We won! That is, the forces of science-based public health
policy seem to have won — if not the war, at least a major battle.
At long last, federal risk assessors and regulators have come
around to the view that administering chemicals to rodents in
super-high doses does not reliably predict human risk — of cancer,
or anything else — and that a better method needs to be employed,
if we are to avoid more unnecessary bans, anti-chemical media
hysteria, and activist crusades.
High dose animal tests on one rodent species don’t reliably
predict cancer risk in another rodent type, much less in humans.
The same tests for “carcinogens” that are used to condemn synthetic
chemicals also give false positive findings for a whole spectrum of
natural substances that we safely eat, breathe, and drink every
day.
The sort-of good news is that the National Institutes of Health
(NIH) and the Environmental Protection Agency (EPA) just announced
a new collaboration: the development of a “new paradigm” for
testing potentially toxic chemicals. Drawing upon the unique
testing methodologies to be found in their various sub-agencies,
they plan to shift from testing chemicals on whole animals to
testing the chemicals on cells and “isolated molecular targets,”
using high-speed, automated screening robots.
It sounds a bit science-fictiony — a brave new world, perhaps,
of chemical toxicity testing. Bypassing the high dose, long-term
animal experimentation for test “subjects” — cells — in Petri
dishes will undoubtedly save the government testers a lot of money
(and also spare the lives of many rats and mice). But the real
question is, will it bring some sense to the testing process for
evaluating suspected chemical toxins?
ONE GOOD THING can be deduced from this new collegiality. It seems
to be a clear (and overdue) acknowledgment of what my colleagues at
the American Council on Science and Health have been telling
federal risk assessors (and the public) since our group was founded
in 1978: the old way of testing for chemical carcinogens is not
valid. In our 2005 book America’s War on “Carcinogens”, we
warned against allowing high-dose rat tests to paint us into a
regulatory corner — leading to bans and restrictions on hundreds
of chemicals merely because rodents became ill after long periods
of high exposure.
Forty-plus experts in various relevant fields reviewed our
publication and agreed with our conclusions: high-dose animal tests
do not predict human toxicity or cancer risk. Yet, when we tried to
get someone in the regulatory bureaucracy to acknowledge this fact
— well known to toxicologists for decades — we were met with
either stony silence or the disingenuous, “Well, we know, but we’ve
been doing it this way for years, and we have nothing to replace it
with.” Not a resounding endorsement for a system that has cost our
economy billions in regulatory compliance efforts over decades.
DURING THE CREATION of our book, we asked the then-director of the
Harvard Center for Risk Analysis, George M. Gray, Ph.D., to review
it. He was so enthusiastic, he agreed to write its preface, and he
stated (among other things) that animal testing was “badly flawed.”
Relying on such tests “can have important public health
consequences.” Gray added: “It is important for public health [that
this book] be heeded.”
However, some months later, when we (with the help of the
Washington Legal Foundation) petitioned the EPA to re-assess its
approach to carcinogen testing based on our book, who was the EPA
assistant administrator who, after months of stonewalling, rejected
our brief?
The same Dr. Gray. Yet now he has turned up again as a co-author
of the article announcing the “new paradigm” (a phrase echoing from
our book) in chemical testing.
So is a new era coming, one in which real toxins and carcinogens
will be weeded out from the countless hypothetical and negligible
ones that we have spent the past fifty years (and billions of
dollars) pointlessly fighting? That’s still up in the air. My gut
reaction is to say it can’t be any worse than the useless current
method.
But of course, it can be. If the new high-output micro-assays do
show chemical-induced cellular abnormalities, will that
now be taken as conclusive evidence of increased human risk,
without further confirmatory evidence? This is an all too likely
scenario in our “zero-risk” environment. If so, the efficiency of
the new testing paradigm could lead to even more chemicals being
regulated than is now the case using (more lengthy and tedious)
rodent tests.
So before we start celebrating, we should remember to be careful
what we wish for. The larger mission of basing regulatory policy on
scientific sense has not yet been accomplished.
