UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES,

AND TOXIC SUBSTANCES

MEMORANDUM

DATE:	04-DEC-2009

SUBJECT:	Novaluron.  Chronic Dietary (Food and Drinking Water) Exposure and Risk Assessment for the Proposed Uses on Vegetable, Fruiting, Group 8; Vegetable, Cucurbit, Group 9; Berry, Low-growing, Subgroup 13-07G; Miscellaneous Fruiting Vegetables; Bean, Snap; Bean, Dry, Seed; and Swiss Chard.

PC Code:  124002	DP Barcode:  D364235

Decision No.:  407555	Registration No.:  66222-35-400

Petition No.:  9E7546 	Regulatory Action: Section 3 Registration

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

TXR No.:  NA	CAS No.:  116714-46-6

MRID No.:  NA	40 CFR:  §180.598

FROM:	Julie L. Van Alstine, MPH, Environmental Health Scientist

		Risk Assessment Branch 1 (RAB1)/Health Effects Division (HED) (7509P)

THROUGH:	Donna S. Davis, Chemist

Nancy Dodd, Chemist

		Dietary Exposure Science Advisory Council (DESAC)

HED (7509P)

and

George F. Kramer, Ph.D., Branch Senior Chemist

RAB1/HED (7509P)

TO:		Julie L. Van Alstine, Risk Assessor

RAB1/HED (7509P)

and

		Barbara Madden/Laura Nollen (RM 05)

Registration Division (RD; 7505P)

Executive Summary

A chronic aggregate dietary (food and drinking water) exposure and risk assessment was conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (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 analysis was performed to support Section 3 requests for use of novaluron on the fruiting vegetable group 8; cucurbit vegetable group 9; low-growing berry subgroup 13-07G; miscellaneous fruiting vegetables; snap bean; dry bean seed; and Swiss chard.

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

An acute dietary assessment was not conducted for novaluron because an endpoint of concern attributable to a single dose was not identified.

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

A chronic dietary (food and drinking water) exposure and risk assessment was conducted for the proposed new uses on the fruiting vegetable group 8, cucurbit vegetable group 9, low-growing berry subgroup 13-07G, miscellaneous fruiting vegetables, snap bean, dry bean seed, and Swiss Chard; all established uses; and drinking water.  A partially refined assessment was conducted.  Estimated drinking water concentrations (EDWCs) were provided by the Environmental Fate and Effects Division (EFED).  The chronic analysis assumed 100% crop treated for all commodities; incorporated average field trial residues for some commodities (pome fruit, sugarcane, bushberries, Brassica leafy greens, stone fruit, bell pepper, non-bell pepper, cucumber, summer squash, cantaloupe, strawberry, succulent snap bean, dry bean seed, and Swiss chard); average greenhouse trial residues for tomatoes; empirical processing factors for apple juice (translated to pear and stone fruit) and tomato paste and purée; and DEEM( (ver. 7.81) default processing factors for the remaining processed commodities.  Furthermore, anticipated residues (ARs) were used for meat, hog, and milk commodities.

The chronic dietary (food and drinking water) exposure to novaluron is below HED’s level of concern for the general U.S. population and all population subgroups.  The chronic dietary exposure results in a risk estimate that is 25% of the chronic population-adjusted dose (cPAD) for the general U.S. population and 84% of the cPAD for children 1-2 years old, the most highly exposed population subgroup.

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

A cancer dietary assessment was not conducted because novaluron is classified as “not likely to be carcinogenic to humans.”

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 the 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 novaluron was conducted by J. Van Alstine (09-SEP-2009, DP#359460).

II.	Food Residue Information

Novaluron Use:

Novaluron tolerances are published in 40 CFR§180.598.

Residues of Concern:  The residue of concern in crops and livestock, for purposes of tolerance enforcement and risk assessment, is novaluron only.  The residues of concern in drinking water for purposes of risk assessment are novaluron, the chlorophenyl urea degradate (1-[3-chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)phenyl]urea), and the chloroaniline metabolite (3-chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)aniline) (Memo, G. Kramer et al., 03-FEB-04; DP#297646).

Residue Data used for Chronic Assessments:

Recommended Tolerances:  Based on the residue chemistry data submitted with the current petition, HED recommended for establishment of the following tolerances for residues of the insecticide novaluron, including its metabolites and degradates, in or on the commodities in the table below.  Compliance with the tolerance levels specified below is to be determined by measuring only novaluron (N-[[[3-chloro-4-[1,1,2-trifluoro-2-(trifluoromethoxy)ethoxy]phenyl]amin o]carbonyl]-2,6-difluorobenzamide) in or on the following raw agricultural commodities (Memo, J. L. Van Alstine, 04-DEC-09; DP#364237):

Vegetable, cucurbit, group 9	0.15 ppm

	Okra	1.0 ppm

Vegetable, fruiting, group 8	1.0 ppm

	Roselle	1.0 ppm

Cocona		1.0 ppm

	Sunberry	1.0 ppm

Eggplant, African	1.0 ppm

	Tomato, bush	1.0 ppm

Eggplant, pea	1.0 ppm

	Tomato, currant	1.0 ppm

Eggplant, scarlet	1.0 ppm

	Tomato, tree	1.0 ppm

Goji berry	1.0 ppm

	Berry, low-growing, subgroup 13-07G 	0.45 ppm

Huckleberry, garden	1.0 ppm

	Bean, snap, succulent	0.60 ppm

Martynia	1.0 ppm

	Bean, dry, seed	0.30 ppm

Naranjilla	1.0 ppm

	Swiss chard	12 ppm

™ and were therefore not included in the chronic assessment: cocona, African eggplant, pea eggplant, scarlet eggplant, goji berry, garden huckleberry, martynia, naranjilla, roselle, sunberry, bush tomato, and currant tomato.  However, tree tomato is included in DEEM and was therefore included in the chronic assessment.

	Drinking Water Data

The drinking water residues used in the dietary risk assessment were provided by EFED in the following memorandum:  “Novaluron and Novaluron Degradates (Chlorophenyl urea and Chloroaniline) Drinking Water Assessment in Support of New Use Registration Action for Sorghum, Fruiting Vegetables (Group 8, D364309), Cucurbit Vegetables (Group 9), Low-growing Berry Subgroup (13-07G), Snap and Dry Bean, and Swiss Chard” (I. Maher, 16-JUL-09; DP#363989) 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.”  Since the application rates are significantly lower for the proposed uses than for pome fruits and stone fruits, the estimated drinking water concentrations provided in the previous drinking water assessments dated 10-MAR-2009 (DP#357061) and 11-FEB-2004 (DP#285477) are applicable for the proposed uses.

Monitoring data are not available for novaluron or its chlorophenyl urea and chloroaniline degradates.  Concentrations in surface water and ground water were estimated using modeling.

Novaluron:  EFED used Tier 2 Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) modeling to estimate drinking water concentrations for surface water for novaluron per se.  The EDWC (1-in-10-year annual mean) for novaluron only is 0.76 ppb in surface water.  For groundwater, the Screening Concentration in Ground Water (SCI-GROW) model was used to predict a groundwater concentration for novaluron.  The EDWC for novaluron only is 0.0056 ppb in drinking water from shallow ground water sources.

