Why do you think these standards are differentiated in the FD&C Act?

Question 1. The safety standard of an added component of food is based on the may render injurious determination as indicated in FD&C Act Section 402(a)(1). The safety standard of a non-added component of food is based on the ordinarily injurious determination as indicated in FD&C Act Section 402(a)(1). The latter standard (ordinarily injurious) is much less stringent than the former standard (may render injurious). Why do you think these standards are differentiated in the FD&C Act? (Point Value: 3 points)

Question 2. Referring again to the different safety standards of added components and non-added components of food: (A) Do you think that any poisonous or deleterious substance that becomes a component of food regardless of whether it was added or non-added, should have the same safety standard applied? (B) Why or why not? (Point Value: 3 points)

Question 3. This question presents a hypothetical scenario. The FDA publishes an advanced notice of proposed rulemaking in the Federal Register to inform the food industry of an upcoming proposed regulation that could affect certain categories of food. Specifically, the FDAs notice defines the pathogen Listeria monocytogenes as an added substance. Certain populations are affected more severely than other populations when the pathogen is consumed in low doses: specifically, children, the elderly, immunocompromised, and pregnant woman are more susceptible. You are counsel for a soft cheese manufacturer that sells some cheeses made from unpasteurized milk, but the cheeses are labeled with the warning: May be dangerous to those with compromised immune systems and pregnant women. As counsel, how would you advise the cheese company of the potential impact of the FDA proposal? (Point Value: 3 points)

Question 4. The FD&C Act provides the legal authority for the FDA to set tolerances of any poisonous or deleterious substance added to food if such substance is required in the production…or cannot be avoided by good manufacturing practice…. Considering that the substance in question is poisonous or deleterious, should such substance be permitted in food at any level? (Answer either — and not both — 4A or 4B below.) (Point Value: 3 points)

Subquestion 4A. If so permitted in food, should there be more strict regulatory authority than just the establishment of a guideline tolerance? If there should be more strict authority, what regulatory procedures could be put in place to assure that the permitted substance does not pose a health or safety problem?

Subqueston 4B. If such a poisonous or deleterious substance should not be permitted in food at any level, how could the regulatory authorities and the food industry cooperate in order that appropriate substitute components could replace the required or cannot be avoided substances?

Question 5. Pesticide chemicals on food articles are regulated by two regulatory agencies: the EPA and the FDA. As the purpose of a pesticide chemical is to be applied to food articles for production reasons, should pesticide chemical regulation be streamlined under the authority of one (1) agency instead of two (2) agencies? Or does the current system of dual-regulatory authorities function sufficiently well to protect consumers? For either answer, describe why. (Point Value: 3 points)

Question 6. (Two-part question.) Environmental contaminants pose a very difficult regulatory problem. This is best illustrated in the court case United States v. Anderson Seafoods, Inc. (Pp. 175-178).

(A) How did the court rule in this case with regard to added v. non-added mercury in swordfish? What was the legal reasoning used to reach the courts decision? (Point Value: 3 points)

(B) Do you agree or disagree with the courts reasoning of added v. non-added mercury in swordfish? Why do you agree or disagree? (Point Value: 3 points)

Question 7. HACCP plans are required prevention-based food safety systems for several food categories (e.g., seafood articles, juices, meat/poultry). However, not all food categories are required to have HACCP plans as an integral part of their production/handling/transportation systems. Should all food manufacturing facilities be required to have HACCP plans? If so, why should all food categories have such HACCP plans? If not, what food categories should not be regulated to have HACCP plans? Why or why not? (Point Value: 3 points)

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