Risk values are presented for each route of exposure (i.e., dermal or
inhalation) in each scenario, because risk mitigation measures are
specific to the route of exposure.  A total MOE was also calculated
because the dermal and inhalation toxicological endpoints of concern are
based on the same adverse effects.  The total MOE values were calculated
using the formula below:

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

			<IP_ADDRESS>	Occupational Non-cancer Risk Summary (using PHED and ORETF
data)  tc "<IP_ADDRESS>	CAMA Non-cancer Risk Summary (using PHED and ORETF
data) " \l 4

	Table 19 presents the risk assessments for short and intermediate-term
dermal and inhalation exposures at baseline, with additional personal
protective equipment, and with engineering controls.  All of the risk
calculations for occupational chlorflurenol handlers completed in this
assessment are included in Appendix B of the May13, 2006 Chlorflurenol
Occupational and Residential Exposure RED..

Table  19. Occupational Handler Short-and Intermediate-term Dermal,
Inhalation and Total Exposure and Risks

Exposure Scenario	Crop or Target	App Rate	Area Treated Daily	MOEs (Level
of Concern = 100)

Dermal	Inhalation	Total

Baseline (unless indicated otherwise)	PPE-G, SL: Single layer w/gloves
PPE-G, DL: Double layer w/ gloves	Baseline (unless indicated otherwise)
Baseline Dermal + Baseline Inh. (unless indicated otherwise)	PPE-G, SL
Dermal + Baseline Inh.	PPE-G, DL Dermal + Baseline Inh.

Mixer/Loader

1a) Mixing/

Loading Liquids Concentrates for Airblast Applications (PHED)	Pineapple
1.0 lb a.i./A (Label & BEAD)	40 acres	19	2,400	3,200	45,000	19	2,200
3,000

1b) Mixing/

Loading Liquids Concentrates for Groundboom Applications (PHED)
Pineapple	1.0 lb a.i./A (Label & BEAD)	80 acres	9.4	1,200	1,600	23,000
9.3	1,100	1,500

	Turf: Golf Course	1.0 lb a.i./A (Label)	40 acres	19	2,400	3,200	45,000
19	2,200	3,000

3.0 lb a.i./A (BEAD)	40 acres	6.2	790	1,100	15,000	6.2	750	990

1c) Mixing/

Loading Liquid Concentrates to Support LCO Handgun Applications
(mixing/loading supports 20 LCOs) (PHED)

	Lawn and Ornamental Turf (including golf course)	1.0 lb a.i./A (Label)
100 acres	7.5	940	1,300	18,000	7.5	900	1,200

3.0 lb a.i./A (BEAD)	100 acres	2.5	310	430	6000	2.5	300	400

1d)  Mixing/

Loading Liquid Concentrates to Support Rights of Way (PHED)	Gymnosperms
0.0025 lb a.i./gal (Label)	1,000 gal	300	38,000	51,000	720,000	300
36,000	48,000

5 lb a.i./acre (BEAD)	80 acres	1.9	240	320	4,500	1.9	220	300

	Hardwoods, Hedges, Vines	0.01 lb a.i./gal (Label)	1,000 gal	75	9,400
13,000	180,000	75	9,000	12,000

5 lb a.i./acre (BEAD)	80 acres	1.9	240	320	4,500	1.9	220	300

	Non-agricultural rights-of-ways/fence rows and hedge rows	3.0 lb a.i./A
(Label & BEAD)	80 acres	3.1	390	530	7,500	3.1	370	500

	Turf:  growing in culverts, ROW, median strip, ditches	3.0 lb a.i./A
(Label & BEAD)	80 acres	3.1	390	530	7,500	3.1	370	500

	Shrubs, Shade Trees, and Vines	4.5 lb a.i./A (BEAD)	80 acres	2.1	260
350	5,000	2.1	250	330

	Hedges, Vines	0.01 lb a.i./gallon (Label)	80 acres	75	9,400	13,000
180,000	75	9,000	12,000

	High density Forestry Vegetation	4.0 lb a.i./A (BEAD)	80 acres	2.3	290
400	5,700	2.3	280	370

2) Mixing/ Loading Granules for Tractor Drawn Spreader Application
(PHED)	Lawns and Ornamental Turf (including golf course)

Lawns and Ornamental Turf (including golf course)	1.1 lb a.i./A

(Label -100% DA)	40 acres	5,900	7,100	15,000	29,000	4,900	5,700	9,700

1.1 lb a.i./A (Label - 10% DA)	40 acres	59,000	71,000	150,000	29,000
19,000	21,000	24,000

3.0 lb a.i./A (BEAD - 100% DA)	40 acres	2,200	2,600	5,300	11,000	1,800
2,100	3,500

3.0 lb a.i./A (BEAD - 10% DA)	40 acres	22,000	26,000	53,000	11,000	7,100
7,600	8,900

Applying

3) Applying Sprays via Airblast Equipment (PHED)	Pineapple	1.0 lb a.i./A
(Label & BEAD)	40 acres	  SEQ CHAPTER \h \r 1 150	230	250	12,000	150	220
240

4) Applying Sprays via Groundboom Equipment (PHED)	Pineapple	1.0 lb
a.i./A (Label & BEAD)	80 acres	1,900	1,900	2,500	37,000	1,800	1,800
2,300

	Turf: Golf Course	1.0 lb a.i./A (Label)	40 acres	3,900	3,900	4,900
73,000	3,700	3,700	4,600

3.0 lb a.i./A   (BEAD)	40 acres	1,300	1,300	1,600	24,000	1,200	1,200
1,500

5) Applying Sprays via Handgun Equipment (PHED)

	Lawn and Ornamental Turf (including golf course)	1.0 lb a.i./A (Label)
5 acres	No Data	1,300	2,300	310,000	No Data	1,300	2,300

3.0 lb a.i./ A   (BEAD)	5 acres	No Data	430	760	100,000	No Data	420	760

6) Applying Sprays via Rights of Way Equipment (PHED)	Gymnosperms
0.0025 lb a.i./gal (Label)	1,000 gal	670	2,200	3,000	220,000	670	2,200
3,000

5 lb a.i./A (BEAD)	80 acres	4.2	14	19	1,400	4.2	14	18

	Hardwoods	0.01 lb a.i./gal (Label)	40 gal	170	560	750	56,000	170	550
740

5.0 lb a.i./A (BEAD)	80 acres	4.2	14	19	1,400	4.2	14	18

	Non-agricultural rights-of-ways/fence rows and hedge rows	3.0 lb a.i./A
(Label  & BEAD)	80 acres	7.0	23	31	2,300	6.9	23	31

	Turf:  growing in culverts, ROW, median strip, ditches	3.0 lb a.i./A
(Label  & BEAD)	80 acres	7.0	23	31	2,300	6.9	23	31

	Shrubs, Shade Trees and Vines	4.5 lb a.i./A (BEAD)	80 acres	4.6	15	21
1,500	4.6	15	21

	Hedges and Vines	0.01 lb a.i./gallon (Label)	1000 gal	170	560	750
56,000	170	550	740

	High Density Forestry Management	4 lb a.i./A (BEAD)	80 acres	5.2	17	23
1,700	5.2	17	23

7) Applying granules with tractor drawn (PHED)	Lawns and Ornamental Turf
(including golf course)	1.1 lb a.i./A (Label - 100% DA)	40 acres	5,000
6,800	12,000	41,000	4,400	5,900	9,100

1.1 lb a.i./A (Label - 10% DA)	40 acres	50,000	68,000	120,000	41,000
4,400	26,000	30,000

3.0 lb a.i./A (BEAD - 100% DA)	40 acres	1,800	2,500	4,300	15,000	1,600
2,200	3,300

3.0 lb a.i./A (BEAD - 10% DA)	40 acres	18,000	25,000	43,000	15,000	8,300
9,400	11,000

Mixing/Loading/Applying

8) Mixing/

Loading/

Applying Liquid Concentrates with Low Pressure Handwand (PHED)	Lawns and
Ornamental Turf (including golf course)	1.0 lb a.i./A (Label)	5 acres
4.3	1,000	1,200	14,000	4.3	940	1,100

3.0 lb a.i./A (BEAD)	5 acres	1.4	340	390	4,800	1.4	310	360

	Gymnosperms	0.0025 lb a.i./gal (Label)	40 gal	220	50,000	59,000	720,000
220	47,000	54,000

5.0 lb a/A (BEAD)	5 acres	0.87	200	230	2,900	0.87	190	220

	Hardwoods, Hedges, Vines	0.01 lb a.i./gal	40 gal	54	13,000	15,000
180,000	54	12,000	14,000

5.0 lb a/A (BEAD)	5 acres	0.87	200	230	2,900	0.87	190	220

	Non-agricultural rights-of-ways/fence rows and hedge rows	3.0 lb a.i./A
(Label & BEAD)	5 acres	1.4	340	390	4,800	1.4	310	360

	Turf:  growing in culverts, ROW, median strip, ditches	3.0 lb a.i./A
(Label & BEAD)	5 acres	1.4	340	390	4,800	1.4	310	360

	Shrubs, Shade Trees and Vines	4.5 lb a.i./A (Label & BEAD)	5 acres	0.96
220	260	3,200	0.96	210	240

	Hedges, Vines	0.01 lb a.i./gallon (Label)	40 gal	54	13,000	15,000
180,000	54	12,000	14.000

	Trees- bark banding	0.083 lb a.i./gal (Label)	40 gal	6.5	1,500	1,800
22,000	6.5	1,400	1,600

	Ornamental Trees	2.5 lb a.i./A (BEAD)	5 acres	1.7	400	470	5,800	1.7	380
430

	High Density Forestry Vegetation	4.0 lb a.i./A (BEAD)	5 acres	1.1	250
290	3,600	1.1	240	270

9) Mixing/

Loading/

Applying Liquid Concentrates with Low Pressure Handwand – Ground
Directed (ORETF OMA 006)	Lawns and Ornamental Turf (including golf
course)	1.0 lb a.i./A (Label)	5 acres	29	1,300	No Data	160,000	29	1,300
No Data

3.0 lb a.i./A (BEAD)	5 acres	9.6	440	No Data	54,000	9.6	430	No Data

	Non-agricultural rights-of-ways/fence rows and hedge rows	3.0 lb a.i./A
(BEAD)	5 acres	9.6	440	No Data	54,000	9.6	430	No Data

	Turf:  growing in culverts, ROW, median strip, ditches	3.0 lb a.i./A
(BEAD)	5 acres	9.6	440	No Data	54,000	9.6	430	No Data

	Shrubs, Shade Trees, and Vines	4.5 lb a.i./A (BEAD)	5 acres	6.4	290	No
Data	36,000	6.4	290	No Data

	Hedges	0.01 lb a.i./gal (Label)	40 gal	360	16,000	No Data	2,000,000	360
16,000	No Data

	Trees- bark banding	0.083 lb a.i./gal (Label)	40 gal	44	2,000	No Data
240,000	44	2,000	No Data

10) Mixing/

Loading/

Applying Liquid Concentrates with Low Pressure Handwand –

Overhead Directed (ORETF OMA 005)	Gymnosperms	0.0025 lb a.i./gal (Label)
40 gal	720	No Data	No Data	5,700,000	720	No data	No data

5 lb a.i./A (BEAD)	5 acres	2.9	No Data	No Data	33,000	2.9	No Data	No
Data

	Hardwoods	0.01 lb a.i./gal (Label)	40 gal	180	No Data	No Data	2,100,000
180	No Data	No Data

