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#51 -- American Nurses Adopt Precaution, 16-Aug-2006

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Rachel's Precaution Reporter #51

"Foresight and Precaution, in the News and in the World"

Wednesday, August 16, 2006...........Printer-friendly version
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Table of Contents...

American Nurses Association Adopts Precautionary Approach
In October, 2003, the American Nurses Association formally adopted
a precautionary approach, focusing on the prevention of hazards. "The
precautionary principle states that if it is within one's power, there
is an ethical imperative to prevent rather than merely treat disease,
even in the face of scientific uncertainty."
The Precautionary Approach; Thinking Like a Nurse
What does it mean for a nurse to take a precautionary approach to
occupational hazards and to the health of patients? Charlotte Brody
and Ann Melamed offer five specific steps a nurse can take to
implement precaution.
The Genetically Modified Foods Debate
Two nurses examine the issues surrounding genetically modified
foods and conclude that, until more is known, a precautionary approach
is called for.
An Important Ruling from the WTO on Genetically Modified Foods
"At the heart of the dispute is the right of countries, in light of
their international trade obligations, to control the introduction
into their markets of GMOs.... The dispute was viewed by some as a
contest between the environmentalists' 'precautionary principle' and
the more traditional view that hard scientific support is needed to
justify banning a product on the basis of health concerns."
'J'accuse!' Says a Canadian to His Government
"I accuse the governments, federal and provincial, of deliberately
covering up environmental degradation that will, given just a little
more time, make this world unlivable."
Enforcing the 'Polluter Pays' Principle in South Africa
"While the polluter pays principle is part of South Africa's legal
framework, cases tying emissions to particular companies are rare due
to lack of monitoring and data collection."

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From: American Nurses Association, Oct. 15, 2003
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AMERICAN NURSES ASSOCIATION ADOPTS PRECAUTIONARY APPROACH

EXECUTIVE SUMMARY: This report provides background information and
direction for the American Nurses Association's (ANA) environmental
safety policy formation and advocacy through a precautionary approach
that focuses on prevention of hazards. The precautionary principle
states that if it is within one's power, there is an ethical
imperative to prevent rather than merely treat disease, even in the
face of scientific uncertainty. The ANA Board of Directors adopted the
precautionary approach in October 2003.

1. ANA will broaden its work in occupational and environmental health
and apply a precautionary approach when an activity raises threats of
harm to human health or the environment.

2. ANA will advocate for public policy that utilizes the precautionary
approach that focuses on prevention of hazards to people and to the
natural environment.

ISSUE STATEMENT:

While Florence Nightingale spoke about the importance of clean air,
water and environment; modern day nursing has not paid as much
attention to the relationship between health and the environment.
ANA's involvement in environmental health has focused on the work
environment (occupational health and safety) and the toxic byproducts
of the health care environment. ANA's work on the environmental
impacts of the health care industry has been implemented primarily
through ANA's membership and involvement in the international
coalition, Health Care Without Harm (HCWH), the campaign for
environmentally responsible health care (www.noharm.org). As a result
of the success of the Health Care Without Harm coalition, and
visibility of ANA in HCWH and the Hospitals for a Healthy Environment
(H2E) partnership (www.h2e-online.org), ANA is increasingly in demand
to be a leader in environmental health issues.

ANA needs to develop a foundation in policy for these activities
beyond the 1997 House of Delegates Report: Reduction of Health Care
Production of Toxic Pollution, incorporating the recommendations from
the 1995 Institute of Medicine Report: Nursing, Health and the
Environment.

BACKGROUND ON ENVIRONMENTAL HEALTH & NURSING:

In 1860, Florence Nightingale provided the foundation for nursing
attention to environmental exposures and health effects when she wrote
about the need for fresh air and clean water in Notes on Nursing
(Nightingale, 1860).

The International Council of Nursing (ICN) published a position
statement in 1986, The Nurse's Role in Safeguarding the Human
Environment. It states: "The preservation and improvement of the human
environment has become increasingly important for man's survival and
well-being. The vastness and urgency of the task place on every
individual and every professional group the responsibility to
participate in the efforts to safeguard man's environment, to conserve
the world's resources, to study how their use affects man, and how
adverse effects can be avoided."

This position statement was incorporated into the recommendations of
the Institute of Medicine (IOM) Committee on Enhancing Environmental
Health Content in Nursing Practice published in 1995 in its report:
Nursing, Health and the Environment (IOM, 1995). The IOM report
recommended environmental health competencies for nurses to include:
1) Basic knowledge and concepts; 2) assessment and referral; 3)
advocacy, ethics, and risk communication; and 4) legislation and
regulation. That same year the National Institute of Nursing Research
(NINR) convened a second workgroup to develop an environmental health
research agenda for the profession. The group emphasized that because
nurses are employed in so many settings, the profession is uniquely
suited to conduct applied research addressing the impact of
environmental hazards on vulnerable populations and communities.

Precautionary Principle

The precautionary principle is explained thus: "when an activity
raises threats of harm to human health or the environment,
precautionary measures should be taken even if some cause and effect
relationships are not fully established scientifically"
(http://gdrc.org/u-gov/precaution-3.html). The principle includes
taking action in the face of uncertainty; shifting burdens of proof to
those who create risks; analysis of alternatives to potentially
harmful activities; and participatory decision-making methods. The
precautionary principle takes the life cycle of products or chemicals
into account and adds the proactive step of pre-market analysis of
environmental harm.

CONCLUSION STATEMENT:

As nurses, who are educated in disease prevention, we can appreciate
and should advocate for a precautionary approach when it may prevent
injuries and illness. Nurses, as trusted and credible sources of
information and education regarding environmental health issues, have
the potential to lead patients and communities. ANA can assist nurses
in educating and guiding policy makers, including elected officials,
to a new way to see the relationship between life's choices (both
individual and societal) and their impact on health.

ANA will advocate for a precautionary approach to environmental health
that provides an opportunity for prevention instead of focusing most
of our resources on curing disease resulting from preventable
exposures.

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From: American Journal of Nursing (Vol. 4, #4), Mar. 1, 2004
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THE PRECAUTIONARY APPROACH; THINKING LIKE A NURSE

By Charlotte Brody, RN, and Ann Melamed, MA, RN

Q. I heard that the ANA [American Nurses Association] adopted the
"precautionary approach" to address environmental health hazards. What
does this mean?

A. In October 2003 the ANA board of directors adopted the
"precautionary approach" based on the "precautionary principle"
developed by German policymakers in the 1970s to address strongly
suggestive but unproven links between air pollution and the death of
trees. The result of this effort to save trees includes principles
that nurses promote daily: early detection and monitoring; reduction
of stressors; preventive action where the likely benefit justifies the
costs; and reducing risks before full proof of harm is available if
the effects could be serious or irreversible.

In "Late Lessons from Early Warnings: The Precautionary Principle
1896-2000," a review of radiation illustrates what can happen when we
wait for irrefu--table proof before taking preventive action. Thomas
Edison warned about the harm that could result from overexposure to X-
rays in 1896, only a few years after the discovery was made. The
possibility of fetal damage from pelvimetry (an X-ray method of
diagnosing pregnancy) was documented as early as 1908. These warnings
continued to be discounted, though, and it was only after other
studies affirmed these findings that the practice of pelvimetry
stopped and requirements were added to other medical exposures to
radiation. By then, the damage had been done. A 1989 study estimated
that 5% of all childhood cancers were caused by pelvimetry. If health
care practitioners and the government had heeded the warnings 30, 40,
or 50 years earlier, how many cases of cancer could have been
prevented? The history of radiation shows how the precautionary
principle could have been used to prevent, not merely treat, disease.

