(WHO): GM foods currently available on the international market have passed risk assessments and are not likely to present risks for human health.

- 2002101520 http://www.who.int/fsf/ ?2

.

1994

FlavrSavr Tomato, Calgene

Photo by Jack Dykinga. Sources ARS Photo Unit, 2001, USDA.3

/ ()Bt4 (Input Traits)Source: Monsanto

()A5(Output Traits)

[! ] 2001! ()6(Output Traits)

(91.8.8)7

? Genetically Modified (GM) ?8

? Genetically Modified Organism (GMO) GMO GMO?9

:1.: 2.: 3.:?10

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Chart1

1.7

11

27.8

39.9

44.2

52.6

58.6

Sheet1

19961.7

199711

199827.8

199939.9

200044.2

200152.6

200258.6

Sheet1

0

0

0

0

0

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Sheet2

Sheet3

()GM - 12

Chart2

0.50.270.80.14

5.13.21.41.3

14.58.32.52.4

21.611.13.73.4

25.810.35.32.8

33.39.86.82.7

Soybean

Corn

Cotton

Canola

36.5

12.4

3.0

Sheet1

1996199719981999200020012002

Soybean0.55.114.521.625.833.336.5

Corn0.273.28.311.110.39.812.4

Cotton0.81.42.53.75.36.86.8

Canola0.141.32.43.42.82.73

Sheet1

0.50.270.80.14

5.13.21.41.3

14.58.32.52.4

21.611.13.73.4

25.810.35.32.8

33.39.86.82.7

36.512.46.83

Soybean

Corn

Cotton

Canola

Sheet2

Sheet3

GM - 13

Chart2

66

23

6

4

4%

Sheet1

19961.7

199711

199827.8

199939.9

200044.2

200152.6

200258.6

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0

0

0

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66

23

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75%17%8%2002< 1%14Stacked traitsGM ()

?15

47.13 8.61 8.58 3.86 2.75 16.40 8.61 4.95 4.59 4.03 4.00 2.91 28.92 15.00 6.01 2.11 1.79 10.39 6.02 5.02 4.55 4.51 3.32 2.58 Sources: US Foreign Agricultural Service's Production, Supply and Distribution (PS&D) online database. Data for 2001-2002.:(2001-2002)16

- () (1)(1)(1)(3)(1) ( - 7) - / 17

GMO

(1997.3.2002.1.) Submissions: 695 -plants: 558 -microbes: 134 -fish: 3

Approvals: 50118* Presented at The 6th APEC ATCWG meeting, Taipei, 2002.

GM 19

1. ()2. ()3. () 20

()

()

21

http://food.doh.gov.tw/life/biotech22

2001-200223

# 1 40-3-2 (RRS) 91.07.2296.07.222 MON810 91.10.1596.10.153 GA21 91.06.034 NK603 92.04.1197.04.115 / Bt11 92.03.316 Event176 92.03.317 T25 ( )91.08.1696.08.16

GM 2003.4.1124

Chart3

19

20

16

12

11

Sheet1

FDA19

20

16

12

11

Sheet1

Sheet2

Sheet3

GMO25

1

496

5116

11015

11681

Approval

Deny

Year

Cases

Sheet1

ApprovalDeny

1997496

19985116

199911015

200011681

Sheet1

00

00

00

00

Approval

Deny

Year

Cases

Sheet2

Sheet3

Codex Ad Hoc Intergovernmental Task Force on Foods Derived From Biotechnology,,, 200234-81. Draft Principles for the Risk Analysis of Foods Derived from Modern Biotechnology ()2. Draft Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants ()3. Draft Annex on the Assessment of Possible Allergenicity ()Papers on Traceability ( )Consideration of Analytical Methods ( ) : (Codex)26

Codex Ad Hoc Intergovernmental Task Force on Foods Derived From Biotechnology,,, 2003311-14Draft Guideline for the Conduct of Food Safety Assessment of Foods Produced using Recombinant-DNA Microorganisms ( )2. Draft Annex on the Assessment of Possible Allergenicity (Proteins) ()3. Open discussion on TraceabilityPotential future work : (Codex)27

Principles for the Risk Analysis Risk Assessment Risk Management Risk Communication Consistency Capacity Building and Information Exchange Review Processes28

