Document ID: EPA-HQ-OPP-2006-0874-0013
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-11-01T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF   

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES 

		PC Code No.:	098801

DP Barcode:	362456

		Date:	June 30, 2006

								[Revised Oct 24, 2006; p.3 deletion]

SUBJECT:	Environmental fate and ecological risk assessment for
re-registration of chlorflurenol methyl ester (ME), an herbicide/plant
growth regulator for use on ornamentals, hedge and fence rows, turf,
shade trees, woody shrubs and vines, and to produce planting material
for pineapple production.

TO:		Tawanda Spears, Chemical Review Manager

		Michael Goodis, Branch Chief

Special Review and Re-registration Division (7508P)

FROM:		ERB V Team for Chlorflurenol ME:

Jennifer Leyhe, M.S., Biologist, Ecological Effects Reviewer

Larry Liu, Ph.D., Chemist, Environmental Fate Reviewer

Environmental Fate and Effects Division (7507P)

THROUGH:	Karen Whitby, Ph.D., Acting Branch Chief

Environmental Risk Branch V

Environmental Fate and Effects Division (7507P)

The attached document contains the Environmental Fate and Effects
Division’s (EFED) screening-level environmental risk assessment for
Chlorflurenol ME.  The risk assessment has been conducted in accordance
with the Agency guidance on ecological risk assessment and the OPP
ecological risk assessment Overview document. Chlorflurenol ME is used
as an herbicide/plant growth regulator on ornamentals, hedge and fence
rows, turf, shade trees, woody shrubs and vines, and to produce planting
material for pineapple production.  An evaluation of environmental risk
to aquatic and terrestrial organisms as a result of the use of
chlorflurenol ME is summarized in the Executive Summary and the Risk
Characterization sections of the attached document.  This assessment was
conducted with minimal data and therefore contains major uncertainties.

Outstanding Data Requirements and Data Gaps  

Environmental Fate:

The environmental fate data gaps are listed in Table 1 (also Appendix H,
the attached environmental risk assessment document).  In order to meet
data requirements and reduce uncertainty, the registrant is requested to
conduct:

161-1 Hydrolysis

161-2 Aqueous photolysis

161-3 Soil photolysis

162-1 Aerobic soil metabolism

162-2 Anaerobic soil metabolism

162-3 Anaerobic aquatic metabolism

163-1 Adsorption/desorption

164-1 Terrestrial field dissipation

165-4 Fish bioaccumulation

201-1 Droplet Size Spectrum 

202-1 Drift Field Evaluation

Ecological Effects: 

The screening-level risk assessment for chlorflurenol ME has been
conducted, despite unfulfilled guideline requirements and existing data
gaps.  Table 2 (also Appendix H, the attached environmental risk
assessment document) lists the status of the ecological effects data
requirements for chlorflurenol ME. In order to reduce uncertainty in
this risk assessment, we are requesting that the registrant submit the
following:

  SEQ CHAPTER \h \r 1 Guideline 72-1: Acute freshwater fish.

Guideline 72-2: Acute freshwater invertebrate.

Guideline 72-3: Acute estuarine/marine fish and invertebrate.

Guideline 72-4: Chronic fish.

  SEQ CHAPTER \h \r 1 Guideline 71-4: Avian reproduction.

Guideline 123-1: Terrestrial plant seedling emergence and vegetative
vigor. 

Guideline 123-2 Aquatic plant growth 

  SEQ CHAPTER \h \r 1 Guideline 141-1: Honey bee acute contact toxicity.

Uncertainties

Environmental Fate:

The registrant has submitted three studies to support the environmental
fate data requirements; however, these studies were considered either
supplemental or unacceptable (see reasons below).  As a result, the
uncertainty analysis could not be performed with confidence. 

  SEQ CHAPTER \h \r 1 Guideline 161-1: The study was conducted at pHs 3,
6 and 9 rather than pHs 5, 7 and 9 as required in Subdivision N
Guidelines.  This study was determined to be supplemental.  The
hydrolysis data requirements have not been fulfilled.  A new study
including pH 7 is required.

  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 Guideline 162-1: The study
was conducted outdoors in the summer where the environmental conditions,
soil aerobicity, microbial viability, and soil moisture were neither
controlled nor reported.  Subdivision N Guidelines require that the
study be conducted in the dark at 25 ± 1°C.  This study was determined
to be unacceptable.  The aerobic soil metabolism data requirements have
not been fulfilled.  A new study is required.  

Guideline 163-1:  Only one test soil type was used in the adsorption
study and it could not be determined if this German soil was comparable
to soils found in typical use areas in the United States.  Subdivision N
guidelines specify that four different soil types should be used.  This
study was determined to be supplemental.  The adsorption/desorption data
requirements have not been fulfilled.  A new study including three soils
is required.  SEQ CHAPTER \h \r 1  

Ecological Effects: 

  SEQ CHAPTER \h \r 1 Acute oral and dietary toxicity studies in birds
and acute oral toxicity studies in mammals failed to establish
definitive acute LD50/LC50 values (i.e., the LC50 was expressed as
“greater than” the highest dietary concentration tested); thus,
significant uncertainty was introduced into the avian oral- and
dietary-based and mammalian oral-based acute RQ calculations.

