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Endothall - Denial of Major Change in Labeling 10/96

New York State Department of Environmental Conservation
Division of Solid & Hazardous Materials
50 Wolf Road, Albany, New York 12233-7250
Phone 518-457-6934 FAX 518-457-0629

October 22, 1996

CERTIFIED MAIL
RETURN RECEIPT REOUESTED

Mr. Christopher Davis
Manager, Product Registrations
Agrichemicals Division
Elf Atochem North America, Inc.
2000 Market Street
Philadelphia, PA 19103-3222

Dear Mr. Davis:

Re:	Registration Decision for a Major Change in Labeling to Aquathol K Aquatic Herbicide,
    EPA Reg. No. 4581-204 and Aquathol K Granular Aquatic Herbicide, EPA Reg. No. 4581-201.

  We have reviewed all the information submitted in support of the referenced application
to make two label amendments to the subject labels, as follows: 1) the removal of the skull
and crossbones from the Aquathol K liquid label; and 2) the removal of the 24-hour
swimming restriction from both Aquathol K labels. These amendments were submitted as
routine amendments but, because the removal of the swimming restriction presents the
potential for increase in exposure to swimmers, the Department determined that they
constituted a Major Change in Labeling (MCL).

  As a result of our review we have determined the following:

1.     Removal of the Skull and Crossbones/Poison signal word

       Removal of the Skull and Crossbones/Poison signal word is acceptable. Comparison of
       test results for the product to the U.S. EPA's criteria for signal word designation
       supports removal.

2.     Removal of the 24-hour swimming restriction is not acceptable

       Endothall is a very severe eye irritant and there are no dose-response data from
       animal studies to evaluate the risk of eye irritation. Similarly, there are no
       dose-response data for irritation to abraded or sunburned skin. Further, the data
       show highly variable dissipation rates within the first 12 hours or so. For example,
       some field studies in Illinois found levels up to 17 times the target concentration
       at one-hour post application and three- . times target concentration at two-hour post
       application. Studies in Florida found levels to be at or below target concentrations
       within about 12 hours. Given these data, we believe that a minimum swimming restriction
       of "day after application" is warranted. Completely removing the 24-hour swimming
       restriction would allow swimming immediately after, or even during, application.

  As discussed in our September 5, 1996 letter to Gary Sandburg of Elf Atochem, we believe
it is necessary to restrict swimming for some time period following application in
order to allow adequate mixing. You responded on September 17, 1996 questioning our
conclusions but providing no further information. Contrary to your assertion that the
product is uniformly distributed "even nine minutes after application," the data show
highly variable dissipation rates within the first 12 hours as discussed above. Therefore,
a minimum swimming restriction of "day after application" will be required in New York
State.

  Therefore, your application to register a major change in labeling is denied. In order
for Elf Atochem to register this product in New York State under your new federal label,
Elf Atochem must, as stated in our September 5, 1996 letter, submit a Special Local Needs
(SLN) registration specifying a minimum swimming restriction of "day after application."
This SLN label would have to be istributed with all product. The alternatives are to either:

  1. modify the new federal label to add the statement, "treated areas may not be used for
     swimming until the day after treatment"; or

  2. continue using the previous label containing the 24-hour swimming restriction.

  As stated in the New York State Environmental Conservation Law, you may pursue the
options specified in Section 33-0711.

  With regard to your intention to perform tests to demonstrate that Aquathol K is not an
irritant to the eye, we cannot assure you that we will accept removal of swimming
restrictions if the results are negative. The information supplied does not
discuss the concentrations that you intend to test. You may submit a test protocol for
our review and acceptance.

  If you have any additional questions please contact Frank Hegener, of our Pesticide Product
Registration Section, at (518) 457-7446.

Sincerely,

Norman H. Nosenchuck, P.E.
Director
Division of Solid & Hazardous Materials

cc: A. Grey - NYSDOH
D. Rutz/W. Smith - Cornell