Genetically Engineered Food

An Overview
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Lxecuuve Summary ................................................................................................................................................. 2
A 8ackground on Ceneuc Lnglneerlng and 8loLechnology ..................................................................................... 3
WhaL Are Lhe CL Crops? .......................................................................................................................................... 5
1he nexL lronuer: Ceneucally Lnglneered Anlmals ................................................................................................ 7
lnsumclenL ÞroLecuon ............................................................................................................................................. 8
lmpacL on Consumers............................................................................................................................................ 10
lmpacL on Lhe lood SysLem ................................................................................................................................... 11
lmpacL on larmers ................................................................................................................................................ 13
uebunklng MonsanLo's MyLhs ............................................................................................................................... 15
Concluslon ............................................................................................................................................................. 17
8ecommendauons................................................................................................................................................. 17
Appendlx: 1he u.S. 8egulaLory SysLem for CL lood .............................................................................................. 18
LndnoLes ............................................................................................................................................................... 23
2 Ceoeucolly íoqloeeteJ looJ. Ao Ovetvlew
For centuries, farmers were able to use generations’
worth of knowledge to breed seeds and livestock for
the most desirable traits. However, technological in-
novation has gradually made this method of breeding
nearly obsolete. Today, most soybeans, corn and cot-
ton have been genetically engineered — altered with
inserted genetic material — to exhibit traits that repel
pests or withstand the application of herbicides.
Mergers and patent restrictions have increased the mar-
ket power of biotechnology companies. The onslaught of
genetic engineering has not only diminished the ability
of farmers to practice their own methods of seed selec-
tion, but also turned another sector of agriculture into a
business monopolized by a few corporations.
Farmers, who now depend on the few firms that sell
seeds and afiliated agrochemicals, face higher prices
and patent infringement lawsuits if a patent is alleged-
ly violated. Genetic contamination is a serious threat
to the livelihoods of non-GE and organic farmers who
bear the financial burden for these incidents.
GE crops can take a toll on agriculture and surrounding
wildlife as well. The environmental efects of GE crops
include intensified agrochemical use and pollution,
increased weed and insect resistance to herbicides and
pesticides, and gene flow between GE and non-GE crops.
Once GE products are on the market, no labeling is
required. This means that U.S. consumers blindly eat
and drink GE ingredients every day and are not given
the knowledge or choice to do otherwise. Several
studies point to the health risks of GE crops and their
associated agrochemicals, but proponents of the tech-
nology promote it as an environmentally responsible,
profitable way for farmers to feed a growing global
population. Yet the only ones experiencing any benefits
from GE crops are the few, massive corporations that are
controlling the food system at every step and seeing large
profit margins.
New technologies — like genetic engineering — create
uncertainties and risk that should be carefully evaluat-
ed rather than being rapidly pushed onto the market.
The existing regulatory framework for GE foods simply
does not measure up. The U.S. Department of Agri-
culture, Environmental Protection Agency and Food
and Drug Administration have failed to protect the
environment, the food system or public health from
GE foods.
Food & Water Watch recommends:
- A moralorium on new approvals of genelically engi-
neered plants and animals;
- Mandalory labeling of GF foods,
- Liabilily for GF conlaminalion lhal resls wilh seed
patent holders;
- Use of lhe precaulionary principle for lhe evalualion
of GE crops, animals and food;
- A new regulalory framework for GF crops, animals
and food; and
- Improved agency coordinalion and increased posl
market regulation of GE foods.
lood & WaLer WaLch - !anuary 2014 3
Additionally, a lack of responsibility, collaboration or
organization from three U.S. federal agencies — the
Food and Drug Administration (FDA), the U.S. De-
partment of Agriculture (USDA) and the Environ-
mental Protection Agency (EPA) — has put human
and environmental health at risk through inadequate
review of genetically engineered (GE) foods, a lack of
post-market oversight that has led to various cases
of unintentional food contamination and to a failure
to require labeling of these foods. Organic farming,
which does not allow the use of GE, has been shown to
be safer and more efective than using modified seed.
Moreover, public opinion surveys indicate that people
prefer food that has not been manipulated or at least
want to know whether food has been modified.
A 8ackground on Genenc
Engineering and Biotechnology
Biotechnology involves manipulating the genetic
makeup of plants or animals to create new organ-
isms. Proponents of the technology contend that
these alterations are improvements because they add
new desirable traits. Yet this manipulation may have
considerable unintended consequences. Genetic engi-
neering uses recombinant DNA technology to transfer
genetic material from one organism to another to
produce plants, animals, enzymes, drugs and vaccines.

GE crops became commercially available in the United
States in 1996 and now constitute the vast majority of
corn, coton and soybean crops grown in the country.

More recently, biotechnology firms have developed
genetically engineered animals, including food animals
such as hogs and salmon.
Genetic engineering modifies the genetic material
of crops to display specific traits.
Most commercial
biotech crops are developed to be either herbicide
tolerant, allowing herbicides to kill weeds without
harming crops, or insect resistant, which protects
plants from destructive pests.
Afer nearly 20 years,
only one high-yield GE seed had been considered for
approval by 2013.
Farmers have bred their best livestock and saved seeds
from their most productive crops for thousands of
years. Selective crop breeding was accelerated by the
development of crop hybridization, which cross-bred
Since the 1996 introduction of genetically engineered crops — crops that are altered
with inserted genetic material to exhibit a desired trait — U.S. agribusiness and
policymakers have embraced biotechnology as a silver bullet for the food system. The
industry promotes biotechnology as an environmentally responsible, profitable way
for farmers to feed a growing global population. But despite all the hype, genetically
engineered plants and animals do not perform beter than their traditional
counterparts, and they raise a slew of health, environmental and ethical concerns.
The next wave of the “Green Revolution” promises increased technology to ensure
food security and mitigate the efects of climate change, but it has not delivered.
The only people who are experiencing security are the few, massive corporations
that are controlling the food system at every step and seeing large profit margins.
4 Ceoeucolly íoqloeeteJ looJ. Ao Ovetvlew
plants that had desirable traits and helped reverse the
stagnating corn yields of the 1930s. By 1960, 95 percent
of U.S. corn acreage was cultivated with hybrid seed.

Biotechnology has challenged traditional breeding
methods for desirable crop and livestock traits.
seeds were bred within the same plant species until
the discovery of the human genome in the 1950s. This
breakthrough spurred the development of genetic
engineering techniques, which allow breeders to splice
genes from very diferent species.
Genetic engineer-
ing can insert a specific gene from any plant, animal
or microorganism into the DNA of a host organism of
a diferent species.
One GE tomato even used a fish
gene to make the tomato frost-resistant.
splicing diferent organisms together could pose risks
to consumers that have allergies to the added traits —
in this case, consumers with seafood allergies could be
exposed inadvertently to an allergen in the tomato.

In 2u!2, more lhan 42u million acres of GF crops were
cultivated in 28 countries—representing more than 10
percent of global cropland.
The United States is the
world leader in GE crop production, with 172 million
acres, or nearly half of global production.
cultivation grew rapidly from only 7 percent of soybean
acres and 1 percent of corn acres in 1996, to 93 percent
of soybean and 90 percent of corn acres in 2013.

Inserling desirable genelic lrails from one organism
into the embryo of another produces so-called “trans-
genic” animals.
Additionally, the technology of clon-
ing creates artificially reproduced plants or animals
that identically replicate the original animal without
DNA modificalion. In lhe Uniled Slales, cloning is
used primarily to produce rodeo bulls and other non-
food animals, but several hundred cloned food ani-
mals also are believed to exist in the country.
cloning primarily duplicates conventional livestock
animals, but in the future it could be used to copy
transgenic animals. Cloning could be used to replicate
livestock that have superior meat or milk yields or to
mass-produce animals with marketable traits such as
lower cholesterol or fat content.
Although no meat or
milk in the United States has been disclosed as coming
from clones, cloned animals undoubtedly already have
entered the food supply.
5ootce. u5uA
Biotech Share of U.S. Cultivation
2000 2001 2002 2003 2004 200S 2006 2007 2008 2009 2010 2011 2012 2013
lood & WaLer WaLch - !anuary 2014 5
Transgenic animals have been developed to promote
faster growth, disease resistance or leaner meat, as
well as to minimize the impact of animal waste.
2uu4, lhe largesl biolech firms had filed !2 palenls for
GE animals.
As of this writing, no transgenic food
animals had been approved in the United States, al-
though some animal-derived products, such as phar-
maceuticals, had been approved.
The USDA National
Organic Program prohibits GE crops from being utilized
in certified organic crops for food and animal feed.
What Are the GE Crops?
The United States has approved a host of GE commodi-
ties, including fruits and vegetables. Bioengineered
crops fall into three broad categories: crops with traits
to deter pests and disease; crops with value-added traits
to provide nutritional fortification; and crops with in-
dustrial traits for use in biofuels or pharmaceuticals.

Herbicide-tolerant or insect-resistant commodities —
corn, canola, coton and soybeans — make up the over-
whelming majority of GE crops.
Other GE crops that
have been approved for field trials but are not com-
mercially available include rice, melon, potato, apple,
petunia, millet, switchgrass and tobacco.
GE flax,
tomatoes, potatoes and squash have made it through
the field trial approval process, although they are not
necessarily currently commercially available.

Herbicide-tolerant and insect-resistant crops:
Herbicide-tolerant crops are designed to withstand
specific herbicides. Co-branded herbicides designed to
work with specific herbicide-tolerant seeds kill weeds
without damaging GE crops. Most of these crops are
resistant to the herbicide glyphosate (sold commer-
cially as Roundup and produced by the agrichemical
company Monsanto).
By 2012, Monsanto’s Roundup
Ready trait was present in 98 percent of the U.S. GE
corn market and 86 percent of the U.S. GE coton mar-
Other herbicide-tolerant crops include Bayer’s
Liberly Link corn and Calgene`s BXN couon.

Inseclresislanl crops conlain genes lhal deler in-
sects. The most common variety contains a Bacillus
thuringiensis (Bt) soil bacterium gene that is designed
to repel the European corn borer and several coton
However, key pests already have devel-
oped resistance to Bt crops. A University of Missouri
entomologist found that corn rootworms could pass
on Bt resistance to their ofspring.
And University
of Arizona researchers found that within seven years
of Bt coton introduction, coton bollworms developed
Bt resistance that they later passed on to ofspring,
meaning that the resistance was dominant and could
evolve rapidly.

Value-added crops: Some GE crops alter the nutri-
tional quality of a food and are promoted by the bio-
tech industry as solutions to malnutrition and disease.
“Golden Rice” — rice enhanced with the organic com-
pound beta-carotene — has been engineered to reduce
the prevalence of vitamin A deficiency in the develop-
ing world.
GE canola and soybean oils are manipu-
lated to have lower polyunsaturated faty acid levels
and higher monounsaturated faty acid (oleic acid)
In 2u!u, lhe USDA approved a Pioneerbrand
soybean that is modified to produce more oleic acid.

Because soybean oil is the most commonly consumed
vegetable oil in the United States, the industry main-
tains that the reduced-fat oil could provide significant
health benefits.
Industrial and pharmaceutical crops: Other GE
crops contain genes that are useful for the energy and
pharmaceutical industries. The USDA has approved
amylase corn, which produces an enzyme that is
suitable for producing ethanol, a key biofuel.
also are engineered to mass-produce certain vac-
cines or proteins that can be used in human drugs.
For example, the USDA has approved field tests for
a saflower variety that is engineered to produce a
precursor to human insulin that can be used in the
treatment of diabetes.
ALFALFA· The USDA approved Monsanto’s Roundup Ready
alfalfa, an important forage crop for livestock, in 2005.
2007, organic alfalfa producers challenged the USDA’s ap-
proval on grounds that GE alfalfa could contaminate and
wipe out non-GE alfalfa.
The USDA’s 2010 Environmental
Impacl Slalemenl demonslraled lhe polenlial negalive eco-
nomic impacts for organic and conventional alfalfa farmers,
including increased costs needed to prevent contamination,
reduced demand and lost markets due to contamination.

Nonetheless, the USDA approved GE alfalfa without any
planting restrictions in January 2011.

APPLF· The USDA is currently considering approving Okan-
agan Specialty Fruits’ reduced-bruising Arctic Apple, which
would be aimed at the packaged pre-sliced apple market.

CORN: In 2u!!, lhe USDA approved Syngenla`s amylase
corn, which produces an enzyme that facilitates ethanol
Although the corn is intended specifically for
ethanol use, the USDA determined that it was also safe for
food and animal feed, allowing it to be planted alongside
GE corn destined for the human and animal food supply.

Contamination of corn destined for the food supply is pos-
sible, especially without a bufer zone to minimize wind
Even the USDA admits that contamination
of high-value organic, blue, and white corns may produce
“undesirable efects” during cooking, like darkened color or
sofened texture.

PAPAYA: In !999, lhe FPA approved lwo papaya varielies
that are resistant to the papaya ringspot virus.
GE papa-
yas constituted 30 percent of Hawaii’s papaya cultivation in
1999, rising to 77 percent by 2009.
The USDA approved a
third ringspot-resistant papaya in 2009.
POTATO: In !99¯, lhe FPA and FDA approved Monsanlo`s
Colorado polalo beelleresislanl NewLeaf polalo.
santo withdrew the potato from the market in 2001 but
maintains it may return to potato research in the future.

In 2u!u, lhe Furopean Union approved German chemical
company BASF’s Amflora potato for cultivation, although
the crop is designed for industrial paper and textile use, not
for food.
Amflora was the EU’s first GE approval since
The USDA is currently considering the approval of
a low-acrylamide, reduced-bruising potato produced by
McDonald’s major supplier, J.R. Simplot.
RICF· In !982, lhe Rockefeller Foundalion launched lhe
Golden Rice initiative to combat vitamin A deficiency,
which annually causes blindness in a quarter-million mal-
nourished children worldwide.
The first Golden Rice strain
failed to deliver enough biofortified beta-carotene to ad-
dress vitamin A deficiency.
In 2uu4, Syngenla fieldlesled
Golden Rice 2 al Louisiana Slale Universily.
Golden Rice
must undergo field tests and receive approval by Bangla-
desh and the Philippines’ regulators before being released
into target markets in the developing world.
SAFFLOWFR· In 2uu¯, lhe USDA approved field lesls for
a saflower variety engineered by the Canadian company
SemBioSys to produce proinsulin, a precursor to human in-
Although saflower primarily self-pollinates, insects
could still cross-pollinate conventional saflower crops with
GE pharmaceutical traits.
Gene flow also can occur if birds
carry the GE seeds outside of the testing area.
Despite the
contamination risk, SemBioSys has an application pending
to bring the GE pharmaceutical to market and is continuing
field trials in the United States.

SOYBEAN: In lhe pasl few years, lhe USDA has approved
two soybeans designed to have healthier oil profiles.
December 2011, the USDA approved a soybean lower in
saturated fat, and in July 2012 it approved a soybean with
higher omega-3 faty acids.
SUGAR BEET: The USDA approved Monsanto’s Roundup
Ready sugar beet in 2005 afer determining that cultiva-
tion poses no risks to other plants, animals or the environ-
In 2uu8, lhe Cenler for Food Safely and lhe Sierra
Club challenged the approval in court on grounds that
the USDA’s Environmental Assessment ignored important
environmental and economic impacts.
The USDA finally
approved GE sugar beets in July 2012.
SWEET CORN: In 2u!!, Monsanlo announced lhal ils
Roundup Ready sweet corn would be available for plant-
Although sweet corn is Monsanto’s first commercial-
ized GE vegetable, the USDA swifly approved it since the
seed’s traits — insect resistance and glyphosate tolerance —
were previously approved for other crops in 2005 and 2008.

