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POLICY & REGULATION: A quiet release of GE mosquitoes in Malaysia



                                  PART 1


------------------------------- GENET-news -------------------------------

TITLE:   A QUIET RELEASE

SOURCE:  The Star, Malaysia

AUTHOR:  Tan Shiow Chin

URL:     http://thestar.com.my/health/story.asp?file=/2011/1/30/health/7886740&sec=health

DATE:    30.01.2011

SUMMARY: "The covert manner in which GM mosquitoes were released in Bentong calls into question the level of transparency of the whole affair. WITH transparency being one of the key watchwords in Prime Minister Datuk Seri Najib Tun Razak?s administration, it was heartening to note the efforts made by the National Biosafety Board to elicit public feedback during the approval process for the Institute for Medical Research?s application to release genetically-modified male Aedes aegypti mosquitoes in Bentong, Pahang, and Alor Gajah, Malacca."

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A QUIET RELEASE

The covert manner in which GM mosquitoes were released in Bentong calls into question the level of transparency of the whole affair.

WITH transparency being one of the key watchwords in Prime Minister Datuk Seri Najib Tun Razak?s administration, it was heartening to note the efforts made by the National Biosafety Board (NBB) to elicit public feedback during the approval process for the Institute for Medical Research?s (IMR) application to release genetically-modified (GM) male Aedes aegypti mosquitoes in Bentong, Pahang, and Alor Gajah, Malacca.

Not only did the board open the issue up for comment and feedback from the public, but they also actively solicited opinions from environmental non-governmental organisations (NGOs) due to a slow response rate during the one-month long public consultation period last August.

However, all that effort was negated by the rather clandestine way IMR carried out the actual release last month.

It was announced on Wednesday that the institute, and its partner in the project ? United Kingdom-based biotech company Oxitec Ltd, had conducted a single release of about 6,000 male GM A. aegypti mosquitoes at an uninhabited site in a forested area near Bentong on Dec 21.

This has made Malaysia the second country in the world to release these GM mosquitoes into the wild after the Cayman Islands in 2009.

The trial, which also saw the release of an equal number of unmodified male mosquitoes at the same time, was meant to study and compare the flight range and survivability of the GM mosquitoes under natural conditions against their wild counterparts.

IMR had applied for approval to conduct the limited mark-release-recapture study to the NBB last year. The male GM mosquitoes have been modified to include a gene that causes their offspring to die before reaching sexual maturity in the absence of the antibiotic tetracycline.

The idea behind this piece of genetic engineering is to lower the population of A. aegypti mosquitoes by continuously releasing the male GM mosquitoes to mate with wild female mosquitoes.

After some time, the population of these mosquitoes should decrease enough to curtail the spread of dengue fever, which is caused by a virus transmitted to humans through the bite of the female A. aegypti mosquito.

The limited study is one of a few preliminary trials necessary before the Government can decide on whether or not to use these GM mosquitoes to help control dengue.

IMR?s application, which was assessed by the board?s Genetic Modification Advisory Committee (GMAC) under the Biosafety Act 2007, was approved with terms and conditions last October.

Kids taking a close look at a model of an A. aegypti mosquito at a health exhibition in Penang. Around 6,000 male genetically-modified A. aegypti mosquitoes were quietly released at an uninhabited site in Bentong last month without any prior publicity.

Informing the public

While the institute has adhered to the word of the terms and conditions laid out to them by the NBB, it is arguable whether they have followed the spirit of the guidelines.

This relates in particular to the clause stating that it is mandatory for IMR to obtain consensus and approval from the inhabitants at the release sites through a public forum before releasing the mosquitoes.

An IMR scientist with the project said that as the release was only being conducted at an uninhabited site, the public forum to gain approval from the local community was not required.

GMAC head Dr Ahmad Parveez Ghulam Kadir said that the committee and IMR had agreed during discussions that for an uninhabited site, the institute had to obtain clearance from the local municipal council, and put up notices informing the public about the field trial around the release site at least two weeks before the planned release.

Fit4Life had reported on Nov 21 that the Bentong Municipal Council had given their permission for the trial to be conducted within a three-month period from mid-November.

