Oxydemeton-Methyl; Receipt of Request to Cancel Registrations

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DATES: Unless the request is withdrawn, the Agency is likely to publish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:

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EPA Reg. No. Company Name Product Name

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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

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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]

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