TOMATO: In !99!, DNA Planl 1echnology Corporalion
used a gene from the winter flounder (a type of flatfish) to
create a cold-tolerant tomato.
The crop was approved for
field trials but was never approved for sale or commercial-
In !992, Calgene`s Flavr Savr lomalo, engineered lo
stay fresher longer, was the first GE food on the market,
although it later was withdrawn from the market due to
harvesting problems and lack of demand.

WHEAT: In 2uu2, Monsanlo pelilioned lhe USDA lo ap-
prove Roundup Ready red spring wheat, the first GE crop
designed primarily for human food consumption rather
than for livestock feed or for a processed food ingredient.

Given that Japan and the EU have diferent restrictions
for GE food crops, the large-scale cultivation of GE wheat
could damage oplions for U.S. wheal exporls. A 2uu4 Iowa
State study forecasted that approving GE wheat could lower
U.S. wheat exports by 30 to 50 percent and depress prices
for both GE and conventional wheat.
Because of export
concerns, Monsanto abandoned GE wheat field trials before
obtaining commercial approval, although the company
resumed research in 2009.
Notable GE Crops
6 Ceoeucolly MoJlfeJ looJs 101
lood & WaLer WaLch - !anuary 2014 7
1he Next Ironner: Genenca||y
Engineered Animals
There are fewer transgenic animals than GE crops,
but the number of new GE animals that are await-
ing government approval has accelerated. Geneti-
cally engineered animals and biotechnology livestock
treatments are designed either to boost production or
to insert traits that may compensate for the negative
impacts of factory-farmed livestock.

Dairy products were the first bioengineered animal
products in the food supply.
In !99u, lhe FDA deler-
mined that chymosin, a cheese-manufacturing enzyme
produced using a “safe” strain of genetically engineered
E. coli bacteria, was “generally recognized as safe”; by
2001, the bioengineered enzymes were used to produce
60 percent of hard cheese in the United States.
In !993, lhe FDA approved lhe use of recombinanl
bovine somatotropin (rBST), also known as recombi-
nant bovine growth hormone (rBGH), to increase milk
production in cows.
Although dairy cows naturally
produce BST, artificially elevating the hormone levels
with rBGH injections can lead to increased milk pro-
duction and significant animal health problems. Cows
injected with rBGH can have serious health problems,
including higher rates of mastitis, an udder infection
that requires antibiotic treatment.
In lurn, lhe use
of antibiotics in industrial dairies contributes to the
growth of antibiotic-resistant bacteria, a growing public
health problem.

rBGH injections also increase production of the
pasleurizalionresislanl growlh hormone called IGF!.
The European Commission found that consumption
of milk from rBGH-treated cows increases human
inlake of IGF!.
IGF! has been linked lo breasl and
prostate cancer.
RBGH has never been approved for
commercial use in Canada or the EU due to concerns
about the drug’s impact on animal health.

By 2007, the use of rBGH was on the wane, especially
on small farms.
U.S. factory-farmed dairies with
more than 500 cows are over four times as likely to use
rBGH than small dairies with fewer than 50 cows.
Genetically engineered livestock also have been devel-
oped in an atempt to mitigate the problems of manure
pollution from factory farms. One Canadian university
is developing transgenic Enviropigs that produce the
phosphorus-absorbing enzyme phytase as a way to
decrease the phosphorus levels from manure that com-
monly pollutes waterways.
The United States and
China are potentially lucrative markets for the Envi-
ropig, but this research project is currently stalled.

Yet changing the chemical content of the Enviropig’s
manure would not reduce total manure discharges
from factory farms. An alternative solution to achieve
the same phosphorus reduction in manure would be to
use phylase as a feed supplemenl. In realily, lhe only
beneficiaries of Enviropigs would be factory farms.
Engineering livestock to fit the factory farm model
fails to address the systemic problem of overcrowded,
poorly regulated livestock operations that overwhelm
the land’s ability to utilize manure for crop production.
Researchers are developing transgenic animals that
allegedly reduce the spread of disease in animals and
humans as well. The University of Edinburgh has en-
gineered chickens that cannot spread H5N1 avian flu
to other birds.
The USDA has funded research that
would prevent catle from developing infectious prions
that can cause bovine spongiform encephalopathy, or
mad cow disease, which can be fatal to humans who
eat the tainted beef.
And U.K. biotechnology compa-
ny Oxitec has engineered sterile mosquitoes to combat
the spread of dengue fever in the developing world.
Yet genetically engineered livestock will merely treat
the symptoms of a poorly regulated food safety sys-
tem. They will not adequately combat disease. More-
over, current GE regulatory approval processes do not
account for health impacts that may accompany the
intended modifications.
A 2u!! USDA Ofice of Inspeclor General (OIG) reporl
on regulatory control over GE animals and insects
urged the agency to revise its regulations and im-
prove oversight of animal research.
Without a clear
framework, research projects have led to breaches
of the food supply and to untracked field releases.

1he OIG reporled lhal belween 2uu! and 2uu3, lhe
Universily of Illinois allowed al leasl 386 GF pigs
from a study to be slaughtered and sold for human
consumption, even though GE pigs have never been
approved for U.S. consumption.
Genetic engineers commonly use fish as research sub-
jects because their external eggs simplify the manipula-
tion of DNA.
Transgenic fish are being produced for
food, for use in pharmaceuticals and to test water qual-
In 2u!u, lhe FDA considered approving lhe firsl GF
fish for human consumption.
This is despite that fact
lhal a 2uu4 Nalional Research Council reporl concluded
that GE seafood posed food safety risks either by the
introduction of known or unknown allergens.
The GE fish under consideration is Aquabounty’s
AquAdvantage salmon, which combines genes from
the ocean pout (a member of the eel family) and the
chinook salmon to create an Atlantic salmon that
grows to market size twice as fast as non-
GE salmon.
In ils submission lo lhe FDA,
Aquabounty acknowledges that it cannot
guarantee that its transgenic fish will not
escape from salmon farms.

Although the biotech salmon purportedly
would be sterile, the large, voracious GE
salmon could out-compete wild fish for
food, habitat and mates but then fail to
successfully reproduce, efectively driving
wild salmon to extinction.
Moreover, car-
nivorous farmed fish eat pellets made from
wild fish, among other ingredients.
salmon would require more wild-caught
fishmeal feed than non-GE fish, puting
more strain on ocean fish populations to
provide feed.
Insumc|ent Þrotecnon
The patchwork of federal agencies that
regulates genetically engineered crops and
animals in the United States has failed
to adequately oversee and monitor GE
producls. Lax enforcemenl, uncoordinaled
agency oversight and ambivalent post-
approval monitoring of biotechnology have
allowed risky GE plants and animals to slip
through the regulatory cracks.
Federal regulators approve most applica-
tions for GE field trials, and no crops have
been rejected for commercial cultivation.

Although some biotechnology companies
have withdrawn pending applications,
federal regulators approve most GE crops
despite widespread concerns about the
risk to consumers and the environment.

Nonetheless, the biotech industry has
pressed for lighter regulatory oversight.
Between 1999 and 2009, the top agricul-
tural biotechnology firms spent more than
S¯4¯ million on lobbying and campaign
contributions to ease GE regulatory over-
sight, push for GE approvals and prevent
GE labeling.

The current laws and regulations to ensure
the health and environmental safety of
biotechnology products were established
before genetic engineering techniques
were even discovered.
The agencies
responsible for regulating and approving
biotechnology include the USDA, the EPA
and the FDA. Although the missions of
Biotechnology Regulatory Timeline
1930: The Plant Patent Act of 1930 provided 17-year patent protection for
plant varieties, including hybrids.
1952: The Patent Act of 1952 extended broader patent rights to agricul-
tural developments to “any new and useful […] composition of
matter” including chemicals and processes.
1961: The International Convention for the Protection of New Varieties of
Plants established an intergovernmental organization that provided
intellectual property rights to the breeders of new plant varieties.
1970: The Plant Variety Protection Act of 1970 provided plant variety
breeders with exclusive patent rights for 18 years.
It included a
“farmer’s exemption” that allowed farmers to save seed and to sell
saved seeds to other farmers.
1980: The U.S. Supreme Court decision Diamond v. Chakrabarty extended
patent rights to genetically engineered oil-eating bacteria.
Court ruled that laboratory-created living things were not “products
of nature” under the 1952 Patent Act and were thus patentable.
This watershed decision bestowed patent protection on GE plants,
animals and bacteria.
1981: The first transgenic mice were produced for tissue manipulation and
1985-88: A series of rulings by the U.S. Patent and Trademark Office
awarded patent protection to plants and nonhuman animals.
1985: The first transgenic sheep and pigs were modified to display en-
hanced growth.
1986: The Reagan White House determined that no new laws were neces-
sary to regulate biotechnology since it did not pose any special or
unique risks.

1986: The Technology Transfer Act allowed the USDA to share publicly
financed research and technology with private businesses.
1987: The USDA authorized field trials of GE plants.
1992: The USDA approved the first GE commercial cultivation, Calgene’s
Flavr Savr tomato.
1994: The United States ratified the International Convention for the Pro-
tection of New Varieties of Plants, which extended plant patents to
20 years for most crops and prohibited farmers from selling saved
patented seed without the patent owner’s permission.
1995: The EPA registered the first pest-protected plant, Monsanto’s New-
Leaf potato.
1996: The U.S government approved commercial cultivation of GE soy-
beans and Bt corn.
2000: GE StarLink corn, approved for animal feed, unintentionally contami-
nated the human food system before being approved for human
2001: The FDA released guidance allowing food companies to voluntarily
label GE or non-GE foods, provided that the labels are not false or

2009: The FDA announced that GE animals would be regulated as veteri-
nary drugs instead of food (known as Guidance 187) and defined
transgenic animals as veterinary drugs under the Federal Food, Drug
and Cosmetics Act.
8 Ceoeucolly MoJlfeJ looJs 101
lood & WaLer WaLch - !anuary 2014 9
these agencies overlap in some areas, it is the respon-
sibility of the USDA to ensure that GE crops are safe
to grow, the EPA to ensure that GE products will not
harm the environment and the FDA to ensure that GE
food is safe to eat.
Safe to grow?
The USDA is responsible for protecting crops and the
environment from agricultural pests, diseases and
weeds, including biotech and conventional crops.

1he Animal and Planl Heallh Inspeclion Service
(APHIS) oversees lhe enlire GF crop approval process,
including allowing field testing, placing restrictions on
imports and interstate shipping, approving commercial
cultivation and monitoring approved GE crops.
The USDA reviews permit applications and performs
environmental assessments to decide whether GE
plants will pose environmental risks before field trials
may begin.
The USDA has approved most of the ap-
plications for biotech field releases it has received, giv-
ing the green light to 92 percent of all submited appli-
cations between 1987 and 2005.
Once field trials are
complete, the USDA can deregulate a crop, allowing it
to be grown and sold without further oversight.
2008, the USDA had approved nearly 65 percent of new
GE crop deregulation petitions.

Safe for the environment?
The EPA regulates pesticides and herbicides, includ-
ing GE crops that are designed to be insect resistant.

A pesticide is defined as a substance that “prevents,
destroys, repels or mitigates a pest,” and all pesticides
that are sold and used in the United States fall under
EPA jurisdiction.
The EPA also sets allowable levels of
pesticide residues in food, including GE insect-resistant
crops. Between 1995 and 2008, the EPA registered 29 GE
pesticides engineered into corn, coton and potatoes.
Bioengineered pesticides are regulated under the
Federal Inseclicide, Fungicide and Rodenlicide Acl
(FIFRA), firsl enacled in !94¯.
New pesticides —
including those designed for insect-resistant GE crops
— must demonstrate that they do not cause “unrea-
sonable adverse efects on the environment,” includ-
ing polluting ecosystems and posing environmental
and public health risks.
The EPA must approve
and register new GE insect-resistant crop traits, just
as the agency does with conventional pesticides.

Biotech companies must apply to field test new
insect-resistant GE crop traits, establish permissible
pesticide trait residue levels for food and register the
pesticide trait for commercial production.

Safe to eat?
The FDA is responsible for the safety of both conven-
tional and GE food, animal feed and medicines. The
agency regulates GE foods under the Food, Drug and
Cosmetics Act, which also gives the FDA authority
over the genetic manipulation of animals or products
intended to afect animals.
GE foods, like non-GE
foods, can pose risks to consumers from potential
allergens and toxins.
The FDA does not determine
the safety of proposed GE foods; instead, it evaluates
whether the GE product is similar to comparable non-
GE products.
Denied Approved
USDA GE Field Test Determinations
1987 – 2005
5ootce. u5uA
Notification or
Permit for Field
Trials Granted
“Generally Recognized
As Safe”
Notice Accepted
Experimental Use
Permit for Field
Trials Granted
If Food Additive,
Safety Measures Met
Plant Registered
as a Pesticide
Petition for
Petition for Residue Tolerance
or Exemption Authorized
8|otech Crop kegu|atory Approva| Þrocess
10 Ceoeucolly íoqloeeteJ looJ. Ao Ovetvlew
The biotechnology industry self-regulates when it
comes lo lhe safely of GF foods. In seeking approval,
a company participates in a voluntary consultation
process with the FDA, and the agency classifies the
GE substances either as “generally recognized as safe”
(GRAS) or as a food additive. So far, only one GE prod-
uct has ever been through the more rigorous “food-ad-
ditive” process; the FDA has awarded GRAS status to
almost all (95 percent) of foods and traits in food since
The FDA also enforces tolerances set by the
EPA for pesticidal residues in food.
The FDA does
no independent safety testing of its own and instead
relies on data submited by biotech companies.
The FDA also regulates genetically engineered animals
as velerinary medicines. In 2uu9, lhe agency decided lhal
the Food, Drug and Cosmetics Act definition of veteri-
nary drugs as substances “intended to afect the struc-
ture of any function of the body of man or other ani-
mals” includes genetically altered animals.
As of late
2013, only GE salmon and Enviropig had been considered
for commercial approval, but no transgenic animals had
been approved to enter the food supply.
(See Appendix
for more about the U.S. regulation of GE food.)
Impact on Consumers
Uncertain Safety
Despite the FDA’s approval of common GE crops,
questions about the safety of eating these crops
persist. GE corn and soybeans are the building blocks
of the industrialized food supply, from livestock feed
to hydrogenated vegetable oils to high-fructose corn
syrup. Safety studies on GE foods are limited because
biotechnology companies prohibit cultivation for re-
search purposes in their seed licensing agreement.

Some of the independent, peer-reviewed research that
has been done on biotech crops has revealed some
troubling health implications. A 2012 Food and Chemi-
cal Toxicology study done by toxicologist Gilles-Eric
Séralini found that rats that consumed GE corn over
two years had deteriorated liver and kidney function-
ing and a higher rate of tumor development.
study faced criticism for its findings; yet in June 2013,
the EU funded a long-term carcinogen rat feeding
study using the same variety of corn.
Studies have
found irregularities in the livers of rats as well as im-
paired embryonic development in mice following a GE
soybean diet.
And a 2007 study found significant liver
and kidney impairment of rats that were fed insect-resis-
tant Bt corn, noting that, “with the present data it cannot
be concluded that GE corn MON863 is a safe prod-
Even GE livestock feed may have some impact on
consumers of animal producls· Ilalian researchers found
biotech genes in the milk from dairy cows that were fed
a GE diet, suggesting the ability of transgenes to survive
The Roundup Ready trait lowers the nutritional con-
tent of crops by inhibiting the absorption of nutrients
including calcium, iron, magnesium and zinc, making
plants more susceptible to disease.
Studies indicate
that fusarium — a soil-borne pathogen that infects plant
roots — becomes more prevalent when crops are treated
with Roundup.

