FNPS 3680 Exam 2 | UPDATED Questions with 100% Verified Answers

FNPS 3680 Exam 2 | UPDATED Questions with 100% Verified Answers

Question:
When did the ban on acrylonitrile bottles become effective?

Answer:
Dec 1977


Question:
When was the ban on acrylonitrile bottles first proposed?

Answer:
March 1977


Question:
How did Coco-Cola respond to the ban on acrylonitrile
bottles?

Answer:
Made a switch from quart-sized acrylonitrile bottles to two-liter (half-gallon) bottles
made of PET
• Started in Spartanburg, SC


Question:
What company produced quart-sized acrylonitrile bottles that
Coca-Cola bought?

Answer:
Monsanto Company


Question:
What rival drink company used PET bottles years before
Coca-Cola?

Answer:
Pepsico Inc.


Question:
T or F: PET is a type of polyester?

, Answer:
True


Question:
Main polyester supplier

Answer:
Goodyear Tire and Rubber Company


Question:
Who was Goodyear Tire and Rubber Company rapidly
sending shipments to?

Answer:
Fabricators of PET bottles:
• Amoco Chemicals Corporation
• Sewell Plastics Inc.
• The Hoover Ball and Bearing Company
• Owen-Illinois Inc.
• Continental Diversified Industries
Result of two of the largest bev companies using PET bottles (Coke + Pepsi)


Question:
When did Monsanto have until to challenge the FDA in the
ban against acrylonitrile?

Answer:
Nov 1977


Question:
What was the FDA's ruling on acrylonitrile based on?

Answer:
Polymerized acrylonitrile contains stray molecules, called monomers, of acrylonitrile ->
leech into drinks during warehouse storage (bc heated to 120°F sometimes)


Question:
Tests done to support FDA ruling

, Answer:
Tests, conducted by the Dow Chemical Company for the Manufacturing Chemists'
Association, showed that laboratory rats fed very large doses of the monomer for their
lifetimes developed an excess of tumors and birth defects.


Question:
Why are monomers of acrylonitrile under FDA jurisdiction?

Answer:
If the monomer can leach from the plastic into the soft-drink, it becomes a food additive
subject to FDA


Question:
What did Monsanto call their bottles?

Answer:
"Cycle-Safe"


Question:
What does Monsanto argue?

Answer:
Monsanto has asserted that this could not happen to real bottles under real conditions.
- If the bottles, which Monsanto calls "Cycle-Safe," were stored at 120°F, the pressure
from the carbon dioxide in the drink would build up and the bottles cease to be
functional containers in just a few days (rupture, enlargement, deformed)
- In other words, there is no way a Cycle-Safe bottle, filled with soft drink, could survive
this kind of abuse for one month, let alone six, says Monsanto
- Accused FDA of simulating beverage-filled bottles to get around the problem of gas-
pressure buildup


Question:
Monsanto vs. FDA ending

Answer:
• Monsanto won procedural battle in courts March 1977 which suspended the ban
• However, did not change FDA ruling, Coca-Cola stopped placing orders and Monsanto
shut down manufacturing facilities

, • In May, E.I. duPont de Nemours & Company announced health data on workers that
linked exposure to acrylonitrile to an excess of cancer cases and cancer deaths


Question:
The 1938 Food, Drug & Cosmetic Act - Creation

Answer:
Left gaps for future amendments to cover
• Denoted as "R" (reserved)
• FDA can use this category for something not covered by the 1938 law


Question:
The 1938 Food, Drug & Cosmetic Act - Layout Overview

Answer:
(A): General, Regulations
(B): Food and Drug, Prodcuts
(C): Animal Drugs
(D): Human Drugs
(E): "R"
(F): Biologics
(G): Cosmetics
(H): "R"
(I): "R"
(J): Radiological
(K): "R"
(L): Import Milk, Import Tea, Caustic Portions


Question:
CFRs

Answer:
Code of Federal Regulations
Where regulations for laws are published annually
• Many different sections + volumes (like encyclopedia)