[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: 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
[[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:
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]
. 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:
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Parts per
Commodity million Expiration Date
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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:
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Parts per
Commodity million
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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
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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
