Reply to IMR: Procedures NOT complied with in GM mosquitoes release!

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.

4. Recommendations

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.

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:

Obtain prior Informed consent from inhabitants in GM mosquito release sites

The Consumers’ Association of Penang (CAP) and Sahabat Alam Malaysia (SAM) are very anxious of the eventual release of the GM Aedes aegypti mosquitoes in Bentong, Pahang and Alor Gajah, Melaka despite objections and concerns raised by NGOs, public and scientists.
The National Biosafety Board on 5 October 2010 approved the application submitted by the Institute for Medical Research (IMR) for approval for release of these GM Aedes aegypti mosquitoes.

One of the conditions of the approval, which has to be fulfilled before the start of the field releases, is that of public notification and consensus. The terms and conditions for the certificate of approval state that: “It is mandatory that the applicant through a public forum obtains prior consensus and approval for the inhabitants in the release sites regarding the proposed MRR [mark-release-recapture] field trial”.

CAP and SAM have already made clear our objection to the proposed field trials and the reasons why we have taken this stance. However, in view that the releases may still occur despite the objections of NGOs and the public, we would like to stress that the highest standards of prior informed consent must apply when it comes to obtaining the consensus and approval of the local communities in the release sites.

In the first place, any public forum conducted for the purpose of obtaining the consensus and approval of local inhabitants must be independent, open and balanced, presenting both the benefits and risks of the GM mosquitoes.

In our view, the public forum should not be conducted by IMR, although they may be called upon to provide technical or scientific inputs or to answer any specific questions on the trials. With all due respect to IMR, a public forum conducted by IMR would be seen as a clear conflict of interest, as IMR is the applicant for this field trial.

Secondly, the local inhabitants at the release sites must also be adequately notified and informed in advance about the public forum, and should be free to make their views known without fear of reprisals.

Thirdly, obtaining the consensus and approval of local inhabitants should be premised first on providing them transparent and comprehensive information about the proposed field releases. We would like to highlight paragraph 24 of the World Medical Association’s Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, in this respect (highlighted in bold for emphasis):

In medical research involving competent human subjects, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information. After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject's freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.

We hope that IMR will apply the letter and spirit of the Helsinki Declaration in obtaining the consensus and approval of the local communities at the field release sites. Any less would be a breach of internationally recognized standards.

Fourthly, one issue that does not seem to be adequately disclosed is the involvement of the UK-based company Oxitec in the proposed research. It is not clear from the information provided to the public whether and how Oxitec is involved and what role it is playing. This, despite the known fact that the transgenic technology used in the GM mosquitoes is owned and patented by Oxitec. The public and the local communities should be adequately informed on this issue as well.

Finally, it is not too late for the government to call off the experiment and field release of the GM Aedes aegypti mosquitoes.  Genetic engineering gives rise to unintended and unpredictable effects and the risks to public health and environment should not be underestimated. Thus we urge the Malaysian government to withdraw the approval and opt for safer solutions to control the spread of dengue fever.

Letter to the Editor – 14 December 2010

Read the Open Letter sent to the Government by CAP and other Malaysian NGOs on the issue of genetically engineered Aedes aegypti mosquitoes. To know more about GM mosquitoes, please see 10 things you should know about GM mosquitoes.

An Open Letter to the Government from Malaysian NGOs on genetically engineered Aedes aegypti mosquitoes

This is an open letter from organisations in Malaysia concerned by the recent Government approval to release GM mosquitoes for the purpose of a field experiment.

Kindly support our cause by highlighting the issue for the welfare of the public  and the conservation of our environment by copying and personally sending this letter to its intended recipients.

Sincerely,
S M Mohamed Idris
President
Consumers Association of Penang

 


17 December 2010

To:
Y.B. Dato’ Sri Liow Tiong Lai, Minister of Health
Y.B. Dato Sri Douglas Uggah Embas, Minister of Natural Resources & Environment
Tan Sri Dato’ Sri Dr Hj Mohd. Ismail bin Merican, Director General of Health
Dato’ Zoal Azha bin Yusof, Secretary General, Ministry of Natural Resources & Environment and Chairperson, National Biosafety Board (NBB)
Mr Letchumanan Ramatha, Director General of Biosafety
Dr Shahnaz Murad, Director, Institute of Medical Research (IMR)
Dr Ahmad Parveez Hj. Ghulam Kadir, Chairperson, Genetic Modification Advisory Committee (GMAC)

Re: Open letter from Malaysian NGOs on genetically engineered Aedes aegypti mosquitoes

We, the undersigned organizations of Malaysia, representing the public health, environmental, consumer and other movements, are very concerned by the recent approval to release genetically modified (GM) male Aedes aegypti mosquitoes OX513A(My1), for the purpose of a field experiment. We are even more worried that the field releases may have already happened, without adequate notification or information provision to the public. We urge the government to be transparent on the issue and to immediately disclose the details and specific sites of the releases.

