UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

  OFFICE OF CHEMICAL SAFETY AND

                                                                                POLLUTION PREVENTION

DATE:		June 7, 2010

MEMORANDUM

	SUBJECT:	Indaziflam:  Occupational and Residential Exposure Assessment for the First Food Use of the Herbicide on Citrus Fruit, Stone Fruit, Pome Fruit, Grapes, Tree Nuts, Pistachios and Olives.

PC Code: 080818	DP Number: D376907

Decision No.:  416570	Registration Nos.: 264-xxxx (Indaziflam 200 SC Herbicide and Indaziflam 500 SC Herbicide)

Petition Nos: 9F7589, 9E7588	Regulatory Action:  Section 3 Registration

Assessment Type: Occupational/Residential	Case No.: NA

TXR No.:  NA	CAS Number:   950782-86-2

MRID:  NA	40 CFR: NA

FROM:		Margarita Collantes, Biologist

		Risk Assessment Branch (RAB) II

		Health Effects Division (7509P)

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

		Risk Assessment Branch (RAB) II

		Health Effects Division (7509P)

TO:		Erik Kraft/James Tompkins, RM Team 25

		Herbicide Branch

		Registration Division (7505P)

ACTION REQUESTED:

The Registration Division (RD) requested that the Health Effects Division (HED) conduct an exposure and risk assessment for proposed uses of the active ingredient indaziflam to control annual grasses and broadleaf weeds in citrus fruit, stone fruit, pome fruit, grapes, tree nuts, pistachios and olives.  Occupational handler and postapplication exposure assessments were conducted for the proposed indaziflam uses.  Residential use patterns are not expected for the proposed uses but have been assessed in a previous memorandum.

TABLE OF CONTENTS

  TOC \o "1-3" \h \z \u    HYPERLINK \l "_Toc260396302"  1.0	EXECUTIVE SUMMARY	  PAGEREF _Toc260396302 \h  3

  HYPERLINK \l "_Toc260396303"  2.0.	HAZARD CHARACTERIZATION	  PAGEREF _Toc260396303 \h  4

  HYPERLINK \l "_Toc260396304"  2.1	Hazard Profile	  PAGEREF _Toc260396304 \h  4

  HYPERLINK \l "_Toc260396305"  2.2	FQPA and Uncertainty Factor Considerations	  PAGEREF _Toc260396305 \h  5

  HYPERLINK \l "_Toc260396306"  3.0	PROPOSED USE PATTERNS	  PAGEREF _Toc260396306 \h  7

  HYPERLINK \l "_Toc260396307"  4.0	RESIDENTIAL (NON-OCCUPATIONAL) EXPOSURE	  PAGEREF _Toc260396307 \h  7

  HYPERLINK \l "_Toc260396308"  5.0	 OCCUPATIONAL EXPOSURE	  PAGEREF _Toc260396308 \h  9

  HYPERLINK \l "_Toc260396309"  5.1	Occupational Handlers	10

  HYPERLINK \l "_Toc260396318"  5.2	Occupational Postapplication Exposure	  PAGEREF _Toc260396318 \h  13

  HYPERLINK \l "_Toc260396319"  5.2.1	Postapplication Inhalation Exposure	  PAGEREF _Toc260396319 \h  13

  HYPERLINK \l "_Toc260396320"  5.2.2	Postapplication Dermal Exposure	  PAGEREF _Toc260396320 \h  14

1.0	EXECUTIVE SUMMARY TC \1 " 1.0	Executive Summary

Indaziflam ([1,3,5-triazine-2,4-diamine,N-[(1R,2S)-2,3-dihydro-2,6-dimethyl-1H-inde n-1-yl]-6-(1-fluoroethyl)]) is a selective, pre-emergent and post-emergent alkylazine herbicide that controls weeds by inhibiting cellulose biosynthesis in plants. The proposed end-use products evaluated in this assessment include Indaziflam 200 SC Herbicide and Indaziflam 500 SC Herbicide, both formulated as suspension concentrates containing 19.05% and 45.05% indaziflam as the active ingredient, respectively. These products are used as a pre-emergent herbicide for weed control in citrus fruit that have been established for at least one year after transplanting, and in stone fruit, pome fruit, grapes, tree nuts, pistachios and olives that have been established for at least three years after transplanting.  Proposed uses are anticipated to result in short- and intermediate-term durations of exposure.

Proposed Use Profile

For all crops, indaziflam may be applied to the soil as a uniform broadcast or band application using ground application equipment only (i.e., groundboom and handgun).  Chemigation and aerial applications are prohibited. The maximum single application rate is 0.085 lb ai/A and the maximum annual application rate is 0.13 lb ai/A.  The minimum retreatment interval is 30 days (except 90 days in Florida and Georgia).  The pre-harvest interval is 7 days for citrus and 14 days for the other crops.

Hazard Characterization

Indaziflam shows low acute toxicity by all routes of exposure (Toxicity Category III, oral and dermal and Category IV, inhalation) and is not an ocular or dermal irritant or a dermal sensitizer.

The point of departure (PoD) selected for regulation of oral, dermal and inhalation risk at all durations is the no observed adverse effect level (NOAEL) of 7.5 mg/kg/day, based on brain, spinal cord and sciatic nerve degenerative lesions observed at the lowest observed adverse effect level (LOAEL) of 15 mg/kg/day from a subchronic oral (gavage) dog study.  Since the dermal PoD was selected from an oral study a 7.3% dermal absorption factor was used to estimate dermal exposure.  Since the dermal and inhalation PoDs were the same, margins of exposure (MOEs) were combined to provide a total margin of exposure for handler exposure scenarios.

