PART III PROCESS SAFETY
2. Familiarity and Substantial Equivalence
using products from the genetically engineered plant should not adversely affect the health or nutritional status of the consumer. Implications for the population as a whole and for specific subgroups like children and/or the elderly should be considered.
improvement in risk/safety assessment and monitoring methods. One perfect tool is available to fulfil the presented task – namely the global Clearing House of the Convention on Biological Diversity (CBD, 2005), where all national and regional regulations, experiences, case studies and all information on genetically modified organisms will be continuously cumulated in the subunit named The Biosafety Clearing House.
Transfer of knowledge obtained by those countries with experience in risk/safety assessment to all those who need it, seems to be an additional chal- lenge, which is under progress. Along with the above mentioned CBD Clearing House, which was established primarily for the Parties of the Convention, there are many other biosafety information exchange mechanisms and databases, e.g.
those of OECD, UNEP, UNDP, FAO and others (such as OECD 2005).
In performing the environmental safety assessment of GM plants, the concept of familiarity is coupled in some countries with that of substantial equivalence.
The latter is based on the principle that novel plants can be compared with their non-transformed counterparts that have an established history of safe use (Kuiper et al., 2002). The objective is to determine if the novel plant presents any new or greater risk in comparison with its traditional counterpart, or whether it can be used interchangeably with its traditional counterpart without negatively affecting the environment in which it is grown. The goal is to establish a relative level of safety, so that there is a reasonable certainty that no undue risk to the environment will result from the cultivation of the novel plant under anticipated conditions of production.
The OECD and FAO recommended that substantial equivalence could be taken as an important component in the safety assessment of foods and food ingredients derived from genetically modified plants intended for human consumption (OECD, 1993; FAO, 1996). This concept embodies a science-based approach in which a genetically modified food is compared with its existing, appropriate counterpart. The approach is not intended to establish absolute safety, which is an unattainable goal for any food. Rather, the aim is to ensure that the food or any substance that has been introduced into the food as a result of genetic modifica- tion is as safe as its traditional counterpart.
In most countries there are common safety concerns that must be addressed on a case-by-case basis prior to commercialization of a novel plant. As summarized by OECD and FAO these include:
● stability of the genetic modification
● gene transfer to related plants
● gene transfer to unrelated organisms
● potential for weed growth
● secondary and non-target adverse effects.
The safety assessment of a genetically modified food is directed by the results of a comparison between the GM food and its conventional counterpart. It follows
a stepwise process aided by a series of structure questions. Factors taken into account in the safety assessment include:
i. identity ii. source iii. composition
iv. effects of processing/cooking v. transformation process
vi. the recombinant DNA (stability of insertion, potential for gene transfer) vii. protein expression product of the novel DNA (effects on function, potential
toxicity, potential allergenicity)
viii. possible secondary effects from gene expression or the disruption of the host DNA or metabolic pathways, including composition of critical macronutri- ents, micronutrients, antinutrients, endogenous toxicants, allergens, physio- logically active substances
ix. potential intake and dietary impact of the introduction of the genetically modified food.
The above factors are particularly pertinent to the assessment of foods derived from GM plants. When assessing the safety of foods derived from GM animals and microorganisms, other factors may need to be taken into account on a case- by-case basis.
It was noted that very little is known about the potential long term effects of growing or eating any food, including traditional ones, let alone GM foods (OECD, 1996). In many cases the wide genetic variability in the human popula- tion inevitably means that some individuals may have a greater predisposition to suffer from food-related effects. Therefore it should be accepted that for GM foods, the pre-marketing safety assessment already gives assurance that the food is as safe as its conventional counterpart.
FAO and WHO (FAO, 1996) are of the opinion that there are presently no available alternative strategies that would provide better assurance of the safety of GM foods than the appropriate use of the concept of substantial equivalence.
Nevertheless, some aspects of the steps in the safety assessment process could be refined to keep abreast of developments in genetic modification technology. New methodologies, such as profiling techniques, offer the means of providing a more detailed analytical comparison (WHO, 2000).
Substantial equivalence acknowledges that the goal of the assessment is not to establish absolute safety but to consider whether the genetically modified food is as safe as its traditional counterpart, where such counterpart exists. Consumers have a right to be informed about the products they buy. However, whether or not the labelling of genetically modified foods is the most appropriate way to enable consumers to make informed choices about the food products is the subject of an active and ongoing debate in number of countries (Hoban, 1997; Codex, 1999;
IFT, 2000). There is substantial variation in the labelling policies and procedures for GMOs that have been adopted by various governments.