The John Snow East-West Sleza Summit Conference


 
dr Halat, medical epidemiology consultant, President, The John Snow International Society for Common Sense in Public Health

Dear Colleagues

The John Snow's East-West Sleza Summit Conference II will be held end-June 2004 at the foot of Sleza massif, Lower Silesia, ca 40 km from Wroclaw, south-western Poland.

The Conference will offer an unique opportunity for brain-storming type of exchange of ideas among those medical doctors, who devoted themselves to public health.

In my opinion professional ethics make physicians strongly obliged to scrutiny health risk assessment procedures, support precautionary-principle-based health risk management measures and take active part in health risk communication debates. Health risks related to transgenic foods, BSE/nvCJD, anthrax, other terror warfare, and variety of other scares require today dr John Snow's common sense approach to save lives,  prevent human suffering, and counteract human rights violation.

Please note three attachments to this message:
British Medical Association's 1999 position on gmo (1) confronted with what was addmitted mid-December 2001 and early February 2002 on non-existent gmo safety data (respectively 2 and 2a) and material on Sleza Mountain, Mt Sinai of the Middle Europe (3).

We are trying hard to minimize participants' costs and looking for private and public sponsors of the conference. Most of the preparatory work will be done online, as well as working papers will be accessible to the public on this web page.

We hope for your active participation in this initiative.

Sincerely Yours

Dr Zbigniew Halat, MD, Epidemiologist
President,
The John Snow International Society
for  Common Sense in Public Health
including Consumer Health Protection

former Health Viceminister (Undersecretary of State)
and Chief Sanitary Inspector in three governments
of Poland
 


 

UNIVERSAL DECLARATION OF HUMAN RIGHTS
(in English, French, Russian, and Polish)


2003 CONFERENCE ANNOUNCEMENT


7th annual all-Poland multidisciplinary conference of a hundred specialists
WATER WHOLESOME AND SAFE 

October 16 - 18, 2003

Nowy Targ, Podhale Region (foothills of Tatra Mountains), Poland
 

PRICE OF WATER
 
 

CALL FOR PAPERS, PARTIAL/SPECIFIC TOPIC PAPERS,
POSTERS, ADVERTISEMENTS, STANDS, ETC.

01. Determinants of tap water consumer price

02. Investor's costs of home well localization and drilling

03. Price offers of water filters appliances and servicing

04. Price calculation for bottled water in retail shops and home delivery

05.Water wholesome and safe in Poland, the E. U. , and the U. S. A.

06. Town water supply crisis situation

07. Interpretation of microbiological analysis of raw and processed water

08. Interpretation of physico-chemical analysis of raw and processed water

09. Interpretation of radiological analysis of raw and processed water

10.Quality of waters withdrawn for consumption in Poland

11. Sanitary assessement of water intended for human consumption in Poland

12. Health quality guarantee of tap, filtered, and bottled water

13. Health hazards of tap, filtered, and bottled water

14. Journalists and consumers on tap, filtered, and bottled water

DETAILS
 

w


IN AQUA SANITAS

WATER INSTITUTE, WARSAW, POLAND

WATER INSTITUTE, WARSAW, POLAND

 


 
 
 
 
The John Snow East-West Sleza Summit Conference

(1)

The British Medical Assocciation report of 18 May, 1999
The Impact of Genetic Modification on Agriculture, Food and Health

In the first statement on genetically modified organisms by a major medical organisation, the British Medical Association today says   there should be an moratorium on the commercial planting of GM crops until there is a scientific consensus on their long term environmental effects.

The BMA report The Impact of Genetic Modification on Agriculture, Food and Health, warns that any adverse effects from GMOs are likely to be irreversible. As we cannot yet know whether there are any serious risks to the environment or human health, the precautionary principle should apply.

The BMA report is an interim statement which will be reviewed as scientific evidence develops. The report reviews the available evidence on genetically modified organisms in the food chain, the regulatory process, environmental precautions and public health risks. The BMA is concerned that unless public confidence over GM crops and GM foods is considerably enhanced, there is a danger that medical biotechnological advances will be rejected by the public, at great cost to medical progress.

The BMA report has 19 recommendations for action. These include :

  • there should be an open-ended moratorium on the commercial planting of GM crops, until there is a scientific     consensus on safety;
  • GMOs should not be released into the environment until the level of scientific certainty makes this acceptable;
  • there should be a ban on the use of antibiotic resistant marker genes in GM food as the risk to human health from  antibiotic resistance is one of the major public health threats we face in the 21st century;
  •  the Food Standards Agency should be established as a matter of urgency and given statutory powers to regulate GMO production
  • GM foodstuffs should be segregated at source to ensure traceability and the Food Standards Agency should consider banning mixed GM and non-GM products or insist that they are clearly labelled
  • because of the risk of cross-pollination, the standard separation distance between GM and non-GM crops should be reviewed
  • further research is needed on allergic reaction to GM products, the cumulative effect of GMOs in the environment a the food chain and the fate of transgenic DNA.
  • the UK Government should promote a review of the World Trade Agreement to ensure that sovereign governments, rather than companies, determine whether the importation of GM foods and seeds is restricted.
Commenting on the report, Sir William Asscher, Chairman of the BMA’s Board of Science and Education, says :
"Once the GM genie is out of the bottle, the impact on the environment is likely to be irreversible. That is why the precautionary principle is so particularly important on this issue. It is even more serious than the licensing of medicines, which can, if necessary, be withdrawn. That is why the BMA is pressing for an open-ended moratorium until there is much greater scientific certainty about the risks and potential benefits of GMOs."

Dr Vivienne Nathanson, BMA Head of Health Policy and Research says :
"Antibiotic resistance, the threat of new allergic reactions and the unknown hazards of transgenic DNA mean that on health grounds alone the impact of GMOs must be fully assessed before they are released. The environmental implications and therefore the long term effects on human health cannot be safely predicted at this stage and caution must therefore prevail."
 


