New UCS report on biopharma crops

USDA to Allow “Safe” Levels of Drugs in Food?

Download: Pharma Crop "Safe Levels" Briefing Paper

The U.S. Department of Agriculture (USDA) appears committed to allowing biotechnology companies to grow food crops such as rice, corn, and soybeans genetically engineered to produce drugs and industrial chemicals, despite the real and serious risk of contamination of our food supply. The USDA currently allows such crops to be grown outdoors in food-producing regions, and has signaled that new rules expected soon will incorporate vague measures the department hopes will avert a food safety disaster. These measures might include superficial food safety assessments that the department would use to allow so-called “safe” levels of drugs in our food supply.

UCS believes that contamination of the food supply is inevitable if the USDA continues to allow this risky practice. Discovery of a contaminant even at a “safe” level will surely cause economic disruption for food companies and farmers, as consumers will not accept any amount of drugs in their food. An outright ban on pharma food crops is the only sure way to avoid such an outcome.

Our briefing paper, “Food Safety Assessments Won’t Quell Consumer Fears About ‘Safe’ Levels of Drugs in Food,” evaluates the approach put forward by the USDA—that a ban is not necessary if food risk is assessed and confinement measures are adopted commensurate with risk. The paper concludes that such a regulatory scheme would neither reassure consumers nor protect food manufacturers and moreover would be a waste of government resources.

Ventria sowing a storm with altered rice

http://www.gmwatch.org/archive2.asp?arcid=8475

COMMENT from Dr Doug Gurian-Sherman of the Union of Concerned Scientists (UCS): The food industry's concerns that production of this pharmaceutical protein in rice could have negative impacts on sales or exports are well founded. The industry's now long track record of contamination should not give anyone confidence that they can keep their pharma rice out of our food.

This article mentions that the Ventria company intends to market this product as a 'medical food'. This is an ill-defined regulatory category at the Food and Drug Administration that, similar to other GE crops, requires little regulatory oversight or safety testing.

The human-derived protein, called lactoferrin, that Ventria is producing in rice, is modified compared to the human version. This is the same class of modification that occurred in peas containing an engineered bean protein, reported several years ago to have acquired the ability to cause adverse immune responses in mice, and causing the CSIRO in Australia to cancel the project after a decade of work.

One type of adverse immune response that may be possible (although no one really knows for sure) is autoimmunity to the altered protein. This means that the body's built-in ability to distinguish its own proteins from foreign ones (e.g. from bacterial or viral pathogens), and thereby avoiding a dangerous immune response against one's own body, is lost. Well known autoimmune diseases are diabetes, lupus, and rheumatoid arthritis. The disease that might be caused by an autoimmune response against one's own lactoferrin is not well understood, but any immune attack against important proteins in the body is cause for concern.

Especially troubling is that Ventria apparently is able to declare that this protein should be classified as a medical food rather than a drug, which would require rigorous safety testing. For example, another company, Agenix, is producing human lactoferrin in yeast in a contained facility for treating cancer, and is going through the typical drug safety-testing route. The actions of Ventria are yet another demonstration of the recklessness of the industry.

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North Sacramento-based Ventria sowing a storm with altered rice
SacramentoBee, November 6 2007
http://www.sacbee.com/103/story/469124.html

Biopharm rice

FOR IMMEDIATE RELEASE May 17, 2007

Contacts: Dan Nagengast, Kansas Rural Center, 785-748-0959

Bill Freese, Center for Food Safety, 202-547-9359 x14

Bill Wenzel, Farmer to Farmer Campaign on Genetic Engineering, 608-444-0292

USDA Approval of Drug-Producing Rice in Kansas Poses Threat to Food Safety, Say Food Safety & Farming Groups

Tornadoes, Floods Could Contaminate Foods With Drugs Not Approved By FDA

20,000 Citizens, Scientists, Farming and Rice Organizations In Opposition

WASHINGTON — The Center for Food Safety, Kansas Rural Center and Farmer to Farmer Campaign on Genetic Engineering object to USDA’s May 16th approval of drug-producing rice cultivation in Kansas, charging that it poses needless risks to the safety of the American food supply. USDA’s approval permits cultivation in the Junction City area of up to 3,200 acres of rice genetically engineered to produce pharmaceutical compounds that the U.S. Food and Drug Administration (FDA) has refused to approve. FDA approval is not required for planting to proceed.

