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
slide 11 cdc
: Not a regulatory agency
Responsible for ongoing surveillance and acute investigations in collaboration with state and local health departments
How do you
Conduct a hazard analysis
Determine the critical control points
Establish critical limits
Establish monitoring procedures
Establish corrective actions
Establish verification procedures
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
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The Food Safety Modernization Act (2010) gives the FDA and USDA increased authority to ensure the safety of foods
Ensures the ability to track foods including origin and date of production in case an outbreak source needs to be identified
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) Cluster: a larger number of people than expected have the same illness in a given time period and area
When a cluster is determined and they have something in common to explain why they have the same illness, this is called an outbreak
1) Cluster
2) Outbreak
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
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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 Dalkon Shield (an IUD) produced thousands of cases of infection and infertility and Led to increased regulation of medical devices in the mid-1970s
Thalidomide
In response to this, the Kefauver-Harris Drug Amendments were established
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
Phase 1 drug trials
Phase 1 drug trials
Phase 1 drug trials
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1) What is the gold standard for establishing efficacy for one particular indication?
2) What is a limitation of this?
1)
2)
Phases 1-3 do not establish that the drug has effectiveness
New drugs are approved based on data collected in preclinical testing and phases 1,2,3
Phase 4 Spontaneous reporting system:
Prescribers and patients are encouraged (not a requirement) to report side effects to the FDA
Example: new rotavirus vaccine caused intussusception in a small number of cases a few weeks after it was given
Limitations of Spontaneous Reporting?
Only a small % may be reported, especially when the effect is not dramatic or closely linked in time to the treatment
Side effects 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
Unsuspected side effects may escape detection or not be attributed to the treatment
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FDA approval implies the new drug may be __________ and ______________ for a particular indication.
advertised and marketed
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Politics of the FDA
“Too Slow” in approving new drugs
Importing from other countries
