Required Report - public distribution

**Date:** 7/19/2005

**GAIN Report Number:** JA5038

JA5038

**Japan**

**Food and Agricultural Import Regulations and Standards**

**Agricultural Biotechnology Report**

**2005**

**Approved by:**

![](media/image1.wmf)Clay Hamilton

U. S. Embassy

**Prepared by:**

Tetsuo Hamamoto

**Report Highlights:**

Report Highlights: Japan, as one of the largest importers of US
agricultural biotechnology products from the U.S., has approved 61
biotech events for food, 38 for feed and 50 for planting. Japan does not
produce any biotech products commercially but does have several products
under development. Japan ratified the Biosafety Protocol in November
2003 and has implemented mandatory biotech labeling on certain foods
containing biotech derived ingredients. In general, biotech products are
not well received by the Japanese food industry or consumers.

Includes PSD Changes: No

Includes Trade Matrix: No

Annual Report

Tokyo \[JA1\]

\[JA\]

Table of Contents

[**SECTION I. EXECUTIVE SUMMARY 3**](#section-i.-executive-summary)

[SECTION II. BIOTECHNOLOGY TRADE AND PRODUCTION
3](#section-ii.-biotechnology-trade-and-production)

[Biotechnology crop production in Japan
3](#biotechnology-crop-production-in-japan)

[Biotech crop development in Japan
3](#biotech-crop-development-in-japan)

[Import of biotech crops 4](#import-of-biotech-crops)

[SECTION III. BIOTECHNOLOGY POLICY
4](#section-iii.-biotechnology-policy)

[Regulatory framework of agricultural biotechnology
4](#regulatory-framework-of-agricultural-biotechnology)

[Approved biotechnology products 7](#approved-biotechnology-products)

[Biotechnology products under field trials
11](#biotechnology-products-under-field-trials)

[Safety approvals of stacked events
11](#safety-approvals-of-stacked-events)

[National policy on coexistence between biotechnology and
non-biotechnology plants
12](#national-policy-on-coexistence-between-biotechnology-and-non-biotechnology-plants)

[Local government regulations on coexistence
13](#local-government-regulations-on-coexistence)

[Labeling policy for biotechnology products
13](#labeling-policy-for-biotechnology-products)

[Monitoring of "Biotechnology" or "Non-biotechnology" labeled foods
15](#monitoring-of-biotechnology-or-non-biotechnology-labeled-foods)

[Monitoring for unapproved biotechnology events
15](#monitoring-for-unapproved-biotechnology-events)

[Implementation of requirements for export of biotechnology products
(living modified organisms, LMOs) under the Biosafety Protocol
16](#implementation-of-requirements-for-export-of-biotechnology-products-living-modified-organisms-lmos-under-the-biosafety-protocol)

[SECTION IV. MARKETING ISSUES 16](#section-iv.-marketing-issues)

[SECTION V. CAPACITY BUILDING AND OUTREACH
20](#section-v.-capacity-building-and-outreach)

[SECTION VI. REFERENCE MATERIALS 21](#section-vi.-reference-materials)

# SECTION I. EXECUTIVE SUMMARY

Japan is one of the largest importers of U.S. agricultural products,
importing around 16 metric tons of corn and 4.5 metric tons of soybeans,
two major biotechnology plant products, from the U.S. per year. The
Japanese government has taken extensive measures to address regulatory
and public concerns; including biotech labeling, mandatory safety food
and feed review systems as well as domestic regulations pertaining to
the Biosafety Protocol based environmental review system. Japan ratified
the Biosafety Protocol on November 21, 2003.

The Ministry of Health, Labor and Welfare (MHLW) is responsible for food
safety assurances of biotechnology products, while Ministry of
Agriculture, Forestry and Fisheries (MAFF) are in charge of feed and
environmental safety. The Food Safety Commission (FSC), a risk
assessment government body established in July 2003, performs food and
feed safety risk assessment for MHLW and MAFF. Japan has approved 61
biotechnology events for food, 38 for feed and 50 for planting. Import
of biotechnology events that have not obtained the necessary approvals
is strictly prohibited.

Japan is not commercially producing biotechnology plants. A number of
public research institutes are carrying out research on the development
of plant biotechnology but has not progressed to the field trial stage
because of strong consumer concern over biotech products. The private
industry is generally limiting its research to the basic level but one
company has developed a uniquely colored (blue) carnation but it is
grown abroad and imported into Japan.

Japan requires biotech labeling on food products in which traces of
biotechnology derived DNA or protein is found. Food manufacturers of
those subject to the labeling, without exception, request U.S. suppliers
to provide non-biotechnology products based on IP handling. To be
labeled as non-biotech, documentation of IP handling is required. Many
manufacturers of foods outside the labeling requirement, such as oil,
utilize biotech products, however many others such as the end users of
corn sweeteners, often request non-biotech products. These end products
are then labeled as non-biotech as a marketing tool. The Japanese food
industry and the public are reluctant to accept agricultural
biotechnology products. This situation can change over take time by
educating the consumer to the safety and benefits of biotechnology. The
availability of biotech products with consumer benefits will also help
speed acceptance.

# SECTION II. BIOTECHNOLOGY TRADE AND PRODUCTION

## Biotechnology crop production in Japan

There is no substantial commercial production of biotech crops in Japan.
There had been a few farmers "experimentally" growing biotech soybeans
in Japan in order to confirm their benefits but they terminated their
experiments before the crops flowered in order to avoid concerns about
cross contamination from surrounding farmers and agricultural coops who
oppose biotech crops. Some localities, including the Hokkaido Prefecture
have passed resolutions banning all biotech crop production.

## Biotech crop development in Japan

Japan is one of the leading countries in the world in the field of
biotech research. A number of public research institutes are actively
engaging in plant and industrial biotech research and development.
However agricultural biotechnology severely lags behind and there are no
new food products in the pipeline for commercialization because of
strong anti-biotech concerns among consumers Japan. Ongoing research
includes the introduction of fungal resistance and pollen allergy
suppressing traits into rice. Most of this research is at the early
experimental stage and has not progressed to the field trial stage.
Taking into consideration the time required to obtain necessary
regulatory approvals, it will be years before these products can
commercially available. Private industry is generally limiting its
research to the basic stage. A uniquely colored (blue) carnation
developed by genetic recombination is commercially available by Suntory
Co. but it is grown abroad and imported into Japan.