 
The John Snow East-West Sleza Summit Conference

(2)

Chem & Eng News Article, January 7, 2002

Federal agencies seek allergenicity protocols 
to test and regulate genetically modified foods

Over the years, as genetically engineered crops have been developed  and marketed, critics have raised many objections. They fear the crops may cross with wild relatives and create superweeds, or the levels of toxins in the plants may turn out to be unexpectedly higher than those in conventional varieties, or insects may become resistant to the insecticides in the genetically modified plants.

But the potential drawback that has caused regulators and marketers the most consternation is the possibility that a novel protein--the protein coded by the transferred gene--in a genetically engineered plant may turn out to be a new allergen.

For example, Aventis' StarLink corn--genetically engineered to produce the insecticidal protein called Cry9C, which is derived from the soil bacterium Bacillus thuringiensis--was approved  for animal or industrial, but not human, use because of the possibility that Cry9C may be an allergen. Because of this, after StarLink was discovered in some 300 corn products for people, mainly because of inadvertent commingling with non-StarLink corn, Aventis was forced to buy back all the StarLink from farmers and compensate food producers at an estimated cost of several hundred million dollars (C&EN, Jan. 22, 2001, page 23). 

The Environmental Protection Agency has been unable to determine conclusively whether Cry9C is or is not an allergen. It finally decided there is a "medium likelihood" that Cry9C protein is an allergen, but a "low probability" that allergic responses would occur in populations exposed to the very low levels in the food supply. The main reason the agency had so much difficulty making decisions about StarLink was a lack of scientific knowledge about  how to test for allergenicity, says Linda S. Birnbaum, director of the Human Studies Division at EPA's National Health & Environmental Effects Research Laboratory.

TO AVOID FUTURE StarLink-like imbroglios, and to preserve the advantages of growing genetically engineered crops, federal agencies are trying to work out an allergenicity testing protocol to use in regulating  genetically engineered foods. To aid in this effort, EPA, the National  Institutes of Health, and the Food & Drug Administration held a conference on Dec. 10-12 in Chapel Hill, N.C. Among the problems discussed were how to tell if a protein is a potential allergen and what animal models might be used to screen products for possible human problems.

Attending the meeting were a wide variety of allergy experts, EPA and FDA regulators, and scientists from public interest groups. During the conference, they formulated a broad list of research projects that could help in developing a solid testing protocol for allergenicity. In a few months, a report from the meeting will be sent to EPA, NIH, and FDA in the hope that they will fund research in the areas that could be most  helpful in allergenicity testing, said Lynn R. Goldman, a professor of environmental science at Johns Hopkins University Bloomberg School of Public Health who was one of the conference
organizers.

This was not the first conference to discuss the potential allergenicity of transgenic food. A year ago, the United Nations Food & Agriculture Organization and the World Health Organization jointly sponsored a meeting in Europe and worked out a decision tree for assessing whether a particular genetically modified food is likely to cause allergic reactions.

But the decision tree is controversial, in part because the science behind several individual parameters in the scheme is not definitive.

It is easy to test for known allergens. For example, when a gene from the brazil nut was inserted into a soybean, a common test for known allergic reactions immediately showed that the brazil nut allergen had been transferred to the soybean, and the development of that particular transgenic soybean ceased.
But if the potential allergen is new, its allergenicity cannot be established or disproved with any standard test.

At the conference, Dean D. Metcalfe, chief of the Laboratory of Allergic Diseases at the National Institute of Allergy & Infectious Diseases, explained many of the unknowns about allergies that would apply to potential allergens from genetically engineered food. For example, most allergens are proteins, and two of the predictors of allergenicity are thought to be resistance to digestion and amino acid sequence homology with known allergens. But it is unclear how resistant to digestion a protein must be in order to be an allergen, and it is also unclear what  degree of sequence similarity a potential allergen must have to a known allergen to raise concern, he said.

ANOTHER AREA in need of more research is mechanisms for cross-reacting allergens, Metcalfe said. For example, many people who are allergic to birch trees also become allergic to apples and pears. But  there is no definitive way to screen for cross-reactivity. Also, there are no well-developed animal models to use in allergenicity testing, Metcalfe claimed.

And finally, while some food allergens are allergen-specific immunoglobin E (IgE) mediated--that is, they elicit IgE antibody responses--others are non-IgE mediated. Both of these mechanisms are poorly understood, especially non-IgE mediation, Metcalfe said. In addition, "we need to understand thresholds for sensitization to food allergens and thresholds for elicitation of a reaction with food allergens," he said.

Resistance to digestion is considered one of the characteristics shared by food allergens. However, this assumption may not apply to all of them, said Tong-Jen Fu, a research scientist at FDA. Her research has shown that a wide range of digestive stabilities are exhibited among food allergens. Also, digestion degradation products as small as 1 kilodalton--roughly eight amino acids--can be allergens, she said. "Allergens can be more stable or less stable than nonallergenic proteins in regard to digestion," she said.

PART OF THE PROBLEM with research on digestive stability of allergens is that the assay conditions have not been standardized, Fu said. Because of these inconsistencies, "research is needed to validate the notion that stability to digestion in the human gastrointestinal system is related to food allergy," she said.

Katherine Sarlo, principal scientist in the department of human and environmental services at Procter & Gamble, explained that P&G has been experimenting with animals for years to test  for allergic reactions to the enzymes it uses in its detergents. She suggested that a similar approach might be used to investigate potential allergic reactions to genetically engineered food.
In the 1960s when P&G first started using enzymes in detergents, many of its workers developed allergies to the enzymes, Sarlo said. In some plants, up to 50% of the workers had become sensitized to the enzymes, and a large proportion developed occupational asthma.

At this time, P&G began using certain strains of guinea pigs and mice to test the allergenicity of enzymes. The guinea pigs showed an immunoglobin G (IgG) response to the enzymes that caused allergic reactions in some workers, and the mice showed both IgG and IgE responses to the enzymes. In choosing the strains of lab animal, P&G made sure the animals' responses toenzymes correlated with human responses, Sarlo said.

