 

<EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF
FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER  >

<EPA Biopesticides and Pollution Prevention Division contact: [Raderrio
Wilkins; (703) 308-1259]>

 

<INSTRUCTIONS:  Please utilize this outline in preparing the pesticide
petition.  In cases where the outline element does not apply, please
insert “NA-Remove” and maintain the outline. Please do not change
the margins, font, or format in your pesticide petition. Simply replace
the instructions that appear in green, i.e., “[insert company
name],” with the information specific to your action.>

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

<TEMPLATE:>

<[Biomor Israel Ltd.]>

<[9F7558]>

<	EPA has received a pesticide petition ([9F7558]) from [Biomor Israel
Ltd.], [PO Box 81, Qatzrin 12900, ISRAEL] 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 to establish an exemption from the
requirement of a tolerance for biochemical pesticide [Tea Tree Oil].>

<	Pursuant to section 408(d)(2)(A)(i) of  FFDCA, as amended, [insert
company name] has submitted the following summary of information, data,
and arguments in support of their pesticide petition. This summary was
prepared by [insert company name] 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. [Biomor Israel Ltd.]  Petition Summary>

<	[9F7558]>

<A. Product Name and Proposed Use Practices>

<	[Tea Tree Oil Technical is intended for use in a formulated pesticide
product (Timorex Gold; 23.80% ai) to be applied as a fungicide to
growing crops.]>

<B. Product Identity/Chemistry>

α-terpinene,1,8-cineole, γ-terpinene, p-cymene and terpinen-4-ol, all
of which are cleared by the FDA for use as direct food additives (21 CFR
172.515; Synthetic flavoring substances and adjuvants).  Tea Tree Oil
has a long history of safe use in a wide range of cosmetics and personal
care products (mouthwash, toothpaste, shampoo, deodorants, lotions,
antifungal treatments), as well as in animal care products.

	Tea Tree Oil has antifungal properties and is effective against broad
spectrum of plant pathogenic fungi, including powdery and mildews, downy
mildew, early and late blights and rust diseases in a broad range of
crops.  The mode of action of the fungicidal activity of Tea Tree Oil is
not clearly understood.  Tea Tree Oil has been shown to effect
respiration in yeast and showed alternations in cell membrane structure.
 From that information it can be concluded that Tea Tree Oil has a broad
and non-specific mode of action similar to inorganic compounds like
copper salts with multi-site contact activity.]>

<	2. Magnitude of residues at the time of harvest and method used to
determine the residue. [NA-REMOVE]>

<	3. A statement of why an analytical method of detecting and measuring
the levels of the pesticide residue are not needed. [An analytical
method for residues is not applicable.  It is expected that, when used
as proposed, Tea Tree Oil would not result in residues that are of
toxicological concern.]>

<C. Mammalian Toxicological Profile>

<	[Acute Toxicity:  In acute toxicity studies Tea Tree Oil has shown an
oral LD50 of 1.9 mL/kg bw (1682 – 1721 mg/kg bw) for the technical
grade active ingredient (100%) and an oral LD50 of >2000 mg/kg bw for
the formulated end-use product (Timorex Gold; 23.80%).  A dermal LD50 of
>2000 mg/kg bw for the technical grade active ingredient (100%) and the
formulated end-use product (Timorex Gold; 23.80%).  An inhalation LC50
>5.4 mg/L air for the formulated end-use product (Timorex Gold; 23.80%)
(Schuler, 2009); equivalent to Toxicity Category IV.  Both the technical
grade active ingredient (100%) and the formulated end-use product
(Timorex Gold; 23.80%) are irritants to eyes and skin. The technical
grade active ingredient (100%) is not sensitizer and the formulated
end-use product (Timorex Gold;23.80%) is a dermal sensitzer.> 

Genotoxicity:  Three genotoxicity studies have been performed on the
technical grade active ingredient (100%) and all reported Tea Tree Oil
is not a mutagen.

