[Federal Register Volume 63, Number 44 (Friday, March 6, 1998)] [Notices] [Pages 11237-11240] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-5855] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [OPP-60053; FRL-5770-5] 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 [[Page 11238]] 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: Francisca Liem, Office of Compliance (2225A), Agriculture and Ecosystem Division, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460, (202) 564-2365. SUPPLEMENTARY INFORMATION: I. 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 Fairfax Biological Laboratories P.O. Box 300, Electronic Road Clinton Corners, NY 12514 SUBJECT: Suspension of Registration of Pesticide Product(s) Containing Bacillus popillae and Bacillus lentimorbus for Failure to Comply with the Bacillus popillae and Bacillus lentimorbus Section 4 Phase 5 Reregistration Eligibility Document Data Call-In Notice Dated September 30, 1992 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 sections 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, 401 M St., SW., 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 [[Page 11239]] 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, 401 M St., SW., 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 II. 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.--List of Products ---------------------------------------------------------------------------------------------------------------- EPA Registration Registrant Affected Number Active Ingredient Name of Product Date Issued ---------------------------------------------------------------------------------------------------------------- Fairfax Biological Laboratories 403-9 Bacillus popillae Doom Milky Disease 2/6/98 and Bacillus Powder lentimorbus ---------------------------------------------------------------------------------------------------------------- III. Basis for Issuance of Notice of Intent; Requirement List The following companies failed to submit the following required data or information: [[Page 11240]] Table B.--List of Requirements ---------------------------------------------------------------------------------------------------------------- Guideline Original Active Ingredient Registrant Affected Requirement Name Reference Number Due Date ---------------------------------------------------------------------------------------------------------------- Bacillus popillae and Bacillus Fairfax Biological 90-Day Response ** 12/20/92 lentimorbus Laboratories Acute Pulmonary 152-30 10/20/93 Toxicity/ 152-32 10/20/93 Pathogenicity 154-16 10/20/93 Acute Intravenous 154-23 10/20/93 Toxicity/ Pathogenicity Avian Oral Toxicity/ Pathogenicity Non-Target Insects ---------------------------------------------------------------------------------------------------------------- IV. Attachment III Suspension Report--Explanatory Appendix This Explanatory Appendix provides a discussion of the basis for the Notice of Intent to Suspend issued herewith. On September 30, 1992, EPA issued the Phase 5 Reregistration Eligibility Document Data Call-In Notice imposed pursuant to section 4(g)(2)(B) of FIFRA which required registrants of products containing Bacillus popillae and Bacillus lentimorbus used as the active ingredients to develop and submit certain data. These data/information were determined to be necessary to satisfy reregistration data requirements of section 4(g). Failure to comply with the requirements of a Phase 5 Reregistration Eligibility Document Data Call-In Notice is a basis for suspension under section 3(c)(2)(B) of FIFRA. The Bacillus popillae and Bacillus lentimorbus Phase 5 Reregistration Eligibility Document Data Call-In Notice dated September 30, 1992 required each affected registrant to submit data/information to the Agency to address each of the data requirements. Those data/ information were required to be received by the Agency within 8 months of the registrant's receipt of the Notice. Fairfax Biological Laboratories was sent the original 1992 Data Call-In. According to a U.S. Postal Service return receipt, you received the original Data Call-In Notice on October 10, 1992. You subsequently failed to respond within 90 days of receipt as required, and failed to submit the required data within 8 months as required. Repeated attempts to contact the company via telephone were unsuccessful. Fairfax was sent a letter on March 25, 1996, with a May 1, 1996 deadline for response to the Data Call-In and its requirements. You received the letter on April 2, 1996, as evidenced by the U.S. Postal Service return receipt. The Agency received no response. Because you have failed to submit appropriate or adequate data/ information within the time provided for the data/information requirements listed in Attachment II and have yet to provide the required response to date, the Agency is issuing this Notice of Intent to Suspend. V. 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. Dated: February 18, 1998. Elaine G. Stanley, Director, Office of Compliance. [FR Doc. 98-5855 Filed 3-5-98; 8:45 am] BILLING CODE 6560-50-F