Through the ANA's long involvement with coalitions, including Health
Care Without Harm, occupational health and pollution prevention are
being promoted simultaneously. As part of the ANA's prevention
philosophy, when research demonstrates a possible toxic relationship
between chemical exposure and health effects, nursing should be an
advocate for a precautionary approach. Actions should include
reduction or elimination of exposures as well as continued scientific
investigations.

Nurses can implement the precautionary approach in their work and
apply it to all areas of nursing practice, policy, research,
education, and workplace strategies. Here are five activities to help
apply the precautionary approach in nursing practice.

** Get involved on product committees and be an advocate for reviewing
the potential effects of new and old products and therapies on workers
and the environment before they are implemented.

** Negotiate contract language that includes staff nurse input on
product selection with criteria that includes patients, workers, and
long-term environmental impact.

** Organize a product fair with PVC- and DEHP-free products and
include educational materials about their hazards. Develop a plan to
phase out the use of PVC, beginning with the NICU [neonatal intensive
care unit] and maternal-child units.

** Research alternatives (see www.sustainablehospitals.org) to toxic
cleaning products, disinfectants, and sterilants and develop a plan to
use them instead.

** Encourage nursing research to "clarify the complex relationship
between human disease and the physical and biological effects of
environmental hazards with the goal of facilitating social and
behavioral changes," as stated in the 1995 Institute of Medicine
report.

Using a precautionary approach will help all of us see through the fog
of controversy to discern what the science is trying to show. Then we
can determine what we can reasonably do to protect ourselves and our
planet. What better way to celebrate Earth Day on April 30?

Resources

Institute of Medicine (IOM) Report, 1995. Nursing, Health and the
Environment
. Washington, DC: National Academy Press.

Late Lessons from Early Warnings: The Precautionary Principle
1896-2000
. Environmental issue report no. 22, European environmental
agency.

Wingspread Statement on the Precautionary Principle.

Charlotte Brody is coexecutive director of Health Care Without Harm
(www.noharm.org) and executive director of Commonweal
(www.commonweal.org). Ann Melamed is an environmental health
specialist with the ANA.

Copyright 2006 The American Nurses Association, Inc.

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From: Maryland Nurse, Feb. 1, 2005
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THE GENETICALLY MODIFIED FOODS DEBATE

By Katie Huffling, RN, BSN and Barbara Sattler, PhD, RN, FAAN

Over the past few years there has been growing controversy over
genetically modified foods. Unfortunately, it can be difficult to find
independent, scientifically rigorous information about this hotly
debated topic. As nurses, our patients, families, and friends look to
us for information regarding a variety of health matters, including
nutrition; yet many of us have not been formally educated about
nutrition. By educating ourselves about this important subject, we can
become advocates for our communities and ourselves in regards to
genetically modified foods.

Genetically modified foods are described in the literature under a
variety of other names. These all refer to the same process. They
refer to the selection of desired traits from one organism and its
genetic placement into another organism. Theoretically, genetically
modified foods have the potential to be very beneficial. For example,
traits that make plants resistant to harmful insects can be inserted,
nutrients that were not previously in that particular plant may be
added, or modifications can be made to improve the ability of a plant
to grow in regions of the world where the conditions are inhospitable
to the growth of traditional, non-modified plant varieties.
Genetically modified foods have been increasingly used by farmers and
were grown on over 109 million acres in 2001 and over half of the soy
grown worldwide has been genetically engineered. So why is there so
much controversy surrounding genetically modified foods? In order to
understand the differing views one should first know how genetically
modified foods are made.

The method of genetically modifying foods is a highly technical
process. In order to produce the desired trait, many different genes,
from a variety of organisms, need to be inserted. Many genetically
modified foods have over 30 added genes. First the gene that produces
the desired trait is isolated. This gene is then spliced into bacteria
that are known to attach to seeds and transmit genes into them. The
bacteria is mixed with the seeds that the scientist would like
modified and if all goes as planned the bacteria transmits the gene to
the seed. It is not enough that the gene is transmitted but the gene
must be inserted in the right place on the seed DNA for the trait to
be produced.

Scientists have developed a system to easily determine if the gene is
in the correct position. They add a gene that causes resistance to a
particular antibiotic. After the genes have been transmitted, they
expose the seeds to this antibiotic. If the inserted genes are in the
correct place, the antibiotic will not kill the seeds. These resistant
seeds are then selected and grown. The plants grown from these seeds
will then be tested for the desired trait.

====================================================

The many names of genetically modified foods:

** Transgenic

** Genetically engineered

** Bioengineered

** Genetically modified organisms

====================================================

The use of antibiotic resistant traits in genetic modification has
been one of the sources of controversy and raises a red flag for
nurses. There is concern that these traits could be transferred to the
humans and animals that eat these foods, exacerbating an already
widespread problem of antibiotic resistance. This could negatively
impact the ability of nurses to provide quality care for our patients.
Nurses are painfully aware of the limited armament we have to combat
infections and recognize the threat that antibiotic resistant
organisms could present.

In a study that addresses safety concerns such as changes in
nutrients, toxins, and allergens, the National Academy of Sciences
(NAS) has recently released guidelines for implementing safety
assessments of genetically modified foods (Safety of Genetically
Engineered Foods: Approaches to Assessing Unintended Health Effects,
2004). Current mandates require companies to assess for "intended and
predictable" effects of genetic modification. The NAS is recommending
these mandates be changed to a more thorough safety assessment that
includes unexpected changes. They also recommend that genetically
modified organisms be evaluated after market introduction in order to
monitor the real life experience and validate the initial safety
assessment. This tracking system would be especially useful in
identifying allergens within genetically modified foods and
determining the prevalence of allergic reactions to these foods within
the general population.

One of the marketing ploys most frequently sited by the companies that
create genetically engineered seeds is that these seeds may have the
ability to reduce the impact of important global diseases. For
example, Vitamin A deficiency is common in developing countries
worldwide. This deficiency is the most common cause of childhood
blindness and is implicated in the deaths of many malnourished
children and adults. Even though supplementation is inexpensive and
easy to provide, many developing countries do not have the resources
to distribute it. Scientists have developed a type of rice that
produces beta-carotene (which the body converts to Vitamin A). The
ability to produce beta-carotene was taken from a daffodil gene. This
gene makes the rice turn a yellow color and the rice has thus been
called "Golden Rice."

On the surface "Golden Rice" sounds like an amazing advancement, but
as you delve deeper, some yellow flags emerge. First, beta-carotene
must be converted into Vitamin A. It is estimated that only 10% of
beta-carotene is actually made into Vitamin A. When using this
estimate, a child would have to eat approximately six pounds of cooked
Golden Rice each day in order to get the recommended daily allowance
of Vitamin A. Also, some fat in the diet is required to adequately
absorb beta-carotene. Many malnourished people do not have sufficient
fat in their diet, thereby impeding their ability to absorb beta-
carotene. Golden Rice is still not available for use by the public so
its ability to reduce Vitamin A deficiency remains to be seen.