EU Regulation
Biotechnology regulation in the European Union is far stricter than in the United States and operates under the “precautionary principle,”
assessing each food’s safety before approving its commercialization.
The EU has approved more than 30 GE products for sale in the
region, most of which is GE soy and corn (maize) in animal feed.
Only two GE crops are currently approved for cultivation in the EU: Mon-
santo’s insect-resistant corn and BASF’s high-starch potato.
Moreover, domestic GE production is very limited in Europe, which grows less
than one-tenth of a percent of the global genetically engineered cropland.
Despite having separate regulation for novel food, EU biotechnology regulation still allows some GE products to fall through the cracks. EU
law requires that all foods and feeds with any GE content bear labels, including those with more than 0.9 percent accidental biotech content.
GE products considered “processing aids,” like GE enzymes used to make cheese, are exempt from the labeling process.
In this way, the
majority of GE use, including soy and corn imports, is hidden from consumers in unlabeled meat and milk from GE-fed livestock. European
consumers, who have widely opposed GE foods, have been duped into believing that these products have been withdrawn from the food
chain when consumers are in fact unwittingly supporting the GE industry via imported animal feed.
European consumers are skeptical of the safety of GE foods. A 2010 biotechnology survey performed by the European Commission reported
that 59 percent of Europeans think that GE food is unsafe for their health and that of their family, and 61 percent do not think that the de-
velopment of GE food should be encouraged.
These opinions are reflected in the nearly one-quarter of EU member countries that are oper-
ating bans on GE products despite agribusiness and World Trade Organization pressure.
Under the EU’s Deliberate Release Directive, which
regulates GE crops that go on the market, a “safeguard clause” allows member countries to restrict or prohibit GE use or sale, provided there
is evidence that the crop poses significant risks.
lood & WaLer WaLch - !anuary 2014 11
Moreover, some evidence suggests that the most
common GE-afiliated herbicide, glyphosate, may
pose animal and human health risks. A 2010 study
published in Chemical Research in Toxicology found
that glyphosate-based herbicides caused highly
abnormal deformities and neurological problems in
Another study found that glyphosate
caused DNA damage to human cells even at lower
exposure levels than those recommended by the her-
bicide’s manufacturer.
The potential long-term risks from eating GE food are
unknown. The FDA contends that there is not sufi-
cient scientific evidence demonstrating that ingesting
these foods leads to chronic harm.
But GE variet-
ies became the majority of the U.S. corn crop only in
2005 and the majority of the U.S. soybean crop only
in 2000.
The potential cumulative, long-term risks
have not been studied. These considerations should
be critical in determining the safety of a product prior
to approval, and not lef to atempt to assess once the
product is on the market.
GE insect-resistant crops may contain potential aller-
gens. One harmless bean protein that was spliced onto
pea crops to deter pests caused allergic lung damage
and skin problems in mice.
Yet there are no defini-
tive methods for assessing the potential allergenicity
of bioengineered proteins in humans.
This gap in
regulation has failed to ensure that potential allergenic
GE crops are kept out of the food supply.
In !998, lhe FPA approved reslricled cullivalion of
Avenlis` inseclresislanl SlarLink corn, bul only for
domestic animal feed and industrial purposes because
the corn had not been tested for human allergenic-
However, in 2uuu, SlarLink lraces were found in
taco shells in U.S. supermarkets.
The EPA granted
Avenlis`s requesl lo cancel SlarLink`s regislralion,
helping to remove the GE corn from the food supply.

1he SlarLink episode is a caulionary lale of lhe failure
of the entire regulatory system to keep unapproved
GE crops out of the human food supply.
lnsu§cient Lobe/inq
The FDA governs the proper labeling of U.S. food
products. However, because the agency views GE foods
as indistinct from conventional foods, the FDA does
not require the labeling of GE food products as such.
The FDA does permit voluntary GE labeling as long
as the information is not false or misleading.
manufacturers can either afirmatively label GE food
or indicate that the food item does not contain GE
ingredients (known as “absence labeling”). Virtually no
companies disclose that they are using GE ingredients
under this voluntary scheme. Moreover, consumers in
the United States blindly consume foods that contain
GE ingredients.
For consumers to have the opportunity to make in-
formed choices about their food, all GE foods should
be labeled. A 2013 New York Times poll found that
93 percent of respondents were in favor of a manda-
tory label for genetically engineered food.
A 2010
Consumers Union poll found that 95 percent of U.S.
consumers favor mandatory labeling of meat and
milk from GE animals.
Yet despite this overwhelm-
ing support, the FDA will not require labeling of food
that comes from genetically modified animals such as
the AquAdvantage salmon.
In 2u!3, over 2¯ slales
introduced legislation to label GE foods, and these bills
passed in Connecticut and Maine.

Impact on the Food System
In lhe !¯ years since herbicideloleranl crops were
first introduced, weeds already have become resistant
to GE-afiliated herbicides. Ubiquitous application of
Roundup has spawned glyphosate-resistant weeds,
a problem that is driving farmers to apply more
toxic herbicides and to reduce conservation tilling to
combat weeds, according to a 2010 National Research
Council report.
Al leasl !4 weed species in lhe Uniled Slales (and 24
worldwide) have been confirmed to be resistant to
including aggressive crop weeds such as
ragweed, mare’s tail and waterhemp.
A 2009 Pur-
due University study found that glyphosate-tolerant
mare’s tail could “reach staggering levels of infesta-
tion in about two years afer it is first detected.”
industry currently estimates that 61.2 million acres
of cropland are now infested with weeds resistant to
Research shows that higher densities of
GE Additive Rejected GE Additive Approved GRAS Withdrawn GRAS Approved
1 0
FDA Food Determinations
1998 – 2010
5ootce. luA
12 Ceoeucolly íoqloeeteJ looJ. Ao Ovetvlew
glyphosate-resistant weeds reduce crop yields.
due University scientists found that Roundup-resistant
ragweed can cause 100 percent corn-crop losses.
Potent Power ond 5eed conso/idonon
Only a few biotechnology companies dominate the
U.S. seed industry, which once relied on universities for
most research.
Farmers depend on the few firms that
sell seeds, and these companies have raised the prices
of seed and afiliated agrochemicals as the market has
become increasingly concentrated. High levels of con-
centration can raise seed prices for farmers.
corn seed prices increased by an average of 13 percent
annually between 2002 and 2012, and soybean seed
prices rose by an average of 11 percent annually.

Between 1996 and 2007, Monsanto acquired more than
a dozen seed companies.
The two largest firms sold
58 percent of corn seeds in 2007 and 60 percent of
soybean seeds in 2005.
Biotechnology firms control how their patents are
used, form joint ventures and impose stringent require-
ments on farmers who grow patented seeds. Mergers
combined with patent restrictions have increased the
market power of biotechnology companies.
Strict patents protect genetically engineered seeds.

These seeds were not even considered patentable until
the 1980s, when several court cases extended patent
rights to GE organisms.
Biotech companies further
Biotech Industry Tries to Block Milk Labels
When the FDA approved the synthetic growth hormone rBGH to enhance milk production in cows, it stated that because there was no distin-
guishable difference between the milk that comes from cows treated with rBGH and milk that does not, it could not require any label on milk that
was produced using the hormone.
Given the amount of controversy surrounding rBGH, this decision was surprising, and dairies that were not
using the artificial hormone quickly began labeling their products as “rBGH-free.”
However, the FDA made any attempts at labeling the absence of rBGH extremely difficult when it issued a 1994 guidance suggesting that the
simple phrase “rBGH-free” was misleading.
The guidance also recommended that producers include on any rBGH-free label a lengthy qualify-
ing sentence stating that: “No significant difference has been shown between milk derived from rbST-treated and non-rbST-treated cows.”
Just days after the FDA released the document, Monsanto filed suit against two dairy farms that had labeled their milk “rBGH-free.”
also got involved and sent warning letters to several dairies that had labeled their milk “hormone-free,” stating that they were violating the fed-
eral Food, Drug, and Cosmetic Act for misbranding.
Monsanto even complained to the FDA and the Federal Trade Commission about allowing
any rBGH-related labels to appear on milk, claiming that the practice was damaging its business.
Ben & Jerry’s was one company that made an immediate and significant push to label its products as free of rBGH. The Vermont-based ice cream
manufacturer first included an rBGH-free label on its products in February 1994.
It aggressively defended that decision by continually modifying
the label in order to withstand challenges,
as well as by suing the state of Illinois to protect its right to label its products.
Illinois was one of
the first states to ban any labeling of an absence of rBGH, essentially making it impossible for Ben & Jerry’s to market its products nationwide as
not produced with rBGH.

Varying state labeling requirements effectively prevent national dairy manufacturers and milk retailers from truthfully labeling their products as
rBGH-free, since it is easier to have no label than to develop a different label for each state.
Ben & Jerry’s settlement with the state of Illinois
in 1997 enabled that company and others to market and label their products nationwide as not produced with rBGH provided that they include
the disclaimer: “The FDA has said no significant difference has been shown and no test can now distinguish between milk from rBGH treated and
untreated cows.”
In 2007 and 2008, several additional states, at the urging of groups backed by Monsanto,
made significant moves to restrict the type of rBGH-
free labeling that could appear on dairy products. Some states, such as Utah,
developed proposals that were modeled after FDA guidelines,
while others, including Ohio, issued more specific requirements regarding the type, size and location of the FDA disclaimer.
Missouri and Penn-
sylvania went even further by attempting to ban any mention of an absence of rBGH.
In Pennsylvania, the Secretary of Agriculture attempted to
create an outright ban on any rBGH labeling, but this was reversed in response to consumer backlash and was reduced to a rule that was similar
to the original FDA proposal.
A bill introduced in Missouri was met with a similar reaction, and in response to consumer protest the original bill
had to be modified
before eventually dying in committee.

Despite years of grappling with the issue, most attempts made by state legislatures and agriculture departments to ban rBGH labeling have been
unsuccessful. In 2010, the U.S. Court of Appeals for the Sixth Circuit ruled against portions of Ohio’s restrictive limits on affirmative “rBGH-free”
labeling, and Ohio finally abandoned its regulation to restrict such labeling in October 2011.
lood & WaLer WaLch - !anuary 2014 13
leverage the limited patent monopoly of their seeds
through joint ventures and cross-licensing agree-
The patent owner controls how partnering
companies use and combine the traits.
ly, although there are numerous seed companies, most
of the available corn, soybean and coton seeds include
Monsanto-patented traits that have been cross-
licensed to other seed companies.
By 2012, nearly all
(98 percent) of the corn and most (86 percent) of the
coton cultivated in the United States were grown from
seeds covered by Monsanto patents.
Farmers pay licensing fees and sign contracts for
limited permission to plant GE seeds.
The licenses
typically prohibit farmers from saving the seeds from
harvested crops to plant the next season; they also
delineate specific farming practices, mandate spe-
cific sales markets and allow the company to inspect
farmers’ fields.
Indeed, farmers musl buy new
seeds every year because they face patent infringe-
ment suits if they run afoul of GE seed-licensing
agreements by saving seed.
And biotech companies
zealously pursue farmers that allegedly violate their
patents. Monsanto has hired private investigators
to videotape farmers, infiltrate community meet-
ings and interview informants about local farming
By January 2u!3, Monsanlo had filed !44
patent infringement lawsuits, recovering as much as
$160.6 million from farmers.
Impact on Farmers
The USDA prohibits the use of GE material — includ-
ing enzymes, seeds or veterinary treatments — in any
product that carries the agency’s “certified organic”
Certified organic farmers can face significant
economic hardship if biotech traits contaminate their
organic crops or organic livestock feed. Contamina-
tion can occur either when GE seeds are inadvertently
mixed with non-GE seeds during storage or distri-
bution, or when GE crops cross-pollinate non-GE
A Union of Concerned Scientists study found
that 50 percent of non-GE corn and soybean and 83
percent of non-GE canola seeds in the United States
were contaminated with low levels of GE residue.

Il is well documenled lhal a farmer`s field can be
inadvertently contaminated with GE material through
cross-pollination and seed dispersal.
Even Monsanto
admits that “a certain amount of incidental, trace level
pollen movement occurs.”
Farmers who unintentionally grow GE-patented seeds
or who harvest crops that are cross-pollinated with GE
traits could face costly lawsuits by biotechnology firms
for “seed piracy.” Farmers who intentionally grow GE
crops are not required to plant non-GE bufer zones
to prevent contamination unless this is stipulated in
14 Ceoeucolly íoqloeeteJ looJ. Ao Ovetvlew
the farm’s USDA permit.
Yet even the use of bufer
zones has proven inefective because these areas are
usually not large enough to prevent contamination.

The USDA’s approval of Roundup Ready alfalfa in 2010
highlights the significant ramifications that contamina-
tion can have for organic producers. Alfalfa is the most
important feed crop for dairy cows.
However, GE al-
falfa can easily cross-pollinate organic alfalfa crops and
cause organic farmers to lose their markets if testing
reveals contamination.
Conventional alfalfa farm-
ers could face seed piracy suits from Monsanto even if
their crops are inadvertently pollinated by GE alfalfa.
At least one farmer contends that he was sued when
his canola fields were contaminated with GE crops
from neighboring farms.

Organic dairy farmers already face dificulty secur-
ing organic feed, and this challenge will only worsen
if GE alfalfa begins to contaminate organic alfalfa.

Organic dairy farmers receive a price premium of $6.69
(44 percenl) for lheir milk, bul lhey also have produc-
tion costs of $5 to $7 more per hundred pounds of milk
— 38 percent higher than conventional dairies.
contamination could eliminate this premium that cov-
ers the higher organic production costs, making these
farms unprofitable.
Alfalfa contamination is already occurring in the
Uniled Slales. In Augusl 2u!3, a Washinglon slale
farmer reported that his alfalfa was rejected for export
due to the presence of a genetically engineered trait.
However, the USDA decided not to take any action to
investigate transgenic alfalfa gene flow or to address
ways lo prevenl conlaminalion.23¯ In addilion lo al-
falfa, GE wheat — which hasn’t been field-tested since
2005 — was found in an Oregon farm in May 2013,
causing Japan and South Korea to suspend some U.S.
wheal imporls. Il is unclear how lhe GF wheal ap-
peared, but a Monsanto representative tried to claim it
was the result of potential sabotage.

6/obo/ 1rode
Although the United States has readily approved GE
crops and products, many countries, including key
export markets, have not done so. Three-quarters of
consumers in Japan, Ilaly, Germany and France are
skeptical of the safety of GE foods.
Europe has been
restrictive in its approval of biotech foods because of
uncertainty about the safety of the products for hu-
man consumption.

