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POLICY & REGULATION: It is time to update decades-old U.S. regulation of genetically engineered crops



                                  PART 1


------------------------------- GENET-news -------------------------------

TITLE:   GROWING PAINS

SOURCE:  Nature

AUTHOR:  Vol. 475: 265?266, Editorial

URL:     http://www.nature.com/nature/journal/v475/n7356/full/475265b.html

DATE:    21.07.2011

SUMMARY: "US regulation of GM crops relies on its authority to control plant pests, and so the USDA has regulated crops on the basis of the way plant-pest-based tools are used to make them. It is a bizarre approach, given the low pest risk from the tools. But it had some merit when it was first developed because foreign genes were often inserted into the plant genome by a bacterium that can be lethal to some plants. Once in place, the expression of the foreign gene was guided by a series of genetic elements pulled from plant viruses. ?In the United States, genetic-modification regulation rests not on the final product but on the methods used.?"

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GROWING PAINS

It is time to update decades-old regulation of genetically engineered crops.

Researchers at Scotts Miracle-Gro have a vision of a greener future. The lawn-care company, based in Marysville, Ohio, wants to develop a dwarf grass that needs less frequent maintenance than standard Kentucky bluegrass. But there is a catch: such grass is unlikely to stand up to weeds. No problem, the company reasons, it will make a dwarf grass that is resistant to herbicide to help homeowners to nip those weeds in the bud.

Development of this genetically modified (GM) Kentucky bluegrass made headlines this month when the US Department of Agriculture (USDA) told Scotts that it did not have the authority to regulate it (see page 274). As a result, Scotts is free to start selling its new crop without oversight.

The reason for this is historical. US regulation of GM crops relies on its authority to control plant pests, and so the USDA has regulated crops on the basis of the way plant-pest-based tools are used to make them. It is a bizarre approach, given the low pest risk from the tools. But it had some merit when it was first developed because foreign genes were often inserted into the plant genome by a bacterium that can be lethal to some plants. Once in place, the expression of the foreign gene was guided by a series of genetic elements pulled from plant viruses.

?In the United States, genetic-modification regulation rests not on the final product but on the methods used.?

To get around this, researchers at Scotts made GM grass without using plant pests. It took more work, but the company reasoned that the streamlined regulation ? as well as possible greater consumer acceptance and relief from the patent stranglehold on more traditional genetic-engineering methods ? would make it worthwhile. So they mined the wealth of plant genomic data now available, snipped a herbicide-resistance gene from the model plant Arabidopsis thaliana, sewed it to genetic elements pulled from maize (corn) and rice to drive the gene?s expression, and used a gene gun to blast it into the Kentucky bluegrass genome.

This technique is not the only GM method likely to fall outside USDA regulations. Plant biologists have made tremendous strides since the current rules were cobbled together in 1986, advancing both our fundamental understanding of plant genetics and the technical know-how in manipulating gene expression. Genetic changes can now be made at specific sites in the genome, and foreign genes can even be expressed in plant cells without integrating them into the genome at all. And gene expression can be regulated using RNA molecules ? including, in some cases, ones made by the plant in response to attack by a pathogen.

Many of these advances are still years from commercialization. But regulators must prepare the ground. Monsanto GM soya beans, which use RNA interference to modulate the expression of endogenous genes, are already awaiting a decision from the USDA.

The USDA and others need to reconsider how they define and control GM species. If a crop developer uses genetic engineering to delete a discrete segment of a plant genome, how much regulation does that require? Would those same guidelines be appropriate for a crop that expresses half-a-dozen foreign herbicide- and insect-resistance genes, engineered without the use of plant pests? Such questions are particularly important where ? as in the United States ? GM regulation rests not on the final product of genetic engineering, but on the methods used in the process.

The European Commission is tackling the issue, and has commissioned a study into how new plant techniques fall under the rubric of the European Union definition of GM crops. Similarly, the USDA?s Advisory Committee on Biotechnology and 21st Century Agriculture has raised the problem as a point of concern. But the USDA?s proposed changes to its GM regulatory powers, released in draft form in 2008, failed to address challenges posed by new technologies.

The USDA?s Kentucky bluegrass ruling comes at a crucial time for agricultural biotechnology. Some estimate that the world must increase the rate of growth in agricultural productivity by 25% per year to meet growing worldwide demand for food and biofuels. Many argue that advances in agricultural biotechnology, some of which may come from GM crops, will be needed to meet this demand. Industry, particularly smaller companies, needs to know how these crops will be regulated before they will invest to develop new techniques.