With a combination of lab animal research and medical surveillance of workers, P&G found that if it kept nominal levels of enzymes below 5 ng per m3, only 3% of the workers would become sensitized to the enzymes each year, and virtually none would exhibit allergic symptoms, Sarlo said. "The thresholds for sensitization are lower than the thresholds for symptomology. Now, a small fraction of workers are still getting sensitized but are not exhibiting symptoms," she explained.

Bob B. Buchanan, professor of plant and microbial biology at the University of California, Berkeley, described his research on allergies in dogs. Dogs are a useful animal model for studying human allergens, he said, because dogs and humans share many characteristics. The set of substances that cause common allergic reactions in dogs is almost the same as the set of common human allergens, and the relative strength of individual allergens is the same in dogs  as it is in humans. Also, allergy symptoms in dogs and humans are nearly identical, and the gastrointestinal systems of the two have many similar properties.

Buchanan has found that if the small protein thioredoxin is given to dogs allergic to milk, it reacts with a major milk allergen, b-lactoglobulin, and reduces vomiting and diarrhea.

In related work, he has introduced the thioredoxin gene into wheat in an attempt to make hypoallergenic wheat for dogs. The results of this research are not yet in. Buchanan's work may eventually have a double benefit. "It may be a good way to assess the allergic potential of genetically engineered foods, and it may help prevent allergies in dogs," he said. About 10 to 15% of dogs in the U.S. have allergies, most often to soy or corn.

Ricki M. Helm, an immunologist at Arkansas Children's Hospital Research Institute, said that swine have many advantages as an animal model for allergens. Like humans, swine develop the allergic symptoms, such as rhinitis, runny noses, and diarrhea, to food and environmental allergens. With skin tests, pigs show positive responses to allergen extracts. Also, their anatomy, physiology, and nutritional requirements are very similar to humans, and their immune systems mature in much the same way as
human immune systems.

IN SWINE TESTS that Helm conducted for peanut allergy, piglets were sensitized to peanuts by giving them large doses soon after birth. Later they were exposed to high levels of peanuts, and many exhibited allergic symptoms, such as rashes and puffiness around the eyes. No animal was allowed to go into anaphylactic shock. The research on peanut allergies in swine may help in understanding and preventing peanut allergies in children, he said. It also shows that swine may be useful for testing the allergenic potential of transgenic food.
Speakers at the meeting disagreed about whether political leaders and the public would ever condone studies conducted on people to see whether they respond to potential food allergens. "Use of serum from people who have allergies may be the closest we ever get to human testing," said Steven M. Gendel, chief of FDA's Biotechnology Studies Branch.

But some participants said double-blind placebo-controlled food challenges (DBPCFCs) are the only way to determine conclusively whether an individual is reacting to a particular food. "I disagree with the idea that it is unethical to do DBPCFCs on people to possible allergens," said I. Leonard Bernstein, professor of clinical medicine at the University of Cincinnati College of Medicine. "Once you find a suspicious case, it is unethical not to do the challenges," he said, "because you can miss an allergy with a skin test." But DBPCFCs should not be used to screen the general population, he warned.

"Ultimately, we will have to rely on human studies to answer questions once and for all," said Robert G. Hamilton, director of the Johns Hopkins University Dermatology, Allergy & Clinical Immunology Reference Laboratory. "Limited clinical study of humans consuming approved genetically modified foods will be necessary," he said.

The meeting participants laid out a broad list of research projects that could help strengthen the regulation of transgenic food. Some of them are to identify and characterize known food allergens, develop clinically well-defined human serum banks to use in testing potential allergens, make available purified allergenic proteins for further development of animal models, and study how specific levels of IgE correlate with clinical disease. The conference proceedings and entire list of research needs will be published this year in Environmental Health Perspectives.

Val Giddings, vice president for food and agriculture at the Biotechnology Industry Organization, stressed that it may not be necessary to know the answers to all the research questions to ensure safety of transgenic food if the novel protein in the food is easily digested and not structurally similar to known allergens. "Some parties will say, 'These products should not be approved until you know all the answers,' " he said. But Giddings added that the lack of complete answers to all research issues should  not prevent approval of all genetically engineered food products.
 

STARLINK CORN
CONTAINING PLANT INCORPORATED PESTICIDE Cry9C


The John Snow East-West Sleza Summit Conference

(2a)

Better testing needed for GM foods - UK scientists 

LONDON - British scientists called this week for more rigorous, explicit and comprehensive checks of foods made from genetically modified (GM) crops before they are sold to consumers.

A report by Britain's Royal Society of leading scientists said improvements in testing were needed, particularly if GM products are to be added to infant formula in the future.

"There is no reason to question the safety of foods made from GM ingredients that are currently available, nor to believe that genetic modification makes foods inherently less safe than their counterparts," said Dr Jim Smith, who chaired the committee that produced the report.

But he said regulations were not clear enough and there were important gaps and inconsistencies between countries.

"It is important that we get the regulations tight," Smith told a news conference, adding that the criteria of assessing safety should be made explicit and objective.

The report assessed all the scientific evidence available since 1998 on GM plants, whose genes have typically been engineered to enhance such attributes as resistance to pests or herbicide.

British and EU laws should ensure that rigorous tests are conducted if GM ingredients are used in infant formula, because babies are very vulnerable to changes in the nutritional content of their diet, it added.

New drugs undergo years of rigorous tests on animals and humans before they are approved for general use. The safety of GM plants is determined by a looser measure known as "substantial equivalence", showing a genetically modified plant is chemically similar to its natural equivalent.

But scientists and environmentalists have criticised substantial equivalence, saying it is too subjective and not accurate enough.

Smith and his colleagues said new genetic screening techniques that will detect very subtle differences between GM and natural foods will improve "substantial equivalence" but the criteria must be objective, comprehensive and consistent.

"New technology can give us a more explicit fingerprint of the GM and non-GM plants," Dr Clare Mills, of Britain's Institute of Food Research, explained.

The report concluded that DNA from viruses used in GM plants during the modification technique or eating food containing plant DNA that had been modified would not be harmful to humans.

It also called for screening of all new foods for allergic reactions, including risks from inhaling.

