Denatonium Saccharide Summary Document

Registration Review: Initial Docket

June 2008

Case # 7625



Denatonium Saccharide Summary Document

Registration Review: Initial Docket

June 2008

								

Approved By:

								

___________________

								Steven Bradbury, Ph.D.

								Director, Special Review and

		       Reregistration DivisionTABLE OF CONTENTS

											Page #

Preliminary Work Plan (PWP)						4

Fact Sheet									9

Glossary of Terms and Abbreviations					12

      

________________________________________

Please Note

This Preliminary Work Plan and Fact Sheet summarize the Environmental
Protection Agency's current position based on the following documents:  

Amended Problem Formulation for Ecological Risk Assessment for
Denatonium Saccharide.  May 2, 2008.

Denatonium Saccharide (PC code 129045). Revised Human Health Risk
Scoping Document in Support of Registration Review.  DP Barcode D352579.
 June 2, 2008.

. 

Additional supporting documents for denatonium saccharide may be found
in the docket EPA-HQ-OPP-2008-0441 which may be found on the internet at
www.regulations.gov.

 

I. Preliminary Work Plan – Denatonium Saccharide

Introduction:

The Food Quality Protection Act of 1996 mandated a program: registration
review.  All pesticides distributed or sold in the United States
generally must be registered by the U.S. Environmental Protection Agency
(USEPA, EPA; or the Agency), based on scientific data showing that they
will not cause unreasonable risks to human health, workers, or the
environment when used as directed on product labeling.  The registration
review program is intended to make sure that, as the ability to assess
risk evolves and as policies and practices change, all registered
pesticides continue to meet the statutory standard of no unreasonable
adverse effects.  Changes in science, public policy, and pesticide use
practices will occur over time.  Through the registration review
program, the Agency periodically reevaluates pesticides to make sure
that as change occurs, products in the marketplace can be used safely. 
Information on this program is provided at
http://www.epa.gov/oppsrrd1/registration_review/. 

The Agency has begun to implement the registration review program, and
will review each registered pesticide every 15 years to determine
whether it continues to meet the FIFRA standard for registration.  The
public phase of registration review begins when the initial docket is
opened for each case.  The docket is the Agency’s opportunity to state
what it knows about the pesticide and what additional risk analyses and
data or information it believes are needed to make a registration review
decision.  After reviewing and responding to comments and data received
in the docket during this initial comment period, the Agency will
develop and commit to a final work plan and schedule for the
registration review of denatonium saccharide.

Denatonium Saccharide (case #7625) is a bittering agent in 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 paintbrush to the point of runoff.  Additionally, the product is
sprayed onto seeds and bulbs  before planting.  The largest use is for
structural pest control.  

Anticipated Risk Assessment and Data Needs:

The Agency anticipates conducting a comprehensive ecological risk
assessment including an endangered species risk assessment for all
pesticide uses of denatonium saccharide.  

Ecological Risk:

The Agency has not conducted a comprehensive ecological risk assessment
or an assessment that supports a complete endangered species risk
assessment determination for registered pesticide uses of denatonium
saccharide.  Please see Amended Problem Formulation for Ecological Risk
Assessment for Denatonium Saccharide for a detailed discussion of the
anticipated risk assessment needs.

The Agency anticipates needing the following data in order to conduct a
complete ecological risk assessment for the uses of denatonium
saccharide, including an endangered species assessment:

(GLN 835.2120) Hydrolysis of parent and degradates as a function of pH
at 25 C

(GLN 835.4100) Aerobic soil metabolism

(GLN 835.1230) Sediment and soil adsorption/desorption for parent and
degradates

(GLN 850.2100) Avian acute oral toxicity test

(GLN 850.2200) Avian dietary toxicity test

(GLN 850.1010) Aquatic invertebrate acute toxicity test, freshwater
daphnids, and

(GLN 850.1075) Freshwater fish acute toxicity test.

The planned ecological risk assessment will allow the Agency to
determine if denatonium saccharide’s use has “no effect” or “may
affect” federally listed threatened or endangered species (listed
species) or their designated critical habitat.  If the screening level
assessment indicates that denatonium saccharide “may affect” a
listed species or its designated critical habitat, the assessment will
be refined.  The refined assessment will allow the Agency to determine
whether use of denatonium saccharide is “likely to adversely affect”
the species or critical habitat or "not likely to adversely affect" the
species or critical habitat.  When an assessment concludes that a
pesticide's use “may affect” a listed species or its designated
critical habitat, the Agency will consult with the U.S. Fish and
Wildlife Service and/or National Marine Fisheries Service (the
Services), as appropriate.

