GM-FREE IRELAND

news

NEWS ABOUT GM ISSUES • July 2007

Archives 2007: JanuaryFebruaryMarchAprilMayJune
Archives 2006: JanuaryFebruaryMarchAprilMayJuneJulyAugustSeptemberOctoberNovemberDecember
Archives 2005: Jan/Feb/MarApr/May/Jun/JulAug/Sept/OctNov/Dec


Ireland: GM policy u-turn 'could cost farmers dearly'

Roscommon Herald, 31 July 2007.

THE DECISION by the Minis- ter for Agriculture to u-turn on Government policy to date on the importation of genetically modified (GM) feed has the potential to badly damage Irish agricul ture, according to Deputy Frank Feighan.

"Fine Gael has continually called for a full debate on GM in agriculture but the Gov ernment up to now has per sistently refused to engage in one. There is no getting way from the fact that these decisions have huge impli cations that need to be fully thought through and not developed on a political whim. In 2006, € 144.6m worth of animal feed was imported into Ireland, of which 97% contained some genetically engineered material. The fact is that the vast majority of imported animal feed now used by Irish farmers has been genetically modified in some manner - we cannot pretend other wise.

"One of the consequences of the Nitrates Directive, which penalises grass-based production systems as we have here in Ireland, is that there will be even greater demand for imported feed in the future. However, despite assurances to the contrary from the Agriculture Minister, the Irish Government decided in June to abstain on an EU vote which has the effect that animal feed companies here will no longer be able to import maize by-products from the US," he said.

"I am informed by the Connacht Gold Feed Mill that 800,000 tonnes of maize by-products which are used in the production of animal feed are imported from the US every year. Connacht Gold, like other animal feed companies, is now in the position of having to source replacement ingredients and estimates that this could lead to an additional cost of up to € 50 million a year. The knock-on effect on the price of feed and therefore on farmers' margins is obvious and potentially very damaging.

"It is now time for a full debate on the whole GM issue and not off-the-cuff, knee-jerk policy which deter mines this issue in isolation from the broader and more practical factors which must be considered. Fine Gael believes that the best way to facilitate such a debate is to establish a Dail Committee on Science & Technology which would, as its first function, facilitate a fully informed debate on GM food, feed and crops and their use or not in this country. "As the Taoiseach has not yet established the Dail Committees, now is an ideal opportunity to have a specific forum not only to deal with the issue of GM but all other scientific developments which have an impact on society and our economy.

"Such a recommendation was made a number of years ago by an all-party Oireachtas committee and a similar committee is in place in many other EU Countries including the UK. It is high time that we have a mechanism to bring facts on scientific developments into the public domain instead of half truths that are spun to the benefit of one side or another," concluded Deputy Feighan.

Comment by GM-free Ireland:

Misinformation and nonsense! Ireland's policy on GM is well thought out. The article gives the impression that 95% of Irish animal feed is GM, whereas it is only the portion of the feed which contains maize and soya ingredients which is GM. This means that around half of the animal feed sold to Irish farmers is made up of non-GMO ingredients.

The claim that Ireland's abstention on a vote to retroactively legalise a single variety of GM maize "has the effect that animal feed companies here will no longer be able to import maize by-products from the US" defies logic. Numerous varieties of GM maize remain on sale in Ireland. The notion that Connacht Gold and other animal feed companies are consequently "having to source replacement ingredients" for 800,000 tonnes of maize by-products - at an additional cost of up to € 50 million a year - is a total lie.

The biotech industry spin doctors are freaking out because there is no market for GM food in Europe, and leading retailers now exclude meat and dairy products from livestock fed on GM ingredients, as outlined in the article "Declaring Ireland a GMO-free zone" published in the Irish Examiner farm supplement on 26 July (see below).

Moreover, there is a current European surplus of GM-free maize, around half the US crop is GM-free, EU maize imports have greatly declined in the last decade, and certified non-GMO soya is widely available at minimal extra cost which can easily be recouped by premia now on offer from European retailers.

Fine Gael had plenty of opportunity to raise the GM issue in the pre-election campaign, but failed to do so. The only actions taken were a half-hearted call by TD candidate Brody Sweeney to keep Ireland free of GM crops as part of Fine Gael's Green Ireland policy, a failed attempt by Mairead McGuinness MEP to promote the EU-wide release of GM pharmaceutical crops that would contaminate our food crops with industrial chemicals and drugs in perpetuity, and a defeatist statement by FG Agriculture Spokesperson Dennis Naughten that nothing can be done because Ireland does not have the right to decide.

Deputy Feighan should heed his own advice and "bring facts on scientific developments into the public domain instead of half truths that are spun to the benefit of one side or another"!

_______________________

31 July 2007

EU: urgent call for agrofuel moratorium

Econexus, 31 July 2007, by Helena Paul.

Organisations and individuals around the world are extremely concerned about the way the European Union (EU) is rushing into agrofuels and the signals this sends to the rest of the world to race into agrofuel production.

The impacts are already serious worldwide. Millions of hectares are being designated for agrofuel production and export in Africa, Asia and South America. Indigenous peoples and local communities are being expelled from their land or forced into agrofuel production, forests and biodiversity are being destroyed.

In many places no impact assessment or consultations have been carried out; land is simply being handed over to European companies to exploit for export to Europe. In Africa, for example, land on which pastoralists depend and which only they can manage is being treated as unused or degraded land suitable for agrofuel production. In other countries, companies are taking over the most fertile, well watered land for agrofuels and driving food production to dry, marginal lands.

Agrofuels pose an unprecedented threat to regions that have hitherto not experienced the impact of industrial agriculture. Many of these are the final refuge of indigenous peoples, of precious biodiversity. The protection of such regions is also vital if we are to have any hope of preventing runaway climate change.

In the autumn, the EU will hope to finish the process of putting its agrofuel targets into law and drafting certification rules to reassure consumers and justify this unprecedented new push for agrofuel monocultures. We have to stop this process.

This is why we need more organisations and individuals to sign up to the call for an immediate moratorium on EU incentives for agrofuels, EU imports of agrofuels and EU agroenergy mopnocultures so that we can oppose the push more effectively. We will also need help in the Autumn!

Please think for a few moments about how to get more signatures.

To read the call and to sign up, please visit: http://wwweconexus.info/agrofuel_moratorium_call.html

_______________________

India: Field trials of GM crops trigger row

The Statesman, July 31 2007. By Anindita Chowdhur.

* Field trials for the genetically modified (GM) varieties of eight major food crops, including rice, potato, mustard and tomato, are in the pipeline but guess how prepared India is?

Field trials of genetically modified crops in the state have triggered off a war of letters between some members of the state agriculture commission and the department of biotechnology under the Union science and technology ministry.

The department of biotechnology under GOI has brushed aside allegations of illegal field trials of genetically modified (GM) crops in North 24 Parganas and a lax regulatory system, as raised by some members of the state agriculture commission. The commission itself, however, plans to discuss the issue of GM contamination and human hazards, in its coming meetings.

Citing reports by the monitoring authority, Bidhan Chandra Krishi Viswavidyalaya (BCKV), Prof. TK Bose, a member of the commission, had alleged that Maharashtra Hybrid Seeds company (Mayco) has conducted illegal field trials on Bt brinjal, Bt tomato without following bio safety measures and monitoring as suggested by DBT although they were given permission only for trials on Bt rice and Bt okra (ladies finger). He had demanded legal action against the company.

BCKV had informed DBT that biosafety protocols were not adhered to during the trials. Moreover, the monitoring visit was timed when the trials were at a finishing stage and the university was not consulted about site selection, trial details and methodology followed .

However, Dr KK Tripathi, advisor, DBT has dismissed these allegations of conducting illegal trials without informing regulatory authority as being "unfounded" since both the chief secretary and commissioner of agriculture of the state were informed about the trials. While admitting that the company did not seek permission for conducting field trials for GM tomato or brinjal crop he explained that the presence of such crops was probably due to the practice of "seed companies to keep testing their different hybrids (non GM) in different locations for agronomic performance and evaluation. This is reiterated because no company can do any GM trial without adhering to the conditions specified in the permit letter and cannot abandon it the way indicated in your letter."

He has also argued that the regulatory system put in place by the Government of India has been functioning effectively in regulating the DNA research and GM product commercialisation in the country in respect to biosafety as well as various risk benefit analysis and socio-economic issues.

Prof. Bose has countered Dr Tripathi's arguments in a recent letter saying that the report of BCKV has been ignored. He has also pointed out that in small holdings in states like West Bengal it would be impossible to protect non GM variety from contamination with pollens of GM hybrids or keep an isolation of 200 metres.

When contacted, Prof. RN Basu, chairman of the commission, said it would give its own recommendations on the use of GM seeds in the state.

_______________________

India: ASSOCHAM report on Bt cotton incredulous'
APCDD ridicules survey report


The Hindu, July 31 2007

HYDERABAD: AP Coalition in Defence of Diversity (APCDD), representing civil society groups against genetically modified crops, has challenged the recent Associated Chambers of Commerce and Industry of India (ASSOCHAM)'s survey report on Bt cotton farming and termed it "incredulous."

At a press conference here on Monday, P.V. Satheesh, convenor of the APCDD, said the survey was part of a huge campaign launched by the genetic engineering industry to bamboozle public opinion. The seed major, Monsanto has produced 29 short films to counter the APCDD's film, "A disaster in search of success: Bt cotton in global south", he added.

Wrong priorities

"For Monsanto and the ASSOCHAM, foreign direct investment is far more important than the lives of the farmers lost in the pursuit of Bt cotton that left a trail of Bt-infected toxicity in the soils and plants leading to livestock morbidity."

Releasing the findings of the APCDD's own survey, he said the Bt cotton farmers earned just nine per cent more, a paltry difference of Rs. 380 per acre between Bt and non-Bt and not "additional income of Rs. 7039 crore as claimed by ASSOCHAM." Similarly cultivating Bt cotton was more expensive as farmers have to spend more on pest control than others.

New diseases

The raising of Bt cotton has brought to the fore diseases like "root rot", not seen by cotton farmers before, he said.

The survey also found that genetically engineered seed industry was deliberately closing all non-Bt options to farmers, forcing them to go in for Bt cotton.

The APCDD wanted the Government to promulgate a law to ensure production and distribution of non-Bt seed up to 50 per cent of their trade volume and to ask National Institute of Nutrition to investigate death of cattle after grazing in areas where Bt cotton was grown.

_______________________

S.Africa worried GMO labels could raise food prices

Reuters, 31 July 2007. By Wendell Roelf

CAPE TOWN (Reuters) - South Africa is resisting labelling its genetically modified foods because of fears it could raise prices and make food less available for consumers, a senior health official told the country's parliament on Tuesday.

The country, Africa's economic powerhouse and one of the few on the continent to accept genetically modified organisms, or GMOs as they are popularly known, does not currently require that the modified foods be labelled.

But pressure is growing on the government to consider doing so amid a growing debate over their use. Supporters say that GMOs could help solve many of Africa's food problems, while critics say they are an experiment that puts millions at risk.

"If we had to label the foodstuffs, we have to determine the costs and benefits of it. Would it increase food prices and, therefore, decrease the accessibility of that foodstuff for a vast majority of people ?" Renusha Chanda, an assistant director in South Africa's department of health, said in a presentation.

However, Chanda added that the government believed that all GMOs currently on the South African market were safe, making labels unnecessary.

