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Mutant bacteria biowars threaten apocalypse now

May 17
Agence France Presse

Genetic engineers already have it within their grasp to devise a lethal bio-weapon for terrorists and rogue states, the British science publication Nature warns this week.

Small changes in the DNA of well-known bacteria and viruses could turn these agents into mass killers, the journal says.

The publication echoes warnings by a pair of Australian scientists, Dr Ron Jackson and Dr Ian Ramshaw, who accidentally created an astonishingly virulent strain of mousepox, a cousin of smallpox, among laboratory mice.

They realized that if similar genetic manipulation was carried out on smallpox, an unstoppable killer could be unleashed. They decided to publish their findings in January to draw attention to the potential misuse of biotechnology.

Nature warns: "Making subtle genetic alterations to existing pathogens to increase their virulence or durability in the environment, or to make them harder to detect or to treat with drugs, is within the limits of today's technology.

"With the decoding of a pathogen's entire genome now commonplace, and transgenic techniques advancing all the time, some researchers believe that the sinister potential of biology can no longer be ignored."

Biowarfare - use of germs or viruses such as anthrax or smallpox - has long been considered by military strategists. However, the risk has increased thanks to advances in knowledge about how genes work, new techniques for moving pieces of DNA around, and the relative ease with which a rogue organization could build or hire a lab to build such a weapon.

Scientists interviewed by Nature ruled out, for the time being, the ability to build new, artificial agents from a set of component parts.

A far simpler way would be to tweak the performance of an existing bacteria to make it more resistant to antibiotics, they said.

The genetic sequences of bacteria such as tuberculosis, cholera, leprosy and the plague are already in the public domain - as is that of a food poisoning bug, Staphylococcus aureus, that is already becoming resistant to antibiotics.

By identifying the genes from Staphylococcus aureus that make the bug resistant, and inserting them into the other bacteria, a scientist could make a killer for which there would be scant defence.

Dr Willem Stemmer, chief scientist with Maxygen, a California pharmaceutical research firm, used one of these techniques to explore how resistance genes work, Nature reports.

He created a strain of the common intestinal bug Escherichia coli that was 32,000 times more resistant to the antibiotic cefotaxime than conventional strains. He destroyed the superbug in response to the American Society for Microbiology's concerns about potential misuse.

"It's time for biologists to begin asking what means we have to keep the technology from being used in subverted ways," said Harvard University molecular biologist Professor Matthew Meselson, who has often spoken of the dangers of biowarfare.

The debate nobody wants - GM

May 15
Guardian (UK)

Quite simply, following BSE, the public did not want their food mucked about with, and when they thought about it, their countryside either.

Despite this unprecedented revolt by consumers, Tony Blair, while avoiding mention of the issue at all, remains a GM enthusiast.

The fact that during his first term every supermarket chain has withdrawn genetically modified foods from its shelves and gone to extensive lengths to insist suppliers are GM free seems to have passed the prime minister by.

Currently there is no market in Britain for GM food and most chains are also banning GM crops from animal feed. Even Coca Cola is saying it does not want sugar from GM sugar beet in its drinks.

Despite all this, full scale trials of genetically modified crops are under way, even though there is serious public opposition.

Even the food standards agency, one body set up to restore confidence in British food, seems happy to endorse GM products on the basis that they cannot find any danger to the public.

The only question still left in the government's mind is whether GM crops might damage the environment, and that answer will not be known until 2003, even if the current trials do manage to produce a result.

None of this grapples with the central problem that there is no gain in the technology for the consumer and only perceived threats.

Why they should be talking about it?

GM as an issue is not going away. Britain has a lot of expertise and money invested in the biotech industry, and potentially a lot of jobs. The future of British farming, whether organic agriculture has a future, and the shape of the countryside are all tied up in the the debate.

The perception that the prime minister is a pushover for big business interests is partly tied up with his perceived lack of interest in genuine public concerns about the consequences of embracing this technology. So far multi-national companies controlling GM patents appear to be the only winners from the GM revolution, at least as far as the farmer and consumer are concerned. If politicians believe that GM food and crops are the future they should be prepared to discuss the issues with environment groups and allay public fears.

What could be done?