The groups note that the decision comes just a week after tornadoes in the Kansas River Valley and heavy rains caused severe flooding in east-central Kansas , including floodwaters on the Smoky Hill River , which passes just a mile from one of the proposed planting sites. USDA had earlier dismissed concerns raised by the groups that floodwaters could carry the pharmaceutical rice into surrounding cropland and contaminate farmers’ crops with drugs unapproved by the FDA. USDA concluded in its environmental assessment that: “Extreme weather events are rare and unlikely to occur in the area of the field trial.”

“About two weeks ago, I was huddled with other travelers in a rest stop on Interstate 70 as tornadoes were reported on the ground in the very area where Ventria proposes to expand their production between Junction City and Topeka ,” said Dan Nagengast, Executive Director of the Kansas Rural Center .

“I also question whether the company has adequately engineered their water control systems to deal with the amounts of torrential rainfall that are quite common here. This just represents an unconscionable food safety complication in a food-producing region. Why grow these crops in wide open nature, when other companies have found it possible to use genetic engineering techniques to produce biotech drugs in confined settings where food contamination is not an issue?”

USDA approved the “pharma rice” plantings despite receiving 20,000 comments in opposition from citizens, scientists, farming and rice groups. Groups opposing the scheme include the USA Rice Federation, U.S. Rice Producers Association, Riceland Foods, Mississippi Rice Council, Arkansas Rice Growers Association, Missouri Rice Research and Merchandising Council, and Rice Producers of California. In addition, fourteen independent scientists signed a joint scientific assessment warning of potential adverse health impacts from even trace-level exposure to one of the rice-produced drugs.

“These rice-grown drugs are unapproved by FDA, may be hazardous, and whether hazardous or not could cause huge economic losses to Kansas farmers whose wheat, soy or other crops become contaminated with drug rice,” said Bill Freese , Science Policy Analyst with Center for Food Safety.

“In 2002, corn containing an experimental swine vaccine got mixed into soybeans and regular corn, which then had to be destroyed at a cost of several millions dollars,” said Nagengast. “Over the past year, rice farmers have lost millions of dollars from contamination of their crop with unapproved genetically engineered rice grown under USDA’s watch,” he added.

“The USDA needs to stop rubber-stamping schemes like drug-producing crops that put farmers and the rural economies they support at great risk,” said Bill Wenzel, National Director of the Farmer to Farmer Campaign on Genetic Engineering. “The USDA should be focused on representing farmers rather than carrying water for the biotech industry,” he added.

Developed by California-based Ventria Bioscience, the rice is engineered with modified human genes to serve as a “biofactory” for production of synthetic human milk proteins that have antimicrobial and other drug-like properties. Ventria has proposed using the rice-extracted protein drugs to treat infants with diarrhea, and as additives in infant formulas, yogurt, granola bars and sports drinks, among other uses.

Last month, the Center for Food Safety released a report detailing the potential human health impacts of Ventria’s pharmaceutical rice and the FDA’s refusal to approve Ventria’s rice-grown drugs. The report, “A Grain of Caution,” also disputes the need for Ventria’s pharmaceutical rice, discussing cheap and effective solutions for prevention and treatment of diarrhea recommended by the World Health Organization and other public health experts. The report notes that these existing solutions have cut deaths due to diarrhea from 4.6 million a year in 1980 to 2 million today, and could save many more lives if adequate funding were provided.

Center for Food Safety’s “A Grain of Caution” is available at:

http://www.centerforfoodsafety.org/pubs/Pharmaceutical%20Rice-FINAL.pdf

For Center for Food Safety’s comments to USDA warning of contamination and other risks, see:

http://www.centerforfoodsafety.org/pubs/Biopharm%20Rice%20Kansas%20comments_final.pdf

__________

Center for Food Safety is a national non-profit membership organization working to protect human health and the environment by curbing the use of harmful food production technologies and promoting sustainable agriculture. In 2000/2001, CFS was part of a coalition that discovered widespread contamination of the food supply with genetically engineered StarLink corn, which had not been approved for human consumption due to concerns it could cause food allergies. In the past year, CFS has won three cases against USDA for the Agriculture Department’s reckless and illegal approval of genetically engineered crops. See www.centerforfoodsafety.org.

