Federal Agriculture Minister Marie-Claude Bibeau on Wednesday announced updated guidance from the Canadian Food Inspection Agency that sets gene-edited seeds on the same regulatory level as conventionally-bred seed varieties.

Taken with last year’s related updates by the federal health department to Canada’s Novel Food Regulations, CFIA’s new opinion opens the door for gene-edited seeds’ unregulated use in Canadian fields.

Grower groups whose members have waited years for gene-edited seed to come to Canada lined up Wednesday to hail CFIA’s decision as a potential watershed moment for the domestic ag industry.

But advocates for Canadian organic growers, whose buyers consider gene-edited to also be genetically modified, say the decision will leave the organic sector dependent on seed and biotech firms’ willingness to disclose their handiwork.

Risks not ‘unique or identifiable’

In its updated directive, CFIA said it’s the “scientific opinion of (the agency) that gene-editing technologies do not present any unique or specifically identifiable environmental or human health safety concerns as compared to other technologies of plant development.”

With that in mind, CFIA said it “does not foresee an outcome of conventional breeding where an authorization for environmental release would be required, other than in the case of herbicide-tolerant plants.”

In other words, a company wanting to release a plant with novel traits (PNT) will still need to apply for, and receive, CFIA authorization before that plant is released into the environment — that is, if the PNT still has any DNA from foreign organisms, and/or a new commercially-viable herbicide tolerance trait.

That would also apply to any gene-edited PNT in which any foreign DNA used to encode “gene-editing machinery” — such as in the CRISPR process — remains in the final product and hasn’t been removed through rounds of breeding and selection.

In cases where a plant isn’t a PNT, CFIA said, a plant’s proponents are “expected to fully participate in mechanisms that provide transparency about non-novel products” — such as the Health Canada Transparency Initiative and the Canadian Variety Transparency Database.

It also “remains the proponent’s responsibility to notify the CFIA if the plant could have significant negative environmental impacts and be considered a PNT.”

CFIA said its decision follows consultations with plant breeding, industry and regulatory experts and stakeholders, as well as a public consultation that ran from May through September 2021.

In its release Wednesday, the federal ag department noted the U.S., Japan, Australia, Argentina and Brazil have already “clarified the pathway” for gene-edited products, while New Zealand, the U.K. and the European Union (EU) “are in the process of doing so.”

‘Trusted and safe’

Canada’s competitiveness in world ag markets — and its crops’ resilience against environmental and climate stresses — were common themes among the groups hailing CFIA’s decision Wednesday.

“The CFIA’s updated guidance helps Canada stay competitive on the global stage,” Krista Thomas, vice-president of seed innovation for the Canada Grains Council, said in a separate release.

“Many of our trading partners have already adopted similar science-based policies, and farmers outside of Canada have been growing gene edited crops since 2015. When we let the science be the core of regulatory decision making, we know that the end result can be trusted and is safe.”

Keith Currie, president of the Canadian Federation of Agriculture, said in the government’s release that CFIA’s new guidance “will ultimately help Canadian farmers access new plant varieties that are more resilient to pests and extreme weather events and support our food security and sustainability objectives.”

Greg Sears of the Alberta Wheat Commission said seeds gene-edited for efficient use of resources give farmers “another opportunity to manage inputs more effectively, while sustaining ecosystems and reducing greenhouse gas” — an important development after another year in which Alberta growers “seeded the most expensive crop in recent history.”

Canola Council of Canada president Jim Everson said the guidance will also “encourage new and additional research and development investment in Canada.”

Soy Canada, in a separate statement, noted the country’s soy industry has “excelled at meeting diverse customer needs” including organic, non-genetically modified, genetically modified and identity-preserved soybeans — and meeting any such specific needs “remains an important priority for the industry.”

“Our customers know that we excel at providing a diverse range of products,” Soy Canada’s executive director Brian Innes said in a release. “We’re committed to continue providing customers what they want once we commercialize soybeans created using gene editing.”

