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Diazinon; Products Cancellation Order
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: July 19, 2001 (Volume 66, Number 139)] [Notices] [Page 37673-37677] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr19jy01-74] ----------------------------------------------------------------------- EVIRONMENTAL PROTECTION AGENCY [OPP-34225G; FRL-6791-9] Diazinon; Products Cancellation Order AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice announces EPA's cancellation order for the product and use cancellations as requested by three companies (Drexel Chemical Co., Aventis Environmental Science and Gowan Co., hereafter collectively referred to as the ``MUP Registrants'') that hold the registrations of pesticide manufacturing-use and end-use products (MUPs and EUPs) containing the active ingredient diazinon and accepted by EPA, pursuant to section 6(f) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This order follows up a May 30, 2001, notice of receipt of the three companies' requests for cancellations and amendments of their diazinon product registrations to terminate all indoor uses and certain agricultural uses. In the May 30, 2001 notice, EPA indicated that it would issue an order confirming the voluntary product and use registration cancellations unless the Agency received any substantive comment within the comment period that would merit its further review of these requests. The Agency received comments on outdoor non-agricultural uses. This notice addresses these comments, which do not effect the [[Page 37674]] Agency's decision to grant the MUP registrant's request. Any distribution, sale, or use of the products subject to this cancellation order is only permitted in accordance with the terms of the existing stocks provisions of this cancellation order. This notice also announces EPA's amendment to a cancellation order that was issued on April 24, 2001 and published in the Federal Register on May 2, 2001. The order is amended to include an existing stock provisions for products bearing instructions for any of the canceled agricultural uses. DATES: The cancellations are effective July 19, 2001. FOR FURTHER INFORMATION CONTACT: By mail: Ben Chambliss, Special Review and Reregistration Division (7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460, telephone number: (703) 308-8174; fax number: (703) 308-7042; e-mail address: chambliss.ben@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. You may be potentially affected by this action if you manufacture, sell, distribute, or use diazinon products. The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, does not apply because this action is not a rule, for purposes of 5 U.S.C. 804(3). Since other entities may also be interested, 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? 1. Electronically. 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/. To access information about the risk assessment for diazinon, go to the Home Page for the Office of Pesticide Programs or go directly to http://www.epa.gov/pesticides/op/ diazinon.htm. 2. In person. The Agency has established an official record for this action under docket control number OPP-34225G. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805. II. Receipt of Requests to Cancel and Amend Registrations to Delete Uses A. Background In separate letters dated February 20, 2001, for Aventis Environmental Science, March 6, 2001, for Drexel Chemical Company and April 26, 2001, for Gowan Company, manufacturers of MUPs and registrants of EUPs containing diazinon, requested cancellation of all indoor and certain agricultural uses from their diazinon products to reduce the potential exposure to children associated with diazinon containing products. The letters, with the exception of the letter from Aventis, also requested that EPA cancel their registrations for the manufacturing-use pesticide products containing diazinon, conditioned upon issuance of replacement registrations which do not allow their use in formulation of end-use products for the deleted uses, and which includes expiration of the registration for outdoor non-agricultural uses. The letter from Aventis Environmental Science, requested cancellation of its MUPs without issuance of replacement registrations. EPA has acted on the requests and issued new registrations in March and May 2001. In addition, these companies have asked EPA to cancel or amend their registrations for end-use products containing diazinon consistent with the use cancellation request. The uses for which termination was requested are identified in the following List 1. List 1. -- Uses Requested for Termination Indoor uses. Pet collars, or inside any structure or vehicle, vessel, or aircraft or any enclosed area, and/or on any contents therein (except mushroom houses), including food/feed handling establishments. greenhouses, schools, residences, museums, sports facilities, stores, warehouses, and hospitals. Agricultural uses. Alfalfa, bananas, Bermuda grass, dried beans, dried peas, celery, red chicory (radicchio), citrus, clover, coffee, cotton, cowpeas, cucumbers, dandelions, forestry (ground squirrel/ rodent burrow dust stations for public health use), kiwi, lespedeza, parsley, parsnips, pastures, peppers, potatoes (Irish and sweet), sheep, sorghum, squash (winter and summer), rangeland, Swiss chard, tobacco, and turnips. Pursuant to section 6(f)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA announced the Agency's receipt of these requests from the MUP registrants by a Federal