5.0 lb a.i./A (BEAD)	5 acres	2.9	No Data	No Data	33,000	2.9	No Data	No
Data

	Vines	0.01 lb a.i./gallon (Label)	40 gal	180	No Data	No Data	2,100,000
180	No Data	No Data

	Shade Trees and Vines	4.5 lb a.i./A (BEAD)	5 acres	3.2	No Data	No Data
37,000	3.2	No Data	No Data

	Ornamental Trees	2.5 lb a.i./A (BEAD)	5 acres	5.8	No Data	No Data
67,000	5.8	No Data	No Data

	High Density Forestry Vegetation	4 lb a.i./A (BEAD)	5 acres	3.6	No Data
No Data	42,000	3.6	No Data	No Data

11) Mixing/

Loading/

Applying Liquid Concentrates with a Handgun Sprayer (LCO ORETF data OMA
002)	Lawn and Ornamental Turf	1.0 lb a.i./A (Label)	5 acres	No Data	960
1,800	240,000	No Data	960	1,800

3.0 lb a.i./A  (BEAD)	5 acres	No Data	320	590	80,000	No Data	320	590

	Gymnosperms	0.0025 lb a.i./gal (Label)	1,000 gal	No Data	1,900	3,500
480,000	No Data	1,900	3,500

5.0 lb a.i./A (BEAD)	5 acres	No Data	190	350	48,000	No Data	190	350

	Hardwoods	0.01 lb a.i./gal (Label)	1,000 gal	No Data	480	890	120,000	No
Data	480	880

5.0 lb a.i./A (BEAD)	5 acres	No Data	190	350	48,000	No Data	190	350

11) Mixing/

Loading/

Applying Liquid Concentrates with a Handgun Sprayer (LCO ORETF data OMA
002) (cont.)	Non-agricultural rights-of-ways/fence rows and hedge rows
3.0 lb a.i./A (Label & BEAD)	5 acres	No Data	320	590	80,000	No Data	320
590

	Turf:  growing in culverts, ROW, median strip, ditches	3.0 lb a.i./A
(Label & BEAD)	5 acres	No Data	320	590	80,000	No Data	320	590

	Shrubs, Shade Trees, Vines	4.5 lb a.i./A (BEAD)	5 acres	No Data	210	390
54,000	No Data	210	390

	Hedges, Vines	0.01 lb a.i./gallon (Label)	5 acres	No Data	480	890
120,000	No Data	480	880

	Ornamental Trees	2.5 lb a.i./A (BEAD)	5 acres	No Data	390	710	96,000	No
Data	380	700

	High density Forestry Vegetation	4.0 lb a.i./A (BEAD)	5 acres	No Data
240	440	60,000	No Data	240	440

12) Mixing/ loading/applying granules with a bellygrinder (PHED)	Lawns
and Ornamental Turf (including golf course)	1.1 lb a.i./A (Label –
100% DA)	1 acre	200	210	350	32,000	200	210	340

1.1 lb a.i./A (Label – 10% DA)	1 acre	2,000	2,100	3,500	32,000	1,900
2,000	3,100

3.0 lb a.i./A (BEAD – 100% DA)	5 acres	72	78	130	12,000	72	77	130

12) Mixing/ loading/applying granules with a bellygrinder (PHED) (cont.)
Lawns and Ornamental Turf (including golf course)	3.0 lb a.i./A (BEAD
– 10% DA)	5 acres	720	780	1,300	12,000	680	730	1,100

13) Mixing/ loading/applying granules with a push-type spreader (LCO
ORETF OMA 001)	Lawns and Ornamental Turf (including golf course)	1.1 lb
a.i./A (Label – 100% DA)	5 acres	1,100	1,800	3,600	54,000	1,100	1,700
3,400

1.1 lb a.i./A (Label – 10% DA)	5 acres	110,000	180,000	36,000	54,000
9,300	13,000	22,000

3.0 lb a.i./A (BEAD – 100% DA)	5 acres	410	660	1,300	20,000	400	640
1,200

3.0 lb a.i./A (BEAD – 10% DA)	5 acres	41,000	66,000	13,000	20,000
3,400	4,900	7,900

		7.1.4 	Cancer Occupational Handler Exposure and Risk Assessment

	No cancer endpoints of concern for chlorflurenol were identified;
therefore cancer risks to handlers were not assessed.

	7.1.5 	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  tc "<IP_ADDRESS>	Summary of Risk
Concerns " \l 3

	For dermal and inhalation exposures (short- and intermediate-term), the
level of concern or target MOE is 100.  The calculated dermal and
inhalation risks were combined for short-term and for intermediate-term
because the dermal and inhalation endpoints were based on the same
toxicological effects.

	For all occupational scenarios, the inhalation risks were below HED’s
level of concern at the baseline level.

	For all occupational scenarios, the dermal risks were below HED's level
of concern at some level of mitigation for all occupational scenarios
except applying liquid sprays using rights-of-way equipment:

to turf growing in culverts, rights of way, median strips, ditches,
and/or under security fences at the 3 lb a.i./A rate (Label & BEAD) and
80 acres per day  -- the baseline dermal MOE was 7.0 and with the
highest dermal mitigation level (double layer clothing with gloves), the
dermal MOE and the total MOE (dermal plus inhalation) is 31;

to non-agricultural rights-of-ways/fence rows and hedge rows at the 3 lb
a.i./A rate (Label & BEAD) and 80 acres per day  -- the baseline dermal
MOE was 7.0 and with the highest dermal mitigation level (double layer
clothing with gloves), the dermal MOE and the total MOE (dermal plus
inhalation) is 31;

to gymnosperms at the 5 lb a.i./A rate (BEAD) and 80 acres per day  --
the baseline dermal MOE was 4.2 and with the highest dermal mitigation
level (double layer clothing with gloves), the dermal MOE and the total
MOE (dermal plus inhalation) is 18;

to shrubs, shade trees, and vines at the 4.5 lb a.i./A rate (BEAD) and
80 acres per day  -- the baseline dermal MOE was 4.6 and with the
highest dermal mitigation level (double layer clothing with gloves), the
dermal MOE and the total MOE (dermal plus inhalation) is 21; and

to high density forestry management at the 4.0 lb a.i./A rate (BEAD) and
80 acres per day  -- the baseline dermal MOE was 5.2 and with the
highest dermal mitigation level (double layer clothing with gloves), the
dermal MOE and the total MOE (dermal plus inhalation) is 23.

For the following scenarios, the dermal and total risks were of concern
at baseline level of mitigation, but were not a concern with single
layer clothing plus gloves):

mixing/loading liquid concentrates for all scenarios, except
mixing/loading liquid concentrates to support rights-of-way applications
to gymnosperms at the 0.0025 lb a.i./gal (label) application rate –
these dermal risks were not of concern at baseline;

mixing/loading/applying liquid concentrates with low pressure handwand
(PHED data) for all scenarios, except applications to gymnosperms at the
0.0025 lb a.i./gal (label) application rate – these dermal risks were
not of concern at baseline;

mixing/loading/applying liquid concentrates with low pressure handwand
(ground directed ORETF data), for all scenarios except applications to
hedges at the 0.01 lb a.i./gal (Label) application rate – these dermal
risks were not of concern at baseline; and

mixing/loading/applying liquid concentrates with low pressure handwand
(upward directed ORETF data), for all scenarios except applications to
hardwoods and vines at the 0.01 lb a.i./gal (Label) application rate and
applications to gymnosperms at the 0.0025 lb a.i./gal (label)
application rate – these dermal risks were not of concern at baseline.

	For the following scenario, the dermal and total risks were of concern
at baseline and single layer plus gloves levels of mitigation, but were
not a concern with double layer body protection plus chemical-resistant
gloves:   loading/applying granular formulations with a bellygrinder
(PHED data) for the 3.0 lb a.i./A (BEAD) application rate and assuming
100% dermal absorption

	There are no data to assess baseline dermal risks for application via
handgun equipment and mixing/loading/applying via handgun equipment.
Dermal risks are below HED’s level of concern for handlers of these
scenarios when personal protective equipment (i.e., single layer
clothing plus gloves) is considered.

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

	There are no data gaps associated with the occupational handler
scenarios.

		7.1.6	Recommendations for Refining Occupational Handler Risk
Assessment  tc "2.1.6	Recommendations For Refining Occupational Handler
Risk Assessment " \l 3

	In order to refine this occupational risk assessment, data on actual
use patterns including rates, timing, and areas treated would better
characterize chlorflurenol methyl ester risks.  Exposure studies for
many equipment types that lack data or that are not well represented in
PHED or ORETF (e.g., because of low replicate numbers or data quality)
should also be considered based on the data gaps identified above and
based on a review of the quality of the data used in this assessment.

	7.2	Occupational Postapplication Exposures and Non-Cancer Risk
Estimates

HED uses the term “postapplication” to describe exposures to
individuals that occur as a result of being in an environment that has
been previously treated with a pesticide (also referred to as reentry
exposure).  HED believes that there are distinct job functions or tasks
related to the kinds of activities that occur in previously treated
areas.  Job requirements (e.g., the kinds of jobs to cultivate a crop),
the nature of the crop or target that was treated, and how the chemical
residues degrade in the environment can cause exposure levels to differ
over time.  Each factor has been considered in this assessment.

		7.2.1	Occupational Postapplication Exposure Scenarios

Currently, chlorflurenol uses are varied as it can be used on
agricultural crops (i.e. pineapple) and in a variety of other outdoor
occupational settings (i.e., rights-of-way, golf course turf).   As a
result, a wide array of individuals can potentially be exposed by
working in areas that have been previously treated.  HED is concerned
about the kinds of exposures one could receive in the workplace.

	HED uses a concept known as the transfer coefficient to numerically
represent the postapplication exposures one would receive (generally
presented as cm2/hour).  The transfer coefficient concept has been
established in the scientific literature and through various exposure
monitoring guidelines published by the U.S. EPA and international
organizations such as Health Canada and the Organization for Economic
Cooperation and Development.  The establishment of transfer coefficients
also forms the basis of the work of the Agricultural Reentry Task Force.
 A transfer coefficient is a measure of the residue transferred from a
treated surface to a person who is doing a task or activity in a treated
area.  These values are the ratio of an exposure for a given task or
activity to the amount of pesticide residue on treated surfaces
available for transfer. HED has developed a series of standard transfer
coefficients that are unique for variety of job tasks or activities that
are used in lieu of chemical- and scenario-specific data.

	To develop a postapplication assessment, HED considers the types of
tasks and activities that individuals are likely to be doing in areas
recently treated with a pesticide. For consistency within
postapplication assessments, HED has developed a list of tasks commonly
associated with specific crops or use-patterns, which are likely to
result in postapplication exposures.  Postapplication pesticide
exposures that result from an individual’s employment are considered
occupational exposures. Common examples include: crop maintenance tasks
(e.g., irrigating, weeding, and mowing) and crop advisor tasks (e.g.,
scouting).

