Document ID: EPA-HQ-OPP-2009-0127-0014
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-08-27T04:00Z

BIOPESTICIDE REGISTRATION ACTION DOCUMENT 

 

S-Abscisic Acid

PC Code: 272000

U.S. Environmental Protection Agency

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

Last updated- February 25, 2010

TABLE OF CONTENTS

 TOC \f I.     EXECUTIVE
SUMMARY………………………………………………………
…………. p.4           

II.    ACTIVE INGREDIENT
OVERVIEW……...……………….…………………………….. 
p.6

III.   REGULATORY
BACKGROUND……………………………………………………
…… p.6

IV.   RISK
ASSESSMENT……………………………………………………
…………………. p.7

A.  PRODUCT ANALYSIS ASSESSMENT
…………………………………………..   p.7

   1.  Product Chemistry and
Composition…………………………………………….p.7

2.  Analysis and Certification of
Limits……………………………………………..p.8

   3.  Physical and Chemical
Characteristics…………………………………………. p.8

B.  HUMAN HEALTH
ASSESSMENT.....……………………………………...……….p.
8

			1.  Toxicological Hazard
Assessment……………………………………………….p.8

			2.  Dose
Response………………………………………………………
………….p.11  

3.  Dietary Exposure and Risk
Characterization………………………………..….p.12

			4.  Drinking Water Exposure and Risk
Characterization…………………….…….p.12

		5.  Acute and Chronic Dietary Exposure and Risks for Sensitive 

                           Subpopulations, Particularly Infants and
Children………………………….…p.12

6.  Occupational, Residential, School, and Daycare Exposure and Risk    
                                                                        
                                                                        
                                                                        
               
Characterization………………………………………………
……………..…p.13                                                
                                                                        
                                                                      

	7.  Aggregate Exposure from Multiple Routes Including Dermal, Oral, 

and
Inhalation……………………………………………………
……………..p.13

	8.  Cumulative
Effects………………………………………………………
……...p.14

	9.  Risk
Characterization………………………………………………
…………...p.14

	C.  ENVIRONMENTAL
ASSESSMENT.……………………………………………... p.14

	1.  Summary of Non-Target Organism Testing and Waiver
Rationales……….…..p.14

                  2.  Environmental Fate and
Groundwater……………………………………….....p.16

                 	3.  Ecological Exposure and Risk
Characterization………………………….…….p.16  

                  4.  Threatened and Endangered Species
Assessment………………………....……p.16

V.     ENVIRONMENTAL
JUSTICE………………………………………………………
….. p.16

VI.    RISK MANAGEMENT AND REGISTRATION
DECISIONS…………………………. p.17

A. DETERMINATION OF
ELIGIBILITY……………………………………………...p.17

B. REGULATORY
DECISION………………………………………………………
…p.17

C.
LABELING………………………………………………………
………………...…p.18

VII.   ACTIONS REQUIRED BY THE
REGISTRANT……………………………………......p.18

 A. REPORTING OF ADVERSE EFFECTS AND HYPERSENSITIVITY                   
                                                                        
                      
INCIDENTS………………………………………………………
………….……....p.18

VIII.  GLOSSARY OF ACRONYMS AND
ABBREVIATIONS………………………….…...p.19

 IX.    BIBLIOGRAPHY STUDIES SUBMITTED IN SUPPORT OF THIS 

   
REGISTRATION……….…………………………………………
……………….……p.19

            A. STUDIES SUBMITTED IN SUPPORT OF THIS
REGISTRATION…..…………..p.19

      B. EPA RISK ASSESSMENT
MEMORANDA…...…..….…………………………….p.29

 APPENDIX A - BIOCHEMICAL PESTICIDE DATA
REQUIREMENTS…………..….……p.30

 BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

Biochemical Pesticides Branch (BPB)

					Chris Pfeifer							Regulatory Action Leader

					Linda Hollis							Branch Chief

					Clara Fuentes, Ph.D					Lead Science Reviewer

Russell Jones, Ph.D					Senior Biologist

I.    EXECUTIVE SUMMARY tc "I.    EXECUTIVE SUMMARY/FACT SHEET" 

S-Abscisic Acid,
(S)-5-(1-hydroxy-2,6,6-trimethyl-4-oxo-1-cyclohex-2-enyl)-3-methyl-penta
-(2Z,4E)-dienoic Acid, commonly known as ABA, is a plant regulator
present in all vascular plants, algae, and some fungi. Its name derives
from its purported role in abscission—the shedding of leaves, fruits,
flowers, and seeds. As a plant hormone, ABA is known to be a strong
actor in regulating plant growth by aiding in stress resistance, and
contributing to the control of fruit set, ripening, and senescence. It
is naturally present in fruits and vegetables at various levels,
generally not in excess of 10 parts per million (ppm), and has always
been a component of any diet containing plant materials. To date, no
toxic effects to humans have been associated with the consumption of ABA
in fruits and vegetables.  In addition to our long history of
consumption of ABA without known toxicological effect, all the
information submitted to the Agency in conjunction with this exemption
from a requirement of tolerance confirms that ABA is virtually non-toxic
and poses no dietary risks to humans.  

Because ABA is considered to be “toxicologically innocuous,” no
residue studies are required to support an exemption from the
requirement of a tolerance.  ABA’s low toxicity profile
notwithstanding, another justification for this exemption from the
requirement of a tolerance is the unlikelihood of residues for this
biochemical pesticide.  ABA is intended for preharvest application; and
as a biochemical, it biodegrades rapidly.  Data indicate that the active
ingredient is more than 95% biodegraded within 24 hours (MRID 47131404).
 Calculations indicate that residues would be largely biodegraded before
harvest, and that they should be statistically indistinguishable from
background levels at the time of consumption.

	

Acute, subchronic and developmental studies submitted in the application
for registration provided sufficient information to satisfy all
mammalian toxicology data requirements.  No toxicological endpoints were
established, and no adverse effects were observed with regard to
mammalian health. 

No dietary risks are expected with regard to the use of the active
ingredient ABA.  Significant dietary exposures (including exposures via
drinking water) are not expected for the active ingredient ABA. In the
event of dietary exposure, the toxicological data demonstrate that ABA
is not toxic or pathogenic to mammals.  It is a regular constituent of
the human diet; and there have been no health effects associated with
its consumption by people.  Furthermore, all data demonstrate that no
acute, sub-chronic, chronic, immune, or endocrine-disrupting effects are
associated with the use of the active ingredient.  Accordingly, no harm
to infants, children, and the general U.S. population is anticipated
with regard to dietary exposure. Because of the nontoxic profile and the
lack of expected residue of the active ingredient, the risks associated
with the proposed food uses of this active ingredient are expected to be
negligible.  

The potential for aggregate, non-occupational exposure is expected to be
insignificant as the active ingredient is largely biodegraded within a
day, and applications of ABA are expected to be limited due to the
potential deleterious effects to crops associated with the
over-application of plant regulators.  Moreover, given a lack of acute
toxicological endpoints and because ABA is not known to share any
structural similarity to any chemicals with common mechanisms of
toxicity, the likelihood of risks resulting from such miniscule
exposures is negligible.

Non-target organism and environmental fate data requirements were
satisfied through the submission of studies.  ABA occurs naturally in
the terrestrial environment, and is not associated with any known
detrimental effect.  All information available to the Agency validates a
non-toxic mode of action, and a lack of adverse effect relative to
non-target organisms.      

In accordance with the T-REX Model (the Individual Effects Chance Model
Version 1.1), the GENEEC Model, and the non-target data submitted, the
Agency has made a “No Effect” (NE) determination for direct and
indirect effects to any listed threatened and endangered species and
their habitat as a result of the proposed uses of ABA.

On October 1, 2009, EPA announced a new policy to provide a more
meaningful opportunity for the public to participate on major
registration decisions before they occur.  According to this new policy,
EPA will provide a public comment period prior to making a registration
decision for, at minimum, the following types of applications: new
active ingredients, first food use, first outdoor use, first residential
use, and other actions for which we anticipate significant public
interest.  The registration application for ABA is for a “new active
ingredient” whose registration would result in a “first outdoor
use” and a “first food use.”  Therefore, consistent with the new
policy of making registration actions more transparent, the Agency
provided a 30-day comment period on the ABA application and EPA's
preliminary risk assessment.  EPA did not receive any comments during
the comment period.    

EPA believes, based on the risk assessment and information submitted in
support of the registration of ABA, that it is in the best interests of
the public and the environment to issue the registration for ABA.  The
basis for this preliminary decision can be found in the risk assessment
for ABA, which is characterized in this BRAD.  As discussed above, acute
toxicity data for ABA indicate a nontoxic profile.  ABA does not
demonstrate subchronic or developmental toxicity, and it is not
mutagenic or genotoxic.  EPA has no concerns for any non-target
organisms exposed to ABA in accordance with approved label directions. 
EPA has not identified any toxic endpoints for non-target mammals,
birds, plants, aquatic, or soil organisms. Nor are there concerns for
any threatened and endangered species.  Thus, given that ABA has very
low toxicity, and presents little if any risk to non-target organisms,
and data confirm its effectiveness as a plant regulator, EPA concludes
that it is in the best interests of the public and the environment to
issue the registration for ABA.  

EPA reviewed data requirements for granting registration under Section
3(c)(5) of the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA).  It was determined that the data/information submitted
fulfilled current data requirements (refer to 40 CFR Subpart U §
158.2000).  

II.	ACTIVE INGREDIENT OVERVIEW

Common Name: 			S-Abscisic Acid (ABA)

Chemical Names: 	
(S)-5-(1-hydroxy-2,6,6-trimethyl-4-oxo-1-cyclohex-2-enyl)-3-methyl-penta
-(2Z,4E)-dienoic Acid

Trade & Other Names:	ABA

CAS Registry Number: 	21293-21-8

OPP Chemical Code: 	272000

Type of Pesticide: 		Plant Regulator 

 		III.  REGULATORY BACKGROUND

On March 16, 2009, EPA published in the Federal Register (Volume 74,
Number 49) a notice announcing that Valent Biosciences Corporation, 870
Technology Way, Libertyville, IL 60048, submitted an application to
register a pesticide product (EPA File Symbol 73049-UAE) containing a
new active ingredient (ABA) not included in any currently registered
products.  On May 6, 2009, EPA published in the Federal Register (Volume
74, Number 86) a notice announcing that Valent Biosciences Corporation,
870 Technology Way, Libertyville, IL 60048, submitted an application
proposing to establish an exemption from the requirement of a tolerance
for residues of the biochemical pesticide, S-Abscisic Acid, in or on all
food commodities (PP# 8F7391).  No substantive comments were received
following the publication of either notice.  In addition, on January 26,
2010, EPA provided the opportunity for a 30-day comment period on the
Agency’s draft risk assessment and intention to register this
pesticide product.  EPA did not receive any comment on the proposed
action.

