Document ID: EPA-HQ-OPP-2007-0199-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-04-30T04:00Z

EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF
FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER 
(7/1/2006)

EPA Biopesticides and Pollution Prevention Division contact: [insert
name and telephone number with area code]

 

INSTRUCTIONS:  Please utilize this outline in preparing tolerance
petition documents.  In cases where the outline element does not apply
please insert “NA-Remove” and maintain the outline.  The comment
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Please do not remove or alter these comment notes or change the margins,
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the information specific to your action.]

SUBMISSION: E-mail the completed template to: hollis.linda@epa.gov.

TEMPLATE:

[Valent BioSciences Corporation]

[# 73049-EUP-_]

	EPA has received a pesticide petition ([# 73049-EUP-__]) from [Valent
BioSciences Corporation], [870 Technology Way, Libertyville, IL 60048]
proposing, pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.

	2. to establish an exemption from the requirement of a tolerance for

	2. biochemical pesticide [S-Abscisic Acid;
(S)-5-(1-hydroxy-2,6,6-trimethyl-4-oxo-1-cyclohex-2-enyl)-3-methyl-penta
-(2Z,4E)-dienoic Acid]

	

	3.  in or on [grape berry commodities].

	Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, [Valent
BioSciences Corporation] has submitted the following summary of
information, data, and arguments in support of their pesticide petition.
This summary was prepared by [Valent BioSciences Corporation] and EPA
has not fully evaluated the merits of the pesticide petition. The
summary may have been edited by EPA if the terminology used was unclear,
the summary contained extraneous material, or the summary
unintentionally made the reader conclude that the findings reflected
EPA’s position and not the position of the petitioner.

I. [Valent BioSciences Corporation]  Petition Summary

	[# 73049-EUP-__]

A. Product Name and Proposed Use Practices

	[Abscisic acid (ABA) is a hormone that has been found in all vascular
plants thus far analyzed as well as in algal plants.  Levels of ABA vary
from 3 to 5 ppb in aquatic plants to 10 ppm in avocado fruit.  ABA is
also produced by some phytopathogenic fungi including Cercospora cruenta
and Botrytis cinerea.

ABA is involved in many major process during plant growth and
development including dormancy, germination, bud break, flowering, fruit
set, general growth and development, stress tolerance, ripening,
abscission and senescence.  One of the best-known roles of ABA is its
regulation of water loss through control of stomatal closure.  ABA is
one of the five major hormones found in plants.  In July of 2005 the
Agency classified ABA as a biochemical pesticide because of its
ubiquitous presence in nature.

Valent BioSciences Corp. is requesting a EUP and a temporary tolerance
exemption for Abscisic Acid (ABA) for the use on grapes for enhanced
fruit coloring.

Proposed Applications, Rates, and Timings      

Table and wine grapes (food use):  ABA will be applied from two to three
weeks before harvest in one or two sprays of 50 to 200 ppm each in a
water volume of 75 to 200 gallons per acre.  Use of higher rates is
expected to be necessary in desert areas where grapes have a history of
being difficult to color..]

B. Product Identity/Chemistry

	1. Identity of the pesticide and corresponding residues. [S-Abscisic
acid;
(S)-5-(1-hydroxy-2,6,6-trimethyl-4-oxo-1-cyclohex-2-enyl)-3-methyl-(2Z,4
E)-pentadienoic acid, (CAS #: [21293-29-8]) has been tested and
characterized.]

	2. Magnitude of residues at the time of harvest and method used to
determine the residue. [Residues of ABA from application to grapes can
be expected to rapidly dissipate to levels consistent with those
observed naturally.]

	3. A statement of why an analytical method of detecting and measuring
the levels of the pesticide residue are not needed. [Residues of ABA
applied to plants are subject to rapid degradation and
photoisomerization, the route and rate of which is well understood. 
Because of the natural occurrence of ABA in all plant derived food or
feed items, the use rate and pattern, no residues are expected be
present above the natural background of ABA in and on grapes at harvest.
 Analytical methods for the measurement of Abscisic acid in crop
materials are present in the literature.  A tolerance exemption petition
normally does not require submission of analytical methods to measure
residues for which a tolerance is not being established..]

C. Mammalian Toxicological Profile

[Acute toxicity:   The acute oral toxicity determined using the rat was
greater than 5,000 mg/kg of body weight in female rats.  The acute
dermal toxicity using the rat, was greater than 5,000 mg/kg body weight
in male and female rats.  The acute inhalation toxicity was greater than
2.06 mg/L in male and female rats.

Primary eye irritation, tested in rabbits, showed mild irritation to the
eye.  Iritis and conjunctivitis cleared after 24 hours.   Primary skin
irritation, tested in the rabbit, showed this material to be slightly
irritating.  This irritation cleared within 24 hours after treatment. 
ABA was tested for Sensitization in the Guinea Pig and found not to be a
skin sensitizer.  

Genotoxicity:   From three mutagenicity studies (Ames test, mouse
micronucleus assay, and unscheduled DNA synthesis assay in the rat), it
was determined that abscisic is not mutagenic.  

Developmental Toxicity:  Because ABA is a biochemical material, and all
acute toxicity studies did not show ABA to be acutely toxic, and these
test re listed as conditional requirements, developmental toxicity was
not tested and is not believed to be of concern

Subchronic Toxicity:  Because ABA is a biochemical material, and all
acute toxicity studies did not show ABA to be acutely toxic, and these
test are listed as conditional requirements, subchronic toxicity was not
tested and is not believed to be of concern.  ]

D. Aggregate Exposure

	1. Dietary exposure. [ABA, being a natural biochemical, is already
present in food and feed items at various levels and has always been a
component of any diet containing plant materials.  The proposed uses of
this product are not expected to results in residues in or on any food
or feed items, above the natural background levels typically found in
these materials. .]

	i. Food. [Residues of ABA applied to grapes can be expected to rapidly
dissipate to levels consistent with those observed naturally.  The rapid
metabolism, photoisomerization, and rapid degradation of ABA within
plants have been described.  ABA, being a natural biochemical, is
already present in food and feed items at various levels and has always
been a component of any diet containing plant materials.  The proposed
uses of this product are not expected to results in residues in or on
any food or feed items, above the natural background levels typically
found in these materials.]

	ii. Drinking Food. [Applications are expected to be made to vineyard
for the grape using a maximum rate of 200 ppm using a maximum of 200
gallons per acre.  Using this low concentration and volume of
application solution, leaching into groundwater is unlikely. 
Applications are directed to the grape fruit clusters, therefore
accidental application to lakes or steams is unlikely.  Because ABA (a
biochemical material) is expected to be rapidly metabolized and
photo-isomerized, no residues of ABA from application of this product
are expected in water.  Additionally, the natural presence of ABA in
water from algal physiology has been documented.  Therefore, lakes and
stream waters would be expected to have a natural level of ABA.]

	2. Non-dietary exposure. [The only non-dietary ABA exposure potential
would be to applicators.  However, the protective measures prescribed by
the product’s label are expected to be adequate to minimize exposure
and protect applicators during the label use of the chemical.  The low
application rate, low toxicity and proposed use of ABA are not likely to
result in chronic exposure of workers or the public to ABA at levels
above what might be expected through natural occurrence..]

E. Cumulative Effects

[The proposed uses of ABA are not likely to result in chronic exposure
of workers or the public to ABA at levels above what might be expected
through its natural occurrence.  Residues of ABA applied to grapes can
be expected to rapidly dissipate to levels consistent with those
observed naturally.  The rapid metabolism, photoisomerization and rapid
degradation of ABA within plants have been described.  ABA, being a
natural biochemical, is already present in food and feed items at
various levels and has always been a component of any diet containing
plant materials.  

Given;  -the negligible potential for chronic exposure to residues of
ABA above what might be expected through natural occurrence,  -the rapid
metabolism resulting in no residues above background levels,  -the non
toxic picture presented by the acute toxicity testing, and  -the
abundant public information available on the metabolism and degradation
of ABA, the proposed limited uses on grapes poses minimal risk to human
health or the environment..]

F. Safety Determination

	1. U.S. population. [‘NA-Remove’.]

	2. Infants and children. [‘NA-Remove’.]

G. Effects on the Immune and Endocrine Systems

	[‘NA-Remove’.]

H. Existing Tolerances

	[‘NA-Remove’.]

I. International Tolerances

	[‘NA-Remove’.]