Register notice published on May 30, 2001 (66 FR 29310) (FRL-6785-2). In that notice, EPA provided a 30-day comment period. The registrants requested that the Administrator waive the 180-day comment period provided under FIFRA section 6(f)(1)(C). EPA also approved the replacement registrations for the registrants' diazinon manufacturing-use products in March and May 2001. Before the May 30th publication of the 6(f) notice announcing the diazinon product and use cancellation requests, EPA received many comments from growers, as well as the U.S. Department of Agriculture, expressing that the use of diazinon pesticide products is vital for many of the agricultural uses identified in List 1 of this notice. According to the comments, there is a nationwide need for the application of diazinon products on spinach, strawberries, and tomatoes. There are also needs for the application of diazinon products on certain crops in certain states. These needs are identified in the following Table 1. Table 1. -- Specific Regional Need for Diazinon End-Use Products ------------------------------------------------------------------------ Crop Use Area(s) ------------------------------------------------------------------------ Bananas Hawaii Celery Texas [[Page 37675]] Cucumbers Texas Ground squirrel/ rodent burrow dust California stations for public health use Parsley Texas and California Parsnips Texas and Oregon Peas, succulent Texas and Maryland Peppers Texas and California Potatoes, Irish Texas, Washington and Michigan Potatoes, sweet Texas Squash, summer and winter Texas and California Swiss Chard Texas Turnips, root Texas and Oregon Turnips, tops Texas and Oregon ------------------------------------------------------------------------ In response to these comments, the MUP Registrants agreed to maintain on their diazinon product registrations the use on spinach, strawberries and tomatoes. EPA's assessment of risks associated with the use of diazinon products concluded that all acute and chronic dietary risk estimates are below the Agency's level of concern. EPA's assessment considered all currently registered uses, including the agricultural uses identified in List 1. There may also be adequate data to support the tolerances for spinach, strawberries and tomatoes. EPA is currently reviewing residue data for these crops recently provided by the registrant to determine their acceptability. Accordingly, pursuant to FIFRA section 3(c)(7)(A), EPA approved the amendments of the MUP Registrants' replacement manufacturing-use product registrations to permit formulation and reformulation into products bearing instructions for spinach, strawberries and tomatoes. As amended, the approved replacement registrations for the MUP Registrants diazinon manufacturing-use products permit formulation and reformulation into products bearing instructions only for the agricultural uses identified in the following List 2. List 2. -- Agricultural Uses in Technical Registrants' Replacement Manufacturing-Use Product Registrations Almonds, apples, apricots, beans (seed treatment only) except soybeans, beets, blackberries, blueberries, boysenberries, broccoli, cattle (non-lactating; ear tags only), Chinese broccoli, Brussels sprouts, cabbage, Chinese cabbage (bok choy and napa), cantaloupes, carrots, Casaba melons, cauliflower, cherries, collards, field corn (seed treatment only), sweet corn (including seed treatment), cranberries, Crenshaw melons, dewberries, endive (escarole), ginseng, grapes, honeydew melons, hops, kale, lettuce, lima beans (seed treatment only), loganberries, melons, muskmelons, mustard greens, Chinese mustard, nectarines, onions, peaches, pears, peas (seed treatment only), Persian melons, pineapples, plums, prunes, radishes, Chinese radishes, raspberries, rutabagas, spinach, strawberries, sugar beets, tomatoes, walnuts, watercress (Hawaii only), and watermelons. Similarly, in today's cancellation order, EPA is approving the registrants' requested cancellations and amendments of the diazinon end-use products registrations, to terminate all uses identified in List 1 except spinach, strawberries and tomatoes. The individual states identified in Table 1 of this notice, may wish to issue special-local- need registrations under FIFRA section 24(c) for diazinon end-use products to address the specific agricultural needs in their states respectively, as identified in Table 1. EPA also received two comments asking that EPA cancel the outdoor non-agricultural uses of diazinon products now rather than in 2004. In assessing outdoor non-agricultural uses of diazinon products, EPA has considered many factors, including: 1. The risks and the benefits associated with such uses. 2. The phasing out over the next 3 years of the production of diazinon technical products that can be formulated or reformulated into products labeled for outdoor non-agricultural uses. 3. The possibility of and potential impacts from any litigation that may result from a proceeding by EPA to cancel these uses. Based on its consideration of all of these factors, EPA currently is not contemplating initiating a regulatory proceeding to cancel these uses. B. Requests for Voluntary Cancellation of Manufacturing Use Products Pursuant to FIFRA section 6(f)(1)(A), the registrants submitted requests for voluntary cancellation of the registrations for their diazinon manufacturing-use products, conditioned upon EPA's issuance of replacement registrations for these products which do not allow their formulation or reformulation into products bearing instructions for indoor