GMO Myths and Truths

Conclusion to Section 2
The regulatory regime for GM crops and foods is
weakest in the US, the origin of most such crops,
but is inadequate in most regions of the world,
including Europe. The US regime assumes that GM
crops are safe if certain basic constituents of the
GM crop are “substantially equivalent” to those of
their non-GM counterparts – a term that has not
been legally or scientifically defined. The European
regime applies the same concept but terms it
“comparative safety assessment”. But often, when
a scientific comparison of a GM crop and its non-
GM counterpart is undertaken, the assumption
of substantial equivalence is shown to be false, as
unexpected differences are found.
No regulatory regime anywhere in the world
requires long-term or rigorous safety testing of
GM crops and foods. Regulatory assessments
are based on data provided by the company
that is applying to commercialise the crop – the
same company that will profit from a positive
assessment of its safety.
The regulatory procedure for GM crops is not
References to Section 2
1. Pollan M. Playing God in the garden. New York Times Magazine.
25 October 1998. http://www.nytimes.com/1998/10/25/
magazine/playing-god-in-the-garden.html
2. US Food and Drug Administration. Statement of policy: Foods
derived from new plant varieties. FDA Federal Register. 29 May
1992; 57(104): 229.
3. European Food Safety Authority (EFSA). Frequently asked
questions on EFSA GMO risk assessment. 15 May 2006.
4. European Commission. GMOs in a nutshell. 2011. http://
ec.europa.eu/food/food/biotechnology/qanda/a1_en.print.htm
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genetically engineered crops. Institute for Social Ecology
Biotechnology Project. June 2006. http://environmentalcommons.
org/RegulatoryDeficiencies.html
6. Freese W, Schubert D. Safety testing and regulation of genetically
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7. Kahl L. Memorandum to Dr James Maryanski, FDA
biotechnology coordinator, about the Federal Register document,
“Statement of policy: Foods from genetically modified plants”.
US Food & Drug Administration. 8 January 1992. http://www.
biointegrity.org/FDAdocs/01/01.pdf
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coordinator: Regulation of transgenic plants – FDA Draft Federal
Register Notice on Food Biotechnology. US Department of Health
& Human Services. 5 February 1992. http://www.biointegrity.org/
FDAdocs/08/08.pdf
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transformed by technology methods”. US Food & Drug
independent or objective. The GM crop industry,
notably through the industry-funded group, the
International Life Sciences Institute (ILSI), has
heavily influenced the way in which its products
are assessed for safety. ILSI has successfully
promoted ideas such as the comparative safety
assessment, which maximize the chances of a
GMO avoiding rigorous safety testing and greatly
reduce industry’s costs for GMO authorisations.
The GM crop industry restricts access to its
products by independent researchers, so their
effects on human and animal health and the
environment cannot be properly investigated.
Independent researchers who have published
papers containing data that is not supportive of
GMOs have been attacked by the industry and
pro-GMO groups and individuals. This has had
a chilling effect on the debate about GM crops
and has compromised scientific progress in
understanding their effects.
Administration. October 28 1991. http://www.biointegrity.org/
FDAdocs/02/02.pdf
10. Shibko SL. Memorandum to James H. Maryanski,
biotechnology coordinator, CFSAN: Revision of toxicology section
of the “Statement of policy: Foods derived from genetically
modified plants”. US Food & Drug Administration. Institution.
Date 1992. http://www.biointegrity.org/FDAdocs/03/03.pdf
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Biotechnology Document. US Food & Drug Administration. 18
March 1992. http://www.biointegrity.org/FDAdocs/12/ljpp.pdf
12. Pribyl LJ. Comments on Biotechnology Draft Document,
2/27/92. US Food & Drug Administration. 6 March 1992. http://
www.biointegrity.org/FDAdocs/04/04.pdf
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facts: An interview with FDA’s Jim Maryanski. FDA Consumer.
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14. Bittman M. Why aren’t GMO foods labeled? New York
Times. 15 February 2011. http://opinionator.blogs.nytimes.
com/2011/02/15/why-arent-g-m-o-foods-labeled/
15. US Food and Drug Administration. Biotechnology consultation
agency response letter BNF No. 000001. 27 January. 1995. http://
www.fda.gov/Food/Biotechnology/Submissions/ucm161129.htm
16. Millstone E, Brunner E, Mayer S. Beyond “substantial
equivalence”. Nature. 1999; 401(6753): 525–526.
17. Organisation for Economic Cooperation and Development
(OECD). Safety Evaluation of Foods Derived by Modern
Biotechnology: Concepts and Principles: OECD Publishing; 1993.
GMO Myths and Truths 34