[Federal Register Volume 59, Number 48 (Friday, March 11, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-5727]


[[Page Unknown]]

[Federal Register: March 11, 1994]


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ENVIRONMENTAL PROTECTION AGENCY
[OPP-64018; FRL 4759-5]

 

Oxydemeton-Methyl; Receipt of Request to Cancel Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Receipt to Cancel Registrations.

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SUMMARY: This notice issued pursuant to section 6(f)(1) of the Federal, 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et 
seq., announces EPA's receipt of requests from Miles, Inc. and all 
remaining registrants to voluntarily cancel their registrations for 
products containing oxydemeton-methyl (ODM). Further, this notice will 
provide guidance for existing stocks.
DATES: Unless the request is withdrawn, the Agency is likely to publish 
a cancellation order in the Federal Register on or about June 9, 1994.

FOR FURTHER INFORMATION CONTACT: By mail: Philip J. Poli, Review 
Manager, Special Review Branch, Special Review and Reregistration 
Division (7508W), Environmental Protection Agency, 401 M St., S.W., 
Washington, DC 20460. Office location and telephone number: Special 
Review Branch, 3rd floor, 2800 Crystal Drive, Arlington, VA 22202, 
(703) 308-8038.

SUPPLEMENTARY INFORMATION: This notice announces the receipt of 
requests for cancellation of the registrations for the products 
containing oxydemeton-methyl.

I. Background

    Oxydemeton-Methyl (ODM) is the common name for an insecticide and 
acaricide of the organophosphate class; its trade name is Metasystox-
R. The chemical name for ODM is S-[2-(ethylsulfinyl)ethyl] 
O,O-dimethyl phosphorothioate. Miles Incorporated (Agriculture 
Division) is the sole producer of a 50 percent oxydemeton-methyl 
product, for formulating purposes only.
    ODM is a broad spectrum insecticide/acaricide which is registered 
for use to control many insects, including mites. Its mode of action is 
systemic and contact. It is used predominantly on terrestrial food 
crops (vegetable, tree fruit, and nut crops), but is also registered 
for use on terrestrial nonfood crops (ornamentals and forest trees).

II. Intent to Cancel

    On September 30, 1993, Miles, Inc., submitted a letter to EPA 
requesting voluntary cancellation of all its products containing 
oxydemeton-methyl. As the basis for requesting voluntary cancellation, 
the company concluded that the expenditures necessary to generate 
required data under the reregistration process did not justify 
continued registration of its products. In addition, the Agency has 
since received notice from all other oxydemeton-methyl registrants 
requesting voluntary cancellation of their registrations. The 
registrations subject to this action are listed below:


------------------------------------------------------------------------
    EPA Reg. No.            Company Name              Product Name      
------------------------------------------------------------------------
                                                                        
3125-99.............  Miles Incorporated       METASYSTOX-R 50%         
                                                                        
3125-111............                           METASYSTOX-R Spray       
                                                Concentrate             
                                                                        
CA-820103...........                           METASYSTOX-R Spray       
                                                Concentrate             
                                                                        
CA-820104...........                           METASYSTOX-R Spray       
                                                Concentrate             
                                                                        
CA-910029...........                           METASYSTOX-R Spray       
                                                Concentrate             
                                                                        
ID-770006...........                           METASYSTOX-R Spray       
                                                Concentrate             
                                                                        
ID-780001...........                           METASYSTOX-R Spray       
                                                Concentrate             
                                                                        
MI-890004...........                           METASYSTOX-R Spray       
                                                Concentrate             
                                                                        
NM-79002503.........                           METASYSTOX-R Spray       
                                                Concentrate             
                                                                        
NV-770014...........                           METASYSTOX-R Spray       
                                                Concentrate             
                                                                        
OH-890004...........                           METASYSTOX-R Spray       
                                                Concentrate             
                                                                        
OR-770019...........                           METASYSTOX-R Spray       
                                                Concentrate             
                                                                        
OR-790067...........                           METASYSTOX-R Spray       
                                                Concentrate             
                                                                        
OR-800071...........                           METASYSTOX-R Spray       
                                                Concentrate             
                                                                        
OR-800079...........                           METASYSTOX-R Spray       
                                                Concentrate             
                                                                        
OR-890004...........                           METASYSTOX-R Spray       
                                                Concentrate             
                                                                        
OR-920009...........                           METASYSTOX-R Spray       
                                                Concentrate             
                                                                        
TX-800024...........                           METASYSTOX-R Spray       
                                                Concentrate             
                                                                        
WA-770014...........                           METASYSTOX-R Spray       
                                                Concentrate             
                                                                        
WA-770058...........                           METASYSTOX-R Spray       
                                                Concentrate             
                                                                        
WA-800069...........                           METASYSTOX-R Spray       
                                                Concentrate             
                                                                        
WA-800077...........                           METASYSTOX-R Spray       
                                                Concentrate             
                                                                        
WA-850003...........                           METASYSTOX-R Spray       
                                                Concentrate             
                                                                        
WA-890033...........                           METASYSTOX-R Spray       
                                                Concentrate             
                                                                        