Human Health Risk:

Acute oral, dermal, and inhalation toxicities for the formulated product
of denatonium saccharide are low  (category IV).  Denatonium saccharide
is not an eye irritant, skin irritant or a skin sensitizor.  No
subchronic or chronic toxicity studies are available for denatonium
saccharide.

No dietary exposure assessment was conducted previously.   There are no
food uses for denatonium saccharide, and contamination of homegrown
produce from residential use is unlikely.  The Agency has not conducted
a drinking water assessment for denatonium saccharide; however,
depending on the outcome of the Agency’s drinking water exposure
assessment, a chronic dietary assessment for drinking water exposure may
be needed.  The Agency does not believe that there are acute dietary
risks of concern because denatonium saccharide is a bitter compound that
is unlikely to be consumed by humans in large enough quantities to
produce acute toxic effects.

No residential exposure assessment was conducted previously.  Exposures
to residential handlers during application can occur, especially dermal
exposure.  Therefore, a dermal absorption study on the active ingredient
is needed.  A dermal residential handler dermal assessment may be
necessary if denatonium saccharide is dermally absorbed.

If results from environmental fate studies, requested in this document,
predict drinking water concerns, an aggregate risk assessment may be
needed

No occupational risk assessment was conducted previously.  However, no
assessment is needed at this time because of denatonium saccharide’s
low acute toxicity of the formulation, the required personal protective
equipment stated on the product label, and the fact that no incidents
have been reported so far.  However, if denatonium saccharide is found
to be dermally absorbed, an occupational risk assessment may be needed.

The Agency anticipates needing the following data in order to conduct a
complete human health risk assessment for the uses of denatonium
saccharide:

(GLN 870.3200) 21 day dermal absorption study, and

(GLN 870.3100) 90 day oral toxicity study – rodent.

Please refer to Denatonium Saccharide (PC code 129045) Revised Human
Health Risk Scoping Document in Support of Registration Review for more
information regarding the human health effects of denatonium saccharide

Timeline:

EPA has created the following estimated timeline for the completion of
the denatonium saccharide registration review.  

Registration Review for denatonium saccharide

Projected Registration Review Timeline

Activities 	Estimated Month/Year

Phase 1: Opening the docket

Open Public Comment Period for denatonium saccharide Docket  	2008 –
Jun.

Close Public Comment Period 	2008 – Sept.

Phase 2:  Case Development

Develop Final Work Plan (FWP)	2008 – Nov.

Issue DCI	2009 –Jul. – Sept.

Data Submission	2011 – Oct. – Dec.

Open Public Comment Period for Preliminary Risk Assessments 	2013 –
Apr. – Jun.

Close Public Comment Period	2013 – Jul. – Sept.

Phase 3: Registration Review Decision

Open Public Comment Period for Proposed Reg. Review Decision 	2013 –
Oct. – Dec.

Close Public Comment Period 	2014 – Jan.—Mar.

Final Decision and Begin Post-Decision Follow-up	2014 – Jul. – Sept.


Total (years)	6



Guidance for Commenters:

The public is invited to comment on EPA’s preliminary registration
review work plan and rationale.  The Agency will carefully consider all
comments as well as any additional information or data provided prior to
issuing a final work plan for the denatonium saccharide case.  

Denatonium saccharide is not identified as a cause of impairment for any
water bodies listed as impaired under section 303(d) of the Clean Water
Act, based on information provided at
http://oaspub.epa.gov/tmdl/waters_list.impairments?p_impid=3.  The
Agency invites submission of water quality data for this pesticide.  To
the extent possible, data should conform to the quality standards in
Appendix A of the OPP Standard Operating Procedure: Inclusion of
Impaired Water Body and Other Water Quality Data in OPP’s Registration
Review Risk Assessment and Management Process (see:   HYPERLINK
"http://www.epa.gov/oppfead1/cb/ppdc/2006/november06/session1-sop.pdf" 
http://www.epa.gov/oppfead1/cb/ppdc/2006/november06/session1-sop.pdf ),
in order to ensure they can be used quantitatively or qualitatively in
pesticide risk assessments. 

