Document ID: EPA-HQ-OPP-2005-0494-0031
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-11-14T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

MEMORANDUM	Date:  May 24, 2006

SUBJECT:	Environmental Fate and Ecological Risk Assessment Chapter (DP
Barcode D307382) in Support of Phase IV of the Reregistration
Eligibility Decision on Rotenone (PC Code 071003)

FROM:	R. David Jones, Ph.D., Senior Agronomist

		Thomas Steeger, Ph.D., Senior Biologist

		Environmental Risk Branch IV

Environmental Fate and Effects Division (7507C)

		Office of Pesticide Programs		

		

THROUGH:	Elizabeth Behl, Branch Chief

		Environmental Risk Branch IV

		Environmental Fate and Effects Division (7507C)

		Office of Pesticide Programs

		

TO:		Katherine Hall, Chemical Review Manager

		Tom Myers, Risk Manager

		Special Review and Reregistration Divison (7508C)

Office of Pesticide Programs

The Environmental Fate and Effects Division (EFED) has completed the
draft environmental fate and ecological risk assessment chapter (DP
Barcode D307382) in support of Phase IV of the reregistration
eligibility decision on rotenone (PC Code 071003).  The chapter has been
revised to reflect comments received during the public comment phase
(Phase III) of reregistration.  Conclusions regarding the environmental
fate, ecological effects and ecological risks associated with the
current uses of rotenone can be found in the executive summary of the
attached document.  Although agricultural/commercial uses of rotenone
will no longer be supported, the science chapter discusses these uses
along with the piscicidal use. EFED recommends that application of
rotenone directly to water only be made through close adherence to
established standard operating procedures intended to limit the extent
to which rotenone can move outside of treatment areas.

As indicated during Phase I (DP Barcode D307390), the risk assessment of
terrestrial uses (agricultural, commercial and residential) relied on
conservative assumptions regarding the application rate and frequency
since labels were not specific.  These assumptions were based on
recommendations provided through personal communication with the Special
Review and Reregistration Division (SRRD).  Although conservative
assumptions were made regarding application rates and frequencies, the
assessment explores the extent to which application rates would have to
be modified to get below acute and chronic risk levels of concern.

Data Gaps

Table A1 identifies the status of environmental fate and transport study
requirements and Table A2 identifies the status of ecological effect
study requirements.    SEQ CHAPTER \h \r 1 No data were available to
quantify the following fate characteristics of rotenone:
photodegradation on soil (Guideline §161-3), aerobic soil metabolism
(Guideline §162-1), and anaerobic soil metabolism (Guideline §162-3). 
The lack of soil metabolism data is the most critical given the
potential for this process to greatly affect the persistence of rotenone
following application to crops.  Another source of uncertainty is the
lack of a terrestrial field dissipation study (Guideline §164-1).   

Most of the ecological effect data gaps result from uncertainties
surrounding potential ecological risks associated with the
agricultural/commercial and residential uses of rotenone in terrestrial
environments.  However, there are ecological effect data gaps associated
with the use of rotenone as a piscidide.  Acute (Guideline §72-3) and
chronic toxicity (Guideline §72-4) data are not available for
estuarine/marine fish or invertebrates.  Additionally, there are no data
to evaluate the toxicity of rotenone to aquatic (Guideline §123-2) or
terrestrial plants (Guideline §123-1).  These data are important in
assessing direct risks to Federally listed threatened and endangered
plant species and the potential for indirect effects to a wide variety
of Federally listed threatened and endangered animals.

Labeling Recommendations

	According to the Label Review Manual, the following label statements
are recommended:

  SEQ CHAPTER \h \r 1 Non-Target Organism Statements

  SEQ CHAPTER \h \r 1 The following statement is required because the
pesticide is intended for outdoor use and contains an active ingredient
which has a mammalian acute oral LD50 ≤100 mg/kg: 

"This pesticide is toxic to mammals." 

	The following statement is required because the pesticide is intended
for outdoor use and contains an active ingredient with a fish acute LC50
and an aquatic invertebrate EC50 ≤1 ppm:

"This pesticide is toxic to fish, aquatic invertebrates, oysters and
shrimp.”

