ENVIRONMENT RISKS PRINCIPLES

CONCERNING GMOs
Maria Toader, Isabela Ivanovici

GMO risks upon environment

and human health
Estimation of risks upon environment and human health, on account

of genetically modified organisms deliberate introduction on the

market is defined as the process meant to evaluate genetically
modified organisms direct or indirect, immediate or delayed risks,
which the deliberate introduction within the environment and the
introduction on market of genetically modified organisms,
continuously called GMO, can have upon environment and human
health.
The objective of risks estimation is of identifying and evaluating, for
each case the potential adverse effects of the genetically modified
organisms, such as direct or indirect, immediate or delayed risks,
which the deliberate introduction within the environment and the
introduction on market of genetically modified organisms can have
upon environment and human health. Risk evaluation upon human
health and environment has to establish if the achievement of risks
management is necessary and if the answer is positive, it has to
find out which are the most adequate methods in this regard.

GMOs possible risks

Problems which may occur in different fields :
Human health
Environment
Economy
Ethical, cultural, social context

 Ecological aspects :

species invasion - biodiversity

biological pollution
super-weeds
organisms impact
pests resistance

Are there advantages for the environment?

Pesticides quantity use diminishment

Replacement of many unefficient pesticides
Use of no-tillage agriculture system reduces erosion and leaching
High productivity of the surface unit

General Principles
According to the caution principle, the risks evaluation must

be based on the following general principles :

a. The identified characteristics of one GMO and of its use,
which may have adverse effects, must be compared with
the ones presented by the original unmodified organism and
with
its
use
in
similar
situations.
In order to identify the potential characteristics of GMOs
which may be dangerous, previously it must be defined a
reference system concerning
the receiving system,
respectively the organisms which populate them and their
interactions , as well as all known variants. All the future
changes may be compared with this reference system. For
example, for the plants crops with vegetative multiplication,
it will be made the comparative analysis with the used
parental species, in order to obtain transgenic lines.

 For

the plants crops with sexuated reproduction, the

comparative analysis elements include adequate isogenetic
lines. The case when the transgenic crops are obtained by
retro-crossing, it is important that the research concerning
substantial equivalent should use the most adequate control
element and it should not be based only on the comparisons
with the original material of parental species.
If the existent data arent enough, it is defined another
reference system starting from other criteria, in order to allow
a comparison.
The reference system depends mostly on the receiving
medium, including biotic and non-biotic factors (for example
naturally preserved habitats , agricultural fields or
contaminated fields), or on a mixture of different mediums.

 b) Risks estimation must be analyzed in a transparent manner,

on the basis of an adequate method and on scientific and

technical available data.
Potential adverse effects must be based on scientific and
technical data but also on a common methodology concerning
the identification, collecting and interpreting relevant data.
Data, measurements and tests must be clearly described
.Besides, the use of some modeling scientific data might assure
the achievement of the data which miss, useful for the risks
evaluation.
ER doesnt always offer definitory answers to all the questions
taken into account , on account of data shortage. Particularly, for
the effects on long term , sometimes there are few available
data.
This way, it must be taken into account an adequate risks
management (caution measures), according to the caution
principle, in order to prevent potential adverse effects upon
human health and environment..

 Risks estimation must take into account the incertitude degree at

different levels. Scientific incertitude usually derives out of 5

characteristics of the applied scientific method: chosen variable
element, effected measurements, taken samples, used samples and
considered causal relationships.
Scientific incertitude degree may also be variable on account of
existent contradictory data or of relevant data shortage. Incertitude
may also be related to quantitative or qualitative analysis elements.
Knowledge level concerning the reference system or data quantity
is mirrored in the incertitude level, which must be specified by the
notifying person (incertitude estimation, including shortage of data,
knowledge shortage, standard nonconformity, complexity, etc.), in
comparison with the incertitude resulted out of present scientific
methods.
For GMOs , which are about to be introduced on the market, there
be must be assured relevant and available data, came from the
deliberate introductions in the environment types, where these ones
are about to be used.