The Kansas Rural Center is a non-profit research, education and advocacy organization that promotes environmentally sound farming practices and a safe and healthy food system, benefiting both farmers and consumers. See www.kansasruralcenter.org.

The Farmer to Farmer Campaign on Genetic Engineering was formed in 1999 to provide a national voice for farmers on agriculture biotechnology. The Campaign provides education, training and support to farmers and farm groups on agricultural biotechnology issues.

Center for Food Safety

Kansas Rural Center

FOR IMMEDIATE RELEASE April 24, 2007

Contacts: Bill Freese or Joseph Mendelson, Center for Food Safety, 202-547-9359

Dan Nagengast, Kansas Rural Center, 785-748-0959

Genetically Engineered Pharmaceutical Rice Is Not the Solution to Diarrhea

Drugs in Rice Not Approved by FDA, Will Likely Contaminate Foods

Groups Urge Ban on All Drug-Producing Genetically Engineered Food Crops

WASHINGTON — Genetically engineered, pharmaceutical rice is not a safe or cost-effective solution for infants suffering from diarrhea, concludes an exhaustive report released today by the Center for Food Safety, as the U.S. Dept. of Agriculture (USDA) considers whether to allow planting of the rice in Kansas this spring. The report discusses potential adverse health impacts of the rice-grown drugs, which have not been approved by the U.S. Food and Drug Administration (FDA).

Developed by California-based Ventria Bioscience, the rice is engineered with modified human genes to serve as a “biofactory” for production of synthetic human milk proteins that have antimicrobial and other drug-like properties. Ventria has proposed using the rice-extracted protein drugs to treat infants with diarrhea, and as additives in infant formulas, yogurt, granola bars and sports drinks, among other uses.

The report details Ventria’s failed attempts to gain FDA approval of its rice-grown drugs dating back to November 2003. Ventria is seeking USDA approval to grow up to 3,200 acres of its rice in the Junction City , Kansas area.

“USDA must not allow Ventria to grow genetically-engineered rice containing drugs that our nation’s food and drug authority have refused to approve,” said Joseph Mendelson, Legal Director at Center for Food Safety (CFS). “We call on USDA to unconditionally deny Ventria’s permits.”

“Policy makers in Kansas do not seem to have a sense of either the marginal benefits to be gained or the high risks entailed in this enterprise,” said Dan Nagengast, Executive Director of the Kansas Rural Center . “Clearly the food industry, and rice farmers elsewhere in the country, understand the risk to their businesses when contamination occurs.” He noted that rice supplies roughly 20% of the world’s calories.

Nagengast also pointed out that the USA Rice Federation, representing the rice industry, had asked USDA ‘in the strongest possible terms’ to deny Ventria’s requested permits. The Grocery Manufacturers of America and other groups representing the $500 billion food industry have also opposed drug-producing food crops.

“These genetically engineered drugs could exacerbate certain infections, or cause dangerous allergic or immune system reactions,” added Bill Freese , CFS Science Policy Analyst and author of the report, which references peer-reviewed scientific articles, the National Academy of Sciences, and FDA regulatory documents.

Freese notes that mothers of two infants who participated in a Ventria-sponsored clinical trial of its rice-grown drugs in Peru reported that their children had developed allergic reactions to numerous foods, leading to a Peruvian government investigation of the trial.

“USDA simply cannot be trusted to keep this pharmaceutical rice out of our foods,” said Nagengast. “Just a few years ago, corn containing an experimental swine vaccine got mixed into soybeans and regular corn, which then had to be destroyed. Rice has twice been contaminated with unapproved genetically engineered rice in just the past year,” he added.

The report also disputes the need for Ventria’s pharmaceutical rice, and discusses cheap and effective solutions for prevention and treatment of diarrhea recommended by the World Health Organization and other public health experts. The report notes that these existing solutions have cut deaths due to diarrhea from 4.6 million a year in 1980 to 2 million today, but are not adequately funded.

“What developing countries need most is clean water and basic sanitation facilities to prevent diarrhea, and improved access to existing oral rehydration solutions to treat it,” said Freese. “Even if Ventria’s rice-grown drugs eventually prove to be safe, they would be expensive, and divert funding from existing, cost-effective solutions that aren’t adequately funded,” he added.