The government is considering changing GMO legislation and has heard appeals from environmentalists and farmers for tighter controls to halt the import and creation of such crops.

Zimbabwe, Zambia and several other nations have banned GMOs, saying that they could mix with indigenous crops.

Chanda said that more studies and research were needed to determine the costs and benefits of labelling GMOs. They are only mandatory when they include genes from fish, animals and humans or when they differ substantially in nutritional content.

The amount of South African land devoted to genetically modified crops was 1.4 million hectares in the 2006/2007 growing season, a 180-percent increase over the previous year.

One million hectares was devoted to maize cultivation, the staple diet of the majority of the country's 47 million people, with the remainder allocated to soybean and cotton.

_______________________

EU: Decision on ice structuring proteins

http://www.food.gov.uk/news/newsarchive/2007/jul/isp

The Agency's expert advisers on novel foods, the Advisory Committee on Novel Foods and Processes (ACNFP), have provisionally approved an application to use an ice structuring protein preparation in food.

Their opinion now goes to other European Union member states for comment.

Ice structuring proteins (ISPs) are naturally occurring proteins and peptides, which are found in a variety of living organisms (such as fish, plants and insects). ISPs protect these organisms from tissue damage in very cold conditions by lowering the temperature at which ice crystals grow and by changing the size and shape of the ice crystals.

The applicant, Unilever, wants to use an ice structuring protein preparation in ice creams and similar products to influence the formation of ice structure during their manufacture.

Before any new food product can be introduced on the European market it must be rigorously assessed for safety. In the UK, the assessment of novel foods is carried out by the ACNFP, an independent committee of scientists.

_______________________

30 July 2007

World: Precautionary Principle left out by Codex Alimentarius

NutraIngredients, France, 30 August 2007. By Alex McNally.

Codex has agreed to exclude the controversial precautionary principle in its risk analysis standards, marking the end of a long battle between the EU and trade groups.

The final decision was made at the Codex Alimentarius Commission meeting in Rome this month when the "Working Principles for Risk Analysis for Food Safety for Application by Governments" was finally adopted, excluding the precautionary principle.

The controversial plan would have allowed governments to take certain preventative measures for foods in cases where scientific evidence on the safety of the food is uncertain, but were seen by many governments and organisations as a tool to create unjustified trade barriers.

The principle, which has already been formally established by the European Commission (EC/178/2002), granted food risk managers the ability to take measures to protect health if they feared an unacceptable level of health risk exists. These measures ranged from a total ban on the substance, to food manufacturers being ordered to carry out further safety tests.

The International Alliance of Dietary/Food Supplement Associations (IADSA) and the US Council for Responsible Nutrition (CRN USA) both feared the precautionary principle would create unfair trading opportunities around the globe if it was adopted.

It was omitted from the set of principles for risk analysis adopted by Codex in 2003. However, since then a number of countries have tried to introduce it into Codex texts, to no avail.

David Pineda, IADSA's manager of regulatory affairs, said: "Despite the numerous attempts to introduce this principle into the text, there has again been sufficient resistance from both governmental and non-governmental organisations to prevent it from happening."

Pineda added that consumers were not being put at risk by the exclusion of the precautionary principle.

He told NutraIngredients.com this morning: "Scientific evaluations are carried out when there are justified doubts about the safety of a food product and therefore there are systems in place to protect the health of the consumers. However, the use of the precautionary principle is often abusive in cases where there is no scientific proof of the unsafety of a food product.

"It is encouraging for the dietary/food supplement associations that this principle is not adopted by Codex and therefore not being applied worldwide."

There have been three unsuccessful attempts by the EU and other countries to include the principle in key Codex documents.

In April, the full Codex Committee of General Principles (CCGP) debated the new draft and, after rallying of both government and non-governmental organisations - notably the CRN USA - agreed to omit the precautionary principle.

---------

World: Codex's Precautionary Principle inclusion thwarted

NutraIngredients, France, 4 May 2007.

The International Alliance of Dietary/Food Supplement Associations (IADSA) has revealed that latest attempts to insert the precautionary principle into Codex's draft risk analysis standards for food safety have been foiled.

The news marks the third unsuccessful attempt by the EU and other countries to include the principle in key Codex documents, and could represent that last hurdle for adoption without the inclusion of the precautionary principle.

David Pineda, IADSA's manager of regulatory affairs, told NutraIngredients.com: "We are very happy with the outcome of this week. This new decision by the committee means there are fewer possibilities to introduce the precautionary principle [into the Codex framework]."

The precautionary principle allows governments to take certain preventive measures for foods in cases where scientific evidence on the safety of the food is uncertain, and many governments and other organizations believe that it is used to create unjustified trade barriers.

"The new document just accepted by the committee appropriately follows an earlier one by excluding the precautionary principle, an action needed to help assure fair opportunities for trade in supplement products," said Dr John Hathcock VP of scientific and international affairs of the Council Responsible Nutrition (CRN USA).

The full Codex Committee of General Principles (CCGP) in Paris this week debated the new draft and, after rallying of both government and non-governmental organisations - notably the US Council for Responsible Nutrition (CRN USA) - agreed to omit the precautionary principle. To enter the Codex framework, the Commission must adopt the Committee's draft.

Pineda said that whether or not the Commission accepts the document as a Step 5 [document up for revision] or Step 8 [accepted document], this week's decision means there are less possibilities to introduce the precautionary principle.

"The introduction of this principle has been consistently rejected since the Codex principles were first drafted. However, the text is at an intermediate stage of the Codex procedure and changes can still be made. There could, therefore, be attempts to include this principle into the text during the next Commission meeting later this year which will have to consider this week's decision of the CCGP," said Pineda.

_______________________

Philanthropy Gates Style

ISIS Press Release, 30 JULY 2007

The world's biggest philanthropic foundation is reaping huge profits investing in companies responsible for causing the problems it tries to solve; its grant-giving is also doing more harm than good in undermining health and agricultural systems, distorting national and global priorities, and preventing the necessary paradigm change that could help secure the future of the planet.

Read the rest of this article here: http://www.i-sis.org.uk/PhilanthropyGatesStyle.php

See also:

Dark cloud over good works of Gates Foundation
By Charles Piller, Edmund Sanders and Robyn Dixon
Los Angeles Times, January 7 2007
http://www.latimes.com/news/nationworld/nation/la-na-gatesx07jan07,0,4205044,full.story.

_______________________

European crop yields hit by extreme weather

ENDS Europe DAILY 2368, 30/07/07

Farmers are predicted to suffer significant economic losses in parts of Europe as a result of extreme weather that has hit the continent in recent months, according to an annual crop yield forecast released by the EU's joint research centre (JRC) on Tuesday.

Total EU cereal production will still be higher than in 2006 by around 10 million tonnes due to increases in the three main producers Germany, France and Spain where crops have enjoyed warmer weather. But heatwaves in Eastern Europe and heavy rains in Northern regions have had a detrimental effect, JRC says.

Most affected areas are Romania, Bulgaria and Hungary where both summer and winter crops are being hit by unseasonably high temperatures, JRC says. In Romania, wheat yields are projected to be 20 per cent below a five-year EU average. In Bulgaria, maize production could drop by up 40 per cent.

In northern Europe crop yields have been reduced as a result of heavy rainfalls. First harvests in the UK, Northern France, Germany, Belgium, Denmark, the Netherlands, Luxembourg and Poland have been partly spoilt, JRC's forecast shows. In the UK national farmers union NFU says recent severe flooding - which has reduced vegetable yields to 50-60 per cent - will affect the food industry "well into 2008". In some parts of the country up to 60 per cent of pea crops have been lost, the union says. Floods also threaten to halve cereal harvest, national news agencies report.

_______________________

New Zealand: Councils to canvass more support for GE bans

Radio New Zealand, 30 July 2007

Councils from Auckland northwards are considering territorial bans on genetically modified crops after a rebuff from the Government on liability issues.

Seven Auckland and Northland councils want the Government to relieve them of liability for GE contamination or give them a say in GE releases.

The Government has said the councils would have responsibilities under the Resource Management Act for dealing with any adverse effects of a crop release. However, the councils have been told that the Government will not provide indemnity against any costs involved, and say their request for greater influence with the national regulating authority has been rebuffed.

A working party of seven councils has been lobbying for a user liability regime around the crops, and more influence with the regulating authority, ERMA.

Dr Kerry Grundy, the working party chairperson, says the Government has recently made it clear it will not give way on either point. He says as things stand, councils and adjoining landowners could end up paying if there is a mishap with genetically modified crops.

Dr Grundy says the councils are planning to poll electors on the idea of creating exclusion zones for the crops.

Whangarei District Councillor Robin Lieffering, a member of the working party, says the financial risk local bodies face because of genetically engineered crop trials is unacceptable.

Greens support councils

The Green Party says councils are right to consider territorial bans on genetically modified crops.

The party does not want any GE crops planted, but say that if they are, full liability should rest with the grower. It says other growers should not have their crops put at risk.

Science group defends GE cropping

The Life Sciences Network says any ban on genetically engineered crops by local councils would deny farmers choice and cost ratepayers millions of dollars.

The group says any regime of strict liability over GE products would create a de facto moratorium against their development, denying New Zealanders access to this branch of science.

It says an exclusion zone would be unworkable and expensive to police, and the money would be better spent protecting New Zealand from threats like foot and mouth disease.

Comment from GM Watch:

This article describes the Life Sciences Network as a "science group", whereas in fact it's a notorious industry-backed lobby group, see: http://www.gmwatch.org/profile1.asp?PrId=77.

_______________________

GLobal Trade give EU more time before GMO resolution

PR-GM.com, 30 July 2007. By George2007.

The World Trade Organization (WTO) recently vouched its initial censure of the European Union (EU) in an argument with other member nations of the global trade such as Canada, Argentina, and the United States regarding the genetically modified organisms (GMOs). The WTO gave each party a 60-day time frame to pass their appeals. The said WTO officially made a report on the incrimination submitted by three member countries of the global trade three years ago, and accusing that a certain European legal permission or moratorium over GMO imports was entirely regarding trade protectionism rather than affairs about consumer health and the environment.

The three countries blamed EU of exploiting a global trade deal that lets member nations to limit imports that violate health grounds. On the other corner, EU retorted that the said moratorium was necessary to provide more time in collecting the necessary information from biotechnology firms, and agree on how to possibly modify rules and policies on GMOs.

The US clamored that the approval system of EU on imports of modified foods has led to delays that caused global trade barriers. On the other hand, the EU said that a huge number of consumers have deemed genetically altered foods as dangerous, based on the poll made by the union last June.

The said case, according to a campaigner opposing to GMOs, has declared more losers than winners. He also said that the global trade argument regarding the GMOs is a futile exercise because EU will continually decline GMOs.

Howard Minigh, of Croplife International, said that the rules imposed by the WTO is very essential, however, the global trade demand is triggering increased adoption of GMOs and biotech farm goods. Minigh also said that the policies were derived from the exaggerated warnings given by several groups that are against GMOS.

Most of the contents of the WTO report, which was supposedly confidential, were exposed on Friday, with involved parties believing that they won their cause. The official WTO publication took no stand on the secured debate regarding the GMOs, and it permits for a lawful postponement of 60 days for global trade members to file their petitions. In an interview last Friday, the involved parties said that the WTO has not made a decision regarding the appeals.

