Is FDA continuous inspection a sufficiently-important issue that it should be instituted? Why or why not?

Question 1. The FD&C Act has been broadly interpreted through legal actions. Of most importance is the phrase …introduction into interstate commerce… as this can include several establishments, facilities, warehouses, transport modes, etc. If a particular location such as a pass-through warehouse (that receives food articles and then transports the articles onward to the next location) holds and stores an adulterated food article, the facility can be held liable under the introduction interpretation. Is this possibility too broad an interpretation of the introduction term? Why or why not? Does this broad interpretation result in improved safety of food articles? Why or why not? (Point Value: 5 points)

Question 2. The Food Safety Modernization Act (FSMA) expanded the FDAs authority and responsibility with regard to recall of food articles that are adulterated or misbranded. Prior to promulgation of the FSMA the FDA relied on voluntary recalls by food manufacturers of potentially violative food articles. Research the new FSMA recall authority given to the FDA and write a short description of the two-step process (i.e., two determinations) the FDA must show before it can order a recall. (Point Value: 5 points)

Question 3. (Two-part question.) The USDA/FSIS has the responsibility for continuous inspection of the meat and poultry products establishments under its authority. This continuous inspection is an important protocol to ensure that food articles manufactured by the establishment are safe to enter the marketplace. The FDA does not have continuous inspection of food establishments under its (FDAs) authority and responsibility. (Point Value: 6 points)

(A) Is FDA continuous inspection a sufficiently-important issue that it should be instituted? Why or why not?

(B) If certified third-party entities (such as the organic food certification process used by the USDA) were employed to assist the FDA in more frequent inspections of food facilities, describe the basic protocols that the FDA could use to assure the third-party entities conducted their inspections appropriately and legally.

Question 4. The legal principle strict liability is an important judicial tool used to remedy a wrong that has occurred. The landmark legal case United States v. Park is an example of the use of the principle. Do you think the principle of strict liability is a fair principle to prosecute and potentially punish a company official for a violation of federal (FD&C Act) law and regulation? Why or why not? (Point Value: 5 points)

Question 5. The issue of an FDA inspector taking photographs of food facilities during an inspection has been a concern for both the regulatory agency and for food facilities. There are advantages and disadvantages to each party if an inspector is authorized to take photographs. (Point Value: 6 points)

(A) What are the advantages and disadvantages to a food establishment if the FDA inspector is authorized and obligated to take photographs of the facilities?

(B) What are the advantages and disadvantages to the FDA if the FDA inspector is authorized and obligated to take photographs of the facilities?
Use FDA and other government websites as sources needed

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