Another marketing strategy of the genetically modified seed industry
is its claim that genetically modified crops will increase worldwide
production of food, thereby reducing world hunger. They extend this
argument to claim that if larger quantities of food are produced on
existing farmland, the world's growing population will be able to be
fed without further destruction of rainforests and other
environmentally sensitive areas. This supposition does not address the
true causes of hunger in most of the world. As stated by the American
Dietetic Association, "There is sufficient food to feed
everyone...Poverty, gender inequity, ethnocentrism, racism, and lack
of
political will are all key constraints to solving the problem of world
hunger and malnutrition" (Struble & Aomari, 2003). Hunger is not
caused by a lack of food being produced, but rather an inability to
pay for food and social and political unrest that make it difficult to
obtain, distribute and/or grow food. Also, most of the genetically
engineered crops being developed are not varieties that can be grown
in climates where malnutrition is most prevalent. The varieties being
developed are those that will have the ability to make the most
profit, such as corn and soybeans, which are key elements in the
processed foods that are likely to be consumed in developed countries,
like the United States.

Another argument of the industry is that genetically modified plants
may reduce the amount of agricultural pesticides used. Pesticides can
have a significant, negative health effect on the farmers who use
them, the consumers who ingest pesticide residues on the foods they
consume, and the whole ecosystem. As genetically modified crops have
become more prevalent, a reduction in pesticide use is not always
found. In fact, in some areas of the United States, pesticide use has
actually increased. This may be due to the difficulty in growing these
crops in certain areas of the country. Also, some crops have been
engineered to be resistant to herbicides (a type of pesticide). With
this resistance, farmers can now spray more herbicides, such as weed
killers, without having to worry about the chemicals affecting their
crop, thus increasing the amount of pesticides used.

One way that decreased pesticide use may be achieved is by the
addition of a gene from the bacteria Bacillus thurengiensis (Bt). This
causes plants to produce a substance that is toxic to insects. Organic
farmers have used Bt for years as a natural insecticide.
Unfortunately, insect pests are very good at becoming resistant to
insecticides. The widespread use of genetically modified Bt crops has
made many in the organic farming community concerned that one of the
few resources they have available to combat insect pests may soon be
ineffective. Bt is also used in many communities to control the
mosquito population. With the increasing number of mosquito-born
illnesses, such as the West Nile virus, it is vital that the
effectiveness of this important form of mosquito control be
maintained. Finally, there is evidence that Bt enhanced crops may
negatively affect monarch butterfly populations (Losey et al, 1999).
While there are conflicting studies regarding this outcome, it seems
likely that monarch butterflies have the potential to be seriously
harmed by Bt containing plants. Are there other vulnerable populations
- animal, insect, human -- that could also be affected? The science is
not yet developed to answer this question.

Nurses consistently support full disclosure labeling policies on the
basis that people have the right to know and make informed decisions
about what they eat, drink, and breathe. However, corporations have,
to date, successfully lobbied against labeling genetically modified
foods. They state that these foods have been deemed safe by the
federal government so no additional labeling is required. Still,
consumers have consistently asked for labeling of genetically modified
foods. As the acclaimed food and nutrition author and professor at New
York University Marion Nestle states, "If we are what we eat and we
don't know what we are eating, do we know who we are?" There is the
potential for allergic reactions and labeling would allow people with
known allergies to make informed food choices. Individuals who do not
eat meat may object to eating products that have animal genes added.
Without labeling they are unable to know if what they are eating goes
against their religious or moral beliefs.

The issues regarding genetically modified foods are complex It may be
that a cautious approach is the best one. In 2003, the American Nurses
Association adopted the Precautionary Principle as its guiding tenet
for environmental health. This principle advocates a cautious approach
to technologies that have the potential to cause negative
environmental or health effects. Though there are many potential
benefits from genetically modified foods, the possibility of far-
reaching negative outcomes should direct us towards a more thorough
study of these foods before their widespread use. Such an approach
would place us on a safer, more precautionary path.

References

Committee on Identifying and Assessing Unintended Effects of
Genetically Engineered Foods on Human Health, National Research
Council. (2004). Safety of Genetically Engineered Foods: Approaches to
Assessing Unintended Health Effects. The National Academies Press:
Washington, D.C.

Losey, J.E., Rayor, L.S., &Carter, M.E. (1999). Transgenic pollen
harms monarch larvae. Nature, 399, 214.

Struble, M.B. & Aomari, L.L. (2003). Addressing world hunger,
malnutrition and food insecurity. Retrieved September 15, 2004 from
American Dietetic Association web site

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From: Mondaq, Aug. 9, 2006
[Printer-friendly version]

THE WTO RULES ON GENETICALLY MODIFIED ORGANISMS

By John W. Boscariol and others**

A recent World Trade Organization (WTO) interim ruling on the
regulation of genetically modified organisms (GMOs), EC-Measures
Affecting the Approval and Marketing of Biotech Products, will be of
significant interest to companies operating in the food and
agricultural sectors. The ruling arises from a dispute initiated in
2003 by the United States, Canada and Argentina against the European
Community (EC) over its treatment of GMOs and products containing
GMOs. These countries claimed that the EC approval system delayed the
commercialization of GMOs, and that some European countries had
effectively banned certain genetically modified crops.

The long-awaited ruling may have very broad implications, and not just
for the agri-food sector. It signals a WTO preference for science
rather than mere concern as a tool of justification of trade-
restrictive measures designed to protect health or the environment.
The fact that the Panel did not consider the provisions of the
Cartagena Protocol on Biosafety in its analysis also raises far-
reaching questions about the interplay between the WTO agreements and
other international treaties. As the world's third largest grower and
exporter of GMO crops, Canada no doubt stands to benefit from the
Panel's decision.

Background

The case was considered controversial from the outset. At the heart of
the dispute is the right of countries, in light of their international
trade obligations, to control the introduction into their markets of
GMOs. The United States, Canada and Argentina (the "Complaining
Parties") were concerned that the EC's regulatory system for the
approval of GMOs was being used to shut out imports of various GMO
crops without any scientific basis. The dispute was viewed by some as
a contest between the environmentalists' "precautionary principle" and
the more traditional view that hard scientific support is needed to
justify banning a product on the basis of health concerns.

The precautionary principle, manifested in the EC regulatory system
for GMOs, provides that the mere possibility of harm to human health
or the environment is enough to justify precautionary measures, even
in the absence of scientific certainty or probability of harm.

The precautionary principle has been endorsed in several international
treaties, including the recently concluded Cartagena Protocol on
Biosafety, which specifically deals with "living modified organisms
resulting from modern biotechnology". (The EC has ratified the
Cartagena Protocol, while the United States has not signed on to the
treaty, and Canada and Argentina have not ratified it.)

The Measures in Dispute

The Complaining Parties challenged three EC regulatory measures:

** an alleged moratorium on GMO approvals,

** the alleged failure to consider new applications for GMO approvals;
and

** GMO-specific bans or restrictions imposed by several European
countries.

The Complaining Parties argued that these measures imposed barriers to
trade, in breach of several WTO agreements including the Agreement on
Agriculture, the GATT 1994, the Agreement on Technical Barriers to
Trade, and the Agreement on the Application of Sanitary and
Phytosanitary Measures (SPS). In the claims under the SPS Agreement,
which deals with food safety and animal and plant health regulations,
the measures were challenged as inconsistent with both the science-
based requirements of the SPS and its procedural requirements.

