### EPA BIOPESTICIDES AND POLLUTION PREVE NTION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLIS H ED IN THE FEDERAL REGISTER (7/1/2006) EPA Biopesticides and Pollution Prevention Division contact : [insert name an d 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 no t es 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 [Va lent BioSciences Corp .], [870 Technology Way, Libertyville, IL 60048] proposing. pursuant to section 408(d) ofthe 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 S ummary [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 aphi ds, mites, spider mites (including two-spotted mites, pacific mite s and Willamette mites) leafhoppers, whiteflies (including silverleafand greenhouse), thrips (including western flower), algae , moss, and liverwortslhomworts/ pearlworts. Fungicidal Cinnamaldehyde products a r e registered for use to control powdery mildew, rhizoctonia, pythium, dollar spot, and pitch canker d isease. Pesticide products containing cinnamaldehyde were first registered in 1994 for use in soil casing fo r mushroom, row crops, horticultural crops, turf and all food commodities, corn rootworm baits and dog and cat repellents. In 1999 , E PA exempted from the requiremen ts for a tolerance cinnamaldehyde (3-p henyl-2- propenal) in or on all food commodities when used as a fu n gicide, insecticide, or algaecide in accor dance 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 cinnamal dehyde as a nematicide. Cinnamaldehyde is used within the end use product ReSetTM (60% ofthe end use formula t ion). ReSetTM (also referred to as VBC-90017 within this submission) is an eatable-oil based liquid form u lation that can be used to control or suppress important nematode pests including but not limited to the fo ll owing plant nematodes parasitizing food, fiber and ornamental crops: Meloidogyne spp. (root-knot nema todes), Heterodera and Globodera spp. (cyst nematodes), Pratylenchus spp. (lesion nematodes), Tylenchu lu s sernipenetrans (citrus nematode) , Trichodorus spp . (stubby-root nematodes), Xiphinema index (dagger nematode), Paratylenchus spp . (pin nematodes), Hoplolaimus spp. (lance nematodes), Criconemoi des spp. (ring nematodes), Rotylenchus spp . (spiral nematodes), Belonolaimus spp. (sting nematodes). R eSetTM must be applied to the soil and incorporated into the soil. Apply Re SetTM to the s o il as a pre-plant, at planting, or post-plant soil treatment on annua l 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, transpl a nt water treatment, sub

- surface or under plastic drip tape, surface band, or soil shank injection, all foll o wed immediately by so il incorporation or irrigation to move the m aterial 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 sufficien t incorporation. When using p l anters which do not provide adequate incorporation of**ReS~t** ; ; .t int:> th e 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 o f f <:i! c . 

## ::=:J not apply by mist sprayer or aerial spray equipment. Application timing s and rates will vary depending on the crop, nematode pressure, soil typ e, 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 in to the root zon e, or using drip irrigation systems with quantities ofwater sufficient to provide full movement of ingredi e nts into the soil and penetration of the root zone of the plants. This will produce litt l e environmental expos ure beyond the soil. App lication to the soil with incorporation will greatly limit or eliminate potential exposureto birds, fish or other aquatic organisms. Application to bodies of water is very unlikely with thes e application methods. Runoff into bodies of water is also unlikely, because the nematicide will be applied to and incorporated into the so il , and will not have the oppo rtunity to be washed into bodjes of water. Valent Bio Sc iences is seeking an amendment to the exemption fro m the requirement of a tolerance for the registration of cinnamal dehyde as a nematicide within the end use product ReSetTM. 40 CFR 

### § 180.1156 Cinnamaldehyde; exemption from the requirement ofa tolerance. Cinnamaldehyde (3-phenyl-2-propenal) is exempted from the requirement of a tolerance in or on all food commodities, when u s ed as a fungicide, insecticide, algaecide and nematicid e in accordance with good agricultural practices.


### B. Product Identify Chemistry 1. Identity ofthe 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 a s well as cinnamon bark and cinnamon oi l. It occurs naturally in the bark of cinnamon trees and other species ofthe genus C inn amomum. The e ssential 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 wh ich utilize food grade cinnam aldehyde in non-alcoholic beverages, ice cream, candy, baked, goods, chewing gum, condiments and meats at levels ranging from 9 ppm to 4900 ppm. Cinnama ldehyde is Generally Recognized as Safe (GRAS) by the Flavoring Extract Manufacturers Association and i s 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 re s idue at the time of harvest and method used to detennine the residue. EPA , Pr el imin ary Assessment for the Registration review ofCinnamaldehyde , has been p ublished , (12/ 01/2010). An Exemption from the requirement of a tolerance has been established by the EPA (40 C FR 

### § 180.1156) for Cinnamaldehyde (3-phenyl-2-propenal) in or on all food commoditi es, when used as a fungicide, insecticide, and algaecide in accordance with goo d agricu lt ural practice , (64 FR 7804, Feb 17, 1999; 64 FR 14099, Mar. 24, 1999].
40 CFR 