Indaziflam is classified as “Not likely to be carcinogenic to humans.”

FQPA and Uncertainty Factors

HED recommends reduction of the FQPA safety factor to 1X.  HED has retained the traditional uncertainty factors of 10X for inter-species extrapolation and 10X for intra-species variability.  Therefore, HED’s level of concern (LOC) for residential and occupational handler and postapplication risk is equal to a Margin of Exposure (MOE) of 100.  Scenarios resulting in MOEs greater than or equal to 100 do not exceed HED’s level of concern.

Residential Exposure:

A residential assessment for use of indaziflam on turf was previously conducted and resulted in no risks of concern.  No new residential uses are being requested at this time.  The previous residential assessment resulted in handler and postapplication MOEs ranging from 2,800 to 2,100,000.

Occupational Handler Exposure:

No chemical specific data were available to assess potential exposure to pesticide handlers.  The estimates of exposure to pesticide handlers are based upon surrogate study data available in the PHED (v. 1.1, 1998) and from the Outdoor Residential Exposure Task Force (ORETF: MRID 44972201).   Short- and intermediate-term exposure and risks resulted in total MOEs ranging from 360 to 43,000 and; therefore, do not exceed HED’s level of concern.

Occupational Postapplication Exposure

Based on the Agency's current practices, a quantitative postapplication inhalation exposure assessment was not performed for the proposed uses of indaziflam, primarily because it has a very low vapor pressure, it is applied at relatively low application rates (maximum rate is 0.085 lbs ai/A), and it is not projected to be applied via typically high inhalation exposure application equipment (e.g., airblast or aerial equipment). The proposed uses for indaziflam are ground-directed uses where no crop foliage is treated.  Currently, HED has no data to assess postapplication dermal exposures to treated soil by occupational workers.  In general, such exposures are considered to be negligible. Therefore, for the proposed soil-directed uses, postapplication exposures and risks to occupational workers were not quantitatively assessed, but are not considered to be of concern.

Restricted Entry Interval

The restricted entry interval (REI) is based on the acute toxicity of indaziflam technical material.  Active ingredients classified as category III or IV for acute dermal toxicity, eye irritation potential, and skin irritation potential are assigned a default REI of 12 hours under the Worker Protection Standard for Agricultural Pesticides.  Based on the acute toxicity profile of indaziflam, the 12-hour REI which appears on the proposed labels is adequate.

Review of Human Research

This risk assessment relies in part on data from studies in which adult human subjects were intentionally exposed to a pesticide or other chemical.  These studies, which comprise the Pesticide Handlers Exposure Database (PHED), and the Outdoor Residential Exposure Task Force (ORETF) Database, have been determined to require a review of their ethical conduct, have received that review, and have been determined to be ethically conducted.

2.0.	HAZARD CHARACTERIZATION TC \2 " 2.0	HAZARD CHARACTERIZATION

2.1	Hazard Profile TC \2 " 2.1	Hazard Profile

Indaziflam shows low acute toxicity by all routes of exposure (Toxicity Category III, oral and dermal and Category IV, inhalation) and is not an ocular or dermal irritant or a dermal sensitizer.  The database for acute toxicity for indaziflam is complete and is summarized below in Table 2.1a.

The short- and intermediate-term incidental dermal and inhalation no observed adverse effect level (NOAEL) of 7.5 mg/kg/day is based on brain, spinal cord and sciatic nerve degenerative lesions observed at the LOAEL of 15 mg/kg/day from a subchronic oral (gavage) dog study.  Since the dermal PoD was selected from an oral study, a 7.3% dermal absorption factor was used to estimate human dermal absorption.  Since no inhalation absorption data are available, toxicity by the inhalation route is considered to be equivalent to the estimated toxicity by the oral route of exposure (i.e., 100% inhalation absorption is assumed).  The dermal and inhalation PoDs were the same; therefore, margins of exposure (MOEs) were combined to provide a total margin of exposure for handler exposure scenarios.

The selected PoD (neurotoxicity) is the most sensitive NOAEL available from a study of appropriate exposure duration (90-days) for short- and intermediate-term exposure.  The subchronic oral dog study was selected over other studies because the dog was the most sensitive species for neurotoxicity and the subchronic study had the overall lowest NOAEL.  Although a 28-day dermal toxicity study in the rat showed no effects at the limit dose (including neuropathology), it was not selected as a PoD for the dermal exposure scenario due to the significantly greater sensitivity for neurotoxicity seen in the dog relative to the rat.  Neurotoxic effects in the dog were identified at doses that were 10-20 times lower than in the rat.  The PoD is nonetheless considered conservative because the effects in the dog were observed following gavage dosing, in contrast to a relatively slower dermal absorption rate expected for occupational  exposure.

Indaziflam is classified as “Not likely to be carcinogenic to humans.”

A summary of the toxicological doses and PoDs for occupational exposure scenarios is provided in Table 2.1b.

2.2	FQPA and Uncertainty Factor Considerations

HED recommends reduction of the FQPA safety factor to 1X.  The toxicity database for indaziflam is complete, including the required studies that characterize potential susceptibility of infants and children. There was no evidence of increased quantitative or qualitative pre- and/or postnatal susceptibility; developmental effects in the rat were observed only at high doses in the presence of maternal/parental toxicity.  Although indaziflam causes neurotoxicity, the effects are well characterized and served as the basis for endpoint selection.  Therefore, the risk assessment is protective of potential neurotoxicity and other effects which occurred at higher doses.

