[Federal Register Volume 61, Number 90 (Wednesday, May 8, 1996)]
[Proposed Rules]
[Pages 20780-20781]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11342]



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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: [email protected]. 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: 
[email protected].

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

[[Page 20781]]

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:
    [email protected]


    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]

    . 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
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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
------------------------------------------------------------------------

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[FR Doc. 96-11342 Filed 5-7-96; 8:45 am]
BILLING CODE 6560-50-F