## Import of biotech crops

Japan is one of the largest food importers in the world with around 40%
of its food being imported (on an energy supply base). Japan
particularly relies heavily on imports for corn and soybeans, two major
biotech crops produced in the U.S. Japan also imports canola mainly from
Canada, which is a major biotech crops produced in Canada.

In order to avoid having to label foods as " containing biotech" almost
all retailers require that food use corn and soybeans be supplied as IP
handled non-biotech products. The US supplies about 95% of Japan's 16
million MT of corn imports per year. Corn for feed consisting accounts
for 12 million MT of the total 16 million MT, which is bulk general corn
not segregating biotech corn events with the remainder being non-biotech
corn for food uses.

For soybeans, Japan imports about 4.5 million MT per year that includes
3.5 million MT from the U.S. Around 3.5 million MT of soybeans are used
for crushing annually. Since vegetable oil is exempted from the
labeling, almost all of the soybeans imported for crushing are bulk
general shipments not segregating biotech products. The soybean food
industry (tofu, etc) demands soybean importers supply non-biotech food
beans to be used as raw ingredients alongside the 0.2 million MT of
domestically produced non-biotech soybeans.

# SECTION III. BIOTECHNOLOGY POLICY

## Regulatory framework of agricultural biotechnology

In Japan, commercialization of biotech plant products requires
environment, food and feed approvals. Four ministries are mainly
involved in the regulatory framework for agricultural biotechnology;
Ministry of Agriculture, Forestry and Fisheries (MAFF), Ministry of
Health, Labor and Welfare (MHLW), Ministry of Environment (MOE), and
Ministry of Education, Culture, Sports, Science and Technology (MEXT).

Those ministries act as a secretariat in the regulatory framework to
obtain appropriate ministers' approvals. Risk assessments and safety
evaluations are performed by each ministries' advisory committees and
scientific expert panels. The scientific assessments and evaluations are
performed by the scientific expert panels, which mainly consist of
researchers of universities and public research institutions. The
decisions by the expert panels are reviewed or consulted by the advisory
committees whose members include technical experts and opinion leaders
from a broad scope of interested parties such as consumers and
industries. The advisory committees report back the decision to the
responsible ministries.

As Japan ratified the Biosafety Protocol in November 2003, Japan
enforced a law (Law Concerning the Conservation and Sustainable Use of
Biological Diversity through Regulations on the Use of Living Modified
Organisms, "Cartagena Law") in February 2004. Under the law, MEXT
requires its minister's approval before performing early stage
agricultural biotech experiments in laboratories and greenhouses. MAFF
and MOE require their Ministers' joint approvals for the use of biotech
plants in an isolated field for the evaluation of influences on
biodiversity (Type 2 use). After the necessary scientific data are
collected through the isolated field experiments, under permission by
MAFF and MOE Ministers, a risk assessment of the event will be done
through the use of field trials (Type 1 use). A joint MAFF and MOE
expert panel carries out the environmental safety evaluations. Non-food
biotech plant products such as flowers may be produced commercially once
the Type 1 use risk assessment is completed.

Biotech plants that are used for food must obtain food safety approvals
from the MHLW Minister. Based on the Food Sanitation Law, upon receiving
a petition for review from an interested party (either, but not limited
to, the biotech company or industry), the MHLW minister will request the
Food Safety Commission (FSC) to review the food safety of the biotech
products. The FSC is an independent government organization under the
Cabinet Office that was established to perform food safety risk
assessments by expert committees. Within the FSC is a Genetically
Modified Foods Expert Committee, consisting of plant biotech scientists
from universities and public research institutes, that does the actual
scientific review. Upon completion, the FSC provides its risk assessment
conclusions to the MHLW Minister. The standards used by the FSC for food
risk assessment of biotech foods are available in English at the
following website:
([http://www.fsc.go.jp/senmon/idensi/gm_kijun_english.pdf]{.underline}).

Biotech products that are also used as feed must obtain approvals from
the MAFF Minister based on the Feed Safety Law. Upon requests from
petitioners, the MAFF Minister asks the Experts Panel on Recombinant DNA
Organisms

, which is part of the MAFF affiliated Agricultural Materials Committee
(AMC), to review the event. The Expert Panel evaluates feed safety on
livestock animals, which is then reviewed by the AMC. The MAFF Minister
also asks the FSC Genetically Modified Foods Expert Committee to review
any possible human health effects from consumption of livestock products
from animals fed with biotech event under review. Based on the reviews
of AMC and FSC, the MAFF Minister grants approval for the feed safety of
biotech plants. Following is a schematic chart of the flow of the
approval process.

Biotech products that require new standards or regulations not related
to food safety, such as labeling or new risk management procedures
including IP handling protocols, may need to be discussed by the
Pharmaceutical Affairs and Food Sanitation Council of MHLW, and/or Japan
Agricultural Standards Council of MAFF.

![](media/image1.wmf)

Expert Panel1): Expert Panel on Recombinant DNA Technology, Bioethics
and Biosafety Commission, Council for Science and Technology, MEXT

Expert Panel2): Experts with special knowledge and experience concerning
adverse effect on biological diversity selected by MAFF/MOE Ministers

Expert Panel3): Genetically Modified Foods Expert Committee, FSC

Expert Panel4): Expert Panel on Recombinant DNA Organisms, Agricultural
Materials Council, MAFF

Committee1): Food Safety Commission

Committee2): Feed Committee, Agricultural Materials Council, MAFF

Subcommittee1): Safety Subcommittee, Feed Committee, Agricultural
Materials Council, MAFF

Red (broken) arrow: Request for review or risk assessment

Blue (solid) arrow: Recommendation or risk assessment results (thick
arrows: with public comment periods)

Numbers beside the arrows indicate the order of requests/recommendations
within the respective ministries.

Petitions for products within the R&D stage are reviewed first for the
Type 2 use under the Cartagena Law and those for import and/or
cultivation (products in the R&D stage whose safety are already
confirmed) are reviewed for the Type 1 use, and food and/or feed, as
necessary. Petitions for products imported only as non-LMO such as
processed foods are reviewed only for food and/or feed review.

This chart outlines principle flow of the approval procedure in Japan,
and the process may vary depending on the nature of individual
biotechnology products.

