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November 2008 Updates

Gene-altered Animals and Food Safety

By Rick Weiss
Boston Globe
November 10, 2008

Perhaps you're still getting used to the idea that some of the meat, milk, and cheese you are eating may come from cloned cows or their offspring, a controversial culinary advance that the Food and Drug Administration green-lighted in January after deeming food from clones to be safe. Well, hurry up and swallow, because the next course is on its way.

Largely unnoticed due to the mayhem of the markets and the presidential race, the FDA recently proposed rules that would allow, for the first time, the marketing of foods from genetically engineered farm animals as well. Unlike clones - which are weirdly procreated from a single parent but are otherwise conventional creatures - engineered animals have had their DNA codes rewritten to endow them with traits never before seen in those species.

Among the gene-altered animals angling to appear on our dinner tables are farmed salmon with novel DNA that makes them grow faster; pigs with bacterial genes that make their manure less environmentally damaging; and perhaps even cattle bearing fish genes for omega-3 fatty acids. Imagine filet mignon as healthful as fillet of sole.

The good news is that the agency wants to regulate gene-altered animals under its strict "new animal drug" provisions. Usually novel foods can be introduced into the food supply without restrictions, and the FDA does not get involved unless problems arise. But under the new animal drug provisions, each new kind of animal produced through genetic engineering would have to get FDA approval before being commercialized, the way new drugs are approved. That's the right approach for dealing with the biological complexities and cultural sensitivities of allowing gene-altered animal products on supermarket shelves.

The bad news is that the drug approval process in this country is extremely secretive. Under its provisions it would be illegal for the FDA (without a company's permission) to reveal that it had even received an application for a new gene-altered food animal until after the agency had approved it for marketing. Once approved, there would be virtually no recourse available to consumers. And although the agency would ultimately release a summary of safety data, details could remain hidden forever as "confidential business information."

Most of us accept this approach for new medicine approvals, but such a closed-door system is inappropriate for new foods. For one thing, patients understand that medicines carry both benefits and risks, and we count on trusted intermediaries - our doctors - to sort through those details. With no such experts to help with our grocery shopping, we deserve more information on gene-altered food.

A good start would be to require that applications for gene-altered food animals get an initial public review, perhaps through the FDA's veterinary medicine advisory committee, which publically advises the agency on animal drug issues. FDA also needs to take seriously consumer demands that DNA-doped foods be labeled as such. And it should strengthen its system of post-marketing surveillance to watch for unanticipated outcomes.

Beyond human health concerns, rapid commercialization of engineered animals risks disrupting trade with countries not ready for future food. There may also be environmental issues (what happens when gene-enhanced salmon escape their offshore cages and mate with their wild cousins?). And there may be legitimate concerns about the welfare of some engineered animals. In a transparent system, citizens could at least weigh in on industry priorities and shoppers could vote with their pocketbooks.

The United States needs a system for approving some gene-altered animals, in part because this is about more than just food. Scientists are also engineering animals to make human medicines in their blood and milk. Others are striving to craft animals bearing life-saving organs suitable for human transplantation. Still others simply want to give animals new genes to help them resist debilitating diseases.

The proposed FDA rules, open for public comment through Nov. 18, could speed the advancement of these and other innovative endeavors. But they will do more harm than good if they don't also promise transparency and accountability. As demonstrated by this year's Korean riots over US beef imports and by the repeated domestic incidents of tainted food, trust is the American food supply's most precious ingredient.


Why Eating GM Food Could Lower Your Fertility

By Sean Poulter
The Daily Mail/UK
November 12, 2008

Genetically modified corn has been linked to a threat to fertility in an official study that could deliver a hammer blow to controversial 'Frankenstein Food'.

Most of the research on GM crop safety has been conducted by biotech companies, such as Monsanto, rather than outside independent laboratories.

A long-term feeding trial commissioned by the Austrian government found mice fed on GM corn or maize had fewer offspring and lower birth rates.