__________

For the full report, go to http://www.centerforfoodsafety.org/pubs/Pharmaceutical%20Rice-FINAL.pdf

.

Center for Food Safety is a national non-profit membership organization working to protect human health and the environment by curbing the use of harmful food production technologies and promoting sustainable agriculture. In 2000/2001, CFS was part of a coalition that discovered widespread contamination of the food supply with genetically engineered StarLink corn, which had not been approved for human consumption due to concerns it could cause food allergies. In the past year, CFS has won three cases against USDA for the Agriculture Department’s reckless and illegal approval of genetically engineered crops. www.centerforfoodsafety.org.

The Kansas Rural Center is a non-profit research, education and advocacy organization that promotes environmentally sound farming practices and a safe and healthy food system, benefiting both farmers and consumers. www.kansasruralcenter.org.

New Oakland Institute briefing

Press Release

For Immediate Release: March 29, 2007

Contact: Anuradha Mittal, (510) 469-5228; amittal@oaklandinstitute.org


Communities Versus Pharmaceutical Conglomerates

How Food Became a Casualty of Biotechnology’s Promise

(Oakland, CA) – A new policy brief from the Oakland Institute, How Food Became a Casualty of Biotechnology’s Promise, exposes how pharmaceutical conglomerates are using the agricultural sector to underwrite their research and development efforts as they work to transform plants and animals into drug and organ factories to further their profits.

While there are over 30 protein-based medicines in the market and an additional 371 in the research and development phase, using single cells to produce biotech drugs, also known as biologics, is a complicated and time-consuming process. This has pushed the pharmaceutical industry to invest heavily in biotechnology and begin “pharming” – a term combining farming and pharmaceutical – whereby genetic material from a foreign species is inserted into a plant or animal with the intent of extracting novel pharmaceutical products from the resulting tissues, fluids, and organs.

“Ancient alchemists dreamed of transmuting base metals into gold, discovering a universal cure for disease, and indefinitely prolonging life. Biotechnologists are now promising to convert soil and sunlight into the building blocks of human life,” said Michael Heimbinder, Oakland Institute Fellow and author of the policy brief. “This experiment, unprecedented in human history, masquerades as a humanitarian effort directed toward growing more food and feeding more people. In reality, these claims are a smoke screen for the development and monopolization of proprietary biotechnology platforms that ultimately will be deployed towards more profitable ends than growing more corn.”

“GE crops have little to do with growing food and feeding people,” said Anuradha Mittal, Executive Director of the Oakland Institute, publisher of the policy brief. “Agricultural biotechnology has been financed by the promise of future profits from products unrelated to food. Food is merely the conduit through which the pharmaceutical conglomerates hope to develop and monopolize the basic technologies that promise profits far exceeding any imaginable from high-yielding crops bearing vitamin-fortified food.”

The policy brief also exposes how taxpayer dollars have supported the failures of biotechnology. The industry has increased the demand for GE seeds through government supports, subsidizing their supply through public research, and crafting a regulatory framework in which these products might receive society’s stamp of approval. “All this has been done in the name of creating a more productive agriculture, when the ‘Gene Revolution’ simply represents the latest frontier in the laboratory’s struggle to subject farms and farming to the logic of capital,” said Michael Heimbinder. “The space wherein the productivity of agriculture will be enhanced – the genome – is inaccessible to farmers even though it exists in their fields and sheds.”

The policy brief warns against using resources earmarked for agriculture to shore up the finances of the pharmaceutical industry and recommends several online resources for readers to take action to reverse this trend.

How Food Became a Casualty of Biotechnology’s Promise is a publication of the Oakland Institute, a think tank for research, analysis, and action whose mission is to increase public participation and promote fair debate on critical social, economic, and environmental issues.

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Download the Policy Brief

Take Action: Support AB 541, The Food And Farm Protection Act

Kanji

GMO ACTION ALERT
Children With Diarrhoea need Rice “Kanji”, Not Cannibal Rice

Dr. Mira Shiva Dr. Vandana Shiva

Initiative on health, Equity and Society Navdanya / RFSTE

International Peoples Health Council (South Asia)

California based Ventria Bioscience has been given preliminary approval to grow a rice containing human genes on 3000 acres in Kansas.

