Risks of GMOs to Biodiversity and Human Health
Norway submitted a review of the science on the adverse effects of genetic engineering on biodiversity, including risks to human health, to the Cartagena Protocol on Biosafety, convened under the Convention on Biological Diversity.
April 19, 2010 | Source: THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE | by
Submission
from Norway on the Risks of GMOs to Biodiversity and Human Health
At
its fourth meeting in 2008, Parties to the Cartagena Protocol on
Biosafety established an Ad Hoc Technical Expert Group (AHTEG) on Risk
Assessment and Risk Management. The AHTEG is considering, among other
things, the framework to identify GMOs or specific traits that may have
adverse effects on the conservation and sustainable use of biological
diversity, including risks to human health.
its fourth meeting in 2008, Parties to the Cartagena Protocol on
Biosafety established an Ad Hoc Technical Expert Group (AHTEG) on Risk
Assessment and Risk Management. The AHTEG is considering, among other
things, the framework to identify GMOs or specific traits that may have
adverse effects on the conservation and sustainable use of biological
diversity, including risks to human health.
Governments
and relevant organizations were invited to submit scientifically sound
information on the types of GMOs or traits that may have adverse effects
on biological diversity and human health that would be compiled and
included in a synthesis report for consideration by the AHTEG and
Parties.
and relevant organizations were invited to submit scientifically sound
information on the types of GMOs or traits that may have adverse effects
on biological diversity and human health that would be compiled and
included in a synthesis report for consideration by the AHTEG and
Parties.
In
its submission, Norway highlighted information from scientific studies
which raise “early warning” signs on the effects of GMOs on biological
environments and on human health.
its submission, Norway highlighted information from scientific studies
which raise “early warning” signs on the effects of GMOs on biological
environments and on human health.
It
noted that GMOs harbouring Bacillus thuringiensis (Bt) Cry endotoxins
may cause unintended direct adverse effects on biological diversity
including but not limited to insects, aquatic life, soil microbes, and
their food web dynamics, as well as on the sustainable use of biological
diversity related to crop plants and their progenitors important for
sustainable agricultural production and food security. Similar caution
was expressed towards GMOs with genes that confer herbicide tolerance as
well as GM plants with tolerance to abiotic stresses such as tolerance
to drought and cold and GMOs with stacked events.
noted that GMOs harbouring Bacillus thuringiensis (Bt) Cry endotoxins
may cause unintended direct adverse effects on biological diversity
including but not limited to insects, aquatic life, soil microbes, and
their food web dynamics, as well as on the sustainable use of biological
diversity related to crop plants and their progenitors important for
sustainable agricultural production and food security. Similar caution
was expressed towards GMOs with genes that confer herbicide tolerance as
well as GM plants with tolerance to abiotic stresses such as tolerance
to drought and cold and GMOs with stacked events.
In
addition, Norway recommended caution with regard to GM fish with traits
such as cold tolerance, increased growth rate or high tolerance to
environmental pollutants. It also noted that GM trees with long
life-spans would be a challenge for risk assessment. Norway also
expressed caution with regard to GM viruses with altered traits and host
specificity and was concerned about GM pharmplants entering the food
chain.
addition, Norway recommended caution with regard to GM fish with traits
such as cold tolerance, increased growth rate or high tolerance to
environmental pollutants. It also noted that GM trees with long
life-spans would be a challenge for risk assessment. Norway also
expressed caution with regard to GM viruses with altered traits and host
specificity and was concerned about GM pharmplants entering the food
chain.
Given
the broad uncertainties surrounding the current scientific knowledge on
the impacts of novel organisms into complex environments, Norway called
for the adoption of the precautionary approach as well as for further
studies, especially long term studies, to be conducted.
the broad uncertainties surrounding the current scientific knowledge on
the impacts of novel organisms into complex environments, Norway called
for the adoption of the precautionary approach as well as for further
studies, especially long term studies, to be conducted.
The
AHTEG is holding its second meeting from 19-23 April in Slovenia, where
it will among other items on the agenda, have the synthesis report of
the submissions available for its consideration.
AHTEG is holding its second meeting from 19-23 April in Slovenia, where
it will among other items on the agenda, have the synthesis report of
the submissions available for its consideration.
With
best wishes,
best wishes,
Third
World Network
World Network
131
Jalan Macalister,
Jalan Macalister,
10400
Penang,
Penang,
Malaysia
Email:
twnet@po.jaring.my
twnet@po.jaring.my
Website:
www.biosafety-info.net
and www.twnside.org.sg
www.biosafety-info.net
and www.twnside.org.sg
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Attachment
1
1
Response
to the call from the CBD secretariat for “submission of scientifically
sound information regarding the identification of living modified
organisms or specific traits that may have adverse effects on the
conservation and sustainable use of biological diversity, taking also
into account risks to human health”.
to the call from the CBD secretariat for “submission of scientifically
sound information regarding the identification of living modified
organisms or specific traits that may have adverse effects on the
conservation and sustainable use of biological diversity, taking also
into account risks to human health”.
Introduction
Beforehand,
there are a number of important considerations with respect to the
scientific appraisal that are not only of value to risk assessors, but
risk managers, when reviewing this information that we wish to make note
of:
there are a number of important considerations with respect to the
scientific appraisal that are not only of value to risk assessors, but
risk managers, when reviewing this information that we wish to make note
of:
First,
we wish to note to the CBD secretariat that it would also be useful to
also request scientifically sound information that document not only
adverse effects, but evidence of safety (as opposed to evidence no
effects) for biodiversity and human health.
we wish to note to the CBD secretariat that it would also be useful to
also request scientifically sound information that document not only
adverse effects, but evidence of safety (as opposed to evidence no
effects) for biodiversity and human health.
