Proposed Release of GM Moths Fraught with Unaddressed Risks

THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE 

Dear Friends and Colleagues 

Proposed Release of GM Moths Fraught with Unaddressed Risks 

Gene Watch U.K. has released a publication summarising concerns over the proposed release of genetically modified (GM) diamondback moths in New York State. The applicant is UK-based company Oxitec (now owned by US company Intrexon), working in collaboration with Cornell University.  

Up to 1.44 million male GM moths are to be released per year, for three years, in 60 acres of fields planted with brassicas in a university research farm. The purported aim is that released male GM moths will mate with wild female moths, producing offspring which will inherit a genetically engineered trait which will kill most of the females before adulthood, thereby reducing wild populations of the moths. Diamondback caterpillars feed on a group of plants called brassicas, which includes cabbage, cauliflower, broccoli, brussel sprout and canola. 

Gene Watch cautions that open releases of GM diamondback moths are premature because of the serious limitations of the technology itself, its risk assessment, and regulation. In particular, it warns that these GM insects are not sterile and food supplies for humans and animals are likely to become contaminated with dead female GM caterpillars, making them unfit for consumption. In addition, the use of tetracycline to breed the GM diamondback moths in the lab may facilitate the spread of antibiotic resistance via gut bacteria or discharges from the GM insect breeding facility. In general, approach is not compatible with either conventional or organic methods of control for other pests, and increases in such pests are therefore likely to occur. 

Missing safeguards and information including inadequate safety testing to demonstrate that the GM moth larvae are safe for humans, animals and wildlife to eat; no published risk assessment which meets European standards (which Oxitec is obliged to meet); and no clarification on who will be liable for contamination of conventional or organic crops if the GM moths spread outside the trial sites.  

The report calls for revised regulations and a new approval process for GM insects before any open releases of GM insects can be properly considered. The summary of the report is reproduced below.  

With best wishes, 

Third World Network
131 Jalan Macalister
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OXITEC’S GENETICALLY MODIFIED MOTHS: SUMMARY OF CONCERNS 

Gene Watch
http://www.genewatch.org/uploads/f03c6d66a9b354535738483c1c3d49e4/DBMbrief_fin.pdf 

Summary  

The UK-based company Oxitec is seeking to release genetically modified (GM) moths (also known as GE moths) into open fields in New York State. This briefing summarises the concerns about the proposed releases of the moths.  

Problems identified with this approach include:  

(i) The use of late-acting lethality (rather than sterility) – which means the moths will mate and produce viable offspring, the females of which die mostly at the larval stage. This means that food supplies for humans and animals are likely to become contaminated with dead female GM caterpillars;  

(ii) Lack of adequate safety testing to demonstrate that consuming dead GM female caterpillars in crops will be safe for humans, birds or animals, including threatened species. Adult insects could also be swallowed during mass releases;  

(iii) In addition, the use of tetracycline to breed the GM Diamondback moths in the lab may facilitate the spread of antibiotic resistance via gut bacteria or discharges from the GM insect breeding facility;  

(iv) Oxitec’s approach is not compatible with conventional or organic controls for other pests. Impacts of the single-species approach on other pests may include increases in the numbers of such pests or establishment in new areas: this may include invasive pests;  

(v) The use of a female-killing approach, in which only the female GM larvae die, is likely to lead to the dispersal of GM males to neighbouring crops or weeds, where they may survive and breed for multiple generations. Male GM moths may spread over significant distances in the longer term, via migration, or if contaminated crops enter the food chain. Surviving females may also be dispersed and the numbers of female survivors may increase as resistance develops or if the GM moths breed in areas contaminated with the antibiotic tetracycline;  

(vi) The use of a strain of diamondback moth which is not indigenous to the area poses further risks, as does the proposed release of non-GM wild diamondback moths, some of which may be expected to disperse and persist in the environment;  

(vii) The presence of contamination with dead GM caterpillars in a crop is not compatible with organic production systems and could put organic certification at risk. Contamination would also likely damage markets for both organic and conventional crops, including export markets, many of which require safety testing and labelling of GMOs. It is unclear who would be liable for the loss of markets in the event of such contamination.  

Open releases of GM diamondback moths are premature because of the serious limitations of this technology, lack of information needed to assess the risks, and inadequate regulation.  

Although the USDA APHIS permit for the trial includes conditions which require destruction of the crop and spraying of insecticide for 100m around the site, these conditions are insufficient to guarantee that GM diamondback moths, or any wild moths that are released, will not spread to other areas and perhaps into the human food chain. If even a few of the wild moths turn out to be resistant to the insecticide used, or escape spraying, those moths will proliferate. The GM moths may do so too if they develop resistance to the genetic killing mechanism.  

Missing safeguards and information include the lack of:  

• Adequate safety testing to demonstrate that Oxitec’s GM moth larvae are safe for humans, animals and wildlife to eat;  

• A published risk assessment which meets European standards: which Oxitec is legally required to provide before exporting GM diamondback moth eggs to the USA for open release into the environment;  

• Demonstration from the applicant that the use of tetracyclines in the GM moth breeding facility is compliant with FDA Guidance on the use of antibiotics;  

• A detailed risk assessment for the proposed releases of non-GM, wild diamondback moths at the site;  

• Clarification of who will be liable for contamination of conventional or organic crops if GM moths spread outside the trial site;  

• Adequate public consultation, especially with brassica growers, including organic growers.  

