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avermectin (Agri-Mek, Affirm) Pesticide Tolerance 11/95

[Federal Register: November 15, 1995 (Volume 60, Number 220)]
[Rules and Regulations]               
[Page 57361-57364]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 3F4258/R2181; FRL-4983-1] RIN 2070-AB78
Avermectin B1 and Its Delta-8,9-Isomer; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This document establishes a tolerance for combined residues of the 
insecticide avermectin B1 and its delta-8,9-isomer in or on the raw 
agricultural commodity bell peppers. Merck Research Laboratories requested the 
regulation to establish a maximum permissible level for residues of the 
pesticide pursuant to a petition submitted to EPA under the Federal Food, Drug 
and Cosmetic Act (FFDCA).

EFFECTIVE DATE: This regulation becomes effective November 15, 1995.

ADDRESSES: Written objections and hearing requests, identified by the document 
control number, [PP 3F4258/R2181], may 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), 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 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 [PP 3F4258/R2181]. 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: George LaRocca, Product Manager (PM) 
13, Registration Division (7505C), Environmental Protection Agency, 401 M St., 
SW., Washington, DC 20460. Office location and telephone number: Rm. 204, CM 
#2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-6100; e-mail: 
larocca.george@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 20, 1995 (60 
FR 48681), EPA issued a proposed rule that gave notice that Merck Research 
Laboratories, Inc., had submitted a pesticide petition, PP 3F4258, under 
section 408 of the FFDCA, 21 U.S.C. 346a, to establish a tolerance for 
combined residues of the insecticide avermectin B1 and its delta-8,9-isomer in 
or on the raw agricultural commodity bell peppers at 0.01 part per million 
(ppm).
    There were no comments or requests for referral to an advisory committee 
received in response to the proposed rule.    The data submitted with 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 will protect the public health. Therefore, the 
tolerance is established 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 requester'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 requester would, if established, resolve 
one or more of such issues in favor of the requester, taking into account 
uncontested claims or facts to the contrary; and resolution of the factual 
issue(s) in the manner sought by the requester would be adequate to justify 
the action requested (40 CFR 178.32).
     A record has been established for this rulemaking under docket number [PP 
3F4258/R2181] (including any 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 Rm. 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 3F4258/R2181], 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 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 of 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: October 24, 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. By amending Sec. 180.449(b) in the table therein by adding and 
alphabetically inserting an entry for bell peppers, to read as follows:

Sec. 180.449   Avermectin B1 and its delta-8,9-isomer; tolerances for 
residues.

*        *        *        *        *    (b) *  *  *

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                                     Parts per 
Commodity                             million  
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                  *        *        *        *        *                 
Peppers, bell......................... 0.01
                                                                        
                  *        *        *        *        *                 
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