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Humulin
human insulin developed by Eli Lilly, Inc. in 1980 through recombinant E. coli, approved by FDA in 1982
Dr. Normal Borlaug (1914-2009)
- father of the Green Revolution
- winner of the Nobel Peace Prize
- credited with saving 1 billion people from starvation through his development of a semi-dwarf wheat which can handle environmental conditions better
- later brought it to Africa and Asia
Central Dogma
DNA -> transcription -> RNA -> translation -> protein
Conventional breeding
the crossing of male and female organisms within a species that are designed to make improvements to the organism followed by selection of improved progeny
Phenotyping
the systematic determination of an organism's observable traits (anatomical, physiological, and biochemical properties)
CRISPR-Cas9
gene editing technique that that is more efficient and precise than other techniques
Bt RNAi
used to "silence" specific genes in corn rootworms that are key for their survival so they can't damage corn crops
Patents
are allowed on biotech organisms (ex: bacteria that break down crude oil)
Coordinated Framework for the Regulation of Biotechnology
(1986, 1992, 2017) defined the roles for federal agencies to regulate biotech products
EPA
ensures biotech crops are good for the planet
FDA-HFP and USDA-APHIS
ensures biotech products are safe to eat
USDA-APHIS
ensures biotech products are safe to grow
Substantial equivalence
FDA-HFP determines whether biotech crops is similar enough to the existing crop. must be free from:
- unanticipated effects
- increases in natural toxins
- changes in nutrient content
- new allergens
Biotech statistics
- 80% of processed foods contain GMOs
- 90% cheese is made with biotech chymosin
- biotech improves crop yields by ~20%
FlavrSavr tomato
ripening tomatoes usually soften as polygalacturonase (PG) which breaks down pectin, the Favrsavr turns off PG gene
Round-up Ready soy
genetically modified soybeans produce more of an enzyme (EPSPS) that allows them to tolerate the herbicide glyphosate (Roundup)
Bacillus thuringiensis (Bt)
a common soil bacteria that produces Cry proteins
Bt-corn
genetically modified corn that produces a Cry protein that kills certain insect pests by binding to their gut receptors to form spears that punch holes in the gut
Rainbow papaya
papaya that is immune to papaya ring spot virus (prsv) by adding proteins to disrupt host-pathogen interaction
Artic Apple
non-browning apple because the expression of polyphenol oxidase (PPO) enzyme is suppressed though RNA interference (RNAi)
Innate potato
has reduced levels of free asparagine which significantly decreases acrylamide formation when tubers are baked or fried
FDA-CVM: FD&C Act, Rule 187
allows CVM to regulate biotech food animals as New Animal Drugs
AquAdvantage Salmon
genes from chinook salmon and ocean pout to allow them to grow to market size much faster (all female and sterile)
mold/mycotoxins
reducing injury by pests leads to less mold infiltration and lower mycotoxin
Pioneer Seed Soy
in 1996, Pioneer Seed tried improving the protein quality of soy by inserting it with DNA from a Brazil nut which resulted in allergic reactions from people allergic to the Brazil nut
GalSafe Pig
genetically enhanced to eliminate alpha-gal sugar so their organs can be harvested for human transplant
PRRS-Resistant Pig
pigs resistant to porcine reproductive and respiratory syndrome (PRRS) because a gene that encodes for a protein that allows the viruses to enter the cell is deleted
Jamaican Ginger Paralysis
Jamacian ginger extract caused the condition Jake Leg from the addition of triorthocresyl (TOCP)
Elixir of Sulfanilamide
many people died after ingesting the antibacterial drug sulfanilamide because it was contaminated with diethylene glycol
FD&C orange no. 1
color additive was banned in 1956 after many children became ill after eating orange halloween candy
Food Additive Amendment 1958
- burden for demonstrating safety of the additive was now placed on the manufacturer (no longer the government)
- all additives are ingredients, but not vice versa
- requires labeling of irradiation as a food additive
