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 risksProblems which may occur in different fields : Human health

EnvironmentEconomyEthical, 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 PrinciplesAccording 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 aren’t 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 doesn’t 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.

GMO’s 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.