	HED considers how and when a pesticide is applied to estimate the level
of transferable residues to which individuals could be exposed over
time.  Label directions and other use data are considered to determine
application rates and application frequency.  HED completes non-cancer
postapplication risk assessments using maximum application rates for
each scenario. When postapplication non-cancer risks are a concern using
maximum application rates, HED may also consider typical application
rates or application frequency, to further evaluate the overall risks
associated with the use of the pesticide.  To estimate the amount of
transferable residues on a treated surface, HED uses, when possible,
chemical- and crop-specific studies as described in HED guidelines for
exposure data collection (Series 875, Occupational and Residential
Exposure Test Guidelines: Group B - Postapplication Exposure Monitoring
Test Guidelines).  For postapplication exposures, unique techniques are
used to measure the amount of pesticide residue on a treated surface
available for possible transfer.  These techniques are distinct from
those which measure total pesticide residue on a treated surface and
absorbed into a treated entity. When appropriate chemical- and
crop-specific transferable residue data are unavailable, HED also has
developed a standard modeling approach to predict transferable residues
over time (best described in HED’s SOPs for Residential Exposure
Assessment).  All agricultural occupational postapplication scenarios
(i.e. pineapple) were evaluated using HED’s default assumptions that
20 percent of the initial application is available for transfer on day 0
(i.e., 12 hours after application) and that the residue dissipates at a
rate of 10 percent per day.  All commercial occupational postapplication
scenarios (i.e. lawn and turf) were evaluated using HED’s default
assumptions that 5 percent of the initial application is available for
transfer on day 0 (i.e., 12 hours after application) and that the
residue dissipates at a rate of 10 percent per day.

renol.  Short-term (30 days) always are considered in these
assessments.  Intermediate-term (greater than 30 days to several months)
exposure durations are appropriate for postapplication occupational
exposures scenarios where the pesticide is reapplied several times over
a growing season, or the pesticide residues persist for relatively long
periods of time, or the crop or use-pattern is such that occupational
postapplication workers may be exposed to several different treated
areas in the course of their work.  For example, migrant and seasonal
workers may move from farm to farm and be exposed several weeks to
several months or different fields or greenhouses on an individual
establishment may be treated over a period of weeks due to differing
levels of infestation or staggered crop cycles.  For chlorflurenol, the
exposure durations for non-cancer postapplication risk assessment were
short-term (30 days) and intermediate-term (greater than 30 days up
to several months).  However, since the dermal toxicological endpoint of
concern is the same for short- and intermediate-term exposures, the
short- and intermediate-term postapplication risks are numerically
identical.

	Inhalation exposures are thought to be negligible in outdoor
postapplication scenarios, since chlorflurenol has low vapor pressure
and the dilution factor outdoors is considered infinite.

	HED has used the basic approach described above since the mid 1980s for
calculating postapplication risks to pesticides.  From that time to the
present, several revisions and modifications were made to Agency
policies as data, which warranted such changes, became available.  In
1995, the Agency issued a Data Call-In for postapplication agricultural
data that prompted the formation of the Agricultural Reentry Task Force
(ARTF).  This task force has generated a number of exposure studies and
associated documents that are currently under review.  The work of the
ARTF is not yet complete; however, sufficient data were available from
the group that warranted a significant interim change in Agency policy
related to the data which were already available as the efforts of the
ARTF paralleled a push for tolerance reassessment stipulated by the
timelines established by FQPA.  As a result of the need for the revision
and using the latest data, the Agency developed a revised policy on
August 7, 2000 entitled Policy 003.1 Science Advisory Council for
Exposure Policy Regarding Agricultural Transfer Coefficients.  The
revision to this policy entailed linking worker activities to more
specific crop/agronomic groupings and making better use of the available
occupational postapplication exposure data.  In the new policy, transfer
coefficients were selected to represent the activities associated with
18 distinct crop/agronomic groupings based on different types of
vegetables, trees, berries, vine/trellis crops, turf, field crops, and
bunch/bundle crops (e.g., tobacco).

Within each agronomic group, a variety of cultural practices are
required to maintain the included crops.  These practices are varied and
typically involve light to heavy contact with immature plants as well as
with more mature plants.  HED selected transfer coefficient values in
its revision of Policy 003 to represent this range of exposures within
each agronomic group.  In the policy, transfer coefficients were placed
in 1 of 5 generic categories based on the exposures relative to that
group.  These 5 categories include: very low exposure, low exposure,
medium exposure, high exposure, and very high exposure.  Numerical
values were not necessarily assigned to each category for each crop
group.  Selections depended upon the actual agronomic practices that
were identified for each group (i.e., some groups had 2 assigned
transfer coefficients while others had 5).  The transfer coefficient
values which have been used for pineapple are excerpted directly from
Agency Policy 003.1 for the vegetable, stem/stalk category.  The ARTF
Scoping Survey does not specifically include pineapple; therefore, all
exposure levels (low, medium, and high) for the vegetable, stem/stalk
category were used. For lawn and turf activities, transfer coefficient
values from Agricultural Reentry Task Force (ARTF) study were used.

	In addition to transfer coefficients, occupational postapplication
exposures to workers are estimated, in general, using transferable turf
residue, dislodgeable foliar residue or soil transferable residue
values. Transferable turf residues (TTRs) are the amounts of pesticide
available on the turf surface that can potentially be transferred to the
skin of workers who contact treated turf.  Dislodgeable foliar residues
(DFRs) are the amounts of pesticide available on the surface of crops
(other than turf) that can potentially be transferred to the skin of
workers who contact treated crop. DFRs and TTRs are measured using
techniques that specifically determine the amount of residues on the
surface treated leaves or other plant surfaces.  In order to define the
amount of transferable residues to which individuals can be exposed,
whenever possible HED relies on chemical- and crop-specific studies as
described in HED guidelines for exposure data collection (Series 875,
Occupational and Residential Exposure Test Guidelines: Group B -
Postapplication Exposure Monitoring Test Guidelines).  However, when no
chemical- and crop-specific TTR or DFR studies are available, HED uses a
standard modeling approach to predict transferable residues over time
(best described in HED’s SOPs for Residential Exposure Assessment).

		7.2.2	Data/Assumptions for Postapplication Exposure Scenarios  tc
"2.2.2	Data/Assumptions for Postapplication Exposure Scenarios " \l 3

	A series of assumptions and exposure factors served as the basis for
completing the occupational postapplication worker risk assessments.
Each assumption and factor is detailed below on an individual basis. In
addition to these values, transfer coefficient values were used to
calculate risk estimates.  The transfer coefficients for pineapple were
taken from HED’s revised policy entitled Policy 003.1 Science Advisory
Council for Exposure Policy Regarding Agricultural Transfer Coefficients
(August 7, 2000).  The transfer coefficients for turf were taken a more
recent study by the Agricultural Reentry Task Force. The assumptions and
factors used in the risk calculations are presented below:

There are many factors that are common to handler and postapplication
risk assessments such as body weights, duration, and application rates.
See Section <IP_ADDRESS> for these values. In the postapplication risk
assessment, maximum application rates were considered.

Levels of Concern: HED has established levels of concern (LOC) for
occupational postapplication risks – margins of exposure of less than
100 for occupational non-cancer dermal and inhalation risks are a
concern.

Dislodgeable Foliar Residues: No chlorflurenol-specific dislodgeable
foliar residue (DFR) data were available for pineapple.  Therefore, this
assessment uses HED’s default assumption that 20 percent of the
application rate is available on day 0 (i.e., 12 hours after
application) and the residue dissipates at a rate of 10 percent per day.

Transferable Turf Residues: No chlorflurenol-specific transferable turf
residue (TTR) data were available.  Therefore, this assessment uses
HED’s default assumption that 5 percent of the application rate is
available on day 0 (i.e., 12 hours after application) and the residue
dissipates at a rate of 10 percent per day.

Exposures were calculated to reflect default DFR and TTR values over
time coupled with surrogate transfer coefficients.

		7.2.3	Occupational Postapplication Exposure and Non-cancer Risk
Estimates

	Occupational non-cancer risks were calculated using a Margin of
Exposure (MOE), which is a ratio of the daily dose to the toxicological
endpoint of concern.

	Daily Exposure: Daily dermal exposures were calculated on each
postapplication day after application using the following equation (see
equation D2-20 from Series 875-Occupational and Residential Test
Guidelines: Group B-Postapplication Exposure Monitoring Test Guidelines
and Residential SOP 3.2: Postapplication Dermal Potential Doses from
Pesticide Residues on Gardens):

DE(t) (mg/day) = (TR(t) (µg/cm2) x TC (cm2/hr) x Hr/Day)/1000 (µg/mg)

Where:

DE(t)	=	Daily exposure or amount deposited on the surface of the skin at
time (t) attributable for activity in a previously treated area, also
referred to as potential dose (mg a.i./day);

	TR(t)	=	Transferable residues that can either be dislodgeable foliar or
turf transferable residue at time “t” (µg/cm2);

	TC	=	Transfer Coefficient (cm2/hour); and

	Hr/day	=	Exposure duration meant to represent a typical workday
(hours).

Note that the (TR(t)) input may represent levels on the day of
application in the case of short-term risk calculations.

	Daily Dose and Margins of Exposure:  The manner in which daily
postapplication dermal exposures were calculated is inherently different
than with handler exposures.  However, once daily exposures are
calculated, the calculation of daily absorbed dose and the resulting
Margin of Exposures use the same algorithms that are described above for
the handler exposures (See Section 2.1.3).  These calculations are
completed for each day or appropriate block of time after application.

		Non-cancer Risk Summary  tc "2.2.3	Non-cancer Risk Summary " \l 3

For pineapple applications, the MOEs are greater than 100 on day 0 (REI
= 12 hours) for all of the exposure levels.

For the golf course turf using the 1.0 and 1.1 lb a.i./A (Label) rates
for sprays and granular applications respectively, the calculated MOE on
day 0 (12 hours following application) is 71 for liquid applications and
65 for granular applications (assuming 100% dermal absorption) at the
highest exposure level (hand weeding and transplanting). For these
postapplication scenarios, the target MOE is not reached until the 4th
day after application (MOE =110) for liquid formulations, and the target
MOE is not reached until the 5th day after application (MOE = 110) for
granular formulations.  All other postapplication turf scenarios using
the 1.0 and 1.1 lb a.i./A (Label) rates have risks below HED’s level
of concern on day 0 (12 hours following application).

For the golf course turf using the 3.0 lb a.i./A (BEAD) rates for sprays
and granular applications, the calculated MOE on day 0 (12 hours
following application):

for liquid and granular applications (assuming 100% dermal absorption)
is 24 at the higher exposure level (hand weeding and transplanting) and
the target MOE is not reached until day 14 (MOE=100);

for liquid and granular applications (assuming 100% dermal absorption)
is 47 at the lower exposure level (mowing) and the target MOE is not
reached until day 8 (MOE=110);

for granular applications (assuming 10% dermal absorption) is 240 at the
higher exposure level (hand weeding and transplanting);

for granular applications (assuming 10% dermal absorption) is 470 at the
lower exposure level (mowing).

	Table 20 presents a summary of occupational postapplication risks
associated with use of chlorflurenol. The risk calculations for
occupational chlorflurenol handlers are included in Appendix C.

Table 20.  Summary of Occupational Postapplication Risks

Crop Grouping	Application rate

(lb a.i./acre)	Transfer Coefficient (µg/cm2)	Day after Application	MOE

(Level of Concern = 100)

Pineapple	1.0 (Label & BEAD)	300 (irrigation, scouting, thinning, hand
weeding)	0 (12 hours)	400

500 (irrigation, scouting)	0 (12 hours)	240

1,000 (hand harvesting, hand pruning)	0 (12 hours)	120

Turf	1.0 – liquid (Label)	3,400 (mowing)	0 (12 hours)	140

6,800 (hand weeding, transplanting)	4	110

	3.0 – liquid (BEAD)	3,400 (mowing)	8	110

6,800 (hand weeding, transplanting)	14	100

	1.1 – granular (LABEL)

100% dermal absorption	3,400 (mowing)	0 (12 hours)	130

6,800 (hand weeding, transplanting)	5	110

	1.1 – granular (LABEL)

10% dermal absorption	3,400 (mowing)	0 (12 hours)	1,300

6,800 (hand weeding, transplanting)	0 (12 hours)	650

	3.0 – granular (BEAD)

100% dermal absorption	3,400 (mowing)	8	110

6,800 (hand weeding, transplanting)	14	100

	3.0 – granular (BEAD)

10% dermal absorption	3,400 (mowing)	0 (12 hours)	470

6,800 (hand weeding, transplanting)	0 (12 hours)	240

7.2.4	Occupational Postapplication Exposure and Risk Estimates for
Cancer  tc "2.2.4	Occupational Postapplication Exposure and Risk
Estimates for Cancer " \l 3

	Since no toxicological endpoint of concern was identified for cancer,
cancer risks from occupational postapplication exposures were not
assessed.