Unlike the United States, the EU regulatory frame-
work specifically addresses the new properties and
risks of biotech crops and afirmatively evaluates the
safety of every GE crop.
EU member states currently
allow animal feed imports to contain up to 0.1 percent
of unapproved GE material.
Additionally, the EU
requires all foods, animal feeds and processed prod-
ucts with biotech content to bear GE labels.
Six EU
countries currently ban GE cultivation altogether: Aus-
lria, France, Germany, Greece, Hungary and Luxem-
Countries that ban GE foods typically impose
strict rules to prevent unauthorized GE imports, which
blocks or limits U.S. exports of corn and soybeans that
are primarily GE crops. Japan does not grow GE crops
and requires mandatory labeling of all GE foods.
Despite the advanced grain-handling system in the
United States, GE grains have contaminated non-GE
shipments and devastated U.S. exports. The Govern-
ment Accountability Ofice (GAO) identified six known
unauthorized releases of GE crops between 2000 and
In 2uuu, Japan discovered GF SlarLink corn,
which was not approved for human food, in 70 percent
lood & WaLer WaLch - !anuary 2014 15
of lesled samples, even lhough SlarLink represenled
under 1 percent of total U.S. corn cultivation.
lhe SlarLink discovery, Furope banned all U.S. corn
imports, costing U.S. farmers $300 million.
In Augusl
2uu6, unapproved GF Liberly Link rice was found lo
have contaminated conventional rice stocks.
pan halted all U.S. rice imports and Europe imposed
heavy restrictions, costing the U.S. rice industry $1.2
In 2uu¯, Ireland impounded imporled U.S.
livestock feed that tested positive for GE, unapproved
in the country.

The United States is aggressively seeking to force its
trading partners to overturn their GE prohibitions. The
U.S. Trade Representative is lobbying trading partners
to remove “unjustified import bans and restrictions to
U.S. biotech products” and is even pressing countries to
eliminate GE labeling requirements.
The diplomatic
push by U.S. biotech interests extends to developing
countries as well: in recent years, the U.S. State Depart-
ment has pressured governments all over the world to
lif GE restrictions.

Debunking Monsanto’s Myths
MCNSAN1C M¥1n: ívetytbloq Moosooto Joes
belps to moke oqtlcoltote mote ptoJocuve ooJ
mote ptoftoble fot fotmets.
Biotech companies such as Monsanto claim that their
products strengthen farm productivity by improving
yields and reducing costs.
Yet the cost savings are
largely illusory, and the yield gains have been limited.
GE seeds and afiliated herbicides are typically more
expensive than conventional products. For example,
in 2009, Roundup Ready soybean seeds cost twice as
much as non-GE seeds.
Although biotech compa-
nies contend that farmers save on afiliated herbicides,
the herbicide savings are less than the increased seed
costs. Soybean farmers were able to save between $3
and $20 per acre on reduced herbicide costs,
but GE
soybean seed can cost $23 more per acre than conven-
tional seed.
In 2u!3, biolech corn and soybean seeds
cosl 4¯ and 32 percenl more, respeclively, lhan non
biotech varieties.
And these higher costs do not generate higher yields.
A 2009 Union of Concerned Scientists survey found
that herbicide-tolerant corn and soybeans showed no
yield increase over non-GE crops, and insect-resistant
corn had only a slight advantage over conventional
A 2007 Kansas State University study found
that non-GE soybeans had 10 percent higher yields
than biotech soybeans.

MCNSAN1C M¥1n: Moosooto wlll belp to
cteote mote oottluoos, vltomlo-tlcb fooJs fot
Some scientists and development advocates have
promoted biotechnology as a means to combat malnu-
trition. Scientists in Spain, for example, are atempt-
ing to engineer beta-carotene, folate and vitamin C
into African corn.
One well-known biofortification
project, Golden Rice, adds beta-carotene to rice to help
fight the vitamin A deficiency that causes blindness
in a quarter million children annually.
Yet engineer-
ing crops with beta-carotene may not even reduce
vitamin A deficiency because consumption alone does
not ensure absorption.
Diets of malnourished people
ofen lack the fats and oils crucial to absorbing vitamin
One of the few clinical trials on humans to exam-
ine Golden Rice’s nutrition efects studied only five,
healthy American volunteers, hardly representative of
the target population.

Development agencies, foundations such as the Bill
and Melinda Gates Foundation, and biotech compa-
nies are investing in uncertain technological solutions
to a problem that needs a more practical solution. De-
veloping new biotech crops is expensive, challenging,
time consuming and regionally specific. To date, no
biofortified crops have been successfully commercial-
Vitamin A deficiency can instead be combated
by consuming conventionally grown orange-colored
produce (sweet potatoes, carrots or mangos) and dark
leafy green vegetables, supplemented with fats and
Providing low-income rural families with the
capacity to grow crops that provide balanced nutri-
tion is a more practical approach than asking them to
spend more money for seeds that may not have beter
yield or bear more nutritious food.
MCNSAN1C M¥1n: Moosooto wlll belp fotmets
Jo mote wltb less.

Most GE crops are designed to be tolerant of specially
tailored herbicides, the most common of which is
glyphosate, marketed by Monsanto under the brand
name Roundup.
Farmers can spray the herbicide on
their fields, killing the weeds without harming their GE
crops. Monsanto’s Roundup Ready (herbicide-tolerant)
corn, soybeans and coton were planted on 150 million
U.S. acres in 2009.
Glyphosate use on Roundup Ready
crops has grown steadily. The total volume of glypho-
sate applied to corn, coton and soybeans has increased
10-fold from 15 million pounds in 1996 to 159 million
pounds in 2012.
Ubiquitous Roundup application has spawned glypho-
sate-resistant weeds, driving farmers to apply even
16 Ceoeucolly íoqloeeteJ looJ. Ao Ovetvlew
more toxic herbicides, according to a 2010 National Re-
search Council report.
Farmers may resort to other
herbicides lo combal superweeds, including 2,4D (an
Agent Orange component) and atrazine, which have
been associated with health risks including endocrine
disruption and developmental abnormalities.

Monsanto’s solution to the emerging Roundup-resistant
weeds has been to ofer certain farmers “residual con-
trol” rebates of up to $20 per acre to apply additional
herbicides afer Roundup fails.
Biotech companies
also are developing seeds that are tolerant of multiple
herbicides to cope with weed resistance. Dow is seek-
ing approval for GE corn and soybean varieties that
are loleranl of 2,4D and glufosinale
— which could
be dangerous lo eal because a melabolile of 2,4D is
known to cause skin sores, liver damage and sometimes
death in animals.
Monsanto, meanwhile, has devel-
oped dicamba-tolerant soybeans and coton.
MCNSAN1C M¥1n: Moosooto spoeezes mote
fooJ ftom o toloJtop.
Biotechnology proponents contend that high-tech
solutions can reduce poverty and hunger in the devel-
oping world, but high-priced seeds and herbicides are
ill suited to poor farmers in the developing world. The
prestigious 2009 International Assessment of Agricul-
ture Knowledge, Science and Technology for Develop-
ment, a reporl wriuen by more lhan 4uu scienlisls and
sponsored by the United Nations and World Bank,
concluded that the high costs for seeds and chemicals,
uncertain yields, and potential to undermine local food
security makes biotechnology a poor choice for the
developing world.

Monsanlo uses couon expansion in India as an ex-
ample of improving food security.
Indian farmers,
wooed by Monsanto’s marketing, have widely adopted
GE coton.
Many take out high-interest loans to
aford the GE seeds, which can be twice as expensive
as conventional seeds.
Half of all pesticides applied
in India are now used on couon, and some farmers
significantly over-apply the chemicals, making agricul-
tural workers highly vulnerable to health problems.

More lhan half of Indian farmers lack access lo
irrigation, leaving them dependent on a punctual rainy
season for a good crop.
And when GE coton crops
fail, farmers are ofen unable to repay the substantial
debt. The steeper treadmill of debt with GE crops con-
lribules lo a rising number of farmer suicides in India
— exceeding 17,000 in 2009.
By contrast, a 2006 study published in Environmental
Science and Technology found that low-input farms
in developing countries had significant yield gains.

And a 2007 University of Michigan study found that
organic farming in the developing world had higher
yield gains than conventional production and could
feed the global population without increasing the
amount of cultivated land.
Despite the huge public
relations campaigns, biotechnology is not solving our
sustainability problems — it’s making them worse and
creating more.
MCNSAN1C M¥1n: Moosooto wlll belp to
mluqote cllmote cbooqe lmpocts by eooblloq
fotmets to oJopt to tbe cbooqloq eovltoomeot.
Global warming, drought and catastrophic weather
events will afect agriculture for decades to come.
tech firms have promised high-yield and drought-resis-
tant GE seeds, but by 2013 only one variety of drought-
tolerant corn was approved.
Crop research has yet to
achieve the complex interactions between genes that are
necessary for plants to endure environmental stressors
such as drought.
Monsanto’s approved drought-
tolerant corn has overestimated yield benefits, and there
is insuficient evidence that it will outperform already
available conventionally bred alternatives.

Traditional methods of breeding for stress tolerance
produce crops that are more resilient to disruption
and climate change than GE crops because these crops
complement and thrive in nutrient-rich and biodiverse
The development of patented drought-tolerant
crops allows biotechnology companies to control any
viable seeds, potentially puting new seeds out of
reach for poor farmers.
MCNSAN1C M¥1n: Moosooto mokes tbe most
e[cleot ose of lmpottoot tesootces lo otJet to
belp fotmets sostolo oot plooet.
Expanding thirsty GE crops to more arid developing
countries will exacerbate water scarcity. The develop-
ing world faces the most pronounced environmental
Global agriculture uses nearly 2 quadril-
lion gallons of rainwater and irrigation water annually
— enough to flood the entire United States with two
feet of water.
In lhe developing world, 8¯ percenl of
water withdrawals go toward agriculture.

Already, parls of norlhern India pump ¯u percenl
more water than the aquifers can refill.
Even Nobel
Laureale Norman Borlaug, lhe godfalher of lhe Green
Revolution, noted that the rapid rise of ill-planned
irrigation schemes to accommodate new crops in Asia
ofen led to waterlogged or salty fields, which reduced
agricultural productivity.
In lhe Uniled Slales, irrigaled corn acreage increased
23 percent and irrigated soybean acreage increased
lood & WaLer WaLch - !anuary 2014 17
32 percent between 2003 and 2008.
The rising U.S.
cultivation of GE corn and soybeans further threatens
the strained High Plains Aquifer, which runs beneath
eight western states and provides nearly a third of
all groundwater used for U.S. irrigation.
seven percent of High Plains water withdrawals go
to agriculture, and these withdrawals now far exceed
the recharge rate across much of the aquifer.
worldwide expansion of industrial-scale cultivation of
water-intensive GE commodity crops on marginal land
could magnify the pressure on already overstretched
water resources. But these are the crops the biotech
industry has to ofer.
The U.S. experiment with GE food has been a failure.
Impacls on lhe environmenl, food syslem and public
health are not fully documented but are clearly not
worlh il. Il is lime for a new approach lo biolechnol-
ogy in the food system.
Enact a moratorium on new U.S. approvals of
genetically engineered plants and animals.
Require mandatory labeling of GE foods: An
afirmative label should be present on all GE foods,
ingredients and animal products.
Shif liability of GE contamination to seed pat-
ent holders: The financial responsibility of contami-
nation should be on the patent holders of the GE
technology, rather than on those who are economi-
cally harmed. The patent-holding biotechnology
company should financially compensate farmers
whose crops are contaminated.
Institute the precautionary principle for GE
foods: Currently in the United States, most GE
foods, donor organisms and host organisms are
generally considered safe for consumption and the
environment until proven otherwise.
The United
States should enact policy that would more rigor-
ously evaluate the potentially harmful efects of GE
crops before their commercialization to ensure the
safety of the public.
Develop new regulatory framework for biotech
foods: Congress should establish regulations specifi-
cally suited to GE foods.
Improve agency coordination and increase
post-market regulation: The EPA, USDA and FDA
should create mechanisms for coordinating informa-
tion and policy decisions to correct major regulatory
deficiencies highlighted by the GAO.
the agencies should adequately monitor the post-
market status of GE plants, animals and food.
18 Ceoeucolly íoqloeeteJ looJ. Ao Ovetvlew
The USDA is responsible for protecting crops and
the environment from agricultural pests and weeds,
including biotech and conventional crops. The Animal
and Planl Heallh Inspeclion Service (APHIS) oversees
the entire GE crop approval process, from field tests to
commercial cultivation.
Biotech companies must either enter a “notification”
or “permit” process before GE field trials begin.

Under the streamlined notification process, compa-
nies submit data showing that the new GE plant will
not harm agriculture, the environment or non-target
organisms, and the USDA either approves or denies
the field-testing application within one month.

If lhe USDA denies lhe nolificalion applicalion, lhe
company can re-apply under the more involved permit
The notification process does not require ei-
ther an Environmental Assessment (EA) or an Environ-
menlal Impacl Slalemenl (FIS) for GF crops lhal are
neither new species nor new modifications.
Under the more rigorous permit application pro-
cess, the USDA determines if the GE field trial poses
significant environmental impact before issuing a
The USDA reviews scientific submissions
for four months before granting or denying the field
test permit request.
If approved, lhe permil imposes
restrictions on planting or transportation to prevent
the GE plant material from escaping and posing risks
to human health or the environment.
approved the vast majority — 92 percent — of the ap-
plications for biotech field releases between 1987 and
The applying company is required to submit
field-trial data to the USDA within six months of the
test, demonstrating that the crop poses no harm to
plants, non-target organisms or the environment.

If lhe applicanl violales lhe permil, lhe USDA can
withdraw it.
1he USDA musl complele an FA and/or FIS before
approving any new crop release (including biotech
crops) that will afect the environment under the Na-
Append|x: 1he U.S. kegu|atory System for GL Iood
lood & WaLer WaLch - !anuary 2014 19
tional Environmental Policy Act.
The EA determines
whether the GE crop will pose significant risks to hu-
man health or the environment if cultivated.
If lhere
is no significant risk, the USDA issues a “finding of no
significanl impacl" (FONSI).
But if the USDA finds
more significant environmental implications, it must
also perform a more lhorough FIS.

The USDA is accelerating its approval process for
GE crops even as the seed companies hurry the new,
unlesled varielies lo markel. In November 2u!!, lhe
USDA unveiled its new streamlined process for GE
crop approvals to shorten approval timelines by 13 to
15 months.

If a field lrial does nol reveal significanl risks, lhe com-
pany can petition for nonregulated status, allowing the
crop to be cultivated and sold commercially without
further oversight.
The USDA solicits public com-
ments on the deregulation for 60 days.
Afer review-
ing available data, the USDA makes a final decision
within six months.
By 2008, the USDA had approved
nearly 65 percent (73 of 113) of new GE crop deregula-
tion petitions, according to the Government Account-
ability Ofice, the investigative arm of Congress.
Afer GE crops are approved, the USDA performs
almost no post-release oversight and has no program
for monitoring approved GE plants.
Inslead, lhe
USDA’s primary post-market role with GE crops is
through the Agricultural Marketing Service (AMS),
which helps facilitate the export of transgenic crops
by verifying their genetic identity.
The AMS does
not test for GE presence in grains; it only works with
interested shippers who participate in a voluntary
verification program.

Pesticide residue standards: The EPA establishes
allowable pesticide residue limits for food or feed
crops and is required to meet all food and feed safety
standards enforced by the FDA.
These tolerance
levels, or safe levels of pesticide residues, are based
both on immediate exposure risks and on the potential
accumulated risk from consuming pesticide residues
over time.