Chlorophenyl urea and chloroaniline degradates:  A Tier 1 drinking water analysis was performed using the FQPA Index Reservoir Screening Tool (FIRST) model to obtain surface water estimates for the chlorophenyl urea and chloroaniline degradates.  For surface water, the annual average EDWC for the chlorophenyl urea degradate is ≤0.89 ppb and the annual average EDWC for the chloroaniline degradate is ≤2.6 ppb.  The SCI-GROW model was used to predict groundwater concentrations.  The predicted groundwater EDWC for the chlorophenyl urea degradate is <0.0045 ppb, and for the chloroaniline degradate, the EDWC is <0.0090 ppb.

These EDWC values are meant to represent upper-bound estimates of the concentrations that might be found in surface water and groundwater based upon existing and proposed uses.  Of the three EDWC values, the chronic estimate for the terminal degradate, chloroaniline, is the highest (100% conversion from parent to the chloroaniline degradate was assumed).  This is consistent with the expected degradation of novaluron.  Therefore, the EDWC value for chloroaniline (2.6 ppb) was used to assess chronic aggregate risk for this dietary assessment.

IV.	Percent Crop Treated

For all commodities in the chronic assessment, the assumption of 100% crop treated was made.

V.	DEEM-FCID™ Program and Consumption Information

A novaluron chronic dietary exposure assessment was conducted using DEEM-FCID™, Version 2.03 which incorporates consumption data from USDA’s CSFII, 1994-1996 and 1998.  The 1994-96 and 1998 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 and 1998 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.

VI.	Toxicological Information

The RAB1 toxicologists have reevaluated the novaluron database and reaffirmed the previous conclusion of the Hazard Identification Assessment Review Committee (HIARC; 16-DEC-2003, TXR# 0052361) that the Food Quality Protection Act (FQPA) Safety Factor (SF) for increased susceptibility of infants and children can be reduced to 1X.  The decision was based on a lack of increased susceptibility in the rat and/or rabbit developmental toxicity studies at levels up to the limit dose.  Also, no increased qualitative and/or quantitative evidence of increased susceptibility was found following pre/post-natal exposure in a two-generation reproduction study in rats.  The risk assessment team has concluded that the FQPA SF for increased susceptibility of infants and children can be reduced to 1X based on toxicological considerations (above), the conservative residue assumptions used for dietary risk assessments, the completeness of the residue chemistry database, and conservative drinking water assessment.  Table 1 is a summary of the decisions made by the HIARC concerning dietary exposure assessment.  These endpoints have been confirmed by the risk assessment team as appropriate for the current risk assessment.

Table 1.  Summary of Toxicological Doses and Endpoints for Novaluron 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 (All Populations)	N/A	N/A	N/A	An endpoint of concern attributable to a single dose was not identified.  An acute RfD was not established.

Chronic Dietary (All Populations)	NOAEL =

1.1  mg/kg/day	UFA = 10X

UFH = 10X

FQPA SF = 1X

	Chronic RfD = 0.011

mg/kg/day

cPAD = 0.011 mg/kg/day	Combined chronic toxicity/carcinogenicity feeding in rat.  LOAEL = 30.6 mg/kg/day based on erythrocyte damage and turnover resulting in a regenerative anemia.

Cancer (oral, dermal, inhalation)   	Classification: “Not likely to be Carcinogenic to Humans.”

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.

VII.	Results/Discussion

As stated above, for a chronic assessment, HED is concerned when dietary risk exceeds 100% of the cPAD.  The chronic analysis was performed using DEEM-FCID( (ver. 2.03).  The DEEM-FCID( analysis estimates 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, adults 20-49, adults 50+ years old, and females 13-49.  The resulting food and drinking water exposure estimates were not of concern to HED ((100% cPAD).  The chronic dietary exposure estimates are 25% of the chronic population-adjusted dose (cPAD) for the general U.S. population and 84% of the cPAD for children 1-2 years old, the most highly exposed population subgroup (see Attachment 3 for details).

Table 2.  Summary of Chronic Dietary Exposure (Food and Drinking Water) and Risk for Novaluron.

Population Subgroup	Acute Dietary	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	0.002749	25	N/A	N/A

All Infants (< 1 year old)

	0.004732	43

Children 1-2 years old

	0.009204	84

Children 3-5 years old

	0.007142	65

Children 6-12 years old

	0.004307	39

Youth 13-19 years old

	0.002365	22

Adults 20-49 years old

	0.001944	18

Adults 50+ years old

	0.001965	18

Females 13-49 years old

	0.001856	17

VIII.	Characterization of Inputs/Outputs

The chronic dietary assessment was refined through the use of empirical processing factors, some average field trial residues (pome fruit, sugarcane, bushberries, Brassica leafy greens, stone fruit, bell pepper, non-bell pepper, cucumber, summer squash, cantaloupe, strawberry, succulent snap bean, dry bean seed, and Swiss chard), average greenhouse trial residues for tomatoes, and ARs for meat, hog, and milk commodities.  Empirical processing factors for apple juice were translated to pear and other pome fruit juice and all stone fruit juice.  In accordance with HED SOP 2000.1, average field trial residues were translated from representative commodities in the crop group to other commodities in that crop group as needed (see Appendix 1).  Despite this, HED concludes that the chronic estimates are still highly conservative since they assumed average residues based on field trial data [maximum application rate; minimum pre-harvest interval (PHI); frozen immediately after harvest] and assumed 100% crop treated.  The current chronic analysis could be further refined through the following:  use of percent crop treated data; monitoring data; preparation/cooking factors; and/or ARs for poultry commodities.

IX.	Conclusions

A chronic dietary risk assessment was conducted using DEEM-FCID( (ver. 2.03).  For this assessment, average field trial residues for bell pepper, non-bell pepper, cucumber, summer squash, cantaloupe, strawberry, succulent snap bean, dry bean seed, and Swiss chard were added to the last dietary assessment.  The last dietary assessment incorporated empirical processing factors, average field trial residues (pome fruit, sugarcane, bushberries, Brassica leafy greens, and stone fruit), average greenhouse trial residues (tomatoes), and ARs for meat and milk commodities.  EDWC values, provided by EFED, were included in this dietary assessment.  The chronic dietary (food and drinking water) exposure to novaluron is below HED’s level of concern for the general U.S. population and all population subgroups.  The chronic dietary exposure estimates are 25% of the cPAD for the general U.S. population and 84% of the cPAD for children 1-2 years old, the most highly exposed population subgroup.

X.	List of Attachments

Attachment 1:	AR Table.

Attachment 2:	DEEM-FCID( Chronic Residue Input File.