The claim is that food products using the human proteins from rice could help save millions of children who die of diarrhoea and the resulting dehyrdration. The company plans to harvest the proteins from the rice and use them in drinks, desserts and muesli bars. Children with diarrohoea are not given muesli bars. Rehydration needs liquids, not solids.

The best rehydration for breast fed babies is mother’s milk. Ventria is in fact using the ‘lacto ferrin’ found in breast milk to produce the transgenic rice. Breast fed babies can directly get lacto ferrin in breast milk instead of getting it through Ventria’s “genetically engineered” rice with human genes in it.

Older Children, do not need the “cannibal rice” either. Oral rehydration is an established, time tested, safe method for diarrhoea and prevention of dehydration.

Oral Rehydration Therapy (ORT) / Oral Rehydration Solution (ORS) was considered the greatest medical revolution of the 20th century. It saved lives of millions starting from 1971 Bangladesh war of Independence and has been successfully used in the developing countries’ war for child survival. Diarrhoea and acute respiratory infection have been identified as the two major causes of infant mortality, worsened by the malnutrition of children.

While UNICEF / WHO ORS packets have been promoted, it has been the home made ORS called “Jeevan Jal” Salt sugar solution that has saved lives of children, especially where the free, low cost UNICEF ORS packets did not reach, and costly commercial ORS packets are the only alternative and the later are not easily affordable. A packet costs Rs. 6 – 10/- i.e for one litre. Over two packs may be required for each episode of diarrhoea. Large numbers of the afflicted children come from poor families whose income may be less than the cost of the packet. For over two decades anganwadi workers and village health workers, trained mothers and the community in making and using homemade ORS for the children with diarrhoea.

In India, for centuries, diarrhoea has been treated with home fluids for rehyrdration eg. Rice Kanji, Coconut Water, Butter Milk, Aniseed Water.

Rice Kanji not only provides calories to the child with diarrhoea, but it has an added advantage that it does no cause OSMOTIC DIARRHOEA. Butter Milk, besides providing fluid to compensate for the fluid loss in diarrhoea, it has natural Lacto Baccillus which helps in controlling diarrhoea. Lacto Baccillus capsules are being prescribed for diarrhoea care commercially.

When simple, low cost, locally available culturally appropriate safe and effective options for addressing diarrhoea care exist, as stated and promoted by International Public Health bodies such as UNICEF and WHO, International Peoples Health Council, there is absolutely no scientific, basis for a genetically modified rice with human genes to be introduced in the name of diarrhoea care.

Respected public health advocates David Werner of Health Wrights and David Sanders in “Questioning the Solution” had dealt with the politics of the ORS. They show that promotion of cereal based oral rehydration solution was delayed till the pharmaceutical companies could get their cereal based ORS packets commercially produced. This happened even though community health oriented health personnel, whether in India or Mozambique, recognised the value of cereal-based fluids and supported and promoted rice kanji – the rice fluid obtained by boiling rice. On epidemiological grounds, availability of clean drinking water and effective sewage treatment would be more useful in addressing water borne diseases like diarrhoea especially in the Third World. Promoting genetically modified rice with human genes in the name of diarrhoea care is an insult to the very concept of comprehensive health care – it is an unadulterated marketing stunt in the name of a diarrhoea care. The effective solution for which already exists and needs to be implemented and promoted as part of health literacy. Children need clean water and rice Kanji. They do not need untested “cannibal rice”.

GM rice can't cure diarrhoea (20/3/2007)

EXTRACTS: Diarrhea is an illness that has well-known causes, and proven, inexpensive solutions. Ventria's GM rice is unproven, unnecessary, and a distraction from ongoing programmes to save children suffering from diarrhea on our continent. (item 1)

In the media, Ventria claims these proteins will be used in oral rehydration solutions to treat diarrhea. But elsewhere, the company says it will use them as supplements in yogurt, sports drinks and granola bars. (item 2)

...an experiment using this technology has already been conducted in Peru on 140 infants from five to 33 months in age, in hospitals attended by the poorest sectors of the population. Several reports indicate that parents of the children were not adequately informed of the experimental nature of the treatment, and at least two mothers of infants in the clinical trial reported that their infants suffered from allergic reactions, causing the Peruvian government to launch an enquiry into the experiment. (item 2)

