U.S. to Mull Changes to Oversight of Biotech Crops

By Christopher Doering
Reuters
July 12, 2007

WASHINGTON - U.S. oversight of genetically modified crops, which critics charge is insufficient, may be overhauled following a series of proposed changes released on Thursday by the Agriculture Department.

Cindy Smith, associate administrator with USDA's Animal and Plant Health Inspection Service, said any revisions it makes to its existing framework would be "the first comprehensive review of our regulatory structure" for genetically engineered crops.

One change USDA is considering would abandon the existing two-tiered permit system in favor of a multilevel one.

The new system would provide more stringent review for plants with which USDA is less familiar, or those that may pose an increased risk, such as plants that produce substances not intended for food use. Plants engineered for herbicide tolerance or insect resistance would be less complicated.

The proposed changes would "expand our regulatory oversight while at the same time minimizing our regulatory burden for those (genetically engineered) organisms that have been safety field tested for more than 20 years," said Rebecca Bech, an acting deputy administrator at APHIS.

USDA is also considering expanding its oversight to include organisms that have the potential to become noxious weeds. This would increase review of genetically engineered organisms that may damage crops to include plants that pose a broader risk to agriculture, the environment and public health.

The draft environmental impact statement, which evaluates potential revisions to existing regulations, will be open to public comment for 60 days starting on Friday.

The draft, public comments and further scientific information will be used to create a proposed rule. USDA first announced in 2004 it was beginning a review of its biotech regulations.

Oversight under fire

Consumer groups, environmentalists and organic farmers oppose biotech crops, which they fear could mix with other crops or develop super weeds resistant to herbicides. They said the current system was not working and was in need of a major overhaul to better protect farmers, consumers and the environment.

"We welcome the fact that USDA is attempting an overhaul of its regulations, the question is going to be, as always, the devil will be in the details," said Doug Gurian-Sherman with the Union of Concerned Scientists.

"We are concerned given the record of this agency over the least few years that we're worried they may go in the wrong direction," he added.

Currently, USDA no longer has oversight of a plant once it is deregulated and determined to be safe.

"We're exploring whether a different type of system might be applicable," said John Turner, another biotechnology official at APHIS.

"You might envision a system where certain things would be unconditionally approved ... whereas others might be approved with conditions," he said.

A string of court cases has criticized USDA oversight. In May, U.S. District Judge Charles Breyer upheld a ban on the planting of a genetically modified alfalfa crop variety developed by Monsanto Co. until government studies on its environmental effects were concluded.

The judge found in a preliminary injunction that U.S. regulators had not properly examined the effects of the alfalfa before allowing it to be commercialized.

A separate ruling in February by a District of Columbia judge found "substantial evidence that the field tests may have had the potential to affect significantly the quality of the human environment.

Tortilla-hungry Mexico Setting Rules on GMO Corn

Reuters
July 18, 2007

MEXICO CITY - Mexico, widely considered the birthplace of corn, is close to finalizing rules governing experimental planting of genetically modified corn strains, a senior biosecurity official said on Tuesday.

In Mexico, where tortillas made from corn are eaten with almost every meal, the government is determined to boost output in the next few years to offset rising prices driven by U.S. demand for corn-based ethanol fuel.

Mexico's biggest grain farmers have long lobbied to lift a 1998 ban on GMO corn plantings, arguing it would help lift lagging crop yields. But environmental activists say GMO would put Mexico's numerous local corn strains at risk.

Reynaldo Alvarez, who heads Mexico's biosecurity commission, said the president's office now had a copy of the proposed regulations.

"They are revising the final draft," Alvarez told Reuters. "I would hope it will be ready in the next two months."

Mexico last year passed a biosecurity law designed to permit plantings in certain regions under controlled conditions to be set in the regulatory document.

The rules would likely prohibit farmers in regions that contain the oldest strains of corn from planting GMO material, Alvarez said.

Even with the rules established, he said, it could still take time for test requests from biotech firms to be approved. He said such requests would be resolved with within 90 days.

U.S. companies like Monsanto Co. and DuPont Co. want to enter the Mexican seed market with GMO strains. A large group representing small corn farmers recently signed a good-will deal with Monsanto.

Scientists have found evidence the grain was grown in Mexico as far back as 5,300 BC, placing it as the likely cradle of corn cultivation. The country has a huge variety of locally specific corn strains that farmers have bred over generations.

Despite that history, Mexico imports millions of tons of corn each year and was hard hit when grains prices rocketed in January as demand for ethanol fuel soared in the United States.