Second,
it is important to acknowledge there are broad uncertainties
surrounding the current scientific knowledge on the impacts of novel
biologics into complex environments. This includes appraising the
relevance empirical data collected within specific time and/or spatial
scales under investigation, and especially within particular ecological
or management contexts. Further, it must also be kept in mind the
difficulty in extrapolation of small-scale experiments, or those using
small sample sizes, which often
can
detect only large differences or effects, to real-world effects. In
order to achieve sufficient statistical power, studies utilizing small
sample sizes must accept higher levels of Type II error or “false
negatives” that would miss effects that may indeed in reality be
occurring within the scientific observation.
it is important to acknowledge there are broad uncertainties
surrounding the current scientific knowledge on the impacts of novel
biologics into complex environments. This includes appraising the
relevance empirical data collected within specific time and/or spatial
scales under investigation, and especially within particular ecological
or management contexts. Further, it must also be kept in mind the
difficulty in extrapolation of small-scale experiments, or those using
small sample sizes, which often
can
detect only large differences or effects, to real-world effects. In
order to achieve sufficient statistical power, studies utilizing small
sample sizes must accept higher levels of Type II error or “false
negatives” that would miss effects that may indeed in reality be
occurring within the scientific observation.
Clearly,
more intensive empirical studies are needed to ascertain the likelihood
of field level impacts to biodiversity and human health. As widely
agreed, the case by case approach can best inform what scientific
aspects will be important and relevant parameters for the proposed site
and conditions of investigation. In sum, the emergent uncertainties
should not be equated with risk, but rather incorporated systematically
into any risk characterization. That is, the science evidence may or may
not be informative under certain scenarios or environments, but can,
and should, inform and inspire certain
scientific considerations or needed lines of biosafety
investigation specific contexts. This kind of scientific information
becomes particularly valuable as possible “early warnings”, as without
such data there exists no basis for opening potentially critical modes
inquiry would otherwise be left unexamined, leading to insufficient
protection of environmental and human/animal health. This is especially
important where a precautionary approach is the desired norm, as stated
in the Cartagena Protocol on Biosafety Article 1, which states its
objective to be “[I]n accordance with the precautionary approach
contained in Principle 15 of the Rio Declaration on Environment and
Development”.
more intensive empirical studies are needed to ascertain the likelihood
of field level impacts to biodiversity and human health. As widely
agreed, the case by case approach can best inform what scientific
aspects will be important and relevant parameters for the proposed site
and conditions of investigation. In sum, the emergent uncertainties
should not be equated with risk, but rather incorporated systematically
into any risk characterization. That is, the science evidence may or may
not be informative under certain scenarios or environments, but can,
and should, inform and inspire certain
scientific considerations or needed lines of biosafety
investigation specific contexts. This kind of scientific information
becomes particularly valuable as possible “early warnings”, as without
such data there exists no basis for opening potentially critical modes
inquiry would otherwise be left unexamined, leading to insufficient
protection of environmental and human/animal health. This is especially
important where a precautionary approach is the desired norm, as stated
in the Cartagena Protocol on Biosafety Article 1, which states its
objective to be “[I]n accordance with the precautionary approach
contained in Principle 15 of the Rio Declaration on Environment and
Development”.
Thirdly,
it should be noted that the request for scientifically sound
information also should also follow with a scientifically sound and
logical inference when interpreting this information. For example, a
common logical fallacy in the interpretation of risk data is that
absence of evidence of harm is the same as evidence of absence of harm.
More explicitly, the absence of observable effects should not be
interpreted as evidence safety for any particular effect. The committees
and working groups utilizing this information should not lose sight of
this basic logic when drawing conclusions, especially from risk
it should be noted that the request for scientifically sound
information also should also follow with a scientifically sound and
logical inference when interpreting this information. For example, a
common logical fallacy in the interpretation of risk data is that
absence of evidence of harm is the same as evidence of absence of harm.
More explicitly, the absence of observable effects should not be
interpreted as evidence safety for any particular effect. The committees
and working groups utilizing this information should not lose sight of
this basic logic when drawing conclusions, especially from risk
relevant
scientific evidence derived from statistical hypothesis testing.
scientific evidence derived from statistical hypothesis testing.
Lastly,
and with the above in mind, we wish to call attention to a recent
investigative report that appeared in Nature magazine (Waltz, September
3, 2009) that document ad hominem attacks and other threats towards
scientists who have published empirical evidence of potential adverse
effects of LMOs. The political fallout from such public controversy
creates a kind of scientific silence, where biosafety investigators may
fear retribution for merely publishing their experimental work. As one
prominent scientist interviewed stated:
and with the above in mind, we wish to call attention to a recent
investigative report that appeared in Nature magazine (Waltz, September
3, 2009) that document ad hominem attacks and other threats towards
scientists who have published empirical evidence of potential adverse
effects of LMOs. The political fallout from such public controversy
creates a kind of scientific silence, where biosafety investigators may
fear retribution for merely publishing their experimental work. As one
prominent scientist interviewed stated:
“When
scientists are even afraid to ask the questions¦that’s a serious
impediment to our progress” (Ibid., 32).
scientists are even afraid to ask the questions¦that’s a serious
impediment to our progress” (Ibid., 32).
The
main point we wish to highlight, is that these troubling developments in
the discourse over LMOs likely have led, and will continue to lead to
situations where the adverse effects of LMOs are likely to be under
reported, and under investigated.
main point we wish to highlight, is that these troubling developments in
the discourse over LMOs likely have led, and will continue to lead to
situations where the adverse effects of LMOs are likely to be under
reported, and under investigated.
Given
the often political nature of the scientific debates surrounding the
vital issue of food production, many of the studies mentioned in this
report are not without their critics. Nevertheless, much of the evidence
give compelling insights into the dynamics of novel biologics into
complex ecosystems and the difficulty in establishing safety of use of
modern biotechnologies in agriculture, medicine, and animal husbandry.
Clearly, further research needed to make informed decisions and
conclusions. While appropriate policies regarding LMOs are not limited
only to scientific considerations, science will play an important role
in appraising potential risks.
the often political nature of the scientific debates surrounding the
vital issue of food production, many of the studies mentioned in this
report are not without their critics. Nevertheless, much of the evidence
give compelling insights into the dynamics of novel biologics into
complex ecosystems and the difficulty in establishing safety of use of
modern biotechnologies in agriculture, medicine, and animal husbandry.