7946-10.............  J.J. Mauget Co.          INJECT-A-CIDE            
                                                                        
64014-2.............  Tree Technology System,  HARPOON                  
                       Inc.                                             
                                                                        
CA-89003500.........  Robert E. Jones          METASYSTOX-R Spray       
                                                Concentrate             
                                                                        
CA-89003800.........  Nature's Harvest         METASYSTOX-R Spray       
                                                Concentrate             
------------------------------------------------------------------------


    It should be noted that EPA classified ODM as a Restricted Use 
pesticide in September 1987, and initiated a Special Review on October 
5, 1987 (52 FR 37248), which is ongoing, based on potential adverse 
reproduction effects resulting from exposure for persons mixing, 
loading and applying this pesticide. That notice was based on a 
determination that products containing ODM met or exceeded the criteria 
for initiation of Special Review set forth in 40 CFR 154.7(a)(2). In 
addition, studies required to support the registration of ODM were due 
about the time of the cancellation request from Miles, Inc.
    Section 6(f) of the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA), as amended, provides that a pesticide registrant may, at 
any time, request that any of its pesticide registrations be cancelled. 
The Act further provides that EPA must publish a notice of receipt of 
any such request in the Federal Register before acting on the request.
    If any current registrant of ODM notifies the Agency during the 90-
day comment period of an agreement to transfer one or more of its 
registrations, EPA will not issue the cancellation order provided that, 
within 30 days of notifying the Agency, a request for transfer of 
registration has been submitted to the Agency in accordance with 40 CFR 
152.135. Nevertheless, the new registrant would be responsible for all 
outstanding data requirements. As noted above, at the time voluntary 
cancellation was requested, Miles, Inc. had studies which were 
approaching the required due date and EPA could have initiated a 
suspension action upon lapse of the due date. The due dates for these 
studies have since expired and if an ODM registration is transferred 
during the 90-day period, the new registrant would be at risk of 
suspension until all outstanding data requirements are met.
    Comments on this voluntary cancellation request may be submitted to 
the contact person listed under FOR FURTHER INFORMATION CONTACT by June 
9, 1994. In addition, interested persons desiring retention of a 
registration should contact the registrant directly during this 90-day 
period at the following address: Ms. Karen Cain, Miles, Inc., 8400 
Hawthorn Road, P.O. Box 4913, Kansas City, MO 242-2000, (816) 242-2838.
    Unless the request for voluntary cancellation is withdrawn by a 
registrant, or a registration is transferred as described above within 
90 days of publication of this notice, an order is likely to be 
published in the Federal Register, cancelling all previously listed 
registrations for oxydemeton-methyl.
    Unless the burden of supporting oxydemeton-methyl through 
reregistration is assumed by a registrant holding a registration for 
ODM, oxydemeton-methyl will no longer be a registered active 
ingredient. Once an active ingredient is cancelled, any person wishing 
to bring the pesticide back on the market would need to apply to EPA 
for a ``new chemical'' registration. Such a registration generally 
would not be approved until all applicable data requirements are 
satisfied.

III. Procedures for Withdrawal of Request

    If a registrant chooses to withdraw its request for cancellation, 
it must submit such withdrawal in writing to Brigid Lowery, 
Reregistration Branch, Special Review and Reregistration Division 
(7508W), Environmental Protection Agency, 401 M St., S.W., Washington, 
DC 20460, postmarked on or before June 9, 1994. This written withdrawal 
of the request for cancellation must include a commitment to pay any 
reregistration or registration maintenance fees due, and to fulfill any 
applicable unsatisfied data requirements.

IV. Existing Stocks Determination

    Miles, Inc. also requested in its September 30, 1993 voluntary 
cancellation letter a 1-year existing stocks provision, whereby 
products containing ODM may be sold by the registrant for a period of 
1-year from the date listed on the voluntary cancellation letter to the 
Agency.
    The Agency's established policy for determinations concerning 
existing stocks was published in the Federal Register of Wednesday, 
June 26, 1991 (56 FR 29362). Consistent with that policy, the Agency is 
proposing to allow all registrants to continue to sell and distribute 
existing stocks for 1-year from September 30, 1993. Hence, the 1-year 
existing stocks provision will expire on September 30, 1994. EPA will 
continue to permit after this date the shipping, sale and use of 
existing stocks of product containing ODM already in the channels of 
distribution by persons other than the registrant or supplemental 
registrants, (i.e., stocks already in the hands of dealers or users). 
EPA believes it is appropriate to allow sale and use until stocks 
already in channels of distribution are exhausted rather than impose a 
time limit on use of existing stocks, so that persons who have legally 
purchased stocks of ODM will be able to sell or use those stocks 
without violating the cancellation order (although the Agency may place 
restrictions if such stocks are not exhausted in a reasonable time).

List of Subjects

    Environmental protection, Agricultural commodities, Pesticides and 
pests.

    Dated: March 2, 1994.

Douglas D. Campt,
Director, Office of Pesticide Programs.

[FR Doc. 94-5727 Filed 3-10-94; 8:45 am]
BILLING CODE 6560-50-F