Bioscience Resource Project News and Views

Both a lack of adequate and science-based risk assessment for genetic engineering (GE) (e.g. Hilbeck et al. 2012; Freese and Schubert 2004; Pelletier, D. 2006) and actual GE regulatory failures (e.g. Latham and Wilson 2013; Gurian-Sherman, D. 2007; Bratspies R.M., 2003) have been extensively documented. Without a complete regulatory rethink, future failures seem assured. The latest case is the heavily promoted GE technology known as RNAi (Williams et al. 2004), whose use seems set to expand while regulators and developers fail to ask or answer key scientific questions.

A recent paper by JA Heinemann, SZ Agapito-Tenfen and JA Carman (2013) “A comparative evaluation of the regulation of GM crops or products containing dsRNA and suggested improvements to risk assessments” presents a careful assessment of three regulatory regimes (Australia, New Zealand and Brazil) and their use of assumption-based reasoning to discount the risks of RNAi technology and the likelihood of harmful and unintended consequences. The authors discuss evidence from the scientific literature showing key assumptions made by these regulators are already known to be wrong. In addition, they provide case studies of previous regulatory failures, such as Vioxx and BSE, that stemmed directly from faulty assumption-based risk assessment. Heinemann et al. outline an alternative science-based risk assessment strategy for RNAi technology that takes into account known sequence-specific hazards and the current state of scientific knowledge.

References:

Bratspies RM, (2003) Myths of Voluntary Compliance: Lessons from the StarLink Corn Fiasco

Freese and Schubert: Safety Testing and Regulation of Genetically Engineered Foods (2004)

Gurian-Sherman, D (2007) Transgene Escape! – But No One Has Called Out the Guards

Hilbeck et al.: (2012) Underlying Reasons of the Controversy over Adverse Effects of Bt toxins on Lady Beetle and Lacewing Larvae

Latham and Wilson (2013): Regulators Discover a Hidden Viral Gene in Commercial GMO Crops

Pelletier, D (2006) FDA’s regulation of genetically engineered foods: Scientific, legal and political dimensions

Williams, Matt, et al. (2004) RNA Interference and its Application in Crop Improvement

Watch the new video of Dr. Jonathan Latham’s 2012 talk at the Rachel Carson Institute‘s Perspectives on Silent Spring at 50 Symposium. The talk can be heard at Greenwashing and the Food Industry. For background information on the topic see: Way Beyond Greenwashing: Have Corporations Captured Big Conservation? and Greenwashing and the Food Industry Further Reading.

The UK based GM Freeze and the USA based Bioscience Resource Project today published a Q&A of key issues regarding the recent revelation that the majority of GM crops contain sequences encoding fragments of the viral Gene VI, which has not been fully assessed for safety.

Read the Joint GM Freeze and BSR Q&A  Press Release

Read the Viral Gene VI Q&A

Dr Jonathan Latham of the Bioscience Research Project, who originally raised concerns about Gene VI in January 2013, [1,2] said:

“We are supposed to believe that EFSA and other GMO regulators are acting in the public interest and in accordance with the best scientific understanding. The belated discovery of Gene VI, and the subsequent actions of regulators, suggest this is not so. Regulators can begin to restore public confidence, however, by never again approving viral sequences and recalling transgenic events containing FMV and CaMV promoters.”

Commenting, Pete Riley of GM Freeze said:

“The presence of Gene VI in many commercial crops raises serious concerns about the safety of GM crops and the regulatory systems around the world. We are very concerned that it appears to have slipped through the regulatory system unnoticed and the response has been ‘so what?’”

“GM foods and feeds are global commodities and therefore have the capacity to cause harm to millions of people or farm animals. This is one very good reason why the regulatory system must be thorough and based on the precautionary principle. No crop showing evidence of questionable safety should enter the environment or food chain.”

1. Regulators Discover a Hidden Viral Gene in Commercial GMO Crops

2. Is the Hidden Viral Gene Safe? GMO Regulators Fail to Convince

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. A systematic, independent, and publicly accessible analysis of this claim is now provided in: Impacts of genetically engineered crops on pesticide use in the U.S. — the first sixteen years by Charles Benbrook (2012).

