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Risk Assessment generated by a regulatory process
(RA)
last updated: 05 Jul 2022
Review of Risk Assessment of the Application from the Council for Scientific and lndustrial Research (CSIR), Savanna Agricultural Research Institute (CSIR-SARI) for Environmental Release and Placing on the Market of Cowpea (Vigna unguiculata L. Walp.) Genetically Modified for Resistance to Maruca pod borer (Maruca vitrata) Event AAT-7Ø9AA-4 in Ghana
EN
09 Jun 2022
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Accra,Competent National Authority:Food & Drugs Board ()
, GhanaPhone: +233-302 233200,Fax: 0302-229 794,Email: fdb@fdbghana.gov.gh,Website: http://www.fdbghaha.gov.gh, -
Competent National Authority:Ghana Atomic Energy Commission ()P.O. BOX LG. 80, LegonAccra,
, GhanaPhone: +233 21 287225/404963,Fax: +233 21 400807,Website: http://www.gaecgh.org, -
Competent National Authority:Ghana Revenue Authority (GRA) - Customs Laboratory (Customs Division) ()P.O.BOX 9046 K.I.AAccra,
, GhanaPhone: +233302773354,Fax:Email: dbrandful@yahoo.com, -
Competent National Authority:National Biosafety Authority ()Proton Street, Campus of the Graduate School of Nuclear and Allied Science, Ghana Atomic Energy Commission, KwabenyaAccra, Greater Accra Region
Gh, GhanaPhone: +233 303944235,Fax:Email: info@nba.gov.gh,Website: https://nba.gov.gh,
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Organization:NBA-Technical Advisory Committee (TAC)Government agency (National/Federal)Proton Street, SNAS Ghana Atomic Energy CommissionAccra, Greater Accra Region
Gh, GhanaPhone: +233303944235,Fax:Email: info@nba.gov.gh,Website: http://www.nba.gov.gh,
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AAT-7Ø9AA-4 - Pod Borer-resistant cowpea| African Agricultural Technology Foundation and Institute of Agricultural Research | Resistance to antibiotics (Kanamycin), Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths))
- Risk Assessment Report [ English ]
The applicant noted that cowpea (Vigna unguiculata L. Walp.) is an important staple in the diet of more than 200 million households in sub-Saharan Africa (SSA) and provided information regarding its uses. Insect pests constitute one of the main constraints to cowpea production and many studies have shown that pesticide application at flowering and podding can increase yields up to two-fold. The Maruca pod borer (Maruca vitrata) is considered the most devastating insect of cowpea, accounting for yield losses ranging from 20–80 percent.
To address the challenge stated above, the applicant has developed pod borer resistant 709A cowpea event from Agrobacterium tumefaciens, intended to reduce pre-harvest losses and over-reliance on expensive, potentially damaging, and increasingly less effective chemical insecticides that are in routine use. Following general release authorization of event 709A the Cry1Ab insect resistance trait will be introgressed into additional farmer-preferred varieties suitable for variety evaluation and release.
Cowpea was genetically modified to express the trait of resistance to the legume pod borer, Maruca vitrata, (Lepidoptera: Crambidae). Transgenic cowpea event 709A was produced by Agrobacterium tumefaciens-mediated transformation resulting in the introduction of the cry1Ab gene from Bacillus thuringiensis subsp. kurstaki strain HD-1 and the neomycin phosphotransferase ll encoding gene (nptII) from the Tn5 transposon of Escherchia coli strain K12 as a selectable marker. The Cry1Ab and neomycin phosphotransferase II (NPTII) proteins have a history of safe use in approved genetically modified crops in many countries.
The applicant provided data on the identity of cowpea event 709A, a detailed description of the transformation method, data and information on the insertion site, gene copy number and levels of gene expression in the plant and the role of the inserted genes and regulatory sequences. The newly produced proteins (Cry1Ab and NPTII) were identified and characterized.
Cowpea event 709A was field tested in Nigeria in 2014 and 2015, and in Ghana in 2016. Event 709A's agronomic and phenotypic characteristics, and nutritional components were observed in the field studies.
Overall assessment of the agronomic data from multiple years of testing at locations in Ghana and Nigeria did not identify trends of significant differences between 709A and control cowpea except for resistance to Maruca damage. Collectively, the comparative agronomic and phenotypic data support the conclusion that the genetic modification resulting in event 709A did not have an unintended, unexpected, effect on plant growth habit and general morphology, vegetative vigour, or grain yield.
Observed agronomic characteristics included germination, days to 50% flowering, plant height, pods per plant, Maruca damaged pods per plant, sucking insect damaged pods per plant, total seed per plant, Maruca damaged seed per plant, sucking insect damaged seed per plant, healthy seed per plant, and plant vigour.
There were also no indications that 709A cowpea would be more invasive or persistent in the environment, or have altered susceptibility to pests and diseases compared to the conventional cowpea. Except for the intended resistance to Maruca pod borer, 709A cowpea is agronomically and phenotypically equivalent to conventional cowpea.
The compositional analysis compared the concentrations of major nutrient components in samples of whole grain, leaves, and fodder collected from event 709A and control cowpea. Whole grain, leaves, and fodder were measured for proximates (crude protein, crude fat, ash, and carbohydrates), calories and moisture. In addition, concentrations of key minerals and phytic acid were also determined in samples of whole grain.
Data were provided for the evaluation of the potential toxicity and allergenicity of the novel proteins to humans, livestock and other non-target organisms.
Furthermore, the applicant has provided the NBA with an event-specific method for the detection and identification of cowpea event 709A.
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| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
