THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE
Dear Friends and Colleagues
GM Mosquito Releases in the Caymans Risky and Ineffective
GeneWatch UK has released an updated report on Oxitec's releases of GM mosquitoes in the Cayman Islands based on new documents made available as a result of a Freedom of Information request. The new documents confirm (1) the poor efficacy of Oxitec’s technology and (2) an inadequate basis for approval of the roll out and increase concerns regarding risks.
The new information shows that the releases have been ineffective and large numbers of biting female GM mosquitoes, which may transmit disease, have been released. Oxitec has struggled to suppress the wild population of mosquitoes with its GM releases, which have only had an effect in the dry season, when numbers are low, and when combined with spraying. Any suppression in adult female numbers is preceded by increases (spikes) in adult female numbers associated with the releases, which might be caused by the inadvertent releases of GM females. Although the project allowed up to 1,000 biting female GM mosquitoes to be released per week, up to 9,000 biting females were released per week due to a problem with sorting males and females.
There remains no evidence that the GM mosquito releases reduce the risk of transmission of dengue, zika or chikungunya. GeneWatch recommends a halt to any further releases while considering the new information. It advises that before any further open releases of GM mosquitoes are considered, decision-makers should thoroughly consider whether releases of Oxitec’s GM mosquitoes are effective and cost-effective, and the existence of alternatives. The recommendations of the WHO’s Vector Control Advisory Group (VCAG) should be implemented, including the need for proper scientific protocols to assess the impacts of the proposed releases on all relevant diseases; and the need for rigorous independent monitoring and evaluation. Finally, a clear process needs to be set out for decision-making on proposed future trials requiring detailed answers to specific questions such as: What is the proposed procedure for environmental risk assessment and will the draft policy and regulations be published and subject to public consultation? Will protocols be developed and published to minimise and detect the risk of the accidental release of biting female mosquitoes, the use of contaminated feed, and the evolution or accidental introduction of GM mosquitoes which are resistant to the killing mechanism?
With best wishes,
Third World Network
131 Jalan Macalister
Websites: http://www.twn.my/ and http://www.biosafety-info.net/
To subscribe to other TWN information services: www.twnnews.net
GENEWATCH UK PR: NEW DOCUMENTS SHOW OXITEC'S GM MOSQUITOES INEFFECTIVE AND RISKY
4 September 2017
GeneWatch UK today released an updated report on Oxitec's releases of genetically modified (GM) mosquitoes in the Cayman Islands (1). The report cites new information regarding ineffectiveness and risks, including the annual report of the project, recently released as a result of a Freedom of Information request (2).
The annual report was not available to the National Conservation Council (NCC) at its June 4th meeting, when it approved an island-wide roll-out of GM mosquito releases.
The new information shows that the releases have been ineffective and large numbers of biting female GM mosquitoes have been released.
"Plans to roll-out Oxitec's GM mosquito releases island-wide must be halted whilst this new information is properly considered", said Dr Helen Wallace, Director of GeneWatch UK, "Oxitec's GM technology is failing in the field and poses unnecessary risks. Islanders' money should not be thrown away on an approach which has not been successful."
The new information shows:
- Oxitec has struggled to suppress the wild population of mosquitoes with its GM releases, and has only had an effect in the dry season, when numbers are low, and when combined with spraying;
- Oxitec has been criticised for using egg traps to claim its GM mosquito releases have suppressed the local mosquito population, because egg traps do not measure the number of adult females which bite and cause disease. In the annual report, for the first time, adult female numbers are reported, which show that any suppression in adult female numbers is much delayed compared to what is measured by the egg traps, and is preceded by increases (spikes) in adult female numbers associated with the releases;
- Spikes in adult females which follow the GM releases might be caused by the inadvertent releases of GM females (although other explanations are also possible);
- Controversially, the project allowed up to 1,000 biting female GM mosquitoes to be released per week, but in practice up to 9,000 biting females were released per week due to a problem with sorting males and females;
- When the roll-out is scaled up, this could lead to up to 180,000 GM biting females being released per week if the sorting problem is not solved, or 20,000 GM biting females per week even if the sorting criterion is met.
There remains no evidence that the GM mosquito releases reduce the risk of transmission of dengue, zika or chikungunya.
