Davis, California
April 8, 2005Kent
Bradford and Allen Van Deynze (SBC), Neal Gutterson (Mendel
Biotech), Wayne Parrott (University of Georgia) and Steve
Strauss (Oregon State University) have published an article in
Nature Biotechnology
(2005, 23: 439-444) titled Regulating
transgenic crops sensibly: lessons from plant breeding,
biotechnology and genomics.
The abstract states: The costs
of meeting regulatory requirements and market restrictions
guided by regulatory criteria are substantial impediments to the
commercialization of transgenic crops. Although a cautious
approach may have been prudent initially, we argue that some
regulatory requirements can now be modified to reduce costs and
uncertainty without compromising safety. Long-accepted plant
breeding methods for incorporating new diversity into crop
varieties, experience from two decades of research on and
commercialization of transgenic crops, and expanding knowledge
of plant genome structure and dynamics all indicate that if a
gene or trait is safe, the genetic engineering process itself
presents little potential for unexpected consequences that would
not be identified or eliminated in the variety development
process before commercialization. We propose that as in
conventional breeding, regulatory emphasis should be on
phenotypic rather than genomic characteristics once a gene or
trait has been shown to be safe.
The full article can be
obtained at
http://www.nature.com/nbt/journal/v23/n4/full/nbt1084.html
or from the SBC website at
http://sbc.ucdavis.edu
.
Related news item from
CropBiotech Net
Research proposes new
regulatory requirements for GM
Genetically modified (GM) crops are stringently
regulated before market entry, and the process of regulation
itself, although thorough, is growing to be increasingly costly.
Kent Bradford and colleagues at the University of California
Davis provide new proposals on "Regulating transgenic crops
sensibly: lessons from plant breeding, biotechnology and
genomics." Their paper is published in the latest issue of
Nature Biotechnology.
The
researchers admit that a cautious approach to admitting GM was
prudent, but the experience of long years of work with GM crops,
as well as expanding knowledge of plant genome structure and
dynamics, can allow regulatory requirements to be modified, in
order to reduce costs and uncertainty without compromising
safety. They also propose that, as in conventional breeding,
regulatory emphasis should be on phenotypic rather than genomic
characteristics once a gene or trait has been shown to be safe.
Using studies
of regulatory processes used for genetically modified crops over
the years, the researchers proposed to following to streamline
the current regulatory process: Deregulate the transgenic
process, where the product, and not the process, should be
evaluated; Rationalize the basis for transgenic regulation,
since some molecules, such as the 35s promoter of the
cauliflower mosaic virus, have already been consumed by humans
at much higher levels than those in transgenic plants; Exempt
selected transgenes and classes of transgenic modification from
regulation, such as RNAi, use of nontoxic proteins to modify
plant development, well-studied marker genes that impart
antibiotic resistance, and selected marker genes that impart
reported phenotypes; Create regulatory classes in proportion to
potential risk; and eliminate the event-specific basis of
transgenic regulation.
Access to the complete article is at
http://www.nature.com/nbt/journal/v23/n4/full/nbt1084.html
|