The government claims the technology is safe but there is no liability regime in place if anything goes wrong. GM companies should be required to provide insurance to indemnify farmers against successful claims from organic producers and beekeepers if they lose their markets because of GM crops. Shops also need cover if genetically modified foods cause allergies or other ailments.

If, as some claim, GM crops and organic farming cannot exist side by side in such a small country, then the government should enter a genuine debate on which the public wants.

We need have no fear of interference of nature

Emotion is stopping us from embracing the benefits of gene manipulation

May 15
Guardian (UK) column by Mary Warnock

Prince Charles is no fool. He did not need his father or his sister to point out, as they did, that human beings had been interfering with nature as long as they had sown crops for their own use, or bred cattle for milk or meat. But he contrasted producing genetically modified crops with traditional methods of agriculture which have stood the test of time because "they are working with the grain of nature". Which way does nature's grain lead us?

Human nature is thought to be determined by its genes, genes which may be shared across all species from the lowly fruit fly to plants themselves. So are those who fear that genetic manipulation is a threat to nature simply expressing their outrage at the diminution of the status of man, his now unspecial place in nature, as the Victorians did in the great rows of the 19th century with the church?

I do not think so. After all, many people who probably believe in no gods at all nevertheless accuse biological scientists of seeking to "play God". In this country at least there are not many who would deny the theory of evolution. The argument has moved on; and those who object that genetic manipulation is against nature are not merely re-enacting the passionate disputes of earlier times, for they accept most of the Darwinian premises.

The fear that lies behind the objections seems to be a fear that the laws of nature themselves are no longer to be relied upon. Jonathon Porritt, former director of Friends of the Earth, wrote in his book Playing Safe that "the hard lines between different organisms and species are beginning to melt away. We can now pick and choose individual genes from one organism to introduce into a totally different and unrelated organism, crossing all biological boundaries in combinations that nature never could and never would bring together."

In a society which we are constantly reminded is "plural" - no one set of moral principles or even laws being better or more valid than any other - it seems particularly terrible if the certainties of laws of nature itself can be eroded.

It was upon such fears that, Mary Shelley played, as long ago as 1818, in her story Frankenstein or the New Prometheus. She deliberately sought to "speak to the mysterious fears of our nature, and awaken thrilling horror".

This was the myth of an unnatural creature being formed in the laboratory whose growth and behavior could not be controlled. In the 1920s, we had the myth of Aldus Huxley's Brave New World, in which races of creatures could be produced who would be all too well controlled, who would be designed indeed to fulfill specific functions. Both myths, not so much scientific as social and political, certainly inspire terror, and both live on in the kind of language used of biological scientists.

Our attitude towards nature is complex and has a history; the word itself has resonances which are strongly influenced both by the attitude of respectful observation of nature and that of the romantic searching of nature for our own proper dwelling, for where we feel that we most deeply belong.

Both of these attitudes derive from the change in sensibility that came about roughly at the time of the French revolution, the end of the Age of Enlightenment.

It would be impossible for us to free ourselves from such attitudes if only because of the immense influence on us that is exercised by European and American art of the period. Nor do I suppose that many of us would want to be rid of them, since for many they afford the greatest pleasures in life.

But we are also subject to the influence of Darwinian biology, and the new way in which we have been taught to think of nature as one organism, whose "building blocks", as we are frequently told, are genes.

In such a world, we are confronted not only by science which has discovered and will discover more and more about how these genes work, with one another and with their environment, but also by increasingly sophisticated technology, needed both for the discoveries themselves and for any interventions which agriculturists or doctors may decide to undertake.

It is doubtless prudent to be fairly cautious in what interventions there should be. But a modest conservatism does not entail that nothing new should ever be tried. Nor do I believe that the resonance and emotive force contained in the word "nature" should have any power to influence the decisions of society as to what is or is not an acceptable intervention.

If it can be shown, as I believe it can, that the genetic modification of rice to make it more tolerant of adverse weather conditions would make a great difference to the level of nutrition in countries where rice is the most important element of diet, then common humanity demands that such modified rice should be made accessible.

If it can be shown that nuclear cell transplant (and thus the transplant of genes) can effectively restore someone's damaged liver, brain or spinal cord, then the common humanitarian concerns which have always been the concerns of medicine should be permitted to develop the technology necessary for such treatment.

