[Federal Register Volume 65, Number 250 (Thursday, December 28, 2000)]
[Notices]
[Pages 82346-82349]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 00-33173]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-60058; FRL-6756-2]


Intent to Suspend Certain Pesticide Registrations

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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SUMMARY:  This notice, pursuant to section 6(f)(2) of the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 to 
136-y, announces that EPA has issued Notices of Intent to Suspend 
pursuant to sections 3(c)(2)(B) and 4 of FIFRA. The notices were issued 
following issuance of Section 4 Reregistration Requirements Notices by 
the Agency and the failure of registrants subject to the Section 4 
Reregistration Requirements Notices to take appropriate steps to secure 
the data required to be submitted to the Agency. This notice includes 
the text of a Notice of Intent to Suspend, absent specific chemical, 
product, or factual information. Table A of this notice further 
identifies the registrants to whom the Notices of Intent to Suspend 
were issued, the date each Notice of Intent to Suspend was issued, the 
active ingredient(s) involved, and the EPA registration numbers and 
names of the registered product(s) which are affected by the Notices of 
Intent to Suspend. Moreover, Table B of this notice identifies the 
basis upon which the Notices of Intent to Suspend were issued. Finally, 
matters pertaining to the timing of requests for hearing are specified 
in the Notices of Intent to Suspend and are governed by the deadlines 
specified in FIFRA section 3(c)(2)(B). As required by FIFRA section 
6(f)(2), the Notices of Intent to Suspend were sent by certified mail, 
return receipt requested, to each affected registrant at its address of 
record.

FOR FURTHER INFORMATION CONTACT:  Harold Day, Office of Compliance 
(2225A), Office of Enforcement and Compliance Assurance, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (202) 564-4133; e-mail address: day.harold@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. Although this 
action may may be of particular interest to persons who produce or use 
pesticides, the Agency has not attempted to describe all the specific 
entities that may be affected by this action. If you have any questions 
regarding the applicability of this action to a particular entity, 
consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    You may obtain electronic copies of this document, and certain 
other related documents that might be available electronically, from 
the EPA Internet Home Page at http://www.epa.gov/. To access this 
document, on the Home Page select ``Laws and Regulations,'' 
``Regulations and Proposed Rules,'' and then look up the entry for this 
document under the ``Federal Register--Environmental Documents.'' You 
can also go directly to the Federal Register listings at http://
www.epa.gov/fedrgstr/. (PIRIB), Information Resources and Services 
Division (7502C), Office of Pesticide Programs (OPP), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
To access the OPPTS Harmonized Guidelines referenced in this document, 
go directly to the guidelines at http://www.epa.gov/opptsfrs/home/
guidelin.htm/.

 II. Text of Notice of Intent to Suspend

    The text of a the Notice of Intent to Suspend, absent specific 
chemical, product, or factual information, follows:

United States Environmental Protection Agency

[[Page 82347]]

Office of Prevention, Pesticides and Toxic Substances
Washington, DC 20460

Certified Mail
Return Receipt Requested

SUBJECT: Suspension of Registration of Pesticide Product(s) 
Containing Lindane for Failure to Comply with the Lindane Data Call-
In Notice Dated March 31, 1997.

Dear Sir/Madam:
    This letter gives you notice that the pesticide product 
registration(s) listed in Attachment I will be suspended 30 days 
from your receipt of this letter unless you take steps within that 
time to prevent this Notice from automatically becoming a final and 
effective order of suspension. The Agency's authority for suspending 
the registrations of your products is section 3(c)(2)(B) of the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Upon 
becoming a final and effective order of suspension, any violation of 
the order will be an unlawful act under section 12(a)(2)(J) of 
FIFRA.
    You are receiving this Notice of Intent to Suspend because you 
have failed to comply with the terms of the 3(c)(2)(B) Data Call-In 
Notice. The specific basis for issuance of this Notice is stated in 
the Explanatory Appendix (Attachment III) to this Notice. The 
affected product(s) and the requirement(s) which you failed to 
satisfy are listed and described in the following three attachments:

