[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: opp-docket@epamail.epa.gov. 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: horne.diana@epamail.epa.gov.
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:
opp-docket@epamail.epa.gov
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