CLASSIFICATION 

S-Abscisic Acid is well recognized as a plant hormone naturally present
in all vascular plants, algae and fungi.  With regard to its active
properties, it is a plant regulator, which aids in plant growth by
bolstering stress resistance, improving fruit set, and controlling the
pace of ripening, and senescence. It does not work directly against
pests; rather it regulates plant growth, allowing growers to improve
plant strength, to bolster plant defenses and to cultivate desirable
attributes in fruits and vegetables.  As such, ABA is not associated
with any toxic mode of action.  With regard to classification, ABA is
considered to be a biochemical pesticide due to its nontoxic mode of
action to the target pest, natural occurrence in the environment, and
its history of exposure to humans and the environment without known
toxicity. 

FOOD CLEARANCES/TOLERANCES 

This active ingredient is permitted for food use. The Agency’s risk
assessment finds no evidence of dietary risk and supports Pesticide
Petition# 8F7391, which establishes an exemption from the requirement of
a tolerance for residues of the biochemical pesticide, S-Abscisic Acid,
in or on all food commodities 

IV.  RISK ASSESSMENT

 tc "III.  SCIENCE ASSESSMENT"  

On October 26, 2007, the Agency issued a Final Rule in the Federal
Register on the data requirements to support registration of biochemical
and microbial pesticides, and updated the definitions for biochemical
and microbial pesticides (  HYPERLINK
"http://www.epa.gov/fedrgstr/EPA-TOX/2007/October/Day-26/t20828.htm"  72
FR 61002 ). The rule became effective on December 26, 2007. The data and
information evaluated for this Biopesticides Registration Action
Document (BRAD) were considered in light of these requirements.

The classifications that are found for each data submission are assigned
by EPA science reviewers and are an indication of the usefulness of the
information contained in the documents for risk assessment. A rating of
“ACCEPTABLE” indicates the study is scientifically sound and is
useful for risk assessment. A “SUPPLEMENTAL” rating indicates the
data provide some information that can be useful for risk assessment.
The studies may have certain aspects determined not to be scientifically
acceptable (“SUPPLEMENTAL: UPGRADABLE”). If a study is rated as
“SUPPLEMENTAL: UPGRADABLE,” the Environmental Protection Agency
always provides an indication of what is lacking or what can be provided
to change the rating to “ACCEPTABLE.” If there is simply a
“SUPPLEMENTAL” rating, the reviewer will often state that the study
is not required by the current 40 CFR Part 158. Both “ACCEPTABLE”
and “SUPPLEMENTAL” studies may be used in the risk assessment
process as appropriate. An “UNACCEPTABLE” rating indicates that new
data need to be submitted.

For the acute toxicity data requirements, toxicity categories are
assigned for providing the appropriate precautionary labeling statement,
based on the hazard(s) identified from studies and/or other information
submitted to the Agency in support of a pesticide registration.  The
active ingredient or particular product is classified into Toxicity
Category I, II, III, or IV, where Toxicity Category I indicates the
highest toxicity and Toxicity Category IV indicates the lowest toxicity.
 

	A.  PRODUCT ANALYSIS ASESSMENT  tc "A.   Physical and Chemical
Properties Assessment " \l 2 

	

1.  Product Chemistry and Composition 

ABA is a naturally occurring plant hormone found in all vascular plants,
algae and fungi.  As an active ingredient, ABA is distilled and
concentrated into an odorless white powder.  ABA’s mode of action is
as a signal agent – helping plants to mediate their developmental
processes.  Specifically, it serves plants by modulating water uptake,
tempering plant growth and fruit set, and by slowing plant metabolism. 
Pesticidal applications of ABA are absorbed by the plant, triggering
specific biosynthetic responses relative to the plant’s developmental
stage.  

All product chemistry data requirements for ABA have been satisfied. As
a manufactured active ingredient, ABA extract is indistinguishable from
the plant hormone that is produced naturally in plants.  The extract has
a high degree of purity and contains no impurities of toxicological
significance.  All data requirements for physical and chemical
characteristics have been adequately addressed.     

2.  Analysis and Certification of Limits

The submitted data satisfied the requirement for Analysis and
Certification of Limits.  Five batch analyses and the analytical method
used to determine the purity of ABA were examined and determined to be
acceptable by the Agency.  The certified limits for the active and inert
ingredients fall within the ranges specified by OPPTS Guideline
830-1750.   

3.  Physical and Chemical Characteristics

The Agency has determined that the submitted data adequately describe
the physical and chemical characteristics of ABA.  Refer to Table 1 in
Appendix A for The Series 830 physical and chemical properties.   

	B.   HUMAN HEALTH ASSESSMENT 

	1.  Toxicological Hazard Assessment 

Adequate mammalian toxicology studies were provided in support of the
registration of ABA for each data requirement. Acute toxicology data for
ABA indicates that the active ingredient is virtually non-toxic to
mammals, and that there are no toxicological endpoints relative to the
use of ABA as a plant regulator.  Accordingly, the data submitted
demonstrate that the proposed uses of ABA pose no significant risks to
human health and support a finding of reasonable certainty that no harm
to the general U.S. population, including infants and children, will
result from exposure to this active ingredient.  

Refer to Table 2 in Appendix A for a summary of the Toxicity Data
Requirements for this food use active ingredient.

			a. Acute Toxicity – Tier I (40 CFR § 158.2050) 

Acute Oral Toxicity – Rat [OPPTS Guideline 870.1100; Master Record
Identification (MRID) Numbers (No.) 46895611]:  An acute oral toxicity
study shows that the active ingredient ABA has an acute oral median
lethal dose (LD50)of greater than 5000 milligrams per kilogram (mg/kg)
in rats.  This was the maximum dose rate.  There were no observed
toxicological effects on the test subjects at the maximum dose.   The
study supports the finding that this active ingredient poses no
significant human health risk with regard to food uses.  The study was
found “ACCEPTABLE” and ABA was classified as TOXICITY CATEGORY IV
for this route of exposure when used as a plant regulator. 

Acute Dermal Toxicity– Rabbits (OPPTS Guideline 870.1200; MRID No. 
46895612):  An acute oral toxicity study shows that the active
ingredient ABA has an LD50 of greater than 5000 mg/Kg in rats, which is
considered to be virtually non-toxic.  Data substantiate the active
ingredient’s relative dermal non-toxicity to both occupational users
and the general public.   The study was found “ACCEPTABLE” and ABA
was classified as TOXICITY CATEGORY IV for this route of exposure when
used as a plant regulator.

Acute Inhalation Toxicity (OPPTS Guideline 870.1300; MRID No. 46895613):
 An acute oral inhalation study shows that the active ingredient ABA has
a median lethal concentration (LC50) of greater than 1.02 milligrams per
liter mg/L in rats, which shows no significant inhalation toxicity. 
This was the maximum dose rate, and no toxicological effects were
observed on the test subjects.   The study was found “ACCEPTABLE”
and ABA was classified as TOXICITY CATEGORY IV for this route of
exposure when used as a plant regulator.  

Primary Eye Irritation (OPPTS Guideline 870.2400; MRID No. 46895614):  A
primary eye irritation study on rabbits demonstrated ABA to be mildly
irritating to the eye. However, all iritis and conjunctivitis cleared
after 24 hours. The study was found “ACCEPTABLE” and ABA was
classified as TOXICITY CATEGORY III for this route of exposure when used
as a plant regulator.  

Primary Dermal Irritation (OPPTS Guideline 870.2500; MRID No. 46895615):
 A skin irritation study on rabbits demonstrated that ABA was not
irritating to the skin.  The findings are consistent with the other
dermal studies and confirm that ABA is not toxic through this route of
exposure.  The study was found “ACCEPTABLE” and ABA was classified
as TOXICITY CATEGORY IV for this route of exposure when used as a plant
regulator.

Skin Sensitization (OPPTS Guideline 870.2600; MRID No. 46895616):  Data
indicate ABA is not a dermal sensitizer.   However, any reported
incidents may cause this position to be reconsidered.  

Subchronic Testing (OPPTS Guideline 870.3100, 870.3250, 870.3465; MRID
Nos. 47470509 and 47470510):   In accordance with footnote seven and
eight in the Biochemical Pesticides Human Health Assessment Data
Requirements table in 40 CFR § 158.2050, subchronic dermal and
subchronic inhalation testing were not required for a lack of exposure. 
Two subchronic oral tests were submitted in support of ABA’s food use.
These studies satisfy the data requirement for subchronic oral testing
and indicate that ABA has no subchronic toxicological effect through the
oral route of exposure.  A 28-day oral toxicity study found no
toxicological effects regarding mortality, clinical observations,
neurotoxicity assessment, body weight, food consumption, hematology,
clinical chemistry, organ weights, and macroscopic or microscopic
observations.  The No Adverse Effects Level (NOAEL) was determined to be
20,000 milligrams per kilogram per day (mg/kg/day). A 90-day oral
toxicity study found no statistical difference in hematology, clinical
chemistry, or urinalysis between test subjects and the control.  The
NOAEL was determined to be 20,000 mg/kg/day.  All subchronic oral
toxicity studies indicate that ABA is not subchronically toxic through
the oral route of exposure. 

Developmental Toxicity (OPPTS Guideline 870.3700; MRID Nos. 47470511 and
47470512):  Data submitted to the Agency satisfy the data requirement
and support the Agency’s conclusion that there is no risk of
developmental toxicity associated with the new food uses.  A guideline
prenatal developmental toxicity study on rats found no significant
reproductive effects or fetal abnormalities, and established a NOAEL of
1,000 mg/kg/day (the limit dose).  The findings suggest negligible risk
with regard to developmental toxicity.  A supplemental study submitted
to the Agency on rats established a NOAEL of 20,000 mg/kg, confirming a
lack of developmental toxicity and supporting the Agency’s conclusion
that there is no risk of developmental toxicity associated with new food
uses.  Data submitted to the Agency satisfy the data requirements for
developmental toxicity and indicate that ABA poses negligible risk with
regard to developmental toxicity.

Mutagenicity Testing (OPPTS Guidelines 870.5100, 870.5300, 870.5375;
MRID Nos. 4703901, 4703902 and 4703903):  Three genotoxicity studies (a
Bacterial Reverse Mutation Test, an In Vitro Mammalian Cells in Culture
Assay and a Bone Marrow Micronucleus Assay) were performed on the active
ingredient ABA and satisfy the data requirement.  The Reverse Mutation
Assay showed that the ABA did not induce mutant colonies over expected
background levels. The In Vitro Mammalian Cells in Culture Assay
demonstrated that ABA did not damage to chromosomes or the mitotic
apparatus of bone marrow cells.  A Bone Marrow Micronucleus Assay
indicated no mutagenicity in the bone marrow cells of mice up to the
limit dose of 2,000 mg/kg.  These mutagenicity studies are sufficient to
confirm that there are no expected dietary, occupational, or
non-occupational risks of mutagenicity with regard to ABA.

b.	Acute Toxicity – Tier II and Tier III (40 CFR § 158.2050)

No Tier II and Tier III studies were required based on a lack of acute
toxicity in the Tier I studies and a lack of exposure relative to its
preharvest use pattern as a plant regulator.

			c.   Effects on the Endocrine System

As required under FFDCA section 408(p), EPA has developed the Endocrine
Disruptor Screening Program (EDSP) to determine whether certain
substances (including pesticide active and other ingredients) may have
an effect in humans or wildlife similar to an effect produced by a
“naturally occurring estrogen, or other such endocrine effects as the
Administrator may designate.”  The EDSP employs a two-tiered approach
to making the statutorily required determinations. Tier 1 consists of a
battery of 11 screening assays to identify the potential of a chemical
substance to interact with the estrogen, androgen, or thyroid (E, A, or
T) hormonal systems.  Chemicals that go through Tier 1 screening and are
found to have the potential to interact with E, A, or T hormonal systems
will proceed to the next stage of the EDSP where EPA will determine
which, if any, of the Tier 2 tests are necessary based on the available
data. Tier 2 testing is designed to identify any adverse endocrine
related effects caused by the substance, and establish a dose-response
relationship between the dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA is issuing test orders/data
call-ins for the first group of 67 chemicals, which contains 58
pesticide active ingredients and 9 inert ingredients.  This list of
chemicals was selected based on the potential for human exposure through
pathways such as food and water, residential activity, and certain
post-application agricultural scenarios.  This list should not be
construed as a list of known or likely endocrine disruptors.

