February 20, 1974

Mrs. Betty Rae Stevick

Chairman

Realth Task Group

Arlington Branch

American Association of University Women
Arlington, Virginia

Dear Mrs. Stevick,
Thank you for your letter of February 14th.

The position I have taken on the Delaney Amendment is that, for
the time being, its practical advantages ae a deterrent to the introduction
of potentially dangerous additives far outweighs the technical criticisms
that can be lodged against it. The statement that was quoted in your
letter from the subcommittee hearings is perhaps derived from the language
of my talk at the Forum, a few pages of which are enclosed, but is un-
fortunately susceptible to being read out of context. As you will see
from my remarks about cylcamates, I have for a long time tried to in-
crease public vigilance about food additives; however, I have also believed
it essential that we develop the technical insight that is required to
justify long-range policy on careful, measured, quantitative considerations.
It is clear that a great many compounds have the potential of some low
level of carcinogenic effect —~ undoubtedly including natural metabolites —
and I fear that concerns about food additives will be discredited if we
take an arbitrary position rather than one that seeks to examine and to
balance benefits and risks. As far as I am concerned, this ie still a
hypothetical problem and I have no quarrel with any of the regulatory
actions on food additives that the FDA has undertaken to date. It is
also true that Mr. Hutt believes that the Delaney Amendment is relatively
unimportant but its existence on the statute books is undoubtedly a
significant reminder to an agency that has no always been so responsive to
these needa. I agree, that at least as far as I am aware, that as quoted
in your letter no instances of extraordinary justification have yet been
presented or documented, although it is hard to understand how tobacco can
be exempted from regulatory control except under such a doctrine.

I am not sure whether the Delaney Amendment does or does not apply
to natural products. The very first entry in the food chemicals codex,
and a typical member of the socalled GRAS group, is acacia, or gun arabic.
There are of course hundreds of other vegetable products of this kind that
could be regarded either as foods or as food additives, and I suspect
would be embraced by the Delaney Amendment if they presented a clear
hazard under its terms, If you have other legal advice to the contrary, I
would be interested to see it.
Mra. Betty Rae Stevick -2- 2/20/74

One specific example of a food stuff which contains a highly
suspect constituent is horse raddish. I do not mean to suggest that
horse raddish or mustard necessarily present significant hazards to
human health in the quantities ordinarily consumed. The critical
constituent, allyl isothiocyanate, has been reported to be carcinogenic
when applied to the skin, but I know of no studies upon which one could
rely fpo its safety or toxicity when fed to any animal. I would be
surprised if this compound were not carcinogenic, albeit at probably ea
rather low level, if fed, and were this to be pursued I suspect that
FDA would have a dilemma with regard to allowing the sale of synthetic
mustard ofl. This would then raise an interesting question with respect
to allowing natural sources of the same material to continue to be marketed.

Aflatoxin presents a very similar question and I would be interested
indeed in whether the legal doctrine has been tested that peanuts used as
inputs to food processing applications might be obliged to earry a zero
tolerance for the presence of mobdjy peanuts, a condition that would be
impossible to verify in practice if the term is teken literally. Perhaps
indeed a legal technical distinction will be sustained as between a raw
agricultural product, and specific chemical consituents obtained therefroa;
this would hardly seem to be a very rational way to make policy distinctions.
However, I say this from a very different vantage point than the one that
is attributed to me by implication of wanting to overturn the Delaney
Amendment. Certainly it should not be disturbed until we have efi1l more
effective means of technical control to take its place and these are not
now in sight.

Most of ay discussion at the Forum was concerned vith drugs rather than
with food additives. However, I enclose some of wy other writings on the
subject. If you will read them in chronological order, I think you will
have a fair idea of my present day viewpoint.

Sincerely yours,

Joshua Lederberg
Professor of Genetics

JL/rr
Enclosures