‘Shocking’

Other groups, however, don’t expect the new guidance will assure buyers looking for non-GMO or organic crops from Canadian growers.

In a joint release Wednesday, several such groups said CFIA’s guidance means gene-edited crops that have no foreign DNA — and any foods produced from those crops — “will not go through any government approval process at Health Canada or the CFIA, but can be released onto the market by companies without any safety data submitted to the government.”

Given that organic standards allow only for conventionally-bred crops and not for gene-edited or genetically modified plants, the result will be “unknown (genetically modified) foods and seeds on the market that have not been subject to any independent safety assessment,” they said.

Lucy Sharratt, co-ordinator of the Canadian Biotechnology Action Network, called CFIA’s guidance “a shocking abdication of responsibility by our regulators” that “asks Canadian farmers and consumers to trust unseen corporate science.”

Allowing gene-edited seed to enter Canadian agriculture unchallenged could “ultimately destroy the systems that farmers and many food companies have set up to deliver non-GM choices to consumers,” National Farmers Union president Jenn Pfenning said in the same release.

“This decision needs to be reversed, or over time, it will eliminate our ability to offer reliable non-GM food choices, including organic food.”

Garry Johnson, president of SaskOrganics, said “not ensuring full disclosure of all GM seeds through a mandatory public registry, will make it challenging for organic farmers to meet the requirements of the Canadian Organic Standards.”

‘Informed decisions’

In her release Wednesday, Bibeau said that “in light of discussions with the government-industry committee, we will protect the integrity of organic certification.”

Her announcement Wednesday included plans for creation of a “government-industry steering committee on plant breeding innovations transparency, to facilitate ongoing discussions as gene-edited products are introduced in the marketplace.”

Bibeau also said an expansion of the Seeds Canada Canadian Variety Transparency Database will provide transparency around individual seed varieties — and new federal oversight of that database “will ensure (its) completeness and robustness.”

Bibeau also committed Ottawa to “again provide funding to support the review of Canada’s organic standards.” Those standards, updated every five years, are next due for renewal in 2025.

CFA’s Currie, in the government’s release, said those commitments “will help ensure farmers can continue to make informed decisions on what they produce.” — Glacier FarmMedia Network

The post Gene-edited crops clear CFIA’s regulatory bar appeared first on Grainews.

The first of the transgenic chicks will be hatched later this year at the Roslin Institute at the University of Edinburgh in Scotland, said Wendy Barclay, a professor of virology at Imperial College London who is co-leading the project.

The birds’ DNA has been altered using a new gene editing technology known as CRISPR. In this case the “edits” are to remove parts of a protein on which the flu virus normally depends, making the chickens totally flu-resistant.

The idea is to generate poultry that cannot get flu and would form a “buffer between wild birds and humans,” Barclay said.

Global health and infectious disease specialists cite the threat of a human flu pandemic as one of their biggest concerns.

The death toll in the last flu pandemic in 2009-10 — caused by the H1N1 strain and considered to be relatively mild — was around half a million people worldwide. The historic 1918 Spanish flu killed around 50 million people.

The greatest fear now is that a deadly strain could jump from wild birds via poultry into humans, and then mutate into a pandemic airborne form that can pass easily between people.

“If we could prevent influenza virus crossing from wild birds into chickens, we would stop the next pandemic at source,” said Barclay.

In research published in 2016 in the journal Nature, Barclay’s team found that a gene present in chickens called ANP32 encodes a protein that all flu viruses depend on to infect a host. Laboratory tests of cells engineered to lack the gene showed they cannot be infected with flu.

Teaming up scientists at the Roslin, Barclay said the plan is to use CRISPR to edit the chicks’ DNA so that only one part of the key protein is changed, leaving the rest of the bird exactly the same, genetically, as it was before.

“We have identified the smallest change that will stop the virus in its tracks,” she said.

Roslin Institute scientists gained fame in 1996 as creators of “Dolly the sheep,” the world’s first cloned animal. They have also created gene-edited pigs to make them resistant to a virus.

