  SEQ CHAPTER \h \r 1 APPENDIX  A.  Environmental Fate and Transport
Data

a. Degradation

Hydrolysis (161-1): The hydrolysis of non-radiolabeled chlorflurenol ME
applied at a rate of 1.8 or 18 mg a.i./L (ppm) was studied in the dark
at 25°C in sterile pH 3, pH 6 and pH 9 aqueous buffer solutions for up
to 50 days (MRID 43496201).  Quantitative data for pH 3 buffer solution
was not provided; however an extrapolated (not defined) half-life of 336
days was reported by the study author.  In the pH 6 buffer,
chlorflurenol ME applied at 18 ppm decreased only slightly from ca.
94.4% of the applied at time 0 and 10 days, to ca. 77.8% at 50 days
posttreatment. In pH 9 buffer, chlorflurenol ME applied at a rate of 18
ppm, decreased from ca. 111.1% of the applied at time 0, to ca. 55.6% at
4.5 hours (0.19 days; study termination); applied at a rate of 1.8 ppm,
chlorflurenol ME decreased from ca. 116.7% of the applied at time 0, to
ca. 41.7% at 7 hours (0.29 days; study termination). The only major
transformation product reported was
2-chloro-9-hydroxyfluorene-9-carboxylic acid (Compound II), however,
quantitative data and further details were not reported.

MRID 43496201 was classified as supplemental because the material
balance was incomplete, the analytical methods were inadequate, and
tabular data for chlorflurenol ME and quantitative data for its
transformation products were not reported.

Summary of Hydrolysis of Chlorflurenol ME (MRID 43496201)

At 25°C	Linear Half-life (days)	Major Transformation Products

pH 6	161.2	2-Chloro-9-hydroxyfluorene-9-carboxylic acid (Compound II)

pH 9	0.19-0.20

Photodegradation in water (161-2):  No photodegradation in water studies
were submitted.

Photodegradation in soil (161-3):  No photodegradation in soil studies
were submitted.

b. Metabolism

Aerobic soil metabolism (162-1): Unlabeled chlorflurenol ME (formulation
CF125, 12.5% a.i.) applied at a rate of 8.75 kg a.i./ha to outdoor field
plots degraded in sandy loam soil from Germany (pH 6.0, organic matter
3.5%; soil moisture content not provided) with a linear and non-linear
half-life of 1.3 days, and an observed half-life of <5 days (MRID
43595403).  Chlorflurenol ME decreased from ca. 66.3% of the applied at
time 0, to ca. 4.5% at 5-12 days, and was not detected at 26 days (study
termination).  One major degradation product was confirmed by a
colormetric method.  2-Chloro-9-fluorenone (Compound IV; fluorenone)
increased to a maximum of ca. 14.3% of the applied at 5-12 days and was
not detected at 26 days.

MRID 43595403 was classified as unacceptable because the study was
conducted outside where the environmental conditions were neither
controlled nor reported, the material balance was incomplete, volatiles
were not collected, the sampling intervals were inadequate to accurately
establish a half-life, and the analytical method was inadequate at
identifying all potential transformation products.

Also it could not be determined if the German soil used was comparable
to soils found in a typical chlorflurenol ME use area in the US.  An
aerobic soil metabolism study using 4 soils may be required.

Summary of aerobic soil metabolism of Chlorflurenol ME (MRID 43595403)

Soil	Half-life (days)	Major Transformation Products (maximum)

Sandy loam (German)	1.3  	2-Chloro-9-fluorenone (14.3% of the applied at
12 days)

Anaerobic soil metabolism (162-2):  No anaerobic soil metabolism studies
were submitted.

Anaerobic aquatic soil metabolism (162-3):  No anaerobic aquatic soil
metabolism studies were submitted.

Aerobic aquatic soil metabolism (162-4):  No aerobic aquatic soil
metabolism studies were submitted.

c. Mobility

Mobility/Adsorption/Desorption (163-1):  The column leaching of
[phenyl-U-14C]-labeled chlorflurenol ME was studied in unaged sand (A),
sandy loam (B), and two loam (C and D) German soils and one aged sandy
loam (B) German soil  (MRID 43496202a). For the unaged soil columns, the
application rate of the test substance to each soil column ranged from
50.26 µg to 53.70µg (not further specified); the test substance was
applied to the aged soil at a rate of 1 µg/mL.  The unaged soil columns
were leached under saturated conditions with 437 mL of distilled water
(equivalent to 20.6 ha/cm rain) for up to 24 hours; the aged soil column
was leached daily with 11 mL distilled water (equivalent to 0.52 ha/cm
rain) for 45 days.

ro-9-hydroxyfluorene-9-carboxylic acid was identified but not quantified
in the leachate; ≤0.7% of the applied radioactivity was detected in
the leachate in the other three soils.

In the aged column leaching portion of the study, following the 30-day
aging period under aerobic conditions, [14C] residues were 38.1% of the
applied radioactivity, of which chlorflurenol ME comprised 0.6% of the
applied.  The transformation products
2-chloro-9-hydroxyfluorene-9-carboxylic acid and 2-chloro-9-fluorene
were 11.5% and 1.8% of the applied, respectively.  Following 45 days of
leaching, an average of 18.0% of the applied radioactivity was recovered
in the aged soil.  Chlorflurenol ME was not detected in the soil
segments.  2-Chloro-9-fluorene-9-carboxylic acid totaled 1.0% of the
applied in the aged soil and 1.9% in the soil segments (0-20 cm);
2-chloro-9-fluorene totaled 2.6% in the aged soil and 4.1% in the soil
segments (0-20 cm). Unextractable residues totaled 27.9% of the applied.
 The leachate contained an average of 0.7% of the applied radioactivity,
first detected at 22 days, and containing a maximum of 5.0 ng
equivalents of [14C]chlorflurenol ME/mL effluent at 44 days.

MRID 43496202a was classified as supplemental because for both unaged
and aged soil column leaching studies, it could not be determined if the
German soil used was comparable to soils found in a typical
chlorflurenol ME use area in the US.  In addition, for the aged soil
column leaching study, the test substance was aged for longer than one
half-life prior to use in the leaching portion of the study, and the
material balances were incomplete (<90% of the applied).

The adsorption of [14C] chlorflurenol ME was studied in sandy loam soil
(pH 7.3; organic carbon 1.1%) from Germany in a batch equilibrium
experiment (MRID 43496202b).  Based on the McCall Classification System,
chlorflurenol ME was high to very highly mobile.

This study was classified as supplemental because it could not be
determined if the German soil used was comparable to soils found in a
typical chlorflurenol ME use area in the US and the material balances
were not determined.

Mobility results for Chlorflurenol ME (MRID 43496202b)

	Adsorption	Desorption

	KF	1/N	r2	KFoc	KF	1/N	r2	KFoc

Sandy loam (German)	1.203	0.7740	0.9966	109.36	1.264	0.6993	0.9998
114.91

Laboratory volatility (163-2):  No laboratory volatility studies were
submitted.

Field volatility (163-3):  No field volatility studies were submitted.

d. Dissipation

Terrestrial Field Dissipation (164-1):  No terrestrial field dissipation
studies were submitted.

e. Accumulation

Fish bioaccumulation (165-4):  No fish bioaccumulation studies were
submitted.

f. Special Field Studies

Small-scale prospective groundwater study (166-1):  No small-scale
prospective groundwater studies were submitted.

g. degradates

The table below summarized the degradates which were detected in the
fate studies:

Chlorflurenol ME and its transformation products.

Transformation Product Name and Structure	Maximum Percent of Applied
Dose (Interval)	Percent of Applied Dose at Final Sampling Interval
(Interval)	Study and Guideline Number	Comments (e.g. Half Life,
Radiolabel, Soil Type)

Chlorflurenol ME:

(RS)-2-Chloro-9-hydroxyfluorene-9-carboxylic acid methyl ester

	94.4% @ 0 d	77.8% @ 50 d	43496201

161-1	pH 6, applied at 18 ppm

	111.1% @ 0 d	55.6% @ 0.19 d	43496201

161-1	pH 9, applied at 18 ppm

	116.7% @ 0 d	41.7% @ 0.29 d	43496201

161-1	pH 9, applied at 1.8 ppm

	66.3% @ 0 d	0.0% @ 26 d	43595403

162-1	Sandy loam soil (Germany)

T1/2 =  1.3 d (non-linear), DT50 = 1.5 days

Fluorenone:

2-Chloro-9-fluorenone

(Compound IV)

	14.3% @ 12 d	0.0% @ 26 d	43595403

162-1	Sandy loam soil (Germany)

Chlorflurenol:

2-Chloro-9-hydroxyfluorene-9-carboxylic acid

(Compound II)

	Not quantified.	Not quantified.	43496201

161-1	pH 6, applied at 18 ppm

pH 9, applied at 18 ppm

pH 9, applied at 1.8 ppm

Table A-2. Chlorflurenol ME: Parnet and Suspected transformation
Products in Laboratory and Field Studies

Code Name	Chemical Name

	Chlorflurenol ME

(Chlorflurenol-methyl; Chlorflurenol-methyl ester; Chlorflurecol-methyl;
Clorflurecol-methyl ester; Compound I)
(RS)-2-Chloro-9-hydroxyfluorene-9-carboxylic acid methyl ester

	Transformation Product 1

(Fluorenone; Compound IV)	2-Chloro-9-fluorene

	Transformation Product 2

(Chlorflurenol; Compound II)	2-Chloro-9-hydroxyfluorene-9-carboxylic
acid

Table A-3. Environmental Transformation Products of Chlorflurenol ME

Confirmed Transformation Product	Lab Results

Max %AR1 (Study)	Chemical Structure

Fluorenone	14 (aerobic soil)

Chlorflurenol	Not quantified.

1%AR = % of applied radioactivity.

  SEQ CHAPTER \h \r 1 APPENDIX  B.

Table B1. Chlorflurenol ME Uses and Application Rates (derived by HED).