The EPA pesticide tolerances appear generous. A 2010
Nalional Inslilules of Heallh cancer risk sludy re-
ported criticism by environmental health profession-
als and advocates that agribusiness influence at EPA
deterred the agency from establishing suficiently
strong pesticide limits.
The EPA can even exempt
20 Ceoeucolly íoqloeeteJ looJ. Ao Ovetvlew
pesticides from establishing tolerances if it finds a low
probability of risk to public health.
tolerance exemptions allow food to contain any amount
of that pesticide residue.

Field trials and final approval: The EPA consid-
ers any substance that “prevents, destroys, repels or
mitigates a pest” a pesticide, including insect-resistant
crops, which the agency terms “plant incorporated
All new pesticides must be registered
with the EPA.
Additionally, the EPA reviews and
grants experimental use permits for field tests of un-
registered pesticides or of registered pesticides tested
for an unregistered use.
Biotech companies must ap-
ply for an experimental use permit for insect-resistant
GE crops if they are grown on more than 10 acres of
Experimental use permits typically limit field
trials to one year.
Biotech companies must submit
all test data detailing a plant’s toxicity and environ-
mental risk to the EPA within six months of the field
trial’s completion.
If lhe lesl demonslrales lhal lhe
crop poses acceptable risks, the company can apply to
register the new crop for commercial distribution. The
EPA may solicit expert scientific input as well as public
comment on pending applications.

Applications for permit registration must include
management plans that describe any limitation on
cultivating the new insect-resistant GE crops.
management plans ofen require the designation of a
non-insect-resistant seed bufer refuge along the border
of the GE crop.
This “refuge” is intended to give pests
access to non-pesticidal plants so that a pest does not
develop resistance to the pesticide.
Biotech seed com-
panies are responsible for ensuring that farmers follow
these management plans. For example, in 2010, the EPA
imposed a $2.5 million fine on Monsanto for selling GE
seed between 2002 and 2007 without informing Texas
farmers about EPA-mandated planting restrictions.

lood & WaLer WaLch - !anuary 2014 21
In mosl cases, lhe biolechnology induslry self
regulates when it comes to the safety of genetically
engineered foods. In !992, lhe FDA issued guidance
that gave the biotech industry responsibility for ensur-
ing that new GE foods are safe and compliant with the
federal Food, Drug and Cosmetics Act.
In 2uu!, lhe
FDA proposed a rule requiring companies to submit
data and information on new biotech-derived foods
120 days before commercialization.
As of 2013, the
decade-old rule still had not been finalized and the
industry data submissions remained voluntary.

For whole foods (intact foods such as a whole apple or
potato), safety responsibility is on the manufacturer
and no FDA premarket approval is necessary.
ever, for substances added to food, such as biotech
traits, the FDA classifies them as “generally recog-
nized as safe” (GRAS) or as food additives.
grants GRAS determinations to GE-derived foods that
are considered equivalent to the structure, function
or composition of food that is currently considered
A company may voluntarily submit a GRAS no-
tification and scientific documentation to the FDA, but
it is not a requirement.
If lhe FDA delermines lhal
the GE food or ingredient is GRAS, it is not required
to make a pre-market safety determination to approve
the substance the way it would for a food additive.

The FDA has awarded “generally recognized as safe”
status to almost all — 95 percent — of the GRAS appli-
cations submited for food since 1998, according to the
agency`s GRAS Nolice Invenlory.
By contrast, the FDA must pre-approve food addi-
tives before they can be sold. However, the FDA trusts
biotechnology companies to certify that their new
GE foods and traits are the same as foods currently
on the market. The company may send information
on the source of the genetic traits (i.e., which plants
or organisms are being combined) and on the digest-
ibility and nutritional and compositional profile of the
food, as well as documentation that demonstrates the
similarity of the new GE substance to a comparable
conventional food.
The FDA evaluates company-
submited data and does not do safety testing of its
The agency can approve the GE substance,
establish certain regulatory conditions (such as seting
tolerance levels) or prohibit or discontinue the use of
the additive entirely.
The FDA evaluates the safety
of all additives, but it has evaluated only one GE crop
trait as an additive, the first commercialized GE crop,
Flavr Savr tomatoes.
Once a GE food product has been approved and is on
the market (either by GRAS designation or as a food
additive), the FDA is responsible for its safety. Until
recently, the agency could ask companies to recall
dangerous food products only voluntarily; however,
the Food Safety Modernization Act of 2011 granted
the FDA mandatory recall authority.
the FDA has awaited outbreaks of foodborne illness
before taking action, rather than vigorously moni-
toring and inspecting food manufacturers.
reactive approach has been inefective in preventing
foodborne illnesses. The FDA did pressure a company
lo recall one GF food producl SlarLink corn, which
was unapproved for human consumption — when it
entered the food supply.
The FDA’s lack of post-
market monitoring can expose the public to unap-
proved GE traits in the food supply.
GE Animals
The federal government regulates genetically engi-
neered animals lhe same as velerinary medicines. In
2009, the FDA decided that the Food, Drug and Cos-
metics Act definition of veterinary drugs as substances
“intended to afect the structure of any function of the
body of man or other animals” includes genetically
altered animals.
This allows the FDA’s Center for
Veterinary Medicine to approve GE animals under a
procedure that is unsuited for the complex interactions
of transgenic animals with other livestock and the
environment. This regulatory interpretation (known as
Guidance 187) was released in the same year as some
companies publicly announced their intentions to
bring transgenic food animals to market.

The FDA must approve a New Animal Drug applica-
tion before it can be commercialized. The application
must demonstrate the GE animals’ safety and eficacy
as well as contain methods for detecting residues in
food-producing animals, a description of manufactur-
ing practices, and any proposed tolerance levels.

Veterinary drug manufacturers that are introducing
their products for investigational use are exempt from
new animal drug approval requirements.

A transgenic investigational animal or animal product
requires an investigational food-use authorization
from both the FDA and the USDA in order to enter the
food supply.
The biotech company must also pre-
pare an Environmental Assessment for investigational
GE animals.
In 2uu9, lhe FDA used lhe invesligalion-
al use process to approve the first commercial biologic
from a GE animal, the anticloting agent ATryn pro-
duced with transgenic goat milk.
Many of the FDA’s
processes involving drugs are exempt from disclosure,
making it dificult for the public to participate fully in
regulatory decisions concerning GE animals.