Current tests are only done on GM ingredients that are eaten, but the report said there could be risks of allergic reactions among people growing the plants who breathed in pollen and dust.
 


 


 
 

AN OLD MAP OF SIL
ESIA

old map of Lower Silesia from Wroclaw to Sudety Mts


 
 

AN OLD MAP OF MT SLEZA


old map of Mt Sleza Group Lower Silesia Poland


 
  DETAILED AND ILLUSTRATED INFO ON SLEZA MT
Mt Sleza  Silesian Sleza Mountain
 
THE STRUGGLES FOR POLAND

BY NEAL ASCHERSON

excerpts of  the 
First American Edition
Random House Inc.,
New York 1988

web page
 


 



 
 

HEALTH AND ENVIRONMENT
IN EASTERN EUROPE TEN YEARS AGO
more
in Letters from Poland
by Karin Chopin
British Medical Journal 1992
read


National Geographic 
Volume 179, No. 6   JUNE 1991
pp. 44-45

Pollution's long shadow

From the Baltic to the Black Sea, half a century of runaway industrialization has left a smear of destruction through the heart of Eastern Europe. Under orders from Moscow, factories appeared where only farms and markets had stood. The historic university of Krakow  was "given" the huge Nowa Huta steelworks simply because the Stalinist regime mistrusted the city's intellectual elite. Now the city lies within "the dirty triangle" formed by Poland, Czechoslovakia, and eastern Germany - a region of dense population where pollution controls are often nonexistent". Eastern Europe's network of rivers has become a convenient method of disposal - especially the Danube, recipient of eight nations' waste.


 
 
 
National Geographic 
Volume 179, No. 6   JUNE 1991
pp. 44-45

ACID RAIN

Already choking on its own waste, Eastern Europe is also the acid rain dumping ground for the West, thanks to winds that bring pollutants from as far as Britain. In Poland more than 600,000 acres of woodland have been damaged; in Czechoslovakia, close to one million acres.

HEALTH AND ENVIRONMENT
IN EASTERN EUROPE NOW

BBC, 23 MARCH 2002

Environmentalists mull river clean-up

By Nick Thorpe 
Tirgu Mures, Romania 
Thousands of fish were killed in the cyanide spill

Environmentalists from East and Central Europe are meeting in the Romanian city of Tirgu Mures to discuss ways to clean up the heavily polluted rivers of the region. 

Two years have passed since cyanide and heavy metals from Romanian mines devastated life in the Tisza river. 

Scientists co-operate closely to monitor the state of the rivers, but are asking their governments to do more to enforce existing laws to protect the environment. 

"Let the rivers run free and clean" is the title of the conference in Tirgu Mures. 

Environmentalists from Romania, Hungary, Slovakia and Ukraine have been working closely together for the past decade, gathering and publishing details of the flora and fauna of the many rivers flowing down from the Carpathian mountains. 

Prevention 

This conference is a chance to pool their experiences and appeal to the governments and water management authorities, who are also taking part in the conference, to prevent further disruption. 

The problems of the rivers, highlighted by the cyanide and heavy metal spills two years ago, are enormous. 

Gravel and sand extraction have scraped the riverbed down to the bedrock in places, speeding up the flow of rivers and leaving little for fish to feed on. 

Deforestation in Ukraine and Romania cause floods each spring. 

External pressure 

Waste from mines and other industries and nutrients from sewage and agriculture also cause serious harm. 

On the positive side, the desire of all the countries in the region to join the European Union means outside pressure to impose stricter environmental standards. But the cost often makes that difficult. 

The environmentalists meeting in Tirgu Mures hope that increased public awareness of the problems at home and abroad will help save this still beautiful but badly damaged region. 


 
 
 
The John Snow East-West Sleza Summit Conference


Precautionary Principle
expresses the need for the authorities to take measures (under certain conditions), in order to prevent potentially serious risks, 
even in the absence of full scientific knowledge.
Only food or other product or service 
that is demonstrably safe should be sold

Press release

Commission adopts Communication on Precautionary Principle

Brussels, 2 February 2000

The European Commission has today adopted a Communication on the use of the precautionary principle. The objective of the Communication is to inform all interested parties how the Commission intends to apply the principle and to establish guidelines for its application. The aim is also to provide input to the on-going debate on this issue both at EU and international level. The Communication underlines that the precautionary principle forms part of a structured approach to the analysis of risk, as well as being relevant to risk management. It covers cases where scientific evidence is insufficient, inconclusive or uncertain and preliminary scientific evaluation indicates that that there are reasonable grounds for concern that the potentially dangerous effects on the environment, human, animal or plant health may be inconsistent with the high level of protection chosen by the EU. Today's Communication complements the recently adopted White Paper on Food Safety and the agreement reached in Montreal this week-end on the Cartagena Protocol on Bio-safety.

The Communication also qualifies the measures that may be taken under the precautionary principle. Where action is deemed necessary, measures should be proportionate to the chosen level of protection, non-discriminatory in their application and consistent with similar measures already taken. They should also be based on an examination of the potential benefits and costs of action or lack of action and subject to review in the light of new scientific data and should thus be maintained as long as the scientific data remain incomplete, imprecise or inconclusive and as long as the risk is considered too high to be imposed on society. Finally, they may assign responsibility or the burden of proof - for producing the scientific evidence necessary for a comprehensive risk assessment. These guidelines guard against unwarranted recourse to the precautionary principle as a disguised form of protectionism.

Today's Communication was presented to the Commission by Mr Erkki Liikanen, Enterprise and the Information Society Commissioner, Mr David Byrne, Health and Consumer Protection Commissioner, and Ms Margot Wallström, Environment Commissioner. It is a follow-up to President Romano Prodi's speech to the European Parliament on 5 October 1999.

The Communication recalls that a number of recent events have undermined the confidence of public opinion and consumers because decisions or absence of decisions were not supported by full scientific evidence and the legitimacy of such decisions was questionable.

