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avermectin (Agri-Mek, Affirm) Proposed Renewal of Time-Limited Tolerances 5/96

[Federal Register: May 8, 1996 (Volume 61, Number 90)]
[Notices]               
[Page 20817-20818]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180, 185 and 186
[OPP-300423; FRL-5364-8]
RIN 2070-AC18
Avermectin B1, and its Delta-8,9-Isomer; Proposed Renewal of Time-Limited
    Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes to renew time-limited tolerances for the 
residues of the insecticide avermectin B1 and its delta-8,9-Isomer in or on 
certain raw agricultural commodities. This rule which would renew the 
effective date for the time-limited tolerances of this insecticide in or on 
these commodities was requested by Merck & Co., Inc., Merck Sharp and Dohme 
Research Laboratories.

DATES: Comments identified by the docket number, [OPP-300423], must be 
received on or before June 7, 1996.

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: Public Docket, Rm. 1132, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA 22202. Information submitted as a comment 
concerning this document 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 as 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 will be included in the public docket by EPA without 
prior notice. The public docket is available for public inspection in Rm. 1132 
at the above address, from 8 a.m. to 4:30 p.m., Monday through Friday, 
excluding legal holidays.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: opp-docket@epamail.epa.gov. Electronic comments 
must be submitted as an ASCII file avoiding the use of special characters and 
any form of encryption. Comments and data will also be accepted on disks in 
WordPerfect 5.1 file format or ASCII file format. All comments and data in 
electronic form must be identified by the docket number [OPP-300423]. No CBI 
should be submitted through e-mail. Electronic comments on this proposed 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 T. LaRocca, Registration 
Division (7505C), Office of Pesticide Programs, Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone 
number: Rm. 202, CM #2, 1900 Jefferson Davis Hwy., Arlington, VA 22202, (703) 
305-5419; e-mail: larocca.george@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: The Agency issued a conditional registration for 
avermectin B1 for use on cotton on May 22, 1989 with an expiration date of 
March 31, 1992 (see the Federal Register of August 27, 1989 (54 FR 35059)). 
This conditional registration was subsequently amended on July 25, 1989 to 
include citrus (see the Federal Register of August 2, 1989 (54 FR 31836)) and 
on April 1, 1992 the expiration date for conditional registration was extended 
to April 30, 1995. On May 1, 1995 the expiration date for conditional 
registration was again extended to November 15, 1996. The registrations were 
made conditional since certain data were lacking and required by the Agency to 
allow it to evaluate the effects of avermectin B1 on fish and aquatic 
organisms. See the Federal Register of August 23, 1989 (54 FR 35059) and 
August 3, 1994 (59 FR 39505) for the status of specific data requirements. 
Because of the lack of these data the tolerances on cotton and citrus were 
made temporary until the conditions of registration were fulfilled.
    The Agency's evaluation of the risk reduction measures to assess aquatic 
hazard and exposure from use of this pesticide on cotton and citrus will not 
be completed in time to establish a permanent tolerance prior to the 
expiration date (April 30, 1996) for the time-limited tolerances. The Agency 
therefore proposes that to be consistent with the extensions issued for the 
conditional registration (November 15, 1996) the time-limited tolerances for 
cotton and citrus, meat, meat by-products, milk and processed food/feed 
commodities be renewed until November 15, 1997. The Agency has determined that 
renewing the tolerances will protect the public health. Therefore tolerances 
on cotton, citrus and other affected commodities are proposed to be renewed as 
set forth below.
    The data submitted in support of these tolerances and other relevant 
material have been reviewed. The toxicological and metabolism data and 
analytical methods for enforcement purposes considered in support of these 
tolerances are discussed in detail in related documents published in the 
Federal Register of May 31, 1989 (54 FR 23209--cottonseed) and August 2, 1989 
(54 FR 31836--citrus).
    Residues remaining in or on the above raw agricultural commodity after 
expiration of these tolerances will not be considered actionable if the 
pesticide is legally applied during the term and in accordance with the 
provisions of the conditional registrations.
    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 the ingredient listed herein, may request 
within 30 days after the publication of this document in the Federal Register 
that this rulemaking proposal be referred to an Advisory Committee in 
accordance with section 408(e) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA).
    Interested persons are invited to submit written comments on the proposed 
rule. Comments must bear a notation indicating the document control number, 
[OPP-300423]. All written comments filed in response to this proposed rule 
will be available in the Public Response and Program Resources Branch at the 
above address from 8 a.m. to 4:30 p.m., Monday through Friday, except legal 
holidays.
    A record has been established for this rulemaking under docket number 
[OPP-300423] (including comments and data 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, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments can be sent directly to EPA at:
                     opp-docket@epamail.epa.gov
    Electronic comments 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 all 
comments 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 comments submitted directly in writing. The official 
rulemaking record is the paper record maintained at the address in ADDRESSES 
at the beginning of this document.
    The Office of Management and Budget has exempted this document from the 
requirement of review pursuant to Executive Order 12866. In addition, this 
action does not impose any enforceable duty, or contain any "unfunded 
mandates" as described in Title II of the Unfunded Mandates Reform Act of 1995 
(Pub. L. 104-4), or require prior consultation as specified by Executive Order 
12875 (58 FR 58093, October 28, 1993), entitled Enhancing the 
Intergovernmental Partnership, or special considerations as required by 
Executive Order 12898 (59 FR 7629, February 16, 1994).
    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

