Document ID: EPA-HQ-OPP-2009-0237-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-05-07T04:00Z

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

(7/1/2007)

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: duggard.mari@epa.gov.

TEMPLATE:

AgraQuest, Inc.

[To be assigned]

	EPA has received a pesticide petition (To be assigned) from AgraQuest,
Inc., 1540 Drew Avenue, Davis, California, 95618 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.

(Options (pick one)

	1. by establishing a tolerance for residues of NA-Remove

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

	

3. to establish an amendment/expansion of an existing tolerance
exemption for the NA-Remove

(Options (pick one)

	1. microbial pesticide  [insert name of active ingredient] NA-Remove

2. biochemical pesticide Extract of Chenopodium ambrosioides near
ambrosioides (ECANA) and ECANA Mimic (Extract of Chenopodium
ambrosioides near ambrosioides Mimic)

	

	3. plant-pesticide [insert name of active ingredient] in or on [insert
commodity]. NA-Remove

	Pursuant to section 408(d)(2)(A)(i) of  FFDCA, as amended, AgraQuest,
Inc.

 has submitted the following summary of information, data, and arguments
in support of their pesticide petition. This summary was prepared by
AgraQuest, Inc. 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. AgraQuest, Inc. Petition Summary

	[To be Assigned]

A. Product Name and Proposed Use Practices

	Extract of Chenopodium ambrosioides near ambrosioides (ECANA) is the
active ingredient in the formulated end-use product QRD 400 (EPA Reg.
No. 69592-22), which is intended for use on ornamentals in greenhouses
and nurseries under the brand name Metronome, and  intended for use on a
variety of agricultural crops under the brand name Requiem 25EC.  ECANA
Mimic is the active ingredient in the proposed formulated end-use
product QRD 452.  The formulated products containing either ECANA or
ECANA Mimic are intended for use as contact insecticides / acaricides
for the control or suppression of foliage feeding pests including
lepidopterous larvae, aphids, plant-feeding mites, whiteflies, mealy
bugs, leafminers, thrips, lygus bugs, scale, leaf hoppers, and certain
psyllids.   Like Requiem 25EC, QRD 452 is intended primarily for use on
a variety of agricultural crops.  End-use products consist of an
emulsifiable concentrate formulation that is mixed with water and
applied as a foliar spray with conventional application equipment. 

B. Product Identity/Chemistry

	1. Identity of the pesticide and corresponding residues. 

Extract of Chenopodium ambrosioides near ambrosioides (ECANA) is a
biochemical pesticide active ingredient composed of a modified essential
oil extract of Chenopodium ambrosioides near ambrosioides. Chenopodium
is a common plant in the US, Mexico, and Central America and is used as
a spice and herb in cooking.  ECANA is a complex mixture of terpenes and
terpene derivatives, including three main terpenes that make up almost
70% of the mixture. The combination of the three terpenes is considered
to be the active ingredient in ECANA. ECANA Mimic is a blend of the same
three nature-identical terpene components in the same proportions as
found in ECANA. Therefore, the active ingredient in ECANA and ECANA
Mimic is essentially the same. ECANA Mimic and ECANA are contact
insecticide/acaricides. The mode of action has not been completely
determined, however, based on laboratory and field trial observations
the primary mechanism for controlling and suppressing insect pests is
thought to involve the degradation of the cuticle of soft-bodied insects
and mites after contact.  

	2. Magnitude of residues at the time of harvest and method used to
determine the residue.

 No residues of Extract of Chenopodium ambrosioides near ambrosioides
(ECANA) or ECANA Mimic are expected to occur at the time of harvest
because the components of the active ingredient are volatile and
dissipate soon after application.  Residue studies have been previously
submitted to support the registration applications for both products. 
Data submitted clearly demonstrates that the active ingredient
components are not detectable shortly after application, even at 2 - 4X
the maximum label rate, and as such ECANA and ECANA Mimic will not be
present or detectable at the time of harvest.