Chlorflurenol:  Uses and Application Rates

Crop	EPA Reg. No.	Max. Application Rate	Specific Instructions Regarding
Intervals	Likely Applications per Unit Area per Year	Likely Applications
by Occupational or Residential Applicator per Year

Occupational Uses

Turf:  ornamental and lawns	69361-1

water dispersible solution	1.0 lb ai/acre	Apply when weeds are actively
growing	8 (FL)	40 (FL)

	69361-3

dry	0.26 lb ai/acre	Wait at least 4 weeks before 2nd application

Apply anytime weeds actively growing and temp is >60°F	8 (FL)	40 (FL)

	69361-6

liquid	3.0 lb ai/acre	Apply when grass just beginning to green up.
Apply throughout growing season.	8(FL)	40 (FL)

Turf:  golf courses	69361-1

water dispersible solution	1.0 lb ai/acre	Apply when weeds are actively
growing	8 (FL)	40 (FL)

Weed Turf:

growing in culverts, ROW, median strips, ditches, under security fences
69361-6

liquid	3.0 lb ai/acre	Apply throughout growing season	6	60

Weed Hardwoods:

growing under utility lines, as screens or ground cover, adjacent to
highways	69361-6

liquid	1.0 lb ai/100 gallons	Retards growth up to 1 year	1	10

Weed Hedges:

growing under utility lines, as screen	69361-6

liquid	1.0 lb ai/100 gallons	Retards growth up to 2 months	6	60

Weed Vines

growing under utility lines, as screens or ground cover, ROW, hedgerows
69361-6

liquid	1.0 lb ai/100 gallons	Retards growth up to 6 months	2	20

Weed Gymnosperms	69361-6

liquid	0.25 lb ai/100 gallons	Must be treated before buds expand	1	10

Trees:

bark banding to inhibit growth	69361-6

liquid	depends on trunk diameter & tree type

1	10

Agricultural Uses

Turf:  sod farms	69361-6

liquid	3.0 lb ai/acre	Apply throughout growing season beginning when
turf is just beginning to green up. (REI 48 hours)	6	30

Pineapple plants:

for plant material production (non food use)	69361-6 (SLN)

liquid	1.0 lb ai/acre	A 2nd application may be made after an interval of
10-12 days.  Apply to mature pineapple plants at time of forcing, and 6
months prior to desired planting material harvest.   	2	10

Residential Uses

Turf:  lawns	69361-3

dry	0.26 lb ai/acre	Wait at least 4 weeks before 2nd application

Apply anytime weeds actively growing and temp is >60°F	6	6

  SEQ CHAPTER \h \r 1 APPENDIX  C.  T-REX Model (Version 1.2.3, August,
2005)

  SEQ CHAPTER \h \r 1 I.  Introduction

This spreadsheet-based model calculates the residues on avian and
mammalian food items along with the dissipation rate of a chemical
applied to foliar surfaces (for single or multiple applications) in
order to estimate acute and reproductive risk quotients.  LD50 ft-2
values are calculated for both broadcast and banded (granular and
liquid) applications using an adjusted LD50 method.  The results are
presented by weight class for various sized birds and mammals for each
type of application.  Avian and mammalian risk quotients are also
calculated for seed treatment applications to various crop seeds.

T-REX uses the same principle as the batch code models FATE and TERREEC
that calculate terrestrial exposure concentration estimates on plant
surfaces following pesticide application.  However, T-REX performs a
number of calculations that neither FATE nor TERREEC perform.  For
example, T-REX adjusts acute and chronic toxicity values based on the
relative body weight of the animal being assessed compared with the
animal used in the toxicity studies.  T-REX also calculates risk
quotients for granular applications and seed treatments.

II.  Inputs

Inputs needed to run T-REX include the following (inputs denoted with an
* are required; inputs denoted with a *C are required when multiple
applications are being modeled:

  SEQ CHAPTER \h \r 1 A. Pesticide Application Data

Chemical name:		Either the chemical or common name used in the
assessment.

Use:		The type of use (e.g., turf, residential, crop, foliar,
right-of-way, etc.)  applicable, also provide crop name.

Product name and form:	The name of the formulated product as it appears
on the subject label, including any indication of the form of the
product (e.g. 10g - 10% granular, wp - wettable powder, etc.)

% A.I.*:		The % A.I. for the formulation (from the label). If an
application rate for a formulated product is used, use the % A.I. for
the formulation.  However, if the application rate to be entered has
already been adjusted for % A.I., use 100 % in this cell.

Application Rate*:		The maximum label application rate (pounds ai/acre).
If your application rate has already been adjusted for active
ingredient, make sure you have entered 100 in the % A.I. cell above;
otherwise, enter your application rate in lbs formulation/A here and
then the % A.I. in the product in the above cell.

Foliar Dissipation Half-life*:	The foliar dissipation half-life in days.
 EFED policy requires the risk assessor to consult available magnitude
of residue (171-4), the reduction of residue (171-5) and the foliar
dissipation (132-1) studies submitted by the registrant to HED for
determining pesticide residue half-life for wildlife food items used for
terrestrial wildlife exposure modeling.

  SEQ CHAPTER \h \r 1 Another source for dissipation data for wildlife
exposure modeling purposes is Willis and McDowell (1987; available at
F:\USER\SHARE\Models\Terrestrial Exposure\TREX).  In the event that the
above data sources do not provide a suitable half-life estimate, the
EFED default value is 35 days.  When using the defaults, the risk
assessor is urged to evaluate the effect of alternative assumptions of
residue half life assumption on the outcome of the terrestrial wildlife
risk assessment and include this evaluation in the discussion of risk
assessment uncertainties.

Application Interval*c:	The minimum interval (days) between multiple
applications (if any).  Note: This version of the model can only
accommodate uniform application intervals; subsequent models may
incorporate a provision of intervals of varying length.  The risk
assessor may evaluate the effect of using application intervals other
than the minimum interval on the label to explore possible mitigation
effort effects on risk outcomes.

Number of Applications*c:	The number of applications. EFED policy states
that screening risk assessments should consider the maximum number of
applications specified on the product label.  However, the risk assessor
may elect other numbers of applications to explore possible mitigation
effort effects on risk outcomes.

  SEQ CHAPTER \h \r 1 B.  Avian and Mammalian Endpoints

To calculate risk quotients, user-supplied avian and mammalian toxicity
endpoints need to be entered into the 'Endpoints' section of the Inputs
worksheet.  These endpoints can be found in avian acute oral LD50, avian
acute dietary LC50, avian reproduction NOAEC/L, acute mammalian LD50 or
LC50, and mammalian reproduction NOAEC/L toxicity studies.

T-REX requires that both the chosen endpoint (entered in the blue cell)
and the test species be included (chosen from the drop-down menu
options).  For example, one would enter an avian LD50 of 500 mg/kg-bw
and that this endpoint was based on a Bobwhite quail study (i.e., chosen
from the drop-down menu immediately to the right of the LD50 input
cell). Typically, endpoint data for bobwhite quail, mallard duck, and
laboratory rats from submitted studies or open literature will be used.
In the case where data on bird species other than bobwhite quail or
mallard duck are assessed (e.g. Japanese quail), choose "other" from the
species drop down menu and enter the body weight of the species.  A
similar option for mammals is not currently available in this version of
T-REX.  Calculations for animals other than rats need to be done by hand
using equations included in this user's guide until the release of the
next version of T-REX.  See the program author for assistance if needed.

  SEQ CHAPTER \h \r 1 1.  Avian Endpoints

The following avian toxicity endpoints may be entered into T-REX :

LD50				LD50 for dose-based acute effects endpoint (mg/kg-bw).

LC50				LC50 for dietary-based acute effects endpoint (mg/kg-diet).

Reported Chronic Endpoint	NOAEL if reported in mg/kg-bw or NOAEC if
reported in mg/kg-diet.

Mineau Scaling Factor		If chemical-specific data are available the user
can specify the avian scaling factor (see Mineau, et al.,1996)
Otherwise, use the EFED default value of (1.15).   T-REX will not run
unless a Mineau scaling factor is entered.  However, zero can be entered
if the assessor believes that body weight does not influence toxicity of
the chemical being assessed.

EFED policy states that for screening risk assessments, the lowest LD50,
LC50, NOAEC and/or NOAEL from acceptable or supplemental studies be
used.  For non-screening risk assessments, the risk assessor may elect
other values as necessary, but must document in the risk assessment why
the lowest tested endpoint was not used.  However, the assessor should
determine that the lowest toxicity value from a laboratory study results
in the lowest adjusted toxicity values for the various weight classes
being assessed.  This is important when the toxicity values from
different species are similar to each other because T-REX adjusts the
toxicity values based on body weight and food intake of the tested
organism compared with the assessed organism.  Therefore, when data are
available from multiple species, adjusted LD50s should be calculated for
all species and the lowest value should be used.

The risk assessor should note that this version of the model assumes a
set body weight for tested bobwhite quail (178 g) and mallard duck (1580
g) unless another body weight is entered to the right of this cell or
"other" is selected for a test species.  Use of "other" species or
studies involving subject animals markedly different from the assumed
body weights requires the risk assessor to provide the alternate body
weight and the species name.  These data should be obtained from the
study report if possible (time weighted average).  Alternatively,
reference body weight values may be obtained from a variety of sources
including U.S. EPA (1993) and the testing laboratory.

	2.  Mammalian Endpoints

The following mammalian endpoints may be entered into T-REX:

LD50				LD50 (mg/kg-bw) for dose-based acute effects endpoint.

LC50				LC50 (mg/kg-diet) for dietary-based acute effects endpoint.

Reported Chronic Endpoint	NOAEL if reported in mg/kg-bw or NOAEC if
reported in mg/kg-diet.

EITHER the NOAEL or the NOAEC.  To the right of the cell is a drop down
menu for the units in which the endpoint is expressed.  The model will
automatically make default adjustments for units to express the endpoint
BOTH as NOAEC and NOAEL by assuming that a laboratory rat consumes 5% of
its body weight daily (i.e., divide the concentration in food (ppm) by
20 to calculate the dose in mg/kg-bw).  However, if a reproduction study
reports toxicity values in units of dose (mg/kg-bw) and dietary
concentration (mg/kg-diet), then both of these values should be used
over the estimated values calculated by T-REX.  Because the current
version of T-REX only allows for input of either a dose or dietary
concentration (not both), T-REX needs to be run twice when a study
reports toxicity values in terms of concentration (mg/kg-diet) and dose
(mg/kg-bw).

If a rat reproduction study is unavailable, the risk assessor may use
the rat teratogenicity study NOAEL or NOAEC, but must identify this
alternative endpoint use and must discuss in the risk description the
limitations.  Studies other than reproduction or developmental toxicity
studies are not currently used by EFED to calculate risk quotients.

