t

!

E. I. du Pont de Nemours & Company
Wilmington, Delaware 19898

DEPARTMENT

Dr. John P. Frawley
Dr. William A. Knapp

My apologies for being slightly off the time
schedule set for your review.

I would appreciate your

comments on the attached as soon as possible.
I have no pride of authorship^ so please dig
in as you see fit.
Very truly yours

Taylor W/ Hanavan
TWH:ema
Attachment

cc:

M. M. Hoover
R. M. Miller
Dr. J. A. Zapp, Jr.

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Section 409(c)(3) states that "No such regulation shall
issue if a fair evaluation o.f the data before the Secretary (A)

fails to establish that the proposed use
of the food additive, under the conditions
of use to be specified in the regulation,
will be safe."

There follows a proviso, the so-called Delaney Amendment,
which states,
"Provided, That no additive shall be deemed
to be safe if it is found to induce cancer
when ingested by man or animal, or if it is
found, after tests which are appropriate for
the evaluation of food additives, to induce
cancer in man or animal;..."
Other than the recent application by FDA of the Delaney
Amendment to cyclamates, the Amendment has not been much of a
burden to industry since its enactment in 1953To date, the term "cancer" as used in the Amendment has
been limited to tumors that matastasize (malignancies) and the mere
presence of benign growths has not resulted in application of the
Amendment.

Moreover, in spite of the efforts of various scientific

groups including a special FDA advisory committee, no special pro­
tocol for cancer testing has been devised.

As a result, no such

protocol has been required by FDA as part of the safety evaluation
of any new additive.
The lack of significant burden on industry to date does
not mean that the Delaney Amendment could not in the future result

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C

in the imposition on industry of an unrealistic^insurmountable
burden which could pose a serious threat to the development of
new products that would contribute to food technology and be bene­
ficial to the food supply.

The Act could be construed to include

within the term "cancer" any growth regardless of malignancy.

New

protocols may be proposed which go beyond what is scientifically
reasonable and the economic parameters of new product development.
Most significant, however, is that with today’s analytical proce­
dures, almost any substance in some quantity is capable of detec­
tion by highly refined analytical equipment and methods sensitive
(to parts per billion and even parts per trillion.

Coupled with

this is the fact that our biological scientists have developed
unique toxicological testing techniques that given the right
species, dosage form, timing and method of administration, almost
any substance can be found to induce a tumor of some type whether
benign or malignant - a result which, however meaningless, might
require the Secretary to refuse to approve or ban the additive
involved.
The Act as presently constituted imposes a per se con­
cept so that the Secretary by statute is precluded with respect
to cancer from exercising any reasonable scientific judgment on
the question of toxicologically significant hazard or risk to man.
Yet the legislative history of the Act and experiences thereunder
demonstrate the inadequacy of a per se approach to a scientific

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question of this type.

We need only point out In this regard that

the 1933 Act In effect imposed a per se concept.

A substance once

found harmful or deleterious at some level was barred at any level
Of use.

However, experience over the years demonstrated that such

a nonscientific approach was unreasonable and unnecessary.

With

the Food Additives Amendment of 1953, Congress recognized the need
for reasonable scientific judgment in this area by authorizing the
Secretary to establish safe limits of a substance for man even
where such substance was found to cause in animals a chronic or
acute toxic response at a higher level or levels.

Yet in 1953,

Congress by the Delaney Amendment also at the last moment reim­
posed the per se concept with respect to cancer; demonstrably
unworkable by past experience and again demonstrated to be unwork­
able by the recent cyclamate experience.
This is not to say that elimination of the Delaney
Amendment automatically would authorize the Secretary to set
tolerances for carcinogens.

Naturally, before any such tolerance

could be established, just as with any other toxic effect the
Secretary as a matter of scientific judgment would have to con­
clude from the scientific evidence available whether a threshold
limit could be established for a suspected carcinogen.

In this

regard, with few exceptions there is fairly general agreement
that at least in some cases It may be possible to set such thresh­
old limits.

Yet the Delaney Amendment as phrased precludes any

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scientific judgment - the same scientific judgment which Congress
entrusted to the Secretary for the safeguarding of the public
health with respect to all other toxicity problems pertinent to
food additives.
Actually, there is no reasonable justification for con­
tinuing the Delaney Amendment in any form.

However, it would be

difficult from a legislative enactability point of view to accom­
plish outright appeal.

For this reason, it is suggested that the

Amendment be revised to restore to the Secretary the right and
obligation of exercising scientific judgment in the area of car­
cinogenicity.

To this effect, we would suggest that the semicolon

and the word "or" be deleted from the last sentence of the socalled Delaney Amendment and the following language added:
"...unless in the opinion of the Secretary
sufficient evidence exists to permit estab­
lishment of a safe or toxicologically insig­
nificant level of intake for man of such
substance so found to induce cancer."

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