Past Discussions 2013
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National regulatory context and current capacity for detecting LMOs
Dear Participants of the Laboratory Network,
Welcome to the discussions of the Network of Laboratories for LMO Detection & Identification. As mentioned in the email sent out by the Secretariat on the 9th May the activities of the network are reconvening with the view to achieve the mandates set out by the COP-MOP in their decision BS-V/9 and in the Strategic Plan for the Cartagena Protocol on Biosafety.
As indicated this discussion will focus on the “National regulatory context and current capacity for detecting LMOs”. Participants are encouraged to share and discuss the scope of their current capabilities to detect and identify LMOs, be it through national and/or regional access to LMO detection laboratories, ease of accessibility to required laboratory materials or the feasibility of research and development projects. Furthermore participants can also elaborate on how this capacity fulfils the requirements set out by their country’s national regulatory context.
This is with the view to establishing a baseline of the current status of each Party’s capacity to ultimately develop a strategy that could help Parties in addressing their needs for capacity building in the field of detection and identification of LMOs in the context of the requirements of their national regulatory framework.
We are looking forward to a fruitful discussion!
posted on 2013-05-20 02:50 UTC by Dina Abdelhakim, SCBD
I appreciate the Secretariat for the organization of such discussion, it is very important for all the parties and people, especially in the developing world. I like to say some brief words on the situation in China; just try to give a crude remark in the hope to draw forth valuable ones. In the Chinese regulatory documents regarding of labelling, we currently have a ‘zero permit’ of GM component in products. Any percentage of presence should be labelled. I believe it is a good policy to prevent the potential spread of GM materials and to benefit the environment and people health.
In addition, in China the GMOs detection laboratories should be certified by the Ministry of Agriculture to be able to give official detection reports. Though this policy will assure the quality of detection, there is a potential risk to block innovation and to slow the emergent response to the unexpected GM presence. We should recognize the capability and the report of other institutions once the result is proved to be scientifically sound.
(edited on 2013-05-30 03:24 UTC by Wei Wei)
posted on 2013-05-30 03:21 UTC by Mr. Wei Wei, China
Special thanks for the secretariat for the proposed discussion which is crucial to help us for regulatory implementation and to establish our strategy in the domain of LMO detection. I will say as an introduction that as a consequence of the increasing number of approved LM varieties in Europe and to ensure the consumer’s right, a strict European legislation has been established. This legislation regulates the use of recombinant DNA technology, the release of LM crops into the environment as well as the use of these crops and any genetically engineered product in the food and feed chains. Since 1996 up till now, the regulatory framework for LMOs has evolved a lot. Whereas some questions remained unsolved with the first directives and regulations, the current EU legislation much more reflects the needs of the production and both food and feed distribution sectors as well as the final consumer. Major topics in the present legislation are LM crop Biosafety evaluation based on an integrated risk assessment analysis, comprehensive labelling provisions and a reliable traceability system. Along with the lack of confidence from the consumer, there has been a field of stress between policy makers and scientists in the competent authorities or laboratories in charge of implementation of this legislation. With the enforcement of mandatory labelling of LM-derived products, some problems arose for the practical implementation of this legislation.
We intended to contribute to a correct implementation of LMO legislation in our country as well as standardization and harmonization of LMO analysis. In this context that North African countries such as Tunisia have actually prepared a draft of the regulation taking into account all the gaps that were described before in the EU and all the local conditions and needs as well in all domains (environment, industry…). This regulation is already under discussion and the implementation will offer the opportunity to offer freedom to consumers with the labeling LM and derived products and by constructing a network of LMO laboratories for the detection and quantification of LMO depending on the matrix to be tested and collaborating with the respective ministry such as the Agriculture ministry for seeds and grains for example and Environment ministry for environmental samples or industry Ministry to test food and feed samples.
