UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

June 12, 2007

Memorandum

SUBJECT:	Chlormequat Chloride: Occupational and Residential Exposure
Assessment for the Reregistration Eligibility Decision Document.

FROM:	Charles Smith, Environmental Scientist

		Reregistration Action Branch II/Health Effects Division (7509C)

THROUGH:	Alan Nielsen, Branch Senior Scientist

		Reregistration Action Branch II/Health Effects Division (7509C)

TO:		Donald Wilbur, Chemist/Risk Assessor

		Reregistration Action Branch II/Health Effects Division (7509C)

PC Code:	018101

DP Barcode:	D336714

The attached assessment contains the occupational and non-occupational
(residential) exposure and risk estimates for chlormequat chloride to
support HED’s reregistration eligibility decision (RED) document.

Table of Contents

  TOC \o "1-4" \h \z \u    HYPERLINK \l "_Toc168278212"  Executive
Summary	  PAGEREF _Toc168278212 \h  3

  HYPERLINK \l "_Toc168278214"  1.0	Occupational and Residential
Exposure/Risk Assessment	  PAGEREF _Toc168278214 \h  5

  HYPERLINK \l "_Toc168278215"  1.1	Purpose	  PAGEREF _Toc168278215 \h
5

  HYPERLINK \l "_Toc168278216"  1.2	Criteria for Conducting Exposure
Assessments	  PAGEREF _Toc168278216 \h  5

  HYPERLINK \l "_Toc168278217"  1.3	Summary of Hazard Concerns for
Chlormequat Chloride	  PAGEREF _Toc168278217 \h  5

  HYPERLINK \l "_Toc168278218"  1.4	Incident Reports	  PAGEREF
_Toc168278218 \h  8

  HYPERLINK \l "_Toc168278220"  1.5	Summary of Physical and Chemical
Properties of Chlormequat Chloride	  PAGEREF _Toc168278220 \h  8

  HYPERLINK \l "_Toc168278221"  1.5.1	Structure and Nomenclature
PAGEREF _Toc168278221 \h  8

  HYPERLINK \l "_Toc168278222"  1.5.2	Physical and Chemical Properties
PAGEREF _Toc168278222 \h  9

  HYPERLINK \l "_Toc168278223"  1.6	Summary of Use Patterns and
Formulations	  PAGEREF _Toc168278223 \h  9

  HYPERLINK \l "_Toc168278224"  1.6.1	End-Use Products	  PAGEREF
_Toc168278224 \h  9

  HYPERLINK \l "_Toc168278225"  1.6.2	Registered Use Categories and
Sites	  PAGEREF _Toc168278225 \h  9

  HYPERLINK \l "_Toc168278226"  1.6.3	Application Methods and Rates
PAGEREF _Toc168278226 \h  10

  HYPERLINK \l "_Toc168278227"  2.0	Occupational Exposures and Risks
PAGEREF _Toc168278227 \h  11

  HYPERLINK \l "_Toc168278228"  2.1	Occupational Handler Exposures and
Risks	  PAGEREF _Toc168278228 \h  11

  HYPERLINK \l "_Toc168278229"  2.1.1	Data and Assumptions for Handler
Exposure Scenarios	  PAGEREF _Toc168278229 \h  12

  HYPERLINK \l "_Toc168278230"  <IP_ADDRESS>	Assumptions for Handler Exposure
Scenarios	  PAGEREF _Toc168278230 \h  12

  HYPERLINK \l "_Toc168278231"  <IP_ADDRESS>	Exposure Data for Handler
Exposure Scenarios	  PAGEREF _Toc168278231 \h  13

  HYPERLINK \l "_Toc168278232"  2.1.2	Chlormequat Chloride Handler
Exposure Scenarios	  PAGEREF _Toc168278232 \h  14

  HYPERLINK \l "_Toc168278233"  2.1.3	Non-cancer Chlormequat Chloride
Handler Exposure and Assessment	  PAGEREF _Toc168278233 \h  15

  HYPERLINK \l "_Toc168278234"  <IP_ADDRESS>	Non-cancer Chlormequat Chloride
Handler Exposure and Risk Calculations	  PAGEREF _Toc168278234 \h  15

  HYPERLINK \l "_Toc168278235"  <IP_ADDRESS>	Chlormequat Chloride Non-cancer
Risk Summary (using    HYPERLINK \l "_Toc168278236"  PHED data)
PAGEREF _Toc168278236 \h  16

  HYPERLINK \l "_Toc168278237"  2.1.4	Summary of Risk Concerns and Data
Gaps for Occupational Handlers	  PAGEREF _Toc168278237 \h  17

  HYPERLINK \l "_Toc168278238"  <IP_ADDRESS>	Summary of Risk Concerns
PAGEREF _Toc168278238 \h  17

  HYPERLINK \l "_Toc168278239"  <IP_ADDRESS>	Summary of Data Gaps	  PAGEREF
_Toc168278239 \h  17

  HYPERLINK \l "_Toc168278240"  2.2	Occupational Postapplication
Exposures and Risks	  PAGEREF _Toc168278240 \h  17

  HYPERLINK \l "_Toc168278242"  3.0	Residential and Other
Non-Occupational Exposures and Risks	  PAGEREF _Toc168278242 \h  17

Executive Summary tc "Executive Summary"

This document is the occupational and residential/non-occupational risk
assessment for chlormequat chloride from its use as a plant growth
regulator.  In this document, which is for use in EPA's development of
the Health Effects Division (HED) chapter of the chlormequat chloride
RED Document, EPA presents the results of its review of the potential
human health effects of occupational and residential/non-occupational
exposure to chlormequat chloride.

Hazard Concerns:  The toxicological endpoints used to complete the
occupational risk assessments have been selected by HED and are
summarized below.  Adverse effects were identified at durations of
exposure ranging from short-term (up to 30 days) to intermediate-term
durations (> 30 days up to 6 months) durations.  No cancer endpoint was
identified; therefore cancer risks are not assessed.  There are no
residential uses for chlormequat chloride so residential exposures are
not expected.

No dermal endpoint was selected for chlormequat chloride because the
21-day dermal rat study for chlormequat chloride did not result in
systemic toxicity up to the limit dose of 1000 mg/kg/day.  Therefore, a
quantitative dermal assessment is not appropriate for chlormequat
chloride.  The short- and intermediate-term (non-cancer) inhalation risk
assessment for chlormequat chloride is based on a NOAEL of 30 mg/kg/day
from an oral developmental toxicity study in rats.  Absorption via the
inhalation route is presumed to be equivalent to oral absorption
therefore; a default inhalation factor of 100% was applied to inhalation
exposures.  Long-term exposures to chlormequat chloride (i.e., greater
than 6 months) are not expected for current registered uses.    HED’s
level of concern (LOC) for chlormequat chloride inhalation exposures is
100 (i.e., a margin of exposure (MOE) less than 100 exceeds HED’s
level of concern) for all scenarios.  The level of concern is based on
10x for interspecies extrapolation and 10x for intraspecies
extrapolation.

Use Patterns:  Chlormequat chloride is a plant growth regulator that
belongs to the quaternary ammonium class of chemicals.   tc "1.6.2
Registered Use Categories and Sites " \l 3 Chlormequat chloride
(formulated as an emulsifiable concentrate) is currently registered for
use on ornamentals grown in greenhouses, shadehouses, and nurseries.
Use is restricted to containerized ornamentals in situations where
production areas are not under cover.  Chlormequat chloride applications
are applied using several types of application equipment – including
groundbooms, low pressure handwands, backpack sprayers, and high
pressure handwands.

Occupational Handler Risks:  It has been determined that exposure to
pesticide handlers is likely during the occupational use of chlormequat
chloride.  The anticipated use patterns and current labeling indicate
several dermal and inhalation occupational exposure scenarios based on
the types of equipment and techniques that can potentially be used for
chlormequat chloride applications.  No dermal occupational
postapplication risk assessment was performed because a dermal endpoint
was not selected for chlormequat chloride due to its lack of systemic
toxicity via the dermal route.  Results indicate that all of the
inhalation occupational handler risks for chlormequat chloride do not
exceed HED’s level of concern [i.e., MOEs are greater than 100].

Occupational Postapplication Risks:  No dermal occupational
postapplication risk assessment was performed because a dermal endpoint
was not selected for chlormequat chloride due to its lack of systemic
toxicity via the dermal route.  When there is no dermal occupational
postapplication risk assessment the restricted entry interval (REI) is
based on the acute toxicity of the chemical.  The current chlormequat
chloride label requires a 12-hour REI but chlormequat chloride has been
classified as Category II for acute dermal toxicity.  In accordance with
the requirements in the Worker Protection Standards (WPS) - 40CFR170,
ingredients classified as Category II are assigned a 24-hour REI.  The
Health Effects Division (HED) recommends that the Registration Division
(RD) ensure that the proper REI for ornamental plants grown in
containers in greenhouses, nurseries, and shadehouses be included on the
chlormequat chloride labels.

An inhalation occupational postapplication assessment was not performed
for chlormequat chloride due to its low vapor pressure.  However, in
nurseries and greenhouses, the WPS prohibits workers from entering the
treated area for the first four hours after an application is completed
to allow time for sprays and dusts to settle out of the air to protect
workers against postapplication inhalation exposures.

