Rethinking GMO risk assessment - repensando a avaliação de riscos de OGMs
Autor: http://genpeace.blogspot.com | Publicado: 2016-05-12T09:09:00-07:00


Dear
readers



Suddenly a
stream of fresh air is flowing in the GMO risk assessment field: the old
paradigm of event-specific evaluation is being challenged. Moreover, respected
researchers claim risk assessment must be directed to the product, not to the
technology. And, finally, the same authors clarify that regulation must be
risk-based. 



The
Brazilian GMO regulatory framework, established more than 10 years ago, requires
a case-by-case evaluation for all GMOs and regulates the technology, not the
product. The strategy worked well for a while, but had a very high cost and
demanded a lot of time from CTNBio specialists to evaluate the large dossiers
for commercial release. Every genetic transformation, even if with the same
genes and the same host, was considered potentially different and was named an
“event”. The idea behind this approach was that the random gene insertion made
every transformation very different from one anothe, even if the constructs
were essentially the same. However, after 20 years of genetic engineering, it
is clear that events harboring the same or similar genes behave in a very
similar way, irrespective on how many copies they have and where they are
inserted in the genome. It is clear now that the genomic intrincacies are
irrelevant for risk assessment: the phenotypic changes are to be valued. Under
this new perspective, the event-based approach has no support. 



CTNBio has
already recognized the limits of the event-based approach and issued a
normative by which a recurrent construction used in a new event could be
assessed in a more streamlined, fast systematics. But a list of “safe” events
was never produced, even if this is a provision of the Cartagena Protocol, also
never fulfilled. It is time to open the windows and reduce the burden on safe
products, using the principles of familiarity and history of safe use.



On the
other hand, a change on the regulatory viewpoint from technology to products
depends on a revision of the Biotechnology law. However, this is imperative and
should be a priority as many new technologies are coming to the market and will
make the scenario rather confusing. The Obama administration started a
discussion on this subject one year ago and USA may have a new regulatory
framework in a near future. The changes in our regulatory framework are
certainly less extensive, but a meaningful discussion should be started as soon
as possible. For the next Brazilian GMO regulatory framework some premises have
to be kept very clear in the regulator´s and in the legislator´s minds:



<!--[if !supportLists]-->a)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <!--[endif]-->A GMO is an organism with a new
phenotype, derived from any new technique encompassed under the large umbrella
of the “new biotechnology” – it is cumbersome to split regulations among technologies,
as the final product is what has to be regulated, not the way it was produced. 

<!--[if !supportLists]-->b)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <!--[endif]-->The risk assessment procedure is
product-directed and is now consolidated: in proceeds step by step, case by
case, but takes into account the previous history of safe use and the
familiarity of the genes, construct and host. This is to say there should be no
difficulty in producing a reasonable list of safe organisms and a template to
quickly review new products and put them on the list of safe GMOs or,
otherwise, send the product to a more thorough assessment.

<!--[if !supportLists]-->c)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <!--[endif]-->Any change in the regulatory
framework should be risk-driven. Restrictions should be proportionate to risks.



Here we add
two new papers to the first one we recommended some days ago to risk assessors
(Conko et al, 2016). All of them stress essentially the same points:

a)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; regulation must be risk-based

b)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; products should be regulated, not
technologies



A risk-based approach to the regulation of genetically
engineered organisms&nbsp;&nbsp;&nbsp;pp493 - 503
Gregory&nbsp;Conko,
Drew L&nbsp;Kershen, Henry&nbsp;Miller and Wayne A&nbsp;Parrott
doi:10.1038/nbt.3568



 

  
Ending event-based
  regulation of GMO crops&nbsp;&nbsp;&nbsp;pp474 - 477
  Steven H&nbsp;Strauss and
  Joanna K&nbsp;Sax
  doi:10.1038/nbt.3541



 

  
Regulate
  genome-edited products, not genome editing itself&nbsp;&nbsp;&nbsp;pp477 - 479
  Dana&nbsp;Carroll, Alison
  L&nbsp;Van Eenennaam, Jeremy F&nbsp;Taylor, Jon&nbsp;Seger and Daniel
  F&nbsp;Voytas
  doi:10.1038/nbt.3566

 




We wish all
of you a good reading. Please contact me if you don’t have access to any of
these papers (andrade@ufpe.br).

Paulo Andrade

Dept.Genetics/ Universidade Federal de Pernambuco