	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, Extract of Chenopodium ambrosioides near
ambrosioides (ECANA) and ECANA Mimic would not result in detectable
residues or residues that are of toxicological concern. 

C. Mammalian Toxicological Profile

Both Extract of Chenopodium ambrosioides near ambrosioides (ECANA) and
ECANA Mimic contain essentially the same proportions of the three
terpene components. It is not unreasonable to conclude, based on the
similarity in product composition, measured physical/chemical and
residue decline characteristics, and performance results, that data
generated for ECANA can be used to bridge any data gaps for which there
are no corresponding ECANA Mimic toxicity data. Studies to evaluate the
safety to mammals have been conducted on the technical grade active
ingredient ECANA and ECANA Mimic (referred to below as “tgai”) and
on the 25% emulsifiable concentrate end-use products (referred to below
as “25EC”), and are summarized as follows:

1.	Acute Oral Toxicity (OPPTS 870.1100):  Acute Oral LD50s in rats for
ECANA tgai and ECANA 25EC were 2,000 – 5,000 mg/kg and >5,000 mg/kg,
respectively. In comparison, acute Oral LD50s limit tests in rats were >
2,000 mg/kg and >5,000 mg/kg in studies with ECANA Mimic tgai and 25EC
formulation, respectively.

2.	Acute Dermal Toxicity (OPPTS 870.1200):  Dermal LD50 limit test
results for both ECANA tgai and 25EC formulation were > 5,000 mg/kg. In
comparison, dermal LD50 limit test results in rats for both the ECANA
Mimic tgai and 25EC formulation were > 2,020 mg/kg.

Acute Inhalation Toxicity (OPPTS 870.1300):  In acute inhalation
toxicity limit tests no adverse effects or deaths were seen in rats
exposed for four hours to the tgai and the 25EC as an aerosol. The LC50
for the ECANA tgai and ECANA 25EC was > 2.03 mg/L and > 2.02 mg/L,
respectively. 

Primary Eye Irritation (OPPTS 870.2400):  In an eye irritation study on
rabbits, the ECANA tgai was classified as mildly to moderately
irritating to the eye.  The ECANA 25 EC was classified as minimally to
mildly irritating. 

Primary Dermal Irritation (OPPTS 870.2500):  In a skin irritation study
on rabbits, the ECANA tgai was classified as moderately irritating to
the skin.  In a similar study, the ECANA 25EC was classified as
moderately irritating to the skin.

	

6. 	Dermal Sensitization (OPPTS 870.2600): In a dermal sensitization
study in Guinea pigs (Buehler method), the ECANA tgai was classified as
a dermal sensitizer. In a similar study, the ECANA 25EC was classified
as a dermal sensitizer. Naïve control animals in both studies did not
have any positive reactions after challenge. 

7. 	Genotoxicity (OPPTS 870.5100, 870.5375, and 870.5550):   Three
genotoxicity studies were performed on the ECANA tgai. The results of a
bacterial reverse mutation assay, an in vitro mammalian chromosome
aberration test, and an unscheduled DNA repair assay were all negative. 

Waivers were requested and granted for all other Tier 1 biochemical
pesticide data requirements for ECANA, including reproductive and
developmental toxicity, immunotoxicity, sub-chronic toxicity and acute
toxicity to non-target species.  Data waiver rationales were based on
the lack of residues shortly after application; ubiquity in nature of
the terpene components; history of use the main terpene components in
the food, fragrance, and flavoring industries; favorable toxicological
profile in acute toxicological studies; and the inconsequential exposure
resulting from the label-directed use rates. The ECANA data waivers and
rationales are cited in the ECANA Mimic registration application as
fulfilling all the other Tier 1 biochemical pesticide data requirements
for ECANA Mimic.