## Approved biotechnology products

As of June, 2005, Japan has approved 61 biotech events for food, 38 for
feed and 50 for planting. Until the Biosafety Protocol was ratified in
November 2003, Japan had approved 106 events for import and 74 for
planting. Those approvals expired when the new legal framework under the
Biosafety Protocol was introduced except for those developers who
requested to maintain the approvals temporarily. All products approved
prior to the ratification of the Biosafety Protocol must be reviewed
before being re-approved. Currently under the Biosafety Protocol, Japan
does not grant separate environment approvals for import and planting.

Following list shows the status of the approvals.

  --------------- ------------- ------------------- --------------------- --------------------------------------- ---------- ----------
  **List of                                                                                                                  
  Currently                                                                                                                  
  Approved                                                                                                                   
  Biotechnology                                                                                                              
  Products in                                                                                                                
  Japan**                                                                                                                    

  **As of May                                                                                                                
  2005 (feed as                                                                                                              
  of July 2003)**                                                                                                            

  **Plant         **Trait or    **Developer**       **Characteristics**   **Approvals**                                      
  species**       Variety**                                                                                                  

                                                                          **BSP (OECD UI)**                       **Feed**   **Food**

  Canola          RT73          Monsanto Japan      Herbicide tolerant    2004\* (MON-00073-7)                    1996       2001

                  HCN92         Bayer Crop Science  Herbicide tolerant    2004\* (Topas19/2, ACS-BN007-1)         1996       2001

                  HCN10         Bayer Crop Science  Herbicide tolerant                                            1998       2001

                  PGS1          Bayer Crop Science  Herbicide tolerant    2004\* (ACS-BN004-7xACS-BN001-4)        1996       2001

                  PHY14                                                                                           1998       2001

                  PHY35                                                                                           1998       2001

                  T45           Bayer Crop Science  Herbicide tolerant    2004\* (ACS-BN008-2)                    1997       2001

                  PGS2          Bayer Crop Science  Herbicide tolerant,   2004\* (MS1RF2,                         1997       2001
                                                    male sterile,         ACS-BN004-7xACS-BN002-5)                           
                                                    sterility recovery                                                       

                  PHY36                                                                                           1997       2001

                  PHY23                                                                                           1999       2001

                  Oxy-235       Bayer Crop Science  Herbicide tolerant    2004\* (ACS-BN001-5)                    1999       2001

                  MS8RF3        Bayer Crop Science  Herbicide tolerant,   2004\* (ACS-BN005-8xACS-BN003-6)        1998       2001
                                                    male sterile,                                                            
                                                    sterility recovery                                                       

                  MS8           Bayer Crop Science  Herbicide tolerant,   2004\* (ACS-BN005-8)                    1999       2001
                                                    male sterile                                                             

                  RF3           Bayer Crop Science  Herbicide tolerant,   2004\* (ACS-BN003-6)                    1999       2001
                                                    sterility recovery                                                       

                  RT200         Monsanto Japan      Herbicide tolerant    2004\* (MON-89249-2)                    2001       2001

  **Plant         **Trait or    **Developer**       **Characteristics**   **BSP**                                 **Feed**   **Food**
  species**       Variety**                                                                                                  

  Carnation       11            Florigene/Suntory   Color change          2004 (FLO-07442-4)                      N/A        N/A

                  123.2.38      Florigene/Suntory   Color change          2004 (FLO-40644-4)                      N/A        N/A

                  123.8.8       Suntory             Color change          2004 (FLO-40685-1)                      N/A        N/A

                  123.2.2       Suntory             Color change          2004 (FLO-40619-7)                      N/A        N/A

                  11363         Suntory             Color change          2004 (FLO-11363-1)                      N/A        N/A

  Corn            T-14          Bayer Crop Science  Herbicide tolerant    2004\* (ACS-ZM-002-1)                   1997       2001

                  T-25          Bayer Crop Science  Herbicide tolerant    2004 (ACS-ZM003-2)                      1997       2001

                  MON810        Monsanto Japan      Insect resistant      2004 (MON-00810-6)                      1997       2001

                  Bt11          Syngenta Seeds      Insect resistant      2004\* (SYN-BT011-1)                    1996       2001

                  Sweet corn,                                                                                     \-         2001
                  Bt11                                                                                                       

                  Event176      Syngenta Seeds      Insect resistant      2004\* (SYN-EV176-9)                    1996       2001

                  CBH351        Starlinc Logistic   Insect resistant,     2004\*                                  \-         \-
                                Inc.                herbicide tolerant                                                       

                  GA21          Monsanto Japan      Herbicide tolerant    2004\* (MON-00021-9)                    1999       2001

                  DLL25         Monsanto Japan      Herbicide tolerant    2004\* (DKB-89790-5)                    2000       2001

                  DBT418        Monsanto Japan      Insect resistant,     2004\* (DKB-89614-9)                    2000       2001
                                                    herbicide tolerant                                                       

                  NK603         Monsanto Japan      Herbicide tolerant    2004 (MON-00603-6)                      2001       2001

                  MON863        Monsanto Japan      Insect resistant      2004 (MON-00863-5)                      2002       2002

                  1507          DuPont              Insect resistant and  2005 (DAS-01507-1)                      2002       2002
                                                    herbicide tolerant                                                       

                  MON88017      Monsanto Japan      Insect resistant,     2004\* (MON-88017-3)                    \-         \-
                                                    herbicide tolerant                                                       

                  MON863 x      Monsanto Japan      Herbicide tolerant,   2004 (MON-00863-5xMON-00603-6)          \-         2003
                  NK603                             Insect resistant                                                         

                  GA21 x MON810 Monsanto Japan      Herbicide tolerant,   2004\* (MON-00021-9xMON-00810-6)        \-         2003
                                                    Insect resistant                                                         

                  MON810 x      Monsanto Japan      Herbicide tolerant,   2004 (MON-00603-6xMON-00810-6)          \-         2003
                  NK603                             Insect resistant                                                         

                  MON810 x T25  Monsanto Japan      Herbicide tolerant,   2004\* (ACS-ZM003-2xMON-00810-6)        \-         2003
                                                    Insect resistant                                                         

                  1507 x NK603  DuPont              Herbicide tolerant,   2005 (DAS-01507-1xMON-00603-6)          \-         2004
                                                    Insect resistant                                                         

                  MON810 x      Monsanto Japan      Insect resistant      2004 (MON-00810-6xMON-00863-5)          \-         2004
                  MON863                                                                                                     