The lowest LD50, LC50, NOAEC and/or NOAEL from acceptable or
supplemental studies are used in screening-level risk assessment of
mammals.  For non-screening level assessments, the risk assessor may
select other values as necessary, but must document in the risk
assessment why the lowest tested endpoint was not used.

The risk assessor should note that this version of the model assumes a
set body weight of 350 g for the tested organism, assuming they are
laboratory rats.  Use of other species, or studies involving subject
animals markedly different from the assumed body weight of 350 g will
result in inaccuracies when extrapolating test endpoints to modeled
animals.  Therefore, if a mammalian species other than rats is used
(e.g. dog, rabbit, mink), use the time-weighted average body weight  of
the animals that were tested in the experiment (from the DER or the
original study report).  Alternatively, reference body weight values may
be obtained from a variety of sources including U.S. EPA (1993) and the
testing laboratory.  However, T-REX does not currently allow the use to
enter body weights of mammals that differ from the 350-gram laboratory
rat.  Therefore, adjusted toxicity values would need to be performed by
hand.

	C.  Additional Inputs for LD50 ft-2 analysis

Chlorflurenol ME is not intended for use as a seed treatment.

	D. Additional Inputs for Seed Treatment Analysis

Chlorflurenol ME is not intended for use as a seed treatment.

  SEQ CHAPTER \h \r 1 III.  Risk Estimation Based on Dietary Residue
Concentrations (Foliar Spray)

The methods used by T-REX to estimate risk from consumption of selected
contaminated food items is described below.  For this analysis, T-REX
calculates EECs and risk quotients based on both the upper bound and
mean residue concentrations as presented by Hoerger and Kenaga (1972)
and modified by Fletcher et al. (1994).  These concentrations are
determined using nomograms that relate application rate of a pesticide
to residues remaining on dietary items of terrestrial organisms.  The
results of the upper bound and mean residue levels are presented in
separate tabs (“upper bound Kenaga” and “mean Kenaga”); however,
the methods used to calculate EECs and risk quotients are equivalent.
Only RQs from the upper bound Kenaga worksheet are to be used for
comparison to levels of concern in the assessment.  The mean residues,
and the RQs generated from them, presented in the mean Kenaga worksheet
are to be used only for risk description.  Replacing the upper bound
residues with the mean residues is not a valid mitigation approach when
upper bound residues result in LOC exceedances.  Based on the estimated
dietary residue concentrations from the upper bound and mean Kenaga
values, T-REX calculates the associated doses for various size classes
of birds and mammals.  Both the dietary concentration (mg/kg-dietary
item) and the resulting estimated doses (mg/kg-bw) may be used for risk
estimation.  The resulting dietary based and concentration based risk
quotients are discussed below.

This section describes how T-REX estimates the following:  (1) residue
concentrations on selected food items (mg/kg-dietary item); (2)
dose-based EECs (mg/kg-bw) from dietary concentrations on selected food
items; (3) adjusted toxicity values; and (4) risk quotients.

	A.  Calculation of Dietary Concentrations on Selected Food Items

The spreadsheet calculates the pesticide residue concentrations on each
selected food item on a daily interval for one year.  When multiple
applications are modeled, residue concentrations resulting from the
final application and remaining residue from previous applications are
summed.  The maximum concentration calculated out of the 365 days is
returned as the EEC used to estimate potential risk to birds and mammals
as described below.  Dissipation of a chemical applied to foliar
surfaces for single or multiple applications is calculated assuming a
first order decay rate from the following first order rate equation:

			CT = Cie-kT

	or in log form:

			ln (CT/Ci) = kT

	Where

	CT =	concentration at time T = day zero.

Ci =	concentration, in parts per million (PPM), present initially (on
day zero) on the surfaces. Ci is calculated by multiplying the
application rate, in pounds active ingredient per acre, by 240 for short
grass, 110 for tall grass, and 135 for broad-leafed plants/small insects
and 15 for fruits/pods/large insects based on the Kenaga nomogram
(Hoerger and Kenaga, 1972) as modified by Fletcher (1994).  For maximum
concentrations, additional applications are converted from pounds active
ingredient per acre to PPM on the plant surface and the additional mass
added to the mass of the chemical still present on the surfaces on the
day of application.

k = 	If the foliar dissipation data submitted to EFED are found
scientifically valid and statistically robust for a specific pesticide,
the 90% upper confidence limit of the mean half-lives should be used.
When scientifically valid, statistically robust data are not available,
EFED recommends using a default half-life value of 35 days.  The use of
the 35-day half-life is based on the highest reported value (36.9 days),
as reported by Willis and McDowell (Pesticide persistence on foliage,
Environ. Contam. Toxicol, 100:23-73, 1987).

T =	time, in days, since the start of the simulation.  The initial
application is on day 0.  The

		simulation is designed to run for 365 days.

The dietary concentrations estimated using the above methodology may be
used directly to calculate risk quotients, but may also be used to
calculate dose-based EECs (mg/kg-bw) for various size classes of mammals
and birds as below.

	B. 	Calculating EEC Equivalent Doses based on Estimated Dietary
Concentrations on Selected Bird and Mammal Food Items

EECs (mg/kg-bw) for various size classes of mammals and birds may be
calculated based on the dietary residue concentrations derived using the
equations presented above.  To allow for this type of analysis, the EECs
and toxicity values are adjusted based on food intake and body weight
differences so that they are comparable for a given weight class of
animal.  The size classes assessed are small (20-gram), medium
(100-gram), and large (1000-gram) birds, and small (15-gram), medium
(35-gram), and large (1000-gram) mammals.  Equations used to calculate
food intake (grams/day) and to adjust toxicity values for dose-based
risk quotients are presented below.

		Calculating Food Intake for Different Size Classes of Birds and
Mammals:

Daily food intake (g/day) is assumed to correlate with body weight using
the following empirically derived equation (U.S. EPA, 1993):

			Avian consumption

 			where:

				F = food intake in grams of fresh weight per day (g/day)

				BW = body mass of animal (g)

				W =	mass fraction of water in the food (EFED value = 0.8 for birds
and herbivorous mammals, 0.1 for granivorous mammals)

Based on this equation, a 20-gram bird would consume 22.8 grams of food
daily (114% of its body weight), a 100-gram bird would consume 65 grams
of food daily (65% of its body weight daily), and 1000-gram bird would
consume 290 grams of food daily (29% of its body weight).  These data,
together with the residue concentrations (mg/kg-food item) on selected
food items calculated from the Kenaga nomogram, are used to estimate the
dose (mg/kg-bw) of residue consumed by the three size classes of birds
as discussed below.  Using a small (20-gram) bird as an example, a
dietary concentration of 100 mg/kg-diet (ppm) x 1.14 kg diet/kg bw
(114%) would result in an equivalent dose-based EEC of 114 mg/kg-bw.
T-REX calculates food intake based on dry weight and wet weight of food
items.  The dose-based assessment uses the wet weight food consumption
values by assuming that dietary items are 80% water by weight.  However,
if dietary items of a species being assessed are known, then a refined
dose-based EEC can be calculated using appropriate water fractions of
the food items.

A similar relationship between body weight and food intake has been
derived for mammals (U.S. EPA 1993):

			Mammalian food consumption (g/day)

			where:

				F = food intake in grams of fresh weight per day (g/day)

				BW = body mass of animal (g)

				W = 	mass fraction of water in the food (EFED value = 0.8 for birds
and herbivorous mammals, 0.1 for granivorous mammals)

The scaling factors result in a percent body weight consumed presented
in the following table for each weight class of mammal.  These values
are used in the same manner described for birds to calculate dose-based
EECs (mg/kg-bw).  Note the difference in food intake of grainivores
compared with herbivores and insectivores.  This is caused by the
difference in the assumed mass fraction of water in their diets.

  SEQ CHAPTER \h \r 1 Table C1.  Scaling factors and percent body weight
consumed for 3 weight classes of mammals.

Organism and Body Weight	Food Intake (g day -1) a	Percent Body Weight
Consumed (day -1) a

15 g	14.3 / 3.2	95 / 21

35 g	23 / 5.1	66 / 15

1000 g	150 / 34	15 / 3

a The first number in this column is specific to
herbivores/insectivores.  The second number is for granivores.  These
groups have markedly different consumption requirements.

  SEQ CHAPTER \h \r 1 T-REX calculates food intake based on dry weight
and wet weight of food items (wet weight is used for RQ calculations).
The dose-based assessment uses the wet weight food consumption values by
assuming that dietary items are 80% water by weight (10% for
granivores).  However, if dietary items of a species being assessed are
known, then a refined dose-based EEC can be calculated using appropriate
water fractions of the food items.

	C.  Calculating Adjusted Toxicity Values

The dose-based EECs (mg/kg-bw) derived above are compared with LD50 or
NOAEL (mg/kg-bw) values from acceptable or supplemental toxicity studies
that are adjusted for the size of the animal tested compared with the
size of the animal being assessed (e.g., 20-gram bird).  These exposure
values are presented as mass of pesticide consumed per kg body weight of
the animal being assessed (mg/kg-bw).  EECs and toxicity values are
relative to the animal's body weight (mg residue/kg bw) because
consumption of the same mass of pesticide residue results in a higher
body burden in smaller animals compared with larger animals.  For birds,
only acute values (LD50s) are adjusted because dose-based risk quotients
are not calculated for the chronic risk estimation.  Adjusted mammalian
LD50s and reproduction NOAELs (mg/kg-bw) are used to calculate
dose-based acute and chronic risk quotients for 15-, 35-, and 1000-gram
mammals.  The following equations are used for the adjustment (U.S. EPA
1993):

		Adjusted avian LD50:

		where:

			Adj. LD50 = adjusted LD50 (mg/kg-bw) calculated by the equation

			LD50 = endpoint reported from bird study (mg/kg-bw)

			TW = body weight of tested animal (178g bobwhite; 1580g mallard; 350g
rat)

			AW = body weight of assessed animal (avian: 20g, 100g, and 1000g)

			x = Mineau scaling factor for birds; EFED default 1.15

Adjusted mammalian NOAELs and LD50s (note that the same equation is used
to adjust the NOAEL):

		where:

			Adj. NOAEL or LD50 = adjusted NOAEL or LD50 (mg/kg-bw)

			NOAEL or LD50 = endpoint reported from bird study (mg/kg-bw)

			TW = body weight of tested animal (350g rat)

			AW = body weight of assessed animal (15g, 35g, 1000g)

	D.  Calculating Risk Quotients

Two types of risk quotients are calculated by T-REX based on the
estimated dietary residue concentrations determined from the Kenaga
nomogram:  (1) dietary based RQs; and (2) dose based RQs.  These RQs are
not equivalent.  Dietary risk quotients are calculated by directly
comparing the concentration of a pesticide administered (or estimated to
be administered) to experimental animals in the diet in a toxicity study
to the concentration estimated to be on selected food items.  These risk
quotients do not account for the fact that smaller-sized animals need to
consume more food relative to their body weight than larger animals or
that differential amounts of food are consumed depending on the water
content and nutritive value of the food.  The dose-based risk quotients
do account for these factors.  The dose-based RQs incorporate the
ingestion rate-adjusted exposure from the various food items to the
different weight classes of birds and the weight class-scaled toxicity
endpoints.  Formulas presented in Table C2 are used to calculate
dose-based and dietary based risk quotients:

  SEQ CHAPTER \h \r 1 Table C2. Formulas used to calculate dose- and
dietary-based risk quotients.