HED has retained the traditional uncertainty factors of 10X for inter-species extrapolation and 10X for intra-species variability.  Therefore, HED’s level of concern (LOC) for residential and occupational handler and postapplication exposure is an MOE of 100.  Therefore, scenarios resulting in MOEs greater than or equal to 100 do not exceed HED’s level of concern.

Table 2.1a	Acute Toxicity Profile - Indaziflam

Guideline No.	Study Type	MRID(s)	Results	Toxicity Category

870.1100	Acute oral - rat	47443281	LD50 > 2000 mg/kg (both sexes)	III

870.1200	Acute dermal - rabbit	47443282	LD50 > 2000 mg/kg (both sexes) III

870.1300	Acute inhalation - rat	47443283	LC50 > 2.3 mg/L (both sexes)	IV

870.2400	Acute eye irritation - rabbit	47443284	Non-irritant	IV

870.2500	Acute dermal irritation - rabbit	47443285	Non-irritant	IV

870.2600	Skin sensitization - guinea pig	47443286	Not a sensitizer (Buehler method)	N/A

Table 2.1b Summary of Toxicological Doses and Points of Departure for Indaziflam for Use in Occupational and Residential Risk Assessments

Exposure/

Scenario	Point of Departure (PoD)	Uncertainty Factors	Level of Concern for Risk Assessment	Study and Toxicological Effects

Incidental Oral Short-Term (1 to 30 days) and Intermediate-Term (1 to 6 months)	NOAEL = 7.5 mg/kg/day	UFA=10X

UFH=10X

FQPA SF = 1X (residential)	Occupational & Residential LOC = MOE = 100 Subchronic oral (gavage) in the dog

LOAEL = 15 mg/kg/day, based on axonal degenerative microscopic findings in the brain, spinal cord and sciatic nerve.

Dermal Short-Term (1 to 30 days) and Intermediate-term (1 to 6 months) NOAEL = 7.5 mg/kg/day

DAF = 7.3%	UFA=10X

UFH=10X FQPA SF = 1X (residential)	Occupational & Residential LOC MOE = 100	Subchronic oral (gavage) in the dog

LOAEL = 15 mg/kg/day, based on axonal degenerative microscopic findings in the brain, spinal cord and sciatic nerve.

Dermal, Long-Term (>6 months)	Not required for this assessment (exposure is seasonal; long-term occupational exposure scenarios are not anticipated).

Inhalation Short-Term (1 to 30 days) and Intermediate-Term (1 to 6 months)	NOAEL= 7.5 mg/kg/day.  Inhalation absorption assumed to be 100% (default) relative to oral.	UFA=10X

UFH=10X

FQPA SF = 1X (residential)	Occupational & Residential LOC = MOE = 100 Subchronic oral (gavage) in the dog

LOAEL = 15 mg/kg/day, based on axonal degenerative microscopic findings in the brain, spinal cord and sciatic nerve.

Inhalation Long-Term (> 6 months)	Not required for this assessment (exposure is seasonal; long-term occupational exposure scenarios are not anticipated).

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).  MOE = margin of exposure.  LOC = level of concern.  N/A = not applicable.

3.0	PROPOSED USE PATTERNS

Table 3 provides a summary of the proposed uses of indaziflam.  The proposed product label involved in this assessment directs handlers to wear long sleeved shirt and long pants, shoes plus socks, and chemical resistant gloves.

Table 3: Proposed Uses of Indaziflam

Product	Use Site	Target of Application	Treatment Type	Application Method Maximum Application Rate	Comments

Indaziflam 200 SC Herbicide

(5.0 to 6.5 fl oz product/A)

1.67 lbs a.i./gal

and

Indaziflam 500 SC Herbicide (2.0 to 2.6 fl oz product/A)

4.16 lbs a.i./gal

(EPA Reg. 264-xxxx)

	Citrus Fruit, Stone Fruit, Pome Fruit, Grapes, Trees Nuts, Pistachios, Olives	Soil (preemergence control of annual grasses and broadleaf weeds) Broadcast and band application	Groundboom, handgun	0.085 lb ai/A per application	Only apply to citrus trees that have been established for at least one year after transplanting.

Only apply to all other labeled tree and vine crops that have been established for at least three years after transplanting.

Retreatment Interval: 30 days (except 90 days in   FL and   GA)

Preharvest Interval: 7 days for citrus, 14 days for other crops

Maximum annual application rate is 0.13 lb ai/A.

Do not apply by chemigation or air.

4.0	RESIDENTIAL (NON-OCCUPATIONAL) EXPOSURE

A residential assessment for use of indaziflam on turf was previously conducted in D372538 (M. Collantes; 4/21/10).   No new residential uses are being requested at this time.   Handler MOEs were significantly greater than 100 (ranging from 3,000 to 510,000) and are not of concern.

Dermal postapplication exposures were assessed for adults and children.  Additionally, oral non-dietary ingestion exposures were assessed for children (i.e. soil ingestion, and hand-/object-to-mouth).  The postapplication scenarios resulting from commercial and residential applications were assessed using the HED Draft Standard Operating Procedures (SOP’s) for Residential Exposure Assessments, 2000.   All adult and children residential lawn and golf dermal scenarios resulted in MOEs greater than the level of concern (ranging from 2,800 to 90,000) for short-term exposure and are not of concern to HED.

