New and Classic Articles
Unscientific Foundations of GMO Regulation
How a U.S. District Court Revealed the Unsoundness of the FDA’s Policy on Genetically Engineered Foods (2003)
A Report on the Results of Alliance for Bio-Integrity v. Shalala, et al. by Steven M. Druker, Executive Director Alliance for Bio-Integrity. In this case the judge determined that: (1) The FDA is not regulating GE foods at all; (2) The FDA’s politically appointed bureaucrats disregarded the advice and warnings of the agency’s scientific staff; (3) There is currently significant disagreement among scientific experts about the safety of GE foods.
Pelletier discusses how the FDA decided on its regulatory policy for GMOs, which remains in place today. “This paper reveals that the FDA responded to political pressure for a permissive regulatory approach by exploiting gaps in scientiﬁc knowledge, creatively interpreting existing food law and limiting public involvement in the policy’s development.” Pelletier documents the unscientific basis of GMO regulation, revealing the contrast between government and industry assurances that GMO regulation is science based and stringent and that GMOs are “safe” and the actual situation, which continues to be one of “great uncertainty“, due to the lack of a “major public research effort.”
Scientific Risk Assessment and Regulation
Food safety and pharmaceutical regulators frequently rely on “arguments of ignorance” and “assumption-based reasoning” when assessing the risks of commercial products. Relying on these unscientific theoretical methods, rather than on experimental data and the precautionary principle, regulators routinely make regulatory mistakes that cause enormous harm to the public. With this in mind, Heinemann et al. critique current GMO regulation and suggest improved risk assessment for GM crops or products that contain dsRNA.
Regulators Discover a Hidden Viral Gene in Commercial GMO Crops (2013)
Latham and Wilson, Independent Science News, 21 January 2013
A scientific paper published in late 2012 shows that US and EU GMO regulators have for many years been inadvertently approving transgenic events containing a fragment of an unsuspected viral gene. As a result, 54 different transgenic events commercialized internationally contain a substantial segment of the multifunctional Gene VI from Cauliflower Mosaic Virus (CaMV) within them. Among these are some of the most widely grown GMOs, including Roundup Ready Soybean (40-3-2) and MON810 Maize. The oversight occurred because regulators failed to appreciate that Gene VI overlaps the commonly used CaMV 35S gene regulatory sequence. The authors of the paper (Podevin and du Jardin 2012), working for the European Food Safety Authority, concluded that functions of Gene VI were potential sources of harmful consequences. They further concluded that, if expressed, the fragments of Gene VI are substantial enough for them to be functional. Latham and Wilson discuss the multiple ramifications of this discovery for biotechnology. See also the followup article: Is the Hidden Viral Gene Safe? GMO Regulators Fail to Convince.
The Problem with Nutritionally Enhanced Plants (2009) Schubert (2009) J of Medicinal Food 11(4) 601-605
Among the next generation of genetically modified (GM) plants are those that are engineered to produce elevated levels of nutritional molecules such as vitamins, omega-3 fatty acids, and amino acids. Based upon the U.S. current regulatory scheme, the plants and their products may enter our food supply without any required safety testing. The potential risks of this type of GM plant are discussed in the context of human health, and it is argued that there should be very careful safety testing of plants designed to produce biologically active molecules before they are commercially grown and consumed. This will require a mandatory, scientifically rigorous review process.
Safety Testing and Regulation of Genetically Engineered Foods (2004)
W. Freese and D. Schubert, Biotechnology and Genetic Engineering Reviews 21: 299-324.
A sophisticated and robust assessment of the problems with the voluntary U.S. regulatory system for the approval of transgenic food crops. Utilizes Bt Corn as a case study.
Science, Law, and Politics in FDA’s Genetically Engineered Foods Policy: Scientific Concerns and Uncertainties (2005)
David Pelletier, Nutrition Reviews 63: 210-23.
This paper discusses the urgent need for nutritionists to define safe, unsafe, desirable and indifferent levels of nutrients and toxins in food plants. This is necessary so that breeders can select and reject appropriate lines and enable regulators to make scientifically informed decisions.
Schubert, David. “A different perspective on GM food.” Nature biotechnology 20.10 (2002): 969-969.
