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.

Sugar and diabetes

 sugar-and-diabetesAlthough the exact causes of diabetes are still not fully understood, excessive sugar consumption is known to indirectly play a role. A high sugar intake may not by itself cause diabetes, but it can be a major contributing factor to weight gain and obesity — factors that clearly promote diabetes.

Researchers around the world have come to the conclusion that the consumption of refined sugar is detrimental to the health of people without diabetes and disastrous for those with it.

A review of 88 published studies shows a clear and consistent relationship between drinking sugary (non-diet) soft drinks and poor nutrition, increased risk for obesity — and increased risk for diabetes.

There is no denying that sugar-loaded soft drinks are having “a negative impact on health”, Dr Kelly Brownell, director of the Rudd Center for Food Policy and Obesity at Yale University in New Haven, Connecticut, US, said in a telephone interview with Reuters Health.

Results of a study of more than 91,000 women followed for 8 years provides one of the most striking links between soft drinks and health outcomes, the investigators note in the American Journal of Public Health (April 2007).

In the study, women who drank 1 or more sodas per day — an amount less than the US national average — were twice as likely as those who drank less than 1 soda per month to develop diabetes over the course of the study.

When diet soda replaced regular soda in the analysis, there was no increased risk, “suggesting that the risk was specific to sugar-sweetened soft drinks”, note the authors.

Different Results from Industry

However, there was a “remarkable difference” in results from industry-funded and non-industry-funded studies on soft drink consumption and health outcomes, Brownell said, “with the industry-funded studies much more likely to find the results favourable to industry”.

“The bigger issue here, in this arena in particular but in science in general,” Brownell said, “is how you can get a distorted view of reality if industry-funded studies are considered in the mix — and usually they are — especially, when industry uses these studies in advertising, lobbying, and in talking to the press.”

Two Different Types of Diabetes

There are 2 types of diabetes: Type 1 develops when insulin-producing cells in the pancreas — which help to regulate blood-sugar levels — have been destroyed.  Type 2 usually appears when the body no longer responds normally to its own insulin and/ or does not produce enough insulin.

Type 1 diabetes is an autoimmune disease. An autoimmune disease results when the body’s system for fighting infection (the immune system) turns against a part of the body. In diabetes, the immune system attacks and destroys the insulin-producing beta cells in the pancreas. The pancreas then produces little or no insulin. A person who has Type 1 diabetes must take insulin daily to live.

The most common form of diabetes is Type 2 diabetes. About 90-95% of people with diabetes have Type 2, according to American statistics. This form of diabetes is most often associated with older age, obesity, family history of diabetes, previous history of gestational diabetes, physical inactivity, and certain ethnicities.

People who are overweight are particularly likely to develop Type 2 diabetes. However, Type 2 diabetes is increasingly being diagnosed in children and adolescents today.

Many Health Complications

Diabetes can cause a cascade of medical problems that can lead to heart attacks, strokes and other medical problems.  In people with diabetes, their blood sugar stays too high, and sugar in those high levels is toxic. Over the years, that high blood sugar damages nerves and small and large blood vessels. Those problems can ultimately result in blindness, kidney failure, amputations, premature heart attacks and strokes.

For example:

  •  Every 30 seconds, a leg is lost to diabetes somewhere in the world.  In fact, up to 70% of all leg amputations happen to people with diabetes (Star, 13.11.05).  In Malaysia itself, there are thousands of amputation cases a year.  About 85% of the amputees are diabetics (Star, 15.10.06).
  •  About 1.2 million Malaysians could be suffering from diabetic retinopathy, a common diabetic eye disease that can lead to blindness (NST, 11.10.07).
  •  At least 57% of Malaysians suffering from kidney diseases are also diabetic patients. There were about 15,000 patients in the country seeking haemodialysis treatment, with an average of 3,000 new kidney failure cases reported annually, said Island Hospital consultant physician and nephrologist Dr Goh Huck Keen (Star, 7.4.08).

Diabetes can also have a major effect on disability and quality of life as people age.  According to a study in 2002, older women with diabetes were twice as likely as non-diabetic women to be unable to perform tasks such as walking a quarter of a mile, climbing 10 steps or cooking their own meals.

