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cinnamaldehyde Exemption From Tolerance Requirement 9/95

[Federal Register: September 20, 1995 (Volume 60, Number 182)]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 0E3858/R2171; FRL-4977-7]
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 
pesticide tolerance for residues of the fungicidal pest control agent 
Cinnamaldehyde in or on all raw agricultural commodities. The 
Interregional Research Project No. 4 (IR-4) requested this tolerance 
exemption on behalf of Monterey Laboratories and pursuant to the 
Federal Food, Drug and Cosmetic Act (FFDCA). This regulation eliminates 
the need to establish a maximum permissible level for residues of 
cinnamaldehyde.

DATES: This regulation becomes effective September 20, 1995.

ADDRESSES: Written objections and hearing requests, identified by the 
document control number, [PP 0E3858/R2171], may be submitted to: 
Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M 
St., SW., Washington, DC 20460. Fees accompanying objections shall be 
labeled "Tolerance Petition 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 should be identified by the document 
control number and submitted to: Public Response and Program Resources 
Branch, Field Operations Division (7506C), 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. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202.

    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect in 5.1 
file format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket number 
[0E3858/R2171]. No Confidential Business Information (CBI) should be 
submitted through e-mail. Electronic copies of objections and hearing 
requests on this rule may be filed online at many Federal Depository 
Libraries. Additional information on electronic submissions can be 
found below in this document.

FOR FURTHER INFORMATION CONTACT: By mail: Shanaz Bacchus, Biopesticides 
and Pollution Prevention Division (7501W), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460, Office location and telephone number: CS1, 5th floor, 2800 
Crystal Drive, Crystal City, VA 22202, (703)-308-8733; e-mail: 
                  bacchus.shanus@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 26, 1995 (60 
FR 38331), EPA issued a notice of PP OE3858 from IR-4, New Jersey, 
08903, proposing to amend 40 CFR part 180 by establishing a regulation 
pursuant to section 408 of the FFDCA, 21 U.S.C. 346a(d), to exempt from 
the requirement of a tolerance the residues of cinnamaldehyde, a pest 
control agent, in or on all raw agricultural commodities when used to 
control certain fungal pest species.
    There were no comments received in response to the notice of 
filing. The data submitted in the petition and all other relevant 
material have been evaluated and are summarized below.
    Cinnamaldehyde (cinnamic aldehyde) is the main component in cassia 
oil as well as cinnamon bark oil and is used in flavoring compounds to 
impart a cinnamon flavor. Considerable safety data exist from the food 
and flavoring industry, which use food-grade cinnamaldehyde in 
nonalcoholic beverages, ice cream, candy, baked goods, chewing gum, 
condiments, and meats at levels ranging from 9 parts per million (ppm) 
to 4,900 ppm. Cinnamaldehyde is Generally Recognized As Safe (GRAS) by 
the Flavoring Extract Manufacturers' Association and is approved for 
food use (21 CFR 182.60) by the Food and Drug Administration. Cinnamon 
oil, which contains 70% to 90% cinnamaldehyde, is also classified as 
GRAS and, like cinnamaldehyde, is used in the food and flavoring 
industry.

Toxicology Assessment

    The toxicological data provided in support of the exemption from 
the requirement of a tolerance include the following: two acute dermal 
toxicity studies and published data/information for acute oral 
toxicity, eye irritation, dermal irritation, and dermal sensitization. 
The registrant has requested waivers for the remaining acute mammalian 
toxicology requirements (Series 152B) as outlined in 40 CFR 158.690.
    Acute Oral Toxicity in Rats, Guideline 152B-10. The published 
information submitted was used to establish an acute oral LD50 of 
1.15 g/kg (guinea pig), 2.25 g/kg or 3.35 g/kg (rat).
Classification: Acceptable. Toxicity Category III.
    Acute Dermal Toxicity in Rats, Guideline No. 152B-11. Two acute 
dermal toxicity studies were submitted. From these studies, the 
LD50, was determined to be greater than 1.2 g/kg. This LD50 
value corresponds to the dermal LD50 value of 1.31 g/kg (rabbit) 
provided in the material safety data (MSDS) sheet submitted by the 
registrant.
Classification: Acceptable. Toxicity Category II.
    Primary Eye Irritation, Guideline No. 152B-13. Exposure of human 
test subjects for 48 hours to a solution of 8% active ingredient 
demonstrated that it is an eye irritant. Although no corneal 
involvement was observed in this study, no information was provided as 
to the time for the eye irritation to clear.
Classification: Acceptable. Toxicity Category II.
    Primary Dermal Irritation, Guideline 152B-14. No primary dermal 
irritation was observed in human subjects exposed for 48 hours to a 
solution containing 3% active ingredient, while severe primary dermal 
irritation was observed in human subjects after exposure to 8% active 
ingredient.
Classification: Acceptable. Dermal irritant.
    Dermal Sensitization, Guideline 152B-15. Cinnamaldehyde was 
considered a sensitizer based on published results of the dermal 
effects of a 2% active ingredient on guinea pigs.
Classification: Acceptable. Strong sensitizer.
    Other Toxicology Data: Reference Dose (RfD) and maximum permissible 
intake (MPI) considerations are not relevant to this petition because 
of the low toxicity of the pesticide as reported in the data submitted.

