Document ID: EPA-HQ-OPP-2008-0441-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-06-25T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF   

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES 

		PC Code No.:	129045

DP Barcode:	352197

		Date:	May 2, 2008

MEMORANDUM

SUBJECT:	Amended Problem Formulation for Ecological Risk Assessment for
Denatonium Saccharide

TO:		Joy Schnackenbeck, Chemical Review Manager

Special Review and Re-registration Division (7508P)

FROM:	ERB V Team for Denatonium Saccharide:

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

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

Allen Vaughan, M.S., Entomologist, Ecological Effects Reviewer

Environmental Fate and Effects Division (7507P)

THROUGH:	Mah Shamim, Ph.D., Branch Chief

Environmental Risk Branch V

Environmental Fate and Effects Division (7507P)

Please find attached the amended ecological risk assessment problem
formulation for all denatonium saccharide uses. The document has been
amended to incorporate endangered species language into the rationales
for data requirements and to amend the requirement for avian acute oral
testing to include passerine species.

Specifically:

Table II.2, P. 4:  added red-winged blackbird to examples of surrogate
species for birds

Table II.3, P. 11:  added red-winged blackbird to examples of surrogate
species for birds

P. 12, under “Endangered Species Considerations”  :  added ES
rationale for data requirements

Table B2, Pp. 17-20:  added ES rationale for data requirements for
testing with fish, aquatic invertebrates, and birds.

Problem Formulation,

 For Ecological Risk Assessment

 For Denatonium Saccharide

(Amended)

Environmental Fate and Effects Division

Office of Pesticide Programs

U.S. Environmental Protection Agency

Table of Contents

  TOC \o "1-3" \h \z \u    HYPERLINK \l "_Toc191796375"  II.       
Problem Formulation	  PAGEREF _Toc191796375 \h  3  

  HYPERLINK \l "_Toc191796376"  A.	Nature of Regulatory Action	  PAGEREF
_Toc191796376 \h  3  

  HYPERLINK \l "_Toc191796377"  B.	Stressor Source and Distribution	 
PAGEREF _Toc191796377 \h  3  

  HYPERLINK \l "_Toc191796378"  1.	Chemical and Physical Properties	 
PAGEREF _Toc191796378 \h  3  

  HYPERLINK \l "_Toc191796379"  2.	Mode of Action	  PAGEREF
_Toc191796379 \h  3  

  HYPERLINK \l "_Toc191796380"  3.	Overview of Pesticide Usage	  PAGEREF
_Toc191796380 \h  3  

  HYPERLINK \l "_Toc191796381"  C.	Receptors	  PAGEREF _Toc191796381 \h 
4  

  HYPERLINK \l "_Toc191796382"  1.	Aquatic and Terrestrial Effects	 
PAGEREF _Toc191796382 \h  4  

  HYPERLINK \l "_Toc191796383"  2.	Ecosystems Potentially at Risk	 
PAGEREF _Toc191796383 \h  5  

  HYPERLINK \l "_Toc191796384"  D.	Assessment Endpoints	  PAGEREF
_Toc191796384 \h  5  

  HYPERLINK \l "_Toc191796385"  E.	Conceptual Model	  PAGEREF
_Toc191796385 \h  6  

  HYPERLINK \l "_Toc191796386"  1.	Risk Hypothesis	  PAGEREF
_Toc191796386 \h  6  

  HYPERLINK \l "_Toc191796387"  2.	Conceptual Diagram	  PAGEREF
_Toc191796387 \h  7  

  HYPERLINK \l "_Toc191796388"  F.	Analysis Plan Options	  PAGEREF
_Toc191796388 \h  8  

  HYPERLINK \l "_Toc191796389"  1.	Conclusions from Previous Risk
Assessments	  PAGEREF _Toc191796389 \h  8  

  HYPERLINK \l "_Toc191796390"  2.	Preliminary Identification of Data
Gaps	  PAGEREF _Toc191796390 \h  8  

  HYPERLINK \l "_Toc191796391"  3.	Measures of Effects and Exposure	 
PAGEREF _Toc191796391 \h  9  

  HYPERLINK \l "_Toc191796392"  4.	Endangered Species Considerations	 
PAGEREF _Toc191796392 \h  12  

  HYPERLINK \l "_Toc191796393"  Appendix A.  Data Requirement Tables.	 
PAGEREF _Toc191796393 \h  15  

  HYPERLINK \l "_Toc191796394"  Appendix B.  Data Call-In Rationales.	 
PAGEREF _Toc191796394 \h  17  

 

II.        Problem Formulation

The purpose of this problem formulation is to provide the foundation for
the ecological risk assessment being conducted for denatonium
saccharide.  As such, it articulates the purpose and objectives of the
risk assessment, evaluates the nature of the problem, and provides a
plan for analyzing the data and characterizing the risk (EPA, 1998). 

