1. Unit J Biotechnology Ethics Biotechnology and Agriscience Research II

2. Competency 16.00: Discuss ethical and practical issues surrounding biotechnology Objective 16.01: Analyze regulatory organizations and issues concerning genetically modified organisms.

3. A. Regulatory Agencies 1.United States Department of Agriculture (USDA)- responsible for oversight on nearly all genetically modified organisms. Sets most policy regarding genetically modified organisms.

4. 2.Food & Drug Administration (FDA)- US regulatory agency responsible for ensuring the safety of genetically modified foods. a.Genetically modified foods DO NOT need to be labeled in the US- as long as they are not SIGNIFICANTLY different than traditional foods. b.Agrimedicines produced in GMO’s (through the process of pharming) fall under the same regulations as traditional medicines.

5. 3.Animal & Plant Health Inspection Service (APHIS)- responsible for ensuring the safety of introducing a new genetically modified organism to the environment and existing populations. a.Specifically monitor all field trials for genetically modified organisms.

6. 4.Environmental Protection Agency (EPA)- the EPA plays varying roles in monitoring the use of genetically modified organisms. a.Pay particular attention to the use of GMO’s in pest management and environmental science.

7. 5.European Union- forms legislation governing the regulation of genetically modified foods and biotechnology techniques in western Europe.

8. B. Regulatory Issues 1.Unexpected results from the release of genetically modified organisms have been extremely rare. a.A recent study indicated that monarch butterflies were being killed by pollen from Bt corn. – The study upon reexamination was proven FALSE. 2.In 2004, 56 genetically engineered products were approved for human consumption in the United States. a.The number has been increasing each year, though Bt corn and Bt soybeans are by far the most common.

9. 3.The successful development of a genetically modified organism usually takes between 6-12 years and costs between $50-$300 million dollars.

10. 4.Bans on GMO foods in many foreign countries (particularly in Europe and Africa). a.African nations have even declined or destroyed food aid during crises rather than allow consumption of GMO’s. b.Though economics could be a sub context, food safety is the primary concern.

11. C. Specific GMO Regulations 1.In the US, GMO foods must only be labeled if they are NOT SUBSTANTIALLY EQUIVILANT to normal products. 2.Any GMO can be certified organic in North Carolina and many other states.

12. Objective 16.02: Examine ethical issues concerning the use of genetic manipulation to improve the agricultural productivity of living organisms.

13. A. Defining Ethics 1.Ethics are a theory or system of moral values and principles that govern interactions in society. a.Vary between cultures and religious groups - often conflicting in the US. b.Many times ethical decisions are not absolutely right or wrong, but somewhere in the middle. 2.Ethics is the discipline dealing with what is good and bad and with moral duty and obligation.

14. B. Ethical Examples 1.The use of embryonic stem cells in research. a.Positives- because of the ability of stem cells to differentiate, research could result in tremendous medical breakthroughs. i.Producing spare organs, skin for grafts, and other biological products for medical treatments. b.Negatives- requires the destruction of developing human embryos for the collection of genetic information.

15. 2.The process of cloning. a.Occurs naturally in many varieties of plants through processes like layering, rhizomes and division. b.Usually (the exception is identical twins) requires human intervention in animals. i.Often damages embryos, resulting in the death of developing baby- highly objectionable in animals and humans.

16. 3.MOST BIOTECHNOLOGY TECHNIQUES & PRODUCTS DO NOT POSE AN ETHICAL DILLEMNA FOR A MAJORITY OF PEOPLE IN DEVELOPED NATIONS. a.Ethical objections, especially for those uneducated in regard to techniques, remain the most common objection for the use of biotechnology in agriculture.

17. b.Despite concerns over food safety, increasing use of biotechnology as occurred as a result of demands for increased production and sustainability. c.Ethical objections are centered more around the human element as to who makes decisions that life is expendable in one case and not in another. d.The misuse of biotechnology is at the center of ethical objections.

18. e.Objections to products focus on the uncertainty as to what long-term effects the use of genetically modified materials might have in the absence of long-term records. i.Will genetically modified foods have a chronic effect on the animals that consume them? ii.Will Bt crops create “super pests” that adapt over a period of time? iii.Will Bt products lose their effectiveness over time?