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Methyl Anthranilate; Exemptions from the Requirement of a Tolerance

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

 [Federal Register: February 22, 1995]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 2E4071/P603; FRL 4936-2]
RIN 2070-AC18
 
Methyl Anthranilate; Exemptions from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.

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SUMMARY: EPA proposes to establish exemptions from the requirement of a 
tolerance for residues of the biochemical methyl anthranilate in or on 
the raw agricultural commodities blueberry, cherry, and grape when the 
pesticide is used in accordance with good agricultural practices. The 
Interregional Research Project No. 4 (IR-4) requested these exemptions 
in a petition submitted to EPA.

DATES: Comments, identified by the document control number, [PP 2E4071/
P603], must be received on or before March 24, 1995.

ADDRESSES: By mail, submit written comments 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 comments to: Rm. 1132, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA 22202. Information submitted 
as a comment concerning this notice may be claimed confidential by 
marking any part or all of that information as ``Confidential Business 
Information'' (CBI).
    Information so marked 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. 1132 at the address given above, from 8 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Hoyt Jamerson, Registration 
Division (7505W), Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location and telephone number: Sixth 
Floor, Crystal Station #1, 2800 Jefferson Davis Hwy., Arlington, VA 
22202, (703)-308-8783.

SUPPLEMENTARY INFORMATION: The Interregional Research Project No. 4 
(IR-4), New Jersey Agricultural Experiment Station, P.O. Box 231, 
Rutgers University, New Brunswick, NJ 08903, has submitted pesticide 
petition (PP) 2E4071 to EPA on behalf of the Agricultural Experiment 
Station of Washington. Pesticide petition 2E4071 requests that the 
Administrator, pursuant to section 408(e) of the Federal Food, Drug and 
Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), establish exemptions from the 
requirement of a tolerance for residues of the biochemical methyl 
anthranilate in or on the raw agricultural commodities blueberry, 
cherry, and grape. Methyl anthranilate will be applied as a dilute 
foliar spray to these crops to repel birds and reduce bird depredation. 
Methyl anthranilate is a natural constituent of food that can be found 
in grape and citrus. Methyl anthranilate is also synthetically produced 
and used in the purified form (not less than 99 percent pure) as a 
flavoring agent in beverages, ice cream, candy, baked goods, gelatins, 
puddings, and chewing gum. The synthetic product mimics the chemical 
structure and function of the natural plant constituent. Methyl 
anthranilate is listed by the Food and Drug Administration (FDA) as a 
flavoring compound under 21 CFR 182.60, and is classified generally 
recognized as safe (GRAS) by the Expert Panel of the Flavor and Extract 
Manufacturer's Association (FEMA). Registrants who produce end-use 
products for this active ingredient that are intended for use on 
blueberry, cherry, or grape will be required to use methyl anthranilate 
produced to meet or exceed U.S. Food Chemical Codex and U.S. 
Pharmacopoeia specifications.
    Residue data submitted with the petition indicate that residues of 
methyl anthranilate would not exceed 35 parts per million (ppm) on 
blueberry, cherry, and grape from the proposed use. The incremental 
dietary exposure to methyl anthranilate is not significant compared to 
naturally occurring levels, or levels resulting from use of the 
chemical as a flavoring agent. For example, naturally occurring levels 
of methyl anthranilate are reported at 33 ppm in concord grapes, and 
the use of methyl anthranilate as a flavoring agent results in residues 
of approximately 30 ppm in [[Page 9817]] baked goods and hard candies 
and almost 400 ppm in chewing gum.
    Methyl anthranilate is hydrolyzed in the small intestine to form an 
alcohol and either anthranilic acid or an N-alkyl anthranilic acid. 
Anthranilic acid is a common human metabolite that is excreted in the 
urine or converted to anthranilic acid glucuronide prior to excretion.
    The available information is sufficient to demonstrate that there 
are no foreseeable human health hazards likely to arise from dietary 
exposure resulting from the proposed use of methyl anthranilate on 
blueberry, cherry, and grape.
    There is also no reasonable expectation of secondary residues in 
meat, milk, poultry, or eggs from the proposed use.
    No enforcement actions based on the level of residues in food are 
expected. Therefore, the requirement for an analytical method for 
enforcement purposes is not applicable to the exemption from the 
requirement of a tolerance.
    Based on the information and data considered, the Agency concludes 
that tolerances are not needed to protect the public health. Therefore, 
it is proposed that the exemptions from the requirement of a tolerance 
be established as set forth below.
    Any person who has registered or submitted an application for 
registration of a pesticide, under the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA) as amended, which contains any of the 
ingredients listed herein, may request within 30 days after publication 
of this notice in the Federal Register that this rulemaking proposal be 
referred to an Advisory Committee in accordance with section 408(e) of 
the FFDCA.
    Interested persons are invited to submit written comments on the 
proposed regulation. Comments must bear a notation indicating the 
document control number, [PP 2E4071/P603]. All written comments filed 
in response to this petition will be available in the Public Response 
and Program Resources Branch, at the address given above from 8 a.m. to 
4 p.m., Monday through Friday, except legal holidays.
    Under Executive Order 12866 (58 FR 51735, October 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. 96-354, 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: February 9, 1995.

Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.

PART 180--[AMENDED]

    Therefore, it is proposed that 40 CFR part 180 be amended as 
follows:

    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. 180.1143, to read as follows:

Sec. 180.1143   Methyl anthranilate; exemption from the requirement of 
a tolerance.

    Methyl anthranilate, a biochemical pesticide, is exempt from the 
requirement of a tolerance when used in accordance with good 
agricultural practices on the following raw agricultural commodities: 
Blueberry, cherry, and grape.

[FR Doc. 95-4306 Filed 2-16-95; 2:39 pm]
BILLING CODE 6560-50-F

 
 

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