According to Natural Resources and Environment Ministry Biosafety Department Research and Evaluation director Dr Mohamad Mohd Salleh, signboards on the release had been put up around the release site on Dec 1.

?The signs were put up on Dec 1. The release was suppose to be on Dec 15, but was postponed to Dec 21 because of the weather,? he told Fit4Life.

Non-profit Third World Network?s senior researcher (biosafety) Lim Li Ching opined that IMR had obviously decided to do the release in an uninhabited area as it would be ?quite tricky? to obtain the approval of the local community.

?In their interpretation of the conditions (of the approval), they would not have to organise a public forum for the release in an uninhabited area,? she said.

?However, we think that, even if it is in an uninhabited area, the local community who live around the area have a right to know (about the release).?

Lim pointed out that although the area might not have anyone living within it, it did not mean that people do not go into the area.

According to Dr Ahmad Parveez, the uninhabited site proposed by IMR was located about half a kilometre from a road.

Conflicting reports

Further confusion was caused by media reports published earlier this month that the trial had actually been postponed, and that no new date had been set for the release as yet.

AFP reported that the postponement was due to protests by NGOs, while two local English dailies quoted Dr Mohamad and Biosafety director-general Letchumanan Ramatha respectively as saying it was because of the rainy weather.

Dr Mohamad clarified that the delay (and the reason for it) he was referring to in the earlier report was the one that had occurred in December.

He added that at that time, he could not reveal that the release had already taken place as the Biosafety Department had been instructed not to release that information to anyone for fear that people might ?disturb? the release site.

However, Health Minister Datuk Seri Liow Tiong Lai said that the postponement that was referred to was actually for the phase of the trial involving an inhabited area.

He added that that phase would have involved getting the agreement of local residents, as per the conditions set out by the NBB.

However, currently, there are no plans to conduct any further releases of the GM mosquitoes.

The press release by IMR director Dr Shahnaz Murad stated: ?No further release has been planned until the post-trial monitoring is completed in accordance with the Natural Resources and Environment Ministry guidelines, and the results are analysed and presented in peer-reviewed scientific journals and/or meetings.?

According to Dr Shahnaz, the trial was completed on Jan 5, and the site fogged with insecticide the following day.

She added that they would continue to monitor the site for surviving GM mosquitoes for as long as necessary, up to two months.

NGO concern

Lim said that the lack of transparency over the release was not good, especially considering criticisms on the same issue by international observers for the Cayman Island trials.

Most of the world only found out that the British Overseas Territory had released the male GM mosquitoes of the strain OX513A on the island when Oxitec and the island?s Mosquito Research and Control Unit (MRCU) announced the results of the suppression study they had conducted from June to October 2010 in a London press conference last November.

Many scientists and NGOs had criticised both bodies for not publicising the release beforehand, although both Oxitec and MRCU said that local residents had been informed of the trial before it was carried out. Following that, Lim said that IMR and Oxitec ?should be aware of the concern and interest internationally in this trial?.

Various international NGOs have voiced their opinion on Malaysia?s intent to release the male GM mosquitoes into the wild, albeit in a limited area and in comparatively small numbers. Among them is GeneWatch UK, a non-profit organisation specialising in genetic engineering and biosafety issues.

In its 13-page report published this month, the science-based organisation offered its opinion on the risk assessment performed by GMAC on the field trial during the approval process.

While they commended GMAC for the systematic approach they followed, the organisation said that ?the risk assessment process would have been more transparent had the GMAC also listed all the potential hazards it has identified and its evaluations of their likelihood, consequences and estimated overall risk?.

The report added that: ?A description of the process the GMAC has used to undertake these steps (ie how it has made its evaluations) would have also increased transparency, which is an important factor in decision-making, particularly given the intense interest and debate over this new area of transgenic technology.?

Locally, various NGOs have also continued to voice their worry over the trial, despite the public consultation period organised by the NBB.

Among their reservations were the novelness and unpredictability of this relatively new technology, as well as the fact that there are other less controversial methods of preventing dengue.



