[Federal Register Volume 59, Number 148 (Wednesday, August 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-18759]


[[Page Unknown]]

[Federal Register: August 3, 1994]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180, 185, and 186

[PP 7F3500, 8F3592, FAP 8H5650/P586; FRL-4898-6]
RIN 2070-AC18

 

Pesticide Tolerances for Avermectin B1 and its Delta-8,9-
Isomer; Renewal of Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes to renew tolerances for the residues of 
the insecticide avermectin B1 and its delta-8,9-isomer in or on 
certain raw agricultural commodities and food and feed commodities. 
Merck & Co., Inc., requested this proposal to renew the effective date 
for tolerances for maximum permissible levels of residues of this 
insecticide in or on these commodities.

DATES: Written comments, identified by the document control number [PP 
7F3500, 8F3592, FAP 8H5650/P586) must be received on or before 
September 2, 1994.

ADDRESSES: Written comments, identified by the document control number, 
[PP 7F3500, 8F3592, FAP 8H5650/P586], may be submitted to: Public 
Response Section, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, Rm. M3708, 401 M 
St., SW., Washington, DC 20460. In person, bring comments to Rm. 1132, 
CM #2, 1921 Jefferson Davis Hwy., Arlington, VA. 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 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 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 
9 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: George T. LaRocca, Product 
Manager (PM) 13, 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, 1921 
Jefferson Davis Hwy., Arlington, VA 22202, 703-305-6100.

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 
23, 1989 (54 FR 35059)). This conditional registration was amended on 
July 25, 1989, to include citrus (see the Federal Register of August 2, 
1989 (54 FR 31836)). On April 1, 1992, this expiration date was 
subsequently extended to April 30, 1995, to allow the Agency sufficient 
time to review the data. 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), 
for specific data requirements. Because of the lack of these data the 
tolerances on cotton and citrus were established with an expiration 
date of March 31, 1993.
    On November 20, 1992, Merck & Co. requested a waiver of the aquatic 
field study (mesocosm study) due to a change in Agency policy regarding 
the need for higher tiered fate and ecological effects data. In 
addition, Merck & Co. agreed to implement interim risk reduction 
measures designed to reduce the potential for aquatic exposure from 
application of avermectin B1 to cotton and citrus. The interim 
risk reduction measures included label changes aimed at reducing 
exposure to aquatic organisms such as (1) reduction in the number of 
applications and total seasonal applications; (2) increase in 
retreatment intervals; (3) geographic limitations; and (4) inclusion of 
aquatic buffer zones.
    The Agency reexamined the existing ecological effects data base and 
concluded that it had sufficient baseline data to characterize aquatic 
hazard for this pesticide. Thus, on January 10, 1993, the Agency waived 
the requirement for a mesocosm study. However, the Agency still 
concluded that this pesticide may pose aquatic risk from use on cotton 
and citrus and that the registration must remain conditional until the 
Agency had evaluated the effectiveness of the risk reduction measures 
and completed its aquatic risk assessment. By April 30, 1995, or 
sooner, the Agency intends to complete review of all data and other 
information submitted and to make FIFRA section 3(c)(5) or other 
appropriate regulatory decisions for the cotton and citrus use of 
avermectin B1.
    To be consistent with the extensions issued for the conditional 
registrations, the Agency is proposing to renew the tolerances on 
cotton, citrus and other affected commodities. The Agency has 
determined that renewing the tolerances will protect the human health. 
Therefore, renewals for the tolerances on cotton, citrus, and other 
affected crops are proposed 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 Registers of May 31, 1989 (54 FR 
23209) for cottonseed and August 2, 1989 (54 FR 31836) for 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 of 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 any of the 
ingredients listed herein, may request within 30 days after 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 FIFRA.
    Interested persons are invited to submit written comments on the 
proposed regulation. Comments must bear a notation indicating the 
document control number (PP 7F3500, 8F3592, FAP 8H5650/P586). All 
written comments filed in response to this petition will be available 
to the Public Response Section, at the address given above from 9 a.m. 
to 4 p.m., Monday through Friday, except legal holidays.
    The Office of Management and Budget has exempted this rule from the 
requirements of Executive Order 12866.
    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 food/
feed additive regulations or raising tolerance or food/feed additive 
regulation 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 Parts 180, 185, and 186

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

Dated: July 19, 1994.

Lois Rossi,
Acting Deputy Director, Registration Division, Office of Pesticide 
Programs.

    Therefore, it is proposed that chapter I of title 40 of the Code of 
Federal Regulations be amended as follows:

PART 180--[AMENDED]

    1. In part 180:

    a. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 346 and 371.

    b. 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, to expire on April 30, 1996, are established for 
the combined residues of the insecticide avermectin B1 and its 
delta-8,9-isomer (a mixture of avermectins containing > 80 percent 
avermectin B1a (5-O-demthyl avermectin B1a) and < 20 percent 
avermectin B1b (5-O-demethyl-25-di (1-methylpropyl)-25-1 (1-
methylelthyl) avermectin A1a) in or on the following commodities:

------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
Citrus, whole fruit........................................         0.02
Cattle, meat...............................................         0.02
Cattle, mbyp...............................................         0.02
Cottonseed.................................................        0.005
Milk.......................................................        0.005
------------------------------------------------------------------------

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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. 346a and 348.

    b. By revising Sec. 185.300, to read as follows:


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

    Tolerances to expire on April 30, 1996, are established for the 
combined residues of the insecticide avermectin B1 and its delta 8,9-
isomer (a mixture of avermectins containing  80 percent 
avermectin B1a (5-O-demethyl avermectin A1a) and less than or 
equal to 20 percent avermectin B1b (5-o-demethyl-25-di (1-
methylpropyl) -25-(1-methylethyl) avermectin A1a)) 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 April 30, 1996, are established for the 
combined residues of the insecticide avermectin B1 and its delta 8,9-
isomer (a mixture of avermectins containing  80 percent 
avermectin B1a (5-O-demethyl avermectin A1a) and less than or 
equal to 20 percent avermectin B1b (5-O-demethyl-25-di (1-
methylpropyl) -25-(1-methylethyl) avermectin A1a)) in or on the 
following commodity:

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

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[FR Doc. 94-18759 Filed 8-2-94; 8:45 am]
BILLING CODE 6560-50-F