202105_CBIJ_academia_tool_ENG_final.pptx

Slide Materials on Genetically
Modified (GM) Crops
Prepared in May 2021
1
Genetic modification technologies are developing possibilities for
contributing to people’s everyday lives.
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2

I. Significance 4
Future Global Challenges Related to Agriculture 5
Contributions and Potential of Genetically
Modified Crops
6
II. Technology 11
Biotechnology Basics 12
Wild and Cultivated Species 13
History of Agriculture and Breeding 14
Major Conventional Breeding Technologies 15
Differences Between Conventional and Genetic
Recombination Breeding
17
Methods for Producing Genetically Modified
Crops
18
New Breeding Technologies 20
III. Examples 21
From Development to Practical Application of
Genetically Modified Crops
22
Herbicide-tolerant Crops 23
Insect-resistant Crops 24
Disease-resistant Crops 25
Drought-tolerant Crops 26
Other Genetically Modified Crops 27
Genetically Modified Crops under Development 28
IV. Usage 29
Global Usage Status 30
Usage Status in Japan 33
Evidence Indicating Safety 35
Three Projects in Europe That Reconfirmed
Safety
36
Carcinogenicity to Animals That Has Been
Denied
37
V. Regulatory System 38
International Regulatory Framework 39
Definition of Genetically Modified Organisms 40
Regulatory Systems in Japan 41
Assessment of Adverse Effects on Biological
Diversity
43
Food Safety Assessment 46
Feed Safety Assessment 48
Labeling 49
Regulatory Systems in Other Countries 51
VI. Acceptance 55
Consumer Awareness Survey Conducted by the
Council for Biotechnology Information Japan
56
Investigation by the Food Safety Commission of
the Cabinet Office
60
Table of Contents
3

5
1. World Population Prospects 2017 (UN, 2017)
2. Building a common vision for sustainable food and agriculture - Principles and Approaches 2014 (FAO, 2014) http://www.fao.org/3/a-i3940e.pdf
Future Global Challenges Related to Agriculture
Rapidly increasing global population1
75.5
97.7
2017 2050
(Unit: 100 million people)
Climate change
• Rise in temperature
• Increasing pest and disease threats
• Shortage of water resources
• Extreme weather
Increasing food demand
By 2050, due to rapid population growth and dietary
changes associated with economic growth,
60% more food will be needed.2
Environmental impact of agriculture
25% of greenhouse gas emissions by humans are
caused by the agriculture, forestry, and livestock
industries.2
Soil tillage Use of fertilizers
Deforestation Methane from
livestock animals

Contributions of GM crops that have been cultivated to date
6
Contributions and Potential of Genetically Modified Crops (1)
Stable Supply of Food
A stabilized harvest and secondary cropping allow:
• An increase in yield of 20% or more, compared to non-GM crops1
• An annual yield growth effect equivalent to 24 million ha of
agricultural land worldwide2 Expected to ease the impact
of climate change on harvests
Insect-resistant Crops
Herbicide-tolerant Crops Disease-resistant Crops
Flood-resistant Crops
Salt-resistant Crops
GM crops under development
Drought-tolerant Crops
1. Klümper and Qaim (2014) A Meta-Analysis of the Impacts of Genetically Modified Crops. PLoS ONE 9(11).
2. Brookes and Barfoot (2020) GM crop technology use 1996-2018: farm income and production impacts
DOI:10.1080/21645698.2020.1779574

7
Suppression of expansion of farmland area
Without GM crops, 24 million hectares of new land would be required to maintain the production volume of
2018.1
Reduction in the amount of emitted carbon dioxide
Reduction in carbon dioxide emissions of 23 billion kg (equivalent to 15.27 million automobiles) in
2018, by reducing tractor fuel consumption and reducing soil carbon emissions into the atmosphere
via no-tillage cultivation*2
Suppression of soil erosion
Suppression of soil erosion and outflow of organic substances to rivers by no-tillage cultivation
Conservation of water resources
The WEMA (Water Efficient Maize for Africa) project is developing corn possessing a combination of
drought-tolerance and insect-resistance for small-scale farmers in the sub-Saharan region, via a joint
effort by the public and private sectors.
Reduction in the amount of food waste
GM apples and potatoes, which are resistant to browning caused by scratches or physical impact, enable the
elimination of unnecessary disposal due to poor appearance.
Conservation of the Natural Environment
* No-tillage cultivation = cultivation without
plowing agricultural land to control weeds
1. Graham Brookes & Peter Barfoot (2020)GM crop technology use 1996-2018: farm income and production impacts,
DOI:10.1080/21645698.2020.1779574
2. Graham Brookes & Peter Barfoot（2020）Environmental impacts of genetically modified (GM) crop use 1996–2018: impacts on pesticide
use and carbon emissions, DOI：10.1080/21645698.2020.1773198

8
Mitigation of the Environmental Impacts of Agricultural
Chemicals
Reduction in agricultural chemical usage
Agricultural chemicals are essential materials for agriculture. However, the impacts on the environment is an issue
that must be considered at all times. Normally, farmers need to use pesticides and herbicides several times per
year. This frequency can be reduced through the adoption of GM crops.
Replacement with agricultural chemicals with lower environmental impact
In addition to the reduction in agricultural chemical usage, the environmental impact quotient (EIQ, an index
calculated using the toxicity and environmental exposure data of individual products to determine the impact of
agricultural chemical use on the environment) has also decreased, because the agricultural chemicals used for
GM crops impose a lower impacts on the environment, compared with agricultural chemicals previously used.
37%
Annual usage of
agricultural chemicals
reduced by the
cultivation of GM
crops1
8.3%
Agricultural chemical
usage reduced by the
cultivation of GM crops
(cumulative total, 1996
to 2018)2
18.5%
Environmental Impact
Quotient (EIQ)
reduced by the
cultivation of GM crops
(cumulative total, 1996
to 2018)2
1. Klümper W, Qaim M (2014) A Meta-Analysis of the Impacts of Genetically Modified Crops. PLoS ONE 9(11).
2. Graham Brookes & Peter Barfoot (2020)Environmental impacts of genetically modified (GM) crop use 1996–2018: impacts on
pesticide use and carbon emissions, DOI:10.1080/21645698.2020.1773198

9
Labor-Saving and Improved Profitability for Farmers
Farmers' profit increased by an average of 68%1, while farmers’ income increased by a total of 18.9 billion
dollars2 in 2018, a breakdown of which is as follows:
• 52% is attributed to farmers in developing countries, while 48% is attributed to farmers in developed countries.2
• 72% are the result of improved yield, while 28% are due to cost savings.2
Conventional cultivation
• Spraying multiple herbicides, multiple times
• Periodic tillage
Herbicide-tolerant crops
• Decreases in work volume and cost due to a
reduction in the amount and frequency of
agricultural chemical spraying
• Shortens the production cycle by no-tillage
cultivation, increasing the production volume
Conventional cultivation
• Spraying multiple pesticides, multiple times
• Ineffective against pests that burrow into plants
Insect-resistant crops
• Decreases in work volume and cost due to a
reduction in the amount and frequency of
agricultural chemical spraying
• Effective for difficult-to-control pests, increasing the
production volume
• Reduction of the risk of mycotoxins
Damage due to insects
• Reduced yield
• Transmission of crop diseases
• Cause of mycotoxins
• Reduced quality due to
feeding damage
Damage caused by weeds
• Reduced yield
• Pest habitats
• Difficult harvesting
• Reduced product quality due to contamination
1. Klümper W, Qaim M (2014) A Meta-Analysis of the Impacts of Genetically Modified Crops. PLoS ONE 9(11).
2. Graham Brookes & Peter Barfoot (2020) GM crop technology use 1996-2018: farm income and production impacts
DOI:10.1080/21645698.2020.1779574