Residential Risks:  Chlormequat chloride does not currently have any
registrations for residential use nor is it registered for use in any
residential settings.  As a result, no residential chlormequat chloride
handler or postapplication assessments are required at this time.

Review of Human Research:  This assessment relies in part on data from
studies in which adult human subjects were intentionally exposed to a
pesticide.  These studies, listed below, have been determined to require
a review of their ethical conduct.  The listed studies have either
received the appropriate review or are in the process of being ethically
reviewed.

The PHED Task Force, 1995.  The Pesticide Handler Exposure Database
(PHED), Version 1.1.  Task Force members Health Canada, U.S.
Environmental Protection Agency, and the National Agricultural Chemicals
Association, released February 1995.

1.0	Occupational and Residential Exposure/Risk Assessment tc "1.0
Occupational and Residential Exposure/Risk Assessment"

	1.1	Purpose tc "1.1	Purpose " \l 2

This document is the occupational and residential/non-occupational risk
assessment for chlormequat chloride from its use as a plant growth
regulator.  In this document, which is for use in EPA's development of
the Health Effects Division (HED) chapter of the chlormequat chloride
RED Document, EPA presents the results of its review of the potential
human health effects of occupational and residential/non-occupational
exposure to chlormequat chloride.

	1.2	Criteria for Conducting Exposure Assessments  tc "1.2	Criteria for
Conducting Exposure Assessments " \l 2

An occupational and/or residential exposure assessment is required for
an active ingredient if (1) certain toxicological criteria are triggered
and (2) there is a potential for exposure to handlers (mixers, loaders,
applicators) during use or to persons entering treated sites or exposed
to vapors after application is complete.  Toxicological endpoints were
selected for short- and intermediate-term inhalation exposures to
chlormequat chloride.  No dermal endpoint was selected for chlormequat
chloride because the 21-day dermal rat study for chlormequat chloride
did not result in systemic toxicity up to the limit dose of 1000
mg/kg/day.  Therefore, a quantitative dermal assessment is not
appropriate.  There is a potential for chlormequat chloride inhalation
exposure from mixing/loading, applying, and other handling tasks
involved in applications to ornamentals and from postapplication
activities after applications to ornamentals.  Therefore, short- and
intermeditate-term inhalation risk assessments are required for
occupational handlers that can occur as a result of chlormequat chloride
use.  No long-term occupational handler assessment was performed for
chlormequat chloride because long-term exposure is not expected based on
the current use profile.  Chlormequat chloride is likely used in
greenhouses and nurseries throughout the year on various ornamental
species.  These uses would likely result in a series of short-term
exposures as opposed to 6 months of consecutive daily exposure (i.e.,
long-term exposure).

	1.3	Summary of Hazard Concerns for Chlormequat Chloride  tc "1.3
Summary of Hazard Concerns for MGK-264 " \l 2

The toxicological endpoints used to complete the occupational risk
assessments have been selected by HED and are summarized below.  Adverse
effects were identified at durations of exposure ranging from short-term
(up to 30 days) to intermediate-term durations (> 30 days up to 6
months) durations.  No cancer endpoint was identified; therefore cancer
risks are not assessed.  There are no residential uses for chlormequat
chloride so residential exposures are not expected.

	Dermal Route (non-cancer)

No dermal endpoint was selected for chlormequat chloride because the
21-day dermal rat study for chlormequat chloride did not result in
systemic toxicity up to the limit dose of 1000 mg/kg/day.  Therefore, a
quantitative dermal assessment is not appropriate for chlormequat
chloride.

Although no systemic toxicity was observed in the 21-day dermal toxicity
rabbit study when tested higher than the limit dose (1035 mg/kg/day), a
review of the dermal toxicology data for chlormequat chloride suggests
the potential for significant dermal irritation.  Localized dermal
toxicity was observed (days 10-21) in the 21-day dermal rabbit study at
345 mg/kg/day in the form of dermal irritation (erythema, edema, and
fissuring), gross lesion of treated skin (foci), and histopathological
lesions in the treated skin (acanthosis, subacute inflammation and
edema), in females only.  The test substance was in contact with the
skin of the rabbit by a secured gauze dressing for 6 hours/day and 5
days/week.  The primary dermal irritation study with rabbits also
applied the pesticide to secured gauze for 4 hours.  This single
exposure produced slight irritation that was resolved by 48 hours
post-exposure.  In contrast, the pesticide was applied directly to the
skin of the rabbits for 24 hours in the acute LD50 dermal toxicity
rabbit study.  Mortality (1/10) was observed at the lowest dose of 312
mg/kg.  This increased toxicity was likely due to the direct application
and occlusion of the pesticide to the skin of the animal.  As protection
against dermal irritation from occupational handler exposures is
addressed through proper labeling and protection against dermal
irritation from occupational worker exposures is addressed by the worker
protection standard, and as dermal irritation cannot be quantified for
dermal risk assessments, it is concluded that if adequate measures are
in place to protect against dermal irritancy, (through proper labeling
language and/or worker protection standard), then quantitative risk
assessment is not necessary for pesticide chemicals meeting the above
criteria.

	Inhalation Route (non-cancer)

The short- and intermediate-term (non-cancer) inhalation risk assessment
for chlormequat chloride is based on a NOAEL of 30 mg/kg/day from an
oral developmental toxicity study in rats.  Long-term exposures to
chlormequat chloride (i.e., greater than 6 months) are not expected for
current registered uses.  Absorption via the inhalation route is
presumed to be equivalent to oral absorption therefore; a default
inhalation factor of 100% was applied to inhalation exposures.

	Non-cancer Level of Concern (LOC)

HED’s level of concern (LOC) for chlormequat chloride inhalation
exposures is 100 (i.e., a margin of exposure (MOE) less than 100 exceeds
HED’s level of concern) for occupational and residential scenarios.
The level of concern is based on 10x for interspecies extrapolation and
10x for intraspecies extrapolation.

	Cancer

No cancer endpoint was identified for chlormequat chloride.

	Acute Toxicity

The acute toxicity data indicate that chlormequat chloride is moderately
toxic (Category II) via oral and dermal routes of exposure, and
minimally toxic via acute inhalation exposure (Category IV).  It is
slightly irritating to the skin and moderately irritating to the eye
(Category IV and III, respectively).  Chlormequat chloride did not
produce sensitization in test with guinea pigs.

	Body Weight

The adverse effects for the inhalation endpoint are based on a
reproductive study; however, the effects were seen in both males and
females.  Therefore, the body weight of an average adult (i.e., 70 kg)
was used to estimate inhalation exposure.

Table 1:  Acute Toxicity Data on Chlormequat Chloride

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

870.1100

81-1	Acute oral [rat]	41721604	LD50 Males = 487 mg/kg

(95% C.I.= 369-643)

Females = 560 mg/kg

(95% C.I.= 399-786)

Combined = 522 mg/kg (95% C.I.= 423-646)	II

870.1200

81-2	Acute dermal [rabbit]	41721605	LD50 Males = 964 mg/kg (95% C.I.=
509-1825)

Females = 1621 mg/kg (95% C.I.= 856-3069)

Combined = 1250 mg/kg (95% C.I.= 647-2414)	II

870.1300

81-3	Acute inhalation [rat]	41721606	LC50 => 4.57 mg/L

(males, females combined)	IV

870.2400

81-4	Acute eye irritation [rabbit]	41721607	Slight irritation.  No
positive signs at 48 hours.	III

870.2500.

81-5	Acute dermal irritation [rabbit]	41721608	Mildly irritating	IV

870.2600

81-6	Skin sensitization [guinea pig]	41721609	Not a sensitizer	N/A

Table 2.  Summary of Toxicological Doses and Endpoints for Chlormequat
Chloride for Use in Human Risk Assessments

Exposure

Scenario	Dose Used in Risk Assessment, UF	Special FQPA SF* and Level of
Concern for Risk Assessment	Study and Toxicological Effects

Short-Term (1 to 30 days) Dermal

Intermediate-Term

(1 to 6 months) Dermal	No dermal endpoint was selected for chlormequat
chloride because the 21-day dermal rat study for chlormequat chloride
did not result in systemic toxicity up to the limit dose of 1000
mg/kg/day.

Short-Term (1 to 30 days) Inhalation

Intermediate-Term (1 to 6 months) Inhalation	NOAEL (oral study) = 30
mg/kg/day

(Inhalation Absorption Factor = 100%)	Occupational LOC for MOE = 100
Developmental toxicity-rat (MRID 42246604)

LOAEL= 90 mg/kg/day, based on decreased body weight gain (38-112%-GD
6-9; 21-67% GD 6-12) and food consumption and greater incidences of
increased salivation and chromorrhinorrhea

Cancer (oral, dermal, inhalation)	Classification: “Not likely to be
Carcinogenic to Humans” based on the no carcinogenic potential was
noted in the available studies.

UF = uncertainty factor, NOAEL = no observed adverse effect level, LOAEL
= lowest observed adverse effect level, MOE = margin of exposure, LOC =
level of concern

	1.4	Incident Reports  tc "1.4	Incident Reports " \l 2

Public health/epidemiology data were not available for the development
of this assessment.