How many affected:
 
1 in 20 of the world’s adult population now has some form of diabetes (Phyllis A. Balch in Prescription for Dietary Wellness). Diabetes struck 246 million people worldwide in 2006 [“Insulin Delivery Systems Market analysis (2007-2010)”, RNCOS].  There were 6 diabetes deaths every minute in the world (WHO, 2004).
An estimated 25% of the world’s nations have not made any specific provision for diabetes care in national health plans although the human and economic costs of diabetes could be significantly reduced by investing in prevention, particularly early detection to avoid the onset of diabetes complications (Diabetes Australia — NSW).
In Malaysia, some 3.5 million people are diabetic (NST, 12.6.06). About 98% of diabetics here have Type 2 diabetes (Star, 3.4.07).

Find out more about sugar and diseases in the CAP Guide How Sugar Destroys Your Health

RELATED ARTICLES:
Sugar and cancer
Sugar and obesity
Why sugar subsidy should be withdrawn immediately

Sugar and obesity

sugar-and-obesityFor years, dietary experts blamed fat as the root of obesity.  Millions of people diligently reduced their fat intake, but they were still fat.  Researchers then began to realise that many people who were taking fat out of their diets were replacing it with sugar — for example, cookies that were free of fats but loaded in sugar and calories.
 
“The problem is that with sugar, you’re getting a very large number of calories with a comparatively small volume of food. And we know that calories do count.

“A tablespoon of sugar, for example, contains between 50 and 60 calories but very little else from the standpoint of nutritional content,” says Dr Robert Keith, an Alabama Cooperative Extension System nutritionist in the US.

Many studies have now linked sugar to overweight and obesity, including childhood obesity. 

  •  A recent study published in Pediatrics and led by researchers at Columbia University Mailman School of Public Health in the US, concludes that childhood obesity epidemic is fueled by consumption of sugar-sweetened beverages, now increasingly a large part of children’s and teens’ diets.  (Source: Medical News Today, 3 June 2008)
  •  In Fat Land: How Americans Became the Fattest People in the World, Greg Crister writes: “In 2001 researchers from the Department of Medicine at Children’s Hospital Boston tracked 548 ethnically diverse Massachusetts schoolchildren (average age 11) for 19 months, looking at the association between their weight at the beginning of the period, intake of carbonated drinks, and weight at the end of the period.
  •  The results were revealing: 57% increased their intake of carbonated drinks over the 19-month period. The calories of just 1 extra soft drink a day gave the child a 60% greater chance of becoming obese. (Source: The Ecologist, November 2003)
  •  In 1999, the American Journal of Clinical Nutrition published a revealing graph, which indicated the growth rates of new food products (mainly fructose-laden convenience foods, snacks and sweets) and of the US average Body Mass Index over the previous 35 years.  The 2 growth rates were practically identical. (Source: The Ecologist, November 2003)

In spite of such findings, the sugar industry continues vehemently to deny any link between sugar and obesity, hounding those who dare to suggest otherwise.  “Many of the experts we spoke to refused to be quoted, fearing further pressure from the industry,” says The Ecologist (November 2003).

“British Sugar’s website even goes as far as to claim: ‘Of the various foods and drinks available in the shops, sugar has been shown to be less likely to encourage overeating than some others, especially fat-containing foods.  Surveys have shown that people who eat more than the average amount of sugar tend to be slimmer than those who eat less.’”

How Sugar Causes Obesity

The body works to maintain a certain level of blood sugar (glucose) in the blood at all times.  Sugary foods and drinks increase the amount of sugar in the blood.  The more processed the food, and the more refined and simply constructed the sugar, the quicker it is absorbed into the blood.

As blood sugar levels rise, the pancreas releases the hormone insulin, which works to remove the sugar from the blood into the body’s cells.  Once sugar leaves the blood it will either be used straight away to provide energy, be converted to glycogen for later use as a source of energy, or stored as fat.  

Simply put, as the amount of sugar in the blood increases, there is less need to use it to provide energy and more of the sugar is converted into fat.

How many affected:

Around 400 million people worldwide are obese today.  This includes 20 million children under age 5 (WHO, 2007). In Malaysia, 48% of men and 62% of women are fat (2006).

Find out more about sugar and diseases in the CAP Guide How Sugar Destroys Your Health

RELATED ARTICLES:
Sugar and cancer
Sugar and diabetes
Why sugar subsidy should be withdrawn immediately

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: