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Week 2 Homework MGMT 520

1). State the administrative agency which controls the regulation. Explain why this agency and your proposed regulation interest you (briefly). Will this proposed regulation affect you or the business in which you are working? If so, how?
DEPARTMENT OF HEALTH AND HUMAN SERVICES (Food and Drug Administration)
The reason I chose this agency and this particular regulation is because of my concern with the number of food borne illnesses. I’m a single mom of two and I want to make sure that my family isn’t exposed to food borne illnesses. Also, being in the Military and deploying it’s crucial that the FDA step in to make sure that food that’s supplied for us to eat while deployed is within standards. On one of my deployment we were hit with a case of salmonella poisoning that shut down a good portion of the base because of sickness from consumption. We were later told that the contaminated items were on our salad bar. When in a deployed location in a foreign country the last thing you need is for your troops to be anything but ready for combat, so situations like these have to be maintained.
2) Describe the proposal/change
The first rule proposed would require makers of food to be sold in the United States, whether produced at a foreign- or domestic-based facility, to develop a formal plan for preventing their food products from causing foodborne illness. The rule would also require them to have plans for correcting any problems that arise. The FDA is proposing that many food manufacturers be in compliance with the new preventive controls rules one year after the final rules are published in the Federal Register but small and very small businesses would be given additional time.
The FDA also seeks public comment on the second proposed rule, which proposes enforceable safety standards for the production and harvesting of produce on farms. This rule proposes science- and risk-based standards for the safe production and harvesting of fruits and vegetables.
The FDA is proposing that larger farms be in compliance with most of the produce safety requirements 26 months after the final rule is published in the Federal Register. Small and very small farms would have additional time to comply, and all farms would have additional time to comply with certain requirements related to water quality
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.
As stated in why I chose this regulation it’s has to do with the wellbeing of my family both immediate and professional. I would like some reassurance that when shopping or eating out that the food I’m consuming s met ALL FDA approval. I want to be reassured that when I pick up the newspaper or turn on the news that I want get hit with a recall of something that I have either purchased or consumed. I want the FDA to make ALL necessary changes to assure me (us) that when consuming food that our last worry has to be contamination. I think that having all food produced in the United States is a GREAT idea this way if contamination should arise researchers want have to dig deep to find out which country supplied the contaminated 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.
Submit either electronic or written comments on the proposed rule by May 16, 2013.
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.)
Parties who made comments on the rules during their proposal stage can challenge the validity of the rules in court 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
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
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. 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 regulations cannot then turn the proposed regulations into agency rules after the comment period. The promulgated rules must be the result of the proceedings. Forth for challenging a regulation is that the regulation is unconstitutional.
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 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? The 3ard challenge would be my choice for challenging the regulations.

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