1. Risky approach to dengue control
While dengue is a very serious problem in Malaysia and needs to be urgently addressed, going down the GM path takes us into risky territory. Genetic engineering often results in unintended effects. We do not know enough about the GM mosquitoes and how their interactions with non-GM mosquitoes in the wild, other species in the ecosystem, the dengue virus and human populations, will be affected.

There are several health and environmental risks associated with the field releases. For example, a small proportion of the GM larvae will survive – some of which would be female – despite claims that the technology is safe because the larvae will die. As female mosquitoes bite humans and transmit disease, has the risk of an increased disease burden been assessed? The surviving GM larvae would also lead to the persistence of the GM genes in the environment, with unknown consequences.

2. Field trials a first step to large-scale release
Although the field releases are characterized as small-scale and limited, we are extremely concerned that they are but one step in a technological approach to dengue control that is based on dependency and ‘locking-in’. At the commercial release stage, the continuous release of millions of GM mosquitoes at several places in Malaysia would be needed in order to successfully suppress mosquito populations. The risks would be greatly amplified at such large numbers.

One serious concern is the likely possibility that other closely related and disease-transmitting species would take over the ecological niche of Aedes aegypti once its populations are successfully reduced. This would continue to cause, or even worsen, the dengue problem and may even cause a rise in other mosquito-borne diseases.

While we realize that large-scale and eventual commercial releases would have to undergo a separate approvals and risk assessment process, the government cannot afford to ignore the implications of going down the GM path and must consider these concerns, even at this early stage.

3. In the public or private interest?
We understand that Oxitec Limited, a UK-based company, holds the patents on the technology used in these GM mosquitoes. While Oxitec will presumably collect rewards for their invention, will they bear the liability should anything go wrong?

A review of Oxitec’s accounts (available from Companies House, which is the UK government agency responsible for registering limited companies) shows that it made losses in 2008 and 2009 of £1.7 million a year. While Oxitec has received grants for its research, it is clear that the company expects to gain income from continual releases of GM mosquitoes in large numbers in several countries.  

4. Our demands
a. As citizens of Malaysia, we demand a wider and broader public debate on the issue than there has been to date. This field experiment will have tremendous implications for Malaysia’s health and environment. There must be a national discussion as to whether GM mosquitoes are indeed the right approach to address dengue. The general public are integral to effective dengue control and there must be consensus on this issue.

b. The prior informed consent of the communities living in and around the proposed field release sites must be obtained. This means that they must also have the potential risks of the study adequately explained to them, and information about the sources of funding and any possible conflicts of interest provided.

c. We ask the government to call off the experiment and field releases of the GM mosquitoes, and to instead invest in safer approaches to addressing dengue.

Thank you.

Yours sincerely,

1. Centre for Environment, Technology & Development, Malaysia (CETDEM)
2. Consumers’ Association of Penang (CAP)
3. Institute for Development of Alternative Living (IDEAL)
4. Malaysia Youth and Students Democratic Movement (DEMA)
5. Parti Sosialis Malaysia – Cameron Highlands Branch
6. Penang Suya Meiyarivagam
7. Persatuan Kakitangan Akademik Universiti Malaya (PKAUM)
8. Persatuan Karst Malaysia
9. Persatuan Kebajikan Nelayan-Nelayan Pantai Pulau Pinang (Penang Inshore Fishermens' Welfare Association)
10. Persatuan Pengguna-Pengguna Pahang (PAC)
11. Persatuan Pengusaha Pertanian Kecil Felda Chini, Pekan, Pahang (Chini Smallholders Network)
12. Pesticide Action Network Asia and the Pacific (PAN-AP)
13. Sahabat Alam Malaysia (SAM)
14. Sarawak Dayak Iban Association (SADIA)
15. Secretariat Ulama Assembly of Asia (SHURA)
16. SOS-Selangor
17. Southeast Asian Council for Food Security & Fair Trade (SEACON)
18. Malaysian Physicians for Social Responsibility
19. Sustainable Development Network (SUSDEN)
20. TERAS Pengupayaan Melayu
21. Third World Network (TWN)
22. Treat Every Environment Special S/B (TrEES)
23. Environmental Protection Society Malaysia (EPSM)

To know more about the seriousness of this issue, please see how we have demanded for Prior Informed Consent by inhabitants of GM mosquito release sites and also 10 things you should know about GM mosquitoes.