The trial has triggered a call from Greenpeace for a recall of all GM food crops currently on the market worldwide on the grounds of the threat to human health.

Most of the research on GM crop safety has been conducted by biotech companies, such as Monsanto, rather than outside independent laboratories.

GM advocates have argued that the fact the US population has been eaten some types of GM food for more than a decade is proof of its safety.

However, these reassurances have been turned on their head by the study commissioned by the Austrian Ministries for Agriculture and Health, which was presented yesterday at a scientific seminar in Vienna.

Professor Dr Jurgen Zentek, Professor for Veterinary Medicine at the University of Vienna and lead author of the study, said a GM diet effected the fertility of mice.

GM expert at Greenpeace International, Dr Jan van Aken, said: 'Genetically Engineered food appears to be acting as a birth control agent, potentially leading to infertility.

'If this is not reason enough to close down the whole biotech industry once and for all, I am not sure what kind of disaster we are waiting for.

'Playing genetic roulette with our food crops is like playing Russian roulette with consumers and public health.'

The Austrian scientists performed several long-term feeding trials with laboratory mice over a course of 20 weeks.

One of the studies was a so-called reproductive assessment by continuous breeding (RACB) trial, in which the same parent generation gave birth to several litters of baby mice.

The parents were fed either with a diet containing 33per cent of GM maize, a hybrid of Monsanto's MON 810 and another variety, and a normal feed mix..

The team found changes that were 'statistically significant' in the third and fourth litters produced by the mice given a GM diet. There were fewer offspring, while the young mice were smaller.

Prof Zentek said there was a direct link between the changes seen and the GM diet.

A press release from the Austrian Agency for Health and Nutrition, said the group of mice given a diet of genetically engineered corn saw a significant change in fertility.

It said: 'The number of litters and offspring decreased in the GE-fed group faster than in the control. In the GE-fed group more females remained without litters than in the control group.'

Monsanto press offices in the UK and USA were unable to provide a comment on the findings.

CropGen, which speaks for the biotech industry, claims GM crops have been accepted as safe by Government authorities on both sides of the Atlantic.

British scientists recently unveiled a GM purple tomato they claimed could help people avoid developing cancer. The tomato is high in antioxidants - naturally found in other fresh produce such as blueberrys, cranberries and carrots - which are seen as a protection against ill health.


Austrian Study Finds Eating Genetically Engineered Corn May Reduce Fertility

Press Release
Center for Food Safety
November 13, 2008

Center for Food Safety calls for moratorium on genetically engineered foods pending thorough safety studies

Vienna, Austria - The Center for Food Safety cited results of an important study released Monday by the Austrian government as cause for great concern over the long-term consumption of genetically engineered crops. The study found that mice fed a type of genetically engineered corn developed by the Monsanto Company produced fewer offspring than those fed conventional corn.

"This meticulous study suggests that a popular type of genetically engineered corn may harbor fertility-reducing substances," said Bill Freese, Science Policy Analyst at the Center for Food Safety and co-author of a peer-reviewed study on GE crop regulation. "It's no surprise to us that U.S. regulators did not catch this. None of our regulatory agencies require any long-term animal feeding trials before allowing genetically engineered crops on the market."

The study was sponsored by the Austrian Ministry of Health, Families, and Youth, and led by Dr. Jürgen Zentek, Professor of Veterinary Medicine at the University of Vienna. For 20 weeks, Zentek and his team fed mice diets consisting of either 33% genetically engineered (GE) corn, or 33% of a closely related non-GE variety. The diets were otherwise nutritionally equivalent.

Mice fed the GE corn diet had fewer litters, fewer total offspring, and more females with no offspring, than mice feed the conventional corn. The effects were particularly pronounced in the third and fourth litters, after the mice had consumed the GE corn for a longer period of time. The authors attributed the reduced fertility to the GE corn feed, and said it might be related to unintended effects of the genetic modification process. Dr. Zentek said that further studies are "urgently needed" to corroborate his team's findings.

