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] 

. I ~ 

INSTRUCTIONS: Please utilize this outline in preparing tolerance petition 

documents. In cases where the outline element does not apply please insert "NARemove" and maintain the outline. The comment notes that appear on the left 

margin represent hidden typesetting codes designed to expedite the processing of the 

Federal Register document. Please do not remove or alter these comment notes or 

change the margins, font, or format in your document. Simply replace the 

instructions that appear in italics and brackets, i.e., "[insert company name]," with 

the information specific to your action.) 

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

TEMPLATE: 

[Valent BioSciences Corp.] 

(Insert petition number] 

EPA has received a pesticide petition ([insert petition number]) from [Valent 

BioSciences Corp.], [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 an1end 40 CFR part 180. 

(Options (pick one) 

3. to establish an amendment/expansion of an existing tolerance exemption fo:- :h..: 

(Options (pick one) 

2. biochemical pesticide [cinnamaldehyde] in or on [all food commodities]. 

Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, [Vaient 

BioSciences Corp.] has submitted the following summary of information. data. and 

arguments in support of their pesticide petition. This summary was prepared by [Valent 

BioSciences Corp.] 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 

stmlmary 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 Corp.] Petition Summary 

[Insert petition number] 

A. Product Name and Proposed Use Practices 

Cinnamaldehyde is the organic compound that gives cinnamon its flavor and odor. The pale 

yellow viscous liquid occurs naturally in the bark of cinnamon trees and other species of the genus 

Cinnamonum. The essential oil of cinnamon bark is about 90% cinnamaldehyde. Cinnamaldehyde 

products are registered for use as fungicides, insecticides, algaecides and miticides for agricultural crops, 

horticultural crops and turf. Cinnamaldehyde products are registered for use to control a variety of pests 

including aphids, sharpshooter aphids, mites, spider mites (including two-spotted mites, pacific mites and 

Willamette mites) leafhoppers, whiteflies (including silverleafand greenhouse), thrips (including western 

flower), algae, moss, and liverwortslhomworts/pearlworts. Fungicidal Cinnamaldehyde products are 

registered for use to control powdery mildew, rhizoctonia, pythium, dollar spot, and pitch canker disease. 

Pesticide products containing cinnamaldehyde were first registered in 1994 for use in soil casing for 

mushroom, row crops, horticultural crops, turf and all food commodities, corn rootworm baits and dog and 

cat repellents. In 1999, EPA exempted from the requirements for a tolerance cinnamaldehyde (3-phenyl-2-

propenal) in or on all food commodities when used as a fungicide, insecticide, or algaecide in accordance 

with good agricultural practices (40 CFR § 180.1156) [EPA-HQ-OPP-2010-0918 for more details]. Valent 

BioSciences is requesting this tolerance be extended to the use of cinnamaldehyde as a nematicide. 

Cinnamaldehyde is used within the end use product ReSetTM (60% of the end use formulation). 

ReSetTM (also referred to as VBC-90017 within this submission) is an eatable-oil based liquid formulation 

that can be used to control or suppress important nematode pests including but not limited to the following 

plant nematodes parasitizing food, fiber and ornamental crops: Meloidogyne spp. (root-knot nematodes), 

Heterodera and Globodera spp. (cyst nematodes), Pratylenchus spp. (lesion nematodes), Tylenchulus 

sernipenetrans (citrus nematode), Trichodorus spp. (stubby-root nematodes), Xiphinema index (dagger 

nematode), Paratylenchus spp. (pin nematodes), Hoplolaimus spp. (lance nematodes), Criconemoides spp. 

(ring nematodes), Rotylenchus spp. (spiral nematodes), Belonolaimus spp. (sting nematodes). 

ReSetTM must be applied to the soil and incorporated into the soil. Apply ReSetTM to the soil as a 

pre-plant, at planting, or post-plant soil treatment on annual and perennial crops. ReSetTM is mixed with 

water and the mixed suspension applied as a banded spray with mechanical incorporation or through drip 

irrigation. Applications may be made as an in-furrow spray, drip irrigation, micro-emitters, transplant 

water treatment, sub-surface or under plastic drip tape, surface band, or soil shank injection, all followed 

immediately by soil incorporation or irrigation to move the material to the plant root zones where 

nematodes reside and feed. Incorporation may be accomplished by mechanical equipment, and/or 

irrigation. For soil applications made at planting, the action of some planters may provide sufficient 

incorporation. When using planters which do not provide adequate incorporation of ReS~t ; ;.t int:> the soil, 

equipment designed for incorporation may be used behind the planter. Material should n<·t contr.ct crop 

foliage and overhead chemigation is not allowed. Do not allow treated water to move off <:i!c. ::=:J not 

apply by mist sprayer or aerial spray equipment. 

