MEMORANDUM
TO:

FILE

DATE

February 3, 1970

subject:

MCA-FDCC Conn
Delaney Clause

Meeting of subcommittee of FDCC Committee of MCA
to draft revision of Dalaney clause in FDC Act.
Those .
present were Mr. Taylor Hanavan, du Pont, Chairman;
Dr.
John Zapp, du Pont, Dr. Jack Frawley, Hercules, Mr. Robert
Miller, Hercules, Mr. Morgan Hoover, MCA, and the writer.
Although the Nelson bill (S3295) eliminates the
GRAS (generally recognized as safe) list MCA was not asked
to comment on this aspect.
Mr. Hanavan will draft the proposed reply to
Mr. Creed Black, Assistant Secrecary of HEW, but the appro­
priate content will be as follows:
(a) that the Delaney clause is not necessary by
reason of the fact that the Secretary is directed not to
issue a food additive regulation if a fair evaluation of
the data fails to establish that the proposed use is safe.
(b) that the present wording of the clause remains
substantial as a present to alleviate any fear that indus­
try would tolerate deleterious effects for food additives,
and
(c) that a proviso be added to present wording to
the effect that "unless in the opinion of the Secretary
sufficient evidence exists to permit the establishment of a
(safe) or toxicologically insignificant level of intake for
man of the substance so found to induce cancer.
It was the concensus of opinion of the group that
simple deletion of the Delaney clause would be politically
unacceptable.
Dr. Frawley indicated that the industry Committee of
the Food Additives Committee of NAS-NRC has advocated repeal
of the Delaney clause but that the NRC had contended it could
not act until asked for its opinion.
They have apparently now
been asked and will submit comment via Dr. Handler, President
of NRC-NAS.
A point of conflict;
Dr. Frawley had heard that
Rep. Delaney was in favor of modification where'*Mr. Hoover
heard from Mr. Black that Rep. Delaney opposed introduction
of legislation to delete.

C-639 (6-63)

PTD. IN U.S.A.

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Although the Secretary now has power to abolish
GRAS list, Mr. Ilanavan believes that legislation would be
required to eliminate prior sanctions.
In answer to question as to what would haooen if
Delaney clause not deleted agreed to general answer that
given right species, amount, time of administration, etc.,
almost any substance might be carcinogenic (i.e. not mention
specific oroducts or types of products which might be in
danger of elimination).
Further_Notes_ on Delaney_ Clause Meeting
(1)
Zapp commented on legislative history of Act ~
In 1938 believed there was sharp line between poisonous and
non-poisonous substances;
by 1958 knew this assumption was
false but believed substances were carcinogenic or not - now
know that this also in error - carcinogens weak or potent.
(2)
See paper by Epstein and Lijinski - Nature,
January 3. 1970.
Believe NaN02 is precurser of nitrosamines
in body - these potent carcinogens - no presently known sub­
stitutes for nitrates and nitrites in curing meat - other sub­
stances do not retain red color.
Smoked meats use nitrates and other thincs - now
smoke only few hours and after injection with needle.
(3)
Du Pont feeding studies on regeherated cellulose
for Lehman of FDA, then had to do a lot of additional work for
Cellophane reg. because this not regenerated cellulose i.e.
other things added.

W. A. Knapp
Consultant - Toxicology

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