The new breed of GM crops could help gain wider acceptance for the technology, by settling long-standing unease about the use of foreign genes and the inability to target such genes to a specific location in the genome. But it is doubtful that dubious consumers are ready for GM crops to escape regulation altogether.



                                  PART 2

------------------------------- GENET-news -------------------------------

TITLE:   TRANSGENIC GRASS SKIRTS REGULATORS

SOURCE:  Nature News, UK

AUTHOR:  Vol. 475: 274-275, by Heidi Hedford

URL:     http://www.nature.com/news/2011/110720/full/475274a.html

DATE:    21.07.2011

SUMMARY: "Technological advances remove basis for government oversight of genetically modified crops. When the US Department of Agriculture announced this month that it did not have the authority to oversee a new variety of genetically modified Kentucky bluegrass, it exposed a serious weakness in the regulations governing GM crops. These are based not on a plant?s GM nature but on the techniques used for its genetic modification. With changing technologies, the department says that it lacks the authority to regulate newly created transgenic crops."

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TRANSGENIC GRASS SKIRTS REGULATORS

Technological advances remove basis for government oversight of genetically modified crops.

When the US Department of Agriculture (USDA) announced this month that it did not have the authority to oversee a new variety of genetically modified (GM) Kentucky bluegrass, it exposed a serious weakness in the regulations governing GM crops. These are based not on a plant?s GM nature but on the techniques used for its genetic modification. With changing technologies, the department says that it lacks the authority to regulate newly created transgenic crops.

The grass, a GM variety of Poa pratensis, is still in the early stages of development by Scotts Miracle-Gro, a lawn-care company based in Marysville, Ohio. The grass has been genetically altered to tolerate the herbicide glyphosate, which would make it easier to keep a lawn weed-free. On 1 July, secretary of agriculture Tom Vilsack wrote to the company to say that the variety ?is not subject? to the same regulations that govern other GM crops. The decision allows Scotts to bypass the years of environmental testing and consultation typically required by the regulators for GM plants, although the company says there are no plans to market this particular variety.

The grass can evade control because the regulations for GM plants derive from the Federal Plant Pest Act, a decades-old law intended to safeguard against plant pathogens from overseas. Previous types of GM plants are covered because they they were made using plant pathogens. The bacterium Agrobacterium tumefaciens ? which can cause tumours on plants ? shuttled foreign genes into plant genomes. Developers then used genetic control elements derived from pathogenic plant viruses such as the cauliflower mosaic virus to switch on the genes.

By revealing similar elements in plants? DNA, genome sequencing has liberated developers from having to borrow the viral sequences. And Agrobacterium is not essential either; foreign genes can be fired into plant cells on metal particles shot from a ?gene gun?. Scotts took advantage of both techniques to construct the herbicide-resistant Kentucky bluegrass that put the USDA?s regulatory powers to the test.

?The Plant Pest Act was completely inappropriate for regulating biotech crops, but the USDA jury-rigged it,? says Bill Freese, science-policy analyst at the Center for Food Safety in Washington DC. ?Now we can foresee this loophole getting wider and wider as companies turn more to plants and away from bacteria and other plant-pest organisms.? The USDA has not made public any plans to close the loophole and has also indicated that it will not broaden its definition of noxious weeds, a class of plants that falls under its regulatory purview, to facilitate the regulation of GM crops.

Nevertheless, Agrobacterium is still industry?s tool of choice for shuttling in foreign genes, says Johan Botterman, head of product research at Bayer BioScience in Ghent, Belgium. The technique is well established for many crops, and particle bombardment is less predictable, often yielding multiple, fragmented insertions of the new gene.

But Agrobacterium isn?t suitable for some new techniques. Many companies are developing ?mini-chromosomes? that can function in a plant cell without needing to be integrated into the plant?s genome. Last summer, agribusiness giant Syngenta, based in Basel, Switzerland, conducted the first field trials of maize (corn) containing engineered mini-chromosomes, and showed that the mini-chromosomes, which carried multiple genes for insect and herbicide resistance, were stable in the field. ?I would expect that by the end of the decade, this technology will be well used by many as a way to deliver large stacks of genes to plants,? says Roger Kemble, head of technology scouting for Syngenta.