CAP and SAM: Revoke approval for field trial of GM mosquitoes

 
gm-mozzie-idrisCAP and Sahabat Alam Malaysia (SAM) call upon the National Biosafety Board (NBB) to revoke the approval given to the Institute for Medical Research (IMR) in October 2010 to release genetically modified (GM) male Aedes aegypti mosquitoes for the purpose of a field experiment.
 
The applicant and implementer of the field trial is the IMR which had developed the GM mosquitoes in a joint research with UK-based biotech company Oxitec Ltd. The field trial which was supposed to be carried out last December in uninhabited and inhabited sites in the districts of Bentong, Pahang and Alor Gajah, Melaka was reportedly delayed because of bad weather.
 
Following the NBB’s decision, CAP and SAM had submitted a memorandum to the Malaysian Government on 20 December 2010 raising our concerns on serious ethical, legal, public health and human rights issues.   Twenty-nine organizations in Malaysia and 87 civil society organizations throughout the world, concerned by the impending release of the GM mosquitoes had also raised their apprehension in open letters to the authorities.

Malaysia will be the first country to release this particular strain of GM Aedes aegypti mosquitoes OX513A (My1). The only other country which has released GM Aedes mosquitoes with the same transgenic construct is the Cayman Islands – a British overseas territory. In November 2010, international reports had revealed that Oxitec publicly announced its GM Aedes mosquitoes’ field trials in the Cayman Islands only one year after the event.

The field releases in the Cayman Islands in 2009 and 2010 were controversial and calls have been made for a transparent assessment of the full, long-term health and environmental impacts of these trials in the Cayman Islands, pending which, no further field releases of GM mosquitoes should occur anywhere else.

Besides this, GeneWatch UK, a science-based not-for-profit organisation, has conducted and published an investigation of Oxitec’s role in the development, patenting and promotion of the use of these genetically-modified (GM) mosquitoes. [Please see GeneWatch UK’s December 2010 report titled “Oxitec’s genetically-modified mosquitoes: in the public interest?”]

GeneWatch UK is concerned that the novelty of this application of GM technology has made regulators in several countries too dependent on advice provided by Oxitec which has a vested interest in speeding its products into the market place in order to generate financial returns for its investors. In GeneWatch UK’s view this means that a number of potential risks have been omitted or downplayed.

[Please click on the link below this statement to read GeneWatch UK's comments on Risk Assessment report of the  Malaysian Genetic Modification Advisory Committee (GMAC) for an application to conduct a limited Mark-Release-Recapture of Aedes aegypti (L.) wild type and OX513A strains].

The fact that this project involves the creation and propagation of a deadly insect and its eventual release in the natural environment means that it is a dangerous and risky enterprise.

The GM mosquitoes will be released into a complicated ecosystem, involving other mosquito species, predators and prey, the dengue virus, and the humans who are bitten. Because this system is poorly understood there remain unanswered questions about the impacts of the proposed releases.   

The outcome of this experiment is thus unpredictable and largely unknown. If the unintended occurs in the environment, these releases would be impossible to monitor, contain or mitigate and they are irreversible.

Mosquitoes, natural or engineered, do not respect national borders. It is not possible for any country to control mosquitoes from crossing their 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 as it will potentially affect every nation on the planet. Hence, were Malaysia’s neighbouring countries such as Singapore, Indonesia and Thailand officially informed about the impending release?

Given the unpredictable consequences and potential risks, the chances of things going wrong cannot be overstated. Why are we allowing ourselves to be guinea pigs for this doubtful 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 is the applicant for the release.

It is regrettable that the authorities seem intent on allowing the trials to go ahead, despite public calls to be cautious and to take into account the precautionary approach based on valid concerns. That we are dealing with GM insects especially disease-carrying mosquitoes’ on which there are very few guidelines for biosafety assessment simply because there is very little information to go on, should be a push for the precautionary approach.

Malaysia should uphold transparency, rigorous scientific standards, the precautionary principle, justice and human rights, and ethical and lawful practices. Otherwise, we will be opening the floodgates for foreign corporations to dump in Malaysia other GM insects, crops, food, feed and processing in the future. What is at stake is the health of Malaysians and our neighbours, our environment and biological diversity.

We hereby call upon the NBB in consultation with the Genetic Modification Advisory Committee to review and revoke the approval for the field release of these GM mosquitoes as allowed for under the Biosafety Act 2007.

Press Statement – 17 January 2011


Read more about our campaign against GM mosquitoes in our Focus: