[Federal Register Volume 61, Number 55 (Wednesday, March 20, 1996)]
[Proposed Rules]
[Pages 11357-11359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-6447]



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ENVIRONMENTAL PROTECTION AGENCY

40 CFR PART 180

[PP 4E4419/P647; FRL-5356-2]

RIN 2070-AB18


Avermectin B1 and its Delta-8,9 Isomer; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed Rule.

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SUMMARY: EPA proposes to extend a time-limited tolerance for the 
Combined residues of the insecticide avermectin B1 and its delta 
8,9-isomer in or on the raw agricultural commodity dried hops. This 
rule, which would extend the effective date for the avermectin 
tolerance on dried hops to December 31, 1996, was requested by the 
Interregional Research Project No. 4 (IR-4).
DATES: Comments, identified by the document control number [PP 4E4419/
P647], must be received on or before April 19, 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: Rm. 1132 CM #2, 
1921 Jefferson Davis Highway, Arlington, VA 222(92. Comments and data 
may also be submitted to OPP by sending electronic mall (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 [PP 4E4419/
P647]. 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.
    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) . CBI should not be 
submitted through e-mail. Information marked as CBI 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

[[Page 11358]]

confidential may be disclosed publicly by EPA without prior notice. All 
written comments will be available for public inspection in Rm. 1132 at 
the Virginia address given above, from 8 a.m. to 4:30 p.m., Monday 
through Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Hoyt L. Jamerson, 
Registration Division (7505W), office of Pesticide Programs, 
Environmental Protection Agency, 401 M St. SW., Washington, DC 20460. 
Office location and telephone number: Sixth Floor, Crystal Station #1, 
2800 Jefferson Davis Highway, Arlington, VA 22202, 703-308-8783, 
[email protected].

SUPPLEMENTARY INFORMATION: EPA issued a time-limited tolerance in the 
Federal Register of February 7, 1996 (61 FR 4593) under section 408(e) 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), 
for combined residues of the insecticide avermectin B1 [a mixture 
of avermectins containing greater than or equal to 80% avermectin 
B1a (5-O-demethyl avermectin Al and less than or equal to 20% 
avermectin Blb (5O demethyl-25-de(l-methylpropyl)-25-(1-
methylethyl) avermectin Al)] and its delta-8,9-isomer in or on the 
raw agricultural commodities dried hops at 0.5 parts per million (ppm) 
and cattle fat at 0.015 ppm. These tolerances were requested in 
pesticide petition (PP) 4E4419, which was submitted by the 
Interregional Research Project eat No . 4 (IR-4), New Jersey 
Agricultural Experiment Station, P.O. Box 231, Rutgers University, New 
Brunswick, NJ 08903. EPA established the tolerance for dried hops with 
an expiration date to allow IR-4 additional time to submit residue data 
in support of a permanent tolerance, and to allow EPA time to complete 
its evaluation of the enforcement method for dried hops. In addition, 
when the time-limited tolerance for dried hops was requested by IR-4, 
the established tolerances for secondary residues of avermectin in 
meat, meat byproducts, and milk were also time-limited and were 
established to expire on April 30, 1996. The time-limited tolerances 
for meat, meat byproducts, and milk were established in conjunction 
with the Conditional registration for use of avermectin on cotton and 
citrus. The time-limited tolerance for cattle fat, which is required 
for the cotton and citrus uses, was inadvertently omitted when the 
other time-limited tolerances were established. EPA intends to make a 
decision on the avermectin registrations for cotton and citrus prior to 
April 30, 1996. If full registration is issued, the time-limited 
restriction will be removed from the tolerances for meat, meat 
byproducts, cattle fat, and milk. The time-limited tolerances for 
secondary residues of avermectin B1 and its delta-8,9-isomer, 
however, are no longer relevant to the use on hops, since tolerances 
for secondary residues are no longer required in conjunction with 
pesticide registrations for hops. In response to comments received 
relating to ``Table II (June 1994): Raw Agricultural and Processed 
Commodities and Feedstuff Derived from Field Crops,ll the Agency has 
concluded that spent hops are not a significant livestock feed 
commodity. This means that pesticide tolerances are not required for 
spent hops and that tolerances for meat and milk will not be 
established in support of registration for pesticide use on hops.
    After submitting PP 4E4419, IR-4 submitted a second petition (PP 
5E4566) for dried hops, which proposes a permanent tolerance for 
residues of avermectin Be and its delta-8,9-isomer in or on the raw 
agricultural commodity dried hops. EPA's evaluation of PP 5E4566 will 
not be completed in time to establish a permanent tolerance, prior to 
the expiration date for the time-limited tolerance. EPA, therefore, 
proposes that the expiration date for the time-limited tolerance for 
dried hops be extended to December 31, 1996, to allow EPA additional 
time to review IR-4's petition for a permanent tolerance for residues 
of avermectin on dried hops.
    The data considered in support of the time-limited tolerance is 
discussed in the proposed rule, which was published in a Federal 
Register notice of September 13, 1995 (59 FR 49826).
    There are presently no actions pending against the continued 
registration of this chemical. EPA has completed an evaluation of the 
analytical method and has concluded that it is a valid enforcement 
method. Several minor modifications to the method have been suggested 
by EPA, and IR-4 is in the process of rewriting the method to include 
these modifications.
    Prior to its publication in the Pesticide Analytical Manual, Volume 
II (PAM II), the enforcement method is being made available in the 
Interim to anyone who is interested in pesticide residue enforcement 
from: By mail, Calvin Furlow, Public Response and Program Resources 
Branch, Field operations Division (7506C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. office location and telephone number: Crystal Mall #2, Rm 
1128, 192S Jefferson Davis Hwy., Arlington, VA 22202 (703)305-5805.
    Based on the information and data considered, the Agency has 
determined that the tolerance established by amending 40 CFR 180 would 
protect the public health. Therefore, it is proposed that the 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 
docket number, [PP 4E4419/P647].
     A record has been established for this rulemaking under docket 
number [PP 4E4419/P647] (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, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments can be sent directly to EPA at:
    opp-D[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.
    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the 
Agency must determine whether the regulatory action is ``significant'' 
and therefore

[[Page 11359]]

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: March 11, 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. a and 371.


    2. In Sec. 180.449, by revising paragraph (a) to read as follows:


Sec. 180.449  Avermectin B1 and its delta-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 than or equal to 80% avermectin B1a (5-O-demethyl 
avermectin Al) and less than or equal to 20% avermectin Blb 
(5-O- demethyl-25-de(1-methylpropyl)-25-(1-methylethyl) avermectin 
Al)] and its delta-8,9-isomer in or on the following commodities:


------------------------------------------------------------------------
                                         Parts                          
               Commodity                  per        Expiration date    
                                        million                         
------------------------------------------------------------------------
Cattle, fat...........................   0.015         Apr.30, 1996     
Cattle, meat..........................   0.02               Do          
Cattle, mbyp..........................   0.02               Do          
Citrus whole fruit....................   0.02               Do          
Cottonseed............................   0.005              Do          
Hops, dried...........................   0.5          Dec. 31, 1996     
Milk..................................   0.005        Apr. 30, 1996     
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[FR Doc. 96-6447 Filed 3-19-96; 8:45 am]

BILLING CODE 6560-50-F