Nature of Regulatory Action

This report summarizes the Environmental Fate and Effects Division’s
(EFED) Problem Formulation for the Registration Review of denatonium
saccharide.  

Stressor Source and Distribution

Chemical and Physical Properties

No chemical and physical property data for denatonium saccharide have
been submitted.

Mode of Action

The mode of action for denatonium saccharide is unknown.

Overview of Pesticide Usage

Denatonium saccharide is a squirrel, vole, dog, and cat repellant used
on outdoor surfaces and structures such as trees, fences, poles, decks,
planters, siding, garbage cans, furniture, seeds and bulbs.  For
structures, it is applied as a spray or with a paint brush to the point
of runoff.  It can be applied again in two to seven days.  The product
can be sprayed onto seeds and bulbs in a plastic or metal container
before planting.

There is no information on the typical usage (number of applications,
“rate” or interval between applications) for denatonium saccharide. 
The state of California does report usage of this pesticide (refer to
table named Denatonium Saccharide Usage below).  In California, the
chemical total pounds a.i. applied was minimal, ranging from 0.0217 lb
(in 2004) to 0.0489 lb (in 2005).  The largest use appears to be
structural pest control.  However, not all home owner usage is reported
so the numbers below may underestimate actual usage.  EFED assumes usage
is low since there is no commercial use of the product.

 

Denatonium Saccharide Usage

Publicly available data from the California Department of Pesticide
Regulation was used to produce the following table outlining the pounds
of denatonium saccharide used in California over the three most recent
years available (2004-2006).

Site	2004 lbs a.i. Applied	2005 lbs. a.i. Applied	2006 lbs. a.i. Applied

Beet	--	0.0027	--

Landscape Maintenance	0.0118	0.0108	--

Structural Pest Control	0.0099	0.0300	0.0465

Vertebrate Control	--	0.0054	--

Chemical Total	0.0217	0.0489	0.0465

           

Receptors

Aquatic and Terrestrial Effects

The receptor is the biological entity that is exposed to the stressor
(EPA, 1998).  Due to the outdoor uses, the types of receptors that may
be exposed to denatonium saccharide include both aquatic and terrestrial
receptors, such as birds, reptiles, mammals and freshwater and
estuarine/marine fish and non-target invertebrates.  This list may not
be comprehensive.

Consistent with the process described in the Overview Document (EPA,
2004), this risk assessment uses a surrogate species approach in its
evaluation of denatonium saccharide.  T  SEQ CHAPTER \h \r 1
oxicological data generated from surrogate test species, which are
intended to be representative of broad taxonomic groups, are used to
extrapolate to potential effects on a variety of species (receptors)
included under these taxonomic groupings.  

Only acute rat data have been submitted at this time.  No other toxicity
studies have been submitted.  Mammalian toxicity data indicate that
denatonium saccharide is not acutely toxic; therefore, acute effects to
mammals are not expected.  However, toxicity to birds is unknown.  Birds
may eat treated seeds without being deterred since the product is not
labeled as a bird repellent.  Effects to birds cannot be precluded. 
Additionally, aquatic organisms may be subjected to denatonium
saccharide by ingestion of seeds that have washed into aquatic systems. 
Chronic effects are not expected due to the limited use of the product
by homeowners (i.e. no commercial use).

At this time, a full and complete ECOTOX search has not been performed,
but will be conducted prior to issuance of any Data Call-in.  The open
literature studies will be identified through EPA’s ECOTOX database ( 
HYPERLINK "http://cfpub.epa.gov/ecotox/"  http://cfpub.epa.gov/ecotox/
), which employs a literature search engine for locating chemical
toxicity data for aquatic life, terrestrial plants, and wildlife.   The
evaluation of data can also provide insight into the direct and indirect
effects of denatonium saccharide on biotic communities from loss of
species that are sensitive to the chemical and from changes in structure
and functional characteristics of the affected communities.

Table II.2 provides a summary of the taxonomic groups and the surrogate
species tested to help understand potential acute ecological effects of
pesticides to these non-target taxonomic groups.  