22 Ceoeucolly íoqloeeteJ looJ. Ao Ovetvlew
Once the FDA approves the production of experimen-
tal GE animals, the USDA must consider if and under
what restrictions these animals can be slaughtered,
processed and enter the food supply.
As of 2013, GE
salmon and Enviropig had been considered for com-
mercial approval, but no transgenic animals had been
approved to enter the food supply.
Il seems unlikely lhal lhe USDA will keep meal prod-
ucts derived from GE livestock out of the food supply,
based on the FDA’s tacit approval of food from cloned
liveslock. In 2uu8, lhe FDA delermined lhal lhere
are no risks associated with eating meat from cloned
livestock or meat from the ofspring of clones.
USDA then asked producers of cloned animals, several
hundred of which were believed to be on the market at
the time, to abide by a voluntary moratorium on selling
meat or milk from cloned animals.
The moratorium
was supposed to allow time for a proposed USDA study
on the potential economic impacts of cloned animals on
U.S. agriculture and international trade.
As of 2013, that
study had not been completed, and there are no known
FDA eforts to ensure that owners of cloned animals com-
ply with the moratorium on sales of meat or milk.
lood & WaLer WaLch - !anuary 2014 23
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agrlculLure by farmland blrds: lmpllcauon for geneucally modlñed crops."
íovltoo. 8losofety kes.. vol. 7. 2008 aL 248.
6S Sem8loSys (2010), uSuA-AÞPlS-8loLechnology 8egulaLory Servlces. Þubllc
ÞermlL uaLa. Aprll 28, 2011.
66 76 led. 8eg. 78232 (uec. 16, 2011), 77 led. 8eg. 413S0 (!ul. 13, 2012)
67 lblJ., uSuA. ºMonsanLo lmproved lauy Acld Þroñle MCn 8770S Soybean,
Þeuuon 09-201-01p: llnal LnvlronmenLal AssessmenL." SepLember 2011 aL 3.
68 70 led. 8eg. 13007-13008. (Mar. 17, 200S).
69 ceotet fot looJ 5ofety v. 1bomos I. vllsock. no. C 10-04038 !SW 1S (n.u. Cal 2010).
70 Cowan, 1adlock and krlsuna Alexander. Congresslonal 8esearch Servlce.
ºueregulaung Ceneucally Lnglneered Alfalfa and Sugar 8eeLs: Legal and
AdmlnlsLrauve 8esponses." May 22, 2013 aL Summary.
71 Clllam, Carey. ºMonsanLo launchlng lLs ñrsL bloLech sweeL corn." keotets.
AugusL 4, 2011.
72 MonsanLo. ºSafeLy Summarles for MonsanLo's 8reedlng SLack ÞroducLs."
Avallable aL hup://Þages/ sLacked-producL-
safeLy-summarles.aspx. Accessed AugusL 16, 2011., uSuA AÞPlS. ºuSuA/
AÞPlS ueclslon on MonsanLo Þeuuon 04-12S-01Þ Seeklng a ueLermlnauon of
nonregulaLed SLaLus for 8L ctyJ8b1 lnsecL 8eslsLanL Corn Llne MCn 88017."
uecember 14, 200S aL Appendlx l, uSuA AÞPlS. ºueLermlnauon of nonregu-
laLed sLaLus for corn evenL MCn 89034." !uly 1S, 2008 aL 1.
73 uSuA. ºLnvlronmenLal AssessmenL and llndlng of no SlgnlñcanL lmpacL." Þer-
mlL number 91-079-01. 1991. Avallable aL hup://
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74 uSuA. 8loLechnology 8egulaLory Servlces. ºAll 8elease ÞermlL Appllcauons."
Avallable aL hup:// Accessed leb-
ruary 8, 2011, uSuA. ºÞeuuons for nonregulaLed SLaLus CranLed or Þendlng
by AÞPlS as of !uly 18, 2011."
7S Shoemaker (2001) aL 21.
76 WaLers 8ass, Cwenell L. Congresslonal 8esearch Servlce. ºSLaLus of Ceneucally
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!usun. ºMonsanLo Þulls Þlan Lo Commerclallze Cene-AlLered WheaL." wosb-
loqtoo lost. May 11, 2004.
77 Wlsner, 8oberL. lowa SLaLe unlverslLy. º8ound-upº 8eady Sprlng WheaL:
lLs poLenual shorL-Lerm lmpacLs on u.S. wheaL exporL markeLs and prlces."
CcLober 2004 aL Lxecuuve Summary.
78 lblJ. aL 1, MonsanLo. ºlrequenLly Asked Cuesuons abouL MonsanLo and
WheaL." Avallable aL hup://Þages/wheaL-faq.
aspx. Accessed lebruary 7, 2011.
79 vogL and Þarlsh (2001) aL 1, unlverslLy of Cuelph. ºLnvlroplg."
80 vogL and Þarlsh (2001) aL S.
81 lblJ.
82 ºMonsanLo's 8S1 barely beaL LomaLo Lo markeL." cblcoqo 5oo-1lmes. March
20, 1994 aL 28.
83 uohoo, lan eL al. PealLh Canada, urug and PealLh ÞroducLs. º8eporL of Lhe
Canadlan veLerlnary Medlcal Assoclauon experL panel on r8S1." november
84 Þew Commlsslon on lndusLrlal larm Anlmal Þroducuon. ºÞumng MeaL on Lhe
1able." 2008.
8S Luropean Commlsslon. ulrecLoraLe Ceneral for PealLh and Consumer ÞroLec-
uon. º8eporL on Þubllc PealLh AspecLs of Lhe use of 8ovlne SomaLoLrophln."
ln looJ 5ofety-ltom lotm to lotk. March 1999.
86 ?u, P. and 1. 8ohan. 8evlew: 8ole of Lhe lnsulln-llke CrowLh lacLor lamlly ln
Cancer uevelopmenL and Þrogresslon. Iootool of tbe Nouoool coocet losu-
tote. vol. 92. 2000 aL 1472 Lo 1489.
87 uohoo eL al. (1998) aL secuon 7, Croves, MarLha. ºCanada 8e[ecLs Pormone
LhaL 8oosLs Cows' Mllk CuLpuL." los Aoqeles 1lmes. !anuary 1S, 1999, Luro-
pean Commlsslon (1999).
88 uSuA AÞPlS. ºualry 2007: ÞarL l: 8eference of ualry Caule PealLh and Man-
agemenL Þracuces ln Lhe unlLed SLaLes, 2007." CcLober 2007 aL 79.
89 lblJ.
90 unlverslLy of Cuelph. ºLnvlroplg-Commerclallzauon and 8egulaLory." Avallable aL
hup:// and on ñle. Acccessed november 29, 2010.
91 lblJ, SchmldL, Sarah. ºCeneucally englneered plgs kllled afer fundlng ends."
1be voocoovet 5oo. !une 22, 2012.
92 !ha, Alok. ºCM chlckens creaLed LhaL could prevenL Lhe spread of blrd ßu." 1be
CootJloo (unlLed klngdom). !anuary 13, 2011.
93 8lchL, !urgen A. eL al. ºÞroducuon of caule lacklng prlon proLeln." Notote
8lotecbooloqy. vol. 2S, !anuary 2007 aL 132, uSuA lSlS. º8ovlne Sponglform
LncephalopaLhy - Mad Cow ulsease." March 200S. Avallable aL hup://www.
ease/lndex.asp and on ñle. Accessed AugusL 1S, 2010.
94 Connor, SLeve. ºCM mosqulLoes deployed Lo conLrol Asla's dengue fever." 1be
loJepeoJeot (London). !anuary 27, 2011.
9S uSuA Cmce of lnspecLor Ceneral. ºConLrols over Ceneucally Lnglneered
Anlmals and lnsecL 8esearch." AudlL 8eporL. May 2011 aL 3.
96 lblJ. aL 14.
97 lblJ.
98 8orgam, 8achel and Lugene 8uck. Congresslonal 8esearch Servlce. ºCeneu-
cally Lnglneered llsh and Seafood." 2004 aL 2.
99 lblJ.
100 Þollack, Andrew. ºCeneucally AlLered Salmon CeL Closer Lo Lhe 1able." New
¥otk 1lmes. !une 2S, 2010.
101 nauonal 8esearch Councll (2004) aL 117 Lo 119.
102 ºAqua8ounLy 1echnologles Admlsslon Lo 1radlng on AlM." March 1S, 2006. AL
18 and 124.
103 Aqua8ounLy. ºLnvlronmenLal AssessmenL." 2010 aL 72.
104 Mulr, Wllllam and 8lchard Poward. ºÞosslble Lcologlcal 8lsks of 1ransgenlc Cr-
ganlsm 8elease When 1ransgenes AñecL Maung Success: Sexual Selecuon and
Lhe 1ro[an Cene PypoLhesls." ícoloqy. november 1999, Mulr, 8lll, º1ransgenlc
ñsh could LhreaLen wlld populauons." lotJoe News. Aprll 2000. Avallable aL
hup://[an.hLml. Accessed
CcLober 18, 2010.
10S 1acon, AlberL eL al. ºuse of llshery 8esources as leed lnpuLs Lo AquaculLure
uevelopmenL: 1rends and Þollcy lmpllcauons." lAC llsherles Clrcular no. 1018,
lood and AgrlculLure Crganlzauon of Lhe unlLed nauons, 8ome. 2006 aL v.
106 lernandez-Corne[o (2004) aL 19.
107 lblJ., 3S u.S.C. 101.
108 lernandez-Corne[o (2004) aL 19.
109 7 u.S.C. 2483, uSuA. ºÞlanL varleLy ÞroLecuon AcL and 8egulauons and 8ules
of Þracuce." 200S aL 14, noLe 30.
110 7 u.S.C. 2S43, uSuA. ºÞlanL varleLy ÞroLecuon AcL and 8egulauons and 8ules
of Þracuce." 200S aL 19.
111 447 u.S. 303. (1980).
112 CosLanunl, lranklln and LllzabeLh Lacy. ºlnLroducuon of a rabblL 8-globln gene
lnLo Lhe mouse germ llne." Notote. vol. 294, lss. S. november 1981 aL 91 Lo 93.
113 lernandez-Corne[o (2004) aL 19.
114 Pammer, 8oberL eL al. ºÞroducuon of Lransgenlc rabblLs, sheep and plgs by
mlcroln[ecuon." Notote. vol. 31S. !une 198S aL 680.
11S S1 led. 8eg. 23302. (!un. 26, 1986).
116 Shoemaker (2001) aL 7.
117 uSuA AÞPlS. º8loLechnology 8egulaLory PlsLory." Avallable aL hup://www.aphls. Accessed !anuary 4, 2010.
118 Shoemaker (2001) aL 21, uSuA AÞPlS. º8loLechnology 8egulaLory PlsLory."
119 lernandez-Corne[o (2004) aL 19, Shoemaker (2001) aL 9.
120 uSuA AÞPlS. º8loLechnology 8egulaLory PlsLory."
121 Curlan-Sherman, uoug. unlon of Concerned SclenusLs. ºlallure Lo ?leld." Aprll
2009 aL 1S.
122 u.S. LnvlronmenLal ÞroLecuon Agency (LÞA). uraf WhlLe Þaper. Concernlng dl-
eLary exposure Lo C8?9C proLeln produced by SLarllnkC corn and Lhe poLenual
rlsks assoclaLed wlLh such exposure. CcLober 16, 2007.
123 luA. Culdance for lndusLry: volunLary Labellng lndlcaung WheLher loods
Pave or Pave noL 8een ueveloped uslng 8loenglneerlng, uraf Culdance.
2001. Avallable aL hup://
Accessed uecember 1S, 2010.
124 luA. CenLer for veLerlnary Medlclne. ºCuldance for lndusLry 187: 8egulauon
of Ceneucally Lnglneered Anlmals ConLalnlng PerlLable 8ecomblnanL unA
ConsLrucLs." llnal Culdance. !anuary 1S, 2009 aL S.
12S uSuA. Þubllc uaLa of ÞermlL lnformauon. Aprll 28, 2011, uSuA. ºÞeuuons for
nonregulaLed SLaLus CranLed or Þendlng by AÞPlS as of !uly 18, 2011."
126 uSuA. Þubllc uaLa of ÞermlL lnformauon.
lood & WaLer WaLch - !anuary 2014 25
127 lood & WaLer WaLch analysls of CenLer for 8esponslve Þollucs daLa, avallable
aL See lood & WaLer WaLch. ºlood and AgrlculLure
8loLechnology lndusLry Spends More 1han Palf a 8llllon uollars Lo lnßuence
Congress." lssue 8rlef. november 2010 aL 1.
128 Þew lnluauve on lood and 8loLechnology (2001) aL 2.
129 uSuA. 8loLechnology 8egulaLory Servlces. ºAÞPlS 8loLechnology: Þermlmng
Þrogress lnLo 1omorrow." lacLsheeL. lebruary 2006 aL 1.
130 7 u.S.C. §7701(3) (2000), uSuA 8loLechnology 8egulaLory Servlces (2006) aL 1 Lo 4.
131 7 Cl8 §372.S (b)(3) (199S).
132 lernandez-Corne[o and Caswell (2006) aL 3.
133 7 Cl8 §340.6(a) (2008), Þew lnluauve on lood and 8loLechnology (2001) aL 11 Lo 12.
134 u.S. CovernmenL AccounLablllLy Cmce (CAC). ºCeneucally Lnglneered
Crops: Agencles Are Þroposlng Changes Lo lmprove CverslghL, buL Could 1ake
Addluonal SLeps Lo Lnhance Coordlnauon and MonlLorlng." 8eporL Lo Lhe
Commluee on AgrlculLure, nuLrluon, and loresLry, u.S. SenaLe. (CAC-09-60).
november 2008 aL 11.
13S 7 u.S.C. 136(u)(1), 40 Cl8 174.3. See ºplanL-lncorporaLed proLecLanL."
136 7 u.S.C. 136(u)(1).
137 CAC (2008) aL 11.
138 7. u.S.C. prec. 121, LÞA. ºlll8A AmendmenLs of 1988." [Þress 8elease]. CcLo-
ber 26, 1988.
139 7 u.S.C. 136a(c)(S).
140 40 Cl8 1S2.1(a).
141 40 Cl8 172.3(a), 40 Cl8 180, 40 Cl8 1S2.1(a), Þew lnluauve on lood and
8loLechnology (2001) aL 13 Lo 14.
142 21 u.S.C. 301 (2002), Þew lnluauve on lood and 8loLechnology (2001) aL 1S.
143 CAC (2002) aL 9.
144 21 Cl8 170.3S(c)(1)(lll), Þew lnluauve on lood and 8loLechnology (2001) aL 20 Lo 21.
14S Þew lnluauve (2001) aL 21, noLe 1S., luA. C8AS nouce lnvenLory. uaLa on ñle
and avallable aL hup://
cfm?rpL=grasLlsung. Accessed Aprll 28, 2011.
146 LÞA (2007) aL 6.
147 luA CenLer for veLerlnary Medlclne (2009) aL 4 Lo S.
148 8loLechnology lndusLry Crganlzauon. ºCeneucally Lnglneered Anlmals lre-
quenLly Asked Cuesuons." CcLober 22, 2009 aL 2 Lo 4.
149 Luropean ÞarllamenL and Lhe Councll. ºulrecuve 2001/18/LC of Lhe Luropean
ÞarllamenL and of Lhe Councll of 12 March 2001 on Lhe dellberaLe release
lnLo Lhe envlronmenL of geneucally modlñed organlsms and repeallng Councll
ulrecuve 90/220/LLC." O[clol Iootool of tbe íotopeoo commoolues. March
12, 2001 aL 7 and 2S.
1S0 Luropa-Luropean Commlsslon.ºLu 8eglsLer of Ceneucally Modlñed lood and
leed." 2011. See hup://
1S1 lblJ.
1S2 Luropean Commlsslon. ºAgrlculLure ln Lhe Lu: SLausucal and Lconomlc lnfor-
mauon 8eporL 2010." March 2011 aL 43 and 381, !ames (2012) aL 6.
1S3 Luropean ÞarllamenL and Councll. º8egulauon (LC) no 1829/2003 of Lhe
Luropean ÞarllamenL and of Lhe Councll of 22 SepLember 2003 on geneucally
modlñed food and feed." O[clol Iootool of tbe íotopeoo uoloo. CcLober 18,
2003 aL Arucle 12.2.
1S4 Þew Clobal AmLudes Þro[ecL. º8road opposluon Lo geneucally modlñed
foods." !une 20, 2003.
1SS Speclal LurobaromeLer 341/Wave 73.1. º8loLechnology." 8eporL. CcLober
2010 aL 18.
1S6 Luropa-Luropean Commlsslon. º8ules on CMCs ln Lhe Lu- 8an on CMCs
Culuvauon." Avallable aL hup://
gmo_ban_culuvauon_en.hLm, lvanova, lrlna. º8ulgarla parllamenL bans CMC
crops Lo sooLhe fears." keotets. March 18, 2010, kovalyova, SveLlana. ºlLaly
reglons push mlnlsLer for omclal CM ban." keotets. SepLember 30, 2010.
1S7 Luropean ÞarllamenL and Lhe Councll (2001) aL L 106/13, Arucle 23.
1S8 Þollack, Andrew. ºCrop SclenusLs Say 8loLechnology Seed Companles Are
1hwarung 8esearch." New ¥otk 1lmes. lebruary 20, 2009.
1S9 Serallnl, Cllles-Lrlc eL al. ºLong Lerm LoxlclLy of a 8oundup herblclde and a
8oundup-LoleranL geneucally modlñed malze." looJ ooJ cbemlcol 1oxlcoloqy.
vol. S0, lss. 11. november 2012.
160 Þollack, Andrew. ºloes of modlñed corn ñnd supporL ln sLudy." New ¥otk
1lmes. SepLember 19, 2012, Luropean Commlsslon. º8esearch and lnnova-
uon, lÞ Calls: leed1rlals k88L 2013." Accessed SepLember S, 2013, Serallnl eL