Clearly, further research needed to make informed decisions and
conclusions. While appropriate policies regarding LMOs are not limited
only to scientific considerations, science will play an important role
in appraising potential risks.
With
respect to scientific information, we wish to submit the following
requested scientific information on the two classes of potential effects
(A) unintended effects on biodiversity, which includes direct and
indirect effects, and (B) unintended effects on human and animal health.
Both groupings can be further categorized as direct and indirect
effects. Please refer to the end of this report where all scientific
studies and reports under discussion are cited.
respect to scientific information, we wish to submit the following
requested scientific information on the two classes of potential effects
(A) unintended effects on biodiversity, which includes direct and
indirect effects, and (B) unintended effects on human and animal health.
Both groupings can be further categorized as direct and indirect
effects. Please refer to the end of this report where all scientific
studies and reports under discussion are cited.
A.
Scientific information on LMOs or traits that “may have adverse effects
on the conservation and sustainable use of biological diversity”
including direct and indirect effects.
Scientific information on LMOs or traits that “may have adverse effects
on the conservation and sustainable use of biological diversity”
including direct and indirect effects.
A1.1:
Unintended direct adverse effects of Bacillus thuringiensis (Bt) Cry
endotoxins on biological diversity, both lethal and sub-lethal,
including but not limited to insects, aquatic life, soil microbes, and
their food web dynamics
Unintended direct adverse effects of Bacillus thuringiensis (Bt) Cry
endotoxins on biological diversity, both lethal and sub-lethal,
including but not limited to insects, aquatic life, soil microbes, and
their food web dynamics
In
two meta-analyses of published studies on non-target effects of Bt
proteins in insects, Lovei and Arpaia (2005) document that 30% of
studies on predators and 57% of studies on parasitoids display negative
effects to Cry1Ab transgenic insecticidal proteins. A review by Hilbeck
and Schmidt (2006) on all Bt-plants found 50% of studies documenting
negative effects on tested invertebrates.
two meta-analyses of published studies on non-target effects of Bt
proteins in insects, Lovei and Arpaia (2005) document that 30% of
studies on predators and 57% of studies on parasitoids display negative
effects to Cry1Ab transgenic insecticidal proteins. A review by Hilbeck
and Schmidt (2006) on all Bt-plants found 50% of studies documenting
negative effects on tested invertebrates.
Another
quantitative review by Marvier et al, (2007) suggested a reduction in
non-target biodiversity in GM in some classes of invertebrates (Bt)
cotton fields vs. non-pesticide controls, yet found little reductions in
biodiversity in others.
quantitative review by Marvier et al, (2007) suggested a reduction in
non-target biodiversity in GM in some classes of invertebrates (Bt)
cotton fields vs. non-pesticide controls, yet found little reductions in
biodiversity in others.
More
recent research on aquatic environments has sparked intense interest in
the impact of GM (Bt) crops on aquatic invertebrates Daphnia magna
(Bøhn, 2008), and Trichoptera species (Rosi-Marshall, 2007). These
publications warrant future study, given the potential load of novel
target proteins that may end up in agricultural runoff and end up in
aquatic environments. Further, Douville et al. (2007) present evidence
of the persistence of the transgenic insecticidal protein Cry1Ab in
aquatic environments and suggest that that sustain release of this
bioactive compound in Bt maize production could result in
recent research on aquatic environments has sparked intense interest in
the impact of GM (Bt) crops on aquatic invertebrates Daphnia magna
(Bøhn, 2008), and Trichoptera species (Rosi-Marshall, 2007). These
publications warrant future study, given the potential load of novel
target proteins that may end up in agricultural runoff and end up in
aquatic environments. Further, Douville et al. (2007) present evidence
of the persistence of the transgenic insecticidal protein Cry1Ab in
aquatic environments and suggest that that sustain release of this
bioactive compound in Bt maize production could result in
negative
impact on aquatic biodiversity.
impact on aquatic biodiversity.
Impacts
on soil microflora and fauna, including earthworms (Zwahlen, 2002),
mycrorhizal fungi (Castaldini et al. 2005) and microarthropods in
response to Cry endotoxins have also been reported (Wandeler et al 2002,
Griffiths et al 2006, Cortet et al 2007).
on soil microflora and fauna, including earthworms (Zwahlen, 2002),
mycrorhizal fungi (Castaldini et al. 2005) and microarthropods in
response to Cry endotoxins have also been reported (Wandeler et al 2002,
Griffiths et al 2006, Cortet et al 2007).
The
significance of tritrophic effects of accumulation of, particularly of
insecticidal Cry toxins (Harwood et al 2005, Obrist et al 2006) however
is yet to be firmly established. Subchronic dosages of Cry proteins have
been demonstrated to affect both foraging behavior and learning ability
in non-target bees (Ramirez-Romero et al 2008), and may have indirect
effects on recipient populations on other species. The evolutionary
implications in terms of fitness are unclear.
significance of tritrophic effects of accumulation of, particularly of
insecticidal Cry toxins (Harwood et al 2005, Obrist et al 2006) however
is yet to be firmly established. Subchronic dosages of Cry proteins have
been demonstrated to affect both foraging behavior and learning ability
in non-target bees (Ramirez-Romero et al 2008), and may have indirect
effects on recipient populations on other species. The evolutionary
implications in terms of fitness are unclear.
A1.2:
Unintended direct effects of insect resistance (Bt) and herbicide
tolerance genes on the sustainable use of biological diversity related
to crop plants and their progenitors, important for sustainable
agricultural production and food security.
Unintended direct effects of insect resistance (Bt) and herbicide
tolerance genes on the sustainable use of biological diversity related
to crop plants and their progenitors, important for sustainable
agricultural production and food security.