 	1.5	Summary of Physical and Chemical Properties of Chlormequat
Chloride  tc "1.5	Summary of Physical and Chemical Properties of MGK-264
" \l 2

		1.5.1	Structure and Nomenclature tc "2.2	Structure and Nomenclature "
\l 2

Table 3.  Test Compound Nomenclature

Chemical Structure

Empirical Formula	C5H13Cl2 N

Common Name	Chlormequat chloride

Company Experimental Name	N/A

IUPAC Name	2-chloroethyl trimethyl ammonium chloride

CAS Name	2-chloro-N,N,N-trimethylethanaminium chloride

CAS Registry Number	999-81-5

End-use Product/EP	CYCOCEL® Plant Growth Regulator

Chemical Class	quaternary ammonium compound

Use Type	plant growth regulator

Known Impurities of Concern	N/A

		1.5.2	Physical and Chemical Properties tc "2.3	Physical and Chemical
Properties " \l 2

Table 4.    SEQ CHAPTER \h \r 1 The Physicochemical Properties of
Chlormequat Chloride

Parameter	Value	Reference

Molecular Weight	158.1	MSDS CYCOCEL® Plant Growth Regulator by BASF
Canada, 08/15/2000

Melting Point	245ºC	MSDS CYCOCEL® Plant Growth Regulator by BASF
Canada, 08/15/2000

pH	5.14 	MSDS CYCOCEL® Plant Growth Regulator by BASF Canada,
08/15/2000

Density	1.241 g/ml	Study: Surface Tension, Density and Vapour Pressure
of Chlormequat-Chloride (PAI) by BASF Germany, 03/27/2001

Water Solubility (20° C)	74 g/100 ml	MSDS CYCOCEL® Plant Growth
Regulator by BASF Canada, 08/15/2000

Surface Tension 	70.3 mN/m	Study: Surface Tension, Density and Vapour
Pressure of Chlormequat-Chloride (PAI) by BASF Germany, 03/27/2001

Vapor Pressure ( 20°C)	 <1.0 x 10-8 mbar	Study: Surface Tension,
Density and Vapour Pressure of Chlormequat-Chloride (PAI) by BASF
Germany, 03/27/2001

Octanol/water partition coefficient,

log KOW (25°C)	Not Applicable 	MSDS CYCOCEL® Plant Growth Regulator by
BASF Canada, 08/15/2000

	1.6	Summary of Use Patterns and Formulations  tc "1.6	Summary of Use
Patterns and Formulations " \l 2

		1.6.1	End-Use Products  tc "1.6.1	End-Use Products " \l 3

Chlormequat chloride is a plant growth regulator that belongs to the
quaternary ammonium class of chemicals.  Chlormequat chloride works
through inhibition of gibberellin biosynthesis in the early stages of
the pathway.  This early blockage prevents the synthesis of numerous
gibberellins needed for normal plant growth and development.  It is
formulated as an soluble concentrate/liquid (SC/L).

Registered Use Categories and Sites

  tc "1.6.2	Registered Use Categories and Sites " \l 3

Chlormequat chloride is currently registered for use on a wide variety
of ornamentals grown in greenhouses, shadehouses, and nurseries.  Crops
include herbaceous and woody annual and perennial plants such as
begonias, vincas, azaleas, and poinsettias.  Use is restricted to
containerized ornamentals in situations where production areas are not
under cover.

1.6.3	Label Personal Protective Equipment (PPE) Requirments

The current chlormequat chloride labels require that applicators and
other handlers wear the following personal protective equipment (PPE):

Long-sleeved shirt and long pants.

Chemical resistant gloves, such as butyl rubber ≥ 14 mils, natural
rubber ≥ 14 mils, neoprene rubber ≥ 14 mils, or nitrile rubber ≥
14 mils.

Shoes plus socks.

1.6.4	Application Methods and Rates tc "1.6.3	Application Methods " \l 3

Chlormequat chloride applications are applied using several types of
application equipment – including groundbooms, low pressure handwands,
backpack sprayers, and high pressure handwands.  Table 5 includes a
description of application methods and rates that are currently
registered for chlormequat chloride.

Table 5. Chlormequat Chloride Use Patterns and Formulations

Formulation	Use Site	Method of Application 	Use Sites	Application Rate
Label Restrictions

CYCOCEL® Plant Growth Regulator - liquid

(11.8% a.i.)

For Commercial Use

EPA Reg #241-74 	Shadehouses and nurseries	foliar spray by low pressure
handwand, backpack sprayer, or groundboom	Ornamentals	0.017 lb ai/gal

(at 2,000 ppm)

3.7 lb ai/A

(at 2,000 ppm and

1 gal/200 ft2) or 5.5 lb ai/A (at 2,000 ppm and 1.5 gal/200 ft2 – only
for larger plants with well defined canopies)	Do not apply through any
type of irrigation equipment.  Apply only to containerized plants.  Do
not apply as a soil drench.

	Greenhouse	foliar spray by low pressure handwand, backpack sprayer
Ornamentals	0.013 lb ai/gal (at 1,500 ppm)	Do not apply through any type
of irrigation equipment.

	Greenhouse	drench by high pressure handwand	Ornamentals	0.025 lb ai/gal
(at 3,000 ppm)	Do not apply through any type of irrigation equipment.

  HYPERLINK "http://www.etigra.com/product_chlormequat.php"  Chlormequat
E-Pro Plant Growth Regulator  - liquid

(11.8% a.i.)

For Commercial Use

EPA Reg #   HYPERLINK "http://ppis.ceris.purdue.edu/htbin/prodset.com"
\l "#"  81959-12  	Greenhouse	foliar spray by low pressure handwand,
backpack sprayer	Ornamentals	0.034 lb ai/gal

(at 4,000 ppm)

Greenhouse	drench by high pressure handwand	Ornamentals	0.034 lb ai/gal

(at 4,000 ppm)

2.0	Occupational Exposures and Risks tc "2.0	Occupational Exposures and
Risks"

There is a potential for exposure to chlormequat chloride in
occupational settings from handling chlormequat chloride products during
the application process (i.e., mixer/loaders, applicators, and
mixer/loader/applicators) and during postapplication activities.  As a
result, short- and intermediate-term risk assessments have been
completed for a number of occupational handler and postapplication
scenarios.

2.1	Occupational Handler Exposures and Risks  tc "2.1	Occupational
Handler Exposures and Risks " \l 2

HED uses the term “handlers” to describe those individuals who are
involved in the pesticide application process.  HED believes that there
are distinct job functions or tasks related to applications and that
exposures can vary depending on the specifics of each task. Job
requirements (e.g., amount of chemical to be used in an application),
the kinds of equipment used, the target being treated, and the level of
protection used by a handler can cause exposure levels to differ in a
manner specific to each application event.

HED uses exposure scenarios to describe the various types of handler
exposures that may occur for a specific active ingredient. The use of
scenarios as a basis for exposure assessment is very common as described
in the U.S. EPA Guidelines for Exposure Assessment (U.S. EPA; Federal
Register Volume 57, Number 104; May 29, 1992).  Information from the
current labels, use and usage information, toxicology data, and exposure
data were all key components in the development of the exposure
scenarios.  HED has developed a series of general descriptions for tasks
that are associated with pesticide applications.  Tasks associated with
occupational pesticide handlers are categorized using one of the
following terms:

Mixers and/or Loaders: These individuals perform tasks in preparation
for an application.  These individuals would mix the chlormequat
chloride and transfer it into the application equipment.

Applicators: These individuals operate application equipment during the
release of a pesticide product into the environment.  These individuals
would apply the chlormequat chloride.

Mixer/Loader/Applicators and or Loader/Applicators: These individuals
are involved in the entire pesticide application process (i.e., they do
all job functions related to a pesticide application event).  These
individuals would transfer chlormequat chloride into the application
equipment and then also apply it.

A chemical can produce different effects based on how long a person is
exposed, how frequently exposures occur, and the level of exposure.  HED
classifies exposures up to 30 days as short-term and exposures greater
than 30 days up to several months as intermediate-term.  HED completes
both short- and intermediate-term assessments for occupational scenarios
in essentially all cases, because these kinds of exposures are likely
and acceptable use/usage data are not available to justify deleting
intermediate-term scenarios.  Based on use data and label instructions,
HED believes that occupational chlormequat chloride exposures may occur
over a few days for many use-patterns and that intermittent exposure
over several weeks also may occur.  Long-term handler exposures are not
expected to occur for chlormequat chloride based on the current use
profile.  Chlormequat chloride is likely used in greenhouses and
nurseries throughout the year on various ornamental species.  These uses
would likely result in a series of short-term exposures as opposed to 6
months of consecutive daily exposure (i.e., long-term exposure).  Note
that the same toxicological endpoint of concern (from the same
developmental study) has been selected for short- and intermediate-term
inhalation exposures to chlormequat chloride, therefore, the risk
results for these inhalation durations of exposure also are numerically
identical.

Other parameters are also defined from use and usage data such as
application rates and application frequency.  HED always completes
non-cancer risk assessments using maximum application rates for each in
order to ensure there are no concerns for each specific use.

