[Federal Register Volume 60, Number 35 (Wednesday, February 22, 1995)]
[Proposed Rules]
[Pages 9816-9817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-4306]
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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