10
Vitamin A deficiency
More than two billion people are said to be suffering from hidden hunger
(micronutrient deficiencies, without a feeling of hunger) worldwide.1 In
developing countries in Africa and Asia, 250,000 to 500,000 children
have lost their sight each year due to vitamin A deficiency, half of whom
have died within six months after going blind.2
Development of golden rice
In order to improve vitamin A deficiency in such poverty-stricken areas
through a staple diet, golden rice, which is a GM rice that produces beta-
carotene, a precursor of vitamin A, is under development. Developing
countries in need can utilize it free of charge.
Letter by Nobel Prize winners
Golden rice is also targeted by a campaign against GM crops. In 2016,
more than 100 Nobel Prize winners who were concerned about this
situation jointly announced a letter expressing, “Campaigns against GM
crops, especially golden rice, should be ceased immediately.”3
1. FAO (2017) The future of food and agriculture ? Trends and challenges.
2. WHO (2017) Micronutrient deficiencies/Vitamin A deficiency.
3. http://supportprecisionagriculture.org/nobel-laureate-gmo-letter_rjr.html, Japanese translation http://supportprecisionagriculture.org/Japanese_letter.docx
Improving Nutritional Status in Poverty Areas
(C) Syngenta Japan Co., Ltd. (C) Council for Biotechnology Information Japan

12
Biotechnology Basics
Genetic modification technologies are utilized all around us.
• Food additives (vitamins/amino acids/the enzyme chymosin used in the manufacture of natural cheese, etc.)
• Medicinal products (human insulin/human growth hormone/antibody drug, etc.)
• Enzymes contained in household detergents
A gene is a sequence of four bases:
adenine (A), thymine (T), guanine
(G), and cytosine (C).
Amino acids are sequentially
connected to produce a protein.
ATGGCAAGCT ...
Amino acids are connected
sequentially, according to the
information contained in the gene.
ATGGCAAGCT ...
Human
Cell Nucleus Chromosome
DNA
(Deoxyribonucleic acid)
All organisms have “genes.”
Their primary component is a
chemical substance called “DNA.”
A gene is a blueprint for a protein.

13
Wild and Cultivated Species
The agricultural products we consume have not always had their current appearances and
tastes.
In order to survive in a harsh natural environment, a wild species may possess an uneven growth period, have
seeds covered with a thick seed coat or thorns, or contain harmful components. Since humans began selecting
wild species and farming, selective breeding has been repeatedly performed over a long period of time, resulting in
the creation of cultivated species that are convenient for humans.
Original species of cabbage
Kale Cabbage
Kohlrabi
Broccoli Brussels sprouts
Teosinte
(Original species of corn)
Corn
Cauliflower

14
Reference: https://cbijapan.com/wp-content/uploads/2018/01/GMOA-History-of-GM-in-Crops-05-16-2017.pdf
10,000 years ago 19th century 20th century 1940s to 1960s 1990s
Agriculture is an “unnatural activity. ”
Agriculture is the cultivation of species created through human intervention, in an environment developed by
humans, under the control of humans.
History of Agriculture and Breeding
Selective breeding
Individuals suitable
for food and
cultivation have been
selected from wild
species and turned
into cultivated crops.
Hybridization
breeding
The concept of
heredity and evolution
has spread, and
crossbreeding has
actively been
performed to
intentionally create
individuals with
excellent properties
through hybridization.
Mutation-induced
breeding
Mutation-induced
breeding was started
to artificially induce
mutation using
radiation and
chemical substances,
in order to create new
varieties.
The Green
Revolution
Increased food
production was
achieved through the
introduction of high-
yield varieties and
chemical fertilizers.
Dr. Norman Borlaug,
who led these
initiatives, was
awarded the Nobel
Peace Prize in 1970.
GM crops
By using genetic
modification
technologies for
conventional selective
breeding, GM crops
have been produced.

15
1. IAEA (International Atomic Energy Agency) Mutant Variety Database https://mvd.iaea.org/
• Hybridization
Selective breeding technique using pollination, which is the most common method
• Mutation induction
 Mutations are induced by mutagens such as chemical substances, radiation, or tissue
culture (examples: “Star Ruby” and “Rio Red” pink grapefruits, “Gold Nijisseiki” Japanese
pears, and “Milky Queen” and “Hae-nuki” rice1).
 Polyploid crops are artificially produced by inhibiting meiosis using chemicals such as
colchicine (examples: seedless watermelon, triticale).
Since conventional breeding is also a technique for artificially changing combinations of genes, it is
possible to create new plants that do not exist in nature.
Major Conventional Breeding Technologies (1)
Grapefruit
Gene damaged Error during
self-repair
Pink flesh

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Major Conventional Breeding Technologies (2)
• Embryo culture
Technology to extract embryos that are produced by remote crossing and usually do not develop, and to grow
them in an appropriate medium (example: Hakuran).
• Cell fusion of plants belonging to the same family
Technology to obtain hybrid cells by fusing protoplasts (cells with the cell wall removed) from two species
(example: Oretachi)
Cabbage
(Kanran)
Chinese cabbage
(Hakusai)
Removing fertilized embryos
Pollen
Pistil
Embryo
Sweetness/aroma of cabbage
Texture/softness of Chinese
cabbage
Culturing embryos
Hakuran
Removing cell walls
Trifoliate orange
(Karatachi)
Large fruit
Resistant to
diseases
Fusion of
protoplasts
Oretachi
Large fruits
resistant to
diseases
Orange

17
Differences Between Conventional and
Genetic Recombination Breeding
Genetic modification technologies are a more reliable and efficient means for selective breeding.
Selective breeding by
genetic recombination
Genes conferring the desired traits
from a wide range of species are
selected and introduced.
Detailed analysis of
introduced genes and
selection of individuals
Conventional
selective breeding
Unintended traits are also
inherited by progeny
following hybridization.
Crossing and selection are
repeated to gain a group of hybrid
to produce an individual close to
one having only the desired traits.
Hybridization

18
• Agrobacterium method
Agrobacterium, a soil bacterium, has the property of infecting some plants and inserting a DNA
region called T-DNA from a plasmid of its own into the plant genome. The Agrobacterium
method incorporates a gene of interest together with T-DNA into the plant genome by using
this property.
GM crops are primarily created using the following methods:
Methods for Producing Genetically Modified Crops (1)
1. A plasmid is prepared that
contains a gene of interest in
the T-DNA region.
3. T-DNA is excised
and transferred
into plant cells.
2. Plant cells are infected with
Agrobacterium carrying the
desired plasmid.
4. T-DNA is
introduced into
plant
chromosomes.
5. Selection and
breeding of
recombinants
Ti plasmid
Agrobacterium
Plant cell
Chromosome
Chromosome
Nucleus
Ti plasmid

19
Methods for Producing Genetically Modified Crops (2)
• Particle gun method
This is a method for incorporating a gene of interest into the plant genome by coating metal
particles with the gene of interest and physically shooting them into plant cells.
1. Metal particles are coated with a
gene of interest.
2. Gene-coated particles are shot
into plant cells.
4. Selection and breeding of
recombinants 3. Plants are regenerated from cells
that have been transfected with
the gene.
Metal particles
Gene of interest

20
In recent years, the development of new breeding technologies has been progressing, in which
biotechnology is used during the breeding process to create agricultural products that possess no
exogenous genes, and are equivalent to those obtained via conventional selective breeding
techniques.1
• Genome editing technologies (ZFN, TALEN, CRISPR/Cas9, etc.)
This technology uses artificial restriction enzymes to induce mutations that are equivalent to those that
occur in the natural world, at targeted sites on the genome. They may be classified as SDN1, SDN2, or
SDN3 depending on the usage.
• Oligonucleotide-directed mutagenesis (ODM)
This technology induces mutations by injecting oligonucleotides (short nucleic acid fragments) that are
homologous to a target base sequence on the genome and carry intended mutations, into cells.
• RNA-directed DNA methylation (RdDM)
This technology controls gene expression via the methylation of some bases, without changing the base
sequence in the genome of the crop.
• Cis-genesis/intra-genesis
The method of introducing genes of the same species or closely related crossable species (cis-gene) into
agricultural crops via genetic modification technologies is called cis-genesis, while the method of
introducing such genes with different combination of regulatory elements is called intra-genesis.
• Agroinfiltration
An agrobacterium into which specific genes have been incorporated infects a part of the plant body (non-
reproductive organs) to locally induce the expression of a gene of interest. Since the Agrobacterium
infection is generally localized, it is considered that if the infection site is removed, the genes derived from
the Agrobacterium will not remain in the plant.
New Breeding Technologies
1. New Plant Breeding Technique Study Group, Secretariat of the Agriculture, Forestry and Fisheries Research Council (2015). Towards the
development and practical application of crops using new plant breeding techniques (NPBTs) such as genome editing.
http://www.affrc.maff.go.jp/docs/commitee/nbt/pdf/siryo3.pdf

22
Flow from Development to Practical Application
of Genetically Modified Crops
An average of 13 years and 130 million dollars are required from the research and development
stage to practical application.1
1. Croplife International (2011). https://croplife.org/wp-content/uploads/pdf_files/Getting-a-Biotech-Crop-to-Market-Phillips-McDougall-Study.pdf
Reference https://cbijapan.com/wp-content/uploads/2018/01/Lifecycle-of-a-GMO-Infographic_JPN.pdf
Greenhouse test
Tests are conducted in a greenhouse
from various perspectives, and an
optimal plant is selected.
Regulatory science
Various assessment tests are
conducted in the field and laboratory
to confirm safety.
Identification of traits
A gene is identified that confers the
desired trait.
Transformation
A gene of interest is introduced into
the plants to create GM crops.
Field test
Data that is important for making a
decision during development.
Commercialization
Established as one
option for farmers.