Occupational handler exposure assessments are completed by HED using
different levels of risk mitigation.  Typically, HED uses a tiered
approach.  The lowest tier is designated as the baseline exposure
scenario (i.e., long-sleeve shirt, long pants, shoes, socks, and no
respirator).  If risks are of concern at baseline attire, then
increasing levels of personal protective equipment or PPE (e.g., gloves,
double-layer body protection, and respirators) are evaluated.  If risks
remain a concern with maximum PPE, then engineering controls (e.g.,
enclosed cabs or cockpits, water-soluble packaging, and closed
mixing/loading systems) are evaluated.  This approach is used to ensure
that the lowest level of risk mitigation that provides adequate
protection is selected, since the addition of PPE and engineering
controls involves an additional expense to the user and – in the case
of PPE – also involves an additional burden to the user due to
decreased comfort and dexterity and increased heat stress and
respiratory stress.

		2.1.1	Data and Assumptions for Handler Exposure Scenarios  tc "2.1.1
Data and Assumptions For Handler Exposure Scenarios " \l 3

<IP_ADDRESS>	Assumptions for Handler Exposure Scenarios  tc "<IP_ADDRESS>
Assumptions for Handler Exposure Scenarios " \l 4

A series of assumptions and exposure factors served as the basis for
completing the occupational handler risk assessments.  Each assumption
and factor is detailed below on an individual basis. The assumptions and
factors used in the risk calculations include:

HED has patterned this risk assessment on a series of likely
representative scenarios that are believed by HED to represent the vast
majority of chlormequat chloride uses.

Occupational handler exposure estimates were based on surrogate data
from the Pesticide Handlers Exposure Database (PHED).

Average body weight of an adult handler is 70 kg because the toxicity
endpoint values used for the assessments are appropriate for average
adult body weight representing the general population

Generic protection factors (PFs) were used to calculate exposures when
data were not available.  For example, an 80 percent protection factor
was assumed for the use of a respirator equipped with a dust/mist
filter.

For non-cancer assessments, HED assumes the maximum application rates
allowed by labels in its risk assessments (see Table 5).

The average occupational workday is assumed to be 8 hours.

The daily areas treated were defined for each handler scenario (in
appropriate units) by determining the amount that can be reasonably
treated in a single day (e.g. acres, square feet, cubic feet, or gallons
per day).  When possible, the assumptions for daily areas treated are
taken from the HED ExpoSAC SOP #9: Standard Values for Daily Acres
Treated in Agriculture which was completed on July 5, 2000.

Groundboom: 1 acre (based on label requirements);

Low Pressure Handwand Sprayer: 40 gallons per day;

Backpack Sprayer: 40 gallons per day; and

High Pressure/Volume Handwand: 1,000 gallons per day.

<IP_ADDRESS>	Exposure Data for Handler Exposure Scenarios  tc "<IP_ADDRESS>
Exposure Data for Handler Exposure Scenarios " \l 4

HED uses unit exposure to assess handler exposures to pesticides.  Unit
exposures are estimates of the amount of exposure to an active
ingredient a handler receives while performing various handler tasks and
are expressed in terms of micrograms or milligrams of active ingredient
per pounds of active ingredient handled.  HED has developed a series of
unit exposures that are unique for each scenario typically considered in
our assessments (i.e., there are different unit exposures for different
types of application equipment, job functions, and levels of
protection).  The unit exposure concept has been established in the
scientific literature and also through various exposure monitoring
guidelines published by the U.S. EPA and international organizations
such as Health Canada and OECD (Organization for Economic Cooperation
and Development).

Pesticide Handler Exposure Database (PHED) Version 1.1 (August 1998):
PHED was designed by a task force of representatives from the U.S. EPA,
Health Canada, the California Department of Pesticide regulation, and
member companies of the American Crop Protection Association.  PHED is a
software system consisting of two parts – a database of measured
exposures for workers involved in the handling of pesticides under
actual field conditions and a set of computer algorithms used to subset
and statistically summarize the selected data.  Currently, the database
contains values for over 1,700 monitored individuals (i.e., replicates).

Users select criteria to subset the PHED database to reflect the
exposure scenario being evaluated.   The subsetting algorithms in PHED
are based on the central assumption that the magnitude of handler
exposures to pesticides are primarily a function of activity (e.g.,
mixing/loading, applying), formulation type (e.g., liquids, granulars),
application method (e.g., aerial, groundboom), and clothing scenarios
(e.g., gloves, double layer clothing).

Once the data for a given exposure scenario have been selected, the data
are normalized (i.e., divided by) by the amount of pesticide handled
resulting in standard unit exposures (milligrams of exposure per pound
of active ingredient handled).  Following normalization, the data are
statistically summarized.  The distribution of exposure for each body
part (e.g., chest, upper arm) is categorized as normal, lognormal, or
“other” (i.e., neither normal nor lognormal).  A central tendency
value is then selected from the distribution of the exposure for each
body part.  These values are the arithmetic mean for normal
distributions, the geometric mean for lognormal distributions, and the
median for all “other” distributions.  Once selected, the central
tendency values for each body part are combined into a “best fit”
exposure value representing the entire body.

The unit exposures calculated by PHED generally range from the geometric
mean to the median of the selected data set.  To add consistency and
quality control to the values produced from this system, the PHED Task
Force has evaluated all data within the system and has developed a set
of grading criteria to characterize the quality of the original study
data.  The assessment of data quality is based on the number of
observations and the available quality control data.  While data from
PHED provide the best available information on handler exposures, it
should be noted that some aspects of the included studies (e.g.,
duration, acres treated, pounds of active ingredient handled) may not
accurately represent labeled uses in all cases.  HED has developed a
series of tables of standard unit exposure for many occupational
scenarios that can be utilized to ensure consistency in exposure
assessments.  Unit exposures are used which represent different levels
of personal protection as described above.  Protection factors were used
to calculate unit exposures for varying levels of personal protection if
data were not available.

		2.1.2	Chlormequat Chloride Handler Exposure Scenarios  tc "2.1.2
MGK-264 Handler Exposure Scenarios " \l 3

It has been determined that exposure to pesticide handlers is likely
during the occupational use of chlormequat chloride in greenhouse,
nurseries, and shadehouses.  The anticipated use patterns and current
labeling indicate several occupational exposure scenarios based on the
types of equipment and techniques that can potentially be used for
chlormequat chloride applications. The quantitative exposure/risk
assessment developed for occupational handlers is based on the following
scenarios. [Note: The scenario numbers correspond to the tables of risk
calculations included in the occupational risk calculation aspects of
the appendices.]

Mixer/Loaders:

	(1) Liquid Formulations for Groundboom Applications

	Applicators:

(2) Groundboom Spray Applications

	Mixer/Loader/Applicators:

(3) Liquid Formulations: Low Pressure Handwand/HandwandBackpack Sprayer
(using PHED liquid low pressure handwand data)

(4) Liquid Formulations: High Pressure Handwand

	2.1.3	Non-cancer Chlormequat Chloride Handler Exposure and
Assessment tc "2.1.3	Non-cancer MGK-264 Handler Exposure and Assessment
" \l 3

<IP_ADDRESS>	Non-cancer Chlormequat Chloride Handler Exposure and 			Risk
Calculations  tc "<IP_ADDRESS>	Non-cancer MGK-264 Handler Exposure and Risk
Calculations " \l 4

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

Daily Exposure (mg ai/day) = Unit Exposure * Application Rate * Daily
Area Treated

Where:

μg ai/day) inhaled that is available for 				inhalation absorption;

Unit Exposure 		=	Unit exposure value (mg or μg ai/day) derived from
August 1998 			PHED data;

Application Rate		=	Normalized application rate based on a logical unit
treatment, such as 			acre or gallon; and

Daily Area Treated	=	Normalized application area based on a logical unit
treatment such as 	acres/day (A/day) or gallons/day (gal/day).

Daily Dose:  The daily inhalation dose is calculated by normalizing the
daily exposure by body weight and adjusting, if necessary, with an
appropriate inhalation absorption factor.  For all inhalation exposure
scenarios for chlormequat chloride, an average adult body weight of 70
kilograms was used, since the toxicological endpoint of concern was not
gender-specific.  Since the inhalation toxicological endpoint of concern
is based on an oral study, an inhalation absorption rate of 100% was
used to estimate the amount of chlormequat chloride likely to be
absorbed through the lungs following inhalation exposures.

Daily dose was calculated using the following formula:

Average Daily Dose (mg/kg/day) = Daily Exposure * Absorption Factor /
Body Weight

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) inhaled that is available for
inhalation absorption;

Absorption Factor	= 	A measure of the amount of chemical that crosses a
biological 							boundary such as the lungs (% of the total available
absorbed); and

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

	assessment (kg).

Margins of Exposure:  Non-cancer inhalation risks for each applicable
handler scenario are calculated using a Margin of Exposure (MOE), which
is a ratio of the daily dose to the toxicological endpoint of concern.
All MOE values were calculated using the formula below:

MOE = NOAEL or LOAEL (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);

Average Daily Dose	= 	Average Daily Dose or the absorbed dose received
from exposure to a 						pesticide in a given scenario (mg pesticide
active ingredient/kg body 						weight/day); and

NOAEL or LOAEL	= 	Dose level in a toxicity study, where no observed
adverse effects 						(NOAEL) or where the lowest observed adverse
effects (LOAEL) 						occurred in the study.

Risk values are presented below for each scenario.

