Why do you think that food article-GMOs still meet resistance by many consumers and consumer groups even though injectable insulin is fully accepted?

Question 1. (Two-part question.) For over forty (40) years human insulin has been produced by a biotechnology application through the insertion of the human gene for insulin into bacteria, which produce the human insulin. This use of biotechnology for a human-used compound is fully acceptable by the public.
please use FDA website for sources.

(A) Why do you think that food article-GMOs still meet resistance by many consumers and consumer groups even though injectable insulin is fully accepted? (Point Value: 3 points)

(B) Can some form of labeling of food article-GMOs decrease this resistance and increase comfort and acceptability of these products? If yes, what would the labeling look like in terms of words, graphics, etc.? If no, why would labeling not increase the publics acceptance of food article-GMOs? (Point Value: 3 points)

Question 2. (Two-part question.) FDAs regulation of food article-GMOs does not include the term substantial equivalence. More specifically, this term is an analytical tool in assessing the safety of a new food article-GMO and its relation to similar attributes of the non-modified food of the same type. Based on your reading of substantial equivalence:

(A) Do you think that this tool should be promulgated as a regulatory step and not just an analytical tool to assess the safety of a food article-GMO? Why or why not? (Point Value: 4 points)

(B) If substantial equivalence were incorporated into the regulatory framework of food article-GMOs, describe three (3) specific areas that would need to be clarified and explicitly detailed in order for substantial equivalence to have regulatory meaning? (An example might be color, but this attribute should not be used to answer the three areas of the question.) (Point Value: 4 points)

Question 3. Pioneer-Hybrids Smart canola is an herbicide-resistant of canola that has been produced through conventional breeding. (No genetic engineering or modification.) This conventionally-bred plant has the same herbicide-resistant traits as a genetically-engineered or -modified canola. As such, the potentially adverse environmental and health effects are the same in both types of canola (conventionally-bred and genetically-engineered). If the risks are the same, why is Smart canola (conventionally-bred) allowed to be sold without a special regulation or review or labeling, but genetically-engineered canola is often prohibited? Describe a technical position the regulatory agencies could take so that this type of review and prohibition (of a GE food article) would not occur. (Point Value: 4 points)

Question 4. (Four-part question.) The following is a hypothetical scenario that assumes you (the student) are an advisor to a company that undertakes genetic engineering of plant varieties for eventual human consumption. The company NuPlant Foods, Inc. has successfully created a higher protein corn variety by inserting genes from soybeans into the corn variety. NuPlant Foods testing shows the product is as safe as any other corn or soybean intended for human consumption in the marketplace. NuPlant Foods has conducted all its research in Canada and now wants to import its product into the U.S. market.

(A) What communication should NuPlant Foods have with the FDA (regarding its GE corn product)? How specific should the companys communication be to the FDA? What topics might be permitted to inform the FDA about the companys research and products? What topics might not be permitted to inform the FDA? (Point Value: 3 points)

(B) When should NuPlant Foods begin the communication with the FDA? How early or late in the research progress should such communication take place with the FDA? (Point Value: 3 points)

(C) What regulatory issues might arise under the existing laws and regulations that the FDA would discuss with NuPlant Foods? In other words, what questions and requests from the FDA should NuPlant Foods be prepared for when the company begins communicating with the FDA? (Point Value: 3 points)

(D) Should NuPlant Foods begin communications with the USDA/APHIS about its research and intent to import the GE corn variety into the U.S.? If yes, what should that communication be? If no, why should the USDA/APHIS not be communicated with? (Point Value: 3 points)

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