7.2.5	Summary of Occupational Postapplication Risk Concerns and Data
Gaps  tc "2.2.5	Summary of Occupational Postapplication Risk Concerns
and Data Gaps " \l 3

	There are several occupational postapplication scenarios that have
risks above HED’s level of concern for non-cancer risk assessments.
For hand weeding and transplanting of golf course turfgrass treated at
1.0/1.1 lb a.i./A, the target MOE is not reached until the 4th day after
application (MOE =110) for liquid formulations, and the target MOE is
not reached until the 5th day after application (MOE = 110) for granular
formulations.  For the golf course turf using the 3.0 lb a.i./A (BEAD)
rates for sprays and granular applications, the calculated MOE on day 0
(12 hours following application):

for liquid and granular applications (assuming 100% dermal absorption)
is 24 at the higher exposure level (hand weeding and transplanting) and
the target MOE is not reached until day 14 (MOE=100);

for liquid and granular applications (assuming 100% dermal absorption)
is 47 at the lower exposure level (mowing) and the target MOE is not
reached until day 8 (MOE=110);

for granular applications (assuming 10% dermal absorption) is 240 at the
higher exposure level (hand weeding and transplanting);

for granular applications (assuming 10% dermal absorption) is 470 at the
lower exposure level (mowing).

  SEQ CHAPTER \h \r 1 HED has used the most up-to-date information
available to complete this postapplication risk assessment for
chlorflurenol. Several data gaps exist, such as a lack of
chlorflurenol-specific postapplication studies. Additionally, the ARTF
Scoping Survey does not include pineapple, though pineapple was assigned
to the vegetable stem/stalk transfer coefficient category in Policy
003.1.

7.2.6	Recommendations for Refining Occupational Postapplication Risk
Assessment  tc "2.2.6	Recommendations For Refining Occupational
Postapplication Risk Assessment " \l 3

	To refine this occupational risk assessment, data on actual use
patterns including rates, timing, and the kinds of tasks that are
required to produce agricultural commodities and other products would
better characterize chlorflurenol risks.  Exposure studies for many
cultural practices that lack data or that are not well represented in
the revised transfer coefficient policy should also be considered based
on the data gaps identified above.

8.0	Data Needs and Label Requirements    TC \l1 "10.0	Data Needs and
Label Requirements

8.1	Toxicology    TC \l2 "10.1	Toxicology

	Toxicology data requirements are acceptable and satisfied.  However,
another study on reproduction with a more definitive NOAEL for effects
on pups and fertility will be necessary to remove the 3X uncertainty
factor.

8.2	Residue Chemistry    TC \l2 "10.2	Residue Chemistry

	A study on the UV/visible spectra is necessary.

8.3	Occupational and Residential Exposure    TC \l2 "10.3	Occupational
and Residential Exposure

	No studies are required at this time.

References:    TC \l1 "References:

	Memorandum from Shana Recore to David G Anderson , dated June 30, 2006,
Subject: Chlorflurenol: Occupational and Residential Exposure Assessment
for the Reregistration Eligibility/Decision [RED].

Appendix A:  Toxicology Assessment  TC \l1 "Appendix A:  Toxicology
Assessment

A.1	Toxicology Data Requirements TC \l2 "A.1  Toxicology Data
Requirements

	A confirmatory study on reproduction [guideline 870.300] is necessary
to remove the extra 3X uncertainty factor and establish a NOAEL for pup
effects and fertility effects in adult offspring.

The requirements (40 CFR 158.340) for Non food use for CHLORFLURENOL
METHYL ESTER are in Table 1. Use of the new guideline numbers does not
imply that the new (1998) guideline protocols were used.

Table A.1:  Data Requirements for a non-food use pesticide, such as
chlorflurenol methyl ester.

Test

	Technical

	Required	Satisfied

870.1100    Acute Oral Toxicity

870.1200    Acute Dermal Toxicity

870.1300    Acute Inhalation Toxicity

870.2400    Primary Eye Irritation

870.2500    Primary Dermal Irritation

870.2600    Dermal Sensitization		yes

yes

yes

yes

yes

yes	yes

yes

yes

yes

yes

yes

870.3100    Oral Subchronic (rodent)

870.3150    Oral Subchronic (nonrodent)

870.3200    21-Day Dermal

870.3250    90-Day Dermal

870.3465    90-Day Inhalation		yes

no

no

no

no	yes

no

no A

no

no

870.3700a  Developmental Toxicity (rodent)

870.3700b  Developmental Toxicity (nonrodent)

870.3800    Reproduction		yes

no

no	Yes

no B

no B

870.4100a  Chronic Toxicity (rodent)

870.4100b  Chronic Toxicity (nonrodent)

870.4200a  Oncogenicity (rat)

870.4200b  Oncogenicity (mouse)

870.4300    Chronic/Oncogenicity		no

no

               no

no

no	No

yes C

no

yes D

no

870.5100    Mutagenicity—Gene Mutation - bacterial

870.5300    Mutagenicity—Gene Mutation - mammalian

870.5300    Mutagenicity—Structural Chromosomal Aberrations

870.5550    Mutagenicity—Other Genotoxic Effects		yes

yes

yes

yes	yes

yes

yes

yes

870.6100a  Acute Delayed Neurotox. (hen) E

870.6100b  90-Day Neurotoxicity (hen) E

870.6200a  Acute Neurotox. Screening Battery (rat) F

870.6200b  90-Day Neuro. Screening Battery (rat) F

870.6300    Develop. Neuro F		no

no

no

no

no	-

-

-

-

-

870.7485    General Metabolism

870.7600    Dermal Penetration		no

no	no G

no

Special Studies for Ocular Effects H

Acute Oral (rat)

Subchronic Oral (rat)

Six-month Oral (dog)

See next page for explanation for superscripts A to H.

Footnotes for Table A.1:  A  A formulation rather than the technical
grade of chlorflurenol was studied [technical grade is required].  B
The unacceptable developmental rabbit study and unacceptable
reproduction studies submitted were not required.  C The acceptable
chronic dog study submitted was not required.  D The acceptable
carcinogenicity study in the mouse was not required.  E  Required only
for organophosphate pesticides.  F  Required if the pesticide shows
evidence of neurotoxicity.  G  Not required for pesticides with this use
pattern.  H  Reserved

A.2  Toxicity Profiles TC \l2 "A.2  Toxicity Profiles

Table A.2.1	Acute Toxicity Profile – Chlorflurenol methyl ester

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

870.1100	Acute oral [rat]	43355402 	LD50 > 5000 mg/kg	IV

870.1200	Acute dermal [rabbit]	43355403	LD50 > 5000 mg/kg	IV

870.1300	Acute inhalation [rat]	45147201	LC50 > 5.07 mg a.i./L	IV

870.2400	Acute eye irritation [rabbit]	43355404	Mild irritation, cleared
in 72 hours	III

870.2500	Acute dermal irritation [rabbit]	43355405	Practically non
irritating	IV

870.2600	Skin sensitization [Guinea pig]	43361701	Not a sensitizer
Negative

Table A.2.2:	Subchronic, Chronic, Developmental, Reproduction ,
mutagenicity and other toxicity profile of  chlorflurenol methyl ester.

Guideline/

Study type/

Acceptability

MRID#/Date/

Doses

Results

870.3100

90-Day oral/SD rat

Acceptable

Lot# 45, 99.9%

45441001 [2001]

Acceptable

0,1000,5000,10000 ppm [M: 0,74,361, 697; F: 0,87,390,750 mg/kg/day]

NOAEL = M/F 697/87 mg/kg/day

LOAEL = M/F None/390 mg/kg/day based decreased body weight gain in
females [Female BWt accompanied by decreased food efficiency].  Males
showed a possible treatment related nominal decreased body weight gain
of 11% at 697 mg/kg/day.

870.3100

90-Day oral/Wistar rat

Unacceptable

00120854 & 00120867 [1968] 0, 1000, 5000, 10000 ppm [0, 50, 250, 500
mg/kg/day]

NOAEL = 250 mg/kg/day

LOAEL = 500 mg/kg/day based on body weight decrement in females.

Unacceptable: lacking hematology clinical chemistry & some histology

870.3150

90-Day oral/dog

Unacceptable

00120868 [1968]

Unacceptable

0,300,1000,3000 ppm

0, 8.95, 29.9, 89.5 mg/kg/day

NOAEL = >89.5 mg/kg/day

LOAEL = None.  No treatment related decreases in hematological
parameters, which showed only random fluctuation from control animals
and from pre-dosing conditions in males and female up to 8 weeks.
Although, some parameters at the HDT were slightly numerically less than
control values, they were not consistently less or consistently
numerically less than the initial values for the group.  The 90-day dog
was not entirely inconsistent with the 2-year dog study.

Unacceptable; only 3 dogs/sex/group and dose levels were not verified.

870.3150NG

21-Day dermal toxicity/

rabbit, Proj# 1385

Lot# 759-78

Acceptable/NG

00120883 [1970]

Acceptable/NG

Test material CF-125 [12.5% a.i.] Doses  0, 0.5, 1.0 ml/kg/day or (0,
62.5, 125 mg a.i./kg

NOAEL = None

LOAEL = 62.5 mg a.i./kg/day based on dose related  local degeneration of
hair follicles and epithelial thickening at the 2 dose levels used.  No
systemic effects reported.  Since the test material was applied as a
neat formulation, the dermal effects may have been due to the dispersing
agent in CF-125.  CF-125 is 12.5% active ingredient with 87.5% being
inert ingredients of which most were known skin irritants in the context
of this study.

Acceptable as a non-guideline study.  The toxicity of the technical
grade of the pesticide could not be evaluated.

870.4100b

Chronic toxicity

Dog

Acceptable

00082863 [1975]

0, 300, 1000, 3000 ppm or [M/F: 0/0, 8.7/8.8, 30.6/29.9, 94.0/94.4
mg/kg/day

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.

870.4100a

Chronic toxicity rats

Unacceptable

00082864 [1971]

0, 300, 1000, 3000 ppm or 0, 15, 50, 150 mg/kg/day

52 week interim report.

Tentative NOAEL = 50 mg/kg/day

                LOAEL = 150 mg/kg/day based on one male with elevated
SGPT and alkaline phos.

Unacceptable: Inadequate number of rats were studied histologically for
too short a period.

870.4200b

Carcinogenicity Mouse

Acceptable

00082865 [1976]

0, 1000, 3000, 10000 ppm or 0, 150, 450, 1500 mg/kg/day

NOAEL = 1500 mg/kg/day

LOAEL = None, no dose related carcinogenic response was noted.

Acceptable

Non GDL

Carcinogenicity Rats

Unacceptable

0082866 [1969]

subcutaneous 0, 30  mg/kg/week, and feeding about 92 mg/kg/day or about
700 mg/kg/week.

Subcutaneous dose:

NOAEL = 30 mg/kg/week

LOAEL= None

Feeding study:

NOAEL = 92 mg/kg/day

LOAEL= None

Unacceptable because studied for 1-year only

870.3700a

Developmental toxicity/ SD rat

Acceptable

4510901 [2000]

Acceptable

0, 250, 750, 1000 mg/g/day

	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 increased
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].