Dangerous Field Test of Non-pathogenic GM Bacteria

By Prof. Joe Cummins and Dr. Mae-Wan Ho
This report has been submitted to the USDA on behalf of ISIS
July , 2007

Bacterium causing rice panicle blight The United States Department of Agriculture Animal and Plant Health Inspection Service (USDA/APHIS) carried out an Environmental Assessment [1] in response to a permit application (06-111-01r) received from Dr. Milton Rush of Louisiana State University for a field test of two non-pathogenic, genetically engineered strains of Burkholderia glumae, and is available for public comment by 19 July 2007 at: http://www.regulations.gov/fdmspublic/component/main Burkholderia glumae Kurita et Tabei is a bacterial plant pathogen that causes bacterial panicle blight in rice, and is transmitted by infected seed. This bacterium was first described in Japan as the cause of grain rotting and seedling blight and is considered one of the most important rice pathogens in Japan. Epidemics of panicle blight occurred in the southern rice producing area of the United States during the 1995 and 1998 growing seasons, with yield losses in some fields estimated to be as high as 40 percent. Currently, there is no control method for panicle blight in the US, where most commercially grown rice varieties are susceptible to the disease. Field-testing non-pathogenic, transgenic strains of B. glumae is supposed to provide information on bacterial panicle blight infection of rice, and indicate potential routes for control of the pathogen.

Non-pathogenic transgenic bacteria contain two antibiotic resistance markers B. glumae has been modified by disrupting the disease-causing gene, resulting in avirulent or non-pathogenic transgenic strains. One virulence factor in B. glumae is the compound toxoflavin , a yellowish substance that results in significant damage to rice in the infected plants. Toxoflavin is produced in Burkholderia by an operon (group of genes with a defined function) consisting of the tox gene cluster (toxABCDE) controlled by the toxR gene that is activated when the bacterium invades the rice plant. Disruption of the toxA gene (methyltransferase) results in mutants that do not produce toxoflavin. The cloning vector also contains two selectable markers, the gene (nptII) for neomycin phosphotransferase from Streptomyces kanamyceticus and the gene (bla) for beta-lactamase from Escherichia coli, providing resistance to kanamycin and ampicillin, respectively. The promoter for each of the genes is the Bacteriophage T7 promoter, and the terminator a synthetic TAA codon sequence. The donor DNA sequences are stably and irreversibly integrated into the bacterial genome, where they are maintained and inherited as any other genes of the bacteria cell [1]. The avirulent non-pathogenic strain therefore also carries stable resistance to the antibiotics kanamycin and ampicllin. The potential for horizontal gene transfer of the antibiotic resistance markers to soil bacteria is acknowledged in the USDA/APHIS assessment, but is presumed to have insignificant consequences. This presumption is not borne out by a wealth of evidence we have presented repeatedly to our regulators, the most recent in June 2007 [2] (GM Food Nightmare Unfolding in the Regulatory Sham , ISIS scientific publication)

Pathogenic wild-type bacteria will be released in field-tests of non-pathogenic strains Two experiments will be conducted; the first evaluates toxoflavin as a disease causing agent by challenging the rice plants with wild-type B. glumae, the second involves inoculating the rice with the transgenic avirulent bacterium followed by challenge with the virulent strain to see whether or not the presence of the avirulent strain will protect rice from B. glumae infection. These are obviously dangerous experiments to be carried out in the open fields; as the wild-type pathogen could easily spread from the experimental fields to other rice crops. The risks are unjustifiable, especially when there are other safer strategies. An alternative approach to controlling B. glumae is via 'quorum sensing', a regulatory network influencing virulence based on the local density of bacteria that intercommunicate with one another. Quorum sensing can occur within a single bacterial species as well as between disparate species, and can regulate a host of different processes, essentially serving as a simple communication network. The bacteria signal to one another via special molecules. For example, toxoflavin is regulated by a quorum sensing mechanism that uses N-acyl homoserine lactones as signal molecules. A Burkholderia endophyte (a bacterium that lives inside the plant) was selected from rice and found to be non-pathogenic to rice and to inhibit pathogenic fungi. The endophyte, modified with a gene from Bacillus thuringiensis specifying N-acyl homoserine lactones, was found to prevent toxoflavin synthesis and virulence of B. glumae [3]. Genetic modification involving quorum sensing provides an alternative, also avoids use of the antibiotic resistance genes described above because toxoflavin can be detected by its fluorescence and its absence is readily detected. Another danger from the transgenic B. glumae proposed for release is that the genus contains serious pathogens for humans: B. cepacia is a potent pathogen [4] (Bio-remediation Without Caution, SiS 230; B. thailandensis caused pneumonia and septicemia [5]; B. dolosa is pathogenic for people with cystic fibrosis [6]; B. gladioli caused ocular keratitis in an individual with diabetes, and is also found in other diseases [7]; and a number of other Burkholderia species are associated with human infections. It is not at all surprising, therefore, that a B. glumae infection was observed in an infant with chronic granulomatous disease [8]. Further investigation of the clinically isolated strain of B. glumae showed that the bacterium caused severe disease symptoms in rice, and a quorum sensing regulated secreted lipase was implicated in the pathogenesis of the clinical strain [9]. The USDA/APHIS assessment did not consider human infection by B. glumae a serious matter [1] based on the single human case, nor did it recommend precaution for those working with the pathogen, who will most likely take the pathogen to their homes, families and neighbours. The dangers of the transgenic B. glumae itself as a potential pathogen armed with two antibiotic resistance marker genes that could further transfer horizontally to other known Burkholderia pathogens appear to have completely escaped the notice of USDA/APHIS. Both USDA/APHIS and the scientists involved should be held responsible for any harm caused to people and crops, should they allow this field release to go ahead.