Duration	Dose or Dietary RQ	Surrogate Organism	Equation

Acute	Dose-based	Birds and mammals	Acute Daily Exposure (mg/kg-bw) /
adjusted LD50 (mg/kg-bw)

	Dietary-based	Birds	Kenaga EEC (mg/kg-food item)  / LC50 (mg/kg-diet)

Chronic	Dietary-based	Birds and mammals	EEC (mg/kg-food item) / NOAEC
(mg/kg-diet)

	Dose-based	Mammals	EEC (mg/kg-bw) / Adjusted NOAEL (mg/kg-bw)

  SEQ CHAPTER \h \r 1 These risk quotients are compared to the Agency's
LOCs to determine if risk is greater than EFED's concern level.

IV. Actual Input Parameters

	A. Pesticide Application Data

The actual input parameters used to determine terrestrial EECs on food
items for chlorflurenol  ME are listed below in Table C4. Only one
scenario was modeled using T-REX; a foliar spray application for turf
use.  The label indicates that chlorflurenol ME can be applied at a
maximum application rate of 3.0 lb a.i./A for turf use.  Chlorflurenol
ME is likely applied via foliar spray application 8 times per year and
at a 28-day interval (as derived by HED).

Uncertainties in the terrestrial EECs are associated with a lack of data
on dissipation from foliar surfaces.  When data are absent, as in this
case, EFED assumes a 35-day foliar dissipation half-life, based on the
work of Willis and McDowell (1987).  In this respect, the EECs for
chlorflurenol ME may be an overestimation of actual concentrations if
the half-life under field conditions is lower than the default value.
Because foliar dissipation data are not available, the extent to which
EECs may be overestimated or underestimated is uncertain.

On the other hand, terrestrial EECs could be an underestimation of
actual exposure concentrations in the environment. EFED used a
“likely” application interval and yearly application rate, since no
information was provided on the label.  Risks could be underestimated if
the actual application rates, frequency of application, or number of
applications are higher than the input parameters used for the exposure
scenario that was modeled.

  SEQ CHAPTER \h \r 1 Table C4.  Input parameters used in T-REX v1.2.3
to determine terrestrial EECs for the maximum chlorflurenol ME spray
application scenario. a

Input Variable	Parameter Value	Source

Maximum application rate	3.0 lb a.i./A	Product Label

Maximum # of applications per year	8	HED

Minimum Application Interval	28 days	HED

Foliar half-life	35 days	T-REX Default Value

a Representative exposure scenario for turf use.

  SEQ CHAPTER \h \r 1 	B. Avian and Mammalian Endpoints

Discussion of the available endpoints and those used for determination
of risk quotients for chlorflurenol ME are discussed extensively in
Appendix D.

V.  Actual Terrestrial Estimated Environmental Concentrations (EECs)

A summary of the predicted residues of chlorflurenol ME that may be
expected to occur on selected avian or mammalian food items immediately
following application for the maximum foliar spray application scenario
are presented in Table C5.

  SEQ CHAPTER \h \r 1 Table C5.  Upper-bound and mean terrestrial EECs
estimated for the maximum chlorflurenol ME spray application scenario
using Kenaga values. a

Forage Type

		Upper-bound Residues

(ppm)	Mean Residues (ppm)

short grass	1671.50	591.99

tall grass	766.10	250.72

broadleaf plants and small insects	940.22	313.41

fruits/pods/large insects	104.22	48.75

a  EEC equivalent dose = Upper-bound Kenaga value * (%BW consumed/100).
%BW consumed = 114%, 65%, and 29% for small, medium, and large birds,
respectively.

  SEQ CHAPTER \h \r 1 VI. References

Dunning, J.B.  1984.  Body weights of 686 species of North American
birds.  Western Bird Banding Assoc. Monograph No. 1.

Fletcher, J.S., J.E. Nellesson and T. G. Pfleeger. 1994.  Literature
review and evaluation of the EPA food-chain (Kenaga) nomogram, an
instrument for estimating pesticide residues on plants.  Environ. Tox.
And Chem. 13(9):1383-1391.

Hoerger, F. and E.E. Kenaga. 1972.  Pesticide residues on plants:
correlation of representative data as a basis for estimation of their
magnitude in the environment.  IN: F. Coulston and F. Corte, eds.,
Environmental Quality and Safety: Chemistry, Toxicology and Technology.
Vol 1.  George Theime Publishers, Stuttgart, Germany.  pp. 9-28.

Mineau, P., B.T. Collins, A. Baril.  1996.  On the use of scaling
factors to improve interspecies extrapolation to acute toxicity in
birds.  Reg. Toxicol. Pharmacol.  24:24-29.

Urban, D. J.  2000.  Guidance for Conducting Screening Level Avian Risk
Assessments for Spray Applications of Pesticides.  OPP/EFED, USEPA.
July 7, 2000.

U.S. EPA.  1992.  Comparative analysis of acute avian risk from granular
pesticides.  Office of Pesticide Programs.  U.S. EPA.  March 1992.

USEPA. 1993.  Wildlife Exposure Factors Handbook. Volume I of II.
EPA/600/R-93/187a. Office of Research and Development, Washington, D. C.
20460.

USEPA. 1995. Great Lakes Water Quality Technical Support Document for
Wildlife Criteria. Office of Water, Washington D.C.  Document Number
EPA-820-B095-009.

Willis and McDowell. 1987. Pesticide persistence on foliage. Environ.
Contam. Toxicol.  100:23-73.

  SEQ CHAPTER \h \r 1 APPENDIX  D.  Ecological Effects Data

  SEQ CHAPTER \h \r 1 I.  Overview

The toxicity testing required does not test all species of birds, fish,
mammals, invertebrates, and plants.  Typically, only two surrogate
species for birds (bobwhite quail (Colinus virginianus) and mallard
ducks (Anas platyrhynchos)) are used to represent all bird species (over
900 in the U.S.), three species of freshwater fish (rainbow trout (Salmo
gairdneri), bluegill sunfish (Lepomis macrochirus), and fathead minnow
(Pimephales promelas)) are used to represent all freshwater fish species
(over 900 in the U.S.), and one estuarine/marine fish species
(sheepshead minnow (Cyprinodon variegatus)) is used to represent all
estuarine/marine fish (over 300 in the U.S.).  The surrogate species for
terrestrial invertebrates is the honey bee (Apis mellifera), for
freshwater invertebrates the surrogate species is usually the waterflea
(Daphnia magna), and for estuarine/marine invertebrates the surrogate
species are mysid shrimp (Mysidopsis bahia) and eastern oyster
(Crassostrea virginica).  These four species are used to represent all
invertebrate species (over 10,000 in the U.S.).  For plants, there are
typically ten surrogate species used for all terrestrial plants and five
surrogate species used for all aquatic plants.  There are over 20,000
plant species in the U.S. which includes flowering plants, conifers,
ferns, mosses, liverworts, hornworts and lichens with over 27,000
species of algae worldwide.

The surrogate species testing scheme used in this assessment assumes
that a chemicals mechanism of action and toxicity found for avian
species is similar to that in all reptiles (over 300 species in the
U.S.).  The same assumption applies to amphibians (over 200 species in
the U.S.) and fish; the tadpole stage of amphibians is assumed to have
the same sensitivity as a fish.  Therefore, the results from toxicity
tests on surrogate species are considered applicable to other member
species within their class and are extrapolated to reptiles and
amphibians.  The U.S. species numbers noted in this section were taken
from:     HYPERLINK "http://www.natureserve.org/summary"
http://www.natureserve.org/summary  (NatureServe: An online encyclopedia
of life [web application] 2000) and the worldwide species number from
Ecological Planning and Toxicology, Inc. 1996.

II. Toxicity to Terrestrial Animals

In general, categories of acute toxicity for avian species can be
classified according to the toxicity reference value (LC50) given by a
study (EPA, 2001):

  SEQ CHAPTER \h \r 1 LC50 (ppm)	Toxicity Category

<50	Very highly toxic

50–500	Highly toxic

501–1000	Moderately toxic

1001–5000	Slightly toxic

>5000	Practically nontoxic

  SEQ CHAPTER \h \r 1 Similarly, categories of acute toxicity for avian
and mammalian species can be classified according to the toxicity
reference value (LD50) given by a study (EPA, 2001):

  SEQ CHAPTER \h \r 1 LD50 (mg a.i./kg)	Toxicity Category

<10	Very highly toxic

10–50	Highly toxic

51–500	Moderately toxic

501–2000	Slightly toxic

>2000	Practically nontoxic

  SEQ CHAPTER \h \r 1 	a.  Birds, Acute and Subacute

An acute oral toxicity study using the technical grade of the active
ingredient (TGAI) is required to establish the toxicity of chlorflurenol
ME to birds.  The preferred test species is either mallard duck (Anas
platyrhynchos; a waterfowl) or bobwhite quail (Colinus virginianus; an
upland gamebird).    SEQ CHAPTER \h \r 1 Results of an acute oral
exposure study in bobwhite quail (MRID 43595401; Acceptable) are
detailed below in Table D-1.  Birds were dosed with 10,000 mg a.i./kg
bodyweight by oral gavage in corn oil.  One bird died and upon necropsy
revealed the presence of a yellow creamy substance resembling the sample
in the crop.  Other necropsy results are listed in the table below.
Results show that the LD50 for chlorflurenol ME is >10,000 mg a.i./kg
body weight; therefore, chlorflurenol ME is categorized as practically
nontoxic to avian species on an acute oral basis.  EFED will use the
acute oral LD50 of >10,000 mg a.i./kg body weight to evaluate acute
dose-based risk to avian species.  The guideline requirement [§71-1] is
fulfilled.

