[Federal Register Volume 64, Number 10 (Friday, January 15, 1999)]
[Notices]
[Pages 2642-2644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1024]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-64039; FLR-6056-5]
Isofenphos; Receipt of Request to Cancel Registrations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of Receipt to Cancel Registrations.
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SUMMARY: In accordance with section 6(f)(1) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), as amended, EPA is issuing a
notice of its receipt of requests for amendment by Bayer Corporation,
the sole U.S. registrant of the insecticide isofenphos, to terminate
their registrations for all products containing isofenphos. This notice
describes the Agency's current intention to grant Bayer Corporation's
request for cancellation of all product registrations for the
organophosphate isofenphos. It further provides an opportunity for the
public to provide comment on the pending cancellation. Finally, this
notice describes the terms and conditions under which the Agency
intends to allow existing stocks to be sold, distributed, and/or used
if the cancellations take effect.
DATES: In order to be considered, public comment on this notice must be
received by March 16, 1999. Unless the cancellation request is
withdrawn or adverse comments are received, the Agency intends to
publish a final cancellation notice in the Federal Register on or about
March 16, 1999, subject to the existing stocks provision specified
herein.
ADDRESSES: By mail, submit written comments to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person, deliver comments to:
Rm. 119, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
Comments and data may also be submitted electronically to: docket@epamail.epa.gov. Follow the instructions under Unit V of this
document. No Confidential Business Information (CBI) should be
submitted through e-mail.
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 will be included in the public docket by EPA without prior
notice. The public docket is available for public inspection in Rm. 119
at the address given above, from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail: Philip Poli, Special Review
and Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location, telephone number and e-mail: Reregistration Branch 3,
Crystal Mall #2, 6th floor, 1921 Jefferson Davis Highway, Arlington,
VA; (703) 308-8038; e-mail: poli.philip@epamail.epa.gov.
SUPPLEMENTARY INFORMATION:
I. Introduction
Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may, at any time, request that any of its pesticide
registrations be canceled or amended. FIFRA further provides that,
before acting on the request, EPA must publish a notice of receipt of
any such request in the Federal Register. Thereafter, the EPA
Administrator may approve or deny the request consistent
[[Page 2643]]
with the provisions established pursuant to section 6(f)(1).
On December 11, 1998 Bayer Corporation transmitted a letter to the
Agency requesting a phased cancellation of all their isofenphos product
registrations. The Agency is providing a 60-day comment period, during
which the public may submit comments concerning this action. If any
current registrant of isofenphos notifies the Agency during the 60-day
comment period of an agreement to transfer one or more of Bayer's
registrations, EPA will not issue the cancellation order provided that
the following conditions are met. Within 30 days of notifying the
Agency of its intention to transfer a registration, a request for
transfer of registration must be submitted to the Agency in accordance
with 40 CFR 152.135. Once all required documentation have been
submitted, the Agency will notify the transferor and transferee of its
approval. Thereafter, the transferee will be regarded as the registrant
for all purposes under FIFRA. The new registrant or transferee would be
responsible for ensuring all data requirements are satisfied including
all outstanding requirements consistent with established deadlines
since Bayer Corporation has outstanding studies which are approaching
the required due date.
The Agency will proceed with the cancellation of these isofenphos
products according to the scheduled dates within unless the request for
voluntary cancellation is withdrawn by Bayer Corporation, a
registration is transferred, or substantive comments are received from
the public which cause the Agency to reconsider its approach to
canceling the Bayer Corporation isofenphos registrations. If the Agency
grants some or all of the request for voluntary cancellation, it will
publish a final cancellation order in the Federal Register canceling
some or all registrations of isofenphos. Once an active ingredient is
canceled, any person wishing to bring the pesticide back on the market
would need to apply to EPA for a ``new chemical'' registration. Such a
registration generally would not be approved until all applicable data
requirements are satisfied.
II. Background
Isofenphos is the common name for an insecticide of the
organophosphate class; its trade name is Oftanol. The chemical name for
isofenphos is 1-methylethyl 2-[ethoxy[(1-methylethyl)-amino]-
phosphinothioyl]-oxy]ben-zoate. Bayer Corporation is the sole technical
manufacturer of isofenphos and manufactures the technical material
overseas. Isofenphos is presently registered in the United States for
use on turf and ornamentals for control of white grubs and
molecrickets, although only turf use products are currently being sold.