Chlormequat Chloride Non-cancer Risk Summary (using

	PHED data)

 tc "<IP_ADDRESS>	MGK-264 Non-cancer Risk Summary (using PHED, ORETF, and
proprietary data) " \l 4

The results indicate that all of the occupational handler risks do not
exceed HED’s level of concern [i.e., MOEs are greater than 100].  A
summary of the short- and intermediate-term risks for each exposure
scenario are presented below in Table 6.

Table 6.  Chlormequat Chloride Inhalation Occupational Handler Risks

Exposure Scenario	Crop or Target	Application Rate a	Area Treated Daily
Baseline Inhalation Unit Exposure (ug/lb ai)	Baseline Inhalation Dose
(mg/gk/day)  b	Baseline Inhalation MOE c

Mixer/Loader

Mixing/Loading Liquids Concentrates for Groundboom Applications (1)
ornamentals: shadehouses and nurseries	5.5 lb ai/A	1 A d	1.2	0.000094
320000

3.7 lb ai/A

	0.000063	470000

Applicator

Applying Sprays via Groundboom Equipment (2)	ornamentals: shadehouses
and nurseries	5.5 lb ai/A	1 A d	0.74	0.000058	520000

3.7 lb ai/A

	0.000039	770000

Mixer/Loader/Applicator

Mixing/Loading/Applying Liquid Concentrates with Low Pressure Handwand
(PHED) (3) 	ornamentals: shadehouses and nurseries	0.017 lb ai/gal	40
gals	30	0.00029	100000

	ornamentals: greenhouse	0.034 lb ai/gal

	0.00058	51000

	ornamentals: greenhouse	0.013 lb ai/gal

	0.00022	130000

Mixing/Loading/Applying Liquid Concentrates with a High Pressure
Handwand (only study is for greenhouse use) (4)	ornamentals: greenhouse
0.025 lb ai/gal	1000 gals	120	0.043	700

	ornamentals: greenhouse	0.034 lb ai/gal

	0.058	510

a	Application rates are the maximum application rates determined from
EPA registered labels for chlormequat chloride

b	Average Daily Dose (mg/kg/day) = Daily Exposure * Absorption Factor /
Body Weight

c	MOE = NOAEL / Average Daily Dose (mg/kg/day)

d	Maximum area treated per day of 1 acre for groundboom applications is
based on label restrictions.

2.1.4	Summary of Risk Concerns and Data Gaps for Occupational
Handlers  tc "2.1.5 	Summary of Risk Concerns and Data Gaps for
Occupational Handlers " \l 3

			<IP_ADDRESS>	Summary of Risk Concerns

All of the chlormequat chloride occupational handler risks do not exceed
HED’s level of concern [i.e., MOEs are greater than 100].

			<IP_ADDRESS>	Summary of Data Gaps  tc "<IP_ADDRESS>	Summary of Data Gaps " \l 4

There are currently no specific data gaps for chlormequat chloride.

2.2	Occupational Postapplication Exposures and Risks

No dermal occupational postapplication risk assessment was performed
because a dermal endpoint was not selected for chlormequat chloride due
to its lack of systemic toxicity via the dermal route.  When there is no
dermal occupational postapplication risk assessment the restricted entry
interval (REI) is based on the acute toxicity of the chemical.  The
current chlormequat chloride label requires a 12-hour REI but
chlormequat chloride has been classified as Category II for acute dermal
toxicity.  In accordance with the requirements in the Worker Protection
Standards (WPS) - 40CFR170, ingredients classified as Category II are
assigned a 24-hour REI.  HED recommends that RD ensure that the proper
REI for ornamental plants grown in greenhouses, nurseries, and
shadehouses be included on the chlormequat chloride labels.

An inhalation occupational postapplication assessment was not performed
for chlormequat chloride due to its low vapor pressure.  However, in
nurseries and greenhouses, the WPS prohibits workers from entering the
treated area for the first four hours after an application is completed
to allow time for sprays and dusts to settle out of the air to protect
workers against postapplication inhalation exposures.

3.0	Residential and Other Non-Occupational Exposures and Risks tc "3.0
Residential and Other Non-Occupational Exposures and Risks"

n

‚

ï

,

¦

ý

	o

	n

n

(

P

m

o

€

‚

ƒ

š

›

-›

œ

¹

º

»

¼

Í

Î

Ï

é

ê

ë

ì

í

î

ï

ð

ñ

jJ

jÇ

&

'

(

)

*

+

,

-

.

J

K

L

M

P

Q

„

…

†

¡

¢

£

¤

¥

¦

§

¨

Ä

Å

Æ

Ç

Ê

Ë

Û

Ü

Ý

÷

ø

ù

ú

û

ü

ý

þ

ÿ

 h:

h:

h:

h:

 h:

h:

h€

Å

&

¶

\

혈F娃똀損㘔$将

혈F娃똀損㘔$将

혈F娃똀損㘔$将

혈F娃똀損㘔$将

혈F娃똀損㘔$将

혈F娃똀損㘔$将

혈F娃똀損㘔$将

鐇Ė혈F娃똀損㘔$将

摧墂I

摧猷

葞ￂ摧猷

摧猷

摧猷

摧绁~

摧绁~

摧妭Ô

h€

„@

÷^„@

„@

÷^„@

„@

÷^„@

옍)

옍)

Chlormequat chloride does not currently have any registrations for
residential use nor is it registered for use in any residential
settings.  As a result, no residential chlormequat chloride handler or
postapplication assessments are required at this time.

References tc \l1 "References

U.S. Environmental Protection Agency.  (1992).  U.S. EPA Guidelines For
Exposure Assessment (Federal Register Volume 57, Number 104; May 29,
1992).  National Center for Environmental Assessment.

U.S. Environmental Protection Agency.  Pesticide Handler Exposure
Database (PHED) Version 1.1.  Office of Pesticide Programs.  August
1998.

U.S. Environmental Protection Agency.  Health Effects Division, ExpoSAC
SOP #9: Standard Values for Daily Acres Treated in Agriculture.  July 5,
2000.

Page   PAGE  10  of   NUMPAGES  18


Site Visit Report

	East River Generating Station

	801 East 14th Street

	New York, NY 10009

April 15, 2008

Background and Objectives

The Environmental Protection Agency (EPA) is in the process of
developing 316(b) cooling water intake structure requirements that
reflect the best technology available (BTA) for minimizing adverse
environmental impact for all existing power plants and manufacturing
facilities. As part of this process, EPA staff is visiting electric
generators and manufacturers to better understand the cooling water
intake structure (CWIS) technologies in use at facilities, including the
site-specific characteristics of each facility and how these affect the
selection and performance of CWIS technologies.  EPA is also visiting
facilities to better understand cooling water use and specific issues or
technologies that can affect 316(b) compliance.  East River Generating
Station (East River) was selected for a site visit due to its use of
fine mesh traveling screens and large intake flows.

Facility Description

East River is located on a 3.5 acre site on the eastern side of lower
Manhattan in New York City.  The facility is owned by Consolidated
Edison (Con Edison) and employs approximately 240 workers.  East River
began operations in 1927 and withdraws cooling water from the East
River.

Facility representatives started that the facility’s NPDES permit
(NY0005126) was renewed in the summer of 2007.  East River discharges
via a north and south outlet tunnel both of which are located north of
the intake.  East River primarily discharges through the South tunnel
and only discharges water associated with cable cooling via its North
tunnel.

Electricity Generation and Transmission

East River currently operates 4 generating units with a combined
generating capacity of 600 MW.  However, aside from generating
electricity, the facility is a primary source of steam used to heat
nearby buildings, thereby reducing the amount of electricity generated.
The facility produces approximately 5.5 million pounds of steam per hour
and also serves as a gateway for transporting steam between the uptown
and downtown areas.

Units 1 and 2 began operations in 1927 and have since been repowered as
cogeneration units with a gas turbine.  Units 6 and 7 (built in 1951 and
1955, respectively) are dual fuel cycling units that typically run
during the day and may frequently change operating modes between
generating steam and electricity.  Unit 6 has a nameplate capacity of
130 MW, but typically generates approximately 75 MW due to the lost heat
from generating and transmitting steam.  Unit 6 also provides backup
steam to Units 1 and 2 and has a very high utilization rate (typically
greater than 90%).  Unit 7 was constructed as a baseload generating unit
(nameplate rating of 180 MW) that operates at approximately 70% capacity
in the winter as a steam generator and at approximately 50% capacity in
the summer as an electricity producer.

Each unit has a scheduled 2 weeks outage in the spring and fall, with a
major overhaul approximately every 6 years that can last as long as 6-8
months. The facility is located in a “load pocket,” with limited
infrastructure to generate and transmit electricity to nearby users.

Con Edison owns the switchyard.

Cooling Water Intake Structure

Unit 6 has two circulators with design flow of 59,200 gpm each.  Unit 7
also has two circulators with design flow of 69,000 gpm each. Cable
cooling design flow is 2670 gpm.  East River operates one cooling water
intake structure with a design intake flow of 371.5 million gallons per
day (MGD).  The facility’s average flow typically approaches the DIF
from May to September.

