regulatory toxicology

Question 1

FDA organization

Answer 1

executive branch agency
under secretary of HHS
senate confirmation
more political than in the past

Question 2

vaccine act of 1813

Answer 2

passed after bad smallpox vaccine
first federal law about consumer protection and drugs
short lived

Question 3

biologics act of 1902

Answer 3

passed after deaths from bad diptheria antitoxin

Question 4

the jungle

Answer 4

book of unsanitary food processing industry

lead to 1906 act

Question 5

1906 act

Answer 5

basic structure of fda
followed in broad outline today
authority over interstate shipment of adulterated foods and drugs
narrow use of commerce clause power

Question 6

1938 act

Answer 6

for drugs in cosmetics
passed because of public outcry
broadened definitions of adulteration and misbranding

Question 7

1962 amendment

Answer 7

shift from premarket notification to premarket approval
required drugs to be effective
required reevaluation of all marketed drugs
still not done

Question 8

MDA 1976 (medical device amendments)

Answer 8

for regulating medical devices like pacemaker

Question 9

MDA 1976 (medical device amendments)

Answer 9

for regulating medical devices like pacemaker
passed after pacemaker and other medical device scandals
risk class regulation
new devices must be safe and effective

Question 10

US department of agriculture (USDA)

Answer 10

food safety Inspection service - FSIS (meat, poultry, eggs)

same philosophy as FDA

Question 11

Environmental protection Agency -1970

Answer 11

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

Question 12

examples of environmental protection agency (EPA)

Answer 12

Federal insecticide, fungicide and rodenicide act (FIFRA)
toxic substances control act - TSCA
Resources Conservation and Recovery Act - RCRA

Question 13

FIRFA

Answer 13

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

Question 14

Toxic chemical substance act (TSCA)

Answer 14

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

Question 15

resource conservation and recovery act

Answer 15

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

Question 16

examples of other EPA programs

Answer 16

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)

Question 17

OSHA (occupational safety and health act)

Answer 17

sets health in work
health standards include workplace
includes toxic chemicals, stress and noise
train peronnel and educate workers
must prove problem exists

Question 18

consumer product safety commission CPSC

Answer 18

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

Question 19

impact of legislation on product evaluation and approval

Answer 19

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