01-10998. 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 two companies that hold the registrations of pesticide manufacturing-use and end-use products 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 January 10, 2001, notice of receipt of the two companies' requests for cancellations and amendments of their diazinon product registrations to terminate all indoor uses and certain agricultural uses. In the January 10, 2001 notice, EPA indicated that it would issue an order confirming the voluntary product and use registration cancellations. 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.

DATES:

The cancellations are effective May 2, 2001.

FOR FURTHER INFORMATION CONTACT:

Ben Chambliss, Special Review and Reregistration Division (7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: [phone]; fax 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. 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-34225D. 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 [phone].

II. Receipt of Requests to Cancel and Amend Registrations to Delete Uses

A. Background

In December 2000, Syngenta Crop Protection, Inc. (Syngenta) and Makheteshim Agan of North Amenrica, Inc./Makheteshim Chemical Works, Ltd. (collectively referred to as the “Technical Registrants”), the basic manufacturers of the active ingredient diazinon and registrants of products containing diazinon, and EPA agreed to several voluntary measures that will reduce the potential exposure to children associated with diazinon containing products. EPA initiated the negotiations with the Technical Registrants after finding that diazinon, as currently registered, was an exposure risk, especially to children. As a result, the Technical Registrants respectively submitted a letter under section 6(f) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requesting cancellation or amendment of all of their diazinon product registrations to terminate all indoor uses and certain agricultural uses. The uses for which termination was requested are identified in the following List 1:

List 1.—Uses Requested for Termination

1. 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.

2. Agricultural uses: Alfalfa, bananas, Bermuda grass, dried beans, celery, red chicory (radicchio), citrus, clover, coffee, cotton, cowpeas, cucumbers, dandelions, kiwi, lespedeza, parsley, parsnips, pastures, peppers, Irish potatoes, sheep, sorghum, spinach, squash (winter and summer), sweet potatoes, rangeland, strawberries, Swiss chard, tobacco, tomatoes, turnips. The uses for dried beans, dried peas, chicory, cowpeas and dandelions were removed from all labels in 1991.

**In addition, Syngenta has requested that “lawns” be removed from three of its commercial agricultural products (EPA Registrations 100-460, 100-461 and 100-784).

The letters requested that EPA cancel the registrations of all of their diazinon manufacturing-use products, conditioned upon EPA's issuance of replacement registrations for these products which do not allow formulation or reformulation into products bearing instructions for the uses identified in List 1. The letters also requested cancellations or amendments of the Technical Registrants' end-use product registrations to terminate these uses. These letters were followed by a memorandum of agreement between the Technical Registrants and EPA (MOA), in which the Technical Registrants agreed to phase out non-agricultural uses of its diazinon products. A copy of the Technical Registrants' letters requesting voluntary cancellation and the above-mentioned MOA are located in docket control number OPP-34225D.

Pursuant to section 6(f)(1) of the FIFRA, EPA announced the Agency's receipt of these requests from the Technical Registrants by a Federal Register notice published on January 10, 2001 (66 FR 1977) (FRL-6763-7). In that Notice, EPA provided a 30-day comment period. The Technical 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 Technical Registrants' diazinon manufacturing-use products on January 11, 2001.

Following the publication of the 6(f) notice, 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. 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
Cucumbers	Texas)
Ground Squirrel/ Rodent Burrow Dust Stations for Public Health Use	California
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 Technical 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 Technical 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 Technical 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 Technical Registrants' requested cancellations and amendments of the their 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 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.

B. Requests for Voluntary Cancellation of Manufacturing Use Products

Pursuant to FIFRA section 6(f)(1)(A), the Technical 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
Makhteshim Chemical Works, Ltd.	11678-6	DIAZOL Technical Stabilized
	11678-20	DIAZOL(Diazinon) Stabilized Oil Concentrate
Syngenta Crop Protection, Inc.	100-524	D.Z.N(R) DIAZINON MG 87% INSECTICIDE
	100-714	D.Z.N(R) DIAZINON MG 5%
	100-771	D.Z.N(R) DIAZINON MG 22.4% WBC
	100-783	D.Z.N(R) DIAZINON MG 56%

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 Technical Registrants had proposed to cancel. In response to these comments, pursuant to FIFRA section 3(c)(7)(A), EPA approved the Technical 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 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 Technical 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:

Table 3.—End-Use Product Registration Cancellation Requests

Company	Reg. No.	Product
Syngenta Crop Protection, Inc.	100-445	D.Z.N(R) DIAZINON 2D
	100-477	D.Z.N(R) HOME PEST CONTROL LIQUID
	100-478	D.Z.N(R) HOME PEST CONTROL PRESSURIZED LIQUID
	100-625	D.Z.N(R) HOME PEST CONTROL — XP
	100-659	D.Z.N(R) 0.5% RTU
	100-685	D.Z.N(R) 1/2% EW
	100-686	D.Z.N(R) 1% EW
	100-687	D.Z.N(R) 5.0 EW

EPA did not receive any comments expressing a need of 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.

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
Makhteshim-Agan of North America, Inc.	66222-10	DIAZOL Diazinon 50W
	66222-9	DIAZOL Diazinon AG500
Syngenta Crop Protection, Inc .	100-460	D.Z.N(R) DIAZINON 50W
	100-461	D.Z.N(R) DIAZINON AG500
	100-463	D.Z.N(R) DIAZINON
	100-469	D.Z.N(R) DIAZINON 14G
	100-784	D.Z.N(R) DIAZINON AG600 WBC
	100-785	EVICT(TM) INDOOR/OUTDOOR WBC

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 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 3 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 and the diazinon end-use product registrations identified in Table 3 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 will not be lawful under FIFRA after May 2, 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.

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 for formulation or reformulation into any product that bears instructions for indoor use will not be lawful under FIFRA after May 2, 2001. All other use 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 for formulation or reformulation into any product bearing instructions for the agricultural uses identified in List 1, except spinach, strawberries and tomatoes, will not be lawful under FIFRA after May 31, 2001. All other use 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.

4. Sale or distribution of indoor end-use products by Technical Registrants. Sale or distribution by the Technical Registrants of the existing stocks of any product identified in Table 3 or Table 4 that bear instructions for indoor use will not be lawful under FIFRA after May 2, 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 that bear instructions for indoor use will not be lawful under FIFRA after December 31, 2002, except for the purposes of returns for re-labeling 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.

List of Subjects

• Environmental protection
• Pesticides and pests

Dated: April 24, 2001.

Lois Rossi,

Director, Special Review and Reregistration Division, Office of Pesticide Programs.