23
Outline
Herbicide-tolerant crops are crops created by
genetic modification technologies, such that
they do not wither after the application of a
particular herbicide. Since the application of
specific herbicides during cultivation allows
weeds to be withered without damaging such
crops, their use permits a reduction of the
burdens involved in farm work.
Herbicide-tolerant Crops
Before applying herbicides
After applying herbicides
Typical mechanism
Usually, when herbicides are applied to weeds,
they become unable to make nutrients and consequently wither.
Furthermore, accumulated ingredients may be toxic to their growth.
In contrast, with herbicide-tolerant crops,
Such crops can grow by degrading the herbicides or creating a
synthesis path that is not hindered by the herbicides.
Photo provider: Bayer Crop Science Co., Ltd.
Herbicide
Ingredients Nutrients
Herbicide
Herbicide

Neutral or alkaline
gastrointestinal tract
Receptors present in the
Activation in the
Gastrointestinal tract
destruction
Target pest
Fatal
Humans, livestock
animals, etc.
Safe
Degraded in the
No activity
Bt proteins
Acidic
No receptors in the
24
Insect-resistant Crops
Outline
Pest control with pesticides requires
repeated spraying in accordance
with the timing of pest outbreaks,
and also has the additional
disadvantage of being ineffective
against pests that burrow into plants.
Insect-resistant crops that produce
“Bt proteins,” which have an
insecticidal activity, allow farmers to
reduce the time and effort of
pesticide application, as well as the
amount of pesticides used.
Damage caused by insidious pests (Left) Non-GM, (Central) Insect-resistant GM, (Right)
Non-GM sprayed with pesticides
Safety
Bt proteins produced
by soil
microorganisms
(Bacillus
thuringiensis) act
specifically on the
target pests. It has
been used safely as
a biopesticide for
decades and is also
approved for use in
organic farming.

25
Disease-resistant Crops
Crop damage due to diseases
Crop diseases caused by bacteria and viruses are always a source of distress to farmers. A disease can spread in
cultivation areas so quickly that the development of agricultural chemicals and disease-resistant varieties cannot
keep pace, which may force many farmers out of business.
Rainbow papaya
This is a GM papaya developed in Hawaii, which is resistant to the papaya ringspot virus.
A conventional variety of papaya that is infected with the viral disease
and is expressing ring spots.
Fruit is unripe due to the disease
Symptoms
GM virus-resistant papaya
In the early 1990s, the papaya ringspot virus
spread rapidly in Hawaiian papayas. If infected
with this virus, the whole tree will eventually
wither and die. Due to this disease, the
production of papayas in Hawaii dropped
significantly.
In 1997, researchers from the University of
Hawaii and Cornell University developed
papayas that are resistant to ringspot virus, in
order to save the papaya industry in Hawaii,
which was in danger of being destroyed. When
commercial cultivation was authorized in 1998,
the developed papayas were offered to papaya
farmers free of charge, and papaya production
was restored to its original level.
In 2011, the safety of the GM papaya was
confirmed in Japan and it was approved for
import. It is now popular with many people as
rainbow papaya.
Photo provider: University of Hawaii, Hawaii Papaya Industry Association, National Agricultural Statistics Service USDA, Hawaii Field Office
25

26
Drought-tolerant Crops
Outline
Drought-tolerant corn reduces plant damage and loss of yield due to dry conditions, and ensures a
stable yield even in cases of drought or low precipitation. It is also useful for conserving water
resources, since the amount of water necessary for irrigation is reduced.
Conventional corn under
dry conditions
GM drought-tolerant corn
under dry conditions

27
Other Genetically Modified Crops
• Potato that reduces acrylamide production1
Potatoes produce acrylamide, which is a carcinogen, during the cooking
process. GM potatoes capable of reducing acrylamide production have
already been distributed in the United States.
• Apple resistant to browning1
Apples that become brownish due to scratches, etc. are landfilled when
disposed of due to poor appearance, which has become the main source of
methane gas generation. To reduce such wasteful disposal, GM apples that
are resistant to browning have been developed and marketed in the United
States.
• Pink pineapple1
This is a pineapple that inhibits the activity of an endogenous enzyme that
converts a pink pigment lycopene to yellow beta-carotene, resulting in a
pink flesh color. It is grown in Costa Rica and sold in the United States.
• Rare-colored flowers2
Bluish-purple carnations incorporating petunia genes and blue roses
incorporating pansy genes are sold both in Japan and overseas. Genetic
modification technologies also changed the flower language of the blue
rose from “impossible” to “a dream comes true.”
• Strawberries as raw materials for medicinal products3
Research to make plants produce pharmaceutical components is also in
progress. In Japan, this has already been put into practical use for
veterinary medicinal products, and GM strawberries that produce canine
interferon as a therapeutic drug for canine periodontal disease have been
approved and marketed.
1. ISAAA. Brief 52, and 53, 2. Photo provider: Suntory Holdings Limited, 3. Photo provider: Hokusan Co., Ltd.

28
Genetically Modified Crops under Development
Japan
• Disease-resistant rice1
Rice resistant to multiple diseases, such as blast and bacterial leaf blight, has been
being developed.
• Cedar pollen rice1
This rice produces a protein that is an allergen for Japanese cedar pollinosis. The
consumption of this rice for a certain period of time is expected to induce a
therapeutic effect against Japanese cedar pollinosis.
Overseas
• Orange resistant to citrus greening disease2
This orange is resistant to citrus greening, a prevalent disease in the United States.
• Nutrient-enhanced and quality-improved banana, cassava, and
sorghum2
Nutrient-enhanced crops of banana, cassava, and sorghum, which are the major food
crops in Africa, have been developed at research institutes in several countries in
Africa.
• Drought-tolerant corn3
The WEMA (Water Efficient Maize for Africa) project is developing corn possessing a
combination of drought-tolerance and insect-resistance for farmers in the sub-
Saharan region via a joint effort by the public and private sectors.
1. National Agriculture and Food Research Organization. Biotechnology proposing the future of food and agriculture (September 2016).
http://www.naro.affrc.go.jp/nias/gmo/files/syokutonou2016.pdf
2. ISAAA. Brief 52 and 53
3. https://wema.aatf-africa.org/

30
Global Usage Status (1)
Cultivation Status of Genetically Modified Crops
by Trait (2019)
Stacks: Hybrid variety developed by crossing GM varieties with different traits.
Summarized by the Council for Biotechnology Information Japan based on ISAAA Brief 55
1.7
11.0
27.8
39.944.2
52.6
58.7
67.7
81.0
90.0
102.0
114.3
125.0
134.0
148.0
160.0
170.3
175.2
181.5
179.7
185.1
189.8
191.7
190.4
82
24
85
0
50
100
150
200
250
1 million (ha)
Cultivation Area of GM Crops by Trait (1996-2019)
Total Herbicide tolerance Insect resistance Stacks (Insect resistance/herbicide tolerance)
Roughly five times as
large as
the entire land of Japan

31
Cultivation Status of Genetically Modified Crops
by Crop (2019)
Percentage of cultivated GM crops (%, 2019)
Soybean Corn Cotton Rapeseed
Worldwide 74 31 79 27
United States 94 92 98 100
Brazil 96 91 91 0
Argentina 100 93 100 0
Canada 82 90 0 95
Australia 0 0 100 31
92
61
26
10
0
20
40
60
80
100
120
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
million (ha)
Cultivation Area of GM Crops by Crop (1996 - 2019)
92
61
26
10
33
133
7 28
125
193
32 38
0
50
100
150
200
million (ha)
Cultivation Area by Crop (2019)
Non-GM
GM