The EC -- Biotech Interim Decision

The WTO Panel narrowed its ruling to address only the claims brought
under the SPS. The Panel also made it clear that it would not examine
whether biotech products in general are safe or not, or whether they
are "like" their conventional counterparts. The Panel also did not
consider whether the EC has the right to require the pre-marketing
approval of GMOs, as this was not raised by the Complaining Parties.
Because the complaint was made prior to the implementation of the EC's
traceability and labelling requirements for products that contain a
minimum threshold amount of GMO content, the Panel also did not
consider the WTO-legality of these measures.

Regarding the alleged moratorium on the approval of GMOs, the Panel
found that the EC had applied a de facto moratorium between June 1999
and August 2003. As a legal matter, this moratorium was considered to
be inconsistent with the EC's obligation under Annex C(1)(a) of the
SPS, which requires parties to complete testing and approval
procedures without undue delay. The Complaining Parties had argued
that the moratorium was inconsistent with numerous other obligations
under the SPS, but the Panel ruled against them on all points except
that of "undue delay". Because the moratorium had ended after the
establishment of the Panel, with the approval of several GMO products,
the Panel did not make any recommendations on this point.

Regarding the complaint that the EC had failed to consider specific
GMOs for approval, the Panel ruled that the EC had acted
inconsistently with its obligation under Annex C(1)(a) to undertake
and complete such procedures without undue delay with respect to
numerous GMOs. Under the U.S. complaint, the Panel found undue delay
in the EC's consideration of 21 out of 25 specified GMOs. For Canada,
the inconsistent treatment was found for all four GMOs identified. For
those products that remained outstanding, the Panel recommended that
the EC bring its product-specific measures into conformity with its
SPS obligations, that is, to commence and complete the approvals
process without undue delay.

Finally, regarding the individual European country bans on GMO
products, the Panel ruled that bans were not based on risk assessments
as required by Article 5.1 of the SPS Agreement, and were therefore
inconsistent with the countries' WTO obligations. The conclusions
reached in this aspect of the decision were the only ones in which the
Panel found breaches of substantive, rather than merely procedural,
provisions of the SPS Agreement. Significantly, the Panel found that
the bans were not consistent with Article 5.7 of the SPS, which
permits parties to adopt provisional measures (such as product bans)
where there is insufficient scientific evidence to assess the risk of
the product. The EC scientific committee and competent national
authorities had carried out assessments of each of the products in
question, and each was approved as safe. These assessments were deemed
to be proper risk assessments as defined in the SPS Agreement. The
studies relied upon by the individual countries for their bans were
found not to constitute sufficient risk assessments and, because
acceptable risk assessments were available, Article 5.7 could not be
relied upon.

This in turn led the Panel to conclude that these country bans were
also inconsistent with Articles 2.2 and 2.3 of the SPS, which prohibit
a party from maintaining a restrictive measure without sufficient
scientific evidence to justify it (Article 2.2), and from applying
such measures in a way to constitute a disguised restriction on
international trade (Article 2.3). The Panel recommended that the
individual countries bring their safeguard measures into compliance,
and remove the bans on the specified GMO products.

Reactions to the Decision

The European Union and the United States have reacted very differently
to the ruling. In the United States, the reaction to the ruling was
that it was an unequivocal victory, sending a strong signal to other
countries that it is WTO-illegal to impose restrictions on the import
of GMO products, and that it is a warning that the EC cannot now
impose a new de facto ban on GMOs. In Europe, the consensus is that
the ruling is primarily of "historical interest", as the de facto
moratorium has since been lifted. Since new rules were adopted in
2004, the EC has approved nine GMO products for import and sale to
Europe. Also, the ruling does not require the EC to alter its strict
system for approving GMOs. The true consequences of the decision fall
somewhere in the middle.

While the Panel did not pronounce on the validity of the EC's
regulatory system for GMOs, it did rule that bans on GMO products that
are not based on risk assessments, as defined in the SPS, are
inconsistent with WTO rules. On the other hand, the Panel did not
question the right of individual countries to impose bans if new risk
assessments support such measures. Regarding the moratorium on
approvals of GMO products, the Panel did find that the 1999-2003
moratorium was inconsistent with the SPS Agreement, insofar as it had
the effect of unduly delaying the results of the approvals process.
The Panel did not suggest that future moratoria would necessarily also
be inconsistent. If additional scientific evidence were brought to
light that would justify restrictions, the EC would be permitted to
impose them, provided decisions were made without undue delay.

Implications of the Decision

There are two potentially significant implications that arise from
this decision. First, the decision may be used as precedent for the
proposition that the precautionary principle is not a valid basis for
measures relating to human and environmental health. Second, it may
now be in doubt whether future WTO Panels have to balance WTO rules
with obligations created by other international treaties.

The Panel dismissed the EC's argument that its regulatory procedures
were consistent with the precautionary principle. The EC had argued
that there was still scientific uncertainty as to the effects of GMOs
on human health and environmental well-being and that, under Article
5.7 of the SPS, this permitted precautionary measures such as import
restrictions until better evidence is available. The Panel had a
different technical interpretation of Article 5.7 but, more
importantly, it ruled that the precautionary principle was too
controversial and unsettled a concept to be deemed a general principle
of law. In this, the Panel relied on the earlier EC -- Hormones
Appellate Body decision, which also noted that it was unclear whether
the precautionary principle had been widely accepted by WTO members as
a principle of general or customary international law.

By so ruling, the Panel interpreted the obligations of the SPS
agreement without reference to any precautionary principle and
reaffirmed that a restrictive measure said to be based on health or
environmental concerns will have to be justified by science, and not
by mere concerns or desires to be prudent.

If taken as precedent, this position could affect the regulation of
many other industries. For example, the EC has proposed draft rules
for testing the effects of certain industrial chemicals for their
public health consequences. If those rules incorporate the
precautionary principle, any resulting restrictions could be
challenged for not being based on hard scientific evidence.

The Panel took a firm and arguably inconsistent approach to the effect
of other international treaties on its interpretation of WTO rules.
The Panel ruled that it only had to rely on other treaties if it found
them useful, and that it was under no circumstances obliged to do so.
Despite the fact that the Cartagena Protocol, ratified by 132
countries (although, as noted above, not by the Complaining Parties),
is a comprehensive agreement specifically addressing genetically
modified organisms, the Panel found that it did not need to consider
it in interpreting the SPS Agreement. As part of its reasoning, the
Panel found that, because the Complaining Parties were not parties to
the Cartagena Protocol, the treaty was not applicable in their
relations as WTO members.

A significant international legal debate exists regarding the
relationship between the WTO and multilateral environmental
agreements, such as the Cartagena Protocol. In previous WTO case law,
such international agreements have been considered as part of the WTO-
compliance analysis. The EC -- Biotech ruling may signal that other
treaties are only relevant when all parties to the dispute, or even
possibly all WTO members, are parties to the other treaties. One
strategy to minimize exposure to other countries' trade restrictions
would therefore be to withdraw from, or not sign on to, treaties which
contemplate trade-limiting obligations or powers.

Next Steps

The Panel is now receiving comments from the Parties, and is expected
to issue its final decision in September. That decision may be
appealed to the WTO's Apellate Body, which may uphold, modify or
reverse the Panel's legal findings. If the EC fails to comply with the
recommendations contained in a Panel or Appellate Body Report, the
United States, Canada and Argentina may seek and obtain WTO
authorization to impose trade sanctions against the EC until it
complies with its WTO obligations.