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1.'Hybrid Rice Can't Cure Diarrhea'
By Godwin Haruna
This Day (Nigeria), 20 March 2007
http://www.thisdayonline.com/nview.php?id=73347

2.Does Africa need a genetically modified solution to diarrhea?
Comment and analysis
Nnimmo Bassey
Pambazuka News (South Africa), 15 March 2007
http://www.pambazuka.org/en/category/comment/40303

Arroz biofarmacéutico

WARNING OVER GM PHARMACEUTICAL FOOD CROPS AS USA PLANS TO ALLOW HUMAN GENES IN GM RICE

Meanwhile another GM rice contamination incident hits US

Friends of the Earth Press Release Immediate release: Tuesday 6 March 2007

Friends of the Earth is calling for the production of drugs in food crops grown outside to be banned after the US Department of Agriculture (USDA) gave preliminary approval to the commercial production of GM pharmaceutical rice containing human genes [1]. The environmental campaign group warned of the potentially devastating consequences if pharmaceutical crops end up on consumers’ plates.

The warning comes as US authorities have confirmed that a third GM rice contamination incident in less than a year has hit the United States. In the latest incident a type of non-GM long grain rice (known as Clearfield CL131, produced by BASF) was found to contain unknown GM contamination. The USDA has stepped in to stop rice farmers planting the variety because of the likelihood that the GM trait is unapproved [2].

Last week, US authorities confirmed that Clearfield CL131 had also been contaminated by GM LL62 rice – produced by biotech company Bayer CropScience. Because this rice is legal in the US, farmers had decided to plant the variety this spring because of a shortage of seed. This follows the initial contamination incident with Bayer’s LL601 rice which affected long grain rice exported around the world, including the UK [3].

Friends of the Earth's GM campaigner, Clare Oxborrow, said: "This latest GM contamination incident should set alarm bells ringing about the dangers of allowing GM pharmaceutical crops to be grown. Using food crops and fields as glorified drug factories is deeply worrying. The biotech industry has repeatedly failed to prevent experimental GM rice contaminating food crops. If pharmaceutical crops end up on consumers' plates, the consequences for our health could be devastating."

"The UK Government must urge the US to ban the production of drugs in food crops grown outside. It must also introduce tough measures to prevent illegal GM crops contaminating our food and ensure that biotech companies are liable for any damage their products cause."

[1]. The USDA has given preliminary approval for the first GM pharmaceutical rice containing human genes to be grown commercially. The rice, produced by a company called Ventria, has been engineered to produce human proteins to be extracted to produce anti-diarrhea medicine.
http://www.washingtonpost.com/wp-dyn/content/article/2007/03/01/AR2007030101495_pf.html

[2] http://www.foe.co.uk/resource/press_releases/call_for_ban_on_us_imports_21082006.html

[3] http://www.aphis.usda.gov/newsroom/content/2007/03/ge_riceseed_statement.shtml

Letter re. molecular farming in Canada

CFIA /ACIA
Coalition For Imputability in Agriculture
Alliance pour Cibler l'Imputabilité en Agriculture

The Honorable Stephen Harper
Prime Minister of Canada
Office of the Prime Minister
80 Wellington Street
Ottawa (Ontario) K1A 0A2

Fax: 613-941-6900
Email: pm@pm.gc.ca

May 2006

Consultation by the Canadian Food Inspection Agency (CFIA) concerning Assessment Criteria for the Evaluation of the Environmental Safety of Genetically Engineered Plants intended for Commercial Plant Molecular Farming

The Honourable Prime Minister Stephen Harper,

We are appealing to you directly to urge your intervention to stop the attempt by various Federal government departments and / or agencies to authorize the commercial and the environmental release of genetically engineered (GE) plants intended for molecular farming. Should GE plants intended for molecular farming be authorized in Canada, it would inevitably lead to the contamination of the environment, the food chain and would further damage the ability of Canadian farmers to access overseas markets.

According to the Canadian Food Inspection Agency, plant molecular farming:

'is the use of plants in agriculture for the production of novel compounds rather than for the production of food or livestock feed. Potential novel compounds include pharmaceuticals, diagnostic products, vaccines, biologics, industrial chemicals, biodegradable plastics, etc.'