Since the short- and intermediate-term dermal endpoints are the same, only short-term dermal exposures were assessed for adults and children.  HED estimates short-term dermal postapplication exposure based on day-0 residues.  Using day-0 residues to assess intermediate-term exposure does not take into account dissipation of residues over time and thus results in a conservative estimation.  Therefore, the short-term dermal postapplication exposure assessment represents the worst case scenario and is protective of intermediate-term dermal exposure.

All short-term hand-to-mouth (HTM), object-to-mouth (OTM) and soil ingestion scenarios resulted in MOEs ranging from 5,300 to 2,100,000; therefore, these exposures pose no risk of concern to HED.

Based on the Agency's current practices, a quantitative postapplication inhalation exposure assessment was not performed for the proposed uses of indaziflam at this time primarily because it has a very low vapor pressure (vapor pressure less than 5 x 10-10 mmHg at 25ºC), it is applied at low application rates (maximum rate is 0.085 lbs ai/A), and it is not projected to be applied via typically high inhalation exposure application equipment (e.g., airblast or aerial equipment).  However, volatilization of pesticides may be a potential source of postapplication inhalation exposure to individuals nearby to pesticide applications.  The Agency sought expert advice and input on issues related to volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009.  The Agency received the SAP’s final report on March 2, 2010 http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html).  The Agency is in the process of evaluating the SAP report and may, as appropriate, develop policies and procedures to identify the need for and, subsequently, the way to incorporate postapplication inhalation exposure into the Agency's risk assessments.  If new policies or procedures are put into place, the Agency may revisit the need for a quantitative postapplication inhalation exposure assessment for indaziflam.

4.1	Spray Drift

Spray drift is a potential source of exposure for residents living in close proximity to spraying operations.  This situation is particularly the case with aerial application.  However, to a lesser extent, spray drift resulting from the ground application of indaziflam could also be a potential source of exposure.  The Agency has been working with the Spray Drift Task Force (a membership of US pesticide registrants), EPA Regional Offices, State Lead Agencies for pesticide regulation, and other parties to develop the best spray drift management practices.  The Agency is now requiring interim mitigation measures for aerial applications that must be placed on product labels/labeling.  The Agency has completed its evaluation of the new database submitted by the Spray Drift Task Force, and is developing a policy on how to appropriately apply the data and the AgDRIFT computer model to its risk assessments for pesticides applied by air, orchard airblast, and ground hydraulic methods.  After the policy is in place, the Agency may impose further refinements in spray drift management practices to reduce off-target drift, and risks associated with pesticide application.

Spray drift is always a potential source of exposure to residents nearby to spraying operations.  It is noted that the 0.094 lb ai/acre application rate for turf was modeled to estimate postapplication residential exposure of children (ages 1 to 6 years of age).  As this rate is equal to or higher than many of the commercial application rates, this scenario is protective of any exposure of children via spray drift from commercial indaziflam applications.

 4.2	Combined Residential Exposure:

HED combines risk values resulting from separate exposure scenarios when it is likely they can occur simultaneously based on the use-pattern and the behavior associated with the exposed population.  HED evaluated the following combined residential uses of indaziflam, 1.) adult dermal and inhalation handler (lawns only) exposure, and 2.) child postapplication dermal and oral exposures.  Since HED generally does not combine adult handler and dermal postapplication exposure, such a combined quantitative residential exposure estimate was not provided.  However, combined residential scenario assessments for children which could occur simultaneously were performed and did not result in risks of concern.

Table 4.2:  Combined Residential Exposure and Risk

Product	Use Site	Handler Total

MOE 1	Post-application Dermal MOE 2	Hand-to-Mouth MOE 3	Combined MOE 4

Adult

Lawn 3FL Concentrate /Ready to spray

72155-IO	Lawns, hardscapes and ornamentals

3,000

4,700

NA

NA

Child

Lawn 3 FL (72155-IO)	Lawns, hardscapes and ornamentals

NA

2,800

5,300

1,800

See Table 4.1.2: Indaziflam Residential Handler Exposure and Risk (Hand Held Pump); D372538; 4/21/10

See Table 4.2.2b Dermal Postapplication Exposure and Risk (DFR data); D372538; 4/21/10

See Table 4.2.3 Hand-To-Mouth Exposure and Risk ; D372538; 4/21/10

Adult Combined MOE = NA = HED does not combine adult handler and postapplication exposure

Child Combined MOE = NOAEL (7.5 mg/kg/day)/dermal postapplication dose (0.00266) + HTM dose (0.00141)

HED did not combine risk resulting from adult homeowner handler, postapplication and golfer exposure to treated turf because HED considers the probability of co-occurrence for these scenarios to be low.

OCCUPATIONAL EXPOSURE

The proposed uses of indaziflam are for control of annual grasses and broadleaf weeds in citrus fruit, stone fruit, pome fruit, grapes, tree nuts, pistachios and olives. This document assesses occupational exposures and risks from the proposed uses of Indaziflam 200 SC Herbicide (suspension concentrate, 19.05% ai, 1.67 lb ai/gal) and Indaziflam 500 SC Herbicide (suspension concentrate, 45.05% ai, 4.16 lb ai/gal).

5.1	Occupational Handlers

The quantitative exposure/risk assessment for occupational handlers is based on the following exposure scenarios, which are considered to be the most highly exposed scenarios by HED:

mixing/loading liquids for groundboom applications (PHED);

applying sprays using groundboom equipment (PHED); and

mixing/loading/applying liquids with handgun sprayer (ORETF).