In the light of our knowledge, there is a huge problem in Tunisia which is the vote of the new GMO regulation and its implementation. However, huge efforts in term of reinforcement of the capacities via the BCH programs and the trainings, workshops were done and targeting operators of the Laboratories selected to develop the platform of LMO detection (in the Tunisian Gene Bank for example). In addition there is at least one research laboratory in Tunisia (High Institute of Biotechnology Monastir) that detected and quantified in food products LMO especially in maize and soybean and still develop new methodologies for LMO analysis (Chaouachi et al. 2013). Finally I will say that we are still waiting the Tunisian LMO Regulation and in the near future the Tunisian National laboratories will have the appropriate competences for LMO analysis. The discussion are also undergoing for the laboratory accreditation (ISO17025) and looking for funding to be used for this purpose.
MAHER Chaouachi, PhD
posted on 2013-05-30 14:06 UTC by Dr MAHER CHAOUACHI, Tunisia
Dear participants of the Laboratory Network,
First, I would like to acknowledge the Secretariat for the opportunity to share our experiences in this platform; also for invite expert colleagues involved with analytical aspects of GMO detection around the world as well as promoting an active networking process that I hope will assist in building up the international capacities and help address current common challenges, identify synergies and take advantage of installed networks on this relevant topic.
As you might know, Mexico established its regulatory framework in 2005 with the advent of The National Biosafety Law (LBOGM) which regulates the use of GMOs. The Country had prior experience on GM risk assessment based on Phytosanitary regulations set earlier in 1990. (http://www.cibiogem.gob.mx/Norm_leyes/Paginas/default.aspx
Our current regulation system aims to prevent, avoid or reduce the possible risks that activities using GMOs might pose on human health, environment or its biological diversity, including animal or vegetal health. National Competent Authorities from the Ministries of Health, Environment and Agriculture are directly responsible for enforcing Biosafety measures in compliance with our legislation, and according to their competences. Each Competent Authority has installed capacity for the detection of GMOs, and a reference laboratory for each one is actively working for supporting the decisions on these sectors since such labs are in charge of official detection reports. Additionally, the National Center for Metrology was established as the Primary lab of reference which oversees all metrological procedures and assists the establishment and validation of methods for GMO analysis and detection, providing guidance for acceptance, performance and quality parameters as part of the scope of its Biometrology Division. Coordinated actions are facilitated across by our National Biosafety Commission (CIBIOGEM), the organism in charge of public policy on biosafety.
LBOGM Law indicates that compliance with official standards (related to biosafety) can be evaluated by the certifying bodies, verification units and laboratories that are approved by the three Competent Authorities. Furthermore, the laboratories have also responsibility to conform to Metrology and Normalization Laws and standards according to LBOGM. At the moment, several national standards are on preparation for enforcing applicability of our regulatory framework; in parallel work has been carried out on technical aspects for training human resources, installing facilities, providing equipment and performing the validation of methods for analyzing different events and matrices, in an attempt to strengthen the capacities of local labs according to their main objectives. Some of the labs are coupled to the pipeline of the national entities in charge of performing GMO monitoring, and as such provide confirmatory evidence for the identification of GM material, which is essential for inspection and surveillance. Therefore these reference labs face a strong responsibility.
Most of them have capacity for performing qualitative and quantitative analysis and their activities are supported by the fact that they are accredited on ISO17095, other relevant GM standards, and have participated periodically on international proficiency tests. Here, I wish to point out that even if this can be regarded as a certain aptitude from the labs, they face several limitations: heavy workloads, sampling and processing capacity, lack of standard protocols for detection of transgenes on local species, limited personnel and finances to mention some. Also, the access to certified reference materials is not always possible and this happens more often as the number of GMO increases. All those issues have an impact on the labs ability to suit the analytical demands and holds back their time of response.
Is on this light that efforts have been made for collaborating with local experts as an alternative, and the possibility was sought to establish a National Network for the Detection, Identification and Quantification of GMOs. The Network was officially recognized last year as a Technical Group after several rounds of tests and diagnostics to interested institutions, and is expected to assist the National Labs by including laboratories from Public Institutes and Universities; in the hope to provide an expanded capacity that helps abide by recognized performance criteria and can provide high quality reliable results. I shall post more details on the respective section of this forum for your information later on I you may.