Table II.2.  Test Species Evaluated for Assessing Potential Ecological
Effects of Denatonium Saccharide 

Taxonomic Group	Example(s) of Surrogate Species	Toxicity 

Birds1	  SEQ CHAPTER \h \r 1 Mallard (Anas platyrhynchos)

Bobwhite (Colinus virginianus)

Red-winged blackbird (Agelaius phoenicius)	Data Gap

  SEQ CHAPTER \h \r 1 Mammals	  SEQ CHAPTER \h \r 1 Laboratory rat
(Rattus norvegicus)	Acute - LD50 >5,000 mg/kg

Chronic - Data Gap

  SEQ CHAPTER \h \r 1 Insects	  SEQ CHAPTER \h \r 1 Honey bee (Apis
mellifera L.)	Data Gap

  SEQ CHAPTER \h \r 1 Freshwater fish2		  SEQ CHAPTER \h \r 1 Bluegill
sunfish (Lepomis macrochirus)

Rainbow trout (Oncorhynchus mykiss)	Data Gap

  SEQ CHAPTER \h \r 1 Freshwater invertebrates	  SEQ CHAPTER \h \r 1
Water flea (Daphnia magna)	Data Gap

  SEQ CHAPTER \h \r 1 Estuarine/marine fish	  SEQ CHAPTER \h \r 1 
Sheepshead minnow (Cyprinodon variegatues)	Data Gap

Estuarine/marine invertebrates	Mysid shrimp (Americamysis bahia)

Eastern oyster (Crassostrea virginica)	Data Gap

  SEQ CHAPTER \h \r 1 Terrestrial plants3	  SEQ CHAPTER \h \r 1 Monocots
– corn (Zea mays)

Dicots – soybean (Glycine max)	Data Gap

  SEQ CHAPTER \h \r 1 Aquatic plants and algae	  SEQ CHAPTER \h \r 1
Duckweed (Lemna gibba) 

Green algae (Selenastrum capricornutum)	Data Gap

  SEQ CHAPTER \h \r 1 1 Birds represent surrogates for terrestrial-phase
amphibians and reptiles.

2 Freshwater fish may be surrogates for aquatic-phase amphibians.

3 Four species of two families of monocots, of which one is corn; six
species of at least four dicot families, of which one is soybeans.

Incident Reports  

The Agency’s Ecological Incident Information System (EIIS) does not
contain any reports of damage or adverse effects to non-target organisms
attributed to the use of denatonium saccharide.  No incidents of
contamination of surface, ground and drinking water have been reported
to the Agency.  A lack of reported incidents does not necessarily mean
that such incidents have not occurred.  In addition, incident reports
for non-target plants and animals typically provide information on
mortality events only.  Reports for other adverse effects, such as
reduced growth or impaired reproduction, are rarely received.

Ecosystems Potentially at Risk 

The ecosystems at risk are often extensive in scope, and as a result it
may not be possible to identify specific ecosystems during the
development of a baseline risk assessment.   However, in general terms,
terrestrial ecosystems potentially at risk due to the use of denatonium
saccharide, could include the areas immediately adjacent to the treated
seeds/bulbs that may receive runoff or directly from the seeds (direct
animal ingestion).  

Aquatic ecosystems potentially at risk due to the use of denatonium
saccharide include water bodies adjacent to, or down stream from, the
treated seeds/bulbs and might include impounded bodies such as ponds,
lakes and reservoirs, or flowing waterways such as streams or rivers. 
For uses in coastal areas, aquatic habitat also includes marine
ecosystems, including estuaries. 

	

Assessment Endpoints

Assessment endpoints are defined as “explicit expressions of the
actual environmental value that is to be protected.”  Defining an
assessment endpoint involves two steps: 1) identifying the valued
attributes of the environment that are considered to be at risk; and 2)
operationally defining the assessment endpoint in terms of an ecological
entity (i.e., a community of fish and aquatic invertebrates) and its
attributes (i.e., survival and reproduction).  Therefore, selection of
the assessment endpoints is based on valued entities (i.e., ecological
receptors), the ecosystems potentially at risk, the migration pathways
of pesticides, and the routes by which ecological receptors are exposed
to pesticide-related contamination.  The selection of clearly defined
assessment endpoints is important because they provide direction and
boundaries in the risk assessment for addressing risk management issues
of concern.  Changes to assessment endpoints are typically estimated
from the available toxicity studies, which are used as the measures of
effects to characterize potential ecological risks associated with
exposure to pesticides.

To estimate exposure concentrations, the ecological risk assessment
typically considers a single application at the maximum application rate
to fields that have vulnerable soils.  The most sensitive toxicity
endpoints are used from surrogate test species to estimate
treatment-related direct effects on acute mortality and chronic
reproductive, growth and survival assessment endpoints.  Toxicity tests
are intended to determine effects of pesticide exposure on birds,
mammals, fish, terrestrial and aquatic invertebrates, and plants.  These
tests include short-term acute, sub-acute, and reproduction studies and
are typically arranged in a hierarchical or tiered system that
progresses from basic laboratory tests to applied field studies.  The
toxicity studies are used to evaluate the potential of a pesticide to
cause adverse effects, to determine whether further testing is required,
and to determine the need for precautionary label statements to minimize
the potential adverse effects to non-target animals and plants.

Since no chemical fate data were submitted, exposure cannot be
estimated.

 tc \l2 "C.	Assessment and Measurement Endpoints  Conceptual Model

For a pesticide to pose an ecological risk, it must reach ecological
receptors in biologically significant concentrations.  An exposure
pathway is the means by which a pesticide moves in the environment from
a source to an ecological receptor.  For an ecological pathway to be
complete, it must have a source, a release mechanism, an environmental
transport medium, a point of exposure for ecological receptors, and a
feasible route of exposure.

A conceptual model provides a written description and visual
representation of the predicted relationships between denatonium
saccharide, potential routes of exposure, and the predicted effects for
the assessment endpoint. A conceptual model consists of two major
components: risk hypothesis and a conceptual diagram (EPA, 1998).

Risk Hypothesis

For denatonium saccharide, the following ecological risk hypothesis is
being employed for this baseline risk assessment:

Denatonium saccharide, when used in accordance with the label, results
in potential adverse effects upon the survival, growth, and reproduction
of non-target terrestrial and aquatic organisms.

 

Conceptual Diagram tc \l3 "2.         Diagram 

The conceptual site model is a generic graphic depiction of the risk
hypothesis, and assumes that denatonium saccharide, which has outdoor
uses, is capable of affecting terrestrial and aquatic animals provided
that environmental concentrations are sufficiently elevated as a result
of proposed label uses.  Through a preliminary iterative process of
examining available data, the conceptual model (i.e., the representation
of the risk hypothesis) has been refined to reflect the likely exposure
pathways and the organisms that are most relevant and applicable to this
assessment (Figure II.2). It includes the potential pesticide or
stressor (denatonium saccharide), the sources and/ or transport
pathways, exposure media, exposure points, biological receptor types,
and attributes changes.

In the specific case of denatonium saccharide, the product has no
commercial uses and contains a material to ensure it adheres to treated
surfaces, seeds, and bulbs.  Drift from the ground sprayer and runoff
from treated surfaces, seeds, and bulbs are assumed to be minimal. 
However, terrestrial animals may directly ingest seeds and bulbs. 
Effects to birds cannot be precluded.  EFED assumes the product is not
systemic and that non-target organisms will not be affected by consuming
foliage sprouted from treated seeds and bulbs.  However, without the
necessary product chemistry data, this may underestimate risk.

For aquatic receptors, the major point of exposure is through direct
contact with treated seeds.  If seeds are planted by broadcast methods,
the seeds may be washed into water bodies, where aquatic organisms may
ingest them.  In addition, since no hydrolysis studies have been
submitted, the fate of the product is unclear once completely submerged
for any length of time.  Aquatic organisms may be subjected to
denatonium saccharide and potential degradates in the water column or in
the sediment.  Indirect effects to aquatic organisms can also occur
through impact to various food chains.  Exposure to aquatic environments
via runoff and to plants is unlikely given that drift and runoff of the
product is assumed to be minimal.

Since little data are available, it is presumed that both aquatic and
terrestrial receptors will be at risk from denatonium saccharide
exposure.  The representative aquatic receptors are certain freshwater
fish and invertebrates.  The representative terrestrial receptor is
birds. The attribute changes used to assess risk for aquatic and
terrestrial receptors depend on the type of test (e.g., reduced
survival, growth, or reproduction).  

 tc \l2 "D.        Conceptual Model Analysis Plan Options tc \l2 "E.    
   Analysis Plan 

Conclusions from Previous Risk Assessments

No previous risk assessments have been conducted.

Preliminary Identification of Data Gaps

Only acute rat data have been submitted at this time.  No other acute or
chronic toxicity studies have been submitted. No environmental fate
studies have been submitted.  

Status of Data Requirements

Ecological Effects

Acute oral and dietary data for avian species are suggested at this time
to reduce the uncertainty surrounding the risk posed by denatonium
saccharide.  The product is not labeled as a bird repellent and
according to efficacy study MRID 44589301, geese may not be deterred by
the chemical (this study has not been officially reviewed at this time;
however, it will be reviewed prior to the completion of the full
assessment).  Therefore, birds may continue to eat seeds treated with
denatonium saccharide.  Acute oral and dietary toxicity data are needed
to reduce the uncertainty.

Acute fish and invertebrate data are suggested to reduce the uncertainty
of risk.  Treated seeds may be carried to aquatic environments where
aquatic organisms may feed on them.  In addition, denatonium saccharide
may wash off the seed or break down once the seed is submerged. Acute
freshwater fish and invertebrate toxicity data are needed to reduce the
uncertainty.