EPA seeks to achieve environmental justice, the fair treatment and
meaningful involvement of all people, regardless of race, color,
national origin, or income, in the development, implementation, and
enforcement of environmental laws, regulations, and policies. To help
address potential environmental justice issues, the Agency seeks
information on any groups or segments of the population who, as a result
of their location, cultural practices, or other factors, may have
atypical, unusually high exposure to denatonium saccharide compared to
the general population. Please comment if you are aware of any
sub-populations that may have atypical, unusually high exposure compared
to the general population.

Stakeholders are also specifically asked to provide information and data
that will assist the Agency in refining the ecological risk assessment,
including any species-specific effects determinations.  The Agency is
interested in obtaining the following information regarding the use of
denatonium saccharide:

confirmation on the following label information

sites of application

formulations

application methods and equipment

maximum application rate

frequency of application, application intervals, and maximum number of
applications per year

geographic limitations on use

use history

sub-county location data

typical interval (days)

state or local use restrictions

ecological incidents (non-target plant damage and avian, fish,
reptilian, amphibian and mammalian mortalities) not already reported to
the Agency

monitoring data

Next Steps:

After the comment period closes, the Agency will review any comments
received, and then issue a Final Work Plan for this pesticide.

II. FACT SHEET

Background Information:

Denatonium saccharide is a squirrel, vole, dog and cat repellant used on
outdoor surfaces and structures.

Registration Review case number: 7625

PC code: 129045		CAS #: 90823-38-4 

No technical registrant 

Special Review and Reregistration Division (SRRD), Chemical Review
Manager (CRM): Joy Schnackenbeck: schnackenbeck.joy@epa.gov

Registration Division (RD) Contact: Dan Peacock: peacock.dan@epa.gov

One active product

  

Use Information:   

Usage data for denatonium saccharide is extremely limited.

Denatonium saccharide is sold as a ready to use liquid.

Denatonium saccharide is applied with a sprayer or paintbrush.

Limited denatonium saccharide usage information is only available for
the State of California.

Denatonium saccharide’s use is primarily residential.

Ecological Risk Assessment Status:

The following ecological outcomes are anticipated based on limited data
and risk assessments currently available.  Please refer to Amended
Problem Formulation for Ecological Risk Assessment for Denatonium
Saccharide for a detailed discussion of the anticipated ecological risk
assessment needs.  A summary follows.

No previous ecological assessment has been completed for denatonium
saccharide.

No environmental fate data have been submitted; the fate of denatonium
saccharide in the environment remains unknown.

Acute effects of denatonium saccharide to mammals and terrestrial plants
are unlikely because mammalian toxicity is low, and exposure of
terrestrial plants will be minimal.

Acute effects of denatonium saccharide to birds and aquatic organisms
exposed are unknown.  Birds may eat treated seeds without being deterred
since the product is not labeled as a bird deterrent.  Additionally,
aquatic organisms may be subjected to denatonium saccharide by ingestion
of seeds that have washed into aquatic systems and denatonium saccharide
that may wash off seeds once they are submerged.  

Before the risk assessments are developed for public comment, the Agency
will

ensure that all currently registered uses of denatonium saccharide have
an endangered species assessment completed.  The ecological risk
assessment will allow the Agency to determine whether denatonium
saccharide use has "no effect" or "may affect" federally listed
threatened or endangered species (listed species) or their designated
critical habitat.  If the assessment concludes that a pesticide's use
"may affect" a listed species or its designated critical habitat, the
Agency will consult with the U.S. Fish and Wildlife Service and/or
National Marine Fisheries Service (Services), as appropriate.

Human Health Risk Assessment Status:

Please refer to Denatonium Saccharide (PC code 129045) Revised Human
Health Risk Scoping Document in Support of Registration Review for a
detailed discussion of the anticipated risk assessment needs for human
health.  A summary follows.

Dietary (Food and Water):

There are no food uses for denatonium saccharide and contamination of
homegrown produce from residential use of denatonium saccharide is
unlikely.

Dietary exposure from drinking water is unknown.  A dietary assessment
for drinking water exposure may be performed as part of the registration
review of denatonium saccharide.

Residential: 

Exposures to residential handlers during application may occur through
dermal exposure.  A dermal residential handler assessment may be
necessary if denatonium saccharide is found to be dermally absorbed.

Occupational:

Occupational exposure is unlikely because of the product’s low
acute-toxicity, the required personal protective equipment, and the
predominately-residential use pattern.  However, if denatonium
saccharide is found to be dermally absorbed, an occupational risk
assessment may be needed.