The Commission has consistently striven to achieve a high level of protection, inter alia in the environmental and human, animal and plant health fields. It is the Commission's policy to take decisions aimed to achieve this high level of protection on a sound and sufficient scientific basis. However, where there are reasonable grounds for concern that potential hazards may affect the environment or human, animal or plant health, and when at the same time the lack of scientific information precludes a detailed scientific evaluation, the precautionary principle has been the politically accepted risk management strategy in several fields.

Although the precautionary principle is not explicitly mentioned in the EC Treaty except in the environment field, the Commission considers that this principle has a scope far wider than the environment field and that it also covers the protection of human, animal and plant health.

The Communication makes it clear that the precautionary principle is neither a politicisation of science or the acceptance of zero-risk but that it provides a basis for action when science is unable to give a clear answer. The Communication also makes it clear that determining what is an acceptable level of risk for the EU is a political responsibility. It provides a reasoned and structured framework for action in the face of scientific uncertainty and shows that the precautionary principle is not a justification for ignoring scientific evidence and taking protectionist decisions.

The horizontal guidelines established in this Communication will provide a useful tool in the future for taking political decisions in this regard and will contribute to legitimate decisions taken when science is unable to assess completely the risk rather than decisions based on irrational fears or perceptions. Thus, one of the objectives of the Communication is to clearly describe the situations in which the precautionary principle could be applied and determining the scope of measures taken in this respect. It will therefore help ensuring the proper functioning of the Internal Market as well as a high level of protection and predictability for consumers and economic operators located in the EU and elsewhere.

Annex

Communication from the Commission on the precautionary principle

SUMMARY

1. The issue of when and how to use the precautionary principle, both within the European Union and internationally, is giving rise to much debate, and to mixed, and sometimes contradictory views. Thus, decision-makers are constantly faced with the dilemma of balancing the freedom and rights of individuals, industry and organisations with the need to reduce the risk of adverse effects to the environment, human, animal or plant health. Therefore, finding the correct balance so that the proportionate, non-discriminatory, transparent and coherent actions can be taken, requires a structured decision-making process with detailed scientific and other objective information.

2. The Communication's fourfold aim is to:

- outline the Commission's approach to using the precautionary principle,

- establish Commission guidelines for applying it,

- build a common understanding of how to assess, appraise, manage and communicate risks that science is not yet able to evaluate fully, and

- avoid unwarranted recourse to the precautionary principle, as a disguised form of protectionism.

- It also seeks to provide an input to the ongoing debate on this issue, both within the Community and internationally.

3. The precautionary principle is not defined in the Treaty, which prescribes it only once - to protect the environment. But in practice, its scope is much wider, and specifically where preliminary objective scientific evaluation, indicates that there are reasonable grounds for concern that the potentially dangerous effects on the environment, human, animal or plant health may be inconsistent with the high level of protection chosen for the Community.

The Commission considers that the Community, like other WTO members, has the right to establish the level of protection - particularly of the environment, human, animal and plant health, - that it deems appropriate. Applying the precautionary principle is a key tenet of its policy, and the choices it makes to this end will continue to affect the views it defends internationally, on how this principle should be applied.

4. The precautionary principle should be considered within a structured approach to the analysis of risk which comprises three elements: risk assessment, risk management, risk communication. The precautionary principle is particularly relevant to the management of risk.

The precautionary principle, which is essentially used by decision-makers in the management of risk, should not be confused with the element of caution that scientists apply in their assessment of scientific data.

Recourse to the precautionary principle presupposes that potentially dangerous effects deriving from a phenomenon, product or process have been identified, and that scientific evaluation does not allow the risk to be determined with sufficient certainty.

The implementation of an approach based on the precautionary principle should start with a scientific evaluation, as complete as possible, and where possible, identifying at each stage the degree of scientific uncertainty.

5. Decision-makers need to be aware of the degree of uncertainty attached to the results of the evaluation of the available scientific information. Judging what is an "acceptable" level of risk for society is an eminently political responsibility. Decision-makers faced with an unacceptable risk, scientific uncertainty and public concerns have a duty to find answers. Therefore, all these factors have to be taken into consideration.

In some cases, the right answer may be not to act or at least not to introduce a binding legal measure. A wide range of initiatives is available in the case of action, going from a legally binding measure to a research project or a recommendation.

The decision-making procedure should be transparent and should involve as early as possible and to the extent reasonably possible all interested parties.

6. Where action is deemed necessary, measures based on the precautionary principle should be, inter alia:

- proportional to the chosen level of protection,

- non-discriminatory in their application,

- consistent with similar measures already taken,

- based on an examination of the potential benefits and costs of action or lack of action (including, where appropriate and feasible, an economic cost/benefit analysis),

- subject to review, in the light of new scientific data, and

- capable of assigning responsibility for producing the scientific evidence necessary for a more comprehensive risk assessment.

Proportionality means tailoring measures to the chosen level of protection. Risk can rarely be reduced to zero, but incomplete risk assessments may greatly reduce the range of options open to risk managers. A total ban may not be a proportional response to a potential risk in all cases. However, in certain cases, it is the sole possible response to a given risk.

Non-discrimination means that comparable situations should not be treated differently, and that different situations should not be treated in the same way, unless there are objective grounds for doing so.

Consistency means that measures should be of comparable scope and nature to those already taken in equivalent areas in which all scientific data are available.

Examining costs and benefits entails comparing the overall cost to the Community of action and lack of action, in both the short and long term. This is not simply an economic cost-benefit analysis: its scope is much broader, and includes non-economic considerations, such as the efficacy of possible options and their acceptability to the public. In the conduct of such an examination, account should be taken of the general principle and the case law of the Court that the protection of health takes precedence over economic considerations.

Subject to review in the light of new scientific data, means measures based on the precautionary principle should be maintained so long as scientific information is incomplete or inconclusive, and the risk is still considered too high to be imposed on society, in view of chosen level of protection. Measures should be periodically reviewed in the light of scientific progress, and amended as necessary.

Assigning responsibility for producing scientific evidence is already a common consequence of these measures. Countries that impose a prior approval (marketing authorisation) requirement on products that they deem dangerous a priori reverse the burden of proving injury, by treating them as dangerous unless and until businesses do the scientific work necessary to demonstrate that they are safe.

