Contrary to what Dr Lee Han Lim of IMR has written (‘GM mosquitoes: Procedure strictly complied with’ in The Sun, Feb. 6 , http://www.thesundaily.my/news/287130), the GM Aedes mosquitoes release was riddled with non-compliance of international biosafety standards, non-transparency, lack of public accountability and lack of proper due process prior to the GM mosquito release. Moreover, recently revealed data shows that survival rate of the GM mosquitoes can be as high as 15%, not the mere 3% that Dr. Lee claims.
The import, contained trials and release of the GM mosquitoes clearly do NOT conform to national and international laws e.g. Malaysia’s Biosafety Act 2007 and the Cartagena Biosafety Protocol. In addition, the UK Parliament has questioned Oxitec’s activities in developing countries. Recently, international biotech scientists have also criticized Oxitec’s introduction of new technology via a meticulously planned ‘back door’ approach (http://www.spiegel.de/international/world/0,1518,812283-2,00.html ).
It is crucial to note that when the GM mosquitoes were first imported and the contained trials were carried out in Malaysia, the Genetic Modification Advisory Committee (GMAC) and the National Safety Board (NBB) did not exist yet. Nevertheless, GM mosquitoes importation, contained trials and field releases were already by then governed by national laws and international treaties e.g.:
• The Biosafety Act 2007 which is under the authority of the Ministry of Natural Resources and Environment (MNRE) only came into force in December 2009.
• The NBB was only established in March 2010 under the Biosafety Act but the Oxitec-IMR contained trials were done about five years earlier and thus did not go through the NBB or GMAC.
• No details of the GM mosquitoes in the Biosafety Clearing House registries (as required under the Cartagena Protocol on Biosafety) prior to the GM mosquitoes release in Malaysia in December 2010.
Despite strong reservations and appeals from both local and international scientists and civil society organizations - local and worldwide - to adopt the precautionary approach, the GM mosquitoes were quietly released on 21 December 2010. This secretive release was only made publicly known a month after the event, on 26 January 2011.
1. International and National Laws and Procedures Not Followed
The IMR under the Ministry of Health (MOH) was reported to have invited Oxitec in 2006 (when the Biosafety Act under MNRE was not yet in force) to bring in GM mosquitoe eggs from the UK. Thus, MOH/IMR was the importer of the GM mosquito eggs or in other forms, and Oxitec UK was the exporter.
a) International Procedures not followed
The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is an international agreement which aims to ensure the safe handling, transport and use of living modified organisms (LMOs) resulting from modern biotechnology. It was adopted on 29 January 2000 and entered into force on 11 September 2003 (http://bch.cbd.int/protocol/). The Cartagena Protocol thus regulates the transboundary movements of the GM mosquitoes too. Malaysia is a signatory to this Protocol.
Firstly, under the Protocol’s notification rules (Articles 7 and 8), the exporter (in this case, Oxitec UK) must inform in writing the competent authority of the Party of import (in this case, MNRE) prior to the international transboundary movement of a living modified organism (LMOs) for international introduction into the environment of the importing country. However, there is no evidence that the MNRE had given consent prior to the 2006 importation date for the shipment of the GM mosquito eggs from Oxitec in the UK to IMR/MOH in Malaysia.
Secondly, the Protocol also stipulates that the importing party (in this case, Malaysia and MOH/IMR) is required to inform in writing both the Protocol’s Biosafety Clearing House and the exporting party (in this case, the UK government) before it decides to release GM Mosquitoes (Article 10 para 3). Again, as evidenced by the Biosafety Clearing House Registries where no details of the GM mosquitoes could be found until shortly before the GM mosquitoes release in December 2010, this Protocol requirement has not been adhered to. At this stage, the UK Parliament also began questioning Oxitec actions under the Protocol.
Releasing GM mosquitoes must be considered as a global release as the mobile and breeding GM mosquitoes can effect an unintentional transboundary movement. The Cartegena Biosafety Protocol requires each government to notify and consult other potentially affected governments should LMOs under their jurisdiction cross international borders due to release into the environment. Have the neighboring countries been consulted to prepare for contingencies in case the GM mosquitoes cross national boundaries?
b) National Procedures not followed in Malaysia
Since the NBB and GMAC were not in existence in 2006/7 when the GM mosquitoes were imported into Malaysia from the UK, questions arise over the proper procedure. Which regulatory authority was responsible for the import process then? It should be the MNRE which is also the competent national authority for the Cartagena Protocol which has been in force since 2003.
Did the IMR/MOH notify the MNRE under whose jurisdiction the Act falls, prior to its importation of the GM mosquito eggs? Did MNRE approve? Under which process & criteria? Was the DG of Biosafety within the MNRE tasked with the responsibility? Under the Biosafety Act, the DG acts under the general authority and direction of the NBB. Since the NBB was only formed in 2010, under what laws or powers was the DG acting? Or were decisions simply made by administrative fiat bypassing legal requirements?
Issues on Risk Assessments are addressed separately below.
2. Risks Assessments
There was no credible risk assessments made. Unfortunately, there is no peer-reviewed scientific proof that blood-sucking GM female mosquitoes are not released also and thus the larva-killing protein cannot be injected into the human blood stream. Instead, there is evidence that the RIDL technology is thwarted by even small amounts of tetracycline in the environment, hence contributing to higher survival of GM mosquitoes.
In its scientific analysis of risk assessment of the GM mosquitoes field release, the MNRE had reportedly reviewed and taken into account the Environmental Impact Statement (EIS) by the US Department of Agriculture on the release of insects carrying a dominant lethal gene (RIDL) i.e. the GM pink bollworm and the GM fruit fly as this RIDL technology is similar to that applied in the production of GM mosquitoes. The GM bollworm and the GM fruit fly were the only two cases reviewed and cited by the MNRE.
