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: (1) a Word doc with the questions and your answers and (2) a copy of the proposed regulation you used for this assignment. (10 points) Food and Drug Administration – I love going to the beach to enjoy the sun, but burn easily and rely on sunscreen to protect me.
This interests me because I burn very easily and this regulation will make going to the beach expensive. This will affect me directly as it will force me to see a doctor to obtain sufficient sunscreen protection at the beach instead of my local drug store. 2. Describe the proposal/change. (10 points)
The proposal limits the maximum labeled SPF value for over-the-counter (OTC) sunscreen drug products to 50 SPF. 3. Write the public comment which 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) I am writing in regard to the fact that you want to limit over the counter use of sunscreen to 50SPF this will only increase the cost of the average American family’s bills, and during this economy that’s simply not an option. Going to the beach or just playing outside is supposed to be an inexpensive activity that any family can do, this rule however will limit that to only people who don’t need sunscreen over 50SPF or families who can afford to go to the doctor and can get a prescription for sunscreen.
This rule will also add to the obesity crisis facing our country currently. By not allowing children to play outside because they won’t have the appropriate protection they will end up sitting inside on the couch. I would like to have this rule reconsidered until further testing is conducted and or funding is available for free prescription sun block and doctors office visits for prescription acquisitions as well. 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) The deadline by which public comments must be made is Sep 15, 2011 11:59 PM ET 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.) The public comment period cannot be fewer than 30 days, but most agencies make the public period much longer. Private Citizens, government officials, industry representatives, businesspeople, and corporations can all send comments. With this opportunity, businesses can provide information and express concerns about proposals.
A comment to an agency on a proposed rule need not use a formal format; most just appear in letter form. Anyone who wishes to challenge the validity of a federal regulation after it becomes law must participate in the comment period and voice his or her concerns at that time. Any party who submits a comment is legally entitled to challenge the validity of the rule in court. b. If the proposal passes, identify and explain the five legal theories you could use in an attempt to have the regulation declared invalid and overturned in court.
The first ground on which to challenge an agency rule is that it is arbitrary, capricious, and 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. 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 regulation, substantial evidence requires that more convincing evidence exist in support of the regulation than against it. 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 rule after the comment period. A fourth 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. The fifth and final 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 tires to change the substance and purpose of the enabling through regulation, the regulations would be ultra vires. 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? Answer all of these questions for #5 even if you are in favor of your proposed regulation. The response to question 5 should be a minimum of 2-3 paragraphs long. (15 points) I think the best way the regulation could be challenged would be through the second theory because the agency’s regulation is unsupported by substantial evidence.
The FDA is citing their reason as clinical studies showing no benefit from over the counter sun block over 50 SPF however they don’t submit who did the studies or how many studies were done. Along with how they were conducted in detail such as number of participants, age, time span, etc… Although this may not be enough to have the regulation overturned it is certainly enough to challenge the regulation.