 c) Risks estimation must be made for each case, this meaning

that the requested information may be variable, depending

upon the kind of involved genetically modified organisms, on
predicted use and on potential receiving environment , taking
into account among others, the genetically modified organisms
already existent in the environment.
Risks estimation must use estimation risk for each case, due to
the large variety of individual traits proper to different
organisms or or to different organisms or each GMO and
different environments.( for each location or area ).
It may exist a huge environment effects variety produced by
GMOs (due to their reduced dimensions and to the interactions
among them, often unknown), by plants (such as superior
plants used for human alimentation, and as feed for animals
and trees, due to their potential longevity), as well as by
animals (for example by insects, due to their reduced
dimensions and of their high potential of surpassing ecological
barriers, or fish of salted water, due to their high spreading
potential).

 d) A general principle in risks estimation is an analysis

achievement of <<long term cumulative effects>>in connection

with deliberate introduction into the market and environment.
Long term cumulative effects refers to the cumulative effects
of authorizations on human health and environment, inter alia,
on flora and fauna, on soil fertility , on organic material
decomposition in the soil, on trophic chain biological diversity,
animals health, as well as the aspects connected to antibiotics
resistance.
Taking into account potential cumulative long term effects, risks
estimation must consider aspects such as: long term
interactions between GMOs and receiving environment; GMOs
characteristics which become important on long term, deliberate
introductions in the environment and market, repeated for a
long period of time, GMOs deliberately introduced on the
market, and environment , in the past.

Environment risks estimation

methodology
Risks estimation must take into account
relevant scientific and technical data concerning
the characteristics of the following factors :
- Receiving /parental organism's)
- genetically change's), respectively genetically material
insertion or erosion, as well as relevant information on vector
and donor;
- GMOs;
Intentional introduction or use , including ampleness;
Potential receiving environment ;
Interaction among the factors previously mentioned;

 The information concerning the receiver, the donor, the vector,

genetically change and GMOs , supplied according the present laws

(anexes no. 3A and 3B l to OUG no. 43/2007), are independent of the
environment and the conditions where GMOs are about to be
experimentally introduced on the market .
This information constitutes the identification basis of some potential
dangerous characteristics (possible dangers ) of GMOs .
The knowledge and experience gathered in introducing the same GMO
or of a similar GMO may supply important information concerning the
possible dangers of the respective introduction.
The information concerning the introduction on purpose in the
environment , the receiving environment and the interaction among
these, it refers especially to the environment where GMOs are about to
be introduced , as well as to the conditions of the introduction including
the introduction ampleness. This information determines the size of any
potentially dangerous traits of GMOs.

The stages of risk

environment evaluation
The danger" is defined as the potential of an

organism to harm or to produce adverse

effects
upon
human
health
and/or
environment.
The risk is a resulting element of one
danger ampleness consequences, if this one
produces itself and of the possibility that this
one could produce.

Stage 1 :
Identification of the characteristics which may cause adverse effects "

There must be identified any characteristics of GMOs ,

connected to a genetically change which might have

adverse effects upon human health and environment .
A comparison of GMOs characteristics with the genetically
unmodified organism in similar conditions and use help to
the identification of special, potential adverse effects,
determined by the genetic change.
It is important not to neglect any potential adverse effect,
even if it is less possible to happen.

 GMOs possible adverse effects may be variable depending on

the case and they may include:

Humans illnesses, including allergenic or toxic effects;
Plants and animals diseases , including toxic effects and when
it is the case allergenic effects ;
Effects on species population dynamics in the receiving
environment and on genetic diversity of each individual from
these populations;
An alteration of susceptibility to pathogenic agents, making
easier infectious diseases spreading and/or creating sources or
new vectors;
A compromise of prevention or therapeutic, medical, veterinary
and phyto-sanitary treatments, for example by genes transfer
which conveys resistance to the antibiotics used in human or
veterinary medicine;
Effects on bio-geo-chemistry (bio-geo-chemical cycles),
especially upon carbon and nitrogen by the change of organic
material decomposition in the soil.

