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RISK ASSESSMENT & APPROVAL: U.S. does not regulate GE Bluegrass made without plant pest DNA



                                  PART 1


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TITLE:   U.S.D.A. RULING ON BLUEGRASS STIRS CRIES OF LAX REGULATION

SOURCE:  The New York Times, USA

AUTHOR:  Andrew Pollak

URL:     http://www.nytimes.com/2011/07/07/business/energy-environment/cries-of-lax-regulation-after-usda-ruling-on-bluegrass.html?_r=1

DATE:    06.07.2011

SUMMARY: "The situation with the Kentucky bluegrass arises because genetically engineered crops are regulated under rules pertaining to plant pests. The rules are really meant for pathogens and parasites, not corn stalks. Still, they could be stretched to cover the crops because most of them contain a snippet of DNA from a plant virus that functions as a genetic on-switch. And the foreign gene is often inserted using a bacterium that can cause a disease in plants.

But in creating its bluegrass, Scotts deliberately avoided using any material from plant pests. [...] The company then sent a letter to the Agriculture Department in September, arguing that the grass was therefore not subject to regulation. The Agriculture Department agreed. It also declined to regulate the bluegrass as a noxious weed [...] the strategy means that the bluegrass will not encounter the regulatory problems that have beset Scotts?s genetically engineered creeping bentgrass, which does contain material from plant pests."

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U.S.D.A. RULING ON BLUEGRASS STIRS CRIES OF LAX REGULATION

The Agriculture Department has exempted a genetically engineered grass from federal regulation, a decision that some critics say could portend a loosening in oversight of biotech crops.

The department said that an herbicide-tolerant Kentucky bluegrass being developed by Scotts Miracle-Gro was not subject to federal regulation because its creation did not entail use of any plant pests.

The decision, issued late Friday, frees Scotts to sell the grass, which is meant for lawns, without federal approval. The company also does not need federal permits to conduct field trials, even though a different type of genetically engineered grass escaped from company test plots in the past and established itself in the wild.

The genetically engineered bluegrass contains a gene that allows it to tolerate the widely used herbicide Roundup, also known as glyphosate. That allows the chemical to be sprayed to kill weeds without harming the grass.

Michael C. Gregoire, who oversees biotechnology crop regulation at the Agriculture Department, said in an interview Wednesday that the ruling did not represent ?a change in policy or a relaxing or abandoning of the regulation of G.E. crops.? He said other genetically engineered crops, like a petunia, had been exempted from regulation in the past.

Still, the decision shocked some critics of biotechnology crops. ?It?s a blatant end-run around regulatory oversight,? said George Kimbrell, senior lawyer at the Center for Food Safety, a Washington advocacy group.

Margaret Mellon, director of the food and environment program at the Union of Concerned Scientists, said other companies might follow the same strategy, putting the Agriculture Department ?out of the game of regulation.?

The critics say there have been other signs that the Agriculture Department has been looking to weaken regulation, like a proposed pilot project that would let companies provide more input into the environmental assessments of their crops.

While some environmental groups say regulation is too lax, some biotechnology executives and academic plant scientists say it is unnecessarily rigorous and slow, impeding development of important new crops.

The situation with the Kentucky bluegrass arises because genetically engineered crops are regulated under rules pertaining to plant pests.

The rules are really meant for pathogens and parasites, not corn stalks. Still, they could be stretched to cover the crops because most of them contain a snippet of DNA from a plant virus that functions as a genetic on-switch. And the foreign gene is often inserted using a bacterium that can cause a disease in plants.

But in creating its bluegrass, Scotts deliberately avoided using any material from plant pests. The herbicide resistance gene and the genetic on-switch came from other plants and were fired into the grass?s DNA with a gene gun, rather than being carried in by a bacterium.

The company then sent a letter to the Agriculture Department in September, arguing that the grass was therefore not subject to regulation.

The Agriculture Department agreed. It also declined to regulate the bluegrass as a noxious weed, denying a request from the Center for Food Safety.

Richard Shank, chief environmental officer at Scotts, said the company?s strategy ?wasn?t designed specifically to get around regulations or anything like that. It just made more sense. There was a lot of concern about using plant pest materials in biotechnology and we wanted to get away from that.?

Still, the strategy means that the bluegrass will not encounter the regulatory problems that have beset Scotts?s genetically engineered creeping bentgrass, which does contain material from plant pests.

That grass, meant for golf courses, is still awaiting approval eight years after the company submitted its application.

Scotts was fined $500,000 in 2007 after the bentgrass escaped from field test sites in central Oregon and established itself in the wild. More recently the grass, presumably from a field test in Idaho, was found growing in nearby southern Oregon.

Mr. Shank said limited field testing of the Kentucky bluegrass would begin soon but the product would not come to market for years.

In a letter to Scotts on Friday, Tom Vilsack, the secretary of agriculture, told the company to work with others to make sure that the grass did not spread where it was unwanted, for example, pastures where organic cows graze. Mr. Shank said Scotts would do that.

Doug Gurian-Sherman, a senior scientist at the Union of Concerned Scientists, said many of the genetically engineered crops now under development did not use viral material so they could conceivably escape regulation.

But L. Val Giddings, an industry consultant, disagreed, saying most crops continue to use material from plant pests. Monsanto, the leading developer of genetically engineered crops, said products in its current pipeline would be regulated.

Stanley H. Abramson, a Washington lawyer who has represented biotech companies, said that genetically engineered food crops would not be accepted by the market without government approval. So only developers of nonedible plants like grass or flowers might try to exempt themselves from regulation, he said.