The intake structure is 150 feet long and 30 feet wide, with the river
depth at approximately 30 feet.  It is separated into 8 intake bays, but
only 4 of the bays are currently open to the river.  Bay 4 has a
crossflow opening that connects it with the other bays, even when the
circulating pumps are not operating for that bay.  This allows the
facility to enlarge the effective size of its intake structure and
reduce its intake velocity.  Initial estimates by the facility showed
that constructing a similar crossflow opening in one additional intake
bay would be sufficient to meet the 0.5 ft/sec threshold for impingement
requirements in the Phase II rule.  Facility representatives also noted
that the intake velocity across the face of the screen may not be
uniformly 0.5 ft/sec across the entire screen; achieving this level of
flow regulation may be exceedingly expensive.

The shoreline intake structure consists of bar racks (with 4” spacing)
and dual flow traveling screens with 1/8” smooth wire mesh a debris
return in Bay 4,5,6,and 7.  Each screen has a capacity of 90,000 gpm at
low water level.  These screens were installed in 1989 as an upgrade to
the previous configuration.  The screens are cleaned by a spray wash
into a single return trough; facility representatives noted that debris
is a constant challenge, especially plastic bags.  The return trough
discharges near the main outfall for the facility.  The river is
approximately 30 feet deep at the intake structure.

Of the original nine circulating inlet water pipes (each 6 ft in
diameter), East River currently only uses 2 pipes.  All of the pipes are
buried under 8 to 15 feet of concrete.

The facility retired Unit 5 in 1994 and has been granted a commensurate
flow reduction towards meeting impingement and entrainment requirements.

Facility representatives stated that the design intake velocity has not
been calculated, but that they have initially used the intake velocity
at the nearby Arthur Kill plant (0.56 ft/sec at mid-tide).
Facility-specific velocity measurements will be conducted this summer.
Facility representatives stated that the tides (approximately 11 ft
between high and low tide) have minimal effect on the intake velocity,
but can have a substantial effect on the thermal plume.

No biocides are in use at the facility.  The intake structure is cleaned
by divers once per year.  There is significant siltation in the intake
screen and bays due to the sediment load in the waterbody and near
constant disturbance by tides and vessel traffic.  However, the facility
does not dredge since the sediment would quickly re-accumulate.

Impingement and Entrainment Information

Facility representatives noted that the East River ecosystem is rapidly
recovering.  The facility conducted biological monitoring in 1993, 2004,
and 2005/2006; facility representatives stated that this would be
sufficient data to conduct the analyses required in a Comprehensive
Demonstration Study.  Impingement and entrainment reductions were
calculated based on a simple count and a flow-weighted analysis,
respectively.  During the most recent study, the facility collected,
categorized and enumerated impingement and entrainment once a week.  For
impingement, the facility analyzed all organisms; for entrainment, the
facility analyzed organisms that passed through 0.365 mm net.  East
River then used the sampling results to construct a model that predicts
the I&E reductions of age-1 equivalent organisms associated with fine
mesh for I (69%) and flow reduction opportunities for E (31%).  The
study considered seasonal and diel variations.  Facility representatives
indicated diel variations were minimal.  East River indicated that three
species dominated the sampling and that the species composition in the
more recent sampling was somewhat different than in 1993, but the total
count was approximately the same.  Facility representatives also stated
that the peak spawning period in the East River generally overlaps with
periods of peak power generation.

Cooling Tower Feasibility

The facility is located in a highly urban, densely developed
environment.  The facility is located adjacent to the East River, with
its intake screenhouse located on the eastern side of FDR Drive.  The
facility’s substation and oil storage tanks are to the south, as are
other city-owned buildings and low-income housing.  To the west are
medium-rise residential buildings.  To the north are two recreational
baseball fields on property owned by Con Edison used by the city parks
department; however, facility representatives stated that the scarcity
of parkland in the city and political pressure has effectively
eliminated any possibility of alternate uses for the space.  Facility
representatives stated that there is no readily available adjacent land
for purchase and that land prices are increasing as the area is
recognized as an “up and coming” neighborhood.

NY Department of Environmental Conservation (NYDEC) noted that the space
required for wet cooling towers is approximately the same size as the
ballfields, but has agreed that closed cycle cooling is not feasible at
the site, due to issues with sufficient space to build the towers and
the impacts from the plume.  Facility representatives also noted that
they would expect heavy resistance to permits for the plume from a
cooling tower, as well as noise and visual impacts.  Dry cooling was
also briefly considered by NYDEC, but would require an even larger
parcel of land.

Additional Information

In lieu of installing closed cycle cooling, East River will propose a
suite of technologies as BTA after conducting a series of analyses
required by its current permit (i.e., alternative technology analysis).
The permit contains many of the same requirements as the now-suspended
Phase II rule (including a performance range for reducing impingement
and entrainment).  The facility has already submitted a study that
examines closed cycle cooling, seasonal flow reductions, the current
intake technology and other information.  A subsequent study evaluated
alternative intake technologies.  Because Con Edison considers fine mesh
traveling screens to be a promising technology for this site, East River
will also be conducting technology pilot tests using screens 6 and 7
this summer, including a 1 mm mesh traveling screen.  Once the
technology studies are complete, a construction and implementation
schedule will be developed.

Facility representatives stated that restoration was not considered a
viable alternative under the Phase II rule, as the facility believed it
could meet the performance standards.  Additionally, there are few sites
nearby that would be suitable as restoration projects.

Given the age of the facility, it is not completely clear what
infrastructure is located underground.  Facility representatives were
not sure about the location of all water, steam, and other utility
pipes, particularly beneath the substation and other areas of the
facility.

The condenser for Unit 6 was re-tubed in 2000.  Unit 7 was re-tubed in
1989.

Attachments

Attachment A		List of Attendees

Attachment B		Aerial Photo

Attachment C		PowerPoint slideshow #1, April 15, 2008

Attachment D		Site Visit Photos

Attachment A--List of Attendees

Paul Shriner, EPA

Jan Matuszko, EPA

Kelly Meadows, Tetra Tech

Mike Kessler, Con Edison

Ming Lau, Con Edison

Jack Steenbeek, Con Edison

Tim Ellis, Con Edison

Danielle Bacskay, Con Edison

Attachment B—East River Aerial Photo

Please see DCN 10-6506B accompanying this document.

Attachment C--PowerPoint slideshow #1, April 15, 2008

Please see DCN 10-6506A accompanying this document.

Attachment D--Site Visit Photos

Please see DCNs 10-6506C-F accompanying this document.

 Facility representatives noted that, depending on the direction and
strength of the tides, some intake water may be withdrawn from Long
Island Sound or the Hudson River.

 A fifth unit was retired in 1994.

 Bays 1, 2, 3 and 8 are blocked off with bulkheads.

 During outages, a second set of trash racks are put in place.

 The buckets on the screens are not of the modified/Ristroph design.

 The original traveling screens were oriented parallel to the river
flow.  The dual flow screens were designed to fit into the existing
screenwells.

 FDR Drive was built in the 1930s and bisects the facility’s property.
 Access to the pumphouse (and all piping) is via underground tunnels.

 The facility stores kerosene as an emergency fuel.  It also stores #6
fuel oil for Units 6 and 7, as well as the nearby South Steam Station,
which has 5 dual fuel boilers that supply steam to the city and operate
approximately 50% of the time.

 Facility representatives stated that it is not uncommon for Con Edison
property to be used by the city or local residents for recreational or
open space; previous efforts by Con Edison to develop these lands have
resulted in substantial resistance from residents and city staff.

 Under existing operational conditions, there have been instances of
leaked steam forming ice on nearby roads in winter.

 Variable speed pumps were excluded from further study due to concerns
over head loss across the intake structure.

 PAGE

 PAGE   7


[Federal Register Volume 76, Number 89 (Monday, May 9, 2011)]
[Notices]
[Page 26749]
[FR Doc No: 2011-11279]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1973-DR; Docket ID FEMA-2011-0001]

Georgia; Amendment No. 3 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Georgia (FEMA-1973-DR), dated April 29, 2011, and
related determinations.

DATES: Effective Date: May 2, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Georgia is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of April 29, 2011.

    Gordon, Harris, Heard, and Lumpkin Counties for Individual
Assistance.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-11279 Filed 5-6-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 83, Number 27 (Thursday, February 8, 2018)]
[Rules and Regulations]
[Pages 5524-5525]
[FR Doc No: 2018-02133]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2017-0344; Airspace Docket No. 17-AWP-11]

Modification of Air Traffic Service (ATS) Routes; Western United
States

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action modifies VOR Federal Airways V-113 and V-244 which
caused navigational aid gaps due to the decommissioning of Manteca and
Maxwell VORs.

DATES: Effective date 0901 UTC, March 29, 2018. The Director of the
Federal Register approves this incorporation by reference action under
Title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA, Order 7400.11 and publication of conforming
amendments.

ADDRESSES: FAA Order 7400.11B, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11B at NARA, call<PHONE_NUMBER>, or go
to http://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Kenneth Ready, Airspace Policy Group,
Office of Airspace Services, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, 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
the 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 modifies the air traffic service route structure in the
western United States to maintain the efficient flow of air traffic.

History

    The FAA published a notice of proposed rulemaking (NPRM) in the
Federal Register for Docket No. FAA-2017-0344 (82 FR 41182; August 30,
2017). The NPRM proposed to amend two VOR Federal airways, V-113 and V-
244, in the western United States. Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal. One comment was received.

