[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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DATES: Unless the request is withdrawn, the Agency is likely to publish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
