This article originally appeared in Food in
Canada and is republished with the permission of the
Here's a little true story I've used with my students to
show that non-science considerations are always necessary and
appropriate in science-based regulation. It illustrates how shallow
and misleading is the current discussion about the need for greater
separation between science and politics, an argument currently
advanced by many academics and public sector scientists.
Once upon a time about 20 years ago when I was still a food
regulator, a considerable body of research began to show that
neural tube defects (NTDs) in newborns, such as spina bifida and
anencephaly, could be significantly reduced if women took folic
acid supplements in the months before and just after conception.
But this is before most women know they are pregnant, and in the
U.S. more than half of pregnancies were unplanned. So regulators
there decided to require the fortification of a common food and
proposed to require the mandatory fortification of flour with folic
Health Canada, concerned about the health hazard to the general
population and citing the precautionary principle, wrote the U.S.
Food and Drug Administration (FDA) urging it not to act until the
science was clearer. Aware of the growing evidence of the
effectiveness of folic acid, the FDA decided it could not wait for
all the science, applied the precautionary principle and made
fortification of flour mandatory (proving, once again, that the
precautionary principle is never helpful as an aid to
decision-making but always useful to justify decisions arrived at
for other reasons — but that's a topic for another
This is where the story gets interesting. Under Canadian law,
once the American regulation came into effect, Canada would have to
ban the importation of all products containing the fortified flour
and we could no longer export flour products to the U.S. That's
a lot of food. Under trade laws, Canada would have to have a
science-based risk assessment to show that the fortification was
unsafe. We had no such science. Scientists conduct science-based
risk assessments, then elected politicians and their senior
advisors take the science and weigh it with economic, political,
environmental, legal and ethical factors (this is not
politicization of science; this is evidence-based policy making.)
Appropriately applying non-science considerations, Health Canada
rushed through a regulation matching the U.S. law, coming into
effect the month before the American change. This continues to be
our law today: see B.13.001, Food and Drug Regulations
Now, 17 years later, 76 countries have followed Canada and the
U.S. and require mandatory folic acid fortification of at least one
major cereal, with nearly all fortifying at least wheat flour.
Studies show a significant reduction in NTDs in those countries
with fortification. In Canada the reduction is estimated to be as
much as 46 per cent.
But mandatory fortification is still a controversial public
policy option. Citing safety concerns, no European Union country
has mandated fortification. In New Zealand the issue is still hotly
debated, with an interesting alliance between the Green Party and
the Association of Bakers describing mandatory fortification as
"mass medication" of the food supply, and insisting that
the argument for fortification is not "science
In the U.K., the Food Standards Agency has recommended
fortification, but the debate continues: both sides insist that the
position of the other is "not backed by science." In
Canada, the department that initially fought fortification now
highlights that "the decline in rates of NTDs in Canada is a
tremendous public health success story." A major science
journal recently described folic acid fortification as "one of
the most successful public health initiatives in the past 50 to 75
What's the moral of our story? Policy considerations enter
into every stage of the process of science risk assessment. You
can't take policy out of science yet much of our public
discourse is still dominated by the quaint Utopian view that
science and policy can, and should, be strictly separated. We
urgently need to engender a broad debate about the role of science
and scientists in policy making.
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