Checks and Balances: Designing a System to Ensure the Safety of Genetically Engineered Agricultural Products. By Doug Golick - AgBiosafety Web Coordinator

Introduction: Most major nations have a governmental regulatory system to ensure the safety of our food products. These systems help ensure that the food and agricultural products we purchase are safe to eat and healthy for our environment. Before any genetically engineered food product enters the marketplace, they must be approved and deemed safe by governmental agencies and regulatory systems. This lesson introduces students to the concept of a regulatory system, their purpose and how they help to insure the safety of agricultural products.

Objectives: Students will: Learn about the crop safety regulatory systems focusing on elements for crops of biotech origins. Design a regulatory system for an imaginary crop product developed through the use of biotechnology. Write an essay on regulatory systems and attached regulatory tree diagram. Lesson: 1. Students will learn about genetically engineered crops (biotech crops) and those regulatory systems through class discussion. 2. Students will be given an imaginary genetically engineered crop and be asked to design an appropriate regulatory system for that product. 3. Students will develop a written summary outlining their regulatory design and include a diagram/map showing the steps their product must travel through to insure its safety. Ideas for imaginary crops: Glow in the Dark Roses- Add some flare to your garden. Saves you the trouble and expense of installing lights along your drive-way. Butter Corn – Corn modified to have the distinct taste of butter added to the kernal. No longer a need to butter your corn on the cob. Saves money and calories. Super Tomatoes – Tomatoes genetically altered to contain higher levels of calcium. Ketchup and spaghetti sauce consumed in-mass quantities in the US why not make this top vegetable healthier? Considerations students should take into account when developing their regulatory system are: Will you use existing government agencies or create new agencies to regulate biotech crops? Why? What individuals make up your regulatory agencies or panels? Will there be a series of “checks and balances” for your regulatory process? What testing is needed to insure that these food crops are safe for the environment, for animal consumption, or human consumption? How many tests will be needed to insure that these products are safe? If a new product is deemed to be too risky in terms of environmental, animal feed, or human safety who will decide or which agencies will decide to reject these products. Can a product be approved for animal feed but not for human consumption in your system? If a product is rejected by your regulatory system, will food producers have another opportunity to retest or gather new data to seek further approval? If you test and approve a product in your regulatory system, what procedures would you perform if that product is later found to be unsafe? Are there consequences? Who is at fault and why? How would you inform the public about new food products? Should the public have a chance to comment on new developments in biotechnology? When in your regulatory process would you allow public comment? Should there be public announcements of where biotech crop testing plots are placed? How is proof of testing and safety of these food products going to be made available to the public? Are genetically engineered products going to be labeled under your system? Why? Assessment: Students should be graded on how well they address each of the above questions. Certainly opinions will vary from expert to expert on the correct answer for some of the questions. However, grading for this assignment should be assessed by the completeness of answering each question and the amount of critical thinking displayed in the answer to each of these questions. The questions listed above should be used to stimulate ideas. Clearly for most of these questions a simple yes or no answer will not suffice Grading Suggestions A suggestion is to give each of the above answers a value of 5 points. One point given for a question answered poorly to five points given for an answer with high insight. Additional points should be given for the completion of the diagram or regulatory map and how well the entire package is put together. For example: 13 questions X 5 = 65 points regulatory tree diagram X 10 = 10points grammar overall completeness = 25 _____________________ Total= 100 points Certainly the level of insight or understanding the instructor expects should be dictated by how much exposure students have had to the subject at hand, their grade and learning levels. Prior understanding: This lesson is intended for students that have had some exposure to genetics, topics in plant breeding, or agricultural biotechnology. This lesson in its current format is recommended for advanced educational audiences such as upper-grade high school and undergraduate college level. However, instructors can direct this lesson for younger audiences by limiting the requirements of the essay and by introducing limited concepts in regulatory systems. Teacher background: The regulation of plant biotechnology products in Canada and the US. Crop Protection Institute of Canada Plant Biotechnology in Canada http://www.cropro.org/english/pdf/plantbiotechnology.pdf Student Handout: Click here for student handout