(1) Oxitec’s Genetically Modified Mosquitoes: Failing in the field? GeneWatch UK Briefing. September 2017. http://www.genewatch.org//uploads/f03c6d66a9b354535738483c1c3d49e4/Oxitec_GWbrief_Sep17_fin.pdf
(2) Annual report MRCU - June 2017. Friendly Aedes aegypti project in West Bay. http://www.genewatch.org//uploads/f03c6d66a9b354535738483c1c3d49e4/MRCU_annual_report___Oxitec_project___June_2017.pdf
OXITEC’S GENETICALLY MODIFIED MOSQUITOES: FAILING IN THE FIELD?
Further information about the completed (phase 1) and proposed (phase 2) releases has been published following the June 2017 meeting of the National Conservation Council (NCC). (4) This information includes:
- Two interim reports on the releases of GM mosquitoes made in 2016 and early 2017: one from October 2016 (5) and one from February 2017 (6);
- Applications/permits relating the releases made to June 2017: (i) application to import genetically modified mosquitoes, beginning June 2016 (date stamped to indicate permission given on 8 th June 2016) (7) ; (ii) application/permit to import genetically modified mosquitoes, Nov 2016 to June 2017 (date stamped 10th November 2016) (8);
- Two corresponding permits for import of GM mosquitoes: (i) the original permit valid from 20th June 2016 to 30th June 2017, for import of 150 million GM mosquito eggs (1.64kg), over a 12 month period: (ii) a variation to the permit valid from 10th November 2016 to 10th June 2017, allowing up to an additional 1kg of eggs to be imported and pupae to be “contained within sealed release devices” at the MRCU insectary (9);
- The Mosquito Research and Control Unit’s (MRCU’s) submission to the NCC for a further “expansion phase” of open releases (10);
- The application for the proposed expansion phase, allowing import of up to 2kg of eggs per month (not date stamped at the time of publication i.e. permit unissued at that time (11); and
- The Department of Environment’s “screening evaluation” of the risks of the expansion proposal. (12)
A version of the National Conservation Council (NCC) Guidance Note on Risk Assessment of alien and genetically altered species is also now publicly available.(13) However, there has been no public consultation on this guidance.
In addition, an MRCU annual report on the “Friendly Aedes aegypti project in West Bay”, published in June 2017 and covering the releases up to 25th June 2017, has been released in response to a Freedom of Information request.(14)
The new documents confirm poor efficacy of Oxitec’s technology
In relation to the now completed (phase 1) releases, at public meetings in May 2016, Oxitec stated that between 100,000 and 200,000 GM male mosquitoes would be released each week in the target area in West Bay for several weeks and that, after two to three months, the population of the Aedes aegypti mosquitoes was expected to fall dramatically. (15)
However, the February 2017 interim report shows that Oxitec did not manage population suppression until the dry season (early 2017), when the population had already dropped significantly, and to get the observed effect the MRCU had to first spray as well. Releases were increased to 500,000 to achieve any observable effect (as measured using egg traps). They claim 79% population suppression (based on egg traps) but as with earlier experiments, there is no clear baseline or measurement of adult female numbers (discussed further below). The existence of the November 2016 permit variation, which allows pupae to be “contained within sealed release devices” at the MRCU insectary may reflect the need to release greater numbers of adults, or might suggest the company may have resorted to releasing pupae from release devices, to top up the adult releases (as they did in earlier experiments). Releases of pupae, if they occurred, could be a means to get around the restriction on adult male releases, without providing further public information.
Minutes of the NCC’s discussion of the original permit for releases (16) have been published which confirm that conditions agreed for the original permit include that not more than 22 million adult male mosquitoes may be released during the course of the project (page 3 of the minutes from the NCC’s 18th May 2016 meeting). This limit remained unchanged when the permit for additional eggs was approved on 10th November 2016, however the minutes signed off the following March (17) merely state that the MRCU had been sent a copy of the decision and that the permit is attached. No in-depth discussion of the permit variation by the NCC has been recorded.
Documents from a “special meeting” of the NCC, held on 3rd May 2017, reveal a further application made on 25th April 2017 (pages 3 to 7), to import an additional 500 grams of eggs as part of phase 1 of the project (before the roll out was approved). (18) There is no reference in the application to any restriction on numbers to be released. There is also no record in the minutes of the meeting (released as a result of a Freedom of Information request), as to whether this application was discussed or approved. However, the existence of the application would suggest that Oxitec has not succeeded in maintaining population suppression using the number of GM mosquitoes originally suggested, and was looking to significantly increase release numbers again.