The 86 open field trials on molecular culture conducted in Canada (1994-2005) used the following GE plants: safflower (32), canola (28), tobacco (13), flax (4), white mustard (2), white clover (2), alfalfa (1) etc... . Over 80% of the field trials on molecular farming since 2001 are on plants genetically modified to produce industrial compounds.

Your intervention on this issue would be an opportunity for your government to break away from the previous Liberal government's irresponsible and secretive practices as well as to protect the environment, and the rights of the public, farmers and consumers. We would like to remind you of some of the very worrying conclusions reached by the Auditor General in her 2004 report concerning the Canadian Food Inspection Agency:

· '...the Agency may not be regulating the unconfined release of these plants in a consistent manner.
· Given that the next generation of plants with novel traits could pose new and more complex environmental risks, it is important that the Agency act on our recommendations if it is to be prepared to meet these future challenges.
· We found that there is a risk that undeclared and undetected plants with novel traits could be imported into Canada, and may therefore escape Canada's regulatory system. There is also a risk that unapproved ornamental plants with novel traits could be present in Canada.
· To support its decisions regarding unconfined release, we found deficiencies in standard operating procedures, a lack of complete documentation in the files, and incomplete definition of data quality standards to guide the evaluations. For example we found that the Agency did not have complete documentary evidence and, therefore, was not transparent about how it was evaluating the long-term effects on the environment before authorizing unconfined release of plants with novel traits.''

Currently, the Plant Biosafety Office of the Canadian Food Inspection Agency (CFIA) is holding online public consultations. The CFIA's introduction to these consultations states:

'As a science-based regulator, the CFIA will be seeking technical feedback on the approach it has taken in developing these guidelines, and will not be seeking feedback on socio-economic or ethical issues. These issues are not within the CFIA's mandate to address; however, these issues will be addressed by the appropriate federal government departments.' (our emphasis)

We are extremely disturbed by the approach adopted by the government: consulting first on technical details BEFORE consulting on broader socio-economic or ethical issues and before initiating a public debate on the overall merit of going ahead with GE plants for molecular farming.

As you know, the level of concern and scientific uncertainty regarding the safety of GE plants for food already approved commercially (like corn, soy and canola) is already very high among Canadians. Authorizing GE plants for molecular farming would be taking the risks and controversy to a much more serious and concerning level.

Are Canadians, consumers and farmers willing to accept having their food supply contaminated by industrial and pharmaceutical organisms? Are Canadians willing to take the risk of eating industrial or pharmaceutical products with their cornflakes? Canadians are expecting the government to act in a responsible manner on this issue.

If GE plants for molecular farming are authorized there will be contamination regardless of the measures taken to prevent such contamination. Such contamination has already occured even when alleged monitoring systems have been in place. For example:

1. ProdiGene case in 2001-2002.
'Despite all the alleged safety measures by the US Department of Agriculture (USDA), there has been at least two publicly reported cases of contamination of a food crop (corn) and food (soya) by a GE molecular farming crop in Iowa. The USDA revealed that 500,000 bushels of soya for human consumption had been contaminated by GE corn (harvested in 2001) designed to produce transmissible gastroenterisits virus (TGEV). More
than likely some volunteers from the engineered corn grew in the following season (2002), then pollinated and contaminated the neighbouring corn fields. Despite the fact that the USDA forced the company ProdiGene to pull up and incinerate a 155 acre corn field in September 2002, it is very likely that the volunteers from the GE engineered corn were able to contaminate the surrounding corn and the environment'.

2. 'In the North Dakota State University's Foundation Seedstocks Program non-GE natto soybeans had been contaminated with transgenic material, apparently in Chile during the production of seed. The EPA has also fined Pioneer Hi-Bred and Dow Agro Sciences for violating regulations to assure isolation of the experimental molecular farming crop and prevent pollen drift. Considering that, in 2002, about 300 acres of US cropland was planted with experimental molecular farming crops, the level of reported genetic contamination is quite staggering. However, some promoters of biotech anticipate that 10 % of US corn production will be devoted to molecular farming by 2010. Some 20 US corporations and universities conducted more than 315 open-air field trials in secret locations.'

3. In Quebec (in 2004) and Ontario (in 2002), there has been several officially reported incidents of GE pigs used as bioreactors for molecular farming that were mistakenly sent to the food chain. GE pigs, despite being relatively easy to monitor and control under laboratory conditions are nevertheless mistakenly finding their way into the food chain. Government and industry will not be able to prevent contamination from GE plants for molecular farming once released in the open environment.

