10/12/2014

Food LABELING
Fdca labeling
o No fals/misleading, not under different name
o No misleading containers- needs to be labeled
o Standard of identity
Construction of label
o PDP
Common/usual name
Standard of identity
Net weight
o IP
Statement of ingredients
Manufacturers name/address
Other laws
o FPLA 1966
o NLEA 1990- nutrition education act
Scientific information
Standardized the format of providing nutrition
information on containers to the consumers
Nutrition facts panel on all packaged foods
Nutrient and health claims- have to be based on
scientific information

Must comply with standard format that not just for

mandatory nutrients, but also for the format
Font size etc.
o FFMA 1997
o FALCPA 2004

HEALTH CARE REFORM BILL

Signed into law on march 23, 2010
o obama
Patient protection and affordable care act
o Divided into 9 titles
o Long
Section 4205- creating healthier communities
o 2 new requirements:
1. Menu and board nutrition labeling information
2. Vending machine content nutrition labeling

rationale for the HEALTH CARE REFORM law

o 68% of adults and 32% children/adolescents are overweight
or obese
obesity related medical cost $147 billion (<9% of US
medical costs)
over consumption of calories and minimal physical
activity
increased risk of health problems (coronary heart
disease, type 2 diabetes, stroke, hypertension, arthritis,
types of cancer)

o 33% of calories are consumed outside of home

o 50% of annual food dollars for food prepared outside of home
o portion sizes have doubled in the last 20 years
super size = more for their dollar
o 5% of money spent on food away from home goes in vending
machines
o 1 machine for every 40 adults
o REAL OPTION IS:
Consumer education
Informed decision making
Transparency to increase consumers in lower
calorie options
Seek lower calorie options
o NLEA exemptions
served in restaurants or other establishments in which
food is served for immediate consumption
sold for sale or for use in such establishments
gas stations
state/local laws require calorie declaration but laws
VARY
state menu labeling policy:
implement state law: California, NY
want consistency across US
one standard for the industry
uniform across US

additional amendments to FDCA

officially amends FDCA sect. 403

the law and the timeline

law signed by Obama in march 2010
o FDA authority to write rule and enforce rule
o Published it in the federal register 75 no. 141. 7/23/10
march 2011- lawsuit calling affordable care act unconstitutional
o law stopped. Put a halt on implementing law everywhere
federal register by FDA 76 no. 66 4/6/11
June 28, 2012- us supreme court upheld PPACA
o to implement the act!
o Law could move forward
October 2013- federal government shutdown
Final rule by FDA has not been published yet!
o Published proposal in federal register
o Has comments on how theyre going to implement
o But has not been published.
Proposal: restaurant provision of lawmenu needs to say
whats inside

Restaurant chains, retail food establishments

278,000 establishments
1,640 chains
cost of initial compliance estimated $315.1 million with recurring
costs
approximately $1,100 per establishment
o new printing
o adding new information on menus

vending machine provision of law

13,500 companies operate vending machines in US
o 10,800 companies under this regulation
o Includes 5,000 firms 1 degree business
Primary form of business is vending machines
4-5.6 million machines in 1.5 million locations
initial cost of $25.8 million with recurring costs- items in machine
change
o not as much as restaurant
cost per operator = $2,400
who is affected by restaurant provision?
All restaurants and similar retail establishments that:
o Operate 20+ locations
o Use the same name (aka franchisesApplebees)

o Sell the same menu items

Easy to take one generic menu and make minor
modifications to be able to work in all locations
Restaurants with <20 location can register to be
voluntarily included in the program
o Not required
o Usually to their advantage
o Allows consistency and keeps them from regulating from state
requirements
Restaurant food and SIMILAR as primary business
o Presents itself as a restaurant or
o >50% of total floor sales from food
some are mixed establishments- dont meet
requirements
generally includes:
o table service
o quick service
o cafeterias
o pastry
o coffee shops
o snack bars ice cream
o multi purpose establishmentsDAVE AND BUSTERS
o establishments within larger establishments that are a part of
a chain ex. starbucks in barnes and nobles
o grocery stores
o convenience stores