ABA is not among the group of 58 pesticide active ingredients on the
initial list to be screened under the EDSP.  Under FFDCA sec. 408(p) the
Agency must screen all pesticide chemicals.  Accordingly, EPA
anticipates issuing future EDSP test orders/data call-ins for all
pesticide active ingredients. 

For further information on the status of the EDSP, the policies and
procedures, the list of 67 chemicals, the test guidelines and the Tier 1
screening battery, please visit our website:    HYPERLINK
"http://www.epa.gov/endo/"  http://www.epa.gov/endo/ .

While no data are presently being required for ABA, a non-guideline
study on the effects of the endocrine system was submitted and found
“ACCEPTABLE.” (Reporter Gene Assays for Abscisic Acid (ABA) Using
Human Estrogen and Androgen Receptors, MRID No. 47470513)  The study
determined that ABA is not an estrogenic, anti-estrogenic, androgenic or
anti-androgenic compound.

In addition to this study, all available information supports the case
that ABA is not an estrogenic, anti-estrogenic, androgenic or
anti-androgenic compound. ABA is a naturally occurring compound that is
present in all of our fruits and vegetables.  To date, there is no
evidence to suggest that our natural exposure to ABA affects the immune
system, functions in a manner similar to any known hormone, or that it
acts as an endocrine disruptor.  Moreover, the use of ABA is not
expected to result in any significant exposures, effectively obviating
any opportunity for negative effects on humans or the environment. 
Therefore, it is unlikely that ABA would have estrogenic or endocrine
effects.  However, the Endocrine Disruption Screening Program (EDSP) has
established a protocol, which guides the Agency in selecting suspect
ingredients for review; and the Agency reserves the right to require new
information, should the program require it.  Presently, based on the
lack of exposure and the negligible toxicity profile of the extract, no
adverse effects to the endocrine or immune systems are known or
expected.  

		2.   Dose Response Assessment 

No toxicological endpoints were identified; therefore, a dose response
assessment was not required.  

		3.   Dietary Exposure and Risk Characterization

Exposure to residues of ABA on foods is expected to be negligible; and
even in the event of dietary exposure, no dietary risks are anticipated.
 Residues of ABA applied to food crops are expected to dissipate to
background levels before they are distributed for consumption. Data
submitted by the registrant confirm ABA’s rapid dissipation through
metabolization, photo-isomerization, and degradation (MRID No.
47131404). Data demonstrate that ABA residues on grape leaves are 95%
degraded within 24 hours of application. Moreover, confirmatory data on
the degradation of ABA on wheat leaves show a half-life ranging between
5 and 8 hours. Given ABA’s preharvest application and rapid
degradation, no significant residues are expected.  Even in the event of
exposure to residues, no dietary risks are anticipated.  Acute,
subchronic, and teratogenicity studies support its non-toxic profile. 
It is already present in the human diet – in all fruits and vegetables
- without any known detrimental effect.  Furthermore, there is no
information in the public literature suggesting any health issues to
either animals or plants relative to this compound.  In sum, no dietary
exposure is expected; and any potential dietary exposures would not be
expected to pose any quantifiable risk, due to its nontoxic profile.

 

	4.   Drinking Water Exposure Risk Characterization 

Applications of ABA are to be made directly to food crops. Accidental
application to surface water is unlikely. Negligible ABA residues might
runoff after application but are not expected to reach surface water or
percolate through the soil to ground water given the rapid
biodegradation of ABA and the rapid metabolization of ABA by soil
microbes (MRID No. 47131404). Therefore, the Agency concludes that any
residues resulting from the application of ABA to food crops are not
expected to result in any significant drinking water exposure beyond
natural background levels of ABA already present in water. Altogether,
drinking water exposure is not expected to pose any quantifiable risk,
due to both a lack of residues and the nontoxicity of ABA.

5.   Acute and Chronic Dietary Exposure and Risks for Sensitive
Subpopulations, Particularly Infants and Children 

Dietary exposure to humans, including infants and children, are
considered negligible with regard to the pesticidal use of ABA.  Because
ABA is mostly biodegraded within 24 hours and applications of ABA are
exclusively preharvest, no significant residues of ABA are expected on
foods.  In the event that there are any residues, acute toxicity studies
indicate that ABA has negligible toxicity.  It is ubiquitous in nature
and present in all edible plants, and there is no history of
toxicological incident involving its consumption.  While no dietary
exposures are expected, the Agency has determined there is a reasonable
certainty of no harm to the general US population, including infants and
children, from exposure to this active ingredient.

6.   Occupational, Residential, School and Day Care Exposure and Risk
Characterization

As an agricultural pesticide, some occupational exposure to ABA can
reasonably be expected.  Such occupational exposures are expected to be
insignificant because - by virtue of ABA’s mode of action as plant
regulator - applications are directed and infrequent.  The
insignificance of any exposure is even more pronounced for residential,
school, or daycare areas.  Even in the event of incidental exposure,
health risks to humans, including infants and children, are considered
negligible, given ABA’s nontoxic profile.  

	

			a. Occupational Exposure and Risk Characterization

Occupational exposures are expected to be minimal.  As a biochemical
plant regulator with a biosynthetic mode of action, applications of ABA
are expected to occur at more infrequent intervals than most other
pesticides because plant regulators are only effective at particular
seminal times, and plant regulators require time to be effectualized in
plants.  Also, applications are expected to be foliarly directed in
order to be most effective, further diminishing the chance of spray
drift associated with area-wide sprays.  Regardless, requirements for
the use of appropriate personal protective equipment and precautionary
statements are required on product labels to mitigate any potential
risks to pesticide handlers due to prolonged exposure. But even in the
event of occupational exposure, any health risks associated with regular
exposure seem unlikely.  People have regularly consumed ABA in their
fruits and vegetables with no history of detrimental effects.  And with
regard to pesticidal applications, all acute, subchronic, and
developmental toxicity data submitted in support of this application for
ABA confirm its lack of toxicity through all routes of exposure. 
Because of a lack of likely exposure to residues and a well established
nontoxic profile for ABA, no occupational risks are expected with regard
to the use of this active ingredient.

			b. Residential, School, and Daycare Exposure and Risk
Characterization

The Agency does not expect any risks to children (or adults) in any of
these environments.  Due to the agricultural use pattern of ABA, the
potential for significant exposure is negligible.  Even in the remote
event of incidental residue, the active ingredient has a nontoxic
profile for all routes of exposure and a long history of consumption
without incident.  Due to limited exposure scenarios and negligible
toxicity hazards, no risks are expected relative to these exposure
scenarios.   

7.   Aggregate Exposure from Multiple Routes Including Dermal, Oral, and
Inhalation 

The potential for aggregate exposure is expected to be insignificant. 
Directed ABA spray is not expected to result in significant amounts of
respirable mist, and is not anticipated to be in non-occupational
environments at all.  Likewise directed foliar applications, are not
likely to result in dermal exposures, especially in non-occupational
environments.  The chance of significant incidental residues, which
could be consumed are also slight. Given a lack of any significant
non-occupational exposure, a lack of concern regarding its naturally
occurring background levels, and a lack of any acute toxicological
endpoints for ABA, the aggregate exposure scenario presents no
significant concerns for risk.

		8.   Cumulative Effects 

Pursuant to FFDCA section 408(b)(2)(D)(v), EPA has considered available
information concerning the cumulative effects of ABA residues and other
substances that have a common mechanism of toxicity. These
considerations include the potential for cumulative effects on infants
and children of ABA residues and other substances with a common
mechanism of toxicity. Because ABA has a long history of dietary
consumption without incident, and because no toxicological endpoints
have been established, the Agency concludes that ABA does not share a
common mechanism of toxicity, and that there are no cumulative effects
arising from ABA residues in or on food commodities.

		9.  Risk Characterization

The Agency considered human exposure to ABA in light of the relevant
safety factors in FQPA and FIFRA.  A determination has been made that no
unreasonable adverse effects to the U.S. population in general, and to
infants and children in particular, will result from the use of ABA when
label instructions are followed. 

	C.  ENVIRONMENTAL ASSESSMENT

1.   Ecological Hazards (Relative to the Biochemical Pesticides
Nontarget Organisms and Environmental Fate Data Requirements - 40 CFR §
158.2060)

Adequate non-target toxicology data/information are available to support
registration of S-Abscisic Acid (S-ABA).  All non-target toxicology data
requirements for S-ABA have been satisfied.

There are no concerns for any non-target organisms when S-ABA is applied
in accordance with EPA-approved label use directions.  No toxic
endpoints have been identified for non-target mammals, non-target birds,
non-target aquatic organisms, non-target insects, and non-target soil
organisms such as earthworms in laboratory testing.  The estimated
environmental concentrations of S-ABA in terrestrial (maximum residues
up to approximately 1200 ppm) and aquatic environments (maximum residues
up to approximately 19 ppb) are well below the maximum concentrations
and doses of S-ABA used in laboratory testing at which no adverse
effects were observed.   

Residues of ABA applied to food crops are expected to dissipate to
background levels before they are distributed for consumption. Data
submitted by the registrant confirm ABA’s rapid dissipation through
metabolization, photo-isomerization, and degradation (MRID No.
47131404). Data demonstrate that ABA residues on grape leaves are 95%
degraded within 24 hours of application. Moreover, confirmatory data on
the degradation of ABA on wheat leaves show a half-life ranging between
5 and 8 hours. Given ABA’s preharvest application and rapid
degradation, no significant residues are expected.

For a complete list of the ecotoxicity data submitted to support the use
of ABA, refer to Table 3 in Appendix A and the Bibliography in Section
IX of this BRAD.  

