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

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.

False

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

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 .
Differed among the federal regulatory agencies

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

False

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

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?

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.

True

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

True

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

FDA

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

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?

FDA, USDA, and EPA

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

Clinical trials

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

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?

Regulation