingly, this rule has not been reviewed by
the Office of Management and Budget (OMB), and pursuant to OMB guidance
it is exempt from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration, and time-of-year of the safety zone. This safety
zone will restrict vessel traffic from entering or remaining within a
500 yard area around a research vessel for approximately three days.
Vessels can safely transit around the zone, which impacts a small area
of the Gulf of Mexico. Moreover, the Coast Guard will issue Broadcast
Notice to Mariners via VHF-FM marine channel 16 about the zone, and the
rule allows vessels to seek permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Commandant Instruction M16475.1D, which guide the
Coast Guard in complying with the National Environmental Policy Act of
1969 (42 U.S.C. 4321-4370f), and have determined that this action is
one of a category of actions that do not individually or cumulatively
have a significant effect on the human environment. This rule involves
a safety zone lasting 3 days that will prohibit entry within 500 yards
of the research vessel being used for sub-surface research. It is
categorically excluded from further review under paragraph L60(a) of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A
Record of Environmental Consideration supporting this determination
will be made available in the docket where indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T08-1062 to read as follows:

Sec.  165.T08-1062   Safety Zone; Mississippi Canyon Block 20, South of
New Orleans, LA, Gulf of Mexico.

    (a) Location. The following area is a safety zone: All navigable
waters within a 500 yard radius around the research vessel OCEAN
INTERVENTION II in Mississippi Canyon Block 20, South of New Orleans,
LA, in the Gulf of Mexico.
    (b) Effective period. This section is effective from 6 a.m. on
December 2,

2018 through 8 p.m. on December 4, 2018.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into or remaining within this zone is
prohibited unless authorized by the Captain of the Port Sector New
Orleans (COTP) or designated representative. A designated
representative is a commissioned, warrant, or petty officer of the U.S.
Coast Guard assigned to units under the operational control of USCG
Sector New Orleans.
    (2) Vessels requiring entry into this safety zone must request
permission from the COTP or a designated representative. They may be
contacted on VHF-FM Channel 16 or 67 or by telephone at<PHONE_NUMBER>.
    (3) Persons and vessels permitted to enter this safety zone must
transit at their slowest safe speed and comply with all lawful
directions issued by the COTP or the designated representative.
    (d) Information broadcasts. The COTP or a designated representative
will inform the public of the enforcement times and date for this
safety zone through Broadcast Notices to Mariners (BNMs), Local Notices
to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs),
as appropriate.

    Dated: November 27, 2018.
K.M. Luttrell,
Captain, U.S. Coast Guard, Captain of the Port Sector New Orleans.
[FR Doc. 2018-26147 Filed 11-30-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 180 (Friday, September 16, 2016)]
[Notices]
[Pages 63815-63818]
[FR Doc No: 2016-22255]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78816; File No. SR-NASDAQ-2016-123]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Rule 4770

September 12, 2016.
    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 August 29, 2016, The NASDAQ Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I and II below, which Items have been prepared by the Exchange.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange proposes to amend Rule 4770 to modify certain data
collection requirements of the Regulation NMS Plan to Implement a Tick
Size Pilot Program.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaq.cchwallstreet.com, at the principal office of
the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange 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. The Exchange 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
    On August 25, 2014, Nasdaq and several other self-regulatory
organizations (the ``Participants'') filed with the Commission,
pursuant to Section 11A of the Act \3\ and Rule 608 of Regulation NMS
thereunder,\4\ the Plan to Implement a Tick Size Pilot Program (the
``Plan'').\5\ The Participants filed the Plan to comply with an order
issued by the Commission on June 24, 2014.\6\ The Plan was published
for comment in the Federal Register on November 7, 2014, and approved
by the Commission, as modified, on May 6, 2015.\7\
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78k-1.
    \4\ 17 CFR 242.608.
    \5\ See Letter from Brendon J. Weiss, Vice President,
Intercontinental Exchange, Inc., to Secretary, Commission, dated
August 25, 2014.
    \6\ See Securities Exchange Act Release No. 72460 (June 24,
2014), 79 FR 36840 (June 30, 2014).
    \7\ See Securities Exchange Act Release No. 74892 (May 6, 2015),
80 FR 27513 (May 13, 2015) (``Approval Order'').
---------------------------------------------------------------------------