Avian Testing (OPPTS Guidelines 850.2100; MRID No. 47067901): 

No avian toxicity is expected with regard to the pesticidal use of ABA. 
In an acute oral toxicity study, there were no mortalities and no signs
of adverse effects on test subjects - all birds appeared healthy during
the test, and macroscopic examination revealed no abnormalities in any
birds. The acute oral LD50 was >2182.5 mg/kg, the highest dose tested. 
The exposure calculation suggests that even if a bird consumed an entire
acre of the active ingredient, a toxic threshold would not occur.  A
lack of toxicological endpoints indicates that ABA is nontoxic to birds.

Aquatic Organism Testing (OPPTS Guidelines 850.1010, 850.1075; MRID Nos.
47131401 and 47131402):   No risks are expected with regard to the
exposure of aquatic organisms to ABA.  Aquatic exposure is unlikely due
to the rapid biodegradation of ABA.  But in the event of aquatic
exposures, no hazards are expected for aquatic organisms.  In an acute
toxicity test, groups of Daphnia magna were exposed to concentrations of
ABA up to 116 mg/L ABA. No daphnid mortality or immobility was seen in
any of the test groups after 24 or 48 hours. In this study, the 48-hr
NOEC and EC0 were each ≥116 mg/L, and the LOEC and EC50 were >116
mg/L.  In an acute toxicity test, groups of juvenile rainbow trout were
exposed to a nominal concentration of 0 or 121 mg/L ABA for 48 hours. No
mortality or adverse clinical signs were seen at any intervals or in any
of the test groups. The 48-hr LC50 for ABA in juvenile rainbow trout was
>121 mg/L.  The aquatic organism studies confirm a lack of toxicological
endpoints, and indicate that ABA is nontoxic to aquatic organisms 

Non-Target Plant Testing (OPPTS Guidelines 850.4100, 850.4150; MRID No.
4713404):  The data requirement was satisfied by information
demonstrating a lack of both toxicity and exposure to non-target plants.
 The active ingredient is to be directed at agricultural crops; and
incidental residues would be negligible.  To the degree that there is
incidental exposure, ABA has been shown to have a non-toxic mode of
action relative to plants.  As a plant regulator, ABA simply modulates
plant growth.  Given the environmental conditions that predicate its
use, ABA would actually be expected to have a strengthening effect on
non-target plants.  Indeed, information submitted confirms that ABA has
no significant toxic effects with regard to a myriad of terrestrial and
aquatic non-target plants.  Further, this lack of effect was established
through many parts of the plant life cycle including seed germination
and root elongation phases.  Altogether, no significant exposure or
toxicity is expected with regard to application of ABA.   

Non-Target Insect Testing (OPPTS Guideline 880.4350, 850.3020); MRID No.
47151201):  Data indicate that the residues of ABA pose no risks of
toxicity to non-target insects, through either contact or oral routes of
exposure.  In a laboratory study, groups of honey bees were exposed for
48 hours to 100 μg/bee of ABA, the limit dose.  No toxic effects were
observed at the highest dose, and no toxic endpoints were established. 
There was no statistically significant difference in mortality between
the treated honey bees and the untreated control groups.  In an acute
oral toxicity test, groups of honey bees were fed a limit dose of 108
μg/bee, and then monitored for mortality at intervals up to 48 hours.
After 48 hours, there was no difference in mortality of the untreated
control and test material groups, and no toxic endpoints were
established.  Data indicate that exposures to ABA are not expected to
result in any adverse effects to non-target insects. 

2.  Environmental Fate and Ground Water Data

The need for environmental fate and groundwater data was not triggered
because results of the acute toxicity assessment did not trigger any
additional Tier I studies.

Ecological Exposure and Risk Characterization

Maximum residues on plant foliage following 12 consecutive applications
of S-ABA were estimated using the Terrestrial Exposure Model (T-REX;
EPA, 2008) ranged from 7.62 ppm of fruits, pods, seeds, and large
insects (present on foliage at the time of applications), to 68.58 ppm
on broadleaf plants and small insects, and up to 121.92 ppm on short and
tall grasses.  

Data submitted by the registrant demonstrate that ABA degrades rapidly
in the environment metabolization, photo-isomerization, and degradation
(MRID No. 47131404); ABA residues on grape leaves are 95% degraded
within 24 hours of application. Moreover, confirmatory data on the
degradation of ABA on wheat leaves show a half-life ranging between 5
and 8 hours.  	

	

4.   Threatened and Endangered Species Assessment

Based on the fact that S-Abscisic Acid (S-ABA) is not toxic to
non-target organisms and on its use pattern and use instructions, EPA
has determined it will have "No Effect" on any currently listed
threatened or endangered species or any designated critical habitat. 

V.   ENVIRONMENTAL JUSTICE

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 ABA, 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.

VI.   RISK MANAGEMENT AND REGISTRATION DECISIONS tc "V.   RISK
MANAGEMENT AND REGISTRATION DECISION" 

	A.  Determination of Eligibility 

 tc "A.  Determination of Eligibility " \l 2 

Section 3(c)(5) of FIFRA provides for the registration of new active
ingredients if it is determined that (A) its composition is such as to
warrant the proposed claims for it; (B) its labeling and other materials
required to be submitted comply with the requirements of FIFRA; (C) it
will perform its intended function without unreasonable adverse effects
on the environment; and (D) when used in accordance with widespread and
commonly recognized practice it will not generally cause unreasonable
adverse effects on the environment. 

The four criteria of the Eligibility Determination for Pesticidal Active
Ingredients are satisfied by the science assessments supporting products
containing ABA.  Such products are not expected to cause unreasonable
adverse effects, and are likely to provide protection as claimed when
used according to label instructions. Therefore, EPA concludes that ABA
is eligible for registration for the labeled uses.

	B.  Regulatory Decision

On October 1, 2009, EPA announced a new policy to provide a more
meaningful opportunity for the public to participate on major
registration decisions before they occur.  According to this new policy,
EPA intends to provide a public comment period prior to making a
registration decision for, at minimum, the following types of
applications:  new active ingredients; first food use; first outdoor
use; and first residential use.  Accordingly, this pesticide was subject
to a 30-day comment period as a new active ingredient with both food
uses and outdoor uses.  No comments were received during that comment
period.

At this time, EPA believes, the data submitted fulfill the requirements
of registration for products containing ABA for use as a plant
regulator. Acute toxicity data for ABA demonstrate that it is toxicity
category III and IV for all routes of exposure.  (No toxicological
endpoints were established.)  Data confirm that ABA does not demonstrate
subchronic or developmental toxicity, and it is not mutagenic or
genotoxic.  EPA has no concerns for any non-target organisms exposed to
ABA in accordance with its approved uses.  EPA has not identified any
toxic endpoints for non-target mammals, birds, plants, aquatic, or soil
organisms. Nor are there concerns for any threatened and endangered
species.  Given, the non-toxic character of ABA, EPA supports its
registration under Section 3(c)(5) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA).  Refer to Appendix B for
product-specific information.

		1.  Conditional/Unconditional Registration

All data requirements are fulfilled and EPA has determined that an
unconditional registration for S-Abscisic Acid is warranted under
Section 3(c)(5) of FIFRA. 

		C.  Labeling

Before releasing pesticide products containing S-Abscisic Acid for
shipment, the applicant is required to provide appropriate labels.

VII.   ACTIONS REQUIRED BY THE REGISTRANT

The Agency evaluated the data submitted in connection with the initial
registration of S-Abscisic Acid and determined that these data fulfill
current registration guideline requirements.  No additional data are
required to be submitted to the Agency at this time.  Additional data
may be required for new uses and/or changes to existing uses.  

Notwithstanding the information stated in the previous paragraph, it
should be clearly understood that certain, specific, data are required
to be reported to the Agency as a requirement for maintaining the
Federal registration for a pesticide product. A brief summary of these
types of data are listed below.   

	A.  Reporting of Adverse Effects and Hypersensitivity Incidents

Reports of all incidents of adverse effects to the environment must be
submitted to the Agency under the provisions stated in FIFRA, Section
6(a)(2).

Additionally, all incidents of hypersensitivity (including both
suspected and confirmed incidents) must be reported to the Agency under
the provisions of 40 CFR Part 158.2140 OPPTS Guideline reference number
885.3400.

VIII. GLOSSARY OF ACRONYMS AND ABBREVIATIONS

BPPD	Biopesticides and Pollution Prevention Division

BRAD	Biopesticide Registration Action Document

CFR	Code of Federal Regulations

cm3 	cubic centimeter

CSF	Confidential Statement of Formula

°C 	degrees Celsius

EDSP	Endocrine Disruptor Screening Program

EDSTAC	Endocrine Disruptor Screening and Testing Advisory Committee

EPA	Environmental Protection Agency (the “Agency”)

FFDCA	Federal Food, Drug, and Cosmetic Act

FIFRA	Federal Insecticide, Fungicide, and Rodenticide Act

FQPA 	Food Quality Protection Act

FR	Federal Register

g 	gram

kg	kilogram

L                  liter

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, or inhalation). It is expressed as a weight of

	substance per unit weight of animal (e.g., mg/kg).

MRID No.	Master Record Identification Number

mg	milligram

mL	milliliter

MP	manufacturing-use product

MPCA	microbial pest control agent

NE	“No Effect”

NIOSH 	National Institute for Occupational Safety and Health

OPP	Office of Pesticide Programs

OPPTS 	Office of Prevention, Pesticides, and Toxic Substances

PCR	polymerase chain reaction 

PPE 	personal protective equipment

TGAI 	technical grade of the active ingredient

IX. BIBLIOGRAPHY STUDIES SUBMITTED IN SUPPORT OF THIS REGISTRATION

Studies Submitted in Support of this Registration.

