!! spellx done
178   The Safety of Food
      The Washington Post  November 15, 1969

     Proving the safety of food additives is one of the most difficult
scientific challenges incumbent on governments of advanced
societies.  We have enough problems assuring the adequacy of diets
from basic farm sources that we might be tempted to dismiss new
synthetic compositions altogether, which would still leave plenty
of work for the chemical industry in the imitation of nature.  If
this position is too extreme, we must at least place a great burden 
of responsibility on the promoters of dispensable additives to assure
consumers that they are not victims of callously ignored side-effects
of hasty technology.

     That burden is multiplied for additives which are secondarily
incorporated into processed foods to be eaten by vast number of people
often without their knowledge.  These materials should surely be 
pretested at least as carefully as, say, prescription drugs, which are 
used (ideally) only under the direction of professionals well-informed
about the balance of probable benefits and hurts.

     The Delaney amendments of 1958 established the first U.S. law to
require the pretesting of additives and to place the burden of proving
their safety on industry rather than on the public.  Representative
Delaney's bill also contained the famous clause that specifically 
prohibited any additive "found to induce cancer in man or animal,"
apparently leaving no room for administrative judgment.  In fact, the
clause has never been used (in my opinion) except to lend extra force
to decisions that would have been prudently required from the basic 
requirement for proof of safety.

     Ironically, the "cancer clause" applies only to food additives
and was never extended to pesticide residues, although Representative
Delaney said he had been provoked into writing it by the FDA's 
vacillation about setting tolerances for a mite-killer, "aramite" when 
this was first found to cause liver tumors in rats.

     The recent ban on cyclamates has been applauded by almost all of
my colleagues, but was less popular with the editors of Chemical &
Engineering News, who deplore "the unrealistic and unscientific 
constraints placed on food additives by the Delaney clause." They 
complain that no inference about safety for man should be drawn from  
tests on rats with 50 times the dosage level likely to be used in man.
There is, unfortunately, some merit to the logic of this complaint--but
it is a small comfort.  There are undoubtedly cancer-causing compounds
that are unrevealed in less than ten years' application, or for many
other reasons would fail to be detected by animal tests like those
that did indict cyclamates.  There really is hardly any other way 
besides stressing animals with large doses that we can practically
use to pick up potential hazards.

     Obviously, this principle could be used in a wooden-headed way,
and sometimes is.  When we know something of the chemical or biological
actions of a compound like salt or a natural hormone or amino
acid, we can cautiously attempt to relate the effects of lower doses
to the natural environment of the body.  There is no theoretical
reason to believe, however, that the effect of cyclamate is 
proportionately much less at lower doses -- with many carcinogens, the 
observed rule is that lower doses simply take a longer time to take
effect.  Taking account of the failure to find any direct evidence so
far of harmful effect in man.  I would still have to judge that 
continued heavy exposure, especially starting with youngsters, might 
have caused a million cases of bladder cancer in the U.S.-- even if 
humans are intrinsically no more sensitive than rats. This is only 
slightly better than a wild guess, but it might err on either side. Some
cancer-inducers are more effective in malnourished subjects, which
might enhance the effect of cyclamate taken in place of real food.
Others interact with environmental injuries and other chemicals in
ways never yet tested with cyclamates.  There will be a great deal 
of variation among animal strains, and among human individuals.
Finally, good scientific evidence of chromosome-breakage by 
cyclohexylamine ( a known derivative of cyclamate in the body) was
reported a year before the ban.  So we are not completely in the
dark about how cyclamate works.

     FDA's failure to ring the bell on cyclamate with this evidence
alone may be the most important, realistic, and scientific 
justification for the validity of the Delaney amendment.
-----------------------------------------------------------------------