                                  PART 2

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TITLE:   IN MAJOR SHIFT, USDA CLEARS WAY FOR MODIFIED BLUEGRASS

SOURCE:  The New York Times, USA

AUTHOR:  Greenwire, USA, by Paul Voosen

URL:     http://www.nytimes.com/gwire/2011/07/06/06greenwire-in-major-shift-usda-clears-way-for-modified-bl-51693.html

DATE:    06.07.2011

SUMMARY: "Given the large volume of corn and soybean crops already engineered to resist glyphosate, there will likely be concerns that resistant bluegrass, widely deployed in parks and homes, could further exacerbate the number of glyphosate-resistant weeds that have appeared in recent years. APHIS has ?little authority? to regulate modified plants solely under that concern, though, it said. ?To date APHIS has never regulated a weed as ?noxious? due to its resistance to an herbicide alone, nor has it ever taken action to prevent the evolution of noxious weeds,? it said. ?Herbicide resistant weeds are not an issue exclusively associated with the use of herbicides on genetically engineered ... crops.?"

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IN MAJOR SHIFT, USDA CLEARS WAY FOR MODIFIED BLUEGRASS

In a decision set to upturn the biotech industry and outrage its opponents, the Agriculture Department announced late last week that it does not consider a lawn grass genetically engineered to resist a weedkiller within its regulatory domain, ratifying a pathway for certain classes of bioengineered plants to bypass federal regulation.

The USDA?s authority over biotech plants largely stems from its oversight of plant pests such as bacteria, fungi and insects. Since companies have created most genetically modified crops, like herbicide-resistant corn and soybean, using either genes or tools derived from microbes, USDA has long extended its powers to nearly every biotech plant developed in the country.

Unlike these predecessors, the herbicide-tolerant Kentucky bluegrass, developed by Scotts Miracle-Gro Co., contains no microbial material. The grass?s tolerance to glyphosate, a common weedkiller, stems from the genetic material of corn, rice and Arabidopsis plants, and Scotts spliced the bluegrass?s DNA with a gene gun, a common lab technique that shuttles DNA on high-velocity heavy metals.

Given these specifics, and its determination that modified bluegrass should not be controlled as a weed at the federal level, USDA?s Animal and Plant Health Inspection Service (APHIS) will allow Scotts to proceed with commercializing its bluegrass product, the agency said in a statement, released on the Friday before the Fourth of July weekend.

?Because no plant pests, unclassified organisms or organisms whose classification is unknown were used to genetically engineer Scotts? [genetically engineered] Kentucky bluegrass,? the agency said, ?APHIS has no reason to believe it is a plant pest and therefore does not consider the Kentucky bluegrass described in the Scotts letter to be regulated.?

The agency?s decision, prompted by a query from Scotts last year, could clear the way for biotech crops incorporating the genes from unrelated plant species to avoid the long review required by APHIS for modified crops. APHIS will examine such situations on a case-by-case basis, according to a list (pdf) of questions and answers released by the agency.

?If a [genetically engineered] organism is not a plant pest, is not made using plant pests, and APHIS has no reason to believe that it is a plant pest, then the [genetically engineered] organism would not fall under APHIS? regulatory authority,? it said.

This is not the first time APHIS has decided a modified plant was beyond its regulatory authority. The agency recently concluded that bioengineered petunias did not fall under its jurisdiction, a precedent cited by Scotts, and more than a decade ago a modified geranium was also cleared. Neither of these plants has the potential broad appeal of Scotts? turf, however.

Kentucky bluegrass is widely grown across the United States, providing dense green sod often popular in parks and home lawns. The grass is also grown in pastures and prairies, and can migrate into lightly populated forests. It is also known to appear among row crops, though it is not considered a troublesome weed, USDA said. Given its broad spread, Scotts turf could potentially be grown more broadly than any previous biotech plant.

Anticipating the anger that could accompany its decision from the organic community and longtime opponents of biotech plants, Agriculture Secretary Tom Vilsack urged Scotts in a letter (pdf) to engage with growers of bluegrass seed, among others, who will be concerned that the plant could threaten their exports to regions sensitive to modified crops.

?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,? Vilsack wrote.

Is it a weed?

Kentucky bluegrass?s weed status is bound to be a future point of contention. In 2002, the Center for Food Safety, one of the most vocal and litigious opponents of bioengineered plants, petitioned USDA to regulated modified bluegrass as a ?noxious weed,? claiming its resistance to glyphosate, commonly sold under the brand name Roundup, could turn the common grass into a persistent threat.

In a parallel decision last week, USDA said that while the modified bluegrass did in fact meet the definition of a noxious weed, it would not ?cause impacts significant enough to warrant regulation at the federal level.? Kentucky bluegrass has a low-to-moderate rating for management difficulty, the agency said (pdf), adding that USDA ?[does] not think tolerance to one herbicide would justify increasing that ... rating to high.?

Even if the agency wanted to regulate the grass as a weed, it couldn?t, USDA noted.

?Funding for federal regulatory response for Kentucky bluegrass is unlikely to be available at a time when our noxious weed program is facing funding limitations,? it said, ?and the required response would be beyond the combined federal and state regulatory capacity.?

Given the large volume of corn and soybean crops already engineered to resist glyphosate, there will likely be concerns that resistant bluegrass, widely deployed in parks and homes, could further exacerbate the number of glyphosate-resistant weeds that have appeared in recent years. APHIS has ?little authority? to regulate modified plants solely under that concern, though, it said.

?To date APHIS has never regulated a weed as ?noxious? due to its resistance to an herbicide alone, nor has it ever taken action to prevent the evolution of noxious weeds,? it said. ?Herbicide resistant weeds are not an issue exclusively associated with the use of herbicides on genetically engineered ... crops.?

Scotts plans to conduct field trials of the modified bluegrass in the near future, the company says.