Regulatory    |   Vol. 3 Issue 3   

Keeping you informed of legislative and regulatory changes in Europe and abroad — from lawsuits to approvals to other regulatory issues affecting your business.



The Department of Environment, Food and Rural Affairs will allow Rothamsted Research to conduct field trials of genetically modified camelina plants at the Rothamsted Farm in 2016 to 2017. The field trials will be conducted to evaluate the amount of omega-3 long chain polyunsaturated fatty acids (LC-PUFAs) in camelina seeds. Omega-3 LC-PUFAs exhibit benefits to human health including protection against coronary heart diseases. The research team has also developed camelina plants that accumulate astaxanthin, a pigment commonly used as a feed additive in aquaculture. The field trials will also assess the performance of this new trait.


The EU Standing Committee on Plants, Animals, Food and Feed continues to be deadlocked over the renewal of licences for glyphosate use, which will expire on 30 June 2016, unless extended. The Green Alliance, composed of 46 Members of the European Parliament, is opposing the renewal. The Green Alliance’s concern is that the opinion of the European Food Safety Authority (EFSA) on glyphosate as unlikely to cause cancer in humans, is flawed, since it was based on unpublished regulatory studies—which the industry has offered to make available.

Colin Ruscoe, chairman of British Crop Production Council, has contacted Keith Taylor, Green MEP for South East England, to challenge this stance, saying EFSA’s conclusions were based on studies that have been comprehensively reviewed by EU regulators, which considered risk as well as intrinsic hazard. The BCPC also challenges the Green Alliance’s opposition to GM (and associated) technologies. Ruscoe cites the recent US National Academies of Sciences, Engineering and Medicine report covering 900 studies over three decades, which found no evidence of adverse effects of GM foods on human health or the environment. ‘Given this report, I would like to know how the Alliance can continue to justify its ideological opposition to genetic modification of crops’, says Ruscoe.


The Department for Environment, Food and Rural Affairs has approved the Sainsbury Laboratory’s (TSL) application to conduct field trials of GM potato crops on a designated trial site at the Norwich Research Park between 2016 and 2020. The field trials are part of the TSL’s Potato Partnership Project to develop a Maris Piper potato that is blight and nematode resistant, bruises less, and produces less acrylamide when cooked at high temperatures. Jonathan Jones, senior scientist at TSL, said, ‘I am delighted that we have approval for the field trials necessary to test our potato plants in standard field conditions. We will spend the rest of this year making sure we can get the desired traits into Maris Piper plants, and plan to conduct field trials from next year onwards’.



In a statement, the Philippine American Academy of Science and Engineering (PAASE) expressed strong support for the continuation of research, development and field testing of Bt eggplant in the Philippines, following the Supreme Court order halting its field testing in December 2015. Under the new biosafety guidelines of the Philippines, signed by five government departments, PAASE urged ‘all parties involved to take prompt and responsible actions … to implement the resumption and continuation of research’. Elaborating Bt eggplant and GM technology’s human, animal and environmental safety, and its potential contribution to food security in its 22-page statement, PAASE urged various stakeholders to mobilise and partner with eggplant farmers ‘to build scientific and technological capacity best suited to their circumstances’. They also committed to ‘working with the Philippine government, universities and the public in providing expert advice and recommendations on the various facets of the development and use of Bt talong in the Philippines’.


As part of its ongoing registration review of the herbicide glyphosate, the US Environmental Protection Agency (EPA) has published its official classification of glyphosate as ‘not likely to be carcinogenic to humans’. This determination is the published conclusion of EPA’s Cancer Assessment Review Committee (CARC), and is based on the overwhelming weight of evidence on glyphosate. The CARC report is publicly available on EPA’s glyphosate docket. The EPA is the third regulator to publish its conclusion that glyphosate is not a carcinogen, as part of a registration review since the International Agency for Research on Cancer announced an inconsistent classification in March 2015. The European Food Safety Authority determined in November 2015 that glyphosate is ‘unlikely to pose a carcinogenic hazard to humans’. Also in 2015, the Canadian Pest Management Regulatory Authority (PMRA) concluded that ‘glyphosate is unlikely to pose a human cancer risk’. These conclusions by the EPA and European and Canadian regulatory authorities are based on standard scientific principles and the overwhelming weight of evidence.


DuPont Pioneer announced waxy corn hybrids as its first commercial agricultural product developed through the application of CRISPR-Cas enabled advanced breeding technology. This next generation of elite waxy corn hybrids is expected to be available to US growers within five years, pending field trials and regulatory reviews. ‘We’re applying our 90 years of knowledge of corn biology to develop the next generation of high-quality waxy corn hybrids for the benefit of the entire value chain from growers to processors and end users’, said Neal Gutterson, vice-president of research and development for DuPont Pioneer. ‘Starting with an identity-preserved product as our initial CRISPR-Cas offering allows us to lay a solid foundation for success of future larger volume products from this plant breeding innovation’.

The United States Department of Agriculture (USDA) recently published its response to Pioneer’s ‘Regulated Article Letter of Inquiry’ stating that it does not consider next-generation waxy corn developed with CRISPR-Cas enabled advanced breeding technology as regulated by USDA Biotechnology Regulatory Services. ‘DuPont Pioneer believes that CRISPR-Cas as an advanced plant breeding tool holds great promise for maintaining the world’s ability to produce an abundant and healthy food supply. The USDA’s confirmation is an important first step toward clarifying the US regulatory landscape and the development of seed products with CRISPR-Cas technology’, said Gutterson. ‘We continue to consult with global regulatory bodies and government agencies in order to understand the potential regulations around the world’.

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