genes from one species to another without added hazard.Agrobacterium tumefaciensis a
natural genetic engineer, moving short pieces of prokaryotic bacterial DNA into eukaryotic
nuclei and having the transferred genes integrate into the host genome. Many popular bread
wheat (Triticum) cultivars carry fragments of rye (Secale) chromosomes.
- No jurisdiction has sufficient resources to “test everything for everything,” so a sen-
sible system to prioritize regulatory resources evolved the maxim that products posing the
greatest risk should face the greatest regulatory scrutiny. But this sensible approach has been
abandoned in the case of biotechnology. Consider two canola cultivars, one made resistant
to acetolactate synthase (ALS) inhibitor herbicides using rDNA, and the other with identi-
cal herbicide resistance, except that it was developed using induced mutagenesis. The two
similar cultivars pose similar risks, yet the biotech cultivar faces far greater regulatory
scrutiny. Similar cultivars posing similar risks should face similar degrees of regulatory
scrutiny. - There is an unsubstantiated assumption that the risks posed by biotechnology are
unique and should be evaluated as absolutes. However, risk is relative or comparative.
Instead of asking “What are the risks associated with this GMO crop cultivar?” a scientifi-
cally valid question is “What are the risks associated with this GMO crop cultivar relative to
the risks associated with the conventional cultivar that it will displace?” By focusing exclu-
sively on the “new” thing and ignoring the status quo or current counterpart cultivar, any
identified risk with the GMO cultivar (and everything poses some degree of risk) can be
and has been used as an argument to justify banning the GMO, even though a proper, rela-
tive risk assessment might show it to be substantially superior to the riskier but currently
grown cultivar. - The assertions that regulations are scientifically sound are invariably buttressed by
scientific documentation showing the technical validity of the various assays, tests,
measurements, and other criteria required by the risk assessors. But this line of argument
merely supports the technical, not the overall, scientific validity. Technical skill in con-
ducting a technically sound assay is not sufficient to satisfy scientific validity; it is
necessary in addition to scientifically justify the rationale for conducting the test in the
first place. For example, testing an extracted purified protein from a GM plant for poss-
ible allergenicity might seem a prudent regulatory requirement. But conducting the aller-
genicity trials is not scientifically valid, even if the trials themselves are conducted in a
technically sound manner, unless there is a hypothesis or evidence suggesting that the
protein may actually be allergenic. If the gene were cloned from a known allergenic
source, or if the protein shared amino acid sequence homology with a known allergen,
then yes, the technical allergenicity assays might be scientifically valid and prudently
required. But to demand and conduct such trials merely to show the public that scientific
tests for potential allergenicity were being conducted, or to exercise control over the
developer, fails to increase real confidence in the safety of the product and jeopardizes
public trust when the test was later found to be unnecessary, done only to appease
public concerns. - Most risk assessments of GM plants are overly onerous and unnecessary in terms of
informing risk management policies. Once sufficient data are collected to reach a determi-
nation of relative safety (or otherwise) of the GM cultivar, the law of diminishing returns
kicks in; input resources escalate dramatically, but the additional data gleaned from the
expenditure are usually superfluous and unconstructive. These additional data requirements
304 REGULATIONS AND BIOSAFETY