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6-Genetech §§: BIOSAFETY - On the Precautionary Principle



-------------------------- GENET-news ---------------------------

TITLE:  A) European chemical producers question precautionary
           rules
        B) Compelling transgenetic evidence for transmission of
           bovine spongiform encephalopathy prions to humans
SOURCE: A) Chemical Market Reporter, by Sean Milmo
        B) Proceedings of the National Academy of Sciences, USA,
           Vol. 96, Issue 26, by M. R. Scott et al.
DATE:   A) January 3, 2000
        B) December 21, 1999
----------------- archive: http://www.gene.ch/ ------------------


Dear GENET-news readers,

the Precautionary Principle is under heavy attack - not only at
the biosafety negotiations. Apart from being incorporated in the
Agenda 21 (Chapter 15) and the Convention on Biological Diversity
(Preamble) it has as fundamental concept of European
environmental and health policy also been written into the
Maastricht Treaty (§130r), the central legal document of the EU. 

What are the implications of the Precautionary Principle in our
every day life? The weaker side in economical and political
struggles - e.g. consumer, environment - can use it for
strengthening its position against the stronger side - e.g.
politics, industry.

What would have happen in the BSE-scandal without the application
of this Principle? I guess we had to wait ages for any political
actions until - full and widely accepted - scientific proof
concerning the causal agents and damages had been provided. One
important and disturbing piece of such science has been published
in December 99. For the full evidence of the links between BSE
and nvCJD we surely have to wait some more years. Without the
power of the Precautionary Principle, industry - be it the
agroindustry supplying infected sheep meal as feed or the
chemical industry mixing different phthalates into baby toys -
will be granted some more 10 to 15 years to make profits while
escaping responsibility before science can proof links between
those products and possible environmental or health damages.

Yours,
Hartmut Meyer

                          *****

European chemical producers question precautionary rules

The European chemical industry is becoming increasingly concerned
that the European Union and EU governments may misuse the
precautionary principle to ban or restrict chemicals. The Rio
Declaration on the Environment - the 1992 Earth Summit -
sanctions the use of the precautionary approach to environmental
measures when there are "threats of serious or irreversible
damage" and a "lack of full scientific certainty."

The European Chemical Industry Council (Cefic) supports the use
of the principle provided a proper risk assessment has been
carried out and the need for action is backed by scientific
evidence. But the EU and its member states have recently cited
the precautionary principle as a reason for taking measures and
initiatives that worry the chemical industry.

The European Commission, the EU executive, is drawing up a policy
paper on the principle. The Commission is expected to reiterate
that the principle is essential for safeguarding public health
and the environment. The Commission is likely to stress that
precautionary action should be taken only when scientific
evidence is "insufficient, inconclusive or uncertain." The EU
would retain the right to decide what level of protection is
appropriate. "There is a risk now that scientific evidence may be
interpreted in an arbitrary manner to justify measures," cautions
Jean-Marie de Vos, Cefic's secretary-general. "We don't want the
precautionary principle to become a vague and loose concept which
becomes the basis for administrative and political decisions on
chemicals."

Earlier this month, the EU launched an emergency ban on PVC
teething toys that contain phthalates. The ban was primarily
aimed at diisononyl phthalate (DINP) and di-(2-ethylhexyl)
phthalate (DEHP), the two main plasticizers in PVC toys. But the
ban also covered four other phthalates for which the European
Commission decided to adopt a precautionary approach even though
its scientific advisers, the Scientific Committee on Toxicity,
Ecotoxicity and the Environment (SCTEE), found they pose no risk.

The four are di-n-octyl phthalate (DNOP), di-iso-decyl phthalate
(DIDP), butylbenzyl phthalate (BBP) and dibutyl phthalate (DBP).
"The committee thought the margin of safety with DINP and DEHP
was inadequate but concluded there was no problem with the other
four," says David Cadogan, secretary of the European Council for
Plasticisers and Intermediates (ECPI). "There is a danger that
the precautionary principle will be used to make what are, in
effect, political decisions."