Attachment 3:	DEEM-FCID( Chronic Results File.

cc: Julie L. Van Alstine

J.L.Van Alstine:S-10954:PY-S:(703)603-8866:7509P:RAB1

Attachment 1:  Processing Factors and Residue Estimates from Previous Novaluron Dietary Assessments (Memo, G. Kramer, 22-MAR-2004, DP#298783; Memo, J. Van Alstine, 09-SEP-2009, DP#359460) Updated to Include Proposed Commodity Processing Factors and Residue Estimates.

crop

commodity

processing factor1

residue (ppm)1

comment

meat2	meat	1	0.112	AR

dried beef meat	dried meat	1.92	0.112	AR; DEEM (ver. 7.78) default proc. fact.

fat2	fat	1	2.43	AR

liver2	liver	1	0.190	AR

kidney2	kidney	1	0.183	AR

milk	Milk, fat	1	2.82	AR, calculated assuming residues partition into fat

	Milk, nonfat solids	1	0.113	AR for whole milk, used to account for low residues observed in skim milk

	Milk, water	1	0	All residues assumed to be associated with fat and solids.

	Milk, sugar	1	0	All residues assumed to be associated with fat and solids.

pork meat	meat	1	0.0024	AR

pork skin	skin	1	0.053	AR (fat)

pork fat	fat	1	0.053	AR

pork liver	liver	1	0.0040	AR

pork kidney	kidney	1	0.0041	AR

cotton	cottonseed oil	1	0.60	tolerance for RAC adequate to cover residues in processed commodity

tuberous and corm vegetables	All	1	0.025	½ LOQ residue; DEEM (ver. 7.78) default proc. factor of 6.5 used for potato, dry

pome fruit – apple, crabapple3	RAC, sauce	1	0.578	average field trial residue

	dried	8	0.578	average field trial residue; DEEM (ver. 7.78) default proc. fact.

	juice	0.10	0.578	average field trial residue; empirical proc. fact.

pome fruit – pear + other pome fruit3	RAC	1	0.833	average field trial residue

	dried	6.25	0.833	average field trial residue; DEEM (ver. 7.78) default proc. fact.

	juice	0.10	0.833	average field trial residue; empirical apple proc. fact.

sugarcane	sugar	1	0.125	average field trial residue

	molasses	1	0.125	average field trial residue

tomato, tomatillo, tree tomato4	RAC	1	0.161	overall (small- & large-fruit varieties) average of the greenhouse trial residue.

	dried	14.3	0.161	overall average of the greenhouse trial residue; DEEM (ver. 7.78) default proc. fact.

	juice	1.5	0.161	overall average of the greenhouse trial residue; DEEM (ver. 7.78) default proc. fact.

	purée	0.7	0.161	overall average of the greenhouse trial residue; empirical proc. fact.

	paste	1.1	0.161	overall average of the greenhouse trial residue; empirical proc. fact.

bell pepper, eggplant5	RAC	1	0.14	average bell pepper field trial residue

non-bell pepper, okra6	RAC	1	0.16	average non-bell pepper field trial residue

Brassica, leafy greens, subgroup 5B and turnip, greens	All	1	5.33 average mustard green field trial residue

plum 	RAC	1	0.403	average plum field trial residue

	dried	1	2.6	tolerance for dried plum

	juice	0.10	0.403	average plum field trial residue; empirical apple proc. fact.

cherry	RAC	1	2.17	average field trial residue

	juice	0.10	2.17	average field trial residue; empirical apple proc. fact.

peach, nectarine, and apricot4	RAC	1	0.61	average peach field trial residue

	dried	7.0	0.61	average peach field trial residue; DEEM (ver. 7.78) default proc. fact. of 7.0 used for peaches, dried and 6.0 used for apricots, dried

	juice	0.10	0.61	average peach field trial residue; empirical apple proc. fact.

cucumber, Chinese waxgourd, balsam pear8	All	1	0.05	average cucumber field trial residue

cantaloupe, casaba, honeydew melon, winter melon, watermelon9	RAC	1 0.055	average cantaloupe field trial residue

	juice	1	0.055	average cantaloupe field trial residue

summer squash, chayote fruit Christophe, pumpkin, winter squash10	All	1 0.044	average summer squash field trial residue

bushberry subgroup 13-07B11	All	1	1.97	average blueberry field trial residue

low-growing berry subgroup 13-07G12	All	1	0.140	average strawberry field trial residue; DEEM (ver. 7.78) default proc. fact. of 1.1 used for cranberry juice

snap bean (succulent)	All	1	0.18	average succulent snap bean pods with seeds field trial residue

dry bean seed	All	1	0.065	average dry bean seed field trial residue

Swiss chard	All	1	4.2	average Swiss chard field trial residue

egg	RAC	1	0.07	recommended in Memo, S. Levy, 31-JAN-08; DP# 340137

1 See DP#285474, G. Kramer, 3/22/04.

2 Cattle, goat, horse, and sheep.

3 Apple and pear residues were translated to the remaining pome fruit crops using HED SOP 2000.1.

4 Tomato residues were translated to tomatillo and tree tomato using HED SOP 2000.1.

5 Bell pepper residues were translated to eggplant using HED SOP 2000.1.

6 Non-bell pepper residues were translated to okra.

7 Peach residues were translated to nectarine and apricot crops using HED SOP 2000.1.

8 Cucumber residues were translated to Chinese waxgourd and balsam pear using HED SOP 2000.1.

9 Cantaloupe residues were translated to casabas, honeydew melon, winter melon, and watermelon using HED SOP 2000.1.

10 Summer squash residues were translated to chayote fruit Christophe, pumpkin, and winter squash using HED SOP 2000.1.

11 Blueberry residues were translated to currant, elderberry, gooseberry, and huckleberry using the memo titled “ChemSAC Review of USDA IR-4 Crop Grouping Proposal to Amend the Berry Crop Group 13” (B. Schneider, 28-MAR-2006).

12 Strawberry residues were translated to cranberry using the memo titled “ChemSAC Review of USDA IR-4 Crop Grouping Proposal to Amend the Berry Crop Group 13” (B. Schneider, 28-MAR-2006).

Attachment 2:  DEEM-FCID( Chronic Residue Input File

Filename: C:\Documents and Settings\jlangsda\My Documents\Chemicals\Novaluron\Pepper, Strawberry, Snap Bean, Cucumber, etc\DEEM\124002-chronic-2009-JLV__10-NOV-09.R98

Chemical: Novaluron

RfD(Chronic): .011 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: 09-15-2009/11:04:41/8          Program ver. 2.03