Residue Chemistry Data

    Residue chemistry data are necessary only if the submitted 
toxicology studies indicate that additional Tier II or III toxicology 
data would be required as specified in 40 CFR 158.165(e). The submitted 
toxicology data for this use indicate that the product is of low 
mammalian toxicity via the oral route. Therefore, neither Tier II or 
III toxicology data nor residue chemistry data were required for this 
registration action.
    The toxicological data provided are sufficient to demonstrate that 
there are no foreseeable human health hazards likely to arise from 
cinnamaldehyde when applied as a pesticide to mushrooms because of its 
low toxicity profile and the long history of use of both the active and 
inert ingredients in the food and flavoring industry.
    Based on the information cited above, the Agency concludes that the 
establishment of a tolerance for the active ingredient, antifungal 
agent cinnamaldehyde, is not necessary to protect the public health. 
Therefore, 40 CFR part 180 is amended as set forth below.
    Any person adversely affected by this regulation may, within 30 
days after publication of this document in the Federal Register, file 
written objections and/or request a hearing with the Hearing Clerk, at 
the address given above (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 
issue(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 
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 issue(s) in the manner 
sought by the requestor would be adequate to justify the action 
requested (40 CFR 178.32).
     A record has been established for this rulemaking under docket 
number [0E3858/R2171] (including objections and hearing requests 
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 a.m. to 4:30 p.m., Monday through Friday, excluding 
legal holidays. The public record is located in Room 1132 of the Public 
Response and Program Resources Branch, Field Operations Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
Crystal Mall #2, 
1921 Jefferson Davis Highway, Arlington, VA.
    Written objections and hearing requests, identified by the document 
control number [PP 0E3858/R2171], may be submitted to the Hearing Clerk 
(1900), Environmental Protection Agency, Rm. 3708, 401 M St., SW., 
Washington, DC 20460.
    A copy of electronic objections and hearing requests filed with the 
Hearing Clerk can be sent directly to EPA at:
                        opp-Docket@epamail.epa.gov


    A copy of electronic objections and hearing requests filed with the 
Hearing Clerk 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 will be kept in paper form. Accordingly, 
EPA will transfer any 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 which will 
also include all objections and hearing requests submitted directly in 
writing. The official rulemaking record is the paper record maintained 
at the address in ADDRESSES at the beginning of this document.
    Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency 
must determine whether the regulatory action is "significant" and 
therefore subject to all the requirements of the Executive Order (i.e., 
Regulatory Impact Analysis, review by the Office of Management and 
Budget (OMB). Under section 3(f), the order defines "significant" as 
those actions likely to lead to a rule (1) having an annual effect on 
the economy of $100 million or more, or adversely and materially 
affecting a sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local, or tribal 
governments or communities (also known as "economically 
significant"); (2) creating serious inconsistency or otherwise 
interfering with an action taken or planned by another agency; (3) 
materially altering the budgetary impacts of entitlement, grants, user 
fees, or loan programs; or (4) raising novel legal or policy issues 
arising out of legal mandates, the President's priorities, or the 
principles set forth in this Executive Order.
    Pursuant to the terms of this Executive Order, EPA has determined 
that this rule is not "significant" and is therefore not subject to 
OMB review.
    Pursuant to the requirements of the Regulatory Flexibility Act 
(Pub. L. 96-365, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator 
has determined that regulations establishing new tolerances or raising 
tolerance levels or establishing exemptions from tolerance requirements 
do not have a significant economic impact on a substantial number of 
small entities. A certification statement to this effect was published 
in the Federal Register of May 4, 1981 (46 FR 24950).

List of Subjects in 40 CFR Part 180

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

    Dated: September 11, 1995.

Janet L. Andersen,
Acting Director, Biopesticides and Pollution Prevention Division, 
Office of Pesticide Programs.

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 346a and 371.

    2. In subpart D, by adding new Sec. 180.1156, to read as follows:


Sec. 180.1156   Cinnamaledhyde; exemption from the requirement of a 
tolerance.

    Cinnamaldehyde is exempted from the requirement of a tolerance when 
used as a plant pesticide on soil casing for mushrooms.