exclusions
o movie
o airplanes
o trains
o hotels/room service
o bowling alleys
o general merchandise stores with in-house concession stands
or primary business is not to sell food

what is required of restaurants and similar

o on menus, menu boards(including drive thru menus) or on
signs for foods on display
number of calories as calories or cal
adjacent to the name on the menu or to selfservice food and foods on display
clearly associated with the item
can be a range for variable menu items
statement of suggested daily intake
additional nutrition information available upon request
o other inclusions and exemptions:
menu items that are included:
foods, including non- alcoholic beverages
only items on menu
exemptionsno calorie info:
o condiments for general use

o daily specials or temporary items

(<60 days annually)
o market test items(<90 days)
o custom orders
additional nutritional information
must be available upon request
must be written in format
includes on nutrition facts panel:
calories
total fat
saturated fat
cholesterol
sodium
total CHO
sugars
dietary fiber
protein
TRANS FATS ARE NOT INCLUDED
o Self-service and foods on display
Need food tags
Signs adjacent to item
Calories need to be posted on sign adjacent to
each item

 Calories can be per serving or per item

o Vending machines
Self-service devices
Coin, paper, token, card, key
Operators that own or operate 20+ machines
Visible nutrition information at the point of purchase
unless visible to customer from package
Not necessarily on or attached to machine but in close
proximity (poster)
Visible at same time as food
Description name, price of food and button
number
o Vending machines and restaurants
Same NLEA
Rounding factor
Calories to nearest 5 calorie increment up to and
including 50 calories
To the nearest 10 calorie increment for foods over
50 calories
Ex. pickles 25-30 calories. Can list either
o
Determining nutrition content
Databases(product recipe)
Laboratory analyses
Food analyses- chemical test to break down into
parts
How info is obtained
Pre-packaged foods from suppliers (ex. salad dressing)

Containers
Based on serving from suppliers
verify to FDA reasonable basis used to calculate
Restaurants and vending need to be providing
accurate info
Database, lab, pre-packaged

Must

ex. combination meal

cheeseburger, side dish(fries, salad with fat free dressing), med.
Soft drink
o range of cal
total cal: 620-1150 cal
calories from fat: 220-410
total fat
saturated fat
trans fat**** currently not required
cholesterol
sodium
total carb
sugars
sodium
ex. pizza

34 million ways to customize pizza

update menu board: est. 3-5,000 dollars per board because so
many ways to customize
90% phone orders, 2.1 slices
pizza places dont like this law
dominos cal-o-meter
o can calculate own calories based on the pizza they choose
declaration for basic pizza(plain, deep dish 12 pizza)
declaration for optional toppings (individual or in-combination)

university of Missouri study- 2012- survey college town

60% say nutrition info influence where they choose to eat
82% diners say calorie will influence their orders
most indicated a willingness to pay up to $2 more per menu item to
get nutrition information

Last Lecture- health care reform bill

Menu, menu board, food tags and vending machine (contents) need
nutritional labeling
Under PPACA
Chain restaurants (+20 locations) and 20+ vending
machine(available at point of purchase)
o Posted calories on menus, menu boards, food tags (buffet
style) + additional printed info

o Posted or visible nutrition info on machine items

DIETARY SUPPLEMENTS:
extremely controversialespecially in food law
confusing because always changing
o continuous changes in the market
term was not defined until congress passed the DSHEA in 1994
o DSHEA law- dietary supplement and health education act
Regulates ds
deemed to be food within the context of this act
special category of FOOD, not drug
o Not regulated same as food
o Drug vs food
Determined by use
Info on product, label or literature
DSHEA has information on the requirements of dietary
supplements

Why are dietary supplements important?