870.3700b

Developmental toxicity/NZW rabbit

Unacceptable

00120862 [1969]

Unacceptable

Proj# 1624-97

0, 25, 50, 100 mg/kg/day

Maternal NOAEL = 100 mg/kg/day

               LOAEL = None

Devel NOAEL = 100 mg/kg/day

           LOAEL = None, although a wide variation in skeletal variants
were seen among the groups.

Unacceptable due to no demonstrated toxicity and lack of individual
animal data and no indication that fetal soft tissue was evaluated.

870.3800

3-Generation reproduction/Charles River rat

Unacceptable

00082867 [1973]

0, 300, 1000, 3000 ppm or 0, 15, 50, 150 mg/kg/day

Parental, systemic NOAEL = 50 mg/kg/day.

              Systemic LOAEL = 150 mg/kg/day for nominal decreased body
weight.

Offspring NOAEL = 15 or 50 mg/kg/day

                LOAEL = 50 or150 mg/kg/day based on decreased pup weight
at birth and/or litter size from the P0b, F1a and F1b generations.
Decreased absolute thymus and testes weights in the F3b generation
weanling pups [The only group from which organ weight were collected].

Reproduction NOAEL = Unknown.

                       LOAEL = Unknown.  Appears to be considerable
variation in results generation to generation such that NOAEL/LOAEL was
not definitive.  Reviewer could not assign a NOAEL.  Decreased variable
pregnancy rate  in the F1a, F1b, F2a and F2b generation [only F2a shows
a dose relationship], decreased absolute thymus in F3b weanlings [The
only group from which organ weight were collected].  Female F0 and F2
body weight gain was lower than controls premating in the 150 mg/kg/day
group.

Unacceptable due to uncertainty and variability in pregnancy rates in
control and all doses.

870.5100

Ames, S typhimurium

43562802 [1995]

Acceptable

In a reverse mutation assay with S tryphimurim [TA1535, TA 1537, TA1538,
TA98 and TA100] was exposed with and without S9 activation at 250, 500,
750, 1000 or 2500 µg/plate.  Cytotoxicity was seen in all strains at
2500 µg/plate.

There were no signs of a mutagenic response with or without S9.

870.5300

In vitro cell (CHO) Chromosomal Aberration

43562801 [1995]

Acceptable

In this Chinese hamster ovary cell in vitro assay, cells were exposed to
non-activated doses of 5.0-75 µg/mL and activated doses of 50-200
µg/mL.  Treated cultures were scored for structural aberrations.
Cytotoxicity was indicated by approximately 40% reduction in mitotic
index at the highest dose in the non-activated and activated systems.

There was no indication of clastogenic effects in the non-activated or
activated systems.

870.5550

In vitro rat hepatocyte UDS

45137404 [1988]

Acceptable

Chlorflurenol was studied for unscheduled DNA synthesis in rat
hepatocytes at 0, 1.5, 5, 15, 50 or 150 µg/mL.  Cytotoxicity was seen
at 150 µg /mL indicated by decrease [3H] thymidine incorporation.
Since there was no evidence UDS with or without S9 activation, the study
was considered negative for mutagenic evidence.

870.5300

In vitro mammalian cell HGPRT test

45137405 [1988]

Acceptable

In two independently performed mammalian cell gene mutation assays at
the HPRT locus (MRID 45137405), V79 cells cultured in vitro were exposed
to Chlorflurenol-methyl ester in ethanol at  0, 6, 20, 40, or 60 μg/mL
with and without S9 to the solubility limit.   There was no evidence
that Chlorflurenol-methyl ester induced mutant colonies over background
in the presence or absence of S9-activation.

NG

Metabolism & Pharmacokinetics

Unacceptable/NG

00082868 [1972]

Unacceptable/NG

Majority eliminated via the rat kidney and about 1/20 in the feces.  The
small amounts detected in the mammary gland suggested that the test
material was  not secreted in milk.  Recovered test material from the
feces and urine within 72 hours after administration were 64% IT-3456,
75% of IT-5733 and 83% of IT-3294.  Biliary recyclization was indicated.
  Small amounts were detected in the mammary gland of lactating females,
but not in their pups. Identification of potential  metabolites was not
investigated.

Unacceptable due to inadequate replication, distribution not
quantitated, test material inadequately identified.

A.3  Executive Summaries   TC \l2 "A.3  Executive Summaries

	Summaries included are acceptable and unacceptable studies considered,
but not necessarily used to assess risk.

A.3.1	Subchronic Toxicity

90-Day Oral Toxicity – Rat [MRID# 45441001]

EXECUTIVE SUMMARY:  In a 90-day dietary study (MRID 45441001),
chlorflurenol methyl ester (Lot# 45, 99.9% pure) was administered to 10
Sprague Dawley rats/sex/group at dietary levels of 0, 1000, 5000 or
10000 ppm (males: 0.0, 74, 361 or 697 mg/kg/day; females: 0.0, 87, 390
or 750 mg/kg/day).  Body weights, food consumption, and clinical
observations  were recorded.  Ophthalmoscopic examinations were
conducted.  At study termination, rats were sacrificed and blood
collected for hematology and clinical chemistry studies.  Organ weights
were recorded and gross and microscopic examinations were conducted.

	All rats survived to terminal sacrifice.  There were no clinical signs
of toxicity and there were treatment related effects on hematology or
clinical chemistry parameters, organ weights or necropsy findings.  All
treated groups of female rats had dose-related lower final body weight
than control group (not significant) and dose-related lower body weight
gains (reduced in Groups 2, 3 and 4 by 15, 21 and 24%, respectively)
which were statistically significant in the 5000 ppm and 10000 ppm
groups (p<0.01).  The food consumption and food efficiency were also
lower in all treated groups compared with the control group.

	Under the conditions of this study, a NOAEL for females was established
at 1000 ppm (87 mg/kg/day) and a LOAEL at 5000 ppm (390 mg/kg/day) based
on dose-related decrease in body weight gain.  For males the NOAEL was
10000 ppm 697 mg/kg/day and a LOAEL was not established.

	This study is considered to be ACCEPTABLE/GUIDELINE as a 90-day study
and fulfills FIRA Guideline requirements for a subchronic oral toxicity
study in the rat [870.3100 (82-1a)].

COMPLIANCE:  Signed and dated GLP, Quality Assurance and Data
confidentiality statements were provided.

	870.3100	90-Day Oral Toxicity – Mouse

	Not required and none was submitted.

90-Day Oral Toxicity – Dog [MRID# 00120868]

	Not required and unacceptable because only 3 dogs/sex/group were used
and no toxicity was demonstrated

	870.3200	21/28-Day Dermal Toxicity – Rat [MRID# 00120883]

EXECUTIVE SUMMARY:  In a 21-day dermal toxicity study (MRID 00120883),
formulated chlorflurenol methyl ester [Lot# 759-78 (12.5% a.i.,
batch/lot # 759-78)] was applied to the shaved skin of 5 New Zealand
rabbits/sex/group at dose levels of 0, 0.5 or 1.0 ml/kg bw/day
[equivalent to 0, (62.5 mg a.i./kg/day or (125 mg a.i./kg/day, assuming
a density of 1.0 g/ml for CF 125] 24 hours/day for 5 days/week during a
21-day period.  Equal numbers of rabbits and dose levels were evaluated
with abraded and intact skin.

	The only treatment related effects seen were in the treated skin.
Drying and slight fissuring of the skin midway through the study was
noted, which at termination resulted in epithelial thickening and
varying amounts of keratonization with varying destruction of hair
follicles.  Although the varying degrees of destruction of hair
follicles was shown in most dosed animals, the damage was observed to be
less severe among the lowest dosed animals.  The treated skin effects
were believed to be due to the 87.5% of the CF 125 formulation that were
skin reactive inerts.  Only mild skin effects were noted at mid study.

No treatment related changes were noted in body weight, weight gain,
hematology, clinical chemistry, organ weights, or systemic toxicity in
treated animals.  Histological findings were consistent with random
effects in controls and treated animals.

There were no systemic effects.  The LOAEL is 62.5 mg/kg/day, based on
epithelial thickening, keratinization and destruction of hair follicles.
 A NOAEL was not seen for skin effects.

This 21-day dermal toxicity study in the (rabbit) is an
ACCEPTABLE/NON-GUIDELINE study and does not satisfy the guideline
requirement for a 21/28-day dermal toxicity study (OPPTS 870.3200 ; OECD
410) in the rabbit.  The technical grade of the test material was not
studied.  It is not upgradeable because some of the recommended
parameters were not studied, including some hematology, clinical
chemistry and histopathology parameters, but the major parameters were
studied.  The study is useful in that it shows no systemic toxicity at
125 mg/kg/day with a reasonable degree of certainty.

COMPLIANCE:  Signed and dated GLP, Quality Assurance, and Data
Confidentiality statements were (not) provided.  The study was conducted
prior to publication of these regulatory requirements.

	870.3465	90-Day Inhalation – Rat

A.3.2	Prenatal Developmental Toxicity

	870.3700a Prenatal Developmental Toxicity Study – Rat

EXECUTIVE SUMMARY:  In a developmental toxicity study (MRID 45190901)
with chlorflurenol-methyl ester [calculated as 99.1% a.i.; batch/lot# UT
047843] was administered to 31 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 one-half the fetuses viscerally or skeletally.

	Maternal toxicity was seen as a statistically significant decrement in
body weight gain gestational days 6 to 16 at 750 and 1000 mg/kg/day and
at 1000 mg/kg/day gestational day 6-9. Supporting this body weight
decrement was nominally decreased food efficiency at 750 and 1000
mg/kg/day.

The maternal NOAEL was 250 mg/kg/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.  The
incidence of incompletely ossified nasal bones and frontal bone were
increased at 750 and 1000 mg/kg/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/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/day.

The developmental NOAEL is 250 mg/kg/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.

The developmental toxicity study in the rat is classified ACCEPTABLE
[guideline]; and satisfies the guideline requirement for a developmental
toxicity study (OPPTS 870.3700; OECD 414) in the rat.

COMPLIANCE:  Signed and dated GLP, Quality Assurance, and Data
Confidentiality statements were provided.   Historical control data was
submitted for fetuses, but not for litters.

	870.3700b Prenatal Developmental Toxicity Study – Rabbit

	Study not required and unacceptable [MRID# 00120862] due to failure to
submit data on fetal soft tissue and study showed no toxicity in dams or
fetuses.

EXECUTIVE SUMMARY: In a developmental toxicity Study (MRID#s 00120862,
00069980 and 00073536), IT 3456 (chlorflurenol methyl ester, 98% a.i.)
was administered by gastric intubation to 13-14 New Zealand female
rabbits/group at dose levels of 0, 25, 50 or 100 mg/kg/day from days 6
through 18 of gestation.  The submitted study consists of a summary of
the data that was previously submitted to the Agency prior to
implementation of GLP standards as well as copies of the original MRIDs.

There were no treatment related effects in mortality, clinical signs of
toxicity, body weight, or cesarean parameters.   Equivocal reductions in
body weight gain were noted at the mid dose (50 mg/kg/day).  A maternal
LOAEL was not observed.  The maternal NOAEL under the conditions of the
study is => 100 mg/kg/day.

There were no treatment related effects in developmental parameters
including mortality, body weight, abnormalities or skeletal parameters.
A developmental LOAEL was not observed.  The developmental NOAEL under
the conditions of the study is => 100 mg/kg/day.