    The Plan is designed to allow the Commission, market participants,
and the public to study and assess the impact of increment conventions
on the liquidity and trading of the common stock of small-
capitalization companies. Each Participant is required to comply, and
to enforce compliance by its member organizations, as applicable, with
the provisions of the Plan.
    The Plan provides for the creation of a group of Pilot Securities,
which shall be placed in a control group and three separate test
groups, with each subject to varying quoting and trading increments.
Pilot Securities in the control group will be quoted at the current
tick size increment of $0.01 per share and will trade at the currently
permitted increments. Pilot Securities in the first test group will be
quoted in $0.05 minimum increments but will continue to trade at any
price increment that is currently permitted.\8\ Pilot Securities in the
second test group (``Test Group Two'') will be quoted in $0.05 minimum
increments and will trade at $0.05 minimum increments subject to a
midpoint exception, a retail investor order exception, and a negotiated
trade exception.\9\ Pilot Securities in the third test group (``Test
Group Three'') will be subject to the same quoting and trading
increments as Test Group Two, and also will be subject to the ``Trade-
at'' requirement to prevent price matching by a market participant that
is not displaying at the price of a Trading Center's ``Best Protected
Bid'' or ``Best Protected Offer,'' unless an enumerated exception
applies.\10\ In addition to the exceptions provided under Test Group
Two, an exception for Block Size orders and exceptions that mirror
those under Rule 611 of Regulation NMS \11\ will apply to the Trade-at
requirement.
---------------------------------------------------------------------------

    \8\ See Section VI(B) of the Plan.
    \9\ See Section VI(C) of the Plan.
    \10\ See Section VI(D) of the Plan.
    \11\ 17 CFR 242.611.
---------------------------------------------------------------------------

    The Plan also requires a Trading Center \12\ or a Market Maker \13\
to collect and transmit certain data to its designated examining
authority (``DEA''), and requires DEAs to transmit this data to the
Commission. Participants that operate a Trading Center also are
required under the Plan to collect certain data, which is then
transmitted directly to the Commission. With respect to Trading
Centers, Appendix B.I to the Plan (Market Quality Statistics) requires
a Trading Center to submit to the Participant that is its DEA a variety
of market quality statistics. Appendix B.II to the Plan (Market and
Marketable Limit Order Data) requires a Trading Center to

submit information to its DEA relating to market orders and marketable
limit orders, including the time of order receipt, order type, the
order size, and the National Best Bid or National Best Offer (``NBBO'')
quoted price.
---------------------------------------------------------------------------

    \12\ The Plan incorporates the definition of a ``Trading
Center'' from Rule 600(b)(78) of Regulation NMS. Regulation NMS
defines a ``Trading Center'' as ``a national securities exchange or
national securities association that operates an SRO trading
facility, an alternative trading system, an exchange market maker,
an OTC market maker, or any other broker or dealer that executes
orders internally by trading as principal or crossing orders as
agent.'' See 17 CFR 242.600(b).
    \13\ The Plan defines a Market Maker as ``a dealer registered
with any self-regulatory organization, in accordance with the rules
thereof, as (i) a market maker or (ii) a liquidity provider with an
obligation to maintain continuous, two-sided trading interest.''
---------------------------------------------------------------------------