  SEQ CHAPTER \h \r 1 Table D1.  Acute oral toxicity of chlorflurenol ME
to birds.

Species	Test Substance (purity)	Effects

	Toxicity Category	Identification Number  (Author, Year)	Study
Classification

Bobwhite Quail (Colinus virginianus)	TGAI (96% a.i.)	LD50 >10,000 mg
a.i./kg body weight

1 mortality

Necropsies revealed pale livers, enlarged spleen, partial loss of
plumage, dry scaly skin texture.	Practically Nontoxic	43595401

(Estop and Teske 1969)	Acceptable

  SEQ CHAPTER \h \r 1 Two subacute dietary studies using the TGAI are
required to establish the toxicity of chlorflurenol ME to birds.  The
preferred test species are mallard duck (Anas platyrhynchos) (Guideline
§71-2(b), Acute Avian Diet, Duck) and northern bobwhite quail (Colinus
virginianus) (Guideline §71-2(a), Acute Avian Diet, Quail).    SEQ
CHAPTER \h \r 1 Results of subacute dietary studies are tabulated below
in Table D-2.  In both studies (mallard ducks MRID 43623602; Acceptable
and bobwhite quail MRID 43623601; Acceptable) chlorflurenol ME was
administered in the diet in at concentrations of 312, 625, 1250, 2500,
and 5000 ppm a.i.  In both species, the acute dietary LC50 value was
>5,000 mg a.i./kg diet, indicating that chlorflurenol ME is practically
nontoxic on an acute dietary basis.  In both studies, no mortality was
observed in any of the test groups and no clinical signs of toxicity
were noted.  Also, no gross pathology was noted in any of the birds that
were subjected to gross pathological exam.  EFED will use the LC50 value
of >5,000 mg a.i./kg diet to assess the risk of acute dietary exposure
of birds to chlorflurenol ME.  The guideline [§72-1] is fulfilled.

  SEQ CHAPTER \h \r 1 Table D2.  Acute dietary toxicity of chlorflurenol
ME to birds.

Species	Test Substance

(purity)

Effects	Toxicity Category	Identification Number  (Author, Year)	Study
Classification

Mallard Duck (Anas platyrhynchos)	TGAI (98.77% a.i.)	LC50 > 5,000 mg
a.i./kg diet

No mortality was observed.

No gross pathology was noted in any birds.	Practically Nontoxic	43623602
(Pedersen and Solatycki 1995)	Acceptable

Bobwhite Quail (Colinus virginianus)	TGAI (98.77% a.i.)	LC50 > 5,000 mg
a.i./kg diet

No mortality was observed.

No gross pathology was noted in any birds.	Practically Nontoxic	43623601
(Pedersen and Solatycki 1995)	Acceptable

  SEQ CHAPTER \h \r 1 	b.  Birds, Chronic

Avian reproduction studies using the TGAI are required for chlorflurenol
ME because birds may be subject to continuous exposure to the pesticide,
especially preceding or during the breeding season. The preferred test
species are bobwhite quail (Colinus virginianus; an upland gamebird) and
mallard duck (Anas platyrhynchos; a waterfowl).  No studies were
submitted to the USEPA; therefore this guideline requirement has not
been filled.

  SEQ CHAPTER \h \r 1 	c.  Mammals, Acute and Chronic

Wild mammal testing is required on a case-by-case basis, depending on
the results of lower tier laboratory mammalian studies, intended use
pattern and pertinent environmental fate characteristics.  In most
cases, rat or mouse toxicity values obtained from the Agency's Health
Effects Division (HED) substitute for wild mammal testing.  These
toxicity values are reported below in Table D3.

In an acute study (MRID 43355402) chlorflurenol ME was administered in
corn oil to laboratory rats by gavage at a dose of 5,000 mg/kg of
bodyweight.  All the rats survived and gained weight.  Eight of the ten
rats exhibited hunched posture, lethargy, piloerection, soft feces,
diarrhea, and/or ano-genital staining.  Gross necropsy findings at
terminal sacrifice were generally unremarkable.  The LD50 for
chlorflurenol ME is >5,000 mg a.i./kg body weight; therefore,
chlorflurenol ME is categorized as practically nontoxic to mammalian
species on an acute oral basis.  EFED will use the acute oral LD50 of
>5,000 mg a.i./kg body weight to evaluate acute dose-based risk to
mammalian species.

  SEQ CHAPTER \h \r 1 In a chronic toxicity study (MRID 00082863)
chlorflurenol ME technical was administered to 4 Beagle dogs/sex/group
in the diet at dose levels of 0, 300, 1000 or 3000 ppm ( for
male/female, equivalent to 0/0, 8.7/8.8, 30.6/29.9 or 94.0/94.4 mg/kg
bw/day, calculated from test material consumption) for 104 weeks.

  SEQ CHAPTER \h \r 1 Body weight appeared to be slightly reduced by
month 13 at the highest dose tested [HDT].  Dogs showed this body weight
decrement at month 13 when compared with initial body weights for males
[the HDT gained 0% vs. 22.3% for control weight] and for females [the
HDT gained 6.6% vs. 20.3% for control body weight].  Male body weight
gain appeared to be reduced for the remainder of the study.  Male body
weight gain was decreased at 104 weeks [body weight gain was 0.8 kg at
the HDT and 2.5 kg for controls].  At the end of the study female body
weight gain was the same as control weight gain.  Food consumption was
unaffected in both sexes.

ERY, Hb and Ht from the 1000 ppm group of animals did not show
consistent effects.  From week 26-52 to termination, the values for
ERY, Hb and Ht for treated female dogs did not appear to differ
from control.

  SEQ CHAPTER \h \r 1 The NOAEL was 30.6/29.9 mg/kg/day for
males/females.  The LOAEL was 94.0/94.4 mg/kg/day for male/females based
on decreased erythrocytes, hemoglobin and hematocrit by week 4 in males
and females, supported by hemosiderin deposits in liver and increased
incidence of gastritis and possible decreased body weight in males and
females by month 13 of the study, but not in females by study
termination at 24 months.

  SEQ CHAPTER \h \r 1 In a developmental toxicity study (MRID 45190901)
with chlorfurenol-methyl ester was administered to 31 pregnant female,
Crl:CD(SD):BR strain of Sprague Dawley rats/group by gavage at dose
levels of 0, 250, 750 or 1000 mg a.i./kg bw/day from days 6 through 15
of gestation.  Doses were administered in 1% carboxymethyl
cellulose/water in a volume of 5 mL/kg/day.  Maternal toxicity was
evaluated and fetal evaluations were conducted on one-half of the
fetuses viscerally or skeletally.

Maternal toxicity was seen as a statistically significant decrement in
body weight gain during gestational days 6 to 16 at 750 and 1000
mg/kg/day, and at 1000 mg/kg/day during gestational days 6-9. Supporting
this body weight decrement was nominally decreased food efficiency at
750 and 1000 mg/kg bw/day.  The maternal NOAEL was 250 mg/kg bw/day.
The maternal LOAEL is 750 mg/kg bw/day based on body weight gain
decrement and nominally decreased food efficiency.

Delayed ossification was seen in skull bones of fetuses.  The incidence
of incompletely ossified nasal bones and frontal bone was increased at
750 and 1000 mg/kg bw/day (60.9-63.0% vs. 28.6% in control and
55.6%-60.9% vs. 33.3% in control, respectively).  Intrauterine death was
borderline statistically significant [p = 0.0529] at 1000 mg/kg bw/day
[1.7 vs. 0.3 in control].  The post-implantation loss and early
resorptions, which were nominally increased at 1000 mg/kg/day, supported
the intrauterine death at 1000 mg/kg bw/day.  The developmental NOAEL is
250 mg/kg bw/day. The developmental LOAEL is 750 mg/kg bw/day, based on
treatment-related delayed ossification in skull bones [nasal and
frontal] in fetuses and litters.

  SEQ CHAPTER \h \r 1 Table D3.  Toxicity of chlorflurenol ME to
mammals.

Species/Test Type	Test Substance

(purity)	Toxicity Value and Affected Endpoints 	Identification Number

(Author, Year)	Study Classification

Laboratory Rat

Acute	TGAI (98.77%)	LD50 > 5000 mg/kg

Reversible hunched posture, lethargy and diarrhea was seen in 8/10 rats.
43355402

(Wnorowski, 1994)	Acceptable

Domestic Dog

Chronic	TGAI (96%)

NOAEL = 30.6/29.9 mg/kg/day for males/females. LOAEL = 94.0/94.4
mg/kg/day for male/females based on decreased erythrocytes, hemoglobin
and hematocrit by week 4 in males and females, supported by hemosiderin
deposits in liver and incidence of gastritis and possible decreased body
weight in males and females by month 13 of the study, but not in females
by study termination at 24 months.  Transient alkaline phos. and
elevated SGPT was seen at the HDT. 	  SEQ CHAPTER \h \r 1 00082863

(  SEQ CHAPTER \h \r 1 Frohberg, H.; Metallinos, A.; Pies, H.; et al.
1975)	Acceptable

Laboratory Rat

Developmental	TGAI (99.1%)	Maternal: NOAEL = 250 mg/kg/day

                  LOAEL = 750 mg/kg/day based on statistically
significant and treatment related reduced body weight gain during the
treatment period, GD 6-16.