Barclay said one of the biggest hurdles to this approach would be poultry producers’ concerns about public acceptance. “People eat food from farmed animals that have been altered by decades of traditional breeding,” she said. “But they might be nervous about eating gene-edited food.”

— Kate Kelland is a Reuters health and science correspondent based in London.

The post Gene-edited chickens planned in bid to halt next pandemic appeared first on Grainews.

The biotech industry had argued that much of mutagenesis, or gene editing, is effectively little different to the mutagenesis that occurs naturally or is induced by radiation — a standard plant breeding method since the 1950s — but the court disagreed.

“Organisms obtained by mutagenesis are GMOs and are, in principle, subject to the obligations laid down by the GMO Directive,” the Court of Justice of the European Union (ECJ) said in a statement.

“The Court of Justice takes the view, first of all, that organisms obtained by mutagenesis are GMOs within the meaning of the GMO Directive, in so far as the techniques and methods of mutagenesis alter the genetic material of an organism in a way that does not occur naturally,” it added.

The ruling by the ECJ goes against the opinion of the court’s advocate general, who argued in January that the new techniques should be allowed.

Gene editing has the potential to make hardier and more nutritious crops — as well as offering drug companies new ways to fight human disease.

German chemical industry association VCI, which represents companies such as Bayer, BASF and Merck, said the court’s ruling was “backward looking and hostile to progress.”

European biotech association EuropaBio said the ruling failed to provide regulatory clarity.

“Public confidence and science-based decision-making are both important for ensuring that genome editing can deliver needed solutions,” EuropaBio secretary general John Brennan said.

Environmentalists, anti-GM groups and farmers concerned about the potential environmental and health impacts of all genetically engineered products said allowing gene editing would usher in a new era of “GMO 2.0” via the backdoor.

“We welcome this landmark ruling which defeats the biotech industry’s latest attempt to push unwanted genetically-modified products onto our fields and plates,” Mute Schimpf, a campaigner for environmental group Friends of the Earth said in a statement.

The European Union has long restricted the use of GMOs widely adopted around the world, but there was legal uncertainty as to whether modern gene editing of crops should fall under the same rules.

While older GMO technology typically adds new DNA to a crop or animal, gene editing can swiftly cause a mutation by changing a few pieces of DNA code, such as with the CRISPR/Cas9 tool, a type of molecular scissor technology that can be used to edit DNA.

Earlier this month, scientists studying the effects of CRISPR/Cas9 said it could cause unexpected genetic damage which could lead to dangerous changes in some cells.

A group of French agricultural associations brought the case to the ECJ, saying plant varieties obtained via mutagenesis should not be exempt from GMO rules under French law.

The court added that an exception could be made for techniques that have been used conventionally and have a long safety record.

— Robert-Jan Bartunek is a Reuters correspondent in Brussels.

The post GMO rules cover plant gene editing technique, top EU court says appeared first on Grainews.

Soybean cyst nematode (SCN) made its grand entrance in the U.S. in the 1950s, and since then has become soybean producers’ top pest, causing significant yield losses annually. In Canada, it has spread through Ontario and Quebec. Though it has not yet been detected in the Prairies, its arrival is impending.

But research is catching up to the miniature pests and offering hope for new, novel controls. Melissa Mitchum, an associate plant science professor at Missouri University, has discovered a mechanism by which cyst nematodes are able to feed on plants.

Over 10 years ago, Mitchum’s team discovered that these cyst nematodes produce and secrete “plant peptide mimics,” small molecules that look like and function like peptides, which provide chemical signals within the plant. In brief, the nematode finds a root and injects it with a chemical cocktail designed to look like the plant’s own chemical signals, and the plant is “tricked” into feeding the pest a steady stream of nutrients.

Recently, Mitchum proved that nematodes feed on cells near the plant’s vascular tissue. By using these “chemical mimics,” nematodes tap into a plant’s vascular stem cell pathway to form feeding cells that will last them the full 30 days of their life cycle.