** This article was written by John W. Boscariol, Riyaz Dattu, Simon
V. Potter, Orlando E. Silva, Brenda C. Swick and Alastair McNish

Copyright Mondaq
.
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Table of Contents...

American Nurses Association Adopts Precautionary Approach
In October, 2003, the American Nurses Association formally adopted
a precautionary approach, focusing on the prevention of hazards. "The
precautionary principle states that if it is within one's power, there
is an ethical imperative to prevent rather than merely treat disease,
even in the face of scientific uncertainty."
The Precautionary Approach; Thinking Like a Nurse
What does it mean for a nurse to take a precautionary approach to
occupational hazards and to the health of patients? Charlotte Brody
and Ann Melamed offer five specific steps a nurse can take to
implement precaution.
The Genetically Modified Foods Debate
Two nurses examine the issues surrounding genetically modified
foods and conclude that, until more is known, a precautionary approach
is called for.
An Important Ruling from the WTO on Genetically Modified Foods
"At the heart of the dispute is the right of countries, in light of
their international trade obligations, to control the introduction
into their markets of GMOs.... The dispute was viewed by some as a
contest between the environmentalists' 'precautionary principle' and
the more traditional view that hard scientific support is needed to
justify banning a product on the basis of health concerns."
'J'accuse!' Says a Canadian to His Government
"I accuse the governments, federal and provincial, of deliberately
covering up environmental degradation that will, given just a little
more time, make this world unlivable."
Enforcing the 'Polluter Pays' Principle in South Africa
"While the polluter pays principle is part of South Africa's legal
framework, cases tying emissions to particular companies are rare due
to lack of monitoring and data collection."

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From: American Nurses Association, Oct. 15, 2003
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AMERICAN NURSES ASSOCIATION ADOPTS PRECAUTIONARY APPROACH

EXECUTIVE SUMMARY: This report provides background information and
direction for the American Nurses Association's (ANA) environmental
safety policy formation and advocacy through a precautionary approach
that focuses on prevention of hazards. The precautionary principle
states that if it is within one's power, there is an ethical
imperative to prevent rather than merely treat disease, even in the
face of scientific uncertainty. The ANA Board of Directors adopted the
precautionary approach in October 2003.

1. ANA will broaden its work in occupational and environmental health
and apply a precautionary approach when an activity raises threats of
harm to human health or the environment.

2. ANA will advocate for public policy that utilizes the precautionary
approach that focuses on prevention of hazards to people and to the
natural environment.

ISSUE STATEMENT:

While Florence Nightingale spoke about the importance of clean air,
water and environment; modern day nursing has not paid as much
attention to the relationship between health and the environment.
ANA's involvement in environmental health has focused on the work
environment (occupational health and safety) and the toxic byproducts
of the health care environment. ANA's work on the environmental
impacts of the health care industry has been implemented primarily
through ANA's membership and involvement in the international
coalition, Health Care Without Harm (HCWH), the campaign for
environmentally responsible health care (www.noharm.org). As a result
of the success of the Health Care Without Harm coalition, and
visibility of ANA in HCWH and the Hospitals for a Healthy Environment
(H2E) partnership (www.h2e-online.org), ANA is increasingly in demand
to be a leader in environmental health issues.

ANA needs to develop a foundation in policy for these activities
beyond the 1997 House of Delegates Report: Reduction of Health Care
Production of Toxic Pollution, incorporating the recommendations from
the 1995 Institute of Medicine Report: Nursing, Health and the
Environment.

BACKGROUND ON ENVIRONMENTAL HEALTH & NURSING:

In 1860, Florence Nightingale provided the foundation for nursing
attention to environmental exposures and health effects when she wrote
about the need for fresh air and clean water in Notes on Nursing
(Nightingale, 1860).

The International Council of Nursing (ICN) published a position
statement in 1986, The Nurse's Role in Safeguarding the Human
Environment. It states: "The preservation and improvement of the human
environment has become increasingly important for man's survival and
well-being. The vastness and urgency of the task place on every
individual and every professional group the responsibility to
participate in the efforts to safeguard man's environment, to conserve
the world's resources, to study how their use affects man, and how
adverse effects can be avoided."

This position statement was incorporated into the recommendations of
the Institute of Medicine (IOM) Committee on Enhancing Environmental
Health Content in Nursing Practice published in 1995 in its report:
Nursing, Health and the Environment (IOM, 1995). The IOM report
recommended environmental health competencies for nurses to include:
1) Basic knowledge and concepts; 2) assessment and referral; 3)
advocacy, ethics, and risk communication; and 4) legislation and
regulation. That same year the National Institute of Nursing Research
(NINR) convened a second workgroup to develop an environmental health
research agenda for the profession. The group emphasized that because
nurses are employed in so many settings, the profession is uniquely
suited to conduct applied research addressing the impact of
environmental hazards on vulnerable populations and communities.

Precautionary Principle

The precautionary principle is explained thus: "when an activity
raises threats of harm to human health or the environment,
precautionary measures should be taken even if some cause and effect
relationships are not fully established scientifically"
(http://gdrc.org/u-gov/precaution-3.html). The principle includes
taking action in the face of uncertainty; shifting burdens of proof to
those who create risks; analysis of alternatives to potentially
harmful activities; and participatory decision-making methods. The
precautionary principle takes the life cycle of products or chemicals
into account and adds the proactive step of pre-market analysis of
environmental harm.

CONCLUSION STATEMENT:

As nurses, who are educated in disease prevention, we can appreciate
and should advocate for a precautionary approach when it may prevent
injuries and illness. Nurses, as trusted and credible sources of
information and education regarding environmental health issues, have
the potential to lead patients and communities. ANA can assist nurses
in educating and guiding policy makers, including elected officials,
to a new way to see the relationship between life's choices (both
individual and societal) and their impact on health.

ANA will advocate for a precautionary approach to environmental health
that provides an opportunity for prevention instead of focusing most
of our resources on curing disease resulting from preventable
exposures.

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From: American Journal of Nursing (Vol. 4, #4), Mar. 1, 2004
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THE PRECAUTIONARY APPROACH; THINKING LIKE A NURSE

By Charlotte Brody, RN, and Ann Melamed, MA, RN

Q. I heard that the ANA [American Nurses Association] adopted the
"precautionary approach" to address environmental health hazards. What
does this mean?

A. In October 2003 the ANA board of directors adopted the
"precautionary approach" based on the "precautionary principle"
developed by German policymakers in the 1970s to address strongly
suggestive but unproven links between air pollution and the death of
trees. The result of this effort to save trees includes principles
that nurses promote daily: early detection and monitoring; reduction
of stressors; preventive action where the likely benefit justifies the
costs; and reducing risks before full proof of harm is available if
the effects could be serious or irreversible.

In "Late Lessons from Early Warnings: The Precautionary Principle
1896-2000," a review of radiation illustrates what can happen when we
wait for irrefu--table proof before taking preventive action. Thomas
Edison warned about the harm that could result from overexposure to X-
rays in 1896, only a few years after the discovery was made. The
possibility of fetal damage from pelvimetry (an X-ray method of
diagnosing pregnancy) was documented as early as 1908. These warnings
continued to be discounted, though, and it was only after other
studies affirmed these findings that the practice of pelvimetry
stopped and requirements were added to other medical exposures to
radiation. By then, the damage had been done. A 1989 study estimated
that 5% of all childhood cancers were caused by pelvimetry. If health
care practitioners and the government had heeded the warnings 30, 40,
or 50 years earlier, how many cases of cancer could have been
prevented? The history of radiation shows how the precautionary
principle could have been used to prevent, not merely treat, disease.