                  MON810 x      Monsanto Japan      Herbicide tolerant,   2004                                    \-         2004
                  MON863 x                          Insect resistant      (MON-00863-5xMON-00810-6xMON-00603-6)              
                  NK603                                                                                                      

  **Plant         **Trait or    **Developer**       **Characteristics**   **BSP**                                 **Feed**   **Food**
  species**       Variety**                                                                                                  

  Cotton          531           Monsanto Japan      Insect resistant      2004 (MON-00531-6)                      1997       2001

                  757           Monsanto Japan      Insect resistant      2005 (MON-00757-7)                      1997       2001

                  1445          Monsanto Japan      Herbicide tolerant    2004 (MON-01445-2)                      1998       2001

                  10211         Monsanto Japan      Herbicide tolerant                                            \-         2001

                  10215         Monsanto Japan      Herbicide tolerant                                            1998       2001

                  10222         Monsanto Japan      Herbicide tolerant                                            1998       2001

                  15985         Monsanto Japan      Insect resistant      2004 (MON-15985-7)                      2003       2002

                  1445 x 531    Monsanto Japan      Herbicide tolerant,   2004 (MON-01445-2xMON-00531-6)          \-         2003
                                                    Insect resistant                                                         

                  15985 x 1445  Monsanto Japan      Herbicide tolerant,   2005 (MON-16985-7xMON-01445-2)          \-         2003
                                                    Insect resistant                                                         

                  LLCotton25    Bayer Crop Science  Herbicide tolerant                                            \-         2004

                  MON88913      Monsanto Japan      Herbicide tolerant                                            \-         2005

                  MON88913 x    Monsanto Japan      Herbicide tolerant,                                           \-         2005
                  15985                             Insect resistant                                                         

  Papaya          55-1          Hawaii Papaya Ind.  Ringspot Virus        2004\*                                  N/A        \-
                                Assn.               resistant                                                                

  **Plant         **Trait or    **Developer**       **Characteristics**   **BSP**                                 **Feed**   **Food**
  species**       Variety**                                                                                                  

  Potato          BT6           Monsanto Japan      Insect resistant      Not needed                              N/A        2001

                  SPBT02-05     Monsanto Japan      Insect resistant      Not needed                              N/A        2001

                  RBMT21-129    Monsanto Japan      Insect resistant and  Not needed                              N/A        2001
                  (NLP)                             virus resistant                                                          

                  RBMT21-350    Monsanto Japan      Insect resistant and  Not needed                              N/A        2001
                  (NLP)                             virus resistant                                                          

                  RBMT22-82     Monsanto Japan      Insect resistant and  Not needed                              N/A        2001
                  (NLP)                             virus resistant                                                          

                  SEMT15-15     Monsanto Japan      Insect resistant and  Not needed                              N/A        2003
                  (NLY)                             virus resistant                                                          

                  RBMT15-101    Monsanto Japan      Insect resistant and  Not needed                              N/A        2003
                                                    virus resistant                                                          

                  New Leaf Y    Monsanto Japan      Insect resistant and  Not needed                              N/A        2003
                  Potato                            virus resistant                                                          
                  SEMT15-02                                                                                                  

  Soybean         40-3-2        Monsanto Japan      Herbicide tolerant    2005 (MON-04032-6)                      1996       2001

                  260-05        DuPont              High oleic acid       2004\* (DD-026005-3)                    2000       2001

                  A2704-12      Bayer Crop Science  Herbicide tolerant    2004\* (ACS-GM005-3)                    2003       2002

                  A5547-127     Bayer Crop Science  Herbicide tolerant    2004\* (ACS-GM006-4)                    2003       2002

  Sugar beet      T120-7        Bayer Crop Science  Herbicide tolerant    Not needed                              1999       2001

                  77            Monsanto Japan      Herbicide tolerant    Not needed                              2003       2003

                  H7-1          Monsanto Japan      Herbicide tolerant    Not needed                              \-         2003

  Number of total                                                         BSP                                     Feed       Food
  approvals                                                                                                                  

                                                                          22 (28\*)                               38         61

  For each                                                                                                                   
  biotechnology                                                                                                              
  variety, the                                                                                                               
  years safety                                                                                                               
  approvals were                                                                                                             
  granted are                                                                                                                
  shown for BSP                                                                                                              
  environmental                                                                                                              
  (import and                                                                                                                
  planting), feed                                                                                                            
  and food                                                                                                                   
  safety. 'None'                                                                                                             
  indicates the                                                                                                              
  safety has not                                                                                                             
  been confirmed                                                                                                             
  by the                                                                                                                     
  Government of                                                                                                              
  Japan. Potato                                                                                                              
  and sugar beet                                                                                                             
  are imported to                                                                                                            
  Japan only as                                                                                                              
  processed                                                                                                                  
  foods, thus                                                                                                                
  indicated as                                                                                                               
  'Not needed'                                                                                                               
  for import and                                                                                                             
  planting. 'N/A'                                                                                                            
  means not                                                                                                                  
  applicable. \*                                                                                                             
  in BSP                                                                                                                     
  approvals                                                                                                                  
  indicates                                                                                                                  
  temporary                                                                                                                  
  approvals until                                                                                                            
  a full risk                                                                                                                
  assessment is                                                                                                              
  completed.                                                                                                                 
  --------------- ------------- ------------------- --------------------- --------------------------------------- ---------- ----------

The list of approved events for food is also available on line from MHLW
([http://www.mhlw.go.jp/english/topics/food/pdf/sec01.pdf]{.underline}).