                                  PART 2

------------------------------- GENET-news -------------------------------

TITLE:   OVER 200 PEOPLE ATTENDED GM MOZZIE TRIAL TALKS, SAYS IMR OFFICIAL

SOURCE:  The Star, Malaysia

AUTHOR:  Loo Foon Fong

URL:     http://thestar.com.my/news/story.asp?file=/2011/1/31/nation/7905312&sec=nation

DATE:    31.01.2011

SUMMARY: "The Health Ministry held talks with Bentong residents in December over the release of genetically-modified mosquitoes, an Institute for Medical Research official said. [...] About 150 people attended the dialogue in Malay at the Bentong local council building and about 100 residents attended the session in Manda­rin at the Chinese Assembly Hall. ?It?s not true that we have not been transparent with the issue,? he said, commenting on an article in the Fit for Life section in The Star."

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OVER 200 PEOPLE ATTENDED GM MOZZIE TRIAL TALKS, SAYS IMR OFFICIAL

PETALING JAYA: The Health Ministry held talks with Bentong residents in December over the release of genetically-modified (GM) mosquitoes, an Institute for Medical Research (IMR) official said.

The IMR?s Medical Entomology Unit head Dr Lee Han Lim said the institute, in collaboration with the Bentong Municipal Council and Bentong MCA, held two public talks on Dec 9.

About 150 people attended the dialogue in Malay at the Bentong local council building and about 100 residents attended the session in Manda­rin at the Chinese Assembly Hall.

?It?s not true that we have not been transparent with the issue,? he said, commenting on an article in the Fit for Life section in The Star.

Dr Lee said the talks lasted two to three hours and explained the project in detail. Residents were also given time to ask questions.

He said the Natural Resources and Environment Ministry had also invited nine NGOs for feedback during the public feedback period from Aug 5 to Sept 4 last year, and the terms and conditions of the project were publicised on the ministry?s website for a month.

The project comprised tests for uninhabited and inhabited areas from the beginning, he said.

NGOs had reportedly expressed disappointment that the Govern­ment had not postponed the trial following IMR?s announcement on Jan 26 that the trial release of GM mosquitoes had been completed.

The trial, undertaken by the IMR and British-based biotech company Oxitec Ltd, had released about 6,000 male GM Aedes aegypti mosquitoes at an uninhabited forested area near Bentong on Dec 21.

An equal number of unmodified male mosquitoes were released at the same time for the purpose of studying and comparing the GM mosquitoes under natural conditions against their wild counterparts.

The study ended on Jan 5 and the area was fogged to destroy the mosquitoes the following day.

Responding to the NGOs, Health Minister Datuk Seri Liow Tiong Lai said the trial was never postponed as claimed.



                                  PART 3

------------------------------- GENET-news -------------------------------

TITLE:   LIOW CLARIFIES GM AEDES TRIAL

SOURCE:  The Star, Malaysia

AUTHOR:  

URL:     http://thestar.com.my/news/story.asp?file=/2011/1/29/nation/7897715&sec=nation

DATE:    29.01.2011

SUMMARY: "The planned genetically modified Aedes aegypti mosquito trial was not postponed as stated in a media report in early January, said Health Minister Datuk Seri Liow Tiong Lai. The report had caused some confusion, he said, adding that he wanted to address any misunderstanding over the trial that was conducted from Dec 21 last year to Jan 5 at an uninhabited forested area in Bentong."

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LIOW CLARIFIES GM AEDES TRIAL

PETALING JAYA: The planned genetically modified (GM) Aedes aegypti mosquito trial was not postponed as stated in a media report in early January, said Health Minister Datuk Seri Liow Tiong Lai.

The report had caused some confusion, he said, adding that he wanted to address any misunderstanding over the trial that was conducted from Dec 21 last year to Jan 5 at an uninhabited forested area in Bentong.

?On Nov 7, I made a statement that the mosquitoes will be released in an uninhabited area in Bentong. The ministry had put up notices at the site three weeks before the trial was conducted until Jan 6, had discussed with the people there and obtained the necessary permission from the local authorities,? he said.

The Institute for Medical Research had on Jan 26 said the trial was completed and later that day, several non-governmental organisations expressed disappointment that the government did not postpone the trial as promised based on the media report in question.

Liow added that on Aug 5 and 9 last year, the Natural Resources and Environment Ministry had placed advertisements in newspapers on the trial.