al. (2012).
161 MalaLesLa, Manuela eL al. ºulLrasLrucLural MorphomeLrlcal and lmmuno-
cyLochemlcal Analyses of PepaLocyLe nuclel from Mlce led on Ceneucally
Modlñed Soybean." cell 5ttoctote ooJ loocuoo. vol. 27, 2002 aL AbsLracL,
ClsLerna, 8. eL al. ºCan a geneucally-modlñed organlsm-conLalnlng dleL lnßu-
ence embryo developmenL? A prellmlnary sLudy on pre-lmplanLauon mouse
embryos." íotopeoo Iootool of nlstocbemlstty. 2008 aL 263.
162 Serallnl, Cllles-Lrlc eL al. ºnew Analysls of a 8aL leedlng SLudy wlLh a Ceneu-
cally Modlñed Malze 8eveals Slgns of PepaLorenal 1oxlclLy." Atcblves of
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163 Agodl, AnLonella eL al. ºueLecuon of geneucally modlñed unA sequences ln
mllk from Lhe lLallan markeL." lotetoouoool Iootool of nyqleoe ooJ íovltoo-
meotol neoltb. !anuary 10, 2006 aL AbsLracL.
164 Puber, uon M. ºAg Chemlcal and Crop nuLrlenL lnLeracuons- CurrenL updaLe."
Þroceedlngs lluld lerullzer lorum (Scousdale, Arlz.). vol. 27. lluld lerullzer
loundauon. lebruary 14-16, 2010 aL 3.
16S lblJ. aL 8, !ohal, C.S. and u.M. Puber. ºClyphosaLe eñecLs on dlseases of
planLs." íotopeoo Iootool of Aqtooomy. vol. 31. 2009 aL 144., kremer, 8oberL
!. and naLhan L. Means. ºClyphosaLe and glyphosaLe-reslsLanL crop lnLerac-
uons wlLh rhlzosphere mlcroorganlsms." íotopeoo Iootool of Aqtooomy. vol.
31. 2009 aL 1S3.
166 Þaganelll, Ale[andra eL al. ºClyphosaLe-8ased Perblcldes Þroduce 1eraLogenlc
LñecLs on verLebraLes by lmpalrlng 8elnolc Acld Slgnallng." cbem. kes. 1oxlcol.
vol. 23, AugusL 2010 aL 1S86.
167 8enachour, nora and Cllles-Lrlc Serallnl. ºClyphosaLe lormulauons lnduce
ApopLosls and necrosls ln Puman umblllcal, Lmbryonlc, and ÞlacenLal Cells."
cbem. kes. 1oxlcol. vol. 22. 2009 aL 97.
168 CAC (2002) aL 30.
169 uSuA L8S. ºAdopuon of Ceneucally Lnglneered Crops ln Lhe u.S." updaLed
!uly 1, 2011.
170 ?oung, Lmma. ºCM pea causes allerglc damage ln mlce." New 5cleoust.
november 21, 200S.
171 LÞA (2007) aL 7.
172 lblJ. aL 9.
173 lblJ. aL 10.
174 lblJ. aL 1.
17S luA (2001).
176 lernandez-Corne[o and Caswell (2006) aL 1.
177 koplckl, Alllson. ºSLrong SupporL for Labellng Modlñed loods." New ¥otk
1lmes. !uly 27, 2013.
178 Consumers unlon. ºluA wlll noL requlre labellng of meaL or ñsh from geneu-
cally englneered anlmals." [Þress 8elease]. !anuary 1S, 2009.
179 lblJ., luA CenLer for veLerlnary Medlclne. Culdance for lndusLry. º8egulauon
of geneucally englneered anlmals conLalnlng herlLable recomblnanL unA
consLrucLs." !anuary 1S, 2009 aL 23.
180 Senauer, 8en[amln. unlverslLy of MlnnesoLa, lood Þollcy 8esearch CenLer.
ºConslderlng Lhe MandaLory Labellng of Ceneucally-Lnglneered (CL) loods
ln Lhe u.S." lssue 8rlef. AugusL 2013 aL 1, uurkln, Alanna. ºMalne advances
geneucally modlñed food labels." 8osloessweek. !une 12, 2013, nauonal CoL-
Lon Councll. ºConnecucuL approves labellng CL foods." !une 10, 2013.
181 ºlnLerlm guldance on Lhe volunLary Labellng of Mllk and Mllk ÞroducLs lrom
Cows 1haL Pave noL 8een 1reaLed WlLh 8ecomblnanL 8ovlne SomaLoLropln."
S9 led. 8eg. 6279. (leb. 10, 1994).
182 lblJ.
183 lblJ.
184 8osenfeld, SLeven Þ. ºualry cooperauve says lL wlll ñghL MonsanLo sulL." As-
socloteJ ltess. lebruary 21, 1994.
18S luA. ºluA Warns Mllk Þroducers Lo remove 'hormone free' clalms from Lhe
labellng of dalry producLs." [Þress 8elease]. SepLember 12, 2003.
186 Pedges, SLephen !. ºMonsanLo havlng a cow ln mllk label dlspuLe." cblcoqo
1tlbooe. Aprll 1S, 2007 aL C1.
187 McCarLhy, Colman. ºMonsanLo's cash cow Lrlps mllk alarm." wosbloqtoo lost.
March 1, 1994 aL u20.
188 Cllgoñ, Penry. ºualry labels go sour, lL's hard Lo mllk anuhormone senumenL."
New ¥otk NewsJoy. March 24, 1994 aL A49.
189 Wu, Cllvla. ºualry companles sue llllnols Lo allow change ln labels." cblcoqo
5oo-1lmes. May 8, 1996 aL A14, 8erselll, 8eLh. ºSeulemenL reached ln hor-
mone labellng case." wosbloqtoo lost. AugusL 1S, 1997 aL A22.
190 lblJ.
191 º8en and !erry's, sLaLe ln accord on growLh hormone sLaLemenL." cblcoqo
1tlbooe. AugusL 14, 1997 aL 8u4, 8erselll (1997).
192 8erselll (1997).
193 Melcer, 8achel. ºLawmakers conslder blll Lo resLrlcL labels on mllk conLalners."
5t. lools lost-ulspotcb. Aprll 17, 2008 aL 81.
26 Ceoeucolly íoqloeeteJ looJ. Ao Ovetvlew
194 ºuLah proposes rules on mllk labels." AssocloteJ ltess SLaLe & Local Wlre.
lebruary 28, 2008.
19S Lewls, Zachary. ºSLaLe eases label rule for hormone ln cows." clevelooJ llolo
ueolet. March 27, 2008 aL C1.
196 Melcer (2008), Avrll, 1om. ºPormone labellng of Þa. mllk Lo end." lblloJelpblo
lopoltet. uecember 23, 2007 aL A01.
197 Malloy, uanlel. ºSLaLe reverses on dalry labellng, allows hormone clalms."
llusbotqb lost-Cozeue. !anuary 18, 2008 aL A1.
198 Melcer (2008).
199 Acuons on Mlsslourl S8 1279 (2008). Avallable aL: hup://www.senaLe. Ac-
cessed Aprll 1, 2009.
200 lotetoouoool uolty looJs Ass´o v. 8oqqs, 622 l.3d 628, 632 (2010), Clapp,
SLephen. ºSLaLe of Chlo abandons regulauons agalnsL 'r8S1-free' clalms." looJ
cbemlcol News. november 2, 2011.
201 nauonal 8esearch Councll. º1he lmpacL of geneucally englneered crops on
farm susLalnablllLy ln Lhe unlLed SLaLes." Aprll 13, 2010 aL S-3 and S-13. (Þre-
Þubllcauon Copy).
202 Peap, lan. 1he lnLernauonal Survey of Perblclde 8eslsLanL Weeds. ºPerblclde-
8eslsLanL Weeds by SlLe of Acuon." Avallable aL
Accessed May 2, 2013.
203 Clapp (May 18, 2009), Wllson, Mlke. ºMuluple-reslsLance weeds comlng Lo a
ñeld near you?" westeto lotmet 5tockmoo. lebruary 28, 2008.
204 Clapp, SLephen. ºPerblclde dlverslLy called crlucal Lo keep 8oundup eñecuve.
looJ cbemlcol News. !uly 20, 2009.
20S ºClyphosaLe-reslsLanL weed problem exLends Lo more specles, more farms."
lotm loJostty News. !anuary 29, 2013.
206 Clapp, SLephen. ºSLudy says farmers relylng on 8oundup may weaken ben-
eñLs." looJ cbemlcol News. Aprll 20, 2009.
207 lblJ.
208 Poward, Þhll. Mlchlgan SLaLe unlverslLy. ºSeed lndusLry SLrucLure, 1996-
2008." 2009. Avallable aL hups://
and on ñle. Accessed SepLember 8, 2009, lernandez-Corne[o (2004) aL 2S Lo
26 and 1able 18.
209 Poward Þhll. Mlchlgan SLaLe unlverslLy. ºSeed lndusLry SLrucLure, Cross-
Llcenslng AgreemenLs for Ceneucally Lnglneered 1ralLs." 2009, lernandez-
Corne[o (2004) aL 40.
210 lood & WaLer WaLch Analysls of daLa from uSuA nauonal AgrlculLural SLa-
usucs Servlce (nASS). 2000-2012 Þrlce Þald for Corn, Couon, and Soybeans.
uaLa avallable aL hup://
211 Crganlzauon for Compeuuve MarkeLs. ºMonsanLo 1ransgenlc 1ralL uomlnance
ln uS MarkeL, 1996-2007." !une 2008, lernandez-Corne[o (2004) aL 34 .
212 Pendrlckson, Mary and 8lll Peñernan. ueparLmenL of 8ural Soclology, unlverslLy
of Mlssourl-Columbla. ºConcenLrauon of AgrlculLural MarkeLs." Aprll 2007.
213 Shoemaker (2001) aL v.
214 Parl, nell L. Charles l. Curuss ulsungulshed Þrofessor of AgrlculLure and
Þrofessor of Lconomlcs, lowa SLaLe unlverslLy. º1he SLrucLural 1ransformauon
of AgrlculLure." ÞresenLauon aL 2003 MasLer larmer Ceremony, WesL ues
Molnes, lowa. March 20, 2003 aL 10.
21S lernandez-Corne[o (2004) aL 19.
216 8oss, uouglas. ºAnuLrusL enforcemenL and agrlculLure." Address before Lhe
Amerlcan larm 8ureau Þollcy uevelopmenL Meeung. kansas ClLy, Mlssourl.
AugusL 20, 2002 aL 9.
217 MonsanLo lnc. ºMonsanLo Challenges unauLhorlzed use of 8oundup 8eadyº
1echnology by uuÞonL." [Þress 8elease]. May S, 2009, MonsanLo lnc. ºMon-
sanLo - Why we're sulng uuÞonL." Avallable aL hup://
duponLlawsulL/ and on ñle. Accessed uecember 8, 2009.
218 MonsanLo, lnc. Securlues and Lxchange Commlsslon. 10k llllng. CcLober 27,
2009 aL 6, Schlmmelpfennlg, uavld L. eL al, º1he lmpacL of seed lndusLry con-
cenLrauon on lnnovauon: A sLudy of u.S. bloLech markeL leaders." Aqtlcoltotol
ícooomlcs. vol. 30, lss. 2. March 2004 aL 1S9.
219 MonsanLo Co. (2013), uSuA nASS. ºÞlanLed Acreage- Corn, Couon, Soy-
beans." May S, 2013., uSuA L8S. ºAdopuon of Ceneucally Lnglneered Crops ln
Lhe u.S." updaLed !uly 9, 2013.
220 lernandez-Corne[o (2004 aL 21).
221 larmers' Legal Acuon Croup (lLAC). ºlarmers' Culde Lo CMCs." lebruary
2009 aL 9.
222 Þollack, Andrew. ºAs ÞaLenL Lnds, a Seed's use Wlll Survlve." New ¥otk
1lmes. uecember 18, 2009, Cowan, 1adlock. Congresslonal 8esearch Servlce.
ºAgrlculLural 8loLechnology: 8ackground and 8ecenL lssues." (8L32809).
SepLember 2, 2010 aL 27, MonsanLo. º1echnology use Culde: 2011." 2011 aL
2. Avallable aL hup://
223 8arleu, uonald L. and !ames 8. SLeele. ºMonsanLo's harvesL of fear." voolty
lolt. May 2008.
224 CenLer for lood SafeLy. ºSeed ClanLs vs. u.S. larmers." 2013 aL 30.
22S 7 Cl8 20S.2.
226 unlon of Concerned SclenusLs (uCS). ºCone Lo Seed: 1ransgenlc ConLamlnanLs
ln Lhe 1radluonal Seed Supply." 2004 aL 28.
227 lblJ. aL 24.
228 lLAC aL 29 Lo 31, LllsLrand, norman. ºColng Lo CreaL LengLhs Lo ÞrevenL
Lhe Lscape of Cenes 1haL Þroduce SpeclalLy Chemlcals." lloot lbysloloqy.
AugusL 2003.
229 MonsanLo. º1echnology use Culde: 2011" aL 7.
230 7 Cl8 20S.2, Conner, uavld S. ºÞesucldes and Ceneuc urlf: AlLernauve Þrop-
erLy 8lghLs Scenarlo." cbolces. llrsL CuarLer 2003 aL S.
231 Conner (2003) aL S.
232 Mallory-SmlLh, Carol and Marla Zaplola. ºCene ßow from glyphosaLe-reslsLanL
crops." lest Moooqemeot 5cleoce. vol. 64, 2008 aL 434.
233 lblJ.
234 lLAC aL 29 Lo 31, LllsLrand (2003).
23S ulmlLrl, Carolyn and Lydla CberholLzer. uSuA L8S. ºMarkeung u.S. Crganlc
loods: 8ecenL 1rends lrom larms Lo Consumers." 8ulleun number S8. Sep-
Lember 2009 aL AbsLracL.
236 Mc8rlde, Wllllam u. and CaLherlne Creene. uSuA L8S. ºA Comparlson of
Convenuonal and Crganlc Mllk Þroducuon SysLems ln Lhe u.S." Þrepared
for presenLauon aL Lhe Amerlcan AgrlculLural Lconomlcs Assoclauon Annual
Meeung (ÞorLland, Cre.). !uly 29-AugusL 1, 2007 aL 13 and 17, lood & WaLer
WaLch analysls of average consumer prlce daLa from Lhe u.S. 8ureau of Labor
SLausucs, Consumer Þrlce lndex-Average Þrlce uaLa. larmgaLe prlces from
uSuA nASS AgrlculLural Þrlces Annual Summary.
237 Clllam, Carey. ºuSuA wlll noL Lake acuon ln case of CMC alfalfa conLamlna-
uon." keotets. SepLember 17, 2013.
238 kaskey, !ack. ºMonsanLo says rogue wheaL ln Cregon may be saboLage."
8loombetq. !une S, 2013.
239 Þew Clobal AmLudes Þro[ecL. ºvlews of a Changlng World." !une 2003 aL 90 Lo 91.
240 Luropean ÞarllamenL and Councll. 8egulauon (LC) no 1829/2003. CcLober 18,
2003 aL L 268/9.
241 Shoemaker (2001) aL 32.
242 Penshaw, Carollne. ºLu Lo AdmlL CM MaLerlal ln Anlmal leed." woll 5tteet
Iootool. lebruary 22, 2011.
243 Luropean ÞarllamenL and Councll. 8egulauon (LC) no 1829/2003 aL Arucle 12.2.
244 Luropean Commlsslon. ºCMCs ln a nuLshell." See ºWhlch Lu counLrles ban
Lhe culuvauon of CMCs?" Avallable aL hup://
Lechnology/qanda/d4_en.hLm#d. Accessed March 9, 2011.
24S ur. SaLo, Suguro. uSuA lorelgn AgrlculLural Servlce, Clobal AgrlculLure lnforma-
uon neLwork. º!apan 8loLechnology Annual 8eporL 2008." !uly 1S, 2008 aL 3.
246 CAC (2008) aL 14.
247 LÞA (2007), Þollock, kevln. ºAvenus Clves up Llcense 1o Sell 8loenglneered
Corn." New ¥otk 1lmes. CcLober 13, 2000, CAC (2008) aL 16, CarLer, Colln A.
Þrofessor, ueparLmenL of AgrlculLural and 8esource Lconomlcs, unlverslLy of
Callfornla, uavls. SLaLemenL before Lhe uomesuc Þollcy Subcommluee of Lhe
u.S. Pouse CverslghL and CovernmenL 8eform Commluee. March 13, 2008 aL 2.
248 Leake, 1odd. uakoLa 8esource Councll SLaLemenL before Lhe uomesuc Þollcy
Subcommluee of Lhe u.S. Pouse CverslghL and CovernmenL 8eform CommlL-
Lee. March 13, 2008 aL 2.
249 PowlngLon, Parvey. vlce ÞresldenL u.S. 8lce Þroducers Assoclauon. SLaLemenL
before Lhe uomesuc Þollcy Subcommluee of Lhe u.S. Pouse CverslghL and
CovernmenL 8eform Commluee. March 13, 2008 aL 1.
2S0 lblJ. aL 3.
2S1 McConnell, Sean. ºAnlmal feed conLalnlng lllegal CM malze lmpounded." 1be
ltlsb 1lmes. May 21, 2007.
2S2 Cmce of Lhe u.S. 1rade 8epresenLauve. º2010 8eporL on SanlLary and ÞhyLos-
anlLary Measures." 2010 aL 20.
2S3 lood & WaLer WaLch Analysls of: u.S. ueparLmenL of SLaLe (uoS). Cable no.
07S1A1L160639. november 27, 2007, u.S. uoS. ºl? 2009 bloLechnology
ouLreach sLraLegy and deparLmenL resources." Cable no. 08S1A1L129940.
uecember 10, 2008, u.S. uoS. ºl? 2010 bloLechnology ouLreach sLraLegy and
deparLmenL resources." Cable no. 09S1A1L122732. uecember 1, 2009.
2S4 MonsanLo. º8esearch and uevelopmenL Þlpellne." 8rochure. 2011 aL 2. Avall-
able aL hup://
lood & WaLer WaLch - !anuary 2014 27
2SS MonsanLo. ºuo CM Crops lncrease ?leld?" 2009. Avallable aL hup://www.Þages/do-gm-crops-lncrease-yleld.aspx. Accessed
lebruary 26, 2011.
2S6 ºnon-bloLech soybean acreage lncreaslng ln Lhe unlLed SLaLes." looJ cbeml-
col News. AugusL 17, 2009.