MRID	Citation	Receipt Date

46895600	Valent BioSciences Corporation (2006) Submission of Product
Chemistry, Environmental Fate and Toxicity Data in Support of the
Experimental Use Permit of S-Abscisic Acid in/on Ornamental Plants.
Transmittal of 28 Studies.	26-Jul-2006

46895601	Bade, T. (2006) Integrated Manufacturing Process S-ABA
(S-Absisic Acid). Project Number: S/ABA/30054/056/4. Unpublished study
prepared by Valent BioSciences Corporation. 90 p.	26-Jul-2006

46895602	Bade, T. (2006) S-Abscisic Acid: VBC-30054 Technical Powder:
Product Chemistry: Analysis, Certification of Limits, Analytical
Methods. Project Number: S/ABA/30054/056/5. Unpublished study prepared
by Valent BioSciences Corporation. 41 p.	26-Jul-2006

46895603	Bade, T. (2006) Summary of Physical Chemistry Properties of
S-Abscisic Acid: VBC-30054 Technical Material. Project Number:
S/ABA/30054/056/3. Unpublished study prepared by Valent Biosciences
Corporation. 9 p.	26-Jul-2006

46895604	Ponte, M. (2005) Physical Properties of S-Abscisic Acid
Technical Grade Active Ingredient. Project Number: 1438W. Unpublished
study prepared by PTRL West, Inc. 18 p.	26-Jul-2006

46895605	Ponte, M. (2006) S-Abscisic Acid: Dissociation Constant in
Water, Water Solubility and n-Octanol/Water Partition Coefficient.
Project Number: 1437W. Unpublished study prepared by PTRL West, Inc. 68
p.	26-Jul-2006

46895606	Ponte, M. (2006) Vapor Pressure of S-Abscisic Acid. Project
Number: 1436W/1, 1436W. Unpublished study prepared by PTRL West, Inc. 48
p.	26-Jul-2006

46895607	Ponte, M. (2006) Physical Properties: pH Determination of
S-Abscisic Acid Technical Grade Active Ingredient in Water. Project
Number: 1558W. Unpublished study prepared by PTRL West, Inc. 15 p.
26-Jul-2006

46895608	Heiman, D. (2006) VBC 30054: Supplement to Physical and
Chemical Properties: Justification for Waivers From Flammability,
Explodability and Corrosion Characteristics. Project Number:
S/ABA/30054/056/8. Unpublished study prepared by Valent Biosciences
Corp. 5 p.	26-Jul-2006

46895609	Bladi, B.; Bade, T. (2005) Determination of Accelerated Storage
Stability in Accordance with CIPAC Method MT46 S-Abscisic Acid:
VBC-30054 Technical Powder. Project Number: VBC/LG/C/05/11/0010.
Unpublished study prepared by Valent Biosciences Corp. 11 p.	26-Jul-2006

46895610	Rose, J. (2006) Method Validation for the Analysis of
S-Abscisic Acid in Reference Standard, Technical Grade Active Ingredient
and Formulated Products. Project Number: 1442W. Unpublished study
prepared by PTRL West, Inc. 53 p.	26-Jul-2006

46895611	Durando, J. (2005) Acute Oral Toxicity Up and Down Procedure in
Rats: VBC-30054 (ABA). Project Number: 16974, P320/UDP. Unpublished
study prepared by Product Safety Laboratories. 14 p.	26-Jul-2006

46895612	Durando, J. (2005) Acute Dermal Toxicity Study in Rats - Limit
Test: VBC-30054 (ABA). Project Number: 16975, P322. Unpublished study
prepared by Product Safety Laboratories. 14 p.	26-Jul-2006

46895613	Durando, J. (2005) Acute Inhalation Toxicity Study in Rats -
Limit Test: VBC-30054 (ABA). Project Number: 17515, P330. Unpublished
study prepared by Product Safety Laboratories. 22 p.	26-Jul-2006

46895614	Durando, J. (2005) Primary Eye Irritation Study in Rabbits:
VBC-30054 (ABA). Project Number: 16976, P324. Unpublished study prepared
by Product Safety Laboratories. 14 p.	26-Jul-2006

46895615	Durando, J. (2005) Primary Skin Irritation Study in Rabbits:
VBC-30054 (ABA). Project Number: 16977, P326. Unpublished study prepared
by Product Safety Laboratories. 14 p.	26-Jul-2006

46895616	Durando, J. (2005) Dermal Sensitization Study in Guinea Pigs
(Magnusson-Kligman Method): VBC-30054 (ABA). Project Number: 16978,
P329. Unpublished study prepared by Product Safety Laboratories. 26 p.
26-Jul-2006

46895618	Bade, T. (2006) Abscisic Acid (S-ABA): Review of Existing Data
to Request Granting a Reprieve from the Biochemical Pesticide
Registration Requirements for Avian Acute Oral Toxicology, Avian Dietary
Toxicology For an Experimental Use Permit for Abscisic Acid. Project
Number: S/ABA/30054/056/1. Unpublished study prepared by Valent
BioSciences Corporation. 12 p.	26-Jul-2006

46895619	Bade, T. (2006) Abscisic Acid (S-ABA) Review of Existing Data
to Request Granting a Reprieve from the Biochemical Pesticide
Registration Requirements for Freshwater Fish LC50 and Freshwater
Invertebrate LC50 Toxicity Testing for an Experimental Use Permit for
Abscisic Acid. Project Number: S/ABA/30054/056/2. Unpublished study
prepared by Valent BioSciences Corporation. 11 p.	26-Jul-2006

46895620	Bade, T. (2006) Product Identity Confidential Statement of
Formula: VBC 30051. Project Number: S/ABA/30051/056/6. Unpublished study
prepared by Valent BioSciences Corporation. 45 p.	26-Jul-2006

46895621	Bade, T. (2006) Product Identity Confidential Statement of
Formula: VBC 30074. Project Number: S/ABA/30074/056/7. Unpublished study
prepared by Valent BioSciences Corporation. 42 p.	26-Jul-2006

46895622	Baldi, B. (2006) Determination of Accelerated Storage Stability
in Accordance with CIPAC Method MT46 S-Abscisic Acid: VBC-30051 a
Water-Soluble Granule Formulation. Project Number: VBC/LG/C/05/11/0011.
Unpublished study prepared by Valent Biosciences Corp. 11 p.	26-Jul-2006

46895623	Baldi, B. (2006) Determination of Accelerated Storage Stability
in Accordance with CIPAC Method MT46 S-Abscisic Acid: VBC-30074. Project
Number: VBC/LG/C/06/05/0022. Unpublished study prepared by Valent
Biosciences Corp. 11 p.	26-Jul-2006

46895624	Baldi, B. (2006) Physical Chemistry Properties of S-Abscisic
Acid: VBC-30051 a Soluble Granule Formulation. Project Number:
VBC/LG/C/05/11/0013. Unpublished study prepared by Valent Biosciences
Corp. 8 p.	26-Jul-2006

46895625	Baldi, B. (2006) VBC-30074: Determination of Physical
Properties. Project Number: VBC/LG/C/06/04/0021. Unpublished study
prepared by Valent Biosciences Corp. 8 p.	26-Jul-2006

46895626	Heiman, D. (2006) VBC 30051 Supplement to Physical and Chemical
Properties: Justification for Waivers from Flammability, Explodability,
and Corrosion Characteristics. Project Number: S/ABA/30051/056/9.
Unpublished study prepared by Valent Biosciences Corp. 11 p.	26-Jul-2006

46895627	Heiman, D. (2006) VBC 30074 Supplement to Physical and Chemical
Properties: Justicification for Waivers from Flammability, Explodability
and Corrosion Characteristics. Project Number: S/ABA/30074/056/10.
Unpublished study prepared by Valent Biosciences Corp. 11 p.	26-Jul-2006

46895628	Bade, T. (2006) VBC-30051 Justification for Waiver Request from
the Biochemical Pesticide Toxicity Data Requirements. Project Number:
S/ABA/30051/056/11. Unpublished study prepared by Valent BioSciences
Corporation. 53 p.	26-Jul-2006

46895629	bade, T. (2006) Justification for Waiver Request from the
Biochemical Pesticide Toxicity Data Requirements. Project Number:
A/ABA/30074/056/12. Unpublished study prepared by Valent BioSciences
Corporation. 14 p.	26-Jul-2006

46985600	Valent BioSciences Corp. (2006) Submission of Residue Data in
Support of the Experimental Use of S-Abscisic Acid on Grape Berries.
Transmittal of 1 Study.	13-Nov-2006

46985604	Bade, T. (2006) Analytical Method to Measure Residues of S-ABA
in Grape Berries. Project Number: S/ABA/30054/106/1, VBC/M06003/1.
Unpublished study prepared by Valent BioSciences Corporation. 14 p.
13-Nov-2006

47005300	Valent Biosciences Corporation (2006) Submission of Toxicity
and Residue Data in Support of the Experimental Use of Abscisic Acid in
Grape Berries, Wine and Leaves.	14-Dec-2006

47005301	Xu, Y. (2006) In Vivo Mouse Bone Marrow Micronucleus Assay:
Abscisic Acid, Technical Powder: Final Report. Project Number: 7194/103,
27994/0/455OECD. Unpublished study prepared by Covance Laboratories Inc.
49 p.	14-Dec-2006

47005302	Murli, H. (2006) Chromosomal Aberration in Chinese Hamster
Ovary CHO Cells: Abscisic Acid, Technical Powder: Final Report. Project
Number: 7194/102, 27994/0/437OECD. Unpublished study prepared by Covance
Laboratories Inc. 66 p.	14-Dec-2006

47005303	Bade, T. (2006) Fate of VBC 30025 in Grape Berries, Wine and
Leaves: S-Abscisic. Project Number: S-ABA 30025:086/1. Unpublished study
prepared by CSIRO. 41 p.	14-Dec-2006

47030900	Valent BioSciences Corporation (2006) Submission of Toxicity
Data in Support of the Experimental Use of Abscisic Acid on Ornamental
Crops. Transmittal of 1 Study.	17-Jan-2007

47030901	Mecchi, M. (2006) Salmonella-Escherichia
coli/Mammalian-Microsome Reverse Mutation Assay with a Confirmatory
Assay with ABA Technical - VBC 30054. Project Number: 7194/101,
27466/0/409OECD. Unpublished study prepared by Covance Laboratories,
Inc. 26 p.	17-Jan-2007

47067900	Valent BioSciences Corp. (2007) Submission of Toxicity and
Product Chemistry Data in Support of the Experimental Use of Abscisic
Acid on Ornamental Crops. Transmittal of 6 Studies.	15-Feb-2007

47067901	Gallagher, S.; Beavers, J. (2007) Abscisic Acid (ABA),
(VBC-30054): An Acute Oral Toxicity Study with the Northern Bobwhite.
Project Number: 529/111. Unpublished study prepared by Wildlife
International, Ltd. 33 p.	15-Feb-2007

47067902	Bade, T. (2007) Abscisic Acid (S-ABA): Review of Existing Data
to Request Granting a Reprieve from the Biochemical Pesticide
Registration Requirements for Freshwater Fish LC50 and Freshwater
Invertebrate LC50 Toxicity Testing for an Experimental Use Permit for
Abscisic Acid. Project Number: S/ABA/30054/027/3. Unpublished study
prepared by Valent BioSciences Corporation. 15 p.	15-Feb-2007

47067903	Bade, T. (2007) Integrated Manufacturing Process S-ABA
(S-Abscisic Acid). Project Number: S/ABA/30054/027/1. Unpublished study
prepared by Valent BioSciences Corporation. 90 p.	15-Feb-2007

47067904	Bade, T. (2007) S-Abscisic Acid: VBC-30054 Technical Powder:
Product Chemistry: Analysis, Certification of Limits, Analytical
Methods. Project Number: S/ABA/30054/027/2. Unpublished study prepared
by Valent BioSciences Corporation. 41 p.	15-Feb-2007

47067905	Bade, T. (2007) Product Identity: Condifential Statement of
Formula: VBC 30051. Project Number: S/ABA/30051/027/5. Unpublished study
prepared by Valent BioSciences Corporation. 45 p.	15-Feb-2007

47067906	Bade, T. (2007) Product Identity: Confidential Statement of
Formula: VBC 30074. Project Number: S/ABA/30074/027/6. Unpublished study
prepared by Valent BioSciences Corporation. 42 p.	15-Feb-2007

47131400	Valent BioSciences Corporation. (2007) Submission of Toxicity
Data in Support of the Experimental Use of Abscisic Acid on Grapes and
Ornamental Crops. Transmittal of 14 Studies.	16-May-2007