The study is classified UNACCEPTABLE/GUIDELINE (870.3500 OR 83-3b) and
does not satisfy the guideline requirements for a developmental study in
rabbits and a new study must be conducted.  No maternal or developmental
toxicity was observed.  It appears that the animals could have tolerated
a higher dose level, however, the dose rationale was not provided.  In
addition the following acceptance criteria were not met: individual
fetal soft tissue and skeletal examinations were not performed; at least
12 pregnant animals/dose group were not available because 3 pregnant
rabbits died during the study; and food consumption was not reported.
Moreover, this study should have been properly reformatted as per EPA
requirements.  It therefore seems unlikely this study can be upgraded. .

A.3.3	Reproductive Toxicity

	Not required for a non-food use pesticide, but may show subfertility in
offspring.

	870.3800 Reproduction and Fertility Effects – Rat [MRID# 0008267]

EXECUTIVE SUMMARY:   In a three-generation study on reproduction [MRID#
00082867], Charles River rats [20 females/group and 10 males/group] were
administered chlorflurenol methyl ester at 0, 300, 1000 or 3000 ppm
[Standard table equivalent for P0  males and females: 0, 15, 50 or 150
mg a.i./kg/day] in the diet continuously for 3 generations.
Twenty-one-day old pups [10/sex/group] from only the 3rd generation were
subjected to necropsy; organs were weighted and microscopically
examined.

	Female body weight was consistently lower in the 1000 and 3000 ppm
group than in controls in all generations, P0 [96% and 89% of control,
respectively], F1 [93% and 87% of control, respectively] and F2 [93% and
91% of control, respectively]; none of the reductions in weight were
statistically significant.  Male body weight was unchanged.

	Pup weight was statistically significantly decreased at 1000 and 3000
ppm in the P0, first litter  [91% and 89% of control, respectively] at
day 4, but not at birth and only at 3000 ppm in the second litter at
birth (96% of control)and day 4 (91% of control).  Again for the F2
generation at 1000 and 3000 ppm, the first litter weight was
statistically significantly reduced [91% and 92% of control,
respectively] at day 4, but not at birth of for the second litter at
either dose.  Litter size appeared to be sporadically decreased at 3000
ppm in the P0 second litter at birth and at day 4, and the F1 for both
litters, but not for the F2 for both litters.

	Litter size at birth was statistically significantly reduced at 3000
ppm in 3 of the 6 sets of litters produced during the study [P0 second
litter, F1 first and second litter, but not in the F2 first or second
litter].

	Body weight of the F3, 21-day old pups was significantly reduced at
3000 ppm.  Absolute and relative brain weight was statistically
significantly reduced [90% of control].  Absolute gonad weight was
reduced at 1000 and 3000 ppm [85.1% and 84.6% of control, respectively],
but the relative weight did not differ from control.  Microscopic
examination showed no histopathology.  The only comment about the gonads
was that all animals showed immaturity as may be expected from 21-day
old gonads.

	There was a problematic apparent decrease in fertility at all dose
levels in this 1973 study, which showed a statistically significant dose
relationship only in the first mating of the F2 generation at 1000 [50%]
and 3000 ppm [40%] compared with control at 90% and the 300 ppm group at
80%.  The other matings showed lower fertility than control, but little
to no dose response was shown [See accompanying table in the Appendix].
The P0 first and second matings showed no dose related effects on
fertility, while the F1 first and second matings were lower than control
and for the F2 second matings, control and high dose groups were equally
low.  The suggestion of subfertility in these rats may have been shown,
but unproven. Another study on reproduction is needed  to confirm or
reject the potential effects on fertility and pups.

	Out of 479 matings, 145 showed sperm negative vaginal smears of which
29 of these females produced litters.  This appears to be a high number
of pregnancies for which no vaginal sperm were shown.  When all pregnant
females showing no sperm during cohabitation were added together for the
6 total matings, a treatment related increased response was seen in the
data [last four rows of the table of matings, pregnancies, and
pregnancies with out demonstrated sperm during cohabitation in the
Appendix]. {The method used in determining the presence of vaginal sperm
was not stated and may have been inadequate or the sperm count for some
rats was extremely low.} In addition, if estrous cycles were noted they
were not recorded.  Only the time to pregnancy was recorded.  Historical
control levels were not presented for vaginal sperm negative females
producing litters.  It is the experience of this reviewer that out of
145 sperm negative vaginal spears, no more than 2-3 of these rats would
produce pregnancies and none would be expected to produce pregnancies.

	The study raises unanswered questions about possible effects of
chlorflurenol on fertility in rats.  Histopathology on 21 day old F3
pups showed no histological effects on testes or ovaries [the only pups
studied for these effects]. No gonadal effects were noted in the 2-year
chronic dog study or the 90-day study in rats.   The study on
reproduction should be repeated to clarify the questionable results in
MRID# 00082867.

	Neither the NOAEL nor the LOAEL can be determined due to the
variability from generation to generation.  However, litter size at
birth and pup weight decrement were statistically significantly reduced
at the HDT of 3000 ppm..

	The study is UNACCEPTABLE/GUIDELINE and is not satisfactory for a study
on reproduction in rats [870.3800] .  The data in the study was too
variable for adequate interpretation.

Table of Response of litters in the 3-generation study on reproduction
[MRID# 00082867]

Generation	Parameter	Control	15 mg/kg/day	50 mg/kg/day	150 mg/kg/day

P0 1st mating	Pup wt at birth	6.3	6.1	6.0	6.0

	At day 4	11.1	10.4	10.1*	9.9*

	At day 12	29.0	27.1	25.3**	24.9**

	At day21	58.2	50.8	49.9*	47.2**

	Litter size at birth	12.0	12.2	13.1	12.0

	At day 4 	12.1	11.2	12.1	11.4

	At day12	12.0	11.2	11.8	11.4

	At day 21	12.0	11.2	11.8	11.4

P0 2nd mating 	Pup wt at birth	6.5	6.6	6.4	6.2*

	At day 4	11.6	11.7	11.0	10.6*

	At day 12	31.2	30.5	29.9	28.5**

	At day21	58.7	55.5	55.4	52.8

	Litter size at birth	12.4	11.8	11.91	10.7*

	At day 4 	12.0	10.9	11.2	9.8**

	At day12	11.9	10.9	11.1	9.8**

	At day 21	11.9	10.9	11.1	9.7**

F1 1st mating	Pup wt at birth	6.2	6.7	6.6*	6.6

	At day 4	10.2	10.8	9.4	10.1

	At day 12	27.1	28.2	23.7	26.9

	At day21	54.7	53.2	47.1**	50.8

	Litter size at birth	13.1	11.3	11.2	8.8**

	At day 4 	12.2	9.9	10.4	8.1***

	At day12	11.9	9.7	10.0	7.9***

	At day 21	11.8	9.7	10.0	7.9***

F1 2nd  mating	Pup wt at birth	6.7	6.6	6.8	6.7

	At day 4	11.4	10.9	11.1	11.0

	At day 12	28.9	26.2	26.0	26.8

	At day21	55.0	48.5	50.6	49.8

	Litter size at birth	12.9	12.5	11.6	9.8*

	At day 4 	12.3	12.2	12.0	9.3**

	At day12	12.1	11.9	10.7	9.2**

	At day 21	11.9	11.8	11.9	9.2*

F2 1st mating	Pup wt at birth	6.2	6.3	6.2	6.1

	At day 4	10.5	10.5	9.6*	9.7*

	At day 12	27.7	26.9	24.8*	25.6

	At day21	53.4	51.5	48.4*	49.7

	Litter size at birth	12.3	12.9	12.8	10.5

	At day 4 	11.6	12.1	12.2	10.0

	At day12	11.4	11.9	12.0	9.8

	At day 21	11.4	11.9	12.0	9.6

F2 2nd  mating	Pup wt at birth	6.2	6.6	6.4	6.0

	At day 4	10.4	10.7	10.3	10.3

	At day 12	26.0	26.2	24.6	23.9

	At day21	51.0	51.9	50.4	46.1

	Litter size at birth	12.1	13.8	12.2	11.4

	At day 4 	11.0	13.0*	11.5	11.0

	At day12	10.7	12.7	11.3	11.0

	At day 21	10.5	12.2	11.2	11.0

* , **, *** = p < 0.05. <0.01 or 0.001

Table of matings, pregnancies and pregnancies without apparent sperm for
P0, F1 and F2 generations [MRID# 00082867]  Data taken from page 42 -
46.

Dose group [mg/kg/day]	Total mating with  positive sperm smears a	Total
pregnancies

[with positive & negative sperm]	Not pregnant

[with positive & negative sperm]	# rats without sperm positive smears
Pregnancy rate [%]

Total	Pregnant	Not pregnant

	1st P0 Mating with 20 females/group

0	19	20	0	1	1	0	100

300	14	13	7	6	2	4	65**

1000	19	18	2	1	1	0	90

3000	16	18	2	4	2	2	90

2nd P0 mating with 20 females/group

0	18	18	2	2	0	2	90

300	14	15	5	6	2	4	75*

1000	20	20	0	0	0	0	100

3000	18	20	0	2	2	0	100

1st F1 mating with 20 females/group

0	13	14	6	7	2	5	70

300	14	11	9	6	2	4	55

1000	11	12	8	9	1	8	60

3000	9	11	9	11	4	7	55

2nd F1 mating with females/group

0	16	14	6	4	0	4	70

300	12	11	9	8	1	7	55

1000	11	10	10	9	2	7	50

3000	10	12	8	10	2	8	60

1st F2 mating with 20 females/group

0	19	18	2	1	0	1	90

300	15	16	4	5	1	4	80

1000	9	10	10	11	1	10	50*

3000	7	8	12	13	2	11	40**

2nd F2 mating with 19 females in control and 20 females/.dose group

0	12/19	12/19	7/19	7/19	0/19	7/19	63

300	12	11	9	8	1	7	55

1000	7	6	14	13	0	13	30

3000	9	7	13	11	0	11	35

Summary results of total P0, F1 and F2 matings, including controls

Total	324/479	325/479	154/479	155/479	29/479	126/479	68

Summary data from the first and second matings of the PO, F1 and F2
generations

0	97/119	97/119	21/119	22/119	3/119	19/119	80.7

300	81/120	77/120	43/120	39/120	9/120	30/120	64.2

1000	77/120	76/120	44/120	43/120	5/120	38/120	63.3

3000	69/120	76/120	44/120	51/120	12/120	39/120	63.3

a = # females mated with positive sperm smears. * = p > 0.05, **  = p >
0.01.

A.3.4	Chronic Toxicity

	870.4100a (870.4300) Chronic Toxicity – Rat [MRID# 00082864]

	Unacceptable as a chronic study due to several factors, especially
microscopic examination was conducted on only 3 rats/sex

	870.4100b Chronic Toxicity – Dog {MRID# 00082863]

EXECUTIVE SUMMARY:   In a chronic toxicity study (MRID 00082863) IT 3456
[Chlorflurenol, technical (96% a.i., batch/lot # 5/69)] 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, 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.  One extra dog/sex/group was treated with test material for
104 weeks, after which the dogs were untreated for 8 weeks.  Hematology
and clinical chemistry evaluation was performed at 6 intervals during
the study.  Animals were subjected to gross pathology and microscopic
examination.

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.

Erythrocytes [ERY], hemoglobin concentration [Hb] and hematocrit [Ht]
values appeared to be slightly decreased at the HDT in males and females
starting at week 4 [the first time period evaluated] and male dogs
maintained a decrease through out the study.   Some of the values in the
HDT were statistically significantly reduced, but were still within the
normal range for dogs.    The (ERY, (Hb and (Ht values [difference
between measured values and week -2 values] appeared to decrease in
males and females at the HDT starting at week 4 and male dogs maintained
the decrease through out the study.  This decrease is consistent with
the slightly higher incidence and/or severity of siderous in the spleen,
liver and Kupffer cells at the HDT.    Hemosiderin in the 1000 ppm group
was not considered sufficiently consistent to show that the mid dose
group was affected.  In addition the values for 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.

