[Federal Register Volume 65, Number 250 (Thursday, December 28, 2000)]
[Notices]
[Pages 82346-82349]
From the Federal Register Online via the Government Publishing 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: [email protected].
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
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EPA registration
Registrant affected no. Active ingredient
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Kanoria......................... 66951-1........... Lindane
Kanoria......................... 66951-2........... Lindane
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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]
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