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Methyl Anthranilate; Exemptions From the Requirement of a Tolerance

 [Federal Register: April 26, 1995]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 2E4071/R2117; FRL-4941-8]
RIN 2070-AB78
 
Methyl Anthranilate; Exemptions From the Requirement of a Tolerance

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

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SUMMARY: This document establishes an exemption 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 this 
exemption in a petition submitted to EPA.

EFFECTIVE DATE: This regulation becomes effective April 26, 1995.

ADDRESSES: Written objections, identified by the document control 
number, [PP 2E4017/R2117], may be submitted to: Hearing Clerk (1900), 
Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington, 
DC 20460. 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 copy of objections and hearing request to: Rm. 1132, 
CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. 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.

FOR FURTHER INFORMATION CONTACT: By mail: Hoyt Jamerson, Registration 
Division (7508W), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location and telephone number: Westfield Building North, 6th Fl., 2800 
Crystal Drive, Arlington, VA 22202, (703)-308-8783; e-mail: 
Jamerson.Hoyt@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 22, 1995 
(60 FR 9816), EPA issued a proposed rule that gave notice that the 
Interregional Research Project No. 4 (IR-4), New Jersey Agricultural 
Experiment Station, P.O. Box 231, Rutgers University, New Brunswick, NJ 
08903, had submitted pesticide petition (PP) 2E4071 to EPA on behalf of 
the Agricultural Experiment Station of Washington. Pesticide petition 
2E4071 requested 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.
    There were no comments or requests for referral to an advisory 
committee received in response to the proposed rule.
    The data submitted relevant to the proposal and other relevant 
material have been evaluated and discussed in the proposed rule. Based 
on the data and information considered, the Agency concludes that the 
tolerance exemption will protect the public health. Therefore, the 
tolerance exemption is established as set forth below. [[Page 20433]] 
    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 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 issue(s) in the manner 
sought by the requestor would be adequate to justify the action 
requested (40 CFR 178.32).
    Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency 
must determine whether the regulatory action is ``significant'' and 
therefore subject to review by the Office of Management and Budget 
(OMB) and the requirements of the Executive Order. Under section 3(f), 
the order defines a ``significant regulatory action'' as an action that 
is likely to result in 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 referred to 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 the rights and obligations or recipients 
thereof; 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 the 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: April 13, 1995.

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

    Therefore, 40 CFR part 180 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. 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. 95-10251 Filed 4-25-95; 8:45 am]
BILLING CODE 6560-50-F

 
 

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