MY NAME IS LILIANA TOVAR. I'M CURRENTLY WORKING ON THE REGULATION OF ACTIVITIES WITH GMOS AT THE MINISTRY OF AGRICULTURE IN MEXICO. I'M IN CHARGE OF COORDINATING SOME OF THE ACTIVITIES RELATED TO RISK ANALYSIS AND REGULATION OF ACTIVITIES WITH GMOS.
I’M SHARING MY PERSONAL VIEW ABOUT THE ISSUE FOR TODAY. IT'S IMPORTANT TO SAY THAT THE AREA I WORK AT, WAS RECENTLY CREATED AND THE STAFF CONFORMING THAT AREA IS CURRENTLY ON TRAINING.
I AGREE WITH SOME OF THE PARTICIPANTS, IN THE SENSE THAT IS IMPORTANT TO HAVE TRAINED STAFF AND FINANCIAL RESOURCES, IN ORDER TO GAIN MORE EXPERIENCE WITH THIS ACTIVITIES. I ALSO CONSIDER IMPORTANT TO TRAIN THE STAFF ON STATISTICS TO BE ABLE TO TAKE REPRESENTATIVE SAMPLES WHEN MONITORING AFTER RELEASES (PERMITTED AND NO PERMITTED), BECAUSE I HAVE PERCEIVED THAT THERE ARE SOME DEFICIENCIES REGARDING TO THAT, FOR EXAMPLE, WHAT IS THE MINIMUM AREA THAT MUST BE SAMPLED IN ORDER TO GENERATE REPRESENTATIVE RESULTS.
BY THE OTHER HAND, WE ARE IN THE PROCESS OF IMPLEMENTING THE CARTAGENA PROTOCOL, OF CREATING A REGULATORY AND PROCEDURAL FRAMEWORK THAT ALLOWS US TO DO MANY OF THE ACTIVITIES CURRENTLY WE ARE ONLY PLANNING AND THAT NEED LEGAL SUPPORT. IN THIS REGARD, I HAVE ALSO REALIZED THAT AT THIS MINISTRY WE DON’T HAVE ENOUGH INFORMATION TO DO THE RISK ANALYSIS AND TO PERFORM THE MONITORING. NEVERTHELESS, WE ARE CURRENTLY WORKING ON THAT, GENERATING NEW DATA THAT ALLOW US THE DECISION-MAKING AND ALSO REGARDING TO THE MONITORING.

My name is Ann Kingiri, a regulatory officer in Kenya. Just to encourage Liliana, you are not alone. The situation is not different in developing countries where most countries are developing their biosafety systems. As this happen, they are confronted with capacity issues in terms of dealing with imports purported to be GMOs sometimes even as food aid. I would encourage participants from developing countries to share their experiences since I believe some problems may be localised and context specific. We could also compare our experiences with other countries “catching up” like Kenya. Kenya is preparing to deal head on with the LMOs post release after successfully conducting a number of open confined field trials. What is keeping us from this is the non-approval of the Biosafety Bill which is being discussed. Hope to share more on regulatory policy issues that may charter a way for effective regulations to guide in post release era.