47131401	Palmer, S.; Kendall, T.; Krueger, H. (2007) Abscisic Acid
(ABA), (VBC-30054): A 48-Hour Static-Renewal Acute Toxicity Test with
the Cladoceran (Daphnia magna): Final Report. Project Number: 529A/103.
Unpublished study prepared by Wildlife International Ltd. 35 p.
16-May-2007

47131402	Palmer, S.; Kendall, T.; Krueger, H. (2007) Abscisic Acid
(ABA), (VBC-30054): A 96-Hour Static-Renewal Acute Toxicity Test with
the Rainbow Trout (Oncorhynchus mykiss): Final Report. Project Number:
529A/104. Unpublished study prepared by Wildlife International Ltd. 36
p.	16-May-2007

47131404	Bade, T. (2007) S-Abscisic Acid (S-ABA) Justification for
Requesting a Waiver from the Biochemical Pesticide Data Requirements for
Non-Target Plant Testing for Experimental Use Permits for S-Abscisic
Acid. Project Number: S/ABA/30054, 047/02. Unpublished study prepared by
Valent BioSciences Corporation. 16 p.	16-May-2007

47131405	Lowe, C. (2007) S-Abscisic Acid: VBC-30051: Acute Oral Toxicity
Up and Down Procedure in Rats. Project Number: 21340, P320/UDP.
Unpublished study prepared by Product Safety Laboratories. 14 p.
16-May-2007

47131406	Lowe, C. (2007) S-Abscisic Acid: VBC-30051: Acute Dermal
Toxicity Study in Rats - Limit Test. Project Number: 21341. Unpublished
study prepared by Product Safety Laboratories. 14 p.	16-May-2007

47131407	Lowe, C. (2007) S-Abscisic Acid: VBC-30051: Primary Eye
Irritation Study in Rabbits. Project Number: 21342, P324. Unpublished
study prepared by Product Safety Laboratories. 17 p.	16-May-2007

47131408	Lowe, C. (2007) S-Absorbic Acid: ABC-30051: Primary Skin
Irritation Study in Rabbits. Project Number: 21343, P326. Unpublished
study prepared by Product Safety Laboratories. 15 p.	16-May-2007

47131409	Lowe, C. (2007) S-Abscisic Acid: VBC-30051: Dermal
Sensitization Study in Guinea Pigs (Buehler Method). Project Number:
21344, P328. Unpublished study prepared by Product Safety Laboratories.
25 p.	16-May-2007

47131411	Durando, J. (2007) S-Abscisic Acid: VBC-30051: Acute Oral
Toxicity Up and Down Procedure in Rats. Project Number: 21520, P320/UDP.
Unpublished study prepared by Product Safety Laboratories. 14 p.
16-May-2007

47131412	Durando, J. (2007) S-Abscisic Acid: VBC-30051: Acute Dermal
Toxicity Study in Rats - Limit Test. Project Number: 21521, P322/RAT.
Unpublished study prepared by Product Safety Laboratories. 14 p.
16-May-2007

47131413	Durando, J. (2007) S-Abscisic Acid: VBC-30051: Acute Inhalation
Study in Rats - Limit Test. Project Number: 21522, P330. Unpublished
study prepared by Product Safety Laboratories. 22 p.	16-May-2007

47131414	Durando, J. (2007) S-Abscisic Acid: VBC-30051: Primary Eye
Irritation Study in Rabbits. Project Number: 21523, P334. Unpublished
study prepared by Product Safety Laboratories. 15 p.	16-May-2007

47131415	Durando, J. (2007) S-Abscisic Acid: VBC-30051: Primary Skin
Irritation Study in Rabbits. Project Number: 21524, P326. Unpublished
study prepared by Product Safety Laboratories. 15 p.	16-May-2007

47131416	Durando, J. (2007) S-Abscisic Acid: VBC-30051: Dermal
Sensitization Study in Guinea Pigs (Buehler Method). Project Number:
21524, P326. Unpublished study prepared by Product Safety Laboratories.
24 p.	16-May-2007

47151200	Valent BioSciences Corp. (2007) Submission of Toxicity Data in
Support of the Experimental Use of Abscisic Acid on Grapes and
Ornamental Crops. Transmittal of 2 Studies.	11-Jun-2007

47151201	Warmers, C. (2007) Assessment of Side Effects of VBC-30054 to
the Honey Bee, Apis mellifera L. in the Laboratory: Final Report.
Project Number: VBC/30054, 20071029/SI/BLEU. Unpublished study prepared
by GAB Biotechnologie Gmbh. 25 p.	11-Jun-2007

47151202	Bade, T. (2007) Justification for Waiver Request from the
Biochemical Pesticide Toxicity Data Requirement for Acute Inhalation
Toxicity Testing. Project Number: S/ABA/30051/047/01. Unpublished study
prepared by Valent BioSciences Corporation. 53 p.	11-Jun-2007

47153200	Valent BioSciences Corporation (2007) Submission of Toxicity
Data in Support of the Experimental Use of Abscisic Acid (S-ABA).
Transmittal of 1 Study.	12-Jun-2007

47153201	Bade, T. (2007) Literature References in Support of the Report:
S-Abscisic Acid (S-ABA) Justification for Requesting a Waiver from the
Biochemical Pesticide Data Requirements for Non-Target Plant Testing for
Experimental Use Permit for S-Abscisic Acid. Project Number:
S/ABA/30054/047/02/REF. Unpublished study prepared by Valent BioSciences
Corporation. 425 p.	12-Jun-2007

47470400	Valent BioSciences Corp. (2008) Submission of Product
Chemistry, Toxicity, and Risk and Exposure Data in Support of the
Applications for Registration of VBC-30101, VBC-30051, and VBC-30054 and
the Petition for Tolerance of S-Abscisic Acid for Use on Ornamental and
Grape Crops. Transmittal of 20 Studies.	09-Jul-2008

47470401	Rose, J. (2007) Analysis and Certification of Product
Ingredients in Five Batches of Technical S-Abscisic Acid. Project
Number: 1473W. Unpublished study prepared by PTRL West, Inc. 122 p.
09-Jul-2008

47470402	Bade, T. (2008) Product Identity: Confidential Statement of
Formula VBC 30101 (S-Abscisic Acid Liquid Formulation). Project Number:
S/BA/30101, 127/1. Unpublished study prepared by Valent Biosciences
Corporation. 61 p.	09-Jul-2008

47470403	Bade, T. (2008) S-Abscisic Acid: VBC-30054 Technical Powder
Product Chemistry: Certification of Limits. Project Number: S/ABA/30054,
127/2. Unpublished study prepared by Valent Biosciences Corporation. 11
p.	09-Jul-2008

47470404	Baldi, B. (2007) Analysis of S-Abscisic Acid in Five Lots of
VBC-30051 Formulation, by High Performance Liquid Chromatography.
Project Number: VBCL01/48060/07. Unpublished study prepared by Valent
Biosciences Corp. 20 p.	09-Jul-2008

47470405	Baldi, B. (2008) Analysis of S-Ascisic Acid in Five Lots of
VBC-30101 Formulation, by High Performance Liquid Chromatography: Final
Report. Project Number: VBCL08/48060/01. Unpublished study prepared by
Valent Biosciences Corp. 23 p.	09-Jul-2008

47470406	Ponte, M.; Schick, M. (2007) Stability of S-Abscisic Acid
Active Ingredient to Normal and Elevated Temperature, Metals, and Metal
Ions, and Oxidizing Reducing Properties of S-Abscisic Acid Active
Ingredient. Project Number: 1618W, 1618W/1. Unpublished study prepared
by PTRL West, Inc. 59 p.	09-Jul-2008

47470407	Ponte, M.; Schick, M. (2007) Accelerated Storage Stability of
VBC-30051 at Elevated Temperatures. Project Number: 1612W, 1612W/001.
Unpublished study prepared by PTRL West, Inc. 39 p.	09-Jul-2008

47470408	Ponte, M.; Schick, M. (2007) Accelerated Storage Stability of
VBC-30071 at Elevated Temperatures. Project Number: 1613W, 1613W/001.
Unpublished study prepared by PTRL West, Inc. 39 p.	09-Jul-2008

47470409	Schick, M. (2008) Accelerated Storage Stability of VBC-30101 at
Elevated Temperatures. Project Number: 1728W, 1728W/001. Unpublished
study prepared by PTRL West, Inc. 36 p.	09-Jul-2008

47470410	Comb, A. (2007) VBC-30054 Physico-Chemical Properties. Project
Number: ZAB/0083. Unpublished study prepared by Huntingdon Life
Sciences, Ltd. 36 p.	09-Jul-2008

47470411	Schick, M. (2008) Solubility of S-Abscisic Acid in Organic
Solvents. Project Number: 1730W, 1730W/1. Unpublished study prepared by
PTRL West, Inc. 52 p.	09-Jul-2008

47470412	Schick, M. (2008) Hyrolysis of S-Abdscisic Acid at pH 4, 7, and
9. Project Number: 1729W, 1729W/1. Unpublished study prepared by PTRL
West, Inc. 89 p.	09-Jul-2008

47470413	Shi, L. (2004) Evaluation of the Environmental Safety of
S-Abscisic Acid. Project Number: 2004B/04. Unpublished study prepared by
Nanjing Institute of Environmental Sciences. 59 p.	09-Jul-2008

47470414	Zhang, H.; Lin, J. (2004) Certification of S-ABA Reference
Standard (Lot # 030806D1): Laboratory Final Report. Project Number:
VAL0105DX, REP/RC/2004/048. Unpublished study prepared by deCode
Chemistry, Inc. 75 p.	09-Jul-2008

47470415	Zhang, H.; Lin, J. (2005) Retest of S-ABA Reference Standard
(Lot # 030806D1). Project Number: VAL0107DX, REP/RC/2005/039.
Unpublished study prepared by deCode Chemistry, Inc. 27 p.	09-Jul-2008

47470416	Bade, T. (2008) Supplement to Physical and Chemical Properties:
Justification for Waivers from Flammability, Explodability, and
Corrosion Characteristics. Project Number: S/ABA/30101, 127/3.
Unpublished study prepared by Valent Biosciences Corporation. 8 p.
09-Jul-2008

47470417	Schick, M.; Ponte, M. (2007) Physical Properties of VBC-30051.
Project Number: 1614W. Unpublished study prepared by PTRL West, Inc. 22
p.	09-Jul-2008

47470418	Schick, M.; Ponte, M. (2007) Physical Properties of VBC-30074.
Project Number: 1615W. Unpublished study prepared by PTRL West, Inc. 20
p.	09-Jul-2008

47470419	Schick, M. (2008) Physical Properties of VBC-30101. Project
Number: 1720, 1720W/1. Unpublished study prepared by PTRL West, Inc. 16
p.	09-Jul-2008

47470420	Durando, J. (2007) Primary Eye Irritation Study in Rabbits:
VBC-30101. Project Number: P324, 23416, 071023/8D. Unpublished study
prepared by Product Safety Laboratories. 14 p.	09-Jul-2008

