Intent to Suspend Certain Pesticide Registrations

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of issuance of Notices of Intent to Suspend.

SUMMARY:

This Notice, pursuant to section 6(f)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq., 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 section 3(c)(2)(B). As required by 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), Agriculture and Ecosystem Division, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460, (202) 564-4133.

SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me

This action is directed to the public in general. Although this action 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.

II. Text of a Notice of Intent to Suspend

The text of a 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 Methoxychlor for Failure to Comply with the Methoxychlor Section 4 Phase 5 Reregistration Eligibility Document Data Call-In Notice Dated December 9, 1988

Dear Sir/Madam:

This letter gives you notice that the pesticide product registrations 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 Phase 5 Reregistration Eligibility Document Data Call-In Notice imposed pursuant to section 4(g)(2)(b) and section (3)(2)(B) of FIFRA.

The specific basis for issuance of this Notice is stated in the Explanatory Appendix (Attachment III) to this Notice. The affected products and the requirements 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, 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 products.

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, 1900, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., 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 Judicial Officer, 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 4 Phase 5 Reregistration Eligibility Document Data Call-In Notice requirements. 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 Ave., 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 registrations of your products listed in Attachment I are currently suspended as a result of failure to comply with another Section 4 Data Requirements Notice or Section 3(c)(2)(B) Data Call-In 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 4 Data Requirements Notice, please contact Francisca Liem at (202) 564-2365.

Sincerely yours,

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:

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

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

V. Attachment III Suspension Report

A. Explanatory Appendix

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

Methoxychlor

On December 9, 1988, EPA issued the Guidance for the Reregistration of Pesticide Products Containing Methoxychlor as the Active Ingredient (i.e., Methoxychlor Registration Standard). The Registration Standard included a Data Call-In Notice (DCI) issued pursuant to FIFRA section 3(c)(2)(B), which required registrants of products containing methoxychlor used as the active ingredient to develop and submit certain data. The Administrator had determined these data to be necessary to support continued registration of pesticide products containing methoxychlor as the active ingredient. Failure to comply with the requirements of a Data Call-In Notice is a basis for suspension under section 3(c)(2)(B) of FIFRA.

Kincaid Enterprises Inc. (Kincaid) was the sole registrant who committed to produce the generic data for methoxychlor. You received the Registration Standard dated December 9, 1988, as evidenced by your signed Generic Data Exemption Statement (GDE) dated (see supplemental table below for specific date). You requested a Generic Data Exemption in your response to the DCI and were granted the GDE. The DCI in the 1988 Methoxychlor Registration Standard states that a registered product is exempt from the requirement to submit or cite “generic” data concerning an active ingredient if the active ingredient in the product is derived exclusively from purchased, registered pesticide products containing the active ingredient so long as certain conditions are met and remain satisfied. Both the DCI and your GDE statement made clear that if the registrant(s) who have committed to generate and submit the required generic data fail to take appropriate steps to meet the data requirements or are no longer in compliance with the data requirements, the Agency will consider that both they and you are not in compliance and will normally initiate proceedings to suspend the registrations of their product(s) and your product(s), unless you commit to submit and submit the required data in the specfied time frame. Both the DCI and the GDE also state that in such cases, the Agency generally will not grant a time extension for submitting the data.

On April 7, 1998, the Agency issued a Notice of Intent to Suspend to Kincaid because of their failure to submit certain data required by the DCI. On May 13, 1998, Kincaid requested a hearing by filing a hearing request with the Agency. On September 3, 1998, Kincaid and the Agency entered into a settlement agreement that specified the outstanding data requirements from the 1988 DCI and set forth a new schedule for their submission. Kincaid agreed in the Settlement Agreement that if it failed to comply with any of the terms and conditions relating to any of the requirements for data generation and submission, the Agency would request that the Administrative Law Judge (ALJ) issue an order suspending the registrations of Kincaid's affected products without any opportunity for a hearing. On September 14, 1998, the ALJ issued an accelerated decision and order incorporating the Settlement Agreement. The Judge's accelerated decision and order incorporating the Settlement Agreement was entered into the public docket for the matter.

Subsequently, on December 3, 1999, Kincaid failed to satisfy certain data requirements as required by the DCI and the ALJ's order/Settlement Agreement. The Agency requested that the ALJ enter a suspension order and a suspension order was entered for all methoxychlor pesticide product registrations held by Kincaid and became effective on January 14, 2000. The studies that were required to be submitted by December 3, 1999, were Guideline No. 163-1 (Leaching/adsorption/desorption) and Guideline No. 161-3 (Photodegradation- soil).

Subsequently, Kincaid missed a second deadline of March 3, 2000, for a number of other studies. The Agency filed a request to the ALJ that he amend the January 14, 2000 suspension order to include these studies and, on April 12, 2000, the ALJ amended the January 14, 2000 suspension order to include the following studies as additional bases for suspension. The studies are: Guideline No. 83-3(a) (Teratogenicity—rat); Guideline No. 83-3(b) (Teratogenicity—rabbit); Guideline 171-4(a) (Nature of residue—plants); Guideline No. 171-4(b) (Nature of residue—livestock); Guideline No. 171-4(e) (Storage Stability); Guideline No. 171-4(j) (Magnitude of residue—meat, milk); and Guideline No. 162-2 (Anaerobic soil metabolism).

Because Kincaid failed to submit the above referenced data inviolation of the 1988 DCI and the Accelerated Decision and Order incorporating the Settlement Agreement and is no longer in compliance with the DCI, registrants of methoxychlor end-use products who were previously eligible for the GDE are also in noncompliance with the 1988 DCI requirements as amended by the Accelerated Decision and Order incorporating the Settlement Agreement.

On April 14, 2000, the Agency mailed to you a certified letter return receipt requested which revoked your GDE for the methoxychlor products listed in Attachment I and notified you that you had 30 days from your receipt of that letter to satisfy the overdue data requirements referred to above and commit to satisfy the overdue data requirements set forth in the 1988 DCI and the Accelerated Decision and Order incorporating the Settlement Agreement or the Agency would issue a Notice of Intent to Suspend (NOITS) affecting your methoxychlor products. On (see supplemental table below for specific date), the Agency received the green card which evidenced your receipt of the revocation letter.

Because the Agency has not received an adequate or appropriate response from you as a methoxychlor registrant, the Agency is issuing this Notice of Intent to Suspend.

B. Supplemental Table

The following table provides green card receipt dates for Generic Data Exemption (GDE) and letter dates revoking the GDE for registrants for methoxychlor.

VI. Conclusions

EPA has issued Notices of Intent to Suspend on the dates indicated. Any further information regarding these Notices may be obtained from the contact person noted above.

List of Subjects

• Environmental protection