Assessing the “impacts of six major transgenic pest-management traits on pesticide use in the U.S.,” Benbrook found that, “herbicide-resistant crop technology has led to a 239 million kg increase in herbicide use in the U.S., between 1996 and 2011, while Bt crops have reduced insecticide applications by an estimated 56 million kg.” Therefore, due to the use of GMO seed-pesticide systems, between 1996-2011, “Overall pesticide use increased by an estimated 183 million kg, or about 7%.” However, when levels of plant-produced insecticide (i.e. transgenic Cry endotoxins) and not just applied insecticide were included for Bt GMOs, Benbrook found that on average Bt crops actually greatly increased insecticide use. Furthermore, transgenic Bt insecticides are not environmentally degraded before crop consumption, being produced within the plant cells themselves, which has likely greatly increased human and livestock insecticide exposure.

Benbrook discusses the root causes of the increased pesticide use seen in GMO systems. These include rapid emergence of glyphosate-resistant weeds, increases in potency of non-glyphosate herbicides, high levels of insecticide production in Bt crops, and the use of Bt insecticide producing plants in situations where insecticides would not have been used to control for corn borer or rootworm. He predicts that as herbicide-resistant weeds and Bt-resistant insects continue to emerge, pesticide use will further increase.

While showing these cropping systems have high economic costs for farmers and also the public, Benbrook notes that “The seed-pesticide industry is enjoying record sales and profits, and the spread of resistant weeds and insects opens up new profit opportunities in the context of the seed industry’s current business model.”

With no incentive for the seed-pesticide industry to change course, it is up to farmers, citizen groups, non-profits, and government to implement alternatives to GMO seed-pesticide systems and to reinvigorate non-GMO plant breeding (1). Without immediate and strong intervention, U.S. agriculture will continue with its increasingly harmful reliance on GMOs, herbicides, and insecticides.

(1) For some alternatives to industrial agriculture and GMO seed systems see:

Plant Breeding Derailed: moving forward from GMOs and hybrids

How Millions of Farmers are Advancing Agriculture for Themselves

Findings Challenge ‘Necessity’ of Industrial Agriculture

Future of Rice

Agroecologically efficient agricultural systems for smallholder farmers: contributions to food sovereignty

Effects of industrial agriculture on climate change and the mitigation potential of small-scale agro-ecological farms

Published January 21st in Independent Science News: Regulators Discover a Hidden Viral Gene In Commercial GMO Crops by Bioscience Resource Project Scientists Jonathan Latham and Allison Wilson.

Synopsis: A scientific paper published in late 2012 (Podevin and du Jardin) shows that US and EU GMO regulators have for many years been inadvertently approving transgenic events containing unsuspected viral gene sequences. As a result, 54 different transgenic events commercialized internationally contain a substantial segment of the multifunctional Gene VI from Cauliflower Mosaic Virus (CaMV). Among commercial lines with Gene VI coding sequences 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 (i.e. the CaMV 35S promoter). Podevin and du Jardin, 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 [Podevin and du Jardin (2012) GM Crops and Food 3:1-5]. This discovery has multiple ramifications for biotechnology. Foremost, there is the immediate question of GMO biosafety and whether the 54 events should be recalled, but secondly, the failure implicates regulators and the industry in a circle of mutual incompetence and complacency. The fact that regulators have allowed commercialization of poorly characterized and sometimes complex transgene insertion events (Wilson et al. 2006) increases the risk of Gene VI being expressed. The discovery will also strengthen the argument for GMO labeling: if regulators and industry cannot protect the public then why should they not be allowed to protect themselves?

Further resources for those interested:

1. The Bioscience Resource Project has previously published scientific articles with direct bearing on the Podevin and du Jardin paper: (1) the risks associated with virus sequences present in commercialized transgenic plants and (2) the risks arising from complex insertion events and other transformation induced mutations. Both are found at: Scientific Publications.

2. Resources on the BSR Biotechnology page discuss how and why the FDA decided on lax and unscientific regulation of GMOs (see Pelletier 2005, 2006) and how current US regulatory policy represents a “failure of science” (see Lotter 2009 and Freese and Schubert 2004).

3. Anyone wishing to see the actual documents and data that companies present to the US government to obtain GMO approval should go to the USDA’s webpage: Petitions for Determination of Nonregulated Status.