Devel: NOAEL = 250 mg/kg/day

            LOAEL = 750 mg/kg/day based on treatment-related increase in
incompletely ossified anterior skull bones [nasal and frontal bones
about doubled that of controls].   In addition a cleft palate was seen
in each of two litters and one diaphragmatic hernia at 1000 mg/kg/day
and one cleft palate at 750 mg/kg/day [cleft palate is rare in rats,
historical incidence not given].   	  SEQ CHAPTER \h \r 1 45190901

(  SEQ CHAPTER \h \r 1 Muller, W. 2000)	Acceptable

  SEQ CHAPTER \h \r 1 	d.  Terrestrial Insects and Mites: Acute Contact
and Foliar Residue Studies

ms of active ingredient per bee (μg a.i./bee).  The following toxicity
category descriptions were developed by Atkins (1981) and have been used
by EFED to characterize honey bee acute contact toxicity values (EPA,
2004):

  SEQ CHAPTER \h \r 1 LD50 ( μg a.i./bee)	Toxicity Category

<2	Highly toxic

2–<11	Moderately toxic

>11	Practically nontoxic

  SEQ CHAPTER \h \r 1 No acute toxicity data are available to
quantitatively assess risk of chlorflurenol ME exposure to terrestrial
invertebrates.

  SEQ CHAPTER \h \r 1 Terrestrial Insects: Chronic Studies

  SEQ CHAPTER \h \r 1 No chronic toxicity data are available to
quantitatively assess risk of chlorflurenol ME exposure to terrestrial
invertebrates.

  SEQ CHAPTER \h \r 1 III. Toxicity to Freshwater Aquatic Animals

	a.  Freshwater Fish, Acute

Two freshwater fish toxicity studies using the TGAI are required to
establish the acute toxicity of chlorflurenol ME to fish.  The preferred
test species are bluegill sunfish (a warmwater fish) and rainbow trout
(a coldwater fish).  In general, categories of acute toxicity for
aquatic organisms can be classified according to the toxicity reference
value (LC50) given by a study (EPA 2001):

  SEQ CHAPTER \h \r 1 LC50 (ppm)	Toxicity Category

<0.1 	Very highly toxic

0.1–1	Highly toxic

>1–10	Moderately toxic

>10–100	Slightly toxic

>100	Practically nontoxic

Currently, there are no adequate acute freshwater fish data available
for chlorflurenol ME.  Therefore, the guideline (§72-1) is not
fulfilled.

  SEQ CHAPTER \h \r 1 	b.  Freshwater Fish, Chronic

A freshwater fish early life-stage test using the TGAI is required for
chlorflurenol ME because the end-use product may be transported to the
aquatic environment from the intended site use via drift or runoff
events.  Currently, there are no adequate chronic freshwater fish data
available for chlorflurenol ME.  Therefore, the guideline (§72-4a) is
not fulfilled.

  SEQ CHAPTER \h \r 1 c.  Freshwater Invertebrates, Acute

A freshwater aquatic invertebrate toxicity test using the TGAI is
required to establish the toxicity of chlorflurenol ME to aquatic
invertebrates.  The preferred test species is Daphnia magna.  Currently,
there are no adequate acute freshwater invertebrate data available for
chlorflurenol ME.  Therefore, the guideline (§72-2) is not fulfilled.

  SEQ CHAPTER \h \r 1 d.  Freshwater Invertebrate, Chronic

  SEQ CHAPTER \h \r 1 A freshwater aquatic invertebrate life-cycle test
using the TGAI is required for chlorflurenol ME because the end-use
product may be transported to this environment from the intended site
use via drift or runoff events.  Currently, there are no adequate
chronic freshwater invertebrate data available for chlorflurenol ME.
Therefore, the guideline (§72-4b) is not fulfilled.

  SEQ CHAPTER \h \r 1 IV.  Toxicity to Estuarine and Marine Animals

	a.  Estuarine and Marine Fish, Acute

Acute toxicity testing with estuarine/marine fish using the TGAI is
required for chlorflurenol ME because the end-use product may reach the
estuarine/marine environment based on its use in coastal states.  The
preferred test species is sheepshead minnow (Cyprinodon variegatus).
Currently, there are no adequate acute estuarine/marine fish data
available for chlorflurenol ME.  Therefore, the guideline (§72-3d) is
not fulfilled.

  SEQ CHAPTER \h \r 1 	b.  Estuarine and Marine Fish, Chronic

An estuarine/marine fish early life-stage toxicity test using the TGAI
is required for chlorflurenol ME because the end-use product may be
transported to this environment from the intended site use via drift or
runoff events.  The preferred test species is sheepshead minnow
(Cyprinodon variegatus).  Currently, there are no adequate chronic
estuarine/marine fish data available for chlorflurenol ME.  Therefore,
the guideline (§72-4a) is not fulfilled.

  SEQ CHAPTER \h \r 1 	c.  Estuarine and Marine Invertebrate, Acute

An estuarine/marine invertebrate acute toxicity test using the TGAI is
required for chlorflurenol ME because the end-use product may be
transported to this environment from the intended site use via drift or
runoff events.  Currently, there are no adequate acute estuarine/marine
invertebrate data available for chlorflurenol ME.  Therefore, the
guideline (§72-4a) is not fulfilled.

  SEQ CHAPTER \h \r 1 	d.  Estuarine and Marine Invertebrate, Chronic

An estuarine/marine invertebrate chronic test using the TGAI is required
for chlorflurenol ME because the end-use product may be transported to
the aquatic environment from the intended site use via drift or runoff
events.  Currently, there are no adequate chronic estuarine/marine
invertebrate data available for chlorflurenol ME.  Therefore, the
guideline (§72-4b) is not fulfilled.

  SEQ CHAPTER \h \r 1 VI.  Toxicity to Aquatic and Terrestrial Plants

	a.  Aquatic Plants

Aquatic plant testing is required for any pesticide that has outdoor
non-residential terrestrial uses and that may move off-site by runoff or
by drift from aerial applications or ground spray.  Testing on a
vascular plant, Duck weed (Lemna gibba), and the nonvascular
Pseudokirchneriella subcapitata, Anabaena flos-aquae, Navicula
pelliculosa and Skeletonema costatum are required for Tier II.

Currently, there are no adequate data available for chlorflurenol ME.
Therefore, the guideline (§123-2) is not fulfilled.

  SEQ CHAPTER \h \r 1 	b.  Terrestrial Plants

Tier II terrestrial plant tests (seedling germination/seedling emergence
and vegetative vigor) evaluating the effects of the maximum exposure
level of the typical end-use product are required for all herbicides
with outdoor uses and unknown phytotoxicity.  For seedling emergence and
vegetative vigor testing, the following plant species and groups should
be tested: (1) six species of at least four dicotyledonous families, one
species of which is soybean (Glycine max) and the second crop is a root
crop; and (2) four species of at least two monocotyledonous families,
one of which is corn (Zea mays).

Currently, there are no adequate data available for chlorflurenol ME.
Therefore, the guideline (§123-1) is not fulfilled.

  SEQ CHAPTER \h \r 1 APPENDIX E.   The Risk Quotient Method and Levels
of Concern

  SEQ CHAPTER \h \r 1 The risks to terrestrial and aquatic organisms are
determined based on a method by which risk quotients (RQs) are compared
with levels of concern (LOCs).  This method provides an indication of a
chemical’s potential to cause an effect in the field from effects
observed in laboratory studies, when the chemical is used as directed.
Risk quotients are expressed as the ratio of the
estimated攠癮物湯敭瑮污挠湯散瑮慲楴湯⠠䕅⥃琠桴
灳捥敩⵳灳捥晩捩琠硯捩瑩⁹敲敦敲据慶畬吨噒㨩
ഠ–䵅䕂⁄煅慵楴湯䌮䕏㉅†Ĕക

Units for EEC and TRV should be the same (e.g., μg/L or ppb).  The RQ
is compared to the LOC as part of a risk characterization.  Acute and
chronic LOCs for terrestrial and aquatic organisms are given in recent
Agency guidance (EPA, 2004) and summarized in Table E-1 below.

  SEQ CHAPTER \h \r 1 Table E1.  Level of concern (LOC) by risk
presumption category (EPA, 2004).

Risk Presumption	RQ	LOC

Mammals and Birds

Acute Riska	EECb/LC50 or LD50/sqftc or LD50/dayd	0.5

Acute Restricted Usee	EEC/LC50 or LD50/sqft or LD50/day (or LD50 <50
mg/kg)	0.2

Acute Endangered Speciesf	EEC/LC50 or LD50/sqft or LD50/day	0.1

Chronic Risk	EEC/NOAEC	1

Aquatic Animals

Acute Risk 	EECg/LC50 or EC50	0.5

Acute Restricted Use	EEC/LC50 or EC50	0.1

Acute Endangered Species	EEC/LC50 or EC50	0.05

Chronic Risk		EEC/NOAEC	1

Terrestrial and Semi-aquatic Plants

Acute Risk		EEC/EC25	1

Acute Endangered Species	EEC/EC05 or NOAEC	1

Aquatic Plants

Acute Risk	EECh/EC50	1

Acute Endangered Species	EECg/EC05 or NOAEC	1

potential for acute toxicity for receptor species if RQ > LOC (EPA,
2004).

bEstimated environmental concentration (ppm) on avian/mammalian food
items

cmg/ft2

dmg of toxicant consumed per day

ePotential for acute toxicity for receptor species, even considering
restricted use classification, if RQ > LOC (EPA, 2004).

fPotential for acute toxicity for endangered species of receptor species
if RQ > LOC (EPA, 2004).

gEEC = ppb or ppm in water

hEEC = lbs a.i./A

EECs used to assess acute and chronic risk to avian and mammalian
species to chlorflurenol ME were calculated using the model T-REX.
Currently the Agency does not perform assessments for chronic risk to
plants or acute/chronic risks to non-target terrestrial invertebrates.

The Agency has developed an Endangered Species Protection Program to
identify pesticides whose use may cause adverse impacts on endangered
and threatened species, and to implement mitigation measures that will
eliminate the adverse impacts.  At present, the program is being
implemented on an interim basis as described in a Federal Register
notice (54 FR 27984-28008, July 3, 1989), and is providing information
to pesticide users to help them protect these species on a voluntary
basis.  As currently planned, the final program will call for label
modifications referring to required limitations on pesticide uses,
typically as depicted in county-specific bulletins or by other
site-specific mechanisms as specified by state partners.  A final
program, which may be altered from the interim program, will be
described in a future Federal Register notice.  The Agency is not
imposing label modifications at this time.  Rather, any requirements for
product use modifications will occur in the future under the Endangered
Species Protection Program.