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

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

01030150 1CD  Arrowroot, flour                   0.025000   1.000  1.000

01030151 1CD  Arrowroot, flour-babyfood          0.025000   1.000  1.000

01030170 1CD  Artichoke, Jerusalem               0.025000   1.000  1.000

01030820 1CD  Cassava                            0.025000   1.000  1.000

01030821 1CD  Cassava-babyfood                   0.025000   1.000  1.000

01031390 1CD  Dasheen, corm                      0.025000   1.000  1.000

01031660 1CD  Ginger                             0.025000   1.000  1.000

01031661 1CD  Ginger-babyfood                    0.025000   1.000  1.000

01031670 1CD  Ginger, dried                      0.025000   1.000  1.000

01032960 1C   Potato, chips                      0.025000   1.000  1.000

01032970 1C   Potato, dry (granules/ flakes)     0.025000   6.500  1.000

01032971 1C   Potato, dry (granules/ flakes)-b   0.025000   6.500  1.000

01032980 1C   Potato, flour                      0.025000   6.500  1.000

01032981 1C   Potato, flour-babyfood             0.025000   6.500  1.000

01032990 1C   Potato, tuber, w/peel              0.025000   1.000  1.000

01032991 1C   Potato, tuber, w/peel-babyfood     0.025000   1.000  1.000

01033000 1C   Potato, tuber, w/o peel            0.025000   1.000  1.000

01033001 1C   Potato, tuber, w/o peel-babyfood   0.025000   1.000  1.000

01033660 1CD  Sweet potato                       0.025000   1.000  1.000

01033661 1CD  Sweet potato-babyfood              0.025000   1.000  1.000

01033710 1CD  Tanier, corm                       0.025000   1.000  1.000

01033870 1CD  Turmeric                           0.025000   1.000  1.000

01034060 1CD  Yam, true                          0.025000   1.000  1.000

01034070 1CD  Yam bean                           0.025000   1.000  1.000

04023670 4B   Swiss chard                        4.200000   1.000  1.000

05010610 5A   Broccoli                           0.500000   1.000  1.000

05010611 5A   Broccoli-babyfood                  0.500000   1.000  1.000

05010620 5A   Broccoli, Chinese                  0.500000   1.000  1.000

05010640 5A   Brussels sprouts                   0.500000   1.000  1.000

05010690 5A   Cabbage                            0.500000   1.000  1.000

05010710 5A   Cabbage, Chinese, napa             0.500000   1.000  1.000

05010720 5A   Cabbage, Chinese, mustard          0.500000   1.000  1.000

05010830 5A   Cauliflower                        0.500000   1.000  1.000

05011960 5A   Kohlrabi                           0.500000   1.000  1.000

05020630 5B   Broccoli raab                      5.330000   1.000  1.000

05020700 5B   Cabbage, Chinese, bok choy         5.330000   1.000  1.000

05021170 5B   Collards                           5.330000   1.000  1.000

05021940 5B   Kale                               5.330000   1.000  1.000

05022290 5B   Mustard greens                     5.330000   1.000  1.000

05023180 5B   Rape greens                        5.330000   1.000  1.000

05023890 5B   Turnip, greens                     5.330000   1.000  1.000

06010430 6A   Bean, snap, succulent              0.180000   1.000  1.000

06010431 6A   Bean, snap, succulent-babyfood     0.180000   1.000  1.000

06030320 6C   Bean, broad, seed                  0.065000   1.000  1.000

06030340 6C   Bean, cowpea, seed                 0.065000   1.000  1.000

06030350 6C   Bean,  great northern, seed        0.065000   1.000  1.000

06030360 6C   Bean, kidney, seed                 0.065000   1.000  1.000

06030380 6C   Bean, lima, seed                   0.065000   1.000  1.000

06030390 6C   Bean, mung, seed                   0.065000   1.000  1.000

06030400 6C   Bean, navy, seed                   0.065000   1.000  1.000

06030410 6C   Bean, pink, seed                   0.065000   1.000  1.000

06030420 6C   Bean, pinto, seed                  0.065000   1.000  1.000

06030980 6C   Chickpea, seed                     0.065000   1.000  1.000

06030981 6C   Chickpea, seed-babyfood            0.065000   1.000  1.000

06030990 6C   Chickpea, flour                    0.065000   1.000  1.000

08001480 8    Eggplant                           0.140000   1.000  1.000

08002340 8    Okra                               0.160000   1.000  1.000

08002700 8    Pepper, bell                       0.140000   1.000  1.000

08002701 8    Pepper, bell-babyfood              0.140000   1.000  1.000

08002710 8    Pepper, bell, dried                0.140000   1.000  1.000

08002711 8    Pepper, bell, dried-babyfood       0.140000   1.000  1.000

08002720 8    Pepper, nonbell                    0.160000   1.000  1.000

08002721 8    Pepper, nonbell-babyfood           0.160000   1.000  1.000

08002730 8    Pepper, nonbell, dried             0.160000   1.000  1.000

08003740 8    Tomatillo                          0.161000   1.000  1.000

08003750 8    Tomato                             0.161000   1.000  1.000

08003751 8    Tomato-babyfood                    0.161000   1.000  1.000

08003760 8    Tomato, paste                      0.161000   1.100  1.000

08003761 8    Tomato, paste-babyfood             0.161000   1.100  1.000

08003770 8    Tomato, puree                      0.161000   0.700  1.000

08003771 8    Tomato, puree-babyfood             0.161000   0.700  1.000

08003780 8    Tomato, dried                      0.161000  14.300  1.000

08003781 8    Tomato, dried-babyfood             0.161000  14.300  1.000

08003790 8    Tomato, juice                      0.161000   1.500  1.000

09010750 9A   Cantaloupe                         0.055000   1.000  1.000

09010800 9A   Casaba                             0.055000   1.000  1.000

09011870 9A   Honeydew melon                     0.055000   1.000  1.000

09013990 9A   Watermelon                         0.055000   1.000  1.000

09014000 9A   Watermelon, juice                  0.055000   1.000  1.000

09020210 9B   Balsam pear                        0.050000   1.000  1.000

09020880 9B   Chayote, fruit                     0.044000   1.000  1.000

09021020 9B   Chinese waxgourd                   0.050000   1.000  1.000

09021350 9B   Cucumber                           0.050000   1.000  1.000

09023080 9B   Pumpkin                            0.044000   1.000  1.000

09023090 9B   Pumpkin, seed                      0.044000   1.000  1.000

09023560 9B   Squash, summer                     0.044000   1.000  1.000

09023561 9B   Squash, summer-babyfood            0.044000   1.000  1.000

09023570 9B   Squash, winter                     0.044000   1.000  1.000

09023571 9B   Squash, winter-babyfood            0.044000   1.000  1.000

11000070 11   Apple, fruit with peel             0.578000   1.000  1.000

11000080 11   Apple, peeled fruit                0.578000   1.000  1.000

11000081 11   Apple, peeled fruit-babyfood       0.578000   1.000  1.000

11000090 11   Apple, dried                       0.578000   8.000  1.000

11000091 11   Apple, dried-babyfood              0.578000   8.000  1.000

11000100 11   Apple, juice                       0.578000   0.100  1.000

11000101 11   Apple, juice-babyfood              0.578000   0.100  1.000

11000110 11   Apple, sauce                       0.578000   1.000  1.000

11000111 11   Apple, sauce-babyfood              0.578000   1.000  1.000

11001290 11   Crabapple                          0.578000   1.000  1.000

11002100 11   Loquat                             0.833000   1.000  1.000

11002660 11   Pear                               0.833000   1.000  1.000

11002661 11   Pear-babyfood                      0.833000   1.000  1.000

11002670 11   Pear, dried                        0.833000   6.250  1.000

11002680 11   Pear, juice                        0.833000   0.100  1.000

11002681 11   Pear, juice-babyfood               0.833000   0.100  1.000

11003100 11   Quince                             0.833000   1.000  1.000

12000120 12   Apricot                            0.610000   1.000  1.000

12000121 12   Apricot-babyfood                   0.610000   1.000  1.000