The MNRE risk assessment for the GM mosquitoes which came out of the 2008 workshop was published in a paper co-authored by Oxitec staff, Camilla J. Beech and S. Vasan. This paper is the only Risk Assessment conducted on the GM Aedes mosquito release which is in the public domain. Till today, the Risk Assessment if there is really one that exist, has not been made public. As well, no EIA and Social Impact Assessments were done.
a) Percentage of transgenic survivalship higher than reported?
Dr Lee says that information on the 3% survivorship of the GM mosquitoes was available since 2007 and these survivors will have weak or short lives or if they do survive they will mate with their wild counterparts to produce larvae that will die, in the absence of tetracycline.
However, an internal Oxitec document obtained recently by civil society groups shows that Dr. Lee has erred in his statement. GM mosquitoes described by Oxitec as ‘sterile’ are in fact not sterile and their offsprings can have a 15% survival rate, in the presence of the antibiotic tetracycline. Even small amounts of tetracycline can repress the RIDL system. In the confidential report, the GM mosquitoes fed food containing chicken contaminated with low levels of tetracycline were able to reproduce, with their offsprings surviving to adulthood. The female GM mosquitoes can also pass tetracycline accumulated as larvae to the embryos, hence perpetuating the survival of GM mosquitoes into the next generations. (http://libcloud.s3.amazonaws.com/93/de/e/986/MosquitoDocOriginal.pdf)
Tetracycline is widely used in agriculture, livestocks, medical and veterinary areas and it is present in sewage as well as in industrially-farmed meat. Mosquitoes that carry dengue fever are known to breed in environments contaminated with tetracycline e.g. sewage. People undergoing antibiotic treatment may also be bitten. Thus, the failure of the RIDL technology when low levels of tetracycline exist certainly raises the spectre of GM mosquitoes surviving and breeding, including GM females which can bite and transmit disease.
A redacted version of the document, released to GeneWatch UK under UK freedom of information laws, shows that Oxitec tried to hide the evidence that its technology fails to prevent reproduction in the presence of low levels of tetracycline contamination (http://libcloud.s3.amazonaws.com/93/73/a/985/MosquitoDocRedacted.pdf).
Are MNRE, IMR/MOH and Dr Lee aware of these new data?
It would be highly irresponsible if MOH/IMR is still going ahead with plans to release GM mosquitoes in populated areas, given the facts above.
3. Non-transparency and Inadequate Public consultation
Dr Lee Han Lim refers to two public consultations and a media roundtable discussion in which only one NGO turned up. As far as we are aware the touted ‘public consultation’ was actually a ‘feedback’ mechanism. The fact remains that public objections and concerns were ignored; the exact locations of the field trials and the schedule of the field trials were not publicly announced or reported. The Fact Sheet by IMR did not contain substantive data on the technology. MOH Minister even declared that ‘no agreement of any local community was needed because the trials were carried out in an uninhabited area’ (Star 28 January 2011). And up until 7 February 2012, Dr. Lee the Principal Investigator of the GM mosquitoes project from IMR was a mystery…. .
Similarly, the secrecy, non-transparency and lack of public participation also occurred when Oxitec released 3 million GM mosquitoes in the Grand Cayman in 2009/10. The experiment has gone down in scientific history as the first release of GM insects that could bite humans.
a) Oxitec at Cayman Islands
A recent study by Reeves et al. (2012) published in the renowned peer-reviewed scientific journal PLoS Neglected Tropical Diseases criticized Oxitec’s introduction of new technology in the field via a meticulously planned ‘back door’ rash approach where there was lack of transparency (http://www.plosntds.org/article/info:doi/10.1371/journal.pntd.0001502). The study analysed scientific journals, permit applications and regulations and, inter alia, found that Oxitec’s failure to inform the public seemed a strategy used by Oxitec in Cayman Islands and repeated at other sites where its GM mosquitoes were released. The novelty of the technology makes it hard for regulatory authorities to assess the risks associated with the field trials. Moreover, Oxitec has good contacts with decision-makers at US approval bodies. What was also scandalous about this field trial is that it was largely conducted in secret. The trials were made public only a year after the first release of the GM mosquitoes. The local population of Grand Cayman did not know the mosquitoes were genetically modified.
Given the above, especially the recent data on the 15% transgenics survival rate, CAP-SAM urge the government to:
• Apply the Precautionary Principle and halt all further field trials and releases of the GM Aedes mosquitoes;
• Bring Malaysia’s laws on liability and redress up to standard with international rules and procedures for third parties for damage from GM organisms;
• Given that Oxitec Ltd holds the patents on the GM mosquitoes, the government must disclose how much of tax payers’ money were paid for its propriety GM mosquitoes eggs and services, what commercial entity is undertaking this project and which are the public institutions involved;
• As the contained trials were done prior to the enactment of the Biosafety Act and the establishment of the NBB, who or which bodies gave consent for the trials and what safeguards were in place? Make this information public.
• As the IMR/MOH was involved in the importation of the GM mosquito from Oxitec, was MNRE notified and consulted prior to the event? Make this information public.
• Under the Cartegena Biosafety Protocol, a risk assessment (RA) is required to determine the likelihood of an unintentional transboundary movement of GM mosquitoes if they are released in the importing country. Make this RA document public.
• Did the MNRE and MOH officially inform the neighbouring countries about the release? Make this information public.
• As required under the Cartagena Biosafety Protocol, did Oxitec inform MNRE as the ‘competent authority’ in writing prior to the export of its GM mosquitoes into Malaysia? Make this information public.
• Did the MOH or MNRE inform the UK government and the Biosafety Clearing House in writing before it decided to import and release the GM mosquitoes? If so is the relevant documentation available to the public?
Letter to editor, 16 Feb 2012.