[Federal Register Volume 64, Number 31 (Wednesday, February 17, 1999)]
[Rules and Regulations]
[Pages 7801-7804]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-3663]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300769; FRL-6049-9]
RIN 2070-AB78


Cinnamaldehyde; Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule establishes an exemption from the requirement of a 
tolerance for residues of the biochemical cinnamaldehyde in or on all 
food commodities when applied as a broad spectrum fungicide/
insecticide/algaecide in accordance with good agricultural practices. 
The Interregional Research Project No. 4 (IR-4) submitted a petition to 
EPA on behalf of Proguard, Inc., under the Federal Food, Drug and 
Cosmetic Act as amended by the Food Quality Protection Act of 1996 
(FQPA) (Pub. L. 104-170) requesting the exemption from the requirement 
of a tolerance. This regulation eliminates the need to establish a 
maximum permissible level for residues of cinnamaldehyde. The Agency 
also removes the mushroom- specific

[[Page 7802]]

tolerance exemption for cinnamaldehyde (40 CFR 180.1156) and considers 
this tolerance to be reassessed, as required by the FQPA.

DATES: This regulation is effective February 17, 1999. Objections and 
requests for hearings must be received by EPA on or before April 19, 
1999.
ADDRESSES: Written objections and hearing requests, identified by the 
docket control number [OPP-300769], must be submitted to: Hearing Clerk 
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., 
Washington, DC 20460. Fees accompanying objections and hearing requests 
shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA 
Headquarters Accounting Operations Branch, OPP (Tolerance Fees) and 
forwarded to: EPA Headquarters Accounting Operations Branch, OPP 
(Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any 
objections and hearing requests filed with the Hearing Clerk identified 
by the docket control number, [OPP-300769], must also be submitted to: 
Public Information and Records Integrity Branch, Information Resources 
and Services Division (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
In person, bring a copy of objections and hearing requests to Rm. 119, 
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: [email protected]. Copies of electronic objections 
and hearing requests must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption. Copies of 
electronic objections and hearing requests will also be accepted on 
disks in WordPerfect 5.1/6.1 file format or ASCII file format. All 
copies of electronic objections and hearing requests must be identified 
by the docket number [OPP-300769]. No Confidential Business Information 
(CBI) should be submitted through e-mail. Copies of electronic 
objections and hearing requests on this rule may be filed online at 
many Federal Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Diana M. Horne, c/o Product 
Manager (PM) 90, Biopesticides and Pollution Prevention Division 
(7511C), Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. Office location, telephone number and e-mail address: Rm. 
902, Crystal Mall #2 1921 Jefferson Davis Hwy., Arlington, VA 22202, 
(703) 308-8367; e-mail: [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of August 28, 1998 
(63 FR 46017) (FRL-6024-4), EPA issued a notice pursuant to section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e) 
announcing the filing of a pesticide tolerance petition (PP 7E4904) by 
the Interregional Research Project No. 4 (IR-4), on behalf of Proguard, 
Inc. This notice included a summary of the petition prepared by the 
petitioner and this summary contained conclusions and arguments to 
support its conclusion that the petition complied with the Food Quality 
Protection Act (FQPA) of 1996. The petition requested that 40 CFR part 
180 be amended by establishing an exemption from the requirement of a 
tolerance for residues of cinnamaldehyde.

I. Risk Assessment and Statutory Findings

    New section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) defines ``safe'' to 
mean that ``there is a reasonable certainty that no harm will result 
from aggregate exposure to the pesticide chemical residue, including 
all anticipated dietary exposures and all other exposures for which 
there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) requires EPA to give 
special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue...'' EPA performs a number of analyses to determine the risks 
from aggregate exposure to pesticide residues. First, EPA determines 
the toxicity of pesticides. Second, EPA examines exposure to the 
pesticide through food, drinking water, and through other exposures 
that occur as a result of pesticide us in residential settings.

A. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness and reliability 
and the relationship of this information to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children.

B. Mammalian Toxicology Profile

     Acute toxicity. The oral LD50 for cinnamaldehyde is 
greater than 5,000 milligram/kilogram (mg/kg), while the dermal 
LD50 is greater than 2,000 mg/kg. 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% cinnamaldehyde 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).

II. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in food and all other non-occupational exposures, including 
drinking water from groundwater or surface water and exposure through 
pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses).

A. Dietary Exposure

    1. 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). Since flavoring agents are 
added in very small quantities, dietary exposure is expected to be 
minimal. In addition, dietary exposure to residues of cinnamaldehyde as 
a result of uses covered under this tolerance exemption is also 
expected to be insignificant.
    2. Drinking water exposure. Cinnamaldehyde residues in drinking 
water are expected to be minimal due to its low application rate, 
expected rapid

[[Page 7803]]

biodegradation in soil, and its insolubility in water.

B. Other Non-Occupational 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). Based on the small amount of cinnamaldehyde 
and cinnamon oil used in these instances, very minimal non-dietary 
exposure is expected.

III. Cumulative Effects

    Because of the low toxicity and use rates of cinnamaldehyde, EPA 
does not believe that there is any concern regarding the potential for 
cumulative effects of cinnamaldehyde and other substances that have a 
common mechanism of toxicity.

IV. Determination of Safety for U.S. Population, Infants and 
Children

    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. Cinnamaldehyde is applied at low rates, and with its proven low 
toxicity and its history of safe use, does not pose a safety concern.

