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cinnamaldehyde Pesticide Petition Filing 8/98

[Federal Register: August 28, 1998 (Volume 63, Number 167)]
[Page 46017-46019]
>From the Federal Register Online via GPO Access []



[PF-829; FRL-6024-4]

Notice of Filing of Pesticide Petitions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.


SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of 
certain pesticide chemicals in or on various food commodities.
DATES: Comments, identified by the docket control number PF-829, must 
be received on or before September 28, 1998.
ADDRESSES: By mail submit written comments to: Public Information and 
Records Integrity Branch (7502C), Information Resources and Services 
Division, Office of Pesticides Programs, Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. In person bring comments 
to: Rm. 119, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically to: opp- Follow the instructions under ``SUPPLEMENTARY 
INFORMATION.'' No confidential business information should be submitted 
through e-mail.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part or all of that information as 
``Confidential Business Information'' (CBI). CBI should not be 
submitted through e-mail. Information marked as CBI will not be 
disclosed except in accordance with procedures set forth in 40 CFR part 
2. A copy of the comment that does not contain CBI must be

[[Page 46018]]

submitted for inclusion in the public record. Information not marked 
confidential may be disclosed publicly by EPA without prior notice. All 
written comments will be available for public inspection in Rm. 119 at 
the address given above, from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By Mail: Diana Horne, Biopesticides 
and Pollution Prevention Division (7511C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. Office location, telephone number, and e-mail address: Rm. 
9th floor, CM #2, 1921 Jefferson Davis Hwy, Arlington, VA 2202, 703-
308-8367, e-mail:

SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition as 
follows proposing the establishment and/or amendment of regulations for 
residues of certain pesticide chemicals in or on various food 
commodities under section 408 of the Federal Food, Drug, and Comestic 
Act (FFDCA), 21 U.S.C. 346a. EPA has determined that these petitions 
contain data or information regarding the elements set forth in section 
408(d)(2); however, EPA has not fully evaluated the sufficiency of the 
submitted data at this time or whether the data supports granting of 
the petition. Additional data may be needed before EPA rules on the 
    The official record for this notice of filing, as well as the 
public version, has been established for this notice of filing under 
docket control number PF-829] (including comments and data submitted 
electronically as described below). A public version of this record, 
including printed, paper versions of electronic comments, which does 
not include any information claimed as CBI, is available for inspection 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The official record is located at the address in 
``ADDRESSES'' at the beginning of this document.
    Electronic comments can be sent directly to EPA at:

    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption. Comment and data 
will also be accepted on disks in Wordperfect 5.1/6.1 or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket control number [PF-829] and appropriate petition number. 
Electronic comments on this notice may be filed online at many Federal 
Depository Libraries.

List of Subjects

    Environmental protection, Agricultural commodities, Food additives, 
Feed additives, Pesticides and pests, Reporting and recordkeeping 

    Dated: August 17, 1998.

Janet L. Andersen,

Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

Summary of Petition

    Petitioner summary of the pesticide petition is printed below as 
required by section 408(d)(3) of the FFDCA. The summary of the petition 
was prepared by the petitioner and represents the view of the 
petitioner. EPA is publishing the petition summary verbatim without 
editing it in any way. The petition summary announces the availability 
of a description of the analytical methods available to EPA for the 
detection and measurement of the pesticide chemical residues or an 
explanation of why no such method is needed.

IR-4 on behalf of ProGuard, Inc.


    EPA has received a pesticide petition (PP 7E4904) from the 
Interregional Research Project No. 4 (IR-4), Minor Crop Pest 
Management, New Jersey Agricultural Experiment Station, Cook College, 
P.O. Box 321, New Brunswick, NJ 08903-0231, on behalf of ProGuard, Inc. 
, P.O. Box 550, Suisun, CA 94585, proposing pursuant to section 408(d) 
of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 346a(d), to 
amend 40 CFR part 180 by establishing an exemption from the requirement 
of a tolerance for the biochemical pesticide cinnamaldehyde in or on 
all food commodities.
    Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, IR-4, 
on behalf of ProGuard, Inc. has submitted the following summary of 
information, data and arguments in support of their pesticide petition. 
This summary was prepared by ProGuard, Inc. and EPA has not fully 
evaluated the merits of the petition. The summary may have been edited 
by EPA if the terminology used was unclear, the summary contained 
extraneous material, or the summary was not clear that it reflected the 
conclusion of the petitioner and not necessarily EPA.

A. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. 
Cinnamaldehyde is a biochemical pesticide with a history of safe use. 
Cinnamaldehyde is classified as a GRAS substance for use as a flavoring 
agent on food (21 CFR 182.60) and was recently exempt from the 
requirement of a tolerance on mushrooms in response to an IR-4 petition 
(40 CFR 180.1156). The petitioner has requested a waiver of all residue 
chemistry studies for cinnamaldehyde based on the following: the 
application rate for cinnamaldehyde is very low, ranging from 0.2% to 
0.5% cinnamaldehyde; as noted above, cinnamaldehyde is currently used 
as a flavoring agent for food; and, cinnamaldehyde exhibits a low order 
of toxicity and a non-toxic mode of action.
    2. Magnitude of residue at the time of harvest and method used to 
determine the residue. A statement of why an analytical method for 
detecting and measuring the levels of the pesticide residue are not 
needed. Since the petitioner has requested a tolerance exemption, an 
analytical method to detect residues is not required.

B. Mammalian Toxicological Profile

     Acute toxicity. Cinnamaldehyde is practically non-toxic by either 
the oral or dermal route of exposure. The oral LD<INF>50</INF> and 
dermal LD<INF>50</INF> for cinnamaldehyde are >5,000 milligrams/
kilogram (mg/kg) and >2,000 mg/kg, respectively. Cinnamaldehyde is also 
minimally toxic by the inhalation route since the LC<INF>50</INF> is 
>2.09 mg/L. Cinnamaldehyde is a mild skin and eye irritant.
    The petitioner has requested that all sub-chronic, teratology, and 
mutagenicity testing requirements for cinnamaldehyde be waived since 
this substance is (i) a biochemical pesticide that shows a low order of 
toxicity; (ii) applied at very low rates; (iii) currently used in 
several foods as a flavoring agent; and (iv) considered GRAS by the 
FDA. In addition, there are no reports in the published literature of 
any adverse health effects associated with cinnamaldehyde.

C. Aggregate Exposure

    1. Dietary exposure-- Food. Currently, dietary exposure to 
cinnamaldehyde occurs from its use as a food-flavoring agent, and there 
exists a tolerance exemption on mushrooms (40 CFR 180.1156. The 
petitioner believes that this exposure is relatively minor since 
flavoring agents are added in very small quantities. Dietary exposure 
to residues of cinnamaldehyde

[[Page 46019]]

as a result of uses covered under this tolerance exemption petition, is 
also expected to be insignificant.
    2.  Drinking water. Cinnamaldehyde residues in drinking water are 
expected to be minimal due to its low application rate and its expected 
rapid biodegradation in soil.
    3. 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 182.10) and was recently exempt from 
pesticide regulation under FIFRA section 25 (b) because EPA views it as 
having minimal risk. However, based on the small amount of 
cinnamaldehyde and cinnamon oil used in these instances, very minimal 
non-dietary exposure is expected.

D. Cumulative Exposure

    No cumulative mode of exposure is expected. Again, the application 
rate and the toxicity are extremely low.

E. Safety Determination

     U.S. population. The use of products containing cinnamaldehyde, 
which is of low toxicity and is used in such low concentrations, is 
compatible with EPA'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. There is an inconsequential increase in 
dietary exposure resulting from cinnamaldehyde application to growing 
crops. Cinnamaldehyde is applied at low rates and with its proven low 
toxicity and its history of safe use, it does not pose a safety 

F. Effects on the Immune and Endocrine Systems

    There is no evidence to suggest that cinnamaldehyde has a negative 
impact on the immune system, or is active hormonally.

G. Existing Tolerances

    There is an existing tolerance exemption for cinnamaldehyde on 
mushrooms (40 CFR 180.1156)

H. International Tolerances

    There are no approved CODEX maximum residue levels (MRL's) 
established for residues of cinnamaldehyde.

[FR Doc. 98-23210 Filed 8-27-98; 8:45 am]