Unit Exposures:

No chemical specific data were available to assess potential exposure to pesticide handlers.  The estimates of exposure to pesticide handlers are based upon surrogate study data available in the PHED (v. 1.1, 1998) and from the Outdoor Residential Exposure Task Force (ORETF). The ORETF data were designed to replace the present PHED data with higher-confidence, higher quality data that contain more replicates than the PHED data for those scenarios.  In this assessment, ORETF data were used to assess mixing/loading/applying with handgun equipment (data from MRID   SEQ CHAPTER \h \r 1 44972201).

Mitigation Approaches:

For pesticide handlers, it is HED standard practice to present estimates of dermal and inhalation exposure for “baseline,” i.e., a single layer of work clothing consisting of a long sleeved shirt, long pants, shoes plus socks and no protective gloves and no respirator.  If further exposure mitigation is needed to achieve an MOE greater than the LOC, then personal protective equipment (such as chemical-resistant gloves, double layer body protection and/or respirators) or engineering controls may be considered.  The proposed product label involved in this assessment directs handlers to wear long sleeved shirt and long pants, shoes plus socks, and chemical resistant gloves.

Exposure Duration:

Although, handler exposure is expected to be short- or intermediate-term in duration based on information provided on proposed labels, intermediate-term exposure is considered to be less likely.  In addition, the short- and intermediate-term toxicological PoDs are the same; therefore, the estimates of risk for short-term duration exposures are protective of those for intermediate-term durations.  Long-term exposures are not expected; therefore, a long-term assessment was not conducted.

Application Rate:

The proposed maximum application for all crops is 0.085 lb ai/A.

Area Treated:

The area treated in a day is based on HED Exposure Science Advisory Committee SOP No. 9.1 and professional judgment.  An area of 80 acres per day was assumed for mixing/loading and applying using groundboom equipment and an area of 25 acres per day was assumed for mixing/loading/applying using handgun equipment mounted on motorized vehicle.

Body Weight:

The average adult body weight of 70 kg was used for estimating dermal and inhalation dose, since the selected toxicological PoDs are not sex-specific.

Absorption Factors:

Since the short- and intermediate-term dermal PoD was based on an oral study, a dermal absorption factor of 7.3 percent was used to estimate dermal exposure for short-and intermediate-term durations.

Since no inhalation absorption data are available, toxicity by the inhalation route is considered to be equivalent to the estimated toxicity by the oral route of exposure (i.e., 100% inhalation absorption is assumed).

Equations and Calculations:

Daily handler exposures are estimated for each applicable handler task with the application rate, the area treated in a day, and the applicable dermal and inhalation unit exposure using the following formula:

Daily Exposure: Daily handler exposures are estimated for each applicable handler task with the application rate, the amount of acres treated in a day, and the applicable unit exposure using the following formula:

Daily Exposure (mg ai/day) = Unit Exposure (µg ai/lb ai handled) * Application Rate (lbs ai/A) * Daily Amount Handled (lbs/day) * Conversion Factor (mg/1,000 µg)

	Where:

		Daily Exposure =		Amount (mg ai/day) deposited on the surface of the skin that is

	available for dermal absorption or amount inhaled that is available for inhalation absorption,

		Unit Exposure =		Unit exposure value (µg ai/day),

Application Rate=	Normalized application rate based on a logical unit treatment, such as acres; maximum values are used (lb ai/A), and

Daily Amount Handled =	Normalized application area based on a logical unit treatment such as acres (A/day).

Daily Dose:  Daily dose (inhalation or dermal) was calculated by normalizing the daily dermal or inhalation exposure value by body weight and accounting for dermal and inhalation absorption.

Average Daily Dose (mg/kg/day) = Daily Exposure (mg ai/day) x {Absorption Factor (%/100)}

								              Body Weight (kg)

	Where:

		Average Daily Dose = 	Absorbed dose received from exposure to a pesticide in a given

	scenario	(mg pesticide active ingredient/kg body weight/day),

Daily Exposure =	Amount (mg ai/day) deposited on the surface of the skin that is available for dermal absorption or amount inhaled that is available for inhalation absorption,

Absorption Factor = 	A measure of the amount of chemical that crosses a biological boundary such as 	the skin or lungs, and

Body Weight = 	Body weight determined to represent the population of interest in a risk assessment.

Margin of Exposure (MOE): The daily dermal dose and daily inhalation dose received by occupational handlers were compared to the appropriate point of departure (i.e., NOAEL) to assess the risk to occupational handlers for each exposure route. All MOE values were calculated separately for dermal and inhalation exposure levels using the following formula:

	MOE = 	  	NOAEL (mg/kg/day)

                                 Average Daily Dose (mg/kg/day)

	Where:

	MOE   =		Margin of exposure value used by HED to represent risk or how close a

			chemical exposure is to being a concern (unitless),

ADD =	Average daily dose (ADD) is absorbed dose received from exposure to pesticide, and

		NOAEL	 =	Dose level in a toxicity study, where no observed adverse effects occurred in the 				study.

Combined Risks:  Dermal and inhalation risks for short- and intermediate-term exposures were combined in this assessment, since the toxicological effects for the dermal and inhalations routes were the same.  Dermal and inhalation risks were combined to determine a total MOE using the following formula:

		  SEQ CHAPTER \h \r 1  Total MOE = 1/ ((1/ Dermal MOE) + (1/Inhalation MOE))

Handlers Exposure and Risk:

e level of concern (MOEs ≥ 100).