In conclusion, we are urging you to act decisively to put good governance and rational process back into policy-making decision on this issue by:

1) Immediately halting the CFIA's 'technical consultations' on the commercial release of GE plants for molecular farming, at least, until a broader and open public debate on the socio-economic and ethical implications has taken place.

2) Re-examining the 2001 Expert Panel Report of the Royal Society of Canada (the highest scientific authority in the country), largely ignored by the previous Liberal government, with a view to effectively implement the 58 recommendations of the report and be used as the credible science-based framework for a broader public debate on agricultural and food biotechnology.

We hope that you will demonstrate leadership in this issue and show Canadians that your government can take decisive measures to protect farmers, consumers, the environment as well as good, independent and credible science.

Best wishes,

Éric Darier, Ph.D.
On behalf of the following organisations:

Greenpeace
New Brunswick Partners in Agriculture
Union paysanne

cc.
Mr. Richard B. Fadden, President of the Canadian Food Inspection Agency
The Honorable Chuck Strahl, Minister of Agriculture and Agri-Food
The Honorable Tony Clement, Minister for Heath Canada
The Honorable David Emerson, Minister of International Trade
The Honourable Rona Ambrose, Minister for the Environment
The Honourable Stockwell Day, Minister of Public Safety
The leaders and critiques of the opposition parties
The members of the Agriculture and Environment Committees of the House of Commons
The members of the Agriculture and Forestry & Social Affairs, Science and Technology Committees of the Senate
Ms Sheila Fraser, Auditor General of Canada
Ms. Johanne Gélinas, Commissioner for the Environment and Sustainable Development
The Provincial and Territorial Agricultural and Environmental ministers
Ms. Patricia Demers, President of the Royal Society of Canada
The media

Contact: CFIA / ACIA, c/o Greenpeace, 454 Laurier Est, Montréal (QC) H2J
1E7. Tel. (514) 933-0021, ext. 15; Fax : (514) 933-1017.

CFIA definition available at:
1 http://www.inspection.gc.ca/english/plaveg/bio/mf/molecule.shtml
2 http://www.inspection.gc.ca/english/plaveg/bio/mf/sumpnte.shtml
3 Report of the Auditor General (2004) Canadian Food Inspection Agency --
Regulation of Plants with Novel Traits.
http://www.oag-bvg.gc.ca/domino/reports.nsf/html/20040304ce.html
4 Welcome to CFIA's online consultation on plant molecular farming
http://questionnaire.gc.ca/cfia/cfia_e.htm
5 Union of Concerned Scientists, Pharmaceutical and Industrial Crops, A Growing Concern Protecting the Food Supply in an Era of Pharmaceutical and Industrial Crops (Washington, 2004)
http://www.ucsusa.org/food_and_environment/genetic_engineering/
pharmaceutical-and-industrial-crops-a-growing-concern.html
6 See more details from the Greenpeace's petition no.94 to the Commission for Environment and Sustainable development submitted by Greenpeace in September 2003:
http://www.oag-bvg.gc.ca/domino/petitions.nsf/
viewe1.11/6C999524802D1E8F8525704C00779
424
7 Anthony Laos, CEO of ProdiGene quoted in The Nation, 'The Three Mile Island of Biotech' 30 December 2002.
8 Ibid.
9 CFIA news release 'Joint Action to Control Release of GM Animal Material' 16 February 2004 (http://www.inspection.gc.ca/english/corpaffr/newcom/
2004/20040216e.shtml); 'Three dangerous little pigs', Globe and Mail 20 February 2004; 'Des porcs transgéniques se retrouvent à l'écarrissage' Le Soleil, 18 février 2004 p. A3; 'Trois carcasses de porcs transgéniques dans la moulée de poulets...par erreur' Le Journal de Montréal, 18 février 2004; 'Sécurité alimentaire - Tous les morceaux de l'histoire des trois petits cochons transgéniques sont réunis', Le Devoir 18 février 2004.
In the US, 386 offspring of GE pigs were also sent not disposed safety, see :
http://www.gmcontaminationregister.org/
10 Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada (2001) http://www.rsc.ca/