Discussion of Comment

    The commenter wrote that V-113 should be further revised to remove
the Priest, CA, VOR from the route because that VOR is decommissioned.
    FAA response: The Priest VOR is in a shutdown status pending formal
decommissioning. This rule, in part, corrects the coordinates defining
the PATYY intersection in V-113, while further amendment of V-113 is
being developed for a later date. In the interim, RNAV-equipped
aircraft can continue to navigate along V-113,\1\ or they can fly T-329
north-bound or south-bound between the Paso Robles VORTAC and the
Panoche VORTAC, at which point they can resume V-113. For non-RNAV
equipped aircraft, ATC could provide radar vectors or issue alternative
airway routing.
---------------------------------------------------------------------------

    \1\ Advisory Circular 90-108, Use of Suitable Area Navigation
(RNAV) Systems on Conventional Routes and Procedures.
---------------------------------------------------------------------------

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11B, airspace Designations and
Reporting Points, dated August 3, 2017, and effective September 15,
2017. FAA Order 7400.11B is publicly available as

listed in the ADDRESSES section of this document. FAA Order 7400.11B
lists Class A, B, C, D, and E airspace areas, air traffic service
routes, and reporting points.

Differences From the NPRM

    Subsequent to publication of the NPRM, the FAA identified an error
within a set of True (T) and Magnetic (M) coordinates along V-113. The
intersection coordinates ``INT Modesto 208[deg](T) 19(M) and El Nido
277[deg](T) 262[deg](M) radials'' were misidentified as PATYY
intersection in the NPRM; when in fact these coordinates are for WINDY
intersection. The FAA is changing the coordinates to ``INT Modesto
208[deg] (T) 191[deg] (M) and El Nido 298[deg] (T) 283[deg] (M)'' as
the correct coordinates for PATYY intersection.

The Rule

    The FAA is amending Title 14 Code of Federal Regulations (14 CFR)
part 71 to amend VOR Federal Airways V-113 and V-244 in the western
United States due to the scheduled decommissioning of the Manteca and
Maxwell VOR facilities. The routes are outlined below.
    V-113: V-113 currently extends between Morro Bay, CA (MQO) and
Lewistown, MT (LWT) with a gap between Panoche, CA (PXN) and Linden, CA
(LIN). The FAA is filling the gap between Panoche, CA (PXN) and Linden,
CA (LIN). The unaffected portions of the existing route will remain as
charted.
    V-244: V-244 currently extends between Oakland, CA (OAK) and
Salina, KS, (SLN). The FAA is relocating the segment of the route from
Oakland, CA by rerouting the airway approximately 10 nautical miles
north of the previous airway until tied back into the previous route at
Coaldale, NV. The unaffected portion of the existing route will remain
as charted.
    All radials in the regulatory text route descriptions below are
stated in True degrees.
    VOR Federal airways are published in paragraph 6010(a), of FAA
Order 7400.11B dated August 3, 2017, and effective September 15, 2017,
which is incorporated by reference in 14 CFR 71.1. The VOR Federal
airways listed in this document will be subsequently published in the
Order.

Regulatory Notices and Analyses

    The FAA has determined that this 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
Department of Transportation (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 only affects air traffic procedures
and air navigation, it is certified that this rule, when promulgated,
does not have a significant economic impact on a substantial number of
small entities under the criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action modifying VOR Federal
airways V-113 and V-244 qualifies for categorical exclusion under the
National Environmental Policy Act and its agency-specific implementing
regulations in FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures'' regarding categorical exclusions for procedural actions at
paragraph 5-6.5a, which categorically excludes from full environmental
impact review rulemaking actions that designate or modify classes of
airspace areas, airways, routes, and reporting points. Therefore, this
airspace action is not expected to result in any significant
environmental impacts. In accordance with FAA Order 1050.1F, paragraph
5-2 regarding Extraordinary Circumstances, this action has been
reviewed for factors and circumstances in which a normally
categorically excluded action may have a significant environmental
impact requiring further analysis, and it is determined that no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 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

0
1. The authority citation for part 71 continues to read as follows:

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

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11B,
Airspace Designations and Reporting Points, dated August 3, 2017 and
effective September 15, 2017, is amended as follows:

Paragraph 6010--Domestic VOR Federal Airways

V-113 (Amended)

    From Morro Bay, CA; Paso Robles, CA; Priest, CA; Panoche, CA;
INT Modesto 208[deg] and El Nido 298[deg] radials; Modesto, CA;
Linden, CA; INT Linden 046[deg] and Mustang, NV, 208[deg] radials;
Mustang; 42 miles, 24 miles, 115 MSL, 95 MSL, Sod House, NV; 67
miles, 95 MSL, 85 MSL, Rome, OR; 61 miles, 85 MSL, Boise, ID;
Salmon, ID; Coppertown, MT; Helena, MT; to Lewistown, MT
* * * * *

V-244 (Amended)

    From Oakland, CA; INT Oakland 077[deg] and Linden, CA, 246[deg]
radials; Linden; 30 miles, 153 MSL, INT Linden 094[deg] and
Hangtown, CA, 157[deg] radials; 58 miles, 153 MSL, INT Coaldale, CA,
267[deg] and Friant, CA, 022[deg] radials; 23 miles, 153 MSL, INT
Coaldale 267[deg] and Bishop, CA, 337[deg] radials; 43 miles, 125
MSL, Coaldale, NV; Tonopah, NV; 40 miles, 115 MSL, Wilson Creek, NV;
28 miles, 115 MSL, Milford, UT; Hanksville, UT; 63 miles, 13 miles,
140 MSL, 36 miles, 115 MSL, Montrose, CO; Blue Mesa, CO; 33 miles,
122 MSL, 27 miles, 155 MSL, Pueblo, CO; 18 miles, 48 miles, 60 MSL,
Lamar, CO; 20 miles, 116 miles, 65 MSL, Hays, KS; to Salina, KS. The
airspace within R-2531A and R-2531B is excluded.

    Issued in Washington, DC, on January 29, 2018.
Sean E. Hook,
Acting Manager, Airspace Policy Group.
[FR Doc. 2018-02133 Filed 2-7-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: January 8, 2008 (Volume 73, Number 5)]
[Notices]
[Page 1378-1380]
[DOCID:fr08ja08-91]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57082; File No. SR-CBOE-2007-153]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change Relating to Rule 6.14 (Hybrid Agency Liaison)

January 2, 2008.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on December 28, 2007, the Chicago Board Options Exchange, Incorporated
(``CBOE'' or ``Exchange'') filed with the Securities

and Exchange Commission (``Commission'') the proposed rule change as
described in Items I and II below, which Items have been substantially
prepared by CBOE. The Exchange filed the proposal as a ``non-
controversial'' proposed rule change pursuant to section
19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-4(f)(6) thereunder,\4\
which renders the proposal effective upon receipt of this filing by the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    CBOE proposes to modify the application of its Hybrid Agency
Liaison (``HAL'') system. The text of the rule proposal is available on
the Exchange's Web site (http://www.cboe.org/legal), at the Exchange's

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

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

1. Purpose
    CBOE Rule 6.14 governs the operation of the Exchange's HAL system.
HAL provides automated order handling in designated classes trading on
Hybrid for qualifying electronic orders that are not automatically
executed. The purpose of this filing is to modify the HAL eligibility
and order handling process for non-marketable limit orders that improve
the Exchange's disseminated quote.
Description of HAL
    CBOE Rule 6.14 provides that the Exchange, with input from the
appropriate Floor Procedure Committee, shall designate the classes in
which HAL shall be activated.\5\ For these designated classes, HAL
currently (i) processes market and limit orders that are marketable
against the Exchange's disseminated quotation while that quotation is
not the National Best Bid or Offer (``NBBO''), (ii) processes limit
orders that are marketable against the NBBO when CBOE is not the NBBO,
and (iii) processes limit orders that improve CBOE's disseminated
quotation.\6\
---------------------------------------------------------------------------

    \5\ See CBOE Rule 6.14(a).
    \6\ See CBOE Rule 6.14(a).
---------------------------------------------------------------------------

    The HAL order handling process operates as follows.\7\ HAL flashes
an eligible order to gauge if there is any interest from any Market-
Maker or member acting as agent for orders at the top of the Exchange's
book (``Qualifying Member'') to trade the order at the flash price. For
orders that are marketable against the Exchange's disseminated quote or
the NBBO, the flash price is the NBBO price. For limit orders that
``middle'' the Exchange's disseminated quote and that are not
marketable against the NBBO, the flash price is the limit price of the
order(s). This flash/exposure period is configurable but cannot exceed
1.5 seconds. If, during the exposure period, a Market-Maker or
Qualifying Member commits to trade with any portion of the order, then
the exposure period ends and an allocation period begins. The
allocation period, when combined with the flash period, cannot exceed
three seconds.
---------------------------------------------------------------------------

    \7\ See CBOE Rule 6.14(b).
---------------------------------------------------------------------------

    Exposed orders are filled at the conclusion of the allocation
period in accordance with the allocation algorithm in effect for the
option class pursuant to Rule 6.45A or Rule 6.45B. There is no
participation entitlement applicable to exposed orders, and the
response size is limited to the size of the exposed order for
allocation purposes. If no responses are received during the exposure
period, then a linkage order is routed to the NBBO market on behalf of
the exposed order in cases where the exposed order is marketable
against the NBBO, or if there remains an unexecuted portion of a limit
order that is not marketable at the conclusion of the allocation
period, then the limit order or remaining balance is entered into the
electronic book.