Table 5.1.  Occupational Handler Exposures and Risksa

Exposure Scenario	Crop or Target	App. Rateb

(lb ai/A)	Area Treated Dailyc (acres)	Unit Exposured	Dosee

(µg/kg/day)	MOEf,g

Dermal (mg/lb ai)	Inhalation (mg/lb ai)	Dermal 	Inhalation 	Dermal  Inhalation 	Total

Mixer/Loader

Groundboom Equipment (PHED data)	Citrus Fruit, Pome Fruit, Stone Fruit, Grapes, Tree Nuts, Pistachios, Olives	0.085	80	2.9	0.0012	0.021	0.000116 360	65,000	360

Applicator

Groundboom Equipment (PHED data)	Citrus Fruit, Pome Fruit, Stone Fruit, Grapes, Tree Nuts, Pistachios, Olives	0.085	80	0.014	0.00074	0.000099 0.000072	76,000	100,000	43,000

Mixer/Loader/Applicator

Handgun Sprayer (ORETF data)	Citrus Fruit, Pome Fruit, Stone Fruit, Grapes, Tree Nuts, Pistachios, Olives	0.085	25	0.45

(with gloves)	0.0018	0.001

(with gloves)	0.000055	 7,500

(with gloves)	140,000	 7,100

(with gloves)

a.	Risks represent baseline attire (long-sleeve shirt, long pants, no respirator), except where indicated (i.e. addition of chemical-resistant gloves for the mixer/loader/applicator handgun scenario).

b.	Application rates = maximum application rates from labels.

c.	Amount handled per day values are HED estimates of acres treated per day based on Exposure SAC SOP #9.1 “Standard Values for Daily Acres Treated in Agriculture” and professional judgement.

d.  	Unit Exposures based on PHED Version 1.1 or ORETF data.

e.	Dose (mg/kg/day) = Unit exposure (mg/lb ai) x App Rate (lb ai/acre) x Area Treated (acres/day) x  % Absorption (7.3% dermal and 100% inhalation) / Body weight (70 kg).

f.	Dermal and Inhalation   SEQ CHAPTER \h \r 1 MOE = NOAEL (7.5 mg/kg/day) / Dose (mg/kg/day)

g.	Total MOE = 1 / (1/ Dermal MOE) + (1/ Inhalation MOE).

5.2	Occupational Postapplication Exposure

5.2.1	Postapplication Inhalation Exposure

Based on the Agency's current practices, a quantitative postapplication inhalation exposure assessment was not performed for the proposed uses of indaziflam at this time primarily because it has a very low vapor pressure (vapor pressure less than 5 x 10-10 mmHg at 25ºC), it is applied at low application rates (maximum rate is 0.085 lbs ai/A), and it is not projected to be applied via typically high inhalation exposure application equipment (e.g., airblast or aerial equipment).  However, volatilization of pesticides may be a potential source of postapplication inhalation exposure to individuals nearby to pesticide applications.  The Agency sought expert advice and input on issues related to volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009.  The Agency received the SAP’s final report on March 2, 2010 http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html).  The Agency is in the process of evaluating the SAP report and may, as appropriate, develop policies and procedures to identify the need for and, subsequently, the way to incorporate postapplication inhalation exposure into the Agency's risk assessments.  If new policies or procedures are put into place, the Agency may revisit the need for a quantitative postapplication inhalation exposure assessment for indaziflam.

5.2.2	Postapplication Dermal Exposure

The proposed uses for indaziflam are ground-directed uses where no crop foliage is treated.  Currently, HED has no data to assess postapplication dermal exposures to treated soil by occupational workers.  In general, such exposures are considered to be negligible. Therefore, for the proposed soil-directed uses, postapplication exposures and risks to occupational workers were not quantitatively assessed, but are not considered to be of concern.

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Page   PAGE  1  of   NUMPAGES  14


[Federal Register Volume 80, Number 152 (Friday, August 7, 2015)]
[Notices]
[Page 47554]
[FR Doc No: 2015-19413]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. 2015-48]

Petition for Exemption; Summary of Petition Received; Insitu,
Inc.

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Title 14 of the Code of Federal
Regulations. The purpose of this notice is to improve the public's
awareness of, and participation in, the FAA's exemption process.
Neither publication of this notice nor the inclusion or omission of
information in the summary is intended to affect the legal status of
the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before August 27, 2015.

ADDRESSES: Send comments identified by docket number FAA-2015-2904
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Thuy H. Cooper<PHONE_NUMBER> Office
of Rulemaking, Federal Aviation Administration, 800 Independence Avenue
SW., Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on August 4, 2015.
Lirio Liu,
Director, Office of Rulemaking.

Petition For Exemption

    Docket No.: FAA-2015-2904
    Petitioner: Insitu, Inc. (a subsidiary of The Boeing Company)
    Section(s) of 14 CFR Affected: 91.215(a)
    Description of Relief Sought: The petitioner seeks an exemption to
use a Sagetech XPC transponder that does not possess a Technical
Standard Order. Allowing the ScanEagle X200 aircraft to use the
Sagetech XPC transponder will increase the operational safety of the
proposed beyond visual-line-of-sight (BVLOS) flight operations in
central, eastern New Mexico: an area bounded by Clovis, NM and Belin,
NM.
[FR Doc. 2015-19413 Filed 8-6-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 231 (Friday, November 30, 2012)]
[Proposed Rules]
[Pages 71368-71369]
[FR Doc No: 2012-28982]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2012-1098; Airspace Docket No. 12-ACE-5]

Proposed Establishment of Class E Airspace; Tecumseh, NE

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to establish Class E airspace at
Tecumseh, NE. Controlled airspace is necessary to accommodate new
Standard Instrument Approach Procedures (SIAPs) at Tecumseh Municipal
Airport. The FAA is taking this action to enhance the safety and
management of Instrument Flight Rules (IFR) operations for SIAPs at the
airport.

