Gaps in Environmental Assessment for GE Diamondback Moths

THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE
Dear Friends and Colleagues
Re: Gaps in Environmental Assessment for GE Diamondback Moths

The U.S. Animal and Plant Health Inspection Service (APHIS) has conducted an environmental assessment for the field release of genetically engineered (GE) Diamondback moths in New York State. If approved, the proposed release is likely to be the first in the world to use GE insects with a female- killing trait. The objective is to suppress wild populations by introducing a lethal gene (called tTAV) that will kill off (most of) the female larvae. GE male Diamondback moths carrying the gene will be released (outnumbering wild males by around 10 to 1) to mate with wild females.

The GE Diamondback moth is created by UK company Oxitec, which sought approval for field releases in the U.K. in 2011, but failed. GeneWatch UK has released a paper giving comments on the environmental assessment. It raises several serious concerns that it says have been overlooked in the assessment.

The Diamondback moth attacks plants of the Brassica genus, which includes canola, broccoli, radishes, mustard and collards. One risk is that of Brassica crops contaminated by dead GE larvae being consumed by all species, including humans, intentionally or unintentionally. There are no safety data on this. There are instead data of the expressed protein having adverse effects on mice. Other risks highlighted include the emergence of other kinds of pests due to reductions in Diamondback moth populations, and the potential risk for antibiotic resistance development in humans and animals from the use of the antibiotic, tetracycline, to breed GE Diamondback moths in the lab.

GeneWatch UK calls for additional information and monitoring on potential adverse effects. The conclusions of its paper are reproduced below and the full document can be accessed at: http://www.genewatch.org/uploads/f03c6d66a9b354535738483c1c3d49e4/GeneWatch_APHIS_2014_0056_GE_DBM.pdf

An addition commentary by GeneWatch UK on the issue of horizontal gene transfer and its implications for antibiotic resistance; and the use of a multifunctional human viral domain from HSV1, is available at:
http://www.genewatch.org/uploads/f03c6d66a9b354535738483c1c3d49e4/GeneWatch_2ndSub_APHIS_2014_0056_GE_DBM.pdf

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GENEWATCH UK COMMENT ON ANIMAL AND PLANT HEALTH INSPECTION SERVICE DOCKET NO. APHIS–2014– 0056: ENVIRONMENTAL ASSESSMENT FOR THE FIELD RELEASE OF GENETICALLY ENGINEERED DIAMONDBACK MOTHS

Conclusions

There are a number of fundamental flaws with Oxitec’s technology:
(i) The use of late-acting lethality (rather than sterility) means food supplies for humans and animals will become contaminated with large numbers of dead female GE larvae;
(ii) The large numbers of GE adult males required to swamp the wild population pose a risk of swallowing them to farm workers and passersby, as well as wildlife, and may also cause wild-type adult DBM to disperse to surrounding areas;
(iii) Impacts on non-target pests are poorly understood and may include increases in the numbers of such pests or establishment in new areas: this may include invasive pests;
(iv) The use of tetracycline as a chemical switch for the genetic killing mechanism is risky because contamination with tetracycline and related antibiotics is widespread in the environment, meaning the killing mechanism may be inactivated;
(v) In addition, the use of tetracycline to breed the GE DBM in the lab is likely to facilitate the spread of antibiotic resistance via gut bacteria, in breach of FDA Guidance;
(vi) The use of a female-killing only approach is likely to lead to the dispersal of GE males over significant distances in the longer term, especially if contaminated crops enter the food chain;
(vii) Resistance to the genetic killing mechanism is likely to evolve over time, facilitating greater off-site dispersal.

Compared with the no action alternative, the proposed experiments pose unnecessary risks to human health and the environment. Therefore the application should be refused.

Numerous important gaps have been identified in the environmental assessment for open release of GM DBM into the environment. The proposed experiments therefore carry unnecessary risks and are premature. Prior to considering any application for open release, the following additional information should have been required:
• Safety testing for consumption of GE DBM adults or larvae by humans and wildlife, including children and threatened species;
• Prior baseline assessment of DBM and non-target baseline pest populations over several years in the presence of brassica crops;
• Modelling of population responses of target and non-target species to the proposed releases;
• Studies of overwintering of DBM in the proposed test area;
• Studies of dispersal of DBM from the test site to other sites;
• Studies of dose responses of all strains proposed for release to tetracycline and its analogues;
• Studies of insecticide resistance in the parent strain;
• Caged trials of all GE DMB strains;
• Laboratory studies of resistance mechanisms;
• Laboratory studies of antibiotic resistance;
• Caged studies of competitive effects (target and non-target pests).

A strict protocol for the destruction of all contaminated or potentially contaminated crop plants and wild brassicas is also essential for any trial, to avoid contamination of the food chain.
 

Gaps in Environmental Assessment for GE Diamondback Moths

GENEWATCH UK COMMENT ON ANIMAL AND PLANT HEALTH INSPECTION SERVICE DOCKET NO. APHIS–2014– 0056: ENVIRONMENTAL ASSESSMENT FOR THE FIELD RELEASE OF GENETICALLY ENGINEERED DIAMONDBACK MOTHS

Conclusions

There are a number of fundamental flaws with Oxitec’s technology:
(i) The use of late-acting lethality (rather than sterility) means food supplies for humans and animals will become contaminated with large numbers of dead female GE larvae;
(ii) The large numbers of GE adult males required to swamp the wild population pose a risk of swallowing them to farm workers and passersby, as well as wildlife, and may also cause wild-type adult DBM to disperse to surrounding areas;
(iii) Impacts on non-target pests are poorly understood and may include increases in the numbers of such pests or establishment in new areas: this may include invasive pests;
(iv) The use of tetracycline as a chemical switch for the genetic killing mechanism is risky because contamination with tetracycline and related antibiotics is widespread in the environment, meaning the killing mechanism may be inactivated;
(v) In addition, the use of tetracycline to breed the GE DBM in the lab is likely to facilitate the spread of antibiotic resistance via gut bacteria, in breach of FDA Guidance;
(vi) The use of a female-killing only approach is likely to lead to the dispersal of GE males over significant distances in the longer term, especially if contaminated crops enter the food chain;
(vii) Resistance to the genetic killing mechanism is likely to evolve over time, facilitating greater off-site dispersal.

Compared with the no action alternative, the proposed experiments pose unnecessary risks to human health and the environment. Therefore the application should be refused.

Numerous important gaps have been identified in the environmental assessment for open release of GM DBM into the environment. The proposed experiments therefore carry unnecessary risks and are premature. Prior to considering any application for open release, the following additional information should have been required:
• Safety testing for consumption of GE DBM adults or larvae by humans and wildlife, including children and threatened species;
• Prior baseline assessment of DBM and non-target baseline pest populations over several years in the presence of brassica crops;
• Modelling of population responses of target and non-target species to the proposed releases;
• Studies of overwintering of DBM in the proposed test area;
• Studies of dispersal of DBM from the test site to other sites;
• Studies of dose responses of all strains proposed for release to tetracycline and its analogues;
• Studies of insecticide resistance in the parent strain;
• Caged trials of all GE DMB strains;
• Laboratory studies of resistance mechanisms;
• Laboratory studies of antibiotic resistance;
• Caged studies of competitive effects (target and non-target pests).

A strict protocol for the destruction of all contaminated or potentially contaminated crop plants and wild brassicas is also essential for any trial, to avoid contamination of the food chain.
 

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