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United Nations Environment Programme (UNEP) has announced a $38
million initiative to help developing countries set up infrastructure
for the testing and commercialization of products made with recombinant-DNA
technology. The three-year project will center on "building
capacity for assessing risks, establishing adequate information
systems and developing expert human resources in the field of biosafety."
But the proposal
is problematic. Many of the countries for which it is intended have
virtually no regulations in place for acknowledged high-risk
activities (such as public transport and occupational hazards),
and their expenditures on public health are woefully inadequate.
In poor tropical countries, for example, it's not unusual to see
preteens welding or using dangerous machinery with no protective
gear and wearing only a loincloth; and enteric illnesses, malaria,
schistosomiasis, and viral diseases that have been all but eradicated
from industrialized countries are still epidemic in many underdeveloped
countries.
Nonetheless,
the U.N. reckons that what these countries really need is bureaucracies
to "enable scientists to test for transgenic crops." This
is "like offering swimming lessons to people in the Sahara,"
according to Calestous Juma, director of the Science, Technology
and Innovation Program at Harvard University, which focuses on the
role of R&D in developing countries.
The wrongheaded
approach of the U.N. turns on its head a basic tenet of regulation
— that the amount of oversight accorded a product or activity
should be commensurate with risk. In fact, in UNEP's approach there
is actually an inverse proportionality between risk and the amount
of oversight. Only the more precisely crafted and more predictable
recombinant DNA-modified organisms are subjected to extensive and
expensive testing and monitoring (and perhaps, labeling) regimes;
by contrast, plants crafted using less precise and predictable techniques,
such as wide crosses (hybridizations in which genes are moved across
wide phylogenetic distances) and intensive mutagenesis, are exempt.
Consider, for
example, the relatively new manmade "species" Triticum
agropyrotriticum, made by combining the genomes of bread wheat and
a grass sometimes called quackgrass or couchgrass. Possessing all
the chromosomes of the wheat plus one extra whole genome from the
quackgrass, T. agropyrotriticum has been independently produced
in the former Soviet Union, Canada, the United States, France, Germany,
and China. It is grown for both animal feed and human food. At least
in theory, several kinds of problems could result from such a genetic
construction, which introduces tens of thousands of foreign genes
into an established plant variety. These concerns include the potential
for increased invasiveness of the plant in the field, and the possibility
that quackgrass-derived proteins could be toxic or allergenic.
But U.N. regulators
express no concern for these possibilities, and plant varieties
like these — which are certainly "genetically modified"
according to any reasonable definition — are subject to no
review prior to being field tested or introduced into the food chain.
If a single gene from couchgrass (or any other organism) were to
be introduced into wheat by means of recombinant-DNA techniques,
by contrast, the resulting variety would be subject to extraordinary
and hugely expensive regulatory regimes.
How can one
explain such an illogical, improvident proposal? Only as a cynical
attempt by UNEP to "buy" recruits to the U.N.'s unscientific
and flawed Cartagena biosafety protocol. This regulatory instrument
is based on the so-called "precautionary principle," which
dictates that every new technology must be proven safe before it
can be used — or in the case of recombinant DNA, before it
can even be tested! An ounce of prevention is certainly desirable,
but because nothing can be proved totally safe — at least,
not to the standard demanded by anti-technology extremists —
the precautionary principle creates enormous obstacles to the development
of new products. Precaution, in this sense, shifts the burden of
proof from the regulator (who used to have to demonstrate that a
new technology would cause harm) to the innovator (who now must
demonstrate that it won't).
Thus, rather
than creating a scientifically sound framework for effectively managing
genuine risks, the biosafety protocol offers an ill-defined global
regulatory process that permits overly risk-averse, incompetent,
or corrupt regulators to hide behind the precautionary principle
in delaying or deferring approvals. We have already seen many examples
of this — for example, the German government's decision to
block the commercial-scale cultivation of gene-spliced, insect-resistant
corn by the biotechnology company Novartis. This action came one
day before the product was expected to be approved by the Ministry
of Agriculture for commercial use; regulators specifically cited
the need to respect the precautionary principle, and called for
more research into the crop plant's potential hazards. Italian regulators
likewise have cited the precautionary principle as their rationale
for blocking the testing or use of recombinant DNA-modified crops
and food.
Under the biosafety
protocol's standard of evidence, regulatory bodies are free to arbitrarily
require any amount and kind of testing they may wish. Particularly
in developing countries, this will be an invitation to caprice,
intrigue, and corruption.
The UNEP's
cynical attempts to bribe recruits — that is, countries that
will ratify the Cartagena protocol — offer a Faustian bargain
to developing countries. They would receive small grants up front;
in the long term, however, unscientific, excessive regulation of
this promising new technology — and companies' resulting uncertainty
as to their ability to test and market products — will ensure
that the biotechnology revolution passes them by.
Ironically,
the U.N. is pressing developing countries to enact the same flawed,
"precautionary" regulations that cause Europe to lag far
behind the United States in the quest for world markets of biotechnology
— markets that could exceed two trillion euros ($1.762 trillion)
by the end of the decade, according to the European Commission's
estimate.
It is as wrong
for governments to create policies blocking the dissemination of
crucial technologies as it would be for them to sanction the building
of unsafe dams or the use of HIV-contaminated blood. Government
officials should be held as accountable.
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