12000130 12   Apricot, dried                     0.610000   6.000  1.000

12000140 12   Apricot, juice                     0.610000   0.100  1.000

12000141 12   Apricot, juice-babyfood            0.610000   0.100  1.000

12000900 12   Cherry                             2.170000   1.000  1.000

12000901 12   Cherry-babyfood                    2.170000   1.000  1.000

12000910 12   Cherry, juice                      2.170000   0.100  1.000

12000911 12   Cherry, juice-babyfood             2.170000   0.100  1.000

12002300 12   Nectarine                          0.610000   1.000  1.000

12002600 12   Peach                              0.610000   1.000  1.000

12002601 12   Peach-babyfood                     0.610000   1.000  1.000

12002610 12   Peach, dried                       0.610000   7.000  1.000

12002611 12   Peach, dried-babyfood              0.610000   7.000  1.000

12002620 12   Peach, juice                       0.610000   0.100  1.000

12002621 12   Peach, juice-babyfood              0.610000   0.100  1.000

12002850 12   Plum                               0.403000   1.000  1.000

12002851 12   Plum-babyfood                      0.403000   1.000  1.000

12002860 12   Plum, prune, fresh                 0.403000   1.000  1.000

12002861 12   Plum, prune, fresh-babyfood        0.403000   1.000  1.000

12002870 12   Plum, prune, dried                 2.600000   1.000  1.000

12002871 12   Plum, prune, dried-babyfood        2.600000   1.000  1.000

12002880 12   Plum, prune, juice                 0.403000   0.100  1.000

12002881 12   Plum, prune, juice-babyfood        0.403000   0.100  1.000

13020570 13B  Blueberry                          1.970000   1.000  1.000

13020571 13B  Blueberry-babyfood                 1.970000   1.000  1.000

13021360 13B  Currant                            1.970000   1.000  1.000

13021370 13B  Currant, dried                     1.970000   1.000  1.000

13021490 13B  Elderberry                         1.970000   1.000  1.000

13021740 13B  Gooseberry                         1.970000   1.000  1.000

13021910 13B  Huckleberry                        1.970000   1.000  1.000

21000440 M    Beef, meat                         0.112000   1.000  1.000

21000441 M    Beef, meat-babyfood                0.112000   1.000  1.000

21000450 M    Beef, meat, dried                  0.112000   1.920  1.000

21000460 M    Beef, meat byproducts              0.190000   1.000  1.000

21000461 M    Beef, meat byproducts-babyfood     0.190000   1.000  1.000

21000470 M    Beef, fat                          2.430000   1.000  1.000

21000471 M    Beef,fat-babyfood                  2.430000   1.000  1.000

21000480 M    Beef, kidney                       0.183000   1.000  1.000

21000490 M    Beef, liver                        0.190000   1.000  1.000

21000491 M    Beef, liver-babyfood               0.190000   1.000  1.000

23001690 M    Goat, meat                         0.112000   1.000  1.000

23001700 M    Goat, meat byproducts              0.190000   1.000  1.000

23001710 M    Goat, fat                          2.430000   1.000  1.000

23001720 M    Goat, kidney                       0.183000   1.000  1.000

23001730 M    Goat, liver                        0.190000   1.000  1.000

24001890 M    Horse, meat                        0.112000   1.000  1.000

25002900 M    Pork, meat                         0.002400   1.000  1.000

25002901 M    Pork, meat-babyfood                0.002400   1.000  1.000

25002910 M    Pork, skin                         0.053000   1.000  1.000

25002920 M    Pork, meat byproducts              0.004100   1.000  1.000

25002921 M    Pork, meat byproducts-babyfood     0.004100   1.000  1.000

25002930 M    Pork, fat                          0.053000   1.000  1.000

25002931 M    Pork, fat-babyfood                 0.053000   1.000  1.000

25002940 M    Pork, kidney                       0.004100   1.000  1.000

25002950 M    Pork, liver                        0.004000   1.000  1.000

26003390 M    Sheep, meat                        0.112000   1.000  1.000

26003391 M    Sheep, meat-babyfood               0.112000   1.000  1.000

26003400 M    Sheep, meat byproducts             0.190000   1.000  1.000

26003410 M    Sheep, fat                         2.430000   1.000  1.000

26003411 M    Sheep, fat-babyfood                2.430000   1.000  1.000

26003420 M    Sheep, kidney                      0.183000   1.000  1.000

26003430 M    Sheep, liver                       0.190000   1.000  1.000

27002220 D    Milk, fat                          2.820000   1.000  1.000

27002221 D    Milk, fat - baby food/infant for   2.820000   1.000  1.000

27012230 D    Milk, nonfat solids                0.113000   1.000  1.000

27012231 D    Milk, nonfat solids-baby food/in   0.113000   1.000  1.000

40000930 P    Chicken, meat                      0.030000   1.000  1.000

40000931 P    Chicken, meat-babyfood             0.030000   1.000  1.000

40000940 P    Chicken, liver                     0.040000   1.000  1.000

40000950 P    Chicken, meat byproducts           0.040000   1.000  1.000

40000951 P    Chicken, meat byproducts-babyfoo   0.040000   1.000  1.000

40000960 P    Chicken, fat                       0.400000   1.000  1.000

40000961 P    Chicken, fat-babyfood              0.400000   1.000  1.000

40000970 P    Chicken, skin                      0.400000   1.000  1.000

40000971 P    Chicken, skin-babyfood             0.400000   1.000  1.000

50003820 P    Turkey, meat                       0.030000   1.000  1.000

50003821 P    Turkey, meat-babyfood              0.030000   1.000  1.000

50003830 P    Turkey, liver                      0.040000   1.000  1.000

50003831 P    Turkey, liver-babyfood             0.040000   1.000  1.000

50003840 P    Turkey, meat byproducts            0.040000   1.000  1.000

50003841 P    Turkey, meat byproducts-babyfood   0.040000   1.000  1.000

50003850 P    Turkey, fat                        0.400000   1.000  1.000

50003851 P    Turkey, fat-babyfood               0.400000   1.000  1.000

50003860 P    Turkey, skin                       0.400000   1.000  1.000

50003861 P    Turkey, skin-babyfood              0.400000   1.000  1.000

60003010 P    Poultry, other, meat               0.030000   1.000  1.000

60003020 P    Poultry, other, liver              0.040000   1.000  1.000

60003030 P    Poultry, other, meat byproducts    0.040000   1.000  1.000

60003040 P    Poultry, other, fat                0.400000   1.000  1.000

60003050 P    Poultry, other, skin               0.400000   1.000  1.000

70001450 P    Egg, whole                         0.070000   1.000  1.000

70001451 P    Egg, whole-babyfood                0.070000   1.000  1.000

70001460 P    Egg, white                         0.070000   1.000  1.000

70001461 P    Egg, white (solids)-babyfood       0.070000   1.000  1.000

70001470 P    Egg, yolk                          0.070000   1.000  1.000

70001471 P    Egg, yolk-babyfood                 0.070000   1.000  1.000

86010000 O    Water, direct, all sources         0.002600   1.000  1.000

86020000 O    Water, indirect, all sources       0.002600   1.000  1.000

95001280 O    Cottonseed, oil                    0.600000   1.000  1.000

95001281 O    Cottonseed, oil-babyfood           0.600000   1.000  1.000

95001300 O    Cranberry                          0.140000   1.000  1.000

95001301 O    Cranberry-babyfood                 0.140000   1.000  1.000

95001310 O    Cranberry, dried                   0.140000   1.000  1.000

95001320 O    Cranberry, juice                   0.140000   1.100  1.000

95001321 O    Cranberry, juice-babyfood          0.140000   1.100  1.000

95003590 O    Strawberry                         0.140000   1.000  1.000

95003591 O    Strawberry-babyfood                0.140000   1.000  1.000

95003600 O    Strawberry, juice                  0.140000   1.000  1.000

95003601 O    Strawberry, juice-babyfood         0.140000   1.000  1.000

95003620 O    Sugarcane, sugar                   0.125000   1.000  1.000

95003621 O    Sugarcane, sugar-babyfood          0.125000   1.000  1.000

