lecture 1-3 Flashcards
What is an example of a risk assessment?
the nuclear crisis at the power plant in Japan after an earthquake. It was defined as a danger zone for japan, citizens must evacuate within 12 mile radius.
US defined the danger zone to stay 50 miles away from the plant.
What is risk assessment?
a process by which
scientists to evaluate the potential for adverse
health or environmental effects from exposure
to naturally occurring or synthetic agents.
(largely scientifically‐based)
what is risk management?
to develop and execute
the policy to deal with hazards identified
through risk assessment, including the
evaluation of alternative regulatory options.
(in combination of science and administration)
What are the steps that the FDA takes in risk assessment?
Provide the evidence of safety / efficacy.
judge the risk and benefits
identify new risk and seek scientific advice.
examine new risk and provide new technology
when would a substance not need to be reviewed and approved by the FDA?
if it is considered GRAS
what are the steps to risk assessment in FDA in pharmaceuticals?
Drug discovery 2-10 years
Pre clinical research 3-6 years (animal experiments do not have to approved by the FDA. (but ICOOK makes sure it is humane)
Clinical trial 6-7 years - in humans
Phase 1 test in healthy people
Phase 2 study in disease people
Phase 3 Large scale testing in individuals with disease
FDA reviews 1-2 years
Manufacturing
are dietary supplements required for safety tests?
NOPE
What are some consequences of dietary supplements in their risk assemssment?
Generally, manufacturers do not need to register
their products with FDA nor get FDA approval before producing or
selling dietary supplements.
what are the components of risk assessment?
hazard identification,
dose response
exposure
risk characterization
what is the question associated with hazard identification?
is it harmful?
what is the question associated with dose response?
how much to cause harm?
what is the question with exposure assessment?
what is the real exposure?
what is the question associated with risk characterization?
how does it cause the harm, how dangerous is it?
in hazard identification? as conducting research progresses, from structure relationship to human epidemiological data, efficiency ________ and biocomplexity __________.
decreased and increased
Similar to Scoville heat scale,
______________________________ is
the estimate of compound‐
specific toxicity relative to the
toxicity of an index chemical
(such as TCDD).
Toxic Equivalency Factor (TEF)
___ = sum (toxicant)1 x TEFi
TEQ
WHO AND EPA uses ________ to evaluate the toxicity of dioxins.
TEFs
for TEFs what is the reference compound?
TCDD has a TEF of 1
why do we have recommended genetic tests for food additives for? (ames test, in vitro mamalian chromosomal aberattion test)
to detect mutations in DNA and structure changes in chromosome
what does the FDA use to determine minimum toxicitiy tests for the risk assessment of food additives?
concern level (CL)
what are the 3 levels of CL determining by?
chemical structure and potential human exposure
what does a graded DRR look like
straight line, linear
what does a quantal DRR look like
curved at the top and bottom
dose response assesses the __________ DRR of exposures and toxicants
quanitaitive
risk = ________- x _______
hazard x exposure
what is MOE?
a value indicating the difference between the NOAEL in
animals and the actual amount of human exposure in a population.
what is the safe amount of radioactive iodine in tap water? for adults and infanats
300 for adults
100 becquerels/L for infants
what are the two most common sources of toxic agent exposures for humans?
water and food!!
each year about ___ in ____ americans get sick from foodborne illness
1 in 6
about 120,000 people are _________ from foodborne illnesses
hospitalized
_______ people die each year from foodborne illness
3,000
what is the most common pathogen for the vast amount of illnesses?
norovirus
which toxins and poisons ae considered more dangerous?
natural toxins in food, residues in food and microbial food-borne illness
microbial pathogens are known to affect a persons ___________
GI tract
natural toxins and poison chemcials affect ____________
specific organs like the kidneys, brain and heart
what % of cancers are linked to the diet?
30-35%
write out the region of homeostasis graph!!!
what is ciguatera poisoning?
From eating large fish from tropical waters
From dinoflagellates a type of algae like organism
Acts on peripheral nervous system through depolarizing neural synapse
Scombroid poisoning?
from eating decayed fish meat, histamine is the cause
allergic reaction
what is main cause of shellfish poisoning
saxitoxin
____________ is a neurotoxin in many fish like a puffer fish
Tetrodotoxin