Food Additive Amendment Delaney CLause
no additive shall be deemed safe if it is found to induce cancer when ingested by man or animal
Current standard of safety for food additives
the petitioner has the burden to demonstrate a "reasonable certainty of no harm" from the intended use of the food additive
GRAS
generally recognized as safe
3 classes of direct food additives
1) food additives (covered under amendment)
2) food additives generally recognized as safe
3) additives with "prior approval"/prior sanctioned substances
Substances added to food
formerly called Everything Added to Foods in the United States (EAFUS) regulated by the U.S. Food and Drug Administration
Generally recognized as safe
- excluded from the definition of food additive
- put in place so common substances that have been used for a long time without evidence of harm. are permitted
- just because it is safe to use in one food does not make it safe to use in another
- lack of evidence of being unsafe does not prove safety
Prior-sanctioned substances
additives that were in-use before september 1958 became grandfathered in (no fomrla list)
Sucrose
- table sugar
- glucose and fructose
- from sugar cane and sugar beet
Table sugar
we get 50% of sucrose from sugar can and 50% from sugar beet
High fructose corn syrup (HFCS)
- market form of syrup
- HFCS has advantages over sucrose because it is sweeter and cheaper
- HFCS-43 -> 42% fructose
- HFCS-55 -> 55% fructose
- HFCS-90 -> 90% fructose
Glucose isomerase
enzyme that turns glucose into fructose
Cyclamates
- intense, non-nutritive sweetener
- banned in U.S., permitted in Canada
Saccharin
- intense, non-nutritive sweetener
- permitted in U.S., banned in Canada
- was thought to be injurious to health and was removed from the federalist of known carcinogens
Neotame
- intense, non-nutritive sweetener
- PKU not a concern
Rebiana aka Truvia
- intense, non-nutritive sweetener
- natural sweetener from stevia plant
Phenylketonuria (PKU)
- rare genetic disorder causes a build-up of the amino acid, phenylalanine
- leads to cognitive impairment
- Guthrie Test
Endosperm
part of the cereal grain that stores about 80% starch and 20% protein, source of flour and starch
Gelatinization
- the process of starches absorbing water
- requires heat
- very fast (10s)
Pesticide treatments
from 1996 to 2020, global biotech crops reduced pesticide usage 7.2%
Organic crops
becoming inferior to biotech crops due to lower nutrient content and safety
Precautionary principle
products should not be approved for consumption without 70 years of testing to "guarantee" safety
Opportunity cost
- the loss of potential gain from other alternatives when one alternative is chosen
- implementation of the PP affects public health, animal welfare, and climate change by delaying needed technological advances
Golden Rice
- contains increased levels of beta carotene (converted to vitamin A in the body) plus higher iron
- vitamin A deficiency affects 180-250 million children, with 1-2 million deaths annually
- in 2024 a Philippine Court of Appeals banned golden Rice, Greenpeace brought the lawsuit
American Chestnut Blight
- "redwoods of the East"
- occurred when a fungal (Cryphonectria parasiticus) blight from Asia spread from NY
Gums
- most are natural products
- little or no flavor or masking
- little or no caloric impact
- do not require heat for processing
- very safe
- added for texture
Migrating compounds
- compounds that migrate from packaging into foods
- BPA (used to harden plastics for clearer appearance, and in cans)
- regulated as food additives (indirect)
Color Additive Amendment (1960)
prohibited or improper use of unlisted color additive may cause a product to be adulterated
Red No. 3
two studies showed cancer in lab rates exposed to Red No. 3 due to rat specific hormonal mechanism, this mechanism does not occur is humans
Carmine
- aka carminic acid or Natural Red No. 4
- comes from cochineal bugs when the female eat the red buds of cactus which concentrates the red pigment
Bug parts in food
- certain levels of bug parts are allowed in foods
- 100g broccoli allows up to 60 aphids
- 50g cinnamon allows up to 400 insect parts