H=RCUL£S INCORPORATED

MAR e

1970

March 4, 1970

Mr. Carrol S. Well
Mellon Institute
4400 Fifth Avenue
Pittsburgh, Pennsylvania 15213
Dear Carrol:
After hanging up from our telephone conversation yesterday,
I re-read our statement for MCA on the Delaney Clause, and concluded
that your comments were well conceived. Consequently, 1 deleted some
of the preamble and reorganized some parts of the statement and sent it on
to Taylor Hanavan. He has agreed, A copy of the new version is enclosed.
Thanks for your comments, Carrol.
Sincerely,

John P. Frawley, Ph.D.
Chief Toxicologist
JPF:wh
Pnclosure
cc:

Taylor Hanavan

general legal

HER. 1376 200M 7 68 31SI6
► HINTED IN U.fc.A.

permanent
temporary

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1

Section 409 (c) (3) of the Federal Food, Drug, and Cosmetic Act
states that "No such regulation shall issue if a fair evaluation of 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 regulations, 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; ..."
The Act as presently constituted imposes a per se concept 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 fallacy of a per se approach to a scientific
question of this type.

The 1938 Act in effect imposed a per se concept

,*y

that fi/substance which was found harmful or deleterious at some level
was prohibited from use at any level.

However, experience over the years

demonstrated that such a non-scientific approach was unreasonable and
unnecessary.

With the Food Additives Amendment of 1958, Congress recognized

the need for reasonable scientific judgment in the evaluation of safety 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 1958, Congress reimposed

the per se concept with respect to cancer; despite the fact that past
-iW*'

experience had demonstrated it to be unworkable. ^The recent cyclamate
experience confirm^ the unworkable nature of the Amendment, if it is
interpreted in a literal or strict sense.

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-

Because of scientific advances, the continued existence and enforcement
of the Delaney Clause poses a serious threat to production of food and to
the development of new products which would contribute to food technology
and quality of the food supply.

With today's analytical procedures, almost

any substance in some quantity is capable of detection 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 approval or to ban the additive involved.

Strict

application of the Delaney Clause could force the Secretary to ban hundreds
of food additives essential to maintaining public nutrition, especially amongst
the poor.
Elimination of the Delaney Amendment automatically would not
authorize the Secretary to set tolerances for carcinogens.

As with any

other toxic effect before any such tolerance could be established, the
Secretary as a matter of scientific judgment would have to conclude from
the scientific evidence available whether a threshold limit could or should
be established for a suspected carcinogen.

There is general agreement that

in some cases it is possible to set such threshold limits.

Yet the Delaney

Amendment as phrased precludes any scientific judgment - the same scientific
judgment which Congress entrusted to the Secretary for the safeguarding of
the public health with respect to all other toxic effects which can be
produced in experimental animals, including death.

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There is no reasonable justification for continuing the Delaney
Amendment in any form.

However, it would be difficult from a legislative

enactability point of view to accomplish outright repeal.

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
carcinogenicity.

To this effect, we would suggest that the semicolon and

the word "or" be deleted from the last sentence of the so-called Delaney
Amendment and the following language added:

•

", . . unless in the opinion of the Secretary
sufficient evidence exists to permit establishment of a safe or toxicologically insignificant
level of intake for man of such substance so
found to induce cancer."

c^-T

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