Aggregate:

Denatonium saccharide is a non-food use chemical, however dietary
exposure from drinking water is unknown at this time; therefore, an
aggregate assessment may be needed.

Incident Reports:

No cases have been reported in OPP’s Incident Data System (IDS) from
1999 to present.

Tolerances: 

Denatonium saccharide has no food uses; therefore, it has no associated
tolerances. 

Data Call-In Status:

There are no current data call-ins.

Labels: 

Denatonium saccharide is only associated with one registration:
registration number 81117-1, Ro-pel Tree Squirrel, vole, Dog and Cat
Repellent.  Its label can be obtained from the Pesticide Product Label
System (PPLS) website: http://oaspub.epa.gov/pestlabl/ppls.home. 



III. GLOSSARY of TERMS and ABBREVIATIONS

ai		Active Ingredient

AR		Anticipated Residue

CFR		Code of Federal Regulations

cPAD		Chronic Population Adjusted Dose

CSF		Confidential Statement of Formula

CSFII		USDA Continuing Surveys for Food Intake by Individuals

DCI		Data Call-In

DEEM		Dietary Exposure Evaluation Model

DFR		Dislodgeable Foliar Residue

DNT		Developmental Neurotoxicity

DWLOC		Drinking Water Level of Comparison

EC		Emulsifiable Concentrate Formulation

EDWC		Estimated Drinking Water Concentration

EEC		Estimated Environmental Concentration

EPA			Environmental Protection Agency

EUP		End-Use Product

FDA		Food and Drug Administration

FIFRA		Federal Insecticide, Fungicide, and Rodenticide Act

FFDCA		Federal Food, Drug, and Cosmetic Act

FQPA		Food Quality Protection Act

FOB		Functional Observation Battery

GENEEC		Tier I Surface Water Computer Model

IR		Index Reservoir

LC50	Median Lethal Concentration.  A statistically derived concentration
of a substance that can be expected to cause death in 50% of test
animals.  It is usually expressed as the weight of substance per weight
or volume of water, air or feed, e.g., mg/l, mg/kg or ppm.

LD50	Median Lethal Dose.  A statistically derived single dose that can
be expected to cause death in 50% of the test animals when administered
by the route indicated (oral, dermal, inhalation).  It is expressed as a
weight of substance per unit weight of animal, e.g., mg/kg.

LOC		Level of Concern

LOAEL		Lowest Observed Adverse Effect Level

µg/g		Micrograms Per Gram

µg/L		Micrograms Per Liter

mg/kg/day		Milligram Per Kilogram Per Day

mg/L		Milligrams Per Liter

MOE		Margin of Exposure 

MRID	Master Record Identification (number).  EPA's system of recording
and tracking submitted studies.

MUP		Manufacturing-Use Product

NA		Not Applicable

NAWQA		USGS National Ambient Water Quality Assessment

NPDES		National Pollutant Discharge Elimination System

NR		Not Required

NOAEL		No Observed Adverse Effect Level

OPP		EPA Office of Pesticide Programs

OPPTS		EPA Office of Prevention, Pesticides and Toxic Substances

PAD		Population Adjusted Dose

PCA		Percent Crop Area

PDP		USDA Pesticide Data Program

PHED		Pesticide Handler's Exposure Data

PHI			Preharvest Interval

ppb		Parts Per Billion

PPE		Personal Protective Equipment

ppm		Parts Per Million

PRZM/EXAMS		Tier II Surface Water Computer Model  

Q1*	The Carcinogenic Potential of a Compound, Quantified by the EPA's
Cancer Risk Model

RAC		Raw Agriculture Commodity

RED		Reregistration Eligibility Decision

REI		Restricted Entry Interval

RfD		Reference Dose

RQ		Risk Quotient

SCI-GROW		Tier I Ground Water Computer Model

SAP		Science Advisory Panel

SF		Safety Factor

SLN		Special Local Need  (Registrations Under Section 24©) of FIFRA)

TGAI		Technical Grade Active Ingredient

USDA		United States Department of Agriculture

UF		Uncertainty Factor

WPS		Worker Protection Standard

	

Docket Number: EPA-HQ-OPP-2008-0441

www.regulations.gov

 PAGE   

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Docket Number: EPA-HQ-OPP-2008-0441

www.regulations.gov