Another
important consideration is the adverse effect that certain GM crops may
pose for the sustainable use of important crop agrobiodiversity (Gepts
and Papas 2003, Quist 2007). Little research to date has been conducted
on the evolutionary implications of gene flow from GM crops to wild
relatives or landraces. However increased seed production in wild
sunflower with introduced Bt genes by Snow et al (2003). that the
researchers further found that hybrids of Bt and non-Bt sunflowers had
up to 55% more
seeds compared
to the wild type when the target pest insect was found in the
environment, meaning that there was a clear fitness advantage of the
potentially weedy hybrid. This shows the potential of Bt-transgenic
varieties or hybrids to outcompete native varieties and bring a
reduction in diversity from more genetically homogenous domesticated
varieties. Outcrossing between Bt and non-Bt plants is also shown in
rice in China by Rong et al (2005), the transfer of herbicide tolerance
from herbicide tolerate oil seed rape (canola) to weed Brassica napus by
Mikkelsen (2006) and the expression of Bt and herbicide tolerant
proteins in Mexican maize landraces by Dyer et al (2009). This work
presents broad evidence of the occurrence of transgene flow. Further,
modeling studies by Haygood and Andow (2003) suggest that under
recurrent propagule pressure, transgene establishment within a
population can occur even under negative selection. With the evidence of
broad transgene flow, further work on the evolutionary implications for
the sustainable use of biodiversity is warranted.
important consideration is the adverse effect that certain GM crops may
pose for the sustainable use of important crop agrobiodiversity (Gepts
and Papas 2003, Quist 2007). Little research to date has been conducted
on the evolutionary implications of gene flow from GM crops to wild
relatives or landraces. However increased seed production in wild
sunflower with introduced Bt genes by Snow et al (2003). that the
researchers further found that hybrids of Bt and non-Bt sunflowers had
up to 55% more
seeds compared
to the wild type when the target pest insect was found in the
environment, meaning that there was a clear fitness advantage of the
potentially weedy hybrid. This shows the potential of Bt-transgenic
varieties or hybrids to outcompete native varieties and bring a
reduction in diversity from more genetically homogenous domesticated
varieties. Outcrossing between Bt and non-Bt plants is also shown in
rice in China by Rong et al (2005), the transfer of herbicide tolerance
from herbicide tolerate oil seed rape (canola) to weed Brassica napus by
Mikkelsen (2006) and the expression of Bt and herbicide tolerant
proteins in Mexican maize landraces by Dyer et al (2009). This work
presents broad evidence of the occurrence of transgene flow. Further,
modeling studies by Haygood and Andow (2003) suggest that under
recurrent propagule pressure, transgene establishment within a
population can occur even under negative selection. With the evidence of
broad transgene flow, further work on the evolutionary implications for
the sustainable use of biodiversity is warranted.
A2.1
Combinatorial and/or synergistic indirect effects of LMOs with stacked
traits or multiple LMOs
Combinatorial and/or synergistic indirect effects of LMOs with stacked
traits or multiple LMOs
The
recent development and commercialization of LMOs with multiple
transgenic traits has prompted an interest in the possible combinatorial
and/or synergistic effects that may produce unintended and undesirable
changes to endogenous or introduced traits and functions. The indirect
effect of such changes may impact the sustainable development of future
LMOs, and comes with high uncertainty of other unintended effects that
will need to be monitored in the future.
recent development and commercialization of LMOs with multiple
transgenic traits has prompted an interest in the possible combinatorial
and/or synergistic effects that may produce unintended and undesirable
changes to endogenous or introduced traits and functions. The indirect
effect of such changes may impact the sustainable development of future
LMOs, and comes with high uncertainty of other unintended effects that
will need to be monitored in the future.
In
the case of simultaneous exposure to different classes of Cry proteins
introduced in tandem, despite different modes of insecticidal activity,
Tabashnik et al (2009) found evidence of cross reactivity among
“pyramided” (stacked events) of Cry1Ac and Cry2B endotoxins in
transgenic cotton. The cross reactivity led to higher rates of
resistance evolution in pink bollworm, Pectinophora gossypiella, in a
laboratory setting. Their results suggests that in the case of different
Cry protein species, cross reactivity between them may confer increased
rates of insect resistance the would alter the efficacy and perhaps
biological activity of the LMO.
the case of simultaneous exposure to different classes of Cry proteins
introduced in tandem, despite different modes of insecticidal activity,
Tabashnik et al (2009) found evidence of cross reactivity among
“pyramided” (stacked events) of Cry1Ac and Cry2B endotoxins in
transgenic cotton. The cross reactivity led to higher rates of
resistance evolution in pink bollworm, Pectinophora gossypiella, in a
laboratory setting. Their results suggests that in the case of different
Cry protein species, cross reactivity between them may confer increased
rates of insect resistance the would alter the efficacy and perhaps
biological activity of the LMO.
Then
(2009) reviews and discusses the evidence for changes in activity and
specificity of Bt proteins dependent on synergisitc interactions with
extrinsic features. Such changes may critically influence the
bioactivity and hence the potential for unintended effects.
Combinatorial, synergistic effects must be carefully considered in the
development and risk assessment of stacked event LMOs with respect to
the implications on biodiversity and evolutionary consequences for crop
genetic diversity. This will be an important area of investigation for
risk research, as multi-trait (stacked) LMOs are poised to replace the
current generations of GM crops used in global agriculture. More
research in this area is needed.
(2009) reviews and discusses the evidence for changes in activity and
specificity of Bt proteins dependent on synergisitc interactions with
extrinsic features. Such changes may critically influence the
bioactivity and hence the potential for unintended effects.
Combinatorial, synergistic effects must be carefully considered in the
development and risk assessment of stacked event LMOs with respect to
the implications on biodiversity and evolutionary consequences for crop
genetic diversity. This will be an important area of investigation for
risk research, as multi-trait (stacked) LMOs are poised to replace the
current generations of GM crops used in global agriculture. More
research in this area is needed.