### § 180.1156 Cinnamaldehyde; exemption from the requirement ofa tolerance. Cinnamaldehyde (3-phenyl-2-pr openal) is exempted from the requirement of a tolerance in or on all fvvci commodi ties, when u sed 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 berety reonC've d. 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 exem p tion from the requirement of a tolerance.Cinnamal dehyde is the organic compound that g ives 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 esse ntial oil of cinnamon bark is about 90% cinnamalde hyde. C inn amaldehyde products are re g istered fo r use as fungicides , insecticides, algaecides and miticides for agricu ltural crops, horticultural crops and turf. Acute toxicity. The o ral LD50 for cinnamaldehyde is greater than 5,000 milligram/k ilogram (mglkg), while the dermal LD 50 is greater than 2,000 mglkg. Cinnamaldehyde is also minimally toxic via the inhalati on route, since the LC 50 is greater than 2.09 mg/L. Cinnamaldehyde is a mild skin and eye irritant. All sub-chronic, teratology and mu tagenicity testing requirements have been waiv ed since this substance is (1) a biochemical pesticide possessing a low order of toxicity, (2) applied at very low rates, (3) current ly used in foods, such as nonalcoholic beverages, ice creams, can dy , baked goods , condiments a nd meats, as a flavoring agent, and (4) considered GRAS (Genera ll y R ecogni zed as Safe ) by th e FDA. In addition, cinnamon oil (which contains 55-90% cinnama!dehyde is also classified as a GRAS substance and is exten s i vely used 

### in the food and fl avoring industry , as we ll as in perfumery and cosmetic products . Cinnamon oi l was a lso recently exempted from pesticidal regulation under FIFRA section 25(b). Acute oral toxicity (LD5 0) ofReSetTM (end use formulation that is 60% cinnamaldedye) was determined 

### to be I , 030 mglkg body weight in rats. The Derma l LD 50 for ReSetTM was measured as >2,000 mglkg bodyweight and the inhala tion LC 50 was between 2.06 and 5.07 mg/L. ReSetTM is slightly irritating to th e skin and severe l y irritating to the eye, unless washed out immediately
. When was hing is utilized it is mildly irritating to the eye . ReSetTM is con sidered to be a contact dermal sensitizer.


### D.

**Aggre~ate** 

### Expv'illre 1. Dietary exposure1. Food. Current ly, 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 fungic ide, insectic id e , 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 expo sur e. Cinnama ldeh yde r es idues in drinking water are expected to be minimal due to its low application rate, expec ted rapid biode gradabili ty in s oil , and its insolub ility in water. 2. Non-di etary expos ure. There may be minor amoun ts of non-dietary exposure to cinnama ldehyde from the use of cinnamon oil in cosmetics and perfumes. Cinnamon oil contains 55-90% cinnamaldehyde. However, cinnamon oi l 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 p esticide regulation under FIFRA section 25(b ). B ased on the small amount of ci n narnaldehyde and cinnamon oil used in these instances , very minimal non- dietary exposure is expected.


### E. Cumulative 

## Eflec:l.\ Because ofth e low toxici ty and u se rates of cinnamaldehyde, Valent

**BioScienc~>** :l.:> .! s not believe t h at there is any concern regarding the potential f or cumulative effects of cinnamaldel.yde and other substances that h ave a commo n mechanism oftoxicity. 

### 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 objecti ves to regi ster reduced risk pesticide s . Ba sedon its low toxicity, the re is reasonable certainty that no harm will result from aggregate exposure of the U.S
. population, inc luding infants and children, to residues of cinnamaldehyde. This includes all anticipated dietary exposures and all other exposures for whic h there is reliabl e informat ion. An inconseque nti al inc rease in d ietary exposure is expected to result from the application of cinnamaldehyde to growing crops as a nematicide. C innamaldehyde is app lied at low rates, and with its proven low tox ic ity 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. Th ere is a reasonable certainty of no harm for infants and children from exposure to c innamaldehyde from the proposed use. 

### G. Ejftcts on the Immune and Endocrine

**System~·** To date the re is no evidence to suggest that cinnamald ehy d e 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 cinnamal d ehyde (3-phenyl

- 2

- propena l ) 

### in or on all food commodities when used as a fungicide, insecticide, or a lgaecide in accordance with good agricu ltural practices (40 CFR 

### § 1 80.1156) [EPA-HQ-OPP

-20 10

- 0918 for more details].
180.1156 Cinnamaldehyde; exemption from th e requirement of a to lerance.

Cinnamaldehyde (3-p heny l-2 -propenal) i s exempted fro m the requirement of a tolerance 

### in o r on all foo d commodities , when used as a fungicide, insecticide , algaecide and nematicide in accordance with good agricultural practices. The existing tolerance exemption on mushrooms (40 CFR 

### § 1 80.1156) is her eby removed. Valent BioSciences is r equesting an amendment to the tolerance exemption for cinnamaldehyde when used as a nematicide 

### in ReSetTM Nematicide end use formulation, be granted.


### I. Interna tional Tolerances There i s no Codex Alimentarium Co mmission Maximum Residue Levels (MRLs) establi shed for Cinnama ldehyde (3

- phenyl-2-propenal).