Over 54,000 dietary supplements in the National Medicines
Comprehensive database
o 550 primary herbs with 1800 different names

o 73% of adults reported using supplements in the last 12

months
o 85% of adults reported using multivitamins/multimineral
o some products sold as supplements have drug-like effects
lot of interactions that can happen
herbs have risks that are associated with it
incomplete/overlap of research
dont know a lot of the drug interactions
vit K interferes with cumanin(blood thinner)
st johns ward interferes with anti depressants
HISTORY
Before PFDA 1906, peddlers of snake oil (claim to feel younger)
o BOC, later FDA, used power to regulate health claims of snake
oil
1970s- health kick
o DS finds a larger consumer market
o Industry resistance/lobbying against FDA regulation of
power/control
1976-congressman, Proxmire- made amendment Proxmire Vitamin
and Mineral to FD and Cosmetic act
o prohibited estiablishment of maximum limits on the potency
of any vitamin or mineral
o restrictive- also for standard of identity of dietary
supplements
o Stop FDA from regulating dietary supplements
o FIGHT between FDA and wealthy companies

1989 to 1990
o overdose of Tryptophan- helps go to sleep, metabolized to
serotonin, relaxes
o 37 deaths and 1500 cases of permanent disability from
ingestion of L trp. Investigation recommended DS to be
regulated as DRUGS
1990
o NLEA, nutrition labeling and education act
o Gave enhanced authority over labeling of foods/Dietary
Supplements (DS)
1994
o dietary supplement Health and education act (DSHEA)
o result of L- tryptophan investigation and lobbying war
o ** unique because it is the first time that an act or
amendment did NOT expand FDA authority and rather gave
them less authority!
o Congress reasoned public better served DS are less regulated
than drugs, and some food.
o Northcutts opinion:
Congress was trying to be popular
Allow average consumer to decide what to take.
Recognized that health food industry is viewed by
many
As a supplement too and a substitute for
prescription drugs
Dietary supplements are associated with
Reduced health expenses
Disease prevention

WHAT ARE DIETARY SUPPLEMENTS?

Legally DSHEA- meet these criteria to be a DS:
o 1. Products that are taken by mouth and contain dietary
ingredients (except tobacco)
o 2. Categorized as foods; not drugs or food additives (intended
to be ingested)
o 3. May not be represented as a conventional food or meal
(not consumed primarily for taste or aroma)
o 4. Must be labeled as a Dietary supplement
Law dictates the form:
TYPES
o Vitamin
o Mineral
o Botanical/herb
o Sports nutrition supplement
o Weight management product
o Specialty supplements
Concentrates, metabolites, extracts, or combo of
vitamins/minerals/amino acids
FORM:
o Capsule
o Softgels
o Gelcaps
o Tablets

o
o
o
o

Liquids/tinctures
Powders
Bars
Beverages

2 important aspects of DSHEA 1994

1. Excludes DS ingredients from the legal definition of food
additive
o no premarket approval (items before 1994), presumption that
it is safe
2. Categorizes all DS as food and excludes supplements that
make structure/function claims from drug definition
o structure/function claim = general non specific health claim
Definitions of other terms
Nutraceuticals (NUTRITION+PHARMACEUTICAL)
o Supplement or enhancement to provide a specific health
benefit
o Ranges from isolated nutrients, DS, and specific diets to
genetically engineered designed foods, herbal products, and
processed foods such as cereals, soups, and beverages
o Ex. energy booster of herbs, amino acids, vitamin in capsule
Functional food
o Conventional food product enhanced to provide specific health
benefits of disease
Ca+2-rich OJ, ca +2 rich yogurt
FOSHU/pharmafood
o Form of food that has pharmaceutical + food

Prebiotic
o Non digestive carbohydrates broken down by colon bacteria
o Promote of breakdown products foster good bacteria for
digestion
Probiotic
o Live, beneficial bacteria found in fermented foods
o Common in japan and Europe
o In yogurt (activia)

OTHER REQUIREMENTS IN DSHEA

Manufacturers:
o Safety, but dont have to prove it
o Structure/function
And other claims about their products as substantiated
by adequate evidence, not false or misleading
NO FDA approval before marketing EXCEPT if it is a new
dietary ingredient- require premarket approval of safety
data by FDA
Need sanitation
cGMPs be established
identity, purity, quality, strength, and composition
not allowed to mislead the product
THE SCARY TRUTH