95003630 O    Sugarcane, molasses                0.125000   1.000  1.000

95003631 O    Sugarcane, molasses-babyfood       0.125000   1.000  1.000

95003800 O    Tomato, Tree                       0.161000   1.000  1.000

Attachment 3:  DEEM-FCID( Chronic Results File

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for NOVALURON                        (1994-98 data)

Residue file name: C:\Documents and Settings\jlangsda\My Documents\Chemicals\Novaluron\Pepper, Strawberry, Snap Bean, Cucumber, etc\DEEM\124002-chronic-2009-JLV__10-NOV-09.R98

                                                     Adjustment factor #2 used.

Analysis Date 11-10-2009/16:30:36     Residue file dated: 11-10-2009/16:29:35/8

Reference dose (RfD, Chronic) = .011 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)                     0.002749                25.0%

U.S. Population (spring season)             0.002724                24.8%

U.S. Population (summer season)             0.002798                25.4%

U.S. Population (autumn season)             0.002823                25.7%

U.S. Population (winter season)             0.002639                24.0%

Northeast region                            0.002840                25.8%

Midwest region                              0.002775                25.2%

Southern region                             0.002616                23.8%

Western region                              0.002850                25.9%

Hispanics                                   0.002945                26.8%

Non-hispanic whites                         0.002580                23.5%

Non-hispanic blacks                         0.003328                30.3%

Non-hisp/non-white/non-black                0.003396                30.9%

All infants (< 1 year)                      0.004732                43.0%

Nursing infants                             0.002662                24.2%

Non-nursing infants                         0.005518                50.2%

Children 1-6  yrs                           0.007618                69.3%

Children 7-12 yrs                           0.004024                36.6%

Females 13-19 (not preg or nursing)    ††〠〮㈰㔰‶†††††††ㄠ⸸┷䘍浥污獥㈠⬰⠠ 潮⁴牰来漠⁲畮獲湩⥧†††††〠〮㄰㐸″†††† †††ㄠ⸶┸䘍浥污獥ㄠⴳ〵礠獲††††††††† ††††〠〮㈰㐰″†††††††ㄠ⸸┶

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Females 13+ (preg/not nursing)              0.002370                21.5%

Females 13+ (nursing)                       0.002357                21.4%

Males 13-19 yrs                             0.002654                24.1%

Males 20+ yrs                               0.002054                18.7%

Seniors 55+                                 0.001996                18.1%

Children 1-2 yrs                            0.009204                83.7%

Children 3-5 yrs                            0.007142                64.9%

Children 6-12 yrs                           0.004307                39.2%

Youth 13-19 yrs                             0.002365                21.5%

Adults 20-49 yrs                            0.001944                17.7%

Adults 50+ yrs                              0.001965                17.9%

Females 13-49 yrs                           0.001856                16.9%

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

Novaluron	                         Dietary Exposure & Risk Assessment	                 DP#:  364235

PC Code:  124002

 PAGE

Page   PAGE  7  of   NUMPAGES  15


[Federal Register Volume 86, Number 183 (Friday, September 24, 2021)]
[Notices]
[Pages 53089-53091]
[FR Doc No: 2021-20797]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket Number USCG-202-0172]

Port Access Route Study: Seacoast of New Jersey Including
Offshore Approaches to the Delaware Bay, Delaware

AGENCY: Coast Guard, DHS.

ACTION: Notice of availability of draft report; request for comments.

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

SUMMARY: On May 5, 2020, the Coast Guard published a notice of study
and request for comments (85 FR 26695), announcing a Port Access Route
Study (PARS) for the Seacoast of New Jersey Including Offshore
Approaches to the Delaware Bay, Delaware. This notice announces the
availability of a draft report for public review and comment. We seek
your comments on the content, proposed routing measures, and
development of the report. The recommendations of the study may lead to
future rulemakings or appropriate international agreements.

DATES: Your comments and related material must reach the Coast Guard on
or before October 25, 2021.

ADDRESSES: You may submit comments identified by docket number USCG-
2020-0172 using the Federal Decision Making Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice or study, call or email Mr. Jerry Barnes, Fifth Coast Guard
District (dpw), U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

AIS--Automated Information System
DHS--Department of Homeland Security
FR--Federal Register
NEPA--National Environmental Policy Act
PARS--Port Access Route Study
ACPARS--Atlantic Coast Ports Access Route Study
U.S.C.--United States Code
WEA--Wind Energy Area

II. Background and Purpose

    The Ports and Waterways Safety Act (46 U.S.C. 70003(c)) requires
the Coast Guard to conduct a PARS, i.e., a study of potential traffic
density and the need for safe access routes for vessels. Through the
study process, the Coast Guard coordinates with Federal, State, local,
tribal and foreign state agencies (as appropriate) to consider the
views of maritime community representatives, environmental groups, and
other interested stakeholders. The primary purpose of this coordination
is, to the extent practicable, to reconcile the need for safe access
routes with other reasonable waterway uses such as construction and
operation of renewable energy facilities and other uses of the Atlantic
Ocean in the study area.
    In 2019, the Coast Guard announced a supplemental study of routes
used by all vessels to access ports on the Atlantic Coast of the United
States (84 FR 9541, March 15, 2019). This notice announced PARS for
specific port approaches and international transit areas along the
Atlantic Coast. The purpose of the supplemental studies is to align the
Atlantic Coast Port Access Route Study (ACPARS) (81 FR 13307, March 14,
2016) with port approaches. The ACPARS analyzed the Atlantic Coast
waters seaward of existing port approaches within the U.S. Exclusive
Economic Zone and was finalized in 2017 (82 FR 16510, April 5, 2017).
    The purpose of this notice is to announce the availability of the
draft PARS examining the seacoast of New Jersey and the offshore
approaches to the Delaware Bay, Delaware. We encourage you to
participate in the study process by submitting comments in response to
this notice. This PARS used AIS data and information from stakeholders
to identify and verify customary navigation routes as well as potential
conflicts involving alternative activities, such as wind energy
generation and offshore mineral exploitation and exploration off the
seacoast of New Jersey and in the offshore approaches to the Delaware
Bay, Delaware.
    The study area extends approximately 175 nautical miles seaward of
the seacoast of New Jersey, Delaware, and Maryland between Sandy Hook,
New Jersey, and Ocean City, Maryland. An illustration showing the study
area is available in the docket where indicated under ADDRESSES.
Additionally, the study area is available for viewing on the Mid-
Atlantic Ocean Data Portal at http://portal.midatlanticocean.org/visualize/. See the ``Maritime'' portion of the Data Layers section.
    On May 5, 2020, the Coast Guard published a Notice of Study;
request for comments entitled ``Port Access Route Study: Seacoast of
New Jersey Including Offshore Approaches to the Delaware Bay,
Delaware'' in the Federal Register (85 FR 26695). The initial comment
period closed on July 5, 2020. The Coast Guard conducted two virtual
public meetings on October 29 and November 4, 2020. Recordings of the
public meetings are available from the docket. The comment period re-
opened through November 10, 2020. The Coast Guard also conducted
outreach with port partners during this time.