An open literature search will be completed to determine any relevant
endpoints for non-target taxa.  If data are available, an evaluation
will be made as to whether or not the data are adequate for use in a
risk assessment.  The Agency uses the ECOTOX database as its mechanism
for searching the open literature.  ECOTOX integrates three previously
independent databases - AQUIRE, PHYTOTOX, and TERRETOX - into a system
which includes toxicity data derived predominately from the
peer-reviewed literature, for aquatic life, terrestrial plants, and
terrestrial wildlife, respectively.  At this point in time, a full and
complete ECOTOX search has not been performed, but will be done prior to
issuance of any Data Call-In.

Environmental Fate

Since no environmental fate data have been submitted, the fate of
denatonium saccharide in the environment remains unknown. 

Hydrolysis, aerobic soil metabolism, and adsorption/desorption studies
are needed to reduce uncertainty.  Results from these three studies
(hydrolysis half-lives in various pHs, aerobic metabolism half-lives in
various soils, Kd, Kf, and Koc, etc.) will be entered into the models
that are currently available in OPP to predict EECs in the ecological
risk assessment.

Measures of Effects and Exposure

Ecological effects data have been waived with the exception of acute
avian dietary.  There is no evidence to suggest a hazard to the
environment or to non-avian non-target organisms when these pesticides
are used according to the label.  

For a chemical, a number of measures of exposure are used, which are the
measures of stressor existence and movement in the environment and their
contact or co-occurrence with the assessment endpoint.  Measures of
exposure are potentially estimated using models.  Aquatic exposure
usually consists of aquatic EECs based on a total residue approach and
derived using a water-body that is vulnerable and representative of
static ponds and first order waterways.  Terrestrial exposure is usually
estimated using a model that assumes a direct application to a variety
of avian, mammal and reptilian food items.  Exposure to terrestrial
plants is usually estimated using a model that assumes denatonium
saccharide drifts or moves with runoff to adjacent habitats. Models
require quantitative measurements for endpoints to evaluate the effects
of the chemicals on the various species.  In the absence of fate data,
these measures of exposure could not be modeled.

Table II.3 provides a summary of the assessment endpoints previously
identified as survival, growth and reproduction along with the measure
of effects and exposure. 

Table II.3.  Measures of Ecological Effects and Exposure for Denatonium
Saccharide.

Assessment Endpoint

	

Surrogate Species and Measures of Ecological Effect1	

Measures of Exposure

Birds2	Survival	Bobwhite and passerine sp. acute oral LD50(data gap)

Bobwhite and mallard subacute dietary LC50(data gap)	Maximum residues on
food items (foliar)

	Reproduction and growth	Bobwhite and mallard chronic reproduction NOAEC
and LOAEC (data gap)

	Mammals	Survival	Laboratory rat acute oral LD50

	(MRID 43698107)

Reproduction and growth	Laboratory rat oral reproduction chronic NOAEC
and LOAEC (data gap)

	Freshwater fish3	Survival	Rainbow trout and bluegill sunfish acute LC50
(data gap)	Peak EEC4

	Reproduction and growth	Fathead minnow

chronic (early life-stage) NOAEC and LOAEC (data gap)	60-day average
EEC4

Freshwater invertebrates	Survival	Water flea (and other freshwater
invertebrates) acute EC50.

(data gap)	Peak EEC4

	Reproduction and growth	Water flea chronic (life cycle) LOAEC (data
gap)	21-day average EEC4

Estuarine/marine fish	Survival	Sheepshead minnow acute LC50 (data gap)
Peak EEC4

	Reproduction and growth	Sheepshead minnow chronic (early life-stage)
NOAEC and LOAEC (data gap)	60-day average EEC4

Estuarine/marine invertebrates	Survival	Eastern oyster acute EC50 and
mysid acute LC50 (data gap)	Peak EEC4

	Reproduction and growth	Mysid chronic NOAEC and LOAEC (data gap)	21-day
average EEC4

Terrestrial plants5	Survival and growth	Monocot and dicot seedling
emergence and vegetative vigor EC25, EC05, and NOAEC values (data gap)
Estimates of runoff and spray drift to non-target areas

Insects	Survival (not quantitatively assessed)	Honeybee acute contact
LD50 (data gap)	Maximum application rate

Aquatic plants and algae	Survival and growth	Algal and vascular plant
(i.e., duckweed) EC50 and NOAEC values for growth rate and biomass
measurements (data gap)	Peak EEC

1 If species listed in this table represent most commonly encountered
species from registrant-submitted studies, risk assessment guidance
indicates most sensitive species tested within taxonomic group are to be
used for baseline risk assessments.