“These parasites have been co-evolving with host plants for a long time. They’re highly adapted,” says Mitchum. “If we can identify the molecules and then mechanisms to block that process so the nematode can’t form feeding cells, we can create a novel form of resistance. If you shut down the feeding cell the nematode can’t survive.”

Mitchum’s project, which is funded by the National Science Foundation, aims to understand how plant peptides function.

Her lab has proven the mechanism in the model plant arabidopsis, as well as in soybean and potato; the next step is developing plants that are resistant to the nematode’s influence.

“In soybean we have the advantage because we can do peri-root transformation — we can make transgenic soybean roots for testing,” she says. “We’ve done that as a proof of concept. If we see promise we can move this to whole soybean transformation.”

But there’s a challenge to overcome: if breeders block the mechanism nematodes use to help themselves to plant nutrients, they might also block the plant from feeding itself.

Mitchum’s team has rich resources to do this in the form of new, precise gene editing technologies like CRISPR-Cas9, which can help them modify plants to resist nematodes without compromising growth.

It might take five to 10 years to develop new resistant soybean varieties. Mitchum’s team is in the market for an industry partner to make commercialization possible.

Like other pest controls, “this is not going to be a silver bullet,” Mitchum warns. “What we need is to have a diverse set of tools that we can use to try to keep the populations in the field below an economic threshold.

“We need to come together and develop different strategies.” GN

The post Nematodes: they’re molecular mimics appeared first on Grainews.

Management from Monsanto and its farm data systems arm, The Climate Corp., speaking on a conference call Thursday, said they see a launch for their Climate FieldView platform in Western Canada toward the end of 2017, as they work on the platform’s compatibility with small grains and related equipment.

The Climate FieldView suite, launched in 2015 in the U.S. to tie Climate Corp.’s product offerings into one package, comes also to Brazil this year. Launches in Australia, Argentina and South Africa are expected in 2018-19, the companies said.

The company said it will also bring its products into the European market in 2018-19, having taken its first steps there by buying Estonian farm management software firm VitalFields in November.

The FieldView package had its Canadian launch in September at Canada’s Outdoor Farm Show and was offered for sale in the East last month, for use in the 2017 crop season

Climate CEO Mike Stern on Thursday described the East as “very much of a corn and soybean environment,” similar to the company’s markets in Michigan and Ohio.

The FieldView suite of tools is meant to allow farmers to visualize and analyze crop performance, using field data maps as well as satellite imagery.

Thursday’s conference call laid out near-term plans for both Climate Corp.’s and Monsanto’s research and development pipelines, and noted Climate has “more than 35” R+D projects in the works.

“Farming at the zone level is the new reality,” Climate’s chief scientist Sam Eathington said in the company’s release.

Climate, he said, “is already delivering advanced seed scripting and zone-level nitrogen monitoring capabilities, and our robust research pipeline ensures we will continue to provide farmers actionable insights to help them operate more efficiently and sustainably.”

Among those, the company said, it plans to develop variable-rate prescription tools for nitrogen, phosphorus and potassium, creating what it described as “the industry’s first comprehensive fertility solution, delivering customized insights for crop nutrition and fertility management.”

The company, through collection and analysis of “millions” of data points on seed product performance across various geographies, said it also plans to provide seed product selection plans for its farmer users.

Climate said its field health research will lead to development of a disease insights package, identifying and predicting a specific field’s disease vulnerability and diagnosing crop diseases, applying artificial intelligence to images of infected plants.

Climate said it’s also working on a new “directed scouting” tool to help farmers better sort out which fields to prioritize before heading out to scout.

That tool, which Climate said will be “a first for the digital ag industry,” is meant to help farmers save time and protect yield, before yield is impacted at the end of the season.

Collaborations

Monsanto also laid out a number of key projects in its own R+D pipeline, including its Higher-Yielding Corn trait family, a collaboration with BASF; the DeKalb Disease Shield corn hybrids platform; and Acceleron seed-applied disease protection products, a collaboration with Bayer.

The company said it’s also working on an “innovative biological approach” to control varroa mite infestations in bee colonies, and a seed-applied nematode control product, dubbed NemaStrike.