2S7 Þrlce, Cregory k. eL al. uSuA L8S. ºSlze and ulsLrlbuuon of MarkeL 8eneñLs
from Adopung 8loLech Crops." 1echnlcal 8ulleun no. 1906. november 2003 aL
2S8 looJ cbemlcol News. AugusL 17, 2009, Whlgham, kleLh, lowa SLaLe unlverslLy.
ºPow Lo lower soybean seed cosLs." loteqtoteJ ctop Moooqemeot. lC-
480(23). CcLober 12, 1998, lL Lakes abouL 1.3 bags of soybean seeds per acre
(assumlng Lhe mosL common 3,000 seeds per pound and a LargeL 200,000
seeds per acre).
2S9 uSuA nASS. CulcksLaLs: Þrlce Þald for 8ow Crops, 8loLech and non-8loLech
Corn and Soybean. Cn ñle and avallable aL hup://
260 Curlan-Sherman (2009) aL 22 and 33.
261 Cordon, 8arney. ºManganese nuLrluon of glyphosaLe-reslsLanL and conven-
uonal soybeans." 8euet ctops. vol. 91, no. 4. 2007 aL 12.
262 MonsanLo. ºnuLrluon." Avallable aL hup://www.producemoreconservemore.
com. Accessed lebruary 26, 2011.
263 naqvl eL al. º1ransgenlc muluvalLamln corn Lhrough bloforuñcauon of endo-
sperm wlLh Lhree vlLamlns represenung Lhree dlsuncL meLabollc paLhways."
ltoceeJloqs of tbe Nouoool AcoJemy of 5cleoces. vol. 106, no. 19. May 12,
2009 aL 7762.
264 ?e eL al. (2000) aL 303.
26S krawlnkel, Mlchael. ºµ-CaroLene from rlce for human nuLrluon?" Am I cllo
Nott. vol. 90. 2009 aL 696.
266 lblJ. aL 696, 8urgess, Ann and ÞeLer Clasauer. lood and AgrlculLure Crganlza-
uon of Lhe unlLed nauons. ºlamlly nuLrluon Culde." 2004 aL 22.
267 krawlnkel (2009) aL 696, 1ang eL al. ºColden 8lce ls an eñecuve source of
vlLamln A." Am I cllo Nott. vol. 89. 2009 aL 1776 Lo 1778.
268 uSuA. ºÞeuuons for nonregulaLed SLaLus CranLed or Þendlng by AÞPlS as of
!uly 18, 2011."
269 8urgess and Clasauer (2004) aL 22.
270 MonsanLo. ºuo CM Crops lncrease ?leld?" 2009. Avallable aL hup://www.Þages/do-gm-crops-lncrease-yleld.aspx. Accessed
lebruary 26, 2011.
271 MonsanLo. ºMonsanLo 8loLechnology 1ralL Acreage: llscal ?ears 1996-2009."
2009. Cn ñle and avallable aL hup://
menLs/2009/q4_bloLech_acres.pdf, uSuA nASS Culck SLaLs, Acres ÞlanLed,
Corn and Soybeans, MonsanLo. 8oundup Þower Max Perblclde. 8rochure.
2008 aL 4.
272 MonsanLo. ºMonsanLo 8loLechnology 1ralL Acreage: llscal ?ears 1996-2009."
273 lood & WaLer WaLch analysls of uSuA nASS. CulcksLaLs. AgrlculLural Survey,
ÞlanLed Acres (Corn, upland Couon, Soybean ÞlanLed Acres), Chemlcal
use, number of Appllcauons and Average Appllcauons of Acuve lngredlenL
(ClyphosaLe) ln lbs. per acre.
274 nauonal 8esearch Councll (2010) aL S-3 and S-13.
27S lbrahlm eL al. ºWelghL of Lhe Lvldence on Lhe Puman CarclnogenlclLy of 2,4-u."
íovltoomeotol neoltb letspecuves. vol. 96. 1991 aL 213, Payes, 1yrone eL al.
ºPermaphrodluc, demascullnlzed frogs afer exposure Lo Lhe herblclde aLrazlne
aL low ecologlcally relevanL doses." ltoceeJloqs of tbe Nouoool AcoJemy of
5cleoces. vol. 99, no. 8. Aprll 2002 aL S476, SLoker, 1ammy L. eL al. ºMaLernal
exposure Lo aLrazlne durlng lacLauon suppresses suckllng-lnduced prolacun
release and resulLs ln prosLauus ln Lhe adulL oñsprlng." 1oxlcoloqlcol 5cleoces.
vol. S2. 1999 aL 68, LÞA. º2,4-u: Chemlcal Summary." 2007 aL 1 and S.
276 MonsanLo. ºMonsanLo CuLllnes new Weed ManagemenL Þlauorm under Lhe
8oundup 8eady ÞLuS 8rand." [Þress 8elease]. CcLober 19, 2010.
277 uSuA. ºÞeuuons for nonregulaLed SLaLus CranLed or Þendlng by AÞPlS as
of May 6, 2013.", kaskey, !ack. ºuow Þlans new 1ralL Lo CombaL 8oundup-
8eslsLanL Weeds." 8loombetq 8osloessweek. May S, 2010.
278 LaurenL, lrançols eL al. ºMeLabollsm of [14C]-2,4-dlchlorophenol ln edlble
planLs." lest Moooqemeot 5cleoce. vol. 62. 2006 aL SS8.
279 uSuA. ºÞeuuons for nonregulaLed SLaLus CranLed or Þendlng by AÞPlS as of
May 6, 2013."
280 MonsanLo. ºPow can we squeeze more food from a ralndrop?" 2008. Cn ñle.
281 lnLernauonal AssessmenL of AgrlculLural knowledge, Sclence and 1echnology
for uevelopmenL (lAAS1u). ºLxecuuve Summary of SynLhesls 8eporL." Aprll
2008 aL 8 Lo 9.
282 SLelner, Cerald. SLaLemenL of Lhe Lxecuuve vlce ÞresldenL, SusLalnablllLy and
CorporaLe Añalrs, MonsanLo Company, before Lhe Pouse lorelgn Añalrs Com-
mluee. !uly 20, 2010 aL 1.
283 CenLleman, Amella. ºuespalr Lakes Loll on lndlan farmers-Asla-Þaclñc- lnLerna-
uonal Perald 1rlbune." New ¥otk 1lmes. May 31, 2006, SengupLa, Somlnl. ºCn
lndla's farms, a plague of sulclde." New ¥otk 1lmes. SepLember 19, 2006.
284 SengupLa (2006).
28S kuruganu, kavlLha. ºLñecLs of pesuclde exposure on developmenLal Lask per-
formance ln lndlan chlldren." cbllJteo, ¥ootb ooJ íovltoomeots. vol. 1S, lss.
1. 200S aL 86, 1hakur, !.S. eL al. ºLpldemlologlcal SLudy of Plgh Cancer Among
8ural AgrlculLural CommunlLy of Þun[ab ln norLhern lndla." lotetoouoool Ioot-
ool of íovltoomeotol keseotcb ooJ lobllc neoltb. vol. S, lss. S. 2008 aL 40S.
286 SengupLa (2006).
287 SalnaLh, Þ. º17,368 farm sulcldes ln 2009." 1be nloJo. uecember 27, 2010.
288 Þreuy, !.n. eL al. º8esource-Conservlng AgrlculLure lncreases ?lelds ln uevel-
oplng CounLrles." íovltoomeotol 5cleoce ooJ 1ecbooloqy, vol. 40, no. 4. 2006
aL 1114.
289 See 8adgley, CaLherlne eL al. ºCrganlc agrlculLure and Lhe global food supply."
keoewoble Aqtlcoltote ooJ looJ 5ystems. vol. 22, lss. 2. 2007 aL 86 Lo 108.
290 MonsanLo. ºCllmaLe Change." Avallable aL hup://www.producemoreconserve- Accessed lebruary 26, 2011.
291 lAAS1u. ºAgrlculLure aL a Crossroads." Clobal 8eporL. 2009 aL 28S.
292 1o daLe, Lhe unlLed SLaLes has only approved herblclde LoleranL and lnsecL
LoleranL canola, corn, couon and soybeans as well as vlrus reslsLanL squash
and papayas. lernandez-Corne[o (2008) aL 6, lSAAA º8loLech crops polsed for
second wave of growLh." [Þress 8elease]. lebruary 11, 2009, uSuA. ºÞeuuons
for nonregulaLed SLaLus CranLed or Þendlng by AÞPlS as of lebruary 1, 2012."
293 lAAS1u (2009) aL 161.
294 8rasher, Þhlllp. ºMonsanLo Lo LesL seed LhaL mlghL beaL droughL." ues Moloes
keqlstet. May 21, 2011
29S lAAS1u (2009) aL 10.
296 MonsanLo. ºnaLural 8esources." Avallable aL hup://www.producemorecon- Accessed lebruary 26, 2011.
297 lAAS1u (2009) aL 9.
298 PoeksLra, A.?. and A.k. Chapagaln, ºWaLer looLprlnLs of nauons: WaLer use
by Þeople as a luncuon of 1helr Consumpuve Þauern," wotet kesootce Moo-
oqemeot. vol. 21. 2007 aL 38, uSuA L8S. ºMa[or uses of Land ln Lhe unlLed
SLaLes, 2002." Lconomlc lnformauon 8ulleun 14. May 200S aL AbsLracL.
299 World 8ank. World uevelopmenL 8eporL 2008: AgrlculLure for uevelopmenL.
2007 aL 64.
300 lblJ.
301 8orlaug, norman L. º1he Creen 8evoluuon and Lhe 8oad Ahead." Speclal 30Lh
Annlversary LecLure. 1he nobel lnsuLuLe. Cslo. SepLember 8, 2000 aL S and 7.
302 uSuA. º2007 Census of AgrlculLure: larm and 8anch lrrlgauon Survey (2008)."
vol. 3, ÞL. 1. !uly 2010 aL 1able 27.
303 uennehy, kevln l. u.S. Ceologlcal Survey (uSCS). ºPlgh Þlalns reglonal ground-
waLer sLudy." uSCS lacL SheeL, lS-091-00. AugusL 2000 aL 2.
304 Curdak, !ason !. eL al. uSCS. ºWaLer CuallLy ln Lhe Plgh Þlalns Aqulfer,
Colorado, kansas, nebraska, new Mexlco, Cklahoma, SouLh uakoLa, 1exas,
and Wyomlng, 1999-2004." Clrcular 1337. 2009 aL 10, McCulre, v.L. uSCS.
ºChanges ln WaLer Levels and SLorage ln Lhe Plgh Þlalns Aqulfer, Þredevelop-
menL Lo 2007." 2009.
30S Þew lnluauve on lood and 8loLechnology. (2001) aL 20 Lo 21.
306 CAC (2008) aL 4.
307 7 u.S.C. §7701(3) (2000), uSuA. 8loLechnology 8egulaLory Servlces. ºAÞPlS
8loLechnology: Þermlmng Þrogress lnLo 1omorrow." 2006 aL 1 Lo 4.
308 7 Cl8 §340.3 (a)-(b) (2008).
309 7 Cl8 §340.3 (b)-(c),(e)(4) (2008), Þew lnluauve on lood and 8loLechnology
(2001) aL 11.
310 7 Cl8 §340.3 (e)(S) (2008), Þew lnluauve on lood and 8loLechnology (2001) aL
311 7 Cl8 340.3, 7 Cl8 §§372.S (c)-(d) (199S), Þew lnluauve on lood and 8lo-
Lechnology. ºlssues ln Lhe 8egulauon of Ceneucally Lnglneered ÞlanLs and
Anlmals." Aprll 2004 aL 33.
312 7 Cl8 §340.4(b) (2008), Þew lnluauve on lood and 8loLechnology (2001) aL 10.
313 7 Cl8 §340.4(b) (2008), uSuA. 8loLechnology 8egulaLory Servlces. ºAÞPlS
8loLechnology: Þermlmng Þrogress lnLo 1omorrow." (2006) aL 3.
314 7 Cl8 §340.4(f)(2008), uSuA. 8loLechnology 8egulaLory Servlces. ºAÞPlS
8loLechnology: Þermlmng Þrogress lnLo 1omorrow." (2006) aL 2.
31S lernandez-Corne[o and Caswell (2006) aL 3.
316 7 Cl8 §340.4(f)(9) (2008).
317 7 Cl8 §340.4(g) (2008).
318 7 Cl8 §372.S (b)(3) (199S).
319 uSuA 8loLechnology 8egulaLory Servlces. ºnauonal LnvlronmenLal Þollcy AcL and
lLs 8ole ln uSuA's 8egulauon of 8loLechnology." lacLsheeL. lebruary 2006 aL 2.
28 Ceoeucolly íoqloeeteJ looJ. Ao Ovetvlew
320 7 Cl8 §372.9 (a), uSuA. 8loLechnology 8egulaLory Servlces. ºnauonal Lnvlron-
menLal Þollcy AcL and lLs 8ole ln uSuA's 8egulauon of 8loLechnology." (2006) aL 2.
321 7 Cl8 §372.8(b)(1) (199S).
322 uSuA AÞPlS. [Þress 8elease]. ºAÞPlS unvells cusLomer-drlven lmprovemenLs
and soluuons." november 10, 2011.
323 7 Cl8 §340.6(a) (2008), Þew lnluauve on lood and 8loLechnology (2001) aL 11
Lo 12.
324 7 Cl8 §340.6(d)(2) (2008).
32S 7 Cl8 §340.6(d)(3) (2008).
326 CAC (2008) aL 11.
327 1aylor, Mlchael 8. and !ody S. 1lck. Þew lnluauve on lood and 8loLechnology.
ºÞosL-MarkeL CverslghL of 8loLech loods - ls Lhe SysLem Þrepared?" Aprll
2003 aL 19.
328 uSuA. ClÞSA. ºCraln, 8lce & Þulses: 8loLechnology." Cn ñle and avallable aL
rd-bl. Accessed lebruary 9, 2011.
329 67 led. 8eg. S08S3-S08S4. (Aug. 6, 2002).
330 21 u.S.C. 346a(c)(2)(A), Þew lnluauve on lood and 8loLechnology (2001) aL 13.
331 21 u.S.C. 346a(b)(2)(ll) (2002).
332 8euben, Suzanne P. º8educlng LnvlronmenLal Cancer 8lsk: WhaL We Can uo
now." 1he ÞresldenL's Cancer Þanel: 2008-2009 Annual 8eporL, uepL of PealLh
and Puman Servlces, nauonal lnsuLuLes of PealLh, nauonal Cancer lnsuLuLe.
Aprll 2010 aL 46.
333 21 u.S.C. §346a(c)(2)(A) (2002), Þew lnluauve on lood and 8loLechnology
(2001) aL 14.
334 LÞA (2007) aL 7.
33S 7 u.S.C. 136(u)(1), 40 Cl8 174.3. See ºplanL-lncorporaLed proLecLanL."
336 Þew lnluauve on lood and 8loLechnology (2004) aL 39.
337 40 Cl8 172.2(a), Þew lnluauve on lood and 8loLechnology (2001) aL 12.
338 40 Cl8 172.3(a),(c).
339 40 Cl8 172.S(b).
340 40 Cl8 172.8.
341 CAC (2002) aL 7.
342 LÞA. º8lopesucldes 8eglsLrauon Acuon uocumenL: 8oclllos tbotloqleosls (8t)
ÞlanL-lncorporaLed ÞroLecLanLs." CcLober 1S, 2001 aL 17 Lo 18.
343 LÞA. ºlnsecL 8eslsLance ManagemenL lacL SheeL for 8oclllos tbotloqleosls (8t)
Corn ÞroducLs." updaLed lebruary 2011. Cn ñle and avallable aL hup://www., LÞA. ºln-
secL 8eslsLance ManagemenL lacL SheeL for 8aclllus Lhurlnglensls (8L) Couon
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344 LÞA (2001) aL 17.
34S LÞA. ºLÞA llnes MonsanLo for ulsLrlbuung Ceneucally Lnglneered Þesuclde."
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346 S7 led 8eg. 22984. (May 29, 1992 aL l).
347 66 led. 8eg. 4706. (!an. 18, 2001).
348 Þew lnluauve on lood and 8loLechnology (2001) aL 19 Lo 20.
349 lblJ. aL 20.
3S0 21 Cl8 170.30, Þew lnluauve on lood and 8loLechnology (2001) aL 21.
3S1 21 Cl8 170.3S(c)(4), (c)(S), Þew lnluauve on lood and 8loLechnology (2001) aL 20.
3S2 Cowan (SepLember 10, 2010) aL 6.
3S3 luA. C8AS nouce lnvenLory. Accessed Aprll 28, 2011.
3S4 CAC (2002) aL 11 Lo 12.
3SS 21 Cl8 171.1(c).
3S6 21 Cl8 170.38(c).
3S7 66 led. 8eg. 4708. (!an. 18, 2001), Þew lnluauve on lood and 8loLechnology
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3S8 21 Cl8 7.4(c), P.8. 27S1, 111Lh Cong. §206 (2010).
3S9 Shames, Llsa. CAC. 1esumony on Lhe lederal CverslghL of lood SafeLy: luA
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menL lLs lood ÞroLecuon Þlan. Subcommluee on CverslghL and lnvesugauons.
Commluee on Lnergy and Commerce. Pouse of 8epresenLauves. !une 12,
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360 LÞA (2007) 9.
361 luA (2009) aL 4 Lo S.
362 8loLechnology lndusLry Crganlzauon. ºCeneucally Lnglneered Anlmals lre-
quenLly Asked Cuesuons." CcLober 22, 2009 aL 4.
363 21 u.S.C. §360b(b)(1) (2002).
364 21 Cl8 S11.1, 21 u.S.C. §360b(1).
36S 21 Cl8 S11.1(b)(S), Þew lnluauve on lood and 8loLechnology (2001) aL 22.
366 21 Cl8 2S.20 (m).
367 luA. ºluA Approves Crphan urug A1ryn Lo 1reaL 8are Clomng ulsorder."
[Þress 8elease]. lebruary 6, 2009, Cowan (SepLember 10, 2010) aL 2.
368 21 Cl8 2S.S0 (b).
369 luA (2009) aL 11.
370 luA. ºCuldance for lndusLry 179: use of Anlmal Clones and Clone Þrogeny for
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371 knlghL, 8ruce l. ºAnlmal Clonlng: 1ransluonlng from Lhe Lab Lo Lhe MarkeL."
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372 lblJ.
Food & Water Watch
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1616 P St. NW, Suite 300
Washington, DC 20036
tel: (202) 683-2500
fax: (202) 683-2501

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