47470500	Valent Biosciences Corporation (2008) Submission of Toxicity,
Efficacy and Residue Data in Support of the Application for Registration
of S-Abscisic Acid (VBC-30054, TGAI), VBC-30051 and VBC-30101 and the
Petition for Tolerance of S-Abscisic Acid on Ornamental and Grape Crops.
Transmittal of 23 Studies. 	08-Jul-2008

47470501	Bade, T. (2008) Justification for Waiver Request from the
Biochemical Pesticide Toxicity Data Requirements for Acute Oral Toxicity
Testing for VBC-30101. Project Number: S/ABA/30101/127/11, 23416, 21523.
Unpublished study prepared by Valent Biosciences Corp. 79 p.	08-Jul-2008

47470502	Bade, T. (2008) Justification for Waiver Request from the
Biochemical Pesticide Toxicity Data Requirements for Acute Dermal
Toxicity Testing for VBC-30101. Project Number: S/ABA/30101/127/12,
23416, 21523. Unpublished study prepared by Valent Biosciences
Corporation. 79 p.	08-Jul-2008

47470503	Bade, T. (2008) Justification for Waiver Request from the
Biochemical Pesticide Toxicity Data Requirements for Inhalation Toxicity
Testing for VBC-30101. Project Number: S/ABA/30101/127/13, 23416, 21523.
Unpublished study prepared by Valent Biosciences Corporation. 79 p.
08-Jul-2008

47470504	Bade, T. (2008) Justification for Waiver Request from the
Biochemical Pesticide Toxicity Data Requirements for Dermal Irritation
Toxicity Testing for VBC-30101. Project Number: S/ABA/30101/127/14,
23416, 21523. Unpublished study prepared by Valent Biosciences
Corporation. 79 p.	08-Jul-2008

47470505	Bade, T. (2008) Justification for Waiver Request from the
Biochemical Pesticide Toxicity Data Requirements for Dermal
Sensitization Toxicity Testing for VBC-30101. Project Number:
S/ABA/30101/127/15, 23416, 21523. Unpublished study prepared by Valent
Biosciences Corporation. 79 p.	08-Jul-2008

47470506	Bade, T. (2008) Justification for Waiver Request from the
Biochemical Pesticide Toxicity Data Requirements for 90-Day Repeat
Inhalation Toxicity Testing for VBC-30101. Project Number:
S/ABA/30101/127/16. Unpublished study prepared by Valent Biosciences
Corporation. 78 p.	08-Jul-2008

47470507	Shearer, J. (2008) VBC-30054: One Week Dose Range Finding Study
in Rats with Dermal Administration: Final Report. Project Number: 27954,
458194. Unpublished study prepared by Charles River Laboratories. 58 p.
08-Jul-2008

47470508	Shearer, J. (2008) VBC-30054: 3 Week Toxicity Study in Rats
with Dermal Administration: Final Report. Project Number: 27971, 458215.
Unpublished study prepared by Charles River Laboratories. 177 p.
08-Jul-2008

47470509	Perry, C. (2008) VBC-30054: 4 Week Toxicity Study in Rats with
Administration by the Diet: Final Report. Project Number: 27720, 457866.
Unpublished study prepared by Charles River Laboratories . 223 p.
08-Jul-2008

47470510	Perry, C. (2008) VBC-30054: 13 Week Toxicity Study in Rats with
Administration by the Diet: Final Report. Project Number: 457871, 28084.
Unpublished study prepared by Charles River Laboratories . 280 p.
08-Jul-2008

47470511	Yuill, L. (2008) VBC-30054: Preliminary Developmental Toxicity
in Rats: Final Report. Project Number: 494845, 28566. Unpublished study
prepared by Charles River Laboratories. 31 p.	08-Jul-2008

47470512	Fleeman, T. (2008) A Prenatal Developmental Toxicity Study of
S-Abscisic Acid in Rats: Final Report. Project Number: WIL/505004.
Unpublished study prepared by WIL Research Laboratories, Inc. 327 p.
08-Jul-2008

47470513	Saito, K. (2007) Reporter Gene Assays for Abscisic Acid (ABA)
Using Human Estrogen and Androgen Receptors. Project Number:
VBC/SCC/ABA/12/14/07. Unpublished study prepared by Sumitomo Chemical
Co. Ltd., Envr. Health. 19 p.	08-Jul-2008

47470514	Porch, J.; Krueger, H. (2008) Abscisic Acid: An Acute Toxicity
Study with the Earthworm in an Artificial Soil Substrate: Final Report.
Project Number: 529/119. Unpublished study prepared by Wildlife
International, Ltd. 33 p.	08-Jul-2008

47470515	Zhu, Z.; Shan, Z.; Cai, D. (2000) Environmental Safety
Assessment of Natural Abscisic Acid. Project Number: JUNE/2000.
Unpublished study prepared by Nanjing Institute of Environmental
Sciences. 19 p.	08-Jul-2008

47470516	Porch, J.; Krueger, H.; Martin, K. (2008) VBC-30074: A Toxicity
Test to Determine the Effects of the Test Substance on Vegetative Vigor
of Ten Species of Plants: Final Report. Project Number: 529/115.
Unpublished study prepared by Wildlife International, Ltd. 86 p.
08-Jul-2008

47470517	Porch, J.; Martin, K.; Krueger, H. (2008) VBC-30074: A Toxicity
Test to Determine the Effects of the Test Substance on Seedling
Emergence of Ten Species of Plants: Final Report. Project Number:
529/116. Unpublished study prepared by Wildlife International, Ltd. 68
p.	08-Jul-2008

47470518	Patracek, P.; Silverman, P.; Heiman, D. (2008) Background of
Abscisic Acid (ABA): A Plant Growth Regulator for Use on Grapes and
Ornamentals. Project Number: ABA/LS2. Unpublished study prepared by
Valent Biosciences Corp. 26 p.	08-Jul-2008

47470519	Bade, T. (2008) Copies of Referenced Papers in 'Background of
Abscisic Acid (ABA): A Plant Growth Regulator for Use on Grapes and
Ornamentals. Project Number: ABA/LS2/REF. Unpublished study prepared by
Valent Biosciences Corp. 674 p.	08-Jul-2008

47470520	Baldi, B. (2007) Characterization of the 1',4'-trans-diol of
Abscisic Acid Reference Substance (VBC-30084): Final Report. Project
Number: VBCL07/48060/01. Unpublished study prepared by Valent
Biosciences Corp. 25 p.	08-Jul-2008

47470521	Bade, T. (2008) Abscisic Acid (S-ABA) Request for a Waiver from
the Biochemical Pesticide Registration Requirements for Avian Dietary
Toxicity Testing. Project Number: S/ABA/30054/058/1. Unpublished study
prepared by Valent Biosciences Corporation. 9 p.	08-Jul-2008

47470522	Bade, T. (2008) Abscisic Acid (S-ABA) Request for a Waiver from
the Biochemical Pesticide Registration Requirements for Multi Residue
Testing Method. Project Number: S/ABA/30054/058/2. Unpublished study
prepared by Valent Biosciences Corporation. 8 p.	08-Jul-2008

47470523	Davis, M.; Bade, T. (2008) Australian Efficacy Data : S-ABA Use
on Grapes. Unpublished study prepared by Valent Biosciences Corporation.
75 p.	08-Jul-2008

47541800	Valent BioSciences Corporation (2008) Submission of Product
Chemistry and Toxicity Data in Support of the Experiemental Use of
VBC-40009. Transmittal of 12 Studies.	12-Sep-2008

47541801	Devisetty, B.; Bade, T. (2008) Product Identity, Manufacturing
Process: VBC 40009 (S-Abscisic Acid Liquid Formulation). Project Number:
S/ABA/40009/88/01. Unpublished study prepared by Valent BioSciences
Corporation. 110 p.	12-Sep-2008

47541803	Bade, T. (2008) VBC 40009: Supplement to Physical and Chemical
Properties: Justification for Waivers from Flammability, Explodability,
and Corrosion Characteristics. Project Number: S/ABA/40009/88/4.
Unpublished study prepared by Valent BioSciences Corporation. 14 p.
12-Sep-2008

47541804	Bade, T. (2008) Justification for Waiver Request from the
Biochemical Pesticide Toxicity Data Requirements for Acute Oral Toxicity
Testing for VBC-40009. Project Number: S/ABA/40009/88/11. Unpublished
study prepared by Valent BioSciences Corporation. 156 p.	12-Sep-2008

47541805	Bade, T. (2008) Justification for Waiver Request from the
Biochemical Pesticide Toxicity Data Requirements for Acute Dermal
Toxicity Testing for VBC-40009. Project Number: S/ABA/40009/88/12.
Unpublished study prepared by Valent BioSciences Corporation. 156 p.
12-Sep-2008

47541806	Bade, T. (2008) Justification for Waiver Request from the
Biochemical Pesticide Toxicity Data Requirements for Acute Inhalation
Toxicity Testing for VBC-40009. Project Number: S/ABA/40009/88/13.
Unpublished study prepared by Valent BioSciences Corporation. 156 p.
12-Sep-2008

47541807	Bade, T. (2008) Justification for Waiver Request from the
Biochemical Pesticide Toxicity Data Requirements for Primary Eye
Irritation Toxicity Testing for VBC-40009. Project Number:
S/ABA/40009/88/14. Unpublished study prepared by Valent BioSciences
Corporation. 156 p.	12-Sep-2008

47541808	Bade, T. (2008) Justification for Waiver Request from the
Biochemical Pesticide Toxicity Data Requirements for Dermal Irritation
Toxicity Testing for VBC-40009. Project Number: S/ABA/40009/88/15.
Unpublished study prepared by Valent BioSciences Corporation. 156 p.
12-Sep-2008

47541809	Bade, T. (2008) Justification for Waiver Request from the
Biochemical Pesticide Toxicity Data Requirements for Dermal
Sensitization Toxicity Testing for VBC-40009. Project Number:
S/ABA/40009/88/16. Unpublished study prepared by Valent BioSciences
Corporation. 156 p.	12-Sep-2008

47541810	Bade, T. (2008) Justification for Waiver Request from the
Biochemical Pesticide Toxicity Data Requirements for 90-Day Oral
Toxicity Testing for VBC-40009. Project Number: S/ABA/40009/88/17.
Unpublished study prepared by Valent BioSciences Corporation. 156 p.
12-Sep-2008

47541811	Bade, T. (2008) Abscisic Acid (S-ABA): Request for a Waiver
from the Biochemical Pesticide Registration Requirements for Avian Acute
Oral Toxicity Testing, Avian Dietary Toxicity Testing with VBC-40009.
Project Number: S/ABA/40009/88/18. Unpublished study prepared by Valent
BioSciences Corporation. 9 p.	12-Sep-2008

47541812	Bade, T. (2008) Abscisic Acid (S-ABA): Request for a Waiver
from the Biochemical Pesticide Registration Requirements for Fish Acute
Toxicity Testing with VBC-40009. Project Number: S/ABA/40009/88/19.
Unpublished study prepared by Valent BioSciences Corporation. 9 p.
12-Sep-2008