    With respect to Market Makers, Appendix B.III requires a
Participant that is a national securities exchange to collect daily
Market Maker Registration statistics. Appendix B.IV requires a
Participant to collect data related to Market Maker participation with
respect to each Market Maker engaging in trading activity on a Trading
Center operated by the Participant. Appendix C.I requires a Participant
to collect data related to Market Maker profitability from each Market
Maker for which it is the DEA. Appendix C.II requires the Participant,
as DEA, to aggregate the Appendix C.I data, and to transmit this data
to the Commission.
    The Commission approved the Pilot on a two-year basis, with
implementation to begin no later than May 6, 2016.\14\ On November 6,
2015, the SEC exempted the Participants from implementing the Pilot
until October 3, 2016.\15\ As set forth in Appendices B and C to the
Plan, data that is reported pursuant to the appendices shall be
provided for dates starting six months prior to the Pilot Period
through six months after the end of the Pilot Period. Under the revised
Pilot implementation date, the Pre-Pilot data collection period
commenced on April 4, 2016.
---------------------------------------------------------------------------

    \14\ See Approval Order at 27533 and 27545.
    \15\ See Securities Exchange Act Release No. 76382 (November 6,
2015), 80 FR 70284 (November 13, 2015) (File No. 4-657).
---------------------------------------------------------------------------

    On December 9, 2015, FINRA, on behalf of the Plan Participants,
submitted an exemptive request to the Commission, seeking an exemption
from certain data collection and reporting requirements set forth in
the Plan.\16\ On February 17, 2016, the Commission granted Participants
exemptive relief from complying with certain data collection and
reporting requirements in the Plan.\17\ On March 23, 2016, the Exchange
filed with the Commission a proposed rule change to adopt Rule 4770 to
implement the data collection requirements of the Plan, which was
effective on April 4, 2016.\18\
---------------------------------------------------------------------------

    \16\ See Letter from Marcia E. Asquith, Senior Vice President
and Corporate Secretary, FINRA, to Robert W. Errett, Deputy
Secretary, Commission, dated December 9, 2015 (``Exemptive
Request'').
    \17\ See Letter from David S. Shillman, Associate Director,
Division of Trading and Markets, Commission, to Marcia E. Asquith,
Senior Vice President and Corporate Secretary, FINRA, dated February
17, 2016.
    \18\ See Securities Exchange Act Release No. 77456 (March 28,
2016), 81 FR 18925 (April 1, 2016) (SR-NASDAQ-2016-023) [sic].
---------------------------------------------------------------------------