Waivers have been requested for all other Tier 1 biochemical pesticide
data requirements including subchronic and developmental toxicity.  Data
waiver rationales are based on the facts that there is a lack of human
exposure from intended uses, the main components of Tea Tree Oil are
ubiquitous in nature and have a safe history of use in the food,
fragrance, flavoring, cosmetic and personal care product industries, the
results of acute toxicity studies show low toxicity to mammals and there
is a lack of residues of Tea Tree Oil on treated food commodities.

α-terpinene,1,8-cineole, γ-terpinene, p-cymene and terpinen-4-ol) are
cleared by the FDA for use as direct food additives (21 CFR 172.515;
Synthetic flavoring substances and adjuvants).  Tea Tree Oil has a long
history of safe use in a wide range of cosmetics and personal care
products (mouthwash, toothpaste, shampoo, deodorants, lotions,
antifungal treatments), as well as in animal care products.  

The results of toxicity testing, listing of the main components are
direct food additives, and the lack of residues on treated commodities
show there is no risk to human health from Tea Tree Oil.  Both dietary
and non-dietary exposures would not be expected to pose any quantifiable
risk due to a lack of residues of toxicological concern.]

<D. Aggregate Exposure>

<1. Dietary exposure. >

<	i. Food. [Dietary exposure from use of Tea Tree Oil, as proposed, is
minimal.  The intended use of Tea Tree Oil is application to growing
agricultural crops as a fungicide.  Tea Tree Oil is a plant volatile
that rapidly degrades in the environment.  It is a naturally occurring
ingredient and is not considered persistent based on its
characteristics, properties or known degradation pathways. 

		Acute toxicity studies have shown that Tea Tree Oil is not toxic and
is moderately irritating to mammals.  The main components of Tea Tree
Oil (identified as α-terpinene,1,8-cineole, γ-terpinene, p-cymene and
terpinen-4-ol) are cleared by the FDA for use as direct food additives
(21 CFR 172.515; Synthetic flavoring substances and adjuvants).  Tea
Tree Oil has a long history of safe use in a wide range of cosmetics and
personal care products (mouthwash, toothpaste, shampoo, deodorants,
lotions, antifungal treatments), as well as in animal care products. 

		No residues of Tea Tree Oil are expected to occur on food due to the
fact that the components of the active ingredient are volatile and
dissipate soon after application.   Tea Tree Oil has been shown to
volatilize up to 90% twenty-four hours after application and residue
studies with the formulated end-use product (Timorex Gold; 23.80%) on
tomatoes, peppers and grapes have shown no detectable residues.

 

		The results of toxicity testing, listing of the main components as
direct food additives, and the lack of residues on treated commodities
show there is no risk to human health from Tea Tree Oil.  Dietary
exposures would not be expected to pose any quantifiable risk due to a
lack of residues of toxicological concern.]>

<	ii. Drinking water. [Similarly, exposure to humans from residues of
Tea Tree Oil in consumed drinking water would be unlikely.  Potential
exposure to surface water would be negligible and exposure to drinking
water (well or ground water) would be impossible to measure. The
intended use of Tea Tree Oil is application to growing agricultural
crops as a fungicide.  The ingredient is not applied directly to water.

		No residues of Tea Tree Oil are expected to occur on food due to the
fact that the components of the active ingredient are volatile and
dissipate soon after application.   Tea Tree Oil has been shown to
volatilize up to 90% twenty-four hours after application and residue
studies with the formulated end-use product (Timorex Gold; 23.80%) on
tomatoes, peppers and grapes have shown no detectable residues.

