vinclozolin (Ronilan) Section 18 for Ronilan on Snap Beans 5/94
FAX 908 32l-6771 Ph. No. 908 321-6769
NY Department of Environmental Conservation
FAX 518 457-0629 Ph. No. 518 457-7446
FAX 607 255-3075 Ph. No. 607 255-1866
Lloyd Novick MD
NY State Health Department
ESP-Corning Tower - Room 695
Albany NY 12237
Regional Director HFR-MA1
Food and Drug Administration
2nd and Chestnut streets Room 900
Philadelphia, PA 19106
Branch Chief HFF-314
200 C Street S.W.
Residue Evaluation & Planning Division
Room 602 Annex Building
300 Twelfth Street S.W.
Washington D.C. 20250+
Attention: Norman H. Nosenchuck, Director
Division of Hazardous Substance Regulation
The Environmental Protection Agency hereby grants a specific exemption
under the provisions of section 18 of the Federal Insecticide, Fungicide
and Rodenticide Act, as amended, to the New York State Department of
Environmental Conservation for use of vinclozolin (Ronilan) to control gray
mold and white mold on snap beans. This specific exemption is subject to
the following conditions and restrictions:
1. The New York State Department of Environmental Conservation is
responsible for ensuring that all provisions of this specific exemption are
met. It is also responsible for providing information in accordance with 40
CFR 166.32. This information must be submitted to EPA Headquarters and the
EPA Regional Office.
2, The product Ronilan 50DF (EPA Reg. No. 7969-85) manufactured by BASF
Wyandotte corporation may be used. All applicable precautions, directions
and restrictions on the EPA-registered product label must be followed.
3. A maximum rate of 0.75 lb. active ingredient per acre per application
may be used.
4. A maximum of 2 applications is authorized.
5. Applications will be made by ground or air.
6, A 9-day pre-harvest interval is required, for applications not exceeding
0.5 lb. a.i. per acre; a 14-day pre-harvest interval is required for
applications at the 0.75 lb. a.i. per acre rate.
7. A maximum of 14,000 acres of snap beans may be treated.
8. Bean hay from treated fields may not be fed to livestock and livestock
may not be grazed on treated fields.
9. Applications made in accordance with the above provisions are not
expected to result in residues of vinclozolin and its metabolites
containing the 3,5-dichloroaniline moiety in excess of 3 ppm in or on
succulent snap beans and 10 ppm in cannery waste. Secondary residues are
not expected to exceed 0.06 ppm in milk; 0.1 ppm in fat and 0.06 ppm in
muscle, 0.75 ppm in liver and 0.22 ppm in kidney of cattle. This Agency has
determined that those levels are adequate to protect the public health.
Adequate analytical methodology is available in PAM-II and analytical
reference standards for vinclozolin are available from the EPA Pesticides
and Industrial Chemicals repository; at RTP, N.C. The Food and Drug
Administration, DHHS, and the United States Department of Agriculture have
been advised of this action.
10. The EPA (headquarters and EPA Regional office) shall be immediately
informed of any adverse effects resulting from use of Ronilan in connection
with this program.
11. A final report summarizing the results of this program must be
submitted by March 30, 1995.
12. This specific exemption expires on September 30, 1994.
Any future correspondence in connection with the exemption should
refer to file symbol: 94-NY-03.
The regulations governing section 18 of FIFRA requires that the Agency
consider, in its decision whether to grant a repeated section 18, the
progress being made toward section 3 registration of the use. This is the
12th year that this use has been requested under section 18 of FIFRA. I
will not be inclined to grant future section 18 requests unless there is
continued progress toward section 3 registration of the use of vinclozolin
on snap beans. In an April 1992 meeting, this Agency informed the
registrant that it is unlikely that pending major crop tolerance petitions
would be acted upon until the reregistration toxicology testing program was
completed. It would be to your advantage to keep current on the progress
made by the registrant in developing the required data.
For future specific exemption applications for this use, the following
is required: (a) results from monitoring of pest populations for pesticide
resistance problems, (b) results from the proposed research in 1994
concerning alternative strategies, including non-pesticidal methods to
suppress mold development, which offer promising solutions to minimal or no
use of vinclozolin, and (c) comparative product performance evaluations of
alternative pesticides carried to harvest and yields (both quality and
Furthermore, continuing use under this current section 18 depends
heavily on the submission of the toxicological studies currently due by May
31, 1994. All data must be submitted on time; scientifically correct; run
according to Agency guidelines, and found to be acceptable. You are also
advised that additional concerns have recently been raised regarding this
incoming data. If these concerns, or concerns regarding any data yet to be
submitted, cannot be satisfactorily addressed in the registration process,
this is the last year vinclozolin will be available for use on snap beans.
Susan H. Wayland, Deputy Director
Office of Pesticide Programs