use or certain agricultural uses, as identified in List 1 of this notice. The product registrations for which cancellations were requested are identified in the following Table 2. Table 2. -- Manufacturing-Use Product Registration Cancellation Requests ------------------------------------------------------------------------ Company Reg. No. Product ------------------------------------------------------------------------ Aventis Environmental Science 432-1094 Pyrenone Diazinon Aqueous Base Science 432-1130 Pyrenone Diazinon S.E.C. Gowan Company 10163-212 Gowan Diazinon Technical Drexel Chemical Co. 19713-104 Diazinon Technical ------------------------------------------------------------------------ As mentioned in Unit II.A of this notice, EPA received comments requesting that the Agency continues to permit the use of diazinon products on certain agricultural sites that the MUP Registrants had proposed to cancel. In response to these comments, pursuant to FIFRA section 3(c)(7)(A), EPA approved the MUP Registrants' amendments of the replacement registrations for their diazinon manufacturing-use products to permit formulation and reformulation of these replacement manufacturing use products into products bearing instructions for spinach, strawberries, and tomatoes, because there appears to be a nationwide need for the use of diazinon products on these crops. The individual states identified in Table 1 above, may wish to issue special-local-need registrations under FIFRA section 24(c) for diazinon end-use products to meet the specific agricultural needs in their states, as identified in Table 1. Because the concerns expressed in the comments have been addressed, EPA is issuing an order in this notice canceling the registrations identified in Table 2, as requested by the MUP Registrants. C. Requests for Voluntary Cancellation of End-Use Products In addition to requesting voluntary cancellation of its diazinon manufacturing-use product registrations, Syngenta also submitted requests for voluntary cancellation of the registrations for its diazinon end-use products that are registered primarily for indoor use. These end-use product registrations for which cancellation was requested are identified in the following Table 3. [[Page 37676]] Table 3. -- End-Use Product Registration Cancellation Requests ------------------------------------------------------------------------ Company Reg. No. Product ------------------------------------------------------------------------ Syngenta Crop Protection, Inc. 100-463 D.Z.N. DIAZINON 4E Insecticide 100-785 Evict Indoor/ Outdoor WBC ------------------------------------------------------------------------ Aventis Environmental Science 432-907 Ford's Diazinon 4E Insecticide 432-979 Pyrenone Diazinon Residual Concentrate Insecticide 432-987 Pyrenone Diazinon Residual Spray Insecticide 432-1062 Roach and Ant Spray Aqueous 432-1108 Pyrenone Diazinon W.B. 432-1114 Pyrenone Diazinon Water Based Pressurized Spray 432-1119 Pyrenone Diazinon Water Based Pressurized Spray II ------------------------------------------------------------------------ EPA did not receive any comments expressing a need for diazinon products for indoor use. Accordingly, EPA is issuing an order in this notice canceling the registrations identified in Table 3, as requested by Syngenta and Aventis. D. Requests for Voluntary Amendments of End-Use Product Registrations to Terminate Certain Uses Pursuant to section 6(f)(1)(A) of FIFRA, the Technical Registrants submitted requests to amend a number of their diazinon end-use product registrations to terminate the uses identified in List 1 of this notice. The registrations for which amendments to terminate uses were requested are identified in the following Table 4. Table 4. -- End-Use Product Registrations Requests for Amendments to Terminate Uses ------------------------------------------------------------------------ Company Reg. No. Product ------------------------------------------------------------------------ Drexel Chemical Co 19713-91 Diazinon Insecticide 19713-92 D-264 4E Diazinon Insecticide 19713-95 D-264 14G 19713-145 D-264 Captan Seed Protection 19713-263 DIAZINON 5G 19713-264 DIAZINON 2G 19713-317 Bug Spray (SP) 19713-492 Diazinon 50 WP ------------------------------------------------------------------------ As mentioned in Unit II.A of this notice, EPA received comments requesting that the Agency continue to permit the use of diazinon products on certain agricultural sites that the Technical Registrants had proposed to cancel. In response to these comments, the Technical Registrants have agreed to retain the use on spinach, strawberries, and tomatoes on their current diazinon end-use product registrations. The individual states identified in Table 1, may also wish to issue special-local-need registrations under FIFRA section 24(c) for diazinon end-use products to meet the specific agricultural needs in their states, as identified in Table 1. Accordingly, EPA is issuing an order in this notice approving the amendments of the registrations identified in Table 4 to terminate all uses identified in List 1 except spinach, strawberries, and tomatoes. III. Cancellation Order Pursuant to section 6(f) of FIFRA, EPA hereby approves the requested diazinon product registration cancellations and amendments to terminate all indoor uses and certain agricultural uses, as identified in List 1 of this notice, except spinach, strawberries, and tomatoes. Accordingly, the Agency orders that the diazinon manufacturing use product registrations identified in Table 2 of this