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isofenphos (Oftanol) Registration Cancellation 1/99

[Federal Register: January 15, 1999 (Volume 64, Number 10)]
[Page 2642-2644]
>From the Federal Register Online via GPO Access []



[OPP-64039; FLR-6056-5]

Isofenphos; Receipt of Request to Cancel Registrations

AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of Receipt to Cancel Registrations.


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withdrawn or adverse comments are received, the Agency intends to 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 
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: opp- 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:

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
     Registration Number          Product Name        Action Requested
EPA Reg. No. 3125-435         Oftanol 5% Granular   Cancel Registration
                               Turf & Ornamental

EPA Reg. No. 3125-330         Oftanol 5% Granular   Cancel Registration

EPA Reg. No. 3125-331         Oftanol 1.5%          Cancel Registration

EPA Reg. No. 3125-350          Lawn Food and        Cancel Registration

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

    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:

    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]