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Agriculture / Organisms » Insects/Microorganisms

Title: CAP/SAM Raise Serious Concerns on Planned GM Mosquitoes Release
Source: CAP/SAM
Publication date: December 20, 2010
Posting date: December 23, 2010

Serious concerns raised by Malaysia’s planned release of GM mosquitoes

Malaysia is about to release genetically modified (GM) Aedes mosquitoes into the environment. This field release will make Malaysia one of the first countries in the world to release GM Ae. aegypti mosquitoes. The only other known country which has done so is the Cayman Islands, a British overseas territory in 2009 which has been controversial and raised in both the British and European Parliaments.

Below is an abstract of the memorandum by the Consumers’ Association of Penang (CAP) and Sahabat Alam Malaysia (Friends of the Earth Malaysia) outlining serious ethical, legal, public health and human rights concerns regarding the GM Aedes mosquito planned release.

It also put forward a series of proposed actions to be taken.

Click on the link at the bottom of this page for the full version.

Click here for other statements by CAP.  

Evelyne Hong
TWN


 

Memorandum on

Malaysia’s GM Aedes mosquito planned release: ethical, legal and human rights concerns

by

Consumers’ Association of Penang and Sahabat Alam Malaysia


20 December 2010

ABSTRACT

This memorandum outlines some of the serious ethical issues which need to be addressed before any field releases of the GM mosquitoes are allowed to take place. They include the one-year delay by Oxitec in announcing the GM mosquito release in the Cayman Islands which has raised serious concerns among international biosafety experts; the 3-4% unexpected survival of GM mosquito offspring which was not reported by Oxitec or the Institute for Medical Research (IMR) in its public documents; and the import process and the contained trials carried out were approved in the absence of the National Biosafety Board (NBB) under the Biosafety Act 2007.

Additionally, the transboundary environmental release of GM mosquitoes is governed by the Cartagena Biosafety Protocol. As such Malaysia could have contravened national and international laws when it decided to import and release GM mosquitoes. Further, Malaysia could have broken the de facto UN moratorium on Terminator technology.

The absence of effective public participation and the shroud of secrecy surrounding the project, and the undue haste in implementing the field trials have caused unease and anxiety among Malaysians. Conflicts of interests of Oxitec have further fuelled distrust.

While acknowledging that dengue fever and malaria are serious mosquito-borne diseases that need to be controlled using safe measures, it is however very doubtful if the proposed release of GM mosquitoes to control dengue fever is proper and 100 per cent safe under the  present dubious conditions.

These serious ethical, legal, public health and human rights concerns are listed below.

1. Non-transparency of GM Aedes trials in the Cayman Islands

Oxitec announced its GM Aedes mosquito field trials in the Cayman Islands only a year after the event. This has raised serious concerns among international biosafety experts.

Although the Cayman Islands is a British overseas territory, it is a non-Party to the Cartegena Biosafety Protocol, thus the Protocol laws do not apply. It was very convenient for Oxitec to run the release experiments in the Cayman Islands, which did not have biosafety laws in place.

Thus the choice of releasing the GM mosquitoes in the Cayman Islands is similar to MNCs’ behaviour where they avoid the strict environmental laws in developed countries by exporting their dangerous activities to developing countries which have much weaker environmental rules and compliance mechanisms.

2. Non-transparency of GM Aedes trials and planned releases in Malaysia

Under the Cartegena Protocol which Malaysia is a Party to, the exporter of GM organisms is required to inform in writing the importing country before the intentional transboundary movement of the GM organism.

Likewise, Oxitec’s shipment of GM mosquito eggs from the UK is subject to EU laws on GMOs which require the exporter (Oxitec) to notify the relevant authority in the importing country i.e. the Ministry of Natural Resources and Environment (MNRE) and to await its consent to proceed.

To our knowledge, there is no publicly available report that MNRE had given consent for the shipment of GM mosquito eggs from Oxitec in the UK to IMR in Malaysia.

Further, there is no known proper risk analysis having been done. If there was a proper Risk Assessment (RA), it should be made public.

And where are the Environmental and Social Impact Assessments (EIA and SIA)?