The WTO report stated that the EU should adhere to the policies of the global commerce. This set of policies was devised by the member nations of the WTO. The said report regarding the GMOs is considered the biggest report ever published by the global trade regulators.

The mentioned governing body of the global trade can give sanctions and reactive practice and duties to any of its members that have failed to accede to its rules. Although the EU have revoked the entire GMO permission two years ago, thus, escaping the condemnation of the renowned Geneva-based organization, six member nations have preserved the restrictions in their right places. Since last May, when the global trade body has completed their decision, the EU promised to keep the scheme that it uses for monitoring genetically modified seeds.

For more valuable information on Global trade, please visit http://www.toboc.com

Article Source: http://www.answer-site.com

_______________________

Bulgaria: Watch the Monster Tomato tour

Sophia Echo, 30 July 2007. By Olga Apostolova, Gorichka.bg

This summer Friends of the Earth is sending its Monster Tomato on tour around Bulgaria, Macedonia and Romania to raise awareness of GMOs (genetically modified organisms). While 70 per cent of Europeans are firmly against GMOs in their food, fields and countries, few Bulgarians know about the problems that GMOs can cause. Having said that, Bulgaria already has five GMO-free municipalities. The tour will pass through regions that are interested in initiating GMO-free zones.

The Bulgarian Government has been receiving pressure from the European Commission to weaken its laws on GMOs since the countryís accession to the EU, and the Bulgarian Parliament recently announced its wish that the country ban Monsantoís GMO maize. Those wishing to learn more should try to catch the tour as it passes through Sofia, Plovdiv, Smolyan, Bourgas, Varna and Veliko Turnovo from July 14 until July 24.

In Bulgaria, The Tomato Tour is organised by www.agrolink.org/agrolink. Agrolink is an NGO that promotes sustainable agriculture, co-ordinates the national organic farmersí network and supports environmental protection and the implementation of sustainable development principles.

_______________________

28 July 2007

Ireland: Tricks of the trade in PR Battle

The Irish Times Weekend Review, 28 July 2007. Book review by John Fannning.

Thinker, Faker, Spinner, Spy: Corporate PR and the Assault on Democracy
Edited by William Dinan and David Miller Pluto Press, 309pp. £ 11.50.

_______________________

India: States lack facilities to monitor GM crop trials, apex court told

Mint (a business daily of The Hindustan Times), July 28 2007. By Padamaparna Ghosh.

* Many states are yet to form SBCCs which are critical for monitoring and inspection of ongoing trials

New Delhi: An application filed by Aruna Rodrigues and others on Thursday before the Supreme Court under an earlier public interest litigation dating back to 2005 says that several Indian states do not have the required mechanism to monitor trials of genetically modified crops.

By not having this mechanism, the states are flouting a notification, issued in 1989 by the Union ministry of environment and forests. The application is significant because it comes in the wake of an order on 8 May by the Supreme Court that lifted an eight-month ban on field trials of genetically modified (GM) food crops, with some caveats.

Rodrigues's application says that the states of Andhra Pradesh, Tamil Nadu, Kerala and Madhya Pradesh are yet to constitute State Biotechnology Coordination Committees (SBCCs). These committees are critical for monitoring and inspecting ongoing field trials. According to information provided by Greenpeace and collated from the Department of Biotechnology (and presented in Mint on 14 May), six field trials began in Tamil Nadu in 2005 and 2006 and five in Andhra Pradesh. The status of these trials is not known.

According to the rules notified under the Environment Protection Act, the committees have the powers to inspect, investigate and take punitive action in case of violations of statutory provisions. The committees also have to periodically review the safety and control measures in the various industries and institutions handling genetically engineered organisms.

The application states that documents acquired through RTI applications show that these states do not have such committees or even know about field trials of GM crops. According to these documents, copies of which are with Mint, Kerala is not even sure if it has the committee or not, with the stateÇs agriculture department saying that a Kerala Biotechnology Commission, and not a coordination committee, has been formed, and the scientific department denying that any such committee has been formed.

Tamil Nadu has not formed the committee, according to a government officer in Tamil Nadu familiar with the matter. "There are no proposals either (to form a committee)," added the official who did not wish to be identified. The situation is the same in many other states. According to the Department of Biotechnology data previously published in Mint, in 2005 and 2006 alone, field trials of GM crops were launched in 15 states. And even states that have committees have flouted laws, says an environmental activist.

"Punjab has a committee, but it does not have any representation from the department of agriculture, which is mandated and critical," said Kavitha Kuruganti, Centre for Sustainable Agriculture, a technology and policy research organisation based in Hyderabad. Punjab held its first meeting in 2005. West Bengal constituted its committee just two months back and Orissa in 2001.

Other RTI documents collected by the applicant show that Karnataka and Madhya Pradesh are ignorant about the trials happening in their respective states, although the Centre's Genetic Engineering Approval Committee (GEAC) is supposed to apprise the state governments of the approvals. The GEAC approves all trials of GM crops. In the 8 May order, the Supreme Court asked companies conductiong trials of GM crops to disclose toxicity and allergenicity of the crops, increased the distance between GM fields and regular fields to 200 mts to reduce chances of contamination, and said that a designated scientist would be responsible for meeting all conditions laid down by the court. The new appplication has asked the Supreme Court to direct the government to release data on possible contamination and test protocol to the public before it clears any more trials.

_______________________

27 July 2007

USA: Gene therapy safety in question again

St. Louis Post-Dispatch, 27 July 2007. By Tina Hesman Saey and Amy Maxmen.

A research group led by scientists from Washington University and St. Louis University released a study today showing that a genetically altered virus used in human gene therapy trials causes liver cancer in mice.

The findings follow the announcement Thursday that a patient in Seattle died earlier this week after being treated with the same virus. The cause of the patient's death is unknown, but the Food and Drug Administration is reviewing whether 29 human trials using the virus should be allowed to continue.

The treatment, using a virus called adeno-associated virus, is considered one of the most promising avenues for battling genetic diseases such as cystic fibrosis and muscular dystrophy.

"The bottom line is we need more research so that we can really define the risk," said Mark Sands, a Washington University researcher who led the cancer study.

In 2000, researchers at Washington University noticed that the mice they successfully treated for a liver disease using the adeno-associated virus were developing tumors. The virus had already been approved for use in clinical studies on humans.

Sands relayed the findings to the Food and Drug Administration, which oversees gene therapy trials, said Karen Riley, an agency spokeswoman. The FDA convened a safety panel to discuss those results and other safety concerns in March 2001.

"We decided that the safety profile was acceptable and should continue to be evaluated in clinical trials," Riley said.

Sands then pursued a new study, this time to verify whether the virus was directly responsible for causing cancer. About half of the mice treated with the virus got cancer. The results appear today in the journal Science.

"No one is more disappointed about these data than I am," Sands said. "With gene therapy we can cure this disease in mice. But I can't ignore the data. We were anxious to repeat our findings, hoping that the tumors were an artifact, but it's not," Sands said.

In gene therapy, healthy genes are inserted into a person with a genetic disease. One way to insert the gene is through a genetically engineered virus, which is injected into the patient. The healthy gene then makes proteins that reverse the disease.

The death in Seattle raises new questions about whether the virus should be used in human trials. The patient died after receiving a second injection of the gene therapy virus while being treated for arthritis during a clinical trial by Targeted Genetics Corp. The company has treated about 100 people in the trial without adverse affects, the FDA said Thursday.

While it remains unclear whether the virus played a role in the patient's death, the cancer finding is reason enough to step back from human studies, said Ronald Munson, a medical ethicist at the University of Missouri-St. Louis.

"Safety should be established in animals before it is tried in humans," Munson said. "I think therapy using this version of the virus should not go forward until we understand what has happened."

Still, several scientists, including Sands, say they aren't ready to abandon the virus in human studies, given its potential.

"The problem is that no one else has seen the same thing" as Sands, said Nick Muzyczyka, professor at the University of Florida and scientific adviser at Applied Genetic Technologies Corp. in Alachua, Fla. The company is conducting two gene-therapy trials using adeno-associated viruses and has several gene therapy treatments in development.

Meanwhile, Dr. Valder Arruda of the University of Pennsylvania deliberately attempted to use the virus to cause cancer in mice that were already predisposed to the disease. But the mice remained healthy.

While Arruda said he believes Sands' data, the technique is so complex that the virus alone may not be the problem, noting other complicating factors, such as the age of the animal.

Arruda and his colleagues began treating people for hemophilia with the virus in 2001. They have also been treating 30 dogs for hemophilia with the virus, some for more than five years. Thus far, neither the six humans nor the dogs have gotten cancer.

Medical research comes with a certain amount of risk, scientists say. For some reason, gene therapy is given less room for error, said Dr. Markus Grompe, director of the Oregon Stem Cell Center in Portland.

"In general we have a tendency to not accept any side effects of gene therapy," Grompe said. "If we had that attitude we would have never figured out bone marrow transplants; many people died in those trials. The key is how many other options do you have."

Gene therapy has been used to cure only one disease, an immune system disorder called severe combined immunodeficiency, or SCID. Most people know it as "bubble boy disease." When three children in a French study developed leukemia linked to the virus used in gene therapy, treatment was halted. Now only children with no other alternative are given gene therapy to treat the disease.

The first high-profile death in a gene therapy trial happened in 1999 at the University of Pennsylvania. A young man named Jesse Gelsinger died after his immune system reacted badly to the virus used in the trial.

But some people facing miserable lives and early deaths at the hands of disease may think that taking a chance on developing cancer later is worth the risk, said Ana Iltis, an associate professor at the Center for Health Care Ethics at St. Louis University.

At the very least, patients need to know exactly what risks they face before deciding whether to go through gene therapy, she said.

Gene therapy is a promising technology with frustrating problems, Munson said, adding that once researchers work out the kinks, gene therapy can save many lives.

"I think gene therapy has such significant benefits that the problems it faces, though complicated, shouldn't be enough to stop it," he said. "I don't think this is the end of gene therapy at all. It's just another problem that needs to be examined and resolved."

_______________________

EU: Prompt action needed to secure winter feed

The Farmers Guardian, 27 July 2007.

Despite months of discussions, EU approval of the Herculex Root Worm (HXRW) GM-maize variety has yet to be passed, resulting in continuing restrictions on imports of US maize gluten.

The situation will not be resolved before the onset of winter feeding, so livestock farmers are being urged by to act promptly to secure stocks of alternatives, such as UK distillers feeds.

"Although these restrictions were in place at the end of last year, some shipments of US distillers' products and maize gluten did get through in early 2007, and shippers had plenty of stock already in store," said Neil Woolf of Trident.

"Combined with good supplies of alternatives from within the UK, and an early start to spring, most livestock producers managed to secure sufficient cover to see out the winter."

The current position, however, appears significantly worse as the EU body responsible for overseeing food safety issues will not meet for deliberation again for at least another two months

As a result, maize gluten stocks in port are now virtually non-existent, with prices around £110-120 per tonne (ex-port) if supplies can be found at all, said Mr Woolf.

And although shippers may still be able to procure isolated vessels that meet the required standards, import volumes will be insignificant compared to normal levels of demand.

"At least in the UK we have a good range of alternatives, with co-products like distillers wheat, barley and maize pellets still readily available," said Mr Woolf.

"The challenge is that extra demand caused by a lack of gluten and rising cereal prices will mean early booking of these alternatives will be essential if farmers want to secure enough to cover the entire winter.