Finally, I’d like to thank my former colleagues for their comments; following up their interventions I wish to share that in the Mexican Regulation there is neither mandatory labeling nor a threshold set for indicating acceptable GM levels, there is ongoing work discussing this aspect so comments on the advantages or disadvantages will be appreciated.
The progress attained by sharing technical and practical expertise in a network system has proved very useful not only for the technicians at the practical level while standardizing detection methods, but also for addressing interesting scientific questions, common technical issues, and encourage the flow of ideas to fill in the gaps in a way that consider technical and scientific elements for addressing some regulatory needs that I’m sure will be shared by other countries. We would be very happy to hear along the interventions on this forum your contributions. Having said that, we are also aware that bigger challenges are foreseeable in the near future, especially facing the context of novel and unauthorized GM events, environmental monitoring for specific countries needs, more reliable, faster and better detection systems, and ideas for harmonizing the mechanisms for a proper recognition of laboratory results.
On behalf of our National Network colleagues, thanks again; I look forward to a nice interaction and fruitful collaborations.
Natalhie Campos-Reales, Ph.D.
posted on 2013-05-31 02:35 UTC by Dr. Natalhie Campos-Reales, National Commission on Biosafety and GMOs (CIBIOGEM)
I appreciate the Secretariat for the opportunity to participate in in this platform. As you all are aware of on a global level there is an increase in hectarage under genetically modified crops as well as the number of events and it is constantly growing, which makes detection more and more challenging. Croatia count days until full membership in the European Union and has in its legislation fully transposed the EU provisions relating to the marketing, labelling, traceability, control and detection of GM products. This implies that we have tolerance threshold of 0.9% per ingredient for authorised GMOs for placing on the market, and zero tolerance on unauthorised GMOs and LMOs.
We have two laboratories which are authorised for official control by Ministry of health as a competent authority. Laboratories are accredited according to ISO 17025 and members of European network of GMO laboratories (ENGL). Laboratories are able to perform qualitative and quantitative analysis which is confirmed by participating on international end European proficiency tests. Still laboratories are dialing with most probably the same issues as laboratories around the globe: lack of reference materials, lack of standardized and validated methods, high cost of an analysis etc.
Since start of systematic monitoring in 1997 none of the analysed samples of seed was positive which suggests that the Croatian environment and Croatian seed market is still free of genetically modified crops and also suggests that the Croatian system of official control of genetically modified organisms is effective.
posted on 2013-05-31 07:00 UTC by Ms Renata Hanzer, Croatian Centre for Agriculture, Food and Rural Affairs
I thank the secretariat for giving me the opportunity to participate in this forum. Kenya has a biosafety act which was passed into law by the Kenyan parliament in 2008. We also have biosafety regulations in place for environmental release, import, export and transit, containment use and labeling with a tolerance threshold of 1%.
There are very few laboratories in Kenya if any which have the capacity to test GMOs. Kenya Plant Health Inspectorate Service (KEPHIS) is one of the few labs which are able to carry out the tests. We have been facing challenges in terms of getting standardized and validated methods, high cost of analysis which has to be met by KEPHIS. At the moment there are no GM crops that have been commercialized. All current GM activities are under confinement.
Currently KEPHIS is able to carry out qualitative and quantitative real-time PCR tests including the use of lateral flow devices as a quick test. We get our standard reference materials for quantification from JRC. We also normally use JRC methods and at times GMO detection kits from Applied Biosystems which is a quite expensive undertaking compared to having your own primers and reagents. We also participate in a proficiency testing scheme. Since there are still no commercialized GMOs in Kenya, we mostly do surveillance of plant materials coming through our official points of entry which we then sampled and screened for genetic modification. We are in the process of preparing our systems for ISO 17025 accreditation.
posted on 2013-05-31 09:15 UTC by Lilian Okiro
We thank the Secretariat of the Convention on Biological Diversity for organising this platform.
In the regulatory context, Lebanon has issued sanitary and phytosanitary measures that ban the import of GM seeds and seedlings. Moreover, Lebanon has developed its NBF and ratified the CPB on Feb 2013. A draft decree to implement the provisions of the CPB in Lebanon has also been developed but unfortunately is not endorsed yet. Currently, there is no official legislation or policy outlining mandatory GMO labeling in Lebanon.