DATES: 0901 UTC. Comments must be received on or before January 14,
2013.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001. You
must identify the docket number FAA-2012-1098/Airspace Docket No. 12-
ACE-5, at the beginning of your comments. You may also submit comments
through the Internet at http://www.regulations.gov. You may review the
public docket containing the proposal, any comments received, and any
final disposition in person in the Dockets Office between 9:00 a.m. and
5:00 p.m., Monday through Friday, except Federal holidays. The Docket
Office (telephone 1-800-647-5527), is on the ground floor of the
building at the above address.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone: (817) 321-
7716.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2012-1098/
Airspace Docket No. 12-ACE-5.'' The postcard will be date/time stamped
and returned to the commenter.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Central Service Center, 2601
Meacham Blvd., Fort Worth, TX 76137.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking<PHONE_NUMBER>, to
request a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    This action proposes to amend Title 14, Code of Federal Regulations
(14 CFR), Part 71 by establishing Class E airspace extending upward
from 700 feet above the surface to accommodate new standard instrument
approach procedures at Tecumseh Municipal Airport, Tecumseh, NE.
Controlled airspace is needed for the safety and management of IFR
operations at the airport.
    Class E airspace areas are published in Paragraph 6005 of FAA Order
7400.9W, dated August 8, 2012 and effective September 15, 2012, which
is incorporated by reference in 14 CFR 71.1. The Class E airspace
designation listed in this document would be published subsequently in
the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106 describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with

prescribing regulations to assign the use of airspace necessary to
ensure the safety of aircraft and the efficient use of airspace. This
regulation is within the scope of that authority as it would establish
controlled airspace at Tecumseh Municipal Airport, Tecumseh, NE.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1E, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

    1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of FAA Order
7400.9W, Airspace Designations and Reporting Points, dated August 8,
2012, and effective September 15, 2012, is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

ACE NE E5 Tecumseh, NE [New]

Tecumseh Municipal Airport, NE
    (Lat. 40[deg]24'03'' N., long. 96[deg]10'14'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.3-mile radius of Tecumseh Municipal Airport.

    Issued in Fort Worth, TX, on November 1, 2012.
David P. Medina,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2012-28982 Filed 11-29-12; 8:45 am]
BILLING CODE 4901-13-P


[Federal Register: May 7, 2008 (Volume 73, Number 89)]
[Notices]
[Page 25789]
[DOCID:fr07my08-133]

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

SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon written request, copies available from: U.S. Securities and
Exchange Commission, Office of Investor Education and Advocacy,
Washington, DC 20549-0213.

Extension:
    Rule 103; OMB Control No. 3235-0466; SEC File No. 270-410.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget a request for approval of extension of the existing
collection of information provided for in the following rule: Rule 103
of Regulation M (17 CFR 242.103).
    Rule 103 permits passive market-making in Nasdaq securities during
a distribution. A distribution participant that seeks use of this
exception would be required to disclose to third parties its intention
to engage in passive market making.
    There are approximately 214 respondents per year that require an
aggregate total of 214 hours to comply with this rule. Each respondent
makes an estimated 1 annual response. Each response takes approximately
1 hour to complete. Thus, the total compliance burden per year is 214
burden hours. The total compliance cost for the respondents is
approximately $12,037.50, resulting in a cost of compliance for the
respondent per response of approximately $56.25 (i.e., $12,037.50/214
responses).
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Comments should be directed to (i) Desk Officer for the Securities
and Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503 or by sending an e-mail to: Alexander--
<EMAIL_ADDRESS>and (ii) R. Corey Booth, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Shirley
Martinson, 6432 General Green Way, Alexandria, VA 22312 or send an e-
mail to<EMAIL_ADDRESS>Comments must be submitted within 30
days of this notice.

    Dated: April 30, 2008.
Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-10040 Filed 5-6-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Proposed Rules]
[Pages 49024-49026]
[FR Doc No: 2018-21202]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2018-0883]
RIN 1625-AA08

Special Local Regulation; Manasquan Inlet, Manasquan, NJ

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to establish a temporary special
local regulation for certain waters of the Manasquan Inlet between
Manasquan, NJ, and Point Pleasant Beach, NJ. This action is necessary
to protect event participants, spectators, and vessels transiting the
area from potential hazards during the Manasquan Inlet Intercoastal Tug
marine event. During the enforcement period, unauthorized persons or
vessels would be prohibited from entering into, remaining within,
transiting through, or anchoring in the regulated area unless
authorized by the Captain of the Port Delaware Bay or a designated
representative of the Captain of the Port. We invite your comments on
this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before October 5, 2018.