"In Ireland, the situation is more of a challenge, with an annual consumption of around 400,000 tonnes of maize gluten and a much smaller human food and drink industry incapable of filling the void with co-products."

_______________________

26 July 2007

USA: Delta & Pine settles with SEC on foreign payments

Reuters News Service, July 26 2007

WASHINGTON, July 26 (Reuters) - Delta & Pine Co. and a subsidiary have agreed to pay $300,000 to settle charges that the unit paid Turkish officials to get documents needed to operate its business in Turkey, the U.S. Securities and Exchange Commission said on Thursday.

The SEC said top cotton seed producer Delta & Pine, which has since been acquired by Monsanto Co., through its subsidiary Turk Deltapine Inc. made payments of about $43,000 from 2001 through 2006 to officials of the Turkish Ministry of Agricultural and Rural Affairs.

A Monsanto spokesman could not immediately be reached for comment. Delta & Pine and Turk Deltapine settled with the SEC without admitting or denying the charges.

The SEC said the payments violated the Foreign Corrupt Practices Act. It also said Delta & Pine failed to keep accurate books and records in connection with the improper payments. (Reporting by Karey Wutkowski)

The SEC alleges that D&PL failed to keep accurate books and records, and did not have effective internal controls to prevent the bribery.

_______________________

USA: Monsanto takes a punch to the gut

How the World Works, 26 July 2007. By Andrew Leonard.

Last October, How the World Works expressed skepticism over efforts by Daniel Ravicher, the founder and president of the Public Patent Foundation, to invalidate four Monsanto patents involving the methods by which genes from one organism are inserted into another. But even then, we liked how the man expressed himself:

The patent system is being abused by private actors to the detriment of the mostly unaware public. Our health, our freedom, and our economic prosperity are all under assault from bogus rights meted out to the few with the power and expertise to game a system originally established hundreds of years ago to promote progress within society as a whole. The government, through primarily a captured patent office utterly failing to achieve its mission and skewed policies implemented into patent law by Congress and the courts, is not just failing to defend the public interest from abuse of the patent system, but is complicit in and supportive of such efforts.

Then, in April, the Public Patent Foundation scored a major success when the U.S. Patent and Trademark Office rejected three major stem cell patents claimed by the Wisconsin Alumni Research Foundation. Now comes the news that the PTO has similarly rejected Monsanto's patents. http://www.pubpat.org/monsantorejections.htm

If the decision is upheld after Monsanto's inevitable appeal, a process that could take years, it will have enormous implications for the future prospects of corporate ownership of genetic modification technologies.

Back in October, my headline for How the World Work's initial appraisal of Ravicher and the Public Patent Foundation was "Don Quixote, or David vs. Goliath?" That question appears to be answered.

_______________________

USA: Firms take on do-it-yourself regulating

St. Louis Post-Dispatch, 26 July 2007. By Rachel Melcer.

Biotech crop makers on Wednesday said they are increasing self-regulation to avoid the accidental spread of genetic material. These incidents can cost companies access to foreign markets, consumer confidence and big legal bills.

The Biotechnology Industry Organization, a Washington-based trade group, will design and administer the program, dubbed "Excellence Through Stewardship."

Member companies - including the world's six largest providers of genetically modified seeds - will adopt quality management standards, then undergo independent third-party audits to verify compliance. The goal is to track and control genetic crop traits in research discovery, through field trials, marketing and eventual phaseout.

No one wants these genes to turn up in places they're not supposed to be - such as last year's surprise finding of unapproved LibertyLink genes in commercially available long-grain rice. Advertisement

Regulators found the trait, developed by Bayer CropScience, was harmless and subsequently approved it for the market. But damage was done: Japan, the European Union and other countries closed to U.S. rice imports. Prices fell, then farmers suffered and filed a class-action lawsuit against Bayer in U.S. District Court in St. Louis.

"The industry is trying its best, in a world that's not 100 percent perfect, to self-regulate and self-police because it's in their best interest," said Marshall Martin, associate director of agricultural research programs at Purdue University.

The stewardship program will roll out in three phases.

Companies will self-certify they have adopted the program in their domestic operations by early next year. At the end of next year, they will have completed audits by independent firms that are trained and certified by BIO, the industry organization. In 2009, BIO member companies will roll out the program to operations abroad.

"Part of our challenge will be - and we look forward to it - making sure that this is the gold standard and that it is understood around the world," said BIO President and Chief Executive Jim Greenwood.

The initiative is not a reaction to the Bayer incident, he said. Rather, "we see the science evolving, we see the use of these products expanding, and we felt our efforts should evolve as well."

Andrew Baum, chairman of BIO's Food and Agricultural Section Governing Body, said companies always have had quality management standards.

"It's not as if (the Bayer incident) took place and we had an epiphany," he said. "We were moving towards this anyway."

What's more, the stewardship program should raise all boats by making the best practices of industry giants available to smaller companies, university researchers and players abroad, BIO said.

"I wish, when we had five employees, we had something like this. It would have saved us a lot of time and effort," said Baum, president and CEO of SemBioSys Inc., a 70-person plant-based pharmaceutical firm in Calgary, Alberta.

The acid test for this program will be acceptance by stakeholders, such as venture funds that can't afford to risk investments in firms that might implode by having a technology "leak," he said.

BIO presented its program to the U.S. Department of Agriculture, Environmental Protection Agency, and Food and Drug Administration - all of which regulate biotech crops.

The federal agencies do not have this type of quality management and stewardship regulation in place - but ag biotech companies say they are not trying to step on government toes.

"The industry supports strong, science-based federal regulation. This is a complement to that, it's not a substitute. Both are really important," said Jerry Steiner, an executive vice president with Creve Coeur-based Monsanto Co., the industry leader.

Participants hope the program will stave off future leaks of biotech traits into conventional crops, which damage consumer acceptance of their products. It's a pivotal time for the industry, as it nears commercialization of a generation of crops engineered with traits that add consumer benefits - healthy-oil and omega-3 enriched soybeans, for example. Shoppers need to trust the safety of the technology for these to succeed.

"I don't think anyone can say this will prevent any particular incident," said Tom West, a vice president with DuPont unit Pioneer Hi-Bred International Inc. "But this is about raising standards all across the board."

_______________________

USA: When Regulators Become Enablers - Inside Bush's FDA

CounterPunch, July 17 2007. By Evelyn Pringle.

Americans need to stop and consider how many consumers will be killed and injured by dangerous drugs by the time George Bush heads back to Texas at the end of his Presidency, as a direct result of his allowing the interests of the pharmaceutical industry to take control of the FDA.

For nearly 70 years, the common-law tort systems in the individual states have provided a remedy for citizens injured by prescription drugs. However, in one of the most blatant paybacks for political contributions in US history, in January 2006, Bush-appointed officials at the FDA announced that the agency's approval of a drug and its labeling acts to preempt product liability lawsuits filed by patients against the pharmaceutical giants.

On February 23, 2006, Democratic lawmakers Rep Henry Waxman, of the Committee on Government Reform, and Reps John Dingell and Sherrod Brown of the Committee on Energy and Commerce, sent a letter to the Secretary of Health and Human Services, and voiced their outrage.

"The announcement," the lawmakers wrote, "provides unfortunate evidence that the Bush Administration is more committed to protecting drug industry profits than to building a sound system for ensuring drug safety."

"The FDA's preemption announcement," the letter said, "is particularly troubling at a time when FDA's own ability to protect Americans from unsafe drugs has been called into question by a series of cases in which the FDA was slow to warn consumers of significant drug risks."

The new rules went into effect on June 30, 2006, and preemption is now being used in litigation all over the country in an attempt to dismiss lawsuits filed by private citizens against drug companies.

Unbeknownst to average Americans, the administration's gift of preemption is not limited to industries regulated by the FDA. Bush-appointed officials in all federal regulatory agencies are working in concert to ensure that major corporations subject to product liability lawsuits can claim that federal regulation of their products preempts any recovery for consumers harmed, whether the injury involves defective automobiles, pesticides or whatever.

In return, the major corporations are ganging up on private citizens by filing amicus briefs in support of pharmaceutical companies involved in litigation. For instance, the drug giant Wyeth is arguing preemption in a petition currently pending before the US Supreme Court in a case involving one lone woman in Vermont, in an attempt to overturn a jury verdict that was affirmed by the Vermont Supreme Court.

Amicus briefs to support Wyeth's preemption argument are piling up, including one filed by the Product Liability Advisory Council on behalf of just about every major product manufacturer in America.

The plaintiff, Diana Levine, a professional musician, has the support of the Public Citizen Litigation Group. Ms Levine went to the hospital to seek treatment for a headache and left with injuries that led to the amputation of her arm after the drug Phenergan was administered by IV to alleviate the nausea associated with a migraine headache.

Specifically, her arm had to be amputated because the drug reached Ms Levine's arteries, and the lawsuit alleges that Wyeth was aware of the risk of arterial contact when the drug was administered by IV and failed to warn against using a method to administer Phenergan that caused the injury.

In the petition, Wyeth does not dispute that Ms Levine's arm was amputated because the company failed to warn about using this method. Its sole argument is that she is not entitled to damages because the FDA did not require Wyeth to warn about the danger of administering the drug this way.

The Vermont Supreme Court rejected this argument. The agency's claim of conflict with federal law, the Court held, did not warrant deference because it was flatly at odds with both the FDA's regulation permitting manufacturers "to add or strengthen a warning 'to increase the safe use of the drug product' without prior FDA approval," and with Congress' express directive that state law concerning prescription drugs be superseded only when it poses a '"direct and positive conflict' with federal law."

On May 21, 2007, the Supreme Court invited the Solicitor General to file a brief to express the views of the government, which will no doubt add support for a favorable preemption ruling for Wyeth, potentially affecting tens of thousand of private citizens with cases pending all over the country.

A favorable ruling on preemption could provide an escape hatch for GlaxoSmithKline in lawsuits filed by patients injured by the diabetes drug Avandia (rosiglitazone), even though the FDA is aware of the fact that Glaxo concealed the serious cardiovascular risks known to be associated with the drug for years.

Medical experts are now predicting another Vioxx-like disaster with Avandia. In May 2007, prominent cardiologist Dr Steven Nissen, of the Cleveland Clinic, reported a study in the New England Journal of Medicine that found the drug to be associated with a 43% increase in heart attacks and possibly a 64% increase in cardiovascular death.

In a May 26, 2007, speech on the Senate Floor, Senator Charles Grassley (R-Iowa) said that the actual number of heart attacks possibly linked to Avandia may be as high as 20 a day.

Since the drug came on the market about 8 years ago, he said, tens of millions of prescriptions have been written, and Medicare and Medicaid have paid hundreds of millions of dollars for the drug.

At a June 6, 2007, hearing of the House Committee on Oversight and Government Reform to review the FDA's failure to warn the public about Avandia, Chairman Waxman (D-Cal) began the meeting by pointing out: "It is not Congress' role to adjudicate these medical issues."

"But it is our role," he noted, "to ensure that the Food and Drug Administration is taking these concerns seriously and providing doctors and patients with the guidance they need to make informed decisions."

"Although Avandia has been on the market for eight years and has been used by millions of Americans," Rep Waxman said, "the post-market studies have not been done to say conclusively whether Avandia increases or decreases the risk of heart attacks."

"That's a major failure of our system," he said. "And it is what is causing so much confusion and worry among the patients who are taking Avandia today."