 GMO s spreading capacity in the environment mainly depends on

the following :
Capacity of biological adjustment (GMO conceived in order to have
better performances in the environment where they are introduced ,
by expressing some traits which increase competitivity in the
natural environments or by the quantitative or qualitative change
of ingredients composition or GMO presenting a resistance to
natural selection pressure such as the resistance to abiotic stress
factors , such as: heat, coldness, salt or production of antimicrobial
substances in microorganisms);
Conditions of deliberate introduction in the environment or market
(especially the introduction location and surface, as well as the
number of introduced GMOs );
Possibility of a deliberate introduction in the environment or market
or of a unintentional introduction in the environment (for example
GMOs meant for processing); spreading ways of viable material (for
example, seeds, spores etc. ) by means of wind, water, animals,
etc.;

 Specific environment considerations (location or area): in

order to allow an estimation for each place or area, it is useful

the classification of data on categories of habitats, mirroring
aspects of receiving environment, relevant for GMOs ( such
as, botanical data concerning the presence of some wild
relatives of the genetically modified plants, with whom they
can cross, in different agricultural or natural habitats)
It is also important the estimation of a survival period for a
certain MGO or of a certain number of GMOs , belonging to a
certain species, as well as their spreading and integration
capacity in different habitats.
One must pay attention to the species able to reproduce
themselves, of surviving and those in dormant stage, such as:
pollen, seeds, vegetative reproduction, forms viability; for
microorganisms: spores viability as surviving form or
microorganisms potential of becoming viable but without
being capable of cultivation.

Stage 2:
Estimation of potential consequences of each adverse
effect, if this one produces "
One single danger may have multiple adverse effects, and

the size of individual adverse effects may be different. The

adverse effects of one single danger upon human health
and upon human health and agricultural and natural
habitats may vary.
Possible consequences may be turned synthetic so that they
may cover all ecological entytities which might be affected
(such as species, populations, trophic levels, ecosystems),
including the potential effect and the incertitude level.

Stage 3:
Estimation of the possibility of each identified
possible adverse effect appearance "
One of the main important factors in estimation the possibility

of adverse effects appearance is represented by environmental

characteristics where it is foreseen the deliberate introduction
of GMO and the achievement way of introduction.
This stage analyses the real production possibility of an
adverse effect . In certain cases, it is estimated as well
possibility as frequency. Climate, geographical, soil and
demographical conditions such as flora and fauna kinds from
receiving environment are important elements which must be
taken into account.
The possibility may be turned synthetic, in such a way which
should cover all the ecological entities which might be affected
(species, populations, trophic levels, ecosystems), including
measures concerning the potential effect , as well as the
incertitude degree.

Stage 4:
Estimation of the risk determined for each identified
characteristic of one GMO"
An

estimation of the risk for human health and

environment ,determined by each identified characteristic of
MGO, which might have adverse effects, it must be
effected , as much as possible , depending on the case,
combining the possibility of an adverse effect appearance
and consequences ampleness, if this effect appears.
The estimation of each danger consider : consequences size
("important", "moderate", "reduced" si "neglictable");the
possibility of adverse effect ("importanta", "moderata",
"reduced" and "neglictable"); if a danger determines more
adverse effects , the size and possibility of each adverse
effect .

Stage 5:
Risks situation management strategies putting into
practice, due to MGOs unintentional introduction or
trading"
Risks estimation might lead to the identification of the ones which must be

managed and it is also imposed the establishment of a risks management

strategy for the best management method.
Risks management procedures depend on the following factors:
MGO destination (kind and size of deliberate introduction in the environment
or on the market);
MGO kind (superior, annual, perennial plants, superior animals, MGO with a
single or multiple changes, one or more kinds of GMOs);
General type of the habitat and agricultural habitat (for example, arable,
fishing, forestry, rural areas, introduction locations dimension, number of
different GMOs) as well as the kind of natural habitat (for example the one
of protected area).

Stage 6:
Determination of the present global risk , presented by a
GMO "

On the basis of stage 4 , and where it is the case, of stage

no.5 , it is made an estimation of the global risk, comprising

size and probability of the adverse effect, including the
cumulative effects from other GMOs. Final estimation is
expressed under the shape of global risks resulted from the
deliberate introduction in the environment or on the
market., including the global incertitude.

 On the basis of an estimation of the risk upon human health

and environment, achieved, according to the principles and

methodology presented according to OUG no. 43/2007, one
may finally conclude concerning the potential impact on the
environment, as a consequence of the introduction in the
environment or the introduction on market of GMOs.
Future evolutions, especially in different sectors different
from the one of the plants, may lead to future
recommendations concerning the information which must
be included in notices.