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diazinon (D.Z.N., Spectracide) Cancellation Order 4/01


ENVIRONMENTAL PROTECTION AGENCY


[OPP-34225D; FRL-6781-1]



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: (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-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 (703) 305-5805.


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         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 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          66222-10            DIAZOL Diazinon
  America, Inc.                                         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.


[FR Doc. 01-10998 Filed 5-1-01; 8:45 am]
BILLING CODE 6560-50-S