V. Other Considerations

A. Endocrine Disruptors

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

B. Analytical Method(s)

    An analytical method for the detection of residues of 
cinnamaldehyde is not applicable to this tolerance exemption.

C. Codex Maximum Residue Level

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

VI. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a regulation for an exemption from the 
requirement of a tolerance issued by EPA under new section 408(d)and as 
was provided in the old section 408 and in section 409. However, the 
period for filing objections is 60 days, rather than 30 days. EPA 
currently has procedural regulations which governs the submission of 
objections and hearing requests. These regulations will require some 
modification to reflect the new law. However, until those modifications 
can be made, EPA will continue to use those procedural regulations with 
appropriate adjustments to reflect the new law.
    Any person may, by April 19, 1999, file written objections to any 
aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
Hearing Clerk, at the address given under the ``ADDRESSES'' section (40 
CFR 178.20). A copy of the objections and/or hearing requests filed 
with the hearing clerk should be submitted to the OPP docket for this 
rulemaking. The objections submitted must specify the provisions of the 
regulation deemed objectionable and the grounds for the objections (40 
CFR 178.25). Each objection must be accompanied by the fee prescribed 
by 40 CFR 180.33(i). If a hearing is requested, the objections must 
include a statement of the factual issues(s) on which a hearing is 
requested, the requestor's contentions on such issues, and a summary of 
any evidence relied upon by the objector (40 CFR 178.27). A request for 
a hearing will be granted if the Administrator determines that the 
material submitted shows the following: There is a genuine and 
substantial issue of fact; there is a reasonable possibility that 
available evidence identified by the requestor would, if established 
resolve one or more of such issues in favor of the requestor, taking 
into account uncontested claims or facts to the contrary; and 
resolution of the factual issues in the manner sought by the requestor 
would be adequate to justify the action requested (40 CFR 178.32). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information 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.

VII. Public Record and Electronic Submissions

    EPA has established a record for this rulemaking under docket 
control number [OPP-300769]. 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 
public record is located in Room 119 of the Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7502C), Office of Pesticide Programs, Environmental Protection Agency, 
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202.
    Electronic comments can be sent directly to EPA at:
    [email protected]


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above, is kept in paper form. Accordingly, in the 
event there are objections and hearing request, EPA will transfer any 
copies of objections and hearing requests received electronically into 
printed, paper form as they are received and will place the paper 
copies in the official rulemaking record. The official rulemaking 
record is the paper record maintained at the Virginia address in 
``ADDRESSES'' at the beginning of this document.

VIII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule establishes a tolerance under FFDCA section 408 
(l)(6). The Office of Management and Budget (OMB) has exempted these 
types of actions from review under Executive Order 12866, entitled 
Regulatory Planning and Review (58 FR 51735, October 4, 1993). This 
final rule does not contain any information collections subject to OMB 
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., or impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Pub. L. 104-4). Nor does it require any special considerations 
as required by Executive

[[Page 7804]]

Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994), or require OMB review in accordance with Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997).
    In additions, since tolerance exemptions that are established on 
the basis of a petition under section 408(d) of the FFDCA, such as the 
exemption in this final rule, do not require the issuance of a proposed 
rule, the requirements of the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency previously 
assessed whether establishing tolerances, exemptions from tolerances, 
raising tolerance levels or expanding exemptions might adversely impact 
small entities and concluded, as a generic matter, that there is no 
adverse economic impact. The factual basis for the Agency's generic 
certification for tolerance actions published on May 4, 1981 (46 FR 
24950), and was provided to the Chief Counsel for Advocacy of the Small 
Business Administration.

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may 
not issue a regulation that is not required by statute and that creates 
a mandate upon a State, local, or tribal government, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by those governments. If the mandate is unfunded, EPA 
must provide to OMB a description of the extent of EPA's prior 
consultation with representatives of affected State, local, and tribal 
governments, the nature of their concerns, copies of any written 
communications from the governments, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 12875 
requires EPA to develop an effective process permitting elected 
officials and other representatives of State, local, and tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory proposals containing significant unfunded mandates.''
    Today's rule does not create an unfunded Federal mandate on State, 
local, or tribal governments. The rule does not impose any enforceable 
duties on these entities. Accordingly, the requirements of section 1(a) 
of Executive Order 12875 do not apply to this rule.

C. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. If the 
mandate is unfunded, EPA must provide to OMB, in a separately 
identified section of the preamble to the rule, a description of the 
extent of EPA's prior consultation with representatives of affected 
tribal governments, a summary of the nature of their concerns, and a 
statement supporting the need to issue the regulation. In addition, 
Executive Order 13084 requires EPA to develop an effective process 
permitting elected officials and other representatives of Indian tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory policies on matters that significantly or uniquely affect 
their communities.''
    Today's rule does not significantly or uniquely affect the 
communities of Indian tribal governments. This action does not involve 
or impose any requirements that affect Indian tribes. Accordingly, the 
requirements of section 3(b) of Executive Order 13084 do not apply to 
this rule.

IX. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated:January 19, 1999.

Kathleen Knox,

Acting Director, Biopesticides and Pollution Prevention Division, 
Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180-[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:
    Authority: 21 U.S.C. 346a and 371.

    2. Section 180.1156 is revised to read as follows:


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, and algaecide in accordance with good 
agricultual practices. The existing tolerance exemption on mushrooms 
(40 CFR 180.1156) is hereby removed.

[FR Doc. 99-3663 Filed 2-16-99; 8:45 am]
BILLING CODE 6560-50-F