Agriculture Reference
In-Depth Information
of risk assessments were presented in a comparative risk ranking to
clarify the distribution of costs, risks, and benefits. Thus, it is critical for
regulators to improve their communications to the public and to build
confidence in the assessment process, particularly because future GM
crops will contain multigene modifications that will require even more
complex testing and assessment methods. Otherwise, NGOs and other
groups will highlight these complexities, raising more public concerns.
OngoingDebates
Substantial Equivalence
The safety of conventional crops and foods prepared and used in tra-
ditional ways are generally assumed to be based on their long history
of human consumption. Regulators and experts find it therefore use-
ful to screen GM crops by comparing their agronomical and morpho-
logical characteristics to similar conventional crops as a “safe” com-
parator. The Office of Device Evaluation (ODE) of U.S. FDA first
coined the “assessment of substantial equivalence” in evaluating medi-
cal devices.
35
In GM plant breeding, this strategy is known as the OECD
concept of substantial equivalence or comparative safety assessment.
36,37
Its application also requires a comparison of the chemical composition.
Significant differences in these parameters are expected to be indica-
tive for any fundamental change in the GM crop that warrants fur-
ther testing for adverse human health effects. The successful applica-
tion of the concept largely depends on the availability of an appro-
priate comparator and the ability to discriminate between differences
35
Miller H. I. (1999) Substantial equivalence: Its uses and abuses.
Nature Biotechnology
17, 1042-1043.
36
Kuiper, H. A., Kleter, G. A., Noteborn, H. P. J. M., Kok, E. J. (2002b) Substantial
equivalence - an appropriate paradigm for the safety assessment of genetically modi-
fied foods?
Toxicology
181-182: 427-431.
37
EFSA (2004) Guidance document of the scientific panel on genetically modified organ-
isms for the risk assessment of genetically modified plants and derived food and feed,
EFSA Journal
99, 1-93.
