A

2009 4 A270412

< 차례> 1 요약 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 4 (1) 분류학적특성( 일반명 학명 계통분류등) 4 (2) 재배및품종개량의역사 4 (3) 기지의독성또는알레르기유발성 4 (4) 안전한식경험의유무 4 다 공여체에관한자료 4 (1) 분류학적특성( 일반명 학명 계통분류등) 4 (2) 안전한식경험의유무 5 (3) 공여체및근연종의독성 항영양성 알레르기성( 미생물의경우병원성및기지의병 원체와의관련성 ) 5 라 유전자재조합에대한자료 5 (1) 형질전환에관한정보 5 (2) 도입유전자에대한정보 6 마 유전자재조합체의특성에관한자료 8 (1) 유전자재조합체내도입된유전자에관한정보 8 (2) 유전자산물에관한정보 9 (3) 독성 10 (4) 알레르기성 11 (5) 숙주와의차이 12 (6) 유전자산물이대사경로에미치는영향( 숙주가함유한고유의성분을기질로하여반 응할가능성 ) 13 (7) 외국의식품유통승인및식용등의이용현황 14 6 심사신청자료검토결과 14 7 기타 14

A270412 1 A270412 " " A270412 pat PAT (glufosinate) A270412 pat 3 PAT (rat) 14 A270412 A270412 A270412 15 (Broiler) A270412 1

2 (glufosinate) A270412 15 2006 12 14 ( ) ' '( ) 3 대상품목신청자개발자 Bayer A270412 CropScience LP 2006 12 14 : 2006 12 19 : 2007 2 6 : 1 2007 4 17 : 2 2007 5 11 : 2007 6 11 : 2007 10 9 : 3 2007 10 30 : 2008 1 28 : 2008 3 18 : 4 2008 6 17 : 5 2008 6 18 : 2008 9 5 : 2008 10 14 : 6 식품으로서제외국의안전성확인( 승인) 현황 (1998) (2000) (2001) (2002) (2002) (2003) (2004) / (2004) (2007 ) (2007 ) EU(2008) (2009 ) 2

2008 10 15 : 2008 11 12 : 2008 12 9 : 7 2009 2 : ( ) 2009 3 4 ~ 3 23 : 2009 3 24 : 8 4 5 51 A270412 pat (glufosinate) 52 12 53 PAT(phosphinothricin acetyl transferase) 3

(1) ( ) (Family name) : Leguminosae (Genus) : Glycine (Subgenus) : Soja (Species) : max (Common name) : Soybean (2) 17 11 (Hymowitz 1970) 1900 35 (Williams 2005) (3) (trypsin inhibitor) (lectin) (OECD 2001) (Internet Symposium on Food Allergens 1999) (4) 3000 (1) ( ) 35S : Cauliflower Mosaic Virus (Pietrzak et al 1986) 35S : Cauliflower Mosaic Virus (Pietrzak et al 1986) pat : Streptomyces viridochromogenes (Wohlleben et al 1988) 4

(Family) : Streptomycetae (Genus) : Streptomyces (Species) : viridochromogenes (2) Cauliflower mosaic virus Brassicaceae S viridochromogenes (3) ( ) (insert) Cauliflower mosaic virus S viridochromogenes (1) pat (pb2/35sack) PvuI (ampicillin) bla 1) pb2/35sack E coli puc19 Agrobacterium tumerfaciens Ti Right border Cauliflower Mosaic Virus 35S (promoter) 35S (terminator) pat (Berghman & De Beuckeleer 2002) [ 1] 2) A270412 pat ( ) (gene locus) DNA DNA 5

[ 1] pb2/35sack 3) A270412 PAT bla pb2/35sack E coli pb2/35sack puc19 E coli (YanischPeron et al 1985) (2) 1) pat : S viridochromogenes strain Tü 494 pat pat PAT bla : pb2/35sack E coli βlactamase A270412 2) pat Cauliflower Mosaic Virus 35S 35S [ 1] (Berghman and Beuckeleer 2002) 6

