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methazole (Probe) Amendment of Cancellation Order 3/94

[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     |   Company Name/  |      Product     |                    
  Registration   |      Address     |   Registration   |   Product Name     
     Number      |                  |      Number      |                    
-----------------+------------------+------------------+--------------------
                 |                  |                  |                    
55947            | Sandoz Agro,     | 55947-22         | Technical Probe    
                 |  Inc.,           |                  |                    
                 | 1300 East Touhy  | 55947-23         | Probe 75           
                 |  Avenue          |                  |  Wettable Powder   
                 |                  |                  |                    
                 | Des Plaines, IL  |                  |                    
                 |  60018           |                  |                    
-----------------+------------------+------------------+--------------------
   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]