	The results of toxicity testing with ECANA and ECANA Mimic and
information found in published literature support the conclusion that
the proposed use of AgraQuest’s ECANA or ECANA Mimic poses no
foreseeable risks to human health or the environment. 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

Dietary exposure. 

Dietary exposure from use of Extract of Chenopodium ambrosioides near
ambrosioides (ECANA) and ECANA Mimic, as proposed, is virtually
non-existent.   ECANA and ECANA Mimic are intended for application to
ornamentals and agricultural crops to suppress or control certain insect
pests.  Whereas ECANA is an essential oil derived from a plant that is
common in the US, Mexico, and Central America and is used as a spice and
herb in cooking, ECANA Mimic is a blend of nature-identical components
that substantially replicates the composition and activity of the
plant-derived ECANA.    

Food.  

	No residues of Extract of Chenopodium ambrosioides near ambrosioides
(ECANA) or ECANA Mimic are expected to occur on food due to the fact
that the components of the active ingredient are volatile and dissipate
soon after application. Residue decline studies on an ornamental and two
food crops with either ECANA or ECANA Mimic demonstrated that multiple
applications of the formulated end-use product at 2 – 4X the label
rates resulted in no detection of residue shortly after application and
no accumulation of residues over multiple applications.  

	Acute oral and dermal toxicity studies show that ECANA and ECANA Mimic
are not acutely toxic. An acute inhalation toxicity study with ECANA
showed that it was not toxic and is mildly to moderately irritating to
the skin and eyes of mammals. The expectation is that tests with ECANA
Mimic would produce the same toxicological profile.   The major terpene
components in ECANA and ECANA Mimic are naturally occurring in a
multitude of fruits, vegetables, herbs, spices, and other foods and
beverages, including coffee, tea, alcoholic beverages, baked and fried
potatoes, bread and cheese.  In addition the three main terpene
components are approved as direct food additives by the US Food and Drug
Administration, and are approved as fragrances in cosmetics.  The lack
of residues on treated crops, the results of toxicity testing on ECANA
and ECANA Mimic, and information found in published literature on the
main terpene components in ECANA and ECANA Mimic support the conclusion
that the proposed use of AgraQuest’s processed ECANA and ECANA Mimic
poses no foreseeable risks to human health or the environment. 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 Extract of Chenopodium
ambrosioides near ambrosioides (ECANA) or ECANA Mimic 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. ECANA and ECANA Mimic are
intended for application to ornamentals and agricultural crops.  The
products are not applied directly to water.

	

	The lack of residues on treated crops, the results of toxicity testing
with ECANA and ECANA Mimic, as well as information found in published
literature on the main terpene components support the conclusion that
the proposed use of AgraQuest’s processed ECANA and ECANA Mimic poses
no foreseeable risks to human health or the environment.  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 limited.  Extract of Chenopodium
ambrosioides near ambrosioides (ECANA) and ECANA Mimic are intended for
application to ornamentals and agricultural crops to control insect
pests.  

	The lack of residues on treated crops, the results of toxicity testing
with ECANA and ECANA Mimic, and information found in published
literature on the main terpene components in ECANA and ECANA Mimic
support the conclusion that the proposed use of AgraQuest’s processed
ECANA and ECANA Mimic poses no foreseeable risks to human health or the
environment.  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   SEQ CHAPTER \h \r 1 It is not expected that,
when used as proposed, Extract of Chenopodium ambrosioides near
ambrosioides (ECANA) or ECANA Mimic would result in residues that are of
toxicological concern. ECANA is an essential oil derived from a plant
that is common in the US, Mexico, and Central America and is used as a
spice and herb in cooking.  ECANA is a complex mixture of terpenes and
terpene derivatives, including three main terpenes that make up almost
70% of the mixture. The combination of the three terpenes is considered
to be the active ingredient in ECANA.  ECANA Mimic is a blend of the
same three nature-identical terpene components in the same proportions
as found in the plant-derived ECANA.    

