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Fosetyl-Al - Denial of Section 18 Emergency Exemption for Aliette 5/93

Mr. William Smith
Senior Extension Associate
Pesticide Management Education Program
Department of Entomology
Cornell University
Ithaca, New York  14850

Dear Mr. Smith:

May 28, 1993

RE: Denial of Section 18 Emergency Exemption for Use of
Fosetyl-Al (Aliette, USEPA Reg No. 264-467)

Enclosed is the denial, dated May 19, 1993, from the
United States Environmental Protection Agency (USEPA) for a
Section 18 emergency exemption for use of fosetyl-Al (Aliette,
USEPA Reg. No. 264-467) on grapes to control downy mildew in
New York State. This denial was signed by Douglas D. Campt,
Director, Office of Pesticide Programs (H7501c).

The USEPA based its decision to deny the referenced
emergency exemption on Delaney clause criteria of the Food, Drug,
and Cosmetic Act.  Under Delaney, the USEPA is prohibited from
issuing food tolerances for any chemical with a carcinogenic
potential regardless of how infinitesimal the risk (U.S. Court of
Appeals decision, Les. v. Reilly).  Aliette for use on grapes
would have required a temporary food additive tolerance;
therefore, the emergency exemption was denied.

The USEPA is willing to reconsider its decision to deny
Aliette use in New York State if certain conditions are met (see
enclosure).  If you believe that you have any additional
information to contribute concerning this request, please contact
Frank Hegener or Teresa Foster, of my staff, at (518) 457-7446.

Sincerely,

Norman H. Nosenchuck, P.E.
Director
Division of Hazardous Substances
  Regulation

Enclosure

cc w/enc.:  D. Rapp - NYS Dept. of Ag. & Mkts.

Text of EPA Denial of Section 18 Emergency Exemption for Aliette

EPA Region II

Regional Director HFR-MA1
Food and Drug Administration
U. S . Customhouse
2nd and Chestnut Streets, Rm. 900
Philadelphia, PA 19106

Branch Chief HFF-314
FDA/CFSAN
200 C. Street S.W.
Washington  D.C.  20204

Lloyd F. Novick, MD
NY State Health Department
Empire State Plaza - Corning Tower, Rm. 695
Albany, NY  12237

Bill Smith, Associate Coordinator
Pesticide Chemicals
Department of Entomology
Cornell University
Ithaca, NY  14853

Thomas C. Jorling, Commissioner
New York State Department
of Environmental Conservation
50 Wolf Road
Albany, NY  12233-0001

Attn:  Norman H. Nosenchuck, P.E., Director
       Division of Hazardous Substances Regulation

A review of your request for a specific exemption for the use of fosetyl-Al
(Alietta) on grapes to control downy mildew has been completed.  I hereby deny
your request.

In the recent Les v. Reilly decision, the Uniterd States Court of Appeals,
Ninth Circuit, held that the Delaney clause in section 409 of the Federal
Food, Drug, and Cosmetic Act (FFDCA) barred the establishment of a food
additive regulation for any pesticide which meets the induce cancer standard
no matter how infinitesimal the risk.  This decision became effective March
19, 1993.  As a result of this decision, EPA and FDA have adopted the
following policy for emergency exemptions under FIFRA.

EPA will not grant an emergency exemption, will overturn any crisis exemptions
granted by states and or other federal agencies, and will revoke any emergency
exemption currently in force for a pesticide if (1) the pesticide is likely to
meet the Delaney clause's induce cancer in animals standard (e.g., the
pesticide is classified in group A, B, or C under EPA's Cancer Assessment
Guidelines or has been treated as if it falls under one of those
classifications); and (2) EPA is unable to conclude that, under existing EPA
policy, the particular use of the pesticide would not need a food additive
regulation.  EPA will consider departing form this policy only in
circumstances which are truly extraordinary, such as a public health
emergency.

This was adopted for repeat applications because EPA believes that, for
pesticide uses which meet the above criteria, the progress toward registration
consideration weighs heavily against granting such applications.  Where a
pesticide use needs a section 409 food additive regulation but that regulation
is barred by the Delaney clause, EPA will not register the use, and thus
progress toward registration cannot be made.

Consideration of the progress toward registration is not an explicit
requirement for the approval of emergency exemptions for first time
applications.  However, EPA has interpreted the unreasonable adverse effect
standard as having as  a component evaluation of whether all needed tolerances
and food additive regulations have been established.  See 40 CFR 152.112.
Because compliance with the unreasonable adverse effect standard is an express
part of the emergency exemption approval process, EPA believes consideration
of the likelihood that needed tolerances and food additive regulations could
be approved can be considered for first-time emergency exemption applications.
Here, use of fosetyl-Al on grapes would need a food additive regulation under
EPA's existing policies.  However, because fosetyl-Al has been classified in
group C under EPA's Cancer Assessment Guidelines it is unlikely that a food
addition regulation for fosetyl-Al on grapes could be granted.

Additionally, whether or not EPA considers the ability to register this
pesticide use directly in ruling on this application, EPA believes it is
within its discretion to deny applications, in those circumstances where FDA
has stated that it will not exercise its enforcement discretion to allow foods
bearing residues resulting form use under the emergency exemption.  EPA does
not believe it would be rational to approve an emergency exemption only to
have FDA seize the treated crops.  As the attached policy statement makes
clear, FDA would not exercise enforcement discretion for uses that need food
additive regulations where it is unlikely that a food additive regulation
could be approved under the Delaney clause.

The Agency is denying your request for the following reasons.

EPA's Health effects Division Peer Review Committee has classified fosetyl-Al
in groups C under EPA's Cancer Assessment Guidelines (HED Peer Review Document
dated 6/12/86).  Although fosetyl-Al is currently being reevaluated by the
Peer Review Committee, it is being treated as if it falls under Group C at
this time.

Further, residue data submitted in section 18 applications from Michigan and
Pennsylvania show that this use would need a food additive regulation under
existing policy, because the data indicate concentration of residues in dry
grapes pomace and raisin waste.

Given the limited time and data available, EPA was unable to determine whether
the exception to the Delaney clause pertaining to certain pesticide residues
in animal feeds ("DES proviso") would apply to this pesticide use.  If you
believe that the DES proviso does cover this use, you may resubmit your
application if you supply data and analysis in support of your position.

Finally, there is no basis to conclude that any extraordinary circumstance
justifies the issuance of this exemption.  These facts lead EA to deny the
subject exemption.  Under current EPA policies, t his use, in all (likelihood,
could not be registered and, as explained above, EPA believes, absent
extraordinary circumstances, that emergency exemptions should not be grated in
such circumstances.  Additionally, because FDA would not exercise enforcement
discretion regarding residues resulting form this use, EPA does not believe it
is appropriate to grant this emergency exemption use.

If you believe this specific exemption should not be denied, you are welcome
to present data and arguments challenging EPA's factual conclusions or
rationale for denying the exemption.  If you have any questions please do not
hesitate to contact me or members of my staff at (703) 308-8417.

Douglas D. Campt, Director
Office of Pesticide Programs (H7501C)