3. Conflict of interests in Oxitec and close links with agrochemical MNCs

It has been reported that Oxitec has been facing financial losses since 2008. The company is losing some £1.7 million annually. It owes £2.25 million to a US investor which it has to repay by 2013. It is clear Oxitec is under great pressure to sell its GM mosquito project to earn money.

The MNRE Biosafety unit repeatedly cites as reference that there is no evidence of cross-mating of GM Ae aegypti with Ae Albopictus, a paper co-authored by Dr Seshadri Vasan, a member of Oxitec UK and CEO of Oxitec Sdn Bhd (Malaysia). He was not indicated in this 2009 paper as being from Oxitec. This paper also does not carry a conflict of interest statement, usually required in other reputable publications.

Oxitec’s staff is closely linked to big MNCs. Malaysia has worked hard for more than a decade to ensure that biosafety issues are addressed in the Cartegena Biosafety Protocol, it appears ineffective when locally GM mosquitoes are being released in a hasty manner in cooperation with agribusiness and pharma companies and links.

4. The hidden 3 to 4% offspring of male GM mosquitoes and normal females actually survive into adulthood

Please note that the 3-4% unexpected survival was not reported directly by Oxitec or IMR in its public documents. It was first revealed in October 2010 by the head of the Genetic Modification Advisory Committee (GMAC) to reporters at the height of concerns regarding the field releases. According to a SciDevNet report, Ahmad Parveez Ghulam Kadir, head of the GMAC – a technical advisory body to the NBB of the MNRE - said that the committee had been concerned that lab tests had shown that 3% of the offspring of male GM mosquitoes and normal females actually survive into adulthood rather than dying as larvae as intended.

According to the same SciDevNet report, Ricarda Steinbrecher, a geneticist and co-director of EcoNexus, a UK-based non-profit research organisation, said that it is not clear how the offspring of the male GM mosquitoes survive into adulthood and do not die as 'programmed', but it raises the possibility that they could breed and pass on this — as yet unknown — mechanism for overcoming the lethality. She said, "I would suggest that it is far too early for any open field releases. More data are needed from laboratory experiments. Furthermore, trials in field cages [large outdoor enclosures made from netting, i.e. confined field trials] are needed."

However, previous MNRE and Oxitec responses to the public have been that the GM mosquitoes will not affect public health and safety or the eco-system!

Once again, Oxitec has not been truthful and transparent on important biosafety issues regarding the GM mosquitoes, and it seems the IMR has been complicit.

5. Proper due process was not followed prior to GM mosquito release

GM mosquitoes importation, contained trials and field releases are regulated nationally and internationally.

Take note that the NBB was only established in March 2010 under the Biosafety Act 2007, but the Oxitec-IMR contained trials were done a few years ago.

Thus the contained trial conducted much earlier did not go through the NBB. The Biosafety Act requires the establishment of the NBB which will decide on all matters relating to the approval for release and import of living modified organisms.

The contained trial conducted much earlier remains controversial as it was contrary to the spirit and provisions of Malaysia’s Biosafety Act.

The Ministry of Health (MOH) would have been involved in the process of drafting the Biosafety Act 2007. It would appear that the MOH was ready to import GM mosquitoes but the said Act was not in force. In which case, which was the regulatory authority responsible for the import process? Did the MOH notify the MNRE (under whose jurisdiction the Act falls) prior to its importation of the GM Aedes mosquito eggs? Did the MNRE approve? Under which process and criteria?

Since the NBB did not officially exist until March 2010, who or which body was responsible to ensure that the Biosafety Act was implemented? Was the Director General (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 this year, under what laws or powers was the DG acting? Or were decisions simply made by administrative fiat bypassing legal requirements?

The Cartagena Protocol on Biosafety (the Protocol) regulates the transboundary movements of LMOs (living modified organisms) which include GM mosquitoes.

Under the Protocol, the importing country i.e. Malaysia must ensure that risk assessments are carried out.

Thus the risk assessment should determine the chances of an unintentional transboundary movement of GM mosquitoes if they are to be released in the importing country.

