2

on July 20, 1972, which explained that the new controls over the use of
DES in animal feed were instituted because of reports of misuse of DES
resulting in illegal residues, but which emphatically distinguished the
facts with respect to implants, saying:

"No new restrictions were instituted for DES administered by
implant because no violations were or have been found." (P. 3).

This assurance with respect to the safety of implants was reaffirmed
specifically by FDA witnesses, and by an industry witness, before the FDA
National Advisory Drug Committee in a public hearing at FDA on July 25,
1972. The FDA's own investigations thus prove that the factual basis
stated by Commissioner Edwards for the withdrawal of approval of appli-
cations relating to DES (37 F.R. 12251, 12252) does not apply to implants.
As the proven safety record of the implant method of administering
DES shows, it inherently provides a positive and specific means of
control. The conditions for the administration of implants specified
in the label instructions for implants marketed by Vineland, for example,
are simple and easy to follow. Clearly, there is no factual or legal

་

basis for the withdrawal of approval of new animal drug applications which

provide for the use of DES in implants.

Moreover, the alleged increase in the number of DES violations reported by the Department of Agriculture is based upon questionable data developed by the Department of Agriculture's use of a new chemical assay method to report purported detections of DES residues substantially below 2 parts per billion (ppb). According to the testimony to this Subcommittee

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on July 20, this new assay method has not been officially published by the Food and Drug Administration because it has not yet been validated as a reliable means for detecting residues below 2 ppb. Whether the new method is more sensitive than the officially prescribed method, therefore, is seriously in question and the alleged increase in the number of violations reported may in fact be so-called "false positives" resulting from the new method.

Such questionable data cannot validly support the total withdrawal of DES from use. Even if it may have some genuine value as an alert to re-examine and improve control procedures and techniques for administration of DES, such efforts should be directed specifically to uses which have developed violations, not towards the use of DES in implants. Specifically, neither new legislation nor new regulatory actions with regard to DES should be permitted to involve or jeopardize in any way the administration of DES by the proven and safe implant method.

Respectfully submitted,

James L. Kaler

James L. Kaler

710 Ring Building

Washington, D. C. 20036

Counsel for Vineland Laboratories, Inc.

July 27, 1972

84-843 72-6