GMO Myths and Truths

data on GMOs available on the Internet.
However, in the US, significant portions of the
data submitted to regulators are classified as
“commercially confidential” and are shielded from
public scrutiny. 41
2.1.5. Europe’s comparative safety
assessment: Substantial equivalence
by another name
Europe’s GMO safety assessment process is still
evolving. The European Food Safety Authority
(EFSA) is in danger of following the US FDA in
adopting the concept of substantial equivalence
in its GM food assessments – but under another
name. EFSA does not use the discredited term
“substantial equivalence” but has replaced it
with another term with the same meaning:
“comparative safety assessment”.
The change of name was suggested in a 2003
paper on risk assessment of GM plants. 42 The paper
was co-authored by the chair of EFSA’s GMO Panel,
Harry Kuiper, with Esther Kok. In 2010 Kok joined
EFSA as an expert on GMO risk assessment. 43 In
their paper, Kuiper and Kok freely admitted that
the concept of substantial equivalence remained
unchanged and that the purpose of the name
change was in part to deflect the “controversy” that
had grown up around the term. 42
At the same time that Kuiper and Kok
published their 2003 paper, they were part of a
task force of the industry-funded International
Life Sciences Institute (ILSI), that was working
on re-designing GMO risk assessment. 44 In 2004
Kuiper and Kok co-authored an ILSI paper on
the risk assessment of GM foods, which defines
comparative safety assessment. The other coauthors
include representatives from GM crop
companies that sponsor ILSI, including Monsanto,
Bayer, Dow, and Syngenta. 45
EFSA has followed ILSI’s suggestion of treating
the comparative safety assessment as the basis for
GM safety assessments. EFSA has promoted the
concept in its guidance documents on assessment
of environmental risks of GM plants 46 and of risks
posed by food and feed derived from GM animals, 47
as well as in a peer-reviewed paper on the safety
assessment of GM plants, food and feed. 48
In 2012, the EU Commission incorporated
the industry- and EFSA-generated concept of
the comparative safety assessment into its draft
legislation on GM food and feed. 49
A major problem with the comparative safety
assessment is that, as the name suggests, the
authorities are beginning to treat it as a safety
assessment in itself, rather than as just the first
in a series of mandatory steps in the assessment
process. In other words, EFSA and the EU
Commission are moving towards a scenario
in which GM crops and foods that pass this
extremely weak initial screening may not be
subjected to further rigorous testing.
2.1.6. GM foods would not pass
an objective comparative safety
assessment
The comparative safety assessment is a weak test
of safety. Yet if it were applied objectively, GM
crops and foods would not pass even this stage of
the risk assessment. This is because as is explained
above (2.1.2), many studies on GM crops show
that they are not substantially equivalent to
the non-GM counterparts from which they are
derived. There are often significant differences
in the levels of certain nutrients and types of
proteins, as well as unexpected toxins or allergens.
GM proponents have sidestepped this problem
by widening the range of comparison. Adopting a
method originally used by Monsanto in an analysis
of its GM soy, 50,51 they no longer restrict the
comparator to the GM plant and the genetically
similar (isogenic) non-GM line, but recommend
as comparators a range of non-isogenic varieties
that are grown at different times and in different
locations. Some of this “historical” data even dates
back to before World War II. 52
ILSI has created a database of such published
data, including data on unusual varieties that
have untypically high or low levels of certain
components. EFSA experts use this industry
database to compare the composition of the GM
plant with its non-GM counterparts in GMO risk
assessments. 44,53
If, on the basis of this “comparative safety
assessment”, EFSA experts judge the GM crop
to be equivalent to its non-GM counterpart, it is
assumed to be as safe as the non-GM variety. 44,54
GMO Myths and Truths 27