Reasons for Labeling of Genetically Engineered Foods (2012)
Michael Hansen, Ph.D; March 19, 2012
Letter to: AMA Council on Science and Public Health: Based on the scientific uncertainty surrounding both (a) the molecular characterization of genetically engineered (GE) crops and (b) the ability to detect potential allergens before commercialization, Hansen presents a science-based argument for requiring the labeling of foods produced via genetic engineering. Labeling would be a risk management measure and would facilitate identification of unintended health effects that may occur post approval. Hansen summarizes key scientific references to make his case.
Unintended Effects of Genetic Engineering
Frequently claimed to be “precise and predictable”, scientific analysis of genetic engineering shows it to be a very mutagenic and unpredictable method of plant breeding. Commercial GMOs can have harmful unintended effects and certain types of GMOs have transgene-specific risks.
Transformation-induced Mutations in Transgenic Plants: Analysis and Biosafety Implications (2006)
Wilson et. al. (2006) Biotechnology and Genetic Engineering Reviews 23: 209-237
A comprehensive survey of the unintended mutations created during the transgene insertion and plant transformation processes used to create GMOs. Includes risk analysis and suggestions for prevention and removal.
GMO proponents often claim that genetic engineering is precise and predictable. Roundup Ready Soybean is high profile example of multiple harmful unintended effects found in a single widely grown commercial line. RR2Yield , its replacement, claims to have fixed the 7-11% yield loss seen in the original RR soybeans, however RR2 comes with a major agronomic unintended effect of its own, a 5% height decrease. What does this say about the precision of genetic engineering?
Transcomplementation and Synergism in Plants: Implications for Viral Transgenes? (2008)
Latham and Wilson (2008) Molecular Plant Pathology 9: 85-103
It is common practice to use viral DNA in GMOs — usually .
Agronomic Failure of GMOs
Independent research shows that the agronomic and environmental promises made for GMOs are not the reality.
Failure to Yield: Evaluating the Performance of Genetically Engineered Crops (2009) Doug Gurian-Sherman (2009)
This report for the Union of Concerned Scientists is the first to evaluate in detail the overall, or aggregate, yield effect of GE after more than 20 years of research and 13 years of commercialization in the United States. Based on that record, it concludes that GE has done little to increase overall crop yields.
Impacts of genetically engineered crops on pesticide use in the U.S. – the first sixteen years (2012)
Benbrook (2012) Environmental Sciences Europe 24:24
It is a frequent and crucial claim that herbicide-resistant and pest-resistant GMOs reduce pesticide use, with large benefits for farmers and the environment. Benbrook provides a systematic, independent, and publicly accessible analysis of these various claims. He finds a large increase in both herbicide and pesticide use in the U.S. between 1996–2011 and predicts even greater increases in the future due to (1) stacking of insecticidal and herbicide-resistance genes and (2) continued increases in Bt-resistant insects and herbicide-resistant weeds.
Environmental Effects of GMOs
As most research is carried out by companies or scientists with industry links, high quality and independent analysis of the effects of GMOs on non-target organisms is hard to come by.
Underlying reasons of the controversy over adverse effects of Bt toxins on lady beetle and lacewing larvae
Hilbeck A, Meier M, and Trtikova M (2012) Environmental Sciences Europe 24(9)
Hilbeck et al. provide detailed analysis of the science and controversy around the effects of engineered Bt toxins on lady beetle and lacewing larvae. They document the faulty experimental design and unscientific behavior of some GMO proponents. Non-scientific attacks on “results that trigger policy responses one disagrees with” can result in policy that jeopardizes both environmental and human health. The authors call on scientists to demand rigorous scientific protocols, defend legitimate scientific disagreement, and condemn personal attacks.
Clone- and age-dependent toxicity of a glyphosate commercial formulation and its active ingredient in Daphnia magna
Marek Cuhra, Terje Traavik, and Thomas Bøhn (2013) Ecotoxicology 22(2): 251–262
The researchers carried out acute and chronic toxicity tests to assess the effects of both glyphosate-IPA and Roundup herbicide on the aquatic invertebrate Daphnia magna. They found that low levels of glyphosate based herbicide induced significant negative effects, including reduced size, growth, and fecundity and increased abortion and mortality. These results, in combination with their review of published data, lead the authors to conclude that current European Commission and US EPA toxicity classiﬁcation of these chemicals with regard to effects on D. magna and aquatic invertebrates in general, is based on non-representative evidence and needs to be adjusted to account for the fact that glyphosate is more toxic to aquatic invertebrates than formerly understood.