"This study should serve as a wake-up call to governments around the world that genetically engineered foods could cause long-term health damage," said Andrew Kimbrell, Executive Director of the Center for Food Safety. "The Center calls upon national and international authorities to place a moratorium on the distribution of GE products for human consumption unless or until their safety can be undeniably established."

"We hope this study will finally persuade the U.S. Food and Drug Administration to completely overhaul its \u2018rubber-stamp' regulatory process," added Freese. "The FDA must stop letting biotech companies self-certify their GE crops as safe, and instead establish strict, mandatory testing requirements, including long-term animal feeding trials, for every GE crop," he added.

The Center notes that the GE corn used in the study (NK603 x MON810) was developed by the Monsanto Company, and is sold under the brand names YieldGard (Plus)/Roundup Ready. Monsanto's figures show that U.S. plantings of this GE corn have exploded in recent years, from just 2.2 million acres in 2002 to 38.2 million acres in 2008[2]. The corn is a so-called "stacked" variety with two traits: the Roundup Ready trait allows the corn to survive direct spraying with Roundup herbicide, while a built-in insecticide kills certain above-ground insect pests.

The Center further notes that U.S. regulators allow biotech companies to cross GE crops at will to develop "stacked" crops with virtually any combination of traits without any regulatory oversight, despite expert warnings that stacked crops may pose special risks.


Biological Effects of Transgenic Maize NK603xMON810 Fed in Long Term Reproduction Studies in Mice

Dr. A. Velimirov, Dr. C. Binter , Univ. Prof. Dr. J. Zentek
Scientific contribution (alphabetical order):
N. Cyran, Dr. C. Gülly, Dr. S. Handl, G. Hofstätter,
F. Meyer, Dr. M. Skalicky, Prof. Dr. R. Steinborn
October 2008


The aim of the study was to examine effects of the stacked GM crop NK603 x MON810 in different models of long term feeding studies. So far no negative effects of GM corn varieties have been reported in peer- reviewed publications. But the hypothesis, that effects after long term exposure might become evident in multi-generation studies has rarely been investigated.

In this study three designs were used, including a multi-generation study (MGS), a reproductive assessment by continuous breeding (RACB) and a life-term feeding study (LTS), all performed with laboratory mice (strain OF1). The test diets differed only as to the inclusion of 33% NK603 x MON810 corn (GM) versus non-GM corn of a near isogenic line (ISO), both grown under identical conditions in Canada. The MGS also included one group with a non GM corn cultivated in Austria (A REF). All corn varieties used in the MGS and LTS were harvested in 2005, the transgenic and isogenic corn for the RACB were harvested in Canada in 2007. No Austrian corn was used in this case. In the MGS microscopic and ultrastructural investigations were performed to detect changes at the organ and cell level. Gene expression patterns were compared by micro array expression profiles of the intestine as feed-animal interface and by real time PCR.

The results of the MGS showed no statistically significant differences concerning parental body mass. The number of females without litters decreased with time in the GM and ISO group, especially in the 4th generation. In the group fed with A REF corn fewer females were without litters, and accordingly more pups were weaned. The production parameters average litter size and weight as well as number of weaned pups were in favour of the ISO group. These differences were also seen in the RACB design and were statistically significant in the 3rd and 4th litters. In addition, the inter-individual variability was higher in the GM group as compared to the other groups. The LTS showed no statistically significant differences in the survival of 3 groups of mice fed the different maize varieties.

In the MGS the continuative investigations revealed differences between the GM and ISO groups. The comparison of organ weights did not indicate directed dietary effects, except for kidneys. The electron histological investigation of the cell nuclei revealed differences as to fibrillar centres, dense fibrillar components and the pore density in hepatocytes, and cells from spleen and pancreas. This could point to an effect of the GM crop on metabolic parameters. Immunohistochemistry revealed no systematic differences in CD3, CD20 positive cells and macrophages in gut tissue. The microarrays showed differences between the feeding groups. When the data of both non-GM feeding groups from MGS were combined and compared to the GM feeding group, the discrimination became more evident. Analyses of metabolic pathways indicated, that the groups differed regarding some important pathways, including interleukin signalling pathway, cholesterol biosynthesis and protein metabolism.