Ranking Country Area (million ha) Cultivated crop
1 USA 71.5 Maize, soybeans, cotton, alfalfa, canola, sugar beets, potatoes, papaya, squash, apples
2 Brazil 52.8 Soybeans, maize, cotton, sugarcane
3 Argentina 24.0 Soybean, maize, cotton, alfalfa
4 Canada 12.5 Canola, soybeans, maize sugar beets, alfalfa, potatoes
5 India 11.9 Cotton
6 Paraguay 4.1 Soybeans, maize, cotton
7 China 3.2 Cotton, papaya
8 South Africa 2.7 Maize, soybeans, cotton
9 Pakistan 2.5 Cotton
10 Bolivia 1.4 Soybeans,
11 Uruguay 1.2 Soybeans, maize
12 Philippines 0.9 Maize
13 Australia 0.6 Cotton, canola, safflower
14 Myanmar 0.3 Cotton
15 Sudan 0.2 Cotton
16 Mexico 0.2 Cotton
17 Spain 0.1 Maize
18 Colombia 0.1 Maize, cotton
19 Vietnam 0.1 Maize
20 Honduras <0.1 Maize
21 Chile <0.1 Maize, canola
22 Malawi <0.1 Cotton
23 Portugal <0.1 Maize
24 Indonesia <0.1 Sugarcane
25 Bangladesh <0.1 Brinjal/Eggplant
26 Nigeria <0.1 Cotton
27 Eswatini <0.1 Cotton
28 Ethiopia <0.1 Cotton
29 Costa Rica <0.1 Cotton, pineapple
TOTAL 190 32
Cultivation Status of Genetically Modified
Crops by Country (2019)

Corn Soybean Rapeseed Cotton Beet
Papaya Potato Alfalfa Carnation Rose
33
Usage Status in Japan (1)
Consumption Status
Vegetable oil and fat
(soybean oil, rapeseed oil,
cottonseed oil, margarine)
Seasoning (soy sauce) Corn starch
(Pudding, juice, beer)
Feed for livestock
animals
(Cattle, swine, chicken)
Cotton
(Clothing)
1. Honma, M. and K. Saito. Study on Evaluation of the Social Benefits of Genetically Modified Crops. Graduate School of Agricultural and Life Sciences,
The University of Tokyo (September 30, 2016)
GM crops approved for distribution
Primary usage
Economic value equivalent to approximately 0.93%1 of the GDP (roughly 2/3 of the rice
industry) has already been domestically produced by GM crops (corn, soybean).

34
Usage Status in Japan (2)
Import Status (2019)
1. Corn, soybean, rice: Ministry of Agriculture, Forestry and Fisheries, Food Balance Sheet for FY2019, published on March 22, 2021; Rapeseed (for
oil): Ministry of Agriculture, Forestry and Fisheries, FY2019 Crop Statistics; Cotton seed (for oil), cotton: No statistics
2. Ministry of Agriculture, Forestry and Fisheries, Overview of Foreign Trade of Agricultural, Forestry, and Fishery Products for FY2019
3. ISAAA Brief 54
4. Estimated by multiplying the import volume of each country by the adoption rate of GM crops for that country and each crop in 2018.
(Non-GMO crops may be segregated and imported, which may differ from actual data.)
Crop
Domestic
production
volume1
Total import
volume2
Major importing country2
(Adoption rate of GM crops3
)
Estimated import
ratio of GM crops4
Estimated import
volume of GM
crops4
Corn 0 15,983
United States (92%)
Brazil (89%)
Argentina（97％）
91% 14,476
Soybean 218 3,392
United States (94%)
Brazil (96%)
Canada (95%)
94% 3,178
Rapeseed
(for oil)
4 2,359
Canada (95%)
Australia (22%)
China（0％）
91% 2,153
Cottonseed
(for oil)
- 93
United States (94%)
Brazil (84%)
Australia (100%)
82% 76
Cotton - 90
United States (94%)
Australia (100%)
Brazil (84%)
54% 49
Reference:
Rice
8,154 678 United States, Thailand, China 0% 0
Unit: 1,000 tons

35
Although GM crops have been used worldwide for over 20 years, no case has ever been reported of adverse
effects on human or animal health. The safety of GM crops has been confirmed repeatedly by scientists and
research institutes throughout the world.
1. http://www.who.int/foodsafety/areas_work/food-technology/faq-genetically-modified-food/en/
2. The National Academies of Sciences/Engineering/Medicine (2016). Genetically Engineered Crops: Experiences and Prospects. The National Academies
Press. http://nas-sites.org/ge-crops/
3. European Commission (2010). A decade of EU-funded GMO research (2001-2010). http://ec.europa.eu/research/biosociety/pdf/a_decade_of_eu-
funded_gmo_research.pdf
4. http://supportprecisionagriculture.org/nobel-laureate-gmo-letter_rjr.html, Japanese translation http://supportprecisionagriculture.org/Japanese_letter.docx
Letter with the joint signatures
of more than 130 Nobel Prize
winners
Equivalent to more than 1/3 of the total number of
Nobel Prize winners who are currently alive.
“There has never been a single confirmed case of a
negative health outcome for humans or animals due
to the consumption of foods improved through
biotechnology.”4
“no effects on human health have been shown as a
result of the consumption of such foods by the
general population in the countries where they have
been approved.”1
World Health Organization (WHO)
“no substantiated evidence of a difference in risks to
human health between currently commercialized
genetically engineered (GE) crops and conventionally
bred crops.”2
A compilation of nearly 900 studies and research
papers reviewed by more than 20 researchers over a
period of two years
The National Academies of
SCIENCES•ENGINEERING•MEDICINE
“The main conclusion to be drawn from the efforts of
more than 130 research projects, covering a period of
more than 25 years of research, and involving more
than 500 independent research groups, is that
biotechnology, and in particular GMOs, are not per se
more risky than e.g. conventional plant breeding
technologies.”3
European Commission (EC)
Evidence Indicating Safety

36
GRACE
(GMO Risk Assessment and
Communication of Evidence)1
G-TwYST
(GM Plant - Two Year Safety
Testing)2
GMO90+
(Genetically Modified Organism,
90-day to 180-day testing)3
Funded by EU EU French Ministry for an Ecological and
Solidary Transition
Term June 2012 – November 2015 April 2014 – April 2018 February 2014 - December 2016
Objective • Elaborate a transparent framework
for the safety assessment of GM
food/feed
• Reconsider the scientific value of
animal feeding studies for
assessing the safety of GM
food/feed
• Address concerns raised by
Seralini paper
• Reconsider the scientific value of
long-term animal feeding studies
for assessing the safety of GM
food/feed
Identify biomarkers or health effects
related to the feeding of GM plants
Study Four 90-day subchronic toxicity and
one 1-year chronic toxicity studies on
rats fed with a diet containing GM
corn MON810 (inclusion rate: 11 or
33%)
Two 90-day studies and a combined
chronic toxicity (1 year) and
carcinogenicity (2 years) study on
rats fed with a diet containing GM
corn NK603 (inclusion rate: 11, 33, or
50%)
Physiological, metabolomics (blood,
urine), and transcriptomics analyses
(liver, kidney) on rats fed with a diet
containing GM corn NK603 or
MON810 for up to 6 months
(inclusion rate: 11 or 33%)
Conclusion • No health risks of the GM corn tested were revealed4,5
• Do not see the need to continue with the mandatory requirement to conduct
untargeted animal feeding studies for each GM plant4,5
Absence of evidence for biologically
meaningful effects related to the
feeding of GM corn6
Three Projects in Europe That Reconfirmed the Safety of GM Plant
GRACE, G-TwYST, and GMO90+
1. GRACE https://cordis.europa.eu/project/id/311957/reporting, 2. G-TwYST https://www.g-twyst.eu/, 3.GMO90+ http://recherche-
riskogm.fr/en/page/gmo90plus, 4. Policy Brief: Animal Feeding Studies for GMO Risk Assessment Lessons from two large EU research projects, 5.
Steinberg et al. Arch Toxicol (2019). https://doi.org/10.1007/s00204-019-02400-1, 6. Coumoul et al. Toxicological Sciences (2018).
https://doi.org/10.1093/toxsci/kfy298
In order to address concerns about safety of GM plant in Europe, and/or to reconsider the appropriateness and scientific
value of animal feeding studies for the food/feed safety assessment of GM plants in EU, several large public research
projects led by EU or France were carried out from 2012 to 2018, and the safety of GM plants were reconfirmed.

