[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="">1b (5-O-demethyl-25-di (1-methylpropyl)-25-1 (1-
methylelthyl) avermectin A1a) in or on the following commodities:
------------------------------------------------------------------------
Parts per
Commodity million
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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:
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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 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