B
Scientific information “taking also into account risks to human health”,
including direct and indirect effects.
Scientific information “taking also into account risks to human health”,
including direct and indirect effects.
The
gaps of knowledge concerning human and animal health impacts of LMOs are
quite large (Heinemann and Traavik, 2004). In reality, very few LMOs
have been tested on humans (Tayabali et al, 2000). Clinical acute
toxicity studies are not the same as chronic exposures likely in the use
of GM crops, and may not necessarily uncover undesirable effects. Given
the ethical and experimental difficulties in testing of substances on
human subjects, other mammal species, such as mice and rats, are often
used as surrogates for appraising potential human health impacts of
LMOs.
gaps of knowledge concerning human and animal health impacts of LMOs are
quite large (Heinemann and Traavik, 2004). In reality, very few LMOs
have been tested on humans (Tayabali et al, 2000). Clinical acute
toxicity studies are not the same as chronic exposures likely in the use
of GM crops, and may not necessarily uncover undesirable effects. Given
the ethical and experimental difficulties in testing of substances on
human subjects, other mammal species, such as mice and rats, are often
used as surrogates for appraising potential human health impacts of
LMOs.
Further,
with risk appraisal in mind, one must consider that degree of exposures
to GM foods will be different depending on the country. That is, the
risk factors for Belgians will be different from say, Zambians, due to
large differences consumption patterns ofmaize.
with risk appraisal in mind, one must consider that degree of exposures
to GM foods will be different depending on the country. That is, the
risk factors for Belgians will be different from say, Zambians, due to
large differences consumption patterns ofmaize.
B1.1
Direct effects of target proteins on animal and human health.
Direct effects of target proteins on animal and human health.
A
recent publication by Dona and Arvanitoyannis (2009) reviews the
potential health implications of GM foods for humans and animals,
including incidences and effects of increased immunogenicity, amounts of
anti-nutrients, possible pleiotropic and epigenetic effects, including
possible reproductive and developmental toxicity. They conclude that
while there is strong evidence for health concerns on many fronts,
exposure duration many have not been long enough to uncover important
effects and studies should also include subjects with immunodeficiency
or exposed to other stress agents.
recent publication by Dona and Arvanitoyannis (2009) reviews the
potential health implications of GM foods for humans and animals,
including incidences and effects of increased immunogenicity, amounts of
anti-nutrients, possible pleiotropic and epigenetic effects, including
possible reproductive and developmental toxicity. They conclude that
while there is strong evidence for health concerns on many fronts,
exposure duration many have not been long enough to uncover important
effects and studies should also include subjects with immunodeficiency
or exposed to other stress agents.
Bt
Cry toxins
Cry toxins
A
number of studies have raised questions over the possible toxic or
immunogenic effects of Cry proteins on mammals (Ito et al 2004,
Vázquez-Padrón et al 2000). Further, cytotoxic effects were found in
some cases may be tissue specific, meaning effects may be underestimated
if the incorrect tissue type is selected for the assay.
number of studies have raised questions over the possible toxic or
immunogenic effects of Cry proteins on mammals (Ito et al 2004,
Vázquez-Padrón et al 2000). Further, cytotoxic effects were found in
some cases may be tissue specific, meaning effects may be underestimated
if the incorrect tissue type is selected for the assay.
Seralini
et al. 2007 reviewed data from a feeding trial of MON863 by the
producer, which concluded no toxicity, and found evidence for liver and
kidney toxicity in rats fed MON863 Bt maize. While the conclusions of
Seralini et al were rejected by the developer of the data, the case
illustrates that their poor study design, or inappropriate statistical
methods applied to scientific evaluations can lead to important effects
to go undetected. Kilic and Akay (2008) report a significant difference
(up to 10%) granular degenerationin the kidneys of rats fed Bt vs.
non-Bt maize.
et al. 2007 reviewed data from a feeding trial of MON863 by the
producer, which concluded no toxicity, and found evidence for liver and
kidney toxicity in rats fed MON863 Bt maize. While the conclusions of
Seralini et al were rejected by the developer of the data, the case
illustrates that their poor study design, or inappropriate statistical
methods applied to scientific evaluations can lead to important effects
to go undetected. Kilic and Akay (2008) report a significant difference
(up to 10%) granular degenerationin the kidneys of rats fed Bt vs.
non-Bt maize.
Immunological
effects have largely focused on potential allergenicity of LMOs, rather
than broader suites of immunogenic response. Inhalation studies, rather
than oral toxicity are also largely missing from the scientific
literature. One study by Kroghsbo et al (2008) found increase
antigen-specific antibody response to Bt toxin and PHA-E lectin in a 28
and 90-day study of Wistar rats.
effects have largely focused on potential allergenicity of LMOs, rather
than broader suites of immunogenic response. Inhalation studies, rather
than oral toxicity are also largely missing from the scientific
literature. One study by Kroghsbo et al (2008) found increase
antigen-specific antibody response to Bt toxin and PHA-E lectin in a 28
and 90-day study of Wistar rats.
A
study by Schroder et al (2007) found a significance difference in white
blood cell count and reduced kidney weight among male rats in a 90 day
feeding trial with Bt rice. A team of Austrian researchers conducted
feeding trials with a stacked Bt maize event (MON603 x Mon810) and found
significant effects vs. non-Bt maize. Along with reports of kidney
toxicity, the authors indicate “concluded, that multi-generation
studies, especially based on the [reproductive assessment by continuous
breeding (RACB)] design are well suited to reveal differences between
feeds. The RACB trial showed time
related negative reproductive effects of the GM maize under
the given experimental conditions. The RACB trial with its specific
design with the repeated use of the parental generation is a demanding
biological factor for the maternal organism” (p. 4 Velimirov et al.,
2008).
study by Schroder et al (2007) found a significance difference in white
blood cell count and reduced kidney weight among male rats in a 90 day
feeding trial with Bt rice. A team of Austrian researchers conducted
feeding trials with a stacked Bt maize event (MON603 x Mon810) and found
significant effects vs. non-Bt maize. Along with reports of kidney
toxicity, the authors indicate “concluded, that multi-generation
studies, especially based on the [reproductive assessment by continuous
breeding (RACB)] design are well suited to reveal differences between
feeds. The RACB trial showed time
related negative reproductive effects of the GM maize under
the given experimental conditions. The RACB trial with its specific
design with the repeated use of the parental generation is a demanding
biological factor for the maternal organism” (p. 4 Velimirov et al.,
2008).
