2009 2
< 차례> 1 요약서 1 2 심사경위 2 3 심사경과 2 4 심사방법 3 5 심사신청자료검토 3 51 심사신청된식품의개요 3 52 식품으로의적합성검토 3 53 유전자재조합체의안전성 3 가 유전자재조합체의개발목적및이용방법에관한자료 3 나 숙주에관한자료 3 (1) 분류학적특성( 일반명, 학명, 계통분류등) 3 (2) 재배및품종개량의역사 4 (3) 기지의독성또는알레르기유발성 4 (4) 안전한식경험의유무 4 다 공여체에관한자료 5 (1) 분류학적특성( 일반명, 학명, 계통분류등) 5 (2) 안전한식경험의유무 5 (3) 공여체및근연종의독성, 항영양성, 알레르기성( 미생물의경우병원성및기지의병 원체와의관련성 ) 5 라 유전자재조합에대한자료 5 (1) 형질전환에관한정보 5 (2) 도입유전자에대한정보 6 마 유전자재조합체의특성에관한자료 9 (1) 유전자재조합체내도입된유전자에관한정보 9 (2) 유전자산물에관한정보 11 (3) 독성 13 (4) 알레르기성 14 (5) 숙주와의차이 15 (6) 유전자산물이대사경로에미치는영향 ( 숙주가함유한고유의성분을기질로하여 반응할가능성 ) 17 (7) 외국의식품유통승인및식용등의이용현황 17 6 심사신청자료검토결과 17 7 기타 17
1, " " cp4 epsps CP4, (glyphosate) cp4 epsps, CP4,, 15 % 90,,, 1
2 (glyphosate) 15 2006 12 18 ( ) ' ), '( 3 대상품목신청자개발자 제외국의안전성승인현황 제초제내성유전자재조합콩 몬산토코리아( 주) Monsanto Co (USA) 미국(2007 년), 캐나다(2007 년), 일본(2007 년), 필리핀(2007 년), 호주(2008 년), EU(2008 년) 2006 12 18 : 2006 12 25 : 2006 12 28 : 1 2007 6 8 : 2007 7 10 : 2 2007 11 9 : 2007 12 4 : 3 2008 2 19 : 4 2009 1 : (,, ) 2009 1 22 ~ 2 10 : 2009 2 17 : 5 2
4, 5 51 52 cp4 epsps(5enolpyruvyl shikimate3phosphate synthase), 12 53 2 Roundup RReady2Yield Roundup Roundup Ready Roundup Ready (1) (, ) 3
(Species) : max (Genus): Glycine (Family): Leguminosae (Common Name): Soybean (2) ( 1500 ~ 1027 ) (Hymowitz, 1970) 35,,,, 2004 90% (Soya and Oilseed Bluebook, 2005), 1995) 2003),,, (OECD, 2000; Garber and Odland, 1926; Caviness, 1966), (single pod descent),, (Poehlman and Sleper, (Sleper and Shannon, (3) (trypsin inhibitor), (lectin) (OECD, 2001) (Internet Symposium of Food Allergens, 1999) (4) (Hymowitz, 1970) 4
(1) (,, ) (Species) : strain CP4 (Genus) : Agrobacterium (Family) : Rhizobiaceae (Order): Rhizobiaceae group (Domain): Bacteria (2) Agrobacterium sp strain CP4 (Padgette et al, 1996) CP4 (American Type Culture Collection) Agrobacterium Agrobacterium (FAO/WHO, 1991) FAO/WHO(2001), (3),, ( ) Agrobacterium (FAO/WHO, 1991) (1) (,, ) 1) PVGMGOX20 97 kb Agrobacterium cp4 epsps cp4 epsps chimeric FMV/Tsf1, 5
Tsf1, CTP2, E9 3' 2) PVGMGOX20 97 kb cp4 epsps TDNA 43 kb DNA (backbone) 54 kb TDNA chimeric (PFMV/ TSF1), Tsf1 (LTsf1 ITsf1), transit peptide (TSCTP2), cp4 epsps (CScp4 epsps), RbcS2 (TE9) polyadenylation TDNA (ORoriV, ORoriPBR322) (aada) 3) CP4 (Padgette et al, 1996) Agrobacterium tumefaciens Nielson et al, 2000) (Bertolla and Simonet, 1999; (2) 6
cp4 epsps : 455 476 kda CP4 (Padgette et al, 1996) Arabidopsis thaliana epsps Transit Peptide : transit peptide CP4 (Klee et al, 1987; Kishore et al, 1988) 1) PVGMGOX20 aada,, spectinomycin streptomycin transposon Tn7 et al, 1985) (Fling 2) cp4 epsps PFMV/Tsf1 LTsf1 (exon 1) ITsf1 intron (Axelos et al, 1989) CTP2/cp4 epsps Agrobacterium sp strain CP4 subunit (RbcS2) E9 pea ribulose1,5bisphosphate carboxylase 3' TE9 DNA 3' (Coruzzi et al, 1984) 3) DNA DNA PVGMGOX20 DNA PFMV/Tsf1 : 1,039 bp, enhancer Arabidopsis thaliana Tsf1 chimeric TSCTP2 : 227 bp, Arabidopsis thaliana epsps (Klee et al, 1987) transit peptide transit peptide CP4 CScp4 epsps : 1,367 bp, CP4, Agrobacteruim sp CP4 7