2012 Séralini paper G-TwYST
Study protocols Did not follow the internationally accepted protocols Based on OECD guidelines and EFSA recommendations
Strain of rats
tested
SD rats which is known to be prone to development
tumours over their life
Wistar Han RCC rats which showed the lowest incidence
of spontaneous tumours among the main strains of rat
used in carcinogenicity studies
Control group Only one control group (non-GM 33%) for the treatment
groups (GM 11, 22, 33% +/- R*) (*R: Roundup treatment)
Comparative 5 groups (non-GM 33%, non-GM 22% +
GM 11% +/- R, GM 33% +/- R)
# of rats tested 10 rats per group per sex is not sufficient 50 animals per group per sex (carcinogenicity study)
Feed Details on the feed composition, the storage conditions
and the presence of harmful substances (such as
mycotoxins) or chemical contaminants were not provided
Details on the feed preparation and composition analysis
were provided
Feeding trials No food and water intakes were reported Amount of feed consumption was reported
Transparency
of study design
The statistical methods used were unconventional and it
was not clear if these were pre-planned
The study plans were subjected to consultations with a
broad range of stakeholders a priori and the process was
published on the project website
Transparency
of reporting
Did not report the complete set of samples collected and
endpoints measured
All raw data can be accessed on line
Conclusions Retracted because it is inconclusive: In addition to above,
the parameters reported lacked any dose-response
relationships and the mortality and tumour incidence data
fell within the historical control data for the SD rats.
No adverse effects related to the feeding of GM corn
were observed
Animal Carcinogenicity was Denied
G-TwYST rebutted Séralini Paper
In 2012, French biologist Gilles-Éric Séralini published his claim that 2 years-feeding of GM corn induces
tumours in rats1. Though the publication was retracted later due to its insufficient scientific quality2,3, it
has continued to be circulated to claim the risks of GM plants. EU launched a public research project G-
TwYST to repeat this feeding trial under adequate conditions and confirmed that no adverse effects were
observed4.
1. Séralini et al. Food and Chem Toxicol (2012) (Retracted) https://doi.org/10.1016/j.fct.2012.08.005, 2. EFSA Journal 2012;
10(10):2910 https://doi.org/10.2903/j.efsa.2012.2910, 3. EFSA Journal 2012; 10(11):2986 https://doi.org/10.2903/j.efsa.2012.2986,
4. Steinberg et al. Arch Toxicol (2019). https://doi.org/10.1007/s00204-019-02400-1
37

39
International Regulatory Framework
Establishing internationally harmonized scientific regulatory systems for genetic modification
technologies is important for promoting innovation and facilitating international trade. Various
guidelines and rules have been established within the framework of the United Nations, the
Organization for Economic Co-operation and Development (OECD), the World Trade Organization
(WTO), etc.
• OECD Consensus Document
Basic information for the safety assessment of biotechnology-derived agricultural products is organized and
published as a mutually acceptable document by the member states.
• Convention on Biological Diversity and the Cartagena Protocol
The Convention on Biological Diversity adopted by the United Nations Conference on Environment and
Development (Earth Summit) in 1992 and the “Cartagena Protocol on Biosafety to the Convention on
Biological Diversity (Cartagena Protocol),” which came into effect in 2003 as detailed provisions of the said
Convention, are known as the first international law regarding the regulation of living modified organisms.
Measures for the transfer of living modified organisms across borders have been established, and many
countries and regions, including Japan, have entered into this Convention.
In addition, discussions between signatory countries have been continued at various points; for example,
the “Nagoya-Kuala Lumpur Supplemental Protocol” was established for compensation for damage
associated with the transfer of living modified organisms across the border.
• Codex Alimentarius Commission
This commission is an international organization established by the Food and Agriculture Organization of
the United Nations (FAO) and the World Health Organization (WHO) to create international food standards.
Guidelines for the safety assessment of GM foods have been formulated, and the WTO members, including
Japan, have established an assessment system in accordance with the guidelines of the Codex
Alimentarius Commission.

40
Definitions in the Cartagena Protocol
Living Modified Organisms: Any living organism that possesses a novel combination of genetic material obtained through the use of
modern biotechnology
Modern biotechnology: The application of:
a. In vitro nucleic acid techniques, including recombinant DNA and direct injection of nucleic acid into cells or organelles, or
b. Fusion of cells beyond the taxonomic family,
that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection.
Definition of Genetically Modified Organisms
Definition in the Cartagena Act in Japan
• Act on the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use
of Living Modified Organisms (Cartagena Act) (Excerpts)
“Living modified organisms” shall mean an organism that possesses a nucleic acid, or a replicated product thereof, obtained
through use of the any of the following technologies.
(i) Those technologies, as stipulated in an ordinance of the competent ministries, for the processing of nucleic acid extracellularly
(ii) Those technologies, as stipulated in an ordinance of the competent ministries, for fusing of the cells of organisms belonging to
different taxonomical families
• Ordinance for Enforcement of the Cartagena Act (Ordinance of the Ministry of Finance, the Ministry of
Education, Culture, Sports, Science and Technology, the Ministry of Health, Labour and Welfare, the
Ministry of Agriculture, Forestry and Fisheries, the Ministry of Economy, Trade and Industry, and the
Ministry of the Environment) (Excerpts)
 Technologies stipulated in the ordinance of the competent ministries shall be those for extracellularly processing a nucleic
acid for the purpose of introducing the said nucleic acid into cells, viruses, or viroids, to transfer or replicate such nucleic acid,
while excluding those mentioned in the following:
(i) Technology for processing by using only the nucleic acids to be introduced into cells, as presented in the following:
(a) A nucleic acid of a living organism belonging to the same taxonomic species as that from which the said cells originate
(b) A nucleic acid of a living organism belonging to a species that exchanges nucleic acids with the taxonomic species of
the living organism from which the said cells originate under natural conditions
(ii) Technology for processing by using, as a nucleic acid to be introduced into viruses or viroids, only a nucleic acid of a virus or
viroid that exchanges nucleic acids with the said viruses or viroids under natural conditions
 The technology stipulated in the ordinance of the competent ministries shall be those for the fusing of cells of living organisms
belonging to different taxonomic families, excluding those that have been used traditionally, such as hybridization.

41
In Japan, GM crops are reviewed in terms of environmental impacts, safety as food, and safety as
feed. Only products confirmed to be safe by these reviews are allowed to be distributed in Japan.
Law
Risk
management
Risk
assessment
Adverse effects on the
environment
(biological diversity)
Cartagena Act
Ministry of Agriculture,
Forestry and Fisheries
Ministry of the
Environment
Committee on
Assessment of Adverse
Effects on Biological
Diversity
Safety as food
Food Sanitation Act
Food Safety Basic Act
Ministry of Health,
Labour and Welfare
Food Safety
Commission
Safety as feed
Feed Safety Law
Food Safety Basic Act
Agricultural Materials
Council
(Safety assessment for
livestock animals)
Food Safety Commission
(Safety assessment of
livestock products)
Regulatory Systems in Japan (1)
Framework of Safety Assessment

42
 Japan Biosafety Clearing House (J-BCH) http://www.biodic.go.jp/bch/english/e_index.html
 Ministry of the Environment: Biological diversity http://www.env.go.jp/seisaku/list/biodic.html
 Ministry of the Environment: Expert Committee on Living Modified Organisms, Nature Conservation Committee,
Central Environment Council http://www.env.go.jp/council/12nature/yoshi12-07.html
 Ministry of Agriculture, Forestry and Fisheries: Biological diversity and genetic modification
http://www.maff.go.jp/j/syouan/nouan/carta/seibutsu_tayousei.html
 Agriculture, Forestry and Fisheries Research Council: Committee on Assessment of Adverse Effects on
Biological Diversity http://www.affrc.maff.go.jp/docs/commitee/diversity/top.htm
 Ministry of Health, Labour and Welfare: Genetically modified foods
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/bio/idenshi/index.html
 Food Safety Commission: Expert Committee on Genetically Modified Foods http://www.fsc.go.jp/senmon/idensi/
 Ministry of Agriculture, Forestry and Fisheries: Feed safety http://www.maff.go.jp/j/syouan/tikusui/siryo/
 Food and Agricultural Materials Inspection Center (FAMIC): Feed http://www.famic.go.jp/ffis/feed/index.html
 Consumer Affairs Agency: Genetically modified foods
http://www.caa.go.jp/policies/policy/consumer_safety/food_safety/food_safety_portal/genetically_modified_food/
 Council for Biotechnology Information Japan: Japanese law system
https://cbijapan.com/about_legislation/legislation_jp/
Regulatory Systems in Japan (2)
Reference links