40 CFR Part 180

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

40 CFR Part 185

    Food additives, Pesticides and pest.

40 CFR Part 186

    Animal feeds, Pesticides and pest.

Dated: April 26, 1996.

Peter Caulkins, Acting Director, Registration Division, Office of Pesticide 
Programs.

    Therefore, it is proposed that 40 CFR part 180 be 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 Sec. 180.449, by revising paragraph (a), to read as follows:


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

    (a) Tolerances are established for the combined residues of the 
insecticide avermectin B1 (a mixture of avermectins containing greater that or 
equal to 80% avermectin B1a (5-0-dimethyl avermcetin A1a) and less than or 
equal to 20% avermectin B1b (5-0-demethyl-25-de(1-methylpropyl)-25-(1-
methylethyl) avermectin A1a)) and it delta-8,9-isomer in or on the following 
commodities:

------------------------------------------------------------------------
                                      Parts per                         
             Commodity                 million        Expiration Date   
------------------------------------------------------------------------
          Cattle, fat................   0.015         November 15, 1997     
          Cattle, meat..............    0.02          November 15, 1997     
          Cattle, mybp..............    0.02          November 15, 1997     
          Citrus, whole fruit.......    0.02          November 15, 1997     
          Cottonseed................    0.005         November 15, 1997     
          Hops, dried...............    0.5           December 31, 1996     
          Milk......................    0.005         November 15, 1997     
------------------------------------------------------------------------


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PART 185--[AMENDED]

    2. In Part 185:

       a. The authority citation for Part 185 continues to read as follows:
          Authority: 21 U.S.C. 348

       b. Section 185.300 is revised to read as follows:


Sec. 185.300   Avermectin B1 and its delta-8,9 isomer; tolerances for 
residues.

    Tolerances to expire on November 15, 1997 are established for the combined 
residues of theinsecticide avermectin B1 (a mixture of avermectins containing 
greater that or equal to 80% avermectin B1a(5-0-dimethyl avermcetin A1a) and 
less than or equal to 20% avermectin B1b(5-0-demethyl-25-de(1-methylpropyl)-
25-(1-methylethyl)avermectin A1a)) and it delta-8,9-isomer in or on the 
following commodity:

------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
                         Citrus Oil....................         0.10
------------------------------------------------------------------------

PART 186--[AMENDED]

    3. In part 186:

       a. The authority citation for part 186 continues to read as follows:
          Authority: 21 U.S.C. 348.

       b. In Sec. 186.300 by revising paragraph (a) to read as follows:

Sec. 186.300  Avermectin B1 and its delta-8,9-isomer; tolerances for residues.

    (a) Tolerances to expire on November 15, 1997 are established for the 
combined residues of the insecticide avermectin B1 (a mixture of avermectins 
containing greater that or equal to 80% avermectin B1a (5-0-dimethyl 
avermcetin A1a) and less than or equal to 20% avermectin B1b (5-0-demethyl-25-
de(1-methylpropyl)-25-(1-methylethyl) avermectin A1a)) and it delta-8,9-isomer 
in or on the following commodity:

------------------------------------------------------------------------
                                          Parts per 
     Commodity                             million  
------------------------------------------------------------------------
Dried Citrus pulp.......................... 0.10
------------------------------------------------------------------------

*        *        *        *        *