,, cp4 epsps : Agrobacterium sp Strain CP4 cp4 epsps 455 476 kda (Padgette et al, 1996) CP4 (Padgette et al, 1996) PVGMGOX20 DNA CP4 PVGMGOX20 DNA, PVGMGOX20 DNA (Dickinson and Masucci, 2006) 40 bp DNA TDNA 5' 10 3' 6 DNA Agrobacterium (double strand break repair mechanism) (Salomon and Puchta, 1998) DNA 8
(1), cp4 epsps TDNA 43 kb chimeric (PFMV/Tsf1), Tsf1 intron (LTsf1 ITsf1), transit peptide (TSCTP2), cp4 epsps (CScp4 epsps), RbcS2 polyadenylation (TE9) DNA, cp4 epsps Southern blot DNA, DNA 57 kb 57 kb BplI/XmnI 1), : Southern blot, DNA : DNA PVGMGOX20 Right Border 9,604 Left Border 4,242 4,303 bp, MON98788 DNA PVGMGOX20 : 5' genomic DNA 1,103 bp 3' genomic DNA 1,060 bp 9
2) DNA DNA 5' 3' DNA, 6 DB(AD6), DB(TOXIN5), DB (ALLPEPTIDES) FASTA (pairwise comparison),, 1), TDNA DNA 4 Southern blot DNA 2),, R4a, R5b, R6c, R6d, R6e, R7f, R7g CP4 Western blot CP4 R7g CP4 CP4 10
[ ] (2) ( RNA) CP4 : (1) E coli SDSPAGE (2) anticp4 E coli immunoblot (3) N (4) tryptic peptide map MALDITOF(matrix assisted laser desorption ionization time of flight) (5) E coli CP4 CP4 E coli CP4 11
CP4 Roundup (Padgette et al, 1996) CP4 E coli CP4 E coli CP4 CP4,,, E coli CP4 CP4 CP4 Agrobacterium CP4 Roundup CP4 CP4 ELISA(enzymelinked immunosorbent assay) 2005 5 overseason leaf(osl), (grain), (root), (forage) CP4 OSL1, OSL2, OSL3, OSL4,,, CP4 300, 340, 330, 290, 150, 74, 220 μg /g DW A3244 CP4 (LOD) 12
(3) 1) CP4 ( ), (Saccharomyces cerevisiae) (Padgette et al, 1996; Harrison et al, 1996) CP4 CP4 RRS (2000), NK603 (2002), MON88017 (2006), 1445 (2003), MON88913 (2006), GT73 (2003), H71 (2006), J101, J163, J101xJ163 (2007) 2) CP4 ALLPEPTIDES FASTA, CP4 3) : 190 30 Western blot, CP4 99% :, E coli CP4 4) Harrison (1996) CD1 10 1 572mg/kg CP4 13
(4) CP4 (,, ) CP4, CP4 99% MON 89788 CP4, (gliadin), (glutenin) 80 35 % FASTA, 8 sliding window (Codex Alimentarius, 2003), CP4,, 1 CP4 (,, ) CP4,, CP4 CP4 150 μg/g DW 403 % DW CP4 : (150 μg/g 403,000 μg/g 100 % = 0037 %) CP4 0037 % 1 IgE CP4 14
2 IgE A3244 IgE, 24 A3244 IgE IgE (5) 2005 5 3 () (A3244) 63 (,,, ), (ADF), (NDF), (,,, ),,,, (C8C22), phytic acid,, isoflavones, lectins, raffinose, stachyose, E, (combinedsite analyses), daidzein, glycitein E A3244 (16 11%) 99%, A3244, 99% 15
2001) (OECD,, lectins, isoflavones (daidzein, genistein and glycitein), stachyose, raffinose phytic acid : A3244, 90% A3244 99% CP4, A3244 IgE antibody,, cp4 epsps CP4 TDNA 16
(6) ( ) TDNA, CP4 (7) 2007,,,, 2008, EU 6,,,,, 7,,,, 17