IV. Information Requested

    PARS are the means by which program managers determine the need to
establish traffic routing measures or shipping safety fairways to
reduce the risk of collision, allision and grounding, and their impact
on the environment, increase the efficiency and predictability of
vessel traffic, and preserve the paramount right of navigation while
continuing to allow for other reasonable waterway uses. The study
analyzes current routing measures around the approaches to Delaware Bay
and proposes an adequate way to manage forecasted maritime traffic
growth. The study also reviewed coastal port access from the seacoast
of New Jersey and the co-dependent use of the waters in support of
future development.
    The Coast Guard received 34 comments in response to our Federal
Register notice and other outreach efforts. All comments and supporting
documents are available in a public docket and can be viewed at http://www.regulations.gov. To do so, go to https://www.regulations.gov, type
USCG-2020-0172 in the ``SEARCH'' box and click ``SEARCH.'' Next, look
for this document in the Search Results column, and click on it. These
comments were submitted by commercial maritime operators, including
fishing vessel operators, state, and port partners. Topics covered by
these comments included support and requests for additional routing
measures around WEAs, requests for collaboration with state
organizations, and requests for NEPA compliance and Environmental
Impact Studies to be completed. A synopsis of the comments and copies
of the Coast Guard's Public outreach can be found in the report.
    As a result of the data analysis within this study and considering
the comments received the Coast Guard proposes six modified or
additional measures for consideration by the public. We seek your input
on these proposals and welcome comment on any impact to vessel transit
time, fishing activity, and/or navigation safety. All comments received
will be reviewed and considered before a final version of the PARS is
announced in the Federal Register. This notice is published under the
authority of 46 U.S.C. 70004 and 5 U.S.C. 552(a).

V. Public Participation and Request for Comments

    Submitting comments. We encourage you to submit comments through
the Federal Decision Making Portal at https://www.regulations.gov. To
do so, go to https://www.regulations.gov, type USCG-202-0172 in the
search box and click ``Search.'' Next, look for this document in the
Search Results column, and click on it. Then click on the Comment
option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER
INFORMATION CONTACT section of this notice for alternate instructions.
    Viewing material in docket. To view documents mentioned in this
proposed rule as being available in the docket, find the docket as
described in the previous paragraph, and then select ``Supporting &
Related Material'' in the Document Type column. Public comments will
also be placed in our online docket and can be viewed by following
instructions on the https://www.regulations.gov Frequently Asked
Questions web page. We review all comments received, but we will only
post comments that address the topic of the proposed rule. We may
choose not to post off-topic, inappropriate, or duplicate comments that
we receive.
    Personal information. We accept anonymous comments. Comments we
post to https://www.regulations.gov will include any personal
information you have provided. For more about privacy and submissions
to the docket in response to this document, see DHS's eRulemaking
System of Records notice (85 FR 14226, March 11, 2020).

    Dated: September 13, 2021.
Laura M. Dickey,
Rear Admiral, U.S. Coast Guard, Commander, Fifth Coast Guard District.
[FR Doc. 2021-20797 Filed 9-23-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: December 19, 2008 (Volume 73, Number 245)]
[Notices]
[Page 77869-77870]
[DOCID:fr19de08-195]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Petition for Waiver of Compliance

    In accordance with section 238.21 of Title 49 Code of Federal
Regulations (CFR), notice is hereby given that the Federal Railroad
Administration (FRA) received a request for a waiver of compliance with
certain requirements of its safety standards. The individual petition
is described below, including the party seeking relief, the regulatory
provisions involved, the nature of the relief being requested, and the
petitioner's arguments in favor of relief.

Northen Indiana Commuter Transportation District

[Waiver Petition Docket Number FRA-2008-0139]

    The Northen Indiana Commuter Transportation District (NICTD),
further identified herein as the railroad, seeks approval for a waiver
of compliance with the requirements of the Passenger Equipment Safety
Standards contained in 49 CFR 238.105(d)(1), train electronic hardware
and software safety. Section 49 CFR 238.105(d)(1) states that:
    ``Hardware and software that controls or monitors a train's primary
braking system shall either: (i) Fail safely by initiating a full
service brake application in the event of a hardware or software
failure that could impair the ability of the engineer to apply or
release the brakes; or (ii) Access to direct manual control of the
primary braking system (both service and emergency braking) shall be
provided to the engineer.''

    The railroad is purchasing 14 new bi-level electric passenger MU's
and the braking software being provided by the manufacturer only partly
meets the above requirements. The railroad requests that an application
of only emergency brakes in the event of a loss of power, or failure
(hardware and software), of the friction brake control unit be allowed
in lieu of either the requirement for a full service brake application
or restoration of direct manual control of the primary braking system
to the operator.
    The 14 new electric MU locomotives are being built by Sumitomo
Corporation of America/Nippon Sharyo and the air brake system is
provided by Knorr Brake Corporation, Westminster, Maryland. The
railroad explains in their petition that the full service brake
application is transmitted electronically to each MU's Friction Brake
Control Unit (FBCU). The FBCU then provides the requested brake
application without drawing down brake pipe pressure. An Emergency
Magnetic Valve (EMV) is provided on each MU for an electronic emergency
brake application. During normal operations, the EMVs are energized in
the closed position and any loss of power or software malfunction
causes the EMVs to open and vent to atmosphere causing the brakes over
the entire consist to apply at an emergency rate.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number (e.g., Waiver Petition Docket Number FRA-
2008-0139) and may be submitted by any of the following methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Communications received within 45 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the public docket are also available for
inspection and copying on the Internet at the docket facility's Web
site at http://www.regulations.gov.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the comment,
if submitted on behalf of an association, business, labor union, etc.).
You may review DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (Volume 65, Number 70; Pages
19477-78).