The study testing oral toxicity to birds did not state which components
were included in the test material.  EFED assumes the test material
contained all three components which may underestimate risk to birds on
an acute oral basis if in fact the test material only contained one of
the three components.

The mammalian chronic RQs are based on a developmental study that shows
evidence of delayed skull ossification and cleft palates in young rats. 
These endpoints are not adequate for determining risk to the survival
and fecundity of a population.  However, without other studies EFED used
these data.  Therefore, the RQs may not accurately portray chronic risk
to mammals.   Risk may be under- or over-estimated.

Application interval and number of applications per year are not
indicated on the label.  For multiple application scenarios, the T-REX
model requires both of these parameters in order to estimate exposure to
terrestrial organisms.  In the absence of these numbers an application
interval of 28 days and 8 applications per year (as derived by HED,
Appendix B, attached risk assessment document) were used.  HED used
information provided on the labels along with knowledge of the crop/weed
growth cycles, pest pressure timing, etc. to determine the application
interval and yearly number of applications.  Since these numbers are
considered “likely” applications per year, risk to terrestrial
organisms may be underestimated.

EFED Label Recommendations

The EFED recommends the following changes in hazard labeling:

End Use Products

[Strike]	-	The pesticide is toxic to birds and mammals.  [Revised Oct
24, 2006]

This pesticide is toxic to fish and aquatic invertebrates.

This product is highly toxic to bees exposed to direct treatment on
blooming crops or weeds. Do not apply this product or allow it to drift
to blooming crops or weeds while bees are actively visiting the
treatment area.

Do not apply directly to water, or to areas where surface water is
present or to intertidal areas below the mean high water mark.  Do not
contaminate water when disposing of equipment washwater or rinsate.

Drift may be hazardous to aquatic organisms in water adjacent to treated
areas.

Manufacturing Use:

Do not discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans, or other waters unless in accordance with the
requirements of a National Pollutant Discharge Elimination System
(NPDES) permit and the permitting authority has been notified in writing
prior to discharge.  Do not discharge effluent containing this product
to sewer systems without previously notifying the local sewage treatment
plant authority.  For guidance contact your State Water Board or
Regional Office of the EPA.

Table 1. Environmental Fate Data Requirements.

Date:

Case No: n/a

Chemical No:  098801	CHLORFLURENOL ME

DATA REQUIREMENTS FOR THE 

ENVIRONMENTAL FATE AND EFFECTS DIVISION

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

' 158.290 ENVIRONMENTAL FATE

Degradation Studies – Lab:

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

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

	Yes

161-3 Photolysis in Soil	TGAI or PAIRA	10

	Yes

Metabolism Studies – Lab:

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

162-2 Anaerobic Soil Metabolism	TGAI or PAIRA	3

	Yes

162-3 Anaerobic Aquatic Metabolism	TGAI or PAIRA	10

	Yes

Mobility Studies:

163-1 Leaching and adsorption/desorption	

TGAI or PAIRA	

3, 10, 11	

43496202

	

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

Dissipation Studies - Field:

164-1 Terrestrial Field Dissipation	TEP	3, 11

	Yes

164-3  Forestry	TEP	10

	Waived

Accumulation Studies:

165-4 Fish Bioaccumulation	TGAI or PAIRA	3, 10

	Yes

165-5  Aquatic Non-Target Organisms	TEP	10

	Waived

Ground Water Monitoring Studies:

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

	Reserved

' 158.440 SPAY DRIFT

201-1 Droplet Size Spectrum

3, 11

	Yes

202-1 Drift Field Evaluation

3, 11

	yes

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

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

  SEQ CHAPTER \h \r 1 Table 2. Ecological Effects Data Requirements for
Chlorflurenol ME.

Guideline #

	Data Requirement

	Test Substance

	MRID # or Citation

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

71-1	Avian Oral LD50	TGAI	43595401	Acceptable	No

71-2	Avian Dietary LC50	TGAI	43623601

43623602	Acceptable	No

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

72-1	Freshwater Fish LC50	TGAI	120852/00047185

140979

45137401

45242602

45242601

45137402	Invalid	Yes

TEP	90289

119925/120889

120870	Invalid	No

72-2	Freshwater Invertebrate Acute LC50	TGAI	45137403

45242603

	Invalid	Yes

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

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

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

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

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

72-4(c)

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

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

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

123-1(b)	Vegetative Vigor 

(Tier II)	No Data Submitted – Data Gap	Yes

123-2	Aquatic Plant Growth

 (Tier II)	No Data Submitted – Data Gap	Yes

141-1	Honey Bee Acute

 Contact LD50	No Data Submitted – Data Gap	Yes

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

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

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

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

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