Wastes and food highlights Flashcards
What set standards for sanitary landfills?
Resource Conservation and Recovery Act (RCRA)
What holds the key to reducing waste?
Consumer behavior
Which is the most important part of reduce, reuse, recycle when it comes to hazardous wastes?
Reduce
List the 4 federal groups the help with food, and include which isn’t a regulatory agency
FDA
USDA
EPA
CDC: Not a regulatory agency
Who has Overall responsibility for food safety regulation in the United States (seafood and produce)?
FDA
What are the 2 main ways to prevent food-borne diseases?
Temp and radiation
UDSA has regulatory responsibilities for _________, __________, and __________ in the United States
meat, poultry, and eggs
What 2 things are regulated by the EPA?
Regulation of pesticide usage and the establishment of water quality standards
1) What does the CDC not do?
2) Responsible for ongoing ____________ and acute _____________ in collaboration with state and local health departments
1) Not a regulatory agency
2) surveillance; investigations
How do we prevent food-borne diseases? (7 steps)
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
The ______________________ Act (2010) gives the FDA and USDA increased authority to ensure the safety of foods
Food Safety Modernization
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
1) The Food Safety Modernization Act (2010)
2) origin and date
Food Net: What makes this unique?
Unlike passive surveillance, public health officials proactively seek out potential cases.
What are the Steps in Foodborne Outbreak Investigation?
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
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?
1) A cluster
2) When a cluster is determined and they have something in common to explain why they have the same illness
What is “case definition”?
A set of criteria used to define which persons will be considered to have a disease as part of an outbreak
The most common study type conducted in Foodborne Outbreak Investigation is what?
Case-control studies
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?
Source traceback
Foodborne Outbreak Investigation
After you test the hypothesis, you should find the point of ______________ and the ____________ of the outbreak
contamination; source
True or false: Overall dietary behavior has far more impact on health than food contamination
True
The production and distribution of a batch of ____________ vaccine that caused polio; this led to the regulation of vaccines in the 1950s
polio
The ______________ (an IUD) produced thousands of cases of infection and infertility and ed to increased regulation of medical devices in the mid-1970s
The Dalkon Shield
The Kefauver-Harris Drug Amendments were established in response to what?
Thalidomide
The FDA requires what before studying a drug on humans?
animal safety studies
Effects of a drug on an animal may fail to detect the effects on humans or demonstrate high-dose effects. Give an example.
Thalidomide; did not demonstrate the severe limb shortening in animal testing
Phase 1 drug trials:
1) Involve the ________ administration of a drug to ________________.
2) Focuses on the _______________ of the drug (absorption, metabolism, and excretion)
1) initial; humans
2) pharmacology
Phase 1 drug trials
1) Establish the ___________ range and _________________ to be used in subsequent studies.
2) Looks at _____________ issues.
1) dosage; route of administration
2) safety
Phase 1 drug trials:
1) Are capable of identifying common and serious what?
2) What may they focus on? Give an example
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
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?
1) short; small
2) Wide rage of special sensitivities to drug actions that occur among a small number of people
Trial phases 2&3: primarily designed to establish the ____________ of a drug for a particular use or indication
efficacy
1) Phase 2 are _______ , sometimes ___________ trials to determine whether there is __________.
2) What are they NOT primarily focused on?
1) small; uncontrolled; efficacy
2) Not primarily focused on safety
What do phase 2 trials aim to establish?
Proof of concept (provide suggestive evidence that the drug has efficacy)
1) What is the gold standard for establishing efficacy for one particular indication?
2) What is a limitation of this?
1) Phase 3: randomized controlled trials
2) Establishing safety
(Trials are too small, too short, too simple)
Trial phases 1-3 do not establish that the drug has what?
Effectiveness
New drugs are approved based on data collected when?
In preclinical testing and phases 1,2,3
Phase 4 Spontaneous reporting system:
1) Prescribers and patients are _____________ (not a requirement) to report side effects to the FDA
2) Give an example
1) encouraged
2) New rotavirus vaccine caused intussusception in a small number of cases a few weeks after it was given
List 3 limitations of Spontaneous Reporting?
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
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?
1) not
2) Off label prescribing
(The use of FDA approved drugs for indications or at dosages not approved by the FDA)
FDA approval implies the new drug may be __________ and ______________ for a particular indication.
advertised and marketed
List 2 things abt the politics of the FDA
1) “Too Slow” in approving new drugs
2) Importing from other countries