Where there is no prior authorisation procedure, it may be up to the user or to public authorities to demonstrate the nature of a danger and the level of risk of a product or process. In such cases, a specific precautionary measure might be taken to place the burden of proof upon the producer, manufacturer or importer, but this cannot be made a general rule.

Released on 14/02/00

TRANSGENIC PRODUCTS' POLICIES



"Organic farming in an enlarged European Union"Conference

The John Snow International Society's Position presented on an international conference , "Organic farming in an enlarged European Union",  1-2 March, 2002, Warsaw, Ujazdowski Castle, Poland.

The aim of the conference was to strengthen organic agriculture as the alternative method of environmentally and consumer-friendly agriculture. This conference was organised under the patronage of Aleksander Kwaœniewski, President of Poland, by the Heinrich Böll Foundation, and IUCN The World Conservation Union, Office for Central Europe in the cooperation with IFOAM (The International Federation of Organic Agricultural Movements) and organic producer organisations: Biokultura from Hungary, Ekoland from Poland, Ekotrend from Slovakia and Pro-Bio from Czech Republic. The participation of high-ranking officials should give positive impetus for policy and public relations. Ministers and decision-makers from certain Central and East European countries took part in the conference.The conference was a successful dialogue on different political levels and the exchange of experience. The results of the conference will be presented to the national decision-makers and public relations in form of a “Warsaw Declaration”.

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The John Snow International Society's Position presented on 
an international conference "Organic farming in an enlarged European Union",
 1-2 March, 2002, Warsaw, Ujazdowski Castle, Poland

Substantial equivalence of natural and transgenic products 
- need for European laboratory network

Consumers pay extra money for organic foods hoping for their wholesomeness and safety. These categories of food quality are far beyond reach of human senses' analytical ability and what we see, smell and taste usually proves as much misleading as many of advertisements that reveal only bright side of an offered product. To uncover the other side we need to apply more and more sophisticated quality assurance protocols.  Unwillingly consumers are being forced to pay even more for health quality of their food. Genetic pollution is to be blamed for. The most vulnerable sector of agriculture which is organic (natural) farming must be aware of emerging risks and ready to face them.

In May 1999, the British Medical Association called for an open-ended moratorium on the commercial planting of genetically modified crops until there is a scientific consensus on their long-term environmental effects. The same month in Poland, the Consumers' Health Protection Association found numerous gaps in the national food safety systems and demanded from Polish Government ministers to ban introducing transgenic organisms into human food chain.  That time physicians were concerned of  the  use of antibiotic resistant marker genes in genetically modified food as the risk to human health from  antibiotic resistance is one of the major public health threats we face in the 21st century. Uncontrolled spread of antibiotic resistance through cross-pollination and food itself, the threat of new allergic reactions, and the unknown hazards of transgenic DNA made perspective of irreversible impact of transgenic products on human health and the environment totally unacceptable. 

In February 2000, the European  Commission adopted Communication on the use of the precautionary principle: only food or other product or service that is demonstrably safe should be sold.. Precautionary principle expresses the need for the authorities to take measures (under certain conditions), in order to prevent potentially serious risks, even in the absence of full scientific knowledge. The precautionary principle should be considered within a structured approach to the analysis of risk which comprises three elements: risk assessment, risk management, risk communication. The precautionary principle is particularly relevant to the management of risk. It covers cases where scientific evidence is insufficient, inconclusive or uncertain and preliminary scientific evaluation indicates that that there are reasonable grounds for concern that the potentially dangerous effects on the environment, human, animal or plant health may be inconsistent with the high level of protection chosen by the European Union.

Apparently precautionary principle had been not applied yet if US Environmental Protection Agency, the National  Institutes of Health, and the Food & Drug Administration as late as mid-December 2001 held a conference  in Chapel Hill, N.C., to discuss  how to tell if a protein is a potential allergen and what animal models might be used to screen products for possible human problems. A wide variety of allergy experts, EPA and FDA regulators, and scientists from public interest groups formulated a broad list of research projects which could help in developing a solid testing protocol for allergenicity of new and unexpected allergens. The StarLink corn affair indicated that substantial inequivalence of natural and transgenic products is becoming an epidemiological emergency and may influence pathology of living organisms.

In their report on transgenic foods (April 2000), US National Academy of Sciences discussed a critical issue of pleiotropy which is creation of multiple effects within an organism by adding a single new gene. The mechanism for creating unexpected proteins or unexpected toxins or allergens produces a lot of risks: 

  • new allergens may be introduced into foods and  into pollen, then spread into the environment. 
  • new toxins may be introduced into foods; there is reason to expect that organisms in agroecosystems and humans could be exposed to new toxins when they associate with or eat these plants.
  • existing toxins in foods may reach new levels, or may be moved into edible portions of plants; overall increases in the concentrations of secondary plant chemicals in the total plant might cause toxic chemicals that are normally present only in trace amounts in edible parts to be increased to the point where they pose a toxic hazard.
  • previously unknown protein combinations now being produced in plants might have unforseen effects when new genes are introduced into the plants
  • nutritional content of a plant may be diminished.
The broad use of GMO in research and in agrobiotechnology have forced to develop the methods for transgene identification and transgenic organism analysis.

The first is already well established and is developing along the transformation methods improvement. The long time experience in GMO identification led us to important suggestion that the procedure must be additionally based on positive control which is transgenic organism itself. As an example, convincing data on the input of transgenic rye in the feed/food can be provided only when transgenic rye, served as a positive control, is investigated. The ignoring of such a control often resulted in  false GMO identification in food and feed. Thus, the reference laboratory must have its own created or available from other laboratories of network respective transgenic organisms served as source of transgene DNA sample.