2 Birds represent surrogates for amphibians (terrestrial phase) and
reptiles.

3 Freshwater fish may be surrogates for amphibians (aquatic phase).

4 One in 10-year return frequency.

5 Four species of two families of monocots - one is corn, six species of
at least four dicot families, of which one is soybeans.  LD50 = Lethal
dose to 50% of the test population; NOAEC = No observed adverse effect
concentration; LOAEC = Lowest observed adverse effect concentration;
LC50 = Lethal concentration to 50% of the test population; EC50/EC25 =
Effect concentration to 50%/25% of the test population.

 tc \l3 "2.         Measures to Evaluate Risk Hypotheses and Conceptual
Model Endangered Species Considerations           

Pesticide ecological risk assessments for registration review will
address Endangered Species Act, Section 7 (a)(2) obligations.  In the
absence of data, no RQ’s can be calculated to assess the risk to
endangered species.  If future endangered species risk assessments are
performed without these data, the Agency would have to assume that
denatonium saccharide “may affect” birds and aquatic organisms
directly (and endangered species from other taxa indirectly), and use of
denatonium saccharide may need to be restricted in areas where
endangered species could be exposed.  The lack of these data will limit
the flexibility the Agency and registrants have in coming into
compliance with the Endangered Species Act and could result in use
restrictions for this chemical which are unnecessarily severe.

At this time, no incident reports are available that indicate risk to
endangered species.  

Path Forward

The planned ecological risk assessment will evaluate the lines of
evidence and make a determination of potential effects to endangered
species.   If the planned ecological risk assessment indicates that
denatonium saccharide may affect, either directly or indirectly, listed
species or affect critical habitat, the Agency will take steps to refine
the assessment to determine whether this pesticide’s uses are likely
to adversely affect, or are not likely to adversely affect the species. 
In the case of critical habitat, the Agency will assess whether use of
the pesticide may destroy or adversely modify any principle constituent
elements for the critical habitat.  

If the Agency’s assessment results in a determination that the
pesticide may affect but is not likely to adversely affect a listed
species or designated critical habitat, the Agency will request
concurrence by the USFWS and NMFS (Services) on that determination.  If
the Services do not concur, the Agency will enter into Formal
Consultation with them under the Endangered Species Act.   If the
Agency’s assessment results in a determination that the pesticide is
likely to adversely affect a listed species or designated critical
habitat, the Agency will initiate Formal Consultation with the Services.
  Formal Consultation concludes with issuance of a Biological Opinion to
the Agency.  The Agency may seek to change the terms of registration to
address unacceptable risks to a listed species should EPA determine such
risks exist.

Other Information Needs

Information is requested for confirmation on the following label
information:

Use history

State or local use restrictions

Ecological incidents not already reported to the Agency

Maximum number of applications per year

Maximum application rate per year

The analysis plan will be revisited and may be revised depending upon
the data available in the open literature and the information submitted
by the public in response to the opening of the Registration Review
docket. 

Summary

Denatonium saccharide is used as a squirrel, vole, dog, and cat
repellant.

The Agency’s Ecological Incident Information System (EIIS) does not
contain any reports of damage or adverse effects to non-target organisms
attributed to the use of denatonium saccharide.

No ecological data are available except rat acute toxicity.  Available
open literature will be used to evaluate the potential direct effects of
denatonium saccharide to the aquatic and terrestrial receptors
identified.

An open literature search will be completed to determine any relevant
endpoints for non-target taxa.

Bibliography

MRID Studies

43698107	Wnorowski, G. (1995) Acute Oral Toxicity Limit Test (on Rats):
Ro-Pel Animal, Rodent and Bird Repellent: Lab Project Number: 3633:
P320. Unpublished study prepared by Product Safety Labs. 15 p.

44589301	Menard, B. (1997) A Study on the Effectiveness of Ro-Pel on
Canada Geese (Branta canadensis) in Various Mississauga Parks: Lab
Project Number: APC-1. Unpublished study prepared by Abell Pest Control,
Inc. 29 p.

Literature

U.S. Environmental Protection Agency.  1998.  Guidelines for Ecological
Risk Assessment.  Risk Assessment Forum, Office of Research and
Development,  Washington, D.C.  EPA/630/R-95/002F.  April 1998. 

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



Appendix A.  Data Requirement Tables.

Table A1.  Denatonium Saccharide Table of Environmental Fate Data
Requirements

Guide-line #	

Data Requirement	

Study ID	Study Classification	Are Additional Data Needed for Risk
Assessment?