## Biotechnology products under field trials 

The Japanese government requires all entities to obtain approval before
performing field trials of biotech crops. The following table shows the
list of those biotech crops currently in the field trial stage
(extracted from Japan Biosafety Clearing House (J-BCH) website;
[http://www.bch.biodic.go.jp/english/lmo.html]{.underline})

  ------------ --------------------------------------------- ----------------
  Approval     Name of the type of Living Modified Organism  Applicant
  Date                                                       

  2004-06-11   Semidwarf rice (OsGA2ox1, Oryza sativa L.)    NIAS
               (G-3-3-22)                                    

  2004-06-11   Erect-leaved semidwarf rice) (ΔOsBRI1, Oryza  NIAS
               sativa L.) (B-4-1-18)                         

  2004-06-11   Tryptophan rich rice (OASA1D, Oryza sativa    NARO
               L.) (HW1)                                     

  2004-06-11   Tryptophan rich rice (OASA1D, Oryza sativa    NARO
               L.) (HW5)                                     

  2005-04-25   Rice tolerant to low iron availability        Tohoku
               (cry1Ac, Gossypium hirsutum L.) (gHvNAS1-1)   University

  2005-04-25   Rice tolerant to low iron availability        Tohoku
               (HvNAAT-A, HvNAAT-B, Oryza sativa L.)         University
               (gHvNAAT1)                                    

  2005-04-25   Rice tolerant to low iron availability        Tohoku
               (HvIDS3, Oryza sativa L.) (gHvIDS3-1)         University

  2005-04-25   Rice tolerant to low iron availability        Tohoku
               (HvNAS1, HvNAAT-A, HvNAAT-B, Oryza sativa L.) University
               (gHvNAS1-gHvNAAT1)                            

  2005-04-25   Rice tolerant to low iron availability        Tohoku
               (APRT,Oryza sativa L.) (I3pAPRT1)             University

  2005-04-25   Rice tolerant to low iron availability        Tohoku
               (HvNAS1, HvNAAT-A, APRT, Oryza sativa L.)     University
               (I3pNasNaatAprt1)                             

  2005-05-25   Rice producing Japanese cedar pollen allergy  NARO
               preventive peptide (DEF, Oryza sativa, L.)    
               (7Crp#10)                                     

  2005-05-25   Rice resistant to blast and bacterial leaf    NARO
               blight (DEF, Oryza sativa, L.) (AD41)         

  2005-05-25   Rice resistant to blast and bacterial leaf    NARO
               blight (DEF, Oryza sativa, L.) (AD48)         

  2005-05-25   Rice resistant to blast and bacterial leaf    NARO
               blight (DEF, Oryza sativa, L.) (AD51)         

  2005-05-25   Rice resistant to blast and bacterial leaf    NARO
               blight (DEF, Oryza sativa, L.) (AD77)         

  2005-05-25   Rice resistant to blast and bacterial leaf    NARO
               blight (DEF, Oryza sativa, L.) (AD97)         
  ------------ --------------------------------------------- ----------------

NIAS: National Institute of Agrobiological Sciences

NARO: National Agriculture and Bio-oriented Research Organization

## Safety approvals of stacked events

Japan requires separate environment approvals for stacked events - those
that combine two already approved traits, such as herbicide tolerance
and insect resistance.

For environment safety approvals of stacked events, it is not always
necessary to perform field trials. While MAFF and MOE require
environment safety review by their experts, the data and information on
the parents may be used and it is generally unnecessary to carry out
field trials on the stacked events.

For food safety approvals, the FSC presented an opinion paper on January
29, 2004 on its reviews of crossed events between biotech and
non-biotech events and stacked events. In this paper, the FSC
categorized biotech events into three groups: 1) introduced genes which
do not influence host metabolism and mainly endow the hosts with insect
resistance, herbicide tolerance or virus resistance, 2) introduced genes
which alter host metabolism and endow the hosts with high nutritional
component concentration or suppression of cell wall degradation by
promoting or inhibiting specific metabolic pathways, and 3) introduced
genes which utilize certain metabolites to synthesize new metabolites
the hosts originally do not produce.

The FSC requires a safety approval on the crossed event if the crossing
occurs above the subspecies level between a biotech event and a
non-biotech event, and if the crossing occurs biotech events in
category 1. The FSC also requires safety approvals on stacked events
between those in category 1 if the amount consumed by humans, the edible
part or processing method is different from that of the parents. The FSC
requires safety approvals on stacked events between biotech events in 1
and 2, 1 and 3, 2 and 2, 3 and 3, and 2 and 3. Most stacked events that
result from traditional crossbreeding do not require a safety review.

For feed safety of stacked events, MAFF requires approvals from the
Expert Panel on Recombinant DNA Organisms of the Agricultural Material
Committee (AMC). Unlike the feed safety full approvals, the approvals by
the Expert Panel are neither subject to MAFF Minister notification nor
public comments.

## National policy on coexistence between biotechnology and non-biotechnology plants

Japan, which produces no commercial biotech plants, has a guideline
issued by MAFF on February 24, 2004, on field trials of biotech plants.
Before field trials are performed, detail information including
preventive measures for crossing with the same plant species in
surrounding environment, such as buffer zones, must be made public on
websites and through explanatory meetings for local residents.

The buffer zones should isolate the plants subject to field trials from
the same plant species with a minimum distances stated below.

  ----------------------------------- -----------------------------------
  Name of the field tested plant      Minimum isolation distance

  Rice                                26 meters (temporarily amended in
                                      April 2005 from 20 meters)

  Soybean                             10 meters

  Corn (applicable only on those with 600 meters, or 300 meters with the
  food and feed safety approvals)     presence of a windbreak

  Rapeseed (applicable only on those  600 meters, or 400 meters if
  with food and feed safety           non-recombinant rapeseed is planted
  approvals)                          to flower at the same time of the
                                      field tested rapeseed. A width of
                                      1.5 meters surrounding field tested
                                      plants as a trap for pollens and
                                      pollinating insects
  ----------------------------------- -----------------------------------

If the field tested rice or soybeans have not received either food or
feed approval, then, the same plant species should be planted as an
index (index plant) to flower at the same time of the field tested plant
to confirm if crossing took place between the inside and outside of the
test field, and at least 10,000 seeds should be harvested (in the cases
xenia is generated, seeds showing xenia are selected), and tested
through analytical methods such as PCR that can specifically detect
introduced genes of the field tested plant, or the presence of drug
resistance if the introduction includes drug resistance, to confirm if
crossing took place.

Following is a table of the range of "same plant species."

  ----------------------------------- -----------------------------------
  Field tested plant                  Plant belong to the same plant
                                      species

  Rice (*Oryza sativa* L.)            Rice (*Olyza sative* L.)

  Soybean (*Glycine max* L.)          Soybean (*Glycine max* L.)