43
Reference: System to secure the safety of genetically modified agricultural products (Ministry of Agriculture, Forestry and Fisheries)
http://www.maff.go.jp/j/syouan/nouan/carta/kiso_joho/attach/pdf/outline-1.pdf
If GM crops are to be used
• Applying to the Ministry of Agriculture, Forestry and Fisheries/Ministry
of the Environment as Type 1 Use
• Contents of use: Cultivation in an isolated field, cultivation in an open
field, and for the use as food, feed, or for processing (the Cartagena
Protocol does not require approval procedures “for use as food or
feed, or for processing”)
Assessment of Adverse Effects on Biological Diversity (1)
Flow of the Review Process
Applicant
Public
Publication in the official
gazette
Application
Public
comments
Publication
Ministry of the
Environment
Ministry of the
Environment
Committee on
Diversity
Hearing of opinions
Submission of opinions
Type 1 Use
(without containment
measures)
Ministry of the Environment and:
• Research and development:
MEXT
• Alcohol production: Ministry of
Finance
• Medicinal products: Ministry of
Health, Labour and Welfare
• Agriculture, forestry, and
fishery: Ministry of Agriculture,
• Mining and manufacturing
industries: Ministry of
Economy, Trade and Industry
Type 2 Use
(with containment measures)
• Research and development:
MEXT
• Alcohol production: Ministry of
Finance
• Medicinal products: Ministry of
Health, Labour and Welfare
• Agriculture, forestry, and
fishery: Ministry of Agriculture,
• Mining and manufacturing
industries: Ministry of
Economy, Trade and Industry
• Other than the above: Ministry
of the Environment

44
Isolated Field Test
In the assessment of adverse effects on biological diversity for the commercial cultivation and import of
GM crops in Japan, if scientific knowledge regarding their growth in Japan is insufficient, an in-country
isolated field test is mandatory. Note that prior to an isolated field test, assessment of adverse effects on
biological diversity is also conducted to initiate the test.
Reference: http://www.maff.go.jp/j/syouan/nouan/carta/tetuduki/pdf/frame_work.pdf
Diversity
Closed
laboratory/greenhouse/
overseas field study, etc.
Diversity
Isolated field test
Cultivation
Import
(For food/feed/processing)
Photo provider: National Agriculture and Food
Research Organization
* The picture is for illustrative purposes.

45
GM plants
Stance on the Assessment of Adverse Effects on Biological
Diversity
Adverse effects on biological diversity are assessed comprehensively based on the contents and
likelihood of the effects, essentially from the following three perspectives.
Competitive advantage
Property of competing
against wild plants for
resources such as nutrients,
sunlight, and habitat areas
and interfering with the
growth of those plants
GM plants
Productivity of harmful
substances
Property of producing
substances that interfere with
the inhabitation or growth of
wild animals and plants
Crossability
Property of hybridization with
closely related wild plants and
transferring nucleic acids that
are introduced by genetic
modification technologies
Seeds are
carried
Pollen flies...
Harmful
substances
Hybridization
Wild plants,
animals, and
microorganisms
Closely related
wild plants
Results of
competition
Results of
harmful
substance
production
Results of
hybridization

46
Reference: Modified based on the Ministry of Health, Labour and Welfare’s “Safety Assessment of Genetically Modified Foods”
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/idenshi/anzen/anzen.html
Food Safety Assessment (1)
Applicant
Cabinet Office
Public
Publication in
the official
gazette
(1) Application
 (2) Request for
evaluation
 (5) Notification of
assessment results
(6) Publication
Ministry of Health,
Labour and Welfare
Minister of Health,
Labour and Welfare
Food Safety
Commission
Expert Committee on GM
Foods

(4)Reporting
(3)Referral
Food Health
Impact
Assessment
 Exchange of
information and
opinions
When importing or selling food products using GM crops, it is necessary to undergo a safety
review. Distribution in Japan is approved only if there are no problems at the safety review.
(: Provision of information to citizens)

47
Food Safety Assessment (2)
Stance on Safety Assessment
Whether the risk has changed compared with existing foods
Basic
policy
There is no food that is absolutely safe. Evaluation is undertaken from the perspective of how
safety has changed due to the intentional and unintentional changes induced by genetic
modification, compared to conventional crops with a history of use as foods, such as non-GM
crops.
Items to be
assessed
• The presence or absence of history of safe use for the hosts used as a
comparator
• Safety of both the gene to be introduced and the resulting protein
 Whether the donor of the transgene is pathogenic or toxic to humans
 Whether the functions of the transgene and the resulting protein are clear, etc.
• Allergenic properties of proteins to be introduced
 Whether they are similar to known allergens
 Whether the proteins can easily be degraded, etc.
• Changes due to gene insertion
 Insertion status of the transgene
 Expression level and stability of the transgene
 Whether proteins other than the intended protein are produced
 Whether the amounts of nutrients and toxic substances are changed
unintentionally, etc.
• Others
Reference: Standards for the Safety Assessment of Genetically Modified Foods (Seed Plants) (Food Safety Commission)
http://www.fsc.go.jp/senmon/idensi/gm_kijun.pdf, http://www.fsc.go.jp/senmon/idensi/gm_kijun_english.pdf

48
The safety of livestock products that are derived from livestock
animals for human use is assessed from the following three
perspectives.
1. Possibility that new harmful substances derived from
recombinants will be generated and transferred to livestock
products such as meat, milk, and eggs
2. Possibility that components derived from genetic recombination
will be converted to harmful substances and accumulated in
livestock products
3. Possibility that components attributed to genetic recombination
will affect the metabolic systems of livestock animals and
produce new harmful substances
The stance on safety assessment for livestock is basically the same
as that of food safety assessment.
Feed Safety Assessment
Safety as feed is assessed from two perspectives: safety for livestock animals, and safety of
livestock products derived from livestock animals fed with the GM feed.
Applicant
Agricultural Materials Council, Ministry of
Agriculture, Forestry and Fisheries
Food Safety Commission, Cabinet Office
Public
Publication in the
official gazette
Application
Public
comments
Publication
Reference:
Enforcement of Ministerial Ordinance on the Partial Revision of the Ministerial Ordinance on the Ingredient Standards of Feeds and Feed Additives (Ministry of Agriculture, Forestry and
Fisheries) http://www.famic.go.jp/ffis/feed/tuti/14_8598.html,
Stance on Safety Assessments of Genetically Modified Feed and Feed Additives (Food Safety Commission) http://www.fsc.go.jp/senmon/idensi/gm_siryoukijyun_english.pdf
Safety assessment system of genetically modified agricultural products (Agriculture, Forestry and Fisheries Research Council) http://www.affrc.maff.go.jp/docs/anzenka/GMhyouka.htm

49
1. Bean curd, deep-fried bean curd, and similar products 18. Popcorn
2. Frozen bean curd, bean curd refuse, bean curd skin 19. Frozen corn
3. Natto (fermented soybean paste) 20. Canned corn and bottled corn
4. Soybean milk and similar products 21. Products using corn flour as a main ingredient
5. Soybean paste 22. Products using corn grits as a main ingredient (excluding corn flakes)
6. Boiled soybean 23. Products using corn (for cooking) as a main ingredient
7. Canned soybean and bottled soybean 24. Products using any material listed in 16. to 20. as a main ingredient
8. Soybean flour 25. Potato snacks
9. Roasted soybean 26. Dried potato
10. Products using any material listed in 1. to 9. above as a main ingredient 27. Frozen potato
11. Products using soybean (for cooking) as a main ingredient 28. Potato starch
12. Products using soybean powder as a main ingredient 29. Products using potato (for cooking) as a main ingredient
13. Products using soybean protein as a main ingredient 30. Products using any material listed in 25. to 28. as a main ingredient
14. Products using green soybean as a main ingredient 31. Products using alfalfa as a main ingredient
15. Products using soybean sprout as a main ingredient 32. Products using sugar beet (for cooking) as a main ingredient
16. Corn snacks 33. Product using papaya as a main ingredient
17. Corn starch
Source: Food Labeling You Want to Know, June 2016 version (Consumer Affairs Agency)
http://www.caa.go.jp/policies/policy/food_labeling/information/pamphlets/pdf/syoku_hyou_all.pdf
Labeling (1)
Mandatory Labeling
Agricultural products and their processed food products subject to mandatory labeling for genetic modification
(Article 3 of the Food Labeling Standards)
• 8 agricultural crops
Soybean (including green soybean and soybean sprouts), corn, potato, rapeseed, cottonseed, alfalfa, sugar beet,
papaya
• 33 product groups of processed foods
For processed foods, labeling is mandatory for main ingredients (the top three ingredients that account for a high
percentage by weight, and weight of 5% or more of the total ingredient weight).