ADDRESSES: You may submit comments identified by docket number USCG-
2018-0883 using the Federal eRulemaking 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
proposed rulemaking, call or email Petty Officer Thomas Welker, U.S.
Coast Guard; Sector Delaware Bay, Waterways Management Division;
telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

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

II. Background, Purpose, and Legal Basis

    The Manasquan Beach and Recreation Department notified the Coast
Guard that it will be conducting a tug of war event from 11 a.m. to
1:30 p.m. on October 20, 2018. The tug of war will consist of teams on
opposing sides of the Manasquan Inlet with a rope extended between the
sides. The event will span the entire width of the inlet. Vessel
operation in the area of the event could be hazardous to both event
participants and vessels. The Captain of the Port Delaware Bay (COTP)
has determined that a safety concern exists for non-participant vessels
within 400 feet of the tug of war rope.
    The purpose of this rulemaking is to ensure the safety of
participants and vessels transiting the regulated area during the
event. The Coast Guard proposes this rulemaking under authority in 33
U.S.C. 1231.

III. Discussion of Proposed Rule

    The COTP proposes to establish a temporary special local regulation
to be in effect from 11 a.m. to 1:30 p.m. on October 20, 2018. The
regulated area would cover all waters within 400 feet of the event
located between approximate locations 40[deg]6'9.22'' N, 74[deg]2'7.8''
W and 40[deg]6'9.22'' N, 74[deg]2'8.2'' W. During the event, the inlet
would be closed to all non-participant vessel traffic. There is a 30-
minute break tentatively planned for midway through the event. If
circumstances permit, during the break the rope will be removed from
navigable waters and vessels may be allowed to transit through the area
at the discretion of the COTP or COTP's designated representative. The
regulation is intended to ensure the safety of event participants and
vessels during the scheduled 11 a.m. to 1:30 p.m. tug of war event. No
vessel or person would be permitted to enter the regulated area without
obtaining permission from the COTP or a designated representative of
the Captain of the Port. The regulatory text we are proposing appears
at the end of this document.

IV. Regulatory Analyses

    We developed this proposed 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 NPRM has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, the NPRM 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, and duration of the regulated area. While this regulated area
would impact a designated area of the Manasquan River Inlet for 2 and
\1/2\ hours, the event sponsor has organized a 30 minute time period
during the event where vessels would be able to transit through the
inlet. Moreover, the Coast Guard would issue a Broadcast Notice to
Mariners via VHF-FM marine channel 16 about the zone, and the rule
would allow vessels to seek permission to enter the zone during the 30
minute time period during the event.

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
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
regulated area may be small entities, for the reasons stated in section
IV.A above, this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see

ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    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 proposed 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. The Coast Guard will not retaliate against small entities that
question or complain about this proposed rule or any policy or action
of the Coast Guard.

C. Collection of Information

    This proposed rule would 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 proposed 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 proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would 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 proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section.

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 proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

F. Environment

    We have analyzed this proposed 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 made a preliminary
determination 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 proposed rule involves a regulated area lasting 2 and
\1/2\ hours that would prohibit entry within 400 feet of a tug of war
event across an inlet. Normally such actions are categorically excluded
from further review under paragraph L61 of Appendix A, Table 1 of DHS
Instruction Manual 023-01-001-01, Rev. 01. A preliminary Record of
Environmental Consideration supporting this determination is available
in the docket where indicated under ADDRESSES. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule.

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.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to https://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, visit https://www.regulations.gov/privacyNotice.
    Documents mentioned in this NPRM as being available in the docket,
and all public comments, will be in our online docket at https://www.regulations.gov and can be viewed by following that website's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

List of Subjects in 33 CFR Part 100

    Maritime safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

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1. The authority citation for part 100 continues to read as follows:

    Authority: 33 U.S.C. 1233; 33 CFR 1.05-1.

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2. Add Sec.  100.T05-0883 to read as follows.

Sec.  100.T05-0883   Special Local Regulation; Manasquan River;
Manasquan, NJ.

    (a) Location. The following area is a regulated area: All waters of
the Manasquan River within the Manasquan Inlet within 400 feet of the
event located between approximate locations 40[deg]6'9.22'' N,
74[deg]2'7.8'' W and 40[deg]6'9.22'' N, 74[deg]2'8.2'' W. All
coordinates are based on World Geodetic System 1984.
    (b) Definitions. As used in this section, designated representative
means a Coast Guard Patrol Commander, including a Coast Guard petty
officer, warrant or commissioned officer on board a Coast Guard vessel
or on board a federal, state, or local law enforcement vessel assisting
the Captain of the Port Delaware Bay (COTP) in the enforcement of the
safety zone.
    (c) Regulations. (1) All non-participant persons and vessels are
prohibited from entering into, remaining within, transiting through, or
anchoring in the regulated area unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter or remain in the zone, contact the
COTP or the COTP's designated representative

via VHF-FM channel 16 or by telephone at<PHONE_NUMBER>.
    (3) If authorization to enter into, remain within, transit through,
or anchor in the regulated area is granted, all persons and vessels
receiving such authorization shall comply with the instructions of the
COTP or the COTP's designated representative.
    (4) The Coast Guard will provide notice of the regulated areas by
Local Notice to Mariners, Broadcast Notice to Marines, or by on-scene
designated representatives.
    (d) Enforcement. The U.S. Coast Guard may be assisted in the patrol
and enforcement of the safety zone by federal, state, and local
agencies.
    (e) Enforcement period. This zone will be enforced from
approximately 11 a.m. through 1:30 p.m. on October 20, 2018.

K.A. Clarke,
Captain, U.S. Coast Guard, Acting Captain of the Port Delaware Bay.
[FR Doc. 2018-21202 Filed 9-27-18; 8:45 am]
 BILLING CODE 9110-04-P