Another FDA failure that will surely lead to many lawsuits was allowing Permax (pergolide), a drug used by Parkinson's patients, to remain on the market until March 29, 2007, long after its link to valvular heart damage was known.

Eli Lilly gained approval for Permax in 1988 but, at the time of the recall, the drug was manufactured by Valeant Pharmaceuticals and generics were sold by Par and Teva.

As early as December 2002, doctors at the Mayo Clinic reported that 3 Permax patients had developed heart valve disease similar to that caused by the Fen-Phen diet combination. In 2004, HealthDay News reported that a study had confirmed earlier findings that Permax was linked to heart valve damage which required surgery to correct.

On January 4, 2007, two studies in the New England Journal of Medicine said that the number of patients developing valve damage was higher than expected. One study found moderate to severe valve problems in more than 23% of the patients on Permax, compared to less than 6% in the comparison group.

The second study found Permax users were 5 to 7 times more likely to have leaky heart valves than patients taking other Parkinson's drugs, and patients taking the highest doses of Permax were at a 37 times greater risk.

The FDA's preemption policy has the potential to benefit every major drug company. Johnson & Johnson's SEC filings show that the company is currently facing hundreds of lawsuits over the deaths and injuries linked to the Ortho Evra birth control patch in women all over the country who have suffered blood clots, heart attacks and strokes.

Legal analysts predict that many more lawsuits will be filed due to the wide use of the device and as women realize that their injuries are due to the patch. In 2005 alone, there were more than 9.4 million prescriptions issued for the Ortho Evra patch, according to IMS Health, an industry-tracking firm.

A preemption ruling in this litigation would be especially onerous in light of the fact that the injuries are clearly due to the patch, because blood clots, heart attacks and stroke are almost unheard of in the age group of women who use this device.

This is another case where FDA officials knew of the health risks before the drug was approved. Agency records show that in 2000, the FDA scientist in charge of reviewing the preapproval trials submitted, warned that blood clots could occur and recommended that the information be included in the prescribing information for the patch.

The new drug application for the antibiotic, Ketek, marketed by Sanofi-Aventis, was rejected twice, in 2001 and 2003, before FDA management approved the drug on April 1, 2004, based on fraudulent studies, and over the objections of the FDA's own scientists.

Many patients have been harmed because doctors trusted the FDA's approval of Ketek. According to a review of the FDA's Adverse Event Reporting System, by the staff of the Senate Finance Committee, between July 2005 and September 2005 alone, there were two deaths, 35 liver adverse reactions, 44 cardiac events, and 80 visual events in Ketek patients.

In addition, internal FDA emails obtained by staffers, prove that top FDA officials were aware of the problems with Ketek before it was approved, and that FDA scientists, Dr David Ross, Dr David Graham, Dr Charles Cooper, and Dr Rosemary Johann-Liang, all warned FDA management about the serious adverse effects associated with the drug.

A May 16, 2006, FDA memo authored by safety reviewers said Ketek was linked to 12 reported liver failures including 4 deaths, 23 reports of serious liver injury, and a higher rate of adverse reaction reports than other antibiotics on the market, and the reviewers recommended a black box warning for the Ketek-related liver injury.

However, Sanofi-Aventis and FDA officials disregarded the recommendation and announced that only a new bolded warning would be added.

In addition to the massive Vioxx litigation, Merck is facing a large number of plaintiffs in lawsuits over the osteoporosis drug Fosamax, alleging the drug causes jaw-bone death, which is an extremely rare condition.

Kenneth Hargreaves of the University of Texas, discussed the increasing cases of ONJ in the April 3, 2006 LA Times. "We've uncovered about 1,000 patients in the past six to nine months alone," he said, "so the magnitude of the problem is just starting to be recognized."

Oral surgeon, Dr Salvatore Ruggiero, one of the first doctors to notice the increase in 2001, told the Times, "Even though the chances of getting this are small, considering there are 23 million women taking this drug, we could be talking about a significant number of people."

The FDA approved Fosamax in 1995, and because it is a relatively new drug, unreported cases OJN may be higher than expected because doctors may attribute the pain caused by the condition to osteoporosis, according to Diane Wysowski of the FDA's Office of Drug Safety in the Times.

Here again, the FDA and the drug maker were aware of the link between OJN and Fosamax but failed to warn the public until after the drug was prescribed to tens of millions of patients.

The man most credited for the creation of the preemption policy is the FDA's former Chief Counsel, Daniel Troy, who plays for the opposite team in private practice. Prior to his appointment as Chief Counsel, Mr Troy was a partner at Washington's Wiley Rein & Fielding, where he filed lawsuits against the FDA on behalf of the pharmaceutical industry to loosen restrictions on off-label prescribing and advertising of prescription drugs.

In fact, critics say, it was Mr Troy's loyalty to the industry, demonstrated by years of legal battles against FDA regulations, that earned him the appointment by the Bush administration as the industry's inside legal counsel.

Mr Troy himself bragged about his part in implementing the preemption policy in an article he wrote in the October 9, 2006, Legal Times stating: "I was also at the FDA while January's Physician Labeling Rule, which contains a statement in its preamble about the FDA's pre-emption authority, was written."

"And I now," Mr Troy states, "advise and represent companies confronting state-law claims that implicate the pre-emptive effect of FDA requirements."

But the fact is, Mr Troy was testing the viability of the preemption argument with judges in state and federal courts long before the new policy was announced in January 2006, by filing amicus briefs on behalf of drug companies and against private citizens in cases involving the new class of selective serotonin reuptake inhibitor antidepressants (SSRI's) back in 2002.

Critics say it's a toss-up between Vioxx and the SSRI's when it comes to the number of deaths and injuries that could have been prevented if the information about the serious health risks known to the drug makers had not been concealed.

Over the last 2 decades, SSRI's, which include Paxil, Zoloft, Prozac, Celexa, Luvox and Lexapro, have been prescribed off-label for uses not approved by the FDA more often than any other drugs in history. The Journal of Clinical Psychiatry found that 75% of SSRI prescriptions were written for unapproved uses in June 2005.

Critics say that the profits that have resulted from the massive off-label use of SSRI's, and especially with children, are a direct result of their illegal promotion by the drug makers. The success of the off-label marketing of SSRI's is evidenced by a June 29, 2007, report by Reuters that found the most commonly prescribed drugs in the US are antidepressants.

While most of the focus has remained on the risk of suicide, SSRI's have also been linked to extreme violence, including homicides, several life-threatening birth defects, abnormal uterine or gastrointestinal bleeding, a decrease in bone mineral density, sexual dysfunction, fertility problems and a severe withdrawal syndrome.

In September 2002, Mr Troy filed the FDA's first brief in support of preemption in the Zoloft suicide case of Motus v Pfizer, based on a request by Pfizer attorney Malcolm Wheeler. In the brief, Mr Troy claimed that warnings of a causal relationship between Zoloft and suicide would have misbranded the drug and that "any warning, no matter how worded, that could reasonably have been read as describing or alluding to such a relation would have been false or misleading, and therefore in conflict with federal law."

Baum Hedlund partner, Attorney Karen Barth Menzies, has been battling the SSRI makers in the legal arena for more than a decade in representing plaintiffs with claims involving Prozac, Paxil and Zoloft.

Ms Menzies says Mr Troy's argument is absurd because Wyeth strengthened the warning about suicidality on the label of Effexor in August 2003, without obtaining prior FDA approval, and the FDA did not sanction Wyeth or claim the label was false and misleading.

Ms Menzies has defeated the preemption arguments by Mr Troy offered in support of Pfizer and GlaxoSmithKline in a number of cases. The court never reached the preemption issue in Motus because the case was resolved on other grounds, but in September 2002, Mr Troy tried to use the same argument in a lawsuit that alleged Glaxo had failed to warn about the withdrawal effects of Paxil, and the judge stated the argument "contravenes common sense" and "vitiates, rather than advances, the purpose of protecting the public."

Pfizer also submitted Mr Troy's brief from Motus to support a preemption in the case of Witczak v Pfizer. In rejecting the argument, the court pointed out that: "State consumer-protection law compliments, rather than frustrates, the FDA's protective regime."

"This is especially apparent," the court said, "when one considers that prescription drugs were once marketed primarily to trained health care providers -- sophisticated and discerning intermediaries."

"Today, on the other hand, pill-rolling apothecaries and the mortar and pestle have disappeared," he stated. "They have been replaced by drug manufacturers who urge the use of their drugs in mass-market print and television advertisements targeted directly at the public," he said.

As an example, the judge noted that Glaxo had advertised the drug Paxil, "by personifying it as a happy, bouncing-oval cartoon character."

After effectively allocating the power of FDA to drug companies, in 2004, Mr Troy went back to representing the pharmaceutical industry with the preemption policy tucked in his back pocket.

But his departure did not stop Pfizer from trying to use the FDA preemption argument in the Zoloft suicide case of Cartwright v Pfizer, decided in 2005, in which the court rejected Pfizer's preemption argument, finding that Texas tort law "compliments and is parallel to the FDA's regulations regarding safety warnings and, thus, does not interfere with the objectives of the FDA."

The court further noted that the FDA mandates that "manufacturer[s] issue a warning whenever there is 'reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved.'"

The truth is that the FDA knew about the risk of suicidality in children taking Zoloft, because the agency's review of Pfizer's clinical trial data in 1996 showed the risk to be five times that of adults on Zoloft and caused enough concern that FDA reviewer Dr James Knudsen wrote to Pfizer asking for an explanation.

The FDA's new preemption policy also purports to immunize doctors. "Pre-emption would include not only claims against manufacturers," the FDA states, "but also against health-care practitioners for claims related to dissemination of risk information to patients beyond what is included in the labeling."

Critics say this language is absurd because it extends protection to all the doctors who are boosting sales for the drug makers by prescribing drugs off-label, and the FDA labeling carries no prescribing information for an unapproved use and no warnings about the risks that may be associated with a drug in treating patients for an off-label condition.

"The unqualified language of this statement," Mr Waxman's letter states, "would appear to preempt cases against physicians for failure to warn a patient of risks associated with an off-label (unapproved) use, since, by definition, such risks rarely appear in the approved drug label."

However, drug companies have been immunizing doctors who prescribe their drugs off-label for years. For instance, in Eli Lilly's first out-of-court settlement with 8,000 plaintiffs in litigation involving the off-label marketing of the antipsychotic Zyprexa in late 2004, the settlement agreement included a ban on suing the doctors who prescribed Zyprexa off-label, according to a plaintiff involved in the case.

A July 7, 2003, Lilly document entitled, "Diabetes Update," recently made public as a result of litigation, describes a plan to immunize doctors so they would continue to prescribe Zyprexa off-label when Lilly learned that the warning about high blood sugar levels and diabetes was about to be announced by the FDA and the American Diabetes Association.

"We must embrace the fact that many physicians are curtailing their use of Zyprexa (particularly in the moderately-ill patient and in the maintenance phase)," the Lilly memo states, "solely on the basis of personal fear (of being sued)."

"Indemnification," the document notes, "represents the most meaningful demonstration of confidence in Zyprexa--both with our customers and with our employees."

The memo brags about the success of the scheme when used with doctors prescribing the company's SSRI. "Our experience with Prozac," it states, "confirms the impact and goodwill of such an initiative."