Through the ANA's long involvement with coalitions, including Health
Care Without Harm, occupational health and pollution prevention are
being promoted simultaneously. As part of the ANA's prevention
philosophy, when research demonstrates a possible toxic relationship
between chemical exposure and health effects, nursing should be an
advocate for a precautionary approach. Actions should include
reduction or elimination of exposures as well as continued scientific
investigations.

Nurses can implement the precautionary approach in their work and
apply it to all areas of nursing practice, policy, research,
education, and workplace strategies. Here are five activities to help
apply the precautionary approach in nursing practice.

** Get involved on product committees and be an advocate for reviewing
the potential effects of new and old products and therapies on workers
and the environment before they are implemented.

** Negotiate contract language that includes staff nurse input on
product selection with criteria that includes patients, workers, and
long-term environmental impact.

** Organize a product fair with PVC- and DEHP-free products and
include educational materials about their hazards. Develop a plan to
phase out the use of PVC, beginning with the NICU [neonatal intensive
care unit] and maternal-child units.

** Research alternatives (see www.sustainablehospitals.org) to toxic
cleaning products, disinfectants, and sterilants and develop a plan to
use them instead.

** Encourage nursing research to "clarify the complex relationship
between human disease and the physical and biological effects of
environmental hazards with the goal of facilitating social and
behavioral changes," as stated in the 1995 Institute of Medicine
report.

Using a precautionary approach will help all of us see through the fog
of controversy to discern what the science is trying to show. Then we
can determine what we can reasonably do to protect ourselves and our
planet. What better way to celebrate Earth Day on April 30?

Resources

Institute of Medicine (IOM) Report, 1995. Nursing, Health and the
Environment
. Washington, DC: National Academy Press.

Late Lessons from Early Warnings: The Precautionary Principle
1896-2000
. Environmental issue report no. 22, European environmental
agency.

Wingspread Statement on the Precautionary Principle.

Charlotte Brody is coexecutive director of Health Care Without Harm
(www.noharm.org) and executive director of Commonweal
(www.commonweal.org). Ann Melamed is an environmental health
specialist with the ANA.

Copyright 2006 The American Nurses Association, Inc.

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From: Maryland Nurse, Feb. 1, 2005
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THE GENETICALLY MODIFIED FOODS DEBATE

By Katie Huffling, RN, BSN and Barbara Sattler, PhD, RN, FAAN

Over the past few years there has been growing controversy over
genetically modified foods. Unfortunately, it can be difficult to find
independent, scientifically rigorous information about this hotly
debated topic. As nurses, our patients, families, and friends look to
us for information regarding a variety of health matters, including
nutrition; yet many of us have not been formally educated about
nutrition. By educating ourselves about this important subject, we can
become advocates for our communities and ourselves in regards to
genetically modified foods.

Genetically modified foods are described in the literature under a
variety of other names. These all refer to the same process. They
refer to the selection of desired traits from one organism and its
genetic placement into another organism. Theoretically, genetically
modified foods have the potential to be very beneficial. For example,
traits that make plants resistant to harmful insects can be inserted,
nutrients that were not previously in that particular plant may be
added, or modifications can be made to improve the ability of a plant
to grow in regions of the world where the conditions are inhospitable
to the growth of traditional, non-modified plant varieties.
Genetically modified foods have been increasingly used by farmers and
were grown on over 109 million acres in 2001 and over half of the soy
grown worldwide has been genetically engineered. So why is there so
much controversy surrounding genetically modified foods? In order to
understand the differing views one should first know how genetically
modified foods are made.

The method of genetically modifying foods is a highly technical
process. In order to produce the desired trait, many different genes,
from a variety of organisms, need to be inserted. Many genetically
modified foods have over 30 added genes. First the gene that produces
the desired trait is isolated. This gene is then spliced into bacteria
that are known to attach to seeds and transmit genes into them. The
bacteria is mixed with the seeds that the scientist would like
modified and if all goes as planned the bacteria transmits the gene to
the seed. It is not enough that the gene is transmitted but the gene
must be inserted in the right place on the seed DNA for the trait to
be produced.

Scientists have developed a system to easily determine if the gene is
in the correct position. They add a gene that causes resistance to a
particular antibiotic. After the genes have been transmitted, they
expose the seeds to this antibiotic. If the inserted genes are in the
correct place, the antibiotic will not kill the seeds. These resistant
seeds are then selected and grown. The plants grown from these seeds
will then be tested for the desired trait.

====================================================

The many names of genetically modified foods:

** Transgenic

** Genetically engineered

** Bioengineered

** Genetically modified organisms

====================================================

The use of antibiotic resistant traits in genetic modification has
been one of the sources of controversy and raises a red flag for
nurses. There is concern that these traits could be transferred to the
humans and animals that eat these foods, exacerbating an already
widespread problem of antibiotic resistance. This could negatively
impact the ability of nurses to provide quality care for our patients.
Nurses are painfully aware of the limited armament we have to combat
infections and recognize the threat that antibiotic resistant
organisms could present.

In a study that addresses safety concerns such as changes in
nutrients, toxins, and allergens, the National Academy of Sciences
(NAS) has recently released guidelines for implementing safety
assessments of genetically modified foods (Safety of Genetically
Engineered Foods: Approaches to Assessing Unintended Health Effects,
2004). Current mandates require companies to assess for "intended and
predictable" effects of genetic modification. The NAS is recommending
these mandates be changed to a more thorough safety assessment that
includes unexpected changes. They also recommend that genetically
modified organisms be evaluated after market introduction in order to
monitor the real life experience and validate the initial safety
assessment. This tracking system would be especially useful in
identifying allergens within genetically modified foods and
determining the prevalence of allergic reactions to these foods within
the general population.

One of the marketing ploys most frequently sited by the companies that
create genetically engineered seeds is that these seeds may have the
ability to reduce the impact of important global diseases. For
example, Vitamin A deficiency is common in developing countries
worldwide. This deficiency is the most common cause of childhood
blindness and is implicated in the deaths of many malnourished
children and adults. Even though supplementation is inexpensive and
easy to provide, many developing countries do not have the resources
to distribute it. Scientists have developed a type of rice that
produces beta-carotene (which the body converts to Vitamin A). The
ability to produce beta-carotene was taken from a daffodil gene. This
gene makes the rice turn a yellow color and the rice has thus been
called "Golden Rice."

On the surface "Golden Rice" sounds like an amazing advancement, but
as you delve deeper, some yellow flags emerge. First, beta-carotene
must be converted into Vitamin A. It is estimated that only 10% of
beta-carotene is actually made into Vitamin A. When using this
estimate, a child would have to eat approximately six pounds of cooked
Golden Rice each day in order to get the recommended daily allowance
of Vitamin A. Also, some fat in the diet is required to adequately
absorb beta-carotene. Many malnourished people do not have sufficient
fat in their diet, thereby impeding their ability to absorb beta-
carotene. Golden Rice is still not available for use by the public so
its ability to reduce Vitamin A deficiency remains to be seen.