  Corn (*Zea mays* L.)                Corn (*Zea mays* L.) Teosinte (*Zea
                                      mays* subsp. *Mexicana*)

  Rapeseed (*Brassica napus*)         Rapeseed (*Brassica napus*) Chinese
                                      cabbage, Radish, *Komatsuna*,
                                      Quing-geng-cai, *Tsukena*, etc.
                                      (*Brassica rapa*) *Karashina*,
                                      *Takana*, etc. (*Brassica juncea*)
                                      *Kairan* (*Brassica alboglabra*)

  Tomato (*Lycopsicum esculentum*     Tomato (*Lycopsicum esculentum*
  Mill.)                              Mill.)

  Cotton (*Gossypium hirsutum* L.)    Cotton (*Gossypium hirsutum* L.)

  Alfalfa (*Medicago sativa*)         Alfalfa (*Medicago sativa*)

  Potato (*Solanum tuberosum*)        Potato (*Solanum tuberosum*)
  ----------------------------------- -----------------------------------

## Local government regulations on coexistence

Hokkaido prefecture, which occupies the whole island of north Japan and
is one of the major agricultural production areas, is planning to
implement a prefecture law to regulate planting of biotech plants for
field trial and commercial production. The law requires entities
planning to carry out isolated field planting experiments, in addition
to meeting the national government requirements, to report to the
governor. The governor then asks prefecture's food safety expert
committee to examine the appropriateness of the experiments and if not
approved the governor can order the entity to not carry out the
experiments. The law also requires entities to obtain permission from
the governor for any plans to release biotech products to the open
environment as either field trials or commercial production. Violations
of the prefecture law could result in imprisonment or a fine. The law
was enacted to address the emotional concern over biotechnology as well
as concerns from farmers that the presence of biotech crops could damage
the image of their crops through consumer's concern about commingling
with biotech products. Some farmers in Hokkaido had planted test plots
of biotech soybeans in the past, but this new law makes it unlikely that
they will be able to continue.

## Labeling policy for biotechnology products

MAFF and MHLW have implemented labeling requirements under the Food
Sanitation Law and the Japan Agricultural Standards (JAS) Law,
respectively for biotech products that have been approved in Japan. MAFF
introduced the biotech labeling in response to a demand of "the
consumers' right to know" while MHLW introduced its labeling from a more
scientific standpoint to clarify that the biotech ingredients used are
those whose safety is confirmed. Although the labeling requirements for
the Ministries are listed separately, both sets of requirements are
basically identical. MAFF's labeling policy on biotech traits may be
found at the MAFF website
([http://www.maff.go.jp/soshiki/syokuhin/hinshitu/organic/eng_yuki_gmo.pdf]{.underline}).

Both MAFF and MHLW biotech labeling schemes for non-biotech products are
based on and rely on IP handling of non-biotech ingredients from
production to final processing. The initial suppliers and operators of
distribution of the products are responsible for supplying this
certification to the exporter to Japan, who in turn supply its
certification of IP handling in the U.S. to Japan's food importers or
manufacturers. The English version of the manuals for the IP handling of
corn and soybeans, and potatoes are available at MAFF website
([http://www.maff.go.jp/soshiki/syokuhin/hinshitu/e_label/file/Labeling/DistributionManu_SoyCorn.pdf]{.underline}
) and
([http://www.maff.go.jp/soshiki/syokuhin/hinshitu/e_label/file/Labeling/DistributionManu_potato.pdf]{.underline}),
respectively.

As shown below, the 30 foods currently subject to JAS labeling
requirements (and MHLW labeling requirements) were selected because they
are made from ingredients that could include biotech products and
because traces of introduced DNA or protein can be identified in the
foods. If the weight content of the ingredient to be labeled in these 30
foods exceeds 5 percent of total weight of the foods, they must be
labeled with either the phrase \"Biotech Ingredients Used\" or \"Biotech
Ingredient Not Segregated\" if the raw ingredient does not accompany
certificates of the IP handling. In order to be labeled \"Non-Biotech,\"
the processor must be able to show that the ingredient to be labeled was
IP handled from production through processing according to the above
manuals.

+-------------------------------------------------+--------------------+
| Items subject to labeling                       | Ingredient to be   |
|                                                 | labeled            |
+-------------------------------------------------+--------------------+
| 1.  Tofu (soybean curd) and fried tofu          | Soybean            |
|                                                 |                    |
| 2.  Dried soybean curd, soybean refuse, yuba    | Soybean            |
|                                                 |                    |
| 3.  Natto (fermented soybean)                   | Soybean            |
|                                                 |                    |
| 4.  To-nyu (soy milk)                           | Soybean            |
|                                                 |                    |
| 5.  Miso (soybean paste)                        | Soybean            |
|                                                 |                    |
| 6.  Cooked soybean                              | Soybean            |
|                                                 |                    |
| 7.  Canned soybean, bottled soybean             | Soybean            |
|                                                 |                    |
| 8.  Kinako (roasted soybean flour)              | Soybean            |
|                                                 |                    |
| 9.  Roasted soybean                             | Soybean            |
|                                                 |                    |
| 10. Item containing food of items 1 to 9 as a   | Soybean            |
|     main ingredient                             |                    |
|                                                 | Soybean            |
| 11. Item containing soybean (for cooking) as a  |                    |
|     main ingredient                             | Soybean            |
|                                                 |                    |
| 12. Item containing soybean flour as a main     | Soybean            |
|     ingredient                                  |                    |
|                                                 | Edamame            |
| 13. Item containing soybean protein as a main   |                    |
|     ingredient                                  | Soybean sprouts    |
|                                                 |                    |
| 14. Item containing edamame (green soybean) as  | Corn               |
|     a main ingredient                           |                    |
|                                                 | Corn               |
| 15. Item containing soybean sprouts as a main   |                    |
|     ingredient                                  | Corn               |
|                                                 |                    |
| 16. Corn snacks                                 | Corn               |
|                                                 |                    |
| 17. Corn starch                                 | Corn               |
|                                                 |                    |
| 18. Popcorn                                     | Corn               |
|                                                 |                    |
| 19. Frozen corn                                 | Corn               |
|                                                 |                    |
| 20. Canned or bottled corn                      | Corn               |
|                                                 |                    |
| 21. Item containing corn flour as a main        | Corn               |
|     ingredient                                  |                    |
|                                                 | Potato             |
| 22. Item containing corn grits as a main        |                    |
|     ingredient                                  | Potato             |
|                                                 |                    |
| 23. Item containing corn (for processing) as a  | Potato             |
|     main ingredient                             |                    |
|                                                 | Potato             |
| 24. Item containing food of items 16 to 20 as a |                    |
|     main ingredient                             | Potato             |
|                                                 |                    |
| 25. Frozen potato                               | Potato             |
|                                                 |                    |
| 26. Dried potato                                |                    |
|                                                 |                    |
| 27. Potato starch                               |                    |
|                                                 |                    |
| 28. Potato snacks                               |                    |
|                                                 |                    |
| 29. Item containing food of items 25 to 28 as a |                    |
|     main ingredient                             |                    |
|                                                 |                    |
| 30. Item containing potato (for processing) as  |                    |
|     a main ingredient                           |                    |
+-------------------------------------------------+--------------------+

Note: As of July 2005, labeling on alfalfa products is under
consideration as biotech alfalfa events are nearing the end of the
approval process.