3) DNA [ 1 ] pb2/35sack RB P35S pat T35S ori and amp (=bla) Sequence of the vector puc19 Right border repeat Sequence of the vector puc19 Promoter Fragment of octopine plasmid TiAch5 Cauliflower mosaic virus from the vector pdh51 (bp) 188 (YanischPeron et al 1985) 55 (Gielen et al 1984 ) 217 (YanischPeron et al 1985) 543 Polylinker sequence Synthetic 8 Synthetic pat gene Synthetic amino acid sequence from Streptomyces viridochromogenes 552 Polylinker sequence Synthetic 18 Terminator Sequence of the vector puc19 including the polylinker (pos 1851843) the ori (origin of replication) at position 2257 and the βlactamase (bla) gene (pos 38763016) Cauliflower Mosaic Virus from the vector pdh51 203 (Pietrzak et al 1986) (Wohlleben et al 1988) (Pietrzak et al 1986) 2292 (YanischPeron et al 1985) Vector backbone Cisacting element for TDNA transfer Vector backbone High level constitutive expression Plasmid cloning site Herbicide tolerance and selectable marker Stop signal Plasmid cloning site Stop signal Bacterial origin of replication and bacterial marker pat 552 bp [ 1] 1] pat PAT PAT 7

PAT pb2/35sack A270412 DNA bla PvuI ( 1 2 ) A270412 (1) A270412 pat S viridochromogenes strain Tü 494 PAT pat S viridochromogenes PAT A270412 pat (Berghman & De Beuckeleer 2002)( 2 ) 1) A270412 pat HeadtoTail [ 2] A270412 2) (Moens and Habex 2006) 8

[ 2] A270412 A270412 8 ORF / UNIPROT_SWISSPROT UNIPROT_TREMBL PIR NRL3D DAD GenPept Allergen (Herouet 2006) bla A270412 (De Beuckeleer and Botterman 1997) 1) 3 4 5 pat copy 2) 4 (V3 V56 V67 V8) PAT (2) A270412 PAT 183 Lphosphinothricin 9

PAT acetyltransferase 2 PAT (Freyssinet 2002) A270412 PAT (glycosylation) (Currier and Hendrickx 2006) A270412 PAT S viridochromogenes PAT A270412 A270412 (grain) PAT 1243 µg/g 2138 µg/g V2V4 PAT (± ) 223 ± 12 µg/g 763 ± 22 µg/g 145 ± 24 µg/g (3) 1) pat PAT Acetyltransferase (Herouet 2004) PAT 2) PAT PAT UNIPROT_SWISSPROT UNIPROT_TREMBL PIR PDB DAD GenPept 10

(HerouetGuicheney 2006) 3) 4) PAT (ph 20) 30 (ph 75) 30 (Rouquie 2005; Esdaile 2004) 50 10 (Wehrmann 1996) PAT (mouse) 10 mg/kg bw PAT (Kennel 2003) PAT 단백질 (rat) 14 5000 ppm ( 712 mg/kg bw/day 703 mg/kg bw/day) 50000 ppm ( 7619 mg/kg bw/day 7965 mg/kg bw/day) PAT 5 Wistar (Pfister et al 1999) (4) PAT PAT (ph 20) 30 Esdaile 2004) (ph 75) 30 (Rouquie 2005; 50 10 (Wehrmann 1996) PAT UNIPROT_SWISSPROT UNIPROT_ TREMBL PIR PDB DAD 35 % GenPept database 80 11

(HerouetGuicheney 2006) 8 Guicheney 2006) (Herouet 1 A270412 PAT ( 1243 µg/g fresh weight 2138 µg/g fresh weight) A270412 1 488 μg 840 μg PAT 1~2 849 μg 1460 μg PAT 1 PAT 644 10 5 % 111 10 4 % 1~ 2 1 PAT 233 10 4 % 400 10 4 % PAT (5) 1999 2000 9 ( acid detergent fiber neutral detergent fiber) ( ) (phytic acid) (trypsin inhibitor) (raffinose) 12

(stachyose) (lectin) globulin 85 % A2704 A2704 12 16 A2704 event A270412 PAT PAT Nacetyl glufosinate ( LD 50 420 mg/kg bw Nacetyl glufosinate 2895 mg/kg bw ) Ross 208 (broiler) 36 A270412 A2704 20 % 15 (6) ( ) PAT pat 13

(7) (1998 ) (2000 ) (2001 ) (2002 ) (2002 ) (2003 ) (2004 ) / (2004 ) (2007 ) (2007 ) EU(2008 ) (2009 ) 6 7 A270412 14