[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                                               
------------------------------------------------------------------------

    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