Most residential use is by lawn care professionals. There are no
current registered uses on food crops in the United States, and all
tolerances have been revoked. The Agency published a notice in the
Federal Register of Monday, October 26, 1998 revoking the food use
tolerances for isofenphos (63 FR 57067)(6035-8).
III. Voluntary Cancellation Request
Bayer Corporation requested voluntary phased cancellation of all
its product registrations containing the active ingredient isofenphos
in a letter to the Agency dated December 11, 1998. In addition to
declining sales and diminishing use, Bayer Corporation cited the
availability of registered alternatives and the introduction of new and
advanced ingredients for grub and mole cricket control as contributing
to its decision to seek voluntary cancellation. The company further
concluded that the expenditures necessary to generate the outstanding
data required to fulfill reregistration program requirements could not
be recovered, and that such studies would likely not be complete until
after the projected sales ``life'' of the product. The registrations
for which Bayer has requested product cancellation are listed below in
the following Table.
Table --Isofenphos Registrations With Requests To Cancel Pesticide
Registrations
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Registration Number Product Name Action Requested
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EPA Reg. No. 3125-435 Oftanol 5% Granular Cancel Registration
Turf & Ornamental
Insecticide
EPA Reg. No. 3125-330 Oftanol 5% Granular Cancel Registration
Insecticide
EPA Reg. No. 3125-331 Oftanol 1.5% Cancel Registration
Granular
Insecticide
EPA Reg. No. 3125-350 Lawn Food and Cancel Registration
Insecticide
EPA Reg. No. 3125-342 Oftanol 2 Cancel Registration
Insecticide effective September
30, 1999
EPA Reg. No. 3125-326 Oftanol Technical Cancel Registration
Action Requested effective December
31, 1999
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According to Bayer's request, cancellation of Bayer Corporation's
isofenphos registrations would be accomplished in three steps over a
12-month period. First, if the Agency publishes a final cancellation
order as proposed by this notice, the following product registrations
would be immediately canceled:
\ Oftanol 5% Granular Turf and Ornamental Insecticide, EPA Reg.
No. 3125-435
\ Oftanol 5% Granular Insecticide, EPA Reg. No. 3125-330
\ Oftanol 1.5% Granular Insecticide, EPA Reg. No. 3125-331
\ Lawn Food and Insecticide, EPA Reg. No. 3125-350
Second, Bayer's product Oftanol 2 Insecticide (EPA Reg. No. 3125-
342) would be canceled on September 30, 1999. Bayer requested an
existing stocks provision that would allow Bayer until September 30,
2000 to deplete any remaining inventory of Oftanol 2 Insecticide.
Third, the cancellation of Oftanol technical will become effective on
December 31, 1999. Bayer will discontinue any further sales and/or
distribution of Oftanol technical as of this date.
Further, because sales of isofenphos have been steadily declining
since 1994, Bayer has agreed to limit the sale of Oftanol Technical in
1999 to the level of current 1998 sales. Finally, Bayer also stated in
its December 11, 1998 letter to the Agency that they will notify
formulator customers of the schedule for discontinuance of their
isofenphos product registration ``to give them adequate transition time
to develop or identify alterative products.''
The Agency has reviewed Bayer Corporation's proposed phased
cancellation and agrees with the basic tenets of the approach which
have been described above. To better involve the public in the
implementation of the Food Quality Protection Act of 1996 (FQPA), the
Agency and the United States Department of Agriculture
[[Page 2644]]
(USDA) established the Tolerance Reassessment Advisory Committee (TRAC)
on April 30, 1998. The TRAC was established as a subcommittee under the
auspices of EPA's National Advisory Council for Environmental Policy
and Technology. It provides a forum for a broad range of interest
groups to provide input on a variety of matters including tolerance
reassessment and reregistration. The organophosphate pesticides'
tolerance reassessment and reregistration eligibility decision
activities are being brokered through the TRAC process.
