Difference between revisions of "Team:Waterloo/Practices/Human Practices"
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Revision as of 16:59, 18 September 2015
Human Practices
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Text1.1
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Text1.2
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Text1.3
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Text2.1
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Text2.2
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Text2.3
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
Design Criteria
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:
- The name of the product and plane of manufacture
- Description of the product
- Method of manufacture
- Information about following laws and regulation of the product
- Proof that the novel food is safe for consumption
- Information of importance of product and estimated levels of consumption
- 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:
- Specific description and proof of genetic change
- Comparison of the novel food compared to non-modified version
- Potential side effects like toxins and allergic reactions
- 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
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:
- The name of the product and plane of manufacture
- Description of the product
- Method of manufacture
- Information about following laws and regulation of the product
- Proof that the novel food is safe for consumption
- Information of importance of product and estimated levels of consumption
- 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:
- Specific description and proof of genetic change
- Comparison of the novel food compared to non-modified version
- Potential side effects like toxins and allergic reactions
- 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
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:
- The name of the product and plane of manufacture
- Description of the product
- Method of manufacture
- Information about following laws and regulation of the product
- Proof that the novel food is safe for consumption
- Information of importance of product and estimated levels of consumption
- 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:
- Specific description and proof of genetic change
- Comparison of the novel food compared to non-modified version
- Potential side effects like toxins and allergic reactions
- 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
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:
- The name of the product and plane of manufacture
- Description of the product
- Method of manufacture
- Information about following laws and regulation of the product
- Proof that the novel food is safe for consumption
- Information of importance of product and estimated levels of consumption
- 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:
- Specific description and proof of genetic change
- Comparison of the novel food compared to non-modified version
- Potential side effects like toxins and allergic reactions
- 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.