DSHEA defines DSs as non-food additive and as nonpharmaceutical drugs

o Doesnt have to meet these laws
o Loosely regulated
DS manufactures are required to register DS with FDA (bioterrism
act) or to report adverse events
o Paperwork with FDA to know where manufacturers are located
o Loosely regulated
BASICALLY , same standards as 1906
o Can only be removed from market if FDA determines that a
DS contains a poisonous or delirious
o FDA has restrictions of regulating DS

Dietary Supplement labels must include:

1. Statement of identity
o supplement
2. net quantity of contents
3. Direction of use--- dont need to be approved/regulated
4. Other ingredients in descending order of predominance
5. supplemental facts(nutritional label)
6. name and address of manufacturer or distributor
7. If a structure/function statement is used, FDA disclaimer must
appear

LABELING
NEED DISCLAIMER IF USING STRUCTURE FUNCTION STATEMENT
These statements have not been evaluated by the FDA
administration. This product is not intended to diagnose, treat, cure
or prevent any disease
Made to US pharmastudical standards
only standards set in US
look for this on a supplement

STRUCTURE FUNCITON STATEMENTS

Aka. Nutrition support statements
Identifies the role of the nutrient of Dietary Ingredient
Mechanism by which it acts (documented)
o Based on scientific evidence
Nutrient deficiency disease- but must also disclose its prevalence
o How likely? Ex. calcium and osteoporosis
General well-being
No disease claims, UNLESS
o The claim is an authorized health claim for which the product
qualifies
ACCEPTABLE CLAIM

Helps maintains cardiovascular function

Promotes healthy cholesterol level
o Lowers cholesterol
Promotes healthy joints
o Reduces pain of arthritis
Promotes urinary tract health
o Prevents urinary tract infection
To maintain a healthy blood sugar level
o Controls blood sugar in people with insufficient insulin

CONSUMER REPORTS ARTICLE Spends nearly $27 billion annually

6,300 reports of adverse health effects
10,300 serious outcomes = 115 deaths, 2,100 hospitalizations, 900
emergency room
most supplement problems never come to our attention- PhD
director of FDA division of dietary supplement programs

SUMMARY
To be a DS, must meet all of the following:
o Intended use

 To supplement the diet

Not intended as drug or conventional food
o Ingredient
Contain one or more of these items: vitamin, herb,
mineral, amino acid
o Form
Be for ingestion in capsule, tablet, liquid, powder,
softgel, or gelcap OR into products that are in
conventional food forms and must not be represented
as a conventional food nor as a sole item of a meal or
diet
o Label
Be labeled as a dietary supplement
o Exclusions
NOT anew drug (unless sold as a dietary supplement
before 1994) or tobacco
o *** MOST IMPORTATNT LIMITATION
WHEN SOLD IN CONVENTIONAL FOOD FORM, A DS
MUST NOT BE REPRESENTED AS A CONVENTIONAL
FOOD
Intent is important
Has to be supplement the diet
Not because it tastes good
Meal replacements are excluded from DS
category
REGULATING AGENCIES
FDA
Adverse events reporting (AER)
Federal trade commission
o Provide info on Dietary supplement advertising guide

Food allergen labeling consumer protection

LAST LECTURE
Dietary supplement edu act- DSHEA 1194
o First time in food regulation systemLOWERED FDA authority
o Reduced FDA authroirty
o Defined dietary supplement
Botanicals, sport nutrition (aa and protein) weight loss,
vitamins and minerals
Not meant to be a food
5 CRITERIA
intended use of product
ingredient
form
label
exclusion that it can not be a new drug or tobacco
product
regulated less than food or drugs