    Attachment I  Suspension Report--Product List
    Attachment II  Suspension Report--Requirement List
    Attachment III  Suspension Report--Explanatory Appendix

    The suspension of the registration of each product listed in 
Attachment I will become final unless at least one of the following 
actions is completed.
    1. You may avoid suspension under this Notice if you or another 
person adversely affected by this Notice properly request a hearing 
within 30 days of your receipt of this Notice. If you request a 
hearing, it will be conducted in accordance with the requirements of 
section 6(d) of FIFRA and the Agency's Procedural Regulations in 40 
CFR Part 164.
    Section 3(c)(2)(B), however, provides that the only allowable 
issues which may be addressed at the hearing are whether you have 
failed to take the actions which are the bases of this Notice and 
whether the Agency's decision regarding the disposition of existing 
stocks is consistent with FIFRA. Therefore, no substantive 
allegation or legal argument concerning other issues, including but 
not limited to the Agency's original decision to require the 
submission of data or other information, the need for or utility of 
any of the required data or other information or deadlines imposed, 
any allegations of errors or unfairness in any proceedings before an 
arbitrator, and the risks and benefits associated with continued 
registration of the affected product, may be considered in the 
proceeding. The Administrative Law Judge shall by order dismiss any 
objections which have no bearing on the allowable issues which may 
be considered in the proceeding.
    Section 3(c)(2)(B)(iv) of FIFRA provides that any hearing must 
be held and a determination issued within 75 days after receipt of a 
hearing request. This 75-day period may not be extended unless all 
parties in the proceeding stipulate to such an extension. If a 
hearing is properly requested, the Agency will issue a final order 
at the conclusion of the hearing governing the suspension of your 
product(s).
    A request for a hearing pursuant to this Notice must 1) include 
specific objections which pertain to the allowable issues which may 
be heard at the hearing, 2) identify the registrations for which a 
hearing is requested, and 3) set forth all necessary supporting 
facts pertaining to any of the objections which you have identified 
in your request for a hearing. If a hearing is requested by any 
person other than the registrant, that person must also state 
specifically why he asserts that he would be adversely affected by 
the suspension action described in this Notice. Three copies of the 
request must be submitted to:

      Hearing Clerk
      U.S. Environmental Protection Agency
      1200 Pennsylvania Avenue, NW
      Washington, DC 20460

and an additional copy should be sent to the signatory listed below. 
The request must be received by the Hearing Clerk by the 30th day 
from your receipt of this Notice in order to be legally effective. 
The 30-day time limit is established by FIFRA and cannot be extended 
for any reason. Failure to meet the 30-day time limit will result in 
automatic suspension of your registration(s) by operation of law 
and, under such circumstances, the suspension of the registration 
for your affected product(s) will be final and effective at the 
close of business 30 days after your receipt of this Notice and will 
not be subject to further administrative review.
    The Agency's Rules of Practice at 40 CFR 164.7 forbid anyone who 
may take part in deciding this case, at any stage of the proceeding, 
from discussing the merits of the proceeding ex parte with any party 
or with any person who has been connected with the preparation or 
presentation of the proceeding as an advocate or in any 
investigative or expert capacity, or with any of their 
representatives. Accordingly, the following EPA offices, and the 
staffs thereof, are designated as judicial staff to perform the 
judicial function of EPA in any administrative hearings on this 
Notice of Intent to Suspend: the office of the Administrative Law 
Judges, the office of the Environmental Appeals Board, the 
Administrator, the Deputy Administrator, and the members of the 
staff in the immediate offices of the Administrator and Deputy 
Administrator. None of the persons designated as the judicial staff 
shall have any ex parte communication with trial staff or any other 
interested person not employed by EPA on the merits of any of the 
issues involved in this proceeding, without fully complying with the 
applicable regulations.
    2. You may also avoid suspension if, within 30 days of your 
receipt of this Notice, the Agency determines that you have taken 
appropriate steps to comply with the section 3(c)(2)(B) Data Call-In 
Notice. In order to avoid suspension under this option, you must 
satisfactorily comply with Attachment II, Requirement List, for each 
product by submitting all required supporting data/information 
described in Attachment II and in the Explanatory Appendix 
(Attachment III) to the following address (preferably by certified 
mail):