A report of the phase 1 project is required to be provided by July 30th, 2017 under the existing DoE permit, with an additional project conclusion report at a later date if necessary (page 13 of the "Expansion phase” document). However, the NCC did not wait for this phase 1 report before issuing a permit for phase 2 (including an island-wide roll out) on 14th June 2017. An annual report on the project by the MRCU, covering results up to June 25th 2017, has since been released as a result of a Freedom of Information request. This report states that a total of 3136g of GM mosquito eggs had been imported by 22nd May 2017, out of 3140g permitted. Therefore the additional application submitted to the NCC on 3rd of May would have had to be approved for phase 1 releases to have continued to the end of July. The report also highlights problems with egg quality, which has led to storage conditions being improved in both the UK and Grand Cayman.
More importantly, the MRCU annual report reveals problems with the release of adult female GM mosquitoes (which bite and may transmit disease, discussed further below) and spikes in the adult female mosquito population as a result of the releases, both of which may pose risks that have not been fully considered. For the first time, female adult mosquito numbers collected from traps are included in the published data (rather than just egg traps) (Figure 1B). These show, as discussed in the text, that no adult mosquito suppression was observed until February (week 7) in 2017, and that the egg traps therefore provide a poor measure of success in supressing the number of adult female mosquitoes (which bite and transmit disease): a concern that has previously been raised in the scientific literature, and which may invalidate claims of success elsewhere, which are all based on data from egg traps.(19) Further, the graph shows significant increases (spikes) in adult female mosquito numbers (green line) in the release area 5 to 7 weeks after the releases begin, and again 7 to 8 weeks after the releases are increased. These spikes in the adult female population exceed 150% of the comparator population, but their true extent is not shown as the peaks are cut off on the graph. There is no discussion of these spikes in the text, and no consideration of the implications of the increased numbers of adult female mosquitoes for the risk to health of the local population. No explanation for the spikes is given and the absolute number of females is not given, nor whether they are GM or non-GM females. One possible cause could be that the spikes are caused by the inadvertent release of GM females (see further below). Or, female GM mosquito larvae, produced as a result of matings between released GM males and wild females, might have unexpectedly high survival rates. Alternatively, more wild female mosquitoes might have flown in from surrounding areas to mate with the released males.
In addition, the graph reveals that the experiments did not continue long enough to see if the suppression shown in the tail of the graph continues into the wet season. This is critical to establish whether suppression is continued in the longer term, or whether increased releases, with likely further spikes in the adult female population, will be needed in the future.
The expansion proposal relies heavily on the releases being able to achieve suppression so the production capacity can be moved around once treated areas are in a "maintenance phase". In "stage 1" of the phase 2 roll-out (this year) the plan assumes there would not be any new production capacity (current capacity is up to 700,000 GM males per week) but it would be possible to either expand the area of releases in West Bay, or make releases on Cayman Brac, because the releases needed in the "maintenance phase" of the existing West Bay area would be reduced due to suppression having already been achieved. However, this is very dependent on the idea that suppression is achieved and can then be maintained with a lower level of releases. For "stage 2" (roll out over 18 to 24 months, starting in 2018) production capacity would be increased (up to 10 million GM males per week), to do releases across the whole of Grand Cayman. This might be done with more mobile labs, or by converting a warehouse. But this plan is still very dependent on the claims regarding population suppression being achievable, as the release numbers would be kept within production capacity by only treating inhabited areas and moving the releases around as each area enters a maintenance phase. When the whole island is in "maintenance", the plan is for MRCU to take over from Oxitec to treat only localised “hotspots” or re-entry points (p. 9 of "Expansion phase" doc). However, based on the data released so far, this seems very unlikely to be achievable.
The new documents confirm an inadequate basis for approval of the roll out and increase concerns regarding risks
Approval for the proposed island-wide roll out of releases was reportedly given by the National Conservation Council (NCC) on 14th June 2017 with some conditions, including the approval of the Medical Officer of Health.(20) However, the contract between Oxitec and the Cayman Islands Government (referred to on p. 9 of "Expansion phase" document (21) ), has apparently not yet been signed. According to the “Expansion phase” plan, a formal agreement between Oxitec Cayman Limited and the Government of the Cayman Islands is anticipated, to establish the main program activities and responsibilities for each party, including a date by which “significant suppression” of the local population of Aedes aegypti throughout the island of Grand Cayman should be achieved. It is hard to see how such a commitment can be made, given the problems with population suppression identified above.
