which would not be subject to the premarket safety assessment required of GM crops.
Moreover, varieties produced using the methods listed in Table 24.1 would be difficult if
not impossible to distinguish from those produced by spontaneous natural mutations
and conventional breeding. All that could be established in a comparison of two vari-
eties is that their genomic DNA sequences are different, and with some technologies
no detectable differences in the genomic DNA sequence would be observed. It would,
therefore, be impossible to determine the breeding process with which the varieties
were developed. Clearly the “GMO” category has a high level of arbitrariness from a
scientific point of view, and reflects political, economic, trade, and other considerations.
Food Safety of Transgenic
Crops: A Point of Contention
Although each country may have differing laws, regulations, and agency roles associ-
ated with regulation of transgenic crops safety, food-safety assessors the world over
have, for the most part, evolved a common view of the scientific principles upon which
safety assessment should be based. A comprehensive rationale for the food safety assess-
ment of transgenic organisms was published by Codex Alimentarius (2003, 2009).
A number of good reviews that explain the safety assessment process in detail also have
been published (see for example, König et al., 2004). The safety assessment process seeks
to identify potential hazards, assess which hazards present real risks, and characterize
the nature and extent of the identified risks. Responsibility for risk-management plans
and risk communication is the responsibility of risk managers. Product approvals are
informed by the scientific risk assessment; however, scientific risk assessors do not make
approval decisions. The procedure for approval or disapproval of products is a complex
political process that varies from country to country (Chassy, 2008).
The hazards associated with transgenic crops can be divided into two broad
1. Hazards associated with the newly inserted material (usually DNA), expressed
novel proteins, novel metabolites, and intended compositional changes.
2. Hazards associated with unintended changes that may have occurred as a result of
the DNA insertion.
The approach to evaluating these two classes of hazards is, of necessity, fundamentally
different since the nature of the newly introduced material and its products are known a
priori, whereas unintended changes occur randomly as a result of the breeding process.
Procedures have been developed to evaluate whether there are risks of adverse effects
posed by the inserted DNA, any proteins encoded by the DNA, and any new metabolites
or compositional changes that have been introduced. Experimental and computer-based
procedures for evaluating the safety of the inserted material have been published and