That it is perhaps "against the grain of nature" is no more relevant an argument against it than it would be to claim that a replacement hip joint is against the grain of nature.

There is just one hypothetical case in which I might myself be inclined to use the argument that a development was, in an injurious sense, "against nature". This would be the case where someone decided that if one cell in a human or other animal body could be replaced and regenerated then all the cells could be so treated again and again, so that the person or animal never died.

I would argue that all our attitudes to nature, all our love and respect for it depend on its ephemeral, or at least fragile, essence.

And this fragility of course extends to our notion of ourselves. If prolonging our lives indefinitely were really on the cards, then I for one would wish to legislate against it on the grounds that all men are mortal, and to deny this would be to deny our very understanding of the world.

The author is a member of the Lords. Extracted from a lecture at Gresham College.

GM crop DNA has already spread

May 15
Western Mail (UK)

The scientists whose evidence helped to stop the Mathry field trials of genetically-modified maize in Pembrokeshire are now calling for all UK field experiments to be halted as illegal and unsafe.

Dr Mae-Wan Ho, director of the, Science Monitor Institute of Science in Society; Brian Goodwin, biology professor at the Schumacher College, Totnes; Joe Cummins, plant genetics professor at the University of Western Ontario; and Peter Saunders, biomathematics professor at King's College University of London, say GM contamination has already happened.

DNA from GM crops has already been found in non-GM plants and in pollen and honey protein. It means that field trials threaten the UK's £15bn honey industry.

Dr Mae said, 'Any new technology must be tested, but there are important scientific issues that must be addressed before GM crops can be released into the environment even in the context of testing.

'To conduct field trials before this has been done is both premature and hazardous.

'It is like carrying out clinical trials of a drug before the laboratory tests are complete.'

Their main concern is the spread of mutated genes and antibiotic-resistant genes to bacteria in the soil and in the mouth, respiratory tract and gut of both humans and animals.

The legality and safety of Chardon LL maize, the variety to be tested at Mathry, and other GM crops was strongly contested by scientists during the Chardon LL hearing held in the UK last year.

The hearing was adjourned after a press release issued by Maff on October 30 last year admitted that Chardon LL had not passed the main test required for commercial approval.

The possibility of cross-pollination with non-GM and organic crops as well as wild plants is now generally acknowledged.

U.S. Senate declares May 13-20 National Biotechnology Week

May 11
Biotechnology Industry Organization press release

The U.S. Senate passed a resolution (attached) declaring May 13 - 20 National Biotechnology Week, thereby recognizing biotechnology's importance to research and development of medical, agricultural, industrial and environmental products.

``There have been phenomenal advancements in science over the last few years that are allowing us to improve health care, increase crop yields, reduce the use of pesticides and replace costly industrial processes involving harsh chemicals with cheaper, safer biological processes,'' said Sen. Tim Hutchinson (R-AR), the resolution's sponsor. ``These advancements have occurred due to the hard work and diligence of scientists and researchers in the United States, and all around the world, who have spent their lives promoting and perfecting the practice of biotechnology.''

Carl B. Feldbaum, president of the Biotechnology Industry Organization (BIO), thanked Sen. Hutchinson for his efforts, which were key to winning the unanimous consent of the Senate.

``This resolution is but one example of the support Sen. Hutchinson has given the industry over the years, and we plan to honor him next week with a BIO Legislator of the Year Award,'' said Feldbaum. The award ceremony, slated for Wednesday, May 16, is part of BIO's Legislative Day event, which will bring more than 150 biotech executives to the U.S. Capitol for a blitz of 200 meetings with representatives and senators.

BIO represents more than 950 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 33 other nations. BIO members are involved in the research and development of health care, agricultural, industrial and environmental biotechnology products.

Text of the resolution:

107th CONGRESS 1st Session S. RES. 75 Designating the week beginning May 13, 2001, as 'National Biotechnology Week'. 

IN THE SENATE OF THE UNITED STATES RESOLUTION 

Designating the week beginning May 13, 2001, as `National Biotechnology Week'. 