Limitations in the use of chlorflurenol ME may be required to protect
endangered and threatened species, but these limitations have not been
defined and may be formulation specific.  The Agency will notify the
registrants if any label modifications are necessary.  Such
modifications would most likely consist of the generic label statement
referring pesticide users to use limitations contained in county
Bulletins.

Literature Cited

U.S. EPA. 1989. U.S. Environmental Protection Agency. Endangered Species
Program. Washington, DC. Federal Register: 27984-28008, July 3.

U.S. EPA. 2004. U.S. Environmental Protection Agency. Overview of the
Ecological Risk Assessment Process in the Office of Pesticide Programs,
U.S. Environmental Protection Agency: Endangered and Threatened Species
Effects Determinations.  Office of Prevention, Pesticide, and Toxic
Substances.  January 23.

  SEQ CHAPTER \h \r 1 APPENDIX F:  Detailed Risk Quotients

  SEQ CHAPTER \h \r 1 This appendix presents detailed risk quotient (RQ)
calculations for birds and mammals. Exposure for terrestrial animals was
estimated using EECs generated by the model T-REX.  Toxicity values used
to derive RQs were evaluated and taken from both registrant-submitted
and open-literature studies.  Risk quotient values that exceed LOCs are
discussed in the Risk Characterization section of the main report.

  SEQ CHAPTER \h \r 1 Table F1.  Dose- and Dietary-based Chronic RQs for
Mammals Exposed to Chlorflurenol ME Based on Upper Bound Residues as
Calculated by T-REX.

  SEQ CHAPTER \h \r 1 Crop Use

(Application Rate)	Body

Weight (g)	Mammalian Risk Quotients

Short Grass	Tall Grass	Broadleaf Plants/Small Insects	Fruits/Pods/ Large
Insects	Seeds

Dose-based Chronic Mammalian RQs  a

Turf

(3.0 lb a.i./A)	15	2.90  c	1.33  c	1.63  c	0.18	0.04

	35	2.48  c	1.14  c	1.39  c	0.15	0.03

	1,000	1.33  c	0.61	0.75	0.08	0.02

Dietary-based Chronic Mammalian RQs  b

Turf (3.0 lb a.i./A)	0.33	0.15	0.19	0.02	NA

a  Chronic dose-based RQ = EEC/NOAEL, where EEC values are upper bound
residues expressed as equivalent dose (mg a.i./kg body weight) generated
from T-REX and the toxicity value is the chronic dose-based NOAEL = 250
mg a.i./kg/day in the rat.

b  Chronic dietary-based RQ = EEC/NOAEC, where EEC values are upper
bound residues expressed as dietary concentrations (mg a.i./kg diet)
generated from T-REX and the toxicity value is the chronic dietary-based
NOAEC = 5000 mg a.i./kg diet in rats (converted from the rat oral dose
study).

c RQs are above the LOC for chronic risk (LOC 1).

  SEQ CHAPTER \h \r 1 Table F2.  Dose- and Dietary-based Chronic RQs for
Mammals Exposed to Chlorflurenol ME Based on Mean Residues as Calculated
by T-REX.

  SEQ CHAPTER \h \r 1 Crop Use

(Application Rate)	Body

Weight (g)	Mammalian Risk Quotients

Short Grass	Tall Grass	Broadleaf Plants/Small Insects	Fruits/Pods/ Large
Insects	Seeds

Dose-based Chronic Mammalian RQs  a

Turf

(3.0 lb a.i./A)	15	1.02  c	0.43	0.54	0.08	0.02

	35	0.88	0.37	0.47	0.07	0.02

	1,000	0.46	0.20	0.24	0.04	0.01

Dietary-based Chronic Mammalian RQs  b

Turf (3.0 lb a.i./A)	0.123	0.05	0.06	0.01	NA

a  Chronic dose-based RQ = EEC/NOAEL, where EEC values are mean residues
expressed as equivalent dose (mg a.i./kg body weight) generated from
T-REX and the toxicity value is the chronic dose-based NOAEL = 250 mg
a.i./kg/day in the rat.

b  Chronic dietary-based RQ = EEC/NOAEC, where EEC values are mean
residues expressed as dietary concentrations (mg a.i./kg diet) generated
from T-REX and the toxicity value is the chronic dietary-based NOAEC =
5000 mg a.i./kg diet in rats (converted from the rat oral dose study).

c RQs are above the LOC for chronic risk (LOC 1).

  SEQ CHAPTER \h \r 1 APPENDIX  G.  Summary of Endangered/Threatened
Species

	Species Occurrence in Selected States and Selected Taxa

	No species were excluded

	All Medium Types Reported

	Mammal, Marine mml, Bird, Amphibian, Reptile, Fish, Crustacean,
Bivalve, Gastropod,

	Arachnid, Insect, Dicot, Monocot, Ferns, Conf/cycds, Lichen

	Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut,
Delaware, District of

	Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa,
Kansas, Kentucky, Louisiana,

	Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi,
Missouri, Montana,

	Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York,
North Carolina, North

	Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode
Island, South Carolina, South

	 Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West
Virginia, Wisconsin,

	Wyoming

	Alabama	( 87) species

	Alaska	( 5) species

	Arizona	( 59) species

	Arkansas	( 23) species

	California	( 295) species

	Colorado	( 26) species

	Connecticut	( 11) species

	Delaware	( 8) species

	District of Columbia	( 2) species

	Florida	( 105) species

	Georgia	( 61) species

	Hawaii	( 345) species

	Idaho	( 23) species

	Illinois	( 26) species

	Indiana	( 24) species

	Iowa	( 15) species

	Kansas	( 13) species

	Kentucky	( 49) species

	Louisiana	( 23) species

	Maine	( 10) species

	Maryland	( 17) species

	Massachusetts	( 15) species

	Michigan	( 21) species

	Minnesota	( 12) species

	Mississippi	( 32) species

	Missouri	( 30) species

	Montana	( 14) species

	Nebraska	( 11) species

	Nevada	( 38) species

	New Hampshire	( 6) species

	New Jersey	( 12) species

	New Mexico	( 47) species

	New York	( 16) species

	North Carolina	( 58) species

	North Dakota	( 6) species

	Ohio	( 23) species

	Oklahoma	( 19) species

	Oregon	( 47) species

	Pennsylvania	( 9) species

	Puerto Rico	( 70) species

	Rhode Island	( 7) species

	South Carolina	( 40) species

	South Dakota	( 9) species

	Tennessee	( 87) species

	Texas	( 88) species

	Utah	( 38) species

	Vermont	( 5) species

	Virginia	( 62) species

	Washington	( 36) species

	West Virginia	( 18) species

  Wisconsin	( 16) species

  Wyoming		    ( 10) species

	No species were selected for exclusion.

	Dispersed species included in report.

  SEQ CHAPTER \h \r 1 APPENDIX  H.  Data Requirement Tables

Table H1. Environmental Fate Data Requirements.

Date:

Case No: n/a

Chemical No:  098801	CHLORFLURENOL ME

DATA REQUIREMENTS FOR THE

ENVIRONMENTAL FATE AND EFFECTS DIVISION

Data Requirements	Composition1	Use Pattern2	Bibliographic Citation	Study
Classification	Additional Data Required Under FIFRA?

' 158.290 ENVIRONMENTAL FATE

Degradation Studies – Lab:

161-1 Hydrolysis	TGAI or PAIRA 	3, 10, 11	43496201	Supplemental (pH 7
was not used)	Yes (a study should be conducted at pH 7)

161-2 Photolysis in Water	TGAI or PAIRA	3, 10

	Yes

161-3 Photolysis in Soil	TGAI or PAIRA	10

	Yes

Metabolism Studies – Lab:

162-1 Aerobic Soil Metabolism	TGAI or PAIRA 	3, 10, 11	43595403
Unacceptable (an open study system was used)	Yes (a study should be
conducted under the controlled environment)

162-2 Anaerobic Soil Metabolism	TGAI or PAIRA	3

	Yes

162-3 Anaerobic Aquatic Metabolism	TGAI or PAIRA	10

	Yes

Mobility Studies:

163-1 Leaching and adsorption/desorption

TGAI or PAIRA

3, 10, 11

43496202

Supplemental (one German soil was used)	Yes (three additional soils
should be used)

Dissipation Studies - Field:

164-1 Terrestrial Field Dissipation	TEP	3, 11

	Yes

164-3  Forestry	TEP	10

	Waived

Accumulation Studies:

165-4 Fish Bioaccumulation	TGAI or PAIRA	3, 10

	Yes

165-5  Aquatic Non-Target Organisms	TEP	10

	No

Ground Water Monitoring Studies:

166-1 Small Scale Prospective Groundwater Study	TEP	3, 11

	Reserved

' 158.440 SPAY DRIFT

201-1 Droplet Size Spectrum

3, 11

	Yes

202-1 Drift Field Evaluation

3, 11

	yes

Composition:  TGAI = Technical grade of the active ingredient; PAI =
Pure active ingredient; PAIRA = Pure active ingredient, radiolabeled;
TEP = Typical end-use product.

Use Patterns:  1 = Terrestrial/Food; 2 = Terrestrial/Feed; 3 =
Terrestrial Non-Food; 4 = Aquatic Food; 5 = Aquatic Non-Food (Outdoor);
6 = Aquatic Non-Food (Industrial); 7 = Aquatic Non-Food (Residential); 8
= Greenhouse Food; 9 = Greenhouse Non-Food; 10 = Forestry; 11 =
Residential Outdoor; 12 = Indoor Food; 13 = Indoor Non-Food; 14 = Indoor
Medical; 15 = Indoor Residential.

  SEQ CHAPTER \h \r 1 Table H2. Ecological Effects Data Requirements for
Chlorflurenol ME.

Guideline #

	Data Requirement

	Test Substance

	MRID # or Citation

	Study Classification	  SEQ CHAPTER \h \r 1 Are additional data needed
for ecological risk assessment?

