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12 Cards in this Set

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·Gave FDA authority over food
·Ensured safety of food products “pure, wholesome, and safe”
·Defined requirements for truthful labeling of ingredients
Federal Food, Drug, and Cosmetic Act(FFDCA)
Includes 3 standard requirements
·standards of identity
·standard of fill
·standard of minimum quality
·requires FDA to approve additives before they are used in food
·legally defined food additives
·places “Burden of Proof” on the manufacturer
Food Additives Amendment(FAA)
Includes 2 exempted categories of substances
·prior sanctioned substance
·GRAS substances
Substances subject to Delaney Clause
·Requires FDA to approve dyes for use in food, cosmetics, and drugs prior to marketing of those dyes
Color Additives Amendment(CAA)
other info (CAA)
·No substances exempted from safety testing
·Defined “natural” and “synthetic”
·Subject to Delaney Clause
·No additive or pesticide reside can be approved if found to cause cancer in humans or animals

·Originally maintained “zero tolerance”
·In 1996, “Zero tolerance” replaced with “negligible risk”
Delaney Clause
What is tested during Toxicity Testing?
teratogenic effects (birth defects)
mutagenic effects (DNA)
carcinogenic effects (cancer)
Acute Toxicity Testing
$Identify 1st indication of harmful effects
$two+ animal species
$ high level test material fed single dose
Sub-Acute Toxicity Testing
$Determine maximum level without adverse effects
$two+ animal species
$ larger # of animals used
$ < lethal dose fed 90 days
$ larger # of animals used
$ males vs females
¥Behavior, appearance, weight
¥Urine & blood tests
$ Human Max Daily Level = highest level with no adverse effects ¸ 100
Chronic Toxicity Testing
$Check for tumors & chronic disorders
$Animals fed throughout lifetime
$ Rats = 3 years
$ Dogs > 2 years
$ 10 –100x human allowable level
$ sacrificed at intervals and examined
Ames Test
$Identify mutagenic potential
$Mutant Salmonella Typhimurium
$ unable to make histidine from its culture medium
$ Reversable mutation
$if mutagen present, organism can grow
$ called “reversion”