Proposed Changes

    This filing makes two HAL changes. First, for all non-Hybrid 3.0
Classes, limit orders that better the Exchange's quote but that are
not-marketable (orders that fall under 6.14(a)(iii)) will no longer be
flashed through HAL. Instead, these orders will route directly and
automatically to the electronic book. Second, non-marketable limit
orders that would improve the Exchange's disseminated quote in Hybrid
3.0 Classes will be flashed and handled under normal HAL processing,
except when the eligible order is entered on the same side of the
market as a manual quote. In that case, the eligible limit order will
automatically route into the electronic book instead of being processed
by HAL, and the manual quote will automatically cancel, so that the
Exchange's disseminated quote will be represented by the limit order's
bid/offer. This is consistent with how the limit order would currently
be processed in Hybrid 3.0 Classes when a manual quote is present.
    The Exchange proposes the first change in connection with a recent
fee change it submitted (SR-CBOE-2007-152) which provides a rebate,
under certain circumstances, to Market-Makers that ``step-up'' to trade
orders flashed in HAL. The rebate program is meant to reduce the number
of orders that route to away exchanges. Thus, the rebate is geared more
toward encouraging matching better priced quotes on other markets than
it is toward trading middle market limit orders. Therefore, the
Exchange proposes to directly book those middle market limit orders and
not submit them for HAL processing. This way, rebates are not provided
for stepping-up to trade orders that will otherwise book. Additionally,
direct booking allows a wider range of users to trade against the order
sooner.
    The second change allows the Exchange to introduce the HAL process
in Hybrid 3.0 Classes. By initiating HAL in Hybrid 3.0 Classes, the
Exchange will provide further automation to the order handling process
by allowing Market-Makers appointed to the relevant option class to
electronically participate on such orders.
    In all other respects, HAL shall operate as it currently operates
today.
2. Statutory Basis
    The Exchange believes the proposed rule change to amend CBOE Rule
6.14 to modify the eligibility and order handling process for limit
orders that improve the Exchange's disseminated quote when HAL is
activated is consistent with the Act and the rules and regulations
under the Act applicable to national securities exchanges and, in
particular, the requirements of section 6(b) of the Act.\8\
Specifically, the Exchange believes the proposed rule change is
consistent with

the section 6(b)(5) \9\ requirements that the rules of an exchange be
designed to promote just and equitable principles of trade, to prevent
fraudulent and manipulative acts, to remove impediments to and perfect
the mechanism for a free and open market and a national market system,
and, in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

    The Exchange neither solicited nor received comments on the
proposal.

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

    Because the foregoing 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 for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, if consistent with
the protection of investors and the public interest, it has become
effective pursuant to section 19(b)(3)(A) of the Act \10\ and Rule 19b-
4(f)(6) thereunder.\11\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires that a self-regulatory organization submit to the
Commission written notice of its intent to file the proposed rule
change, along with a brief description and text of the proposed rule
change, at least five business days prior to the date of filing of
the proposed rule change, or such shorter time as designated by the
Commission. The Commission notes that CBOE has satisfied the five-
day pre-filing notice requirement.
---------------------------------------------------------------------------

    Normally, a proposed rule change filed under 19b-4(f)(6) may not
become operative prior to 30 days after the date of filing. However,
Rule 19b-4(f)(6)(iii) \12\ permits the Commission to designate a
shorter time if such action is consistent with the protection of
investors and the public interest. The Exchange has requested that the
Commission waive the 30-day operative delay. In its filing, the
Exchange noted that waiver of the 30-day operative delay, and immediate
implementation of the described rule change, would allow the Exchange
to (i) implement direct-booking of non-marketable non-Hybrid 3.0
Classes concurrent with related fee changes, which were filed with the
Commission for immediate effectiveness on December 21, 2007 and which
take effect on January 1, 2008; and (ii) immediately utilize HAL in
Hybrid 3.0 Classes, which will allow Market-Makers appointed to the
relevant Hybrid 3.0 option class to electronically participate on
qualifying flashed orders.
---------------------------------------------------------------------------

    \12\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest.
The proposed rule change will allow a greater number of users to trade
against certain orders sooner. In addition, initiating HAL for Hybrid
3.0 Classes provides further automation to order handling by allowing
Market-Makers to electronically participate on such orders.
Accordingly, consistent with the protection of investors and the public
interest, the Commission designates the proposed rule change to be
operative upon filing with the Commission.\13\
---------------------------------------------------------------------------

    \13\ For the purposes only of waiving the 30-day operative
delay, the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate 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.

IV. Solicitation of Comments

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

Electronic Comments

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

File Number SR-CBOE-2007-153 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2007-153. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of CBOE. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-CBOE-2007-153 and should be
submitted on or before January 29, 2008.
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E8-95 Filed 1-7-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 9 (Tuesday, January 14, 2014)]
[Notices]
[Pages 2450-2451]
[FR Doc No: 2014-00500]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0542]

Guidance for Industry: Considerations Regarding Substances Added
to Foods, Including Beverages and Dietary Supplements; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a guidance for industry entitled ``Guidance for
Industry: Considerations Regarding Substances Added to Foods, Including
Beverages and Dietary Supplements.'' This guidance is intended to
remind manufacturers and distributors of conventional foods about the
requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
regarding substances added to

conventional foods, including beverages. This guidance also is intended
to remind dietary supplement manufacturers and distributors that the
same requirements apply to certain substances that are added to dietary
supplements; namely, those that are not dietary ingredients as defined
in the FD&C Act.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Food Additive Safety, Center for Food Safety and Applied
Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels
to assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Negash Belay, Center for Food Safety
and Applied Nutrition (HFS-255), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance entitled
``Guidance for Industry: Considerations Regarding Substances Added to
Foods, Including Beverages and Dietary Supplements.'' This guidance is
being issued consistent with our good guidance practices regulation (21
CFR 10.115). The guidance represents our current thinking on this
topic. It does not create or confer any rights for or on any person and
does not operate to bind FDA or the public. An alternate approach may
be used if such approach satisfies the requirements of the applicable
statutes and regulations.
    In the Federal Register of December 4, 2009 (74 FR 63759), we made
available a draft guidance entitled ``Draft Guidance for Industry:
Factors That Distinguish Liquid Dietary Supplements From Beverages,
Considerations Regarding Novel Ingredients, and Labeling for Beverages
and Other Conventional Foods'' (draft guidance) and gave interested
parties an opportunity to submit comments by February 2, 2010, for us
to consider before beginning work on the final version of the guidance.
Elsewhere in this issue of the Federal Register, we announce the
availability of the final guidance, now entitled ``Guidance for
Industry: Distinguishing Liquid Dietary Supplements From Beverages.''
    The draft guidance included a section entitled ``Ingredients in
Beverages and Other Conventional Foods are Subject to the Federal Food,
Drug, and Cosmetic Act's Requirements for Substances Added to Food''
(ingredients section). The ingredients section of the draft guidance
described the general requirements of the FD&C Act regarding substances
added to beverages and other conventional foods. We received several
comments on the draft guidance and have modified the final guidance
entitled ``Guidance for Industry: Distinguishing Liquid Dietary
Supplements From Beverages'' where appropriate. The modifications to
the final guidance entitled ``Guidance for Industry: Distinguishing
Liquid Dietary Supplements From Beverages'' include a modified version
of the ingredients section, which refers to the separate guidance that
is the subject of this document.
    The guidance that is the subject of this document derives from the
ingredients section of the draft guidance. It is intended to remind
manufacturers and distributors of conventional foods about the
requirements of the FD&C Act regarding substances added to conventional
foods, including beverages. This guidance also is intended to remind
dietary supplement manufacturers and distributors that the same
requirements apply to certain substances that are added to dietary
supplements; namely, those that are not dietary ingredients as defined
in section 201(ff)(1) of the FD&C Act (21 U.S.C. 321(ff)(1)). We are
issuing this separate guidance, in addition to referring to it within
the guidance entitled ``Guidance for Industry: Distinguishing Liquid
Dietary Supplements From Beverages,'' to make it more prominent and
improve its accessibility to manufacturers and distributors who look
for guidance on the requirements of the FD&C Act regarding substances
added to conventional foods, including beverages. Although we met the
procedural requirements for issuing Level 1 final guidance by making
the draft guidance available for comment, we are issuing this final
guidance as Level 2 guidance under 21 CFR 10.115(g)(4) because it
merely summarizes long-established requirements in the FD&C Act and
regulations without setting forth any new interpretations of those
requirements (see 21 CFR 10.115(c)(1) to (c)(2)).

II. Comments

    Interested persons may submit either electronic comments regarding
the guidance to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/FoodGuidances or http://www.regulations.gov.
Use the FDA Web site listed in the previous sentence to find the most
current version of the guidance.

    Dated: January 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-00500 Filed 1-13-14; 8:45 am]
BILLING CODE 4160-01-P