161-1	Hydrolysis	No data submitted	N/A	Yes

161-2	Photolysis in Water 	No data submitted	N/A	No

161-3	Photodegradation on Soil	No data submitted	N/A	No

162-1	Aerobic Soil Metabolism	No data submitted	N/A	Yes

162-2	Anaerobic Soil Metabolism	No data submitted	N/A	No

162-3	Anaerobic Aquatic Metabolism	No data submitted	N/A	No

162-4	Aerobic Aquatic Metabolism	No data submitted	N/A	No

163-1	Leaching-Adsorption/ Desorption	No data submitted	N/A	Yes

163-2	Laboratory Volatility	No data submitted	N/A	No

163-3	Field Volatility	No data submitted	N/A	No

164-1	Terrestrial Field Dissipation	No data submitted	N/A	No

165-4	Accumulation in Fish	No data submitted	N/A	No

N/A=Not Applicable



  SEQ CHAPTER \h \r 1 Table A2. Ecological Effects Data Requirements
for Denatonium Saccharide

Guideline #	Data Requirement	MRID or Acc. 

Number	Formulation	Study Classification	Are Additional Data Needed for
Risk Assessment?

71-1	Avian Acute Oral Toxicity	No data submitted	N/A	N/A	Yes

71-2	Avian Subacute Dietary Toxicity	No data submitted	N/A	N/A	Yes

71-4	Avian Reproduction Toxicity	No data submitted	N/A	N/A	No

72-1	Freshwater Fish LC50	No data submitted	N/A	N/A	Yes

72-2	Freshwater Invertebrate Acute LC50	No data submitted	N/A	N/A	Yes

72-3(a)	Estuarine/Marine Fish LC50	No data submitted	N/A	N/A	No

72-3(b)	Estuarine/Marine

Invertebrate  (Mollusk )	No data submitted	N/A	N/A	No

72-3(c)	Estuarine/Marine Invertebrate (Mysid)	No data submitted	N/A	N/A
No

72-3 (d)	Estuarine/Marine

Crustacean	No data submitted	N/A	N/A	No

72-4 (a)	Freshwater Fish Early Life-Stage	No data submitted	N/A	N/A	No

72-4	Aquatic Invertebrate Life-Cycle (Freshwater) Chronic Toxicity	No
data submitted	N/A	N/A	No

72-4	Aquatic Invertebrate Life-Cycle (Marine) Chronic Toxicity	No data
submitted	N/A	N/A	No

72-5	Freshwater Fish Full Life-Cycle (marine)	No data submitted	N/A	N/A
No

72-7	Aquatic Field

 Study	No data submitted	N/A	N/A	No

141-1	Acute Honeybee

 Contact Toxicity Test	No data submitted	N/A	N/A	No

141-2	Residues on Foliage Honeybee Toxicity Test	No data submitted	N/A
N/A	No

141-4	Subacute Honeybee Feeding Toxicity Test 	No data submitted	N/A	N/A
No

N/A=Not Applicable

Appendix B.  Data Call-In Rationales.

Table B1.  Environmental Fate Data Gaps Listed for Denatonium Saccharide

OPPTS Guideline	Study Title	Cost 

(if special study)	Rationale

161-1	Guideline 161-1 Hydrolysis	N/A	CFR158 requires this study. 
Currently no acceptable studies have been submitted. 

Denatonium saccharide can be used on outdoor surfaces and structures
such as trees, fences, poles, decks, planters, siding, garbage cans,
furniture, seeds and bulbs.  Since no information is available to
determine the fate properties EFED must assume that it will runoff/drift
in the environment and persist.  

In order to calculate EEC’s and assess the ecological risk and the
drinking water risk, hydrolysis data are needed.

162-1	Guideline 162-1 Aerobic soil metabolism	N/A	CFR158 requires this
study.  Currently no acceptable studies have been submitted. 

Denatonium saccharide can be used on outdoor surfaces and structures
such as trees, fences, poles, decks, planters, siding, garbage cans,
furniture, seeds and bulbs.  Since no information is available to
determine the fate properties EFED must assume that it will runoff/drift
in the environment and persist.  

In order to calculate EEC’s and assess the ecological risk and the
drinking water risk, aerobic soil metabolism data are needed.

163-1	Guideline 163-1 Leaching-Adsorption/desorption	N/A	CFR158 requires
this study.  Currently no acceptable studies have been submitted. 

Denatonium saccharide can be used on outdoor surfaces and structures
such as trees, fences, poles, decks, planters, siding, garbage cans,
furniture, seeds and bulbs.  Since no information is available to
determine the fate properties EFED must assume that it will runoff/drift
in the environment and persist.  

In order to calculate EEC’s and assess the ecological risk and the
drinking water risk, adsorption/desorption data are needed.

Table B2.  Ecotoxicity Data Gaps for Denatonium Saccharide

OPPTS Guideline	Study Title	Cost

(if special study)	Rationale

850.1075	Guideline 72-1: Acute freshwater fish	N/A	CFR158 requires two
acute freshwater fish toxicity tests.  Currently no acceptable studies
have been submitted. 