 

	Acute oral and dermal toxicity studies show that ECANA and ECANA Mimic
are not acutely toxic. An acute inhalation toxicity study with ECANA
showed that it was not toxic and is mildly to moderately irritating to
the skin and eyes of mammals. The expectation is that tests with ECANA
Mimic would produce the same toxicological profile. The main terpene
components in ECANA and ECANA Mimic are naturally occurring in a
multitude of fruits, vegetables, herbs, spices, and other foods and
beverages, including coffee, tea, alcoholic beverages, baked and fried
potatoes, bread and cheese.  In addition the main terpene components are
approved as direct food additives by the US Food and Drug
Administration, and are approved as fragrances in cosmetics.    

	ECANA and ECANA Mimic are intended for application to ornamentals and
agricultural crops to control insect pests.  The lack of residues on
treated crops, the results of toxicity testing on ECANA and ECANA Mimic,
and information found in published literature on the main terpene
components in ECANA and ECANA Mimic support the conclusion that the
proposed use of AgraQuest’s processed ECANA and ECANA Mimic poses no
foreseeable risks to human health or the environment. 

F. Safety Determination

U.S. population. 

	Extract of Chenopodium ambrosioides near ambrosioides (ECANA) is an
essential oil derived from a plant that is common in the US, Mexico, and
Central America and is used as a spice and herb in cooking.  ECANA is a
complex mixture of terpenes and terpene derivatives, including three
main terpenes that make up almost 70% of the mixture. The combination of
the three terpenes is considered to be the active ingredient in ECANA. 
ECANA Mimic is a blend of the same three nature-identical terpene
components in the same proportions as found in the plant-derived ECANA.
Acute oral and dermal toxicity studies show that ECANA and ECANA Mimic
are not acutely toxic. An acute inhalation toxicity study with ECANA
showed that it was not toxic and is mildly to moderately irritating to
the skin and eyes of mammals. The expectation is that tests with ECANA
Mimic would produce the same toxicological profile. The main terpene
components in ECANA and ECANA Mimic are naturally occurring in a
multitude of fruits, vegetables, herbs, spices, and other foods and
beverages, including coffee, tea, alcoholic beverages, baked and fried
potatoes, bread and cheese.  In addition the main terpene components are
approved as direct food additives by the US Food and Drug
Administration, and are approved as fragrances in cosmetics.    

When used as proposed, ECANA and ECANA Mimic would not result in
residues that are of toxicological concern. ECANA and ECANA Mimic are
intended for application to ornamentals and agricultural crops to
control insect pests.  The lack of residues on treated crops, the
results of toxicity testing on ECANA and ECANA Mimic, and information
found in published literature on the main terpene components in ECANA
and ECANA Mimic support the conclusion that the proposed use of
AgraQuest’s processed ECANA and ECANA Mimic poses no foreseeable risks
to human health or the environment.  There is a reasonable certainty of
no harm to the general US population from exposure to these active
ingredients.

	2. Infants and children. 

	As mentioned above, it is not expected that, when used as proposed,
Extract of Chenopodium ambrosioides near ambrosioides (ECANA) and ECANA
Mimic would result in residues that are of toxicological concern. There
is a reasonable certainty of no harm for infants and children from
exposure to ECANA and ECANA Mimic from the proposed uses. 

G. Effects on the Immune and Endocrine Systems

	To date there is no evidence to suggest that Extract of Chenopodium
ambrosioides near ambrosioides (ECANA) and ECANA Mimic will compromise
the immune or endocrine systems, or that either 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 Extract of Chenopodium ambrosioides
near ambrosioides (ECANA) or ECANA Mimic. 

 

I. International Tolerances

	A Codex Alimentarius Commission Maximum Residue Level (MRL) is not
required for Extract of Chenopodium ambrosioides near ambrosioides
(ECANA) or ECANA Mimic.

 PAGE   

 PAGE   2