MANUFACTURING CHEMISTS ASSOCIATION
1825 CONNECTICUT AVENUE, N W# WASHINGTON. D. C. 20009* (202) 483-6126

February 24,

To:

1970

FOOD, DRUG, AND COSMETIC CHEMICALS COMMITTEE
Subject:

MCA Position re Delaney Clause

Gentlemen:
I attach a draft dated February 24 of the subject
statement developed by a task group appointed by your
chairman.
The task group consisted of Taylor Hanavan
as chairman. Bill Knapp, and Jack Frawley.
The state­
ment has the approval of Bob Miller and John Zapp who
assisted the task group.
Your chairman is also in
agreement.
If you have any basic disagreement, it is important
that you let me know by Friday, February 27.
Sincerely yours.

M. M. Hoover, Secretary
Food, Drug, and Cosmetic
Chemicals Committee
MMH:gr
Attachment
Distribution "C"

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Section 409(c)(3)

of the Federal Food,

Drug,

and Cosmetic

Act states that "No such regulation shall issue if a fair evalua­
tion 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;..."

Other than the recent application by FDA of the Delaney Amend­
ment to cyclamates,

the Amendment has not been a serious impediment

to intelligent regulation since its enactment in 1958.
To date,

the term "cancer" as used in the Amendment has been

limited to malignant tumors and the mere presence of non-malignant
tumors 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 reliable and practical protocols

for cancer testing have been devised.
such protocols has

As a result,

testing by

not been a routine requirement by FDA as part

of the safety evaluation of new additives.
The lack of significant interference to date does not mean
that the Delaney Amendment could not in the future become an

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unrealistic insurmountable burden which could pose a serious threat
to the development of new products which would contribute to food
technology and quality of the food supply.

The Act could be con­

strued to include within the term "cancer" any tumor regardless of
its pathologic description.

New protocols may be proposed which go

beyond what is scientifically reasonable and the economic para­
meters of new product development.

Most significant,

that with today's analytical procedures,

however,

is

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,
administration,

dosage form,

timing and method of

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.
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 demon­
strate the fallacy of a per se approach to a scientific question

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of this type.

The 1938 Act in effect imposed a per se concept

that a 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.
ment of 1958,

With the Food Additives Amend­

Congress recognized the need for reasonable scientific

judgment in the evaluation of safety by authorizing the Seer tary
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,

imposed the per se concept with respect to cancer;

Congress re­
despite .the

fact that past experience had demonstrated it to be unworkable.
The recent cyclamate experience confirms the unworkable nature of
the Amendment,

if it is interpreted in a literal or strict sense.

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 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 Amend­

ment as phrased precludes any scientific judgment - the same

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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.
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 Delan y
Amendment and the following language added:
"... unless in the opinion of the Secretary
sufficient evidence exists to permit establish­
ment of a safe or toxicologically insignificant
level of intake for man of such substance so
found to induce cancer."

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