Greetings good people,
My name is Bosibori Bett, a Research Scientist in Kenya.  I have previously participated in conducting Confined Field Trials (CFTs) of GM crops, and currently in containment of GM crops.  I have realized the importance of training the staff involved in experimentations of GM crops.  Depending on the situation, it may require on-going/consistent training sessions, just so that stern Biosafety measures put in place are adhered to.  Eventually, one will realize a good performance in terms of data collection, management, and how to dispose/manage the waste of the transgenic material in question, … to name but a few.  But of course, it must begin from somewhere, so Liliana it is a good start to note that the staff deployed in this new area where you work are currently on training.  With time, you will realize that the personnel will grasp the concepts as they practically do the experiments.  Additionally, Liliana says, “BY THE OTHER HAND, WE ARE IN THE PROCESS OF IMPLEMENTING THE CARTAGENA PROTOCOL, OF CREATING A REGULATORY AND PROCEDURAL FRAMEWORK THAT ALLOWS US TO DO MANY OF THE ACTIVITIES CURRENTLY WE ARE ONLY PLANNING AND THAT NEED LEGAL SUPPORT. IN THIS REGARD, I HAVE ALSO REALIZED THAT AT THIS MINISTRY WE DON’T HAVE ENOUGH INFORMATION TO DO THE RISK ANALYSIS AND TO PERFORM THE MONITORING. NEVERTHELESS, WE ARE CURRENTLY WORKING ON THAT, GENERATING NEW DATA THAT ALLOW US THE DECISION-MAKING AND ALSO REGARDING TO THE MONITORING” I agree that generating data for risk analysis and monitoring is vital, as this is key in making informed decisions; and Annex III of the Cartagena protocol gives some methodologies and points of considerations in doing this.  I am wondering if it is possible for other countries who have conducted risk analysis and monitoring to share information on how they went about it, and maybe can be used as a model in this case?  This may be helpful for those developing such kind of systems.  Or does it mean that these systems vary on a country by country basis/geographical areas?
Thanks.

I am glad that Ms Tovar mentioned capacity building in appropriate sampling techniques. Correct sampling is highly technical and in some cases problematic topic, as scientists that work on samples from the wild populations already knows. Sampling techniques in relation to GMO and its products is extremely important issue that should be covered in capacity building programmes

I am Tom Nickson, a scientist working in the area of environmental risk assessment for Monsanto Company for about 15 years.  I would like to add, what I believe are some important ideas as background to this discussion on capacity building.  These ideas seem particularly relevant to capacity building as it relates to environmental risk assessment.

Over the past 20 years, much has been learned about the process and conceptual basis that underpins environmental risk assessment.  In my experience, one of the most significance challenges facing a risk assessor is discerning the amount of information needed for the risk assessment.  Data requirements are dictated by the level of certainty required in the risk assessment, which is a matter of policy, not science or any particular amount of scientific capacity within a country.  It is important to keep in mind that overall guidance for the risk assessor is environmental protection goals set within policy, which determines what attributes of the environment are valuable, in need of protection and at what cost they will be protected.  Typically, food, feed and fiber production are an environmental attribute whose protection will be balanced against the desire for natural and urban areas. 

As a developer of products improved through biotechnology, I have seen problems arising from not following a stepwise approach that begins with problem formulation (Raybould, 2006).  However, I would also like to highlight another problem, which is the perception that science, particularly ecology, will define or describe "risk".  Recently, Raybould (2007) has commented that risk assessment must have a structure grounded in policy.  He described a commonly encountered problem as a conflict between an ecological versus and ecotoxicological approach.  After reading many postings on these on-line fora, I feel it important to point out this distinction.  Risk assessment should not be a surrogate for basic research.  Public policy must guide the degree and even nature of data needed for decision-making, not a scientist or particular group versed in ecological theory.  A risk assessment based in basic research does not serve the public since it creates excessive costs to the regulatory authority and developer, results in delays to introducing valuable products into the market and provides no greated certainty in decision-making (Raybould, 2007). 

Regardless of the LMO, I believe that environmental risk assessment should begin with proper problem formulation (Raybould, 2007).  This critical first step enables risk assessors to use a guided process that is as efficient as possible, and ensures that sufficient data are collected for a decision based on reasonable certainty and guided by policy.  Building capacity in the concepts forming the basis of environmental risk assessment, especially problem formulation, should be an area of focus in the future.  I am hopeful that some recent publications and activities supporting better understanding of the underlying concepts will become more available to developing countries.  In particular, the International Life Sciences Institute (ILSI) will be establishing such a program within their Research Foundation in 2009.

Raybould A. 2006. Problem formulation and hypothesis testing for environmental risk assessments of genetically modified crops. Envion.Biosafety Res. 5: 119-125

Raybould A (2007) Ecological versus ecotoxicological methods for assessing the environmental risks of transgenic crops. Plant Science: 173: 589-602