  MacroButton macIb01 i  

<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: [Linda
Hollis, 703-308-8733]>

<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:>

<[Plant Impact plc]>

<[9F7619]>

<	EPA has received a pesticide petition ([9F7619]) from [Plant Impact
plc], [12 South Preston Office Village, Cuerdan Way, Bamber Bridge,
Preston, PR5 6BL United Kingdom] 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 the biochemical pesticide [tagetes oil, CAS Number
8016-84-0] in or on [all food commodities including use on all food
crops in EPA’s Crop Groups 1-21].>

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

<	[9F7619]>

<A. Product Name and Proposed Use Practices [Plant Impact plc intends to
use tagetes oil in a formulated pesticide product (Bug Oil Food Use,
0.6% ai) to be applied as an insecticide to growing crops.]>

<

B. Product Identity/Chemistry>

<	1. Identity of the pesticide and corresponding residues. [Tagetes oil
(CAS Number 8016-84-0) is a naturally-occurring oil from the plant
-Tagetes minuta. It consists of a multitude of natural ingredients,
including but not limited to limonene, tagetone, dihydrotagetone,
ocimenone, ocimene, terpineol. The major components are found in many
different oil products and are used in many common consumer items
(including cosmetics, drugs, etc.). They are all naturally-occurring and
many of them have also been approved by FDA for a variety of uses,
including as a food flavoring/coloring substance.  

Tagetes oil acts as an insecticide when applied to all growing crops. It
is effective against mites, whiteflies, aphids, thrips, mealybugs,
scales and psylla. 

Tagetes oil is used at a very low percentage in the end-use product Bug
Oil (0.6% w/w) and then further diluted in water (1-2% solution) at the
time of application. Therefore, the amount of tagetes oil that is
applied to growing crops is quite low.]

>

<	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, when used as
proposed, tagetes oil will not result in residues that are of concern.]>

<C. Toxicological Profile>

Acute toxicity.

i.	Tagetes Oil [Acute oral LD50 value is >5000 mg/kg body weight. Acute
dermal LD50 value is >2000 mg/kg body weight. Tagetes oil is not
irritating to eyes in rabbits, is mild to moderately irritating to
rabbit skin, and is non-sensitizing dermally in the Buehler Test in
guinea pigs.  Acute toxicity studies for tagetes oil support an overall
EPA Toxicity Category III.]

ii.	Bug Oil Food Use [Acute oral and acute dermal LD50 value is >5000
mg/kg body weight. Bug Oil Food Use is not irritating to eyes in rabbits
and is not irritating to rat skin.  Bug Oil Food Use is a sensitizer at
full-strength and is negative at a 1% dilution in the Buehler Test in
guinea pigs.  Acute toxicity studies for Bug Oil Food Use support an
overall EPA Toxicity Category III.]

Genotoxicity.

i.	Tagetes Oil [No mutagenicity data specific to tagetes oil are
available. Plant Impact plc has requested a waiver of Mutagenicity
testing based on the available mutagenicity information on the major
components of tagetes oil.]

Reproductive and developmental toxicity.

i.	Tagetes Oil [No reproductive and developmental data, specific to
tagetes oil are available. Plant Impact plc has requested a waiver of
this testing based on the available information on the major components
of tagetes oil.]

Subchronic and Chronic toxicity.

i.	Tagetes Oil [No subchronic or chronic data, specific to tagetes oil,
are available. Plant Impact plc has requested a waiver of this testing
based on the available information on the major components of tagetes
oil.]

<>

<D. Aggregate Exposure>

<	1. Dietary exposure. 

>

<	i. Food. [Dietary exposure from the use of tagetes oil on growing
crops is expected to be minimal. The application rate is very low.
Tagetes oil is included in Bug Oil Food Use at 0.6% w/w, which is
further diluted with water to a 1%-2% solution at the time of
application. Additionally tagetes oil is a plant volatile that is
expected to rapidly degrade in the environment. The potential dietary
exposure from food treated with tagetes oil is expected to be minimal.
Available acute toxicology data on tagetes oil demonstrates it is not
toxic, mildly irritating to skin, and is not a dermal sensitizer.
Additionally, the main components of tagetes oil have a long history of
safe use in a wide range of products, including cosmetics, drugs and
more. Several of the components are cleared by FDA as food
ingredients/flavorants. Based on the available data on tagetes oil, the
fact that it is not expected to remain on the plant due to
volatilization and environmental breakdown and finally the low
application rate to treated commodities results in no risk to human
health expected.]>

<	ii. Drinking water. [No significant drinking water exposure is
expected to result from application of tagetes oil to agricultural
crops. Tagetes oil is not applied directly to water and potential
exposure to surface water will be negligible. It is also expected that
tagetes oil will volatilize and dissipate soon after application;
therefore, reducing any potential for runoff from the treated area.]

>

<	2. Non-dietary exposure. [The potential for non-dietary exposure to
the general population, including infants and children, is unlikely as
the proposed use of tagetes oil is as an insecticide applied to growing
crops. Tagetes oil is a plant extract that is expected to volatilize and
rapidly degrade once applied. Additionally based on the available
toxicology data, any limited non-dietary exposure should not result in
any risk.]

>

<E. Cumulative Effects>

<	[Plant Impact plc has considered all available information that
relates to the cumulative effect of pesticide residues of tagetes oil
and residues of other materials having a common mechanism of toxicity.
Especially important in these assessments is the effect potential
residues may have on infants and children. Plant Impact plc concludes
that the exact mode of action of tagetes oil is unknown. However, due to
the low order of toxicity and lack of reported toxicity associated with
the use of tagetes oil as an essential oil, no cumulative effect from
the use of tagetes oil is expected.]>

<F. Safety Determination>

<	1. U.S. population. [The results of the available toxicology testing,
natural occurrence of the active ingredient, and the low application
rate show that there is limited potential for exposure and no risk to
human health from tagetes oil. Taking into consideration all available
information on tagetes oil, it is anticipated that there is a reasonable
certainty that no harm to any population subgroup will result from
aggregate exposure to tagetes oil when used as an active ingredient in
pesticide formulations.]

>

<	2. Infants and children. [For reasons stated previously, it is not
expected that tagetes oil will result in residues in or on food. Based
on referenced toxicity data and the general lack of evidence of
mammalian toxicity in public literature, there is a reasonable certainty
of no harm for infants and children from exposure to tagetes oil from
the proposed uses.]

>

<G. Effects on the Immune and Endocrine Systems [To date there is no
evidence to suggest that tagetes oil functions in a manner similar to
any known hormone, or that it acts as an endocrine disrupter.]>

<H. Existing Tolerances [There is no current US EPA tolerance for
tagetes oil.]>

<>

<I. International Tolerances [No known international tolerances are
established for tagetes oil.]>

<>

 PAGE   

 PAGE   2 

