[Federal Register Volume 59, Number 63 (Friday, April 1, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-7852]
[[Page Unknown]]
[Federal Register: April 1, 1994]
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[OPP-66171B; FRL-4770-9]
Methazole; Amendment of Cancellation Order
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice; extension of existing stocks provision.
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SUMMARY: On January 13, 1993, EPA published a cancellation order that
restricted the distribution, sale, and use of methazole (2-(3,4-
dichlorophenyl)-4-methyl-1,2,4-oxadiazolidine-3,5-dione). This
restriction was an interim measure until the Agency reviewed additional
toxicological data. Sandoz had earlier requested voluntary cancellation
of all remaining methazole products and the January 1993 cancellation
order also announced receipt and acceptance of their cancellation
request. EPA subsequently received the additional toxicological data
and concluded based on it, that distribution, sale, and use of
remaining stocks of methazole would be conditionally allowed until
December 31, 1993. This notice is amending the Agency's existing stocks
provision to allow the conditional distribution, sale, and use of
remaining methazole product until December 31, 1994.
DATES: The extension of the conditional distribution, sale, and use of
existing stocks until December 31, 1994, is being granted in order to
allow the use of the remaining stocks of methazole product.
FOR FURTHER INFORMATION CONTACT: By mail: Joseph Bailey, Special Review
and Reregistration Division (7508W), Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. Office location and telephone
number: Special Review Branch, 3rd Floor, Crystal Station 1, 2800
Jefferson Davis Highway, Arlington, VA (703) 308-8173.
SUPPLEMENTARY INFORMATION:
I. Background
Methazole, a selective herbicide used to control several varieties
of weeds in cotton, was registered for preemergence use west of the
Mississippi and directed postemergence use both east and west of the
Mississippi. Most of the methazole produced for cotton production is
applied in Louisiana and Mississippi with some use occurring in other
cotton producing States. The season for methazole use typically begins
in April/May.
On May 18, 1992, as provided for under FIFRA section 6(f)(1)(A),
Sandoz Agro., Inc. requested that EPA cancel their remaining pesticide
registrations containing methazole. Prior to the submission of the
voluntary cancellation request, Sandoz Agro, Inc. had submitted to the
Agency, pursuant to FIFRA section 6(a)(2), preliminary results from a
rat reproduction study indicating that a high percentage of the dosed
generation's offspring developed cataracts. The Agency concluded from
these test results that an unacceptable risk was possible to those
workers exposed to methazole, particularly mixer/loaders and
applicators. The products for which cancellation was requested are
listed in Table 1 below.
Table 1.--Methazole Section 3 (national) Registrations: Voluntary
Cancellation Requests
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Company Product
Registration Company Name/ Registration Product Name
Number Address Number
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55947 Sandoz Agro, 55947-22 Technical Probe
Inc.,
1300 East Touhy 55947-23 Probe 75
Avenue Wettable Powder
Des Plaines, IL
60018
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In September 1992, Sandoz offered to conduct two studies, a dermal
absorption study and a developmental toxicity study, in order to
provide additional data on the potential risks. The Agency agreed to
wait and consider the additional data to revise the risk assessment for
worker exposure before making a final decision on disposition of the
existing stocks. In the Federal Register of January 13, 1993 (58 FR
4167), the Agency published a Notice of Receipt of Request for
Voluntary Cancellation/Cancellation Order which announced acceptance of
Sandoz' request for voluntary cancellation of its methazole products
and restricted the distribution, sale, and use of all remaining stocks
of methazole until the Agency had considered the additional data. In
case the Agency's revised risk assessment indicated an acceptable risk
to workers, Sandoz requested the Agency to review supplemental labeling
revisions that would be applicable to the existing stocks and would
lower worker exposure to methazole. The Agency reviewed the proposed
supplemental labeling revisions and on February 26, 1993, notified
Sandoz that, should the Agency allow any further distribution, sale,
and use of the canceled methazole products, it would condition such
distribution, sale and use on the revised supplemental labeling being
provided at the time of sale of all existing stocks. The approved
supplemental label revisions are as follows: (1) Deletion of all
preemergence uses for methazole, (2) limit use to post-emergence,
directed band application only, and (3) reduce the allowable rate of
application to a maximum of 0.33 pound of product (0.25 pound of active
ingredient) per acre applied on a band.
In March 1993, Sandoz provided the results of the two studies as
agreed upon with the Agency. The Agency reviewed the data and concluded
that risks to adult workers are acceptable when exposed to methazole
used in accordance with approved supplemental labeling. As a result,
the Agency amended the January 1993 cancellation order with a Federal
Register notice (May 26, 1993, 58 FR 30166) that announced the removal
of the restriction on the distribution, sale, and use of existing
stocks of methazole products. Based on the annual usage of
approximately 350,000 to 400,000 pounds of product, Sandoz felt that
the estimated 50,000 pounds of product remaining in the hands of
distributors and sellers would be sold and used during the 1993 growing
season. The Agency requested Sandoz to report any stocks that remained
with distributors or sellers as of December 31, 1993. The end-of-year
accounting of those distributors and sellers originally holding
inventories of existing stocks showed that 1,925 pounds remained. In
order to allow this small amount of product to be sold and used, Sandoz
has requested the Agency to extend the date by which all existing
stocks must be sold through the 1994 growing season. The Agency has
considered the request and has agreed to extend this date until
December 31, 1994.
II. Revised Cancellation Order Amendment
For purposes of this amended Order, existing stocks are defined as
those stocks of methazole product (EPA Registration Number 55947-23)
released for shipment on or before January 13, 1993, and currently in
the hands of distributors, sellers, and users other than Sandoz. The
Agency has determined that short-term exposure to adult mixer/loader/
applicators of the remaining existing stocks of methazole will not
present unreasonable adverse effects when used in accordance with the
revised supplemental labeling discussed earlier in this Notice.
Accordingly, the Agency is further amending the Cancellation Order
issued on January 13, 1993, in order to allow, pursuant to FIFRA
section 6(a)(1), continued distribution, sale, and use of existing
stocks of methazole product until December 31, 1994, provided that the
supplemental labeling discussed earlier in this Notice is provided to
purchasers or recipients at the time of such distribution or sale. No
distribution or sale of existing stocks of methazole is permitted under
this Amended Order unless the revised labeling is so provided. No
product produced in accordance with the terms of the former EPA
Registration Number 55947-23 may be used by any person unless the
product is used in accordance with the terms of the previously-approved
EPA labeling for that product as modified by the terms of the
supplemental labeling discussed earlier in this Notice.
Dated: March 24, 1994.
Douglas D. Campt,
Director, Office of Pesticide Programs.
[FR Doc. 94-7852 Filed 3-31-94; 8:45 am]
BILLING CODE 6560-50-F