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Experience from a complex setting [#8851]
We in CONABIO (where I work) have conducted risk assessment for a while now (since 1998). CONABIO is an Interministerial Comission dedicated to the knowledge and use of biodiversity in Mexico.
It has been conducting risk assessment to inform the decision makers in relation to the possible risks involved in releasing LMOs into the environment (in relation mainly to biodiversity.....specially considering that Mexico is Center of Origin and Center of Genetic Diversity of several crops of human kind relevance, see http://www.biodiversidad.gob.mx/genes/otrosCentros.html).
I recommend as a reading chapter 21 recently published in:
"Ethnobotany of Mexico: Interactions of people and Plants in Mesoamerica"
http://www.springer.com/us/book/9781461466680
titled:
"Biosafety and Environmental releases of GM crops in mesoamerica: Context does matter"
Kind regards to all!
Francisca
posted on 2018-02-01 15:11 UTC by Ms. Francisca Acevedo, Mexico
RE: Experience from a complex setting [#8859]
Dear Colleagues:  My personal experience with risk assessments of living modified organisms  is reviewing them as part of approval process for release of LMOS onto the market, either for food or feed or for release to the environment for commercial use at the European Union level. I also Review risk assessments for field trials of LMOs at the national level.  In my opinion, I find that the quality of the risk assessments sections on the potential effects on environment and biodiversity (which are the points I generally concentrate on) varies enormously between the EU applications and the national applications for field trials.

I consider the risk assessments made for the EU to be of excellent quality. There are very developed technical guides for what a risk assessment should contain, based on the European legislation on GMO’s and guidance by the European Food Safety Agency. The EU applications strictly follow these requirements and guidances. The risk assessments are reviewed thoroughly in a long process by various state and EU authorities and agencies before I receive them at the national level. If I should identify a weakness, it would be that the risk assessments in the EU applications are sometimes weak in describing indirect effects of LMOs over a long-term. They also may have difficulty in identifying potential ecological effects of the LMOs on geochemical processes in the soil. Lack of knowledge of the potential effects on soil processes over a long term  and how to assess these seems to be a general problem.

The risk assessments for field trials on the national level are, in my opinion, often very primitive and unsatisfactory. It is often very difficult to assess the potential environmental risks of the LMO to be field trialed from the information given in the risk assessment. There is a standard application, that is a shortened and streamlined version of the EU applications, yet the applicants have difficulty providing necessary information. The responsible authority must often repeatedly ask the applicant for additional information. The questions that are often very superficially answered are;  potential ecological and genetic effects of gene-spread from the LMO to be trialed on wild relatives; ecological effects on non-target species,  what wild species could be affected and possible effects on their fitness and population dynamics; indirect environmental effects; and ecological effects on the geochemical processes and soil processes and functions. Some applications for field trials are quite thorough in describing measures to prevent environmental effects, others are abysmally bad.  

My personal conclusion is: 1) that guidance needs to be developed to assist risk assessors who only sporadically make risk assessments. It may be enough with a simplified version of existing guidance in the local language.
2) Guidance needs to be further developed to help risk assessors consider, understand and assess long-term effects of cultivation of LMO’s – long-term meaning much more than 3 years. Especially guidance for indirect effects over a long-term need to be further developed. But do we have the scientific knowledge to assess the risks to biodiversity over a long-term and especially non-target species including birds and mammals that may temporarily eat and use the LMO in some way?
3) Guidance on potential effects of LMOs on soil processes including geochemical cycles and soil function is desperately needed to be improved.

In the end, you may develop the best guidance ever, but if it is not widely spread to the right people and if government regulators do not demand a high quality in risk assessments, our work will have been in vain.

With best regards
Melanie Josefsson
Swedish Environmental Protection Agency
(edited on 2018-02-02 16:19 UTC by Ms. Melanie Josefsson)
posted on 2018-02-02 16:16 UTC by Ms. Melanie Josefsson, Sweden