In a
2008 feeding trial on mice with MON810 Bt maize, Finamore et al (2008)
conclude: “induced alterations in intestinal and peripheral immune
response of weaning and old mice. Although the significance of these
data remains to be clarified to establish whether these alterations
reflect significant immune dysfunctions, these results suggest the
importance of considering the gut and peripheral immune response to the
whole GM crop, as well as the age, in the GMO safety evaluation” (Ibid,
p. 11537).
2008 feeding trial on mice with MON810 Bt maize, Finamore et al (2008)
conclude: “induced alterations in intestinal and peripheral immune
response of weaning and old mice. Although the significance of these
data remains to be clarified to establish whether these alterations
reflect significant immune dysfunctions, these results suggest the
importance of considering the gut and peripheral immune response to the
whole GM crop, as well as the age, in the GMO safety evaluation” (Ibid,
p. 11537).
Herbicide
resistance genes
resistance genes
The
effects of a GM vs. non-GM soy diet on the liver of mice were
empirically tested in two scientific studies by Malatesta et al. The
first study (Malatesta et al 2002) found nuclear modifications in DNA
processing in liver cells that may be implicated in metabolic function.
In a 2-year feeding study, (Malatesta et al 2008) the researchers
observed marked changes in features of liver function, including
senescence (ageing) markers and reduced metabolic rates in mice fed GM
soybean vs. non-GM soy controls. The authors conclude:
effects of a GM vs. non-GM soy diet on the liver of mice were
empirically tested in two scientific studies by Malatesta et al. The
first study (Malatesta et al 2002) found nuclear modifications in DNA
processing in liver cells that may be implicated in metabolic function.
In a 2-year feeding study, (Malatesta et al 2008) the researchers
observed marked changes in features of liver function, including
senescence (ageing) markers and reduced metabolic rates in mice fed GM
soybean vs. non-GM soy controls. The authors conclude:
“[T]he
present work demonstrate that GM soybean intake can influence the liver
morphofunctional features during the physiological process of ageing
and, although the mechanisms responsible for such alterations are still
unknown and some data have been discussed on a speculative basis, there
are several findings underlining the importance to further investigate
the long-term consequences of a GM-diet and the potential synergistic
effects with ageing, xenobiotics and/or stress conditions. ” (Ibid. p.
975)
present work demonstrate that GM soybean intake can influence the liver
morphofunctional features during the physiological process of ageing
and, although the mechanisms responsible for such alterations are still
unknown and some data have been discussed on a speculative basis, there
are several findings underlining the importance to further investigate
the long-term consequences of a GM-diet and the potential synergistic
effects with ageing, xenobiotics and/or stress conditions. ” (Ibid. p.
975)
B1.2
Potential bioactive or toxic effects of emerging classes of LMOs
Potential bioactive or toxic effects of emerging classes of LMOs
Schubert
(2008) reviews the published literature documenting potential risks to
human health posed by the impending introduction of nutritionally
enhanced LMOs, designed to prodube bioactive molecules, into the food
supply. Specifically, Schubert highlights the evidence for the potential
production of aberrant transgenic molecules may produce toxic effects
or those with profound effects on human development. He concludes that
“Without proper epidemiological studies, most types of harm will not be
detected, and no such studies have been conducted. ” (Ibid p.604)
(2008) reviews the published literature documenting potential risks to
human health posed by the impending introduction of nutritionally
enhanced LMOs, designed to prodube bioactive molecules, into the food
supply. Specifically, Schubert highlights the evidence for the potential
production of aberrant transgenic molecules may produce toxic effects
or those with profound effects on human development. He concludes that
“Without proper epidemiological studies, most types of harm will not be
detected, and no such studies have been conducted. ” (Ibid p.604)
B2.1Adjuvant
response to LMOs, including cross-reactive and recombinatorial effects.
response to LMOs, including cross-reactive and recombinatorial effects.
The
issue of combinatorial and/or synergistic effect of GM proteins either
with endogenous host proteins or with other inserted GM traits (e.g.
“stacked” events) is an area of nascent scientific inquiry. Several
studies that point towards extrinsic factors may modulate Cry (Bt)
efficacy and specificity. For example Broderick et al (2009) found that
midgut bacterial presence was required for Cry1Ab insecticidal activity
gypsy moth (Lymantria dispar) only suggesting the intestinal microflora
may modulate toxicity in certain target Lepidopteran insect species.
Further, research by Soberon et al (2007) suggest that structural
changes to the engineered Cry1Ab protein in cotton may lack important
oligmerization feature essential to toxin efficacy towards P.
gossypiella.
issue of combinatorial and/or synergistic effect of GM proteins either
with endogenous host proteins or with other inserted GM traits (e.g.
“stacked” events) is an area of nascent scientific inquiry. Several
studies that point towards extrinsic factors may modulate Cry (Bt)
efficacy and specificity. For example Broderick et al (2009) found that
midgut bacterial presence was required for Cry1Ab insecticidal activity
gypsy moth (Lymantria dispar) only suggesting the intestinal microflora
may modulate toxicity in certain target Lepidopteran insect species.
Further, research by Soberon et al (2007) suggest that structural
changes to the engineered Cry1Ab protein in cotton may lack important
oligmerization feature essential to toxin efficacy towards P.
gossypiella.
