Course Title: Advanced Biotechnology
Lesson Title: Introduction to Regulatory Affairs: Agencies and Permit Process
TEKS Addressed in Lesson:
1. 130.364 (c) (8)-A
Lesson Objectives. The student will be able to:
1.
2.
3.
4.
Explain the role major regulatory agencies play in biotechnology.
Apply the oversight of the agencies to specific situations
Explain the APHIS permit process including the notification alternative criteria
Compare the regulation of conventionally bred plants versus that of transgenic plants
Tools and Equipment:
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PowerPoint Presentation: “Introduction to Regulatory Affairs: Agencies and Permit Process”
White board/chalk board/paper for students to present answers during activity
Dry erase marker/chalk/thick sharpie to write on respective surface
Key Terms / Vocabulary:
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USDA: United States Department of Agriculture
APHIS: Animal and Plant Health Inspection Service
EPA: Environmental Protection Agency
FDA: Food and Drug Administration
Biosafety: preserve biological integrity through minimizing risks that biotechnology may pose to
these systems.
Interest Approach/Anticipatory Set
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Have you ever considered if our food supply is safe? How do we know biotech products released
on the market are safe for human consumption? What is the system in place which ensures our
food supply is safe for you and your family? When you see a new biotech trait released on the
market, how do you know it is safe? It is clearly important to understand how the regulatory
affairs of biotechnology as it will allow you to effectively communicate the safety of the
products, and facilitate your navigation of regulatory affairs when you enter the industry.
Teaching Plan and Strategy / Presentation of New Material
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Instructors should present the information from the PowerPoint. In order to facilitate student
comprehension, instructors should continually be asking students questions as they follow along
in the PowerPoint.
Ensure students receive the corresponding note-taking worksheet to follow along with as the
instructor gives the presentation.
Activity/Application/ Student Engagement /Laboratory
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Agency Oversight Activity: Split the students up into groups and provide them with a writing
surface. Instruct students that they should write down their answer, and hold up their answers
for each question when you ask. If they answer correctly, the group wins a point. The group with
the highest number of points wins. You may find it helpful to offer a reward to further motivate
students to perform well outside of inherent competitiveness.
This activity will promote student understanding concerning the role agencies play in regulating
specific applications of biotechnology.
Evaluation / Summary
Ask the following guided questions:
1. What role do the regulatory agencies play in biotechnology?
2. What purpose does the APHIS permit serve?
3. What is the notification alternative?
4. What are the criteria to use the notification alternative?
5. What purpose does deregulation serve?
6. How does the regulatory process differ between a transgenic plant and a conventionally
bred one?
References/Additional Materials / Extended Learning Opportunities/ Enrichment
http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/biotechnology
http://www.usda.gov/wps/portal/usda/usdahome?navid=BIOTECH
http://www.fda.gov/Food/FoodScienceResearch/Biotechnology/
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm352067.htm
http://www.epa.gov/pesticides/biopesticides/reg_of_biotech/eparegofbiotech.htm
College & Career Readiness Standard
Social Studies I C 1
©Texas Education Agency, 2014