E4L11P2 - Molecular Biotechnology and Society

Regulation of GMO crops

must be gown in contained facility, production regulated same as drugs, drug producing plants will not enter food chain

Regulation of GMO livestock

Cloned animal regulation is same for animals from selective breeding. If ill, not allowed to enter food chain. Cloned animals are not genetically modified since no new genes are introduced. Only transgenic animal approved is Chinook salmon.

Reg of GMO Animals for Pharmaceutical Products

Tightly controlled to prevent introduction into environment. Always euthanized.

Societal Concerns about GMOs

Concerns about less nutrient in processed foods. Engineered foods are generally safer due to the mold resistance.

Alteration of Nutritional Content for Plant GMOs

Extensive analysis done to compare the nutritional value of transgenic products and non-GMO equivalent. This is done for all GMO food products, and they will not be allowed to enter the food chain if they see a deviation outside the normal range.

Improved Nutritional Content for GMOs

Golden rice produced to supply beta-carotene in regions where this vitamin A precursor is scarce. Not yet approved for growth.

Concerns Regarding Toxins in GMO Food Products

Concerns arose after the production of Bt(Bacillus thuringiensis) crops. Used to kill inects with Bt toxin. Unlike insects, human digestion will destroy the toxin before it has any effect. Arguments against Bt crops, cited Cry1Ac which caused allergic rxn in mice. Mice produced increased concentrations of IgG. This is a misinterpretation, since IgEs are produced during allergic reactions. Opponents focused on regulatory breach of Cry9C protein. More resistant to digestion and more heat stable. Not approved for human consumption, but approved for animal consumption.

Concerns Regarding Allergens in GMO Food Products

Plants can be modified to be hypoallergenic. Decreases expression of peanut Ara h 2. Primary allergen concentration decreased.

Concerns Regarding Transfer of Transgenes

Large amount of DNA consumed in plant and animal food products. Most DNA degraded during cooking, chewing, digesting. Transgene almost completely digested by end of digestive tract. Studies done with animals that consume transgenic plants. Similar outcome. Transgenic DNA is also non-homologous which decreases the likelihood of it being integrated.

Concerns Regarding Transfer of Antibiotic Resistance to Intestinal Flora

Antibiotic resistance marker degraded after about 1 min incubation in sheep rumen fluid and chicken intestines

Labeling of GMO Derived Foods

2014 law mandating GMO food labeling.

Impact of GMO on Biodiversity

Conventional farming already impacts biodiversity. GMO plants may further decrease biodiversity due to becoming invasive or gene transfer to wild plants. Several weeds now resistant to glyphosate. Small percentage due to crossbreeding with transgenic plants. Concerns about impacts on non-predatory insects. Bt corn impacts on monarch butterflies negligible. Concerns of Bt corn impact on honeybee populations. Bt toxin have no toxicity in honeybees.

Benefits of GMO Crops

Multibillion dollar industry. Crops important in resource poor countries not developed extensively if they are developing. Farmers in developed and developing countries benefit from higher yields, no need to dust pesticides, and decreased fungal infections.

Environmental Benefits from GMO Crops

Prevent soil deterioration from lack of pesticide use due to Cry3Bb1 toxin. No need to remove weeds, reduced soil tilling. Reduced erosion and reduced farm machinery use. Reduced CO2 production.

Impact of GMO on Trade

EU laws on GMO imports had impacts on food aid from the US to other country under the law.

Regulation and Safety of Medical Products

Adverse reactions if used improperly. Smaller test groups can be inaccurate in reflecting the incidence of allergic reactions to drug. Cannot control for interactions with other drugs.

Regulation of New Biological Drugs

Oversight provided by FDA Center for Drug Evaluation and Research, authority granted by Federal Food, Drug and Cosmetics Act. Extensive testing before FDA approval. Phase I: animal testing Phase II: Efficacy in individuals with disease, small test group Phase III: Optimal dosage and interaction with other drugs assessed in larger group.