There is no new information on biosafety issues in the application or permit for expansion, as the applicants say that these were already dealt with in the first application for release. Thus, there has been no attempt to provide further information to answer any of the questions about risks. However, the documents do contain further information about the very limited efficacy of Oxitec’s approach, including significant spikes in the numbers of adult females in the release area, which could pose a risk to health (as noted above). In addition, the annual report on the project by the MRCU, covering results up to June 25th 2017, reports a problem with sorting the male and female GM mosquitoes, which led to increased releases of GM females (which bite and can transmit disease). The report reveals that a sorting criterion of 2 or fewer females per batch of 1,000 pupae had been set, but checks by MRCU on one production batch on May 12th 2017 revealed 9 females in one release pot (of 500), nine times the agreed level. The report claims that additional measures have now been put in place to ensure that no more than 2 females are released per 1,000 mosquitoes. At the peak release rate in phase 1 of 500,000 mosquitoes per week, this nevertheless means that 1,000 biting females a week could have been released even if the sorting criterion was met, with up to 9,000 GM females released a week if the problem later revealed by the MRCU check was occurring during the peak releases. This is a serious problem, which does not seem to have been discussed or addressed during the NCC’s June meeting, when the annual report was not available. During the proposed phase 2 releases (island-wide roll out), many more biting female GM mosquitoes could be released. The increased production capacity (of up to 10 million GM males per week) would result in release of up to 20,000 biting GM females being released a week if the sorting criterion is met, or 180,000 biting GM females being released a week if 9 females were released per pot.
The Department of Environment’s “screening evaluation” was produced before the release of this report and does not address this new information. It relies heavily on the existence of risk assessments already made in other countries and recommends “that the Council be guided primarily by the independent risk assessments referenced below, recognizing these are independent of the applicant and have considerable relevance to the current application”. However, none of these consider the new evidence produced as a result of phase 1 of the experiments in the Cayman Islands. Further, the cited risk assessments published in the USA and Malaysia cover only experimental releases – not a full scale roll out – and have both been withdrawn, as the related experiments did not go ahead at all (in the case of the USA), or beyond the first limited release (to test flying distance) in Malaysia. The risk assessment published in Brazil includes a Dissenting Opinion from two experts (22), raising significant concerns, and commercial releases there have yet to be approved by Brazilian health authority. The previous risk assessments in the Cayman Islands do not meet international standards and do not take account of the new information contained in the MRCU annual report and other documents. Further, they do not account for the proposed scale-up of the releases.
The minutes of the NCC’s June meeting are not available at the time of writing, but the conditions are presumably those recommended by the Department of Environment in its “screening evaluation”, namely: “a. that a plan for disposal of waste water from all current and future rearing facilities for OX513A in the Cayman Islands is submitted and implemented to the satisfaction of the Water Authority and the Department of Environment, such that no potential exists or can be created for OX513 Aedes aegypti to breed in wastewater containing tetracyclines from these facilities. b. that before any OX513A Aedes aegypti are transported to or released on Cayman Brac or Little Cayman, tests are conducted by the applicant to establish whether OX513A Aedes aegypti are at all capable of hybridizing with Aedes mediovittatus, and that expansion of OX313A Aedes aegypti releases to the Sister Isles be subject to separate consultation with the NCC after completion of these tests c. that OX513A Aedes aegypti eggs transported to the Cayman Islands are produced from females whose blood meals are from synthetic blood only d. that active monitoring for persistence or spread of OX513A Aedes aegypti is continued on a permanent, ongoing basis in and around all release areas and around rearing facilities, and that any anomalous occurrences are reported to the Council immediately and investigated by the applicant as a matter of urgency e. that before decision by the Council, the views of the Chief Medical Officer be sought on this application”. There is no mention of any measures to investigate or address the spikes in adult females, revealed in the MRCU annual report (which was not published until after the NCC meeting), or the problems with the release of adult GM female mosquitoes (which bite and may transmit disease).