	

		The results of toxicity testing, listing of the main components as
direct food additives, and the lack of residues on treated commodities
show there is no risk to human health from Tea Tree Oil. Drinking water
exposures would not be expected to pose any quantifiable risk due to a
lack of residues of toxicological concern.]>

<2. Non-dietary exposure. [The potential for non-dietary exposure to the
general population, including infants and children, is unlikely as the
proposed use sites are agricultural.  The intended use of Tea Tree Oil
is application to growing agricultural crops as a fungicide.  Tea Tree
Oil is a plant extract volatile that rapidly degrades in the
environment.  It is a naturally occurring ingredient and is not
considered persistent based on its characteristics, properties or known
degradation pathways. 

	Acute toxicity studies have shown that Tea Tree Oil is not toxic and is
moderately irritating to mammals.  The main components of Tea Tree Oil
(identified as α-terpinene,1,8-cineole, γ-terpinene, p-cymene and
terpinen-4-ol) are cleared by the FDA for use as direct food additives
(21 CFR 172.515; Synthetic flavoring substances and adjuvants).  Tea
Tree Oil has a long history of safe use in a wide range of cosmetics and
personal care products (mouthwash, toothpaste, shampoo, deodorants,
lotions, antifungal treatments), as well as in animal care products.

	The results of toxicity testing, listing of the main components as
direct food additives, and the lack of residues on treated commodities
show there is no risk to human health from Tea Tree Oil. Non-dietary
exposures would not be expected to pose any quantifiable risk due to a
lack of residues of toxicological concern.]>

<E. Cumulative Effects>

<	[  SEQ CHAPTER \h \r 1 It is not expected that, when used as proposed,
Tea Tree Oil would result in residues that are of toxicological concern.
The intended use of Tea Tree Oil is application to growing agricultural
crops as a fungicide.  Tea Tree Oil is a plant extract volatile that
rapidly degrades in the environment.  It is a naturally occurring
ingredient and is not considered persistent based on its
characteristics, properties or known degradation pathways. 

α-terpinene,1,8-cineole, γ-terpinene, p-cymene and terpinen-4-ol) are
cleared by the FDA for use as direct food additives (21 CFR 172.515;
Synthetic flavoring substances and adjuvants).  Tea Tree Oil has a long
history of safe use in a wide range of cosmetics and personal care
products (mouthwash, toothpaste, shampoo, deodorants, lotions,
antifungal treatments), as well as in animal care products.

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pate soon after application.   Tea Tree Oil has been shown to volatilize
up to 90% twenty-four hours after application and residue studies with
the formulated end-use product (Timorex Gold; 23.80%) on tomatoes,
peppers and grapes have shown no detectable residues.  The results of
toxicity testing, listing of the main components as direct food
additives, and the lack of residues on treated commodities show there is
no risk to human health from Tea Tree Oil.]>

<F. Safety Determination>

<	1. U.S. population. [The results of toxicity testing, listing of the
main components as direct food additives, and the lack of residues on
treated commodities show there is no risk to human health from Tea Tree
Oil.  The intended use of Tea Tree Oil is application to growing
agricultural crops as a fungicide.  Tea Tree Oil is a plant extract
volatile that rapidly degrades in the environment.  It is a naturally
occurring ingredient and is not considered persistent based on its
characteristics, properties or known degradation pathways.  There is a
reasonable certainty of no harm to the general US population from
exposure to this active ingredient.]>

<	2. Infants and children. [As mentioned above, it is not expected that,
when used as proposed, Tea Tree Oil would result in residues that are of
toxicological concern. There is a reasonable certainty of no harm for
infants and children from exposure to Tea Tree Oil from the proposed
uses.]>

<G. Effects on the Immune and Endocrine Systems>

<	[To date there is no evidence to suggest that Tea Tree Oil functions
in a manner similar to any known hormone, or that it acts as an
endocrine disrupter.]>

<H. Existing Tolerances>

<	[There is no US. EPA Tolerance for Tea Tree Oil.]>

<I. International Tolerances>

<	[A Codex Alimentarium Commission Maximum Residue Level (MRL) is not
required for Tea Tree Oil.]>

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