      Office of Compliance (2225A)
      Agriculture and Ecosystems Division
      U.S. Environmental Protection Agency
      1200 Pennsylvania Avenue, NW
      Washington, DC 20460

     For you to avoid automatic suspension under this Notice, the 
Agency must also determine within the applicable 30-day period that 
you have satisfied the requirements that are the bases of this 
Notice and so notify you in writing. You should submit the necessary 
data/information as quickly as possible for there to be any chance 
the Agency will be able to make the necessary determination in time 
to avoid suspension of your product(s).
     The suspension of the registration(s)of your company's 
product(s) pursuant to this Notice will be rescinded when the Agency 
determines you have complied fully with the requirements which were 
the bases of this Notice. Such compliance may only be achieved by 
submission of the data/information described in the attachments to 
the signatory below.
    Your product will remain suspended, however, until the Agency 
determines you are in compliance with the requirements which are the 
bases of this Notice and so informs you in writing.
     After the suspension becomes final and effective, the 
registrant subject to this Notice, including all supplemental 
registrants of product(s) listed in Attachment I, may not legally 
distribute, sell, use, offer for sale, hold for sale, ship, deliver 
for shipment, or receive and (having so received) deliver or offer 
to deliver, to any person, the product(s) listed in Attachment I.
    Persons other than the registrant subject to this Notice, as 
defined in the preceding sentence, may continue to distribute, sell, 
use, offer for sale, hold for sale, ship, deliver for shipment, or 
receive and (having so received) deliver or offer to deliver, to any 
person, the product(s) listed in Attachment I.
    Nothing in this Notice authorizes any person to distribute, 
sell, use, offer for sale, hold for sale, ship, deliver for 
shipment, or receive and (having so received) deliver or offer to 
deliver, to any person, the product(s) listed in Attachment I in any 
manner which would have been unlawful prior to the suspension.
    If the registration(s) for your product(s) listed in Attachment 
I are currently suspended as a result of failure to comply with 
another section 3(c)(2)(B) Data Call-In Notice or Section 4 Data 
Requirements Notice, this Notice, when it becomes a final and 
effective order of suspension, will be in addition to any existing 
suspension, i.e., all requirements which are the bases of the 
suspension must be satisfied before the registration will be 
reinstated.
    You are reminded that it is your responsibility as the basic 
registrant to notify

[[Page 82348]]

all supplementary registered distributors of your basic registered 
product that this suspension action also applies to their 
supplementary registered products and that you may be held liable 
for violations committed by your distributors.
    If you have any questions about the requirements and procedures 
set forth in this suspension notice or in the subject section 
3(c)(2)(B) Data Call-In Notice, please contact Frances Liem at (202) 
564-2365.

      Sincerely yours,
        Rick Colbert, Director
        Agriculture and Ecosystems Division
        Office of Compliance

Attachments:
Attachment I--Product List
Attachment II--Requirement List
Attachment III--Explanatory Appendix

III. Registrants Receiving and Affected by Notices of Intent to 
Suspend: Date of Issuance, Active Ingredient, and Products Affected

    The following is a list of products for which a letter of 
notification has been sent:

                          Table A--Product List
------------------------------------------------------------------------
                                   EPA registration
       Registrant affected                no.          Active ingredient
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Kanoria.........................  66951-1...........  Lindane
Kanoria.........................  66951-2...........  Lindane
------------------------------------------------------------------------

IV. Basis for Issuance of Notice of Intent: Requirement List

    The following companies failed to submit the following requirement 
data or information.