GMOs and Developing Countries
Should developing countries be adopting expensive genetically engineered seeds that require extensive inputs of synthetic herbicides, pesticides, and fertilizer, and often require irrigation? Especially when these seeds are poorly tested and regulated and have been developed for industrial agriculture, which displaces small-scale farmers and orients farming towards exports, often creating or exacerbating hunger?
Can the Poor Help GM Crops? Technology, Representation and Cotton in the Makhatini Flats, S. Africa (2006)
Harald Witt et al., Review of African Political Economy 33: 497-513.
The adoption of Genetically Modified (GM) cotton in South Africa’s Makhathini Flats since 1998 is one of the most widely cited GM success stories. Witt, Patel and Schnurr find instead that the privileging of GM adopters and lack of choice appears to better explain patterns of uptake.
This paper discusses what is missing in the risk assessment of Golden Rice, a genetically engineered rice set to be commercially cultivated in 2013. Golden Rice has been engineered to produce carotenoids, the precursors of pro-vitamin A. Its proponents profess to have lofty humanitarian aims, however the truth may be more prosaic — they have used its development repeatedly as an excuse to demand a general lowering of safety standards and testing requirements for all genetically engineered plants.
GMO Politics and the Failure of Science
How good is the science purporting to show GMOs are “safe?” How easy is it to carry out independent research on the human health or environmental consequences of GMOs?
Signed by Bardocz et al. and nearly 200 other researchers globally, Independent Science News, October 2, 2012
This open letter documents the attacks made on independent scientists whose research indicates that GMOs may pose environmental or human health risks. The lastest of these being the new paper by the French group of Gilles-Eric Seralini which describes harmful effects on rats fed diets containing genetically modified maize (variety NK603), with and without the herbicide Roundup, as well as Roundup alone (Seralini et al., 2012). The letter points out the role that industry, government, regulators, conflicted scientists, and the science media play in these attacks and the chilling effect they have on public interest research and on public safety.
Don Lotter, Int. Jrnl. of Soc. of Agr. & Food 16(1): 50-68.
Many scientific and government institutions and individuals promote plant genetic engineering as ‘The Solution’ to everything from global warming to famine. Don Lotter describes watching this position being defended by tactics including defamation of dissenting scientists, manipulation of the information environment, and failure of scientists to hold transgenic research and risk assessment to high scientific standards. These tactics have harmed scientific credibility and allowed private interest science to sideline non-proprietary and ecologically-based alternatives. A return of plant science to Mertonian norms of disinterestedness, critical thinking and openness could revitalize both science and agriculture.
Other Websites with Scientific Resources
These websites provide an independent and public interest science viewpoint on GMOs issues.
The Bioscience Resource Project (BSR) is run by public interest scientists with decades of lab and desk experience researching biotechnology, plant molecular genetics, and plant virology. The BSR website links to their work and to key papers and websites of public interest researchers and NGOs in science, food, and agriculture.
GeneWatch UK is a not-for-profit group that monitors developments in genetic technologies from a public interest, human rights, environmental protection, and animal welfare perspective. GeneWatch believes people should have a voice in whether or how technologies such as genetically engineered crop plants are used and campaigns for safeguards for people, animals and the environment.
Independent Science News (ISN) is a project of the Bioscience Resource Project. ISN publishes articles on contentious issues written by experts in diverse aspects of science, food, and agriculture. BSR scientists have written numerous scientific critiques of different aspects of GMOs. Other topics range from conflicts of interest and the social impacts of industrial agriculture to in situ seed conservation and agroecological farming methods.
GRAIN is a small international non-profit organization that works to support small farmers and social movements in their struggles for community-controlled and biodiversity-based food systems. They cover GMOs, land grabs, food sovereignty and other GMO-related issues.
The Union of Concerned Scientists has written reports on GMO failure to improve yields, Pharma Crops, Gene Contamination and other key issues in genetic engineering. They also provide useful background material on ‘what is genetic engineering?’ and ‘what are the risks of genetic engineering?’ and discuss the many alternatives to GMO use.