    Issued in Washington, DC on December 15, 2008.
Grady C. Cothen, Jr.,
Deputy Associate Administrator for Safety Standards and Program
Development.
 [FR Doc. E8-30158 Filed 12-18-08; 8:45 am]

BILLING CODE 4910-06-P


[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Notices]
[Pages 6637-6639]
[FR Doc No: 2022-02315]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-94109; File No. SR-NYSECHX-2022-01]

Self-Regulatory Organizations; NYSE Chicago, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend Its
Rules To Remove Obsolete References

January 31, 2022.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby given
that, on January 27, 2022, the NYSE Chicago, Inc. (``NYSE Chicago'' or
``Exchange'') 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 prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend its rules to remove obsolete
references to the Board of Governors and constitution of the Exchange.
The proposed rule change is available on the Exchange's website at
www.nyse.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 self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
    The Exchange proposes to amend its rules to remove obsolete
references to the Board of Governors and constitution of the Exchange.
In 2005 the Exchange's ownership structure was demutualized.\4\ As part
of that change, a Board of Directors replaced the Board of Governors as
the governing body of the Exchange.\5\ The Exchange filed an updated
certificate of incorporation and bylaws and ceased having a
constitution.\6\
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    \4\ See Securities Exchange Act Release No. 51149 (February 8,
2005), 70 FR 7531 (February 14, 2005) (SR-CHX-2004-26) (Order
Approving Proposed Rule Change and Amendment No. 1 and Notice of
Filing and Order Granting Accelerated Approval to Amendment No. 3 by
the Chicago Stock Exchange, Inc. Relating to the Demutualization of
the Chicago Stock Exchange, Inc.).
    \5\ See Section Fifth of Exhibit A to Amendment 1, SR-CHX-2004-
26 (November 24, 2004), available at https://www.sec.gov/rules/sro/chx/34-50892exa.pdf (stating that ``[t]he governing body of the
Corporation shall be its Board of Directors''). See also Securities
Exchange Act Release No. 50892 (December 20, 2004), 69 FR 77796
(December 28, 2004) (SR-CHX-2004-26) (Notice of Filing of Amendment
1) and 70 FR 7531, supra note 4, at 7531 (``CHX will have its own
Board of Directors that will manage CHX's business and affairs'') &
7534 (description of Board of Directors).
    \6\ See Exhibit A and Exhibit B to Amendment 1, SR-CHX-2004-26
(November 24, 2004), available at https://www.sec.gov/rules/sro/chx/34-50892exa.pdf and https://www.sec.gov/rules/sro/chx/34-50892exb.pdf (removing all references to the ``Constitution'' by
either replacing them with references to the ``bylaws'' or deleting
them). See also 69 FR 77796, supra note 5. The current governing
documents of the Exchange are the Second Amended and Restated
Certification of Incorporation of NYSE Chicago, Inc., available at
https://www.nyse.com/publicdocs/nyse/regulation/nyse/NYSE_Chicago_Second_Amended_and_Restated_Certificate_of_Incorporation.pdf, and Second Amended and Restated By-laws of NYSE Chicago, Inc.,
available at https://www.nyse.com/publicdocs/nyse/regulation/nyse/NYSE_Chicago_Second_Amended_and_Restated_Bylaws.pdf.
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    Although most references in the Exchange rules to the Board of
Governors and constitution were removed or updated at the time of the
demutualization, some obsolete references remain.\7\ To update those
obsolete references, the Exchange proposes to make the following non-
substantive changes.
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    \7\ See Exhibit E to Amendment 1, SR-CHX-2004-26 (November 24,
2004), available at https://www.sec.gov/rules/sro/chx/34-50892exe.pdf. See also 69 FR 77796, supra note 5.
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     References to the ``Board of Governors'' would be revised
to refer to the ``Board of Directors'' instead. Accordingly, the
Exchange proposes to

replace ``Governors'' with ``Directors'' in Article 13, Rule 4(d)
(Procedure for Reinstatement), and Article 22, Rule 2 (Admittance to
Listing), Rule 3 (Suspension of Securities), Rule 5 (Unlisted Trading
Privileges), Rule 21 (Corporate Governance, Disclosure, and
Miscellaneous Requirements), Rule 25 (Portfolio Depositary Receipts),
and Rule 27 (Trust Issued Receipts).
     The text ``and Article VII of the Exchange Constitution''
would be deleted from Article 12, Rule 8 (Minor Rule Variations).
Because there is no reference to ``disciplinary proceeding'' in the
Second Amended and Restated By-laws of NYSE Chicago, Inc. (``By-
laws''), the Exchange would not replace the reference with one to the
Bylaws.
     In Article 22, Rule 25(b) and Rule 27(e), ``Constitution''
would be replaced with ``bylaws''.
     In Article 22, Rule 25(g), the text ``in the Exchange's
Constitution or'' would be deleted. Because there is no limitation of
liability in the Bylaws, the Exchange would not replace the reference
with one to the Bylaws.
    Finally, the Exchange proposes to amend Article 22, Rule 5, to (a)
delete the redundant text ``by the Exchange'' and (b) add ``or her''
after ``his.'' Neither change is substantive.
    The proposed rule change is a non-substantive change that does not
impact the governance of the Exchange. The proposed change is not
otherwise intended to address any other issues, and the Exchange is not
aware of any problems that member organizations would have in complying
with the proposed change.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Exchange Act \8\ in general, and with Section
6(b)(5) of the Exchange Act \9\ in particular, because it is designed
to designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, 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.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
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    In particular, the Exchange believes that the proposed non-
substantive changes updating obsolete references would remove
impediments to and perfect the mechanism of a free and open market and
a national market system and, in general, protect investors and the
public interest because the proposed non-substantive changes would add
clarity, transparency and consistency to the Exchange's rules. It would
do so by removing obsolete references to the Board of Governors and
constitution and either updating them with references to the Board of
Directors and By-laws, respectively, or, in the case of the
constitution, deleting the reference. In addition, with respect to
Article 22, Rule 5, it would do so by making a non-substantive deletion
of redundant text and revising ``his'' to read ``his or her.''
    By making the changes, the Exchange would ensure that its rules are
consistent with the existing corporate structure and governing
documents, including the By-laws. The Exchange believes that market
participants would benefit from the increased clarity, thereby reducing
potential confusion and ensuring that persons subject to the Exchange's
jurisdiction, regulators, and the investing public can more easily
navigate and understand the Exchange's rules.
    For these reasons, the Exchange believes that the proposal is
consistent with the Act.

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

    In accordance with Section 6(b)(8) of the Act,\10\ the Exchange
believes that the proposed rule change will not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act because it is ministerial in nature and is not
designed to have any competitive impact. The proposed rule change is
not intended to address competitive issues but is rather concerned with
making non-substantive changes to update obsolete references in the
Exchange rules. Since the proposal does not substantively modify system
functionality or processes on the Exchange or put any market
participants at a relative disadvantage compared to other market
participants, the proposed changes will not impose any burden on
competition.
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    \10\ 15 U.S.C. 78f(b)(8).
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    For the reasons described above, the Exchange believes that the
proposed rule change reflects this competitive environment.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \11\ and Rule 19b-4(f)(6) thereunder.\12\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
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, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
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    \11\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \12\ 17 CFR 240.19b-4(f)(6).
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    At any time within 60 days of the filing of such 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. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \13\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \13\ 15 U.S.C. 78s(b)(2)(B).
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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 protected]. Please include
File Number SR-NYSECHX-2022-01 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-NYSECHX-2022-01. 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 website (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 website 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 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSECHX-2022-01 and should be submitted
on or before February 25, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-02315 Filed 2-3-22; 8:45 am]
BILLING CODE 8011-01-P