THIS LECTURE
Why do we need a food allergen labeling law
o Every 3 min, a food allergy sends someone to the emergency
room

o Effects about 15 million people in the us

9 million adults (4%)
6 million children (8%)
o Among children 0-17 years old, prevalence is increasing. CDC
says 18% increased in the last 10 years.
Swollen extremities, covered in hibes
Remember: first time you are exposed to something,
the reaction will not be as servere as the reaction will
get after exposed to the allergen more and more
Multiple allergens- hard for body to fight off
What is a food allergy
o Results when the immune system mistakenly targets a
harmless food protein (or allergen) as a threat and attack it.
o Symptoms= hives, eczema, nausea, vomiting, stomach pain,
nasal congestion, runny nose, sneezing, coughing
What is a food intolerance?
o NOT CELIACS DISEASE
o Does NOT involve the immune system but can include
symptoms similar to allergic reaction
Absence of enzyme need to digest
Irritable bowl syndrome
Sensitivity to food additives(like synthetic color
additives)
Symptoms= trouble swallowing, chest pain
,shortening of breath, weak pulse, drop in blood
pressure.
Mimic food allergen response

BACKGROUND:
Prior to FALCPA-

o FDCA 1938 complete list of ingredients on label (more than 2

items)
o Exception for incidental additives (didnt have to be listed)
o Generic labeling of spices, color additives, and flavors
o Allergenic foods had to be identified by common or usual
name which many consumers did not know
Ex. casein (milk), whey (milk)
Food allergen labeling and consumer protection act FALCPA
o Aug 2004 signed
o Implemented Aug 2006
o Addition to FDCA 1938
o Addresses among other issues and labeling of foods that
contain certain food allergens
90% of all foodborne allergies due to protein in food
big 8 allergens in US
UK is big 12
o 1. Defined term major food allergen in 2 part definition
part 1
milk
eggs
fish (bass, flounder)
crustacean shellfish (crab, lobster, shrimp)
tree nuts (almonds, pecans, walnuts)
peanuts

wheat
soybeans

2
a food ingredient that contains protein derived
from a food specified in paragraph 1. Except
any highly refined oil derived fromm a food
specified in paragraph 1 and any ingredient
derived from such highly refined oil
food ingredient that is exempt under
paragraph 6/7 of section 403
FDA can exempt ingredients for exable
based on pre-market ex
o What is in this law?
Defines major food allergen
Requires major food allergens to be labeled on all foods
by common English names specific to the allergen
source- BIG 8
Gives FDA authority to modify allergen list
Required labeling for flabors, colors, and
incidental additives
o Why do we need a food allergen labeling law?
Increasing % of food recalls over the past 4 years
(nearly 10% increase)
Nearly 90% of all food recalls are due to undeclared
allergens, salmonella, listeria
All undeclared allergen recalls are Class 1
o How is FALCPA enforced?
FDCA 1938 gave FDA authority to inspect food
processing establishments, food
warehouses/distributors
Inspectors ensure compliance with all food laws
Inspectors review all practices, procedures, paper
work, and including making sure practices are in
place to reduce or eliminate cross-contaimination
Inspectors ensure products are properly labeled.

part

o Top 5 food allergen recalls

Foods most often involved in food allergen recal and the
most common allergen
Baked goods
Snack
Candy
Dairy
dressing
most common allergen with these:
milk
wheat
soy
o understanding why food allergen recalls occur
top 5 reasons for undeclared food allergens
wrong package or label-packages for similar
products with different allergens (worker training)
wrong terminology in ingredient list or contains
wrong package or label
terminology
failure to carry forward information from an
ingredient to final label
cross contact
ingredient mislabeled from supplier
o FALCP required format

There are 2 acceptable formats

1. Contains ____
must list all major food allergens in the
product
must be immediately adjacent to the
ingredient statement
2. Parenthetical in ingredient statement for
example Casein (milk)
not required if ingredient name already
identifies the major allergen
not required if the name of the major food
allergen appears elsewhere unless the other
listing is for an ingredient that is exempt
from the major food allergen definition
o ex. soybean oil listed as soya
o need to say it is soybeans
EXAMPLES
Required use of the common English names
for the major food allergens
Products containing treenuts must be
identified with specific nutalmond, pecan,
walnut
Fish/shellfishneed speciestuna, bass,
flounder, shrimp, lobster
Peanut oil- not listed because highly refined.
manufactured on equipment that processes
peanut and milk
1st method-- ingredients- semolina, rice
flour, rolled oats, pinenuts, tomato juice,
whey, sodium caseinate, tuna gelatin,
natural flavorings
o contains: wheat, milk, pine nuts,
peanuts
nd
2 methodsemolina (wheat), rice flour,
rolled oats, pine nuts, tomato juice, whey
(milk) sodium caseinate, tuna gelatin,
natural flavorings (peanuts)
lethicin = soy
ORDER: ingredients, vitamins and minerals,
contains:
o Nutritional facts panel