Denatonium saccharide can be applied to seeds that may wash off to
aquatic environments where fish may ingest them.  Additionally, since no
information is available to determine the fate properties, it is unknown
how the product will react once submerged.  Fish may be exposed to the
parent or possibly degradates in the water column.  In order to assess
risk to freshwater fish, acute toxicity data are needed.

Results of this study will be used to calculate acute risks to
freshwater fish from water column exposure to denatonium saccharide.

In the absence of data, no RQ’s can be calculated to assess the risk
to endangered species.  If future endangered species risk assessments
are performed without these data, the Agency would have to assume that
denatonium saccharide “may affect” fish directly (and endangered
species from other taxa indirectly), and use of denatonium saccharide
may need to be restricted in areas where endangered species could be
exposed.  The lack of these data will limit the flexibility the Agency
and registrants have in coming into compliance with the Endangered
Species Act and could result in use restrictions for this chemical which
are unnecessarily severe.

850.1010

	Guideline 72-2: Acute freshwater invertebrate	N/A	CFR158 requires an
acute freshwater invertebrate toxicity test.  Currently no acceptable
studies have been submitted. 

Denatonium saccharide can be applied to seeds that may wash off to
aquatic environments where invertebrates may ingest them.  Additionally,
since no information is available to determine the fate properties, it
is unknown how the product will react once submerged.  Invertebrates may
be exposed to the parent or possibly degradates in the water column.  In
order to assess risk to freshwater invertebrates, acute toxicity data
are needed.

Results of this study will be used to calculate acute risks to
freshwater fish from water column exposure to denatonium saccharide.

In the absence of data, no RQ’s can be calculated to assess the risk
to endangered species.  If future endangered species risk assessments
are performed without these data, the Agency would have to assume that
denatonium saccharide “may affect” aquatic invertebrates directly
(and endangered species from other taxa indirectly), and use of
denatonium saccharide may need to be restricted in areas where
endangered species could be exposed.  The lack of these data will limit
the flexibility the Agency and registrants have in coming into
compliance with the Endangered Species Act and could result in use
restrictions for this chemical which are unnecessarily severe.

850.2100	Guideline 71-1:Avian Acute Oral Toxicity	N/A	CFR158 requires
avian acute oral toxicity tests with a passerine species and either an
upland gamebird or waterfowl species.   Currently no acceptable studies
have been submitted.

Denatonium saccharide can be applied to seeds that may be ingested by
birds.  The product is not labeled as a bird repellent and according to
efficacy study MRID 44589301, geese may not be deterred by the chemical
(this study has not been officially reviewed at this time; however, it
will be reviewed prior to the completion of the full assessment). 
Therefore, birds may continue to eat seeds treated with denatonium
saccharide.    Additionally, since no information is available to
determine the fate properties of denatonium saccharide, it is unknown if
the chemical is systemic.  Birds may be affected by ingesting the
foliage sprouted from treated seeds.  

In order to assess risk to birds, acute oral toxicity data are needed.

In the absence of data, no RQ’s can be calculated to assess the risk
to endangered species.  If future endangered species risk assessments
are performed without these data, the Agency would have to assume that
denatonium saccharide “may affect” birds directly (and endangered
species from other taxa indirectly), and use of denatonium saccharide
may need to be restricted in areas where endangered species could be
exposed.  The lack of these data will limit the flexibility the Agency
and registrants have in coming into compliance with the Endangered
Species Act and could result in use restrictions for this chemical which
are unnecessarily severe.

850.2200	Guideline 71-2:Avian Dietary Toxicity	N/A	CFR158 requires two
avian dietary toxicity tests. Currently no acceptable studies have been
submitted.

Denatonium saccharide can be applied to seeds that may be ingested by
birds.  The product is not labeled as a bird repellent and according to
efficacy study MRID 44589301, geese may not be deterred by the chemical
(this study has not been officially reviewed at this time; however, it
will be reviewed prior to the completion of the full assessment). 
Therefore, birds may continue to eat seeds treated with denatonium
saccharide.   Additionally, since no information is available to
determine the fate properties of denatonium saccharide, it is unknown if
the chemical is systemic.  Birds may be affected by ingesting the
foliage sprouted from treated seeds.

In order to assess risk to birds, dietary toxicity data are needed.

In the absence of data, no RQ’s can be calculated to assess the risk
to endangered species.  If future endangered species risk assessments
are performed without these data, the Agency would have to assume that
denatonium saccharide “may affect” birds directly (and endangered
species from other taxa indirectly), and use of denatonium saccharide
may need to be restricted in areas where endangered species could be
exposed.  The lack of these data will limit the flexibility the Agency
and registrants have in coming into compliance with the Endangered
Species Act and could result in use restrictions for this chemical which
are unnecessarily severe.

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