Agriculture Reference
In-Depth Information
nutritional equivalence and to the food
safety of such lines (see Chapter 3 for
guidance documents). However, if the
nutritional equivalence is still in doubt, it is
advised by some experts to perform
subchronic toxicity 90-day tests to assess
this uncertainty. Considering this step-by-
step framework for risk assessment, long-
term and multi-generational studies would
only be performed if doubt remained after a
subchronic toxicity 90-day study.
Some of the above-mentioned GM events
have also been subjected to 90-day studies
on rats (to the best of our knowledge, such
studies have not been published on 'older'
events such as Bt 11 and Bt 176; however,
short-term studies using various farm
animals are available for Bt 11; see Chapter
6). Notably, no biologically signii cant
dif erences were found between a GM diet
and a non-GM diet in 90-day studies using
glyphosate-tolerant maize (CP4-EPSPS
gene, event NK603; Hammond
et al
., 2004),
glufosinate-tolerant maize (Mackenzie
et al
.,
2007; Malley
et al
., 2007) or insect-resistant
maize (
cry1Ab
gene, event MON810;
Hammond
et al
., 2006). Similar results were
obtained using glyphosate-tolerant soybean
but which incorporated another gene
(DP356043 lines; Appenzeller
et al
., 2008)
in addition to CP4-EPSPS, which has been
subjected to several long-term studies. h e
latter was assessed in short-term animal
feeding studies, including two independent
4-week studies in rats (one with unprocessed
and one with processed soybeans), a 4-week
dairy cow study, a 6-week chicken study, a
10-week cati sh study and a 5-day quail
study (CERA GM crop database).
h us, no evidence is currently available
indicating that long-term feeding studies of
marketed GM crops could detect adverse
ef ects that remained undetected by short-
term studies.
We compiled a total of 33 publications (17
long-term feeding trials and 16 multi-
generational feeding trials; Tables 8.1 and
8.2). All studies were conducted by public
research laboratories. Nine out of the 17
long-term studies performed (Aulrich
et al
.,
2001; Malatesta
et al
., 2002a,b, 2003;
Vecchio
et al
., 2004; Daleprane
et al
., 2009a,
2010; Domon
et al
., 2009; Steinke
et al
.,
2010) and 8 out of the 15 multi-generational
studies (Brake
et al
., 2004; Rhee
et al
., 2005;
Halle
et al
., 2006; Flachowsky
et al
., 2007;
Kiliç and Akay, 2008; Haryu
et al
., 2009;
Krzyzowska
et al
., 2010; Tudisco
et al
., 2010)
did not mention any specii c funding. It was
therefore assumed that all of the studies
compiled here were publicly funded.
feeding studies
h e evaluation of GM-based diets relies on
the general principles depicted in the OECD
Test Guideline (1998) or as discussed by
EFSA (2008):
1.
h e principle of substantial equivalence,
in which the goal is to make possible the
comparison of chemical composition in
macro- and micronutrients and known anti-
nutrients and natural toxicants between
GM lines and unmodii ed near-isogenic
lines.
2.
h e toxico-nutritional response in
subchronic toxicity tests of animals fed
either a GM-based diet or a control diet, and
if necessary, long-term or multi-genera-
tional studies.
Usually, the comparison of GM lines (with
no deliberate metabolic modii cation) and
their comparator shows their nutritional
equivalence. h e whole process of production
of GM commercial lines, including selection
in laboratory and i eld trials by comparison
with known non-GM lines on various
phenotypic traits, contributes strongly to
of a step-by-step approach
Most of the studies compiled here were not
performed in a step-by-step approach as
part of the pre-marketing regulatory