Noting the still-pending merger plans between Bayer CropScience and Monsanto, the company’s chief technology officer Robert Fraley said Thursday that “parallel development” of herbicides and crop traits would allow the combined company to shave “years” off the delivery timelines for products in its pipeline.

Accelerated earnings, he said, could then be allocated toward additional areas of R+D.

Monsanto on Wednesday also announced it has reached a global licensing agreement with the Broad Institute of MIT and Harvard, for agricultural applications of the institute’s new CRISPR-Cpf1 genome-editing technology.

The agreement’s specific terms weren’t disclosed Wednesday. Monsanto has previously signed deals for other genome-editing technologies for agricultural use, including a license from the Broad Institute for use of the CRISPR-Cas9 system.

CRISPR-Cpf1, Monsanto said, marks “an exciting advance in genome-editing technology, because it has potential to be a simpler and more precise tool for making targeted improvements in a cell’s DNA when compared to the CRISPR-Cas9 system.” — AGCanada.com Network

The post Climate Corp. crop data system in beta for Western Canada appeared first on Grainews.

Hundreds of millions of dollars may be at stake, as the technology promises commercial applications in treating genetic diseases, engineering crops, and other areas.

CRISPR works as a type of molecular scissors that can trim away unwanted parts of the genome, and replace them with new stretches of DNA. It has quickly become the preferred method of gene editing in research labs because of its ease of use compared with older techniques.

The hearing is before the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board in Alexandria, Virginia. It will pit one group of researchers associated with the Broad Institute, affiliated with the Massachusetts Institute of Technology and Harvard University, against another group linked to the University of California at Berkeley and the University of Vienna in Austria.

The latter team, led by Berkeley’s Jennifer Doudna and Vienna’s Emmanuelle Charpentier, applied for a CRISPR patent in 2013.

The Broad team, led by MIT’s Feng Zhang, filed a patent application months later, and became the first to obtain a CRISPR patent in 2014. It has since obtained additional patents. The Berkeley team has obtained CRISPR patents as well, though the 2013 application has not been granted.

In April 2015, the Berkeley team petitioned the patent agency to launch a so-called interference proceeding, claiming Broad’s patents covered the same invention as the Berkeley team’s 2013 application.

Tuesday’s hearing will focus on preliminary motions, which the panel is expected to decide within the next few weeks.

One of those motions, filed by Broad, could end the case. Broad has argued that its patents, which describe the use of CRISPR specifically in animal cells, represent a breakthrough beyond the Berkeley team’s application, which described it more generally. CRISPR occurs naturally in bacteria.

The two teams, Broad has said, are not really claiming the same invention at all. If the panel agrees, the interference proceeding will end, and Broad’s patents will remain intact. Rulings from the panel can be appealed in federal court.

Otherwise, the proceeding will likely go on for another year or more, as the panel weighs evidence to determine which team was first to invent the technology.

Broad spokesman Lee McGuire said in a statement that the institute was confident of its case. Berkeley representatives could not be reached for comment.

The CRISPR dispute is among the last-ever interference proceedings, which were phased out by a 2011 patent reform law. The America Invents Act changed the U.S. patent system from a “first to invent” to “first inventor to file” for patent applications after March 16, 2013.

If the Berkeley team’s challenge succeeds, Broad could lose its patent rights.

Broad has already licensed its CRISPR patents for human therapeutics research to Editas Medicine, a Cambridge, Massachusetts-based biotech firm whose founders included both Zhang and Doudna, who has since left.

It has also licensed its technology to large businesses, including agriculture company Monsanto and General Electric’s medical technology subsidiary GE Healthcare.

Doudna co-founded Berkeley biotech firm Caribou Biosciences, which licenses Berkeley’s intellectual property and is working on CRISPR with other companies, including Novartis and Dupont.

— Brendan Pierson reports on health law for Reuters from New York.

The post U.S. patent agency to weigh rival claims on CRISPR appeared first on Grainews.