Safe Food and Drugs: An Ongoing Regulatory Battle Flashcards
Foodborne Illness
- contamination of foods with bacteria, viruses, or parasites
due to breakdowns in
sanitation and/or proper food handling practices.
Foodborne illness: Bacteria
can be found where?
Bacteria
1) Salmonella - poultry, meat,
and eggs
- raw or not properly cooked
2) Escherichia coli 0157:H7
- ground beef, alfalfa sprouts,
unpasteurized apple juice,
raw milk, lettuce
- common in the intestinal
tracts of cows and are
excreted with their feces
2008, largest foodborne disease
outbreak
it is caused by?
symptoms?
sickened?
deaths? in how many states?
Salmonellosis
- from jalapeno and serrano peppers from Mexico - symptoms: vomiting, diarrhea, and abdominal pain - sickened 1442 people, 2 deaths in 43 states
2011 bacteria problem
it is because of
sickened?
deaths? in how many states?
Listeria - from cantaloupe produced by a Colorado comp - 148 sickened, 30 deaths in 28 states
toxins -
can be destroyed through?
also a way that bacteria causes diseases
can be destroyed in 15 to 20
minutes boiling
the best known and deadlines causing bacteria that caused?
it is a?
common in?
how did it affect the people?
Botulism bacteria - in the absence of oxygen - common in raw home-canned vegetables - released toxins
Causes of foodborne disease: virus
from what?
1) Hepatitis A: green onions from Mexico, shellfish
- typhoid Mary
2) Norwalk virus: shellfish
Causes of foodborne disease: parasites
from?
1) Cyclospora: raspberries from Guatemala
2) Parasites in sushi, sashimi, ceviche
Who is responsible for meat, poultry, and processed eggs?
percentage of disease caused?
how often do they inspect?
US Department of Agriculture (USDA)
26%
almost everyday
who inspects all other food other than mean, poultry and processed eggs?
how often do they inspect? this is due to?
Food and Drug Administration (FDA)
every 10 years
budget constraints
Irrationality of system
- Marion Nestle
- Safe food: the politics of food safety
how much food do they regulate?
focuses on what?
budget on 2015?
1) USDA has bigger budget and more authority. -Regulates 20% of food. -Has detailed laws on regulation of meat. - - budget: $1014M
2) FDA has smaller budget and less authority. -Regulates 80% of food. -Regulates imported food. - budget: $914M
Imported food percentage
seafood - 80
vegetable - 20
fruits - 50
Laws for better food safety
it is under?
define
1) Food Safety Modernization Law - under FDA - expanded inspections and setting standards for the safe growing, harvesting, sorting, packing, and storage of fresh fruits and vegetables
2) Modernization Act of 2011
- under FDA
- has the authority to deny entry of food from a facility that refuses to permit FDA
inspection and it can detain for testing shipments of food that it has reason to believe may be harmful
HACCP Principles
- 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.
Safety measures
1) Hazard analysis critical control point (HACCP)
implemented on?
focuses on?
purpose?
when was it implemented on seafoods?
- December 1997
- focuses on procedures,
- purpose: identity hazard and
how to eliminate, prevent,
or minimize hazards
-1999.
Safety measures
2) irradiation
what does it kill?
is it safe?
it reduces risk of?
- Kills bacteria, parasites, pests - despite claims, it is safe as it does not leave any residue - reduce the Salmonella, E. coli 0157:H7, and cholera bacteria
Safety measures
3) Regulation on establishments
degrees for refrigeration?
degrees for heating?
- 1) hand washing
- 2) temperature regulation
- refrigerated - 40 degrees
- heated - 140 degrees
- refrigerated - 40 degrees
Safety measures
4) Food safety programs of CDC
PulseNet
involves what?
is it considered as active or passive surveillance?
FoodNet
involves what?
is it considered as active or passive surveillance?
4.1) PulseNet
- Epidemiologic
surveillance (passive
surveillance)
- DNA “fingerprinting” on
foodborne bacteria
- has timely comparisons
on outbreaks
- 2)FoodNet
- active surveillance
- asking around
Additives and contaminants
1) Hormones
1.1 banned on? increases risks of? 1.2 allowed for? why? on?
1.1) Diethylstilbestrol Estrogen is banned in chickens - increases breast cancer risks 1.2) Bovine growth hormone is allowed for cows: BGH does not get into milk. - allowed in 1994
Additives and contaminants
2) Antibiotics
why is it not allowed?
- They cause antibiotic
resistance
Additives and contaminants
3) Organic foods
- USDA set standards on?
- what is not allowed?
2004
1) meat, poultry, eggs, and dairy products: no antibiotics and hormones
2) organic products: without pesticides, synthetic fertilizers, sewage sludge, and GMO, and radiation
Additives and contaminants
4) Additives
what is it used for?
it can be approved if?
- They are used to prevent deficiency diseases, - Preservatives - improve color, flavor, or texture. - FDA or GRAS ( "generally regarded as safe" ) list must approve them.
Process for drug approval by FDA
it can be revoked when?
FDA must approve after studies by the pharmaceutical company.
1) Company files a new drug application (NDA).
2) If NDA is approved, there are three phases of trial:
1. Use a small number of subjects; measure absorption, distribution, metabolism, and excretion; look for side effects and toxicities.
2. Test a larger number of patients for signs that the new drug is effective.
3. Conduct a clinical trial.
FDA can revoke approval through post-marketing surveillance.
FDA rules on cosmetics
what is required?
- Cosmetics are loosely
regulated by the FDA. - No requirements exist for safety testing of cosmetics,
BUT a warning label must be attached to any product not
tested.