The drug makers are well aware that the steady flow of profits from off-label marketing schemes would come to a screeching halt without the participation of the prescribing doctors. However, the termination date for the immunization coverage extended to the doctors prescribing Zyprexa by Eli Lilly or the FDA is right around the corner, because the fraudulent billings that have resulted from off-label prescribing of the new class of antipsychotics are bankrupting state Medicaid programs all over the US.

Also, state officials are zeroing in on the money paid to the prescribing doctors. On June 26, in the New York Times, Gardiner Harris reported that states are finding that psychiatrists earn more money from drug companies than doctors in any other specialty, and the psychiatrists who receive the most money from antipsychotic makers prescribe antipsychotics like Zyprexa to children most often.

In the Times, Mr Harris noted that Vermont officials reported that drug company payments to Vermont psychiatrists more than doubled last year, from an average of $20,835 in 2005, up to $45,692 in 2006, and that antipsychotics were among the largest expenses for the Vermont Medicaid program.

He also reported a similar pattern in Minnesota where psychiatrists earned the most money, with payments ranging from $51 to $689,000, and the psychiatrists who took the most money from the makers of antipsychotics prescribed the drugs to children most often.

The atypical antipsychotic makers are currently under investigation by congressional committees and federal and state law enforcement agencies for defrauding public health care programs by marketing the drugs off-label to kids as young as toddlers, as well as elderly citizens in nursing homes, and causing serious injury and death to many patients.

However, Lilly recently purchased a new insurance policy of sorts to keep federal regulators at bay, in hiring Alex Azar II, the former Deputy Secretary of the US Health and Human Services Department, who quit his government job in February 2007 and became a senior vice president at Lilly in May 2007.

According to Lilly's press release, Mr Azar formerly supervised all operations at the HHS, and one of the agencies under his direction was the FDA.

When considering the tens of thousands of lawsuits that have been filed by plaintiffs injured by the new antipsychotics, a favorable ruling on preemption could be worth billions of dollars to the drug makers.

Persons seeking legal advice regarding Avandia can contact the Baum Hedlund Law Firm at: (800) 827-0087; http://www.baumhedlundlaw.com/

Evelyn Pringle is an investigative journalist. She can be reached at: evelyn-pringle@sbcglobal.net

(Written as part of a series on Avandia sponsored by Baum, Hedlund, Aristei, Goldman & Menzies' Pharmaceutical Litigation Department)

Sources

(1) Floor Statement of U.S. Senator Chuck Grassley of Iowa Safety of Avandia Monday, May 21, 2007

(2) Henry Waxman Web site, Avandia Hearing and letters to FDA, Nissen and Glaxo

(3) Avandia Critic Claims FDA Smear Campaign, ABC News, May 30, 2007

(4) Merck Press Release, April 20, 2007, Merck Says Ruling Could Apply to Other Texas Cases

(5) Diane Levine, Brief in Opposition to Wyeth Petition to Supreme Court

(6) Psychiatrists Top List in Drug Maker Gifts, Gardiner Harris, New York Times, June 27, 2007

(7) U.S. hospital, doctor visits balloon, survey finds, Reuters, June 29, 2007

(8) SENATOR SAYS FDA SHOULD STOP CITING A FRAUDULENT KETEK STUDY, SEEKS ACCESS TO INFORMATION, May 16, 2006 Press release, letters and press releases from Senator Grassley's Web site

(9) Ketek documents and articles, The Corporation Citizens For Responsible Care and Research Inc (CIRCARE),

(10) Bone Drugs' Reverse Damage, LA Times, April 3, 2006.

_______________________

Engineering consent in Switzerland

GM Watch, 26 July 2007.

In November 2005, the Swiss people voted via a national referendum for a five-year moratorium on the commercial planting of genetically engineered plants. But if anyone thinks that this commendable piece of genuinely democratic decion making means that is the end of the matter, think again.

A whole programme of national research (known as NFP 59) is underway into the "benefits and risks" of the deliberate release of GM plants. This has already sparked controversy due to the exclusion of a prominent researcher with a track record of genuine investigation of the risks of GM plants in highly questionable circumstances. http://www.lobbywatch.org/archive2.asp?arcid=7953

In that context, the following job advertisement related to NFP59 is very interesting. A psychologist is sought for a post involving the study of the public acceptance of biotechnology (read: GMOs). The implicit assumption, as you will see is that resistance to GM is not rational but the product of emotions/perceptions that can be "better taken into account" by researchers when publicising the deliberate release of GM plants.

Such a perspective tallies with the highly manipulative research we recently reported on in "Engineering acceptance of GM - Oz, U.S. and Canada." http://www.gmwatch.org/archive2.asp?arcid=8127
http://www.gmwatch.org/archive2.asp?arcid=8131

It also tallies with the findings of the research of the social scientist Prof Guy Cook,, as reported in his book, "Genetically Modified Language: The Discourse of Arguments for GM Crops and Food".
http://www.gmwatch.org/p1temp.asp?pid=68&page=1

Cook's research on GM scientists as a group showed that they perceived the "public" as homogeneous, as passive, and as frequently emotional, rather than rational. Cook also found that while many GM scientists, when asked directly, expressed interest in a public "debate", what they meant by that was a one-way "debate" in which members of the public would be "educated".

"This apparent readiness to open the GM debate to the public is thus deceptive," writes Cook, "as it conceals strongly held beliefs that members of the public are interfering when they ask to be heard and to be actors in (instead of spectators of) the decision-making processes."
http://www.gmwatch.org/p1temp.asp?pid=68&page=1

It is a perspective that ultimately sees the public as not just having no legitimate reasons for opposing GM but as essentially malleable, which of course opens the way to attempts to engineer consent.

Doctoral research post

[translation into English of German original]

Beginning in July 2007, the Department for "Consumer Behavior" of the ETH Zürich [= Eidgenossische Technische Hochschule Zurich, that is the University for Technology and Natural Sciences in Zürich, Switzerland; official English name: Swiss Federal Institute of Technology, Zürich] offers a doctoral post in a project of NFP 59 [NFP = Nationales Forschungsprogramm, that is National Research Program] on the issue "Fairness, trust and the perception of genetically modified plants".

Scope of the project:

The introduction and implementation of biotechnology depends on public acceptance. Through various studies, this project is intended to analyse how public trust and powerful emotions affect the perception of biotechnology. For this purpose new implicit measuring methods are to be developed. Whether confidence building procedures lead to more acceptance of the introduction of biotechnology is to be explored and analysed by means of a field experiment. This issue will also be explored by means of a longitudinal study - interviews before and after a GM field release experiment. Comparative interviews with laymen and experts should also provide clues about different risk perceptions. The goal of the project is to improve risk communication in biotechnology by better taking into account strong emotions and fears within the population.

Your main task will be to assist in the design, organisation, performance, evaluation and publication of empirical studies.

Your main task will be to contribute to the design, organisation, implementation, evaluation and publication of the empirical studies.

The doctoral post is limited to 4 years.

Your profile:

- graduate of psychology with interest in biotechnology
- very good knowledge of quantitative research methods
- very good knowledge of statistical evaluation procedures
- interest in scientific publishing
- good mastery command of the English language
- ability to work independently
- ability to work in a team.

For more information ask Prof. Dr. Michael Siegrist
(msiegrist@ethz.ch; +41 44 632 63 21).
Address your application with the usual documents until June 30th to Prof. Dr. Michael Siegrist.

Prof. Dr. Michael Siegrist ETH Zürich
Institute for Environmental Decisions (IED) Consumer Behavior
Universitätsstrasse 22, CHN J75.1 CH-8092 Zürich Switzerland
phone: +41 44 632 6321 fax: +41 44 632 10 29

_______________________

Declaring Ireland a GMO-free zone

The Irish Examiner (Farm Supplement cover story), 26 July 2007.
By Michael O'Callaghan, Co-ordinator, GM-free Ireland Network (
www.gmfreeireland.org)

-------
Cover picture: Green Party MEPs during a protest in the Parliament in 2004.

Photo caption 1: Map of GMO-free zones in the EU

Photo caption 2: Darina Allen on the Ballymaloe Cookery School organic farm, just one of the 1,000 Irish locations declared GM-free on April 22, 2005.
--------

OUR government's policy "to declare the whole island of Ireland a GMO-free zone" aims to prohibit the release of live GM seeds, crops, livestock, trees, insects, crustaceans and fish on this island. (The policy does not apply to the use of GMO bacteria for the production of pharmaceutical products in sealed vats in secure laboratories.) There is no plan to prohibit GM animal feed. The government is, however, encouraging farmers to phase out its use on a voluntary basis, in response to rapidly growing EU market demand for meat, poultry and dairy produce from livestock fed on certified non-GMO feedstuffs.

Because of our geographical isolation from potential contamination by wind-borne GM pollen, declaring this island off limits to GM crops will clearly position Irish farm produce as the most credible, safe GM-free food brand in Europe. If implemented (in collaboration with the Northern Ireland Assembly), this will boost the safety, quality, reputation and economic value of Irish food in the lucrative EU export markets. It will provide a competitive advantage to Irish farmers and food producers for generations to come.

Widely supported

The policy is supported by TDs, senators and MEPs from all the political parties, and by over 130 organisational members of the GM-free Ireland Network – including the Irish Cattle and Sheepfarmers Association, the National Beef Association (NI), all the organic certification bodies, the Irish Doctors Environmental Association, the Restaurants Association of Ireland, Euro-Toques Ireland (representing our 300 leading chefs), the Food Writers Guild, Slow Food Ireland, etc.

It is also supported by the county councils of Cavan, Clare, Fermanagh, Kildare, Kerry, Meath, Roscommon, Monaghan, and Westmeath), the District of Newry and Mourne in counties Armagh and Down, and the towns of Bantry, Bray, Clonakilty, Derry, Galway City, Letterkenny, and Navan), representing over one million citizens on both sides of the border whose elected representatives have declared these local areas off-limits to GM crops.

No market for GM food in Europe

Ireland exports 90% of the food produced here, mostly to European countries which have a near-total market refusal of any food which carries the GM label (required by EU law if it contains or is derived from 0.9% or more of GM ingredients). This market refusal is now rapidly spreading to also exclude meat, poultry and dairy produce from livestock fed on GM ingredients (even though such produce does not yet require a GM label).

In January 2005, Greenpeace published the landmark report, "No market for GM labelled food in Europe", which details a virtual shut-down of the EU market for GM-labelled food. Europe's top 30 retailers and top 30 food and drink producers had by then already declared policies and non-GM commitments which revealed a massive international food and beverage industry rejection of GM produce. This cut across the industry from food and drink manufacturers to retailers, and includes everything from snacks and ready meals to pet food and beer. The combined total food and drink sales of the 49 companies with a stated non-GM policy in their main market or throughout the EU (27 retailers and 22 food and drink producers) amounted to 646 billion, more than 60% of the total 1,069 billion EU food and drink sales in 2005.

Since then, Consumers International has called for a ban on all GM foods, and an EuroBarometer survey found that "Overall Europeans think that GM food should not be encouraged; GM food is widely seen as not being useful, as morally unacceptable and as a risk for society". Most leading EU retailers are now extending their GM bans to gradually exclude meat and dairy produce from GM-fed animals.

