Unit 7 quiz Answers
1.Why were new approaches to regulation of biotechnology were created?

Answer: traditional and current methods were not adequate for innovative biotech products

2.The four federal agencies regulating biotech are the FDA, the USDA, the EPA, and BRS.

Answer: False

3.One of the downsides of the former regulatory guidelines was that federal agencies _____.

Answer: Often did not have the tools to respond to novel or ground-breaking biotech innovations

4.Before the new national strategy was implemented, definitions of biotechnology _____.
Answer: Differed among the federal regulatory agencies

5.The Coordinated Framework essentially eliminated gaps and uncertainty for oversight and regulation in the biotech industry.

Answer:False

6.What does the US Government’s regulatory policies help promote?

Answer:Safety for the consumer and protection for the environment

7.The StarLink™ example about the genetically engineered variety of corn is a good example of what common issue in biotechnology?

Answer: how biotech products can cross regulatory agency boundaries

8.The US Government promotes regulatory policies that protect animals, humans, and the environment while fostering innovation.

Answer: True

9.In 1986, the “Coordinated Framework of the Regulation of Biotechnology” became the organizational network around which the regulation of biotech was framed.

Answer: True

10.Which federal agency regulates drugs for human or animal use, food safety, biologics for human use, and medical devices?

Answer: FDA

11.Why do regulatory agencies require companies to conduct post-market studies?

Answer: to validate continued safety

12.The Coordinated Framework of the Regulation of Biotechnology was enacted in 1986 and affected which of the following federal agencies?

Answer: FDA, USDA, and EPA

13.What are conducted on humans or animals to substantiate effectiveness, safety, and efficacy?

Answer: Clinical trials

14.Biotechnology-derived plant or microbial pesticides or new chemical substances are regulated by which federal agency?

Answer:EPA

15.What is an authoritative rule dealing with details, procedure, rule, or order issued by an executive authority or agency of a government and having the force of law?

Answer: Regulation