Pendimethalin - Followup Letter re SLN Registration for Prowl 3.3 EC 6/94
RETURN RECEIPT REQUESTED
JUN. 02 1994
Ms. Debra A. Logan
State Registration Manager
U.S. Regulatory Affairs
American Cyanamid Company
Agricultural Research Division
PO. Box 400
Princeton, NJ 08543-0400
Dear Ms. Logan:
Re: PROWL 3.3 EC Herbicide, EPA Reg. No. 241-337 Third Party 24(c) Special
Local Need Registration for Use on Onions
Thank you for your April 6, 1994 letter objecting to this Department's
issuance of a third-party 24(c) Special Local Need (SLN) label to the New
York State Vegetable Grower Association for the use of Prowl on onions.
We issued the SLN 24(c) third-party label to the New York State Vegetable
Grower Association on March 31, 1994.
The issue of an SLN registration arose because the application to register
a major change in labeling for Prowl on onions submitted by American
Cyanamid on November 26, 1993 remains incomplete. In order to facilitate
Prowl's use on onions in 1994, an SLN registration with conditions
consistent with the Section 18 registrations was suggested. The American
Cyanamid 24(c) application had omitted the 500-foot setback limitations
which were consistent with the previously issued Section 18 registrations
On January 18, 1994 this Department requested that the American Cyanamid
Company submit additional data to us so that the technical staff in our
Pesticide Product Registration Section could determine the justification
for the need for the third application, and the deletion of the 500-foot
setback. Because the Department did not perform a technical review for the
initial New York State registration of Prowl, and data does not exist
within the Department to address the environmental or toxicological
impacts of Pendimethalin for use on corn, cabbage, etc. we were unable to
assess the impacts of the setback deletion. This data was requested from
the American Cyanamid Company in our January 18, 1994 letter.
American Cyanamid has been provided ample opportunity to provide our
Pesticide Product Registration Section with a complete data package to
support the requested major change in label application for the use of
Prowl on onions. To date, since no additional data has been provided by
the American Cyanamid Company to this Department, the application remains
incomplete and the application was denied, effective May 10, 1994.
Your April 6 letter implies that the Department has made a scientifically,
unsound decision to register a label that is not consistent with the
federally approved Section 3 label. This statement is incorrect. It is the
responsibility of this Department to review all appropriate technical data
supporting any pending application. It would be scientifically unsound for
this Department to issue a SLN with a major change in labeling without
performing an adequate technical review. American Cyanamid's contentions
regarding the adsorption rates and solubility characteristics may, in
fact, be accurate. However, we cannot ascertain this information without
reviewing appropriate data.
Prior to issuing the third-party 24(c) grower label, this Department
contacted Mr. Jim Tompkins, Deputy Chief, Registration Support Branch of
EPA, to discuss the problem and the inadequate data base this State
encountered in reviewing the application for the major change in label for
the use of Prowl on onions. Mr. Tompkins of EPA was informed of and made
recommendation to us concerning the issuance of the third-party grower
We do not intend to rescind the SLN label that was issued to the New York
State Vegetable Grower Association on March 31, 1994. This SLN label
enables the onion growers to operate for this season only, under the same
Section 18 conditions, which were issued for the past five years.
It is my understanding from speaking with Ms. Jean Warholic, of the New
York State Vegetable Grower Association, that American Cyanamid was aware
of and reviewed the SLN label language prior to March 31, 1994. Any
American Cyanamid objections should have been directed to this Department
during the review of the third-party SLN label in March.
Please call Ms. Maureen Serafini, of my staff, at (518) 457-7446, if you
have any questions.
Norman H. Nosenchuck, P.E.
Division of Hazardous Substances
cc: D. Rapp - NYS Dept. of Ag. & Markets
J. Tompkins - EPA
D. Rutz - Cornell University
J. Warholic - NYS Veg. Growers Association