1. State the administrative agency which controls the regulation. Explain why this agency and your proposed regulation is of interest to you (briefly). Will this proposed regulation affect you or the business in which you are working? How?
Food and Drug Administration (FDA) - I decided to choose this proposal to satisfy my curiosity to how the FDA plays a role in examining the safety of sunscreen and the steps taken in the approval for over the counter (OTC) sales. This particular proposal will affect my decision when I purchase sunscreen (brand, dosage, cream/spray, etc.) considering certain ingredients may be unsafe and not effective in protecting from UV Rays or exposure.
2. Describe the proposal/change.
The proposal/change is requesting additional information from sunscreen manufacturers to include in studies regarding sunscreens and their dosages/ingredients to be a part of the OTC review and monograph studies. These studies would serve as indicators to advise if sunscreens are being sold with the proper approval, contain the specified ingredients which have been permitted, and specify if they are effective. There are certain ingredients which are not subject to pre-approval by the FDA. However, there are some which are allowed and those that are restricted for usage as a safety precaution or environmental factors. If there are any violations, legal action may be pursued.
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.
I am in favor of the proposed change. I believe the FDA should take a part in verifying sunscreens and lotions. I say this because examining the product’s ingredients would help to ensure the safety and effectiveness of the product to the consumers who purchase them. Many people take pride in protecting their skin and look for as many facts/tips possible in making a decision when purchasing sunscreen. When a person is educated on relevant product information, this helps support the consumer’s decision to buy a particular product. Most companies are concerned with making a profit and not protecting their customer’s health or well being. Sometimes manufacturers and physicians exaggerate with how much sunscreen to put on, which SPF number is needed, how often it needs to be reapplied, and if it is truly waterproof. With this proposal/change, companies may not be at risk for lawsuit as the result of an allergic reaction from the use of their product.
4. Provide the "deadline" by which the public comment must be made. (If the date has already passed, please provide when the deadline was).
The deadline for public comment expired on September 15, 2011.
5A. 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)?
After the deadline for comments have expired, the document is published in the Federal Register for additional comments- only for an additional 30 day period. Individuals who commented on the rule(s) during the proposal stage can challenge the validity of the rules in court.
There are a few ways in which an administrative rule can be challenged. The first way is to determine if that rule is arbitrary, capricious, an abuse of discretion, or in violation of some other law. This is usually applied to formal rulemaking and simply requires the agency to show evidence to support the proposed rule. Once the comment period is over, there are three choices an agency has to determine what to do with the proposed rule(s). (1) Adopting the rule, (2) Modification of the proposed rules and going through the public comment process again, or (3) withdrawing the rule. The Administrative Procedure Act (APA) allows the agency to adopt a modified version of the rule without having to go through the public comment period again, only if the modification is minor.
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 five legal theories that could be used in an attempt to have the regulation declared invalid and overturned in court would be:
1. The first theory would be contending if the rule is arbitrary, capricious, an abuse of discretion, or in violation of some other law.
2. The second theory which could be used is that the regulation is unsupported by substantial evidence.
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 comply 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. The notice must specify that promulgated rules will be the result of the proceedings.
4. The forth theory for challenging a regulation is determining if that 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 licensing professionals.
5. The fifth theory would be that of 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 act 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?
If I had to choose one of the five challenges as the best way to challenge the regulation I selected, I would go with the second theory stating that the regulation does not have substantial evidence to support it. Most cases that are taken to court will often be thrown out or ruled to agree with the opposing party due to the lack of evidence.