Additional steps that should be taken before any open releases of GM insects can be properly considered include:  

• Revision of the regulation of GM insects to address the concerns raised by the USDA’s own Office of Inspector General, and many others: as part of the current revision of the Coordinated Framework for the Regulation of Biotechnology;  

• Implementation of a new approvals process, including a full Environmental Impact Statement, with full public consultation.  

Beyond the risks of the current trial, future open releases of Oxitec’s GM diamondback moths, perhaps on a commercial scale, are not a credible approach to tackling these pests. Major issues include that:  

• these GM insects are not sterile and their dead and surviving larvae will damage and contaminate the crop, making it unlikely to be fit for human consumption;  

 

• this approach is not compatible with either conventional or organic methods of control for other pests, and increases in such pests are therefore likely to result.

Proposed Release of GM Moths Fraught with Unaddressed Risks

OXITEC’S GENETICALLY MODIFIED MOTHS: SUMMARY OF CONCERNS 

Gene Watch
http://www.genewatch.org/uploads/f03c6d66a9b354535738483c1c3d49e4/DBMbrief_fin.pdf 

Summary  

The UK-based company Oxitec is seeking to release genetically modified (GM) moths (also known as GE moths) into open fields in New York State. This briefing summarises the concerns about the proposed releases of the moths.  

Problems identified with this approach include:  

(i) The use of late-acting lethality (rather than sterility) – which means the moths will mate and produce viable offspring, the females of which die mostly at the larval stage. This means that food supplies for humans and animals are likely to become contaminated with dead female GM caterpillars;  

(ii) Lack of adequate safety testing to demonstrate that consuming dead GM female caterpillars in crops will be safe for humans, birds or animals, including threatened species. Adult insects could also be swallowed during mass releases;  

(iii) In addition, the use of tetracycline to breed the GM Diamondback moths in the lab may facilitate the spread of antibiotic resistance via gut bacteria or discharges from the GM insect breeding facility;  

(iv) Oxitec’s approach is not compatible with conventional or organic controls for other pests. Impacts of the single-species approach on other pests may include increases in the numbers of such pests or establishment in new areas: this may include invasive pests;  

(v) The use of a female-killing approach, in which only the female GM larvae die, is likely to lead to the dispersal of GM males to neighbouring crops or weeds, where they may survive and breed for multiple generations. Male GM moths may spread over significant distances in the longer term, via migration, or if contaminated crops enter the food chain. Surviving females may also be dispersed and the numbers of female survivors may increase as resistance develops or if the GM moths breed in areas contaminated with the antibiotic tetracycline;  

(vi) The use of a strain of diamondback moth which is not indigenous to the area poses further risks, as does the proposed release of non-GM wild diamondback moths, some of which may be expected to disperse and persist in the environment;  

(vii) The presence of contamination with dead GM caterpillars in a crop is not compatible with organic production systems and could put organic certification at risk. Contamination would also likely damage markets for both organic and conventional crops, including export markets, many of which require safety testing and labelling of GMOs. It is unclear who would be liable for the loss of markets in the event of such contamination.  

Open releases of GM diamondback moths are premature because of the serious limitations of this technology, lack of information needed to assess the risks, and inadequate regulation.  

Although the USDA APHIS permit for the trial includes conditions which require destruction of the crop and spraying of insecticide for 100m around the site, these conditions are insufficient to guarantee that GM diamondback moths, or any wild moths that are released, will not spread to other areas and perhaps into the human food chain. If even a few of the wild moths turn out to be resistant to the insecticide used, or escape spraying, those moths will proliferate. The GM moths may do so too if they develop resistance to the genetic killing mechanism.  

Missing safeguards and information include the lack of:  

• Adequate safety testing to demonstrate that Oxitec’s GM moth larvae are safe for humans, animals and wildlife to eat;  

• A published risk assessment which meets European standards: which Oxitec is legally required to provide before exporting GM diamondback moth eggs to the USA for open release into the environment;  

• Demonstration from the applicant that the use of tetracyclines in the GM moth breeding facility is compliant with FDA Guidance on the use of antibiotics;  

• A detailed risk assessment for the proposed releases of non-GM, wild diamondback moths at the site;  

• Clarification of who will be liable for contamination of conventional or organic crops if GM moths spread outside the trial site;  

• Adequate public consultation, especially with brassica growers, including organic growers.  

Additional steps that should be taken before any open releases of GM insects can be properly considered include:  

• Revision of the regulation of GM insects to address the concerns raised by the USDA’s own Office of Inspector General, and many others: as part of the current revision of the Coordinated Framework for the Regulation of Biotechnology;  

• Implementation of a new approvals process, including a full Environmental Impact Statement, with full public consultation.  

Beyond the risks of the current trial, future open releases of Oxitec’s GM diamondback moths, perhaps on a commercial scale, are not a credible approach to tackling these pests. Major issues include that:  

• these GM insects are not sterile and their dead and surviving larvae will damage and contaminate the crop, making it unlikely to be fit for human consumption;  

• this approach is not compatible with either conventional or organic methods of control for other pests, and increases in such pests are therefore likely to result.

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