29

Guideline for the Conduct of Food Safety Assessment Unintended Effects Framework (a stepwise process) Description of the recombinant-DNA plant Description of the donor organism(s) Description of the genetic modification Characterization of the genetic modification(s) Safety assessment Other considerations30

Guideline for the Conduct of Food Safety Assessment Unintended Effects Framework (a stepwise process) 5. Safety assessment 1) Expressed substances (non-nucleic acid) 2) Compositional analyses of key components 3) Evaluation of metabolites 4) Food processing 5) Nutritional modification31

Guideline for the Conduct of Food Safety Assessment Unintended Effects Framework (a stepwise process) 6. Other considerations 1) Potential accumulation of substances significant to human health 2) Use of antibiotic resistance marker genes 3) Review of safety assessment32

Substantial Equivalence (OECD, 1993) Existing traditional foods are considered to be safe, through their long history of use, even though they many contain anti-nutritional or toxic substances Traditional foods can serve as a basis for the safety assessment of GM foods identification of similarities and differences which should be further assessed regarding their impact on the safety and nutritional status of the GM foods33

comparison to a traditional crop investigate differences for safety, include: composition: macronutrients, micro nutrients, anti-nutrients, toxins phenotypic is not a safety assessment in itself, but just a tool to identify differences is the starting point of the assessment, rather than the endpointSubstantial Equivalence (OECD, 1993)34

I. Food SafetyII. Environmental SafetyIII. ELSI(ethical, legal, social issues)IV. TradeGM 36

:

- - - - (HGT, or Gene flow)- 37

- 1998 - (Arpad Pusztai*)- Case Study* Ewen SW, Pusztai A. Lancet. 1999 Oct 16;354(9187):1353-438

(StarLink) 2000 () - - Cry9C (Bt) (CDC)- Case Study39

StarLink Corn : Cry9C(StarLink)40Case Study

(StarLink) SGF stability, pH2 > 4hr2. 90C > 19 minThere is no evidence to indicate that Cry9C is or is not a potential food allergen. - US EPA, 2000.SGF: Simulated Gastric Fluid()41Case Study

Source: Fu, et al. 2002.:Case Study42

Pepsin/testStability of protein in SGF (min)Protein ratio(w/w) 10:1 1:11:10Food allergens b-lactoglobulin B120 120120 ovalbumin5 60120 papain0 00Nonallergenic proteins Zein60 60120 Pea lectin5 120120 Cytochrome c0 0.50.5 Sucrose synthetase 0 00

Allergenicity:Decision Tree Approach: FAO/WHO 2000 Decision Tree43

Allergenicity:Decision Tree ApproachSource of gene allergenicSequence HomologySpecific Serum ScreenTargeted Serum ScreenPepsin Resistance & Animal ModelsHigh +/+ +/- -/- LowProbability of AllergenicityLikely allergenicSequence HomologyYesYesNoNoNoNoYesNo: FAO/WHO 2001 Decision Tree44

DNA(August 2001) Molecular Characterization of the genetic modificationCase StudyWindels P. et al. (2001)45

- 2001.4.2. - (GM Canola): Monsanto vs. Percy SchmeiserHorizontal Gene Transfer (HGT)?(: )Case Study46* http://www.fct-cf.gc.ca ; http://www.percyschmeiser.com

Evaluation of GM canola in sheep and swine* Agriculture and Agri-Food Canada Research Centres, LethbridgeT. A. McAllister, R. Sharma, T. Alexander, K. Stanford LacombeM. Dugan, J. Aahlus, K. LienCase Study* Presented at The 6th APEC ATCWG meeting, Taipei, 2002.Horizontal Gene Transfer (HGT)?47

Sheep study - long-term48

Swine study - spleenDetection of transgene fragmentsF4F5F6P1 P2 +P1 P2 +P1 P2 +F7F8F9F12P1 P2 +P1 P2 +P1 P2 +P1 P2 +F3P1 P2 +49

Detection of transgene fragmentsSwine study - spleen50

Swine study - kidneyDetection of transgene fragmentsF4F5F6P1 P2 +P1 P2 +P1 P2 +F7F8F9F12P1 P2 +P1 P2 +P1 P2 +P1 P2 +51

F4F5F6P1 +P1 +P1 +F7F8F9P1 +P1 +P1 +F12P1 +Swine study - kidneyDetection of transgene fragments52

Conclusions - animal studyGM canola and its parental variety had the same feeding value for both lambs and swine Sheep trialTransgene not detectable in blood or tissuesSwine trialTransgene fragments detected in liver and kidney53Horizontal Gene Transfer (HGT)?

ImplicationsHGT(Horizontal Gene Transfer) Frequency of such transfer

54Horizontal Gene Transfer (HGT)?

To improve resistance of piglet to suffer from diarrhea and anemia by increase of lactoferrin concentration contained in the sow milk. 2. To establish molecular pharming for mass production of pharmaceutics including human clotting factors VIII, IX and allergic proteins such as Derp(s). 3. To generate transgenic pigs for xenotransplantation.Purposes of Transgenic (Tg) Animals55Case Study

Tg gilt No. 8-3Tg gilt No. 8-5Tg pigs harboring both transgenes of LA- pLF &LA- hFIX genes56

Fig. Tissue- and stage-specific expression of aLA-FVIII transgene detected by RT-PCR57Leaky Expression?

02/07/2003 Research Piglets Sold as Food Hard to Find, FDA Accused of Lax Biotech Regulation WHO: (University of Illinois Urbana/Champaign) WHEN: 4/2001 1/2003 WHAT: 386 58Case Study

I. Food SafetyII. Environmental SafetyIII. ELSI (ethical, legal, social issues)IV. TradeGM 59

Case Study60

John Losey (1999) Bt(MilkWeed) () Monarch Butterfly61Case Study

Case StudyThe ProdiGene Incident62WHO - ProdiGene Inc. (College Station, TX) WHAT - edible vaccine grown in corn WHEN - 11/13/2002 USDA investigationWHY - Contamination of 155 Acre soybeansRESULTS:$250,000 + $3,000,000 USDA + $1,000,000 : 68FR11337

(HGT) (HGT)63

I. Food SafetyII. Environmental SafetyIII. ELSI (ethical, legal, social issues)IV. TradeGM 64

What We Could V. What We Should65

I. Food SafetyII. Environmental SafetyIII. ELSI (ethical, legal, social issues)IV. TradeGM 66

Tuesday, 13 May, 2003US launches GM trade warThe United States - and twelve other agricultural exporting nations - want the EU to repeal its five-year moratorium on GM foods, or face trade sanctions under World Trade Organisation (WTO) rules.WTO67

(WTO)GMO Sanitary and Phytosanitary Measures (SPS) Technical Barrier to Trade (TBT)WTO68

GMOs TBT SPS 1995 1 4 1996 2 1 199711 0 199811 5 199920 2 20001420 20012537 2002 4374 2003(1-6)1943 146 186WTO69

Cartegena Protocol on Biosafety()Article 1. ObjectiveThe objective of this Protocol is to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms (LMOs) resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements.World Trade Organization (WTO)is the only international organization dealing with the global rules of trade between nations. Its main function is to ensure that trade flows as smoothly, predictably and freely as possible.WTOCBD11 September 2003 enter into force!70

LMOs v. GMOs v. GMF GMOs LMOsGMFLMOs GMOs GMF*(2002)71

LMOs v. GMOs v. GMF LMOGMO(,)()(),,,,GMF* ()72

http://food.doh.gov.tw/life/biotech.htm

74Call for Experts for Joint FAO/WHO Expert Consultation on Safety Assessment of Foods Derived from Genetically Modified Animals including FishRome, Italy, 17 - 21 November 2003Source: http://www.who.int/fsf/GMfood/fishexperts.htm

(?) (GMO)75

92.07.17

(2001-2002) +9%, +14.4%, +9.3%, +40% Development of a GM plant variety can take 6-12 years at a cost ranging from $50-$300 million Monsanto Co., Du Pont/Pioneer, Bayer/Aventis and Dow were the four leading firms in bio-crop research "Agricultural Biotechnology at the Crossroads." STUDY: BIO-FOOD RESEARCH INCREASINGLY CONCENTRATED February 20, 2003 Reuters WASHINGTON - A report by Bio Economic Research AssociatesUS FDA 55 (19 soy+corn), Health Canada 49 (20), Japan 44 (16), FSANZ 20 (12), DOH 11 (4)