Other techniques under development insert foreign genes into designated sites in the genome, unlike the near-random scattering generated by Agrobacterium. In 2009, researchers at Dow AgroSciences in Indianapolis, Indiana, and Sangamo BioSciences in Richmond, California, announced that they had used enzymes called zinc-finger nucleases to insert a gene for herbicide resistance at a specific site in the maize genome (V. K. Shukla et al. Nature 459, 437-441; 2009). Bayer is interested in harnessing other enzymes called ?meganucleases? to do the same type of targeted engineering, a strategy that Botterman says may make it possible to introduce multiple new traits into existing GM crops.

Regulators need to adapt to these new techniques, or run the risk of over- or under-regulating GM plants, says Roger Beachy, a plant biologist at Washington University in St Louis, Missouri, and former head of the USDA?s National Institute for Food and Agriculture. The Kentucky bluegrass decision drives this point home, he says: ?It really speaks to the importance of reviewing the regulatory process periodically to ensure that it is keeping up with the advances in technology.?



                                  PART 3

------------------------------- GENET-news -------------------------------

TITLE:   WELCOME TO THE AGE OF GMO INDUSTRY SELF-REGULATION

SOURCE:  Mother Jones, USA

AUTHOR:  Tom Philpott

URL:     http://motherjones.com/tom-philpott/2011/07/welcome-age-gmo-industry-self-regulation

DATE:    14.07.2011

SUMMARY: "Scotts is going to release a product that will potentially cause real and arbitrary harm to market actors. [...] USDA therefore strongly encourages Scotts to discuss these concerns with various stakeholders during these early stages of research and development of this GE Kentucky bluegrass variety and thereby develop appropriate and effective stewardship measures to minimize commingling and gene flow between GE and non-GE Kentucky bluegrass. Thus, in lieu of taking action to stop Scotts from doing harm or penalize it if it does, the USDA is encouraging Scotts to talk to stakeholders to avoid harm. In other words, go forth and regulate yourself ... please?"

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WELCOME TO THE AGE OF GMO INDUSTRY SELF-REGULATION

USDA chief Tom Vilsack: not exactly baring his fangs in his role as GMO-industry watchdog.

As I reported last week, the USDA?s recent surprise decision not to regulate genetically modified bluegrass poked yet more holes in an already-porous regime for overseeing GM crops?essentially to the point of regulatory collapse.

There were a few important strands I wasn?t able to wrestle into the story. The main one is an odd letter that USDA secretary Tom Vilksack sent Scotts Miracle-Gro as an addendum to the agency?s response to Scott?s GM bluegrass petition. Vilsack?s letter, dated July 1, acknowledges concerns that GM bluegrass will contaminate non-GM bluegrass?that is, that the Roundup Ready gene will move through wind-blown pollen and work its way into non-modified varieties. This is the process known as ?gene flow,? and it has already been well-established for GM corn and other modified crops.

Since bluegrass shows up (among other places) in cow pastures, organic dairy and beef farmers face the risk of suddenly having their animals nosh on fields full of a GM crop, which would jeopardize their organic status. As the the secretary put it in his letter:

The USDA recognizes that if this GE variety were to be commercially released, producers wishing to grow non-GE Kentucky bluegrass will likely have concerns related to gene flow between the GE variety and non-GE Kentucky bluegrass. Exporters of Kentucky bluegrass seed, growers of non-GE Kentucky bluegrass seed, and those involved in the use of non-GE Kentucky bluegrass in pastures will likely have concerns about the loss of their ability to meet contractual obligations.

So, Scotts is going to release a product that will potentially cause real and arbitrary harm to market actors. What?s Vilsack?s response?

USDA therefore strongly encourages Scotts to discuss these concerns with various stakeholders during these early stages of research and development of this GE Kentucky bluegrass variety and thereby develop appropriate and effective stewardship measures to minimize commingling and gene flow between GE and non-GE Kentucky bluegrass.

Thus, in lieu of taking action to stop Scotts from doing harm or penalize it if it does, the USDA is encouraging Scotts to talk to stakeholders to avoid harm. In other words, go forth and regulate yourself ... please?

