Wastes and food highlights

Question 1

What set standards for sanitary landfills?

Answer 1

Resource Conservation and Recovery Act (RCRA)

Question 2

What holds the key to reducing waste?

Answer 2

Consumer behavior

Question 3

Which is the most important part of reduce, reuse, recycle when it comes to hazardous wastes?

Answer 3

Reduce

Question 4

List the 4 federal groups the help with food, and include which isn’t a regulatory agency

Answer 4

FDA
USDA
EPA
CDC: Not a regulatory agency

Question 5

Who has Overall responsibility for food safety regulation in the United States (seafood and produce)?

Answer 5

FDA

Question 6

What are the 2 main ways to prevent food-borne diseases?

Answer 6

Temp and radiation

Question 7

UDSA has regulatory responsibilities for _________, __________, and __________ in the United States

Answer 7

meat, poultry, and eggs

Question 8

What 2 things are regulated by the EPA?

Answer 8

Regulation of pesticide usage and the establishment of water quality standards

Question 9

1) What does the CDC not do?
2) Responsible for ongoing ____________ and acute _____________ in collaboration with state and local health departments

Answer 9

1) Not a regulatory agency
2) surveillance; investigations

Question 10

How do we prevent food-borne diseases? (7 steps)

Answer 10

1) Conduct a hazard analysis
2) Determine the critical control points
3) Establish critical limits
4) Establish monitoring procedures
5) Establish corrective actions
6) Establish verification procedures
7) Establish record-keeping and documentation procedures

Question 11

The ______________________ Act (2010) gives the FDA and USDA increased authority to ensure the safety of foods

Answer 11

Food Safety Modernization

Question 12

1) The ____________________ gives the FDA and USDA increased authority to ensure the safety of foods.
2) Ensures the ability to track foods including ________ and _________ of production in case an outbreak source needs to be identified

Answer 12

1) The Food Safety Modernization Act (2010)
2) origin and date

Question 13

Food Net: What makes this unique?

Answer 13

Unlike passive surveillance, public health officials proactively seek out potential cases.

Question 14

What are the Steps in Foodborne Outbreak Investigation?

Answer 14

1) Detecting
2) Defining and finding cases
3) Generating hypotheses [abt source]
4) Testing the Hypothesis
5) Finding the point and source
6) Controlling
7) Deciding it’s over

Question 15

1) A larger number of people than expected have the same illness in a given time period and area is called what?
2) What is an outbreak?

Answer 15

1) A cluster
2) When a cluster is determined and they have something in common to explain why they have the same illness

Question 16

What is “case definition”?

Answer 16

A set of criteria used to define which persons will be considered to have a disease as part of an outbreak

Question 17

The most common study type conducted in Foodborne Outbreak Investigation is what?

Answer 17

Case-control studies

Question 18

Foodborne Outbreak Investigation
What is it called when investigators work to find out where the contamination occurred and examine each step in the process of the food preparation?

Answer 18

Source traceback

Question 19

Foodborne Outbreak Investigation
After you test the hypothesis, you should find the point of ______________ and the ____________ of the outbreak

Answer 19

contamination; source

Question 20

True or false: Overall dietary behavior has far more impact on health than food contamination

Answer 20

True

Question 21

The production and distribution of a batch of ____________ vaccine that caused polio; this led to the regulation of vaccines in the 1950s

Answer 21

polio

Question 22

The ______________ (an IUD) produced thousands of cases of infection and infertility and ed to increased regulation of medical devices in the mid-1970s

Answer 22

The Dalkon Shield

Question 23

The Kefauver-Harris Drug Amendments were established in response to what?

Answer 23

Thalidomide

Question 24

The FDA requires what before studying a drug on humans?

Answer 24

animal safety studies

Question 25

Effects of a drug on an animal may fail to detect the effects on humans or demonstrate high-dose effects. Give an example.

Answer 25

Thalidomide; did not demonstrate the severe limb shortening in animal testing

Question 26

Phase 1 drug trials: 1) Involve the ________ administration of a drug to ________________. 2) Focuses on the _______________ of the drug (absorption, metabolism, and excretion)

Answer 26

1) initial; humans 2) pharmacology

Question 27

Phase 1 drug trials 1) Establish the ___________ range and _________________ to be used in subsequent studies. 2) Looks at _____________ issues.

Answer 27

1) dosage; route of administration 2) safety

Question 28

Phase 1 drug trials: 1) Are capable of identifying common and serious what? 2) What may they focus on? Give an example

Answer 28

1) side effects 2) Expected effects based on the known actions of a particular class of drugs or a particular drug -when testing a new antidepressant, examine the electrical conduction system of the heart because antidepressants are known to produce arrhythmias

Question 29

Phase 1 drug trials: 1) Duration of the exposure to the drug likely _______ and the study is usually __________ (*no pregnant women or young children). 2) What is a major limitation?

Answer 29

1) short; small 2) Wide rage of special sensitivities to drug actions that occur among a small number of people

Question 30

Trial phases 2&3: primarily designed to establish the ____________ of a drug for a particular use or indication

Answer 30

efficacy

Question 31

1) Phase 2 are _______ , sometimes ___________ trials to determine whether there is __________. 2) What are they NOT primarily focused on?

Answer 31

1) small; uncontrolled; efficacy 2) Not primarily focused on safety

Question 32

What do phase 2 trials aim to establish?

Answer 32

Proof of concept (provide suggestive evidence that the drug has efficacy)

Question 33

1) What is the gold standard for establishing efficacy for one particular indication? 2) What is a limitation of this?

Answer 33

1) Phase 3: randomized controlled trials 2) Establishing safety (Trials are too small, too short, too simple)

Question 34

Trial phases 1-3 do not establish that the drug has what?

Answer 34

Effectiveness

Question 35

New drugs are approved based on data collected when?

Answer 35

In preclinical testing and phases 1,2,3

Question 36

Phase 4 Spontaneous reporting system: 1) Prescribers and patients are _____________ (not a requirement) to report side effects to the FDA 2) Give an example

Answer 36

1) encouraged 2) New rotavirus vaccine caused intussusception in a small number of cases a few weeks after it was given

Question 37

List 3 limitations of Spontaneous Reporting?

Answer 37

1) Only a small % may be reported, especially when the effect is not dramatic or closely linked in time to the treatment 2) SEs that result from a variety of causes or are similar to the consequences of the disease being treated may be difficult to recognize and attribute to the treatment 3) Unsuspected side effects may escape detection or not be attributed to the treatment

Question 38

FDA approval implies the new drug… 1) May be used by prescribing clinicians who have the authority to use the treatment for indications or at dosages _______ specifically approved by the FDA 2) What is this called?

Answer 38

1) not 2) Off label prescribing (The use of FDA approved drugs for indications or at dosages not approved by the FDA)

Question 39

FDA approval implies the new drug may be __________ and ______________ for a particular indication.

Answer 39

advertised and marketed

Question 40

List 2 things abt the politics of the FDA

Answer 40

1) “Too Slow” in approving new drugs 2) Importing from other countries