Health risks

There is growing scientific evidence linking GM animal feed and food to deaths and disease in laboratory animals, livestock and the human population. Speaking at the launch of his book "Genetic Roulette: the documented health risks of GM food" at a briefing on food safety and GMOs at the EU Parliament office in Dublin recently, the author Jeffrey M. Smith, described the evidence of health risks as "irrefutable", including new diseases, allergies, inflammatory responses, antibiotic resistance, reduced immunity, and pre-cancerous growths. Transgenic DNA in food can survive digestion and activate inside your body, potentially turning you into a living pesticide factory. A leaked European Commission document admits, "there is no unique, absolute, scientific cut-off threshold available to decide whether a GM product is safe or not".

But the European Food Safety Authority (EFSA) claims GM animal feed and GM foods are safe, although it is being challenged for routinely approving such products based on risk assessments provided to it by the companies it is paid to regulate, for not making the relevant data available for independent scientific scrutiny, and for failing to address the concerns of member states. In April 2006, the European Commission issued a statement calling for better test protocols and more research into the long-term effects of GMOs. The European Council has also repeatedly voiced concerns about EFSA's work. EFSA's recommendations on GMOs have never achieved formal backing by the required two-thirds majority of EU member states. No long-term human health studies prove GM foods are safe, and a recent study found that one variety of GM animal feed widely sold to Irish farmers causes liver and kidney damage to laboratory animals.

GM animal feed

Following surveys which found that most EU consumers also do not want to eat GM-fed animal products, more and more leading EU retailers are now extending their previous bans on GM food to also exclude or restrict meat, poultry and dairy produce from livestock fed on GM ingredients (see box below). In response to consumer demand, Irish farmers should therefore phase out the use of GM animal feed as soon as possible.

In February 2007, a petition signed by one million EU citizens called on the Commission to require mandatory labelling for such produce because of citizens' right to information, a fundamental right in the European Union. The petition was delivered to the EC Health and Consumer Affairs Commissioner Markos Kyprianou, who said "it shows strong interest in the issue on the part of EU citizens, who are increasingly concerned about food safety, the quality of food and the use of GMOs in the food chain". Food producers, retailers, restaurateurs and consumers are increasingly alarmed by the growing volumes of illegal and/or toxic GM ingredients which have entered the Irish food chain three or four times in the past few years, including illegal and unlabelled GM rice sold in supermarkets and served in restaurants, and illegal and/or toxic GM animal feed, of which 12,000 tonnes entered the EU market through Dublin port in a single shipment in April 2007, including 5,313 tonnes which appears to have been sold to farmers even though it was reported to cause liver and kidney damage in mammals.

This alarm is exacerbated by open-air experiments with GM "pharma crops" underway in the USA and Germany. These crops are genetically modified to produce industrial chemicals, biofuels and drugs whose contamination of the food chain is clearly unacceptable. Cross-contamination of food from GM biofuel crops (especially GM oilseed rape) is the most immediate threat for Ireland.

Availability of GM-free soya and maize

Unlike most EU countries which practice factory farming, Ireland is renowned for the superior taste of its grass-fed beef, lamb and dairy produce, produced with minimal use of animal feed compounds. The two most important animal feed ingredients imported here are soy meal (mostly from Argentina and Brazil, to boost protein levels), along with maize gluten and distillers grain (for energy), mostly from the USA. Currently, 95% of these imported soy and maize products are genetically modified.

Regarding soya, official representatives of the IFA, ICMSA, ICSA and the National Beef Association (NI) met recently in Co Wicklow with IMCOPA, Brazil's largest exporter of certified non-GMO soya meal, to discuss the option of phasing out GM soya meal. IMCOPA said it can easily supply all of Ireland's needs for non-GMO soya (certified at the very low 0.1% detection threshold), for a premium of about 0.01/kg (1 cent) above the daily commodity price set by the Chicago Board of Trade. This premium includes the costs of shipping to any port in Ireland. Problem solved!

Regarding maize gluten and distiller's grains, the vast majority of the EU maize crop continues to be GM free, with an overall surplus of GM-free maize available from Hungary. But GM experiments in some parts of Spain and France have already contaminated neighbouring farms (despite EC assurances that GM crops can safely "co-exist" with their conventional and organic counterparts). This could turn into an irreversible disaster if Monsanto succeeds in its goal to patent, genetically modify – and thus secure monopoly control of 100% of the EU maize crop within a few years. In the USA, half the maize crop remains GM free, and transportation costs often make it cheaper to import maize to Ireland from America than Southern Europe. However, cheap US maize feed imports may soon become a thing of the past because of peak oil and the massive diversion of US maize for biofuel use.

The Government should therefore foster greater European and Irish self-reliance for the production of maize and other energy-rich animal feed crop substitutes. We should encourage southern European countries which have not already done so to ban the cultivation of GM maize, and support a diversification of Irish agriculture to include more tillage for the production of rolled oats and barley, which would benefit rural communities with more jobs and also protect our biodiversity and food security.

But with the massive diversion of the US maize crop into biofuel, and peak oil expected to drive the costs of chemical farm inputs and transportation rapidly upwards, Ireland will need to produce most of our own animal feed to guarantee our food security, food sovereignty and farming future. The resulting diversification and increased tillage and local food production will boost local economies and keep food affordable.

Value-added production

The shift to GM-free animal feed is a significant market trend which Irish farmers should follow closely.

The GMO-Free World Summit on Diversity will take place May 12-16, 2008 in Bonn, Germany.

And the European Network of GMO-free Regions, which currently includes 39 EU Regional Governments in six member states, will host a conference on "Non-GM feedstuff, Quality Production and European Regional Agriculture Strategies" at the European Parliament on December 5-6, 2007.

Over ten regions in Austria, France, Italy, and Spain have already committed themselves to this approach. Preliminary meetings have been held with the EC, the European Parliament, the Committee of the Regions, AER, CRPM, AREPO, COPA-COGECA and with Brazilian players of the entire sector, and the project is going full steam ahead. The European Commission's Directorates-General for Agriculture, Health and Consumer Protection, Development and Trade have also agreed to participate.

The EU Network of GM-free Regions is phasing out GM animal feed to provide value-added production, to preserve competitive and high-quality agriculture in the context of the globalisation of food markets, and thus boost the sustainability of local rural communities. These regional governments are demanding a special status for quality agriculture which recognises its role in space management, environmental protection, and the strengthening of local communities, and wants all the European Regions to support this strategy in the mid-term review of the CAP in 2008 and its revision in 2013.

Misinformation

Given the vast profits which giant agribusiness-biotech corporations intend to secure by genetically modifying and patenting the world's agricultural seeds and livestock, it is no surprise that the public relations companies and spin doctors they employ in the Irish media are hard at work, even resorting to forged letters, "shoot the messenger" techniques, and scare-mongering with all sorts of incredible claims.

Having failed to convince European farmers and consumers that GM crops are more nutritious, have higher yields, require less chemicals, or will end world hunger, their current strategy – called Public Perception Management – now aims to convince us that nothing can be done to prevent the GMO invasion in general, and that there is no alternative to the use of GM animal feed in particular. The scale of this deception echoes the fraudulent claims about the non-existent "weapons of mass destruction" in Iraq. Just because you believe something does not make it true.

The simple reality is that certified GM-free feed is available, and that the minimal extra costs involved can be recouped by the higher premia already provided by leading European retailers. Irish producers and exporters of live cattle, beef and dairy produce who use certified non-GMO feed are already securing these premia in the export markets.

Foreign direct investment

Declaring the whole island of Ireland a GMO-free zone is also likely to attract foreign direct investment from international agricultural seed developers looking for a safe haven for the production and conservation of certified non-GMO varieties of cereals, vegetables and fruit. Instead of attempting to win an impossible competition for the production of low quality GM-fed beef with countries with cheap labour like Brazil, Ireland's economic advantage clearly lies in the production of the high-quality, safe GM free produce which the markets demand.

Our green image, mostly grass-fed livestock, and geographical isolation give us an invaluable head-start in this regard. Keeping Ireland GM-free is good for business.

--------

More and more retailers move towards excluding meat and dairy produce
from livestock fed on GM ingredients


SOME of the EU retailers who exclude or restrict meat and dairy produce from livestock fed on GM ingredients:

IRELAND:

All of Marks & Spencer's fresh meat and poultry, salmon, shell eggs and fresh milk comes from animals fed on a non-GM diet. The Kepak Group, which controls 60% of Irish beef exports, requires some farmers who produce meat for its flagship KK Club brand to exclude the use of GM animal feed.

All Kepak's chicken meat comes from birds reared on a vegetarian, non-GMO diet. The Silver Pail Dairy in Co Cork has signed multi-million euro foreign direct investment deals with Baskin Robbins (the world's largest ice-cream retailer) and with Ben & Gerry's, to produce GM-free ice cream (made from milk from cows fed a certified non-GMO diet) for the European market.

TLT International in Mullingar exports non GMO-fed live store cattle yearly, mostly to Northern Italy.

All Irish organic meat and dairy producers avoid use of GM animal feed, including Glenisk which recently secured € 5m in foreign direct investment to expand its EU market share.

UK:

Tesco, Sainsburys, M&S and Budgen Stores all have quality labels for meat and dairy produce from livestock fed on certified GM-free animal feed. All of Marks & Spencer's fresh meat and poultry, salmon, shell eggs and fresh milk comes from animals fed on non-GM diet. Moreover, standard poultry sold in most UK supermarkets now carries a label certifying GM-free feed.

The UK has over 40 GMO-free zones, including Scotland, Wales, and Cornwall.

GERMANY:

Most retailers avoid GM-labelled food. A well-known leading supermarket chain is expected to exclude meat and dairy produce from livestock fed on GM ingredients later this year. A second leading retailer is considering the same, beginning with pork meat, but for reasons of corporate social responsibility, rather than marketing.

ITALY:

The largest retailer, Coop Italia, already has a quality label for meat and dairy produce from livestock fed on certified GM-free animal feed. GM crops are banned in most Italian regions, including Tuscany where anyone found growing GM crops faces two years in prison or a € 50,000 fine.

FRANCE:

Carrefour, Cora, Auchan and Monoprix all have quality labels for meat and dairy produce from livestock fed on certified GM-free animal feed. GM crops are banned by many regions and local authorities.

SWITZERLAND:

The two largest retailers, Migros and Coop, systematically ban all GM food – including meat, poultry and dairy produce from livestock fed on GM feed – in their supermarket brands. Following a national referendum, the Swiss government implemented a five-year moratorium on GM crops and livestock in 2006.

POLAND:

Europe's largest agricultural producer has imposed a total ban on GM crops, and also plans to prohibit GM feed by 2008 unless it is scientifically proven to be safe. Farmers have imported certified non-GMO soya since 2006 for their pork meat bound for the German market.

_______________________

Ireland: Greens mean business

The Irish Times, 26 July 2007. By Mary Raftery.

The Green Pary is nothing if not interesting, particularly in the midst of its current maelstrom of activity. One might almost be forgiven for believing that the Greens are running the whole show at the moment.

The Party has come a long way since its dislike of having leaders or personality-based politics. Suggestions based on Buddhist principles (such as that made apparently some yars ago) that their party political election broadcasts should consist of two minutes of silence are unlikely to surface in the new lean, mean, green machine. Their relatively recent political naïveté, or even eccentricity, may well have led many to believe that they would crumble when confronted with the real world of hard decisions and unpleasant compromise inevitably associated with government and even more so with coalition administrations.

However, so far the Greens have displayed considerable steel. Minister for the Environment John Gormley's shot across the bows of Monaghan County Council on the rezoning issue is likely to send shock waves through every local authority in the land.