Vilsack?s letter is deftly summarizes of the agency?s paradigm for overseeing the introduction of new GM crops: Yes, they have the potential to cause serious harm; no, we can?t do anything about it. In one sense, that approach represents progress. Before Vilsack, the agency was loathe to admit that GMOs posed any threat to the environment or to farmers. But as I reported last week, the Roundup Ready bluegrass decision also signals an even higher level of laissez faire: Whereas before the agency regulated novel crops weakly, it now seems content not to regulate them at all.

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This is a critical change. The National Environmental Protection Act (NEPA) requires that the USDA conduct an environmental impact study for all the crops it deregulates. But to deregulate a crop, the agency has to regulate it first. As I explained last week, the USDA has two ?regulatory hooks? under which it can regulate GM crops: ?plant pest? status and ?noxious weed? status. In the bluegrass decision, the USDA signaled that it won?t be applying those hooks to a broad variety of novel crops.

That leaves new crops unregulated?and not subject to NEPA requirements for environmental impact statements. We should recall that it was the requirement to conduct such assessments that forced the USDA to acknowledge some of the pitfalls of GMOs in the first place.

Take the case of the Monsanto?s Roundup Ready alfalfa. The agency deregulated it in 2005 without an impact statement, but because its ?regulatory hooks? had caught the crop in the first place, the watchdog group Center for Food Safety was able to sue the agency for violating NEPA. A federal judge ruled that the release of GM alfalfa be delayed pending an impact statement.

In December 2010, the USDA finally got around to releasing it. The agency?s vast environmental impact statement for GMO alfalfa (PDF)?so sprawling I had to download a new version of Adobe Reader to read it?was blunt on two points: 1) ?gene flow? between GM and non-GM alfalfa is ?probable,? and threatens organic dairy producers and other users of non-GMO alfala; and 2) there is strong potential for the creation of Roundup-resistant ?superweeds? that require ever-higher doses of Roundup and application of ever-more toxic herbicides. The report noted that 2 million acres of US farmland already harbor Roundup-resistant weeds caused by other Roundup Ready crops.

The analysis was so stark that soon after the report?s release, Vilsack felt moved to explain it. He issued an ?open letter to stakeholders? that acknowledged the ?the potential of cross-fertilization to non-GE alfalfa from GE alfalfa?a significant concern for farmers who produce for non-GE markets at home and abroad.? And he signaled that the agency was moving toward a ?new paradigm based on coexistence and cooperation? between GM and non-GM players.

The remarks were significant, because no USDA chief had ever acknowledged that the novel technology could do real damage to organic agriculture. Rumors stirred that the agency was going to impose restrictions on plantings GM alfalfa?something it had never done before. Food-industry critics applauded. NYU professor Marion Nestle declared the notion that Vilsack was even considering restrictions a ?breakthrough.? The biotech industry, meanwhile, reacted to the specter of restrictions on a GMO crop with fury, backed up by farm-state senators.

But soon after, the agency abruptly reversed course and fully deregulated Monsanto?s novel crop without restrictions, brushing aside concerns raised in its own analysis. Just as the bluegrass decision came down late on the Friday before a long holiday weekend, the USDA announced its alfalfa call in that sleepy week between Christmas and New Year?s.

A Wall Street Journal report suggested that the White House had intervened in the decision, preventing the USDA from imposing restrictions on GM alfalfa as part of an effort to combat ?burdensome? regulation. Certainly, the GMO industry maintains a powerful voice in Obama-era Washington, just as it has under every president dating to Reagan. A recent Food & Water Watch report documented the gusher of cash the biotech industry spends on D.C. lobbying. The industry spent more than a half billion dollars on lobbying between 1999 and 2009, FWW reports. In 2009 alone, the GMO giants dropped a cool $71 million pushing its agenda. It?s also worth noting the number of Monsanto-related people who have worked in key policy ag-policy postions in Obama?s adminstration.

Whatever the motivation, the alfalfa dereuglation set a pattern for how the USDA views GMOs: Yes, GMOs cause harm; no, we don?t plan to do anything about it. Last week?s bluegrass decision, by creating an avenue through which the USDA can avoid conducting environmental impact statements, raises that attitude to the level of policy.

Clearly, the USDA has neither the appetite nor the regulatory tools to properly oversee novel GMOs. The only remedy I can see is congressional intervention: a new set of laws governing the oversight of GMOs to replace that the failed ones now in place. But in the money-dominated US political system, the prospect for such reform is dim.