The second comes from the many published reports since 1992 on unpredictable changes in plants just because they are transformed. These changes concern proteins and metabolites which may affect wide range of environmental situation. Thus, it is suggested that each newly created transgenic line and food/feed with transgenic derived material input, should be analysed for the content of basic metabolites (e.g. hormones, glycoalcaloids, etc.) which potentially may affect the consumer health and environment. It is strongly recommended the use of GC-MS for metabolites profiling and LC-MS for protein analysis before releasing of GMO to the environment or before adding it to food/feed. The quantitative data of such analysis must be provided. However before starting these analyses the optimal level of examined proteins and metabolites should be established. To accomplish these it is recommended to establish the laboratory network. The network then guarantee: 

i. positive control providing (transgenic organism or its genomic DNA sample),
ii. standardization of the methods used (PCR, GC-MS, LC-MS, ELISA, etc.),
iii. provides the data on broad proteins and metabolites analysis.

The laboratory of Department of Genetic Biochemistry Wroclaw University and Institute of Plant Genetics of PAS and the laboratory of Phytochemistry of Institute of Bioorganic Chemistry of Polish Academy of Sciences and some of the EU laboratories are now (within Centre of Excellence) under the process of network creation which will be a good startpoint for deep and perfect analysis of market available food and feed.

dr Zbigniew Halat, MD, Epidemiologist
Consumers' Health Protection Association, Warszawa, Poland
prof. Jan Szopa, Geneticist
Department of Genetic Biochemistry
 Institute of Biochemistry and Molecular Biology, 
University of Wroclaw, Wroclaw, Poland
assist. prof. Maciej Stobiecki, Geneticist
Institute of Bioorganic Chemistry
Polish Academy of Sciences, Poznan, Poland
 

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ENS, June 23, 2003

Global Ag Ministers Assemble for Biotech Promotion

SACRAMENTO, California, June 23, 2003 (ENS) - More than 150 agriculture, science and environment ministers from 112 countries gathered at the Sacramento Convention Center today for the Ministerial Conference and Expo on Agricultural Science and Technology at the invitation of the Bush administration.

The Ministerial Conference and Expo on Agricultural Science and Technology, sponsored by the U.S. Department of Agriculture (USDA), the U.S. Agency for International Development and the U.S. Department of State, was met by protesters opposed to the use of biotechnology used to alter the genetic makeup of food crops.

"We want to bring countries together to launch a major new front in the battle against global hunger and poverty," said U.S. Agriculture Secretary Ann Veneman. "This conference offers policymakers in developing countries a unique opportunity to focus on what science and technology can do for their farmers, their consumers and their countries."

But the initial battle took place on the streets of Sacramento. Protesters took part in an unauthorized demonstration Sunday and an authorized march today. The police were out in force with helicopters, a tank, groups of up to 20 police cars , motorcycles and bicycles on patrol.

The Sacramento Police Department says 48 arrests were made that are associated with the conference protesters - 46 from Sunday and two from today. Those arrested were charged with violations ranging from failing to disburse, possessing a switch blade knife, trespassing, vandalism, and violating a city ordinance.

Demonstrators complained that police either did not audibly order them to disperse, or blocked exit streets when they were trying to obey orders to disperse. A group of young people peaceably assembled on the lawn of Capitol Park having a quiet discussion were attacked this afternoon without warning or direction given for dispersal by police with stun guns.

"We are in Sacramento protesting in part because we want healthy food. Here and around the world, people recognize that their bodies won't function well if fed junk food, be it slaughterhouse meat, genetically modified corn, or whatever," said one demonstrator.

The purpose of the ministerial gathering according to the USDA, is to "support the U.S. commitment to strengthen global food security." But many nongovernmental organizations believe that the conference is an attempt to build support among developing countries for the U.S. positions on genetically engineered crops and free trade - as a build up to the World Trade Organization ministerial meeting in September in Cancun, Mexico.

A public rally organized by nongovernmental organizations Public Citizen and the Sacramento Coalition for Sustainable Agriculture was held today on the west steps of the State Capitol building, near the Sacramento Convention Center, followed by a march through the streets.

Organizers called the rally "a celebration of the diverse movements supporting local, organic sustainable agriculture and opposing the industrial agriculture model and use of genetically modified organisms being advanced by the U.S. government. Speakers and participants included local and developing country farmers and farm workers, scientists, people working for consumer rights to healthy and abundant food, and environmentalists.

Inside the Convention Center, Agriculture Secretary Veneman presented a new report, "21st Century Agriculture: A Critical Role for Science and Technology," to serve as a basis for discussions at the conference.

The report describes the benefits of agricultural technologies such as soil management, water and irrigation management, pest management, nutrition content management and increasing yield potential and other desirable traits in crops.

It also discusses precision farming of crops with the use of computer, telecommunication and satellite technologies, and aquaculture and biotechnology.

The report concludes that with supportive policy, strong regulatory and institutional frameworks, and lower trade and other barriers, science and technology can further increase agricultural productivity and economic growth in both developed and developing countries.

National Science Foundation Director Dr. Rita Colwell delivered the keynote address on the power of genomics research to fuel new discoveries that will help feed the world.

While most European Union countries are listed as governments in attendance in Sacramento, the European Agriculture Commissioner Franz Fischler did not appear, although ministers from some Eastern European countries did show up.

In a phone call to Secretary Veneman, she told reporters, Fischler said the Europeans "were going to be in the throes of their discussions about their Common Agricultural Policy reform, which they have been doing over the last few days. And so, because of that we won't have a lot of participation from people from the European Union. And we're disappointed by that because, clearly, we want to have all regions participate and represented."

The European Union countries have been resisting the import of genetically modified crops and seeds prompted by objections from consumer and environmental organizations who fear the contamination of traditional and organic crops and possible allergic reactions to the biotech foods.

The Bush administration is moving forward with a World Trade Organization (WTO) challenge to the European Union moratorium on approvals of new biotechnology products, an Office of the U.S. Trade Representative spokesman said Thursday.

Richard Mills, assistant trade representative, said the administration decided to act after WTO consultations failed to resolve the dispute. In May the United States joined Argentina and Canada with the support of nine other countries in seeking the consultations, a procedural requirement before requesting a WTO dispute settlement panel.