Another marketing strategy of the genetically modified seed industry
is its claim that genetically modified crops will increase worldwide
production of food, thereby reducing world hunger. They extend this
argument to claim that if larger quantities of food are produced on
existing farmland, the world's growing population will be able to be
fed without further destruction of rainforests and other
environmentally sensitive areas. This supposition does not address the
true causes of hunger in most of the world. As stated by the American
Dietetic Association, "There is sufficient food to feed
everyone...Poverty, gender inequity, ethnocentrism, racism, and lack
of
political will are all key constraints to solving the problem of world
hunger and malnutrition" (Struble & Aomari, 2003). Hunger is not
caused by a lack of food being produced, but rather an inability to
pay for food and social and political unrest that make it difficult to
obtain, distribute and/or grow food. Also, most of the genetically
engineered crops being developed are not varieties that can be grown
in climates where malnutrition is most prevalent. The varieties being
developed are those that will have the ability to make the most
profit, such as corn and soybeans, which are key elements in the
processed foods that are likely to be consumed in developed countries,
like the United States.

Another argument of the industry is that genetically modified plants
may reduce the amount of agricultural pesticides used. Pesticides can
have a significant, negative health effect on the farmers who use
them, the consumers who ingest pesticide residues on the foods they
consume, and the whole ecosystem. As genetically modified crops have
become more prevalent, a reduction in pesticide use is not always
found. In fact, in some areas of the United States, pesticide use has
actually increased. This may be due to the difficulty in growing these
crops in certain areas of the country. Also, some crops have been
engineered to be resistant to herbicides (a type of pesticide). With
this resistance, farmers can now spray more herbicides, such as weed
killers, without having to worry about the chemicals affecting their
crop, thus increasing the amount of pesticides used.

One way that decreased pesticide use may be achieved is by the
addition of a gene from the bacteria Bacillus thurengiensis (Bt). This
causes plants to produce a substance that is toxic to insects. Organic
farmers have used Bt for years as a natural insecticide.
Unfortunately, insect pests are very good at becoming resistant to
insecticides. The widespread use of genetically modified Bt crops has
made many in the organic farming community concerned that one of the
few resources they have available to combat insect pests may soon be
ineffective. Bt is also used in many communities to control the
mosquito population. With the increasing number of mosquito-born
illnesses, such as the West Nile virus, it is vital that the
effectiveness of this important form of mosquito control be
maintained. Finally, there is evidence that Bt enhanced crops may
negatively affect monarch butterfly populations (Losey et al, 1999).
While there are conflicting studies regarding this outcome, it seems
likely that monarch butterflies have the potential to be seriously
harmed by Bt containing plants. Are there other vulnerable populations
- animal, insect, human -- that could also be affected? The science is
not yet developed to answer this question.

Nurses consistently support full disclosure labeling policies on the
basis that people have the right to know and make informed decisions
about what they eat, drink, and breathe. However, corporations have,
to date, successfully lobbied against labeling genetically modified
foods. They state that these foods have been deemed safe by the
federal government so no additional labeling is required. Still,
consumers have consistently asked for labeling of genetically modified
foods. As the acclaimed food and nutrition author and professor at New
York University Marion Nestle states, "If we are what we eat and we
don't know what we are eating, do we know who we are?" There is the
potential for allergic reactions and labeling would allow people with
known allergies to make informed food choices. Individuals who do not
eat meat may object to eating products that have animal genes added.
Without labeling they are unable to know if what they are eating goes
against their religious or moral beliefs.

The issues regarding genetically modified foods are complex It may be
that a cautious approach is the best one. In 2003, the American Nurses
Association adopted the Precautionary Principle as its guiding tenet
for environmental health. This principle advocates a cautious approach
to technologies that have the potential to cause negative
environmental or health effects. Though there are many potential
benefits from genetically modified foods, the possibility of far-
reaching negative outcomes should direct us towards a more thorough
study of these foods before their widespread use. Such an approach
would place us on a safer, more precautionary path.

References

Committee on Identifying and Assessing Unintended Effects of
Genetically Engineered Foods on Human Health, National Research
Council. (2004). Safety of Genetically Engineered Foods: Approaches to
Assessing Unintended Health Effects. The National Academies Press:
Washington, D.C.

Losey, J.E., Rayor, L.S., &Carter, M.E. (1999). Transgenic pollen
harms monarch larvae. Nature, 399, 214.

Struble, M.B. & Aomari, L.L. (2003). Addressing world hunger,
malnutrition and food insecurity. Retrieved September 15, 2004 from
American Dietetic Association web site

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From: Mondaq, Aug. 9, 2006
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THE WTO RULES ON GENETICALLY MODIFIED ORGANISMS

By John W. Boscariol and others**

A recent World Trade Organization (WTO) interim ruling on the
regulation of genetically modified organisms (GMOs), EC-Measures
Affecting the Approval and Marketing of Biotech Products, will be of
significant interest to companies operating in the food and
agricultural sectors. The ruling arises from a dispute initiated in
2003 by the United States, Canada and Argentina against the European
Community (EC) over its treatment of GMOs and products containing
GMOs. These countries claimed that the EC approval system delayed the
commercialization of GMOs, and that some European countries had
effectively banned certain genetically modified crops.

The long-awaited ruling may have very broad implications, and not just
for the agri-food sector. It signals a WTO preference for science
rather than mere concern as a tool of justification of trade-
restrictive measures designed to protect health or the environment.
The fact that the Panel did not consider the provisions of the
Cartagena Protocol on Biosafety in its analysis also raises far-
reaching questions about the interplay between the WTO agreements and
other international treaties. As the world's third largest grower and
exporter of GMO crops, Canada no doubt stands to benefit from the
Panel's decision.

Background

The case was considered controversial from the outset. At the heart of
the dispute is the right of countries, in light of their international
trade obligations, to control the introduction into their markets of
GMOs. The United States, Canada and Argentina (the "Complaining
Parties") were concerned that the EC's regulatory system for the
approval of GMOs was being used to shut out imports of various GMO
crops without any scientific basis. The dispute was viewed by some as
a contest between the environmentalists' "precautionary principle" and
the more traditional view that hard scientific support is needed to
justify banning a product on the basis of health concerns.

The precautionary principle, manifested in the EC regulatory system
for GMOs, provides that the mere possibility of harm to human health
or the environment is enough to justify precautionary measures, even
in the absence of scientific certainty or probability of harm.

The precautionary principle has been endorsed in several international
treaties, including the recently concluded Cartagena Protocol on
Biosafety, which specifically deals with "living modified organisms
resulting from modern biotechnology". (The EC has ratified the
Cartagena Protocol, while the United States has not signed on to the
treaty, and Canada and Argentina have not ratified it.)

The Measures in Dispute

The Complaining Parties challenged three EC regulatory measures:

** an alleged moratorium on GMO approvals,

** the alleged failure to consider new applications for GMO approvals;
and

** GMO-specific bans or restrictions imposed by several European
countries.

The Complaining Parties argued that these measures imposed barriers to
trade, in breach of several WTO agreements including the Agreement on
Agriculture, the GATT 1994, the Agreement on Technical Barriers to
Trade, and the Agreement on the Application of Sanitary and
Phytosanitary Measures (SPS). In the claims under the SPS Agreement,
which deals with food safety and animal and plant health regulations,
the measures were challenged as inconsistent with both the science-
based requirements of the SPS and its procedural requirements.