Combinatorial
or synergistic effects of recombinant proteins acting as adjuvants (1)
to immunostimulatory effects, or as potential allergens is also an area
of vigorous scientific inquiry. The protein Cry1Ac has been shown to be
immunogenic in mice (Vazquez- Padron, 2000), and produces an adjuvant
effect on both mucosal and systemic specific antibody responses
(Moreno-Fierros et al 2003, Rojas-Hernandez et al. 2004). In
investigations with Cry1Ab protein, Guimaraes et al. (2009) did not find
a similar type of adjuvant effect elicited against peanut proteins as
with Cry1Ac, yet instead found
evidence
of Cry1Ab acting as an adjuvant leading to early phase production of
leukotrienes and increased Th2 and Th17-cytokine production in
branchoalveolar lavage fluids after airway exposure. The implications of
possible effects of Cry1Ab to produce allergen-induced cytokine
responses are an area of investigation warranting further inquiry.
or synergistic effects of recombinant proteins acting as adjuvants (1)
to immunostimulatory effects, or as potential allergens is also an area
of vigorous scientific inquiry. The protein Cry1Ac has been shown to be
immunogenic in mice (Vazquez- Padron, 2000), and produces an adjuvant
effect on both mucosal and systemic specific antibody responses
(Moreno-Fierros et al 2003, Rojas-Hernandez et al. 2004). In
investigations with Cry1Ab protein, Guimaraes et al. (2009) did not find
a similar type of adjuvant effect elicited against peanut proteins as
with Cry1Ac, yet instead found
evidence
of Cry1Ab acting as an adjuvant leading to early phase production of
leukotrienes and increased Th2 and Th17-cytokine production in
branchoalveolar lavage fluids after airway exposure. The implications of
possible effects of Cry1Ab to produce allergen-induced cytokine
responses are an area of investigation warranting further inquiry.
————————————————-
(1)
That is, adjuvancy, the ability of a compound to enhance or facilitate
an immune response, particularly sensitization to another (food)
protein.
That is, adjuvancy, the ability of a compound to enhance or facilitate
an immune response, particularly sensitization to another (food)
protein.
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Attachment
2
2
This
input was submitted to the Norwegian CP-FP and BCH-FP in Norwegian. The
key paragraphs have been translated
input was submitted to the Norwegian CP-FP and BCH-FP in Norwegian. The
key paragraphs have been translated
¦
the advisory board wishes to emphasise that negative effects on
biodiversity is somewhat different from negative environmental effects.
There is substantial scientific documentation that indicates negative
effects of certain LMOs on the environment, e.g. negative effects of
Bt-maize on non-target insects. This is not the same as documenting that
the use of such LMOs has a negative effect on the functionality of
ecosystems, or the total biodiversity. The advisory board experiences
uncertainty, broad interpretations and extensive debates with regards to
scientific literature and what it tells us about possible effects on
biodiversity. Long term studies are also lacking.
the advisory board wishes to emphasise that negative effects on
biodiversity is somewhat different from negative environmental effects.
There is substantial scientific documentation that indicates negative
effects of certain LMOs on the environment, e.g. negative effects of
Bt-maize on non-target insects. This is not the same as documenting that
the use of such LMOs has a negative effect on the functionality of
ecosystems, or the total biodiversity. The advisory board experiences
uncertainty, broad interpretations and extensive debates with regards to
scientific literature and what it tells us about possible effects on
biodiversity. Long term studies are also lacking.
The
advisory board will not present and discuss the relevant literature but
wish to point out that in the recent years a number of relevant
scientific studies have introduced new elements for consideration. One
example is the work of Ramirez-Romero et al. (2008) indicating that when
honeybees are exposed to the Cry1Ab toxin through their natural diet
(exposure through pollen from GM-plants) this may lead to reduced
capacity for learning and altered pattern of feeding. It is therefore
not a direct lethal effect but a more subtle effect that may have
ecological consequences and an effect on biodiversity due to a possible
reduced survival of the species.
advisory board will not present and discuss the relevant literature but
wish to point out that in the recent years a number of relevant
scientific studies have introduced new elements for consideration. One
example is the work of Ramirez-Romero et al. (2008) indicating that when
honeybees are exposed to the Cry1Ab toxin through their natural diet
(exposure through pollen from GM-plants) this may lead to reduced
capacity for learning and altered pattern of feeding. It is therefore
not a direct lethal effect but a more subtle effect that may have
ecological consequences and an effect on biodiversity due to a possible
reduced survival of the species.
When
risk assessing LMOs the advisory board wishes to point out that the
context of the evaluation is important and that it is necessary to
routinely assess the alternatives to any given LMO. Existing
agricultural practices with the use of mono cultures and efficient
pesticide regimes have had a clear negative effect on biodiversity both
past and present. Less weeds, fewer small mammals and reduced access to
seeds in the fields have had large consequences for biodiversity – even
before LMOs entered the market. An example is the reduction of bird
populations which is well studied and documented in Great Britain. When
the use of a certain LMO is to be related to biodiversity it is
important to consider the consequences of an already established
practice and if the LMO contributes to an existing negative trend, if it
has a positive effect or if it introduces new elements of risk.
risk assessing LMOs the advisory board wishes to point out that the
context of the evaluation is important and that it is necessary to
routinely assess the alternatives to any given LMO. Existing
agricultural practices with the use of mono cultures and efficient
pesticide regimes have had a clear negative effect on biodiversity both
past and present. Less weeds, fewer small mammals and reduced access to
seeds in the fields have had large consequences for biodiversity – even
before LMOs entered the market. An example is the reduction of bird
populations which is well studied and documented in Great Britain. When
the use of a certain LMO is to be related to biodiversity it is
important to consider the consequences of an already established
practice and if the LMO contributes to an existing negative trend, if it
has a positive effect or if it introduces new elements of risk.