In addition to the 30 food items in the table, Japan applies the biotech
labeling on the biotech high oleic acid soybean products even though the
oil extracted from the soybean does not contain traces of the introduced
genes or proteins.

## Monitoring of "Biotechnology" or "Non-biotechnology" labeled foods

Japan recognizes that even though proper IP handling and distribution
methods are used, the possibility exists for adventitious commingling of
biotech products in non-biotech products. Therefore, for corn and
soybeans, Japan set an informal tolerance of 5% for biotech ingredients
in products that are labeled \"non-biotech.\" This tolerance only
applies to events that have been approved in Japan. If MAFF or MHLW
finds a product labeled \"non-biotech\" that has a biotech (corn and
soybeans) content of over 5 %, it is determined that the IP handling had
not been carried out adequately. The ministry orders the manufacturer or
importer to present the IP handling certificates to verify them and
issues guidance directing it to correct the product's label to show that
it was made with \"Biotech Ingredients.\"

## Monitoring for unapproved biotechnology events

Like the United States, Japan has a zero tolerance for unapproved
biotech events in foods. To assure compliance, a sampling program is in
place to test both import shipments and processed food products at the
retail level. Any detection of an unapproved biotech event in a food is
deemed a violation of Japan's Food Sanitation Law. As a part of the
monitoring program for imported foods, testing at ports is handled by
MHLW directly, while local health authorities handle testing for
processed foods at the retail level. All testing is performed according
to sampling and testing criteria set by MHLW. If the detection is at the
port, the shipment must be re-exported, destroyed or diverted for
non-food use. If the detection is at the retail level, the manufacturer
of the product must issue an immediate recall. The main products
currently being tested are corn, soybeans, papayas, and potatoes.

Under the Feed Safety Law, MAFF monitors quality and safety of imported
feed ingredients at the ports. All biotech derived plant materials to be
used as feed in Japan must obtain approvals for feed safety from MAFF.
However, as an exemption from the regulation, MAFF has set a 1%
tolerance for the unintentional commingling of biotech products in feed
that are approved in other countries but not yet approved in Japan. To
apply the exemption, the exporting country must be recognized by the
MAFF minister as having a safety assessment program that is equivalent
to or stricter than that of Japan.

## Implementation of requirements for export of biotechnology products (living modified organisms, LMOs) under the Biosafety Protocol

After it ratified the Biosafety Protocol in November 2003, Japan
implemented the "*Law Concerning the Conservation and Sustainable Use of
Biological Diversity through Regulations on the Use of Living Modified
Organisms*" on February 19, 2004. Although the details on how to
implement the requirements of the first sentence of paragraph 2(a) of
Article 18 of the Protocol on export of LMOs have not been determined
yet, Japan presented its view on compliance to the requirements in
November 2004 at a workshop in Bonn.

For export of LMOs directly used for food, feed and processing (FFP),
Japan proposed that the Parties shall attach the following information
along with the form prescribed by the Regulations related to the
Enforcement of the Law or its package/container or consignment invoice
when LMOs for FFP is exported; "*the LMOs 1) "may contain" living
modified organisms, 2) are not intended for intentional introduction
into the environment, and 3) accompany information on contact point
(name, address, contact details of the exporter and importer)*".

At the workshop, Japan, as an importing Party, stated that it does not
have any threshold levels for unapproved LMOs, and it does not feel it
sis necessary to set an international standard for threshold levels of
approved LMOs. Further, individual parties based on their own labeling
requirements and consumer interests, etc must determine these threshold
levels.

Japan stated it is necessary to use the "may contain" language if there
is a possibility of unintentional commingling of LMOs in a non-LMO FFP
cargo, but it is not necessary to have specific documentation supporting
this claim when the degree of the commingling meets the acceptable
levels determined independently by the importing Parties. Japan
recommended to adopt the unique identifier of OECD because it assures
the access to the necessary information through Biosafety Clearing House
(BCH).

# SECTION IV. MARKETING ISSUES

Although the food industry and the government are generally receptive of
agricultural biotech products, they are cautious about publicly
discussing their benefits. Consumer concerns, particularly among some
small but very vocal consumer associations, have been strong since
biotech products were put on the market in late 1990's. As a result, the
food industry is very hesitant to even attempt to provide a biotech
product to the consumer. In fact, out of a fear of a consumer backlash,
retailers, particularly large supermarket chains, demanded the food
industry to supply non-biotech foods - even for products that do not
have to be labeled, which in turn resulted in procurement of non-biotech
raw ingredients by importers. This tendency for demanding non-biotech
ingredients is particularly strong for foods made from soybeans such as
soy sauce, tofu, miso and natto, and snack foods using corn but also
extends to corn starch and beverages using these ingredients such as
beer. Many retailers use the consumer concerns to their advantage by
marketing their in-house products as "safer" and "more natural" than
those provided by their competitors.

The retailer's hesitancy to provide a biotech product reinforces the
consumer's perception that there is something wrong in biotech foods,
which in turn further strengthens the perceived marketing advantage in
providing non-biotech products. Once a biotech product that has clear
consumer advantage or meets consumer needs is put on the market, this
vicious cycle may be terminated.

The Food Safety Commission did a survey on food safety in 2003 and the
report is available in English
([http://www.fsc.go.jp/english/monien_sum0309.pdf]{.underline}). The
survey targeted 'food safety monitors' who provide suggestions and
opinions to the FSC on its policy; therefore, the participants are
people who are more concerned about food safety than the average person
(see the demographic profile below). The survey found that about a half
of the responders were concerned about the safety of biotech foods.