o Ingredient statement
o Allergen statement
o Gluten free labeling
Estimated 3 million people have celiac diseas
No legal definition for gluten-free until august 2013
when an FDA ruling gave uniform definition
1 gluten free foods must conatin less that 20 ppn
gluten
2. Foods may be labeled as gluten free if they are
inherently gluten free or do not contain an
ingredient that is:-- no reason gluten will be in
the product,
gluten-containing grain ex. spelt wheat
derived from a gluten-containing grain that
has not been processed to remove gluten
ex. wheat flour or
derived from a gluten-containing grain that
has been processed to removed gluten ex.
wheat starch, if the use of that ingredient
results in the presence of 20 ppm or more
gluten in the food
exemptions to the gluten free labeling
fda new regulation applies to all food and
beverages (including packaged foods, dietary
supplements, fruits and veggies, shell eggs, and
fish EXECEPT FOR:
meat, poultry, and certain egg products:
regulated by USDA
most alcoholic beverages (distilled spirits,
wines with 7% or more alcohol by volume,
and beverages made with malted barley and
hops-: regulated by alcohol and tobacco tax
and trade bureau TTB
o FALCP and gluten free labeling regulations
Like most other food laws, these two place the burden
back on the manufacturer but you are 1 or the 15
million with a food allergen or 1 of the 3 million with
celiac you can afford to trust anyone if you look like
this.

Biotechnology and GMO

 Controversial, difficult to understand regulation

Biotechnology
Application of scientific knowledge to living organisms or their
constituents for practical purposes
o Change genetic make up
Heit 2010- refers to the utilization of biologically derived molecules,
structures, cells or organisms to carry out a specific function
Genetically modified or Genetically engineered:
Refers to an organism (plant, animal, or bacteria) that has been
exposed to a technique that changes its genetic makeup or
DNA(carries our genetic material)
When did we start making GMOs?
Modern food science methods/tools?
o Prehistoric time
o Want highest yield
o Started 8000 years ago
History:
o 5000 BCE yeast fermented grapes to make wine
needed water to be uncontaminated
o 4000 years ago: leavening of bread dough using yeast
o bigger, stronger, more productive livestock through breeding
practices and natural selection
gene splicing and recombinant DNA now allows researchers to
combine the genetic elements of two or more living cells to produce
desired traits 1970s/80s
o ex. dairy cows with alterations in RNA results in cows that
produce more milk (more milk per cow increases farmers
productivity without additional costs)
o 1953- England James Watson and Crick
3D double helix of DNA
only reason they found this out: stole data from
Rosaline franklin (pictures) to make DNA models

now able to splice genes with certain traits from one

organism to another

how do you make a GMO?SIX STEPS

DNA extraction
o Gene of interest is extracted from an organism
Gene cloning
o Gene is cloned thousands of times to the it can be inserted
into cells of a different organism
Gene design
o Gene is placed inside a different organism
Transformation
o The new gene is inserted into a chromosome in the nucleus of
a plant cell
o TWO METHODS:
Gene guns
Tiny particles of gold or tungsten coated in
modified DNA are fired at plant cells with
penetrate through the cell
Hole heals itself
Steps:
1. Particles coated in DNA
2. Particles fired at plant by biolistic gun
3. New DNA enters cell, new gene is built
into chromosome
Agrobacterium

A plant can also be modified by using a bacterium

Steps:
1. Desired gene isolated and placed into
DNA section called a plasmid
o plasmid: double stranded different
DNA and replicates when put into
another cell
2. Plasmid transferred into bacterium
o bacterium will naturally insert DNA
into plant which forms tumors
3. Bacterium infects plant cells, transferring
desired gene into chromosome
o replicates tumors
Backcross breeding
o Gene is then crossbred with non-modified plants and
undesirable traits removed to make a new line of plants
Scientists monitor and check future offspring to see if they have
taken on the desired characteristic