To ensure the public has full access to the documents and analysis
providing the basis for its regulatory decision making, the Agency has
established public dockets for the organophosphate pesticides currently
undergoing tolerance reassessment and reregistration. The public
dockets include preliminary human health risk assessments and where
available, ecological risk assessments that have been conducted by the
Agency. Registrants' corrections to these assessments, rebuttal
comments, and other public comments on the Agency's risk assessments
have been docketed also.
Isofenphos, is in the first group of 9 of a total of 43
organophosphates that are slated to have tolerance reassessment and
reregistration eligibility decision made via the TRAC's enhanced
stakeholder involvement process. However, since the sole technical
registrant, Bayer Corporation has elected to voluntarily cancel its
existing registrations on a schedule that the Agency believes is
consistent with the scheduling goals fundamental to the TRAC process,
the Agency is proposing to cancel Bayer's registrations consistent with
the terms and conditions described in this notice. The information
currently available to the Agency on the human health environmental
consequences of allowing Bayer Corporation's proposed phased
cancellation of isofenphos products is not expected to trigger imminent
hazard or other unreasonable adverse effect concerns. Moreover, the
Agency believes that given the declining market for isofenphos, it is
unlikely distribution, sale, or use of existing stocks of a relatively
small volume of canceled products would pose significant human health
or environmental risks. The public is invited to provide comment on
this Agency action and is encouraged to consider all documentation and
risk assessments currently available in providing those comments.
IV. Existing Stocks
If the Agency grants any or all of the requested cancellations, it
is likely that the Agency will establish an existing stocks provision
consistent with the following schedule. Bayer Corporation requested in
its December 11, 1998 voluntary cancellation letter a 1-year existing
stocks provision for its end-use product Oftanol 2 Insecticide (EPA
Reg. No. 3125-342). The effective date of cancellation for this product
will be September 30, 1999. Any remaining product inventory will be
depleted subject to a 1-year existing stock provision, whereby Bayer
Corporation may sell and distribute all remaining inventory until
September 30, 2000.
EPA will continue to permit, after September 30, 2000 (EPA Reg. No.
3125-342) and December 31, 1999 (EPA Reg. No. 3125-326), the sale,
distribution and use of existing stocks of product containing
isofenphos already in the channels of distribution by persons other
than the registrant or supplemental registrants, (i.e., stocks already
in the hands of dealers or users). EPA will also continue to permit the
sale, distribution and use of existing stocks of the following product
registrations already in the hands of dealers or users:
\ Oftanol 5% Granular Turf and Ornamental Insecticide, EPA Reg.
No. 3125-435
\ Oftanol 5% Granular Insecticide, EPA Reg. No. 3125-330
\ Oftanol 1.5% Granular Insecticide, EPA Reg. No. 3125-331
\ Lawn Food and Insecticide, EPA Reg. No. 3125-350
EPA believes it is appropriate to allow sale and use until stocks
already in the channels of distribution are exhausted rather than
impose a time limit on use of existing stocks, so that persons who have
legally purchased stocks of isofenphos will be able to sell or use
those stocks without violating the cancellation order (although the
Agency may place restrictions if such stocks are not exhausted in a
reasonable time). Continued use of existing stocks of a canceled
product until such stocks are exhausted would likely be permitted,
provided that such use is consistent with the previously-approved
labeling for the product.
V. Public Record and Electronic Submission of Comments
The official record for this rulemaking, as well as the public
version, has been established for this rulemaking under docket control
number [OPP-64039] (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 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The official rulemaking record is located at the address in
``ADDRESSES'' at the beginning of this document.
Electronic comments can be sent directly to EPA at:
opp@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 in 5.1/6.1 or ASCII file
format. All comments and data in electronic form must be identified by
the docket control number [OPP-64039]. Electronic comments on this
proposed rule may be filed online at many Federal Depository Libraries.
Lists of Subjects
Environmental protection, Agricultural commodities, Pesticides and
pests, Product registrations
Dated: January 7, 1999.
Jack E. Housenger,
Acting Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. 99-1024 Filed 1-14-99; 8:45 am]
BILLING CODE 6560-50-F
