regulatory toxicology Flashcards
FDA organization
executive branch agency
under secretary of HHS
senate confirmation
more political than in the past
vaccine act of 1813
passed after bad smallpox vaccine
first federal law about consumer protection and drugs
short lived
biologics act of 1902
passed after deaths from bad diptheria antitoxin
the jungle
book of unsanitary food processing industry
lead to 1906 act
1906 act
basic structure of fda
followed in broad outline today
authority over interstate shipment of adulterated foods and drugs
narrow use of commerce clause power
1938 act
for drugs in cosmetics
passed because of public outcry
broadened definitions of adulteration and misbranding
1962 amendment
shift from premarket notification to premarket approval
required drugs to be effective
required reevaluation of all marketed drugs
still not done
MDA 1976 (medical device amendments)
for regulating medical devices like pacemaker
MDA 1976 (medical device amendments)
for regulating medical devices like pacemaker
passed after pacemaker and other medical device scandals
risk class regulation
new devices must be safe and effective
US department of agriculture (USDA)
food safety Inspection service - FSIS (meat, poultry, eggs)
same philosophy as FDA
Environmental protection Agency -1970
deals with chemicals and pesticides
to streamline and strengthen regulation of pesticides
consolidate responsibilites of agencies into EPA
to protect health and environment related to air, water, and soil polllution with risk - benefit considerations
examples of environmental protection agency (EPA)
Federal insecticide, fungicide and rodenicide act (FIFRA)
toxic substances control act - TSCA
Resources Conservation and Recovery Act - RCRA
FIRFA
for pesticides
premarket testing of pesticides - efficacy and safety/environmental impact
establisihing general and special testing procedures
establish tolerances
post market environmental surveillance monitoring
any pesticide must be approved
registration of pesticides and their facilities
classification of pesticides (restricted vs general)
banning pesticides
risk - benefit evaluation
Toxic chemical substance act (TSCA)
not every chemical must be approved by EPA
to bring industrial chemicals under oversight of EPA
not to regulate all chemicals only those that pose unreasonable risk to health and environment
prevent reoccurrrence of industrial exposures and accidents
the purpose is to reduce exposure to toxin
resource conservation and recovery act
controls generation, shipping, storage, treatment, record keeping related to hazardous waste identifies hazardous waste sets guidelines for testing hazardous waste designs HW (hazardous waste) storage facilities
examples of other EPA programs
puts in place level of permissible toxins
water pollution control act/clean water act
safe drinking water act (certain level of contaminant permitted)
clean air act (limiting pollution in air)
OSHA (occupational safety and health act)
sets health in work health standards include workplace includes toxic chemicals, stress and noise train peronnel and educate workers must prove problem exists
consumer product safety commission CPSC
regulates toxins in toys like lead
for any product used for consumption or enjoyment
protects public from risk/injury from consumer products
regulates by labeling
sets standards for flammable clothing, childproof lids, household chemicals
not for pesticides, alcohol or drugs
lacks pre market authority
impact of legislation on product evaluation and approval
the past:
pre/post marketing regulation and oversight
compliance with regulator agency standards for quality/safety/effectiveness and protection of environment.
more in depth product reviews
decrease in animal and human testing
the present:
effort to replace, reduce, and refine animal use in research and testing
effort to increase efficiency of test method evaluation and reduce time from test development to regular acceptance and implementation
obligate industries to asses products
gov and industry seeking ways to satisfy testing requirements
