cinnamaldehyde Pesticide Petition Filing 8/98
[Federal Register: August 28, 1998 (Volume 63, Number 167)]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
Notice of Filing of Pesticide Petitions
AGENCY: Environmental Protection Agency (EPA).
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-
firstname.lastname@example.org. Follow the instructions under ``SUPPLEMENTARY
INFORMATION.'' No confidential business information should be submitted
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
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: email@example.com.
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
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
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
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]
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