50
Foods equivalent to conventional products in composition and nutritional value (soybean altered so as not
to be affected by herbicides; corn resistant to pests, etc.)
(1) Agricultural products and processed food products made therefrom, in which recombinant DNA or the resulting
protein are still detectable, even after processing (8 crops and 33 food groups listed in the table on the previous slide)
* Limited to those for which identity preserved (IP) handling is conducted. Identity preserved handling refers to the
management of GM and non-GM agricultural products to prevent intermixing at each stage of production, distribution,
and processing from farms to food manufacturers, with issuance of an evidentiary document.
(2) Processed food products in which recombinant DNA or the resulting protein are undetectable after processing
(soybean oil, soy sauce, corn oil, isomerized sugar syrup, etc.)
Foods that differ greatly in composition or nutritional value from conventional products (high oleic acid
soybean, etc.)
Mandatory
labeling
GM segregated from
non-GM
a. When GM agricultural products are used as an ingredient (*)
GM not segregated
from non-GM
b. When agricultural products containing unsegregated GM
and non-GM agricultural products are used as an ingredient
Voluntary
labeling
Non-GM segregated
from GM
C. When non-GM agricultural products are used as an
ingredient (*)
Voluntary labeling
GM not segregated from non-GM, and non-GM segregated from GM
Mandatory labeling
Soybean (GM high oleic acid), etc.
Source: Food Labeling You Want to Know, June 2016 version (Consumer Affairs Agency)
http://www.caa.go.jp/policies/policy/food_labeling/information/pamphlets/pdf/syoku_hyou_all.pdf
Labeling (2)
Labeling System

51
Country Jurisdiction Content of regulations under the jurisdiction
United
States
FDA
(U.S. Food and Drug
Administration)
 Confirming safety as food based on a voluntary consultation
Under the FDA laws, those who intend to introduce a new crop or a new food
derived from a new crop are legally responsible for proving that the food meets the
safety standards.
USDA-APHIS
(U.S. Department of Agriculture,
Animal and Plant Health
Inspection Service)
 Regulations over the process from test cultivation to commercial
cultivation
Permitting the import, transfer between states, and environmental release of GM
crops from the viewpoint of plant pest control
EPA
(U.S. Environmental Protection
Agency)
 Environmental impact assessment, authorization for field cultivation
When GM crops producing agricultural chemical components are to be cultivated
outdoors
Canada
HC
(Health Canada)
 Safety review as a new food
Evaluation of safety of foods for humans, and marketing authorization of foods
CFIA
(Canadian Food Inspection
Agency)
 Environmental Release Regulations
Regulations on the import, environmental release, variety registration, and feed
utilization of plants with new traits
EU
EFSA
(European Food Safety
Authority)
 Safety review as a new food
Evaluation of safety of foods for humans, and marketing authorization of foods
EC
(European Commission)
 Import and processing are reviewed and authorized based on the
EFSA’s assessment
 Permitting member states to opt out (authority to prohibit) of
cultivation
 As for the import/processing authorization as food, EFSA’s assessment takes
precedence. Cultivation is assessed by the relevant member states, and assessed by
the EFSA if there are objections from other member states. The European Council and
the European Parliament are also involved in the authorization.
Regulatory Systems in Other Countries (1)
As of December 2018
Cooperation: Professor Masashi Tachikawa, Graduate School of Environmental Studies, Nagoya University

52
China
MoA
(Ministry of Agriculture of the
People’s Republic of China)
 Food safety review and approval
MoA organizes a Biosafety Committee and manages safety reviews and
authorization procedures.
 When GM plants and feed containing GM ingredients are exported to China,
the exporter is required to apply for, and receive a safety certificate from MoA.
 Safety review, issuance of safety certificates
A safety certificate is issued after passing a review of the results of three stages of
testing: intermediate testing, environmental release testing, and productivity
testing. Afterwards, the seed registration procedure is undertaken.
Korea
MFDS+
(RDA/NIE/NIFS)
Ministry of Food and Drug
Safety+
(Rural Development
Administration/National Institute
of Environmental
Research/National Fisheries
Research and Development
Institute)
 Safety review and approval as food (full/conditional approval)
The MFDS conducts reviews for the approval of GM crops for food, in consultation
with the three relevant organizations.
 Full approval: Commercial cultivation and import as food
 Conditional approval: Those already discontinued/not commercially cultivated
for food
RDA+
(NIE/NIFS/KCDC)
Rural Development
Administration+
(National Institute of
Environmental
Research/National Fisheries
Research and Development
Institute/Korea Centers for
Disease Control and Prevention)
 Environmental impact assessment, approval as feed
The RDA conducts reviews for the approval of GM crops for feed, in consultation
with the three relevant organizations.
As of December 2018

India
GEAC
(Genetic Engineering Appraisal
Committee)
 Safety review and approval as food
Until the FSSAI officially becomes functional, the GEAC performs the safety review
and approval processes on behalf of the FSSAI (Food Safety and Standards
Authority of India) (as of October 2017).
RCGM
(Department of Biotechnology,
Ministry of Science and
Technology: Review Committee
on Genetic Manipulation)
 Approval for small-scale cultivation tests
Establishment of guidelines for research and activities, safety monitoring, review of
GM crop import applications submitted to the GEAC, etc.
GEAC
(Genetic Engineering Appraisal
Committee)
 Approval for environmental release
Approval for field tests and commercial cultivation
Brazil
CTNBio
(Brazilian National Biosafety
Technical Commission)
 Safety assessment as food/feed
 Regulations over the process from test cultivation to commercial
cultivation
Evaluation and approval of all technical issues related to GM crops, prior approval
of the import of agricultural products for food, feed, and processing, including those
for biotech events
Argentina
SENASA
(National Service of Agri-food Health
and Quality)
 Safety assessment as food/feed
CONABIA
(National Advisory Commission
on Agricultural Biotechnology)
 Environmental impact assessment
The Minister of Agriculture authorizes commercial cultivation based on assessment
reports from the CONABIA, SENASA, and DMA.
DMA
(Directorate of Agricultural
Markets)
 Assessing impacts on the agricultural economy
53
As of December 2018

Australia
FSANZ
(Food Standards Australia New
Zealand)
 Development of a food standard draft, conduct of safety assessments,
etc.
Assessing potential risks to health such as toxicity and allergenicity
OGTR
(Office of Gene Technology
Regulator)
 Research and development, cultivation, and import license issuance
Assessment of risks to health and the environment, consultations regarding risk
management plans, etc.
APVMA
(Australian Pesticides and
Veterinary Medicines Authority)
 Health and environmental safety assessment of agricultural chemical
components
Advising the OGTR when GM crops producing agricultural chemical components
are to be cultivated outdoors
New
Zealand
FSANZ
(Food Standards Australia New
Zealand)
 Development of a food standard draft, conduct of safety assessments,
etc.
Assessing potential risks to health such as toxicity and allergies
EPA
(Environmental Protection
Authority)
 Regulation of the release of GMOs into the environment
54
As of December 2018