4 CNS Library: Genetically modified mosquitoes. Documentation supplied to National Conservation Council on expansion of GM mosquito programme, June 2017 meeting http://cnslibrary.com/genetically-modified-mosquitoes/
5 Interim report on GM mosquitoes by MRCU-Oxitec, 18 October 2016. http://cnslibrary.com/wpcontent/uploads/Interim-report-on-GM-mosquitoes-by-MRCU-Oxitec-18-October-2016.pdf
6 Interim report on GM mosquitoes MRCU – February 2017. http://cnslibrary.com/wpcontent/uploads/Interim-report-on-GM-mosquitoes-MRCU-February-2017.pdf
7 MRCU application to import genetically modified mosquitoes, beginning June 2016. http://cnslibrary.com/wp-content/uploads/MRCU-application-to-import-genetically-modifiedmosquitoes-beginning-June-2016.pdf
8 MRCU application to import genetically modified mosquitoes, Nov 2016 to June 2017. http://cnslibrary.com/wp-content/uploads/MRCU-application-to-import-genetically-modifiedmosquitoes-Nov-2016-to-June-2017.pdf
9 Dept. Agriculture permits for MRCU to import GM mosquitoes, 10 Nov 2016 to 30 June 2017. http://cnslibrary.com/wp-content/uploads/Dept-Agriculture-permits-for-MRCU-to-import-GMmosquitoes-10-Nov-2016-to-30-June-2017.pdf
10 Aedes aegypti control programme in the Cayman Islands, Expansion phase, Jan 2017. http://cnslibrary.com/wp-content/uploads/Aedes-aegypti-control-programme-in-the-Cayman-Islands-Expansion-phase-Jan-2017.pdf
11 MRCU application to import genetically modified mosquitoes, beginning March 2017. http://cnslibrary.com/wp-content/uploads/MRCU-application-to-import-genetically-modifiedmosquitoes-beginning-March-2017.pdf
12 Department of Environment screening evaluation of MRCU-Oxitec application for operational deployment of GM mosquitoes throughout the Cayman Islands. http://cnslibrary.com/wpcontent/uploads/Department-of-Environment-screening-evaluation-of-MRCU-Oxitec-application-foroperational-deployment-of-GM-mosquitoes-throughout-the-Cayman-Islands.pdf
13 National Conservation Council Guidance Note: Risk Assessment of alien and genetically altered species (consultations for import and applications to release) under section 35 of the National Conservation Law, 2013. 2017-03-22 WP-10 Guidance Note s35 Risk Assessment v4.2 Included in pages 64 to 72 of the NCC’s meeting documents, 22nd March 2017: http://doe.ky/wpcontent/uploads/2017/03/Conservation-Council-22-March-2017-Agenda-Documents-117p.pdf
14 Annual report MRCU - June 2017. Friendly Aedes aegypti project in West Bay. http://www.genewatch.org//uploads/f03c6d66a9b354535738483c1c3d49e4/MRCU_annual_report___Oxitec_project___June_2017.pdf
15 Oxitec to release 200,000 GM mosquitoes weekly. Cayman News Service. 25th May 2016. https://caymannewsservice.com/2016/05/oxitec-to-release-200000-gm-mosquitoes-weekly/
16 National Conservation Council meeting 24 August 2016. http://cnslibrary.com/wpcontent/uploads/National-Conservation-Council-meeting-24-August-2016.pdf
17 National Conservation Council meeting, 22 March 2017, agenda documents: http://cnslibrary.com/wp-content/uploads/National-Conservation-Council-meeting-22-March-2017-agenda-documents.pdf
18 National Conservation Council meeting 3 May 2017, agenda and documents: http://cnslibrary.com/wp-content/uploads/National-Conservation-Council-meeting-3-May-2017-Agenda-and-Documents.pdf
19 Boëte C., Reeves RG (2016). Alternative vector control methods to manage the Zika virus outbreak: more haste, less speed. The Lancet Global Health, 4(6), e363.https://doi.org/10.1016/S2214-109X(16)00084-X
20 Islandwide GM mosquito release approved. Cayman Compass. 15th June 2017. https://www.caymancompass.com/2017/06/15/islandwide-gm-mosquito-release-approved/
21 Aedes aegypti control programme in the Cayman Islands, Expansion phase, Jan 2017. http://cnslibrary.com/wp-content/uploads/Aedes-aegypti-control-programme-in-the-Cayman-Islands-Expansion-phase-Jan-2017.pdf
22 Ministry of Science, Technology and Innovation – MCT. National Biosafety Technical Commission – CTNBio. Technical Opinion no. 3964/2014. http://bch.cbd.int/database/attachment/?id=14514