Consumers Association of Penang

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CAP & SAM Memorandum to the Government on Malaysia’s GM Aedes mosquito planned release

CAP and Sahabat Alam Malaysia (SAM) are deeply concerned of the impending field release of Genetically Modified (GM) mosquitoes after the National Biosafety Board approved an application from the Institute of Medical Research to release GM male Aedes aegypti mosquitoes.


Following this, we are submitting a memorandum to the Malaysian Government raising our concerns on serious ethical, legal, public health and human rights issues which need to be addressed.
 
ABSTRACT

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

by
Consumers’ Association of Penang & Sahabat Alam Malaysia
20 December 2010

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. 1

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 technology, the GM ‘Terminator’ mosquitoes release in Malaysia would be a step backwards for Malaysia.

8. Liability, redress and accountability issues
Given all these unpredictable consequences and potential risks, the chances of things going wrong cannot be overstated. Why is the MOH paying Oxitec to test such a dangerous product on Malaysian soil? Why have we allowed ourselves to be guinea pigs for this dubious technology? What if the experiment does not go according to plan and something goes terribly wrong with the release? First and foremost, Oxitec will not be wholly liable as IMR-MOH is the Applicant for the release.

Moreover, the Biosafety Act is silent on the issue of liability and redress. Does it mean that Oxitec will get away scot free although it owns the patent rights to the GM mosquito? Who, how and where can the communities seek redress should any adverse health and environmental effects occur? Who will be held liable?

There are further issues that touch on the rights of the communities and other ethical considerations. Some of these include the following:
• Is there any commitment from the IMR, MOH and MNRE that in an unexpected adverse event or events, the communities will be compensated?
• Who will be accountable if deaths and/or injury occur through GM mosquitoes, dengue or pesticide poisoning?
• Will the communities be compensated for the time, inconvenience and expenses incurred (if any) for participating in the field trials?
• In the event that opposition to the field trials grows, can the community withdraw their consent at this stage?
• In the absence of any international guidelines on the release of the GM mosquitoes, what are the national guidelines to monitor the field trials? Do they exist?
• What are the guidelines in place to ensure adequate protection for the communities? Have those who may be specifically at risk been identified? As children and the elderly may be at a higher risk, what measures have been put in place to protect them?
• Is there a mechanism in place to inform the public and the communities affected about the progress of the project?

9. Lack of transparency and effective public participation
Based on the comments and letters in the media (both the online and printed media) from the public even after the ‘public consultation’ period had ended, it seems that the public were not fully aware of the GM mosquito release and that more time should have been given for public feedback.

The shroud of secrecy surrounding the project has not only caused great suspicions and alarm, it has created unease and anxiety among the Malaysian public. The undue haste in implementing the field trials has also been a subject of serious concern. In fact, foreign scientists like Ricarda Steinbrecher had said that the Malaysian trials must not proceed until a full, long-term environmental assessment of the Cayman trials is performed.

Please note that according to the NBB’s terms and conditions for the GM mosquito release, ‘It is mandatory that the applicant through a public forum obtains prior consensus and approval from the inhabitants in the release sites …. .’

On 21st November, a press report quoting an official said that the Bentong Municipal Council had given the approval for the trial to go ahead. However without public consensus the release cannot take place.

Even from the time the two GM mosquito field release sites were proposed, the people of Alor Gajah and Bentong were not consulted before the announcement was made. There was no public forum where members of the community could have raised their concerns or sought explanation regarding the GM mosquito release from the authorities. Neither is the public informed as to what are the mechanisms whereby the communities at the release sites will be briefed, and how consensus and consent will be obtained.

Genuine effective public participation allows all voices to be heard and considered, so that the public can make informed decisions. Human well-being is at the core of public health and the government has a duty to respect, protect and fulfil the people’s right to health. It also means that the government’s actions regarding public health must promote public trust and not instil public fear and uncertainty.

10. The members of the GMAC and the NBB
According to the Biosafety Act 2007, the NBB acts on the advice of GMAC.

Most of the members of GMAC have no expertise in mosquitoes let alone GM mosquitoes. Similarly, the NBB members are mainly from the fields of botany, management, public policy and administration.

The lack of entomologists, independent vector control specialists, mosquito experts, geneticists and public health experts is worrying as the approval process of the GM mosquito trials appears to have been conducted without the relevant expertise.

Further, the absence of lawyers familiar with the Cartagena Biosafety Protocol and Malaysia’s Biosafety Act 2007 creates a vacuum on the legal side of the biosafety compliance component.

The following are some proposals from CAP and SAM:
• Stop the planned release of GM Terminator mosquitoes.
• The local councils to withhold or withdraw the consent letter until the two communities at the release sites have been consulted and have given their prior informed consent for the GM mosquito release as stipulated in the terms and conditions by the NBB to the IMR.
• That the NBB should make available on its website all the compliance documents, including the Risk Assessment (RA) and Risk Management (RM) reports, as well as a credible Emergency Response Plan related to this proposed GM mosquito release as per Sections 36, 37 and 60 of the Biosafety Act 2007.
• That the NBB fully engage the public through open informed dialogue and hearings and that this process be made available to the public and the mass media.
• That GMAC and the NBB include in their panel independent experts in the areas of genetics, vector control, mosquitoes and public health.

We urge Members of Parliament:
• To ask the Minister for the MNRE and the Law Minister, as the contained trials were conducted prior to the enactment of the Biosafety Act 2007 and the establishment of the NBB, who or which bodies gave consent for the trials, and what safeguards were in place. Is the relevant documentation available for public scrutiny?
• To ask the Ministers of the MOH and the MNRE that under the Cartagena Biosafety Protocol, a risk assessment is required to determine the likelihood of an unintentional transboundary movement of GM mosquitoes if they are released in the importing country. Did the MOH or the MNRE request Oxitec to do the risk assessment before the decision was made to import the GM mosquito? If so, is the relevant documentation available to the public?
• To ask the Ministers of the MNRE and the MOH, were the neighbouring countries officially informed about the impending release? If so, is the relevant documentation available to the public?
• To ask the Minister of the MNRE, what is the MNRE’s position on the de facto UN moratorium on Terminator technology since Malaysia has imported GM mosquitoes which use Terminator technology?

S.M. MOHAMED IDRIS
President
Consumers’ Association of Penang &
Sahabat Alam Malaysia
20 December 2010

Download the full Memorandum here

Read more about CAP's concern over the GM mosquito issue in: