Protection goal | Plausible pathway to potential Harm | Cause of potential harm | Effect of potential harm | Correlation of Exposure Levels with Transgene Efficacy | Relevance to ERAs for other transgenic mosquito strains | |||||
---|---|---|---|---|---|---|---|---|---|---|
Biodiversity | 1 | Potential toxicological effects of dsxFCRISPRh transgenics on NTOs could reduce ecosystem services. | Transgenic contains toxin or allergen | Direct: Reduced density of valued species or ecosystem services | Positive with gene drive; negative with population suppression; dependent on presence of transgene | All transgenic strains | ||||
2 | Potentially broader tolerances for humidity, temperature, salinity, or desiccation in dsxFCRISPRh transgenics could reduce densities of valued species or ecosystem services. | Increased fitness in transgenic; changes in competitive interactions | Direct: Reduced density of valued species or ecosystem services | Positive with gene drive; negative with population suppression; dependent on presence of transgene | All transgenic strains | |||||
3 | Potentially cumulative Cas9/gRNA off-target or retargeted nuclease activity in dsxFCRISPRh transgenics could cause broader tolerances for humidity, temperature, salinity, or egg desiccation to reduce densities of valued species or ecosystem services. | Off-target or re-targeted mutations; increased fitness in transgenic; changes in competitive interactions | Direct: Reduced density of valued species or ecosystem services | Positive with gene drive; negative with population suppression; independent of presence of transgene | All CRISPR-Cas9-based transgenic strains | |||||
4 | Potential horizontal gene flow of the dsxFCRISPRh transgene that would contain construct backbone sequences could confer a growth advantage to bacteria that are pathogenic to a valued species, thus reducing densities of valued species or ecosystem services. | Gene flow to NTOs | Indirect: Reduced density of valued species or ecosystem services | Positive with gene drive; negative with population suppression; dependent on presence of transgene | All transgenic strains | |||||
5 | Potential horizontal gene flow of the dsxFCRISPRh transgene to a NTO eukaryote could lead to its unintended population suppression, thus reducing densities of valued species or ecosystem services. | Gene flow to NTOs | Indirect: Reduced density of valued species or ecosystem services | Positive with gene drive; negative with population suppression; dependent on presence of transgene | All population suppression gene drive transgenic strains | |||||
6 | Reduction in densities of valued species or ecosystem services could be caused by their increased consumption by a predator. | Transgenic has altered physiology, anatomy, or behaviour; population suppression; changes in predator-prey interactions | Indirect: Reduced density of valued species or ecosystem services | Positive with gene drive; positive with population suppression; independent of presence of transgene in some circumstances | All population suppression gene drive transgenic strains, but potentially applicable any other successful gene drive transgenic strains | |||||
7 | Upon population suppression of Anopheles gambiae via gene drive, its niche could be occupied by competitor species that could cause suppression of a valued species to affect ecosystem services. | Changes in competitive interactions | Indirect: Reduced density of valued species or ecosystem services | Positive with gene drive; positive with population suppression; independent of presence of transgene | All population suppression gene drive transgenic strains, but potentially applicable any other successful vector control approaches | |||||
8 | Potential reductions in densities of valued species or ecosystem servicers due to poor nutrient composition of aquatic habitats could be caused by potentially increased dsxFCRISPRh transgenic larval mortality. | Fitness costs in transgenic | Indirect: Reduced density of valued species or ecosystem services | Positive with gene drive; negative with population suppression; dependent on presence of transgene | Gene drive transgenic strains | |||||
Water quality | 9 | Potential adverse impact on quality of water, and its flora and fauna, from reduced nutrient composition of aquatic habitats could be caused by potential toxicity of dsxFCRISPRh transgenic products. | Fitness costs in transgenic; transgenic contains toxin or allergen. | Indirect: Toxic water quality for NTOs | Positive with gene drive; negative with population suppression; dependent on presence of transgene | All transgenic strains | ||||
10 | Potential adverse impact on drinking water in aquatic habitats could be caused by potentially higher mortality of dsxFCRISPRh transgenic larvae. | Fitness costs in transgenic | Indirect: Reduced water quality for humans and livestock | Positive with gene drive; negative with population suppression; dependent on presence of transgene | All transgenic strains | |||||
Human health | 11 | Transgenic proteins could cause specific allergic or toxicological responses in humans from dsxFCRISPRh transgenic bites beyond responses to non-transgenic bites. | Transgenic contains toxin or allergen | Direct: Increased allergic or immune responses in humans; increased toxicity in humans | Independent of efficacy of gene drive or population suppression as defined by allergic responses in individual humans; dependent on presence of transgene | All transgenic strains | ||||
12 | Potential incidental ingestion or inhalation of dsxFCRISPRh transgenic material could cause specific allergic responses in humans beyond responses to non-transgenic material. | Transgenic contains toxin or allergen | Direct: Increased allergic or immune responses in humans | Independent of efficacy of gene drive or population suppression as defined by allergic responses in individual humans; dependent on presence of transgene | All transgenic strains | |||||
13 | Increased allergenicity in humans could occur from potentially altered levels of endogenous allergens in dsxFCRISPRh transgenics. | Transgenic contains toxin or allergen | Direct: Increased allergic or immune responses in humans | Independent of efficacy of gene drive or population suppression as defined by allergic responses in individual humans; dependent on presence of transgene | All transgenic strains | |||||
14 | Potentially decreased mosquito defence response to pathogen in dsxFCRISPRh transgenics from altered levels of endogenous RNA, protein or microbiome could lead to increased human disease. | Transgenic has altered physiology, anatomy, or behaviour; increased vector competence in transgenic | Direct: Increased disease transmission in humans | Positive with gene drive; negative with population suppression; dependent on presence of transgene | Arises from specific anatomical alterations in homozygous dsxFCRISPRh transgenics but could be applicable to other transgenic strains | |||||
15 | Potentially decreased human defence response to pathogen from altered levels of endogenous RNA or protein in the saliva dsxFCRISPRh transgenics could lead to increased disease in humans. | Transgenic has altered physiology, anatomy, or behaviour | Direct: Increased disease transmission in humans | Positive with gene drive; negative with population suppression; dependent on presence of transgene | Arises from specific anatomical alterations in homozygous dsxFCRISPRh transgenics but could be applicable to other transgenic strains | |||||
16 | Potential immunopathological responses via biting exposure to gRNA expressed in saliva of dsxFCRISPRh transgenic could lead to increases in morbidity and mortality in humans. | Transgenic has altered physiology, anatomy, or behaviour | Direct: Increased allergic or immune responses in humans | Independent of efficacy of gene drive or population suppression as defined by allergic responses in individual humans; dependent on presence of transgene | All CRISPR-Cas9-based transgenic strains | |||||
17 | Potential secondary toxicological effects in humans from consuming NTOs which would have fed on dsxFCRISPRh transgenics. | Transgenic contains toxin or allergen | Indirect: Increased toxicity in humans | Positive with gene drive; negative with population suppression; dependent on presence of transgene | All transgenic strains | |||||
18 | Potentially increased fitness, including insecticide resistance, of dsxFCRISPRh transgenics could increase disease transmission in humans. | Transgenic has altered physiology, anatomy, or behaviour; increased fitness in transgenic | Direct: Increased disease transmission in humans | Positive with gene drive; negative with population suppression; dependent on presence of transgene | All transgenic strains | |||||
19 | Potentially increased biting rate of dsxFCRISPRh transgenics could increase disease transmission in humans. | Transgenic has altered physiology, anatomy, or behaviour; increased biting rates | Direct: Increased disease transmission in humans | Positive with gene drive; negative with population suppression; dependent on presence of transgene | Arises from specific anatomical alterations in homozygous dsxFCRISPRh transgenics but could be applicable to other transgenic strains | |||||
20 | Potentially increased vector competence in dsxFCRISPRh transgenics could increase disease transmission in humans. | Transgenic has altered physiology, anatomy, or behaviour; increased vector competence in transgenic | Direct: Increased disease transmission in humans | Positive with gene drive; negative with population suppression; dependent on presence of transgene | All transgenic strains | |||||
21 | Potentially altered anatomy, or host-seeking behaviour, in dsxFCRISPRh transgenics could increase the transmission of human diseases, including lymphatic filariasis. | Transgenic has altered physiology, anatomy, or behaviour; increased vector competence in transgenic; increased biting rates | Direct: Increased disease transmission in humans | Positive with gene drive; negative with population suppression; dependent on presence of transgene | Arises from specific anatomical alterations in homozygous dsxFCRISPRh transgenics but could be applicable to other transgenic strains | |||||
22 | Potentially altered anatomy in dsxFCRISPRh transgenics could lead them to vector human disease not previously-vectored by Anopheles gambiae. | Transgenic has altered physiology, anatomy, or behaviour; increased vector competence in transgenic | Direct: Novel disease transmission in humans | Positive with gene drive; negative with population suppression; dependent on presence of transgene | Arises from specific anatomical alterations in homozygous dsxFCRISPRh transgenics but could be applicable to other transgenic strains | |||||
23 | Potentially altered physiology in dsxFCRISPRh transgenics could increase disease transmission in humans. | Transgenic has altered physiology, anatomy, or behaviour; increased vector competence in transgenic | Direct: Increased disease transmission in humans | Positive with gene drive; negative with population suppression; dependent on presence of transgene | Arises from specific anatomical alterations in homozygous dsxFCRISPRh transgenics but could be applicable to other transgenic strains | |||||
24 | Potentially altered physiology in dsxFCRISPRh transgenic could lead them to vector human disease not previously-vectored by Anopheles gambiae. | Transgenic has altered physiology, anatomy, or behaviour; increased vector competence in transgenic | Direct: Novel disease transmission in humans | Positive with gene drive; negative with population suppression; dependent on presence of transgene | Arises from specific anatomical alterations in homozygous dsxFCRISPRh transgenics but could be applicable to other transgenic strains | |||||
25 | Potentially cumulative Cas9/gRNA off-target or retargeted nuclease activity in dsxFCRISPRh transgenics could cause heritable increase in insecticide resistance, fitness or vector competence to increase human disease. | Off-target or re-targeted mutations; transgenic has altered physiology, anatomy, or behaviour; increased vector competence in transgenic; increased fitness in transgenic | Direct: Increased disease transmission in humans | Positive with gene drive; negative with population suppression; independent of presence of transgene | All CRISPR-Cas9-based transgenic strains | |||||
26 | Potentially broader tolerances for humidity, temperature, salinity, or desiccation in dsxFCRISPRh transgenic could lead to increased disease transmission in humans. | Transgenic has altered physiology, anatomy, or behaviour; increased transgenic fitness | Direct: Increased disease transmission in humans | Positive with gene drive; negative with population suppression; dependent on presence of transgene | All transgenic strains | |||||
27 | Increased or novel human disease transmission could be caused by replacement of Anopheles gambiae niche with another disease vector. | Population suppression; changes in competitive interactions | Indirect: Increased disease transmission in humans | Positive with gene drive; positive with population suppression; independent of presence of transgene | All population suppression gene drive transgenic strains, but potentially applicable to any other successful vector control approaches | |||||
28 | Potential toxicological effects of dsxFCRISPRh transgenics on NTOs could increase disease transmission in humans. | Transgenic contains toxin or allergen | Indirect: increased disease transmission in humans | Positive with gene drive; negative with population suppression; dependent on presence of transgene | All transgenic strains | |||||
29 | Potentially reduced density of a predator species caused by population suppression of Anopheles gambiae could lead to increases in density of another human disease vector species. | Population suppression; changes in predator-prey interactions | Indirect: increased disease transmission in humans | Positive with gene drive; positive with population suppression; independent of presence of transgene | All population suppression gene drive transgenic strains, but potentially applicable to any other successful vector control approaches | |||||
30 | Potential increases in disease levels beyond those pre-gene drive intervention following a resurgence in pathogen transmission after initial population suppression would have reduced human immunity to pathogen. | Population suppression; changes in herd immunity | Indirect: Increased disease transmission in humans | Positive with gene drive; positive with population suppression; independent of presence of transgene | All population suppression gene drive transgenic strains, but potentially applicable to any other successful vector control approaches | |||||
Animal health | 31 | Potential toxicity in livestock from dsxFCRISPRh transgenic proteins in saliva. | Transgenic contains toxin or allergen | Direct: Increased toxicity in livestock | Positive with gene drive; negative with population suppression; dependent on presence of transgene | All transgenic strains | ||||
32 | Potentially decreased mosquito defence response to pathogen in dsxFCRISPRh transgenics from altered levels of endogenous RNA, protein or microbiome could lead to increased disease in livestock. | Transgenic has altered physiology, anatomy, or behaviour; increased vector competence in transgenic | Direct: Increased disease transmission in livestock | Positive with gene drive; negative with population suppression; dependent on presence of transgene | Arises from specific anatomical alterations in homozygous dsxFCRISPRh transgenics but could be applicable to other transgenic strains | |||||
33 | Potentially decreased livestock defence response to pathogen from altered levels of endogenous RNA or protein in saliva of dsxFCRISPRh transgenics could lead to increased disease in livestock. | Transgenic has altered physiology, anatomy, or behaviour | Direct: Increased disease transmission in livestock | Positive with gene drive; negative with population suppression; dependent on presence of transgene | Arises from specific anatomical alterations in homozygous dsxFCRISPRh transgenics but could be applicable to other transgenic strains | |||||
34 | Potentially increased fitness, including insecticide resistance, of dsxFCRISPRh transgenic could increase disease transmission in livestock. | Transgenic has altered physiology, anatomy, or behaviour; increased fitness in transgenic | Direct: Increased disease transmission in livestock | Positive with gene drive; negative with population suppression; dependent on presence of transgene | All transgenic strains | |||||
35 | Potentially increased biting rate of dsxFCRISPRh transgenic could increase disease transmission in livestock. | Transgenic has altered physiology, anatomy, or behaviour; increased biting rates | Direct: Increased disease transmission in livestock | Positive with gene drive; negative with population suppression; dependent on presence of transgene | Arises from specific anatomical alterations in homozygous dsxFCRISPRh transgenics but could be applicable to other transgenic strains | |||||
