PART III PROCESS SAFETY
3. Novel Foods Based on GMOS
3.2. Risk assessment
Risk assessment is a process of gathering diverse data to identify possible risks in research and development involving genetically modified microorganisms, plants, animals. Risk assessment should focus on the characteristics of the product itself but at the same time take into account the techniques that are used to produce it.
There are some differences in the approach to the risk assessment framework in the USA and Europe. In the framework suggested by the U.S. National Academy of Sciences (Essential Biosafety, 2002), the following factors are recognized to be important in assessing risks of organisms with novel characteristics:
i. For the environment:
● properties of the organism and of the environment into which it may be introduced
● possibility of containing and controlling the organism
● probable effect on the environment should the organism or genetic trait per- sist longer than intended or spread to non-target environments
● risks to human health and the environment that are associated with intro- duction of organisms with novel traits.
ii. For the organism with novel trait, taking into account:
● the recipient host or parental organism that receives the new trait
● the donor organism from which the trait is derived
● the vector used to transfer the trait from donor to recipient
● the inserted or introduced trait, including potential toxicity of a gene prod- uct or its metabolites
● empirical data on the novel organism
● the intended application (contained use, release to environment or planned production)
● the potential receiving environment.
Another way of looking at risk assessment is preferred in Europe (Conner et al., 2003). In this approach hazard and exposure are distinguished as separate parameters. Hazard assessment means evaluating whether an organism can be harmful and assessing whether it is a pest or a pathogen or if it will introduce new pests or pathogens or enhance existing ones.
Exposure assessment involves evaluating the extent to which the environment or humans might be exposed to organisms with novel traits. The degree of exposure depends on the following parameters (Kuiper et al., 2002; Kleter and Kuiper, 2002):
● the route of introduction
● the survival and reproductive potential of the organisms with novel traits
● the mode and rate of dispersal beyond the site of introduction (by wind, water, insects)
● the location and size of any receptive or susceptible population.
Risk in the context of safety includes two elements:
i. hazard, an intrinsic factor (e.g. a biological, chemical or physical agent in, or condition of, food, with the potential to cause an adverse effect on health) that indicates the damage if the event occurs
ii. the probability or chance that the event will occur.
Thus, in relation to chemicals, risk is taken to be the product of hazard and chance of exposure.
In relation to quarantine, it is the product of potential damage by the pest and chance of introduction.
It can be concluded, the risk assessment is a scientifically based process con- sisting of the following steps:
i. hazard identification ii. hazard characterization iii. exposure assessment
iv. risk characterization.
Hazards, and the chance of those hazards occurring, are thereby studied and models constructed to predict the risk. The two components of risk both contain a measure of uncertainty, and it is this measure of uncertainty that is the subjected of many discussions. For example, there is some doubt as to whether risk estima- tion methodologies used for related purposes (e.g. pesticide residues in food and pest introduction) have sufficient predictive value for GMOs. In particular, the haz- ard component of risk analysis is subject to close scrutiny (Kuiper et al., 2001).
3.3. Risk management
Risk assessment is the process of weighing policy alternatives in consultation with interested parties, considering risk assessment and other factors relevant for the protection on consumers’ health and for the promotion of fair trade practices as well as, if necessary, selecting appropriate prevention and control options (FAO 2001).
Environmental hazard is surely less easy to quantify than health hazard. There have been many attempts to monitor some consequences of the effects of GMOs but this task is too complicated, as in most cases the potential change (especially in the environment) can be seen only after very long period of time (Conner et al., 2003). Moreover, only long-term experience can show if both risk assessment and risk management have been successful. When a sound risk management strategy is applied to environmental problems, as distinct from safety problems, it will begin by describing a problem and the goals, objectives and values to be pursued by solving that problem. An analysis of alternatives is then carried out to consider as many solutions as possible. Rather than narrowing the analysis, this allows the creation of new options or combinations of options. When the benefits and draw- backs of a wider range of solution scenarios can be compared, fuller participation by the concerned society can be better assured.
The type of risk management for contained use and/or planned introductions of genetically modified organisms depend on the organism involved and on the intended application. The process involves reviewing alternatives and select- ing the most appropriate regulatory actions based on the findings of the risk assessment. Measures to be taken to minimize risk include physical and bio- logical containment. Doyle and Persley (1996) suggest posing the following questions:
i. What are the risks?
ii. How probable is it that they will occur?
iii. How serious is the damage if they occur?
iv. What can be done to minimize the risks and contain the damage?
v. Do the benefits outweigh the risks?