47541813	Bade, T. (2008) Abscisic Acid (S-ABA): Request for a Waiver
from the Biochemical Pesticide Registration Requirements for Aquatic
Invertebrate Acute Toxicity Testing with VBC-40009. Project Number:
S/ABA/40009/88/20. Unpublished study prepared by Valent BioSciences
Corporation. 9 p.	12-Sep-2008

47572300	Valent BioSciences Corporation (2008) Submission of Product
Chemistry Data in Support of the Experimental Use of VBC-40009.
Transmittal of 1 Study.	17-Oct-2008

47572301	Baldi, B.; Bade, T. (2008) Analysis of S-Abscisic Acid in Lot
64-023-VB of VBC-40009 Formulation, by High Performance Liquid
Chromatography and Certified Limits. Project Number: S/ABA/40009/88/02,
VCB/M04001/5. Unpublished study prepared by Valent Biosciences Corp. 17
p.	17-Oct-2008

47802900	Valent BioSciences Corporation (2009) Submission of Product
Chemistry and Toxicity Data in Support of the Applications for
Registration of VBC-30051, VBC-30101 and S-Abscisic Acid Technical Grade
Active Ingredient and the Petition for Tolerance of S-Abscisic Acid.
Transmittal of 4 Studies.	13-Jul-2009

47802901	Durando, J. (2009) S-Abscisic Acid Technical Grade Active
Ingredient: Acute Inhalation Toxicity Study in Rats. Project Number:
27098, P330, 090303/4R. Unpublished study prepared by Eurofins/Product
Safety Laboratories. 36 p.	13-Jul-2009

47802902	Ponte, M.; Schick, M. (2008) Physical Properties: Storage
Stability and Corrosion Characteristics of VBC-30051. Project Number:
1616W, 1616W/001. Unpublished study prepared by PTRL West, Inc. 56 p.
13-Jul-2009

47802903	Ponte, M.; Schick, M. (2008) Physical Properties: Storage
Stability and Corrosion Characteristics of VBC-30074. Project Number:
1617W, 1617W/001. Unpublished study prepared by PTRL West, Inc. 54 p.
13-Jul-2009

47802904	Schick, M. (2009) Physical Properties: Storage Stability and
Corrosion Characteristics of VBC-30101. Project Number: 1776W,
1776W/001. Unpublished study prepared by PTRL West, Inc. 55 p.
13-Jul-2009

B. EPA Risk Assessment Memoranda

Frazer, C. Science Review of Tier I Acute Mammalian Toxicity Data, and
Non-Target Data Waiver Request in Support of Registration of VBC-30054
(96.2% S-ABA, TGAI).  Memorandum dated 01/03/2007.

 Jones, R. Science Review of Avian Acute and Data Waiver Request for
Non-Target Fish and Aquatic Invertebrate Studies for EUP-U on grapes
04/17/07.

Fuentes, C. Science Review of Tier I Mammalian Toxicity, Acute and
Subchronic Toxicity Data in Support of Registration of VBC-30054 (96.2%
S-ABA, TGAI).  Memorandum dated 10/30/2008.

Fuentes, C. Science Review of Tier I Mammalian Toxicity, Acute and
Subchronic Toxicity, and Non-Target Organisms Data in Support of
Registration of VBC-30054 (96.2% S-ABA, TGAI).  Memorandum dated
03/17/2009.

 Fuentes, C.  Science Review of Tier I Mammalian Toxicity, Acute and
Subchronic Toxicity, and Non-Target Organisms Data in Support of
Registration of VBC-30054 (96.2% S-ABA, TGAI).  Memorandum dated
12/09/2009.

Fuentes, C. Science Review of Chemistry Data in Support of Registration
of of VBC-30054 (96.2% S-ABA, TGAI).  Memorandum dated 12/02/2009.

C.  References

U.S. EPA.  1998.  Guidance for Ecological Risk Assessment.  Risk
Assessment Forum.  EPA/630/R-95/002F, April 1998.

U.S.EPA  2008. Terrestrial Residue Exposure Model (T-REX) Version 1.4.1.
EFED/OPP/USEPA.

U.S.EPA  2004. Individual Effects Chance Model Version 1.1.
EFED/OPP/USEPA.

U.S.EPA  2001. Generic Estimated Environmental Concentration Model
Version 2.0. EFED/OPP/USEPA

APPENDIX A – BIOCHEMICAL PESTICIDE DATA REQUIREMENTS

TABLE 1. Physical/Chemical Properties for ABA

Property	Value	Method reference

Melting point	Did not melt, decomposes	EEC method A.1 and A.2

Temperature of decomposition	159.2-162.2 C (99.7% purity, 96.2% purity)
EEC method A.1 and A.2

Appearance and odour	White odorless powder (25 C, 99.7% purity)	OPPTS
Guidelines 830.630, 830.6302, and 830.6304.  

Density	1.21 g/cm3 (96.2% purity)	OPPTS Guideline No. 830.7300.  

Vapor pressure	<2 x 10-6 Pa (25 C, 99.7% purity active)

5.8 x 10-7 Pa (calculated)	OPPTS Guideline No. 830.7950.  

Henry’s Law constant	4.8 x 10-8 Pa m3/mol	Calculation from vapour
pressure and water solubility.  

Water solubility (99.7% purity active, 20 C)	Distilled water: 3192 mg/L

pH 4 buffer: 3102 mg/L	Shake flask method.  

Solubility in organic solvents (99.7% purity active, 20 C)	Methanol:
506.8 g/L

Acetone: 290.2 g/L

Ethyl acetate: 92.175 g/L

1,2-Dichloroethane: 10.95 g/L

Xylene: 0.265 g/L

Octanol: 54.8 g/L

n-Heptane: 0.0057 g/L	OECD Guideline 105/OPPTS Guideline No. 830.7840

Octanol/water partition coefficient (99.7% purity active)	log10POW
(unionised form) = 1.8

log10POW (unionised form) = 0.94	OPPTS Guideline No. 830.7570.  

Hydrolysis (99.7% purity active, )	pH 4: k (25 C) = -0.00088 days-1
(half life 792 days)

pH 4: k (40 C) = -0.0043 days-1 (half life 162 days)

pH 7: very slow hydrolysis

pH 9: very slow hydrolysis	OECD Guideline No. 111 and OPPTS Guideline
No. 835.2110.  

Dissociation constant	pKa = 4.61 (99.7% purity active)	Titration with
0.1M NaOH

pH of solution	3.32 (1% aqueous solution/suspension of 96.2% purity
active)	OPPTS Guideline No. 830.7000.  

Specific rotation	409.97 (in ethanol, 10.1 mg/mL, 20 C)

	Flammability	Not highly flammable (97.0% purity active)	EEC method A10

Explosive properties	Not heat, friction or shock sensitive (97.0% purity
active)	EEC method A14

Self-ignition temperature	No self heating below 400 C (97.0% purity
active)	EEC method A16

Accelerated storage stability	No significant degradation on storage at
54 C for 14 days (97.0% purity active)	OPPTS Guideline No. 830.6313

Oxidative/reductive stability	Oxidised by 5% potassium permanganate
solution, which was converted to manganese dioxide.  No changes observed
with zinc metal, carbon dioxide or water.  (97.0% purity active)	OPPTS
Guideline No. 830.6314

Stability in the presence of metals and metal ions	No significant
degradation over 14 days at 54 C when stored in the presence of
aluminium shot, iron shot, aluminium acetate or iron(II) acetate. 
(97.0% purity active)	OPPTS Guideline No. 830.6313

TABLE 2.  Toxicity Data Requirements Summary	         

Table 2. 0 Toxicological Results/ Category

Guideline #

Test	Results/Toxicology Category	MRID	Study Conclusion

870.1100

Acute Oral	LD50>5,000 mg/kg

IV	46895611	Acceptable

870.1200

Acute Dermal	LD50>5,000 mg/kg

IV	46895612	Acceptable

870.1300

Acute Inhalation	> 2.06 mg/L

IV	46895613	Acceptable

870.2400

Primary Eye Irritation	Non irritating

III	46895614	Acceptable

870.2500

Primary Dermal Irritation-Rabbits	Slightly irritating

IV

	46895615	Acceptable

870.2600

Dermal Sensitization	Not a sensitizer

IV	46895616	Acceptable 

870.3050

28 day Oral Toxicity-Rat	NOEL=20,000 mg/kg/day	47470509	Acceptable

870.3100

90 day Oral Toxicity-Rat	NOEL=20,000 mg/kg/day	47470510	Acceptable

870.3700 

Prenatal Developmental Toxicity Study - Rat 	Maternal NOEL > 1,000
mg/kg/day

Developmental NOEL > 1,000 mg/kg/day.	47470512	Acceptable 

870.5100

Bacterial Reverse Mutation Test	There was no evidence of induced mutant
colonies over background.	4703901	Acceptable

 870.5300 

In Vitro Mammalian Cells in Culture Gene Mutation Assay	ABA did not
damage to chromosomes or the mitotic apparatus of bone marrow cells.
4703902	Acceptable

870.5395

Bone Marrow Micronucleus assay in mouse  	No toxicity was noted in
either sex at any dose up to the limit dose of 2000 mg/kg bw.	4703903
Acceptable

Non-guideline

Reporter gene Assay  	S-ABA is not an estrogenic, anti-estrogenic,
androgenic or anti-androgenic compound.  	47470513	           
Acceptable 

TABLE 3.  EcoToxicity Data Requirements Summary

Table 3.0 Ecotoxicity Data

Study Type/OPPTS Guideline	

LD50/LC50/EC50 Results	

Toxicity Category	MRID

Acute Oral Toxicity (rat)

OPPTS 870.1100  	>5000 mg/kg	

Practically non-toxic	46895611

Subchronic Oral Toxicity (rat), 4-week Non-Guideline	NOAEL = 20,000 ppm	

Practically non-toxic	47470509

Subchronic Oral Toxicity (rat), 90-day

OPPTS 870.3100  	NOAEL = 20,000 ppm	

Practically non-toxic	47470510

Avian Acute Oral Toxicity

OPPTS 850.2100  	>2182.5 mg/kg	

Practically non-toxic	47067901

Freshwater Fish Acute Toxicity, 96 hr

OPPTS 850.1075  	

>121 mg/L	

Practically non-toxic	47131402

Aquatic Freshwater Invertebrate Toxicity, 48-hr

OPPTS 850.1010 	

>116 mg/L	 Practically non-toxic	47131401

Non-target Plants

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Non-target Insects (Honey Bee Acute Oral Toxicity, 48-hr) 

OPPTS 850.3020	

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Practically non-toxic	47151201

Non-target Insects (Honey Bee Contact Toxicity, 48-hr) 

OPPTS 850.3020	>100 μg/bee	

Practically non-toxic	47151201

Earthworm Subchronic Toxicity, 14-day  

OPPTS 850.6200	>1000 mg/kg dry soil	

Practically non-toxic	HLS, 2009 

ABA	           					Page   PAGE  7 		                                   
                            

Biopesticide Registration Action Document

 

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