At the testing level, our laboratory has acquired the ISO 17025 accreditation and performs the three stages of GMO analysis: detection, identification and quantification in food, feed and derived products. It has adopted many ISO and EU-RL GMFF validated methods and has also optimized additional published protocols. Moreover, the laboratory is currently finalizing the implementation of a cost effective testing strategy that relies on a matrix approach. The matrix comprises all GM events and their relevant DNA sequences which are targeted by PCR in a stepwise order to allow for the detection and identification of a maximum number of events in the minimum experimental steps.
In order to activate GMO testing policies in Lebanon, the laboratory has already started testing the soybean and maize food and feed imports at the Lebanese quarantine, and it is currently screening the Lebanese market.
At the regional level, we have already trained laboratories in neighboring countries and have also participated in developing a regional GMO testing manual.
Finally, we would like to thank the secretariat again for this valuable opportunity of networking.
(edited on 2013-05-31 14:19 UTC by Gretta Abou-Sleymane)
posted on 2013-05-31 14:12 UTC by Dr Gretta Abou-Sleymane, Lebanon
Dear Dina and members of the Laboratory Network,
Special thanks to the Secretariat for organizing these discussions. I must agree with Wei Wei. This is indeed a very important topic for all the parties and people, especially those from the developing world. I would like to share some of my thoughts about the situation in Brazil.
Most of the biosafety-related regulation is based on Constitution of The Federal Republic of Brazil from 1988 article 5 which guarantees individual and collective rights, such as consumer’s rights; and also art. 225 about the right for a balanced environment including integrity of genetic resources. Several other laws and regulatory measurements were created to regulate those constitutional articles, such as The Biosafety Law 11.105 from 2005 and The Consumers Code Law 8.078 from 1990.
Consumers Code Law states about the right for consumers information about commercial product, regardless of its genetic origin. The Biosafety Law clearly states that foods and food ingredients for human consumption or animal feed containing or produced from genetically modified organisms or derivatives/by-products should contain information to this effect on their labels, according to the regulation (art. 40).
Now, it is interesting to note that, so far, no legislation has been created to regulate art. 40. There is Decree 4.680 from 2003, known as the “GM Labeling Decree”. But the GM Labeling Decree was created before the Biosafety Law, and for some regulators, the latter has conflicting points.
For example, art. 3 of the Labeling Decree states that food and ingredients produced from animals fed with genetically modified ingredients should bring in the main panel, the following expression: "(name of animal) were fed with diet containing transgenic ingredient" or "(name of ingredient) produced from animal fed with diet containing GM ingredients. ". However, according the Biosafety Law, only GMOs and their by-products should be labeled. And again, a GMO by-product for the effects of this Law, is considered a product obtained from a GMO with no capability of autonomous replication, or that does not contain a feasible GMO form. Weather an animal fed with diet containing GM product can be considered as a GMO by-product is, at least, a confusing matter.
Nonetheless, both the Biosafety Law and the Labeling Decree are currently considered legal and should, therefore, be followed. In addition to that, and regardless of the conflicting points, the Labeling Decree states that the consumer must be informed about the transgenic nature of the product if it is present above the limit of 1% of the product, being it food and food ingredients for human consumption or animal feeding containing or produced from genetically modified organisms. Such information must be also present in the product invoice, in a way that it accompanies the product during all stages of the productive chain. The transgene donor species name is also required in labeling.
In regards to the inspection/GMO detection, we have a few national laboratories and also a few accredited laboratories that are authorized by the government to perform such analysis. There is not, however, a joint effort in compiling all these information from the different authorities in a transparent matter and, perhaps, unique gateway. The Biosafety Law creates the Biosafety Information Systems (SIB) which is responsible for the management of information arising from activities of analysis, authorization, registration, monitoring and follow-up activities involving GMOs and their derivatives. However, SIB has not yet been implemented in Brazil.
posted on 2013-06-02 19:27 UTC by Dr. Sarah Agapito-Tenfen, GenØk Centre for Biosafety