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Gm520: Legal, Political, and Ethical Dimensions

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TAK MENG CHOY
GM520: Legal, Political, and Ethical Dimensions
Week 2 TCO B Homework

1. State the administrative agency, which controls the regulation. Explain why this agency and your proposed regulation interest you (briefly). How will this proposed regulation affect you or the business in which you are working? Provide the URL to the website where the regulation change proposal is located. (Check your URL to be sure it takes the reader to the actual regulation). (10 points)
The FDA or also known as the Food and Drug Administration are agencies that control the rules and regulations. I decided to used this agency as my reference because the FDA is one the most popular and important agency. This proposed regulation change who filed this petition with the FDA to amend their rule is Cargill. Scientist and researchers in Cargill research and development laboratories and engineering departments have worked on this project for a number of years. If Cargill plant expansion to produce their product on that specific location, this would bring a positive economic impact to that location, only if the rules by the FDA become permanent.

2. Describe the proposal/change. (10 points)
According to the FDA Summary, “amending the health claim regulation entitled ‘Soluble fiber from certain foods and risk of coronary heart disease (CHD)’ to add barley beta fiber as an additional eligible source of beta-glucan soluble fiber.” The FDA has come to the agreement that there is an important scientific agreement in the public domain to support this claim. At the present time, certain whole oat and whole grain barley products are included in the regulation.

3. Write the public comment which you would submit to that proposal. If the proposed regulation deadline has already hit, write the comment you would have submitted. Explain briefly what you wish to accomplish with your comment. (10 points)
Many of my relatives had high cholesterol in their family, even the younger generation has not high but a controllable cholesterol level with medication. After going through the articles, I am very delighted to find out that food additives is being developed that will aid in improved cholesterol results. The cost of health care and prescription drugs are getting expensive and increasing, and thus I have to disagree with the public remark made by Ms. Barbara Sachau on February 25, 2008. The R & D department is studying on the product by multiple and independent party’s offers a great deal of encouragement to those of us with cholesterol problems. The latest statistics show that cardiovascular disease, which includes CHD and stroke, is the leading cause of death in women in America and most developed countries.

4. Provide the "deadline" for which the public comment must be made. (If the time has already run, please provide when the deadline was.) (5 points)
The deadline is, May 12, 2008 and there are only five public submissions.

5. To what does your comment's submission legally entitle you? (See the textbook's discussion of the Administrative Procedure Act.) If the proposal passes, describe one way you could attempt to have the regulation declared invalid and overturned. (15 points)
According to the textbook, the Administrative Procedures Act (APA) “requires agencies to follow certain uniform procedures in making rules.” The public comment period cannot be less than thirty days and most agencies make the period much longer. This is the chance for representatives of government, industry, business, corporations as well as private citizens to express their support or concern about the proposed rule or change. One must have submitted a public comment during the stated comment period in order to legally challenge the validity of the federal regulation at a later date.
One way to have the regulation declared invalid and overturned would be if additional research were performed that presented a challenge or proved that there were flaws in the original research and results. For example, if beta barley fiber did not lower cholesterol, caused other health problems, or was found to harm humans, that evidence could be introduced to the agency. In recent years, this situation has occurred with FDA approved pharmaceutical drugs. One example is Celebrex, which is used in treating osteoarthritis. The drug was being used in a government sponsored cancer prevention trial when it was discovered that patients taking 400 mg to 800 mg daily had a 2.5 time greater risk of major heart problems. This has resulted in a class action suit against the drug’s maker, Pfizer.…...

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