00-33173. Intent to Suspend Certain Pesticide Registrations

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

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: [phone]; e-mail address: [e-mail].

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

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 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 [phone].

 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

Registrant affected	EPA registration no.	Active ingredient
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

Active ingredient	Registrant affected	Guideline no.	Requirement name	Due date
Lindane	Kanoria	870-6300	Developmental Neurotoxicity Study	February, 1999
		870-4200	Oncogenicity Study-Mouse	December, 2000*
* 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

Dated: December 20, 2000.

Richard Colbert,

Director, Agriculture and Ecosystems Division, Office of Compliance.