Application timings and rates will vary depending on the crop, nematode pressure, soil type, anj 

other factors. The optimal application time must be determined based on the cultural practice.~ an•i the 

nematode population dynamics. Multiple applications may be required for best nematode st.wression. 

Incorporation may be accomplished by mechanical equipment, and drip irrigation. 

ReSetTM is a soil applied liquid using ground equipment for incorporation into the root zone, or 

using drip irrigation systems with quantities of water sufficient to provide full movement of ingredients into 

the soil and penetration of the root zone of the plants. This will produce little environmental exposure 

beyond the soil. Application to the soil with incorporation will greatly limit or eliminate potential exposure 
to birds, fish or other aquatic organisms. Application to bodies of water is very unlikely with these 

application methods. Runoff into bodies of water is also unlikely, because the nematicide will be applied to 

and incorporated into the soil, and will not have the opportunity to be washed into bodjes of water. 

Valent BioSciences is seeking an amendment to the exemption from the requirement of a tolerance 

for the registration of cinnamaldehyde as a nematicide within the end use product ReSetTM. 

40 CFR § 180.1156 Cinnamaldehyde; exemption from the requirement of a tolerance. 

Cinnamaldehyde (3-phenyl-2-propenal) is exempted from the requirement of a tolerance in or on all food 

commodities, when used as a fungicide, insecticide, algaecide and nematicide in accordance with good 

agricultural practices. 

B. Product Identify Chemistry 

1. Identity of the pesticide and corresponding residues. 

Cinnammaldehyde (CAS# 104-55-2); EPA PC Code 040506, EPA: Cinnamaldehyde Final Work 

Plan, Registration Review Case 6032, Docket Number: EPA-HQ-OPP-20 10-0918. Cinnamaldehyde or 

cinnamic aldehyde, is the main component in cassia oil as well as cinnamon bark and cinnamon oil. It 

occurs naturally in the bark of cinnamon trees and other species of the genus Cinnamomum. The essential 

oil of cinnamon bark is about 90% cinnamaldehyde. It is used as a food additive to impart cinnamon flavor 

to food. 

Considerable safety data exist from the food and flavoring industry which utilize food grade 

cinnamaldehyde in non-alcoholic beverages, ice cream, candy, baked, goods, chewing gum, condiments 

and meats at levels ranging from 9 ppm to 4900 ppm. Cinnamaldehyde is Generally Recognized as Safe 

(GRAS) by the Flavoring Extract Manufacturers Association and is approved for food use (21 CFR § 

182.60) by the Food and Drug Admiillstration (FDAA). Cinnamon oil, which contains 70% to 90% 

cinnamaldehyde is also classified as GRAS, and like Cinnamaldehyde, is used in the food and flavoring 

industry. 

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

EPA, Preliminary Assessment for the Registration review ofCinnamaldehyde, has been published, 

(12/01/2010). 

An Exemption from the requirement of a tolerance has been established by the EPA ( 40 CFR § 

180.1156) for Cinnamaldehyde (3-phenyl-2-propenal) in or on all food commodities, when used as a 

fungicide, insecticide, and algaecide in accordance with good agricultural practice, (64 FR 7804, Feb 17, 

1999; 64 FR 14099, Mar. 24, 1999]. 

40 CFR § 180.1156 Cinnamaldehyde; exemption from the requirement of a tolerance. 

Cinnamaldehyde (3-phenyl-2-propenal) is exempted from the requirement of a tolerance in or on all fvvci 

commodities, when used as a fungicide, insecticide, and algaecide in accordance with good a~rir.u tur<.l 

practices. The existing tolerance exemption on mushrooms ( 40 CFR § 180.1156) is beret y reonC'ved. 

3. Analytical method. 

An analytical method for residues is not applicable. Residues ofCinnamaldehyde b:.ve been 

granted an exemption for the requirements of a tolerance (40 CFR § 180.1156), (64 FR 78tv.-, f~.-b 17, 1~99; 

64 FR 14099, Mar. 24, 1999]. 

C. Afammalian ToxicoloRica/ Profile 

The active ingredient Cinnamaldehyde has been registered as pesticides and has an exemption 

from the requirement of a tolerance. 
Cinnamaldehyde is the organic compound that gives cinnamon its flavor and odor. The pale 

yellow viscous liquid occurs naturally in the bark of citmamon trees and other species of the genus 

Cinnamonum. The essential oil of cinnamon bark is about 90% cinnamaldehyde. Cinnamaldehyde 

products are registered for use as fungicides, insecticides, algaecides and miticides for agricultural crops, 

horticultural crops and turf. 

Acute toxicity. 