According to the U.S. complaint, the European Union moratorium on approvals of new biotech products for planting or import violates the WTO agreement on sanitary and phytosanitary measures, which requires "sufficient scientific evidence" for regulations aimed at protecting human health and the environment. It also requires regulatory authorities to operate their approval procedures without "undue delay."

In Washington, DC, today President George W. Bush urged governments to "end their opposition" to biotechnology in order advance the global fight against hunger.

Addressing the Biotechnology Industry Organization's annual convention, Bush said many European governments have blocked the import of new biotech crops based on "unfounded, unscientific fears."

"Because of these artificial obstacles," he said, "many African nations avoid investing in biotechnology, worried that their products will be shut out of important European markets."

"For the sake of a continent threatened by famine I urge the European governments to end their opposition to biotechnology," Bush said.

"America and other wealthy nations have a special responsibility to combat hunger and disease in desperate lands," said Bush, noting that the United States will provide more than $1 billion in food and aid in the coming year.

The U.S. Agency for International Development today announced the Collaborative Agricultural Biotechnology Initiative which is intended to "help developing countries access and manage the tools of modern biotechnology as part of an integrated drive to improve agricultural productivity, environmental sustainability and nutrition," the agency said in a statement.

The initiative includes research and technology development, and the strengthening of public institutions for research, development of policy and regulatory frameworks, informed decision making and public outreach to promote safe use of biotechnology.

Local private sector development will help to deliver new technology and integrate it into local agri-food systems.

These strategies to promote the products of American biotechnology assume that the developing countries want biotech solutions to food shortages. But a new report by nongovernmental organizations Food First and the Pesticide Action Network takes issue with that assumption.

"Voices from the South" advances the view that the multilateral institutions and U.S. policy makers are "in the pockets of those who stand to gain from GM foods - the corporations."

"Massive corporate expenditures on public relations are creating a false sense of need, urgency and safety concerning new technologies. Just one biotech industry consortium, the Council for Biotechnology Information, has a $250 million war chest which has helped it place ads promoting biotechnology on television and in the print media," the report says.

The arguments being used in this publicity effort, the report says, are "green washing - 'biotech will create a world free of pesticides,' poorwashing - 'we must accept genetically engineered foods if we are to feed the poor in the Third World,' and hope dashing - 'there are no alternatives.'"

Family farmers from throughout the United States dumped genetically modified corn today at the Sacramento conference to "expose the distortions and lies being perpetuated by the Bush administration and the biotechnology industry in the promotion of genetically engineered seeds and foods."

“Family farmers have suffered significant economic losses from the use of GE products,” said Walter Kessler, California dairy farmer and vice president of the Family Farm Defenders, “but the truth about GE crops and their impacts on family farmers is being buried in the slick multi-million dollar public relations campaign being waged by the biotechnology industry and promoted by the USDA, primary sponsors of this conference.”

Read "21st Century Agriculture: A Critical Role for Science and Technology" online at: http://www.fas.usda.gov/icd/stconf/pubs/scitech2003/index.htm

Read "Voices from the South" online at: http://www.foodfirst.org/progs/global/ge/sactoministerial/voices.php
 


 
 
 
Scientists suspect health threat from GM maize

John Vidal, environment editor
Friday February 27, 2004
The Guardian

Scientists investigating a spate of illnesses among people living close to GM maize fields in the Philippines believe that the crop may have triggered fevers, respiratory illnesses and skin reactions. 

If preliminary results are confirmed, it would be one of the first recorded cases of serious health problems associated with GM crops, and could damage the reputation of the biotech agriculture industry, which is rapidly expanding in developing countries. 

The scientists' findings were immediately challenged by Monsanto, the world's leading GM company, and by the Philippine government. 

The concern surrounds an unnamed village in northern Mindanao, where 39 people living near a field of Bt maize - which contains a pesticide in the gene - started suffering last autumn when the crop was producing pollen. 

Doctors thought they had an infectious disease, but when four families left the village and recovered, and then showed the same symptoms on return, an environmental cause was suspected. 

Terje Traavik, scientific director of the Norwegian Institute of Gene Ecology, was asked to investigate. Blood tests showed the villagers had developed antibodies to the maize's inbuilt pesticide. 

Professor Traavik, who issued a summary of his results yesterday, said more tests were needed, but felt his preliminary findings were reliable. 

His studies suggest that a virus promoter - which is like a motor driving the production of the genetic message - was unexpectedly found intact in human cells. 

His team also said it had found that genetically engineered viruses used in the GM process recombined with natural viruses to create new hybrid viruses with unpredictable characteristics. If confirmed, this could suggest that they could cause new diseases.

Prof Traavik said tests so far showed evidence of an immune reaction. He will return to the Philippines this week to continue the research before publishing full results in a peer-reviewed scientific journal. 

But he rejected accusations that he was trying to scare people with data not yet reviewed by other scientists. "Publication of results typically requires a waiting period of up to one year or more," he said in Kuala Lumpur. 

"With such evidence of possible human health impacts of foods already on the market, we believed that waiting to report our findings through publication would not be in the public's interest." 

Monsanto said it was "extremely unlikely" that the limited production of the GM crop in the Philippines would have produced such results. 

"There have been no documented cases of allergic reactions to Bt maize after seven years of broad commercial use on millions of hectares in the US, Canada, Argentina, Spain and South Africa, starting in 1996," a spokesman said. 

The company was backed by the government in Manila, which approved GM cultivation last year. 

"It's absurd - no biology student will believe it," said Artemio Salazar, the director of the maize programme of the Philippine department of agriculture. 

"The implication of the study is that the resistant gene got inserted into the human gene, which is impossible." 

Greenpeace called for more research. "There is such a huge amount of uncertainty around these crops," a spokesman said. 

But Willy de Greef, a biotech law consultant formerly employed by the Swiss agrochemicals company Syngenta, expressed surprise at Prof Traavik's findings, saying research showed Bt maize pollen did not carry the toxin so no reaction should occur. "One would want a scientific panel to look at Traavik's results," he told Reuters 
 



 

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