36 | Potentially increased vector competence of dsxFCRISPRh transgenic could increase disease transmission in livestock. | Transgenic has altered physiology, anatomy, or behaviour; increased vector competence in transgenic | Direct: Increased disease transmission in livestock | Positive with gene drive; negative with population suppression; dependent on presence of transgene | All transgenic strains | |||||
37 | Potentially altered anatomy, or host-seeking behaviour, in dsxFCRISPRh transgenic could increase disease transmission in livestock. | Transgenic has altered physiology, anatomy, or behaviour; increased vector competence in transgenic; increased biting rates | Direct: Increased disease transmission in livestock | Positive with gene drive; negative with population suppression; dependent on presence of transgene | Arises from specific anatomical alterations in homozygous dsxFCRISPRh transgenics but could be applicable to other transgenic strains | |||||
38 | Potentially altered anatomy in dsxFCRISPRh transgenic could lead it to vector livestock animal disease not previously-vectored by Anopheles gambiae. | Transgenic has altered physiology, anatomy, or behaviour; increased vector competence in transgenic; increased biting rates | Direct: Novel disease transmission in livestock | Positive with gene drive; negative with population suppression; dependent on presence of transgene | Arises from specific anatomical alterations in homozygous dsxFCRISPRh transgenics but could be applicable to other transgenic strains | |||||
39 | Potentially altered physiology in dsxFCRISPRh transgenic could increase disease transmission in livestock. | Transgenic has altered physiology, anatomy, or behaviour; increased vector competence in transgenic | Direct: Increased disease transmission in livestock | Positive with gene drive; negative with population suppression; dependent on presence of transgene | Arises from specific anatomical alterations in homozygous dsxFCRISPRh transgenics but could be applicable to other transgenic strains | |||||
40 | Potentially altered physiology in dsxFCRISPRh transgenic could lead it to vector animal disease not previously-vectored by Anopheles gambiae. | Transgenic has altered physiology, anatomy, or behaviour; increased vector competence in transgenic | Direct: Novel disease transmission in livestock | Positive with gene drive; negative with population suppression; dependent on presence of transgene | Arises from specific anatomical alterations in homozygous dsxFCRISPRh transgenics but could be applicable to other transgenic strains | |||||
41 | Potentially cumulative Cas9/gRNA off-target or retargeted nuclease activity in dsxFCRISPRh transgenic could cause increase in insecticide resistance, fitness or vector competence to increase disease transmission in livestock. | Off-target or re-targeted mutations; transgenic has altered physiology, anatomy, or behaviour; increased fitness in transgenic; increased vector competence in transgenic | Direct: Increased disease transmission in livestock | Positive with gene drive; negative with population suppression; independent of presence of transgene | All CRISPR-Cas9-based transgenic strains | |||||
42 | Potentially broader tolerances for humidity, temperature, salinity, or desiccation in dsxFCRISPRh transgenics could lead to increased disease transmission in livestock. | Transgenic has altered physiology, anatomy, or behaviour; increased fitness in transgenic | Direct: Increased disease transmission in livestock | Positive with gene drive; negative with population suppression; dependent on presence of transgene | All transgenic strains | |||||
43 | Increased or novel disease transmission in livestock animals could be caused by replacement of Anopheles gambiae niche with another disease vector. | Population suppression: changes in competitive interactions | Indirect: Increased disease transmission in livestock | Positive with gene drive; positive with population suppression; independent of presence of transgene | All population suppression gene drive transgenic strains, but potentially applicable to any other successful vector control approaches | |||||
44 | Potential toxicological effects of dsxFCRISPRh transgenics on NTOs could increase disease transmission in livestock. | Transgenic contains toxin or allergen | Indirect: Increased disease transmission in livestock | Positive with gene drive; negative with population suppression; dependent on presence of transgene | All transgenic strains | |||||
45 | Reduced density of a predator species that could be caused by population suppression of Anopheles gambiae could lead to increases in density of another animal disease vector species. | Population suppression: changes in predator-prey interactions | Indirect: Increased disease transmission in livestock | Positive with gene drive; positive with population suppression; independent of presence of transgene | All population suppression gene drive transgenic strains, but potentially applicable to any other successful vector control approaches | |||||
46 | Potential increases in livestock disease beyond pre-gene drive intervention levels following resurgence in pathogen transmission after initial population suppression would have reduced livestock immunity to pathogen. | Population suppression: changes in herd immunity | Indirect: Increased disease transmission in livestock | Positive with gene drive; positive with population suppression; independent of presence of transgene | All population suppression gene drive transgenic strains, but potentially applicable to any other successful vector control approaches |