How to Find a Proposed Regulation:

ASSIGNMENT QUESTIONS:
1a. Make sure you submit a copy of your proposed regulation as an attachment to the Dropbox with this template. The Dropbox allows you to attach multiple documents in the same submission. (5 points)
1b. Identify the administrative agency (full name, not just the acronym) which controls the regulation. Briefly explain why this agency and your proposed regulation interests you. If this proposed regulation will affect you or the business in which you are working, please explain how. It is not required that the proposed regulation affect you professionally or personally. You can use any regulation for this assignment so long as you are able to answer the questions posed here (Questions 1-5).
(10 points)

Answer:
Centers for Disease Control and Prevention (CDC) - This specific agency, and proposed regulation, is of particular interest to me because of my past and future courses of study. My MPH degree was in public health with a concentration in disaster/emergency management so I want to ultimately aide in the education of my community to prevent communicable diseases. In the meantime, while working with medical students and clinical training sites, I am partially responsible for the health clearance of all of the students to ensure that they are able to do their clinical without risk of unnecessary exposure to harmful contagions.
2. Describe the proposal/change in your own words. (10 points)

Answer:
Influenza has several strains that are highly contagious. While the virus is able to unfortunately mutate, monitoring and keeping a strict lid on the strains that are identified as threats to public safety is important. Therefore, including two new strains to the list of influenza virus strains, specifically avian flu strains, would allow public health officials to control the spread of the hemagglutinin (HA) molecule strain.

3. Write a comment which you would submit to the administrative agency regarding this proposed regulation. (For example, are you in favor of the proposed regulation or against it? Why?) If the deadline for comments has already passed, write the comment you would have submitted had there been time. Also, explain briefly what you wish to accomplish with your comment. (10 points)

Answer:
In the case of this proposed regulation, I am fully supportive of the initiative. However, there are a few questions that I would like to ask to ensure that the proper steps are being taken to benefit the larger communities. First and foremost, there are some questions that are asked in the proposal that need to be addressed. There are vaccine candidates that should be excluded from this regulation that include the HA molecule because older strains of vaccinations that are currently available will be replaced by this version making people susceptible to the old strain in lieu of the new one. Additionally, with the mortality rate of hospitalized patients that contract influenza viruses rounding 50%, designating this virus as a Tier 1 HHS select agent, would allow for higher security requirements beyond what is already in place by the USDA and HPAI.

4. Provide the "deadline" (date) by which comments are (or were) due. If the due date has already passed, please provide when the deadline was. (NOTE: If you cannot find the answer to this question, you probably have not found a proposed regulation and you should look for a different one to complete your assignment.) (5 points)

Answer:
The deadline for comments is September 14, 2015 at 11:59 PM ET.
5. a. If the proposal passes, identify and explain the five legal challenges you could use in an attempt to have the regulation declared invalid and overturned. These will be found in the activity at the end of the Week 2 Lecture. (Start a new paragraph for each of the five challenges). (2 points for identifying each of the 5 challenges and 1 point for explaining each of the 5 challenges for a total of 15 points)
Answer:
Arbitrary and Capricious – “Generally applies to informal rule making and simply requires the agency to show evidence to support the proposed rule.” In this case, this instance arises when a decision is made without reasonable grounds or adequate consideration of the circumstances. Therefore if the CDC rushes to make the HA molecule a factor on the select agent list without substantial supporting evidence then this clause would come into play.
Unconstitutional – “Violates the constitution.” Should this agency and this proposal violate the fundamental rights given to the public by the constitution such as any of the ten amendments of the bill of rights –freedoms, petitions, and assembly or right to a fair trial. Should this proposal violate the public to speak out against the update to the list of select agents, then this would violate the first amendment and would be deemed unconstitutional.
Noncompliance with APA – “Agency did not comply with the APA requirements of notice, publication, and public comment or input.” The APA is the Administrative Procedure Act, governs internal procedures of administrative agencies, including how they interact with the public. The APA serves to police improper agency behavior, protect public safety, and secure proper entitlements (Electronic Privacy Information Center- www.epic.org, n.d.). Should this proposal not allow for public comment, this would be in direct violation of the APA and be overturned. Ultra Vires – “The agency has gone beyond the authority given to it in its enabling act.” Typically, if the agency is in violation of the Constitution or their actions exceed the scope of the power given to them by law, then they are in violation of Ultra Vires. Therefore, should the CDC not consult with the USDA, for example, the proposal would be overturned.
Substantial Evidence Test – “Requires that more convincing evidence exist in support of the regulation against it.” There needs to be enough supporting evidence that outweighs the reasonable doubt to support the claims made about the HA molecule in a particular strain.

5b. Which of these challenges would be the best way to challenge the regulation you selected for this assignment and why? (10 points)
Answer this question even if you are in favor of your proposed regulation.
Answer:
The best way to overturn this proposal would be to utilize the “substantial evidence test” as there could be enough argument raised that there is not enough proof that this strain of the virus is transmittable to humans. In fact, when viruses are naturally mutated, epidemiologically, they are not transmittable to humans and are therefore not transmittable from avian. The only way to tell for certain would be to manually manipulate the virus which would then change its molecular structure and would have it fall under a different regulation.

References:
Electronic Privacy Information Center- www.epic.org. (n.d.). Electronic Privacy Information Center. Retrieved July 21, 2015, from https://epic.org/open_gov/Administrative-Procedure-Act.html