References available on request

Monsanto Loses Claims for Roundup Ready Genes

By Jane Roberts
commercialappeal.com
July 26, 2007

For the second time in five months, the U.S. Patent and Trademark Office has rejected patents key to Monsanto's dominance in bioengineered seed, casting suspicion on its science and weakening the argument that helped the company prevail in dozens of lawsuits against farmers.

Tuesday, the Public Patent Foundation said that the U.S. patent office sided with it in its case against Monsanto, saying at least four patents should not have been granted because the gene technology was either not new or so obvious it wouldn't require patenting.

"This is a significant decision," said Daniel Ravicher, executive director of the Washington nonprofit that is focused on rooting out undeserved patents and unsound patent policy. "Monsanto would be much more pleased if the patent office had found the patents were valid. "Instead, it found that every single claim is undeserved and invalid," he said. "It couldn't be going better for our challenge."

Monsanto dismissed the findings, saying rejection is a standard part of any patent re-examination process and that it plans to ask for a reconsideration.

"Our commercial products are covered by multiple patents that are not the subject of this re-examination," said Lee Quarles, spokesman. "This poses no threat to our business or our ability to deliver innovative technologies to farmers."

Opponents disagree, saying Monsanto has profited handsomely because the patents allow it to charge inflated prices for seed. They also say Monsanto has used its dominance to bully farmers into submission through a series of high-profile lawsuits that made examples of people who saved the patented seed for replanting.

"Monsanto is the only company I know of that is suing individual farmers and putting them out of business," Ravicher said.

Monsanto has 60 days to ask for a reconsideration or reduce the breadth of the patents.

The patents in question are part of its Roundup Ready arsenal, a series of genes it patented to make crops immune to the herbicide.

With the modified seed, farmers can spray Roundup over their crops and kill the weeds but not the crop.

The American Seed Trade Association says companies have every right to defend intellectual property. In this case, it's the brainpower that helps farmers produce better yields or provides solutions to reduce the impact of factors they cannot control, including drought.

Monsanto says hundreds of thousands of farmers across the globe rely on the company for breakthroughs that help reduce the cost of raising a crop and the deleterious affects of chemicals on the environment.

"Intellectual property is important because it encourages continuous innovation in an industry, regardless if you're on the farm or reading the newspaper or sitting at your computer," Quarles said.

Monsanto introduced the trait first in cotton in 1997. By 2000, a majority of cotton farmers in the Mid-South were using its genetically altered seed because it vastly reduced fuel and the use of other chemicals. It also saved them time and reduced soil compaction, making the choice hardly a choice at all.

The lawsuits followed shortly later, including cases against Mitchell Scruggs, a farmer in Saltillo, Miss., and Homan McFarling, who farms near Pontotoc, Miss.

Both were charged with saving the patented seed for resale or use on their own farms.

With the patents now in question, attorney Jim Waide of Waide & Associates in Tupelo, Miss., expects the outcomes could be very different.

"Logically, I would think the judgment is void if the patent is void," he said after talking with his clients.

In the midst of the Scruggs case, Monsanto withdrew patent No. 435 because it was generating public scrutiny, he said, and began relying more on No. 605. That patent is now among the four rejected patents, although Monsanto did alter No. 435 enough to get reapproved.

The Public Patent Foundation mounted its campaign against the company last fall, it said, after watching farmers across the country lose suits.

In early March, it celebrated its first victory when the U.S. patent office rejected the first patent. Other rejections followed May 31, June 4 and July 17.

"This poses a real serious challenge to Monsanto's intellectual property position on Roundup Ready crops," said Bill Freese, science policy analyst at the Center for Food Safety in Washington.

He says the standards for issuing patents need stricter scrutiny, especially in molecular biology where the rush to capitalize on genetic breakthroughs leaves companies rushing to patent whole gene sequences before they know how useful they are.

The problem, he said, is that it takes a lot of resources to mount a credible challenge because the patents are extremely technical.

"We need folks to become aware that patents are being granted that are illegitimate," Freese said. "And how many more does Monsanto hold?"

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