![](media/image2.wmf){width="6.000694444444444in"
height="1.520138888888889in"}

![](media/image3.wmf){width="6.004166666666666in"
height="1.9069444444444446in"}

![](media/image4.png){width="4.9118055555555555in"
height="3.4520833333333334in"}

There is also a survey of 500 attendees of an Agriculture Festival in
Tokyo by Society for Techno-Innovation of Agriculture, Forestry and
Fisheries (STAFF), a quasi-MAFF organization funded by MAFF and the
agricultural technology industry which helps to promote agricultural
biotech research and public acceptance.

The survey shows that the Japanese receive information on agricultural
biotechnology mainly through newspapers and TV, and around a half of the
information is negative. The survey indicated that over a half of the
people feel the entities involved in agricultural biotechnology are not
transparent. The survey suggests that it is important to proactively
provide accurate and objective information on agricultural biotechnology
to the media including newspaper and TV stations.

Information contents on agricultural biotechnology are:

![](media/image5.wmf){width="3.9208333333333334in"
height="2.8784722222222223in"}

Source: STAFF survey, March 2005

Information source on agricultural biotechnology:

![](media/image6.wmf){width="3.6625in" height="2.734722222222222in"}

Source: STAFF survey, March 2005

The STAFF survey also shows the people are more willing to accept and
buy nutritionally enhanced or disease preventive biotech products than
products with just a price or production advantages. The results suggest
that the key for acceptance of biotech products is to have products with
clear consumer advantages or that meet consumer needs.

Which approved biotech products would you buy

if they are put on the shelf of retail shops as all other foods do?

![](media/image7.wmf){width="5.000694444444444in" height="3.625in"}

A: Biotech foods with no particular characteristics at the same price

B: Better taste biotech foods at the same price

C: Disease (pollen allergy or diabetes) preventive biotech foods at the
same price

D: Nutritionally enhanced (iron or mineral rich) biotech foods at the
same price

E: Herbicide tolerant biotech foods with 20 % lower price

F: Herbicide tolerant biotech foods with 10 % lower price

Source: STAFF survey, March 2005

Public Acceptance of Agricultural Biotech Products

![](media/image8.wmf){width="4.501388888888889in" height="3.3375in"}

I will accept agricultural biotech if the following products are put on
the market:

A: Agricultural biotech products to be used for beneficial substance
production

B: Agricultural biotech products to prevent desertification

C: Agricultural biotech products for environment remediation

D: Agricultural biotech products to produce pharmaceutical products
including edible vaccines

E: Agricultural biotech products medically effective in disease
prevention

F: Agricultural biotech products contributing to health promotion

G: Agricultural biotech products with better taste

H: Agricultural biotech products with herbicide tolerance for easier
cultivation

I: Agricultural biotech products with insect resistance for easier
cultivation

Source: STAFF survey, March 2005

# SECTION V. CAPACITY BUILDING AND OUTREACH

In March 2004, FAS Tokyo carried out a seminar program by the American
Farm Bureau Federation including its chairperson Bob Stallman in four
cities in Japan, in cooperation with local American Consulate and
American Centers. The seminars, entitled "Agricultural Production and
Biotech Crops - A Look at Environment Benefits" were held in Fukuoka,
Osaka and Sapporo besides Tokyo. Around 200 academics, and industry and
consumer representatives attended the seminars. FAS Tokyo invited
Japanese farmers to present their views on biotech products and their
benefits in production as part of the seminars. AFBF explained the
"win-win (for consumers and producers)" benefits of biotech products,
through prevention of surface soil erosion by no-till farming and
reduction of frequency of pesticide spray that enables
environment-friendly agriculture and allows less works and cost
reduction by reducing frequency of pesticide sprays. Japanese farmers
presented their experiences of growing herbicide tolerant biotech
soybeans.

In August 2004, FAS Tokyo organized a tour by a Japanese team of three
farmers, one college professor, four reporters and one non-governmental
organization representative to the U.S. They visited the U.S. to look at
the use of biotech in the U.S. The team saw biotech papaya production in
Hawaii and had direct communications with growers and a grocery store
producing and selling the biotech papayas. The team also visited several
farmers in the Midwest to see the benefits of no-till farming and how
crops developed through biotechnology reduces labor, increase yield and
require less pesticides. They visited a biotechnology developer
laboratory, a public laboratory of plant biotechnology and finally met
with representatives of USDA, the U.S. Congress, the private sector,
non-profit organizations and trade associations in Washington, D.C. FAS
Tokyo created a 20 minute-video on the benefits of biotechnology based
on the trip scenes, which will be distributed to the media and various
organizations to promote understanding on agricultural biotechnology.

FAS Tokyo hosted Dr. James Maryanski as an Embassy Science Fellow, a
Department of State visitor program for technical experts in the fall of
2004. Dr. Maryanski stayed in Japan for 8 weeks to exchange opinions,
provide information and speak at seminars on not only biotech but also
overall food risk assessment and communication. Dr. Maryanski met with
officials from MAFF, MHLW and FSC, leading scientists in biotech,
Japanese food industry representatives, consumer group leaders and media
reporters. Dr. Maryanski spoke at seminars organized by FAS and
Consulates/American Centers in Tokyo, Osaka and Nagoya, with an audience
of around 200 in total. During his visit to Japan, Dr. Maryanski
successfully conveyed information on the science-based approach to the
safety of biotech foods in the U.S.

# SECTION VI. REFERENCE MATERIALS

Following is a list of website of information on agricultural
biotechnology and biotech foods in English. Please note that this
information is not necessarily current and you may need to download the
Japanese Language Package to read the pdf files even if they are written
in English.

Food Safety Commission (biotech food risk assessment standards)

[http://www.fsc.go.jp/senmon/idensi/gm_kijun_english.pdf]{.underline}

Ministry of Agriculture, Forestry and Fisheries (Information related to
agricultural biotechnology)

[http://www.s.affrc.go.jp/docs/sentan/]{.underline}

Ministry of Health, Labor and Welfare (Information related to biotech
food regulations)

[http://www.mhlw.go.jp/english/topics/food/index.html]{.underline}

(Information on biotech food labeling)

[http://www.mhlw.go.jp/english/topics/qa/gm-food/index.html]{.underline}

Biosafety Clearing House

[http://www.bch.biodic.go.jp/english/e_index.html]{.underline}