It also suggests that the importing country should require the exporting country to assess the likelihood that GM mosquitoes will cross borders unintentionally. It is obvious that if such an event is likely, the release should not be allowed.

Did the MNRE or MOH request Oxitec to do the risk assessment before it made the decision to import the GM mosquitoes?

Mosquitoes, natural or engineered, do not respect national borders. It is not possible for any country to control mosquitoes from crossing their borders. For instance, in the 1990s, the Asian tiger mosquito (Aedes Albopictus), a potential vector for dengue fever virus, was introduced into the US in a shipment of rubber tyres imported from Asia. In fact, Ae. aegypti is an invasive species introduced in the 1970s to Malaysia but is now part of the ecosystem.

What is the likelihood that any country can contain GM mosquitoes to remain within its borders in this age of air travel, and large-scale movements of people and materials? For this reason, releasing a GM mosquito must be considered as a worldwide release which will potentially affect every nation on the planet.

In which case, there is every likelihood that an unintentional transboundary movement of GM mosquitoes will occur. Article 17 paragraph 4 of the Protocol states that the country where the environmental release occurred ‘shall immediately consult the affected or potentially affected States to enable them to determine appropriate responses and initiate necessary action, including emergency measures.’

Hence, were Malaysia’s neighbouring countries such as Singapore, Indonesia and Thailand officially informed about the impending release? The MNRE had told the public that it ‘used the guidelines developed for GM mosquitoes under the Cartagena Protocol on Biosafety.’ Did it really?

6. Risk assessment (RA) lacking

In its scientific analysis of risk assessment concerning the GM mosquito field release, the MNRE had reportedly reviewed and taken into consideration the Environmental Impact Statement (EIS) by the United States Department of Agriculture on the release of insects carrying a dominant lethal gene (RIDL), i.e. the GM pink bollworm (developed by Oxitec) and the GM fruit fly as this RIDL technology is similar to that applied in the production of GM mosquitoes.

However, the GM fruit flies and the GM pink bollworms are plant pests or agricultural pests that do not pose a threat to human health. In the words of a critic who was once involved in vector control: ‘To imply that the same level of criteria should be applied to GM mosquitoes, a known human blood feeder and human disease vector vastly oversimplifies the safeguards that need to be considered.’

There was a workshop on Risk Assessment of Transgenic Insects in Kuala Lumpur in November 2008, organised by MNRE, IMR and Universiti Malaya.

The GM Aedes mosquito case study was conducted as the risk assessment (RA) ‘for a hypothetical large-scale open field release in Peninsular Malaysia’. The RA for this was later published in a paper and the co-authors include Camilla J. Beech and S. Vasan, both of who are from Oxitec Ltd.

Since the Environmental Impact Statements (EIS) on GM bollworm and the GM fruit fly were the only two cases reviewed and cited by the MNRE, and no other risk assessment for GM mosquitoes was reported widely other than the paper from the workshop mentioned above, it appears that the paper is the only Risk Assessment conducted on the GM Aedes mosquito release which is in the public domain. In the absence of further information, this paper could be the sole basis of the approval of the GM mosquito field release, unless the Malaysian government categorically states otherwise.

Hence, the many worrying concerns raised regarding the GM mosquito make it imperative that the Risk Assessment (RA), in line with the Precautionary Principle, be made public. Similar to the Environmental Impact Assessment (EIA) which is required by law, the detailed RA should be in the public domain. This is crucial as the people especially those in the release sites must know the details to make an informed decision.

7. GM mosquito field trials undermine UN CBD moratorium on Terminator technology

GM mosquitoes are Terminator insects as they have been designed to produce sterile offspring. Since 2000, the UN Convention on Biological Diversity (CBD) has imposed a de facto global moratorium on this technology.

Malaysia’s decision to test the GM mosquitoes in the field in effect undermines the global moratorium on Terminator technology. Malaysia’s decision is inconsistent with its international role where it is a key player in the CBD. In fact, Malaysia was responsible for introducing the biosafety issue in the CBD negotiations. Indeed, when countries worldwide are banning and rejecting Terminator

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