Agriculture Reference
In-Depth Information
Animal Feeding Studies
Agnes E. Ricroch,
1
* Aude Berheim,
1
Chelsea Snell,
1,2
Gérard Pascal,
3
Alain Paris
4
and Marcel Kuntz
5
1
Université Paris-Sud, CNRS, AgroParisTech, Paris, France;
2
University of Nottingham, Loughborough, UK;
3
INRA, Saint Alyre
d'Arlanc, France;
4
INRA, met@risk, AgroParisTech, Paris, France;
5
CNRS/CEA/Inra/Univ. Joseph Fourier, Grenoble, France
In the EFSA report, it is therefore suggested
that:
h e use of 90-day studies in rodents should
be considered for the detection of possible
unintended ef ects in food and feed derived
from GM plants which have been more
extensively modii ed in order to cope with
environmental stress conditions like drought
or high salt conditions, or GM plants with
quality or output traits with the purpose to
improve human or animal nutrition and/or
health.
In the European Union, the European Food
Safety Authority (EFSA) holds the re-
sponsibility to assess the safety of genetically
modii ed (GM) food and feed. It recommends
that:
h e safety assessment of GM plants and
derived food and feed follows a comparative
approach, i.e. the food and feed are compared
with their non-GM counterparts in order to
identify intended and unintended
(unexpected) dif erences which subsequently
are assessed with respect to their potential
impact on the environment, safety for
humans and animals, and nutritional quality.
(EFSA, 2008)
h e GM line is compared to its near-isogenic
counterpart, according to specii c determin-
ants such as molecular characteristics and
agronomic and phenotypic traits (see
Chapters 3 and 4). When 'molecular, com-
positional, phenotypic, agronomic and other
analyses have demonstrated equivalence of
the GM food/feed, animal feeding trials do
not add to the safety assessment' (EFSA,
2009; updated in EFSA, 2011; see Chapters
5 and 6). However, valuable information can
be added to the assessment of GM food and
feed safety by animal feeding studies,
especially if elements are found that lead to
the suspicion of possible undetected ef ects.
(EFSA, 2008; see Chapter 7)
h e protocols for
in vivo
toxicological studies
are adapted from the 90-day rodent study
depicted in OECD Test Guideline No 408
(OECD, 1998). h e guidelines describing the
90-day rodent study serve as a basis to
dei ne the experimental material; to test the
practical conditions (target animal species,
housing, number of doses administered,
gender and number of animals, etc.); and to
i nd the appropriate methods used to
measure phenotypic responses (body
weight, food consumption, clinical bio-
chemistry, etc.) for
in vivo
toxicological
studies. h e last few decades have seen a
growing presence of low molecular weight
xenobiotics (drugs, pesticides, additives).
h is has led to a rei nement and an
improvement of toxicological assessments
that constitute a solid foundation for the
