undermine public confidence without adding any compensating features or increased assur-
ance of product safety. The curious public wonders why so many additional and apparently
unnecessary tests are demanded, and speculates that perhaps this product really is more
hazardous than the developer and regulators are letting on. So the barrage of demanded
tests and assays, instead of increasing public confidence, has the opposite effect—the
public becomes even more suspicious and distrustful of both the product and the
regulatory system.
The lesson is simple; to increase public trust as well as to increase confidence in product
safety, before imposing and requiring any test or assay, the regulator should be able to
answer “How will the information from this test/assay help inform or increase confidence
in the safety (or otherwise) of this product?” If the answer is simply “more of the same,”
the regulatory demand is not scientifically valid and disrespects the public right to
effective regulation.
Worldwide, regulations governing products of biotechnology purport to protect health
and environment from the risks posed by the “new” genetic technologies. However,
there is a crucial disconnect between the regulatory approach and actual protection of
health and environment, because the regulations, almost invariably, assume that products
of biotechnology pose greater risk than do similar products generated using other
methods of gene manipulation. Reports from scientific bodies in the United States,
European Union, and elsewhere, going back to the mid-1980s, establish that GMOs (i.e.,
products of biotechnology) are not inherently more hazardous. Therefore, regulations
that specifically capture GMOs for regulatory scrutiny and exempt similar products
produced using non-GM methods of breeding are scientifically unjustified and thus
scientifically invalid.
The ramifications of this approach are clear. Health is sometimes threatened by food-
borne hazards (BSE, dioxins,Salmonellaand foot-and mouth disease outbreaks in EU;
diarrhea-causing strains of Escherichia coli in organic produce in USA; etc.).
Ecosystems and biodiversity have clearly suffered from human agricultural activity and
breeding, such as the introductions of invasive species, particularly in Australia and
North America. To date, there are no verified cases of damage to human or animal
health, or to the environment, from GMOs. All recorded threats come from non-GMOs.
Yet almost all regulations capture for scrutiny only those products resulting from the
process of biotechnology, and explicitly exempt non-GMOs, the sources of all known
damage. The disconnect between the regulatory practice and the scientific recommen-
dations ensures continued threats and damage to health and environment, and will do so
until regulations capture and scrutinize those products posing the greatest risk, regardless
of breeding method.
Recognizing that regulatory resources are limited even in affluent societies means rigid
adherence to the regulatory maxim; regulatory resources should focus on the highest-risk
products. In other words, to be effective, regulatory scrutiny should correlate with degree
of risk. In that situation, regulators will concentrate their expertise to scrutinize true
threats to health or environment, and place less emphasis on those products posing little
or no threat.
Adopting this policy will mean capturing some products currently exempt from regulat-
ory scrutiny, including so-called traditional means of gene modification such as induced
mutagenesis using ionizing radiation. It will also mean exempting some currently captured
12.4. CONCLUSIONS 305