80.6%
69.5%
58.7%
52.0%
40.9%
33.8% 32.7%
26.4% 23.4% 20.2% 18.2% 13.2%
5.1% 0.6%
0.0%
20.0%
40.0%
60.0%
80.0%
100.0%
Price
Best-by
date/shelf-life
date/use-by
date
Whether
domestic
or
imported
products
Origin/production
area
Additives
(preservatives,
coloring
agents,
etc.)
Ingredients
Manufacturer
name
Nutritional
components
and
their
effects
Genetically
modified
foods
No/reduced
pesticides
Whether
wild
or
cultured
Organic
None
Others
56
Consumer Awareness Survey Conducted by the Council for
Biotechnology Information Japan (1)
What have you recently been interested in when purchasing food items? (multiple answers allowed)
(n = 2000)
37.9%
17.2%
13.7% 12.2%
8.4%
3.6% 2.8% 1.3% 0.8% 0.8% 0.8% 0.4% 0.1% 0.0%
0.0%
20.0%
40.0%
Price
Whether
domestic
or
imported
products
Best-by
date/shelf-life
date/use-by
date
Origin/production
area
Additives
(preservatives,
coloring
agents,
etc.)
Ingredients
Nutritional
components
and
their
effects
Manufacturer
name
Genetically
modified
foods
No/reduced
pesticides
Organic
Whether
wild
or
cultured
Others
None
(n = 1898)
Interest in GM foods at the time of food purchase is
not so high
0.8% of respondents chose GM foods as the most
interesting characteristic.
In addition, please choose what you are most interested in (one item)
Source: Consumer awareness survey on genetically modified foods (online survey of 2,000 women in their 20s to 50s), Council for Biotechnology
Information Japan (2017) https://cbijapan.com/document/1671/

57
What image do you have of GM foods? (by conducted year)
The image of GM foods has been improving year by year.
1.9%
8.3%
4.1%
4.5%
3.0%
2.8%
2.8%
27.9%
27.4%
15.4%
15.7%
14.2%
11.5%
47.2%
51.6%
62.0%
64.0%
65.1%
67.6%
14.9%
16.1%
17.7%
17.1%
17.6%
17.9%
2017
(n=2000)
2015
(n=2000)
2004
(n=1447)
2003
(n=1518)
2002
(n=1661)
2001
(n=1271)
Have a good image
Have a somewhat good image
Have a somewhat scary/bad image
Have a scary/bad
image
Have no particular image

3.8%
1.8%
0.8%
1.0%
1.9%
10.0%
7.8%
8.6%
6.6%
8.3%
38.2%
26.4%
22.6%
24.4%
27.9%
38.0%
48.4%
51.4%
50.8%
47.2%
10.0%
15.6%
16.6%
17.2%
14.9%
20s
30s
40s
50s
Overall
58
What image do you have of GM foods? (by age group)
Have a good image
Have a somewhat good image
Have a somewhat scary/bad image
Have a
scary/bad image
Have no particular image
Younger generations have a more positive image of GM foods.
n = 500 in each age group, 2000 in total

59
What sources of information you do think contributed to your image of GM foods? (multiple
answers allowed)
The image of GM foods has been formed by factors such as labeling as “Not genetically modified,” as well as the
information on TV and the Internet. Among these, the negative impact of TV is particularly large.
Have a good (somewhat good) image (n = 202)
Have no particular image (n = 558)
Have a scary/bad (somewhat scary/bad) image (n = 1240)
Labeling
of
“Not
genetically
modified”
TV
Newspaper/magazine
Books
Friends/acquaintances/family
members
Seminars/events/symposiums,
etc.
Consumer
organizations
POP
advertisement/flyers
at
stores
Information
on
the
Internet
SNS
Movies/videos
Others

60
Investigation by the Food Safety Commission
of the Cabinet Office (1)
Ranking of items requiring caution regarding effects on health (Median value)
Source: “Results of Questionnaire Survey on Food Risk Awareness (2015),” Food Safety Commission, Cabinet Office
https://www.fsc.go.jp/osirase/risk_questionnaire.data/risk_questionnaire_20150513.pdf
(Question) Which of the following items do you think you need to be cautious about, in terms of
influence on your health in Japan’s modern diet?
Among the following, please select the 10 items that you need to be cautious about, in
descending order of necessity.
[1. Bacterial pathogen, 2. Natural toxins such as puffer toxins and mushroom toxins, 3. BSE (Bovine
spongiform encephalopathy), 4. Residual pesticides, 5. Food additives, 6. Residual veterinary
medicinal products in livestock products, 7. Acrylamide, chloropropanol, etc.,
8. Chemicals eluting from food containers (Bisphenol A, etc.), 9. Mycotoxins (Aflatoxin, etc.),
10. Metal elements in nature such as cadmium, 11. Dioxins, 12. GM foods,
13. Imported foods, 14. Allergies, 15. Health foods/Supplements, 16. Tobacco, 17. Alcohol
consumption, 18. Unbalanced diet or overeating, 19. Others]
General
consumer online
survey (3600
respondents)
Breakdown:
Gender (2 categories)
Region (10 regions)
Age group (6 categories)
30 persons for each
category above
Food safety
specialists (*)
* Expert Committee
Members of the Food
Safety Commission
(161 persons)
(Ranking)
Bacterial
pathogen
(O-157,
etc.)
Residual
pesticides
Food
additives
(Ranking)
*: The 11th place and below
Chemicals
eluting
from
food
containers
Dioxins
Metal
elements
in
nature
(Cadmium,
etc.)
Natural
toxins
such
as
puffer
toxins
and
mushroom
toxins
BSE
(Bovine
spongiform
encephalopathy)
Residual
veterinary
medicinal
products
in
livestock
products
Tobacco
Unbalanced
diet
or
overeating
Allergy
Alcohol
consumption
Imported
foods
Health
foods/supplements
GM
foods
Acrylamide,
etc.
Mycotoxins
(Aflatoxin,
etc.)
GM foods are not ranked as
one of the top positions in a
diet-linked risk requiring
caution, by either general
consumers or experts.
* * * * * *
* * * * * * *
*

61
Investigation by the Food Safety Commission
of the Cabinet Office (2)
Percentage of respondents who ranked the items first to fifth as the items deemed to
be the cause of cancer
Source: “Results of Questionnaire Survey on Food Risk Awareness (2015),” Food Safety Commission, Cabinet Office
https://www.fsc.go.jp/osirase/risk_questionnaire.data/risk_questionnaire_20150513.pdf
(Question) Which of the following factors in Japan’s modern diet do you think may cause
cancer? Among the following, please select 5 items in the order that you think
most likely to be the cause.
[1. General foods , 2. Burned foods, 3. Alcohol consumption, 4. Unbalanced diet or
overeating, 5. Microorganisms (virus, bacteria), 6. Natural toxins such as puffer toxins and
mushroom toxins, 7. Residual pesticides, 8. Food additives, 9. Medicinal products,
10. Products made during processing, such as acrylamide and chloropropanol,
11. Mycotoxins (aflatoxin, deoxynivalenol, nivalenol), 12. Metal elements in nature such as
cadmium, methylmercury, and arsenic, 13. Dioxins, 14. GM foods, 15. Health
foods/Supplements, 16. Soy isoflavones, 17. Radioactive substances in foods, 18. Natural
radiation (cosmic rays, from the ground), 19. Tobacco, 20. Aging, 21. Sexual activity, 22. Air
pollution/pollution, 23. Others]
General
consumer
online survey
(3600
respondents)
Breakdown:
Gender (2 categories)
Region (10 regions)
Age group (6
categories)
30 persons for each
category above
Food safety
specialists (*)
* Expert Committee
Members of the Food
Safety Commission
(161 persons)
Tobacco
Food
additives
Air
pollution/pollution
Aging
Unbalanced
diet
or
overeating
Alcohol
consumption
Burned
foods
Dioxins
Residual
pesticides
Microorganisms
(virus,
bacteria)
Radioactive
substances
in
foods
Cadmium,
etc.
General
foods
Mycotoxins
Acrylamide
GM
foods
Medicinal
products
Natural
toxins
such
as
puffer
toxins
and
mushroom
toxins
Sexual
activity
Health
foods/supplements
Soy
isoflavones
Natural
radiation
(cosmic
rays,
from
the
ground)
There is a large difference between
general consumers and experts in the
perception of GM foods as a risk of
causing cancer.

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