VIDEO: every cell contains DNA

Isolate strawberry DNA by using household items
o Strawberries: smell nice, pretty, edible, seeds on outside
easy to get DNA out
1. Frozen strawberries in plastic bag
2. DNA into solution to purify- mash up
3. Make lysis solutionbreak open strawberry cells to get to DNA
o 2 tsp of detergent, tsp of salt, cup of water

4. No bubbles- otherwise it will be a bubble bath

5. Filter DNA out of solution- coffee filter
6. DNA fall out of solution
o pour equal amount of rubbing alcohol
o 2 phases formed
o popsicle stick to remove glob off DNA
o = dirty DNA- clean it up before experimenting with it
o analyze DNA and see where it is from
o save by putting it in fridge

TOP 10 COUNTRIES GROWING GM CROPS160 acres total

1. USA
o 69 acres
o maize, soybean, cotton, canola, sugarbeet, alfalfa, papaya,
squash
2. Brazil
3. Argintina
4. India
o cotton
5. canada
6. china

 7. paraguay
8. pakistan
9. South africa
10. Uruguay
Europe- no GM crops
Huge import market

Benefits and cost of using GM or GE foods

Enhanced quality and taste
o Human health impact
Increased productivity and yield
o Effects on non-targeted organisms
Improved health and resistance to disease and pests
o Food monopolies by a few companies
Increased or improved nutrients
o Biopiracy (foreign exploitation of natural resources)
Drought resistance
o Animal stress from over-production
Improved feed conversion

o No world-wide labeling standards

o Mixing GM with non-GM products
Improved food security
o Potential skewed interests of rich countries

History of GMO regulation

Calgene inc. And their GM, flavr savr tomato 1987
o Was the GM tomato considered a food and thereby subject to
all food regulations?
yes
o Field trails testing for environmental impact, and testing for
chemical and molecular composition showed the tomato was
equivalent to its non-modified counterpart
o Prompted use of the term sustainably equivalent in the
resulting 1992 policy statement
Substantially equivalent

1992 policy origination

FDA has no basis for concluding that bioengineered foods differ
from other foods in any way or that as a class, foods developed by
the new techniques present any different or safety concerns than
foods developed by plant breeding
= modified foods were indistinguishable from normal food
if it was, it was substantially equivalent
STATEMENT OF POLICY:
o Food derived from new plant varieties position on
biotechnology established using the idea of substantial
equivalence to its conventional counterpart

cant see how FDA has defined substantially equivalent

o substantially equivalent:
the same intended use and quality characteristics as its
conventional counterpart
o conventional counterpart:
conventional food that is molecularly, compositionally,
toxicologically, and nutritionally comparable to the GMO
o as long as the food is determined to be substantially
equivalent, the food will be regulated as a conventional food
item
the 1992 policy suggests that transferred genetic material can be
presumed as GRAS
o transferred genetic material = results in new proteins or
production of substances produced by enzyme actions
o these substances are often commonly found in food at
comparable or greater levels, thereby assuming the GRAS
status
o for those substances, that are significantly different from or
present at significantly higher levels than common, they may
require regulation as a food additive

REGULATION of gm foods in us
Regulatory status of GM foods does not depend upon the method by
which the food was developed, but rather the characteristics of the
crop/food itself and its intended use or the intended use of its
components
o END PRODUCT!
o Manufacturer must:
Demonstrate that the GM crops do not pose any risk to
huans, animal producing foods, or environment
Demonstrate that the GM crops are comparable with
nature