                                            Table B--Requirement List
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                                      Registrant
        Active ingredient              affected          Guideline no.     Requirement name        Due date
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Lindane.........................  Kanoria...........  870-6300..........  Developmental       February, 1999
                                                                           Neurotoxicity
                                                                           Study.
                                                      870-4200..........  Oncogenicity Study- December, 2000\*\
                                                                           Mouse.
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* The arbitrator's award and decision regarding KCIL's default did not specify any apportionment of over-due
  costs among subject study requirements.

V. Attachment III Suspension Report--Explanatory Appendix

    A discussion of the basis for the Notices of Intent to Suspend 
follows:

Lindane

    On September 30, 1985, EPA issued a Registration Standard for 
Lindane (gamma isomer of hexachlorocyclohexane, CAS Registry No. 58-89-
9). The Registration Standard imposed certain data requirements to 
maintain the registration of pesticide products containing Lindane. 
Subsequent data requirements pertaining to Lindane were required in 
Data Call-In (``DCI'') Notices on September 30, 1991, March 3, 1995, 
October, 1995 and March 31, 1997.
    Kanoria Chemicals & Industries Limited (``KCIL'') registered two 
technical Lindane products on May 1, 1995, for use in the United 
States. KCIL became a member of the Centre International D'Etudes du 
Lindane (``CIEL''), which was conducting studies intended to satisfy 
EPA's data requirements. On June 9, 1997, KCIL notified EPA it was 
terminating its membership in CIEL, that it had made a written offer to 
compensate CIEL and/or to share in the cost of developing data required 
by the March 31, 1997, DCI, and that it agreed to be bound by an 
arbitration decision under FIFRA section 3(c)(2)(B)(iii) if the parties 
failed to reach agreement on terms of the cost sharing.
    Following earlier employment of the American Arbitration 
Association to assist the parties' efforts to reach a cost-sharing 
agreement, on December 10, 1998, CEIL and KCIL notified the arbitrator 
that they had reached an agreement to share the costs of producing data 
in support of registration of pesticides containing lindane required 
under the September 30, 1985, Registration Standard and the four Data 
Call-In Notices issued by the Agency on September 30, 1991, March 3, 
1995, October, 1995 and March 31, 1997. The arbitrator overseeing the 
negotiations leading to this agreement entered the cost-sharing 
agreement as an arbitral Award on January 11, 1999.
    In January 2000, KCIL was presented with invoices for DCI cost-
sharing expenses by CIEL, and KCIL refused to pay its share of certain 
costs related to the DCIs. Pursuant to the dispute resolution 
procedures of the January 11, 1999, Award, CIEL referred this non-
payment to the arbitrator and KCIL cross-claimed. After reviewing the 
claims of both parties, the arbitrator issued an Order dated May 12, 
2000, finding CIEL entitled to reimbursement of the disputed monies and 
interest from KCIL, and declaring KCIL in default of the cost-sharing 
agreement. The arbitrator reaffirmed KCIL's default in a July 20, 2000, 
ruling.
    On May 19, 2000, CIEL requested EPA to issue a Notice of Intent to 
Suspend KCIL's lindane product registrations pursuant to FIFRA section 
3(c)(2)(B)(iv), and to prohibit sale of existing stocks. EPA has 
reviewed materials provided by both CIEL and KCIL and has determined 
that KCIL has failed to ``comply with the terms of an agreement or 
arbitration decision concerning a joint data development arrangement'' 
under FIFRA section 3(C)(2)(B). Accordingly, at this time, EPA is 
issuing this Notice of Intent to Suspend KCIL's registrations for 
pesticides containing lindane due to non-compliance with the March 31, 
1997, DCI.

VI. Conclusions

    EPA has issued a Notice if Intent to Suspend on the dates 
indicated. Any further information regarding these notices may be 
obtained from the contact person above.

List of Subjects

    Environmental protection.


[[Page 82349]]


    Dated: December 20, 2000.

Richard Colbert,

Director, Agriculture and Ecosystems Division, Office of Compliance.
[FR Doc. 00-33173 Filed 12-27-00; 8:45 am]
BILLING CODE 6560-50-S