Clinical chemistry values showed no consistent treatment related
effects.  Organ weights were unchanged from control values.

On microscopic examination increased hemosiderin in liver and liver
Kupffer cells and possibly in the spleen at the HDT seemed to confirm
the hematological effects.  In addition, the highest dose group showed
higher incidence of gastritis and possible stomach lymphatic
hyperplasia.

A single dog/sex was allowed to recover for 2 months and although the
hemosiderin appeared to decrease, effects in one dog are difficult to
interpret.

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.

This study is ACCEPTABLE/GUIDELINE and satisfies the guideline
requirement [870.4100b] for a dog chronic study.   This DER takes
precedence over previous conclusions.

A.3.5	Carcinogenicity

	870.4200a Carcinogenicity Study – rat [MRID# 00082866]

	Unacceptable due to only1-year interim report of a 2-year study was
submitted. and other factors   Not required.

	870.4200b Carcinogenicity (feeding) – Mouse [MRID# 00082865]

SUMMARY: In a carcinogenicity study in mice [MRID 00082865], 50
NMBI-FMD-SPF mice/sex were administered IT 3456 [chlorflurenol methyl
ester] in the feed at 0, 1000, 3000 or10000 ppm  [equivalent to Males:
0, 136, 397 or 1538 mg/kg/day; Females: 0,158, 504 or 1905 mg/kg/day]
for 18 months.  Weekly body weights were determined up to week 12 and
every two weeks to termination.  Weekly food consumption was determined
up to week 12 and every two weeks to termination.  Necropsy and
microscopic examination of the tissue were performed at termination.

No dose related or treatment related effects were noted in any parameter
studied.  Mortality, body weight, and food consumption were unchanged.
Random tumors were seen after microscopic examination, but a dose or
treatment relationship was absent.   Neoplasms of the reticular tissue
were 8.25%, 15.96, 15.63 and 14.13%, respectively  in control, 1000 ppm,
3000 ppm and 10000 ppm.  Since historical control data for this neoplasm
ranges from 5% to 28%, control appear to be low compared with dosed
groups.  In addition, although over a 10 fold dose range, no dose
response was seen.   The highest incidence of tumors were pulmonary
adenomas.  Total pulmonary adenomas [benign and malignant] were 15.5%,
9.6%, 12.5% and 9.8%, respectively in control, 1000 ppm, 3000 ppm and
10000 ppm.

No dose related toxic or carcinogenic effects were noted in mice above
the limit dose level of 1 g/kg/day.

The NOAEL was the highest dose tested of 1538/1905 mg/kg/day in male and
female mice.  A LOAEL was not seen.

The study is ACCEPTABLE/GUIDELINE and satisfies the requirements for a
carcinogenicity study in mice [870.4200].  The study was done prior to
GLPs.   Organ weights were not determined and some summary table were
not presented, but the study results appeared to be adequate to show
that there were no carcinogenic response in mice to chlorflurenol
administration.

A.3.6	Mutagenicity

	See Table A.2.2 for summary of the mutagenicity studies.

A.3.7	Neurotoxicity

	These studies are not required.  Chlorflurenol methyl ester is neither
an organic phosphate nor shows evidence of neurotoxicity.

	870.6100 Delayed Neurotoxicity Study - Hen

	870.6200 Acute Neurotoxicity Screening Battery

	870.6200 Subchronic Neurotoxicity Screening Battery

	870.6300 Developmental Neurotoxicity Study

A.3.8	Metabolism

	870.7485	Metabolism – Rat

	Not required, but an unacceptable study was submitted   Study showed
some information, but study was inadequately replicated since most of
the tests were conducted in only one female rat.

EXECUTIVE SUMMARY: Kinetics and distribution of radiolabeled IT 3456, IT
3294 and IT 5733 [3 components of chlorflurenol methyl ester] were each
assessed [MRID 0082868].  The kinetic were conducted in 3 experiments.
Experiment 1: One female Wistar rat each was administered a single dose
of 5 mg of IT 3456, IT 3294 or IT 5733/kg and the amount excreted n the
urine and feces collected at 24 hours.  Another set of 3 females were
dosed similarly and urine and feces collected at 72 hours and whole body
radio-autography conducted to located residual radiolabel.  Experiment
2: One lactating female/ test material was dosed with 10 mg/kg and 3
days later radio-autography conducted to locate residual radiolabel.
Experiment 3: One nursing dam with 10 pups/dam was dosed with 5 mg/kg
and 3 days later radiolabel was counted in 2 pups/time period of 1, 2, 4
8 and 24 hours.  Doses were administered in 0.5 mL DMSO/kg by
intravenously into the caudal vein in Experiment 1 and 3 and by gavage
in 0.5 ml DMSO/kg in Experiment 2.

	Each of all 3 test materials were excreted almost completely within 24
hours primarily in the urine with lesser amounts in the feces; small
amounts were excreted between 24 and 72 hours.  Enterohepatic
circulation was noted.  Most of the radiolabel detected were in the
lungs and kidney with small amounts of radiolabel detected in the
mammary gland in Experiment 2.  Pups from Experiment 3 showed no
measurable radiolabeled test material.

	Thus, each of all three test materials were rapidly excreted in the
urine and feces, with small amounts being seen in the mammary gland and
none in the milk.

The study is UNACCEPTABLE/NG for a metabolism study in rodents.  The
study results were no replicated and some of the data was not presented
and/or readable and thus conclusions were not verifiable.  Test
materials were inadequately identified.  Distribution of the radiolabel
in the rats was not adequately quantified.  The study may have been a
range-finding study.

COMPLIANCE: These studies were conducted in 1972 prior to GLP Guideline
requirements.  No quality Assurance or Data Confidentiality Claim
statements were provided.

A.3.9	Dermal Absorption

	870.7600	Dermal Absorption – Rat

	A dermal absorption was not submitted.

A.4	References

00082863 	Frohberg, H.; Metallinos, A.; Pies, H.; et al. (1975) Chronic
Toxicity Test with IT 3456 in Beagle Dogs: Administration with the Food
over a Period of Two Years.  (Translation; unpublished study received
Apr 25, 1978 under 21137-EX-3; prepared by E. Merck, West Germany,
submitted by EM Laboratories, Inc., Elms- ford, N.Y.; CDL:097056-A).

00082865	Hofmann, A.; Weisse, G.; Kovac, W.; et al. (1976) IT 3456:
18-month Carcinogenicity Study in Mice, Substance Administered in the
Food: Document No. CF 41 E/76.  (Unpublished study received Apr 25, 1978
under 21137-EX-3; prepared by E. Merck, West Germany, submitted by EM
Laboratories, Inc., Elmsford, N.Y.; CDL: 097058-A)

00082868	Wenzl, H.; Garbe, A.; Nowak, H. (1972) EMD-IT 3294; EMD-IT
5733; EMD-IT 3456: Investigations of the Kinetics and Distribution in
Rats: Document No. CF 6/72.  (Translation; unpublished study received
Apr 25, 1978 under 21137-EX-3; prepared by E. Merck, West Germany,
submitted by EM Laboratories, Inc., Elmsford, N.Y.; CDL:097058-E)

00120883	Kohn, F.; Stahoviak, E.; Vega, S.; et al. (1970) Report to
United States Borax Research Corporation: 21-day Subacute Dermal
Toxicity Study of Maintain CF-125: Lifestream Laboratories Project No.
1385.  (Unpublished study received Jan 7, 1970 under 1624-8; prepared by
Lifestream Corp., submitted by United States Borax & Chemical Corp., Los
Angeles, CA; CDL:108523-A)

43355402	Wnorowski, G. (1994) Acute Oral Toxicity Limit Test:
(Chlorflurenol Methyl): Lab Project Number: 3170.  Unpublished study
prepared by Product Safety Labs.  16 p.

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␱䀀Ħ摧熟¨ༀ355403	Wnorowski, G. (1994) Acute Dermal Toxicity
Limit Test: (Chlorflurenol Methyl): Lab Project Number: 2958.
Unpublished study prepared by Product Safety Labs.  15 p.

43355404	Wnorowski, G. (1994) Primary Eye Irritation: (Chlorflurenol
Methyl): Lab Project Number: 2605.  Unpublished study prepared by
Product Safety Labs.  21 p.

43355405	Wnorowski, G. (1994) Primary Skin Irritation: (Chlorflurenol
Methyl): Lab Project Number: 2864.  Unpublished study prepared by
Product Safety Labs.  16 p.

43361701	Wnorowski, G. (1994) Dermal Sensitization Test--Buehler Method:
(Chlorflurenol Methyl): Lab Project Number: 3035.  Unpublished study
prepared by Product Safety Labs.  24 p. 43595402	Pant, K. (1995)
Evaluation of a Test Article in the Salmonella typhimurium Plate
Incorporation Mutation Assay in the Presence and Absence of
Aroclor-Induced Rat Liver S-9: Chlorflurenol-Methyl: Lab Project Number:
0336-2110: CFM-NITA-842A.  Unpublished study prepared by SITEK Research
Labs.  49 p.

43562801	Thilagar, A. (1995) Test for Chemical Induction of Chromosome
Aberration in Cultured Chinese Hamster Ovary (CHO) Cells With and
Without Metabolic Activation: Final Report: Lab Project Number:
0336-3110: CFM-NITA-842B.  Unpublished study prepared by Sitek Research
Labs.  59 p.

45137404	Timm, A. (1988) Unscheduled DNA Synthesis in Hepatocytes of
Male Rates in Vitro (UDS Test) with Chlorflurenol-Methyl, Technical: Lab
Project Number: 117033.  Unpublished study prepared by CCR Cytotest Cell
Research GmbH & Co. KG.  30 p. {OPPTS 870.5550}

45137405	Heidemann, A. (1988) Detection of Gene Mutations in Mammalian
Cells in Vitro HGPRT Test with Chlorflurenol-Methyl, Technical: Lab
Project Number: 117022.  Unpublished study prepared by CCR Cytotest Cell
Research GmbH & Co. KG.  34 p. {OPPTS 870.5300}

45147201	Moore, G. (2000) Acute Inhalation Toxicity Study in Rats-Limit
Test: Chlorflurenol-Methyl (ICA-MECFOL): Lab Project Number: 9125: P330.
 Unpublished study prepared by Product Safety Labs. 24 p. {OPPTS
870.1300}

45190901	Muller, W. (2000) Chlorflurenol-Methyl, Technical Oral (Gavage)
Teratogenicity Study in the Rat: Lab Project Number: 926-460-028:
460-028.  Unpublished study prepared by Hazleton Laboratories
Deutschland GmbH.  222 p.

45441001	Kuhn, J. (2001) 90-Day Oral Toxicity Study in Rats (Diet):
Chlorflurenol Methyl Ester: Final Report: Lab Project Number: 5472-99.
Unpublished study prepared by Stillmeadow, Inc. 136 p. {OPPTS 870.3100}

		Page   PAGE  1  of   NUMPAGES  82

Page   PAGE  93  of   NUMPAGES  82


[Federal Register: July 8, 2009 (Volume 74, Number 129)]
[Rules and Regulations]
[Page 32421-32423]
[DOCID:fr08jy09-10]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0417; Directorate Identifier 2009-NE-13-AD;
Amendment 39-15955; AD 2009-14-05]
RIN 2120-AA64

Airworthiness Directives; Pratt & Whitney Models PW2037,
PW2037(M), and PW2040 Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
Pratt & Whitney models PW2037, PW2037(M), and PW2040 turbofan engines.
This AD requires 12th stage disks of certain high-pressure compressor
(HPC) drum rotor disk assemblies, to be inspected for cracks by Pratt &
Whitney using a special eddy current inspection procedure. This AD
results from six HPC 12th stage disks found cracked during HPC module
disassembly at overhaul. We are issuing this AD to prevent uncontained
failure of the HPC 12th stage disk and airplane damage.