Employing a little-used section of the 2000 Planning Act, Gormley has instructed the Monaghan Council to rescind no fewer than 29 of the rezonings it had included, against professional planning advice, in the latest development plan for the region.

It is a long overdue signal that wild and wilful behaviour from councils will not longer be tolerated, and that rezonings should follow the principles of good planning as laid out by the various strategies for national development.

There will doubtless be those who will argue that the Minister's action constitutes a gross interference in local democracy and in the rights of local politicians to represent their communities. However, it has become abundantly clear over past decades that the repeated practice of rezoning vast swathes of land for development, often against planning advice and even commons sense, has had a profoundly negative effect on many communities. If the Minister can act to root this out, he will in fact have enhanced the fundamental principles of local democracy by redressing the balance betwee the needs of communities and the profits of developers.

The other issue which the Greens have faced up to squarely is that of GMOs, or genetically modified organisms. The Green Party has always wanted Ireland to be a GM-free zone. It is suspicious of food which has been genetically modified, arguing that it has not been proven to be free of possible health risks.

However, it is almost impossible to prove beyond doubt that anything is risk free. What the bulk of science in the area tells us at present is that there is no evidence that GM foods are unsafe. All of which means that the debate over GM or not GM is likely to rage around Europe for the foreseeable future. I say Europe here, as this is the region of the world where there is the most pronounced consumer resistance to GM foods. So strong is the hostility, in fact, that major European food brands have declared themselves GM-free.

In Ireland we have (as is our wont) lived quite happily with a comfortable and unthreatening fudge. While Fianna Fáil was vehemently anti-GM 10 years ago, this has changed of late to the point where the previous government officially described its attitude to GM as "positive but precautionary". What this seems to have meant in practice was an expectation that Ireland would almost automatically support measures at EU level to free up access for GM products across Europe.

But no longer. The Green Party, with two key ministries in this area (Environment and Food), has begun to make its weight felt with can only be described as a seismic shift in government policy. Over the past six weeks, the new Government has twice indicated at European level hat it now strongly opposes GMOs in all food, including animal feed. At the EU Standing Committee on the Food Chain and Animal Health, Trevor Sargent abstained in a vote on GM animal feed ingredient called Herculex which continues to be banned. And John Gormley moved to support Austria, a firmly anti-GM country, at a recent EU meeting.

Any move to shut down the use of GM-based animal feeds will have enormous financial implications for the Irish beef, dairy, pig and poultry sectors, which have a substantial reliance on these products. However, leaving things as they are may have equally negative economic consequences should the EU move to introduce mandatory labelling of all meat and dairy produce from GM-fed animals – something which is also Green Party policy.

While Ireland as a country likes to market itself as green and clean, the reality is often somewhat different. The current Green Party focus on GM foods, whether for humans or animals, may finally make us confront at least some of the contraditions we usually manage to live with so smugly.

_______________________

GMO Zero Tolerance Devastating For EU Livestock Feed

ThePigSite, 26 July 2007.

EU - Coceral, the European grain and feedstuffs traders and Fefac, the EU compound feed manufacturers have welcomed the new EU Commission report on the economic impact of unapproved GMOs.

The report concludes that there is a "need to take urgent action to avoid negative implications for EU livestock production and agriculture overall".

JeanMichel Aspar, Coceral President, stated that "the present strict zero-tolerance policy of the EU is disproportionate and will lead to a complete halt of vital feed supplies from South and North-America, as no trading company will bear the risk of guaranteeing absence of traces of GMOs approved in some third countries but not yet in the EU".

He stressed that "the EU is totally dependant on soybean meal imports as major source of vegetable proteins, for which no substitutes are available in sufficient quantities on EU or world markets".

Major feed cost increase

Pedro Corrê.a de Barros, Fefac President, stressed that the current de-facto import ban for corn gluten feed will increase feed costs to the EU livestock industry by another € 60-90 million at a time of record-high feed grain prices.

He pointed out that "a similar ban on soybean meal imports will have devastating consequences for European livestock producers, wiping out entire pig and poultry production chains in the EU Safeguard viable livestock industry

Coceral and Fefac have therefore called on the EU Farm Council to safeguard a viable livestock industry in the European Union, which accounts for 40% of the farm revenues, by ensuring reliable access to vital feed material imports.

As demonstrated in the DG-AGRI study, the "CAP Health check" objectives of a more competitive and sustainable EU agriculture cannot be achieved unless solutions are found to address the issue of unapproved GMOs.

Toolbox ingredients

Coceral and Fefac take the view that a "toolbox" with the following key elements is necessary to re-establish normal trading patterns ensuring a regular supply of high-quality feed materials for the European livestock industry:

* aligning the speed of the GMO authorisation procedure between the EU and the major exporting countries;

* a risk proportionate, workable tolerance for the low level presence of products that have obtained a positive EFSA opinion or have been approved by another OECD country to be present in cargoes of traded feed materials.

Comment by GM-free Ireland

The "new EU Commission report" (Economic Impact of Unapproved GMOs on EU Feed and Livestock Production) mentioned above clearly features a prominent disclaimer indicating it does not necessarily reflect the views of the Commission. It was in fact published by DG Agriculture, not the Commission!

The Irish Farmers Journal article of 30 June "Why GM feed issue could be costly for Ireland" (by its News Editor Pat OíKeefe), also falsely described the report in the same way.

The claim that a ban on GM soymeal would "wipe out the entire pig and poultry production chains" in Europe is rubbish, since certified non-GMO soya is widely available, inter alia, from Brazil.

The description of GM animal feed ingredients as "high quality" is totally misleading, since the European-wide move to quality agriculture specifically rejects GM ingredients as well as meat, poultry and livestock derived therefrom.

_______________________

25 July 2007

USA: Monsanto loses claims for Roundup Ready genes

Commercial Appeal, July 25 2007. By Jane Roberts.

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. In other cases, Monsanto sued farmers after wind blew the genetically altered seed into their fields.

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?"

Monsanto facts

Address: 800 North Lindbergh Blvd., St. Louis
Employees: 17,000
Maker of Roundup, the world's best-selling herbicide
Bought Delta and Pine Land cotton breeders this spring for $1.5 billion
Jane Roberts: 529-2512

_______________________

USA: Companies really know beans about moving genes

News Leader, July 25 2007. By Don Maroc.

The transnational seed, pesticide, and drug corporations have known for five or 10 years that the scientific foundation on which genetic engineering is built is false, but with billions of dollars riding on it they, with the support of our governments, continue to mislead us.

In 1956, Francis Crick, co-discoverer of the structure of the DNA molecule, posited his central dogma of molecular biology, that each gene in the human genome contained the code to construct one protein that contributed one characteristic to a human. An article published by a large group of scientists in the journal Nature (June 14 2007), exposes this as wrong.

For years, independent scientists like Barry Commoner, Joe Cummins and Dr. Mae-Wan Ho have repeatedly pointed this out, only to be ridiculed and attacked by the powerful public relations enforcers for the multi-national corporations.

For two decades Monsanto, Bayer, Dupont and Syngenta have told us genetic engineering (GE) is a precise technology. When their scientists insert a bacterial gene into a corn seed they know exactly how it will operate in its new genome. They have always said that a majority of genes serve no function. They called them junk DNA.

Sorry guys, the new, overwhelming evidence says the only junk is the propaganda you have been feeding us. The collective work of 80 organizations worldwide states conclusively that, "the findings challenge the traditional view of our genetic blueprint as a tidy collection of independent genes, pointing instead to a complex network in which genes, along with regulatory elements and other types of DNA sequences that do not code for proteins, interact in overlapping ways not yet fully understood."

When scientists in their understated way say human genetics functions in ways "not yet fully understood", they are really saying they don't know beans about what they've been doing moving genes between animals, fish, bacteria, viruses, and plants.

Any undergraduate biology student can now insert new foreign genes in the plants that provide our food. But neither the student nor the professor, nor the biotech corporation technologists, nor the government scientists have any idea what might result from the forceful invasion of the foreign gene.

Of course there is no way to determine whether the inserted gene (in corn, soybeans, canola, and cotton) caused any human malady, triggered allergic reactions, or set up conditions for cancer, because products containing genetically modified organisms are not labelled.

They are often not allowed to be labelled. When an organic grain processing company tried to label their breakfast cereals as "non-GMO" the supermarket told them to take it off the label or take their products out of the store.

In addition GMO and non-GMO grains are freely mixed at the grain elevators. You never know what you are getting, and market experts say that 60 to 70 per cent of all products in your supermarket contain GMOs.

You want to avoid feeding yourself and your kids GMOs? Eat no processed foods containing corn, soybeans, canola, or cottonseed oil, unless it is certified organic.

Got a tip or a comment? E-mail me at maroc@islandnet.com.

_______________________

Cyprus Greens angry at GMO law shelved

Reuters, 25 July 2007.

NICOSIA, July 25 (Reuters) - Environmental campaigners in Cyprus accused the government of yielding to American influence on Wednesday by refusing to endorse ground-breaking legislation forcing retailers to segregate GMO food.

President Tassos Papadopoulos has referred the law, passed by parliament on June 14, to the Supreme Court, effectively freezing its application until the court convenes to assess its legality. That is not expected to occur before the autumn.

"The only way the law can be applied immediately is if the president withdraws his petition to the Supreme Court," Greens Party spokeswoman Ioanna Panayiotou said.

The law, a first in an EU member state, obliges retail outlets to separate food with a genetically modified content of more than 0.9 percent on separate shelves.

The United States, a pioneer of biotechnology, warned Cyprus in 2005 that the move could contravene Cyprus's obligations as a World Trade Organisation member, and harm bilateral ties.

"This is being done to meet the demands of Americans. Is our government merely an intermediary of American interests?" the Greens Party said in a statement.

The Greens Party supported Papadopoulos's bid for election in 2003. Papadopoulos is seeking re-election next year.

Under the present centre-left administration it has been rare for the presidency to exercise its right to refer parliamentary legislation to the Supreme Court, Panayiotou said.

"Certainly it's the first time a law concerning food safety is referred to court," she said. The Supreme Court was expected to issue a judgment on the validity of the law by autumn, she added.

Papadopoulos's referral letter, seen by Reuters, says the procedure for the adoption of the legislation, and elements of the legislation itself, could be an infringement of European Union regulations.

European consumers are generally suspicious of genetically modified products, fearing health and environment risks.

Advocates of biotechnology insist GMO products are safe and will help eradicate world hunger by improving food supply.

_______________________

New Zealand: Responsiblity for GE clean ups would land on local government and local land owners

Whangarei District Counci Press Release, 25 July 2007.

Central Government has recently confirmed that responsibility and costs fall onto local government and local land owners if genetically engineered crops contaminate natural crops or the environment and have to be cleaned up.

A letter from the Minister for the Environment indicates that when or if contamination occurs it will be the person affected by the "pollution" not the "polluter" who will pay.

These concerns have been raised by a group of councils worried about their vulnerability on behalf of ratepayers generally, as a result of the way Hazardous Substances and New Oganisms (HSNO) Act has been written.

"Until now Government had not clarified that we would be the ones carrying the can, even though that is clearly the way the act is written," said working party member, retiring Whangarei District Councillor Robin Lieffering.

"Finally they have agreed that local councils do have a duty of care under their Resource Management Act responsibilities."

Councillor Lieffering was reporting back to Whangarei District Council on the outcome of a letter to the Minister from the Inter-council Working P