    The Exchange now proposes to further amend Rule 4770 to modify
additional data collection and reporting requirements.\19\ First,
Appendix B.I.a(21) through B.I.a(27) currently requires that Trading
Centers report the cumulative number of shares of cancelled orders
during a specified duration of time after receipt of the order that was
cancelled. The Exchange and the other Participants believe that, for
purposes of reporting cancelled orders, it is appropriate to categorize
unexecuted Immediate or Cancel orders separately as one bucket
irrespective of the duration of time after order receipt, i.e., without
a time increment, to better differentiate orders cancelled subsequent
to entry from those where the customer's intent prior to order entry
was to cancel the order if no execution could be immediately obtained.
The Exchange, therefore, proposes to modify Commentary .04 to provide
that unexecuted Immediate or Cancel orders shall be categorized
separately for purposes of Appendix B.I.a(21) through B.I.a(27).
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    \19\ In connection with this proposed rule change and others
made by Participants, FINRA intends to file an exemptive request on
behalf of Participants seeking relief from certain of the Plan's
data collection requirements.
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    The second change relates to the reporting of daily market quality
statistics pursuant to Appendix B.I. Currently, Appendix B.I sets forth
categories of orders, including market orders, marketable limit orders,
and inside-the-quote resting limit orders, for which daily market
quality statistics must be reported. The Exchange and the other
Participants have determined that it is appropriate to include an order
type for limit orders priced more than $0.10 away from the NBBO for
purposes of Appendix B reporting. The Exchange therefore proposes to
amend Commentary .06 to provide that limit orders priced more than
$0.10 away from the NBBO shall be included as an order type for
purposes of Appendix B reporting, and shall be assigned the number
(22). These orders are not currently required to be reported pursuant
to Appendix B, and the Exchange and the other Participants believe that
requiring the reporting of such orders will produce a more
comprehensive data set.
    The third change relates to the reporting of market quality
statistics pursuant to Appendix B.I for a variety of order types,
including inside-the-quote resting limit orders (12), at-the-quote
resting limit orders (13), and near-the-quote resting limit orders
(within $0.10 of the NBBO) (14). The Exchange and the other
Participants believe that it is appropriate to require Trading Centers
to report all orders that fall within these categories, and not just
those orders that are ``resting.'' The Exchange, therefore, proposes to
amend Commentary .06 to make this change.
    In the fourth change, the Exchange proposes to add new Commentary
.09 to modify the manner in which market maker participation statistics
are calculated. Currently, Appendix B.IV provides that market maker
participation statistics shall be calculated based on share
participation, trade participation, cross-quote share (trade)
participation, inside-the-quote share (trade) participation, at-the-
quote share (trade) participation, and outside-the-quote share (trade)
participation. The Exchange and the other Participants have determined
that it is appropriate to add the count of the number of Market Makers
used in the calculation of share (trade) participation to each
category. The Exchange is therefore proposing this change as part of
Commentary .09. In addition, Appendix B.IV(b) and (c) currently require
that, when aggregating across Market Makers, share participation and
trade participation shall be calculated using the share-weighted
average and trade-weighted average, respectively. The Exchange and the
other Participants believe that it is more appropriate to calculate
share and trade participation by providing the total count of shares or
trades, as applicable, rather than weighted averages, and the Exchange
is therefore proposing this change as part of Commentary .09.
    The fifth change relates to the NBBO that a Trading Center is
required to use when performing certain quote-related calculations.
When calculating cross-quote share (trade) participation pursuant to
Appendix B.IV(d) and inside-the-quote share (trade) participation
pursuant to Appendix B.IV(e), the Plan requires the Trading Center to
utilize the NBBO at the time of the trade for both share and trade
participation calculations. When calculating at-the-quote share (trade)
participation and outside-the quote share (trade) participation
pursuant to Appendix B.IV(f) and (g), the Plan allows the Trading
Center to utilize the NBBO at the time of or immediately before the
trade for both share and trade participation calculations. The Exchange
and the other Participants believe that it is appropriate to calculate
all quote participation (cross-quote share (trade) participation,
inside-the-quote share (trade) participation, at-the-quote share
(trade) participation and outside-the-quote share (trade)
participation) solely by reference to the

