ATLAS

CHEMICAL

INDUSTRIES, i n c
WILMINGTON.

DELAWARE

18009

March 2, 1970

Mr. Morgan M. Hoover
Manufacturing Chemists Association
1825 Connecticut Ave. , N.W.
Washington, D. C.
20009
Dear Morgan:

SUBJECT;

Policy Statement re
Delaney Amendment '

I do not agree with the following statement on
page 1:
Other than the recent application by FDA
of the Delaney Amendment to cyclamates, the
Amendment has not been a serious impediment
to intelligent regulation since its enactment
in 1958.
My disagreement also applies, of course, to "The
lack of significant interference to date" line 2 from the
bottom of page 1.
Moreover, I believe this sentence should
be modified to state that the amendment has posed an unreal­
istic insurmountable burden, etc.
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My reasons are as follows.
Polyethylene(8) stearate
had been used as a direct additive for many years in the United
States.
The validity of its safety status was questioned.
As
a result, extensive new feeding studies were performed.
These
tests included two, two year feeding studies by FDA in rats
at 0, 2, 5, IQ and 25% of the diet.
At the 25% level, 28 of
the 174 rate's had bladder stones and of these, 13 had bladder
tumors.
Of the 13 bladder tumors, 4 were malignant.
None of
the other levels of feeding had any bladder stones or bladder
tumors.
The Food Protection Committee considered this as well
as other data in its report "The Safety of Polyoxyethylene(8)

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Mr.

Morgan M. Hoover

2

March 2, 1970

Stearate for Use in Foods" Publication 646 December 1958 and
concluded that the material was safe for use at a level ade­
quately sufficient to include the bread use as well as some
other minor uses.
However, FDA took the position, presumably from a
legal or administrative view, that this material was banned
by the Delaney clause even though the effect was secondary
due to the bladder stones at the 25% level.
While I have
no written statement of FDA's position (and it was not
challenged), the position of FDA is confirmed by the fact
that there were other polyoxyethylene derivatives fed in the
same studies that did not produce the bladder stone effect.
These other derivatives are permitted for various uses in the
Food Additive Regulations.
In attempts to develop bread additives equivalent
to polyoxyethylene(8)stearate, food technology laboratories
still use polyoxyethylene(8)stearate as the outstanding product
for comparison purposes.
It is also interesting to note the polyoxyethylene(8)
stearate is permitted for rolls and other non-standardized
yeast-raised products in Canada which has no Delaney clause.
On page 2, first complete sentence, I question the
advisability of suggesting that the clause could be construed
to mean any tumor' regardless of its pathological description.
My Webster 1s for the medical definition limits the same to
"malignant" in two places and says specifically carcinoma or
saracoma.
Also., I believe FDA has been pretty consistent in this
interpretation.
It is my understanding that the final hold up
on the FDA cyclamate ruling was to obtain a special panel at NRC
to confirm FDA's judgment that the tumors were malignant.
Since
this was the only question asked, the panel had nothing to say
about safety.
Lastly, the proposed change on page 4 seems to me to

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/

Mr. Morgan M. Hoover

3

March 2, 1970

be inserted in a rather odd place, namely, at the end of
all the exceptions regarding animal feeds.
Wouldn't it be
better to insert this change after the clause you quote on
page 1 (which is really the Delaney Amendment) and then go
oh with the exceptions regarding animal feeds?

Very truly yours,

Kenneth E. Mulford,
Assistant to the President

KEMiAG

cc;

Mr.
Mr.
Mr.
Mr.
Dr.

Taylor Hanavan (DuPont)
William A. Knapp(Allied Chemical)
Jack Frawley
(Hercules)
Robert Miller
John A. Zapp, Jr. (DuPont)

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