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Regulatory

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

National

Reaction Mixed to European Patent Board Decision

Reaction was mixed to the decision of the Enlarged Board of Appeal (EBA) of the European Patent Office, which determined that plants or plant products produced by conventional breeding are not excluded from patentability.

Two cases (one involving broccoli and the other tomatoes) were referred to the EBA to obtain clarification on whether plants or plant products produced by an excluded process are also excluded from patentability. The broccoli patent belongs to Plant Bioscience Ltd. (PBL), a company in the United Kingdom, while the tomato patent is assigned to the State of Israel.

The clarification of the scope of the protection for plants and plant products is welcome news, according to Monsanto Europe-Africa.

“It underlines the value to society of public and private innovation in plant research,” according to the company’s blog. “The patent system is society’s way of encouraging innovation and fairly balancing the interests of inventors and wider society. The patent system is very successful at supporting and stimulating innovation in many fields from phones to cars, buildings, computers and medicines, to name just a few. We are pleased the European Patent Office agrees the benefits of patenting should be available to transformational plant breeders so society can reap the benefits from more innovative crops, delivering better harvests using less resources.”

PBL agrees.

“The decision … is welcome news as it provides much-needed clarity on the scope of patent protection in the European Union for plants and plant products,” reports PBL in a statement. “The broccoli patent has been seen as something of a test case and this decision represents an important step towards encouraging much-needed innovation in agriculture and horticulture in the European Union.”

However, the European Seed Association (ESA) expressed disappointment with the decision.

“It seems that the Enlarged Board of Appeal chose a very narrow and legalistic interpretation of the issue in question and consequently decided in favour of patentability of plants, rather than restricting it,” says Garlich von Essen, ESA secretary-general. “The breeders’ exemption is the cornerstone of a system that successfully balances the protection of individual intellectual property with the common interest of society to introduce innovation broadly and quickly by allowing free access for further research and breeding. This decision has the potential to not only restrict this free access to quite a number of products, but also to generally discourage breeding efforts in areas covered by such patents in the future.”

Von Essen adds that ESA is calling for “an effective breeders’ exemption, and that means an effective exclusion from patentability of not only plant varieties and essentially biological processes but also of plants obtained by such processes. While we support the patentability of true biotechnological inventions, this ruling is shifting the boundary between the two systems in favour of patents. We therefore now have to work for suitable initiatives and measures to shift that boundary back.”

EU Defaults on GM Approvals

Biotech traits awaiting approval by the European Commission will continue to wait as a newly elected commission takes office. “This is, once again, a disappointing failure of the European Union to live up to its own statutory requirements, World Trade Organization commitments and policy guidelines,” says Floyd Gaibler, U.S. Grains Council director of trade policy. “On paper, the EU is committed to a science-based process with transparent standards and a reasonable timetable. In practice, the EU process is politically driven. This hurts U.S. farmers and traders, European livestock producers and of course European consumers, who are the biggest losers.” The traits at issue enhance corn, soy, canola and cotton varieties and have already been found to be safe by the European Food Safety Authority. By declining to act, the outgoing commissioners have punted the issue to their successors. While the new commissioners could act on the approvals immediately, incoming president Jean-Claude Juncker has called for a review of biotechnology approval policies during his first six months in office of 2015.

Ukraine Sets up First ESTA Site Outside of the EU

The European Seed Association’s quality assurance scheme for seed treatment and treated seed, the ‘European Seed Treatment Assurance’ (ESTA), is establishing its position as a true pan-European standard with a new site in Ukraine. Maïsadour Seeds has been awarded ESTA certification at its Ukrainian industrial complex for hybrid seed production. “The successful ESTA certification of the Maïsadour seed treatment site in the Ukraine marks an important next step in the development of our quality assurance scheme. It shows the clear commitment of the industry to implement its high quality standards and procedures not only in the EU itself but also beyond,” says Garlich von Essen, ESA secretary-general. “This is of general importance in view of the increasing international movement of treated seed — and more specifically for such an important seed country as the Ukraine.” Every ESTA-certified site helps to make sure that EU seed companies, farmers and growers alike may safeguard their long-term access to crucial seed and crop protection technologies.

EU Parliament Backs GMO Opt-Out for Member States

New legislation to allow European Union member states to restrict or ban the cultivation of crops containing genetically modified organisms on their own territory, even if this is allowed at EU level, was passed by members. The legislation, informally agreed on by Parliament and Council in December, was originally tabled in 2010 but was then deadlocked for four years due to disagreement between pro- and anti-GMO member states. “This agreement will ensure more flexibility for member states who wish to restrict the cultivation of the GMOs in their territory,” says Frédérique Ries, who is steering the legislation through Parliament. The agreement negotiated with EU ministers was approved by 480 votes to 159, with 58 abstentions. The new rules would allow member states to ban GMOs on environmental policy grounds other than the risks to health and the environment already assessed by the European Food Safety Authority. Member states could also ban GMO crops on other grounds, such as town and country planning requirements, socio-economic impact, avoiding the unintended presence of GMOs in other products and farm policy objectives. Bans could also include groups of GMOs designated by crop or trait. The new legislation will come into force in spring 2015.