notice, and the diazinon end-use product registrations identified in Table 3 of this notice, are hereby canceled. The Agency also orders that all of the uses identified in List 1, except spinach, strawberries, and tomatoes, are hereby canceled from all end-use product registrations identified in Table 4. Any distribution, sale, or use of existing stocks of the products identified in Tables 2-4 in a manner inconsistent with the terms of this order or the existing stock provisions in Unit IV of this notice will be considered a violation of section 12(a)(2)(K) of FIFRA and/or section 12(a)(1)(A) of FIFRA. IV. Existing Stocks Provisions For purposes of this Order, the term ``existing stocks'' is defined, pursuant to EPA's existing stocks policy (56 FR 29362, June 26, 1991), as those stocks of a registered pesticide product which are currently in the United States and which have been packaged, labeled, and released for shipment prior to the effective date of the amendment or cancellation. The existing stocks provisions of this cancellation order are as follows: 1. Distribution or sale of manufacturing-use products. Distribution or sale by any person of the existing stocks of any product identified in Table 2 of this notice, will not be lawful under FIFRA after July 19, 2001, except for the purpose of returns for relabeling consistent with the Technical Registrants' cancellation request letters and the memorandum of agreement (MOA), shipping such stocks for export consistent with the requirements of section 17 of FIFRA, or proper disposal. 2. Use of manufacturing-use products to formulate for indoor use. Use by any person of the existing stocks of any product identified in Table 2 of this notice, for formulation or reformulation into any product that bears instructions for indoor use will not be lawful under FIFRA after July 19, 2001. All other uses of such products may continue until the existing stocks are exhausted, provided that such use does not violate any existing stocks provision of this cancellation order and is in accordance with the existing labeling of that product. 3. Use of manufacturing-use products to formulate for agricultural use. Use by any person of the existing stocks of any product identified in Table 2 of this notice, for formulation or reformulation into any product bearing instructions for the agricultural uses identified in List 1 of this notice, except spinach, strawberries and tomatoes, will not be lawful under FIFRA after the date of publication of this Federal Register notice. All other uses of such products may continue until the existing stocks are exhausted, provided that such use does not violate any existing stocks provision of this cancellation order and is in accordance with the existing labeling of that product. [[Page 37677]] 4. Sale or distribution of indoor end-use products by MUP registrants. Sale or distribution by the MUP registrants of the existing stocks of any product identified in Table 3 or Table 4 of this notice that bear instructions for indoor use will not be lawful under FIFRA after July 19, 2001, except for the purposes of returns for relabeling consistent with the Technical Registrants' cancellation request letters and the MOA, shipping such stocks for export consistent with the requirements of section 17 of FIFRA, or proper disposal. 5. Retail and other sale or distribution of indoor end-use products. Sale or distribution by any person of the existing stocks of any product identified in Table 3 or Table 4 of this notice that bear instructions for indoor use will not be lawful under FIFRA after December 31, 2002, except for the purpose of returns for relabeling consistent with the Technical Registrants' cancellation request letters and the MOA, shipping such stocks for export consistent with the requirements of section 17 of FIFRA, or proper disposal. 6. Distribution or sale of diazinon end-use products bearing directions for use on agricultural crops. Sale and distribution by the registrant of end-use products bearing directions for use on any of the canceled agricultural crops will be unlawful 1-year after the effective date of this cancellation order. Persons other than the registrant may continue to sell existing stocks after the effective date of the cancellation order. V. Amendment to April 24, 2001 Cancellation Order (66 FR 21967 (May 2, 2001)) Pursuant to sections 6(f) and 6(a)(1) of FIFRA, EPA hereby amends its cancellation order that was issued on April 24, 2001 and published in the May 2, 2001 issue of the Federal Register. The order is hereby amended to include in section IV of the order the following existing stocks provision. Distribution and sale of end-use products bearing instructions for use on agricultural crops. The distribution or sale of the existing stocks by the registrant of any product listed in Table 3 or 4 that bears instructions for any of the agricultural uses identified in List 1, except spinach, strawberries and tomatoes, will not be lawful under FIFRA 1-year after the effective date of the cancellation order. Persons other than the registrants may continue to sell or distribute the existing stocks listed in Table 3 or 4 that bears instructions for any of the agricultural uses identified in List 1 after the effective date of the cancellation order. List of Subjects Environmental protection, Memorandum of Agreement, Pesticides and pests. Dated: July 3, 2001. Lois Rossi, Director, Special Review and Reregistration Division, Office of Pesticide Programs. [FR Doc. 01-18097 Filed 7-18-01; 8:45 a.m.] BILLING CODE 6560-50-S