DATES: This AD becomes effective July 23, 2009. The Director of the
Federal Register approved the incorporation by reference of certain
publications listed in the regulations as of July 23, 2009.
    We must receive any comments on this AD by September 8, 2009.

ADDRESSES: Use one of the following addresses to comment on this AD:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: U.S. Docket Management Facility, Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Mark Riley, Aerospace Engineer, Engine
Certification Office, FAA, Engine and Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>.
    Contact Pratt & Whitney, 400 Main Street, East Hartford, CT 06108,
for the service information identified in This AD.

SUPPLEMENTARY INFORMATION: In November 2006, a Pratt & Whitney model
PW2037 turbofan engine was found to have a cracked HPC 12th stage disk
during routine overhaul. The crack extended from the disk bore to the
disk rim. Investigation by Pratt & Whitney revealed that the disk had a
material defect that occurred during original manufacture. In July
2007, a second HPC 12th stage disk was found cracked with the same
defect. In response to the cracking, Pratt & Whitney issued Alert
Service Bulletin (ASB) No. PW2000 A72-736 on January 5, 2009,
recommending removal of 26 additional HPC 12th stage disks,
manufactured from this same material heat. Pratt concluded that this
population might have the same material defects and therefore, be
susceptible to cracking. Thereafter, in February 2009, after Pratt &
Whitney issued the ASB, we became aware of four additional HPC 12th
stage disks, manufactured from the same material heat, that had small
cracks in the disk bores that originated from similar material defects.
Because of Pratt & Whitney's recommended short compliance times in the
ASB, we are issuing this final rule; request for comments AD. This
condition, if not corrected, could result in uncontained failure of the
HPC 12th stage disk and airplane damage.

Relevant Service Information

    We have reviewed and approved the technical contents of Pratt &
Whitney ASB No. PW2000 A72-736, dated January 5, 2009. That ASB
describes procedures for having Pratt & Whitney perform the special
eddy-current inspection performed on the 12th stage disks.

Differences Between This AD and the Service Information

    The recommended compliance times in the Pratt & Whitney ASB are
stated as calendar dates for each engine model. We specify cycles-in-
service rather than calendar dates, because the risk of crack
development is cycle, not time dependant.

FAA's Determination and Requirements of This AD

    The unsafe condition described previously is likely to exist or
develop

on other Pratt & Whitney models PW2037, PW2037(M), and PW2040 turbofan
engines of the same type design. For that reason, we are issuing this
AD to prevent uncontained failure of the HPC 12th stage disk and
airplane damage. This AD requires 12th stage disks of certain HPC drum
rotor disk assemblies, to be inspected for cracks by Pratt & Whitney
using a special eddy current inspection procedure.

FAA's Determination of the Effective Date

    Since an unsafe condition exists that requires the immediate
adoption of this AD, we have found that notice and opportunity for
public comment before issuing this AD are impracticable, and that good
cause exists for making this amendment effective in less than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety and was not preceded by notice and an opportunity for public
comment; however, we invite you to send us any written relevant data,
views, or arguments regarding this AD. Send your comments to an address
listed under ADDRESSES. Include ``AD Docket No. FAA-2009-0417;
Directorate Identifier 2009-NE-13-AD'' in the subject line of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of the rule that might
suggest a need to modify it.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this AD. Using the search function of the
Web site, anyone can find and read the comments in any of our dockets,
including, if provided, the name of the individual who sent the comment
(or signed the comment on behalf of an association, business, labor
union, etc.). You may review the DOT's complete Privacy Act Statement
in the Federal Register published on April 11, 2000 (65 FR 19477-78).

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is the same as
the Mail address provided in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We have determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have a
substantial direct effect on the States, on the relationship between
the national Government and the States, or on the distribution of power
and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a summary of the costs to comply with this AD and
placed it in the AD Docket. You may get a copy of this summary at the
address listed under ADDRESSES.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

0
Under the authority delegated to me by the Administrator, the Federal
Aviation Administration amends part 39 of the Federal Aviation
Regulations (14 CFR part 39) as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2009-14-05 Pratt & Whitney: Amendment 39-15955. Docket No. FAA-2009-
0417; Directorate Identifier 2009-NE-13-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective July 23,
2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Pratt & Whitney models PW2037, PW2037(M),
and PW2040 turbofan engines, with the following high-pressure
compressor (HPC) drum rotor disk assemblies installed:

            Table 1--Affected HPC Drum Rotor Disk Assemblies
------------------------------------------------------------------------
 Drum Rotor Disk Assembly Part No. 1B3702;
1B3702-001; 1B3610; 1B3610-001; or 1B7377--  12th Stage Disk Billet and
                 Serial No.                           Heat No.
------------------------------------------------------------------------
T62805....................................  T/LALY-4013
R80293....................................  T/LALY-4012
R80289....................................  T/LALY-4010
R80322....................................  T/LALY-4009
R80330....................................  T/LALY-4008
R78394....................................  T/LALY-4007
R80281....................................  T/LALY-4006
R80304....................................  T/LALY-4005
R80343....................................  T/LALY-4004
R80299....................................  T/LALY-4003
R80313....................................  T/LALY-4002
R80333....................................  M1/LALY-4035
R80324....................................  M1/LALY-4034
R80310....................................  M1/LALY-4033
R80326....................................  M1/LALY-4030
R80305....................................  M1/LALY-4026
R80315....................................  M1/LALY-4025
R80309....................................  M1/LALY-4024
R80341....................................  M1/LALY-4023
R80329....................................  M1/LALY-4022
R80312....................................  M1/LALY-4020
R80321....................................  M1/LALY-4019
R80319....................................  M2/LALY-4040
R80358....................................  M2/LALY-4039
R80302....................................  M2/LALY-4038
R80336....................................  M2/LALY-4037
------------------------------------------------------------------------

    These engines are installed on, but not limited to, Boeing 757-
200 and 757-300 airplanes.

Unsafe Condition

    (d) This AD results from six HPC 12th stage disks found cracked
during HPC module disassembly at overhaul. We are issuing this

AD to prevent uncontained failure of the HPC 12th stage disk and
airplane damage.

Compliance

    (e) You are responsible for having the actions required by this
AD performed at the following compliance times:
    (1) For PW2040 turbofan engines, within 200 cycles-in-service
(CIS) after the effective date of this AD, unless the actions have
already been done.
    (2) For PW2037 and PW2037(M) turbofan engines, within 400 CIS
after the effective date of this AD, unless the actions have already
been done.

Non-Destructive Inspection

    (f) Have a special eddy-current inspection performed on the 12th
stage disks installed in the HPC drum rotor disk assemblies listed
in Table 1 of this AD, for cracks. Use paragraph 1 of the
Accomplishment Instructions of Pratt & Whitney Alert Service
Bulletin No. PW2000 A72-736, dated January 5, 2009, to do the
special eddy current inspection.

Alternative Methods of Compliance

    (g) The Manager, Engine Certification Office, has the authority
to approve alternative methods of compliance for this AD if
requested using the procedures found in 14 CFR 39.19.

Related Information

    (h) Contact Mark Riley, Aerospace Engineer, Engine Certification
Office, FAA, Engine and Propeller Directorate, 12 New England
Executive Park, Burlington, MA 01803; e-mail<EMAIL_ADDRESS>
telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>.

Material Incorporated by Reference

    (i) You must use Pratt & Whitney Alert Service Bulletin No.
PW2000 A72-736, dated January 5, 2009, to have the special eddy
current inspections performed by this AD. The Director of the
Federal Register approved the incorporation by reference of this
service bulletin in accordance with 5 U.S.C. 552(a) and 1 CFR part
51. Contact Pratt & Whitney, 400 Main Street, East Hartford, CT
06108, for a copy of this service information. You may review copies
at the FAA, New England Region, 12 New England Executive Park,
Burlington, MA; or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://
www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Burlington, Massachusetts, on June 23, 2009.
Peter A. White,
Assistant Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
[FR Doc. E9-15398 Filed 7-7-09; 8:45 am]

BILLING CODE 4910-13-P


MEMORANDUM

SUBJECT:	Meeting with Portland Cement Association et al. Regarding EPA
Proposal to Change the Policy Known as “Once In, Always In”

TO:  		Docket Number EPA-HQ-OAR-2004-0094

Date: 		July 17, 2007

Location: 	Environmental Protection Agency (EPA)

Ariel Rios North

Washington, DC

Attendees: 	Industry Representatives:

Andy O’Hare, Portland Cement Association

		Phil Wakelyn, National Cotton Council of America

		Dave Ailor, National Oilseed Producers Association

		EPA Representatives in DC:

Robert Meyers, EPA Office of Air and Radiation

		Don Zinger, EPA Office of Air and Radiation

		Robert Brenner, EPA Office of Air and Radiation OPAR

		Tamara Saltman, EPA Office of Air and Radiation OPAR

		EPA Representatives via phone in Research Triangle Park:

		Steve Page, EPA Office of Air and Radiation OAQPS

		Peter Tsirigotis, EPA Office of Air and Radiation OAQPS

		Penny Lassiter, EPA Office of Air and Radiation OAQPS

		Fred Thompson, EPA Office of Air and Radiation OAQPS

		Michael Regan, EPA Office of Air and Radiation OAQPS

		Eric Ginsburg, EPA Office of Air and Radiation OAQPS

		Rick Colyer, EPA Office of Air and Radiation OAQPS

Mr. O’Hare, Mr. Wakelyn, and Mr. Ailor requested a meeting with EPA to
discuss EPA’s January 3, 2007 proposal to replace the “Once In,
Always In” policy.  Mr. O’Hare explained that they were part of a
formal coalition of industry trade groups that was following progress of
the proposal.  They expressed interest in the status of the changes to
the policy and the process and timing for completion of a final rule.
They asked if and how they could be of help to expedite the process, and
expressed concern over a pending amendment to a Congressional spending
bill funding EPA which would prohibit funds to be used to promulgate and
implement the final rule.

EPA responded that it was still reviewing the public comments received
on the proposal and was following the customary process for finalizing
rules.  EPA did not identify any expected date or timeline for
finalizing the proposed rule.  EPA also explained that there was limited
staff time to work on this proposal, due to the need to complete
numerous rules with mandatory court deadlines in the near future.  EPA
was also aware of the spending bill amendment but noted that Congress
was going to do whatever it does and that EPA would comply with the
final outcome.

In addition, EPA noted that the potential for some sources to emit more
air toxics (known as “backsliding”) as a result of the proposal than
would have occurred under the existing Once In, Always In policy was a
concern to several commenters.  EPA explained that it does not currently
have sufficient information to indicate that backsliding is a
significant concern.  Mr. O’Hare responded that they believe
backsliding was not a concern in their industry coalition as a result of
EPA’s proposal but was unable to provide any specifics regarding
potential increases or decreases in emissions.  The industry
representatives reiterated to EPA that the proposal is important to them
and that they will continue to follow the rulemaking and work with EPA
and Congress to help facilitate finalizing the proposed changes to the
Once In, Always In policy.

 PAGE

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