The oral LD50 for cinnamaldehyde is greater than 5,000 milligram/kilogram (mglkg), while the 

dermal LD50 is greater than 2,000 mglkg. Cinnamaldehyde is also minimally toxic via the inhalation route, 

since the LC50 is greater than 2.09 mg/L. Cinnamaldehyde is a mild skin and eye irritant. All sub-chronic, 

teratology and mutagenicity testing requirements have been waived since this substance is (1) a 

biochemical pesticide possessing a low order of toxicity, (2) applied at very low rates, (3) currently used in 

foods, such as nonalcoholic beverages, ice creams, candy, baked goods, condiments and meats, as a 

flavoring agent, and (4) considered GRAS (Generally Recognized as Safe) by the FDA. In addition, 

cinnamon oil (which contains 55-90% cinnama!dehyde is also classified as a GRAS substance and is 

extensively used in the food and flavoring industry, as well as in perfumery and cosmetic products. 

Cinnamon oil was also recently exempted from pesticidal regulation under FIFRA section 25(b). 

Acute oral toxicity (LD50) ofReSetTM (end use formulation that is 60% cinnamaldedye) was 

determined to be I ,030 mglkg body weight in rats. The Dermal LD50 for ReSetTM was measured as >2,000 

mglkg bodyweight and the inhalation LC50 was between 2.06 and 5.07 mg/L. ReSetTM is slightly irritating 

to the skin and severely irritating to the eye, unless washed out immediately. When washing is utilized it is 

mildly irritating to the eye. ReSetTM is considered to be a contact dermal sensitizer. 

D. Aggre~ate Expv'illre 

1. Dietary exposure1. Food. Currently, dietary exposure to cinnamaldehyde occurs from its use as a food flavoring agent, 

and there exists a tolerance exemption on all food commodities when used as a fungicide, insecticide, and 

algecide ( 40 CFR § 180.1156). Dietary exposure to residues of cinnamaldehyde as a result of uses covered 

under this tolerance exemption is also expected to be minimal. 

2. Drinking water exposure. Cinnamaldehyde residues in drinking water are expected to be minimal due 

to its low application rate, expected rapid biodegradability in soil, and its insolubility in water. 

2. Non-dietary exposure. There may be minor amounts of non-dietary exposure to cinnamaldehyde from 

the use of cinnamon oil in cosmetics and perfumes. Cinnamon oil contains 55-90% cinnamaldehyde. 

However, cinnamon oil is also classified as a GRAS substance for use as a flavoring agent on food (21 

CFR § 182.1 0) and was recently exempt from pesticide regulation under FIFRA section 25(b ). Based on 

the small amount of cinnarnaldehyde and cinnamon oil used in these instances, very minimal non-dietary 

exposure is expected. 

E. Cumulative Eflec:l.\ 

Because of the low toxicity and use rates of cinnamaldehyde, Valent BioScienc~> :l.:>.!s not 

believe that there is any concern regarding the potential for cumulative effects of cinnamaldel.yde and other 

substances that have a common mechanism of toxicity. 

F. Safery Determination 

1. U.S. population. The use of products containing cinnamaldehyde, which is of low toxicity and is used 

in low concentrations, is compatible with the Agency's objectives to register reduced risk pesticides. Based 
on its low toxicity, there is reasonable certainty that no harm will result from aggregate exposure of the 

U.S. population, including infants and children, to residues of cinnamaldehyde. This includes all 

anticipated dietary exposures and all other exposures for which there is reliable information. An 

inconsequential increase in dietary exposure is expected to result from the application of cinnamaldehyde 

to growing crops as a nematicide. Cinnamaldehyde is applied at low rates, and with its proven low toxicity 

and its history of safe use, does not pose a safety concern. 

2. Infants and children. As mentioned above, residues of cinnamaldehyde are not expected on 

agricultural commodities. There is a reasonable certainty of no harm for infants and children from exposure 

to cinnamaldehyde from the proposed use. 

G. Ejftcts on the Immune and Endocrine System~· 

To date there is no evidence to suggest that cinnamaldehyde has any negative impact on the 

immune system, or is active hormonally. 

H. Existin£ Tolerances 

In 1999, EPA exempted from the requirements for a tolerance cinnamaldehyde (3-phenyl-2-

propenal) in or on all food commodities when used as a fungicide, insecticide, or algaecide in accordance 

with good agricultural practices ( 40 CFR § 180.1156) [EPA-HQ-OPP-20 10-0918 for more details]. 

180.1156 Cinnamaldehyde; exemption from the requirement of a tolerance. 

Cinnamaldehyde (3-phenyl-2-propenal) is exempted from the requirement of a tolerance in or on all food 

commodities, when used as a fungicide, insecticide, algaecide and nematicide in accordance with good 

agricultural practices. The existing tolerance exemption on mushrooms ( 40 CFR § 180.1156) is hereby 

removed. 

Valent BioSciences is requesting an amendment to the tolerance exemption for cinnamaldehyde 

when used as a nematicide in ReSetTM Nematicide end use formulation, be granted. 

I. International Tolerances 

There is no Codex Alimentarium Commission Maximum Residue Levels (MRLs) established 

for Cinnamaldehyde (3-phenyl-2-propenal).