Your company, NuGrow, has developed a novel HT gene containing soybean seed and

Question

Your company, NuGrow, has developed a novel HT gene containing soybean seed and wants to conduct three field studies for the new gene plus different promoters to see which one work best. You are leading the regulatory strategy team and have been asked to describe the path to approval and sale.

Please discuss the following:

(1) Which agency or agencies will be responsible for approving/reviewing your NuSoy HT seed: (a) before commercial introduction, and (b) after approval for commercialization/sale. Specifically cite any relevant Federal Statutes and standards that must be met (HINT: I would consult and cite the Coordinated Framework to start!), and

(2) Provide an analysis of the potential risks you see with going before a particular agency (agency expertise, complexity of rules, history etc.) under the particular regulations identified.

Explanation / Answer

1)The agencies that will be responsible for approving/reviewing your NuSoy HT seed would be the three agencies that are included under the Coordinated Framework for Regulation of Biotechnology Products.

(a) Before commercial introduction :The agency i.e the United States Department of Agriculture (USDA) that includes Animal and Plant Health Inspection Service(APHIS) is responsible before commericial introduction.It is involved in regulation of various field tests and shipments of genetically engineered plants to different states.

(b) after approval for commercialization/sale :The other two agencies i,e the US Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) will be involved after approval for commericialization.

2)The Animal and Plant Health Inspection Service must be notified before field test is done and any interstate shipment is done.The  product i.e genetically engineered soybean has to be declared and given non-regulated status by APHIS after an application is send and a petition is raised by the product sponser to APHIS.This application should include details such as plant genetics, genetic material used and its origin, field test reports and effects on other plants. A notification must be send to either conduct a field test or for interstate shipments to APHIS.Before the geneticially engineered soyabean is transported and commercialized, APHIS has to deregulate it. The risks associated before a particular agency is identified could be:

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