New Genetics, Food and Agriculture: Scientific ... - ArgenBio

32N E W G E N E T I C S, F O O D A N D A G R I C U LT U R E5. Regulatory IssuesKey DocumentsA recent review by Nap et al. (2003) in the online publication,The Plant Journal, gives an excellent overview of the currentre g u l ato ry approa c h es wo r l dwide. Seve ral re ce n tn ational rev i ews we re charged with advising gove r n m e n t son ways to improve their national re g u l ato ry sys tems( e .g. Aus tra l i a, 2000; The Royal Soc i e ty of Can a d a, 2001;Can a d i an Biotec h n ol ogy Advi s o ry Co m m i ttee, 2001, 2002;New Zea l an d, 2001; The Royal Soc i e ty, UK, 2002; Nati o n a lAcademy of Sciences, USA, 2000, 2002). Other internationaland inter gove r n m e n tal agencies are co n cerned with promo ting re g u l ato ry har m o n i zation, regionally (e.g. EC 2001;2002) and inte r n ationally ( e .g. FAO/WHO 2000, 2001a, b ;OECD 2000b; OECD 2001a,b).There are several issues relating to the persistence of transgenicfish in the environment and the effects they may haveon wild fi sh po p u l ations. These need to be res ol ved be fo reany transgenic fi sh can be re l e ased into the env i ro n m e n t(Pew 2003).Areas of ConvergencePr i n c i pl es : T h e re is broad agreement th at re g u l ato ry systemsneed to be science - bas e d, tran s pare n t, and invol vecommunity participation, and that safety assessments shouldbe undertaken on a case-by-case basis, using the best availablescientific techniques.Re g u l ato ry proces s es also need to be suffi c i e n tly fl e x i bl eand rob ust so as to be able to detect early warning of chan g i n gc i rcum s tan ces. Re cent instan ces of food safe ty problems ins eve ral co un tr i es highlight the need for co n ti n uing vigilan ce ine n s uring th at foods brought to mar ket are safe to eat, irres pe c-tive of their source and produ c tion meth ods. These foods maycome from co nve n tional or subsiste n ce agr i cu l ture, org an i ca gr i cu l ture an d /or the cu l tivation of GM foods and crops.Regulatory systems for the applications of modern geneticsin food and agriculture are based broadly on assessing thes afe ty for hum an health and the env i ronment of either th eproduct or the process by which it is produced, or a combinationof the two approaches.A co m parison of the food safe ty re g u l ations for genetic alte r-ation of food crops in selected co un tr i es is sh own in Ta ble 5.1.Si m i l ar i ty of data sets: D i ffe rent re g u l ato ry sys tems bas etheir as s essments on similar sets of data re q ui rements co n-cerning the organism, insert, trait and environment. Thoughthere is variability between the details of risk assessments, theissues that they address are common across many countries(OECD 2001b).For pl an t s, produ ced with the aid of gene te c h n ol ogy, the typeof info r m ation sought by re g u l ato rs for making their risk as s es s-ments prior to env i ro n m e n tal re l e ase is similar, wh e ther the re g-u l ato ry approach is p roduct bas ed or process bas ed (Ta ble 5.2).B i o s afe ty fram ew o r k :The Car tagena Pro tocol on Biosafe tyl ays down a meth od ol ogy for risk /s afe ty an a l ysis including an um ber of sys te m atic steps and a list of points to consider inre l ation to the po s s i ble impact of living mod i fied org an i s m s( LMOs) on biod ive rs i ty. A cur rent project fi n an ced by th eG l obal Env i ronment Fa c i l i ty, and impl e m e n ted primar i l yth rough the Un i ted Nations Env i ronment Program (UNEP) isas s i s ting many co un tr i es in impl e m e n ting biosafe ty sys te m sth at co n form to the re q ui rements of the Car tegena Pro tocol ofthe Co nve n tion on Biol og i cal Dive rs i ty (CBD) ( I SNAR 2002a).Areas of DivergenceAl though the data sought by re g u l ato rs are similar, their inte r-p re tation in risk as s essment and management diffe rs am o n g s tco un tr i es and regions. The substan tive diffe re n ces come as to th e