The ministry, he said, was hopeful of positive results and would proceed to the next step once the collected data are reviewed by international conferences and journals.

He was speaking to reporters yesterday after presenting ang pow to leprosy patients and former patients at Sungai Buloh Hospital.

He also launched the Communication for Behavioral Impact in an effort to fight dengue.

Liow said the ministry was concerned over the high number of dengue cases in Malaysia, which recorded 46,171 cases and 134 deaths last year.

On suggestions that those planning to run for public office should go for a medical check-up, Liow said the ministry would assist in making the necessary arrangements.



                                  PART 4

------------------------------- GENET-news -------------------------------

TITLE:   MALAYSIA FOLLOWS CAYMANS WITH SURPRISE GM MOSQUITO TRIAL

SOURCE:  SciDev.Net, UK

AUTHOR:  Shiow Chin Tan

URL:     http://www.scidev.net/en/news/malaysia-follows-caymans-with-surprise-gm-mosquito-trial.html

DATE:    28.01.2011

SUMMARY: "Malaysia became the second country in the world to release genetically modified mosquitoes into the wild in a trial whose timing has surprised international and local scientists as well as protesters. The country?s Institute for Medical Research announced this week that around 6,000 GM male Aedes aegypti mosquitoes had been released at an uninhabited, forested site in the inland district of Bentong in Pahang state last month."

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MALAYSIA FOLLOWS CAYMANS WITH SURPRISE GM MOSQUITO TRIAL

[KUALA LUMPUR] Malaysia became the second country in the world to release genetically modified (GM) mosquitoes into the wild in a trial whose timing has surprised international and local scientists as well as protesters.

The country?s Institute for Medical Research announced this week (26 January) that around 6,000 GM male Aedes aegypti mosquitoes had been released at an uninhabited, forested site in the inland district of Bentong in Pahang state last month (21 December).

The trial passed all its regulatory hurdles last year. But the actual release took many by surprise ? even the head of Malaysia?s Genetic Modifications Advisory Committee, Ahmad Parveez Ghulam Kadir, admitted he was unaware that it had taken place.

In recent days local media had reported that the release had not yet occurred because of bad weather. Meanwhile the international press agency AFP had said that the release was delayed because of protests by nongovernmental organisations. It quoted a senior government official, Mohamed Mohamad Salleh, the biosafety department?s director of research and evaluation, as saying that the trials had been postponed.

The trial also involved the release of 6,000 ordinary male mosquitoes and both groups were killed with insecticides in early January, with monitoring to continue for several months, said the institute in a press release.

Scientists are comparing the flying ranges and survival rates of the two groups.

Offspring of the mosquitoes die before reaching sexual maturity in the absence of the antibiotic tetracycline. It is hoped this strategy could be used to cut mosquito numbers and fight dengue fever, a disease whose incidence has risen dramatically in recent decades.

No further release can occur until post-trial monitoring is completed in accordance with the guidelines laid out by the advisory committee, with the results analysed and presented in peer-reviewed scientific journals or at meetings.

Releasing the GM mosquitoes in an inhabited area ? which was part of the application the institute and its partner in the project, UK-based biotech company Oxitec, originally made ? would have required the institute to gain the consensus and approval of local communities via a public forum at least two weeks before the release.

Lim Li Ching, senior biosafety researcher at the non-profit Third World Network, said: ?In their interpretation of the conditions [of the approval] they did not have to organise a public forum for the release in an uninhabited area?.

She said that the institute should have been more transparent about its actions considering the criticisms about excessive secrecy that surrounded trials done by Oxitec on the Caribbean island of Grand Cayman in 2009.

Ahmad Parveez emphasised that the release was small-scale (6,000 compared with Grand Cayman?s three million), that the mosquitoes would all die within the monitoring period and that the goal was a modest one of data collection rather than trying to suppress the local mosquito population.

The campaigning organisation Genewatch UK recently published a report saying that the original risk assessment by the Malaysian GM Advisory Committee was incomplete and lacked full transparency because it did not list the potential hazards it had identified and its evaluations of their likelihood, consequences and estimated overall risk.

Genewatch UK also released a report last December about Oxitec and the Grand Cayman trials in which it claimed the company was driven to excessive speed by a poor financial situation.