Whereas biotechnology is increasingly important to the research and development of medical, agricultural, industrial, and environmental products; 

Whereas public awareness, education, and understanding of biotechnology is essential for the responsible application and regulation of this new technology; 

Whereas biotechnology has been responsible for breakthroughs and achievements that have benefited people for centuries and contributed to increasing the quality of human health care through the development of vaccines, antibiotics, and other drugs; 

Whereas biotechnology is central to research for cures to diseases such as cancer, diabetes, epilepsy, multiple sclerosis, heart and lung disease, Alzheimer's disease, Acquired Immune Deficiency Syndrome (AIDS), and innumerable other medical ailments; 

Whereas biotechnology contributes to crop yields and farm productivity, and enhances the quality, value, and suitability of crops for food and other uses that are critical to the agriculture of the United States; 

Whereas biotechnology promises environmental benefits including protection of water quality, conservation of topsoil, improvement of waste management techniques, reduction of chemical pesticide usage, production of renewable energy and biobase products, and cleaner manufacturing processes; 

Whereas biotechnology contributes to the success of the United States as the global leader in research and development, and international commerce; 

Whereas biotechnology will be an important catalyst for creating more high-skilled jobs throughout the 21st century and will lead the way in reinvigorating rural economies; and 

Whereas it is important for all Americans to understand the beneficial role biotechnology plays in improving quality of life and protecting the environment: 

Now, therefore, be it Resolved, That the Senate -- 

(1) designates the week beginning May 13, 2001, as `National Biotechnology Week'; and 

(2) requests that the President issue a proclamation calling upon the people of the United States to observe the week with appropriate programs, ceremonies, and activities.

Review of bioengineered salmon moves forward

May 11
Food Chemical News

While a government review of bioengineered salmon is moving forward at FDA’s Center for Veterinary Medicine, lawmakers joined with consumer and environmental groups last week to demand more stringent government regulation of bioengineering in animal agriculture. 

Reps. Peter DeFazio (D-Ore.) and Dennis Kucinich (D-Ohio) joined consumer and environmental groups May 9 who unveiled petitions seeking a moratorium on the domestic marketing and importation of transgenic fish. 

"The FDA, without even consulting the government’s own environmental experts, is rapidly and carelessly moving toward the approval of a transgenic fish that will further exacerbate the challenges faced by endangered species," DeFazio said. 

Speakers at the news conference focused on an ongoing review at CVM of growth-enhanced salmon, submitted by A/F Protein of Waltham, Mass. The groups criticized the lack of transparency in the review process, said sufficient toxicological studies are needed, and highlighted environmental concerns. 

"We more than anyone else want to do it right," Joseph McGonigle, vice president at Aqua Bounty Farms, told Food Chemical News. Aqua Bounty is beginning to submit data and study protocols on food safety, McGonigle said. He told FCN that the company will conduct toxicological tests if there is a need for them. However, there are no indications of toxic effects at this point, he told FCN. 

The company is in the process of demonstrating the efficacy of the product, which it first submitted to FDA in 1995 as an investigational new animal drug. CVM has said it hopes to regulate bioengineered animals under its current regulatory system for new animal drug applications under the Federal Food, Drug, and Cosmetic Act (see FCN, Aug. 7, Page 1). 

From start to finish, the process of a drug approval at CVM can take six to seven years, and involves several stages, including first the investigational new animal drug application (INAD) and then the new animal drug application (NADA). The transgenic salmon are not out of the investigational stage at this point, but are at the later stages of product development, McGonigle told FCN.

At this point, the company is working on demonstrating efficacy, environmental safety, food safety, and target animal safety, all of which are needed to file an NADA, which is the next phase in the drug review. 

Legislative, petition details 

DeFazio and Kucinich are crafting legislation that would tighten government regulation of bioengineering in plant and animal agriculture. The legislation would span all genetically modified organisms, an aide to DeFazio told FCN. Kucinich has introduced legislation that would require mandatory labeling of bioengineered foods, and is a strong advocate of more stringent regulations. 

The legislation now under development would require agencies with environmental expertise to be included in the review of bioengineered foods, including genetically engineered fish. The action also would enhance pre- and post-market research and data collection, and improve the public’s access to information about genetically engineered products. 

The Center for Food Safety and some 60 other consumer and environmental groups want the government agencies to coordinate their efforts on regulating transgenic fish. They submitted petitions to FDA, the Department of Commerce, USDA and the Department of Defense’s Army Corps of Engineers. 

Andrew Kimbrell, director of the Center for Food Safety, believes that new laws and regulations are needed to address bioengineered salmon because it is inappropriate for CVM to regulate these products under its existing rules, which were not expressly written for products produced through biotechnology. 

Kimbrell and the others are seeking a moratorium on domestic marketing and importation of transgenic fish until FDA completes a comprehensive environmental impact review as mandated by the National Environmental Policy Act. FDA must work with the departments of Commerce, Defense and Agriculture and comply with provisions of other various laws, they said. 

The groups also are demanding mandatory labeling of transgenic fish and all food products containing any ingredients derived from transgenic fish. The groups also want post-marketing monitoring, reporting and inspecting procedures for transgenic fish. They called upon FDA to establish regulations addressing the safety and efficacy of transgenic fish by requiring all transgenic-fish producers to complete a full review of transgenic fish as a new animal drug. 

Kimbrell warned that the groups may sue FDA if their petitions are not answered. The Center for Food Safety, along with many of the same groups, sued FDA a few years ago about its policy on plants derived from biotechnology. A federal judge upheld FDA’s 1992 biotech policy last October and dismissed the groups’ claims (see FCN, Oct. 9, Page 1). 

Points of contention 

One contentious issue appears to be whether Aqua Bounty performs toxicological tests as part of its government review. 

Aqua Bounty’s McGonigle explained that the company will conduct toxicological tests if there is a need for them. Aqua Bounty’s transgene is derived from two edible fish — Chinook salmon and ocean pout. The salmon are used for growth hormone production, and ocean pout for the regulator sequence, McGonigle told FCN. The transgene was microinjected into the fertilized eggs of a third edible fish, Atlantic salmon, four generations ago. 

"Since the transgene results in nothing more than the expression of ordinary salmon growth hormone, there is no indication of potential toxicity," McGonigle told FCN. "Had there been such an indication, FDA would require us to do toxicology testing. Since there is none, we have not been required to run those tests." 

CVM is consulting with other FDA experts in human drugs and biologics, USDA and other agencies on the matter, and plans to convene a symposium on the issue later this summer, McGonigle told FCN. FDA wants to develop open lines of communication with industry and the public on the matter, he said.

Farm lobby takes tough stand on risk of GM contamination

May 10
Western Producer (Canada)

Canada's wheat exports could be jeopardized unless federal regulators demand more safeguards to prevent genetically modified wheat from contaminating non-GM crops.

That was the sentiment of Keystone Agricultural Producers when the farm lobby group met in Brandon recently for a general council meeting.

There is a concern that GM wheat going into test plots this year could spread into other wheat crops. Cross-pollination was cited as a potential source of the contamination.

"I just can't stress the seriousness of this," said David Rolfe, a grain and hog producer from Elgin, Man., and a KAP executive member.

"The whole wheat export market for Western Canada is at stake."

KAP passed a strongly worded resolution warning that it may launch a class action suit against the Canadian Food Inspection Agency for not having adequate regulations to contain GM wheat.

The resolution also demands that the agency immediately revise its GM guidelines to ensure a zero contamination policy until Canada's major wheat customers adopt a reasonable tolerance for GM contaminants in wheat imports.

"We're telling them they better get their ducks in a row," said KAP president Don Dewar.

"We're concerned about the markets. That's the bottom line. We're not opposing the science."

GM varieties of wheat are being developed in Canada but are not yet registered for commercial use by farmers.

Most buyers of Canadian wheat have a zero tolerance toward GM wheat, says the Canadian Wheat Board.

That means those buyers would reject shipments of Canadian wheat containing GM material. Such contamination could also prompt importers to look elsewhere for their wheat supplies.

"We can't afford to lose those markets," Rolfe said.

"We can't afford to lose any markets."

KAP wants a more rigorous policy to ensure that GM wheat varieties are kept isolated.

In the resolution, the farm group warned that Agriculture Canada, the Canada Grain Commission and companies that develop GM crops will be held responsible for harm done to farmers if GM wheat is not contained.

The resolution is an indication of how serious the issue is for farmers, Rolfe said.