Summarizing the findings of this study it can be concluded, that multi- generation studies, especially based on the RACB design are well suited to reveal differences between feeds. The RACB trial showed time related negative reproductive effects of the GM maize under the given experimental conditions. The RACB trial with its specific design with the repeated use of the parental generation is a demanding biological factor for the maternal organism. Compared to the findings in the RACB trials it can be assumed that the physiological stress was considerably lower in the MGS trial. The trial design of using "new" parental generations instead of continuous breeding with the same generation has to be considered as being obviously less demanding. This might have masked the impact of dietary factors on reproductive performance. However, this part of the experiment is valuable as such because it underlines the need for different experimental designs for the assessment of dietary effects that have an unknown impact on animals. The outcome of this study suggests that future studies on the safety of GM feed and food should include reproduction studies. Physiological and genomic traits and depending on the nature of the genetic modification proteomic and metabolomic methods might be taken into consideration as additional tools to the tests performed in this study.

Read the study pdf


Government to Defy Critics with Secret GM Crop Trials

By Andrew Grice
The Independent
November 17, 2008

Ministers are drawing up plans for genetically-modified crops to be grown in secret and more secure locations to prevent trials being wrecked by saboteurs.

They may ask the police to target opponents of GM crops in the way that they have cracked down on animal rights protesters. Another option is for the controversial crops to be grown at a secure government site such as Porton Down near Salisbury, which carries out military research and includes a science park where they could be securely developed away from the public.

The Independent disclosed in June that the Government wants a new public debate on whether GM foods could hold the answer to global food shortages and rising prices. Gordon Brown is moving cautiously, saying he will be guided by scientific experts, because of strong public opposition to previous trials \u02c6 notably from young mothers.

However, no experiments are currently underway in Britain after 400 potato plants were destroyed on a farm run by the University of Leeds in June. Almost all of the 54 GM crop trials which have been conducted since 2000 have been targeted by opponents and vandalised.

Under current rules, scientists must disclose the location of trials on a government website, thereby making it easy for anti-GM protesters to find them. Ministers are now ready to scrap that rule. A review of the security arrangements has also been ordered by Hilary Benn, the Environment, Food and Rural Affairs Secretary and Lord Mandelson, the Business Secretary.

Mr Benn said: "We need to see if they [GM foods] have a contribution to make and we won't know the answer about their environmental impact unless we run controlled experiments. It's important to go with the science."

A government source added: "We need to review the security arrangements. The rules are a charter for people who want to stop the experiments. A lot of information has to be put in the public domain and that makes it very easy for people to trash them."

Lord Mandelson backs the Cabinet's decision that GM policy must depend on science but is anxious to prevent Britain's biotechnology industry falling behind its overseas competitors.

He was a supporter of GM foods in his previous job as a European commissioner, where he tried to change the EU's cautious approach to GM licensing. In a speech last year, he argued: "Safe biotechnology has a crucial role to play in agriculture and agricultural trade both in Europe and the developing world."

Lord Mandelson urged governments, the Commission and the biotech industry to do a better job of setting out the issues. "While technology determines what is possible, consumer demand determines what is economically viable. Public fears may be misplaced, but they cannot and should not be dismissed," he said.

Leeds University plans to make one final attempt to conduct its field trial. It will ask the Government to foot an estimated GBP100,000 bill for installing fences, security cameras and guards on its farm so that the trial is not sabotaged by opponents.

Professor Tim Benton, research dean at its Faculty of Biological Science, said yesterday: "We need to find a way to do crop trials in a safe way and to minimise the environmental risk. We cannot carry on for the next 20 or 30 years saying it's too scary, the public is too frightened, it is politically too dangerous. There is absolutely no way we can move towards a world with food security without using GM technology. The amount of food we need could double because the population is growing, climate change will reduce yields and we will take land out of food production for biofuels."

Ministers, who have been lobbied by the biotechnology industry to improve security at trial sites, are drawing a parallel between anti-GM protesters and opponents of experiments on animals. The law was changed in 2005 to give police new powers to prosecute activists after Huntingdon Life Sciences was targeted and attacked by animal rights extremists.


How To Fight Super Pests? Build Superbugs

By William Pentland
November 18, 2008

USDA paves way for growing predators in the lab to fight threats to agriculture

The Asian Citrix Psyllid is a brown insect that spreads the most devastating citrus disease in the world. Just ask Florida's orange growing industry.

A native of the border regions of Pakistan and India, the parasite, which infects citrus plants with a so-called "greening disease," probably appeared by accident in the southeastern U.S. less than a decade ago. The bug has no natural enemies in its new home and requires far deadlier pesticides to kill it than other insects do. As a result, they've infested much of Florida and decimated the state's orange juice industry.

Until now, growers poured on pesticides and hoped for the best. But now a controversial solution may be at hand: creating predators in the lab.

In October, the U.S. Department of Agriculture's Animal and Plant Health Inspection Service, one of three federal agencies responsible for oversight of genetically modified organisms, said it would soon give the green light for transgenic insects designed to combat the spread of invasive species like the Asian Citrix Psyllid.

The agency released a draft regulation, the most comprehensive overhaul of genetically modified organism (GMO) regulations since 1987, to "respond to emerging trends in biotechnology." It provides the vague parameters that applicants must meet to commercialize genetically engineered (GE) bio-control organisms.

Though it's likely to change before becoming law, the proposal puts in place new permitting procedures for the interstate movement and environmental release of non-vertebrae transgenic animals, promising to usher in a new era. "There are relatively few examples today of genetically engineered biological control organisms, but these may become more common in the future," according to the report.

More than 6,500 invasive species have established themselves in the U.S., disrupting natural habitats, decimating the population of many native species and wreaking havoc on the economy. By at least one estimate, invasive species cost the U.S. roughly $130 billion in losses annually. Mark Hoddle, a professor of entomology at the University of California, Riverside, says the GE insects promise to be a safe, effective way of halting the problem.

"Almost all biological control processes use natural enemies that are highly screened for post-specificity, meaning they feed exclusively on the pests you want to eradicate," says Hoddle. "Genetic engineering allows you to enhance this trait significantly so that the engineered insects eat the desired species and then starve themselves to death."

Bill Freese, a science policy adviser at the Center for Food Safety, a Washington D.C.-based nonprofit, isn't convinced. "The stringency of the rules needs to be much higher than the vague, unclear standards in the [Department of Agriculture] regulation," he says. "This is all experimental stuff and there is a high risk of unintended consequences."

One victim, ironically, could be the booming market for pesticides and herbicides, though many companies like Monsanto and Cargill that developed the pesticides are best positioned to develop the engineered bugs that will replace them.

There is no shortage of applications for using this brand of biological control, especially if regulators ramp up restrictions on pesticide and herbicide as many believe they will in order to protect water supplies and combat a number of environmental problems linked with overuse of pesticides.

In Florida, some citrus growers may shut down operations until they find a more effective way of eradicating the pests. Others have simply poured on heavier and heavier concentrations of chemicals.

Florida's orange growers aren't the only farmers facing pest problems that didn't exist a few years ago. California has waged a decade-long war against the Glassy-Winged Sharpshooter, a half-inch long brown fly, which infects grapes with a rotting disease that has cost the state's wine-growers millions of dollars in losses. Then there's Kudzu sweeping across the American south, along with a host of other threats.

"Everything has a risk, but these risks can be quantified," says Hoddle. "And in many cases, the risk is one most people would accept given the costs of doing nothing."

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