The EC -- Biotech Interim Decision

The WTO Panel narrowed its ruling to address only the claims brought
under the SPS. The Panel also made it clear that it would not examine
whether biotech products in general are safe or not, or whether they
are "like" their conventional counterparts. The Panel also did not
consider whether the EC has the right to require the pre-marketing
approval of GMOs, as this was not raised by the Complaining Parties.
Because the complaint was made prior to the implementation of the EC's
traceability and labelling requirements for products that contain a
minimum threshold amount of GMO content, the Panel also did not
consider the WTO-legality of these measures.

Regarding the alleged moratorium on the approval of GMOs, the Panel
found that the EC had applied a de facto moratorium between June 1999
and August 2003. As a legal matter, this moratorium was considered to
be inconsistent with the EC's obligation under Annex C(1)(a) of the
SPS, which requires parties to complete testing and approval
procedures without undue delay. The Complaining Parties had argued
that the moratorium was inconsistent with numerous other obligations
under the SPS, but the Panel ruled against them on all points except
that of "undue delay". Because the moratorium had ended after the
establishment of the Panel, with the approval of several GMO products,
the Panel did not make any recommendations on this point.

Regarding the complaint that the EC had failed to consider specific
GMOs for approval, the Panel ruled that the EC had acted
inconsistently with its obligation under Annex C(1)(a) to undertake
and complete such procedures without undue delay with respect to
numerous GMOs. Under the U.S. complaint, the Panel found undue delay
in the EC's consideration of 21 out of 25 specified GMOs. For Canada,
the inconsistent treatment was found for all four GMOs identified. For
those products that remained outstanding, the Panel recommended that
the EC bring its product-specific measures into conformity with its
SPS obligations, that is, to commence and complete the approvals
process without undue delay.

Finally, regarding the individual European country bans on GMO
products, the Panel ruled that bans were not based on risk assessments
as required by Article 5.1 of the SPS Agreement, and were therefore
inconsistent with the countries' WTO obligations. The conclusions
reached in this aspect of the decision were the only ones in which the
Panel found breaches of substantive, rather than merely procedural,
provisions of the SPS Agreement. Significantly, the Panel found that
the bans were not consistent with Article 5.7 of the SPS, which
permits parties to adopt provisional measures (such as product bans)
where there is insufficient scientific evidence to assess the risk of
the product. The EC scientific committee and competent national
authorities had carried out assessments of each of the products in
question, and each was approved as safe. These assessments were deemed
to be proper risk assessments as defined in the SPS Agreement. The
studies relied upon by the individual countries for their bans were
found not to constitute sufficient risk assessments and, because
acceptable risk assessments were available, Article 5.7 could not be
relied upon.

This in turn led the Panel to conclude that these country bans were
also inconsistent with Articles 2.2 and 2.3 of the SPS, which prohibit
a party from maintaining a restrictive measure without sufficient
scientific evidence to justify it (Article 2.2), and from applying
such measures in a way to constitute a disguised restriction on
international trade (Article 2.3). The Panel recommended that the
individual countries bring their safeguard measures into compliance,
and remove the bans on the specified GMO products.

Reactions to the Decision

The European Union and the United States have reacted very differently
to the ruling. In the United States, the reaction to the ruling was
that it was an unequivocal victory, sending a strong signal to other
countries that it is WTO-illegal to impose restrictions on the import
of GMO products, and that it is a warning that the EC cannot now
impose a new de facto ban on GMOs. In Europe, the consensus is that
the ruling is primarily of "historical interest", as the de facto
moratorium has since been lifted. Since new rules were adopted in
2004, the EC has approved nine GMO products for import and sale to
Europe. Also, the ruling does not require the EC to alter its strict
system for approving GMOs. The true consequences of the decision fall
somewhere in the middle.

While the Panel did not pronounce on the validity of the EC's
regulatory system for GMOs, it did rule that bans on GMO products that
are not based on risk assessments, as defined in the SPS, are
inconsistent with WTO rules. On the other hand, the Panel did not
question the right of individual countries to impose bans if new risk
assessments support such measures. Regarding the moratorium on
approvals of GMO products, the Panel did find that the 1999-2003
moratorium was inconsistent with the SPS Agreement, insofar as it had
the effect of unduly delaying the results of the approvals process.
The Panel did not suggest that future moratoria would necessarily also
be inconsistent. If additional scientific evidence were brought to
light that would justify restrictions, the EC would be permitted to
impose them, provided decisions were made without undue delay.

Implications of the Decision

There are two potentially significant implications that arise from
this decision. First, the decision may be used as precedent for the
proposition that the precautionary principle is not a valid basis for
measures relating to human and environmental health. Second, it may
now be in doubt whether future WTO Panels have to balance WTO rules
with obligations created by other international treaties.

The Panel dismissed the EC's argument that its regulatory procedures
were consistent with the precautionary principle. The EC had argued
that there was still scientific uncertainty as to the effects of GMOs
on human health and environmental well-being and that, under Article
5.7 of the SPS, this permitted precautionary measures such as import
restrictions until better evidence is available. The Panel had a
different technical interpretation of Article 5.7 but, more
importantly, it ruled that the precautionary principle was too
controversial and unsettled a concept to be deemed a general principle
of law. In this, the Panel relied on the earlier EC -- Hormones
Appellate Body decision, which also noted that it was unclear whether
the precautionary principle had been widely accepted by WTO members as
a principle of general or customary international law.

By so ruling, the Panel interpreted the obligations of the SPS
agreement without reference to any precautionary principle and
reaffirmed that a restrictive measure said to be based on health or
environmental concerns will have to be justified by science, and not
by mere concerns or desires to be prudent.

If taken as precedent, this position could affect the regulation of
many other industries. For example, the EC has proposed draft rules
for testing the effects of certain industrial chemicals for their
public health consequences. If those rules incorporate the
precautionary principle, any resulting restrictions could be
challenged for not being based on hard scientific evidence.

The Panel took a firm and arguably inconsistent approach to the effect
of other international treaties on its interpretation of WTO rules.
The Panel ruled that it only had to rely on other treaties if it found
them useful, and that it was under no circumstances obliged to do so.
Despite the fact that the Cartagena Protocol, ratified by 132
countries (although, as noted above, not by the Complaining Parties),
is a comprehensive agreement specifically addressing genetically
modified organisms, the Panel found that it did not need to consider
it in interpreting the SPS Agreement. As part of its reasoning, the
Panel found that, because the Complaining Parties were not parties to
the Cartagena Protocol, the treaty was not applicable in their
relations as WTO members.

A significant international legal debate exists regarding the
relationship between the WTO and multilateral environmental
agreements, such as the Cartagena Protocol. In previous WTO case law,
such international agreements have been considered as part of the WTO-
compliance analysis. The EC -- Biotech ruling may signal that other
treaties are only relevant when all parties to the dispute, or even
possibly all WTO members, are parties to the other treaties. One
strategy to minimize exposure to other countries' trade restrictions
would therefore be to withdraw from, or not sign on to, treaties which
contemplate trade-limiting obligations or powers.

Next Steps

The Panel is now receiving comments from the Parties, and is expected
to issue its final decision in September. That decision may be
appealed to the WTO's Apellate Body, which may uphold, modify or
reverse the Panel's legal findings. If the EC fails to comply with the
recommendations contained in a Panel or Appellate Body Report, the
United States, Canada and Argentina may seek and obtain WTO
authorization to impose trade sanctions against the EC until it
complies with its WTO obligations.

** This article was written by John W. Boscariol, Riyaz Dattu, Simon
V. Potter, Orlando E. Silva, Brenda C. Swick and Alastair McNish

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