EU governments are also using the precautionary principle,
sometimes to reverse decisions taken at the EU level. A
diplomatic furor broke out between the UK and France last month
after the French government defied a decision by the European
Commission to lift a ban on exports of UK beef, following an
outbreak of bovine spongiform encephalopathy (BSE), or mad-cow
disease, in that country. The Commission's veterinary committee
concluded that because of control measures taken by the UK
government and its livestock industry, British beef is now safe
for human consumption. But the French government decided to
maintain the ban after the French food safety agency (AFSSA)
ruled that British beef still poses a plausible risk.

"The French government has defended its action on the basis of
the precautionary principle," says Mr. de Vos. "But if national
governments start to use the precautionary approach in this way,
they will undermine the EU single market." The Danish government
is drawing up an action plan for reducing the use of all
phthalates, citing the need for a precautionary approach to the
chemicals. The Danish environmental protection agency says
measures against phthalates are necessary because "we now know so
much about [their] effects."

European chemical producers say that the precautionary principle
may have been applied to phthalates in PVC toys because of
political pressure from EU member states that have already
imposed restrictions on the products. "Under current legislation,
the EU did not have a justification for banning all phthalates in
PVC teething toys, so the precautionary principle became the
basis for its action," says Mr. de Vos. "It has resorted to the
principle because of differences of interpretation of the
scientific opinion put forward by the SCTEE." Although the SCTEE
found that releases of DNOP, DIDP, BBP and DBP from teething
products currently present no risk, it cautioned that if the
plasticizers are used in higher concentrations, their releases
will become larger.

The Commission decided to adopt the precautionary principle
because of the likelihood that the four phthalates would be used
as replacements for DINP and DEHP, making them a greater risk to
children. Members of the SCTEE have reportedly complained in
private that the Commission misinterpreted their advice. The
environment committee of the European Parliament also expressed
concern about the scientific basis for the emergency phthalates
ban. Committee chairman Caroline Jackson warned that the
inconsistency of the Commission's treatment of scientific opinion
is "not acceptable."

Not only is the European Commission close to finalizing its
policy on the precautionary principle, CEFIC issued an updated
position paper on the issue last month. The chemical industry
wants the Commission to reaffirm guidelines published in October
1998 which stipulate that the precautionary approach must start
with an objective risk assessment and be proportionate to the
risk.


*****


Compelling transgenetic evidence for transmission of bovine
spongiform encephalopathy prions to humans

Michael R. Scott*, Robert Will+, James Ironside+, Hoang-Oanh B.
Nguyen*, Patrick Tremblay*, Stephen J. DeArmond#, and Stanley B.
Prusiner*
* Institute for Neurodegenerative Diseases, Departments of
Neurology, Biochemistry and Biophysics, and
# Pathology, University of California, San Francisco, CA 94143;
and
+ National CJD Surveillance Unit, Western General Hospital,
Edinburgh EH4 2XU, United Kingdom
Contributed by Stanley B. Prusiner, October 27, 1999

Abstract
There is growing concern that bovine spongiform encephalopathy
(BSE) may have passed from cattle to humans. We report here that
transgenic (Tg) mice expressing bovine (Bo) prion protein (PrP)
serially propagate BSE prions and that there is no species
barrier for transmission from cattle to Tg(BoPrP) mice. These
same mice were also highly susceptible to a new variant of
Creutzfeldt-Jakob disease (nvCJD) and natural sheep scrapie. The
incubation times (250 days), neuropathology, and disease-causing
PrP isoforms in Tg(BoPrP)Prnp0/0 mice inoculated with nvCJD and
BSE brain extracts were indistinguishable and differed
dramatically from those seen in these mice injected with natural
scrapie prions. Our findings provide the most compelling evidence
to date that prions from cattle with BSE have infected humans and
caused fatal neurodegeneration.


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