3 AGENCIES REGULATING GMO

USDAsafe to grow?
o USDA-APHIS-USDA animal and plant health inspection service
Goal of regulation is to protect plant health
APHIS issues permits for the introduction of GE
organisms that may pose a plant pest risk, including
other plants, insects, or microbes
Permit are issued after review of developer applications
Monitored by APHIS
Under federal plant pest act, regulates interstate
movement, importation and field testing of GMs that
have not been proven safe yet
o USDA-FSIS- USDA food and safety inspection service
EPA
o Environmental protection agency
o Evaluate for environmental safety
o Regulate sale, use and testing of plants and microorganisms
that produce pesticidal substances such as Bt corn under the
Federal insecticide, fungicide, and rodenticide Act (FIFRA)
BT CROPS
Bacillus thuringiensis(bt)- a naturally occurring
bacterium in soil
Toxin produced from bt is toxic to certain pest
insects
Genetically transferring the bt gene into plants
allows the plant to synthesize their own bactierial
toxin to kill pests
1995- EPA issued first bt-plant-incorporated
protectants in the US
bt corn, cotton, potatoes
EPA consulted expert groups and data about
health impacts over 2 year period
Concluded no unreasonable risk to
health/environment
o Doesnt hurt animals, only insects

Regulations include:
Farmers must register the bt plant with the
fda
Farmers must plant a bt refuge
o Blocks of crops that are not bt plants
to provide insects that remain
susceptible to the bt toxin
EX. starlink corn
Genetically modified to produce a protein
called CRY9C protein = pesticide
Approved USDA/FDA for animal feed only
because of the proteins potential
allergenicity
Non-governmental organizations tested
tacoshells and found Starlink corn DNA
Food companies implemented a recall
Developer of starlink corn voluntarily
withdrew its registration
o Mostly for cow feed, they are not
effected by starlink corn
o Toxic substance control act allows regulation of GM organisms
that possess pesticidal activities
o Epa grants permits for field testing if protectant is more than
10 hectares of land
FDA
o Food and drug administration
o GMO is safe to be consumed
o Center for food safety/nutrition
o Center for vet medicine
o Center for drug evaluation/research
o Center for biologys evaluation and research
All regulated under FDA 1938 and the definitions of
adulteration and misbranding

o Companies must voluntarily notify the FDA before marketing

new food items
Followed by a consultation process with FDA where FDA
helps developers meet safety requirements
o FDA consultation process- new food items! Gmo or not!
Developer contacts FDA who establishes a biotech eval
team through:
Office of premarket approval
Office of surveillance and compliance
Bet is made of:
CSO
Molecular biologist
Chemist
Environmental scientist
Nutritionist
Toxicologist
The core group may be supplemented with
additional experts related to animals, nutrition,
labeling etc.
Bet reviews submitted summaries from developers that
provide scientific data about the safety and nutritional
value of the new food item
The developer meets with individual experts and
responds to concerns or questions they may have
related to the safety of the food item
Ex. of questions:
What is the purpose of gmo
What is the source, identity, function,
stability of GMO
What anylytical studies?
Tested with any animal feeding?

Safety of GMO?
Fda regulation of labeling
Alsos regulates labeling based on FDCA
Fda regulates labeling of GM foods the same
way they regulates labeling of conventional
foods based on substantial equivalence
Fda defines misleading as:
Representations made/suggested. By
statement, word, design, device or any
combo
Also which label/advertising fails to reveal
facts
o Consequences
Examples:
Foods are not required to be labeled as
GMO but here are exceptions:
o BRAZIL NUT:
Brazil nut plant introduced into
soybean plant to increase
protein concentration in animal
feed
Was found that those with
allergies to brazil nuts were also
allergic to GMO soy
Because soy could cause an
allergic reaction consequence
when consumed by those
sensitive to brazil nuts, food
was misbranded because it
failed to revel facts and there
were consequences
Foods containing an unexpected
allergen may also be considered
adulterated because of its
potential to be injurious to
health
o Labeling: soy oil
Compositional changes in lipid
profile in soy oil could be
misbranding if called soy oil

This is because the new oil is

significantly different from what
is called soy oil
The new oil would have to have
a new name because the
composition was changed

GMOS are regulated by USDA, FDA, EPA with greatest regulatory

burden of FDA
To date, there have been no ill-effects of GMOs on human, animal, or
environmental health
Gmo regulation reqires developer to utilize a consultation with FDA
Gmos are not required to be labeled, but the FDA suggests, doesnt
make it a law.