71-1	Avian Oral LD50	TGAI	43595401	Acceptable	No

71-2	Avian Dietary LC50	TGAI	43623601

43623602	Acceptable	No

71-4	Avian Reproduction	No Data Submitted – Data Gap	Yes

72-1	Freshwater Fish LC50	TGAI	120852/00047185

140979

45137401

45242602

45242601

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	Invalid	Yes

72-3(a)	Estuarine/Marine Fish LC50	No Data Submitted – Data Gap	Yes

72-3(b)	Estuarine/Marine Mollusk EC50	No Data Submitted – Data Gap	Yes

72-3(c)	Estuarine/Marine Shrimp EC50	No Data Submitted – Data Gap	Yes

72-4(a)	Freshwater Fish Early Life-Stage	No Data Submitted – Data Gap
Yes

72-4(b)	Aquatic Invertebrate Life-Cycle (freshwater)	No Data Submitted
– Data Gap	Yes

72-4(c)

	Aquatic Invertebrate Life-Cycle (marine)	No Data Submitted – Data Gap
Yes

72-5	Fish Full Life-Cycle 	No Data Submitted – Data Gap	Yes

123-1(a)	Seedling Emergence (Tier II)	No Data Submitted – Data Gap	Yes

123-1(b)	Vegetative Vigor

(Tier II)	No Data Submitted – Data Gap	Yes

123-2	Aquatic Plant Growth

 (Tier II)	No Data Submitted – Data Gap	Yes

141-1	Honey Bee Acute

 Contact LD50	No Data Submitted – Data Gap	Yes

141-2	Honey Bee Residue on Foliage	No Data Submitted – Data Gap	Waived

81-1	Acute Oral Toxicity to Rat	TGAI	43355402	Acceptable	Yes

83-1b	Dog Chronic Study 	TGAI	  SEQ CHAPTER \h \r 1 00082863	Acceptable
Yes

  SEQ CHAPTER \h \r 1 83-3a	  SEQ CHAPTER \h \r 1 Prenatal Developmental
Toxicity Study - Rat	TGAI	  SEQ CHAPTER \h \r 1 45190901	Acceptable	Yes

  SEQ CHAPTER \h \r 1 APPENDIX  I.  Incident Reports

There are no incidents reported for chlorflurenol ME.  SEQ CHAPTER \h \r
1


[Federal Register Volume 85, Number 84 (Thursday, April 30, 2020)]
[Notices]
[Pages 23953-23954]
[FR Doc No: 2020-09174]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP20-49-000]

Transcontinental Gas Pipe Line Company, LLC; Notice of
Availability of the Environmental Assessment for the Proposed Northeast
Supply Enhancement Project Amendment

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared an environmental assessment (EA) to assess the
environmental impacts associated with a proposed amendment to
Transcontinental Gas Pipe Line Company, LLC's (Transco) Northeast
Supply Enhancement Project which was authorized on May 3, 2019 in
Docket No. CP17-101-000. The Northeast Supply Enhancement Project
Amendment (Amendment) involves utilizing an alternative road for
permanent access to Compressor Station 206 in Somerset County, New
Jersey, rather than constructing the approved access road to the site.
    The EA assesses the potential environmental effects of the
construction and operation of the Amendment in accordance with the
requirements of the National Environmental Policy Act of 1969 (NEPA).
The FERC staff concludes that approval of the Amendment would not
constitute a major federal action significantly affecting the quality
of the human environment.
    The Commission mailed a copy of the Notice of Availability for the
EA to federal, state, and local government representatives and
agencies; elected officials; environmental and public interest groups;
Native American tribes; potentially affected landowners and other
interested individuals and groups; and newspapers and libraries in the
area of the Amendment. The EA is only available in electronic format.
It may be viewed and downloaded from FERC's website (www.ferc.gov), on
the Environmental Documents page (http://www.ferc.gov/industries/gas/enviro/eis.asp). In addition, the EA may be accessed by using the
eLibrary link on FERC's website. Click on the eLibrary link (https://www.ferc.gov/docs-filing/elibrary.asp), click on General Search, and
enter the docket number in the ``Docket Number'' field, excluding the
last three digits (i.e., CP20-49). Be sure you have selected an
appropriate date range. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>,
or for TTY, contact<PHONE_NUMBER>.
    Any person wishing to comment on the EA may do so. Your comments
should focus on the EA's discussion of potential environmental effects,
reasonable alternatives, and measures to avoid or lessen environmental
impacts. The more specific your comments, the more useful they will be.
To ensure that the Commission has the opportunity to consider your
comments prior to making its decision on the Amendment, it is important
that the Commission receive your comments on or before 5:00 p.m.
Eastern Time on May 26, 2020.
    For your convenience, there are three methods you can use to file
your comments with the Commission. In all instances, please reference
the Amendment's docket number (CP20-49-000) with your submission. The
Commission encourages electronic filing of comments and has expert
staff available to assist you at<PHONE_NUMBER> or
<EMAIL_ADDRESS>    (1) You can file your comments electronically using the eComment
feature located on the Commission's website (www.ferc.gov) under the
link to Documents and Filings. This is an easy method for submitting
brief, text-only comments on a project;
    (2) You can also file your comments electronically using the
eFiling feature on the Commission's website (www.ferc.gov) under the
link to Documents and Filings. With eFiling, you can provide comments
in a variety of formats by attaching them as a file with your
submission. New eFiling users must first create an account by clicking
on ``eRegister.'' You must select the type of filing you are making. If
you are filing a comment on a particular project, please select
``Comment on a Filing'' as the filing type; or
    (3) The Commission strongly encourages electronic filings of
comments, protests and interventions in lieu of paper using the
``eFiling'' link at http://www.ferc.gov. Persons unable to file
electronically may mail similar pleadings to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426. Hand
delivered submissions in docketed proceedings should be delivered to
Health and Human Services, 12225 Wilkins Avenue, Rockville, Maryland
20852.
    Any person seeking to become a party to the proceeding must file a
motion to

intervene pursuant to Rule 214 of the Commission's Rules of Practice
and Procedures (18 CFR 385.214). Motions to intervene are more fully
described at https://www.ferc.gov/resources/guides/how-to/intervene.asp. Only intervenors have the right to seek rehearing or
judicial review of the Commission's decision. The Commission may grant
affected landowners and others with environmental concerns intervenor
status upon showing good cause by stating that they have a clear and
direct interest in this proceeding which no other party can adequately
represent. Simply filing environmental comments will not give you
intervenor status, but you do not need intervenor status to have your
comments considered.
    Additional information about the Amendment is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC website (www.ferc.gov) using the eLibrary link. The eLibrary link
also provides access to the texts of formal documents issued by the
Commission, such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription that allows you to keep track of all formal issuances and
submittals in specific dockets. This can reduce the amount of time you
spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to http://www.ferc.gov/docs-filing/esubscription.asp.

    Dated: April 24, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-09174 Filed 4-29-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 52 (Tuesday, March 18, 2014)]
[Notices]
[Pages 15130-15131]
[FR Doc No: 2014-05900]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0223]

Humanitarian Device Exemption: Questions and Answers; Draft
Guidance for Humanitarian Device Exemption Holders, Institutional
Review Boards, Clinical Investigators, and Food and Drug Administration
Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Humanitarian Device
Exemption (HDE): Questions and Answers.'' This draft guidance answers
commonly asked questions about humanitarian use devices (HUDs) and HDE
applications. This guidance document reflects changes to the HDE
program as a result of the Food and Drug Administration Safety and
Innovation Act (FDASIA). This draft guidance is not final nor is it in
effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by June 16, 2014.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Humanitarian Device Exemption (HDE):
Questions and Answers'' to the Division of Small Manufacturers,
International and Consumer Assistance, Center for Devices and
Radiological Health (CDRH), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002 or the
Office of Communication, Outreach and Development (HFM-40), Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one
self-addressed adhesive label to assist that office in processing your
request, or fax your request to<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
    Submit electronic comments on the draft 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. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993-0002, 301-
796-6570; or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION

I. Background

    This draft guidance answers commonly asked questions about HUDs and
HDE applications authorized under section 520(m) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(m)). Section 613
of FDASIA (Pub. L. 112-144), signed into law on July 9, 2012, amended
section 520(m) of the FD&C Act. This draft guidance document reflects
the changes in the HDE program as a result of FDASIA. Upon issuance as
a final guidance document, this guidance will replace the existing HDE
guidance entitled ``Guidance for Humanitarian Device Exemption Holders,
Institutional Review Boards, Clinical Investigators, and Food and Drug
Administration Staff--Humanitarian Device Exemption Regulation:
Questions and Answers,'' issued on July 8, 2010, which was developed
and issued prior to the enactment of FDASIA.
    HUDs approved under an HDE cannot be sold for an amount that
exceeds the costs of research and development, fabrication, and
distribution of the device (i.e., for profit), except in certain
circumstances. FDASIA expands the types of HDE-approved HUDs that are
eligible to be sold for profit, subject to restrictions in section
520(m)(6) of the FD&C Act.
    FDASIA also amends the definition of the annual distribution number
(ADN). Under section 520(m)(6) of the FD&C Act, if FDA makes a
determination that a HUD meets certain conditions, the HUD is permitted
to be sold for profit after receiving HDE approval as long as the
number of devices distributed in any

calendar year does not exceed the ADN that FDA determines for the
device.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on commonly
asked questions about HUDs and HDE applications. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov or from CBER
at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm.
    To receive ``Humanitarian Device Exemption (HDE): Questions and
Answers,'' you may either send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document or send a fax request to
301-847-8149 to receive a hard copy. Please use the document number
1816 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in sections 520(m) and 515A (21 U.S.C. 360e-
1) of the FD&C Act and 613(b) of FDASIA have been approved under OMB
control number 0910-0661; the collections of information in 21 CFR part
803 have been approved under OMB control number 0910-0437; the
collections of information in 21 CFR part 812 have been approved under
OMB control number 0910-0078; the collections of information in 21 CFR
part 807, subpart E have been approved under OMB control number 0910-
0120; the collections of information in 21 CFR part 814, subparts A, B,
and C have been approved under OMB control number 0910-0231; the
collections of information in 21 CFR parts 50 and 56 have been approved
under OMB control number 0910-0755; the collections of information in
21 CFR part 820 have been approved under OMB control number 0910-0073;
the collections of information in 21 CFR part 814, subpart H have been
approved under OMB control number 0910-0332; and the collections of
information in 21 CFR 10.30 have been approved under OMB control number
0910-0183.

V. Comments

    Interested persons may submit either electronic comments regarding
this document 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.

    Dated: March 12, 2014.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2014-05900 Filed 3-17-14; 8:45 am]
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