Homework week 2

1.
The agency that controls the regulation would be the FDA (Food and Drugs Administration). The reason why this agency and my proposed regulation interest me is because I used to work in a food distribution company. My previous company is a company that also import their inventory from overseas; therefore, the FDA regulation is very important to their business and I happen to know this matter the most. I would like to propose regarding the regulation from the FDA, about “The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within ninety days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations.” The regulation is really affecting the business of my previous company. As the company imports the products from overseas, there will be some cases that the products will not pass the FDA inspection. If the products fail the FDA inspection, the product will be destroyed, which will cost the company some big amount of money.

2. The proposal of changing to the regulation in my case would be the change of action to the products that are refused by the FDA or that are not meeting the standard of the FDA to enter and be consumed. The action that will be taken now would be to destroy the products; however, the proposal that I would like to submit would be to return the products to the sender and do not let the products enter the United States and be consumed. 3.The public comment that I would have submitted would be about the effect of the regulation now. The effect would be the importer, would have to shoulder the burden of the cost of failure products, because the FDA would not let the products to be returned to the sender. In a way, the failure of the products would not be considered as recipients’ fault. By letting the products to be returned to the sender, the company who imports the products would not have to pay for the failure products. If its proven that the sender send the same quality of products, the FDA may ban the company to do business with the sender company, until some further inspection will be conducted.
I wish them to have considered this new rule.

4. This will expires on January 27th, 2014.

5. a. From my point of view, I would have to do appeal regarding the regulation. Because the regulation is already there and I am the one who is trying to change the regulation. I think I will have to o submit the petition and go for appeal.
b. 1. The first ground on which to challenge an agency rule is that it is arbitrary, capricious, an abuse of discretion, or in violation of some other law. This standard is generally applied to informal rulemaking and simply requires the agency to show evidence to support the proposed rule. Without such evidence, the rule can be held arbitrary and capricious.
2. A second theory for challenging an agency’s regulation is that the regulation is unsupported by substantial evidence. This substantial evidence test is applied in the review of formal and hybrid rulemaking. Where the arbitrary and capricious standard simply requires some proof or basis for the regulation, substantial evidence requires that more convincing evidence exist in support of the regulation than against it.
3. A third ground on which to challenge an agency’s regulation involves the rule that a regulation can be set aside if the agency did not apply with the APA requirements of notice, publication, and public comment or input. The procedures for rulemaking must be followed in order for the regulatory process and resulting rules to be valid. An agency that seeks public comment for the purposes of drafting legislation cannot then turn the legislation into rules after the comment period.
4. Another basis for challenging a regulation is that the regulation is unconstitutional. Many challenges based on constitutional grounds deal with regulations that give an agency authority to search records or that impose discriminatory requirements for licensed professionals.
5. Another theory for challenging a regulation in court is ultra vires, a Latin term meaning “beyond its powers.” An ultra vires regulation is one that goes beyond the authority given to the agency in its enabling act. Although most agencies stay clearly within their authority, if an agency tries to change the substance and purpose of the enabling through regulation, the regulations would be ultra vires.
c. I think the theory number 5 would be the most suitable for my case. Because FDA in the food industry is powerful, and whatever FDA says it is considered as the law. Sometimes, even if the condition is still in a gray area, if the FDA says fail, then it is fail. By mentioning that everything should be inspected even further and the consequences shouldn’t be put on the importers’ shoulder, FDA may be asked to reconsider their decision and law.

1. State the administrative agency which controls the regulation. Explain why this agency and your proposed regulation interests you (briefly). Will this proposed regulation affect you or the business in which you are working? If so, how? Submit a copy of the proposed regulation along with your responses to these five questions. The proposed regulation can be submitted as either a separate Word document (.doc) or Adobe file (.pdf). This means you will submit two attachments to the Week 2 Dropbox: (a) a Word document with the questions and your answers and (b) a copy of the proposed regulation you used for this assignment. (10 points) 2. Describe the proposal/change. (10 points) 3. Write the public comment that you would submit to this proposal. If the proposed regulation deadline has already passed, write the comment you would have submitted. Explain briefly what you wish to accomplish with your comment. (10 points) 4. Provide the "deadline" by which the public comment must be made. (If the date has already passed, please provide when the deadline was). (5 points) 5. a. Once you have submitted your comment, what will you be legally entitled to do later in the promulgation process (if you should choose to do so)? (See the textbook's discussion of the Administrative Procedure Act.) b. If the proposal passes, identify and explain the five legal theories you could use in an attempt to have (any) administrative regulation declared invalid and overturned in court. c. Which of these challenges would be the best way to challenge the regulation you selected for this assignment if you wanted to have the regulation overturned and why?