  SEQ CHAPTER \h \r 1 

Table A1. Environmental Fate and Transport Data Requirements for
Rotenone

Guideline #	Data Requirement	MRID / ACC # 

		Study Classification	Are Data Adequate for Risk Assessment

161-1	835.2120	Hydrolysis	00141409 	Supplemental	YES

161-2	835.2240	Photodegradation in Water	00141410 	Unacceptable	NO

161-3	835.2410	Photodegradation on Soil	Required

161-4	835.2370	Photodegradation in Air	Not required

162-1	835.4100	Aerobic Soil Metabolism	Required

162-2	835.4200	Anaerobic Soil Metabolism	Required - For rice use

162-3	835.4400	Anaerobic  Aquatic Metabolism	00141273 	Unacceptable

	NO

162-4	835.4300	Aerobic Aquatic Metabolism	00141274 	Unacceptable	NO

163-1	835.1240

835.1230	Leaching-Adsorption/Desorption	00157850 	Acceptable	YES

163-2	835.1410	Laboratory Volatility	Not required

163-3	835.8100	Field Volatility	Not required

164-1	835.6100	Terrestrial Field Dissipation	Required

164-2	835.6200	Aquatic Field Dissipation	42217701

00167851	Supplemental	YES

164-3	835.6300	Forestry Dissipation	No data submitted

165-4	850.1730	Accumulation in Fish	00146183

00143252

ACC# 258460

ACC# 261714 	Acceptable

Acceptable

Supplemental	 YES

165-5	None	Acummulation-Aqautic, Non-Target	40307403

40307405	Acceptable

Acceptable	YES

166-1	835.71	Small Scale Prospective Groundwater	Not required

166-2	None	Small Scale Retrospective Ground Water	No data submitted

166-3	None	Large Scale Retrospective Ground Water	No data submitted

	



Table A2.  Ecological Effects Data Requirements for Rotenone.

Guideline # and Data Requirement	Species 	Test Materiala

(% a.i.)	MRID/ACC#	Study Classification	Are Data Adequate for Risk
Assessment?

Avian and Mammalian Studies:

71-1, Acute 

Avian Oral, Quail/Duck	Mallard Duck		32.38	00143250	Supplemental	YES

	Ring-necked Pheasant		32.38	00143250	Supplemental	YES

71-2, Acute Avian Diet, Quail/Duck		Japanese Quail	34.5	248788
Supplemental	YES

	Mallard Duck	34.5	248788	Supplemental	YES

	Ring-necked Pheasant	34.5	248788	Acceptable	YES

71-4, Avian Reproduction, Quail/Duck

No Data Submitted

	81-1, Acute Mammalian Oral LD50	Rat	TGAI	00145496	Acceptable 	YES

83-1, Chronic Tox Rodent	Rat	TGAI	00141408	Acceptable 	YES

Freshwater Fish Studies:

72-1(a), Acute Freshwater Fish Toxicity, Bluegill	Bluegill Sunfish	2.5 -
98.64

	00061296

00089909

00090288

00090366

00090425

00121874

00121877

00121880

00121881

00121883

00121885

43975101

44382902

00090365

00121888

40063301	Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Supplemental

Supplemental

Supplemental	YES

72-1(c), Acute Freshwater Fish Toxicity, Rainbow Trout

	Rainbow Trout	5 - 98.64	00089905

00089906

00089907

00089908

00090367

00090420

00090421

00121873

00121875

00121876

00121882

00121884

00121886

43975102

44382901

00089904	Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Supplemental	YES

72-4(a), Early Life-Stage Fish	Rainbow Trout	96.47	40063302	Supplemental
YES

72-5 Life Cycle Fish

No Data Submitted 	waived

Freshwater Invertebrate Studies:

72-2(a), Acute Freshwater Invertebrate Toxicity	Daphnia magna	TGAI
40063303	Supplemental

Supplemental	YES

72-4(b), Life 

Cycle Aquatic Invertebrate	Daphnia magna	TGAI	40063303	Supplemental 

(pending study upgrade to acceptable)b	YES

Estuarine/Marine Fish Studies:

72-3, Acute Estuarine/Marine Tox Fish LC50

No data submitted	NO

72-4, Chronic Estuarine/Marine Tox Fish NOAEC

No data submitted	NO

72-7(a), Simulated or actual field testing-- aquatic organism

	Not Required

72-7(b), Actual field-aquatic organism

	Not Required

Estuarine/Marine Aquatic Invertebrates:

72-3(b), Acute Estuarine/Marine Mollusk

No data submitted	NO

72-3(c), Acute Estuarine/Marine Shrimp

No data submitted	NO

72-4, Chronic Estuarine/Marine Shrimp

No data submitted	NO

Terrestrial and Aquatic Plants:

122-1, Seedling Emergence and Vegetative Vigor

No Data Submitted	NO

122-2, Aquatic Plant Growth (Tier I)

No Data Submitted	NO

123-1, Seed Germ,  Seedling Emergence, Vegetative Vigor 

(Tier II)

No Data Submitted	NO

123-2 Aquatic Plant Growth (Tier II)

No Data Submitted	NO

Terrestrial Insect Testing:

141-2, Honey Bee Residue on Foliage	

				No Data Submitted

						NO

144-1, Honey Bee Acute Contact	Honey Bee	> 95	05001991	Acceptable	YES

a TGAI = technical grade active ingredient; TEP = typical end-use
product; ND = not determined, because purity was not reported or
original study was unavailable.

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 Study was classified as supplemental pending upgrade to acceptable. 
The upgrade was denied, but for piscicidal uses EPA did not require a
repeat of the study due to the preponderance of data available.

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