NBBO in effect immediately prior to the trade. The Exchange, therefore,
proposes to make this change as part of Commentary .09.
    Finally, the Exchange proposes to change the end date until which
the Pre-Pilot Data Collection Securities shall be used to fulfill the
Plan's data collection requirements. Currently, Commentary .10 provides
that Pre-Pilot Data Collection Securities are the securities designated
by the Participants for purposes of the data collection requirements
described in Items I, II and IV of Appendix B and Item I of Appendix C
to the Plan for the period beginning six months prior to the Pilot
Period and ending on the trading day immediately preceding the Pilot
Period. The Exchange and the other Participants believe that it is
appropriate to use the Pilot Securities to satisfy the Plan's data
collection requirements prior to the commencement of the Pilot.
Accordingly, the Exchange is revising Commentary .10 (which will be re-
numbered as Commentary .11) to provide that the Pre-Pilot Data
Collection Securities shall be used to satisfy the Plan's data
collection requirements through thirty-one days prior to the Pilot
Period, after which time the Pilot Securities shall be used for
purposes of the data collection requirements.\20\ As noted in Item 2 of
this filing, the Exchange has filed the proposed rule change for
immediate effectiveness. The Exchange has requested that the SEC waive
the 30-day operative period so that the proposed rule change can become
operative on August 30, 2016.
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    \20\ After regular trading hours on September 2, 2016, the
national securities exchanges will establish which securities will
be included as Pilot Securities for purposes of the Plan. The
Exchange and the other Participants have determined that members
should use the Pilot Securities list for data collection purposes
once it becomes available. Thus, the proposed rule change requires
that, beginning thirty days prior to the first day of the Pilot
Period--i.e., September 3, 2016--The Exchange and Exchange members
will comply with the data collection obligations of the Plan by
collecting data on the Pilot Securities. As a result, beginning on
September 3, 2016, members must migrate from using the Exchange's
published Pre-Pilot Data Collection Security list and begin using
the Pilot Securities list. September 2, 2016 will be the last day
that members use the Pre-Pilot Data Collection Security list.
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\21\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\22\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general to protect investors and the public
interest, and Section 6(b)(8) of the Act,\23\ which requires that the
Exchange not impose any burden on competition that is not necessary or
appropriate.
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    \21\ 15 U.S.C. 78f(b).
    \22\ 15 U.S.C. 78f(b)(5).
    \23\ 15 U.S.C. 78f(b)(8).
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    The Exchange believes that this proposal is consistent with the Act
because it implements and clarifies the provisions of the Plan, and is
designed to assist the Exchange in meeting its regulatory obligations
pursuant to the Plan. In approving the Plan, the SEC noted that the
Pilot was an appropriate, data-driven test that was designed to
evaluate the impact of a wider tick size on trading, liquidity, and the
market quality of securities of smaller capitalization companies, and
was therefore in furtherance of the purposes of the Act. The Exchange
believes that this proposal is in furtherance of the objectives of the
Plan, as identified by the SEC, and is therefore consistent with the
Act because the proposal implements and clarifies the requirements of
the Plan.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange notes that the
proposed rule change implements the provisions of the Plan, and is
designed to assist the Exchange in meeting its regulatory obligations
pursuant to the Plan. The Exchange also notes that, other than the
change to require use of the Pilot Securities beginning thirty days
prior to the beginning of the Pilot Period, the proposed changes will
not affect the data collection and reporting requirements for members
that operate Trading Centers; the proposed changes will only affect how
the Exchange and Participants that operate Trading Centers collect and
report data. The Exchange notes that, with respect to the change to
require the use of the Pilot Securities beginning thirty days prior to
the start of the Pilot Period, the proposed change reduces the number
of securities on which affected members otherwise would have been
required to collect data pursuant to the Plan and Rule 4770. In
addition, the proposed rule change applies equally to all similarly
situated members. Therefore, the Exchange 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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \24\ and Rule 19b-4(f)(6) \25\ thereunder
because the proposal does not: (i) Significantly affect the protection
of investors or the public interest; (ii) impose any significant burden
on competition; and (iii) by its terms, become operative for 30 days
from the date on which it was filed, or such shorter time as the
Commission may designate if consistent with the protection of investors
and the public interest.
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    \24\ 15 U.S.C. 78s(b)(3)(A).
    \25\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) \26\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\27\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that so that the
proposed rule change can become operative on August 30, 2016.
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    \26\ 17 CFR 240.19b-4(f)(6).
    \27\ 17 CFR 240.19b-4(f)(6)(iii).
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    The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest
because it will allow the Exchange to implement the proposed rules
immediately thereby preventing delays in the implementation of the
Plan. The Commission notes that the Plan is scheduled to start on
October 3, 2016. Therefore, the Commission hereby waives the 30-day
operative delay and designates the proposed rule change to be operative
upon filing with the Commission.\28\
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    \28\ For purposes only of waiving the operative delay for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such

action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in furtherance of the purposes of
the Act.\29\
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    \29\ 15 U.S.C. 78s(b)(3)(C).
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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 email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2016-123 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2016-123. This
file number should be included on the subject line if email 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 Web site viewing and
printing 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 the Exchange. 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-NASDAQ-2016-123 and should
be submitted on or before October 7, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\30\
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    \30\ 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-22255 Filed 9-15-16; 8:45 am]
BILLING CODE 8011-01-P