Team:Waterloo/Practices/Human Practices

Human Practices

The Product

The product would be a seed with the incorporated CRISPR-cas9 construct technology incorporated in it for immunity against CaMV virus. The system would be introduced into a wild-type plant strain via an Agrobacterium transformation.

When the seed itself is harvested, it will then be screened to ensure that the new seeds have the integrated technology. The seeds would be planted and then a western blot would be performed as a diagnostic tool to detect both normal and abnormal proteins. This blotting procedure would be performed following the transfer of DNA or proteins from an electrophoresis gel. Then the seeds would be grown and exposed to the virus as well to ensure that the system is working. Safety trials will be performed in greenhouses to ensure that the newly grown plants are indeed immune to the virus. Once the safety standards have been met, the product will be made available to farmers for mass production.

End-user consultations

Canada Banana Farms is a local farm in Wingham, Ontario which grows organic, non-GMO bananas and other tropical fruits. We met with them on September 9th 2015 to get a farmer’s perspective on his needs as a potential stakeholder of our project. In addition, his stance on genetic modification of foods and its research were discussed; it was insightful to see the extent to which the role in the food industry has influenced their views.

  • The farm’s priorities are centered on their customer’s needs rather than a philosophical agenda. We were reminded farming is a business and ensuring continuity is a constant consideration, which means profit would partly motivate what kind of produce is to be grown. When asked questions such as “What factors affect your decision of which seed to buy?”, the growers emphasized their interest in meeting the needs of their customers. Therefore, having mentioned desired traits such as palatability, Canada Banana Farms validated some of our ideas for product design criteria.

  • Genetic modification is a valuable tool for addressing higher yield demands. In light of a greater world population, Canada Banana Farms believes genetically modified foods will play an increasingly important role in the future of foods because greater harvests cannot be achieved otherwise.

  • Print sources are an important resource for a farmer when making initial farming decisions, supplemented by good, personal relationships with experts. After the visit, our team is assessing the potential of involving ourselves in the circulation of farmer-centred reading material may be the ideal avenue for which we could eventually market our GM-plants. Also, to further foster the appeal of our hypothetical product, it may work to our advantage to host conferences which attract exposure and allow for these experts to understand the modified plants’ characteristics more intimately.

    • As we concluded the visit: the farmer stated he had no issues with viruses using older farming practices, but encouraged for us to look further into applying our project to banana farming in India.

    Design Criteria
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    Law and Regulation

    Intellectual Property

    Safety Concerns

    Regulation
    In Canada, Health Canada controls the sale of genetically engineered food or products by the guidelines under division 28 (of part B) of the food and drugs regulations. The process of regulating a genetically engineered product is the same as regular products that is introduces for the first time. This is mainly because the Canadian food inspection agency focuses on characteristics expressed in each product rather than the methods used to introduce those characteristics. Independently of the place of origin of the product, genetic engineered products must be approved by Health Canada, the Canadian Food Inspection agency (CFIA) and Environment Canada.

    To obtain approval from such organizations a step by step process is followed and therefore outlined below:

    Step 1: Submitting of pre-manufacture notification
    Information about the product must be submitted to the Food Directorate of Health Products and Food Branch, Health Canada. The information included in this notification has to contain:

    1. The name of the product and plane of manufacture
    2. Description of the product
    3. Method of manufacture
    4. Information about following laws and regulation of the product
    5. Proof that the novel food is safe for consumption
    6. Information of importance of product and estimated levels of consumption
    7. Sample of labelling of product

    Step 2: Submission of a safety assessment data package
    Additional information can be submitted if needed for product. It could include extensive research concerning the safety and health side effects of consumption of the product.

    The information included in this assessment:

    1. Specific description and proof of genetic change
    2. Comparison of the novel food compared to non-modified version
    3. Potential side effects like toxins and allergic reactions
    4. Chemical and microbial considerations

    Step 3: A minimum of 45 days is required until it is decided whether the product is safe or requires additional information by the manufacturers. If more research is required the safety assessment data package must be submitted. This process could be as lengthy as 7 years since the research involves the investigation of long-term effects as well as environmental impacts in extensive depth.

    The need to account for unintended effects

    "Omic" studies as part of Risk Assessment

    References

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