International

Bill Amending Pakistan’s Seed
Act Clears Legislative Process

The bill amending Pakistan’s 1976 Seed Act has cleared the first step of the legislative process as the country’s parliamentary committee on National Food Security and Research has voted to approve the amendment. If approved, the bill would open Pakistan’s seed industry to private sector participation and authorise the registration of biotech seeds. If the bill clears the National Assembly, it will undergo additional legislative steps before final approval. Key provisions include allowing the private sector to register seed companies that produce and market seeds, enhancing penalties to curb the sale of sub-standard seed, establishing accredited seed testing laboratories, and authorising the registration of biotech seeds.

Forage Seed Industry Wants Western
Canada to be a GM Alfalfa-Free Zone

Alfalfa seed growers in Alberta could stand to gain a huge market advantage over their neighbours to the south — if the industry can keep GM alfalfa out of Western Canada. “We’ve got access to potential market gains by picking up markets that are possibly going to be lost in the States,” said Heather Kerschbaumer, a Fairview-area seed grower and president of Forage Seed Canada. Alfalfa is the fourth-largest crop, in acreage and value, in the U.S., but contamination from genetically engineered crops in “supposedly GE-free zones” in California and Washington are raising red flags with Europe, China and other buyers. “In China, zero means zero,” Kerschbaumer said at the Alberta Forage Industry Network AGM in mid-March.

Five Roundup Ready alfalfa varieties were approved for Canada in 2013 and were set to hit shelves in Eastern Canada last spring. Monsanto and marketer Forage Genetics International held off due to “push-back” from the industry, but almost a dozen test plots were planted in Ontario and Quebec last year, with more to come this year. That’s a problem for growers in Western Canada, where the risk of contamination is greater, said Kerschbaumer. The forage seed industry is looking to have Western Canada designated as a “GE-free zone” where clean seed can be produced.

“Seed companies are already starting to move seed production out of the U.S. up into Canada because they need clean seed stocks, even for their own varieties that they’re trying to market into Europe. They still need to have a safe area.”

Kerschbaumer said she suspects that’s partly why Canada grew 5,300 more acres of certified alfalfa seed in 2014 compared to 2013.

The plan has some precedent, she said. In 2011, Monsanto and Forage Genetics International agreed not to commercialize Roundup Ready alfalfa in California’s Imperial Valley, the largest exporter of hay in the U.S. And as seed suppliers for the hay industry, the forage seed industry could make a strong argument to keep GM alfalfa out of Western Canada.

Syngenta Receives Chinese Import
Approval for Corn Trait

Syngenta has received the safety certificate for its Agrisure Viptera trait — event MIR162 — from China’s regulatory authorities, formally granting import approval. The approval covers corn grain and processing byproducts, such as dried distillers grains, for food and feed use. The Agrisure Viptera trait is a key component of Syngenta’s insect control solutions, offering growers protection against the broadest spectrum of above-ground corn pests and enabling significant crop yield gains. Agrisure Viptera has been approved for cultivation in the U.S. since 2010 and has also been approved for cultivation in Argentina, Brazil, Canada, Colombia, Paraguay and Uruguay. Syngenta originally submitted the import approval dossier to Chinese authorities in March 2010. In addition to China, Agrisure Viptera has been approved for import into Australia, New Zealand, Belarus, the European Union, Indonesia, Japan, Kazakhstan, Korea, Mexico, Philippines, Russia, South Africa, Taiwan and Vietnam.

Origin Agritech Renews Bio-Safety
Certificate for GM Phytase Corn

Origin Agritech, a technology-focused supplier of crop seeds in China, has received the renewed bio-safety certificate from the Ministry of Agriculture for its genetically modified phytase corn for the next five years. The bio-safety certificate was originally received in 2009 for Origin Agritech’s GM phytase corn for a period of five years, which expired in August 2014. GM seed products in China must undergo five separate stages of approval beginning with a Phase 1 laboratory approval to the final receipt of the bio-safety certificate in Phase 5.  In addition to the original phytase corn seed, Origin Agritech now has four commercial hybrids with phytase traits in Phase 5 — the bio-safety certificate stage. The company also announced that its next generation GM product glyphosate tolerance corn seed has passed Phase 4 — the production test stage — and is waiting for the Phase 5 the bio-safety certificate. Origin Agritech’s GM corn products with stacked traits of glyphosate tolerance and insect resistance (Bt) have progressed to Phase 3 — the environment release test stage.

Monsanto Cotton Trait Comes To Market

The cotton industry’s next-generation trait technology has been deregulated by the U.S. Department of Agriculture, giving American cotton farmers access to new tools for managing tough-to-control weeds.

A limited introduction of Bollgard II XtendFlex cotton is planned for the 2015 planting season through the Monsanto-owned Deltapine brand, as well as select licensees in varieties that fit broadly across the entire cotton belt. Monsanto anticipates the new cotton varieties will be grown on more than half a million acres.

Bollgard II XtendFlex cotton, part of the Roundup Ready Xtend Crop System, is tolerant to three different herbicides — dicamba, glyphosate and glufosinate. Glyphosate and glufosinate are currently approved for use as in-crop herbicides, while over-the-top dicamba use is pending regulatory approval.

“We are working very closely with farmers during this year’s limited introduction, and we’re taking active steps through multiple avenues to help ensure that growers and retailers are informed of this technology’s authorised and labeled use,” said Jordan Iverson, cotton traits marketing manager at Monsanto Company. “This new cotton technology provides farmers a tremendous value for weed control by adding tolerance to an additional, approved mode of action through Liberty herbicide. Once authorized, dicamba herbicide will deliver a third mode of action.”

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