As
opposed to many of the existing LMOs on the market there are a number of
“new” LMOs that have a large probability of negative impact on
biodiversity if released into the environment. These LMOs must therefore
undergo a thorough risk assessment. The advisory board would advise
caution with regards to:
opposed to many of the existing LMOs on the market there are a number of
“new” LMOs that have a large probability of negative impact on
biodiversity if released into the environment. These LMOs must therefore
undergo a thorough risk assessment. The advisory board would advise
caution with regards to:
–
GM-viruses with altered traits and host specificity – GM-fish with cold
tolerance/increased growth rate/high tolerance environmental pollutions
GM-viruses with altered traits and host specificity – GM-fish with cold
tolerance/increased growth rate/high tolerance environmental pollutions
–
Stress tolerant GM-plants (drought tolerant/cold tolerant)
Stress tolerant GM-plants (drought tolerant/cold tolerant)
–
GM-plants with a more efficient nutritional uptake
GM-plants with a more efficient nutritional uptake
–
Pharma plants
Pharma plants
Even
though these organisms may have what appears to be very useful traits
for purposes of production they may also have selective advantages in
nature. This could lead to increased invasiveness and change in
ecosystem functionality with the consequence that the number of species
drop dramatically or that the balance is altered in other undesirable
ways. One scenario is the displacement of locally adapted species
through spread of stress tolerant GM forage grasses adapted to marginal
habitats/growth areas. Another
though these organisms may have what appears to be very useful traits
for purposes of production they may also have selective advantages in
nature. This could lead to increased invasiveness and change in
ecosystem functionality with the consequence that the number of species
drop dramatically or that the balance is altered in other undesirable
ways. One scenario is the displacement of locally adapted species
through spread of stress tolerant GM forage grasses adapted to marginal
habitats/growth areas. Another
example
is the possible consequences of a GM-fish tolerant to higher
concentrations of environmental pollutants leading to higher
accumulations of pollutants in the food chain which may in turn have
negative health effects.
is the possible consequences of a GM-fish tolerant to higher
concentrations of environmental pollutants leading to higher
accumulations of pollutants in the food chain which may in turn have
negative health effects.
Both
in Norway and the rest of the world the case by case approach is a
central principle for LMO risk assessment. The advisory board believes
this is an important requirement in order to understand the
characteristics of each LMO and reveal the possible effects of the
intended use. We would in that respect underline the challenges that
risk assessors face when dealing with several of the newer LMOs such as
GM-trees (long generation span), GM-viruses (may be difficult to
control, risk of mutation) and pharmaplants (risk of entering the food
chain).
in Norway and the rest of the world the case by case approach is a
central principle for LMO risk assessment. The advisory board believes
this is an important requirement in order to understand the
characteristics of each LMO and reveal the possible effects of the
intended use. We would in that respect underline the challenges that
risk assessors face when dealing with several of the newer LMOs such as
GM-trees (long generation span), GM-viruses (may be difficult to
control, risk of mutation) and pharmaplants (risk of entering the food
chain).
References
Ramirez-Romaro
et al. (2008) Does Cry1Ab protein affect learning performances of the
honey bee Apis mellifera L. (Hymenoptera, Apidae)? Ecotoxicology and
Environmental Safety 70 327-333.
et al. (2008) Does Cry1Ab protein affect learning performances of the
honey bee Apis mellifera L. (Hymenoptera, Apidae)? Ecotoxicology and
Environmental Safety 70 327-333.
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Attachment
3
3
Antibiotic
resistance marker genes (ARMG)
resistance marker genes (ARMG)
Relevant
scientific reports on the topic of ARMG:
scientific reports on the topic of ARMG:
EFSA
Scientific Opinion (2009): Consolidated presentation of the joint
Scientific Opinion of the GMO and BIOHAZ Panels on the “Use of
Antibiotic Resistance Genes as Marker Genes in Genetically modified
Plants” and the Scientific Opinion of the GMO Panel on “Consequences of
the Opinion on the Use of Antibiotic Resistance Genes as Marker Genes in
Genetically Modified Plants on Previous EFSA Assessments of Individual
GM Plants”. EFSA Journal (2009).
http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1211902569520.htm
Scientific Opinion (2009): Consolidated presentation of the joint
Scientific Opinion of the GMO and BIOHAZ Panels on the “Use of
Antibiotic Resistance Genes as Marker Genes in Genetically modified
Plants” and the Scientific Opinion of the GMO Panel on “Consequences of
the Opinion on the Use of Antibiotic Resistance Genes as Marker Genes in
Genetically Modified Plants on Previous EFSA Assessments of Individual
GM Plants”. EFSA Journal (2009).
http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1211902569520.htm
With
regards to the 2009 EFSA report we would like to make the following
comments:
regards to the 2009 EFSA report we would like to make the following
comments:
o
There are geographical differences in the distribution of the antibiotic
resistance genes nptII and aadA in naturally occurring bacteria and the
distribution patterns are often unknown o We would draw the attention
to the mentioned conclusions from the WHO Expert Group on Critically
Important antimicrobials for Human Health regarding the categorization
of the antimicrobials kanamycin, neomycin and spectinomycin as ‘Highly
Important Antimicrobials’ and streptomycin as a ‘Critically Important
Antimicrobial’
There are geographical differences in the distribution of the antibiotic
resistance genes nptII and aadA in naturally occurring bacteria and the
distribution patterns are often unknown o We would draw the attention
to the mentioned conclusions from the WHO Expert Group on Critically
Important antimicrobials for Human Health regarding the categorization
of the antimicrobials kanamycin, neomycin and spectinomycin as ‘Highly
Important Antimicrobials’ and streptomycin as a ‘Critically Important
Antimicrobial’
o
The EFSA opinion had two minority opinions that should be noted
The EFSA opinion had two minority opinions that should be noted
>
VKM (2005). An assessment on potential long-term health effects caused
by antibiotic resistance marker genes in genetically modified organisms
based on antibiotic usage and resistance patterns in Norway. http://www.vkm.no/dav/23de90b2ff.pdf
VKM (2005). An assessment on potential long-term health effects caused
by antibiotic resistance marker genes in genetically modified organisms
based on antibiotic usage and resistance patterns in Norway. http://www.vkm.no/dav/23de90b2ff.pdf