The term containment is used to describe safe methods for maintaining control over the distribution of GMOs in the laboratory and in the environment into which they are introduced. The purpose of containments is to minimize unneces- sary exposure of laboratory workers and the environment to potentially hazardous organisms.
Biological containment of microorganisms principally involves the use of spe- cific combinations of vector and host in such a way that the probability of the transfer of a vector to an unintended host and the subsequent survival of the host- vector combination in the environment is limited. The growth of plants which require special environmental conditions for their survival, like biological con- tainment, can be achieved in either in either the greenhouse or field. Similar results can be obtained with studies using contained animal facilities (Kleter and, Kuiper, 2002).
Physical containment involves physical constraints on the movement of organ- isms of uncertain risk or potential hazard. The aim of physical containment is to prevent inappropriate exposure of humans and the environment to organisms.
Physical containment is achieved by following the principles of good laboratory practice, occupational safety, and hygiene – together with involvement of well- qualified and competent personnel who follow safe, standard procedures and with keeping a working place designed to prevent the unintended spread to the envi- ronment of genetically modified organisms.
Risk management is an attempt to select the most appropriate regulatory strategy or action to prevent or at least to minimize the potential harmful effect of GMOs. It integrates the results of risk assessment with technical, social, economic, and political concerns. Carried out by regulatory agencies under legislative mandates, risk management is a decision-making process that deter- mines reasonable control costs by requiring value judgments that compare poten- tial risks and benefits (Dale et al., 2002). Risk management of the products of biotechnology involves the comparison of their benefits and risks with those asso- ciated with the products they replace. The process of risk management follows the process of risk assessment at each stage of development and use of a geneti- cally modified organism and its products (Dale et al., 2002).
3.4. Risk communication
Risk communication is the interactive exchange of information and opinions among assessors, risk managers, consumers, industry, the academic community and other interested parties throughout the risk analysis process. The information exchange concerns risk-related factors and risk perceptions, including the expla- nation of risk assessment findings and the basis of risk management decisions. It is vitally important that risk communication with the public comes from credible and trusted sources.
In the framework of the Cartagena Protocol on Biosafety, a Biosafety Clearing House was established as a part of the clearing-house mechanisms under the Convention of Biological Diversity (CBD-BCH 2002). The principal tasks of the Biosafety Clearing House (BCH) are as follows:
i. Facilitate the exchange of scientific, technical, environmental and legal infor- mation on, and experience with, genetically modified organisms.
ii. Assist the Parties (to the Protocol) to implement the Cartagena Protocol on Biosafety, taking into account the special needs of developing countries as well as countries that are centres of origin and centres of genetic diversity.
The Biosafety Clearing House will serve as a means through which informa- tion relevant to the implementation of the Protocol is made available. It will also provide access to other international biosafety information exchange mecha- nisms. Each Party to the Protocol will make available to the BCH information rel- evant to the biosafety issues such as:
i. Existing laws, regulations and guidelines for implementation of the Protocol, as well as information required for the advance informed agreement proce- dure.
ii. Bilateral, regional and multilateral agreements and arrangements.
iii. Summaries of its risk assessments or environmental reviews of GMOs gener- ated by its regulatory process including relevant information regarding prod- ucts and processed materials that are of GMO origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology.
iv. Final decisions regarding the importation or release of GMOs.
v. Reports submitted on monitoring of GMOs interactions with environment and human health.
The Biosafety Clearing House will use electronic and other systems for the exchange of information relevant to the Cartagena Protocol on Biosafety. The BCH may draw on a wide variety of existing mechanisms as those of the Organization for Economic Cooperation and Development -OECD (Biotrack http://www.oecd.
org/biotrack), United Nations Industrial Development Organization -UNIDO - Biosafety Information Network and Advisory Service (BINAS http://binas.
unido. org/binas/), International Centre for Genetic Engineering and Biotechnology -ICGEB (Biosafety Bibliographic Database http://www.icgeb.org/-bsfdata1.htm), United Nations Environment Programme – UNEP, Microbial Strain Data Network
(MSDN), Information Resource for the Release of Organisms (IRRO) http://
panizzi.shef.ac.uk/msdn/.